U.S. Department of Justice

Office of the Inspector General

The FBI DNA Laboratory: 

A Review of Protocol and Practice 

Vulnerabilities

Office of the Inspector General 

May 2004

DRAFT
TABLE OF CONTENTS 

EXECUTIVE SUMMARY .................................................................................. i

I. Background .................................................................................. i 

II. Methodology of the OIG’s Vulnerability Assessment..................... iii 

III. Summary of Findings and Recommendations .............................. iii 

A. Protocol Vulnerabilities .......................................................iv 

B. Practice Vulnerabilities .......................................................vi 

C FBI Response to Blake’s Misconduct ..................................vii 

CHAPTER ONE: INTRODUCTION ................................................................. 1

CHAPTER TWO: THE ANALYSIS OF DNA..................................................... 4

I. General Principles of DNA Analysis............................................... 4 

A. The Structure of DNA.......................................................... 4 

B. Overview of the DNA Testing Process .................................. 6 

C. Short Tandem Repeat (STR) Analysis................................... 9 

D. Capillary Electrophoresis .................................................. 11 

II. Standards Governing Forensic DNA Analysis.............................. 14 

A. Sources of DNA Standards................................................ 15 

B. Overview of Applicable DNA Standards.............................. 17 

1. Quality Assurance Standards .................................. 17 

2. NDIS Requirements ................................................. 19 

3. Accreditation Requirements..................................... 19 

III. Accreditation and Standards Compliance ................................... 19 

CHAPTER THREE: THE FBI’s DNA LABORATORY AND 

DNA PROTOCOLS ........................................................................................ 22

I. The FBI Laboratory Division ....................................................... 22 

A. Structure of the Laboratory Division ................................. 23 

B. DNA Analysis Unit I .......................................................... 25 

1. Organization and Functions .................................... 25 

2. Operations .............................................................. 27 

II. The FBI’s DNA Protocols............................................................. 33 

A. Overview of Existing Protocols........................................... 33 

1. FBI Laboratory Division Quality Assurance Manual . 33 

2. DNA Analysis Unit I Quality Assurance Manual ....... 33 
3. FBI Laboratory Division Caseworking 

 Procedures Manual.................................................. 34 

4. Procedures for the Serological Identification of 

Biological Substances on Evidentiary Materials ....... 34 

5. Short Tandem Repeat Analysis Protocol................... 34 

B. Protocols Designed to Protect the Integrity of the 

STR Process...................................................................... 35 

1. Quality Controls ...................................................... 35 

2. Cleaning and Decontamination................................ 36 

3. Separation of Sample Sources and of Stages in the 

DNA Analysis Process.............................................. 37

CHAPTER FOUR: JACQUELINE BLAKE’S MISCONDUCT...........................39 

I. Blake’s Career With the FBI........................................................ 39 

II. Blake’s Misconduct .................................................................... 42 

A. Incompletely Processed Controls ....................................... 42 

B. Falsification of Laboratory Documents .............................. 47 

C. The Impact of Blake’s Misconduct ..................................... 47 

D. Why Blake Was Not Caught Earlier ................................... 49 

1. The Detection of Blake’s Misconduct........................ 49 

2. How Blake Avoided Detection................................... 50 

III. The FBI’s Response .................................................................... 51 

A. Initial Remedial Actions at the Laboratory......................... 52 

B. Identification and Processing of Cases That Required 

Corrective Action............................................................... 55 

1. Early Reaction and Planning.................................... 55 

2. Notifications ............................................................ 57 

3. Evidence Retesting .................................................. 59 

IV. OIG Analysis .............................................................................. 60 

A. Timeliness of Evidence Retesting and Notifications............ 61 

B. The Sufficiency of Legal Services Provided to the Laboratory 

in the Month’s Following Blake’s Detection........................ 65 

C. The Scope of the Laboratory’s Remedial Actions ................ 66 

D. Oversight of Blake’s PCR Qualification Testing and Early 

PCR Work ......................................................................... 68 

V. Recommendations...................................................................... 68 
 CHAPTER FIVE: OIG ASSESSMENT OF THE FBI’s DNA PROTOCOLS AND 

PRACTICES..................................................................................................70

I. Assessment Foundation and Process.......................................... 70 

A. Objectives......................................................................... 70 

B. Selection of Consulting Experts......................................... 71 

C. Expert Introduction to the Work of the FBI Laboratory ...... 71 

D. The Assessment Process .................................................. 74 

II. DNA Unit I Protocols and Practices Identified as Vulnerable to 

Abuse ........................................................................................ 77 

A. Types of Vulnerabilities Examined..................................... 77 

B. Analysis of Protocol Vulnerabilities.................................... 77 

1. Protocols That Lack Sufficient Detail........................ 80 

2. Protocols That Fail to Inform the Exercise of 

 Staff Discretion...................................................... 105 

3. Protocols That Fail to Ensure the Precision of 

Notetaking............................................................. 107 

4. Outdated Protocols ................................................ 109 

5. Summary of Protocol Vulnerabilities...................... 110 

6. Implications of DNA Analysis Unit I Protocol 

Vulnerabilities for DNA Analysis Unit II ................. 112

C. Analysis of Practice Vulnerabilities.................................. 112 

1. Variations in Team Operations .............................. 113 

2. Training and the DNA Analysis Unit I’s 

“Oral Tradition” ..................................................... 114 

3. Communication and Operational Inefficiencies ...... 116 

CHAPTER SIX: OIG RECOMMENDATIONS...............................................119

I. Management Response Recommendations................................ 119 

II. Remedy Protocol Vulnerabilities ............................................... 120 

A. Eliminate Text Vagueness ............................................... 120 

B. Incorporate Decision Aids .............................................. 125 

C. Enhance Notetaking Requirements ................................. 125 

D. Update Protocols............................................................. 126 

E. Implications for the DNA Analysis Unit II ........................ 126 

III. Remedy Practice Vulnerabilities................................................ 127 

A. Promote Greater Consistency in Team Operations........... 127 

B. Formalize Training.......................................................... 128 

C. Improve Information Dissemination ................................ 128 

D. Implement a Laboratory Information 

 Management System....................................................... 129 
CONCLUSION............................................................................................. 130

GLOSSARY OF TERMS AND ACRONYMS .................................................. 132

LIST OF APPENDICIES

Appendix I: Complete DNA Profile........................................................... 139 

Appendix II: Interpretation of DNA Analysis Data .................................... 144 

Appendix III: Forensic and Offender Quality Assurance Standards ........... 147 

Appendix IV: NDIS Requirements ............................................................. 177 

Appendix V: Scientist Biographies........................................................... 180 

Appendix VI: Checklist and Guidance for Scientists.................................. 182 
THE FBI DNA LABORATORY: A REVIEW OF 

PROTOCOL AND PRACTICE VULNERABILITIES 

EXECUTIVE SUMMARY 

I. BACKGROUND

Deoxyribonucleic acid, or DNA, is a molecule that contains the genetic 

code for living organisms. Within the last 15 years, researchers gained the 

ability to produce a computerized record containing a person’s DNA 

characteristics (a DNA profile), a development with far-reaching forensic 

implications. Through comparison of DNA samples, investigators now reliably 

can conclude whether a particular suspect is or is not the source of DNA found 

at a crime scene. The Federal Bureau of Investigation’s (FBI) Laboratory 

Division has played an important role in the development of DNA science to 

solve crimes. 

From August 1988 to June 2002, Jacqueline M. Blake was employed in a 

DNA analysis unit of the FBI Laboratory. Starting in March 2000, she worked 

as a Polymerase Chain Reaction (PCR) Biologist and was responsible for 

performing tests on DNA from crime scenes and convicted offenders. 

Laboratory Examiners used her analyses to reach conclusions regarding the 

characteristics and sources of DNA profiles obtained from evidence items, and 

testified in court in reliance on the integrity of the procedures that she 

employed. During her tenure as a PCR Biologist, Blake performed analyses on 

evidence from crime scenes in slightly more than 100 cases. 

An important step in the DNA testing procedures that Blake was 

obligated to follow is the processing of control samples that identify whether 

contamination has been introduced during the testing process, called negative 

control tests. Starting in the late stages of her training to become a PCR 

Biologist and for more than two years thereafter, Blake consistently failed to 

complete these control tests. Her omissions rendered her work scientifically 

invalid and unusable in court. Without proper processing of the negative 

controls, a Laboratory Examiner is not able to rule out the possibility that 

contamination, rather than the evidence under examination, is the source of 

the testing results. By itself, however, the failure to process the negative 

controls does not change the test results or lead to a particular testing outcome 

(e.g., creating a match between a known and unknown evidence sample). The 

retesting of evidence in Blake’s cases to date indicates that, while she did not 

properly conduct the contamination testing, the DNA profiles that she 

generated were accurate. 

In addition to omitting the negative control tests, Blake falsified her 

laboratory documentation to conceal the shortcut she was taking to generate 
contamination-free testing results. Blake later told the Office of the Inspector 

General (OIG) investigators: “I knew that when I did not properly prepare the 

negative control samples for injection but initialed the related injection sheet 

anyway, I was misrepresenting that the negative control samples were properly 

prepared. . . .” 

Blake generated more than two years’ worth of testing results before her 

omissions were finally caught, and even then her discovery was accidental. In 

April 2002, a colleague of Blake was working late one evening after Blake had 

left the Laboratory for the day, and noticed that the testing results displayed on 

Blake’s computer were inconsistent with the proper processing of the control 

samples. Further inquiry by Laboratory personnel led to the discovery that 

Blake had failed to complete the negative control testing in the vast majority of 

her cases. Blake later resigned from the Laboratory and was investigated by 

the Department of Justice (DOJ or Department) for her misconduct. On May 

18, 2004, Blake pled guilty in the United States District Court for the District 

of Columbia to a misdemeanor charge of providing false statements in her 

laboratory reports. 

Blake’s actions have caused many problems. Although the FBI 

Laboratory has not identified a case where Blake’s misconduct interfered with 

the content of a DNA profile, Blake’s failure to process the negative controls 

rendered all of her DNA analyses scientifically invalid. We found that her 

actions caused substantial adverse effects in at least five respects. First, it 

required the removal of 29 DNA profiles from the national registry of DNA 

profiles, known as NDIS, 20 of which have yet to be restored as of March 

2004.1 Until these profiles are restored there will be an ongoing risk that an 

investigative agency will submit a DNA profile and not generate a match with a 

corresponding Blake profile because the Blake profile has been removed from 

NDIS. Past crimes thus may remain unsolved. Second, Blake’s misconduct 

has delayed the delivery of reliable DNA reports to contributors of DNA 

evidence. Retesting in many of Blake’s cases has taken upwards of two years 

to complete, leaving evidence contributors without information that they 

should have had long ago. Third, in a limited number of cases, Blake’s faulty 

analysis is the only DNA information that is available. The previously 

submitted evidence was consumed in the testing process and new evidence 

samples cannot be obtained. Fourth, Blake’s misconduct has adversely 

impacted the resources of the FBI and DOJ. The efforts that the FBI 

Laboratory and DOJ have had to expend on the corrective measures needed to 

address Blake’s actions have been substantial. Both organizations have 

devoted thousands of hours of work to deal with the consequences of Blake’s 

 1 Of the 20 cases for which profiles have yet to be restored, no DNA remains for 

retesting in 2 cases, the Laboratory is awaiting the resubmission of evidence for reanalysis in 

13 cases, and the Laboratory states it has completed reanalysis on an additional 4 cases. 

Reanalysis is being completed in one case. 

ii 
failure to comply with the FBI Laboratory’s DNA protocols, a cost that does not 

include the funding expended for contractor support to retest evidence. State 

and local investigators and prosecutors who were notified of Blake’s 

misconduct and instituted corrective measures in their cases also have had to 

expend additional resources. And lastly, we believe that Blake’s misconduct, 

and the Laboratory’s failure to detect it for a period exceeding two years, has 

damaged intangibly the credibility of the FBI Laboratory. The Blake 

controversy has fed into a perception that the Laboratory has unresolved 

management and employee oversight issues. 

The FBI’s Office of Professional Responsibility notified the OIG 

approximately one month after the FBI discovered Blake’s omission of the 

control tests. The OIG began an investigation of Blake and interviewed 

Laboratory staff members, analyzed documents, and met with representatives 

of the FBI’s Office of General Counsel. The OIG investigation resulted in Blake 

signing an affidavit confessing to her misconduct. In addition, because the FBI 

Laboratory’s application of its protocols did not lead to Blake’s early detection, 

the OIG initiated this review of the FBI Laboratory’s DNA protocols to assess 

whether the protocols were vulnerable to other abuse and instances of 

noncompliance. 

This report describes the results of the OIG’s review. Our objectives were 

twofold: 1) to analyze the vulnerability of the protocols in the FBI Laboratory’s 

DNA Analysis Unit I (DNAUI) – the unit where Blake worked – to undetected 

inadvertent or willful noncompliance by DNAUI staff members; and 2) to assess 

the DNAUI’s application of the protocols identified as vulnerable.2 The report 

also examines and notes several areas of concern with regard to FBI 

management’s response to Blake’s misconduct. 

II. METHODOLOGY OF THE OIG’S VULNERABILITY ASSESSMENT

The OIG’s vulnerability assessment proceeded in two phases. In the first 

phase, the OIG team reviewed the DNAUI’s protocols for vulnerabilities. The 

second phase consisted of OIG fieldwork at the DNAUI laboratory. 

To facilitate our examination, particularly the review of the protocols, we 

recruited three scientists from the national DNA community to consult with 

our assessment team. OIG staff provided the scientists with the most current 

version of each of the written protocols governing DNAUI activities and 

requested that they identify any weaknesses in them that would render the 

Unit vulnerable to undetected wrongdoing by staff members. The scientists 

 2 The DNAUI identifies and characterizes body fluids and body fluid stains recovered as 

evidence in crimes using traditional serological techniques and related biochemical analysis. It

generates DNA profiles from the nuclei of cells recovered from such evidence.

iii 
reviewed the protocol documents and then met with the OIG assessment team 

to discuss the vulnerabilities identified. 

With input from the scientists, OIG staff members then designed 

fieldwork to verify actual laboratory practices for the protocols deemed 

problematic, and to assess whether these practices served to mitigate any of 

the vulnerabilities identified. Our fieldwork consisted of interviews of more 

than 20 staff members within the DNAUI and the Laboratory Division and 

tours of the DNAUI facility, first at FBI Headquarters in Washington, D.C., and 

later at the new DNAUI facility in Quantico, Virginia. In addition to interviews, 

we also reviewed FBI documentation regarding: 1) the factors considered in the 

design of the new DNA facility; 2) the training curriculum and methods used 

within the DNAUI, along with various staff training records; and 3) the status 

of development of a computerized tracking system to be used by the Laboratory 

for evidence, samples, and other information. We also examined documents 

and interviewed personnel from the Laboratory, FBI OGC, and the 

Counterterrorism Section at the Department regarding FBI management’s 

response to Blake’s misconduct.

We compared the results of our fieldwork with the vulnerabilities 

detected by the scientists to determine whether any information gathered 

during fieldwork affected the extent and nature of the scientists’ conclusions. 

We then discussed our results with the scientists. Generally, they did not 

make any changes to the areas they previously identified as vulnerabilities. 

III. SUMMARY OF FINDINGS AND RECOMMENDATIONS 

Our findings and recommendations focus on two general types of 

vulnerabilities that became apparent during our assessment: protocol 

vulnerabilities and practice or operational vulnerabilities. 

A. Protocol Vulnerabilities 

Our textual analysis of the FBI protocols that govern the DNAUI 

concluded that 31 out of 172 topical sections are significantly vulnerable to 

inadvertent or willful noncompliance by DNAUI staff members. One of four 

reasons typically accounted for each of the vulnerabilities: 1) the protocol 

lacks sufficient detail; 2) the protocol fails to inform the exercise of staff 

discretion; 3) the protocol fails to ensure the precision of manual note taking; 

and 4) the protocol is outdated. In addition, in the course of completing 

fieldwork that examined how staff members implement the protocols that we 

identified as problematic, we discovered operational vulnerabilities in the areas 

of team functions, training, information sharing, and evidence tracking. 

However, our review did not identify any protocol violations in the DNAUI 

regarding the failure to process negative control samples, other than the failure 

iv 
of Jacqueline Blake. It also is important to note that our identification of a 

“vulnerability” should not be misconstrued as an invalidation of the science or 

techniques used by the DNAUI, or as an indication of the inadequacy of the 

entirety of DNAUI policies on a particular subject. Our use of the term 

“vulnerability” is limited to its definition as set forth in Chapter Five, Section 

I.C. 

Approximately 20 percent of the written procedure and protocol sections 

we examined lacked the detail necessary for a technically qualified DNA 

scientist to reproduce all aspects of the analysis procedures in use in the 

DNAUI without the potential for variation. Protocols that lack essential detail 

can create a work environment that encourages use of disparate and unproven 

laboratory practices, can foster disregard for protocols, and can make it 

difficult for staff members and management to identify instances of protocol 

noncompliance. Accordingly, we recommend that DNAUI management ensure 

that the document sections we identified as vague describe completely and 

accurately management expectations, Unit procedures and policies, and “best 

practices” currently in use in the DNAUI. 

Our review also identified protocols that do not describe adequately the 

decision criteria Laboratory staff should employ when their duties require them 

to exercise discretion in the testing process. Greater risk of abuse and error is 

present when testing procedures call upon the use of such judgment. If staff 

members are not equipped with sufficient guidance to exercise their discretion 

properly, they could prematurely halt the testing process when a probative 

DNA result might otherwise have been obtained. To address this deficiency, we 

believe that DNAUI management should add decision aids to its protocols, such 

as workflow diagrams and decision trees, that identify the factors that staff 

should consider when using judgment during the DNA testing process. These 

aids would help to structure decision-making and to ensure that staff members 

do not overlook relevant information. 

We also determined that certain protocols lack comprehensive guidance 

on notetaking methods, even though compliance with the documentation 

requirements in those protocols depends heavily upon Laboratory staff 

implementing the methods properly. The DNAUI team structure makes it 

especially important that all staff members have a comprehensive and 

consistent understanding of how to record information as they complete their 

work, since Examiners draw their conclusions and testify in court based upon 

the work of the Serologists and PCR Biologists as reflected in the case file 

documentation. If staff members are allowed to delay recording observations 

and test results, their documentation of that information may not be fully 

accurate, may be unduly influenced by what they know should have occurred 

pursuant to the applicable protocols, and thus may compromise the accuracy 

of the resulting analytical conclusions. Therefore, we believe that the DNAUI 

should provide sufficient guidance to its employees to ensure that case 

v 
documentation meets quality assurance requirements, and it should also 

guarantee that the Unit's protocols provide comprehensive guidance on 

notetaking requirements. 

Lastly, our review of protocol vulnerabilities identified several protocols 

that are outdated and no longer reflect current procedures in use in the 

DNAUI. By retaining outdated protocols, DNAUI management risks the chance 

that some staff members might not be aware of new requirements and rely 

inadvertently upon standards that have been superseded. While the staff we 

interviewed were aware of the new requirements, we recommend that these 

protocols be revised promptly. 

We found that the work practices of the DNAUI’s staff members served to 

mitigate, at least to some degree, the effects of the protocol vulnerabilities 

outlined above. In other words, the practices described to us by staff members 

indicated that they rely upon internal controls and an understanding of 

management expectations, not reflected in the protocols, that diminish the 

risks posed by the weaknesses in the written documents. However, we believe 

that until the DNAUI revises its protocols in accordance with the 

recommendations in this report, the Unit needlessly will remain subject to an 

increased risk of employee error and inadvertent protocol noncompliance. 

Because of the importance of the DNAUI’s work, we believe this problem merits 

significant attention from the Laboratory and should be resolved promptly. 

B. Practice Vulnerabilities 

In terms of practice vulnerabilities, we recommend that the DNAUI 

should work to: 1) promote greater consistency in DNAUI team operations; 

2) develop a comprehensive, written training curriculum; 3) improve 

management and staff communications; and 4) complete implementation of an 

information management system to improve efficiency and evidence tracking 

capabilities. 

During our interviews with DNAUI staff members we received many 

comments that highlighted the need to ensure that the DNAUI’s protocols are 

comprehensive and address all aspects of the Unit’s operations. As the 

interviewees explained, variations exist in staff member work practices because 

the Unit’s written guidance is silent on many subjects. These variations can 

diminish staff and management sensitivity to protocol noncompliance. 

Therefore, to promote greater consistency and accountability in DNAUI 

functions, we recommend that Laboratory management document and 

standardize the best practices of the Unit’s teams and incorporate them in 

protocols. 

Our review of DNAUI training revealed that the Unit lacks a 

comprehensive, written curriculum and that training consists largely of 

vi 
individual discussions with a mentor and presentations given by various 

experienced staff members. Without a comprehensive, written curriculum, 

mentors and trainers can blur the distinction between team or individual 

preferences and the requirements of the protocols, leaving trainees unclear 

about which methods are mandatory and which are merely suggested. In our 

view, such an environment leaves the Unit vulnerable to inadvertent protocol 

noncompliance, since staff members may choose to alter their methods in ways 

that unwittingly contradict Unit requirements. To enhance the quality of its 

training program, we recommend that DNAUI management convert its “oral 

tradition” of training and other informal training methods into a 

comprehensive, written curriculum to ensure that trainees receive consistent 

instruction that comports with the Unit’s protocols. 

Further, our interviews revealed that the dissemination and solicitation 

of protocol-related information to and from DNAUI staff members are 

inconsistent and ineffective. Interview responses from staff members at all 

levels within the DNAUI revealed that the flow of information often is erratic 

and impeded by an incorrect management assumption that communications 

within the DNAUI, and between the DNAUI and Laboratory management, are 

functioning well. These types of communication weaknesses pose a risk to the 

efficiency and effectiveness of the Unit’s operations and should be addressed. 

Consequently, we make several recommendations to Laboratory and DNAUI 

management that we believe will facilitate the exchange of protocol-related 

information. 

During our review we also observed many DNAUI operations that could 

be made more efficient through use of a Laboratory Information Management 

System (LIMS). A LIMS is a computerized system of databases that track, 

organize, and link the information that must be maintained to document the 

receipt, handling, and disposition of each case and evidence item. The 

Laboratory currently lacks a LIMS, and therefore does not have the benefit of 

greater efficiency, increased detail and timeliness in documentation, and the 

reduced potential for human error or abuse. Accordingly, Laboratory 

management should ensure that a LIMS is implemented successfully and that 

its full utilization remains a top administrative priority of the Laboratory. 

C. FBI Response to Blake’s Misconduct 

Finally, our review identified several issues of concern regarding the 

management response of the FBI to Blake’s misconduct. These include: 1) the 

timeliness of the retesting of evidence and of written notifications to DNA 

contributors and prosecutors; 2) the sufficiency of the legal analysis provided 

by the FBI OGC in the months immediately following the discovery of Blake’s 

misconduct; and 3) the scope of the Laboratory’s remedial actions. We also 

believe that given Blake’s prior work history and training experiences, the 

Laboratory should have paid more careful attention to her performance on her 

vii 
initial PCR qualifying and proficiency tests and on the first several profiles she 

generated after she became a PCR Biologist. 

As of February 2004, nearly two years after Blake’s detection, of the 90 

cases where Blake did not properly complete DNA testing, the FBI Laboratory 

had failed to provide direct, written notification to evidence contributors in 42 

of those cases that Blake failed to process properly the evidence they 

submitted. Of this number, 20 contributors had received no notification at all 

concerning Blake’s processing of their evidence.3 We found that the FBI 

disregarded the views of the Department that written disclosures in these cases 

should have been completed much earlier. It also has taken nearly two years 

since the discovery of Blake’s wrongdoing for the Laboratory to complete DNA 

retesting in her cases, with the result that some of these cases have languished 

at the Laboratory for more than four years. 4 

Our review further revealed that FBI OGC failed to ensure that its staff 

attorney assigned to the Blake matter through the fall of 2002: 1) conducted a 

comprehensive legal analysis of the Blake situation, and 2) fully assisted the 

Laboratory to provide sufficient notice to evidence contributors and 

prosecutors. 

We also found that the Laboratory’s remedial actions were too narrowly 

conceived in two respects. First, we believe that the Laboratory erred when it 

limited its review of Blake’s work to the last 2 years of her 14-year career at the 

FBI. Second, the DNAUI should have taken steps soon after the discovery of 

 3 According to the FBI, notification of these contributors can wait until evidence

retesting is complete because, with two exceptions, the cases where notice has not been 

furnished are ones in which no report has issued from the DNAUI, a suspect has not been

identified, and therefore there is no possibility that an evidence contributor would unwittingly 

rely upon Blake’s invalid test results. We believe that this view overlooks the important 

interest that victims of crime have in the timely testing of evidence. All evidence contributors 

should have been notified directly in writing during the summer of 2002 that Blake had failed 

to process their evidence properly. At that juncture the evidence contributor would have had 

the ability to make an informed decision whether to resubmit new evidence or to seek testing 

services from another laboratory. Because 20 of these contributors were not informed, 

however, they were deprived of the opportunity to make this decision. We also believe that it is 

inappropriate for these contributors to learn about Blake’s misconduct indirectly through 

public reports, rather than directly from the FBI. As explained in text below and in Chapter Six 

of this report, to avoid these problems in the future we recommend that, in circumstances 

where a protocol violation renders the Laboratory’s testing results scientifically invalid, the

Laboratory promptly notify the evidence contributor of the anticipated time needed to complete

any necessary retesting. 

4 Of the 90 cases where Blake failed to process the negative controls, the FBI

Laboratory, with the assistance of its contractors, intends to complete evidence retesting in 64 

cases. In the remaining 26 cases, retesting has been deferred pending the resubmission of 

evidence from the original evidence contributor. As of February 2004, evidence retesting had

been completed in only 27 cases. 

viii 
her misconduct to reassess comprehensively its protocols for vulnerability to 

abuse. 

In light of the management problems above, we recommend the following 

three corrective measures. First, the Laboratory should maintain basic case 

data and contact information for evidence contributors and associated 

prosecutors in an electronic format that can be shared conveniently as needed 

with other FBI components (such as FBI OPR and FBI OGC) and the 

Department. This step will facilitate prompt communications with evidence 

contributors and prosecutors in the event of future testing problems. Second, 

in circumstances where a protocol violation renders testing results scientifically 

invalid and a report from the Laboratory is not expected to issue within 180 

days from the violation’s discovery, the Laboratory should provide the evidence 

contributor with information about the violation, including whether any 

remedial measures have been instituted and the anticipated time to complete 

evidence retesting if necessary, within 90 days of the violation’s detection. 

Lastly, the Laboratory should perform a file review of a sample of cases that 

Blake is known to have worked on prior to becoming a PCR Biologist to 

reconfirm that the procedures that were required in fact are documented as 

appropriate in the case files. 

ix 
CHAPTER ONE 

INTRODUCTION

The Federal Bureau of Investigation’s (FBI) Laboratory Division has 

played an important role in the development of the use of deoxyribonucleic 

acid, or DNA, in the investigation of crimes. The DNA analysis units at the FBI 

Laboratory screen evidence from crime scenes for potential sources of DNA. 

When DNA is identified, FBI forensic scientists isolate and characterize the 

DNA to produce a profile that can be linked to a particular individual. The 

Laboratory relies upon written procedures and protocols to govern the testing 

techniques that are used to produce DNA profiles and to ensure that its DNA 

testing results are scientifically valid.5 

The impetus for this review was the FBI’s discovery that one of its DNA 

analysis unit staff members, Jacqueline Blake, disregarded an important step 

in the DNA testing process and produced dozens of DNA profiles that are 

scientifically invalid and unusable in court. Our review examines the 

vulnerability of the protocols in the unit where Blake worked – the DNA 

Analysis Unit I (DNAUI or Unit) – to undetected inadvertent or willful 

noncompliance by DNAUI staff members.6 

Blake was employed in the DNAUI and its predecessor unit from August 

1988 to June 2002. Starting in March 2000, she worked as a Polymerase 

Chain Reaction (PCR) Biologist and was responsible for performing tests on 

DNA from crime scenes and convicted offenders. Laboratory Examiners 

testified in court in reliance on the integrity of the procedures that she 

employed. During her tenure as a PCR Biologist, Blake performed analyses in 

slightly more than 100 cases. 

Starting in the late stages of her training to become a PCR Biologist and 

for more than two years thereafter, Blake consistently failed to complete tests 

that identify whether contamination has been introduced during the DNA 

testing process, called negative control tests. Her failure called into question 

the integrity of the DNA profiles that her analyses generated, since it was not 

possible to confirm that her results were a true reflection of the evidence 

analyzed, unadulterated by contamination introduced in the Laboratory. Blake 

falsified her laboratory documentation to conceal the shortcut she was taking 

to generate contamination-free testing results. 

 5 Unless otherwise indicated, our references to the Laboratory’s protocols also include

its written procedures. The standards that govern DNA analysis at the FBI Laboratory are

found in procedure manuals and protocol documents, as well as other sources. See discussion

infra at Chapter Two, Section II and Chapter Three, Section II of this report. 

6 The DNAUI identifies and characterizes body fluids and body fluid stains recovered as 

evidence in crimes using traditional serological techniques and related biochemical analysis. It

generates DNA profiles from the nuclei of cells recovered from such evidence.

1
Blake generated more than two years’ worth of testing results before the 

FBI Laboratory realized that Blake had failed to complete the negative control 

testing in the vast majority of her cases. Blake later resigned from the 

Laboratory and currently is under criminal investigation by the Department of 

Justice (DOJ or Department) for her misconduct. 

Blake’s actions have rendered all of her DNA analyses for which she 

failed to complete the negative controls scientifically invalid. In addition, we 

found that her conduct caused substantial adverse effects in at least five 

respects: 1) it required the removal of 29 DNA profiles from NDIS, 20 of which 

have yet to be restored;7 2) it delayed the delivery of reliable DNA reports to 

contributors of DNA evidence in Blake’s cases; 3) her testing consumed all the 

available DNA evidence in several cases, leaving only her suspect DNA profiles 

as a basis on which to draw conclusions; 4) the corrective action necessary to 

address Blake’s misconduct has consumed substantial resources of the FBI 

Laboratory and DOJ, as well as the resources of state and local investigators 

and prosecutors who were notified of her misconduct and had to take 

corrective measures in their cases; and 5) the controversy surrounding Blake 

has caused some measure of credibility loss to the FBI Laboratory. 

Following notification from the FBI’s Office of Professional Responsibility 

(OPR), the OIG began an investigation of Blake and interviewed Laboratory staff 

members, analyzed documents, and met with representatives of the FBI’s Office 

of General Counsel (OGC). The OIG investigation resulted in Blake signing an 

affidavit confessing to her misconduct. In addition, because the FBI 

Laboratory’s application of its protocols did not lead to Blake’s early detection, 

the OIG initiated this review of the FBI Laboratory’s DNA protocols to assess 

whether the protocols were vulnerable to other abuse and instances of 

noncompliance. 

This report describes the results of the OIG vulnerability assessment. 

Our primary objectives were twofold: 1) to analyze the vulnerability of the 

protocols in the DNAUI to undetected inadvertent or willful noncompliance by 

DNAUI staff members; and 2) to assess the DNAUI’s application of the protocols 

identified as vulnerable. The report also notes several areas of concern with 

the management response of the FBI to Blake’s misconduct. 

The OIG’s vulnerability assessment proceeded in two phases. In the first 

phase, the OIG team reviewed the most current version of each of the written 

protocols governing DNAUI activities for vulnerabilities. The second phase 

consisted of OIG fieldwork at the DNAUI laboratory. 

To facilitate our examination, we recruited three scientists from the 

national DNA community to consult with our assessment team. The scientists 

 7 DNA is not available for retesting for two of these profiles. 

2
were responsible for reviewing the DNAUI protocols and identifying any 

weaknesses in them that would render the Unit vulnerable to undetected 

wrongdoing by staff members. The scientists also assisted OIG staff members 

in designing fieldwork to verify actual laboratory practices for the protocols 

deemed problematic, and in assessing whether these practices served to 

mitigate any of the vulnerabilities identified. 

The fieldwork conducted by OIG staff consisted of interviews of more 

than 20 staff members within the DNAUI and the Laboratory Division and 

tours of the DNAUI facility, first at FBI Headquarters in Washington, D.C., and 

later at the new DNAUI facility in Quantico, Virginia. In addition to interviews, 

we also reviewed FBI documentation regarding: 1) the factors considered in the 

design of the new DNA facility; 2) the training curriculum and methods used 

within the DNAUI, along with various staff training records; and 3) the status 

of development of a computerized tracking system for evidence, samples, and 

other information. We then analyzed the DNAUI staff practices described 

during this fieldwork to identify whether vulnerabilities existed in staff 

practices, in addition to the protocol vulnerabilities already identified. Finally, 

we examined documents and interviewed personnel from the Laboratory, FBI 

OGC, and the Counterterrorism Section at the Department regarding the 

management response to Blake’s misconduct.8

The report is divided into six chapters. Following this Chapter, we 

provide an overview in Chapter Two of the DNA testing process and the 

national standards that govern it. In Chapter Three we describe the FBI 

Laboratory, including operations in the DNAUI, and the FBI’s protocols for DNA 

analysis. Chapter Four details Blake’s misconduct and the FBI’s response to 

it. In Chapter Five we describe the protocols and practices that we believe are 

vulnerable to abuse, and lastly, in Chapter Six we provide recommendations to 

enhance protocol compliance in the DNAUI. 

 8 A more detailed explanation of our assessment methodology is provided in Chapter 

Five, Section I of this report. 

3
CHAPTER TWO 

THE ANALYSIS OF DNA

In order to understand the nature of Blake’s misconduct and the 

deficiencies this review identified in the FBI Laboratory’s DNA protocols and 

practices, we first describe in this Chapter the basic characteristics of DNA and 

the work of forensic DNA scientists. We describe below the physical structure 

of DNA, testing methods, and the standards that govern DNA analysis. 

I. GENERAL PRINCIPLES OF DNA ANALYSIS 

A. The Structure of DNA 

All living things are composed of cells, which typically have a nucleus 

that regulates metabolism, growth and/or reproduction. In human beings, the 

nucleus contains chromosomes composed of DNA that encode all of the 

information necessary to produce a complete human body. Chromosomes 

store information in the chemical structure of DNA much like a book or a 

compact disk. The nucleus contains 46 chromosomes, two copies of each of 

the 23 different human chromosomes. One copy of each chromosome is 

inherited from an individual’s mother and one copy is inherited from an 

individual’s father, giving a child DNA characteristics of both its mother and 

father. 

4
Source: National Human Genome Research Institute, by artist Darryl Leja at 

www.accessexcellence.org/AB/GG/chromosome.html

Approximately 99.9 percent of human DNA is the same. Forensic DNA 

scientists are only interested in the 0.1 percent of the DNA that varies among 

people. The human traits that result from the variations in this part of the 

DNA can be obvious, like different eye color or different blood types, but may 

also be so subtle that only laboratory testing can detect them. 

Each chromosome contains many genes, which are the portions of the 

chromosome that code for personally identifying characteristics, like hair color 

or eye color. The characteristics of a specific gene, or of a specific location on a 

DNA strand, is referred to as an allele. For example, if two people both have 

blue eyes, then they have the same alleles for their eye-color gene. It has been 

estimated that only 2 to 3 percent of the information in a chromosome is 

5
organized into genes. While the function of the DNA between the genes is 

unknown, scientists currently believe that it does not code for anything. Since 

it varies widely among individuals, scientists examine the DNA located between 

the genes to determine a person’s DNA profile. Examining this DNA allows 

scientists to determine an individual’s unique DNA profile (except for identical 

twins), without that profile revealing personally identifying characteristics or 

medical conditions. 

Even though forensic DNA scientists focus their analyses on specific 

chromosomal locations that vary widely between individuals, it is not necessary 

to examine every one of these locations to develop a unique DNA profile for an 

individual. Rather, scientists need only examine enough locations to virtually 

eliminate the possibility that two unrelated people have the same DNA profile 

purely by chance. Under current DNA standards applicable in the United 

States, an individual’s DNA profile consists of the alleles present at 13 specified 

chromosomal locations. Scientists have determined that, in general, when 

DNA profiles consist of the alleles present at these locations the probability that 

two unrelated individuals will have the same DNA profile purely by chance is 

less than 1 in 200 billion. As a result, except for identical twins, examining the 

13 locations produces a DNA profile that is essentially unique to an individual. 

See Appendix 1 (which contains an example of a complete DNA profile). 

B. Overview of the DNA Testing Process 

Law enforcement personnel who submit crime scene evidence for DNA 

analysis must package and seal the evidence and then arrange for its secure 

delivery to a DNA laboratory. Upon receipt of the evidence, forensic scientists 

first determine if the evidence might provide DNA by visually examining it for 

indications of body fluid stains, and then performing testing to determine 

whether specific body fluids that might contain DNA are present. 

When possible, forensic scientists analyze only a portion of the stains on 

the evidence and save the remainder in case future testing is necessary. 

Generally, stains on fabric are cut out of the item and the DNA is extracted 

from the cuttings. If the stains are on a hard object, such as a knife, some of 

the dried body fluid is removed from the object with a cotton swab (known as 

swabbing an item) and the DNA is extracted from the cotton swab. The process 

used to extract the DNA varies depending on the organic source of the stain 

and the material containing the stain. 

Once the DNA is extracted from the evidence, it undergoes a process 

known as polymerase chain reaction (PCR), which is also referred to as 

amplification. This process, often analogized as biological photocopying, allows 

scientists to make copies of specific chromosomal segments. The amplification 

process gives forensic scientists the ability to analyze minute DNA samples, 

6
and has allowed DNA analysis to become a much more useful tool for forensic 

scientists. The diagram below illustrates the PCR process: 

Source: Federation of American Societies for Experimental Biology at

www.faseb.org/opar/bloodsupply/pcr.html

After amplification is complete, the DNA is analyzed using a machine 

that separates the DNA fragments present in the sample. This process is 

known as electrophoresis. Special software then measures the length of the 

DNA fragments, determines the alleles that correspond to the fragments, and 

compiles a DNA profile for the sample. The DNA testing process is summarized 

in the diagram on the following page.9

 9 Information concerning the final steps described in the diagram (i.e., data analysis 

and allele calls) is presented in Chapter Two, Section I.D of this report. 

7
Steps in the Analysis of DNA 

8
C. Short Tandem Repeat (STR) Analysis 

As the name implies, short tandem repeat (STR) analysis is a method of 

determining an individual’s DNA profile by counting the number of times a 

small DNA sequence (short tandem repeat unit) is repeated at a specific 

chromosomal location. STR analysis consists of three processes: 

amplification, electrophoresis, and interpretation. 

In amplification, extracted DNA is added to chemical reagents and 

heated, causing the two strands that compose the DNA molecule (they 

resemble two sides of a “ladder,” as seen in the graphic on page 5) to separate. 

Each of the two strands then can be used as a template to make (or synthesize) 

a new double-stranded DNA molecule. 

The reagents in which the DNA is heated contain markers that identify 

the starting and ending points of the DNA fragment that is duplicated. The 

markers also are called primers because they prime (or stimulate) the synthesis 

reaction. Primers are short synthetic pieces of DNA designed to match the 

regions of human DNA which are highly variable. As the DNA and chemicals 

begin to cool, the primers attach to the single-stranded DNA. The primers 

contain fluorescent labels so that they may be detected by lasers later in the 

testing process. 

Once the primers have bound to the beginning and end of the segment 

being copied, individual building blocks of DNA from the reagents fill in the rest 

of the empty spots on the single-strand. See diagram supra at page 7 

describing the PCR process. 

The heating and cooling of the DNA is accomplished by a machine called 

a thermal cycler, in which a tray of capped tubes containing the DNA and 

chemical reagents are placed. The thermal cycler can be programmed to heat 

and cool repeatedly for specific amounts of time. At the end of many 

repetitions, millions of copies of the original DNA section are created. 

Any DNA present in a tube when the amplification process begins, 

whether from evidence or introduced through contamination, will be 

amplified.10 To ensure that the DNA profile generated from the amplified DNA 

is representative of the DNA from the evidence sample and not from 

contamination, and to verify that the testing process is accurate, DNA protocols 

require forensic DNA scientists to analyze a series of control samples. For each 

batch of samples processed, at least one positive control, one negative control, 

 10 DNA from contamination usually can be differentiated from crime scene DNA 

because it is miniscule in comparison to the amount of DNA that is present from the evidence. 

In other words, DNA from contamination typically will be “drowned out” by the DNA that is 

included from the evidence sample. 

9
and one reagent blank are analyzed along with the DNA samples. The positive 

control tube contains the reagents necessary for amplification plus DNA from a 

source for which the DNA profile is known. Since the scientists know the 

correct test results for the positive control, it allows them to determine the 

accuracy and performance of the amplification and analysis processes. The 

negative control tube contains all of the reagents used for amplification. The 

reagent blank contains all of the reagents used to process an item of evidence 

from extraction through electrophoresis. DNA from the evidence is not added 

to these controls, though their contents are amplified. The purpose of the 

negative control and the reagent blank is to reveal any contamination that is 

present in the reagents or introduced during the testing process.11

TYPES OF DNA CONTROLS

Positive Control Reagent Blank Negative Control 

Material 

Tested

Amplification 

reagents and known 

DNA 

All reagents Amplification 

reagents 

Reveals 

Accuracy and 

performance of the 

amplification and 

analysis processes 

Presence of 

contamination 

introduced at any 

point in the analysis 

process 

Presence of 

contamination 

introduced during 

the amplification 

process 

After the DNA has been amplified, the newly formed DNA fragments are 

sorted according to length (i.e., number of short tandem repeats) using 

electrophoresis. In general, electrophoresis is performed by adding DNA to one 

end of a piece of gelatinous material which contains tiny holes that allows the 

material to function as a molecular sieve. An electric current is applied across 

the material, causing the DNA fragments to move. Since it is easier for smaller 

fragments to move through the material, the smaller fragments move farther 

than the larger fragments. As a result, at the end of electrophoresis the DNA 

fragments are sorted by size. The size of the DNA fragments is determined by 

comparing the distance each fragment moved to the distances moved by the 

fragments of known size. The results of electrophoresis are illustrated in the 

following graphic. 

 11 Unless otherwise noted, references to “negative controls” also include reagent blanks.

10
Source: www.accessexcellence.org/AB/GG/forensci_PCR.html ©1998 by Alberts, Bray, 

Johnson, Lewis, Raff, Roberts, Walter. Published by Garland Publishing, a member of

the Taylor and Francis Group.

D. Capillary Electrophoresis 

The principles described above also apply to capillary electrophoresis, a 

form of electrophoresis employed by the DNAUI. Its distinguishing 

characteristic is that the electrophoresis occurs inside a capillary tube (a very 

thin glass tube, comparable to a human hair) with a sieving material inside, 

rather than on a piece of gelatinous material. Capillary electrophoresis is an 

automated process that analyzes many DNA samples and requires minimal 

involvement by DNA scientists after the initial set-up procedures are 

completed. These procedures include cleaning and calibrating the 

electrophoresis machine and preparing the amplified DNA for analysis. 

To prepare amplified DNA for capillary electrophoresis, the DNA scientist: 

• Places a sufficient number of empty tubes in a rack; 

11
• Adds water for dilution and internal size standard12 to each 

of the empty tubes; 

• Adds an appropriate amount of one of the following to the 

tubes containing the internal size standard: 

- amplified DNA from known samples, unknown or 

evidentiary samples, or the positive control; 

- amplified negative control or reagent blank; or 

- an allelic ladder,13 which contains the more common 

alleles in the general population for specific 

chromosomal locations; and 

• Seals the tubes with soft rubber caps. 

Once the tubes are sealed, the rack is ready to be placed on the capillary 

electrophoresis machine. A sample list is prepared which identifies the 

location of each sample on the rack and makes it possible for the machine’s 

computer to locate a specific sample. An injection list is also prepared which 

tells the computer the order in which the samples are to be analyzed. The 

capillary electrophoresis machine has a probe that punctures the soft rubber 

caps on the tubes and withdraws a specific amount of sample. The sample is 

drawn up into the capillary tube (referred to as injecting the sample) where the 

electrophoresis is completed. 

As mentioned previously, the primers used during amplification contain 

fluorescent markers that allow the DNA fragments to be detected by lasers. 

The manufacturer of the capillary electrophoresis machine has developed 

proprietary software to display the test results and to aid in their 

interpretation. Using this software, the capillary electrophoresis machine 

determines the size of the DNA fragments in a sample based on the information 

detected by the lasers. The machine and the software then represent the 

lengths of the various fragments as peaks on a graph as illustrated on the 

following page: 

 12 The internal size standard contains DNA fragments of known sizes that provide

reference points for determining the length of the sample’s DNA fragments. 

13 Allelic ladders are used like molecular rulers to help “measure” the lengths of the

fragments in the reference and evidentiary samples. 

12
Amplified DNA Peaks 

(except red peaks)

GeneScan® View: raw data for a Positive Control (9947A) prepared according to protocol.

Peaks depicted in red originate from the internal size standard added to each sample.

The proprietary software has two components, GeneScan® and 

Genotyper®.14 Data viewed in GeneScan®, as appears above, is the raw, 

unanalyzed, collection data that reflects everything the laser detects, including 

interference that is common in electrophoresis instruments (Genescan® data). 

Genotyper® allows forensic scientists to take GeneScan® data and display it in 

a format that conceals background noise and peripheral information, and to 

focus their review on the results of the control and evidence samples. An 

example of a Genotyper® display is presented on the following page: 

 14 We provide additional information regarding this software in Appendix 2. 

13
Allelic Ladders

DNA Sample

Allele Calls

Genotyper® View: COFiler Ladder with Positive Control Allele call 

 

Information collected during these analyses is used to assemble the DNA 

profile. As mentioned previously, two points of reference are used to help the 

software as it determines the lengths of the DNA fragments detected during 

electrophoresis: 1) the GeneScan® software uses the internal size standard, 

which contains DNA fragments of known sizes; and 2) the Genotyper® software 

uses allelic ladders as a point of comparison for the designation of the number 

of repeats in the DNA sample at particular chromosomal locations, since the 

peaks within the allelic ladder correspond to known fragment lengths at those 

locations. The DNA Examiner then works with the Genotyper® graphs, similar 

to the one above, looking for any peripheral information that should be 

considered. Unless contamination is detected or other complications disrupt 

the testing, the Examiner then documents what the allele values are at each of 

the chromosomal locations analyzed (usually 13 chromosomal locations are 

examined), which, once compiled, constitute a DNA profile. See Appendix 1 for 

an example of a complete DNA profile and the corresponding GeneScan® and 

Genotyper® graphs. 

II. STANDARDS GOVERNING FORENSIC DNA ANALYSIS 

The creation of national standards for DNA analysis played a pivotal role 

in establishing the integrity of the DNA testing process. In addition, by 

adhering to these standards, DNA laboratories, including the FBI’s DNAUI, 

have been able to attest to the validity and reliability of their DNA testing 

results. 

14
A. Sources of DNA Standards 

Forensic DNA laboratories, particularly those participating in the FBI’s 

Combined DNA Index System (CODIS),15 have relied upon three primary 

sources of operational standards since the first forensic DNA laboratories were 

established in the late 1980’s: 1) the Technical Working Group on DNA 

Analysis Methods (TWGDAM); 2) the DNA Advisory Board; and 3) the FBI’s 

National DNA Index System (NDIS) program office. 

TWGDAM was one of several technical working groups sponsored by the 

FBI. The goal of the working groups was to improve communication between 

the various scientific disciplines and to build consensus within the federal, 

state, and local forensic communities. TWGDAM was established in 1989 with 

representatives from 12 federal, state, and local laboratories, and focused 

specifically on the development of forensic DNA methods. Later that same 

year, TWGDAM developed and published in the Crime Laboratory Digest16 a set 

of quality guidelines for forensic DNA laboratories.17 TWGDAM expanded these 

guidelines in 1991 and in 1995.18 In addition, TWGDAM worked with the 

National Institute of Standards and Technology (NIST) to develop model 

reference material that laboratories across the country could use to gauge the 

reliability of their equipment and DNA testing processes. In January 1999, 

TWGDAM was renamed the Scientific Working Group on DNA Analysis 

Methods (SWGDAM),19 and in that capacity produced additional guidance for 

the forensic community, including guidelines for data interpretation, training, 

quality assurance, and health and safety audits. 

 15 For a description of CODIS, see discussion in Chapter Three, Section I.B.1. CODIS 

is a national DNA information repository that allows public laboratories across the country to

store and compare DNA profiles from crime scene evidence, from convicted offenders, and from 

unidentified remains. 

16 The Crime Laboratory Digest was superseded by Forensic Science Communications in 

April 1999. Forensic Science Communications is a peer-reviewed forensic science journal 

published quarterly in January, April, July, and October by FBI Laboratory personnel. 

17 Technical Working Group on DNA Analysis Methods, “Guidelines for a quality 

assurance program for DNA restriction fragment length polymorphism analysis,” Crime

Laboratory Digest, Vol. 16, 1989, pp. 40–59.

18 Technical Working Group on DNA Analysis Methods, “Guidelines for a quality 

assurance program for DNA analysis,” Crime Laboratory Digest, Vol. 18, 1991, pp. 44-75;

Technical Working Group on DNA Analysis Methods, “Guidelines for a quality assurance

program for DNA analysis,” Crime Laboratory Digest, Vol. 22, 1995, pp. 21–43.

19 TWGDAM was renamed SWGDAM after the Department of Justice, Office of Justice 

Programs, created short-term technical working groups that began to be confused by members 

of the DNA community with the FBI’s long-term technical working groups. 

15
While no formal legal authority was granted to TWGDAM and SWGDAM, 

the guidelines they produced were accepted by the Laboratory Accreditation 

Board of the American Society of Crime Laboratory Directors as the benchmark 

for DNA laboratory accreditation. Further, when Congress authorized the 

creation of CODIS in the DNA Identification Act of 1994,20 it provided that the 

guidelines issued by TWGDAM would be deemed to be national standards until 

the FBI issued its own standards pursuant to the Act. 

The second source of DNA standards is the FBI DNA Advisory Board 

(Board). In the DNA Identification Act, Congress required that the FBI 

establish an advisory board to develop national quality assurance standards 

governing all CODIS participants.21 As a result, the FBI established the Board, 

which was formally constituted on March 10, 1995.22 Its members were 

appointed by the FBI Director based upon nominations from a variety of 

forensic and science organizations,23 and included forensic scientists from 

state, local, and private forensic laboratories; molecular and population 

geneticists; a NIST scientist; a quality control specialist; an ethicist; and a 

judge. The Board’s mission was to develop and revise, as necessary, standards 

for quality assurance, including proficiency testing standards for laboratories 

and analysts that examine DNA. The Board members acknowledged that 

TWGDAM had begun this work and that the Board should build upon it. 

The Board fulfilled its mission with the submission to the FBI Director of 

quality assurance standards for two types of DNA laboratories: 

• Quality Assurance Standards for Forensic DNA Testing Laboratories

(Forensic Standards), effective October 1998. 

• Quality Assurance Standards for Convicted Offender DNA 

Databasing Laboratories (Offender Standards), effective April 1999. 

Amendments to these standards must be approved by the FBI Director. 

Recommendations for changes can be requested through SWGDAM. 

 20 Section 210301 to 210306 of Title XXI of Pub. L. 103-322, September 13, 1994, 108 

Stat. 2065.

21 42 U.S.C. 14131(a)(1).

22 The Board was dissolved in December 2000 after a several month extension of its 

original charter of 5 years. 

23 These organizations included the American Academy of Forensic Scientists, the 

American Board of Criminalists, the American Society of Crime Laboratory Directors, and the

National Academy of Sciences.

16
The third source of DNA standards is the FBI NDIS program office, 

currently within the Laboratory Division’s CODIS Unit (see the organization 

chart on page 24 for the placement of the CODIS Unit within the Division). The 

NDIS office has issued programmatic rules that govern the exchange of 

information for NDIS participants and has established standards for the 

submission of DNA data, collectively referred to as NDIS Requirements. 

B. Overview of Applicable DNA Standards 

At present, three sets of standards govern the DNA activities of the 

DNAUI: 1) Quality Assurance Standards; 2) NDIS Requirements; and 

3) Accreditation Standards. These standards are interrelated: to comply with 

the Quality Assurance Standards, a laboratory is supposed to pursue 

accreditation actively; to become accredited, a laboratory must demonstrate 

compliance with the Quality Assurance Standards; and to become a participant 

in NDIS, a laboratory must demonstrate compliance with both the Quality 

Assurance Standards and the NDIS Requirements. We describe each of the 

standards below.

1. Quality Assurance Standards 

 

Quality Assurance Standards consist of two sets of standards: 

1) Forensic Standards that govern the activities of DNA laboratories that 

analyze crime scene evidence, and 2) Offender Standards that govern the 

activities of DNA laboratories that analyze samples from convicted offenders. 

The Forensic Standards contain 155 requirements organized under 15 

headings, and the Offender Standards contain 136 requirements also organized 

under 15 headings.24 For complete versions of the Forensic and Offender 

Standards, see Appendix 3. 

The key categories of requirements addressed in the two sets of 

Standards, which correspond to section headings in the Standards, are the 

following: 

• Quality Assurance Program: written guidelines should be adopted 

and should contain the required categories of standards. 

• Organization and Management: key roles and duties should be 

described in writing, as should the interrelation between the 

personnel involved in DNA analysis. 

 24 A high degree of overlap exists between the two sets of standards. A total of 119

requirements are shared (identical or similar), 36 requirements are unique to the Forensic

Standards, and 17 requirements are unique to the Offender Standards. 

17
• Personnel: personnel filling key roles should be properly educated, 

trained, and should perform duties appropriate to their position. 

• Facilities: the design of the laboratory should ensure security and 

minimize contamination. 

• Evidence Control (Forensic Standards only) and Sample Control 

(Offender Standards only): to ensure the integrity of evidence and 

of offender samples, and their proper disposition, the laboratory 

should have a documented control system and adequate 

implementing procedures. 

• Validation: the laboratory should demonstrate that its analysts 

are capable of using certain equipment and methods properly. 

• Analytical Procedures: every procedure used by the laboratory in 

DNA analysis should be described in detail in writing and formally 

approved by laboratory management. 

• Equipment Calibration and Maintenance: the laboratory should 

establish a written program for ensuring that equipment used for 

DNA analysis receives regular calibration and maintenance in 

accordance with recognized national standards. 

• Reports: the laboratory should have written guidelines for 

maintaining documentation that supports reported conclusions 

regarding case evidence. Reports should describe with specificity 

the information collected and written policies should exist to 

govern the release of such information. 

• Review: administrative and technical reviews should be conducted 

of all reports and supporting documentation for all evidence. The 

testimony of analysts in court should also be reviewed. 

• Proficiency Testing: scientists performing DNA analysis should 

complete an external proficiency test (a test from an outside agency 

or commercial test provider that measures an analyst’s skill in 

performing DNA analysis correctly) every 180 days, which should 

be reviewed and documented. 

• Corrective Action: written procedures should exist governing a 

laboratory’s documentation and resolution of errors made during 

proficiency testing and DNA analysis. 

18
• Audits: the laboratory should undergo an audit every year, and at 

least every other year this audit should be conducted by an 

external entity. 

• Safety: the laboratory should have and follow a written 

environmental health and safety plan. 

• Subcontractor of Analytical Testing for Which Validated Procedures 

Exist: a laboratory making use of a subcontractor for any part of 

the DNA analysis process should establish certain specified 

controls to ensure the integrity of the subcontractor’s work and 

results. 

2. NDIS Requirements 

NDIS Requirements are found in the Memorandum of Understanding 

(MOU) signed by the FBI and each NDIS participant. The MOU requires that 

signatories comply with general requirements already established (i.e., federal 

legislation, the Forensic and Offender Standards) as well as requirements 

specific to the national index that accompany the MOU in three appendices: 

NDIS Responsibilities (Appendix A); NDIS Data Acceptance Standards 

(Appendix B); and the NDIS Procedures Manual (Appendix C).25 

3. Accreditation Requirements 

The primary accreditation or certification entities for forensic and 

offender DNA laboratories are the American Society of Crime Laboratory 

Directors – Laboratory Accreditation Board (ASCLD-LAB) and the National 

Forensic Science Technology Center (NFSTC). Both groups draw upon the 

requirements set forth in the Forensic and Offender Standards for their 

evaluation of a public DNA laboratory’s operations. 

III. ACCREDITATION AND STANDARDS COMPLIANCE 

While TWGDAM/SWGDAM and the Board were pivotal in creating 

standards for DNA laboratories, they lacked the means to enforce them. To 

compensate for this shortcoming, the Board adopted an “Accreditation 

Premise” which set forth the Board’s expectation that standards compliance 

would be assured through the process of accreditation. Accrediting 

organizations would need to adopt and hold laboratories accountable for 

compliance with the Board’s standards. The Board acknowledged that a 

weakness in this approach was the lack of any enforceable requirement that 

 25 We provide a detailed description of these appendices in Appendix 4. 

19
laboratories be accredited, even for CODIS participation. In an attempt to 

address this problem, the Board passed a resolution in February 1999 stating 

that unaccredited laboratories should seek accreditation “with all deliberate 

speed.” In addition, this language was used in the preface to the Forensic and 

Offender Standards to emphasize the importance of accreditation.26 

Compliance with DNA-related standards is an issue previously examined 

by the OIG. In 1999, the OIG performed an audit of CODIS to determine the 

extent of state and local CODIS participation and to verify compliance with the 

FBI's quality assurance standards and national index requirements.27 In the 

report summarizing its findings,28 the OIG explained that the FBI’s practice at 

the time of audit fieldwork was to allow CODIS and NDIS participants to selfcertify their compliance with the Quality Assurance Standards and with NDIS 

Requirements. Because the OIG believed this system of self-certification posed 

a high risk of undetected noncompliance, the OIG undertook compliance 

testing of various CODIS participants and subsequently identified multiple 

instances where the participants were not fully complying with national 

standards. In addition, while the OIG noted that all audited laboratories had 

complied with the Forensic and Offender Standards’ annual audit 

requirement,29 weaknesses were noted with some of the external audits: 

1) audit findings were not binding on the laboratories (they could disregard 

them if they wanted); 2) although accreditation and certification agencies had 

the authority to ensure a laboratory took appropriate corrective action, 

accreditation or certification audits did not typically focus on compliance with 

the quality assurance standards; and 3) laboratory audits were not always 

performed consistently. From these observations, the OIG recommended that 

the FBI develop and implement a process that would ensure that laboratories 

resolve all deficiencies noted during the external audits. 

In response to the OIG’s findings and recommendations, the FBI 

developed a new operational procedure, called National DNA Index System

(NDIS) Review of External Audits, which provides for the formation of several 

NDIS Audit Review Panels. Each panel consists of four qualified or previously 

qualified DNA examiners or analysts selected from the FBI and state or local 

laboratories, with the chief of the FBI Laboratory’s Quality Assurance and 

 26 Despite these efforts, according to an FBI Laboratory study conducted in 1999, of

153 laboratories surveyed (64 local, 87 state, and 2 federal), only 87 were accredited. Of the 

accredited laboratories, 71 were accredited by ASCLD-LAB. 

27 CODIS is described in greater detail in Chapter Three, Section I.B.1. 

28 The OIG audit report, The Combined DNA Index System,” Report No. 01-26, was 

issued in September 2001. See http://www.usdoj.gov/oig. 

29 The Forensic Standards and Offender Standards both require that laboratories 

undergo, every other year, a quality assurance audit conducted by external auditors. Internal 

audits conducted by in-house auditors are required during the alternating years. 

20
Safety Unit serving as chairperson. All panelists are required to have 

completed successfully FBI quality assurance audit training. Under the new 

procedure, NDIS participating laboratories must forward to a review panel, via 

the custodian of the NDIS database, a copy of their external audit report, their 

response to the report, and corrective action plans that address the audit 

report recommendations. The panel reviews the audit report and related 

documents to determine if all findings and recommendations have been 

addressed adequately and/or resolved. If the audited laboratory does not 

respond to clarification requests by the panel, does not resolve an audit 

recommendation, or is determined to be non-compliant with the quality 

assurance standards, a corrective action and conflict resolution process can be 

invoked. A laboratory’s failure to resolve a panel’s concern can result in the 

termination of its access to NDIS. 

In addition to these compliance procedures, the FBI created a 

standardized DNA audit guide (Guide) with input from the Board, ASCLD-LAB, 

and NFSTC to ensure that auditors of local, state, and federal DNA laboratories 

are thorough and interpret the Quality Assurance Standards consistently. The 

FBI offers Guide training for auditors, including those representing accrediting 

and certifying organizations such as ASCLD-LAB and NFSTC. For an audit to 

fulfill the Quality Assurance Standards’ external audit requirement, it must be 

conducted in accordance with the Guide and by an auditor trained in its use. 

However, as this report details, even with these precautions, internal control 

weaknesses are not always uncovered in quality assurance audits. In fact, 

weaknesses in DNAUI procedures and protocols allowed a technician routinely 

to disregard required steps in the analysis of DNA, even while the Unit received 

clean audit reports from both internal and external auditors and while the Unit 

was accredited by ASCLD-LAB. 

21
CHAPTER THREE 

THE FBI’S DNA LABORATORY AND DNA PROTOCOLS

The FBI enforces over 200 federal laws and has jurisdiction to investigate 

all federal criminal violations not specifically assigned by Congress to another 

federal agency. Its investigations routinely address matters such as 

counterterrorism, foreign counterintelligence, organized crime, civil rights, and 

financial crime. As part of its law enforcement mission, the FBI also is 

authorized to provide other law enforcement agencies with cooperative services, 

such as fingerprint identification, laboratory examinations, and police training. 

Because the successful investigation and prosecution of crimes requires, in 

many cases, the collection, preservation, and forensic analysis of evidence, the 

FBI Laboratory Division and the forensic science specialties available to it are a 

central component of FBI operations. 

I. THE FBI LABORATORY DIVISION 

The FBI Laboratory provides leadership in the scientific analysis and 

prosecution of crimes throughout the United States. It is the only full-service 

federal forensic laboratory and is one of the largest forensic laboratories in the 

world. According to the FBI, Laboratory activities further three primary goals: 

1) to provide forensic services to the FBI and other law enforcement agencies; 

2) to deploy effective communications, collection, and surveillance capabilities 

to support investigative and intelligence priorities; and 3) to provide technical 

and forensic assistance through research, training, technology transfer, and 

access to information and forensic databases. The Laboratory seeks to meet 

these goals through forensic examinations, investigative operations support, 

research and development, application of information technology, and training. 

Laboratory personnel conduct scientific examinations of evidence, free of 

charge, for federal, state, and local law enforcement organizations within the 

United States. As part of these examinations, Laboratory personnel may 

analyze physical evidence ranging from blood and other biological materials to 

explosives, drugs, and firearms. According to the FBI, the Laboratory conducts 

more than one million examinations each year. 

In March 2003, the Laboratory moved to its new facility in Quantico, 

Virginia, resulting in the relocation of approximately 650 Laboratory 

employees. The design of the new facility is meant to provide for ideal security 

and evidence control. Offices and public areas are separated from the 

laboratory areas to avoid evidence contamination. Also, laboratory areas are 

22
accessed through “biovestibules” that are meant to provide storage and serve 

as airlocks between laboratories and offices.30 

A. Structure of the Laboratory Division 

The Laboratory is located organizationally within the Law Enforcement 

Services Directorate of the FBI. It is comprised of various branches, divided 

into sections, which are further broken down into units. The subject of this 

review, the DNAUI, is part of the Scientific Analysis Section, as shown in the 

following Laboratory organizational structure: 

 30 Additional information about our assessment of the DNA Analysis Unit I (DNAUI) 

portion of the new Laboratory building is contained in Chapter Five, Section II.B.1.a of this 

report. 

23
 Federal Bureau of Investigation

Cryptanalysis & Racketeering Records Unit

Firearms / Toolmarks Unit

Latent Print Unit 1

Latent Print Unit 2

Latent Print Unit 3

Questioned Documents Unit

Forensic Analysis Section

CODIS Unit

Chemistry Unit

ChemBio Sciences Unit

DNA Unit 1

DNA Unit 2

Explosives Unit

Trace Evidence Unit

Scientific Analysis Section

Forensic Analysis Branch

Bomb Data Center

Evidence Response Team Unit

Hazardous Materials Response Unit

Operational Response Section

CT Forensic Science Research Unit

Evidence Control Unit

Quality Assurance & Safety Unit

Training Unit

Forensic Science Support Section

Administrative Unit

Investigative & Prosecutive Graphics Unit

Special Photographic Unit

Structural Unit

Operational Support Section

Operational Support Branch

Laboratory Division

Executive Assistant Director for Law Enforcement Services

Office of the Director & Deputy Director

24

 Federal Bureau of Investigation

Cryptanalysis & Racketeering Records Unit

Firearms / Toolmarks Unit

Latent Print Unit 1

Latent Print Unit 2

Latent Print Unit 3

Questioned Documents Unit

Forensic Analysis Section

CODIS Unit

Chemistry Unit

ChemBio Sciences Unit

DNA Unit 1

DNA Unit 2

Explosives Unit

Trace Evidence Unit

Scientific Analysis Section

Forensic Analysis Branch

Bomb Data Center

Evidence Response Team Unit

Hazardous Materials Response Unit

Operational Response Section

CT Forensic Science Research Unit

Evidence Control Unit

Quality Assurance & Safety Unit

Training Unit

Forensic Science Support Section

Administrative Unit

Investigative & Prosecutive Graphics Unit

Special Photographic Unit

Structural Unit

Operational Support Section

Operational Support Branch

Laboratory Division

Executive Assistant Director for Law Enforcement Services

Office of the Director & Deputy Director

24
B. DNA Analysis Unit I 

1. Organization and Functions 

In 1988, a DNA Analysis Unit was established in the Laboratory. Prior to 

that time, body fluid examinations were performed by the Serology Unit. 

Although the DNA Analysis Unit was split into two units in 1993, they were rejoined in 1994. In 1998, the DNAUI and DNA Analysis Unit II (DNAUII) were 

formed. DNAUII was created when the Laboratory established a separate group 

to analyze a different type of DNA than is analyzed by the DNAUI. 

The DNAUI analyzes nuclear DNA, or DNA found in the nucleus of a cell, 

while DNAUII analyzes mitochondrial DNA, or DNA found in the mitochondria 

of a cell. The mitochondria are about the size of bacteria and are scattered 

throughout a cell outside its nucleus. Since there are between 500 to 1,000 

mitochondria in every cell, as opposed to one nucleus, mitochondrial DNA 

analysis affords a better chance of a DNA profile than nuclear DNA analysis in 

cases where a sample is decayed or degraded, such as skeletal remains that 

have been exposed to the elements for years. Consequently, the DNAUII 

receives and analyzes evidence samples and human remains that have not, or 

most likely will not, generate a traditional STR profile, such as teeth or pieces 

of bone that have no tissue attached. These types of evidence items are 

common in cases involving unidentified remains and missing persons. DNAUII 

receives evidence from across the country, since the specialized equipment, 

training, and facilities that are required for mitochondrial DNA analysis are 

usually beyond the resources of state and local laboratories. Further, because 

mitochondrial DNA analysis is more sensitive to trace amounts of DNA than 

STR analysis, it requires even greater safeguards in facilities and techniques to 

avoid contamination. 

The DNAUI identifies and characterizes body fluids and body fluid stains 

recovered as evidence in crimes using traditional serological techniques and 

related biochemical analysis. These stains are analyzed and compared to 

results from the known body fluid samples submitted by the victim(s) and/or 

suspected perpetrator(s). This work is completed in the DNAUI in assemblyline fashion by teams of forensic scientists, which include a Serologist, a PCR 

Biologist, and an Examiner. The following chart represents the organization of 

the DNAUI: 

25
DNA Analysis Unit I Organizational Chart

Various personnel are cross-trained in both serology and PCR, and Examiners also serve as managers of various programs. See

Chapter Three, Section I.B.2.b for additional information on team member roles and responsibilities.

*

*

Serology Biologist PCR Biologist

Quality Assurance &

Validation Biologist

Assistant Unit Chief

Training/Validation Program Mgr.

Examiner

PCR Mentor

PCR Biologist

Assistant Unit Chief

PCR Program Manager

Examiner

Quality Assurance Biologist Quality Assurance Specialist

Serology Biologist

FCOP Examiner

FCOP Examiner

FCOP Examiner

FCOP Biologist

Federal Convicted Offender

Program (FCOP) Manager

FCOP Examiner

Serology Trainee

Serology Trainee

Serology Mentor

Serology Biologist

PCR Biologist

Serology Program Manager

Casework Examiner

BSP Analyst

PCR Biologist

Serology/PCR Biologist

CODIS Biologist

CODIS Program Manager

Casework Examiner

Serology Biologist

Serology/PCR Biologist

PCR Biologist

Indian Country Evidence (ICE)

Program Manager

Missing Persons Samples

Casework Examiner

Serology Biologist

 Serology/PCR Biologist

Blood Stain Pattern (BSP)

Program Manager

Casework Examiner

BSP Analyst

Serology Biologist

Hiring Program Manager

Serology Examiner

Serology Biologist

Serology/PCR Biologist

Information Technology

Program Manager

Casework Examiner

Unit Chief

Technical Manager

Examiner

The DNAUI participates in CODIS, which is administered by the CODIS 

Unit within the Laboratory. CODIS is a national DNA information repository 

that allows local, state, and federal crime laboratories to store and compare 

DNA profiles from crime scene evidence, from convicted offenders, and from 

unidentified remains. The FBI provides participating laboratories with special 

software that organizes and manages their DNA profiles and related 

information, including enabling participating laboratories to compare DNA 

26
profiles. CODIS is organized as a hierarchy that encompasses national, state, 

and local indexes. DNA profiles are uploaded into the national index from the 

state indexes and into the state indexes from the local indexes. The forensic 

laboratories at each level of the CODIS hierarchy decide which DNA profiles will 

be uploaded to the next level, and conversely, the state and national levels 

determine, based upon applicable state and federal legislation, what profiles 

they will accept from the local and state indexes. 

The DNAUI operates at the “state index” level, meaning that it uploads 

directly to the national database, or NDIS. The DNAUI has been uploading 

profiles to NDIS since September 1998. As of February 2004, the DNAUI had 

submitted approximately 1,602 forensic profiles (DNA profiles resulting from 

forensic or crime scene analysis work) to NDIS. According to DNAUI 

management, the Unit uploads approximately 30 forensic profiles per month to 

the CODIS database. In addition, the DNAUI oversees the Federal Convicted 

Offender Program, which involves analyzing known DNA samples from 

convicted felons in the federal system and uploading the resulting profiles to 

NDIS for comparison to crime scene evidence profiles from across the country. 

As of February 2004, the DNAUI had uploaded 213 offender profiles to NDIS.31 

One of the goals of CODIS is to match DNA profiles from case evidence to 

other previously unrelated cases or to persons already convicted of other 

crimes. To determine the extent to which this goal is being met, the CODIS 

Unit has collected statistics from CODIS participants on the number of 

investigative leads that have been provided through CODIS’ match capabilities. 

As of February 2004, the DNAUI reported a total of 187 investigations aided by 

CODIS.32

2. Operations 

a) Flow of Evidence to DNAUI 

At the time of our review, the Laboratory’s Information and Evidence 

Management Unit, and specifically the Evidence Control Center (ECC) within 

that Unit, received all incoming evidence for the Laboratory.33 The ECC staff 

 31 The DNAUII, also a CODIS participant, oversees the National Missing Persons DNA 

Database Program. Because missing persons’ remains are frequently too deteriorated for 

nuclear DNA analysis, mitochondrial DNA analysis often is the only forensic option. The

DNAUII also facilitates the collection and analysis of reference samples from relatives of 

missing persons for comparison to unidentified remains that are found as a means of 

determining their identity. 

32 CODIS's primary metric, the "Investigation Aided," is defined by the FBI as a case

that CODIS assisted by producing a match between profiles (linking two cases together, or 

linking a case profile to an offender profile) that would not otherwise have been developed.

33 By the date of this report, the ECC was reorganized into the Evidence Control Unit.

27
were responsible for ensuring that the evidence was sealed properly and that 

its receipt by the FBI was formally documented on a chain-of-custody form. 

The ECC staff would open the outer layer of packaging to retrieve the 

submission paperwork and the individually packaged sealed evidence 

containers. The ECC staff then would review the submission letter to 

determine the contents of the sealed container and what tests were requested. 

In addition, ECC staff labeled each evidence container with unique identifying 

numbers, as well as a Laboratory case number that would link it with other 

items received on the same case. Those identifiers, along with the information 

about the submitter and contents, were entered into the ECC’s tracking 

system. 

After all intake work was completed, the evidence was placed in secured 

storage where it would not deteriorate. The ECC then assigned the evidence to 

a specific unit within the Laboratory, termed the “primary unit.” The primary 

unit was selected based upon an evaluation of the submission paperwork, from 

which ECC staff determined which unit would need to complete its work first to 

avoid contamination or deterioration of the evidence and/or would be 

conducting the most testing. Due to the nature of DNA evidence and its 

sensitivity to contamination, the DNAUI often served as the primary unit. 

After the primary unit assignment was documented in the ECC system, 

the evidence was transferred to the designated unit and the necessary chain-ofcustody documentation was completed. Within the primary unit, a 

coordinating Examiner was assigned to ensure that the evidence was routed in 

the proper order to all other units that will be performing tests on the various 

items of evidence.34 

Throughout the analysis process, FBI policy requires that the chain-ofcustody documentation be maintained to reflect all inter-unit transfers and to 

record which personnel processed the evidence. As part of this policy, after all 

laboratory analysis is completed, an inventory is performed to ensure that the 

evidence is accounted for. The evidence and all by-products of the analysis 

process are then repackaged and transferred back to the ECC for return to the 

submitter. 

b) Team Structure 

In those instances where the primary unit is the DNAUI, the coordinating 

Examiner works with a Serologist and PCR Biologist as a team to inventory 

 34 During our fieldwork, we were notified by the DNAUI Unit Chief that new procedures 

were being drafted and tested. By the date of this report, staff of the Evidence Control Unit 

have taken the place of the coordinating Examiner and are responsible for the routing,

tracking, and administration of evidence movement throughout the Laboratory.

28
evidence items, perform preliminary testing to identify and isolate sources of 

DNA on those items, and analyze any resulting DNA. 

Teams in the DNAUI are divided into a form of assembly line, and each 

member of the team completes a portion of the analysis process and shares in 

the responsibility for that process. The three team members and their duties 

and responsibilities are as follows: 

1) The Serologist assists with the initial and final evidence inventories 

and performs serology testing to determine what body fluids may be present in 

the evidence. Once body fluid screening is completed for a stain on an item of 

evidence, a portion of that stain is transferred to the PCR Biologist. 

2) The PCR Biologist (the position held by Blake) is responsible for 

taking cuttings, swabs, or other material containing DNA from the Serologist 

and completing the PCR/STR process through the production of GeneScan®

and Genotyper® data for the Examiner. Included in this process are the 

following activities: 

• Extraction: the release or removal of DNA from evidence; 

• Quantification: the measurement of the concentration of DNA in a 

sample; 

• Amplification: the replication of extracted DNA so that the DNA 

can be detected by the analyzer or a capillary electrophoresis 

machine; 

• Capillary electrophoresis: the use of a capillary electrophoresis 

machine to detect and measure the DNA fragments in a DNA 

sample; and 

• Initial data review: the review of all data produced by the capillary 

electrophoresis instrument that is collected and analyzed by the 

Genescan® software. 

3) The Examiner on each team serves as the first-line supervisor for the 

team members and are responsible for the work performed by them. Further, 

unless otherwise specified in written protocols and procedures, the Examiners 

are given sufficient autonomy to direct how the team will function. Examiners 

typically can assign work, structure communications, define the decisionmaking authority of other team members, and specify the level of direct 

involvement of the Examiner in the work of the other team members. 

29
The Examiner on the team is supplied with all of the documentation from 

the Serologist and PCR Biologist, as well as the data produced from the 

capillary electrophoresis process (complete with sample lists, injection lists, 

and Genotyper® data). The Examiner is responsible for ensuring that: 

• The decisions made by the Serologist (if not made in direct 

interaction with the Examiner) are sound, and that all evidence 

items are inventoried, examined, and transferred to the PCR 

Biologist properly; 

• The decisions made by the PCR Biologist (if not made in direct 

interaction with the Examiner) are sound, and that DNA is 

extracted from all appropriate sources, quantification is completed 

correctly, batches of samples contain the required positive and 

negative controls and reagent blanks, and capillary electrophoresis 

is completed correctly; 

• Chain-of-custody forms and case file documentation are completed 

properly; and 

• The actions taken by the team members, as revealed by the written 

documentation supplied to the Examiner, are in accordance with 

DNAUI procedures and policies. 

In addition, the Examiner is responsible for reviewing the filtered 

capillary electrophoresis data, or Genotyper® data, and drawing conclusions 

about the usability of that data based upon the control results. For this 

review, the sample and injection lists serve as a guide to show the order that 

the samples were analyzed and to indicate the presence of the appropriate 

control samples. Each Examiner decides whether to complete this data review 

from printouts or directly from the electronic data on the computer. If there 

are data quality problems, or control result problems, then the Examiner will 

work with the PCR Biologist to troubleshoot those issues. Otherwise, the 

Examiner proceeds to draw conclusions about the evidence based upon the 

data generated from the capillary electrophoresis. The Examiner then writes a 

report stating those conclusions and, if necessary, later testifies in court about 

them. 

After the discovery of Blake’s misconduct, the DNAUI changed its policies 

to require that the GeneScan® data be supplied to and reviewed by the 

Examiner, as well as the Genotyper® data, since it was the failure of Examiners 

to review GeneScan® data that allowed Blake to proceed undetected. See 

generally Chapter Four, Section II (describing the DNAUI GeneScan® review 

policy) and Chapter Four, Section V.C (describing the Laboratory’s initial 

remedial actions after the discovery of Blake’s misconduct). 

30
c) Case Documentation and Review 

DNAUI team members demonstrate compliance with the Laboratory’s 

protocols primarily through the documentation that they produce as they 

perform their work. Although the Examiner can be involved at critical 

junctures in the DNA analysis process, the Examiner does not witness most of 

the work performed. Consequently, team members must thoroughly document 

their work in the case file to establish for the Examiner that they have followed 

the applicable protocols. 

According to DNAUI personnel and the written procedures for case file 

documentation, a case file should include the following: 

• Incoming submission letter; 

• Acknowledgment letter (the letter that is sent to the submitter of 

the evidence to acknowledge receipt); 

• Communication log; 

• Chain-of-custody form; 

• Search sheet (a sheet produced by the ECC advising unit staff 

whether previous submissions of evidence on that same case have 

been received, so that individual items can be sequentially and 

uniquely labeled throughout the case); 

• Evidence inventories (listing of the items received, the submitter, 

and when the items were received); 

• Task-specific case notes (includes a set of notes for serology work, 

PCR work, and examiner analysis); 

• Capillary electrophoresis printouts; 

• Population statistics calculations; 

• Documentation of case file review; 

• Administrative sheets (listing information specific to CODIS or 

DNAUI’s new information management system); and 

• The file copy of the final DNA report. 

31
Both technical and administrative case file reviews are required for every 

DNAUI case. The initial technical review is performed by the team’s Examiner. 

In addition, another Examiner who is not involved in the case performs an 

independent technical review or peer review of the case file. The peer reviewer 

draws his or her own conclusions from the supporting documentation without 

regard to the conclusions or report produced by the first Examiner. The 

results of these evaluations are then compared for consistency and any 

discrepancies resolved. Finally, the Unit Chief conducts an administrative 

review of the case file and examines the order and completion of the case file 

documents, report format, and other administrative items. 

According to DNAUI personnel, a thorough technical or peer review 

generally involves checking: 

• The incoming letter to verify the accuracy of the file worksheets, 

specifically confirming: 1) names; 2) exams requested; 

3) evidentiary samples received (referred to as unknown or 

questioned samples); 4) DNA reference samples received (reference 

samples are provided by the victim and/or suspected perpetrator(s) 

for comparison purposes, and are often referred to as known 

samples); 5) case ID number; and 6) any other identifiers or 

miscellaneous information applicable to the case. 

• The chain-of-custody documents to verify that they reflect the 

disposition of every item; 

• Each page of laboratory documentation to verify that it is 

numbered (so it will be evident if any pages are misplaced) and 

that every page is initialed by the team member who produced it;35

• The serology paperwork to verify that: 1) all pertinent serology 

information is recorded and is correct; 2) the required serology 

controls were run; 3) appropriate serology testing was performed, 

and 4) the Examiner agrees that no more serology testing should 

be performed; and 

• The PCR paperwork to verify that: 1) the questioned and known 

samples were processed at different times; 2) the Examiner agrees 

with the quantification results; 3) all samples selected were 

amplified; 4) the worksheet that summarizes the DNA profile 

results (also referred to as a call sheet) agrees with the Genotyper®

printouts; and 5) the technical parameters used to interpret the 

data are consistent with protocol requirements. 

 35 See generally Chapter Four, Section II.B (discussing initialing requirement). 

32
After the Examiner reviews these items, the Examiner (whether the initial 

Examiner or peer reviewer) determines what conclusions and statistics should 

be reflected in the report. For the peer reviewer, this determination is 

compared with the actual case report to verify that both Examiners agree. 

Finally, if the profile will be uploaded to CODIS, both reviewers confirm that 

the identifying paperwork listing the DNA profile is correct, and that the profile 

is appropriate for inclusion in the database. 

II. THE FBI’S DNA PROTOCOLS 

A. Overview of Existing Protocols 

The activities of the DNAUI are governed not only by the Quality 

Assurance Standards that apply to all forensic DNA laboratories (as described 

in Chapter Two, Section II), but also by the FBI Laboratory’s own procedures 

and protocols. These guidelines are contained in five FBI documents: 1) the 

FBI Laboratory Division Quality Assurance Manual; 2) the DNA Analysis Unit I 

Quality Assurance Manual; 3) the FBI Laboratory Division Caseworking 

Procedures Manual; 4) the Procedures for the Serological Identification of 

Biological Substances on Evidentiary Materials; and 5) the Short Tandem 

Repeat Analysis Protocol. As explained in Chapter Five, Section I (Assessment 

Foundation and Process), the OIG’s assessment of vulnerabilities in the 

DNAUI’s internal control structure focused on these protocols.36 A brief 

description of each document is provided below: 

1. FBI Laboratory Division Quality Assurance Manual 

The FBI Laboratory Quality Assurance Manual addresses laboratory 

policies and operational practices. It is organized into 17 sections and 

identifies requirements and guidance for case documentation, evidence control, 

court testimony and testimony monitoring, authorization of deviations, 

corrective action, document control, calibration and maintenance, internal 

audits, laboratory security, proficiency testing, and conflict resolution. The 

document applies to all units in the Laboratory and therefore does not contain 

guidance specific to the DNAUI. 

2. DNA Analysis Unit I Quality Assurance Manual 

The DNAUI Quality Assurance Manual is organized into 20 sections and 

covers topics including: 

 36 The FBI Laboratory also has published five resource documents that add explanation 

to the five manuals described above. These documents address issues such as calibration 

procedures and training programs for Biologists and Examiners. 

33
• Organization, management, authority and accountability; 

• Personnel qualifications, training, and continuing education; 

• Facilities, security and evidence control; 

• Case assignment, documentation and review; 

• Reagents, equipment, and validation; 

• Court testimony monitoring; 

• Proficiency testing, audits, and corrective action; and 

• Environmental health and safety. 

3. FBI Laboratory Division Caseworking Procedures Manual 

The Caseworking Procedures Manual provides guidance for all units 

within the Laboratory. It is divided into 12 sections, each covering a different 

aspect of the caseworking process. Topics include: 

• Processing a request for examination; 

• Inventorying, identifying, recording, acknowledging, examining, 

shipping, and transferring evidence; 

• Formatting, content, review, and issuance of a “Report of 

Examination”; and 

• Retaining case-related documentation. 

4. Procedures for the Serological Identification of Biological 

Substances on Evidentiary Materials 

This document is written specifically for DNAUI Serologists and identifies 

the methods and requirements for each of the serology procedures utilized by 

the DNAUI. It contains 72 sections, describes 6 routine and 8 non-routine 

serological procedures, and provides a general discussion of guidelines 

regulating laboratory set-up. 

5. Short Tandem Repeat Analysis Protocol 

The STR Protocol specifies the procedures and requirements for 

processing DNA evidence using short tandem repeat (STR) analysis. See 

generally Chapter Two, Section I.C (describing STR analysis). The document is 

34
divided into 46 sections and covers the major processes involved in STR 

analysis, including extraction, quantification, amplification, electrophoresis, 

data evaluation and interpretation, and report writing. In addition, the 

Protocol provides information that applies generally to STR analysis, including 

guidelines for reagents, supplies, and equipment; special quality control 

considerations; and laboratory set-up instructions. 

The protocols above implement the Quality Assurance Standards that 

apply to all forensic DNA laboratories. The national standards require 

laboratories to develop and adhere to operational standards that are tailored to 

their specific functions and circumstances. In general, these standards afford 

laboratories broad discretion regarding the content of their written procedures. 

See Section 9 “Analytical Procedures” in Appendix 3. 

B. Protocols Designed to Protect the Integrity of the STR Process 

Certain DNA protocols are specifically designed to protect the integrity of 

the STR process by helping to identify the presence of contamination and 

prevent its occurrence. They include: 1) the required use of quality controls; 

2) on-going cleaning and decontamination; and 3) the systematic separation of 

sample sources and of stages in the analysis process.37 

1. Quality Controls 

As discussed in Chapter Two, Section I (General Principles of DNA 

Analysis) of this report, the use of positive and negative controls and reagent 

blanks serves as an indicator of contamination and whether the equipment and 

reagents functioned properly during the analysis process. The positive control 

allows the PCR Biologist and Examiner to determine the accuracy and 

consistency of the amplification and capillary electrophoresis processes each 

time DNA samples are analyzed. The negative control and the reagent blank 

reveal whether contamination was present in the reagents or whether 

contamination was introduced during the testing process. DNAUI procedures 

require the PCR Biologist to process positive and negative controls and reagent 

blanks with every batch of DNA samples analyzed. The Examiners, along with 

the PCR Biologists, analyze the control results to ensure that the data 

generated from the DNA samples meet the quality standards established for the 

resulting DNA profiles. 

 37 The descriptions below of these procedures reflect information collected during the 

course of our vulnerability assessment and are not necessarily found in the same level of detail 

in the DNAUI’s protocols. This information was obtained during lengthy interviews with DNAUI

staff members and management. Information regarding the weaknesses detected in the DNAUI

protocols is found in Chapter Five, Section II of the report. 

35
The failure to analyze properly the positive and negative controls and 

reagent blanks does not necessarily render DNA testing results inaccurate. 

Rather, it limits the conclusions that the DNAUI scientists may draw from the 

testing. Without properly analyzing the negative control and the reagent blank, 

DNAUI scientists cannot be sure that the only source of the test results is the 

DNA from the evidence under examination. The results could reflect impurities 

in the reagents or contamination introduced during the testing process. If the 

positive control is not analyzed properly, the DNAUI scientists cannot evaluate 

how well the amplification and capillary electrophoresis processes worked. 

2. Cleaning and Decontamination 

Adequate cleaning and decontamination procedures limit the possibility 

that forensic scientists will contaminate DNA samples during the testing 

process. Two types of contamination are of concern: 1) an evidence item or a 

DNA sample can be contaminated with DNA from a different case or from a 

different piece of evidence from the same case; and 2) the forensic scientist 

might also contaminate evidence with his or her own DNA. 

The DNAUI cleaning and decontamination procedures can be 

summarized as follows: 

• The Serologists and PCR Biologists clean their work surfaces and 

then cover those surfaces with clean brown paper each day before 

retrieving the evidence or samples from storage. The brown paper 

should be changed before each new evidence item is examined. 

The work surface always should be cleaned between cases and 

between the processing of items containing unknown DNA samples 

and those containing known DNA samples. If a piece of evidence is 

very messy, or if the item might have touched the work surface, the 

work surface should be cleaned before a new item is examined. 

• Serologists and PCR Biologists wear gloves while examining 

evidence or processing samples. The gloves should be changed 

between items, or more often if necessary. When appropriate, the 

Serologists and PCR Biologists should wear facemasks when 

examining or testing evidence. 

• Non-disposable utensils should be either cleaned or sterilized 

between use on separate evidence items. Pipette tips should be 

disposable and be changed for every use. 

• Vacuum or fume hoods (hoods) should be small, enclosed work 

areas from which the air is vented to another location, often 

outside the building. When necessary, the air also should be 

36
filtered to remove hazardous particles before it is released. The 

hoods should be decontaminated using ultra-violet light at the 

beginning and the end of the workday. The hoods should be 

cleaned on a weekly basis, or more often if necessary. For 

example, if something was spilled in the hood or a piece of evidence 

was extremely dirty, the hood would be cleaned immediately. PCR 

Biologists should cover their hood work-surface with disposable 

paper prior to beginning their work. This paper should be changed 

before each new item is processed. The PCR Biologists also should 

clean the hood between the processing of DNA samples from 

evidence and their processing of DNA samples from known sources 

(such as reference samples). 

• Reagents should be decontaminated using ultra-violet light. 

In addition, the DNAUI uses a contamination log to track occurrences of 

contamination. The log assists Unit management in identifying when staff 

members may need additional training or oversight, or in determining whether 

a procedure needs to be strengthened to avoid future incidents of 

contamination. 

3. Separation of Sample Sources and of Stages in the DNA 

Analysis Process 

The separation of the different types of samples and stages in the 

analysis process is important in reducing the possibility that DNA from one 

sample can contaminate another sample. For instance, samples from crime 

scene evidence (unknown samples) should be processed separately from 

samples submitted by suspects or other known individuals (known samples) to 

eliminate the risk of the suspect’s DNA contaminating an unknown DNA 

sample. In the same way, it is also important to separate large and small 

samples of DNA to avoid the risk that the low quantity DNA will be 

contaminated by the high quantity DNA sample. Depending on the level of 

contamination, the DNA from the low quantity sample could be “drowned out” 

by the contamination, thus altering the test results for the low quantity 

sample. 

The DNAUI Serologists and PCR Biologists attempt to limit such crosscontamination through the following procedures: 

• Serologists work on one case at a time and examine only one piece 

of evidence at a time. The remaining evidence stays in storage 

until the first item is examined and returned to storage. PCR 

Biologists also work on cases sequentially and process samples 

from one item at a time. In addition, while adding samples and 

37
reagents to test tubes, the PCR Biologists are supposed to have 

only one test tube open at a time. The test tubes remain capped 

until the Biologist adds something to the test tube. 

• The Serologists and PCR Biologists always work on the crime scene 

evidence and unknown DNA samples before working on samples 

submitted by known individuals. To the extent possible, they also 

process low quantity DNA samples before working with the high 

quantity samples. 

Several steps in the DNA testing process are performed in separate 

rooms in the DNAUI’s new facility at Quantico, Virginia. The Serologists 

examine evidence and take cuttings or swabbings in one room. The PCR 

Biologists extract the DNA from the cuttings or swabbings in a second room 

under a hood. They also prepare the extracted DNA for amplification in that 

room. The actual amplification process takes place in a third room. 

Once the DNA has been amplified, the DNAUI addresses the potential for 

amplification-related contamination as follows: 

• Once employees work in the amplification room, they are not 

allowed to go back into a pre-amplification area for the remainder 

of the day. Employees must change lab coats and gloves before 

entering the amplification room, and again as they prepare to leave 

the amplification room. There are dedicated lab coats that are only 

worn in the amplification room. 

• All equipment that is used in the amplification room stays there; 

the amplification room has dedicated instruments, equipment, and 

utensils. The tube racks used to transport the unamplified DNA to 

the amplification room are thoroughly cleaned before they are 

returned to use in the pre-amplification area. 

• All amplified DNA stays in the amplification room until it is frozen 

and ready to be sent back to the submitter. The amplified DNA is 

packaged separately and sealed before it is packaged with the rest 

of the evidence being returned to the submitter.

 

The foregoing descriptions of the DNA analysis process, the standards 

and protocols that govern that process, and the structure and operations of the 

FBI Laboratory, particularly the DNAUI, provide context necessary to 

understand fully the findings and recommendations of our vulnerability 

assessment, as well as Blake’s wrongdoing and how she exploited a loophole in 

the Laboratory’s protocols to avoid detection. Before proceeding to address the 

results of our assessment, we describe below the events that precipitated the 

review, namely the discovery of Blake’s disregard of protocols in the DNAUI. 

38
CHAPTER FOUR

BLAKE’S MISCONDUCT

I. BLAKE’S CAREER WITH THE FBI 

Jacqueline Blake was employed by the FBI in the DNAUI and its 

predecessor unit from August 8, 1988, until her resignation from the FBI on 

June 7, 2002. Blake has a Bachelor’s of Science Degree in Biology from 

Benedict College in Columbia, South Carolina. She entered duty with the FBI 

as a Biological Laboratory Technician at the GS-5 grade level and was assigned 

to the Serology Unit of the Laboratory’s Scientific Analysis Section. Her job 

responsibilities as a Serologist included inventorying and storing evidence and 

conducting routine evidence examinations to identify the presence of body 

fluids. Although her early performance appraisals noted that her training 

comprehension was slower than expected, she received fully successful 

evaluations or above from her initial appointment until 1994, and she reached 

the GS-10 grade level in 1991. 

The first indications of problems with Blake occurred in 1991. In that 

year, Blake received an oral reprimand from the DNAUI Unit Chief for abusing 

her sick and annual leave accounts. She was advised in July 1991 that her 

leave balances were in deficit and that she could not take additional leave for 

the rest of the year. Blake nonetheless submitted a leave slip and failed to 

report to work for one day in November 1991 during an absence of the Unit 

Chief, even though she was aware that she had no accrued leave. She also 

took leave for a day in December 1991 without first seeking permission. These

events prompted the DNAUI Unit Chief to audit her leave record, which 

revealed that 37 of her 46 sick leave days occurred either on a Friday, Monday, 

or the day following a holiday. 

Blake’s 1992 and 1993 performance appraisals rated her as “exceptional” 

on all critical elements. In June 1994, however, she received an overall job 

rating of unsatisfactory. Her performance appraisal stated that her 

“examinations are not performed according to acceptable laboratory practices,” 

and that she generated false positive serology testing results during proficiency 

testing and “inaccurate documentation of examinations conducted for blood 

and semen.” Following this evaluation Blake’s conduct was monitored 

intensively for two months, during which time she passed a proficiency test 

and improved all of her job performance ratings to “fully successful.”38 By the 

end of 1994, Blake received an overall job rating of “superior,” a level of 

performance that she maintained through 1996 when she was promoted to the 

GS-11 grade level. 

 38 Around this time Blake also applied to become a Special Agent, but her application 

was rejected due to inadequate testing scores. She also withdrew from a lecture course for 

DNA Examiners because she was receiving failing marks. 

39
Prior to her promotion in 1996, Blake indicated to DNAUI management 

that she wanted to transfer from serology to DNA analysis work. The Unit 

Chief at the time recalled that Blake seemed to have confidence problems and 

that she assigned an Examiner to work with her individually to help with the 

transition. Blake subsequently received training in the use of the DNAUI’s 

preferred DNA testing methodology at the time, called restriction fragment 

length polymorphism (RFLP).39 Blake’s 1996 performance appraisal indicates 

that she demonstrated a “careful attitude” toward her RFLP work and adhered 

to the applicable protocol. Her 1997 performance appraisal rated her as 

“exceptional.” 

In April 1998, Blake was promoted to the position of GS-12 Biologist. In 

this capacity, she analyzed evidence following its examination by a Serologist 

and prepared detailed work notes for DNAUI Examiners describing the tests 

she performed and the results obtained. Over time Blake demonstrated good 

proficiency in the use of RFLP testing procedures and instructed other 

Laboratory employees in its use. Her performance appraisals in 1998 and 

1999 gave her a summary rating of “exceptional.” 

In August 1999, Blake began training to become a PCR Biologist. The 

DNAUI was phasing out its use of RFLP and transitioning to PCR/STR 

technology. One Examiner, who had provided training to Blake when she was 

a Serologist, told the OIG that he advised the Unit Chief of DNAUI that Blake 

should not be allowed to become a PCR Biologist because she lacked the 

necessary skills. The Deputy Director of the Laboratory told the OIG that it 

can take up to two years to bring a new PCR Biologist on staff from outside the 

FBI. Under these circumstances, Laboratory management accepted Blake and 

thereby minimized a staffing shortage. 

Blake took six months to complete the PCR training course, 

approximately two months longer than average, and her instructor noted that 

she seemed to have a difficult time with simple math.40 Her PCR training 

required the completion of three training sets (one each for blood, saliva, and 

semen), and the processing of ten mock cases. The last mock case was 

considered a qualifying test for a later proficiency examination. On 

February 18, 2000, Blake worked on the eighth mock case and, undetected by 

the Laboratory, failed to process the negative controls. She made the same 

 39 RFLP is a technique that detects variation in a DNA sequence according to 

differences in the length of DNA fragments. These fragments are created using enzymes that 

cut the DNA strands at specific points. RFLP is a more restrictive technology than PCR/STR. 

It requires greater amounts of higher quality DNA to generate a profile, and takes considerably 

more time to complete. RFLP also is not as sensitive to contamination.

40 According to one of Blake’s Examiners, however, the instructor indicated to him 

during the training that Blake was performing satisfactorily and meeting the requirements of

the training program. 

40
undetected omission in both her qualifying and proficiency tests, which were 

administered on February 24, 2000, and March 14, 2000. 

Thereafter, Blake assumed her duties as a PCR Biologist, which required 

her to take cuttings, swabs, or other material containing DNA from the Unit’s 

Serologists and to complete the PCR/STR testing process (i.e., extraction, 

quantification, amplification, and capillary electrophoresis). Blake primarily 

worked on the examination team of Alan Giusti, although she also provided 

assistance to another Forensic Biologist Examiner, and the Manager of the 

DNAUII Federal Convicted Offender Program. 

Blake’s 2000 performance appraisal lacked the praise that characterized 

reviews of her RFLP work. Instead, the appraisal stated that Blake’s work was 

“generally high” and that “she has required fairly extensive supervision to 

assist her in the decision-making processes that occur during the analysis.” 

Her 2000 and 2001 performance appraisals graded her work as “fully 

satisfactory” and that she “meets expectations.” 

In fact, Blake’s work in 2000 and 2001 was anything but satisfactory. 

Without the Laboratory’s knowledge, from 2000 to 2002 she failed to process 

the negative controls in 90 out of 92 cases where DNA was detected on the 

evidence. Blake’s misconduct was not discovered by the FBI until April 8, 

2002, more than two years after she began work as a PCR Biologist. She 

initially denied omitting the negative controls when confronted by Richard 

Guerrieri, the DNAUI Unit Chief, on April 9, 2002. After that meeting, Blake 

did not report to the Laboratory again for work. 

On May 10, 2002, Guerrieri notified Blake that she would be on leave 

without pay as of May 19. On June 7, Guerrieri and Joseph DiZinno, the 

Deputy Assistant Director of the FBI Laboratory (Deputy Director), went to 

Blake’s residence to present a notification document from FBI OPR stating that 

her conduct had been referred for investigation. They also told her that the 

OIG was initiating a review of her actions. Blake said that she had thought 

about the matter and decided to resign. She turned over her credentials and 

building entry materials to Guerrieri. Blake composed a handwritten 

resignation letter, effective that day, which she gave to Guerrieri. 

The FBI notified the OIG of Blake’s misconduct in early May 2002. The 

OIG began an investigation, and over the next five weeks interviewed 

Laboratory staff, analyzed documents, and met with representatives of the FBI 

OGC. On July 11, 2002, an OIG attorney and investigator interviewed Blake at 

her home. Blake admitted to the OIG that she knew that she was not 

processing the negative controls that were required by the protocols. She also 

said she knew she was misrepresenting the status of the negative control 

samples when she did not properly prepare them for injection but initialed the 

related injection sheet anyway. On August 23, 2002, Blake executed an 

41
affidavit attesting to these facts. The OIG referred the matter to the 

Department’s Public Integrity Section for a prosecution decision. On May 18, 

2004, Blake pled guilty in the United States District Court for the District of 

Columbia to a misdemeanor charge of providing false statements in her 

laboratory reports. 

In her interview with the OIG, Blake explained that she wanted her cases 

to run smoothly and not to show contamination. Some Laboratory employees 

have speculated that the reason that she failed to process the negative controls 

was because she lacked confidence in her ability to master PCR/STR testing 

methods, which are far more sensitive to contamination than RFLP procedures. 

Below we describe in detail Blake’s wrongdoing, the impact of her 

conduct, why she was not detected sooner, and the adequacy of the FBI’s 

response to the discovery that she had failed to process the negative controls in 

the vast majority of the cases that she handled. 

II. BLAKE’S MISCONDUCT 

A. Incompletely Processed Controls 

Blake’s misconduct in the DNAUI resulted from her failure to process the 

negative controls and reagent blanks in accordance with DNAUI protocols. 

Although she properly prepared these two types of control samples for 

amplification, she failed to follow established procedures when preparing them 

for capillary electrophoresis. The effect of this omission has been to render 

nearly all of Blake’s PCR work scientifically invalid. 

As required during the extraction and amplification processes, Blake 

added all the amplification reagents to the negative control tubes and added all 

the extraction and amplification reagents to the reagent blank tubes. She also 

amplified the negative controls and reagent blanks as required. 

As explained in Chapter Two, Section I.D (Capillary Electrophoresis) of 

this report, after amplification is complete the protocols require the PCR 

Biologist to add internal size standard to tubes. Prior to capillary 

electrophoresis, the PCR Biologist adds an appropriate amount of one of the 

following to the tubes containing the internal size standard: 1) amplified DNA 

from reference samples, evidentiary samples, or the positive control; 

2) amplified negative control or reagent blank; or 3) an allelic ladder. After 

performing these steps, the DNA samples, positive control, negative control, 

reagent blank, and allelic ladders are ready for analysis using capillary 

electrophoresis. 

42
Blake performed most of these steps as required. However, she failed to 

add a portion of the amplified negative controls and reagent blanks to the tubes 

containing the internal size standard. Therefore, the negative control and 

reagent blank samples that were analyzed through capillary electrophoresis 

consisted of only the internal size standard. As a result, the negative controls 

and reagent blanks were useless in detecting contamination that might have 

been introduced during the testing process. In order for these controls to 

detect contamination, the amplified contents of the negative controls and 

reagent blanks must go through capillary electrophoresis. 

As illustrated below, GeneScan® printouts of the raw collection data for a 

properly completed negative control include everything detected during 

capillary electrophoresis, including the primer peaks that result from the 

reagents used during amplification. 

STR Primer Peaks 

(except red peaks) 

GeneScan® View: raw data for a Negative Control prepared according to protocol. 

Peaks depicted in red originate from the internal size standard added to each sample.

When the negative controls and reagent blanks are prepared according to 

the DNAUI protocols, GeneScan® data will appear similar to the illustration 

above. During the amplification process, the primers are amplified along with 

43
any other DNA in the tube (including any contamination that may have been 

introduced during the testing process), which allows the primers and the 

contamination to be detected during capillary electrophoresis. 

If the PCR Biologist fails to add the appropriate portion of the amplified 

contents from the negative controls and reagent blanks to the tubes containing 

the internal size standard, those tubes will not contain any amplified DNA or 

unused primers, and only the internal size standard will be detected during 

capillary electrophoresis. Therefore, GeneScan® printouts of the raw collection 

data for the negative controls and the reagent blanks prepared by Blake do not 

show the primer peaks, as illustrated below. The red peaks shown on the 

printout represent only the internal size standard. 

GeneScan® View: Negative Control without addition of amplified product 

The differences between the graph on the previous page and the graph 

above are readily apparent. Reviewing GeneScan® data allows the Examiner to 

determine whether or not the PCR Biologist prepared the samples and controls 

for capillary electrophoresis in accordance with DNAUI protocols.

The consequence of Blake’s omissions is that her testing results are 

scientifically invalid and cannot be relied upon. Without proper processing of 

the negative controls and reagent blanks, a Laboratory Examiner is not able to 

44
rule out the possibility that contamination, rather than the evidence under 

examination, is the source of the testing results. By itself, however, the failure 

to process the negative controls does not change these results or lead to a 

particular testing outcome (e.g., creating a match between a known and 

unknown evidence sample). For this reason it is not possible to conclude that 

Blake intended to manipulate the testing process to implicate or to absolve 

individual defendants. The retesting of evidence in Blake’s cases to date 

indicates that the DNA profiles that she generated were accurate. 

Before Blake’s misconduct was discovered, the DNAUI’s policy called for 

Examiners to review only the Genotyper® printouts for the negative controls 

and reagent blanks to ensure contamination was not introduced during the 

testing process. This policy of not reviewing GeneScan® data allowed Blake’s 

misconduct to continue undetected for approximately 25 months, since the 

Genotyper® data displays the message “No Size Data” 41 both for properly 

completed negative controls and reagent blanks that reflect no contamination 

(the desired result), as well as when no amplified product has been added 

(what Blake did). An example of this message appears in the following 

Genotyper® graph: 

Allelic

Ladders 

Results of

Positive 

Control

Results of 

Negative

Control

Genotyper View®: COfiler Ladder with Positive Control Allele Call

 41 The statement “No Size Data” is the message that the Genotyper® software displays 

when no DNA is detected in a sample (i.e., there is “no size data” because there were no DNA 

peaks for which Genotyper® could assign a size).

45
Thus, the only way to determine if the controls and samples are prepared 

properly for capillary electrophoresis is to review GeneScan® data that displays 

what the capillary electrophoresis detects. After Blake’s misconduct was 

discovered, the DNAUI changed its policy to require Examiners to review 

GeneScan® data to ensure that the negative controls and reagent blanks are 

prepared properly. 

B. Falsification of Laboratory Documents 

In accordance with DNAUI protocols, Blake initialed each page of the 

case file documentation (including DNA analysis results) that she created. See 

generally Section 11.2.3 of the DNA Analysis Unit I Quality Assurance Manual

(version. 7.28.00)(describing DNAUI initialing procedures).42 A DNAUI 

employee’s initials confirm his or her involvement in the processes and 

procedures described in the documentation. Id. Moreover, statements 

provided by Laboratory personnel, including Blake, indicate that DNAUI 

employees understood at the time of Blake’s misconduct that an employee’s 

initials at the bottom of a case file document signify that the work described is 

complete and accurate. By providing her initials in cases where she did not 

perform the requisite control testing, Blake falsified laboratory documents. As 

Blake has stated to OIG investigators, she knowingly misrepresented her work 

in Laboratory documents that she knew other DNAUI employees would rely 

upon to verify that she had complied with applicable procedures and protocols. 

According to Blake’s signed, sworn statement to the OIG: 

During the OIG interview, I reviewed some documents that came from 

the file for Lab #991005047 GL FY. Included in those documents was an 

Injection List. The Injection List was prepared by me and lists the 

injections that the CE [capillary electrophoresis] machine was 

programmed to run in connection with the specific Lab Number. The 

Injection List that I reviewed was initialed by me in the lower left corner. 

These initials indicate that I generated the paper work and properly 

completed the preparation of the samples listed on the document for 

injection, including the negative controls. I knew that DNA Forensic 

Examiner Giusti, in this case, would have relied on this initialed 

Injection List as proof that all protocols were followed in processing the 

samples on the list. I knew that when I did not properly prepare the 

negative control samples for injection but initialed the related injection 

sheet anyway, I was misrepresenting that the negative control samples 

were properly prepared for injection and properly run on the CE 

machine. I also knew that no one routinely checked the raw data that 

would show the absence of the primer peaks for the negative controls. 

 42 That section provides in pertinent part: “All technicians will typically document their 

involvement in the analytical processing of physical evidence by initialing the lower left corner

of each page of the work product in which they were involved in generating.” 

46
Because she was not processing the negative control samples, Blake 

never had a need during her tenure in the DNAUI to record an entry in the 

Unit’s contamination log. Yet, despite her prior training and performance 

problems, Blake’s noteworthy and unusual record of contamination-free testing 

did not result in heightened scrutiny from Laboratory management. 

C. The Impact of Blake’s Misconduct 

Our investigation of Blake’s misconduct has not revealed any instances 

where Examiners from the FBI Laboratory presented erroneous DNA testing 

results in court based upon Blake’s faulty STR analyses. Notwithstanding this 

fact, with the exception of 2 cases where she processed the negative controls 

and 11 cases where no DNA was found, Blake’s misconduct has rendered over 

two years worth of her STR work scientifically invalid and unsuitable for use in 

court, requiring the FBI Laboratory to repeat DNA testing in her cases.43 

Although the FBI Laboratory has yet to identify any cases where retesting 

did not confirm the accuracy of Blake’s DNA profiles, we found that her actions 

caused significant adverse effects in at least five respects: 1) it required the 

removal of 29 DNA profiles from NDIS, 20 of which have yet to be restored;44

2) it delayed the delivery of reliable DNA reports to contributors of DNA 

evidence in Blake’s cases; 3) her testing consumed all the available DNA 

evidence in several cases, leaving only her suspect DNA profiles as a basis on 

which to draw conclusions; 4) the corrective action necessary to address 

Blake’s misconduct has consumed substantial resources of the FBI Laboratory 

and DOJ, as well as the resources of state and local investigators and 

prosecutors who were notified of her misconduct and had to take corrective 

measures in their cases; and 5) the controversy surrounding Blake has caused 

some measure of credibility loss to the FBI Laboratory. 

After Blake’s actions were discovered, the DNAUI notified the Forensic 

Science Systems Unit (FSSU)45 within the Laboratory, which removed 29 

profiles that Blake processed through STR analysis from NDIS. This work was 

completed by May 2002. As of March 2004, the Laboratory had retested and 

 43 As explained supra, while Blake’s misconduct prevents the Laboratory from stating 

definitively that contamination did not distort her testing results, to date, reexamination of 

Blake’s analyses, including retesting of evidence samples, has confirmed the accuracy of her 

work. As of February 2004, evidence in 27 of 90 cases where Blake failed to process the

negative controls had been retested. 

44 DNA is not available for retesting for two of these profiles. 

45 In 2003, the FSSU was renamed the CODIS Unit. 

47
restored nine profiles; no DNA remains for further analysis in two cases.46 The 

Laboratory recently obtained contractor support to assist with evidence 

retesting in Blake’s cases, and informed the OIG in October 2003 that it 

expected to restore the remaining profiles to NDIS by the end of March 2004. 

Until these profiles are restored there will be an ongoing risk that an 

investigative agency will submit a DNA profile and not generate a match with a 

corresponding Blake profile because the Blake profile has been removed from 

NDIS. Consequently, past crimes may remain unsolved. 

Blake’s misconduct also has delayed the delivery of reliable DNA reports 

to evidence contributors and wasted limited evidence samples. The Laboratory 

is attempting where feasible to obtain from contributors new evidence samples 

that Blake did not handle. In addition, in several cases Blake’s faulty STR 

analysis is the only DNA information that is available. As with the two NDIS 

profiles described above, the earlier submitted evidence was consumed in the 

testing process and new evidence samples cannot be obtained. 

 

Blake’s misconduct also has adversely impacted the resources of the FBI 

and DOJ. The efforts that the FBI Laboratory and DOJ have had to expend on 

the corrective measures needed to address Blake’s actions have been 

substantial. Both organizations have devoted thousands of hours of work to 

deal with the consequences of Blake’s failure to comply with the DNAUI’s 

protocols, a cost that does not include the funding expended for contractor 

support to retest evidence. The DNAUI Unit Chief estimated that in the year 

following the discovery of Blake’s wrongdoing, he devoted more than half of his 

time working on Blake-related issues. The FBI’s OGC and the DOJ’s 

Counterterrorism Section have had to track legal proceedings in her cases and 

have issued dozens of notification letters to contributors explaining the 

possible ramifications of her actions. U.S. Attorney’s Offices have had to 

respond as well. Blake’s conduct has been put at issue in federal criminal 

 46 According to the FBI, as of March 2004 the Laboratory was waiting for the

resubmission of evidence in 13 out of the 29 cases for which NDIS profiles previously were

removed. Reanalysis has been completed in an additional four cases, and currently is being 

completed in one case. 

48
litigation through challenges to the admission of her work into evidence and to 

the integrity of DNA evidence generally.47 

Lastly, we believe that Blake’s misconduct, and the Laboratory’s failure 

to detect it for a period exceeding two years, has damaged to some extent the 

credibility of the FBI Laboratory. Media reports of the Blake matter described 

her actions in the context of past and ongoing problems at the Laboratory.48 

D. Why Blake Was Not Caught Earlier 

1. The Detection of Blake’s Misconduct 

The discovery of Blake’s misconduct was inadvertent. On Friday, April 5, 

2002, a senior DNAUI Biologist and Blake’s former PCR/STR instructor was 

waiting on her capillary electrophoresis machine to generate data when she 

happened to glance at Blake’s machine, which was nearby. The Biologist 

noticed that the information displayed was not consistent with the proper 

processing of STR negative controls because the primer peaks were absent. 

She asked Blake the next time she saw her about the data stream that her 

machine had generated, and Blake provided a nonchalant response that 

heightened the Biologist’s curiosity. She had expected Blake to explain that 

she had erred in her preparations for the electrophoresis; instead Blake 

indicated only that the configuration of the displayed data was not a problem. 

 47 In United States v. Smith, Criminal No. 2000-399(JCL) (D.N.J.), a civil rights action

against five Orange, New Jersey, police officers for the death of a prisoner in their custody, the

defense moved for a new trial after the Government disclosed that DNA test results that were

admitted into evidence by stipulation had been generated by Blake without proper processing 

of the negative controls. After extensive submissions and argument, the court ultimately 

denied the defendants’ motion, concluding that the introduction of the suspect evidence did not

undermine confidence in the result of the trial. According to the DOJ Criminal Division, in the

cases in which evidence that Blake handled was introduced, no defendant has successfully 

persuaded a court that Blake’s protocol violation mandated a reversal of the conviction. 

Challenges to exclude DNA evidence that was tested using STR technology also have

been made in the Superior Court of the District of Columbia on grounds that the FBI’s DNA 

protocols and quality assurance standards are neither minimally reliable nor generally 

accepted in the scientific community, and that Blake’s conduct exemplifies the unreliability of 

the testing procedures. See United States v. Orlando Roberts, Crim. No. F-771-01, and United 

States v. David Veney, Crim. No. F-3986-00. The court in these cases denied the defendants’ 

motions to exclude DNA evidence on these grounds. Blake did not analyze the DNA evidence in

either case.

48 See, e.g., “More Wrongdoing Found at FBI Crime Lab,” Guardian Unlimited, April 16,

2003; “New Misconduct at FBI Lab Threatens Cases – Worker Lied at Trial; Other Accused of 

Shoddy Testing,” The Baltimore Sun, April 16, 2003; see also “Voodoo Science and Another FBI

Scandal,” The Sunday Herald, April 20, 2003. 

49
On Monday, April 8, 2003, the Biologist shared her concerns about Blake 

during lunch with a fellow Laboratory Biologist. Later that day, the first 

Biologist examined the underlying data for several of Blake’s completed DNA 

profiles and discovered that the negative controls had not been processed. 

That evening, the Biologist telephoned her supervisor, the Unit Chief of DNAUI, 

Richard Guerrieri, at his home and told him of her findings. Guerrieri 

immediately recognized the potentially serious consequences if the Biologist’s 

observations proved to be accurate. 

Upon learning of the Biologist’s concerns, Guerrieri contacted Blake’s 

immediate supervisor, Forensic Biologist Examiner Alan Giusti. Guerrieri 

advised Giusti of the potential problem and directed him to conduct an 

“immediate and expeditious review” of multiple electronic raw data files for 

current cases to attempt to determine the nature and extent of the problem. 

The next day Giusti identified several case files for review and examined 

them. He advised Guerrieri that there was “unacceptable performance of 

negative controls within the selected case files.”49 Guerrieri then reviewed the 

data collected by Giusti and concluded that there appeared to have been a 

systemic omission of the negative control within Blake’s casework. With this 

finding, Guerrieri decided to notify then Acting Assistant Director of the 

Laboratory Division, Dwight Adams, of the situation.50 Guerrieri did so the 

same day, April 9. Adams advised Guerrieri to pursue the matter as a 

“technical issue” unless circumstances warranted otherwise, and to interview 

Blake and attempt to ascertain the scope of the problem. According to 

Guerrieri, a “technical issue” is something that is not the result of a deliberate 

act. Guerrieri and Giusti also met with Blake on April 9 and she falsely stated 

that she had followed all required steps in processing her samples, though she 

may have made a few mistakes. Guerrieri informed Blake that until the 

technical issue was thoroughly evaluated and resolved, she was restricted from 

casework examinations and was not authorized to perform any further 

analyses. 

2. How Blake Avoided Detection 

We do not believe that Blake’s success at escaping detection for over two 

years can be attributed to a lack of oversight by any one individual. Rather, 

Blake was not discovered earlier primarily for two reasons: 1) she was adept at 

lying to her supervisors; and 2) the DNAUI had in place a shortsighted policy 

that failed to require Unit Examiners to routinely scrutinize GeneScan® data. 

 49 Memorandum from FBI Laboratory, Scientific Analysis Section to FBI Director’s 

Office, April 30, 2002 at p. 2.

50 Adams has since become the Assistant Director of the Laboratory Division (hereafter

“Laboratory Director”).

50
Blake’s willingness to lie to her supervisors coupled with the lack of 

review of GeneScan® data proved effective in concealing her failure to process 

the negative controls. Her affidavit to the OIG is clear that she knew exactly 

what she was doing when she initialed the CE injection sheet: she was 

misrepresenting to her supervisors that she had performed testing procedures 

that she in fact had omitted. 

Blake also was fully aware that by not processing the negative controls 

and initialing the CE injection sheet she was taking advantage of a loophole in 

the Laboratory’s procedures with respect to GeneScan® data. She told the OIG 

that she “knew that no one routinely checked the raw data.” The DNAUI’s 

standard operating procedures thus allowed Blake to carry out her misdeeds 

without discovery. 

Moreover, the ease with which Blake escaped detection was facilitated by 

the Laboratory’s failure to scrutinize her work in a manner that took into 

account her documented record of evidence handling problems and her prior 

training difficulties. Both during and after training to become a PCR Biologist, 

Blake received the same degree of oversight as a Biologist with an unblemished 

record. The Examiner for whom Blake worked most often, Alan Giusti, told the 

OIG that he was not aware of Blake’s prior performance issues until after she 

was caught. He also did not know that one of his colleagues, who previously 

had trained Blake, had recommended that she not be permitted to become a 

PCR Biologist. The same individual refused to participate in her PCR training. 

Further, Blake’s record of contamination-free testing for more than two years 

did not receive scrutiny. Laboratory personnel explained they thought that it 

was inconceivable that a fellow employee would not process the negative 

controls and therefore her failure to appear in the DNAUI’s contamination log 

did not heighten scrutiny of her actions. 

III. THE FBI’S RESPONSE 

After the FBI Laboratory discovered Blake’s omission of the negative 

controls, it worked quickly to determine the scope of the problem and to 

fashion a remedy to prevent its reoccurrence. The DNAUI isolated all of Blake’s 

PCR/STR cases and performed case file reviews to determine if comparable 

misconduct had been committed by other DNAUI staff members. These initial 

remedial actions later were combined with efforts to repair the damage that 

Blake inflicted on the individual cases that she processed. We believe that, 

with some exceptions, the FBI’s early response to Blake’s misconduct was 

appropriate and timely. Our review revealed, however, that after the initial 

response, the pace of evidence retesting in the cases that Blake handled and of 

the Laboratory’s notifications to evidence contributors and prosecutors has 

been problematic. 

51
A. Initial Remedial Actions at the Laboratory 

The Laboratory’s initial remedial actions largely took place within the 

confines of DNAUI and were implemented under the supervision of Richard 

Guerrieri, the DNAUI Unit Chief. By April 15, 2002, Guerrieri was convinced 

that the lack of negative control data in Blake’s work was not the result of 

equipment failure or other accident. Effective that day, he implemented a new 

policy requiring DNAUI STR case documentation to include hard copies of the 

electronic raw data files for all casework samples that depicted a negative 

result. In addition, the new policy provided that the STR documentation must 

be reviewed by the reporting Examiner and confirmed by a second Examiner. 

The decision also was made to limit the scope of the Laboratory’s initial inquiry 

to the testing that Blake had performed as a PCR Biologist and not to examine 

her serology and RFLP examinations.51 The DNAUI collected all the electronic 

raw data from Blake’s STR tests and the training program files that she had 

completed. 

By April 30, all of Blake’s STR casework for Giusti and a second 

Examiner had been identified and was being categorized through the following 

priority system: reported inclusions (i.e., matches with known DNA samples), 

reported exclusions (i.e., elimination of match possibility with known DNA 

samples), and inconclusive results. This analysis led to the creation by early 

summer 2002 of a database of Blake’s STR cases, which included information 

such as whether a DNA report had been issued from the DNAUI and the case 

status (i.e., phase of DNA testing). In all, Blake’s STR analyses were identified 

 51 In October 2003, the OIG asked the FBI what assessment the Laboratory had 

conducted of the risk that Blake had also committed misconduct while employed in the DNAUI

as a Serologist and RFLP technician. The Laboratory replied that it was not prepared to offer a 

response at the time and thereafter interviewed Blake’s former supervisors about her early

work in the DNAUI. The same month the DOJ Criminal Division wrote to the Laboratory 

Director and recommended that the FBI “formulate a strategy to determine if Jacqueline Blake

violated any protocols in her previous work assignments in the FBI laboratory,” and that “[t]he

FBI should work with the Criminal Division to design a plan for a preliminary inquiry . . . .” 

The Laboratory responded by letter dated January 28, 2004, that its risk assessment was 

completed and that it “is not aware of any outstanding technical issues that would potentially 

compromise the testing results previously generated by Ms. Blake in the areas of serology and 

RFLP analysis.” The Laboratory reached this conclusion based on the facts that: 1) the

analysis of her STR casework had not identified any “procedural departure[s]” other than her 

failure to process the negative controls; 2) the methodologies used in serology and RFLP work

do not involve the use of amplified products from negative control samples; 3) any irregular 

control performance would have been detected through the quality assurance program and 

promptly addressed; and 4) the Laboratory’s quality assurance controls, including proficiency 

testing programs and the direct supervision of Examiners, were in place when Blake was

performing her serology and RFLP work. In short, the FBI Laboratory has expressed that it

does not believe that an examination of Blake’s work from August 1988 to March 2000 is 

warranted because Blake’s primary failing was her aversion to processing STR negative

controls – something that was not part of her serology and RFLP duties - and it is confident 

that its quality assurance controls would have caught her if she engaged in misconduct. 

52
in 103 cases. Of these, no DNA had been identified in 11 cases, Blake failed to 

process the negative controls and reagent blanks in 90 cases, and she properly 

performed the tests in 2 cases. Out of the 90 cases in which Blake failed to 

process properly the controls, DNA analysis reports were sent to evidence 

contributors from the DNAUI in approximately 45 cases. 

Guerrieri also developed a sampling plan to determine whether other 

biologists in the DNAUI failed to conduct the negative control tests. Ten active 

case files from each DNAUI PCR Biologist were scrutinized by the Unit’s 

Examiners. All files, except those for Blake, indicated that the negative control 

specimens had been processed. Based on this evidence, the Laboratory 

concluded that the omissions in question were limited to Blake.

In addition to work within the DNAUI, Guerrieri promptly notified other 

units within the Laboratory of the Blake situation. On April 15, he spoke with 

John J. Behun, Chief of the FSSU and NDIS Manager. Behun concluded that 

all DNAUI specimens that Blake processed through STR analysis that were 

entered into NDIS should be identified and removed and placed into a 

temporary target batch file until the matter was resolved. This work was 

completed by early May 2002, and 29 profiles were removed from NDIS. 

DNAUI agreed to notify the FSSU of any confirmed NDIS matches involving 

DNA profiles generated by Blake and other NDIS contributors, to inform those 

contributors of the problem, and to attempt to reanalyze the negative control 

specimens and/or the remaining physical evidence. The DNAUI subsequently 

identified a single match through NDIS that had been generated by an external 

lab prior to the removal of Blake’s profiles.52 

Guerrieri also met with the DNAUII Unit Chief. In addition to her 

casework, Blake had performed STR analyses on some reference blood samples 

from incarcerated individuals within the Federal Convicted Offender Program 

managed by a DNAUII Examiner. Guerrieri and the DNAUII Unit Chief agreed 

 52 The NDIS match was generated from a convicted offender sample. The underlying 

criminal case involved an investigation of extortion, and the evidence tested was a letter. The

FBI Laboratory, through the local FBI field office, requested a blood sample from the

incarcerated offender to verify the match. After Blake’s misconduct was discovered, the

Laboratory also requested the return of the original evidence sample for retesting. The

Laboratory never received the requested blood sample and the evidence was not returned for

retesting. Follow-up contact by the Laboratory subsequently disclosed that prosecution was 

declined in the underlying criminal action. In another matter, the DNAUI generated a match in 

NDIS between one of Blake’s profiles and an incarcerated offender. After Blake’s misconduct

was discovered, the profile was removed from NDIS and retesting performed. The newly 

generated profile matched the DNA profile of the same offender that previously was identified

by NDIS. In addition, the Laboratory identified matches in a local DNA database from two of 

Blake’s profiles. In one case, the FBI obtained resubmitted evidence and issued a new report. 

The profile from the retested evidence matched a profile in NDIS. The FBI is still waiting to 

receive evidence in the second case despite repeated requests to the contributor to resubmit its 

evidence.

53
that these samples should be located and retesting performed where 

appropriate.53 

The Laboratory also sought guidance from FBI Headquarters, including 

the FBI’s OPR and OGC. In mid-April, Adams met with Michael DeFeo, 

Assistant Director for OPR, and agreed that the Laboratory would forward 

documentation describing Blake’s conduct to OPR for review. DeFeo advised 

Adams that the matter would have to be referred to the OIG. Guerrieri and 

DiZinno subsequently met with an OPR Unit Chief to brief him on the Blake 

matter. DiZinno said that the Laboratory hoped to receive guidance on what 

corrective actions should be implemented, including whether the Laboratory 

needed to evaluate Blake’s serology and RFLP work. The OPR Unit Chief told 

them to furnish him with a written report outlining the misconduct allegations 

and the actions taken by the DNAUI in response to the discovery of the 

misconduct. On April 30, 2002, the Laboratory provided a 6-page 

memorandum to the FBI Director, with a copy to OPR, that described Blake’s 

actions. 

On May 7, 2002, OPR forwarded Guerrieri’s April 30 Memorandum to the 

OIG, which began an investigation. As mentioned earlier, over the next five 

weeks OIG staff interviewed Laboratory personnel, examined documents, and 

met with representatives of FBI OGC. At a meeting on May 21, 2002, OGC 

explained that it would be heavily involved in the FBI’s notifications to 

prosecutors, including providing legal guidance, and that the Laboratory would 

manage the Bureau’s response to the Blake matter. The OGC and OIG agreed 

that the OIG would not be involved in managing the FBI’s activities, though 

information would be shared to ensure that there was no interference with the 

OIG’s investigation. The FBI OGC also explained that a management plan 

would be developed. 

Following these developments, the DNAUI focused some attention on its 

operating procedures. In July 2002, as part of the Unit’s annual review of its 

protocols, Guerrieri requested that DNAUI program managers take into 

account Blake’s misconduct when formulating proposed protocol revisions. 

However, other than the requirement that GeneScan® data be included in the 

case file for review by the Examiners, Guerrieri did not receive any suggested 

modifications to the protocols from his staff. In addition, later that year 

Guerrieri initiated a project to map case processes in the DNAUI to facilitate 

communications and decision-making. See generally Chapter Five, Section 

III.A.2 (describing need for decision aids). 

 53 Blake processed 105 offender samples. The Laboratory has retested 75 of these

samples and expects to complete retesting of the remaining 30 by the end of March 2004. The 

Convicted Offender Program currently has a backlog of 24,000 samples waiting to be 

processed. 

54
B. Identification and Processing of Cases That Required 

Corrective Action 

After the FBI Laboratory took action to remedy the processing of negative 

controls in the DNAUI, its focus turned to correcting the damage that Blake 

caused in the cases she handled. This task has proved difficult for the 

Laboratory. For example, the majority of the evidence that required retesting in 

Blake’s cases remained unevaluated over 23 months after her misconduct was 

detected and, in some cases, the Laboratory’s testing has not been completed 

even though the evidence was submitted to the Laboratory over four years 

ago.54 Moreover, as of March 2004, nearly half of the evidence contributors in 

cases where Blake failed to process the negative controls have not received 

written notification that Blake’s misconduct impacted their evidence.

1. Early Reaction and Planning 

One of the most pressing issues for the DNAUI after the discovery of 

Blake’s misconduct was to identify the cases where an Examiner had relied on 

Blake’s analyses and subsequently issued a report to a requesting party, and 

then to ascertain the status of legal proceedings in those cases. Completion of 

this work was not easy, however, because the Laboratory did not have a system 

to track legal proceedings after its findings were disseminated. As with many 

other issues, the formulation of the Laboratory’s response to this problem was 

left to DNAUI Unit Chief Guerrieri and his staff. With Guerierri’s oversight, the 

Laboratory established a database of Blake’s cases in early summer 2002 to 

track its remedial work and to stay abreast of case developments. 

Guerrieri met with an FBI Assistant General Counsel on April 10, 2002, 

two days after the discovery of Blake’s actions, to inform her of the Blake 

problem.55 From the outset OGC recognized the potential gravity of the 

situation. The OGC lawyer e-mailed her supervisor on April 15 and explained 

as follows: 

There is a major problem brewing in DNA Unit I that concerns a 

technician’s work in preparing cases for the overall review of an 

examiner. They don’t yet know the dimensions of the problem – it could 

be huge – implicating all of the cases of examiner Alan Giusti and other 

examiners as well, for years. They don’t know if mistakes were 

purposeful or inadvertent, but they may threaten the integrity of our 

results across the board (Technicians do most of the underlying bench 

 54 The FBI Laboratory has a goal for each unit to process its evidence within 60 days of 

receipt. 

55 At the time, the Assistant General Counsel was the primary OGC point of contact for 

the Laboratory. 

55
work and examiners make the conclusions and write the reports). They

are in the process of doing a review to try to ascertain the scope of the 

problem and whether it implicates other technicians as well (which they 

don’t think it does). They have not yet notified OPR but they have taken 

the technician off cases immediately. 

We may need a task force on this one – perhaps drawing from ASCLDLAB expertise, and/or others out there in the forensic community. It’s 

too early to tell anything just yet . . . . 

Approximately one month later, OIG staff who were investigating Blake’s 

actions met with OGC staff members and were told a management plan would 

be developed to guide the FBI’s response to Blake’s failure to conduct the 

required contamination testing and that it would be shared both with the OIG 

and the Office of the Deputy Attorney General. The OIG similarly was advised 

by the OGC Assistant General Counsel in May 2002 that “a policy will have to 

be arrived at in concert with the Lab.” With the exception of the April 30, 

2002, memorandum from the Laboratory to the FBI Director described supra, 

which the Laboratory explained to the OIG was its initial strategy, Laboratory 

management has acknowledged that no planning material was created to guide 

its remedial activities and to coordinate the work of the DOJ and FBI personnel 

working on the Blake matter.56 Our review of documents furnished by the FBI, 

including e-mails, did not reveal any communications that outlined 

prospectively for the various participants what the FBI’s response should 

entail, what the various participants were tasked to complete and, as 

appropriate, by when. In addition, in November 2002, the OGC Assistant 

General Counsel advised the OIG that no policy had been formulated for what 

she described then as a “fairly fluid” situation. 

According to Laboratory employees, throughout the Spring and Summer 

of 2002 Laboratory management regularly discussed with the OGC how to 

proceed. The Laboratory Director explained that initially he held regular 

meetings with his staff to address Blake-related issues. The Department was 

not directly included in these meetings though, and the Laboratory Director 

explained that he has never spoken to the DOJ contact who the Criminal 

Division assigned to track developments in the Blake matter – Barry Sabin, the 

Chief of the Counterterrorism Section. According to Sabin, his role was to 

learn the facts of the Blake case, to identify any legal issues that required 

attention and advise the FBI accordingly, and to monitor the FBI’s response on 

 56 The April 30, 2002, memorandum described the Laboratory’s early remedial actions, 

such as requiring inclusion of GeneScan® data in the casefile, the removal of Blake’s profiles

from NDIS, and the collection of Blake’s STR data files. 

56
behalf of DOJ.57 The Laboratory Director further stated that he did not know 

what exactly the Counterterrorism Section was doing.58 He also added that he 

has not asked anyone for an explanation of what the Counterterrorism 

Section’s role is. He stated that he relies upon OGC to provide the Laboratory 

with pertinent guidance. Other Laboratory employees explained that they were 

surprised that there was not more direct contact with DOJ personnel. One 

senior FBI manager told the OIG that there was no leader overseeing the 

response of the FBI and DOJ to the problems caused by Blake’s misconduct, 

and that was a problem because no one was in charge to coordinate activities. 

2. Notifications 

After the Laboratory determined that the failure to process the negative 

controls was limited to Blake and that her omissions were not the result of a 

technical defect, Laboratory management decided, with OGC assistance, to 

notify appropriate contributing agencies and/or prosecuting attorneys of the 

limitations regarding Blake’s STR analyses. Additionally, Laboratory 

management decided that all trials in which Giusti had previously offered 

expert testimony regarding STR analyses based upon Blake’s work would be 

identified, the resulting electronic data files reviewed, and appropriate officials 

notified if unacceptable performance of negative control specimens was 

 57 In response to a draft of this report, the DOJ Criminal Division stated that the role of

its attorneys in the Blake matter was limited to learning the pertinent facts, identifying legal 

issues related to criminal prosecutions that required attention, and monitoring to the extent 

necessary the FBI’s response to these prosecution-related legal issues. The Criminal Division 

further explained that it was never asked to provide programmatic, scientific, or policy advice

on issues related to Blake’s misconduct. Our review found, however, that the work of the

Criminal Division attorneys was not so limited, and the Counterterrorism Section in fact 

provided recommendations to the FBI on matters not specifically identified with criminal 

prosecutions. For example, in October 2003 Sabin wrote to the Director of the FBI Laboratory

and stated that “[t]he FBI should formulate a strategy to determine if Jacqueline Blake violated 

any protocols in her previous work assignments in the FBI laboratory. The FBI should work

with the Criminal Division to design a plan for a preliminary inquiry, and should keep the

Criminal Division advised of any findings.” We also were told that the Counterterrorism 

Section requested the FBI to provide prompt notifications to the evidence contributors who 

have not yet been told that Blake had processed their evidence improperly. These are cases

where the Criminal Division believed that there are no prosecution-related legal issues (e.g., 

that Blake’s work will not be relied upon to gain a conviction). Whether prosecution-related or 

not, we concluded that the advice of the Counterterrorism attorneys was appropriate. 

 58 FBI personnel have expressed confusion over the work that Sabin was directed to 

perform. One FBI employee asserted that Sabin did not explain his role, while another

employee said that he “did not know how DOJ management fits in.” According to the Deputy 

Director of the FBI Laboratory, no meeting was ever held where the various FBI and DOJ

participants identified their roles and responsibilities. Sabin told the OIG that he explained his 

role (as described in text above) to the OGC and to the Deputy Director of the Laboratory. 

57
detected.59 By April 30, 2002, the Laboratory had completed identification of 

Blake’s STR analyses for Examiners Giusti and Garvey and had developed a 

priority notification scheme that accounted for various case considerations, 

including whether the DNAUI previously had provided testimony, trial status, 

terrorism linkages, and whether suspects had been identified. At 

approximately the same time Giusti began notifying evidence contributors by 

telephone of the situation; he also conferred with case prosecutors.

During May 2002, Guerrieri worked with OGC to create a notification 

letter for DNA contributors. Sabin began to assist the FBI with contributor 

notification and other issues at this time. He reviewed and provided input on 

the draft notification letter that Guerrieri and OGC had prepared. 

On June 5, 2002, the first notification letters, signed by the Laboratory 

Director, were sent to 25 DNA contributors and prosecutors who had received a 

DNA report from the DNAUI. The letter stated cryptically that “some of the 

control samples were not processed to completion” during the DNA analysis 

and that the “DNA testing results reflected in [the issued report] should not be 

used for investigation or prosecution purposes until such control samples have 

been evaluated and determined to thoroughly satisfy established 

requirements.” The letter requested that the contributor resubmit the evidence 

for additional analysis. The OIG subsequently raised concerns about these 

letters primarily because they failed to explain Blake’s conduct adequately. 

Additional notification letters signed by the Laboratory Director were sent 

in July and October 2002 to 44 contributors and prosecutors. These letters 

contained the same language used in the Laboratory’s June letter, and were 

not sent consistently to associated prosecutors. According to one Laboratory 

employee, OGC became much more involved in notification and case tracking 

issues beginning in October 2002. A new OGC attorney was assigned that 

month to handle the Blake matter. The OIG was able to verify that OGC 

delivered 71 letters covering 56 cases to contributors and prosecutors in late 

November and December 2002,60 many to the same contributors who received 

earlier notification from the Laboratory.61 OGC’s notification letters described 

 59 One matter that required immediate attention during the week of April 9, 2002, was 

Texas v. Berkley, a homicide case in El Paso, Texas. The Laboratory previously had issued a 

report based upon Blake’s work and Giusti was scheduled to testify about his conclusions 

during the week of April 15, 2002. Guisti requested and received from authorities in El Paso a 

sample for retesting, completed the retesting, and issued a new report dated April 15, 2002,

confirming the results of the original testing. Giusti testified in El Paso on April 17, 2002. 

60 OGC developed notification letter templates to cover cases in which: 1) there was no

DNA to test, 2) Blake had followed the negative control protocols, and 3) a previous letter had 

been sent but more detailed guidance was necessary. 

61 OGC issued another five letters in January 2003, and the Laboratory sent four

letters in August and September 2003.

58
Blake’s misconduct, the function of negative controls, and the initiation of the 

OIG investigation. It also requested the addressee to resubmit evidence for 

testing and to share a copy of the notification letter with any prosecutors who 

were working on cases to which the previously submitted evidence related. 

The Counterterrorism Section at DOJ also assisted the FBI to inform 

DNA contributors and prosecutors of the Blake matter by issuing letters 

supplementing the information contained in the FBI’s notifications. Between 

July and September 2003, the Counterterrrorism Section sent out 27 letters to 

prosecutors and contributors and has issued another 2 since that time. 

Following discussions with prosecutors in Blake’s cases, the Counterterrorism 

Section focused its notifications on matters where the possibility remained for 

Blake’s DNA analyses to be relied upon in future investigative activities and/or 

court proceedings. The Counterterrorism Section prepared different letters 

depending on whether Blake’s conduct previously had been disclosed to 

defense counsel. These letters emphasized disclosure obligations, that Blake 

had custody and control over the original submitted evidence that was used to 

conduct the initial DNA analysis, and that there was no indication that Blake 

failed to abide by any Laboratory protocols in the DNAUI other than those 

regarding the processing of control samples. The Executive Office for United 

States Attorneys also issued an 8-page guidance document regarding the Blake 

matter in June 2003 to all United States Attorney’s Offices based on legal 

analysis performed by the Counterterrorism Section.62 That document 

addressed a host of different legal issues implicated by Blake’s conduct, 

including chain-of-custody and ethical considerations, and was included by the 

Counterterrorism Section in its correspondence to DNA contributors and 

prosecutors. 

Despite these efforts, as of February 2004, DNA contributors in 42 cases 

still had not received written notification that Blake had failed to process 

properly the evidence they had submitted. Of this number, 20 contributors 

received no notification at all concerning Blake’s handling of their evidence. Of 

the written notifications provided, in some situations as many as three letters 

have been sent to the same individual. See further discussion in Chapter Four, 

Section IV. 

3. Evidence Retesting 

In addition to its efforts to notify DNA contributors about the Blake 

problem, the Laboratory developed procedures to provide contributors with 

retesting of evidence. Initially Guerrieri, with the approval of Adams, opted to 

process only the negative controls that Blake had not completed. By late June 

or early July 2002, however, Guerrieri determined that full retesting of all 

 62 This guidance is now being included with the Laboratory’s reports that issue in 

Blake’s cases. 

59
samples in Blake’s STR cases in which the negative controls had not been run 

was required to ensure technically valid results that could be used as evidence. 

Early testing of the uncompleted negative controls had resulted in the 

discovery of DNA contamination in some samples, while other analyses were 

missing a quantification step. Under these circumstances, and based on 

Guerrieri’s recommendation, Adams opted for full retesting.63 According to 

Guerrieri there was no discussion whether this decision had legal 

ramifications, and if so, what they might be. 

The Laboratory also decided in Spring 2002 to perform the retesting itself 

rather than attempt to out-source the work to a contractor. According to one 

Laboratory employee, this decision was made within days of learning of Blake’s 

misconduct. The decision also was made despite the fact that the Laboratory 

was faced with a substantial backlog of cases in the DNAUI. According to 

DiZinno, the Laboratory had, and continues to have, an unacceptable 

turnaround time processing evidence, especially in the DNAUI. By December 

2002 the DNAUI recognized that it could not complete the retesting of Blake’s 

cases in a timely manner. It thereafter reversed course and entered into 

contracts in September 2003 to have the evidence in Blake’s cases retested by 

private laboratories. The Laboratory stated in early 2004 that it expected to 

have this work completed by the end of March 2004. DiZinno acknowledged to 

the OIG that the Laboratory underestimated the time it would take to retest 

Blake’s evidence and that the pace of retesting has been problematic.64 As of 

February 2004, evidence retesting had been completed in only 27 out of the 90 

cases where Blake failed to process the negative controls, and 20 of the original 

29 profiles removed from NDIS still have not been restored.65

IV. OIG ANALYSIS 

Our examination of the FBI’s response to Blake’s misconduct revealed 

that the FBI Laboratory worked quickly to determine the cause of the negative 

control omissions in Blake’s cases and whether other biologists in the DNAUI 

had experienced the same problem. After the Laboratory confirmed that the 

 63 As described by Guerrieri, full retesting entails completing all the duties of the

Serologist, PCR Biologist, and Examiner described in Chapter Three, Section I.B.2.b of this 

report. 

64 The Criminal Division at DOJ has expressed the same sentiment. In a letter to the

Laboratory Director dated October 28, 2003, the Counterterrorism Section recommended that 

“remedial measures [] be taken as soon as possible,” and that “[r]etesting should be conducted 

in an expedited fashion.” 

65 Of the 90 cases where Blake failed to process the negative controls, the FBI

Laboratory, with the assistance of its contractors, intends to complete evidence retesting in 64 

cases. In the remaining 26 cases, retesting has been deferred pending the resubmission of 

evidence from the original evidence contributor. 

60
failure to process the negative controls was limited to Blake and not due to 

technical causes, such as equipment failure, it self-reported the facts and 

circumstances regarding her misconduct to the FBI OPR and sought guidance 

on how to fashion a proper response. OPR advised the OIG of the matter 

approximately one month later.66 The DNAUI also promptly closed the loophole 

in its procedures that allowed Blake to escape detection for over two years: it 

required GeneScan® data to be included in the case file and reviewed by two 

Examiners. The effectiveness of the Laboratory’s early response to Blake’s 

wrongdoing was due largely to the efforts of the DNAUI Unit Chief, Richard 

Guerrieri, and his staff, who deserve credit for these actions. 

However, our review identified other issues of concern regarding the FBI’s 

response to Blake’s misconduct. These include: 1) the timeliness of the 

retesting of evidence and of written notifications to DNA contributors and 

prosecutors; 2) the legal analysis provided by the FBI OGC in the months 

immediately following the discovery of Blake’s misconduct; and 3) the scope of 

the Laboratory’s remedial actions. We also believe that given Blake’s prior 

work history and training experiences, the Laboratory should have paid more 

careful attention to her performance on her initial PCR qualifying and 

proficiency tests and on the first several profiles she generated after she 

became a PCR Biologist. 

A. Timeliness of Evidence Retesting and Notifications 

The retesting of evidence in Blake’s cases has taken too long. The 

Laboratory’s Deputy Director told us that he was not satisfied with the pace of 

the retesting, and the DOJ Criminal Division echoed the same concern in an 

October 2003 letter to the Laboratory Director that requested that evidence 

retesting “be conducted in an expedited fashion.”67 Given that the Laboratory 

has a goal of 60 days for each unit to process its evidence, and that the DNAUI 

has taken over 2 years to complete its reanalysis in many of Blake’s cases (and 

in some matters over 4 years for the Laboratory to complete all requested 

analyses), we think it is self-evident that the pace of retesting has proceeded far 

too slowly.68 

 66 Under the OIG’s Investigative Procedures Relating to FBI Employees, the FBI is 

required to report immediately to the OIG non-frivolous allegations against any employee or

contractor which, if substantiated, would constitute a prosecutable offense. 

67 Letter from Barry Sabin, Chief, Counterterrorism Section, Criminal Division, 

Department of Justice to Dwight Adams, Assistant Director, FBI Laboratory, dated October 28,

2003, at 1.

68 Laboratory Director Adams told the OIG that he was satisfied with the pace of

retesting, a position we find hard to reconcile given the multi-year delays described above. The 

DNAUI Unit Chief stated that he wished he had had the staff to complete the retesting earlier 

but that he was satisfied with the procedures the Laboratory had employed to conduct the

work. He emphasized that he would not sacrifice the quality of the retesting for time savings. 

61
Several factors have contributed to the delays, including events beyond 

the Laboratory’s control, such as the responsiveness of contributors to 

resubmit their evidence. The delays have been significantly exacerbated, 

however, by a decision the Laboratory made soon after Blake’s detection. 

Although the DNAUI at the time had a substantial backlog of cases to analyze, 

and historically has been a bottleneck in the Laboratory’s processing of 

evidence, Laboratory management opted not to seek contractor assistance with 

Blake’s cases and instead attempted to complete the reexaminations itself. The 

result was that the Laboratory had less than ten cases retested by the end of 

2002; it was only at that point that the decision was made to seek contractor 

support. The Laboratory entered into two contracts in September 2003 with 

private laboratories to retest the balance of evidence in Blake’s cases. 

We believe that the Laboratory failed to analyze properly whether it could 

absorb the additional retesting work and complete it in a timely fashion. The 

backlog of unprocessed DNA evidence and manpower constraints should have 

alerted the Laboratory to the need to seek outside assistance sooner than 

December 2002. The consequence of this decision is significant. The 

Laboratory’s failure to seek the necessary resources promptly heightened the 

risk that a criminal would avoid identification because his or her DNA profile, 

which otherwise would be available but for Blake’s misconduct, is not included 

in the appropriate DNA databases for law enforcement agencies to search. 

Similarly, we are concerned with the time it took for the attorneys who 

worked on the Blake matter to generate a sufficient notification letter, and that 

nearly two years after the discovery of Blake’s misconduct there were still 42 

cases where evidence contributors had not received a letter notifying them that 

Blake had failed to process properly the evidence that they submitted. After 

the Laboratory issued its first letters in June 2002, which FBI OGC and the 

DOJ Counterterrorism Section worked on jointly, the OIG questioned the 

sufficiency of the notification. In our view, the June letter failed to describe 

adequately what Blake did. The Laboratory, however, continued to issue 

notification letters in July and October 2002 with the same language as the 

June letter.69 FBI OGC began issuing its own notification letter to contributors 

and prosecutors in late November 2002 that described Blake’s misconduct and 

was drafted largely by OGC supervisors. We believe that this letter was 

sufficient to alert evidence contributors and prosecutors to Blake’s misconduct 

 69 According to the Criminal Division, after the OIG voiced its objection to the June

letter, the Criminal Division drafted a revised letter addressing all of the issues raised by the

OIG and forwarded it to FBI OGC. 

62
such that proper disclosures could be made.70 We are concerned, however, 

that the Laboratory’s letters were not sent or copied to all associated 

prosecutors. 

Within the first two months following Blake’s detection we believe that 

the OGC staff attorney assigned to the Laboratory should have prepared a 

notification letter comparable to the one that was sent by OGC in November 

and December 2002, and that the written notification should have been 

completed by mid-summer 2002 at the latest. These letters should have been 

delivered to all evidence contributors and their associated prosecutors. 

Although we did not find case-related prejudice resulting from the timing of the 

notifications, we believe that the Blake matter required earlier and more 

complete notification than was provided. 

We also are concerned that nearly two years after Blake’s detection, DNA 

contributors in 42 cases had not received written notification that Blake had 

failed to process properly the evidence they submitted, and 20 of these 

contributors received no notification at all concerning their evidence. 

According to the FBI, with two exceptions the cases where notice has not been 

furnished are ones in which no report was issued from the DNAUI and no 

 70 In response to a draft of this report, the FBI OGC took issue with our view that the

letters issued in November 2002 by OGC differed significantly from the Laboratory’s earlier 

letters, which made no mention of Blake’s misconduct and stated simply that “[a] review of the

data used to prepare the DNA analysis reports of examination . . . revealed that some of the

control samples associated with these analyses were not processed to completion.” In contrast, 

the OGC letters stated that “one biology technician in one of the FBI Laboratory’s two DNA

Units systematically and repeatedly violated the Laboratory’s standard operating protocols by 

not processing negative control specimens to completion in approximately 100 cases over

approximately a two-year period.” In its response, the FBI OGC took the position that: 

the only substantive distinction between the initial and subsequent letter was the

inclusion of Blake’s misconduct as the cause of the flawed test results. It is a 

distinction without a difference (and certainly not a difference of any legal import) with 

respect to the sole purpose of the notice: to advise the contributor not to rely on the

results. 

We are concerned by this comment from OGC. As repeatedly explained to the OIG throughout

the course of this review, both the FBI and DOJ issued notification letters to contributors and 

prosecutors so that Brady obligations could be satisfied. The purpose of the notification

therefore was not simply to advise the contributor not to rely on the testing results. It also was 

to satisfy constitutional obligations. Impeachment evidence falls squarely within the dictates of

the Brady rule. The Criminal Division’s notification to federal prosecutors concerning Blake,

which devotes several pages to an analysis of Brady obligations, further recognizes that 

whether information constitutes Brady material can depend upon the extent to which it could

alter defense strategy. As explained in footnote 48, counsel have attempted in a limited 

number of cases, albeit without success, to use Blake’s conduct to question the reliability of 

DNA testing procedures. In light of these considerations, we believe there is a distinction,

indeed an important one, between failing to process negative controls due to an isolated event 

of equipment malfunction versus a laboratory employee who “systematically and repeatedly 

violated the Laboratory’s standard operating protocol.” We encourage the FBI to reevaluate

this issue.

63
suspect has been identified. The FBI also has explained that the individuals 

who submitted the evidence in these cases have not contacted the Laboratory 

to inquire about the evidence, possibly indicating that the case in question is 

inactive. Although 11 of the 20 cases in which no notice was provided 

originated either from the Washington Field Office of the FBI or the Washington 

Metropolitan police, which received written notifications of Blake’s wrongdoing 

in other cases as well as other communications about her misconduct,71 we 

believe that all evidence contributors and associated prosecutors should have 

been notified directly in writing during the summer of 2002 that Blake had 

failed to process their evidence properly. At that juncture the evidence 

contributor would have had the ability to make an informed decision whether 

to resubmit new evidence or to seek testing services from another source. 

Because 20 of these contributors were not informed, however, they were 

deprived of the opportunity to make this decision. Moreover, we believe that 

the failure to provide these notifications by this date violated the spirit of the 

message that the Laboratory conveyed to the FBI Director and FBI OPR in its 

April 30, 2002, memorandum in which it explained that “[w]ith the assistance 

of the OGC, the LD [Laboratory Division] will notify all appropriate contributing 

agencies and/or prosecuting attorneys of the technical issue and potential 

limitations regarding the STR analyses conducted by Ms. Blake.” The 

Counterterrorism Section also informed the OIG that it encouraged the FBI to 

make full and complete written notifications to all evidence contributors and 

associated prosecutors. 

We further believe that the timeliness of the FBI’s evidence retesting and 

notifications was hindered by the Laboratory’s failure to maintain written 

planning materials and to disseminate them to officials who were assisting the 

Laboratory with the Blake problem. The FBI was unable to identify any 

document for us that set forth prospectively for Laboratory staff members the 

steps they should take to address Blake’s misconduct and the timeframes 

contemplated to complete particular tasks. OPR asked for a written plan, and 

the Laboratory should have updated its April 30 memorandum as time 

progressed and shared it with others. FBI OGC explained to the OIG in May 

2002 that a management plan would be created to guide the response over 

time and that it would be shared with the OIG and the Office of the Deputy 

Attorney General. Such a plan was never developed, and the consequence was 

unnecessary inefficiencies and delay. 

We believe that had the Laboratory prepared a management plan, it 

would have diminished the likelihood that three entities – the Laboratory, FBI 

OGC, and the Counterterrorism Section – all would need to send out 

notification letters. It also may have triggered more careful analysis regarding 

 71 The FBI Laboratory made a presentation for the United States Attorney’s Office for 

the District of Columbia, and personnel from the Criminal Division, the FBI OGC, and the

Laboratory briefed that office’s management on the Blake matter. 

64
the decision to keep the retesting of evidence within the Laboratory rather than 

seeking a contractor to assist with the work. This plan should have tasked the 

FBI OGC attorney assigned to the Laboratory with specific notification-related 

assignments and coordination responsibilities. It also should have identified 

milestones for the evidence retesting and triggers for the reevaluation of the 

need for contract support. 

We are also troubled that Laboratory management at the highest levels 

seemed disinclined to seek out DOJ’s views and to coordinate its planning 

activities with DOJ. Adams stated that the Laboratory Division at the FBI was 

“in charge” of the Blake situation, but at the same time he explained that he 

didn’t know what the Counterterrorism Section was doing. We believe that if 

that were the case, the Laboratory Director should have reached out to DOJ to 

understand its views on the Blake problem, and if the Laboratory and DOJ had 

differing priorities, these should have been identified, discussed, and reconciled 

at the earliest possible moment. We believe that DOJ made it clear to FBI OGC 

that it wanted fuller disclosures and more information provided to contributors 

and prosecutors. DOJ pressed for more expedited evidence retesting. The 

Laboratory was slow to respond, with the result that two years after Blake’s 

detection, evidence still is waiting to be retested and many evidence 

contributors still do not know that their evidence was improperly processed by 

Blake. 

B. The Sufficiency of Legal Services Provided to the Laboratory in 

the Months Following Blake’s Detection 

We also question the relationship between the Laboratory and FBI OGC 

in the months following Blake’s detection. Blake’s misconduct required the 

Laboratory to address numerous issues, such as what the permissible uses are 

of Blake’s corrupted profiles and how to conduct the retesting of evidence. 

Indeed, in the initial aftermath of Blake’s discovery, the Laboratory needed 

assistance merely to determine what the issues were that needed to be 

evaluated and resolved. 

The OIG’s interviews with the Assistant General Counsel from OGC who 

handled the Blake matter from April to November 2002, and others have led us 

to conclude that the Laboratory did not receive the quality of legal services that 

one would expect from FBI OGC, and Laboratory management was not 

sufficiently assertive when soliciting legal advice. In our view, substantial effort 

was required at the outset of the Blake matter to: 1) learn the underlying facts, 

2) identify and organize the legal issues that those facts implicated, 3) analyze 

and explain to the Laboratory the legal principles that were pertinent to the 

issues in question, 4) present the litigation risks and legal policy considerations 

associated with particular courses of action available to the Laboratory, and 

5) highlight pitfalls or issues of special concern that warranted the Laboratory’s 

attention. 

65
Both the Laboratory and OGC explained that no meeting was ever held to 

brief the FBI Laboratory on the legal considerations described above or to 

present the findings and conclusions of any legal research. Indeed, the OGC 

attorney told us that she did not conduct any legal research. No memoranda 

were prepared for the Laboratory and our review of the Assistant General 

Counsel’s case file did not reveal any documents, including e-mails or notes, 

that set forth substantive legal analysis or otherwise identified the issues and 

organized them in a way that would be comprehensible to the Laboratory. 

Disclosure issues were obvious from the outset, but there were others that 

should have been addressed in a meaningful way much earlier than they were, 

such as what was permissible with the off-loaded NDIS profiles and chain-ofcustody issues. The Assistant General Counsel’s response to our questions on 

several occasions was that we did not understand the way FBI OGC operated. 

She further explained that she is a traditional counselor at law who rendered 

advice based largely on past experience: someone posed a question and she 

provided an answer. 

This approach was ill-suited to the complexities of the Blake matter, and 

we believe that her conduct had consequences for the response of the FBI and 

DOJ to Blake’s misconduct. The deficit was readily apparent to the OIG in the 

first few months following Blake’s detection, and in our view necessitated, for 

example, that her supervisors become extensively involved in the provision of 

notifications to contributors and prosecutors. We believe that a senior OGC 

staff attorney should have demonstrated the leadership to furnish 

comprehensive and timely legal support services for the Laboratory. 

C. The Scope of the Laboratory’s Remedial Actions 

Our review concluded that the Laboratory’s remedial actions were not 

comprehensive enough in two respects: 1) the scope of the Laboratory’s selfgenerated protocol revisions were too narrowly focused; and 2) the assessment 

of Blake’s work for protocol discrepancies failed to account for her work as a 

Serologist and RFLP technician, which together accounted for 12 of the 14 

years that she was employed in the DNAUI. 

As described earlier, after the Laboratory identified Blake’s wrongdoing, 

the DNAUI promptly changed its operating procedures to require the inclusion 

of GeneScan® data in the case file and its review by two Examiners. Laboratory 

Deputy Director DiZinno explained that once the Laboratory understood 

exactly what Blake had done, the necessary changes in procedure occurred 

quickly. The DNAUI Unit Chief also requested that, as part of the Unit’s 

annual protocol review, his program managers submit recommendations for 

protocol revisions that took into account Blake’s wrongdoing. The only 

suggestion that was offered, however, was to institute what already had been 

done by that time: include GeneScan® data in the case file. 

66
We believe that Blake’s actions should have triggered an extensive 

reevaluation within the DNAUI of its protocols. DiZinno told the OIG that one 

of the lessons learned from the Blake situation is that the Laboratory could not 

count on the trustworthiness of all of its employees. Within the first two 

months of learning of Blake’s wrongdoing, the Laboratory should have laid the 

groundwork for a comprehensive reevaluation of the DNAUI’s protocols. 

Instead, the Laboratory seemed to focus on a far narrower issue – how do we 

spot someone who has developed an aversion to processing negative controls 

involving amplified DNA samples – and did not comprehensively examine its 

protocols, which is a clear deficiency.

We further believe that the Laboratory erred when it decided to limit its 

investigation of Blake to the last two years of her work, pending the discovery 

of additional incriminating evidence against her. The Laboratory did not even 

ask Blake’s serology and RFLP supervisors whether they had noticed anything 

suspicious about her work until the OIG asked in October 2003 what 

assessment the Laboratory had conducted on Blake’s work from 1988 through 

March 2000 concerning the risk that she had violated DNAUI protocols. The 

DOJ Criminal Division also raised this issue in a letter to the Laboratory at the 

end of October 2003. 

The Laboratory has taken the position that no additional inquiry is 

warranted on the cases that Blake handled during her 12-year tenure as a 

serologist and RFLP technician primarily because it appears that Blake’s major 

failing was limited to her aversion to running STR negative controls, there is no 

indication that she ever intended to manipulate test results, and the 

procedural controls in place in the DNAUI would have caught any misconduct. 

We think, however, that the message from the totality of circumstances 

surrounding Blake, including her 1994 performance appraisal and training 

history, is not so narrowly tailored: Blake was an untrustworthy employee who 

manipulated the DNAUI’s procedures and lied about her conduct. The

Laboratory’s confidence in its serology and RFLP protocols to detect 

misconduct by Blake also must be considered in light of the fact that its STR 

protocols did not detect her misconduct.72 

We have no evidence that Blake, in fact, violated DNAUI protocols while 

working as a Serologist or RFLP technician. We also have no indication that 

Blake’s supervisors from 1988 to March 2000 failed to scrupulously evaluate 

her work and catch and correct every discrepancy that appeared in her 

casework. But we also believe that the Laboratory was not fully aware at the 

time of the kind of employee it was dealing with. Under these circumstances, a 

 72 We say this fully aware that the procedures in STR and RFLP are completely 

different. 

67
file review of a subset of Blake’s early work, where identifiable, is appropriate 

taking into account what is now known about Blake’s conduct.73 

D. Oversight of Blake’s PCR Qualification Testing and Early PCR 

Work 

Although Blake’s work and training performance was deficient at times, 

she did not receive additional scrutiny from the Laboratory, either during her 

qualifying testing to become a PCR Biologist or as she completed her first few 

examinations as a PCR Biologist. We believe that this was an error. Blake’s 

record in the DNAUI was inconsistent enough to warrant additional scrutiny. 

The Examiner who oversaw most of Blake’s work as a PCR Biologist was not 

made aware of her negative performance issues until after she was caught. 

Also, no one asked him to pay closer attention to Blake’s work. Blake’s 

supervisors should have had more information, consistent with applicable law 

and regulations, and should have been looking more closely for discrepancies 

in her work. Although it is not possible to say with certainty that Blake’s 

misconduct would have been discovered earlier if her supervisors had had 

more complete information, we believe that the additional scrutiny would have 

increased the probability that she would have been detected prior to April 

2002. Moreover, if her work had been analyzed during her initial qualifying 

and proficiency tests as a PCR Biologist, or during her first several tests as a 

PCR Biologist, her failure to run the negative control tests would likely have 

been detected by the summer of 2000 before she had processed many cases. 

V. RECOMMENDATIONS 

With regard to the FBI’s response to Blake’s misconduct, we recommend 

the following: 

1) To facilitate prompt communications with evidence contributors and 

prosecutors in the event of future testing problems, the Laboratory 

should maintain the following information in an electronic format 

that can be shared conveniently with other FBI components (such 

as, FBI OPR and FBI OGC) and DOJ: all contributor contact and 

case information currently required for an evidence contributor to 

 73 In this regard, we respectfully disagree with the conclusion of the United States 

District Court for the District of New Jersey. See generally United States v. Smith, Criminal 

No. 2000-399(JCL) (Memorandum Order, Jan. 12, 2004, D.N.J.) at 2 (denying motion for a new

trial where Blake had performed DNA examination). Blake’s conduct was not “unsophisticated,” Smith, at 4; we believe that it was calculated and cunning. Blake exploited a loophole

to her advantage that no one previously had recognized. She also was clever enough to 

experiment with her technique in the PCR training program, perhaps to see if anyone would

notice. Its discovery at that point could have been discounted by the difficulty of having to

learn complex test procedures. 

68
request an evidence examination (see FBI Handbook of Forensic 

Services, (http://www.fbi.gov/hq/lab/handbook/intro2.htm); the email address of the evidence contributor; and the name, title, 

agency, address, telephone number, and e-mail address of any 

associated prosecutor(s); 

2) In circumstances where a protocol violation renders testing results 

scientifically invalid and a report from the Laboratory is not expected 

to issue within 180 days from the discovery of the violation, the 

Laboratory should notify the evidence contributor of the following 

information within 90 days of learning of the violation: the nature of 

protocol violation; how the violation occurred; the remedial 

measures that the Laboratory intends to implement in the case to 

generate scientifically valid testing results; and the time needed to 

complete the remedial measures and to issue a final report. 

3) The FBI Laboratory should perform a file review of a sample of cases 

that Blake is known to have worked on prior to becoming a PCR 

Biologist to reconfirm that the procedures that were required in fact 

are documented as appropriate in the case files. 

69
CHAPTER FIVE 

OIG ASSESSMENT OF THE FBI’S 

DNA PROTOCOLS AND PRACTICES

Blake’s misconduct occurred even while the DNAUI received satisfactory 

audit reports from both internal and external auditors. As described 

previously, Blake was able to conceal her actions for almost a 2-year period 

because of inadequate DNAUI internal controls.74 As a result, the OIG 

undertook an assessment of the Laboratory’s DNA protocols and practices to 

determine whether oversight vulnerabilities exist within the DNAUI.75 

I. ASSESSMENT FOUNDATION AND PROCESS 

A. Objectives 

OIG staff designed the assessment to examine comprehensively the 

DNAUI’s protocols and their application. Our objectives were to: 

• analyze the vulnerability of DNAUI protocols to undetected 

inadvertent or willful noncompliance; and 

• assess the DNAUI staff’s application of the protocols identified as 

vulnerable above. 

These objectives were accomplished in two phases. In the first phase, 

the OIG team reviewed the written DNAUI protocols for vulnerabilities. The 

second phase consisted of OIG fieldwork at the DNAUI laboratory. 

 74 The FBI stated in a response to a draft of this report that the DNAUI’s success with 

accreditation and other inspections conducted by internal and external auditors is evidence of 

the adequacy of the DNAUI’s internal controls. As explained elsewhere in this report, we

concluded that Blake’s ability to avoid detection, even though the Laboratory passed these

inspections, is precisely why the additional measures set forth in Chapter Six are warranted. 

Accreditation inspections and quality assurance audits examine compliance with quality 

standards, but do not attempt to review a laboratory’s operations for all needed management 

improvements. Our review identified numerous weaknesses that would not necessarily be

evident in an accreditation or other peer review. 

75 Due to the significant differences between the analysis performed by the DNAUI and

the DNAUII, including the performance of different techniques utilizing different pieces of 

equipment, and the fact that Blake did not work on cases in DNAUII, we limited our review to 

the protocols and practices of the DNAUI. However, we discuss infra the implications of 

potential vulnerabilities within the DNAUII posed by the conclusions of our DNAUI assessment, 

and recommend that the changes made in DNAUI procedures be applied to DNAUII where 

applicable. See Chapter Five, Section II.B.6. 

70
B. Selection of Consulting Experts 

To facilitate the assessment, particularly the review of the protocols, we 

recruited scientists from the national DNA community to assist the OIG. We 

selected the scientists by first soliciting recommendations from various 

contacts in the public and private DNA laboratory community, and then 

selecting three persons who could provide the team with varied experiences 

and a full understanding of the standards that govern forensic DNA 

laboratories. The scientists selected were crucial contributors to the OIG’s 

work and brought to the assessment expertise in academic research and 

instruction; federal, state, and private DNA laboratory analysis and 

administration; and national DNA advisory committee participation. 

The scientists we recruited were: 

• Dr. Arthur J. Eisenberg, Associate Professor in the Department of 

Pathology and Director of the DNA Identity Laboratory, University 

of North Texas Health Science Center; 

• Mr. William David Coffman, Crime Laboratory Analyst Supervisor, 

Florida Department of Law Enforcement, Tallahassee Regional 

Crime Laboratory; and 

• Dr. John H. Ryan, Director of Forensic Programs at Myriad Genetic 

Laboratories Inc. 

Each of these individuals has a distinguished record in the field of DNA 

analysis. Appendix 5 to this report contains brief biographies of the scientists. 

C. Expert Introduction to the Work of the FBI Laboratory 

To formalize the scientists’ participation in the OIG’s work, we conducted 

an orientation meeting in September 2002. At that time, OIG staff briefed the 

scientists on the circumstances surrounding the assessment, including Blake’s 

misconduct. 

During the orientation meeting, the FBI DNAUI Chief explained to the 

scientists the timeline of events and the actions taken by the FBI after their 

discovery of Blake’s actions. The scientists and OIG staff also toured the 

DNAUI facilities – at that time housed at FBI Headquarters in Washington, 

D.C. – to gain an overview of the DNAUI’s operations. 

The OIG staff distributed to the scientists checklists and supplemental 

guidance designed to facilitate the scientists’ review of the DNAUI protocols. 

The checklists and guidance contained key terms and definitions specific to our 

71
assessment, and supplemented the verbal explanations provided by OIG staff 

describing what the scientists were to consider when determining whether a 

protocol is vulnerable. OIG staff structured the checklists so that they 

corresponded to the table of contents for each of the protocols reviewed to 

ensure that each section of the documents was assessed. See Appendix 6 

(examples of the checklists and guidance provided to the OIG scientists). 

For purposes of this assessment, we defined “vulnerability” as a function 

of “impact” and “risk” as follows: 

• “Impact” is the measure of how essential a particular procedure or 

protocol is to the generation of a complete and accurate DNA 

profile, including ensuring that available DNA samples are 

efficiently and effectively processed for analysis. 

• “Risk” is the measure of the sufficiency of existing internal controls 

to prevent, where possible, both inadvertent and willful 

noncompliance and to detect noncompliance when it occurs. 

• “Willful noncompliance” is the intentional circumvention of 

applicable procedures and protocols.76 

In addition to these definitions, categories of severity were defined so that 

numeric ratings could be generated. The scientists were given descriptions of 

the “impact” characteristics that a protocol or procedure would have if it fell 

into low, medium, or high impact categories.77 They also were given similar 

descriptions for the low, medium-low, medium, medium-high, and high risk78

categories.79 These categories are further defined in the guidance contained in 

Appendix 6. 

 76 We applied this definition with the understanding that protocols alone cannot 

prevent malicious acts by staff members. 

77 In general terms, a low impact protocol is not required for the Laboratory to meet

quality assurance requirements, and the procedures it sets forth have little or no impact on the

production of a complete and accurate DNA profile. A protocol of high impact is one that is 

required by and governed by the quality assurance standards and is essential to obtain 

complete and accurate DNA results, and to preserve the integrity of the evidence and of the 

Laboratory’s final conclusions. 

78 In general terms, a low risk protocol contains multiple mechanisms for management 

to ensure staff member compliance and to deter or detect noncompliance. A high risk protocol

is one where no monitoring is being conducted to gauge staff compliance with the protocol, and

the protocol contains no mechanisms to detect noncompliance. 

79 The OIG team divided the risk ratings into five categories, rather than the three

categories used for impact, because the risk category definitions were nuanced enough to allow 

for additional distinctions. See Appendix 6.

72
Along with the checklists and guidance, OIG staff and the scientists 

reviewed the DNAUI protocols described below, which had been supplied to the 

OIG by the FBI. According to the FBI, these documents were the most current 

version of each of the protocols governing DNAUI activities at that time. 

• DNA Analysis Unit I Quality Assurance Manual, issue date of 

July 28, 2000; 

• DNA Analysis Unit I Examiner Training Program, issue date of 

January 30, 2001; 

• DNA Analysis Unit I Procedure for One Point Thermometer 

Calibration, issue date of May 15, 2001; 

• DNA Analysis Unit I Procedure for Pipette Calibration, issue date of 

September 28, 2001; 

• Procedures for the Serological Identification of Biological 

Substances on Evidentiary Materials, issue date of October 31, 

2001; 

• Biologist Training Program & Requirements, DNA Analysis Unit I, 

issue date of January 2002; 

• Short Tandem Repeat Analysis Protocol, FBI Laboratory, issue date 

of March 19, 2002; 

• DNA Analysis Unit I Procedure for Monitoring Ultra-Violet Light 

Intensity, issue date of May 10, 2002; 

• FBI Laboratory Division Caseworking Procedures Manual, issue 

date of July 15, 2002; 

• FBI Laboratory Division Quality Assurance Manual, issue date of 

July 15, 2002; and 

• DRAFT DNA Analysis Unit I Quality Assurance Manual, revision 

completed December 2002.80

 80 At the time of our review, the DNAUI Quality Assurance Manual was being updated. 

We were provided with the August 2002 version of the updated manual, clearly labeled as a 

“Draft” version. Upon review, the scientists found that the updated version was not materially 

different from the earlier version, and therefore the earlier version was used for the document 

review. The Draft version was not finalized until after the document review was completed by 

the scientists. 

73
D. The Assessment Process 

The OIG staff established guidelines for implementation of the 

assessment, including procedures that ensured that the scientists would 

document their conclusions on the checklists provided by the OIG. In addition, 

the scientists were instructed to base their conclusions solely on their analysis 

of the written materials above. In other words, when gauging vulnerability 

within the DNAUI, the scientists were to consider the contents of the protocols 

only, not factoring in any understanding they might have of the FBI’s DNA 

methods or their observations and conversations with DNAUI staff members 

and management during the tour of the DNAUI. OIG staff intended the 

guidelines to enable the scientists to take a fresh look at subjects with which 

they were obviously familiar, so that they could find weaknesses in the internal 

controls that others may have missed. 

The scientists reviewed the protocols in two sequential phases. OIG staff 

worked with the scientists to divide the document sections into two groups for 

review, referred to simply as Phase 1 and Phase 2. Phase 1 covered preanalysis protocols; Phase 2 focused on the remaining protocols, including those 

related to the actual analysis of DNA samples. The checklists used by the 

scientists reflect the division that was made. See Appendix 6. 

The scientists were given a period of time to review the protocol 

documents for each phase and then met with OIG staff to discuss and record 

the vulnerabilities identified. The meetings generated a consensus on the 

impact and risk ratings that should be assigned to each protocol section. In 

addition, the OIG recorded the underlying concerns for the agreed-upon ratings 

assigned by the scientists to ensure that the fieldwork conducted later and the 

conclusions and recommendations ultimately reported were an accurate 

reflection of the specific underlying weaknesses. 

At the conclusion of the Phase 2 meeting, OIG staff asked the scientists 

to assist them in devising fieldwork to identify the actual work practices of 

DNAUI staff members. In preparation for fieldwork design, OIG staff 

summarized the protocol sections in which the scientists had identified key 

vulnerabilities, and analyzed the results to determine if any of the sections 

pertained to similar subject matter. In addition, we analyzed the comments 

voiced by the scientists for recurring themes and categorized them into key 

concern areas. From this analysis, we designed fieldwork to verify actual 

laboratory practices for protocols deemed vulnerable, and to assess whether 

these practices served to mitigate the vulnerabilities identified. 

OIG staff conducted this fieldwork from March 12 through 21, 2003. The 

fieldwork generally was comprised of a tour of the new DNAUI facility in 

Quantico, Virginia, and a series of interviews of staff members from within the 

DNAUI and the Laboratory Division. Where possible, interview responses and 

74
observations made during the tour were checked against supporting 

documentation for verification. 

Fieldwork interviews served as our primary source of insight into the 

DNAUI’s operations. We recognized that it would be important to collect 

information from a broad cross-section of personnel, since we intended to 

analyze their responses for consistency with the protocols, with others of the 

same operational position, and with respondents in different positions. 

Therefore we took the following steps to ensure variety in our sources of 

information. 

Since the DNAUI staff function as teams, with each team generally 

consisting of a Serologist, a PCR Biologist, and an Examiner, we interviewed 

multiple staff members in each of these positions. 

We also recognized that the amount of time that a person had held a 

position could affect his or her fluency in describing certain processes. 

Consequently, we interviewed the most senior and the most junior employees 

in each position, and judgmentally picked a third person in that same role. For 

the third Serologist and Biologist interviewees, we selected a staff member who 

was currently in training for a different team position and thus would have a 

level of familiarity with the duties performed in both roles. 

This interviewing scheme was expanded to include a fourth interviewee 

from among the Examiners, so that our interviewees would include, in addition 

to the most senior and most junior Examiners, the Examiners who also 

supervised the key programs within the DNAUI: the Examiner-Supervisor of 

the Serology Program and the Examiner-Supervisor of the PCR (STR) Program. 

Finally, we interviewed DNAUI management, including the Unit Chief, 

the Assistant Unit Chief, and the Quality Assurance Manager; and Laboratory 

Division management, including the Laboratory Director, the Deputy Director, 

and the Chief of the Scientific Analysis Section. 

We also reviewed documentation and interviewed key personnel 

regarding: 1) the factors considered in the design of the new DNA facility; 

2) the training curriculum and methods used within the DNAUI, along with 

various staff training records; and 3) the status of development of the 

Laboratory Information Management System (LIMS), a computerized tracking 

system for evidence, samples, and other information. However, we did not 

include in our fieldwork design an analysis of case file documentation for two 

reasons: 

• Blake’s misconduct persisted undetected due to the DNAUI’s policy 

that GeneScan® data produced during electrophoresis did not need 

75
to be included in the case file and therefore did not need to be 

reviewed by the Unit’s Examiners. Consequently, a review of the 

case files would not shed additional light on Blake’s misconduct, 

nor would we be able to detect similar misconduct by other staff 

members from a case file review. 

• In April 2002, OIG auditors had reviewed approximately 150 

DNAUI case files as part of an audit of the DNAUI and DNAUII’s 

compliance with standards governing their CODIS participation.81 

We reviewed these case files to determine if the DNA profiles from 

each case, as reflected in NDIS, were complete and accurate.82 

Further, we reviewed the case files to determine if the profiles and 

supporting documentation complied with applicable Forensic 

Standards and NDIS Requirements.83 This review identified no 

deviations from the applicable audit standards. While this work 

was performed prior to the OIG’s knowledge of Blake’s 

misconduct,84 the review did serve as an indicator of the results we 

could expect from a case file review. 

In addition, we relied upon the work performed by DNAUI management 

and staff members, as described in Chapter Four, Section III.A, to determine 

whether other DNAUI Biologists had failed to process the negative controls 

 81 To select case files for review, we first obtained a list of identification numbers for all 

of the profiles that the DNAUI had submitted to NDIS. The list was provided by the FBI

Laboratory’s FSSU, currently referred to as the CODIS Unit, which oversees the NDIS database.

From this listing we selected a random sample of 142 profiles from a universe of 1,693 profiles,

and requested that the DNAUI make available for our review the supporting case file

documentation. 

82 A DNA profile was considered complete if all the analysis results obtained were

reflected in the profile uploaded to NDIS. When the results in the uploaded profile matched 

those on the Examiner’s worksheets, the profile was considered accurate. 

83 We considered the DNAUI case files and resulting profiles compliant with the

Forensic QAS if the required steps in the analysis process were completed and documented, 

including the quantification of each sample’s DNA, and if both technical and administrative

reviews of the analysis work were performed. We concluded that the DNA profiles we reviewed 

complied with the NDIS requirements if the profile qualified for inclusion in NDIS. The NDIS 

requirements prohibit a laboratory from uploading profiles to NDIS that clearly match the DNA

profile of the victim or another known person, unless the known person is a suspected 

perpetrator. 

84 We determined during our vulnerability assessment that one of the 142 cases 

included in our file review was identified by the FBI as a case on which Blake worked and failed 

to complete the negative controls. Our review could not have discerned Blake’s misconduct 

from this case file because it did not include GeneScan® data per DNAUI policy. See discussion 

regarding how Blake’s misconduct was detected in Chapter Four, Section II.D. 

76
prior to the discovery of Blake’s misconduct. That work determined that the 

controls were completed as required. 

We analyzed the results of our fieldwork and compared them with the 

concerns voiced and vulnerabilities detected by the scientists to discern 

whether information gathered during fieldwork confirmed the extent and 

nature of the scientists’ conclusions. We then conducted a follow-up meeting 

with the scientists to discuss the fieldwork results and to adjust, if necessary, 

their earlier conclusions that had been based strictly on the document review. 

The scientists made only a few minor updates to their earlier observations to 

reflect the information obtained during fieldwork. Generally, they did not 

change their conclusions regarding protocols previously identified as 

vulnerable. 

II. DNA UNIT I PROTOCOLS AND PRACTICES IDENTIFIED AS 

VULNERABLE TO ABUSE 

A. Types of Vulnerabilities Examined 

During our assessment within the DNAUI, we examined two types of 

vulnerabilities: protocol vulnerabilities and practice or operational 

vulnerabilities. Our textual analysis of the FBI protocols that govern the 

DNAUI revealed various weaknesses, which are described in detail immediately 

below. In addition, in the course of completing field work that examined how 

staff members implemented the protocols that we identified as problematic, we 

discovered numerous practice vulnerabilities. These are described along with 

our analyses of the various protocols. The specific vulnerabilities we examined 

within the two general categories (protocol and practice) are presented in order 

of significance based upon the scope of the vulnerability (generally, the number 

of document sections associated with it or the pervasiveness of the problem 

across DNAUI functions) and its severity (generally, the extent to which the 

vulnerability could undermine the DNAUI mission). 

B. Analysis of Protocol Vulnerabilities 

As explained in Chapter Five, Section I.C of this report, our analysis of 

protocol vulnerabilities is based on a review of 5 FBI manuals and 5 

instructional documents that collectively contain 172 topical sections.85 See

discussion supra at page 33. From this review we identified 31 sections as 

 85 The manuals are: 1) the FBI Laboratory Division Quality Assurance Manual; 2) the 

DNA Analysis Unit I Quality Assurance Manual; 3) the FBI Laboratory Division Caseworking 

Procedures Manual; 4) the Procedures for the Serological Identification of Biological Substances 

on Evidentiary Materials; and 5) the Short Tandem Repeat Analysis Protocol. Of the five

instructional documents, three specify procedures for equipment monitoring and calibration, 

and the remaining two address training programs for Biologists and Examiners. 

77
significantly vulnerable86 to inadvertent or willful noncompliance. It is 

important to note that our identification of a “vulnerability” should not be 

misconstrued as an invalidation of the science or techniques used by the 

DNAUI, or as an indication of the inadequacy of the entirety of DNAUI policies 

on a particular subject. Our use of the term “vulnerability” is limited to its 

definition as set forth in Chapter Five, Section I.C. 

The sections we identified as significantly vulnerable to inadvertent or 

willful noncompliance are identified below, with the most vulnerable sections in 

bold italics: 

• FBI Laboratory Division Quality Assurance Manual

Of the 17 sections within this document, 2 are vulnerable: 

- Evidence Control Policy 

- Case Documentation Policy 

• DNA Analysis Unit I Quality Assurance Manual 

Of the 20 sections within this document, 5 are vulnerable: 

- Organization and Management 

- Authority and Accountability 

- Evidence Control 

- Facilities (Security) 

- Case Assignment, Documentation, and Review 

• FBI Laboratory Division Caseworking Procedures Manual

Of the 12 sections within this document, 1 is vulnerable: 

- Procedures for the Examination of Evidence 

• Procedures for the Serological Identification of Biological 

Substances on Evidentiary Materials 

Of the 72 sections within this document, 4 are vulnerable: 

 86 As explained in Chapter Five, Section I.C, we assigned categories of severity to the

“impact” and “risk” ratings. We have included in our count of “significantly vulnerable” 

sections those that were categorized by the scientists as being in the “high” or “medium-high” 

impact and risk categories. We also limited our fieldwork testing to this same list of 

significantly vulnerable sections. 

78
- Procedure for the Preparation of Dried Bloodstains from 

Coagulated Whole Blood 

- Procedure for the Preparation of Dried Bloodstains from 

Anticoagulated Whole Blood 

- Procedure for the Extraction of Suspected Semen Stains 

Prior to OneStep ABA Card PSA Test: Quality Control 

Procedures 

- Procedure for the Extraction of Suspected Semen Stains 

Prior to OneStep ABA Card PSA Test: Questioned Stain 

Extraction Procedure 

• Short Tandem Repeat Analysis Protocol 

Of the 46 sections within this document, 19 are vulnerable: 

- Guidelines for Control Samples 

- Extraction (includes a total of 10 sections) 

- Amplification 

- STR Typing: Setting up a Run 

- GeneScan Analysis 

- Interpretation of Control Samples 

- Laboratory Set-up (includes a total of 4 sections) 

Although we identified 31 document sections as vulnerable, the causes of 

the vulnerabilities were few in number. In general, one or more of four reasons 

accounted for each of the vulnerability designations: 1) the protocol lacks 

sufficient detail; 2) the protocol fails to inform the exercise of staff discretion; 

3) the protocol fails to ensure the precision of manual notetaking; and 4) the 

protocol is outdated. 

The following chart depicts the categories of vulnerabilities and the 

document sections to which each category applies. 

79
Protocol Name and Section Title

Protocol 

Lacks

Sufficient

Detail

Protocol Lacks 

Guidance to

Structure Decisionmaking

Protocol Fails to 

Ensure the Precision 

of Manual Notetaking

Protocol is

Outdated

Evidence Control Policy X

Case Documentation Policy X X x

Organization and Management X

Authority and Accountability X

Evidence Control X X

Facilities (Security) X

Case Assignment, Documentation,

and Review

X X

Procedures for the Examination of

Evidence X X

Procedure for...Bloodstains from

Coagulated Whole Blood X X

Procedure for ... Bloodstains from

Anticoagulated Whole Blood X X

Suspected Semen Stains...: 

Quality Control Procedures

X

Procedure for the Extraction of

Suspected Semen Stains...: 

Questioned Stain Extraction 

X X

Guidelines for Control Samples X

Extraction (total of 10 subsections) X

Amplification X X

STR Typing: Setting up a Run X

Genescan Analysis X X

Interpretation of Control Samples X X

Laboratory Set-up (total of 4 

subsections) X

Procedures for the Serological Identification of Biological Substances on Evidentiary Materials

Short Tandem Repeat Analysis Protocol

FBI Laboratory Division Quality Assurance Manual

Protocol Vulnerabilities

DNA Analysis Unit I Quality Assurance Manual

FBI Laboratory Division Caseworking Procedures Manual

Given that each type of vulnerability was observed in multiple document 

sections, for ease of comprehension and to avoid repetition, we describe below 

each of the protocol vulnerabilities according to its cause rather than by 

individual document section. 

1. Protocols That Lack Sufficient Detail 

Our review of the DNAUI protocols revealed that 29 of 172 document 

sections lacked the detail necessary for a technically qualified DNA scientist to 

reproduce all aspects of the analysis procedures in use in the DNAUI without 

the potential for variation. In our view, a qualified DNA scientist should be 

80
able to locate the DNAUI’s essential testing requirements in its protocols and 

not have to resort to peripheral sources. Further, the protocols should contain 

guidance sufficient to ensure that qualified scientists are consistent in their 

interpretation of the testing requirements. 

While the sections we have identified as lacking essential detail are a 

relatively small percentage of the total protocols examined in our review, we 

consider this vulnerability to be the most significant of the ones we identified 

and the most important indicator of the DNAUI’s susceptibility to inadvertent 

noncompliance. Protocols that lack essential detail can create a work 

environment that encourages use of disparate and unproven laboratory 

practices. When laboratory staff members must rely on ad hoc verbal cues 

from their peers to complete their duties, the risk increases that they will 

deviate from the practices that are necessary to generate valid and reliable 

testing results. In addition, protocols that lack essential detail can foster a 

perception among staff members that the protocols are not authoritative and 

can be disregarded, even though they should serve as the DNAUI’s primary 

source of instruction. 

We describe below six sets of protocol sections that share similar 

deficiencies: 1) Evidence Control, Facilities (Security), and Procedures for the 

Examination of Evidence; 2) Extraction, Amplification, and Laboratory Set-Up; 

3) Procedures for the Preparation of Dried Bloodstains from Coagulated Whole 

Blood and from Anticoagulated Whole Blood; and Procedures for the Extraction of

Suspected Semen Stains: Quality Control Procedures and Questioned Stain 

Extraction Procedure; 4) Case Documentation Policy and Case Assignment,

Documentation and Review; 5) Guidelines for Control Samples and Interpretation 

of Control Samples; and 6) Organization and Management and Authority and 

Accountability. 

a) Evidence Control, Facilities (Security), and 

Procedures for the Examination of Evidence

Written Protocol

Forensic Standard 6.1 requires that laboratories have a facility that is 

designed to provide security and minimize contamination. This includes, as 

specified in subsection 6.1.1, controlling and limiting the access to the 

laboratory; and, as specified in subsection 6.1.2, separating by time or space 

evidence examinations, DNA extraction, PCR setup, and PCR amplification. 

Further, Forensic Standard 7.1 requires that DNA laboratories have and follow 

a documented evidence control system to ensure the integrity of physical 

evidence, including (as specified in subsection 7.1.4) secure areas for evidence 

storage. 

81
While the DNAUI protocols address compliance with these standards in 

general terms, certain sections of the protocols lack the level of detail necessary 

to ensure that staff members understand and comply with management 

expectations regarding evidence control and security. We identified four 

sections as problematic: the Evidence Control Policy of the FBI Laboratory

Division Quality Assurance Manual; the Evidence Control and Facilities

(Security) sections of the DNA Analysis Unit I Quality Assurance Manual; and 

the Procedures for the Examination of Evidence section of the FBI Laboratory

Division Caseworking Procedures Manual. 

For example, the Evidence Control Policy requires in Section 3.2 that 

“Evidence will be labeled, stored, secured, and/or sealed to prevent loss, crosstransfer, contamination, or deleterious change.” Additional guidance is not 

provided regarding how staff members should implement this protocol with 

respect to particular kinds of evidence. While this information may not be 

included within a laboratory-wide policy such as this one, we expected to find, 

and did not, a reference to other FBI manuals or protocols where more specific 

guidance can be obtained. Similar language is found in Section 3.5, which 

requires without elaboration the use of “universal precautions . . . to ensure 

the health and safety of personnel.” 

The Evidence Control Section of the DNA Analysis Unit I Quality

Assurance Manual also includes vague provisions. For example, Section 7.6.1 

states that “DNAUI will utilize documented standard operating procedures 

which minimize potential sample loss, contamination and/or deleterious 

change to the evidence.” It does not, however, identify what those procedures 

are or reference another source where they are specified. Section 7.6.2 

requires that “an attempt to limit the consumption of evidence should be made, 

when possible,” and although three subpoints are provided explaining how 

storage should be used to limit consuming an evidence sample, the protocol 

does not clarify what is meant by “when possible” or address methods other 

than storage that can be used to ensure that a remnant of the evidence 

remains for future testing. 

In addition, the proper handling of evidence during examinations is not 

addressed in the Evidence Control section. That section contains a discussion 

of chain-of-custody issues and the proper transfer, storage, and labeling of 

evidence, all of which are crucial to ensuring evidence integrity. Yet, if evidence 

is mishandled during the course of the examination itself, the benefits obtained 

from these precautions will be lost. While we were able to locate some 

examination evidence handling information in the Short Tandem Repeat

Analysis Protocol, no reference was made to it in the evidence control policies, 

and the limited information provided in the STR protocol is no substitute for 

comprehensive guidance. We anticipated, for example, that the DNAUI 

protocols would specify that Serologists with workbenches in close proximity to 

82
each other should not have case evidence open at the same time or that some 

type of “sign-up” sheet would be used to ensure that they do not use adjoining 

areas concurrently. Also, we expected to find a clear description of what it 

means to “separate” known and unknown DNA samples. Separation could 

mean that staff members clean between processing samples but use the same 

area, or alternatively that a different ventilation hood is used for the known 

and unknown samples. However, no such guidance on either issue is 

provided. 

We also identified in the Procedures for the Examination of Evidence

similar broad statements as those found in the Evidence Control Policy.87 For 

example, although Section 4.1.3 directs staff members to “follow established 

unit precautions to preserve the integrity of the evidence,” we were unable to 

locate a listing or explanation of the referenced “unit precautions.” Also, 

Section 4.5.1 directs staff members to place evidence in a limited access 

secured area when they must leave it unattended and “protect the exposed 

areas of the evidence from loss, cross-transfer, and/or contamination.” 

However, no explanation is provided regarding how staff members should 

implement this requirement, or what is intended by terms such as “protect” or 

“exposed areas.” During an OIG tour of the DNAUI, staff members explained 

that evidence items under active examination can be left out while staff take 

breaks and that the evidence is marked with an “Evidence – Do Not Disturb” 

sign. Leaving evidence exposed poses unnecessary risks of evidence 

contamination, and the Procedures for the Examination of Evidence should be 

amended to require the proper storage of evidence when it is not being 

examined.88

In the Facilities (Security) Section of the DNA Analysis Unit I Quality 

Assurance Manual, the discussion of facility access limitations is not clear. For 

example, Section 6.1 specifies that “access to these areas [specific rooms that 

comprise DNAUI space are listed] are controlled by DNAUI personnel.” 

However, no further explanation is provided for how DNAUI personnel are 

expected to accomplish this access control. Further, the Section states that 

“non-DNAUI personnel are permitted entry during normal working hours for 

 87 The Procedures for the Examination of Evidence section appears in the FBI

Laboratory Division Caseworking Procedures Manual, while the Evidence Control Policy is found

in the FBI Laboratory Division Quality Assurance Manual. 

88 Although not an issue that concerns protocol vagueness, we note that the evidence

storage description in Section 6.4.3 of the Facilities (Security) Policy of the DNA Analysis Unit I

Quality Assurance Manual permits large items needing room-temperature storage to be placed 

in a DNAUI room with an “Evidence – Do Not Disturb” sign displayed, if properly sealed in a 

tamper-evident manner, rather than requiring storage in a separately secured space such as 

an evidence vault. While this policy might have been necessitated by the limited storage

available at the DNAUI’s previous facility, its current facility allows for bulky evidence to be

stored in a separately secured area and therefore the DNAUI should change its policy to the

better practice of separately securing all evidence. 

83
purposes relative to laboratory operations.” Yet, no further explanation is 

provided concerning what restrictions should be imposed on non-DNAUI 

personnel (e.g., whether visitors must be escorted and in what areas they are 

permitted access). The Section seems to assume that DNAUI personnel already 

are aware of existing physical access restrictions, for the building and for the 

laboratory space, that serve as components of the Unit-specific access control. 

Instead, access control and physical security should be described (and other 

relevant sources referenced) in the DNA Analysis Unit I Quality Assurance

Manual, and those descriptions should not assume an understanding of other 

physical access limitations.89 

The overly broad or vague language used in the above evidence-control 

related protocols creates a number of problems. Staff members may not fully 

understand how they are expected to avoid loss, cross-transfer, or 

contamination of evidence, and may not realize that they are putting evidence 

at risk through the handling methods they have adopted. One item of evidence 

might be allowed to come too close to another item, and hairs, blood flakes, or 

fibers that become airborne might inadvertently be transferred to other 

evidence, possibly causing the analysis results to reflect improperly a 

connection between the cases or a DNA profile of someone not actually involved 

in the case. 

Further, leaving evidence exposed and unattended poses a risk to the 

Examiner’s ability to attest that team members maintained control over it. The 

importance assigned by DNAUI management to controlling access to evidence 

is apparent from other DNAUI protocols: 1) as a means of verifying limited 

access, evidence not under examination is stored sealed with tamper-evident 

material; and 2) evidence not under examination is secured in locked 

refrigerators, freezers, and bulky-storage space. It is difficult to reconcile these 

policies with protocols that contemplate that evidence will be left unattended 

and that fail to provide clear guidance for how it is to be protected. 

Finally, there is a risk that evidence that is left unattended could suffer 

damage through an unforeseen event, such as fire-alarm sprinklers being set 

off in an emergency, or a plumbing leak that floods and compromises space 

below it. If that evidence were in a locked cabinet or refrigerator/freezer, it 

would be further protected in such events. 

Interviews

In light of these potential risks, we conducted fieldwork to determine 

whether other factors diminished the risks we had detected during our 

 89 In response to a draft of this report, FBI Laboratory management stated that the

DNA Analysis Unit I Quality Assurance Manual has now been revised to include the

information we cite as missing here. 

84
document review. At the time of our fieldwork, the DNAUI had relocated from 

FBI Headquarters to a new laboratory building at Quantico, Virginia. We found 

that the change of facilities mitigated to some extent the impact of the lack of 

detail in several of the facility-related protocols. Specifically: 

• The new facilities provide each Serologist and PCR Biologist with 

an ample evidence examination area that is not in close proximity 

to other examination areas. Further, each of the work areas is 

equipped with a vacuum hood to prevent the sharing of hoods that 

had been necessary at the previous location. 

• Each work station is also equipped with individually securable 

storage for both case files and evidence items.90 Each room is also 

equipped with a lock to which only the staff members with work 

areas in that room (and appropriate management officials) have a 

key, allowing them to secure their work area and evidence under 

examination if the room is left unoccupied. 

• DNAUI now has the use of an evidence vault large enough for 

bulky, room-temperature evidence to be independently secured, 

and therefore the DNAUI should have no further need to store 

sealed room-temperature evidence in a DNAUI laboratory room. 

• DNAUI also has a large evidence examination room for oversized 

items that allows them to be spread out unobstructed in a 

controlled setting. The room is separately securable to ensure that 

only the DNAUI staff members examining a large evidence item 

have access to that room if the evidence must be left unattended. 

Our fieldwork also included interviewing staff members and management 

to determine whether their work practices offset any of the vulnerabilities 

created by weaknesses in the evidence control procedures and protocols. 

We determined that there are several practices, primarily falling under 

the heading of cleaning and decontamination, that mitigate to some extent the 

protocol limitations. For example, we were informed by all staff members 

involved in evidence examinations that it is DNAUI practice to cover the work 

surface with paper prior to laying out an evidence item for examination. Such 

a step reduces the possibility for cross-transfer, since the paper that surrounds 

the item serves as a buffer between the item being examined by one member 

and another in close proximity. Also, we were informed that if an item 

 90 The phrase “independently securable storage” refers to storage that can be secured 

independently of the security of the laboratory rooms in which the evidence might be placed, so

that evidence control is not dependent entirely upon access limitations. 

85
stretches beyond the parameters of the paper, then that portion of the work 

surface is decontaminated before moving on to another item. Further, staff 

members stated that work surfaces are decontaminated between cases, and 

utensils used in the examination of an item are decontaminated between items. 

Almost all staff members and management personnel interviewed regarding 

evidence handling issues reported working on one item at a time and one case 

at a time, separating evidence samples from known samples, using and 

changing gloves, cleaning and/or decontaminating work benches and hoods 

regularly, and changing work surfaces between items.91 Also, the responses of 

staff members that were able to identify where in the protocols these 

requirements are found, as well as the responses provided by management, 

were consistent as to which protocols serve as the source of guidance on 

general evidence handling, cleaning, and decontamination. 

However, not all of the staff members interviewed were able to identify 

where guidance on these topics could be located in the protocols. In addition, 

in spite of the consistency of the responses among those that did know where 

the guidance could be located, their responses indicated in other ways the need 

for greater clarity and detail in the written procedures and protocols. For 

example, several interviewees commented on the lack of general evidence 

handling guidance for serologists (additional deficiencies found in the 

Procedures for the Serological Identification of Biological Substances on 

Evidentiary Materials are addressed in the next section). In addition, when 

questioned regarding the separation of known and unknown samples, interview 

responses lacked a precise indication of the period of time or amount of space 

that meets the requirement for “separation.” Consequently, it was not evident 

from the responses whether staff members have a clear understanding of the 

requirement to separate known and unknown samples. 

Further, of all the staff members and management interviews we 

conducted, only one Laboratory employee, an Examiner, cited as a source of 

guidance the FBI Laboratory Division Caseworking Procedures Manual. This

Manual provides the most detailed guidance available to DNAUI staff members 

on the subjects of inventorying, identifying, and examining evidence. In 

addition, it is the only protocol that addresses the issue of leaving evidence 

unattended during examinations, and the requirements (even though they are 

overly broad) for how that evidence is to be handled. One staff member, a 

senior PCR Biologist, claimed to have never seen the Manual before. 

Many of the interviewees commented on the lack of written guidance 

concerning the routing sequence when evidence needs to be distributed to 

multiple units. These interviewees indicated that they know there is a definite 

 91 The descriptions provided in Chapter Three, Sections II.B.2 & 3, supra, regarding 

cleaning and decontamination, separation of sample sources, and stages in the analysis 

process reflect the responses we typically received during the interviews. 

86
order that evidence needs to follow to preserve each unit’s ability to conduct 

testing. For example, the Latent Fingerprints Unit must test before the DNAUI 

tests, and the item cannot be stored in a refrigerator or freezer prior to the 

latent testing. One Examiner commented on the importance of this issue, 

emphasizing that the Serologists must be very conscious of the items that 

might need testing by other units, and work to preserve the evidence that is 

needed for this testing. The Examiner explained that when there is a question 

about how to route evidence, Serologists are expected to obtain input from the 

other unit. Yet, this guidance is not part of the DNAUI’s serology procedures. 

We also detected variance in responses regarding particular procedures 

in the protocols. While not every variance translates into a problem, diverging 

interpretations by staff members could indicate that they do not fully 

understand protocol requirements or are given a measure of flexibility that is 

not reflected in the protocol. The following examples illustrate these points: 

• Drying of Samples: While most Serologists stated that known and 

unknown samples are dried at different times, one Serologist 

explained that they can dry at the same time.92 The same 

Serologist did not believe there was a requirement for separating 

high and low quantity DNA samples, even though the specific 

requirement is contained in the Short Tandem Repeat Analysis 

Protocol. It is noteworthy that this protocol is one which 

Serologists, because of their duties, are not required to use or 

know. However, a senior Examiner also stated that there is not a 

specific requirement in the protocols for the separation of high and 

low quantity DNA samples, even though the Examiner is required 

to follow the Short Tandem Repeat Analysis Protocol that contains 

this requirement. 

• Examiners’ Understanding of the Biologists’ Cleaning and 

Decontamination Practices: One Examiner stated that the PCR 

Biologists change gloves “whenever they are soiled” whereas 

another stated that they are changed between examination of 

items. One Examiner explained that a PCR Biologist might only 

change the work-surface paper between cases, while another 

stated that, in addition to changing the paper between cases, the 

hoods are cleaned. A third Examiner stated that, while he was 

uncertain, he thought that the hoods are decontaminated with 

ultra-violet light between cases; a fourth Examiner stated that the 

hoods are cleaned with bleach between processing evidence and 

known samples. The fact that each Examiner explained the 

 92 Rather than using liquid blood from a tube for analysis, the practice in the DNAUI is 

to place a small amount of blood on a card, dry the card, and then use a portion of the dried 

stain for analysis. 

87
cleaning and decontamination practices differently casts doubt on 

the clarity of their understanding. This is significant because 

Examiners may be required to describe those practices in court. 

• Leaving Evidence Under Active Examination Exposed and 

Unattended During Staff Breaks: Staff members and managers 

who described this practice in their responses explained that the 

evidence is sealed and secured, and that an “Evidence – Do Not 

Disturb” sign is used (as explained in the written protocol). 

However, some staff members further described methods that 

exceed what is explicitly required. For example, an Examiner 

stated that when taking a break, one Serologist would cover the 

evidence with brown paper, and then place a sign over the 

evidence, or, if possible, return the evidence to its container and 

place a sign over the container. This Examiner was the only staff 

member to mention using paper to protect the evidence. Also, a 

senior PCR Biologist stated that for a quick break, his team uses a 

sign, and for longer breaks they return the evidence to its original 

package and use a sign. The Biologist added that with big items 

that had just been situated, staff members can leave the item out 

and tape off the area, placing a sign on the evidence. This 

Biologist was the only staff member to mention taping off the area 

where evidence was left out. Although these methods – using 

paper as a covering, returning the item to its original container, 

and taping the area off for larger items – serve to mitigate the risks 

associated with leaving evidence exposed and unattended, these 

methods are not reflected in the protocol. Therefore, there is no 

assurance that other staff members know and apply these 

methods, particularly since other respondents did not mention 

them. 

During our fieldwork at the FBI’s new laboratory, we inquired about 

facility security and were informed that access to DNAUI space is limited to 

DNAUI staff members, either by regular keys or by card keys. Although these 

practices seem sufficient, they are not evident from the text of the relevant 

protocol. In addition, after receiving interview comments that showed that 

some Laboratory personnel did not understand the importance of the protocols, 

we inquired whether staff members are required to certify that they have read 

and understand protocol revisions. According to the Unit Chief, staff members 

are required to attest to the receipt of new versions of the protocols. For 

notifications of changes that are made between revisions, no certification of 

receipt is required. The Unit Chief added that during training both trainees 

and trainers must attest to the trainee’s understanding of the importance of 

adherence to protocols. 

88
In light of the foregoing, we concluded that the potential risks posed by 

the lack of detail in the protocols described above, particularly the risks 

associated with facility limitations, have been mitigated somewhat by the 

following: 1) the DNAUI has moved to a new facility that no longer has the 

limitations we noted in the previous facility; 2) interview responses identified 

several methods and practices that exceed protocol requirements and that 

appear to protect the evidence; and 3) interview responses were largely 

consistent and in agreement with the protocols. 

However, several interview responses we received revealed that some 

DNAUI staff members have an incomplete or inaccurate understanding of 

evidence handling and control requirements, and two persons we interviewed 

indicated that the protocols are not essential to their daily activities. We 

believe that staff members who do not understand or appreciate the 

importance of evidence handling and control procedures are susceptible to 

inadvertent noncompliance with the applicable protocols. 

Recommendations

We recommend that DNAUI management: 

4) Supplement the evidence handling and control protocols with 

sufficient detail so that they serve as a comprehensive source of 

guidance for staff members; 

5) Cross-reference the DNAUI manuals, in specific sections where the 

subject matter warrants, with more detailed sources of guidance 

available to DNAUI staff members, such as the FBI Laboratory

Division Caseworking Procedures Manual or the Short Tandem

Repeat Analysis Protocol; 

6) Revise policies for leaving the security of unattended evidence under 

examination dependent upon the facility access limitations, in light 

of the availability of independently securable storage for staff 

members at their workstations and of a bulky evidence examination 

room that is securable; and 

7) Implement a policy that requires staff members to certify that they 

have read, understand, and will comply with each written protocol 

or procedure that governs DNAUI activities, including any approved 

deviations or other guidance issued that have not yet been 

formalized in a protocol. 

89
b) Extraction, Amplification, and Laboratory Set-up

Written Protocol

Forensic Standard 9.1 requires that DNA laboratories follow written 

analytical procedures, including a standard operating protocol for each 

analytical technique employed.93 Forensic Standard 9.1.2 requires that the 

procedures meeting these requirements address reagents, sample preparation, 

extraction, equipment, controls, and data interpretation. While the DNAUI 

meets these standards with the Short Tandem Repeat Analysis Protocol, we 

identified important information that is missing from its Extraction,

Amplification, and Laboratory Set-up sections. 

First, both the Extraction and Amplification sections fail to specify the 

requirements for the separation of known and unknown samples and of highand low-quantity DNA samples. We believe that the Extraction section should 

specifically prohibit having two sample tubes open at once, and the 

Amplification section should require control samples to be processed last. The 

Extraction section also contains provisions that are overly broad: the 

incubation time given in Section 4.1.3 is listed as between 2 and 24 hours, and 

there are provisions in Sections 4.3-9 for staff members to perform additional 

organic extractions, if needed, without information provided regarding when 

and why those additional extractions would be appropriate. Finally, 

Amplification Section 6.7 fails to describe clearly the order in which sample 

tubes should be set up. 

We recognize that some of the missing information cited in the previous 

paragraph is located within the Laboratory Set-up section, specifically the 

requirement for the separation of known and unknown samples and of highand low-quantity DNA samples. The Laboratory Set-up section also clearly 

requires that the negative control samples be processed last as part of the 

amplification set-up, which is important for those samples to indicate 

contamination effectively. However, because the protocols function in part as a 

reference manual, the listing of these requirements in the Laboratory Set-up

section does not diminish the need for them also to be presented in the 

protocol sections that address the stages in the analysis process (i.e., 

extraction and amplification) where an understanding of the requirements is 

most crucial. An employee who seeks guidance on an analytical step should 

find complete information in the relevant sections of the protocol and should 

not have to search elsewhere. 

Moreover, the requirements described above that are included in the 

Laboratory Set-up section do not provide the level of specificity and clarity 

 93 See Forensic Standard 9.1.1.

90
necessary for staff members to understand what is intended by the 

“separation” of the types of samples. For example, special precaution 3 under 

Section 12.2 states that “[i]t is important that the DNA extraction of questioned 

samples be performed at a separate time from the DNA extraction of known 

samples.” Yet, the protocol does not explain what is meant by “separate time.” 

It should state that all the unknown samples must be processed, capped, and 

removed from the immediate work-area before staff members begin to process 

the known samples. Also, special precaution 4 under Section 12.1 directs staff 

members to “[w]henever possible, extract samples containing high levels of 

DNA (whole blood) separately from samples containing low levels of DNA 

(stamps, small bloodstains, etc.) to minimize the potential for sample-to-sample 

contamination.” Unfortunately, the qualifier “whenever possible” renders the 

protocol vague and open to differing interpretation. 

Due to the importance of separating known and unknown samples, the 

risks posed by the lack of detail in the protocols described above are 

substantial. Without the requirement to process, cap, and set aside the 

unknown samples before processing the known samples, the risk of crosscontamination increases. In addition, without a clear requirement that 

separation be maintained during extraction and amplification, samples may be 

compromised later in the DNA analysis process. The implications of this 

particular aspect of a DNA laboratory’s internal controls are far-reaching for 

the evidence tested and the presentation of the analysis results in court: 

adequate separation of known and unknown samples enables examiners to 

testify that the connection made between a suspect and the crime scene 

evidence analyzed is not the result of cross-contamination between the known 

sample from the suspected perpetrator(s) and the evidence items. If the known 

samples were to contaminate the evidence, the analysis results for the evidence 

profile would reflect the profile from a known sample as well as the profile 

obtained from the DNA present on the evidence item. In addition, the strength 

of the DNA in the known sample could serve to “drown out” the results of the 

DNA in the evidence, causing the resultant profile to reflect only faintly the 

DNA present in the evidence. Further, if the profile from a known sample were 

to appear in the analysis results for an evidence sample, an Examiner might 

wrongfully conclude that the contributor of that known sample is the potential 

source of the DNA on the evidence in the case being investigated. 

Lastly, aside from sample separation, the lack of specific guidance in the 

protocols regarding incubation time and the use of additional organic 

extractions leaves Unit staff members at risk of deviating inadvertently from 

management expectations in those areas. 

Interviews

In our interviews with DNAUI staff members regarding extraction, 

amplification, and laboratory set-up procedures, we asked them to comment 

91
on: 1) the separation of sample types and the separation of the stages in the 

analysis process; 2) the exact incubation time used by staff members; 3) the 

use of the provision that governs additional organic extractions; and 4) the 

details of amplification set-up. Responses were virtually identical from the PCR 

Biologists and Laboratory management regarding the incubation time, the 

circumstances under which they would perform additional organic extractions, 

the separation of the stages in the analysis process, and the details of 

amplification set-up. In addition, written guidance had been disseminated to 

staff members restricting the incubation time to a more precise period. 

Responses also were very similar regarding the separation of known and 

unknown samples during analysis. However, as previously described at 

page 86, the interview responses we received regarding sample separation did 

not reveal that staff members share a common understanding of the meaning 

of “separation,” which would mitigate the risk resulting from the lack of clarity 

in the protocols. In addition, staff members and management generally 

indicated that the evidence and known samples are currently separated only 

through the completion of the extraction of the DNA from the samples. From 

that point forward the sample tubes from evidence and known sources can be 

on the same tray and can be set up for amplification at the same time. While 

such a policy limits the risk of contamination during the extraction process, it 

does not address possible contamination during amplification set-up. 

Therefore, evidence samples are still at risk for contamination prior to 

amplification. 

With respect to separation of the analytical stages themselves, one area 

of vagueness surfaced when we interviewed the PCR Biologists about the 

amplification set-up process. Interviewees acknowledged that it is clear in the 

protocols that DNA extraction, PCR set-up, and amplification are to be 

conducted separately. Further, there is a requirement to have dedicated 

equipment for the pre-amplification areas of the Laboratory isolated from the 

dedicated equipment used in the amplification areas. We confirmed that these 

requirements are explained and referred to throughout the Laboratory Set-up

section of the Short Tandem Repeat Analysis Protocol. However, we noted from 

the interview responses that the PCR Biologists have a practice of using a preamplification tray to carry tubes to the amplification room. The tubes are then 

placed into the thermal cycler and the “transport tray” returned to the preamplification area. Since the protocols do not address this practice or provide 

guidelines regarding the cleaning or decontamination steps that should be 

completed before that tray is put back in use, we could not compare the 

interviewee responses to written requirements. However, recognizing that some 

cleaning of the tray is necessary prior to future use, we inquired further with 

the PCR Biologists we had previously interviewed and were told that they 

understand the importance of cleaning these trays, and that they believe this to 

be true for all the PCR Biologists. Each of the interviewees described the 

cleaning method they use, whether a bleach wash, a UV light source, or both. 

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But the PCR Biologists acknowledged that there is no specific guidance on this 

aspect of the process in the protocols. 

Finally, the DNAUI Chief explained that, in light of the foregoing risks, 

the Unit is making arrangements to have the known and unknown samples 

processed in different locations within the Unit. Thus, different staff members, 

equipment, and space will be used to analyze the known and unknown 

samples, mitigating any risk of cross-contamination due to the lack of 

separation. 

Therefore, we concluded that the lack of guidance for Biologists on the 

use of transport trays was mitigated somewhat by Biologist cleaning practices. 

However, we find unmitigated the risks posed by: 1) the lack of clear 

delineation in the protocols or staff responses for what constitutes adequate 

separation of known and unknown samples; and 2) the failure to maintain that 

separation through amplification. While we acknowledge that DNAUI 

management’s proposed solution of analyzing known and unknown samples in 

different sections of the Laboratory would address these risks, we base our 

conclusions and resultant recommendations on the protocols in place at the 

time of our review. 

Recommendations

We recommend that: 

8) DNAUI management amend the protocols to clarify what is required 

to “separate” known and evidence samples and to ensure that such 

separation occurs during examination, extraction, and amplification. 

9) DNAUI management reflect in the protocols: (a) the current 

requirement for incubation time; (b) the procedures described by 

staff during interviews for the use of additional organic extractions; 

(c) the required order that samples are to be set up for amplification, 

as described by staff during interviews; and (d) explicit directions for 

the cleaning of the “transport trays” used by PCR biologists. This 

information, as well as the extraction and amplification evidence 

handling requirements found in the Laboratory Set-up section, 

should be reflected in the extraction and amplification sections of 

the Short Tandem Repeat Analysis Protocol, where that information 

is most pertinent to the surrounding information. 

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c) Procedures for the Preparation of Dried 

Bloodstains from Coagulated Whole Blood and 

from Anticoagulated Whole Blood; and Procedures 

for the Extraction of Suspected Semen Stains: 

Quality Control Procedures and Questioned Stain 

Extraction Procedure

Written Protocols

Our analysis of the Procedures for the Serological Identification of

Biological Substances on Evidentiary Materials, which includes bloodstains, 

semen, quality control, and stain extraction protocols, revealed that it fails to 

provide adequate guidance on various evidence handling procedures. The 

following examples illustrate information gaps that DNAUI Serologists fill using 

unwritten standards. 

• The Procedures for the Extraction of Suspected Semen Stains: 

Quality Control Procedures and Procedures for the Extraction of

Suspected Semen Stains: Questioned Stain Extraction Procedure, do 

not address: 1) the amount of a swab to use for testing; 2) whether 

extracts and swabs are both sent to the Biologist for testing; 

3) general precautionary steps to reduce contamination (such as 

the use of disposable paper); 4) the usable life of the positive 

semen control;94 and 5) what should be done if the stain extraction 

procedure detects no semen. 

• The Procedures for the Preparation of Dried Bloodstains from 

Coagulated Whole Blood and Procedures for the Preparation of Dried 

Bloodstains from Anticoagulated Whole Blood do not state that 

cotton sheeting used in the procedures should be pretested to 

ensure that it is sterile, and do not identify the quantity of blood to 

use when making bloodstains for drying. 

A risk posed by the failure to establish comprehensive guidelines on the 

amount of evidence to use in testing (e.g., items 1 & 2 above for semen 

protocols) is that DNAUI staff members inadvertently may use too much of the 

available body fluid stain or exhaust the supply altogether, making future 

testing impossible. In circumstances where the first analysis run proves 

problematic, such waste could prevent acquisition of scientifically valid testing 

results since staff would not later have the option of reanalyzing a sufficient 

quantity of the evidence. In addition, the lack of general evidence handling 

guidance in these sections (e.g., items 3 & 4 above for semen protocols, and 

use of cotton sheeting in bloodstain protocol) poses an unnecessary risk of 

 94 The DNAUI uses a positive semen control when testing potential semen stains during 

casework as a means of ensuring that the test functioned properly. 

94
contamination, possibly hindering the production of a usable DNA profile. 

Further, the lack of a clear description of what should occur if a stain 

extraction procedure detects no semen (e.g., item 5 above for semen protocols), 

presents the risk that the analysis process could be prematurely halted rather 

than taking additional steps to determine if the evidence sample contains DNA. 

Further, although in isolation the remaining information missing from the 

protocols may have only a minor impact on DNAUI operations, the cumulative 

effect of failing to provide comprehensive guidance in the protocols is to allow a 

significant portion of the Unit’s operations to be determined by the 

idiosyncrasies of individual staff member preferences. This in turn conveys the 

message that the written procedures and protocols are a peripheral source of 

instruction, and puts the DNAUI at greater risk for protocol noncompliance. 

Interviews

During our fieldwork we interviewed DNAUI Serologists and Laboratory 

management regarding various information gaps in the serology protocols. 

Specifically, we asked them to describe: 1) the circumstances in which they 

would or would not perform each of the serology tests; 2) the factors they 

consider to determine how much evidence to test and how much to forward to 

the PCR Biologist; 3) their understanding of the usable life of the semen 

control; and 4) what steps are taken after testing if they obtain a negative 

result (indicating that no semen was detected). Serologist responses were 

generally similar on each of these issues and to the responses provided by 

management, indicating that staff members have acquired a clear 

understanding through training or peer input of management expectations. 

Serologists offered mixed responses on only one issue: the useable life of 

the semen control. While they guessed what the expiration date might be 

(generally their guesses of one year were correct), they also stated that they 

look for a strong result from the control. If they do not obtain one, they simply 

retest a new batch of control sample.95 Further, they commented that the 

semen control is used in significant enough volume that the expiration date is 

not an issue (each batch is used before the expiration date would be reached). 

We reviewed the logs documenting the reagents used and confirmed that 

the last three batches of semen control were depleted prior to each batch’s 

1-year expiration date. In addition, we confirmed from the protocol that an 

expiration date is provided for staff members, but not within the Procedures for 

the Extraction of Suspected Semen Stains section of the protocol. Instead, the 

useable life of semen control samples is set forth in the Procedure for the

Presumptive Identification of Semen. Consequently, we concluded that, while 

Serologists should be reminded of the control expiration dates, the Serologists’ 

 95 According to the protocol, Serologists test the control prior to processing the

evidence samples so that a control failure does not jeopardize the analysis of the evidence. 

95
unfamiliarity with that information does not pose a significant risk to the 

proper analysis of evidence samples. 

In addition, we determined from the interview responses that staff 

member practices include various helpful internal controls that are not 

reflected in the protocols. Specifically, one member of management stated that 

the serology procedures do not reveal that a team’s PCR Biologist also looks at 

and describes the evidence that the team’s Serologist receives, and those 

descriptions can be compared for consistency. Staff member interviews also 

described a practice of performing a “general swabbing” of an item to ensure 

that no possible sources of DNA on that item have been missed. OIG team 

scientists stated that this is a valuable practice to ensure that staff members 

exhaust all options in finding potentially probative DNA sources. 

Thus, our field work demonstrated that staff members generally possess 

a clear and consistent understanding of management expectations regarding 

serology procedures. We therefore conclude that the risk posed by the 

incomplete protocols has been mitigated in large part by communication of the 

necessary information through other means, such as training and peer 

guidance. Despite this fact, we believe that the better practice is for the DNAUI 

to revise its serology protocols to provide comprehensive guidance on all 

serology procedures in use in the Unit. The staff members and managers we 

interviewed agreed that many of the details they described about serology 

procedures are not found in the serology protocols. Further, one of the 

Serologists stated that the methods that staff members are supposed to employ 

to navigate an item through the serology process seems to be addressed only 

through training, and that the work of the Serologists is shaped by the 

preferences and idiosyncrasies of the person who trained them. One 

management interviewee acknowledged that the serology procedures do not 

contain information on administrative processes, such as proper storage of 

evidence, even though Examiners frequently are cross-examined on this topic 

in court. 

Recommendation

10) We recommend that DNAUI management ensure that the Procedures

for the Serological Identification of Biological Substances on 

Evidentiary Materials includes: 

a) Detailed guidance on proper evidence handling methods, 

similar in content to the guidance contained in the Laboratory

Set-up section of the Short Tandem Repeat Analysis Protocol. 

b) In the Procedures for the Preparation of Dried Bloodstains from

Coagulated Whole Blood and the Procedures for the Preparation 

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of Dried Bloodstains from Anticoagulated Whole Blood, a 

requirement to: (a) pretest the cotton sheeting to ensure that 

there is no DNA contamination; and (b) identify the amount of 

blood to use when making dried blood stains. 

c) In the Procedures for the Extraction of Suspected Semen Stains: 

Quality Control Procedures and Procedures for the Extraction of

Suspected Semen Stains: Questioned Stain Extraction

Procedure, guidance regarding: (a) the amount of a swab to 

use for testing; (b) whether extracts and swabs are both sent 

to the Biologist for testing; (c) general precautionary steps to 

reduce contamination (such as the use of disposable paper 

and the pre-testing for sterility of cotton sheeting used to 

make dried blood stains); (d) the usable life of the positive 

semen control; and (e) what should be done if the stain 

extraction procedure detects no semen. 

d) Unwritten internal controls that already are in use by DNAUI 

staff members and management, including (but not limited 

to): (a) the requirement for a team’s PCR Biologist to record 

the characteristics of the evidence, supplementing the 

description generated by the Serologist; and (b) the 

requirement for Serologists to perform a “general swabbing” of 

an item to ensure that no possible sources of DNA on that 

item have been missed. 

d) Case Documentation Policy and Case Assignment, 

Documentation and Review

Written Protocol

Forensic Standard 11.1 requires that DNA laboratories follow written 

procedures for taking and maintaining case notes to support the conclusions 

drawn in laboratory reports. In addition, Forensic Standard 11.1.1 requires 

that DNA laboratories maintain, in a case report, all documentation generated 

by Examiners related to case analyses. While the DNAUI has implemented 

procedures and protocols for these broad standards, we determined that two of 

the protocol sections we reviewed lacked the kind of detailed guidance 

necessary to ensure that all staff members understand and comply with 

management expectations for case documentation and review. Specifically, 

these sections are the Case Documentation Policy section found within the FBI

Laboratory Division Quality Assurance Manual, and the Case Assignment,

Documentation and Review section found in the DNA Analysis Unit I Quality 

Assurance Manual. 

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Although the Case Documentation Policy section is a broad protocol that 

applies to all units within the Laboratory, we expected to find more detailed 

information on case documentation procedures. For example, the section 

currently fails to list the required contents of case files, including the basic 

forms and worksheets universal to all the units. In addition, it lacks a 

reference to the more detailed file content requirements found in each unit’s 

case documentation and review protocol. Further, the section should contain 

general guidance on notetaking methods, with a reference to any additional 

detailed information contained in unit-specific protocols. See Chapter Five, 

Section II.B.3 for additional information on notetaking. 

We identified similar deficiencies in the Case Assignment, Documentation 

and Review section in the DNA Analysis Unit I Quality Assurance Manual. That 

section lacks a detailed description of the requirements for a complete case file 

review, and fails to identify procedures to ensure that documentation of each 

key item within the case file is accounted for. Instead, we found general and 

overly broad guidance regarding review procedures. For example, Section 

11.4.1.1 requires that case file reviews include an evaluation of all data, 

lumigrams, interpretations, conclusions, and other supporting materials 

contained in the case file packet. Although five subparts are included in this 

section that describe the type of information that is subject to these reviews, 

their terms are overly broad and open to interpretation. For example, 

subsection 11.4.1.1.4 requires a confirmation that “all conclusions reached by 

the examiner are consistent with the documented data and within the limits of 

the discipline.” In addition, the section does not contain a precise description 

of notetaking methods and requirements for DNAUI staff members so that they 

are clear on how and when they should be taking notes. We did not find this 

information anywhere in the protocols. See Chapter Five, Section II.B.3 for 

additional information on notetaking. 

Finally, the Case Assignment, Documentation and Review section fails to 

specify the procedures that should be followed to review and confirm case 

evidence profiles for entry into CODIS. A review of approximately 150 case files 

during OIG audit work conducted in April 2002 (prior to the OIG being notified 

of Blake’s misconduct) provided an opportunity to confirm that the DNAUI has 

such procedures, and our examination of their use of those procedures found 

that the profiles were being processed correctly. See Chapter Five, Section I.D 

for further detail on this case file review. However, no information on these 

procedures was reflected in this Case Assignment, Documentation and Review

protocol. 

The risks regarding the lack of specificity in these protocol sections 

primarily are that staff members will not understand, and therefore may not 

comply with, management expectations for case file documentation and review. 

These risks are heightened in environments such as the DNAUI’s, where work 

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is performed by teams and individual team members must rely upon the 

quality and thoroughness of their fellow team members’ case file 

documentation for the completion of their own work. Therefore, without 

detailed guidance for case file documentation and review, the DNAUI is at risk 

of not having proper verification in each case that all necessary testing 

procedures were completed as required. For example, as the Blake matter 

reveals, had DNAUI protocols required the inclusion in the case file and review 

of GeneScan® data, Blake’s supervisors readily could have detected her failure 

to complete the negative controls. Instead, Blake’s misconduct escaped 

detection for more than two years. In addition, without a checklist to assist the 

review, a technically-qualified DNA scientist could miss an important part of 

the review process or fail to notice the omission of a vital document or piece of 

information. For example, an Examiner might be called away suddenly to 

assess analysis difficulties a staff member is experiencing and, upon returning 

to his or her case-file reviews, fail to remember what material had not been 

examined and thus overlook important information. 

Interviews

To determine the extent to which the vulnerabilities we identified were 

mitigated or exacerbated by staff member work practices, we interviewed 

DNAUI staff members and management regarding their understanding of the 

requirements for case documentation and review. From those interviews we 

determined that the interviewees’ comprehension of case file documentation 

requirements was largely consistent, both with other interviewees as well as 

with the general mandates provided in the protocols. The amount of detail in 

the answers varied among the interviewees; however, these variations were 

consistent with the duties and position of the interviewees. Most interviewees 

knew where case file documentation requirements were addressed in the 

protocols, and their answers often expanded upon the information given in the 

protocols. 

Because our interviews with staff members focused on their duties that 

implement the protocols under scrutiny in our review, we interviewed only Unit 

management and Examiners regarding case file review. We found that their 

answers typically were similar, with the Examiners providing the level of detail 

that is consistent with their job responsibilities. We also found that the 

interviewee responses were consistent with the written case review protocol. 

We again noted that the answers, particularly from the Examiners, went 

beyond what is specified in the protocol, revealing that, while the protocol is 

lacking in detail, staff members appear to have gained an understanding of 

what constitutes a proper case file review through other means, such as 

training or peer guidance. Further, the OIG team scientists detected no 

additional risks posed by the methods attested to by staff members or 

management in the interview responses. 

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In conclusion, our fieldwork results revealed that staff members appear 

to understand management expectations regarding case file documentation 

and review, mitigating the risk posed by the lack of detail in the protocols. 

However, until the protocols adequately address the information gaps we 

previously identified, the risk of undetected noncompliance with management 

expectations will remain significant. 

Recommendations

We recommend that DNAUI management: 

11) Ensure that the Case Documentation Policy section found in the FBI

Laboratory Division Quality Assurance Manual contains: 

a) A listing of the minimum contents for all unit case files, along 

with a reference to that part of each unit’s case documentation 

and review protocol that addresses case file contents; and 

b) Guidance on notetaking methods and requirements common 

to all units, along with a reference to the corresponding unitspecific protocols. 

12) Ensure that the Case Assignment, Documentation, and Review

section found in the DNA Analysis Unit I Quality Assurance Manual

contains: 

a) A detailed description of case file review procedures, including 

a checklist to facilitate the review and to document that the 

review accounts for each key item in the case file; 

b) Guidance on notetaking methods to ensure that DNAUI staff 

members understand how and when they should take notes; 

and 

c) A description of the procedures that must be followed to 

review and confirm case evidence profiles for entry into 

CODIS, or at a minimum, a reference to where those 

procedures are described in another policy document. 

e) Guidelines for Control Samples and Interpretation 

of Control Samples

Written Protocol

Forensic Standard 9.4 requires that forensic DNA laboratories monitor 

their analytical procedures using appropriate controls and standards. Forensic 

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Standard 9.4.2 explains that, for PCR casework analysis, those controls and 

standards must include quantification standards, positive and negative 

amplification controls, reagent blanks, and allelic ladders. Further, Forensic 

Standard 9.6 requires that forensic DNA laboratories have and follow written 

guidelines for the interpretation of data, including (in Forensic Standard 9.6.1) 

verifying that all control results are within established tolerance limits. 

Although we found that the DNAUI analytical protocols require and describe 

the use of these various standards and controls, as well as provide general 

guidelines for their interpretation, we identified certain information that is 

missing from the Guidelines for Control Samples and Interpretation of Control 

Samples sections in the Short Tandem Repeat Analysis Protocol that should be 

included to ensure that staff members have a clear and consistent 

understanding of control sample requirements. 

First, both the Guidelines for Control Samples and Interpretation of

Control Samples sections lack comprehensive guidance regarding the material 

staff members should review when they examine control results. In addition, 

both sections fail to differentiate the review responsibilities of the PCR 

Biologists and Examiners. Such guidance could include a checklist or 

summary sheet that would enable reviewers to ensure the completeness of 

their examinations. Further, the guidance should describe the circumstances 

in which a control result would cause an analysis run to “fail” (meaning that 

those samples must be re-analyzed). The sections seem to assume that DNAUI 

staff members already understand fully from another source what it means to 

review the control results and know exactly what to do. 

In addition, we questioned language in Section 10.3.3 of the 

Interpretation of Control Samples that allows DNAUI Examiners to use the 

results of an analysis to exclude a suspect in circumstances where the positive 

control has failed. The relevant provision states: 

If FSB [the DNAUI name for a positive control sample] does not exhibit 

the STR typing results listed above [the correct results are shown in a 

table above this statement], the following steps must be taken. 1) If there 

appears to be an injection or electrophoretic problem, reinject the FSB 

with a ladder. 2) If re-injection of the FSB does not resolve the problem, 

and may be due to amplification issues, all samples set-up and amplified 

with this control will be considered inconclusive for matching purposes, 

but can be used for purposes of exclusion. If sufficient DNA remains of 

samples co-amplified with a failed control, then it is appropriate to reamplify them. 

We questioned this provision primarily because it fails to identify 

precisely when staff members should apply it. Limited information is provided 

regarding the additional steps that might be attempted before reporting results. 

101
Further, it is not clear what a report would state about the results in situations 

where this provision is employed. In circumstances where additional analysis 

has the potential to generate a dispositive result, the lack of detailed guidance 

in this protocol could result in the unnecessary provision of inconclusive 

information to law enforcement agencies. 

In our view, the most significant vulnerability that results from the kinds 

of missing guidance on control results described above is that, similar to the 

previous protocol sections we have discussed that lack information, DNAUI 

management cannot ensure that staff members will know and comply 

consistently with their expectations. Also, when protocols are not 

comprehensive, staff members may become dismissive of them, enhancing the 

potential for inadvertent protocol noncompliance. 

It is important to note that there does not appear to be a significant risk 

that testing results will be used improperly, given the requirement within the 

DNAUI (consistent with Forensic Standard 12.1) that all cases and analysis 

results be reviewed by a technically-qualified peer reviewer as well as by an 

administrative reviewer. In other words, if there is a misunderstanding on the 

part of a PCR Biologist and a supervising Examiner regarding the scrutiny that 

is to be applied to the control results, that misunderstanding would most likely 

be detected by the technical reviewer or the administrative reviewer (who, in 

the case of the DNAUI, is also the technical manager). 

Interviews

To determine whether staff members’ work practices serve to mitigate 

these risks, we interviewed PCR Biologists, Examiners, and management 

regarding: 1) how the responsibility to review control results is divided between 

the Biologists and Examiners; 2) what information staff members look for when 

they review the control results; 3) under what circumstances an analysis of 

samples would fail because of the control results; and 4) the rationale behind 

the policy of using an analysis of samples to exclude a suspect even though the 

positive control failed. Staff members and management responses on these 

issues revealed a high degree of consistency. Regarding the fourth issue, 

DNAUI management explained during our interviews that the practice of using 

a DNA analysis to exclude a suspect even though the positive control failed is 

employed only if the sample results are good but the positive control has some 

malfunction that causes it to fail applicable quality requirements, no remaining 

DNA exists for another test, and where the results clearly indicate that the 

suspect does not match the evidence samples. DNAUI managers stated that 

they believe DNAUI staff members understand these limitations and how they 

should represent pertinent results in a report. They further explained that this 

policy is based upon the belief that it would be inappropriate not to make 

available results that exclude a suspected perpetrator simply because of a 

technical issue on the positive control. While we understand the rationale for 

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the policy, we disagree that the parameters for the use of the policy are 

communicated fully. Information about the policy’s usage is not represented in 

the protocol with the same level of clarity and comprehensiveness that was 

communicated to us through the interview responses. 

The information we received during our interviews of staff members and 

management regarding the four issues above is not found in the protocols, but 

rather is communicated through other means, such as training and peer 

guidance. The high degree of agreement and shared understanding among 

DNAUI staff members serves to mitigate the potential risk to proper scrutiny of 

control results posed by the incomplete protocols. 

Recommendation

13) To ensure that staff members maintain a complete and consistent 

understanding of the requirements in the Guidelines for Control 

Samples and Interpretation of Control Samples Sections in the Short

Tandem Repeat Analysis Protocol, we recommend that the DNAUI 

remedy the above-described lack of detail in these Sections. 

f) Organization and Management and Authority and 

Accountability

Written Protocol

Forensic Standard 4.1(c) requires that forensic DNA laboratories specify 

and document the responsibilities, authority, and interrelation of all personnel 

who manage, perform, or verify work affecting the validity of DNA analyses. 

The DNA Analysis Unit I Quality Assurance Manual includes sections entitled 

Organization and Management and Authority and Accountability that, 

ostensibly, should satisfy the requirements of Standard 4.1(c). However, upon 

examination, we discovered that these sections do not provide an adequate 

description of the interrelation of the various members in the DNAUI team 

structure. We also did not find a clear indication that the Unit Chief, as 

technical leader, has the authority to halt operations if a significant problem is 

detected. Nor did we find a clear delineation of the responsibilities of each 

team member when responding to problems or improper staff member actions. 

The lack of specificity in this protocol increases the likelihood that staff 

members will misunderstand lines of authority and accountability, particularly 

with teams that have been allowed to vary their operations from one another. 

As explained in Chapter Five, Section II.C.1, staff members cited many 

examples of teams adopting their own methods when the protocols are not 

specific, including defining the division of authority and responsibilities of team 

members. Although poor communication resulting from deficiencies in this 

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protocol would not necessarily jeopardize analysis results, it could hinder the 

efficient execution of laboratory duties. Further, misunderstandings could 

cause a delay in the response to significant problems if staff members do not 

understand the lines of authority. 

Interviews

We conducted interviews to determine if staff members and management 

share an understanding of roles and responsibilities within teams and with 

respect to problem resolution. From the responses received we determined 

that, while staff members and management had the same general 

understanding, certain roles vary according to the team Examiner’s preference. 

All interviewees agreed that team member roles and responsibilities, including 

those pertaining to problem resolution, are not clearly delineated in the 

protocols, although a few stated that position descriptions and performance 

plans provided some additional guidance. In addition, Laboratory 

management, Unit management, and staff member interviewees noted the lack 

of guidance concerning how staff members and management should respond in 

situations involving employee misconduct, such as the discovery of Blake’s 

actions. 

Due to the consistency of the interviewee answers from both staff 

members and management, we concluded that a clear understanding of 

general team member roles and responsibilities is provided through means 

other than the protocols, such as training and peer guidance. However, 

problem resolution guidance is lacking. Consequently, we concluded that the 

risk posed by the lack of comprehensive guidance in the protocols on team 

member roles is mitigated by the DNAUI’s provision of that information to staff 

members through other means, while the risks associated with the lack of 

guidance on problem resolution remain unmitigated. 

Recommendations

14) The above-referenced sections of the DNA Analysis Unit I Quality 

Assurance Manual should be revised to add comprehensive guidance 

regarding team member roles and responsibilities, particularly as it 

applies to problem resolution. 

15) Include comprehensive guidance for problem response and 

resolution, similar to that contained in the DNAUI Quality Assurance 

Manual, in the FBI Laboratory Division Quality Assurance Manual. 

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2. Protocols That Fail to Inform the Exercise of Staff 

Discretion 

Written Protocols

In addition to protocols that fail to identify in sufficient detail the 

procedures that DNAUI staff members should follow when they perform DNA 

analysis, we also identified protocols that suffer from a related defect: the 

failure to specify the decision criteria staff members should employ when their 

duties require them to exercise discretion in the testing process. See Chart at 

page 80. Greater risk of abuse and error is present when procedures call upon 

the proper exercise of discretion. 

For example, the amplification set-up process requires DNAUI staff 

members to complete a series of objective steps where precise amounts of 

various substances are added to the amplification tubes. In contrast, 

Serologists are faced with a complex decision when, after completing 

preliminary testing and obtaining a negative result, they must determine what 

step to take next. Serologists must decide whether the presumptive test 

results should be followed or disregarded. In making that decision, they must 

consider, for example, whether other factors may have influenced the results, 

and whether a negative result automatically means that there is no detectable 

DNA on the evidence item. These questions and others like them must be 

answered and judgment applied to decide how the testing process should 

proceed. If staff members are not equipped with sufficient guidance to answer 

these questions, they could prematurely halt the serology process when a 

probative DNA result might otherwise have been obtained. 

Consequently, in our view, the risks inherent in such decision-making 

should be offset by the provision to staff members of adequate evaluative tools 

and guidance to ensure that they are thorough and consistent in their 

consideration of options at each “crossroad” in the DNA testing process. We 

failed to find this type of guidance in five sections that address serology testing 

and electrophoresis data interpretation: the Procedures for the Preparation of

Dried Bloodstains from Coagulated Whole Blood and from Anticoagulated Whole 

Blood; Procedures for the Extraction of Suspected Semen Stains: Questioned 

Stain Extraction Procedure from the Procedures for the Serological Identification

of Biological Substances on Evidentiary Materials;96 and the GeneScan Analysis

and Interpretation of Control Samples sections from the Short Tandem Repeat

Analysis Protocol. 

 96 While only the above-mentioned serology procedures were specifically cited by the

OIG team scientists, all the serology procedures would benefit from work-flow and decisionmaking guidance. See discussion at Chapter Five, Section III.A.2. 

105
Interviews

To understand how staff members exercise discretion under these 

protocols, we interviewed Serologists and Unit management regarding: 1) the 

circumstances in which they do or do not perform each of the serology tests; 

and 2) the procedures they follow if they obtain a negative result (indicating 

that no DNA was detected). Serologist responses were generally very similar to 

each other and to the responses provided by management. For example, 

Serologists provided similar descriptions of the various factors that they 

consider when deciding how to process an evidence item – factors that are not 

explained in the protocols, and Serologists and managers (including the 

Examiners) provided comparable descriptions of the Examiners’ role in serology 

decisions. 

We also interviewed Examiners regarding the discretion they have when 

interpreting electrophoresis results. Specifically, we asked them to describe: 

1) their responsibilities in the DNA analysis process; 2) what they specifically 

look for when reviewing GeneScan® data and control results; and 3) the 

circumstances in which they would decide to fail an analysis run based upon 

the control results. Their responses were generally consistent with one another 

and conveyed a level of detail not found in the protocols. 

In light of the foregoing, we concluded that the work practices of DNAUI 

staff members serve to mitigate the risk posed by the lack of adequate 

evaluative tools and guidance in the protocols. 

Recommendations

16) To minimize the potential for staff members to overlook relevant 

information or considerations when their duties require them to 

exercise discretion in the testing process, we recommend that 

DNAUI management supplement the above-described protocol 

sections with a work-flow diagram or decision tree. These aids 

would help to structure decision-making and better ensure that staff 

members are consistent in their evaluations. 

17) Evaluate protocols beyond those listed above, including all of the 

serology procedures, for process descriptions that would benefit 

from work flow and decision diagrams.

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3. Protocols That Fail to Ensure the Precision of Manual 

Notetaking 

Written Protocols

Forensic Standard 11.1 requires that forensic DNA laboratories follow 

written procedures for taking and maintaining case notes to support the 

conclusions drawn in laboratory reports. Further, Forensic Standard 11.1.1 

requires that forensic DNA laboratories maintain, in a case record, all 

documentation generated by examiners related to case analyses. The DNAUI’s 

protocols refer to these requirements and address, in a limited way, the 

documentation that should be present in a case file. However, we did not find 

comprehensive guidance on notetaking methods in three sections of the 

protocols where manual notetaking is identified as a significant part of staff 

member responsibilities. In addition, the sections lacked an explicit 

requirement for staff members to complete their notes contemporaneously with 

their work. The three sections are: 1) the Case Documentation Policy within 

the FBI Laboratory Division Quality Assurance Manual; 2) the Evidence Control

section within the DNA Analysis Unit I Quality Assurance Manual; and 3) the 

Procedures for the Examination of Evidence within the FBI Laboratory Division 

Caseworking Procedures Manual. 

The team structure in DNAUI makes it especially important that all staff 

members have a comprehensive and consistent understanding of how to record 

information as they complete their work. The case file documentation created 

by the Serologists and PCR Biologists serves a crucial role in communicating to 

the Examiner the results of the DNA analyses they have performed. The 

Examiner draws conclusions from this work and often testifies in court based 

in part on the documentation contained in the case file. 

In addition, contemporaneous documentation is important to ensure that 

the case file accurately reflects the work performed on each evidence item that 

is tested. If staff members are allowed to delay recording observations and test 

results until after they have examined all the items for a case or have 

completed all of their work for the day, their documentation may not be fully 

accurate. Also, staff members may be unduly influenced by protocol 

requirements when relying on memory, and document what they know should 

have occurred when their recollection is vague. Such a situation could lead to 

difficulties when trouble-shooting testing problems. For example, a weak and 

unusable testing result might be caused by a sample with low quantities of 

DNA or by a technical problem in the analysis process. An Examiner reviewing 

such results may not be able to pinpoint how to generate a better outcome if he 

or she is provided with an incomplete record from a staff member who is 

documenting from memory. 

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Interviews

Because we could not find any requirement for contemporaneous 

documentation or comprehensive guidance on how staff members should take 

notes, we asked staff members and management what they believe the 

requirements are on this subject. We interviewed ten DNAUI staff and three 

members of DNAUI management. 

DNAUI management cited a specific section of the protocols as the source 

of guidance on notetaking. However, the five staff members who cited the same 

section stated that the guidance in the protocols is very general and does not 

fully address the subject. Two staff members stated that notetaking is 

addressed in the protocols but did not cite a specific section. Three of the ten 

staff members stated that they did not think the protocols addressed the 

subject at all. Six of the ten staff members stated that documentation methods 

are learned during training. 

Unit management stated that notes are taken contemporaneously as 

testing is performed. Staff members generally indicated that they take 

handwritten notes as they work and then transcribe the notes into the 

computer at a later time (typically on the day they are written). Further, staff 

members did not always give the same answers regarding the time when they 

take notes: one Serologist stated that staff members will process multiple 

items and then type up notes; another Serologist explained that staff members 

create notes immediately after processing each item; and a PCR Biologist stated 

that staff members would not “typically” put off transcribing their notes until 

the following day (indicating that there might be times when that does occur). 

We also noted from interview responses that for those staff members who 

are taking contemporaneous notes on their computer during their work, there 

are no policies in place that require a protective covering (such as plastic wrap) 

to be used and changed at appropriate intervals to prevent contamination or 

cross-transfer as the staff person moves from handling an evidence item to 

typing on the computer keyboard. This issue is of greater concern now that the 

DNAUI has moved to its new facility. During our tour of the new Laboratory, 

the Unit Chief explained that the serology and PCR Biologist areas are 

equipped with a computer for each workstation to permit the immediate 

transfer of examination and analysis notes into the computer. He further 

stated that with the addition of these workstations staff members are expected 

to complete their notes contemporaneously with their work. 

Given the disparities in staff member answers, we concluded that 

Laboratory management has not clearly articulated standards to govern 

notetaking, including handwritten notes that are later transferred to the 

computer. Further, it is evident from the Unit Chief’s responses that while 

contemporaneous documentation previously was a goal, it now is an 

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expectation in the new facility. No written requirement has been published for 

staff members, however, setting forth comprehensive guidance on notetaking 

methods. 

Recommendations

We recommend that Laboratory and DNAUI management: 

18) Supplement documentation guidance found within the Case

Documentation Policy in the FBI Laboratory Division Quality 

Assurance Manual, the Evidence Control section in the DNA Analysis 

Unit I Quality Assurance Manual, and the Procedures for the 

Examination of Evidence in the FBI Laboratory Division Caseworking 

Procedures Manual, to include comprehensive guidance on 

notetaking methods. 

19) Require staff members to document contemporaneously the testing 

performed in each case. 

20) Include in the Unit-specific protocols cleaning and decontamination 

techniques designed to reduce the risk of contamination or crosstransfer as staff members move back and forth between the evidence 

items they are examining and their computer keyboards to take 

notes. 

4. Outdated Protocols 

Our review of the DNAUI’s protocols revealed that, at the time of our 

examination, four document sections had not yet been updated to reflect a new 

policy that had been implemented in the Unit as a consequence of Blake’s 

misconduct. The new policy requires Examiners to review GeneScan® data for 

all samples that show no DNA peaks on the Genotyper® data, and should be 

reflected in: 1) the Case Assignment, Documentation and Review section of the 

DNA Analysis Unit I Quality Assurance Manual, and 2) the Amplification, STR 

Typing: Setting up a Run, and GeneScan Analysis sections of the Short Tandem 

Repeat Analysis Protocol. These sections of the protocols reflect the previous 

requirement for review of only the Genotyper® data by the Examiners, a 

practice that allowed Blake’s actions to escape detection. 

The risk posed by having outdated protocols is that some staff members 

might not be aware of new requirements and inadvertently rely upon standards 

that have been superseded. Unit management stated that their reason for 

delaying the updating of the protocol is two-fold: 1) they anticipated that the 

OIG vulnerability assessment would result in additional changes to their 

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protocols, and 2) because the protocol revision process is lengthy and time 

consuming, they wanted to wait and make all the revisions at one time. 

 

We concluded from our fieldwork interviews that staff members involved 

in data review are aware of the new GeneScan® data review policy and 

understand that adherence to its terms is required. Further, in discussions on 

this subject with Unit management, they informed us that the policy change 

had been executed through an “electronic communication” in April 2002, a 

written format that is used to notify staff members of protocol changes that are 

implemented between formal revisions. OIG staff members were provided a 

copy of the electronic communication and confirmed that it describes the new 

data review requirements. 

Recommendations

21) While we acknowledge that the risk posed by the lack of current 

information in the protocols was mitigated by DNAUI management’s 

notification to staff members of the new data review policy, we 

recommend that Unit management update the protocol sections 

cited above. 

22) Further, based upon the reasons given for delaying the updating of 

the protocols, we recommend that Laboratory management review 

the protocol-revision process to identify and implement methods to 

expedite that process. The revision of the protocols should not be so 

cumbersome that Laboratory management is deterred from keeping 

them current. 

5. Summary of Protocol Vulnerabilities 

 

In conclusion, the OIG team found 31 vulnerable sections in the 5 key 

manuals that govern the work of the DNAUI. In response to these findings, we 

examined the work practices of DNAUI staff members and management to 

determine whether those practices mitigated the vulnerabilities detected in the 

protocols. We found that the vulnerability risks posed by weaknesses in the 

protocols were mitigated to some extent by the work habits of the Unit’s 

employees. 

Although we did not conduct case file reviews throughout DNAUI, we did 

not identify through our interviews and fieldwork any instances of misconduct 

of the sort committed by Jacqueline Blake. Staff member and management 

responses conveyed a level of detail and consistency that reassured us that 

DNAUI employees are obtaining a clear understanding of the Unit’s 

requirements through means other than the protocols, such as training or peer 

guidance. However, staff practice did not mitigate all of the protocol 

weaknesses, and interviewee responses confirmed the remaining protocol 

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vulnerabilities that we detected. Below we summarize whether the 

vulnerabilities identified in the document sections were mitigated or confirmed 

in accordance with the practice information provided by DNAUI staff members 

and management. 

Protocol Name and Section Title

Mitigated* 

Vulnerabilities

Unmitigated

Vulnerabilities

Evidence Control Policy X

Case Documentation Policy X X

Organization and Management X X

Authority and Accountability X X

Evidence Control X X

Facilities (Security) X

Case Assignment, Documentation, and Review X

Procedures for the Examination of Evidence X X

Procedure for...Bloodstains from Coagulated Whole Blood X

Procedure for ... Bloodstains from Anticoagulated Whole Blood X

Procedure for the Extraction of Suspected Semen Stains...: Quality

Control Procedures

X

Procedure for the Extraction of Suspected Semen Stains...: 

Questioned Stain Extraction Procedure

X

Guidelines for Control Samples X

Extraction (total of 10 subsections) X X

Amplification X X

STR Typing: Setting up a Run X

Genescan Analysis X

Interpretation of Control Samples X

Laboratory Set-up (total of 4 subsections) X X

Protocol Vulnerability Status

* The "Mitigated" column is marked for those protocols where interview responses indicated that: 

1) staff members have a comprehensive understanding of the relevant protocol requirements, and 

2) staff members attest that their personal methods comply with this understanding. Conversely, the 

"Unmitigated" column is marked for those protocols where interview responses indicated that either of

these findings were not present. A mark in both columns indicates that some weaknesses were mitigated 

while others were not within the same protocol section.

Procedures for the Serological Identification of Biological Substances on Evidentiary Materials

Short Tandem Repeat Analysis Protocol

FBI Laboratory Division Quality Assurance Manual

DNA Analysis Unit I Quality Assurance Manual

FBI Laboratory Division Caseworking Procedures Manual

Our recommendations to DNAUI management detailing the remedial 

actions that we believe are necessary to correct the identified protocol 

vulnerabilities are set forth in Section C below. We believe that until the 

DNAUI completes the actions prescribed in those recommendations, the DNAUI 

needlessly will remain subject to an increased risk of employee error and 

inadvertent protocol noncompliance. 

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6. Implications of DNAUI Protocol Vulnerabilities for 

DNAUII 

 

While we did not conduct an assessment of DNAUII’s protocols, we 

believe that our conclusions and recommendations regarding the DNAUI would 

also benefit the DNAUII in the following ways: 1) the changes made to the 

DNAUI’s Short Tandem Repeat Protocol will improve STR work performed by or 

for DNAUII personnel; and 2) case file documentation and evidence storage and 

handling in the DNAUII will be improved by changes made to Laboratory-wide 

protocols, such as the FBI Laboratory Division Quality Assurance Manual and 

the FBI Laboratory Division Caseworking Procedures Manual. 

However, based upon the extent of the vulnerabilities identified within 

DNAUI’s protocols, we believe that the risk exists that DNAUII’s protocols 

contain vulnerabilities of a similar nature, vulnerabilities that will not be 

remedied completely by the improvements made as a result of our preceding 

recommendations. Therefore, we make the following recommendation. 

Recommendation

23) The recommendations in this report should be applied to DNAUII 

where applicable. In addition, DNAUII management should conduct 

a comprehensive vulnerability assessment of its own protocols and 

practices, similar in extent and focus to the assessment the OIG has 

conducted on the protocols and practices of the DNAUI, and remedy 

all vulnerabilities identified by that review. We believe that such an 

assessment will have a greater degree of success if DNAUII 

management solicits the participation of scientists outside the 

DNAUII, who can bring an unbiased perspective to the assessment. 

C. Analysis of Practice Vulnerabilities 

As explained earlier, the second type of vulnerability we identified during 

our review – practice vulnerabilities – was detected as we completed our 

fieldwork on the protocol vulnerabilities. These weaknesses result from the 

manner in which the DNAUI implements its protocols, leaving the Unit more 

susceptible to undetected inadvertent or willful protocol noncompliance. Our 

analysis is based largely upon the perceptions of DNAUI staff members, since 

each of the vulnerabilities was identified by multiple staff members and/or 

management during our interviews with them. Of special concern are the 

following: 1) variations in team operations; 2) the “oral tradition” of DNAUI 

guidelines and training; and 3) communication and operational inefficiencies. 

We describe each below. 

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1. Variations in Team Operations 

During our interviews with DNAUI staff members, we regularly received 

comments regarding the degree of variation that exists in the operations of the 

DNAUI teams. For example, a PCR Biologist explained that various aspects of 

the work performed by staff members are not standardized. The Biologist 

further explained that while everyone follows the protocols (e.g., how samples 

are numbered, how to check in cases), the protocols are general and leave a lot 

of room for flexibility. The Biologist stated that, consequently, the teams often 

function very differently. The Biologist stated that this can be beneficial for 

someone who wants to devise and follow his own procedures, but when issues 

arise in the Unit, those variances also can pose a problem. 

Another PCR Biologist provided similar comments, stating that even 

though the protocols are followed very strictly, there is a broad range of 

interpretative leeway for anything that the protocols do not specify. According 

to this Biologist, the practices of Biologists on the DNAUI teams vary, which 

can pose a problem if a Biologist ever has to do work for another team, since 

the supervising Examiner may not be comfortable with the Biologist’s methods. 

In addition, the Biologist explained that since the Examiners testify based upon 

how their team operates, their testimony might not be precise if a Biologist 

from another team has provided assistance and employed another team’s 

methods. The Biologist stated that there needs to be more uniformity between 

teams. The Biologist also explained that Examiners are probably unaware of 

the extent of these variations. 

A Serologist commented that, due to the nature of the “oral tradition” of 

training (covered under the next section), many staff members have developed 

their own style, methods, and preferences for how they perform their work. 

Another Serologist referred to the variations in team operations and explained 

that they make it hard to train new staff members and to learn what is 

required. 

Multiple staff members commented about the flexibilities afforded to 

teams due to the lack of detailed guidance on specific topics in the written 

procedures and protocols. Examples cited by staff members were: 1) how 

forms are filled out; 2) how case file documentation is transferred to the 

Examiner; 3) how responsibilities are divided between the PCR Biologist and 

the Examiner; 4) how much Examiners interact with their team members on 

decisions; 5) the work flow of the serology procedures; 6) notetaking; and 

7) inter-Unit transfer of evidence. 

One member of DNAUI management acknowledged that it would be 

advisable to standardize guidelines for team operations. He said that while he 

thought that the lack of uniformity had not yet caused a problem for the 

DNAUI, it could in the future. He stated, however, that there would probably 

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be resistance to standardizing team operations. He stated that even though 

there may be better ways to do things, staff members are accustomed to their 

own procedures and likely would resist standardization because they would not 

want to sacrifice their autonomy. 

These interview comments highlight the need to ensure that protocols are 

comprehensive and address all aspects of the Unit’s operations. See Chapter 

Five, Section II.B.1 (describing protocols that lack sufficient detail). As many 

interviewees mentioned, practice variations exist because the written guidance 

is silent on many subjects. 

2. Training and the DNAUI’s “Oral Tradition” 

During our interviews with DNAUI staff members and management, we 

were informed that the Unit’s training curriculum consists largely of individual 

discussions with a mentor and presentations given by various experienced staff 

members. Laboratory management was unable to furnish us with a single, 

comprehensive curriculum, though we were provided training program 

manuals for Biologists and Examiners, and PowerPoint slides used during 

training presentations. Also, we saw evidence in the training records that 

these presentations often relied upon other training materials, such as 

handouts and checklists. However, none of these materials has been collected 

and incorporated into a larger training program with a defined curriculum. 

According to DNAUI staff members, this diffuse approach to training is 

founded upon the Unit’s “oral tradition,” since verbal instruction is the primary 

means of conveying training information. During interviews regarding Unit 

operations, several staff members explained their perspective on why the oral 

tradition, as a training philosophy, increases the Unit’s vulnerability to 

inadvertent and willful noncompliance with applicable protocols. 

For example, two staff members cited training as a key weakness in the 

Unit. They explained that when the Unit was created, training was better 

because everyone was “starting fresh and learning the same thing.” However, 

over time people began to teach their own preferences as the only way to 

complete the Unit’s work. In the view of these two individuals, the result is a 

staff that does not have an understanding of the “big picture” and that 

performs work in noticeably different ways. One of the staff members, a 

Serologist, explained that the weaknesses in training are exacerbated by the 

fact that, because many staff members have biology degrees, much is assumed 

about their basic understanding of laboratory operations, which may be 

unwarranted. The other staff member, a PCR Biologist, stated that some 

training improvements were being implemented under the current Unit 

leadership, and cited as examples the development of a written exam to assess 

candidate qualifications and increased stringency in the qualification 

requirements. 

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An Examiner who has served as the training coordinator for the DNAUI 

acknowledged that the oral tradition concerns him since it fosters “protocol 

drift” – something staff members described as the use of personalized testing 

procedures that deviate from and/or add to the letter of the protocols, though 

without jeopardizing the integrity of the testing results.97 The Examiner 

identified several checks and balances on the training process that he felt 

counteracted the risks associated with an oral tradition. These included the 

constant involvement during training of a trainer/mentor and, following 

training, the oversight of an Examiner during casework duties who would 

notice whether something had been overlooked or improperly communicated 

during training. He added that key policies are reiterated throughout training, 

and that there are multiple ways to check to see if a person understands his or 

her duties. Yet, the Examiner acknowledged that in spite of these “checks and 

balances,” protocol drift still occurs. 

We note two considerations regarding the Examiner’s comments. First, 

each of the checks on staff member behavior he identified requires another 

DNAUI staff member, rather than a written document in conjunction with staff 

guidance, to be the source of information and direction for the Unit’s 

employees. Second, based upon the division of duties within DNAUI teams, 

particularly the division of duties and roles described by staff members, we are 

not convinced that the Examiners are sufficiently involved in the day-to-day 

activities of their team members to serve as one of the “checks and balances.” 

This was illustrated by the fact that Blake’s Examiner was unaware of her 

misconduct until Blake’s colleague noticed her omissions. 

In addition, when the distinction between staff member preference and 

protocols is unclear, trainees are left to draw their own conclusions regarding 

proper testing methods. In our view, such an environment leaves the Unit 

vulnerable to inadvertent noncompliance with Unit requirements, since staff 

members may choose to alter their methods in ways that unwittingly contradict 

Unit requirements. 

A DNAUI Serologist, who also is involved in training activities, stated that 

management’s failure to communicate the reasons behind the Unit’s work 

requirements is a weakness and needs to be addressed during training. A PCR 

Biologist reiterated the point, stating that training has been a weakness in the 

Unit and that part of the problem is the failure to teach staff members why 

they are asked to do their work a certain way – the importance and history 

behind what they are doing – not just the actual procedural steps to perform. 

 97 For example, staff members have adopted methods for cleaning their transport trays 

that they believe are sufficient. These procedures are not specifically covered in the existing

protocols; instead, they supplement requirements found in the Amplification and Laboratory

Set-up protocols. Another example of protocol drift, a hypothetical provided by a DNAUI 

Biologist, would be using an incubation time of 1 hour, 55 minutes, when the protocol calls for 

an incubation time of 2 hours. 

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In conclusion, moving away from training that is based on the DNAUI’s 

“oral tradition” will help to ensure that the other recommendations we present 

in this report reduce the DNAUI’s vulnerability to undetected protocol noncompliance. A well-documented and comprehensive training curriculum 

should reinforce application of the revisions we have outlined to the Unit’s 

protocols. 

3. Communication and Operational Inefficiencies 

We determined from our review of DNAUI operations and our analysis of 

interview responses that there are various communication and operational 

inefficiencies within the DNAUI. 

a) Communications 

During our interviews with DNAUI staff members and management, we 

inquired about the way that information is communicated within the Unit. 

This issue was of particular interest to us because of the importance of 

communication to the proper implementation and improvement of DNAUI 

protocols. We asked interviewees the following questions: 

• How are staff members kept apprised of changes in work routine, 

procedures, and resources? 

• What options are available to you if you were to have a 

recommendation, request, suggestion, or a critique regarding Unit 

operations or protocols? 

We observed from interview responses that although members of upper 

management think that communication within the Unit, and between the Unit 

and Laboratory management, is functioning well, several staff members do not 

feel that they are kept informed about operational information and believe that 

communications are at times dysfunctional. Further, several comments we 

received indicate that some staff members do not believe that Laboratory 

management actively solicits and considers their input on issues that affect 

their work. 

Management and staff members identified similar methods that are used 

to keep staff members updated on operational and protocol-related 

information, including e-mail and Unit or program meetings. However, it was 

clear from staff member responses that these methods are not consistently 

effective. Staff members explained that the dissemination of information, 

including protocol-related information, is erratic. Examiners made reference to 

this problem and said that some Examiners are better than others in passing 

along information, a point that also was noted by both a PCR Biologist and 

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Serologist. One Examiner stated that changes in technical operations that 

affect the quality of work are always passed on to staff members, but that 

Examiners may not pass on administrative information. However, we question 

whether Examiners are as consistent as this Examiner claims in conveying 

operational information, given the lack of a requirement that Examiners 

disseminate protocol-related information promptly and accurately to those 

under their supervision. 

In addition, one Serologist added that even when decisions and other 

important information are communicated to staff members, the rationale 

behind them often is not explained, leaving staff members unclear on the goal 

that management is trying to achieve.98 One Examiner said that he felt that 

information does not flow effectively up the hierarchy either, and identified a 

situation where the PCR Biologists decided to initiate a technical change in 

Unit procedures and failed to ensure that all the Examiners were made aware 

of it. 

The types of communication weaknesses mentioned by staff members 

pose a risk to the efficiency and effectiveness of the Unit’s operations and 

should be addressed. Of particular concern is the perception of Laboratory and 

Unit management that communication lines are functioning well, while many 

staff members describe a different perspective that questions whether they are 

being kept well informed of procedural changes and whether management 

properly considers technical input in operational matters. 

b) Operations 

During our review of protocol vulnerabilities, we observed many DNAUI 

operations that could be made more efficient through use of a Laboratory 

Information Management System (LIMS). A LIMS is a computerized system of 

databases that track, organize, and link the information that must be 

maintained to document the receipt, handling, and disposition of each case 

and evidence item. A LIMS allows a laboratory to: 

• Reduce the incidents of human error associated with the manual 

entry of tracking information; 

• Improve evidence handling efficiency, saving time particularly for 

those staff members who have numerous evidence processing and 

transfer responsibilities; 

• Prevent the unauthorized alteration of tracking information; 

 98 For additional discussion on this point, see supra at page 96. 

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• Allow management to trouble-shoot problems and to identify 

causes related to equipment, reagents, and personnel; and 

• Document who has accessed and/or contributed to the 

information contained in the LIMS. 

Because of these capabilities, we believe such a system would strengthen 

the Unit’s internal controls and allow DNAUI staff members to be more efficient 

in their duties. As revealed in their interview responses, Laboratory and Unit 

management, as well as staff members, share this assessment and believe that 

acquisition of a LIMS is a priority for the Laboratory. We were informed that 

Laboratory management began to lay the groundwork for the implementation of 

a LIMS in 2002. During our March 2003 fieldwork, we met with personnel 

involved in LIMS development at the Laboratory and reviewed available 

documentation concerning the progress of implementation. From this 

information, we determined that the Laboratory had completed the bid process 

for a contractor who would design and implement the LIMS, and that all Unit 

Chiefs had been involved in determining the capabilities that the LIMS would 

need in order to suit the activities of their Unit.99 In October 2003, we were 

informed that the LIMS had been procured and that the system should be online in December 2003 and functioning fully in the Laboratory by 

approximately March 2004. The Laboratory Director told us in March 2004 

that he expected the LIMS to be fully operational this fiscal year, and that the 

Laboratory was waiting on security clearances for the staff of the LIMS 

contractor before commencing implementation of the system. 

We recommend that the Laboratory’s LIMS work remain one of its top 

priorities. Specifically, successful implementation requires that all appropriate 

personnel have ready access to the system, have received adequate training, 

and are afforded the resources needed to convert their current methods and 

operations to those that will maximize the capabilities of the LIMS. Further, we 

recommend that Laboratory management continue to set aside sufficient 

resources for the LIMS to ensure that it keeps pace with the changes and 

developments in technology that invariably will occur over time. 

 99 We also were informed by the DNAUI Unit Chief that the DNAUI is implementing a 

unit-specific tracking system that will feed into the Laboratory-wide LIMS, called the Sample

Tracking and Control System (STaCS). While initially STaCS has been used to track federal 

offender samples that are received as part of the Federal Convicted Offender Program (the

federal database of convicted offender samples), management intends to expand STaCS for 

application to case evidence tracking. 

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CHAPTER SIX 

OIG RECOMMENDATIONS

Jacqueline Blake’s misconduct has required the FBI Laboratory to 

reassess its oversight of DNA testing in the DNAUI. The objective of this review 

was to identify ways to make the DNAUI less vulnerable to undetected 

inadvertent or willful noncompliance with the protocols that govern DNA 

analysis. Our recommendations focus on two general types of vulnerabilities: 

protocol vulnerabilities and practice vulnerabilities. In addition, we provide 

recommendations that we believe will address several of the issues of concern 

that we identified regarding the management response of the FBI and DOJ to 

Blake’s misconduct. Our recommendations are listed below. 

I. MANAGEMENT RESPONSE RECOMMENDATIONS 

1) To facilitate prompt communications with evidence contributors 

and prosecutors in the event of future testing problems, the 

Laboratory should maintain the information below in an electronic 

format that can be shared conveniently with other FBI components 

(e.g., FBI OPR and FBI OGC) and the Department of Justice: all 

contributor contact and case information currently required for an 

evidence contributor to request an evidence examination (see FBI 

Handbook of Forensic Services, 

(http://www.fbi.gov/hq/lab/handbook/intro2.htm); the e-mail 

address of the evidence contributor; and the name, title, agency, 

address, telephone number, and e-mail address of any associated 

prosecutor(s); 

2) In circumstances where a protocol violation renders testing results 

scientifically invalid and a report from the Laboratory is not 

expected to issue within 180 days from the discovery of the 

violation, the Laboratory should notify the evidence contributor of 

the following information within 90 days of learning of the 

violation: the nature of the protocol violation; how the violation 

occurred; the remedial measures that the Laboratory intends to 

implement in the case to generate scientifically valid testing 

results; and the time needed to complete the remedial measures 

and to issue a final report; and 

3) The FBI Laboratory should perform a file review of a sample of 

cases that Blake is known to have worked on prior to becoming a 

PCR Biologist to reconfirm that the procedures that were required 

in fact are documented as appropriate in the case files. 

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II. REMEDY PROTOCOL VULNERABILITIES 

Our analysis of the DNAUI’s protocols revealed various weaknesses that 

leave the Unit vulnerable to employee error and wrongdoing. The 

recommendations we present below are designed to reduce the Unit’s exposure 

to this vulnerability and fall in four general areas: 1) eliminate vague and 

ambiguous text from the protocols; 2) incorporate decision aids into the 

protocols; 3) enhance notetaking requirements; and 4) update the protocols. 

A. Eliminate Text Vagueness 

Approximately 20 percent of the protocol sections we examined lacked 

the detail necessary for a technically qualified DNA scientist to identify the 

testing methods that should be in use in the DNAUI. Accordingly, DNAUI 

management should ensure that the document sections identified as vague in 

Chapter Five of this report are corrected to describe completely and accurately 

management expectations, Unit procedures and policies, and “best practices” 

currently in use in the DNAUI. Specifically, DNAUI management should: 

4) Ensure that the Evidence Control Policy of the FBI Laboratory

Division Quality Assurance Manual, the Evidence Control and 

Facilities (Security) sections of the DNA Analysis Unit I Quality 

Assurance Manual, and the Procedures for the Examination of

Evidence section of the FBI Laboratory Division Caseworking 

Procedures Manual, contain: 

a) Comprehensive guidance regarding the prevention of 

evidence contamination, loss, and destruction. At a 

minimum, this information should be included in Evidence 

Control Policy sections 3.2 and 3.5; Evidence Control sections 

7.6.1 and 7.6.2; and Procedures for the Examination of

Evidence sections 4.1.3 and 4.5.1.1. The Laboratory-wide 

sections should identify procedures that are applicable to all 

Units. Sections associated with a particular Unit should 

provide a complete listing of the evidence preservation 

methods in use in that Unit, even when those methods are 

identified elsewhere in the other Unit protocols. 

b) General guidance regarding DNA evidence handling 

procedures that is applicable to all Laboratory Units. This 

information should be provided in Laboratory-wide 

documents, including the Evidence Control Policy of the FBI

Laboratory Division Quality Assurance Manual, and the 

Procedures for the Examination of Evidence section of the FBI

Laboratory Division Caseworking Procedures Manual, and 

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should describe the requirements to process the evidence 

one case at a time, and to handle evidence one item at a 

time. The guidance also should identify procedures to 

ensure that one Unit does not compromise the ability of 

another Unit to test the same item of evidence. 

c) Unit-specific guidance on DNA evidence handling 

procedures. This information should be included in the 

Evidence Control section of the DNA Analysis Unit I Quality 

Assurance Manual, and should contain all evidence 

handling, contamination-prevention, and evidencepreservation methods universal to all technical DNAUI staff. 

d) An identification of facility access limitations, including a 

description of the context and limitations for access to 

DNAUI areas by non-DNAUI personnel. This information 

should be added to Facilities (Security) section 6.1. 

5) Ensure that the Evidence Control Policy of the FBI Laboratory

Division Quality Assurance Manual, the Evidence Control and 

Facilities (Security) sections of the DNA Analysis Unit I Quality 

Assurance Manual, and the Procedures for the Examination of

Evidence section of the FBI Laboratory Division Caseworking 

Procedures Manual cross-reference other relevant guidance to 

ensure that staff members know whether additional information is 

located in other manuals. 

6) Implement a policy that requires staff members to certify that they 

have read, understand, and will comply with each protocol that 

governs DNAUI operations, as well as any approved revisions that 

have not yet been incorporated into the protocols. 

7) Revise policies for securing evidence under active examination to 

reflect the current availability of independently securable storage 

at staff member workstations, and of a securable bulky evidence 

examination room. The policies should require the use of these 

new facilities rather than leaving the security of unattended 

evidence under active examination dependent upon facility access 

limitations. 

8) Ensure that the Extraction and Amplification sections of the Short

Tandem Repeat Analysis Protocol include: 

a) A requirement that the known and unknown (evidence) 

samples are processed separately during examination, 

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extraction, and amplification, including references to 

guidance that specifies the amount of time and space that 

meets the intent of the term “separation.” 

b) A requirement for the “separation” of high- and low-quantity 

DNA samples, as well as references to guidance that specifies 

the amount of time and space that meets the intent of the 

term “separation.” 

9) Ensure that the Extraction, Amplification, and Laboratory Set-up

sections of the Short Tandem Repeat Analysis Protocol include: 

a) Information on the use, cleaning, and decontamination of 

the “transport trays” used by PCR Biologists to move 

samples to the amplification area. 

b) General evidence handling information.100

c) In the Extraction section, a prohibition on having two sample 

tubes open at once, clarification in section 4.1.3 regarding 

required incubation times, and further explanation 

concerning when the additional organic extractions 

permitted by section 4.3-9 are appropriate. 

d) In the Amplification section, a requirement that control 

samples be processed last, and in section 6.7, the 

specification of the order in which sample tubes should be 

set up. 

10) Ensure that the Procedures for the Serological Identification of

Biological Substances on Evidentiary Materials includes: 

a) Detailed guidance on proper evidence handling methods, 

similar in content to the guidance contained in the 

Laboratory Set-up section of the Short Tandem Repeat

Analysis Protocol. 

b) In the Procedures for the Preparation of Dried Bloodstains 

from Coagulated Whole Blood and the Procedures for the 

Preparation of Dried Bloodstains from Anticoagulated Whole 

Blood, a requirement to: 1) pretest the cotton sheeting to 

 100 Currently, this information is included in the Laboratory Set-up section. We

recommend that it be included in all sections of the Short Tandem Repeat Analysis Protocol that 

call for the handling of evidence, but at a minimum, in the Extraction and Amplification

sections. 

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ensure that there is no DNA contamination; and 2) identify 

the amount of blood to use when making dried blood stains. 

c) In the Procedures for the Extraction of Suspected Semen 

Stains: Quality Control Procedures and Procedures for the 

Extraction of Suspected Semen Stains: Questioned Stain 

Extraction Procedure, guidance regarding: 1) the usable life 

of the positive semen control; 2) the size of the swab to use 

for testing; 3) the need to use disposable paper to reduce the 

risk of contamination; 4) whether extracts and swabs are 

both sent to the Biologist for testing; and 5) what happens 

after the stain extraction procedure has been completed (i.e., 

what occurs if there is a negative or positive result). 

d) Unwritten internal controls that already are in use by DNAUI 

staff members and management, including (but not limited 

to): (a) the requirement for a team’s PCR Biologist to record 

the characteristics of the evidence, supplementing the 

description generated by the Serologist; and (b) the 

requirement for Serologists to perform a “general swabbing” 

of an item to ensure that no possible sources of DNA on that 

item have been missed. 

11) Ensure that the Case Documentation Policy section found in the 

FBI Laboratory Division Quality Assurance Manual contains: 

a) A listing of the minimum contents for all Unit case files, 

along with a reference to that part of each Unit’s case 

documentation and review protocol that addresses case file 

contents; and 

b) Guidance on notetaking methods and requirements common 

to all Units, along with a reference to the corresponding 

Unit-specific protocols. 

12) Ensure that the Case Assignment, Documentation, and Review

section found in the DNA Analysis Unit I Quality Assurance Manual

contains: 

a) A detailed description of case file review procedures, 

including a checklist to facilitate the review and to document 

that the review accounts for each key item in the case file; 

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b) Guidance on notetaking methods to ensure that DNAUI staff 

members understand how and when they should take notes; 

and 

c) A description of the procedures that must be followed to 

review and confirm case evidence profiles for entry into 

CODIS, or at a minimum, a reference to where those 

procedures are described in another policy document. 

13) Ensure that the Guidelines for Control Samples and Interpretation 

of Control Samples sections within the Short Tandem Repeat 

Analysis Protocol contain comprehensive guidance on each of the 

following: (a) the procedure to complete a case file review; (b) the 

difference between the review responsibilities of Examiners and of 

the PCR Biologists; (c) the circumstances in which a control result 

should cause an entire analysis run to “fail;” and (d) how and when 

staff members should use section 10.3.3 of the Interpretation of

Control Samples. Further, these sections should contain a 

checklist or summary sheet to assist reviewers to verify the 

completeness of their work. 

14) Ensure that the Organization and Management and Authority and 

Accountability sections of the DNA Analysis Unit I Quality 

Assurance Manual contain: 

a) A complete description of the characteristics, 

responsibilities, interrelation, and limitations of each job 

position in the various DNAUI teams; 

b) Problem-resolution guidance for each team member position 

that describes how to respond to operational and personnel 

problems (such as suspicion of protocol noncompliance), and 

that clearly delineates the options for resolution available to 

staff members; and 

c) A clear statement identifying Laboratory personnel who have 

the authority to halt DNAUI operations if a significant 

problem is detected. 

15) Include comprehensive guidance for problem response and 

resolution, similar to that contained in the DNAUI Quality 

Assurance Manual, in the FBI Laboratory Division Quality 

Assurance Manual. 

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B. Incorporate Decision Aids 

In addition to protocols that fail to specify the procedures that DNAUI 

staff members should follow when they analyze DNA, our review identified 

protocols that do not describe adequately the decision criteria staff members 

should employ when their duties require them to exercise discretion in the 

testing process. To address this deficiency, we recommend that DNAUI 

management: 

16) Add work-flow diagrams and decision trees to its protocols to assist 

staff members to exercise properly their judgment during the DNA 

testing process. These aids would help to structure decisionmaking and to ensure that staff members do not overlook relevant 

information. At a minimum, the following protocol sections should 

include decision-making aids: 

a) in the Procedures for the Serological Identification of Biological

Substances on Evidentiary Materials: 1) the Procedures for 

the Preparation of Dried Bloodstains from Coagulated Whole 

Blood and from Anticoagulated Whole Blood; and 

2) Procedures for the Extraction of Suspected Semen Stains: 

Questioned Stain Extraction Procedure; 

b) in the Short Tandem Repeat Analysis Protocol: 1) the 

GeneScan Analysis section, and 2) the Interpretation of

Control Samples section. 

17) Evaluate protocols beyond those listed above, including all of the 

serology procedures, for process descriptions that would benefit 

from work flow and decision diagrams. 

C. Enhance Notetaking Requirements 

During our review we identified three procedure and protocol sections 

that depend upon the precision of manual notetaking but that lack 

comprehensive guidance on notetaking methods. To address this deficiency, 

Laboratory and DNAUI management should: 

18) Supplement documentation guidance found within the Case

Documentation Policy in the FBI Laboratory Division Quality 

Assurance Manual, the Evidence Control section in the DNA 

Analysis Unit I Quality Assurance Manual, and the Procedures for 

the Examination of Evidence in the FBI Laboratory Division 

Caseworking Procedures Manual, to include comprehensive 

guidance on notetaking methods. 

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19) Require staff members to document contemporaneously the testing 

performed in each case. 

20) Include in the Unit-specific protocols cleaning and 

decontamination techniques designed to reduce the risk of 

contamination or cross-transfer as staff members move back and 

forth between the evidence items they are examining and their 

computer keyboards to take notes. 

D. Update Protocols 

Our review identified several protocols that are outdated and no longer 

reflect current procedures in use in the DNAUI. To address this deficiency, 

DNAUI management should: 

21) Revise the Case Assignment, Documentation and Review section of 

the DNA Analysis Unit I Quality Assurance Manual, and the 

Amplification, STR Typing: Setting up a Run, and GeneScan

Analysis sections of the Short Tandem Repeat Analysis Protocol to 

include the current requirement that Examiners review GeneScan®

data for all samples that show no DNA peaks on the Genotyper®

print-out. 

22) Review the protocol revision process and identify ways to expedite 

it. Protocols should not be so difficult to update that 

administrative burden justifies not keeping them current. 

E. Implications for DNAUII 

Based upon the extent of the vulnerabilities identified within DNAUI’s 

protocols, we believe that the risk exists that DNAUII’s protocols contain 

vulnerabilities of a similar nature, vulnerabilities that will not be remedied 

completely by the improvements made as a result of our preceding 

recommendations. Therefore, we make the following recommendation. 

23) The recommendations in this report should be applied to DNAUII 

where applicable. In addition, DNAUII management should 

conduct a comprehensive vulnerability assessment of its own 

protocols and practices, similar in extent and focus to the 

assessment the OIG has conducted on the protocols and practices 

of the DNAUI, and remedy all vulnerabilities identified by that 

review. We believe that such an assessment will have a greater 

degree of success if DNAUII management solicits the participation 

of scientists outside the DNAUII, who can bring an unbiased 

perspective to the assessment. 

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III. REMEDY PRACTICE VULNERABILITIES 

Our fieldwork focused on the DNAUI staff’s application of the protocols 

we identified as deficient. The information we collected establishes that the 

DNAUI needs to: 1) promote greater consistency in DNAUI team operations; 

2) develop a comprehensive, written training curriculum; 3) improve 

information dissemination; and 4) implement an information management 

system to improve evidence tracking capabilities and efficiency of operations. 

A. Promote Greater Consistency in Team Operations 

Our interviews of DNAUI staff members indicated that variation exists in 

the operations of the Unit’s teams. Unwarranted flexibility in DNAUI 

operations can communicate to staff members that they are free to develop 

idiosyncratic work practices, which can create an environment with greater 

risk for inadvertent or willful noncompliance with protocols. To promote 

greater consistency and accountability in DNAUI functions, we recommend 

that Laboratory and DNAUI management: 

24) Document and standardize the best practices of the Unit’s teams 

and incorporate them in protocols. 

25) To the extent practicable, minimize managerial flexibility permitted 

in team operations, even in areas considered to be of no “impact” 

to the analysis process (as we have defined the term for our 

assessment). 

26) Document in the protocols those flexibilities that remain, with an 

explanation of the circumstances in which team members have 

leeway to exercise discretion and to vary testing methods. This 

documentation should provide staff members with clear guidance 

on the constraints placed by management on their discretion, so 

that they can be alert to practices that exceed those constraints. 

As part of this documentation, the protocols should include 

notations to staff where the precision of their actions can fall 

within an acceptable range (i.e., if the protocol calls for a 2-hour 

incubation time, but 1 hour and 50 minutes is acceptable, the 

protocol should reflect the range of time that is considered 

scientifically acceptable). 

27) Ensure that protocols and training materials address the risks 

posed by protocol drift and protocol noncompliance, and prohibit 

individual staff or team variation from the protocols. This 

information should build upon the above-required analysis of team 

variations, the limitations placed upon existing flexibilities, and the 

delineation of those procedures where a scientifically acceptable 

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range of activity is permitted. In addition, in circumstances where 

DNAUI staff members deviate from the protocols, they should be 

encouraged to note the deviation and its degree in the case file. 

B. Formalize Training 

Our review of DNAUI training practices revealed that the Unit lacks a 

comprehensive curriculum and that training consists largely of individual 

discussions with a mentor and presentations given by various experienced staff 

members. To address this deficiency, DNAUI management should: 

28) Convert this “oral tradition” of training into a comprehensive, 

written curriculum to ensure that trainees receive consistent 

instruction that comports with the protocols. As part of this 

process the Laboratory should: 

a) Collect the training materials that currently are in use and 

organize them into a coherent written course of study; 

b) Cross-reference the training materials to the protocols; and 

c) Ensure that the training materials reflect the standardized 

best practices and limited flexibilities established in 

recommendations 18-20. 

29) Ensure that the training materials are kept current as the DNAUI 

protocols evolve. 

C. Improve Information Dissemination 

Laboratory/or DNAUI management (as appropriate to the 

recommendation) should: 

30) Implement requirements that will ensure that managers within the 

Unit disseminate protocol-related information promptly and 

accurately to those under their supervision. 

31) Ensure that serology and PCR program managers inform Unit 

management (including team supervisors) of changes to 

procedures employed in the DNAUI. 

32) Solicit and evaluate technical input from staff members on 

significant changes that affect Unit procedures and protocols. 

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33) Develop and implement a communications plan that allows DNAUI 

staff members to provide feedback on the effectiveness of the Unit’s 

protocols. 

D. Implement a Laboratory Information Management System 

We determined that Laboratory management had begun to lay the 

groundwork for the implementation of a Laboratory Information Management 

System (LIMS) in 2002, and has since made progress toward the 

implementation of a LIMS. However, given the benefits that a LIMS will bring 

to evidence tracking and chain-of-custody documentation, we recommend that 

Laboratory management: 

34) Ensure that a LIMS is successfully implemented. To accomplish 

this, Laboratory management must provide to all appropriate 

personnel: 

a) Ready access to the system; 

b) Adequate training on the proper use of the system; and 

c) The resources needed to convert their current methods and 

operations to those that will maximize the capabilities of the 

LIMS. 

35) Retain full utilization of the LIMS as one of the top administrative 

priorities of the Laboratory. To accomplish this, Laboratory 

management will need to devote sufficient resources to the LIMS to 

ensure that it keeps pace with the changes and developments in 

technology that will occur over time as the Laboratory evolves. 

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CONCLUSION 

Our investigation was prompted by the misconduct of FBI Staff Biologist 

Jacqueline Blake. Because of her failure to follow DNAUI protocols, and the 

inadequacy of those protocols to expose her misconduct, we assessed the 

DNAUI’s vulnerability to other inadvertent or willful protocol noncompliance by 

its employees. 

Although our review did not identify other instances of misconduct by 

DNAUI staff members, we determined that certain DNAUI protocols and 

operations are vulnerable to abuse. Specifically, in approximately 20 percent of 

the protocol sections we reviewed we identified one or more of the following 

deficiencies: 1) the protocol lacks sufficient detail; 2) the protocol fails to 

inform the exercise of staff discretion; 3) the protocol fails to ensure the 

precision of manual notetaking; and 4) the protocol is outdated. While in most 

instances the work practices of the DNAUI’s staff members served to mitigate 

the effects of these vulnerabilities, we believe that until the DNAUI’s protocols 

are revised in accordance with the recommendations in this report, the DNAUI 

needlessly will remain subject to an increased risk of employee error and 

inadvertent protocol noncompliance. Because of the importance of the DNAUI’s 

work, we believe the Laboratory should address these deficiencies 

expeditiously. 

To remedy the protocol vulnerabilities that we identified, our report 

makes various recommendations to the FBI Laboratory and DNAUI 

management, such as: 1) replace vague sections of the protocols with 

comprehensive guidance and descriptions of the “best practices” currently in 

use; 2) add work flow and decision aids to the specific protocol sections we 

identified to assist staff members to exercise properly their judgment during 

the DNA testing process; 3) provide staff members with guidance sufficient to 

ensure that case documentation and case file reviews meet management 

expectations, and that protocols provide comprehensive guidance on 

notetaking requirements; and 4) update protocols to reflect current methods in 

use in the DNAUI. 

Further, with regard to operations, our analysis revealed that the 

Laboratory and DNAUI management should: 1) promote greater consistency in 

DNAUI operations; 2) develop a comprehensive, written training curriculum; 

3) improve management and staff information sharing; and 4) complete 

implementation of an information management system to improve efficiency 

and evidence tracking capabilities. Until significant progress is made in each 

of these areas, the DNAUI will remain vulnerable to a heightened risk of error. 

Finally, during our review we identified a number of concerns with the 

FBI’s management response to Blake’s misconduct. We recommend that the 

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Laboratory maintain basic case data and contact information for evidence 

contributors and associated prosecutors in an electronic format that can be 

shared conveniently as needed with other FBI components (e.g., FBI OPR and 

FBI OGC) and the Department of Justice, provide prompt notification to 

evidence contributors of future protocol violations, and perform a file review of 

a sample of cases that Blake is known to have worked on prior to becoming a 

PCR Biologist to reconfirm that the procedures that were required in fact are 

documented as appropriate in the case files. 

In sum, Jacqueline Blake’s misconduct exposed weaknesses in the FBI 

DNA Laboratory’s protocols and policies. We found that Blake was able to 

escape detection not only because she deceived her co-workers and her 

supervisors for two years, but also because the FBI failed to develop policies 

that subjected her work and the work of other DNA biologists to adequate 

scrutiny. 

The FBI Laboratory cannot allow the integrity of its DNA testing results 

to rely solely on the trustworthiness of its employees. It must develop and 

enforce adequate quality assurance safeguards to identify staff errors and 

misconduct. Our assessment of the DNAUI’s protocols to undetected 

inadvertent or willful noncompliance by DNAUI staff members revealed 

vulnerabilities. We believe that the recommendations contained in this report, 

if implemented fully and expeditiously, will help eliminate these weaknesses 

and significantly improve the FBI Laboratory’s ability to detect promptly 

instances of protocol noncompliance in the DNAUI. 

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GLOSSARY OF TERMS AND ACRONYMS 

Act: the DNA Identification Act of 1994 (Act) was the vehicle whereby Congress 

authorized the creation of CODIS, and directed the FBI to establish the Board. 

The Act also directed that the guidelines issued by TWGDAM would be deemed 

to be national standards until the FBI issued its own standards pursuant to 

the Act. 

Allele: the characteristics of a single copy of a specific gene, or of a single copy 

of a specific location on a chromosome, is referred to as an allele. For example, 

one copy of a specific STR region might have 10 repeats, while the other copy 

might have 11 repeats. These would represent two alleles of that STR region. 

Allelic ladder: contains the more common alleles in the general population for 

specific chromosomal locations. Allelic ladders are used like molecular rulers 

to help “measure” the lengths of the fragments in the reference and evidentiary 

samples. The Genotyper® software compares the peaks in the evidentiary or 

reference sample to the peaks in the allelic ladder at that same location. 

Amplification: the replication of extracted DNA so that the DNA can be 

detected by an analyzer or a capillary electrophoresis machine. Amplification 

is the third of five stages in the PCR/STR analysis process. 

ASCLD/LAB: the American Society of Crime Laboratory Directors/Laboratory 

Accreditation Board is one of the organizations that provides accreditation for 

labs. The organization performs a thorough inspection of the laboratory before 

it grants accreditation. 

Board: the FBI established the DNA Advisory Board (Board), in response to a 

Congressional mandate within the Act, to develop national quality assurance 

standards that would ensure that the operations of CODIS participants met 

minimum quality standards. The Board was formally constituted on March 10, 

1995, and was comprised of members of a variety of forensic and science 

organizations. The Board’s mission was to develop quality assurance 

standards for laboratories and analysts that examine DNA. 

Capillary electrophoresis: the form of electrophoresis employed by the 

DNAUI. Its distinguishing characteristic is that the electrophoresis occurs 

inside a capillary tube (a very thin glass tube) with a sieving material inside, 

rather than on a piece of gelatinous material. Capillary electrophoresis is an 

automated process that analyzes many DNA samples and requires minimal 

involvement by DNA scientists after the initial set-up procedures are 

completed. 

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Chromosomes: chromosomes store information in the chemical structure of 

DNA much like a book or a compact disk. The nucleus contains 46 

chromosomes, two copies of each of the 23 different human chromosomes. 

One copy of each chromosome is inherited from an individual's mother and one 

copy is inherited from an individual's father, giving a child DNA characteristics 

of both its mother and father. 

Combined DNA Index System (CODIS): provides a framework for storing, 

maintaining, tracking, and searching DNA specimen information. CODIS refers 

to the entire system of DNA databases (convicted offender database, forensic 

database, victim database, etc.) maintained at the national, state, and local 

levels. CODIS currently consists of three distinct levels: the National DNA 

Index System, State DNA Index System, and Local DNA Index System. 

Deoxyribonucleic Acid (DNA): DNA is found in almost all living cells, and 

carries the encoded information necessary for building and maintaining life. 

This encoded information is what makes each person an individual. DNA 

consists of two strands of molecules that wrap around each other to resemble a 

twisted ladder whose sides are connected by rungs of chemicals called bases. 

There are four kinds of these chemical bases (also called nucleotides), and the 

order in which they are arranged is called the DNA sequence. It is this unique 

sequence that is determined when a DNA sample is typed. 

DNA Profile: a set of DNA identification characteristics, i.e., the particular 

chemical bases at specific DNA locations, which permit the DNA of one person 

to be distinguishable from that of another person. 

DNA Sample: a body tissue or fluid sample (blood, a skin cell sample, or 

semen, for example) that can be subjected to DNA analysis. 

DNA Typing: the process by which a DNA sample is examined and a DNA 

profile is produced. 

DNAUI: the DNA Analysis Unit I (DNAUI) identifies and characterizes body 

fluids and body fluid stains recovered as evidence in violent crimes using 

traditional serological techniques and related biochemical analysis. These 

stains are analyzed and compared to results from the known body fluid 

samples submitted by the victim(s) and/or suspected perpetrator(s). 

Electrophoresis: a process whereby DNA fragments are sorted according to 

length (i.e., number of short tandem repeats). In general, the process involves: 

1) Adding DNA to one end of a piece of gelatinous material which contains tiny 

holes that allows the material to function as a molecular sieve; 2) applying an 

electric current to the material, causing the DNA fragments to move; and 3) 

determining the size of the DNA fragments by comparing the distance each 

fragment moved to the distances moved by the fragments of known size. Since 

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it is easier for smaller fragments to move through the material, the smaller 

fragments move farther than the larger fragments. As a result, at the end of 

electrophoresis the DNA fragments are sorted by size. Electrophoresis is the 

fourth of five stages in the PCR/STR analysis process. 

Examiner (Analyst): an individual who conducts or directs the analysis of 

forensic casework samples, interprets data, and reaches conclusions. In the 

context of the DNAUI, the Examiner collects supporting documentation from 

the Serologist and PCR Biologist for the work performed by each, interprets the 

data that resulted from that work, draws conclusions about those results, and 

writes a report describing those conclusions. 

Extraction: a process whereby chemicals are used to release or remove DNA 

from evidence. Extraction is the first of five stages in the PCR/STR analysis 

process. 

Forensic Database: consists of DNA profiles from persons whose identities are 

not known with certainty and who left DNA at the scene of a crime or whose 

DNA was carried away from it. For example, a DNA profile may be developed 

from a bloody knife found at a crime scene or found in a trash dumpster. 

Genes: each chromosome contains many genes, which are the portions of the 

chromosome that code for personally identifying characteristics, like hair color 

or eye color. It has been estimated that only 2 to 3 percent of the information 

in a chromosome is organized into genes. 

GeneScan®: a component of the proprietary software that accompanies the 

capillary electrophoresis machines used by the DNAUI. The GeneScan®

software allows scientists to view and process the raw, unanalyzed data that 

documents everything the laser of the electrophoresis machine detects, 

including background noise that is common in electrophoresis instruments. 

GeneScan® is a registered trademark of Applied Biosystems. 

Genotyper®: a component of the proprietary software that accompanies the 

capillary electrophoresis machines used by the DNAUI. Genotyper® allows the 

forensic scientist to take the processed GeneScan® data and display it in a 

format that applies allele designations to the profile fragments, and to focus his 

or her review on the results of the control and evidence samples. Genotyper® is 

a registered trademark of Applied Biosystems. 

Guide: the FBI created a standardized DNA audit guide (Guide), with input 

from the Board, ASCLD-LAB, and NFSTC, to ensure that auditors of local, 

state, and federal DNA laboratories are thorough and interpret the quality 

assurance standards consistently. The FBI offers Guide training for auditors, 

including those representing accrediting and certifying organizations such as 

ASCLD-LAB and NFSTC. For an audit to fulfill the quality assurance 

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standards’ external audit requirement, it must be conducted in accordance 

with the Guide and by an auditor trained in its use. 

Internal Size Standard: contains DNA fragments of known sizes that provide 

reference points for determining the length of a sample’s DNA fragments. 

GeneScan® software uses the internal size standard to help the software as it 

determines the lengths of the DNA fragments detected during electrophoresis. 

Investigations Aided: the primary measuring unit that the FBI uses to 

quantify the success of CODIS. An investigation is aided when a DNA match 

through CODIS either identifies a potential suspect or links crimes together, 

but only when the DNA match provides new information that would not have 

been otherwise developed. 

Known DNA sample: a DNA sample for which the source is known. These 

samples are generally obtained from the victim and/or suspected perpetrator of 

a crime, as well as from other persons whose DNA might be reflected when 

samples of the evidence are analyzed (could include a boyfriend, husband, or 

other third-party). These samples are also referred to as reference samples, 

since they serve as a reference to which the unknown DNA samples are 

compared with the goal of identifying the source of the unknown DNA samples. 

Mitochondrial DNA: DNA found in the mitochondria of a cell. Mitochondria 

are about the size of bacteria and are scattered throughout a cell outside its 

nucleus. Since there are between 500 to 1,000 mitochondria in every cell, as 

opposed to one nucleus, mitochondrial DNA analysis affords a better chance of 

a DNA profile than nuclear DNA analysis in cases where a sample is decayed or 

degraded, such as skeletal remains that have been exposed to the elements for 

years. 

National DNA Index System (NDIS): the FBI-maintained national component 

to CODIS. NDIS contains DNA profiles uploaded from approved SDIS 

laboratories. 

NDIS Requirements: the NDIS office has issued programmatic rules that 

govern the exchange of information for NDIS participants and has established 

standards for the submission of DNA data, collectively referred to as NDIS 

Requirements. The NDIS requirements are found in the Memorandum of 

Understanding (MOU) that is established between the FBI and each NDIS 

participant. The MOU requires that signatories comply with general 

requirements already established (i.e., federal legislation, the Forensic and 

Offender Standards) as well as requirements specific to the national index that 

accompany the MOU in three appendices: NDIS Responsibilities (Appendix A); 

NDIS Data Acceptance Standards (Appendix B); and the NDIS Procedures 

Manual (Appendix C). 

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Negative Control: the negative control contains all of the reagents used for 

amplification. DNA from the evidence is not added to the negative control, 

though the contents are amplified. The purpose of the negative control is to 

reveal any contamination that is present in the reagents or introduced during 

the testing process. 

NFSTC: the National Forensic Science Technology Center (NFSTC) is one of 

two primary accreditation or certification entities for forensic and offender DNA 

laboratories. 

NIST: the National Institute of Standards and Technology. 

Nuclear DNA: DNA found in the nucleus of a cell. The nucleus is the cell’s 

control center. Nuclear DNA contains the entire genetic make-up of a person, 

including inherited traits such as eye color or height. There is only one group 

of nuclear DNA per cell, since each cell has only one nucleus. Since nuclear 

DNA is sensitive to environmental conditions, it can be difficult to obtain 

useable nuclear DNA from deteriorated and/or old crime scene samples. The 

alternative to nuclear DNA analysis is mitochondrial DNA analysis. 

OGC: the FBI’s Office of General Counsel. 

OPR: the FBI’s Office of Professional Responsibility. 

PCR Biologist: in the context of the DNAUI, the PCR Biologist is the staff 

member responsible for completing the PCR analysis process and providing to 

an Examiner the results of that process from which they can draw conclusions 

and report results. Included within this process is the completion of 

extraction, quantification, amplification, and electrophoresis. 

Polymerase Chain Reaction (PCR): a method used to replicate specific 

portions of the DNA strands. The DNA is heated, causing the two strands to 

separate like a zipper. The two DNA halves are then cooled and mixed with a 

special enzyme. The result of this process is the creation of two DNA strands 

identical to each other and to the original DNA strand. This process is 

repeated many times to replicate a desired DNA sequence millions of times in a 

matter of hours. PCR is especially valuable because it does not require high 

quality or large quantities of DNA. Also, this method lends itself to automation 

and less labor-intensive typing. The PCR/STR analysis process includes five 

stages, which are extraction, quantification, amplification, electrophoresis, and 

data interpretation. 

Positive Control: the positive control contains the reagents necessary for 

amplification plus DNA from a source for which the DNA profile is known. 

Since the DNA scientists know the correct test results for the positive control, it 

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allows them to determine the accuracy and performance of the amplification 

and analysis processes. 

Primers: short synthetic pieces of DNA designed to match places where 

human DNA is both repetitive and highly variable. Primers identify the starting 

and ending points of a DNA fragment that is to be duplicated with PCR. The 

primers also prime (or stimulate) the synthesis reaction when the DNA 

fragments are duplicated. The primers contain fluorescent labels so that they 

may be detected by lasers during electrophoresis. 

Quantification: the process whereby the concentration of extracted DNA in a 

sample is measured, and the second of five stages in the PCR/STR analysis 

process. 

Reagent: a substance that is used (as in detecting or measuring a component, 

in preparing a product, or in developing photographs) because of its chemical 

or biological activity. 

Reagent Blank: the reagent blank contains all of the reagents used to process 

an item of evidence from extraction through electrophoresis. DNA from the 

evidence is not added to the reagent blanks, though their contents are 

amplified. The purpose of the reagent blank is to reveal any contamination 

that is present in the reagents or introduced during the testing process. 

QAS: refers to the Quality Assurance Standards issued by the FBI Director 

upon the recommendation of the DNA Advisory Board. Quality Assurance 

refers to measures that are taken by labs to monitor, verify, and document 

performance. Two sets of QAS exist: QAS for Convicted Offender DNA 

Databasing Laboratories, effective April 1, 1999; and QAS for Forensic DNA 

Testing Laboratories, effective October 1, 1998. 

SDIS: State DNA Index System containing the state-level DNA records 

uploaded from local laboratory sites within the state. SDIS is the state’s 

repository of DNA identification records and is under the control of state 

authorities. The SDIS laboratory serves as the central point of contact for 

access to NDIS. The DNAUI serves as the SDIS laboratory for the FBI. 

Serologist: a Serologist performs testing to determine what body fluids are 

present on the evidence and whether it is possible to extract DNA from it. In 

the DNAUI, the Serologist also assists with the initial and final evidence 

inventories, and is responsible for transferring to the PCR Biologist body-fluid 

stained evidence items and related case file documentation. 

Short Tandem Repeats: short repeating units of identical chemical sequences 

arranged in direct succession in a particular region of the DNA. 

137 
Short Tandem Repeat Analysis (STR): refers to a DNA typing method that 

utilizes PCR technology to quickly amplify and analyze sections of DNA that 

contain short tandem repeats. This method allows a high level of 

discrimination, since 13 chromosomal locations are examined and 

subsequently compared with other samples. 

SWGDAM: TWGDAM was renamed the Scientific Working Group on DNA 

Analysis Methods (SWGDAM) after the Office of Justice Programs created 

short-term technical working groups that began to be confused by members of 

the DNA community with the FBI’s long-term technical working groups. Since 

being renamed, SWGDAM has produced additional guidance for the forensic 

community, including guidelines for data interpretation, training, quality 

assurance, and health and safety audits. 

TWGDAM: the Technical Working Group on DNA Analysis Methods (TWGDAM) 

was the one of several technical working groups sponsored by the FBI to 

examine DNA’s forensic science applications. TWGDAM was established in 

1989 with representatives from 12 laboratories, and focused specifically on the 

development of forensic DNA methods. Later that same year, TWGDAM 

developed and published a set of quality guidelines for forensic DNA 

laboratories, and updated those guidelines in 1991 and in 1995. 

Unknown DNA Sample: a sample of DNA for which the source is not known. 

Unknown DNA samples are also referred to as questioned samples. Unknown 

DNA samples are taken from evidence items submitted to a laboratory, that are 

analyzed by the laboratory and compared to a known DNA sample to determine 

whether the source of the unknown DNA sample can be identified. 

138 
 Appendix 1 

COMPLETE DNA PROFILE 

As noted in Chapter Two, Section I.D, the primers used during the 

amplification process contain different fluorescent labels, which allow the 

lasers in the capillary electrophoresis machine to detect and differentiate the 

various DNA fragments separated during capillary electrophoresis. The label 

on each primer determines the color in which the results are displayed on both 

computer monitors and printouts. At the present time, the fluorescent labels 

produce peaks that are blue, green, and yellow. The yellow peaks are usually 

displayed in black on the Genescan® and Genotyper® printouts, with the 

remaining peaks printed in the corresponding color. In addition, the internal 

lane standard peaks are always displayed in red. 

At the present time, two amplification kits1

 are required for forensic 

scientists to test the 13 chromosomal locations that comprise a DNA profile. 

Scientists also test a 14th location, known as amelogenin, which indicates the 

sex of the DNA contributor. One amplification kit, Profiler Plus,TM contains the 

reagents necessary to test ten chromosomal locations. The fluorescent labels 

in this kit produce results that are shown in blue for three chromosomal 

locations, four locations are shown in green, and three locations are called 

yellow even though they display in black. The COfilerTM amplification kit 

displays the results for two chromosomal locations in blue, four locations are 

displayed in green, and one location representing the yellow peaks is displayed 

in black. Three chromosomal locations are tested with both the Profiler PlusTM 

and COfilerTM kits, which gives forensic scientists points of comparison to 

ensure the results are consistent between the two kits. 

 The Genescan® graphic for the positive control in Appendix 2 reflects the 

DNA profile of a sample used as a positive control by a CODIS participating 

laboratory. The following table represents the allele calls that correspond to 

the electrophoresis results shown in that graphic. 

 1

 In this report, we focus on the amplification kits manufactured by Applied Biosystems 

because they are used by the DNAUI. Some state and local DNA laboratories use kits

manufactured by other companies. These kits examine the same chromosomal locations and 

produce the same type of data as the kits discussed here. 

139 
 Appendix 1 

Example of a DNA Profile 

Applied Biosystems 

Analysis Kit 

Chromosomal 

Location 

Alleles Present in 

DNA Sample 

Genotyper® 

Printout 

D3S1358 14, 15 

VWA 17, 18

FGA 23, 24

Page 141 

Amelogenin X, X 

D8S1179 13, 13

D21S11 30, 30

D18S51 15, 19

Page 141 

D5S818 11, 11

D13S317 11, 11

AmpFlSTR® Profiler 

PlusTM PCR Amplification 

Kit 

D7S820 10, 11

Page 142 

D3S1358 14, 15

D16S539 11, 12

Page 142 

Amelogenin X, X

THO1 8, 9.3

TPOX 8, 8

CSF1PO 10, 12

Page 143 

AmpFlSTR® COfilerTM 

PCR Amplification Kit 

D7S820 10, 11 Page 143 

The following pages contain the Genotyper® printouts supporting the 

allelic values listed in the above chart. These printouts reflect the fact that 

Genotyper® reformats the Genescan® data and allows the forensic scientist that 

reviews the data to review only the specific peaks required for data 

interpretation, including (but not limited to) the specific peaks from the DNA 

sample and the allelic ladders. The background noise is filtered out in the 

Genotyper® view. 

140 
 Appendix 1 

A

A

B

C

Genotyper® View: Profiler Ladder with Positive Control Allele call 

A = Chromosomal Location, B = Allelic Ladder, C = Alleles present in DNA sample

A m e l o g e n i n

Genotyper® View: Profiler Ladder with Positive Control Allele call 

141 
 Appendix 1 

Genotyper® View: Profiler Ladder with Positive Control Allele call 

Genotyper® View: COfiler Ladder with Positive Control Allele call 

142 
 Appendix 1 

Amelogenin

Genotyper® View: COfiler Ladder with Positive Control Allele call 

Genotyper® View: COfiler Ladder with Positive Control Allele call 

143 
 Appendix 2 

INTERPRETATION OF DNA ANALYSIS DATA 

As mentioned in Chapter Two, Section I.D, the manufacturer of the 

capillary electrophoresis machine developed proprietary software to display the 

test results and to aid in their interpretation. The software has two 

components, GeneScan® and Genotyper.® Data viewed in Genescan®, as 

appears below, is the raw, unanalyzed, collection data that documents 

everything the laser detected, including the background noise that is common 

in these types of instruments. The following graphic illustrates the appearance 

and content of this data for a DNA sample. 

Amplified DNA Peaks 

(except red peaks)

Genescan® View: : raw data for a Positive Control (9947A) prepared according to protocol. 

Peaks depicted in red originate from the internal size standard added to each sample.

Genotyper® takes this same data and displays it in a different format. 

With Genotyper®, the forensic scientist selects which peaks are displayed, 

choosing among the internal lane standard, the primer peaks, specific peaks 

from the DNA sample, and the allelic ladders. The background noise is filtered 

out in the Genotyper® view. With the exception of the red peaks, the primer 

peaks are those located between the brackets on the following illustration. 

144 
 Appendix 2 

STR Primer Peaks

(except red peaks)

Genescan® View: raw data for a Negative Control prepared according to protocol. 

Peaks depicted in red originate from the internal size standard added to each sample.

In order to determine accurately the length of the sample’s DNA 

fragments, an internal size standard is added to each sample before it 

undergoes capillary electrophoresis. As mentioned earlier, the internal size 

standard contains DNA fragments of known sizes that provide reference points 

for the software to use when determining the length of the sample’s DNA 

fragments. The peaks corresponding to the internal size standard are shown 

as red peaks in both the Genescan® and Genotyper® printouts. 

 The Genotyper® software uses allelic ladders to assign allele calls, (i.e., 

determine which alleles correspond to the lengths of the sample’s DNA 

fragments as determined by Genescan®). There is an allelic ladder for each 

chromosomal location tested. These ladders contain the most common alleles 

in the general population at each location. The Genotyper® software compares 

the peaks in the evidentiary or reference sample to the peaks in the allelic 

ladder at that same location. Genotyper® then assigns the corresponding allele 

designation to the evidentiary or reference peaks. The number of repeats in the 

DNA fragment determines the allele designation. For example, an allele call of 

145 
 Appendix 2 

15 means the DNA fragment contains 15 repeats. The following illustration 

contains both the allelic ladders and two allele calls for a DNA sample. The 

DNA profile at two chromosomal locations for the sample shown below is: 

alleles 14 and 15 at location D3S1358, and alleles 11 and 12 at location 

D16S539. 

Allelic Ladders

DNA Sample

Allele Calls

Genotyper® View: COFiler Ladder with Positive Control Allele call 

146 
 Appendix 3

FORENSIC AND OFFENDER 

QUALITY ASSURANCE STANDARDS 

Standards For Forensic DNA Testing Laboratories 

Preface 

Throughout its deliberation concerning these quality standards, the DNA 

Advisory Board recognized the need for a mechanism to ensure compliance 

with the standards. An underlying premise for these discussions was that 

accreditation would be required to demonstrate compliance with the standards 

and therefore assure quality control and a quality program. Accordingly, the 

Board recommends that forensic laboratories performing DNA analysis seek 

such accreditation with all deliberate speed. Additionally, the Board strongly 

encourages the accrediting bodies to begin positioning themselves to 

accommodate the increasing demand for accreditation. 

Proposed Mechanism To Recommend Changes To Standards 

Once the Director of the FBI has issued standards for quality assurance for 

forensic DNA testing, the DNA Advisory Board may recommend revisions to 

such standards to the FBI Director, as necessary. In the event that the 

duration of the DNA Advisory Board is extended beyond March 10, 2000 by the 

FBI Director, the Board may continue to recommend revisions to such 

standards to the FBI Director. In the event that the DNA Advisory Board is not 

extended by the FBI Director after March 10, 2000, the Technical Working 

Group on DNA Analysis Methods [TWGDAM] may recommend revisions to such 

standards to the FBI Director, as necessary. 

Effective Date 

These standards shall take effect October 1, 1998. 

147 
 Appendix 3

INTRODUCTION 

This document consists of definitions and standards. The standards are 

quality assurance measures that place specific requirements on the laboratory. 

Equivalent measures not outlined in this document may also meet the 

standard if determined sufficient through an accreditation process. 

REFERENCES: 

American Society of Crime Laboratory Directors-Laboratory Accreditation 

Board (ASCLD-LAB), ASCLD-LAB Accreditation Manual, January 1994, and 

January, 1997. 

International Standards Organization (ISO)/International Electrotechnical 

Commission (IEC), ISO/IEC Guide 25-1990, (1990) 

American National Standards Institute, New York, NY. 

Technical Working Group on DNA Analysis Methods, "Guidelines for a Quality 

Assurance Program for DNA Analysis," Crime Laboratory Digest, April 1995, 

Volume 22, Number 2, pp. 21-43. 

42 Code of Federal Regulations, Chapter IV (10-1-95 Edition), Health Care 

Financing Administration, Health and Human Services. 

1. SCOPE 

The standards describe the quality assurance requirements that a laboratory, 

which is defined as a facility in which forensic DNA testing is performed, 

should follow to ensure the quality and integrity of the data and competency of 

the laboratory. These standards do not preclude the participation of a 

laboratory, by itself or in collaboration with others, in research and 

development, on procedures that have not yet been validated. 

2. DEFINITIONS 

As used in these standards, the following terms shall have the meanings 

specified: 

(a) Administrative review is an evaluation of the report and supporting 

documentation for consistency with laboratory policies and for editorial 

correctness. 

(b) Amplification blank control consists of only amplification reagents without 

the addition of sample DNA. This control is used to detect DNA contamination 

of the amplification reagents. 

148 
 Appendix 3

(c) Analytical procedure is an orderly step by step procedure designed to ensure 

operational uniformity and to minimize analytical drift. 

(d) Audit is an inspection used to evaluate, confirm, or verify activity related to 

quality. 

(e) Calibration is the set of operations which establish, under specified 

conditions, the relationship between values indicated by a measuring 

instrument or measuring system, or values represented by a material, and the 

corresponding known values of a measurement. 

(f) Critical reagents are determined by empirical studies or routine practice to 

require testing on established samples before use on evidentiary samples in 

order to prevent unnecessary loss of sample. 

(g) Commercial test kit is a pre-assembled kit that allows the user to conduct a 

specific forensic DNA test. 

(h) Examiner/analyst is an individual who conducts and/or directs the 

analysis of forensic casework samples, interprets data and reaches 

conclusions. 

(i) Forensic DNA testing is the identification and evaluation of biological 

evidence in criminal matters using DNA technologies. 

(j) Known samples are biological material whose identity or type is established. 

(k) Laboratory is a facility in which forensic DNA testing is performed. 

(l) Laboratory support personnel are individual(s) who perform laboratory 

duties and do not analyze evidence samples. 

(m) NIST is the National Institute of Standards and Technology. 

(n) Polymerase Chain Reaction (PCR) is an enzymatic process by which a 

specific region of DNA is replicated during repetitive cycles which consist of: 

1) denaturation of the template; 2) annealing of primers to complementary 

sequences at an empirically determined temperature; and 3) extension of the 

bound primers by a DNA polymerase. 

(o) Proficiency test sample is biological material whose DNA type has been 

previously characterized and which is used to monitor the quality performance 

of a laboratory or an individual. 

149 
 Appendix 3

(p) Proficiency testing is a quality assurance measure used to monitor 

performance and identify areas in which improvement may be needed. 

Proficiency tests may be classified as: 

1) Internal proficiency test is one prepared and administered by the 

laboratory. 

2) External proficiency test, which may be open or blind, is one which is 

obtained from a second agency. 

(q) Qualifying test measures proficiency in both technical skills and knowledge. 

(r) Quality assurance includes the systematic actions necessary to demonstrate 

that a product or service meets specified requirements for quality. 

(s) Quality manual is a document stating the quality policy, quality system and 

quality practices of an organization. 

(t) Quality system is the organizational structure, responsibilities, procedures, 

processes and resources for implementing quality management. 

(u) Reagent blank control consists of all reagents used in the test process 

without any sample. This is to be used to detect DNA contamination of the 

analytical reagents. 

(v) Reference material (certified or standard) is a material for which values are 

certified by a technically valid procedure and accompanied by or traceable to a 

certificate or other documentation which is issued by a certifying body. 

(w) Restriction Fragment Length Polymorphism (RFLP) is generated by cleavage 

by a specific restriction enzyme and the variation is due to restriction site 

polymorphism and/or the number of different repeats contained within the 

fragments. 

(x) Review is an evaluation of documentation to check for consistency, 

accuracy, and completeness. 

(y) Second agency is an entity or organization external to and independent of 

the laboratory and which performs forensic DNA analysis. 

(z) Secure area is a locked space (for example, cabinet, vault or room) with 

access restricted to authorized personnel. 

(aa) Subcontractor is an individual or entity having a transactional relationship 

with a laboratory. 

150 
 Appendix 3

(bb) Technical manager or leader (or equivalent position or title as designated 

by the laboratory system) is the individual who is accountable for the technical 

operations of the laboratory. 

(cc) Technical review is an evaluation of reports, notes, data, and other 

documents to ensure an appropriate and sufficient basis for the scientific 

conclusions. This review is conducted by a second qualified individual. 

(dd) Technician is an individual who performs analytical techniques on 

evidence samples under the supervision of a qualified examiner/analyst and/or 

performs DNA analysis on samples for inclusion in a database. Technicians do 

not evaluate or reach conclusions on typing results or prepare final reports. 

(ee) Traceability is the property of a result of a measurement whereby it can be 

related to appropriate standards, generally international or national standards, 

through an unbroken chain of comparisons. 

(ff) Validation is a process by which a procedure is evaluated to determine its 

efficacy and reliability for forensic casework analysis and includes: 

1) Developmental validation is the acquisition of test data and 

determination of conditions and limitations of a new or novel DNA 

methodology for use on forensic samples. 

2) Internal validation is an accumulation of test data within the 

laboratory to demonstrate that established methods and 

procedures perform as expected in the laboratory. 

3. QUALITY ASSURANCE PROGRAM 

STANDARD 3.1 The laboratory shall establish and maintain a documented 

quality system that is appropriate to the testing activities. 

3.1.1 The quality manual shall address at a minimum: 

(a) Goals and objectives 

(b) Organization and management 

(c) Personnel Qualifications and Training 

(d) Facilities 

(e) Evidence control 

(f) Validation 

(g) Analytical procedures 

(h) Calibration and maintenance 

(i) Proficiency testing 

(j) Corrective action 

(k) Reports 

(l) Review 

151 
 Appendix 3

(m) Safety 

(n) Audits 

4. ORGANIZATION AND MANAGEMENT 

STANDARD 4.1 The laboratory shall: 

(a) have a managerial staff with the authority and resources needed to 

discharge their duties and meet the requirements of the standards in 

this document. 

(b) have a technical manager or leader who is accountable for the 

technical operations. 

(c) specify and document the responsibility, authority, and interrelation 

of all personnel who manage, perform or verify work affecting the 

validity of the DNA analysis. 

5. PERSONNEL 

STANDARD 5.1 Laboratory personnel shall have the education, training and 

experience commensurate with the examination and testimony provided. The

laboratory shall: 

5.1.1 have a written job description for personnel to include 

responsibilities, duties and skills. 

5.1.2 have a documented training program for qualifying all technical 

laboratory personnel. 

5.1.3 have a documented program to ensure technical qualifications are 

maintained through continuing education. 

5.1.3.1 Continuing education - the technical manager or leader and 

examiner/analyst(s) must stay abreast of developments within the 

field of DNA typing by reading current scientific literature and by 

attending seminars, courses, professional meetings or documented 

training sessions/classes in relevant subject areas at least once a 

year. 

5.1.4 maintain records on the relevant qualifications, training, skills and 

experience of the technical personnel. 

STANDARD 5.2 The technical manager or leader shall have the following: 

5.2.1 Degree requirements: The technical manager or leader of a 

laboratory shall have at a minimum a Master's degree in biology-, 

chemistry- or forensic science- related area and successfully completed a 

minimum of 12 semester or equivalent credit hours of a combination of 

152 
 Appendix 3

undergraduate and graduate course work covering the subject areas of 

biochemistry, genetics and molecular biology (molecular genetics, 

recombinant DNA technology), or other subjects which provide a basic 

understanding of the foundation of forensic DNA analysis as well as 

statistics and/or population genetics as it applies to forensic DNA 

analysis. 

5.2.1.1 The degree requirements of section 5.2.1 may be waived by 

the American Society of Crime Laboratory Directors (ASCLD) or 

other organization designated by the Director of the FBI in 

accordance with criteria approved by the Director of the FBI. This 

waiver shall be available for a period of two years from the effective 

date of these standards. The waiver shall be permanent and 

portable. 

5.2.2 Experience requirements: A technical manager or leader of a 

laboratory must have a minimum of three years of forensic DNA 

laboratory experience. 

5.2.3 Duty requirements: 

5.2.3.1 General: manages the technical operations of the 

laboratory. 

5.2.3.2 Specific duties 

(a) Is responsible for evaluating all methods used by the laboratory 

and for proposing new or modified analytical procedures to be 

used by examiners. 

(b) Is responsible for technical problem solving of analytical 

methods and for the oversight of training, quality assurance, safety 

and proficiency testing in the laboratory. 

5.2.3.3 The technical manager or leader shall be accessible to the 

laboratory to provide onsite, telephone or electronic consultation as 

needed. 

STANDARD 5.3 Examiner/analyst shall have: 

5.3.1 at a minimum a BA/BS degree or its equivalent degree in biology-, 

chemistry- or forensic science- related area and must have successfully 

completed college course work (graduate or undergraduate level) covering 

the subject areas of biochemistry, genetics and molecular biology 

(molecular genetics, recombinant DNA technology) or other subjects 

which provide a basic understanding of the foundation of forensic DNA 

153 
 Appendix 3

analysis, as well as course work and/or training in statistics and 

population genetics as it applies to forensic DNA analysis. 

5.3.2 a minimum of six (6) months of forensic DNA laboratory experience, 

including the successful analysis of a range of samples typically 

encountered in forensic case work prior to independent case work 

analysis using DNA technology. 

5.3.3 successfully completed a qualifying test before beginning 

independent casework responsibilities. 

STANDARD 5.4 Technician shall have: 

5.4.1 On the job training specific to their job function(s). 

5.4.2 successfully completed a qualifying test before participating in

forensic DNA typing responsibilities. 

STANDARD 5.5 Laboratory support personnel shall have: 

5.5.1 training, education and experience commensurate with their 

responsibilities as outlined in their job description. 

6. FACILITIES 

STANDARD 6.1 The laboratory shall have a facility that is designed to provide 

adequate security and minimize contamination. The laboratory shall ensure 

that: 

6.1.1 Access to the laboratory is controlled and limited. 

6.1.2 Prior to PCR amplification, evidence examinations, DNA 

extractions, and PCR setup are conducted at separate times or in 

separate spaces. 

6.1.3 Amplified DNA product is generated, processed and maintained in 

a room(s) separate from the evidence examination, DNA extractions and 

PCR setup areas. 

6.1.4 The laboratory follows written procedures for monitoring, cleaning 

and decontaminating facilities and equipment. 

154 
 Appendix 3

7. EVIDENCE CONTROL 

STANDARD 7.1 The laboratory shall have and follow a documented evidence 

control system to ensure the integrity of physical evidence. This system shall 

ensure that: 

7.1.1 Evidence is marked for identification. 

7.1.2 Chain of custody for all evidence is maintained. 

7.1.3 The laboratory follows documented procedures that minimize loss, 

contamination, and/or deleterious change of evidence. 

7.1.4 The laboratory has secure areas for evidence storage. 

STANDARD 7.2 Where possible, the laboratory shall retain or return a portion 

of the evidence sample or extract. 

7.2.1 The laboratory shall have a procedure requiring that evidence 

sample/extract(s) are stored in a manner that minimizes degradation. 

8. VALIDATION 

STANDARD 8.1 The laboratory shall use validated methods and procedures for 

forensic casework analyses. 

8.1.1 Developmental validation that is conducted shall be appropriately 

documented. 

8.1.2 Novel forensic DNA methodologies shall undergo developmental 

validation to ensure the accuracy, precision and reproducibility of the 

procedure. The developmental validation shall include the following: 

8.1.2.1 Documentation exists and is available which defines and 

characterizes the locus. 

8.1.2.2 Species specificity, sensitivity, stability and mixture studies 

are conducted. 

8.1.2.3 Population distribution data are documented and available. 

8.1.2.3.1 The population distribution data would include the 

allele and genotype distributions for the locus or loci 

obtained from relevant populations. Where appropriate, 

databases should be tested for independence expectations. 

155 
 Appendix 3

8.1.3 Internal validation shall be performed and documented by the 

laboratory. 

8.1.3.1 The procedure shall be tested using known and nonprobative evidence samples. The laboratory shall monitor and 

document the reproducibility and precision of the procedure using 

human DNA control(s). 

8.1.3.2 The laboratory shall establish and document match criteria 

based on empirical data. 

8.1.3.3 Before the introduction of a procedure into forensic 

casework, the analyst or examination team shall successfully 

complete a qualifying test. 

8.1.3.4 Material modifications made to analytical procedures shall 

be documented and subject to validation testing. 

8.1.4 Where methods are not specified, the laboratory shall, wherever 

possible, select methods that have been published by reputable technical 

organizations or in relevant scientific texts or journals, or have been 

appropriately evaluated for a specific or unique application. 

9. ANALYTICAL PROCEDURES 

STANDARD 9.1 The laboratory shall have and follow written analytical 

procedures approved by the laboratory management/technical manager. 

9.1.1 The laboratory shall have a standard operating protocol for each 

analytical technique used. 

9.1.2 The procedures shall include reagents, sample preparation, 

extraction, equipment, and controls which are standard for DNA analysis 

and data interpretation. 

9.1.3 The laboratory shall have a procedure for differential extraction of 

stains that potentially contain semen. 

STANDARD 9.2 The laboratory shall use reagents that are suitable for the 

methods employed. 

9.2.1 The laboratory shall have written procedures for documenting 

commercial supplies and for the formulation of reagents. 

156 
 Appendix 3

9.2.2 Reagents shall be labeled with the identity of the reagent, the date 

of preparation or expiration, and the identity of the individual preparing 

the reagent. 

9.2.3 The laboratory shall identify critical reagents and evaluate them 

prior to use in casework. These critical reagents include but are not 

limited to: 

(a) Restriction enzyme 

(b) Commercial kits for performing genetic typing 

(c) Agarose for analytical RFLP gels 

(d) Membranes for Southern blotting 

(e) K562 DNA or other human DNA controls 

(f) Molecular weight markers used as RFLP sizing standards 

(g) Primer sets 

(h)Thermostable DNA polymerase 

STANDARD 9.3 The laboratory shall have and follow a procedure for evaluating 

the quantity of the human DNA in the sample where possible. 

9.3.1 For casework RFLP samples, the presence of high molecular weight 

DNA should be determined. 

STANDARD 9.4 The laboratory shall monitor the analytical procedures using 

appropriate controls and standards. 

9.4.1 The following controls shall be used in RFLP casework analysis: 

9.4.1.1 Quantitation standards for estimating the amount of DNA 

recovered by extraction. 

9.4.1.2 K562 as a human DNA control. (In monitoring sizing data, 

a statistical quality control method for K562 cell line shall be 

maintained.) 

9.4.1.3 Molecular weight size markers to bracket known and 

evidence samples. 

9.4.1.4 Procedure to monitor the completeness of restriction 

enzyme digestion. 

9.4.2 The following controls shall be used for PCR casework analysis: 

9.4.2.1 Quantitation standards which estimate the amount of 

human nuclear DNA recovered by extraction. 

9.4.2.2 Positive and negative amplification controls. 

157 
 Appendix 3

9.4.2.3 Reagent blanks. 

9.4.2.4 Allelic ladders and/or internal size makers for variable 

number tandem repeat sequence PCR based systems. 

STANDARD 9.5 The laboratory shall check its DNA procedures annually or 

whenever substantial changes are made to the protocol(s) against an 

appropriate and available NIST standard reference material or standard 

traceable to a NIST standard. 

STANDARD 9.6 The laboratory shall have and follow written general guidelines 

for the interpretation of data. 

9.6.1 The laboratory shall verify that all control results are within 

established tolerance limits. 

9.6.2 Where appropriate, visual matches shall be supported by a 

numerical match criterion. 

9.6.3 For a given population(s) and/or hypothesis of relatedness, the 

statistical interpretation shall be made following the recommendations 

4.1, 4.2 or 4.3 as deemed applicable of the National Research Council 

report entitled "The Evaluation of Forensic DNA Evidence" (1996) and/or 

court directed method. These calculations shall be derived from a 

documented population database appropriate for the calculation. 

10. EQUIPMENT CALIBRATION AND MAINTENANCE 

STANDARD 10.1 The laboratory shall use equipment suitable for the methods 

employed. 

STANDARD 10.2 The laboratory shall have a documented program for 

calibration of instruments and equipment. 

10.2.1 Where available and appropriate, standards traceable to national 

or international standards shall be used for the calibration. 

10.2.1.1 Where traceability to national standards of measurement 

is not applicable, the laboratory shall provide satisfactory evidence 

of correlation of results. 

10.2.2 The frequency of the calibration shall be documented for each 

instrument requiring calibration. Such documentation shall be retained 

in accordance with applicable Federal or state law. 

158 
 Appendix 3

STANDARD 10.3 The laboratory shall have and follow a documented program 

to ensure that instruments and equipment are properly maintained. 

10.3.1 New instruments and equipment, or instruments and equipment 

that have undergone repair or maintenance, shall be calibrated before 

being used in casework analysis. 

10.3.2 Written records or logs shall be maintained for maintenance 

service performed on instruments and equipment. Such documentation 

shall be retained in accordance with applicable Federal or state law. 

11. REPORTS 

STANDARD 11.1 The laboratory shall have and follow written procedures for 

taking and maintaining case notes to support the conclusions drawn in 

laboratory reports. 

11.1.1 The laboratory shall maintain, in a case record, all documentation 

generated by examiners related to case analyses. 

11.1.2 Reports according to written guidelines shall include: 

(a) Case identifier 

(b) Description of evidence examined 

(c) A description of the methodology 

(d) Locus 

(e) Results and/or conclusions 

(f) An interpretative statement (either quantitative or qualitative) 

(g) Date issued 

(h) Disposition of evidence 

(i) A signature and title, or equivalent identification, of the 

person(s) accepting responsibility for the content of the report. 

11.1.3 The laboratory shall have written procedures for the release of 

case report information. 

12. REVIEW 

STANDARD 12.1 The laboratory shall conduct administrative and technical 

reviews of all case files and reports to ensure conclusions and supporting data 

are reasonable and within the constraints of scientific knowledge. 

12.1.1 The laboratory shall have a mechanism in place to address 

unresolved discrepant conclusions between analysts and reviewer(s). 

STANDARD 12.2 The laboratory shall have and follow a program that 

documents the annual monitoring of the testimony of each examiner. 

159 
 Appendix 3

13. PROFICIENCY TESTING 

STANDARD 13.1 Examiners and other personnel designated by the technical 

manager or leader who are actively engaged in DNA analysis shall undergo, at 

regular intervals of not to exceed 180 days, external proficiency testing in 

accordance with these standards. Such external proficiency testing shall be an 

open proficiency testing program. 

13.1.1 The laboratory shall maintain the following records for proficiency 

tests: 

(a) The test set identifier. 

(b) Identity of the examiner. 

(c) Date of analysis and completion. 

(d) Copies of all data and notes supporting the conclusions. 

(e) The proficiency test results. 

(f) Any discrepancies noted. 

(g) Corrective actions taken. Such documentation shall be retained 

in accordance with applicable Federal or state law. 

13.1.2 The laboratory shall establish at a minimum the following criteria 

for evaluation of proficiency tests: 

(a) All reported inclusions are correct or incorrect. 

(b) All reported exclusions are correct or incorrect. 

(c) All reported genotypes and/or phenotypes are correct or 

incorrect according to consensus genotypes/phenotypes or 

within established empirically determined ranges. 

(d) All results reported as inconclusive or uninterpretable are 

consistent with written laboratory guidelines. The basis for 

inconclusive interpretations in proficiency tests must be 

documented. 

(e) All discrepancies/errors and subsequent corrective actions 

must be documented. 

(f) All final reports are graded as satisfactory or unsatisfactory. 

A satisfactory grade is attained when there are no analytical 

errors for the DNA profile typing data. Administrative errors 

shall be documented and corrective actions taken to 

minimize the error in the future. 

(g) All proficiency test participants shall be informed of the final 

test results. 

14. CORRECTIVE ACTION 

STANDARD 14.1 The laboratory shall establish and follow procedures for 

corrective action whenever proficiency testing discrepancies and/or casework 

errors are detected. 

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14.1.1 The laboratory shall maintain documentation for the corrective 

action. Such documentation shall be retained in accordance with 

applicable Federal or state law. 

15. AUDITS 

STANDARD 15.1 The laboratory shall conduct audits annually in accordance 

with the standards outlined herein. 

15.1.1 Audit procedures shall address at a minimum: 

(a) Quality assurance program 

(b) Organization and management 

(c) Personnel 

(d) Facilities 

(e) Evidence control 

(f) Validation 

(g) Analytical procedures 

(h) Calibration and maintenance 

(i) Proficiency testing 

(j) Corrective action 

(k) Reports 

(l) Review 

(m) Safety 

(n) Previous audits 

15.1.2 The laboratory shall retain all documentation pertaining to audits 

in accordance with relevant legal and agency requirements. 

STANDARD 15.2 Once every two years, a second agency shall participate in the 

annual audit. 

16. SAFETY

STANDARD 16.1 The laboratory shall have and follow a documented 

environmental health and safety program. 

17. SUBCONTRACTOR OF ANALYTICAL TESTING FOR WHICH VALIDATED 

PROCEDURES EXIST 

STANDARD 17.1 A laboratory operating under the scope of these standards will 

require certification of compliance with these standards when a subcontractor 

performs forensic DNA analyses for the laboratory. 

17.1.1 The laboratory will establish and use appropriate review 

procedures to verify the integrity of the data received from the 

subcontractor. 

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Standards For Convicted Offender 

DNA Databasing Laboratories 

Preface 

Throughout its deliberation concerning these quality standards, 

the DNA Advisory Board recognized the need for a mechanism to ensure 

compliance with the standards. An underlying premise for these discussions 

was that accreditation would be required to demonstrate compliance with the 

standards and therefore assure quality control and a quality program. 

Accordingly, the Board recommends that forensic laboratories performing DNA 

analysis seek such accreditation with all deliberate speed. Additionally, the 

Board strongly encourages the accrediting bodies to begin positioning 

themselves to accommodate the increasing demand for accreditation. 

Introduction 

Forensic DNA identification analysis currently involves forensic casework and 

convicted offender analyses. These complementary functions demand 

adherence to the highest analytical standards possible to protect both public 

safety and individual rights. Separate standards have been drafted for 

laboratories performing these functions. This separation is an acknowledgment 

of the differences in the nature or type of sample, the typical sample quantity 

and potential for reanalysis, and specialization that may exist in a laboratory. 

Standards for convicted offender laboratories, in some instances, are less 

stringent than for those performing forensic casework analyses, but in no case 

should the two documents be interpreted as conflicting. This document 

consists of definitions and standards. The standards are quality assurance 

measures that place specific requirements on the laboratory. Equivalent 

measures not outlined in this document may also meet the standard if 

determined sufficient through an accreditation process. 

Mechanism To Recommend Changes To Standards 

Once the Director of the Federal Bureau of Investigation (FBI) has issued 

standards for quality assurance for convicted offender DNA testing, the DNA 

Advisory Board may recommend revisions to such standards to the FBI 

Director, as necessary. In the event that the duration of the DNA Advisory 

Board is extended beyond March 10, 2000, by the FBI Director, the Board may 

continue to recommend revisions to such standards to the FBI Director. In the 

event that the DNA Advisory Board is not extended by the FBI Director after 

March 10, 2000, the Technical Working Group on DNA Analysis Methods 

(TWGDAM) may recommend revisions to such standards to the FBI Director, as 

necessary. 

Effective Date 

These Quality Assurance Standards for Convicted Offender DNA Databasing 

Laboratories take effect April 1, 1999. 

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REFERENCES: 

American Society of Crime Laboratory Directors-Laboratory Accreditation 

Board (ASCLD-LAB), ASCLD-LAB Accreditation Manual, January 1994, and 

January, 1997. 

International Standards Organization (ISO)/International Electrotechnical 

Commission (IEC), ISO/IEC Guide 25-1990, (1990) 

American National Standards Institute, New York, NY. 

Technical Working Group on DNA Analysis Methods, "Guidelines for a Quality 

Assurance Program for DNA Analysis," Crime Laboratory Digest, April 1995, 

Volume 22, Number 2, pp. 21-43. 

42 Code of Federal Regulations, Chapter IV (10-1-95 Edition), Health Care 

Financing Administration, Health and Human Services. 

1. SCOPE 

The standards describe the quality assurance requirements that a government 

laboratory which is defined as a facility in which convicted offender DNA 

testing is regularly performed should follow to ensure the quality and integrity 

of the data and competency of the laboratory. These standards do not preclude 

the participation of a laboratory, by itself or in collaboration with others, in 

research and development, on procedures that have not yet been validated. 

2. DEFINITIONS 

As used in these standards, the following terms shall have the meanings 

specified: 

(a) Administrative review is an evaluation of the report and supporting 

documentation for consistency with laboratory policies and for 

editorial correctness. 

(b) Amplification blank control consists of only amplification reagents 

without the addition of sample DNA. This control is used to detect 

DNA contamination of the amplification reagents. 

(c) Analytical procedure is an orderly step by step procedure designed to 

ensure operational uniformity and to minimize analytical drift. 

(d) Audit is an inspection used to evaluate, confirm, or verify activity 

related to quality. 

(e) Batch is a group of samples analyzed at the same time. 

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(f) Calibration is the set of operations which establish, under specified 

conditions, the relationship between values indicated by a measuring 

instrument or measuring system or values represented by a material 

and the corresponding known values of a measurement. 

(g) CODIS is the Combined DNA Index System administered by the FBI. 

It houses DNA profiles from convicted offenders, forensic specimens, 

population samples and other specimen types. 

(h) Commercial test kit is a preassembled kit that allows the user to 

conduct a specific DNA identification test. 

(i) Convicted offender is an individual who is required by statute to 

submit a standard sample for DNA databasing. 

(j) Convicted offender database (CODIS) manager or custodian (or 

equivalent role, position, or title as designated by the laboratory 

director) is the person responsible for administration and security of 

the laboratory's CODIS. 

(k) Convicted offender standard sample is biological material collected 

from an individual for DNA analysis and inclusion into CODIS. See 

also database sample. 

(l) Critical equipment or instruments are those requiring calibration 

prior to use and periodically thereafter. 

(m) Critical reagents are determined by empirical studies or routine 

practice to require testing on established samples before use in order 

to prevent unnecessary loss of sample. 

(n) Database sample is a known blood or standard sample obtained from 

an individual whose DNA profile will be included in a computerized 

database and searched against other DNA profiles. 

(o) Examiner/analyst (or equivalent role, position, or title as designated 

by the laboratory director) is an individual who conducts and/or 

directs the analysis of samples, interprets data and reaches 

conclusions. 

(p) Known samples are biological material whose identity or type is 

established. 

(q) Laboratory is a government facility in which convicted offender DNA 

testing is performed or a government facility who contracts with a 

second entity for such testing. 

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(r) Laboratory support personnel (or equivalent role, position, or title as 

designated by the laboratory director) are individual(s) who perform 

laboratory duties and do not analyze samples. 

(s) NIST is the National Institute of Standards and Technology. 

(t) Polymerase Chain Reaction (PCR) is an enzymatic process by which a 

specific region of DNA is replicated during repetitive cycles which 

consist of: 1) denaturation of the template; 2) annealing of primers to 

complementary sequences at an empirically determined temperature; 

and 3) extension of the bound primers by a DNA polymerase. 

(u) Proficiency test sample is biological material whose DNA type has 

been previously characterized and which is used to monitor the 

quality performance of a laboratory or an individual. 

(v) Proficiency testing is a quality assurance measure used to monitor 

performance and identify areas in which improvement may be needed. 

Proficiency tests may be classified as: 1) Internal proficiency test is 

one prepared and administered by the laboratory. 2) External 

proficiency test, which may be open or blind, is one which is obtained 

from a second agency. 

(w) A Qualifying test measures proficiency in both technical skills and 

knowledge. 

(x) Quality assurance includes the systematic actions necessary to 

demonstrate that a product or service meets specified requirements 

for quality. 

(y) A quality manual is a document stating the quality policy, quality 

system and quality practices of an organization. 

(z) Quality system is the organizational structure, responsibilities, 

procedures, processes and resources for implementing quality 

management. 

(aa) Reagent blank control consists of all reagents used in the test process 

without any sample. This is to be used to detect DNA contamination 

of the analytical reagents. 

(bb) Reference material (certified or standard) is a material for which 

values are certified by a technically valid procedure and accompanied 

by or traceable to a certificate or other documentation which is issued 

by a certifying body. 

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(cc) Restriction Fragment Length Polymorphism (RFLP) is generated by 

cleavage by a specific restriction enzyme and the variation is due to 

restriction site polymorphism and/or the number of different repeats 

contained within the fragments. 

(dd) Review is an evaluation of documentation to check for consistency, 

accuracy, and completeness. 

(ee) Second agency is an entity or organization external to and 

independent of the laboratory and which performs DNA identification 

analysis. 

(ff) Secure area is a locked space (for example, cabinet, vault or room) 

with access restricted to authorized personnel. 

(gg) Subcontractor is an individual or entity having a transactional 

relationship with a laboratory. 

(hh) Technical manager or leader (or equivalent position or title as 

designated by the laboratory director) is the individual who is 

accountable for the technical operations of the laboratory. 

(ii) Technical review is an evaluation of reports, notes, data, and other 

documents to ensure an appropriate and sufficient basis for the 

scientific conclusions. This review is conducted by a second qualified 

individual. 

(jj) Technician (or equivalent role, position, or title as designated by the 

laboratory director) is an individual who performs analytical 

techniques on samples under the supervision of a qualified 

examiner/analyst and/or performs DNA analysis on samples for 

inclusion in a database. 

(kk) Traceability is the property of a result of a measurement whereby it 

can be related to appropriate standards, generally international or 

national standards, through an unbroken chain of comparisons. 

(ll) Validation is a process by which a procedure is evaluated to 

determine its efficacy and reliability for DNA analysis and includes: 

1) Developmental validation is the acquisition of test data and 

determination of conditions and limitations of a new or novel DNA 

methodology for use on samples. 2) Internal validation is an 

accumulation of test data within the laboratory to demonstrate that 

established methods and procedures perform as expected in the 

laboratory. 

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3. QUALITY ASSURANCE PROGRAM 

STANDARD 3.1 The laboratory shall establish and maintain a documented 

quality system that is appropriate to the testing activities. 

 

3.1.1 The quality manual shall address at a minimum: 

(a) Goals and objectives 

(b) Organization and management 

(c) Personnel qualifications and training 

(d) Facilities 

(e) Sample control 

(f) Validation 

(g) Analytical procedures 

(h) Calibration and maintenance 

(i) Proficiency testing 

(j) Corrective action 

(k) Documentation 

(l) Review 

(m) Safety 

(n) Audits 

4. ORGANIZATION AND MANAGEMENT

STANDARD 4.1 The laboratory shall: 

(a) have a managerial staff with the authority and resources needed to 

discharge their duties and meet the requirements of the standards 

in this document. 

(b) have a technical manager or leader who is accountable for the 

technical operations. 

(c) have a CODIS manager or custodian who is accountable for CODIS 

operations. 

(d) specify and document the responsibility, authority, and 

interrelation of all personnel who manage, perform or verify work 

affecting the validity of the DNA analysis. 

5. PERSONNEL 

STANDARD 5.1 Laboratory personnel shall have the education, training and 

experience commensurate with the examination and testimony provided. The

laboratory shall: 

5.1.1 have a written job description for personnel to include 

responsibilities, duties and skills. 

5.1.2 have a documented training program for qualifying all technical 

laboratory personnel. 

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5.1.3 have a documented program to ensure technical qualifications are 

maintained through continuing education. 

5.1.3.1 Continuing education - the technical manager or leader, 

CODIS manager or custodian, and examiner-analyst(s) must stay 

abreast of developments within the field of DNA typing by reading 

current scientific literature and by attending seminars, courses, 

professional meetings or documented training sessions/classes in 

relevant subject areas at least once a year. 

5.1.4 maintain records on the relevant qualifications, training, skills and 

experience of the technical personnel. 

STANDARD 5.2 The technical manager or leader shall have the following: 

5.2.1 Degree requirements: The technical manager or leader of a 

laboratory shall have, at a minimum, a Master's degree in biology-, 

chemistry-, or forensic science-related area and successfully completed a 

minimum of 12 semester or equivalent credit hours of a combination of 

undergraduate and graduate course work covering the subject areas of 

biochemistry, genetics and molecular biology (molecular genetics, 

recombinant DNA technology), or other subjects which provide a basic 

understanding of the foundation of forensic DNA analysis, as well as 

statistics and/or population genetics as it applies to forensic DNA 

analysis. 

5.2.1.1 The degree requirements of section 5.2.1 may be waived by 

the American Society of Crime Laboratory Directors (ASCLD) or other 

organizations designated by the Director of the FBI in accordance 

with criteria approved by the Director of the FBI. This waiver shall be 

available for a period of two years from the effective date of the 

standards. The waiver shall be permanent and portable. 

5.2.2 Experience requirements: A technical manager or leader of a 

laboratory shall have a minimum of three years of relevant problem 

solving or related analytical laboratory experience. 

5.2.3 Duty requirements: 

5.2.3.1 General: manages the technical operations of the laboratory. 

5.2.3.2 Specific duties: 

(a) Is responsible for evaluating all methods used by the 

laboratory and for proposing new or modified 

analytical procedures to be used by examiners. 

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(b) Is responsible for technical problem solving of 

analytical methods and for the oversight of training, 

quality assurance, safety and proficiency testing in the 

laboratory. 

5.2.3.3 The technical manager or leader shall be accessible to the 

laboratory to provide on-site, telephone or electronic consultation as 

needed. 

STANDARD 5.3 CODIS manager or custodian shall have the following: 

5.3.1 Degree requirements: A CODIS manager or custodian shall have, at 

a minimum, a Bachelor's degree in a natural science or computer 

science. 

5.3.2 Experience requirements: A CODIS manager or custodian shall 

have a working knowledge of computers, computer networks, and 

computer database management, with an understanding of DNA profile 

interpretation. 

5.3.3 Duty requirements: 

(a) Is the system administrator of the laboratory's CODIS 

network and is responsible for the security of DNA profile 

data stored in CODIS. 

(b) Is responsible for oversight of CODIS computer training and 

quality assurance of data. 

(c) Has the authority to terminate the laboratory's participation 

in CODIS in the event of a problem until the reliability of the 

computer data can be assured. The state CODIS manager or 

custodian has this authority over all CODIS sites under 

his/her jurisdiction. 

STANDARD 5.4 Examiner/analyst shall have the following: 

5.4.1 Degree requirements: An examiner/analyst shall have, at a 

minimum, a Bachelors degree or its equivalent degree in biology-, 

chemistry-, or forensic science-related area and must have successfully 

completed college course work (graduate or undergraduate level) covering 

the subject areas of biochemistry, genetics and molecular biology 

(molecular genetics, recombinant DNA technology) or other subjects 

which provide a basic understanding of the foundation of forensic DNA 

analysis, as well as course work and/or training in statistics and 

population genetics as it applies to forensic DNA analysis. 

5.4.2 Experience requirements: An examiner/analyst shall have a 

minimum of six (6) months of DNA laboratory experience, including 

169 
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the successful analysis of a range of samples typically encountered

in convicted offender analysis prior to independent work using DNA 

technology. 

5.4.3 An examiner/analyst shall have successfully completed a qualifying 

test before beginning independent work responsibilities. 

STANDARD 5.5 Technician shall have: 

5.5.1 on-the-job training specific to their job function(s). 

5.5.2 successfully completed a qualifying test before participating in DNA 

typing responsibilities. 

STANDARD 5.6 Laboratory support personnel shall have: 

5.6.1 training, education and experience commensurate with their 

responsibilities as outlined in their job description. 

6. FACILITIES 

STANDARD 6.1 The laboratory shall have a facility that is designed to provide 

adequate security and minimize contamination. The laboratory shall ensure 

that: 

6.1.1 Access to the laboratory is controlled and limited. 

6.1.2 Prior to PCR amplification, evidence examinations, liquid sample 

examinations, DNA extractions, and PCR setup are conducted at 

separate times or in separate spaces. 

6.1.3 Amplified DNA product is generated, processed and maintained in 

a room(s) separate from the evidence examination, liquid blood 

examinations, DNA extractions and PCR setup areas. 

6.1.4 A robotic work station may be used to carry out DNA extraction 

and amplification in a single room, provided it can be demonstrated that 

contamination is minimized and equivalent to that when performed 

manually in separate rooms. 

6.1.5 The laboratory follows written procedures for monitoring, cleaning 

and decontaminating facilities and equipment. 

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7. SAMPLE CONTROL 

STANDARD 7.1 The laboratory shall have and follow a documented sample 

inventory control system. This system shall ensure that: 

7.1.1 Offender samples are marked for identification. 

7.1.2 Documentation of sample identity, collection, receipt, storage, and 

disposition is maintained. 

7.1.3 The laboratory follows documented procedures that minimize 

sample loss, contamination, and/or deleterious change. 

7.1.4 The laboratory has secure areas for sample storage including 

environmental control consistent with the form or nature of the sample. 

8. VALIDATION 

STANDARD 8.1 The laboratory shall use validated methods and procedures for 

DNA analyses. 

8.1.1 Developmental validation that is conducted shall be appropriately 

documented. 

8.1.2 Novel database DNA methodologies shall undergo developmental 

validation to ensure the accuracy, precision and reproducibility of the 

procedure. 

8.1.2.1 Documentation shall be available which defines and 

characterizes the locus. 

8.1.3 Internal validation shall be performed and documented by the 

laboratory. 

8.1.3.1 The procedure shall be tested using known samples. The 

laboratory shall monitor and document the reproducibility and 

precision of the procedure using human DNA control(s). 

8.1.3.2 Before the introduction of a procedure into database 

sample analysis, the analyst or examination team shall 

successfully complete a qualifying test. 

8.1.3.3 Material modifications made to analytical procedures shall 

be documented and subject to validation testing. 

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9. ANALYTICAL PROCEDURES 

STANDARD 9.1 The laboratory shall have and follow written analytical 

procedures approved by the laboratory management/technical manager. 

9.1.1 The laboratory shall have a standard operating protocol for each 

analytical technique used. 

9.1.2 The procedures shall include reagents, sample preparation, 

extraction, equipment and controls which are standard for DNA analysis 

and data interpretation. 

STANDARD 9.2 The laboratory shall use reagents that are suitable for the 

methods employed. 

9.2.1 The laboratory shall have written procedures for documenting 

commercial supplies and for the formulation of reagents. 

9.2.2 Reagents shall be labeled with the identity of the reagent, the date 

of preparation and expiration, and the identity of the individual 

preparing the reagent. 

9.2.3 The laboratory shall identify critical reagents, if any, and evaluate 

them prior to use. 

STANDARD 9.3 The laboratory shall monitor the analytical procedures using 

appropriate controls and standards. 

9.3.1 The following controls shall be used in RFLP analysis: 

9.3.1.1 When required by the analytical procedure, standards for 

estimating the amount of DNA recovered by extraction shall be 

used. 

9.3.1.2 K562 as a human DNA control. 

9.3.1.3 Molecular weight size markers to bracket samples on an 

analytical gel. No more than five lanes shall exist between marker 

lanes. 

9.3.1.4 A procedure shall be available to monitor the completeness 

of restriction enzyme digestion. Interpretation of the 

autorad/lumigraph is the ultimate method of assessment but a 

test gel or other method may be used as necessary. 

9.3.2 The following controls shall be used for PCR database analysis: 

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9.3.2.1 When required by the analytical procedure, standards 

which estimate the amount of human nuclear DNA recovered by 

extraction shall be used. 

9.3.2.2 Positive and negative amplification controls. 

9.3.2.3 Contamination controls. 

9.3.2.3.1 Samples extracted prior to the effective date of 

these standards without reagent blanks are acceptable as 

long as other samples analyzed in the batch do not 

demonstrate contamination. 

9.3.2.4 Allelic ladders for variable number tandem repeat sequence 

PCR-based systems. 

STANDARD 9.4 The laboratory shall check its DNA procedures annually or 

whenever substantial changes are made to the protocol(s) against an 

appropriate and available NIST standard reference material or standard 

traceable to a NIST standard. 

STANDARD 9.5 The laboratory shall have and follow written general guidelines 

for the interpretation of data. 

9.5.1 The laboratory shall verify that all control results are within 

established tolerance limits. 

10. EQUIPMENT CALIBRATION AND MAINTENANCE 

STANDARD 10.1 The laboratory shall use equipment suitable for the methods 

employed. 

STANDARD 10.2 The laboratory shall identify critical equipment and shall have 

a documented program for calibration of instruments and equipment. 

10.2.1 Where available and appropriate, standards traceable to national 

or international standards shall be used for calibration. 

10.2.1.1 Where traceability to national standards of measurement 

is not applicable, the laboratory shall provide satisfactory evidence 

of correlation of results. 

10.2.2 The frequency of the calibration shall be documented for each 

instrument requiring calibration. Such documentation shall be retained 

in accordance with federal or state law. 

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STANDARD 10.3 The laboratory shall have and follow a documented program 

to ensure that instruments and equipment are properly maintained. 

10.3.1 New critical instruments and equipment, or critical instruments 

and equipment that have undergone repair or maintenance, shall be 

calibrated before use. 

10.3.2 Written records or logs shall be maintained for maintenance 

service performed on instruments and equipment. Such documentation 

shall be retained in accordance with federal or state law. 

11. REPORTS 

STANDARD 11.1 The laboratory shall have and follow written procedures for 

generating and maintaining documentation for database samples. 

11.1.1 The laboratory shall have written procedures for the release of 

database sample information. 

12. REVIEW 

STANDARD 12.1 The laboratory shall have and follow written procedures for 

reviewing database sample information, results, and matches. 

12.1.1 The laboratory shall have a mechanism in place to address 

unresolved discrepant conclusions between analysts and reviewer(s). 

STANDARD 12.2 The laboratory shall have and follow a program that 

documents the annual monitoring of the testimony of laboratory personnel. 

13. PROFICIENCY TESTING 

STANDARD 13.1 Examiners and other personnel designated by the technical 

manager or leader who are actively engaged in DNA analysis shall undergo, at 

regular intervals of not to exceed 180 days, external proficiency testing in 

accordance with these standards. Such external proficiency testing shall be an 

open proficiency testing program. 

13.1.1 The laboratory shall maintain the following records for proficiency 

tests: 

(a) The test set identifier. 

(b) Identity of the examiner. 

(c) Date of analysis and completion. 

(d) Copies of all data and notes supporting the conclusions. 

(e) The proficiency test results. 

(f) Any discrepancies noted. 

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(g) Corrective actions taken. Such documentation shall be 

retained in accordance with applicable federal or state law. 

13.1.2 The laboratory shall establish at a minimum the following criteria 

for evaluation of proficiency tests: 

(a) All reported inclusions are correct or incorrect. 

(b) All reported exclusions are correct or incorrect. 

(c) All reported genotypes and/or phenotypes are correct or 

incorrect according to consensus genotypes/phenotypes or 

within established empirically determined ranges. 

(d) All results reported as inconclusive or uninterpretable are 

consistent with written laboratory guidelines. The basis for 

inconclusive interpretations in proficiency tests must be 

documented. 

(e) All discrepancies/errors and subsequent corrective actions 

must be documented. 

(f) All final reports are graded as satisfactory or unsatisfactory. 

A satisfactory grade is attained when there are no analytical 

errors for the DNA profile typing data. Administrative errors 

shall be documented and corrective actions taken to 

minimize the error in the future. 

(g) All proficiency test participants shall be informed of the final 

test results. 

14. CORRECTIVE ACTION 

STANDARD 14.1 The laboratory shall establish and follow procedures for 

corrective action whenever proficiency testing discrepancies and/or analytical 

errors are detected. 

14.1.1 The laboratory shall maintain documentation for the corrective 

action. Such documentation shall be retained in accordance with federal 

or state law. 

15. AUDITS 

STANDARD 15.1 The laboratory shall conduct audits annually in accordance 

with the standards outlined herein. 

15.1.1 Audit procedures shall address at a minimum: 

(a) Quality assurance program 

(b) Organization and management 

(c) Personnel 

(d) Facilities 

(e) Sample control 

(f) Validation 

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(g) Analytical procedures 

(h) Calibration and maintenance 

(i) Proficiency testing 

(j) Corrective action 

(k) Documentation 

(l) Review 

(m) Safety 

(n) Previous audits 

15.1.2 The laboratory shall retain all documentation pertaining to audits 

in accordance with relevant legal and agency requirements. 

STANDARD 15.2 Once every two years, a second agency shall participate in the 

annual audit. 

16. SAFETY 

STANDARD 16.1 The laboratory shall have and follow a documented 

environmental health and safety program. 

17. SUBCONTRACTOR OF ANALYTICAL TESTING FOR WHICH VALIDATED 

PROCEDURES EXIST 

STANDARD 17.1 A laboratory operating under the scope of these standards 

will require certification of compliance with these standards when a 

subcontractor performs convicted offender DNA analyses for the laboratory. 

17.1.1 The laboratory will establish and use appropriate review 

procedures to verify the integrity of the data received from the 

subcontractor including but not limited to: 

(a) Random reanalysis of samples. 

(b) Visual inspection and evaluation of results/data. 

(c) Inclusion of QC samples. 

(d) On-site visits. 

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NDIS REQUIREMENTS

The NDIS Requirements are found in the Memorandum of Understanding 

(MOU) signed by the FBI and each NDIS participant. The MOU requires that 

signatories comply with general requirements already established (i.e., federal 

legislation, the Forensic and Offender Standards), as well as requirements 

specific to the national index that accompany the MOU in three appendices: 

NDIS Responsibilities (Appendix A); NDIS Data Acceptance Standards 

(Appendix B); and the NDIS Procedures Manual (Appendix C). While the 

Appendices include a multitude of individual requirements, we include in the 

following examples from among the more significant of those requirements. 

Appendix A, NDIS Responsibilities, mandates that laboratories: 

• Comply with FBI requirements for physically and electronically 

safeguarding CODIS against unauthorized use, including providing an 

appropriate and secure site for the NDIS system. 

• Designate one agency within each state to be responsible for ensuring 

that conditions and standards for participation in the national index are 

met. 

• Designate one CODIS liaison within the state agency to handle 

communications with the FBI. 

• Ensure that appropriate personnel are provided copies of, understand, 

and abide by the NDIS Procedures Manual. 

• Identify in writing, in prescribed form, personnel approved to access 

CODIS and ensure that access to CODIS is limited to approved 

personnel. 

• Maintain records on personnel approved to access CODIS, including 

proficiency testing records and any other report required by the FBI, for a 

period of 10 years. 

• Conduct background investigations of personnel designated to input data 

to or access the national index. 

• Maintain a system of controls to ensure that DNA records are kept as 

long as they are substantiated by the laboratory’s internal records and 

are allowed to be retained by federal or state law, by judicial decree or by 

consent, and used in local, state, and national indexes in accordance 

with the Act, applicable state law, and for the national index, in 

accordance with the Privacy Act of 1974. This is the only NDIS 

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requirement that pertains to the convicted offender profile sample as well 

as the forensic profile sample. 

• Report on a monthly basis confirmed national index matches to the FBI 

in a form prescribed by the FBI. 

• Provide to the FBI a written report of deletions/modifications within 10 

business days of discovering a DNA record requires 

deletion/modification. 

Appendix B, NDIS Data Acceptance Standards, requires that: 

• Laboratories using STR technology must use an FBI-approved STR kits. 

• Laboratories must attempt analysis of all 13 STR chromosomal locations 

that constitute a complete DNA profile (see Appendix 3 for an example of 

a complete DNA profile that includes each of these 13 chromosomal 

locations) and must obtain results for a minimum of 10 of those 

locations for a forensic profile to be considered “complete” and be 

included in the national index. An STR convicted offender profile will not 

be included in the national index unless the laboratory tests and obtains 

results for all 13 chromosomal locations. 

• Only forensic profiles derived from crime scene evidence matching the 

suspected perpetrator(s) or an unknown individual can be uploaded to 

the national index. Profiles clearly matching the victim or any known 

person other than the suspected perpetrator(s) cannot be uploaded to the 

national index. However, if the forensic profile is a mixture that cannot 

be clearly separated into a portion matching the victim or other known 

person and the portion matching the suspected perpetrator, such a 

profile would be accepted. 

Appendix C, NDIS Procedures Manual, provides (among other 

information) procedures for confirming and documenting potential matches 

found in the CODIS databases, both for case-to-case matches as well as caseto-offender matches. These procedures require that: 

• Potential or “candidate” matches be refuted or confirmed within 30 

business days. 

• In circumstances where a match is confirmed between two cases, the 

laboratory must notify, at a minimum, the law enforcement agencies 

investigating the cases. 

178 
 Appendix 4

• A report must be generated and filed for each confirmed candidate 

match, including, at a minimum, the prescribed forms and information 

delineated in the procedures. 

179 
 Appendix 5

SCIENTIST BIOGRAPHIES 

Dr. Arthur J. Eisenberg

Dr. Eisenberg received a Ph.D. in Molecular Biology from the State University of 

New York at Albany in 1984. He has worked in the field of DNA identification 

testing for the past 20 years, and has helped in the development of many of the 

reagents and methodologies used in the field. He currently serves as an 

Associate Professor in the Department of Pathology and as the Director of the 

DNA Identity Laboratory at the University of North Texas Health Science 

Center, Fort Worth, Texas. The DNA Identity Laboratory, in addition to 

performing parentage and DNA forensic testing, was designated by the Texas 

Legislature in its 2001 legislative session to serve as the site for the state’s 

Missing Person Database. 

Dr. Eisenberg has been a member of the FBI’s Scientific Working Group on 

DNA Analysis Methodologies for the past 14 years. He is also a member of the 

College of American Pathologists/American Association of Blood Banks 

Parentage Testing Proficiency Committee, and is a former member of the 

American Association of Blood Banks Parentage Testing Standards Committee. 

He was appointed to the United States DNA Advisory Board, an oversight group 

created as a result of the DNA Identification Act of 1994, in the position of 

Molecular Biologist and was later named Chairman. 

Mr. William David Coffman

Mr. Coffman received his Bachelor of Science degree in Chemistry from the 

University of Houston in 1982, and later completed additional coursework in 

the subjects of Molecular Biology, Genetics, and Biochemistry. Mr. Coffman’s 

professional career began with a serology position at the Houston Police 

Department Crime Laboratory in 1984. After a variety of DNA experiences, 

Mr. Coffman accepted in 1987 a position as a forensic biologist with the Florida 

Department of Law Enforcement Tallahassee Regional Crime Laboratory. In 

1990 Mr. Coffman was asked to establish the state of Florida's DNA 

Investigative Support Database and in 1994 was promoted to his current 

position as Crime Laboratory Analyst Supervisor, overseeing Florida's DNA 

Investigative Support Database Program. 

Mr. Coffman has served as an expert witness in the field of Forensic Biology in 

the states of Florida, Texas, New Hampshire, and Wisconsin approximately 150 

times, and has testified or given depositions on the subject of Forensic DNA 

and cases related to DNA Databasing approximately 15 times. 

Mr. Coffman has served in a variety of positions in the national professional 

DNA community, including: Vice Chairman, Scientific Working Group of DNA 

180 
 Appendix 5

Analysis Methods; Combined DNA Index System Subcommittee Chairman, 

Scientific Working Group of DNA Analysis Methods; member of the FBI’s 

Quality Assurance Standards Audit Review Panel; member of the Laboratory 

Funding Working Group that functions as part of the National Commission on 

the Future of DNA Evidence; member of the FBI’s DNA Advisory Board from 

March 1997 to March 2000; member of the National DNA Database Pilot 

Program conducted for the Combined DNA Index System administered by the 

FBI; member of the American Academy of Forensic Scientists; member of the 

Southern Association of Forensic Scientists; member of the Florida Sex Crimes 

Investigators Association, and a Special Subcommittee member for the Missing 

and Exploited Children Information Clearinghouse. 

Dr. John H. Ryan

Dr. Ryan received his Ph.D. in Genetics in 1995 from the State University of 

New York at Stony Brook. Dr. Ryan's professional experience began in 1995 

when he accepted a position as a DNA technician at the Armed Forces DNA 

Identification Laboratory (AFDIL). AFDIL provides worldwide scientific 

consultation, research, and education services in the field of forensic DNA 

analysis to the Department of Defense (DoD) and other agencies. During his 5-

year tenure at AFDIL, Dr. Ryan progressed to the position of Technical Leader 

of the mitochondrial DNA section. Dr. Ryan accepted his current position as 

the Director of Forensic Programs at Myriad Genetic Laboratories, Inc., in June 

of 2000. The Forensic Programs at Myriad Genetic Laboratories provides 

highly automated processing of DNA samples. In addition, Dr. Ryan currently 

serves as a DNA Expert on the Scientific Advisory Board for the International 

Commission on Missing Persons (ICMP) for the former Yugoslavia. The ICMP, 

works to bring resolution to the families of those missing from the conflicts in 

the former Yugoslavia. 

Dr. Ryan has held a variety of positions in the national professional DNA 

community, including President of the Human Identity Trade Association, a 

member of the Mid-Atlantic Association of Forensic Scientists, a provisional 

member of the American Academy of Forensic Scientists, and a Diplomat of the 

American Board of Criminalistics.

181 
 Appendix 6

CHECKLISTS AND GUIDANCE FOR SCIENTISTS 

This Appendix contains the definition of terms, guidance, and forms that 

were used by the assessment team to determine which portions of the FBI 

DNAUI written procedures and protocols were vulnerable to undetected 

inadvertent or willful noncompliance. 

The document sections in the checklists track directly to the table of 

contents of the various documents listed. Separate tables were completed for 

both impact rankings and risk rankings, even though the following documents 

show impact and risk on the same checklist. 

182 
 Appendix 6

FBI DNA Laboratory Vulnerability Assessment 

Instructions for Numeric Ratings of Impact 

Impact is defined as the measure of how scientifically essential a particular 

procedure or protocol is to producing a complete and accurate DNA profile. 

Producing a complete DNA profile includes ensuring that available DNA 

samples are efficiently and effectively processed for analysis. This definition 

does not include a consideration of whether a procedure or protocol is 

essential to the legal utility of a DNA profile. 

Descriptions of Rating Criteria 

Low Impact 

(Value = 1-3) 

A procedure or protocol falling into this category is optional, 

and while it may be beneficial, it is not in any way required. 

The details of this procedure or protocol, and even whether it is

adhered to, have little to no impact on the production of a 

complete and accurate profile. The general focus of the 

procedure or protocol is adherence to organization-specific 

guidelines, or to maintain efficient and consistent operations. 

Non-adherence has no direct impact on the integrity of the 

overall evidence or final conclusions. 

Medium 

Impact 

(Value = 4-7) 

A procedure or protocol falling into this category is required by 

quality standards, and certain aspects of what it includes are 

specified by quality standards. Failure to fully adhere to the 

procedure or protocol could compromise the obtaining of 

complete and accurate DNA results, and could compromise the

integrity of the overall evidence or final conclusions, but not 

necessarily. 

High Impact 

(Value= 8-10) 

A procedure or protocol falling into this category, as well as 

many of its specific contents, are specifically required by 

quality standards. Proper adherence to the procedure or 

protocol is essential to obtaining complete and accurate DNA 

results, as well as preserving the integrity of the overall 

evidence and the final conclusions. 

183 
 Appendix 6

FBI DNA Laboratory Vulnerability Assessment 

Instructions for Numeric Rating of Risk 

Risk is the measure of the sufficiency of existing controls to prevent both 

inadvertent and willful noncompliance and to detect noncompliance when 

it occurs. Willful noncompliance, in the context of this assessment, is 

defined as the intentional circumvention of applicable procedures and 

protocols. We applied this definition with the understanding that protocols 

alone cannot prevent in the first instance malicious acts by staff members. 

Descriptions of Rating Criteria 

Low Risk 

(Value = 1-

2) 

A procedure or protocol falling into this category has several 

mechanisms in place both to ensure staff compliance and to 

deter and detect noncompliance. Mechanisms could include 

hard-wired computerized controls, threshholds or sign-offs; 

checklists; forms; witnesses or reviews; separation of duties; 

random checks, etc. Mechanisms would almost exclusively be

those in which the process is forced to stop until the 

procedure or protocol is properly adhered to, and would be 

very difficult to bypass without the deliberate collusion of 

staff. 

MediumLow Risk 

(Value = 3-

4) 

A procedure or protocol falling into this category has several 

mechanisms in place to ensure staff compliance and to detect 

noncompliance. Mechanisms will generally be those that halt 

the process until the procedure or protocol is properly 

adhered to, but could also be based somewhat on faith in staff

compliance. These mechanisms most likely could not be 

bypassed by a single individual unless there is negligence by 

other staff. 

Medium 

Risk (Value 

= 5-6) 

A procedure or protocol falling into this category has a few 

mechanisms that serve to ensure staff compliance or to detect 

noncompliance. However, the mechanisms generally rely on 

faith in staff compliance, and would not halt the process if not

complied with. Mechanisms could be bypassed for a short 

time by a single individual if other unknowing staff are not 

consistently thorough in their oversight responsibilities. 

184 
 Appendix 6

MediumHigh Risk 

(Value = 7-

8) 

A procedure or protocol falling into this category has minimal 

mechanisms to ensure staff compliance or to detect 

noncompliance. Mechanisms that are in place rely on faith in 

staff to perform as expected without monitoring to detect 

otherwise, and could be bypassed for a lengthy time by a 

single individual, even if other staff are being thorough in 

their oversight responsibilities. 

High Risk 

(Value= 9-

10) 

A procedure or protocol falling into this category is not being 

monitored and has no mechanisms to detect noncompliance. 

Staff are left to themselves to adhere to the procedure or 

protocol, and noncompliance could exist indefinitely unless 

another staff member happens to discover and disclose the 

noncompliance to management. 

185 
 Appendix 6

Impact/Risk Assessment Forms, Phase 1 

 = Lab Wide = Unit Specific 

Instructions: rate each of the following major sections for impact and risk. The 

rating should reflect the highest level of impact or risk of procedures/protocols 

contained within the section. Put N/A if the section is informational only. If the 

sections listed below contain subsections that cover too broad an impact or risk 

range to be assessed as a whole (>3 values), an itemized assessment of each 

subsection should be completed. 

# of FBI Laboratory Division Quality Assurance Manual 

Sections

Laboratory Policies 1 2 3 4 5 6 7 8 9 10 N/A

1 Statements of Policy 

2 Case Documentation Policy 

3 Evidence Control Policy 

Operational Practices 1 2 3 4 5 6 7 8 9 10 N/A

4 Practices for Authorizing Deviations 

Notes:

DNA Analysis Unit I Quality Assurance Manual 

1 2 3 4 5 6 7 8 9 10 N/A

5 Evidence Control 

Notes:

FBI Laboratory Division Caseworking Procedures Manual 

1 2 3 4 5 6 7 8 9 10 N/A

6 Procedures for Processing a Request for Examination 

7 Procedures for Case Assignment 

8 Procedures for Inventorying & Identifying Evidence 

9 Procedures for Recording & Acknowledging Evidence 

10 Procedures for the Examination of Evidence 

11 

Procedures for the Formatting and Content of a Report of 

Examination 

12 Procedures for Reviewing a Report of Examination 

13 Procedures for Issuing a Report of Examination 

14 Procedures for Shipping Evidence 

15 Procedures for Transferring Evidence 

16 Procedures for Retaining Case-Related Documentation 

17 Procedures for Handling Drug and Valuable Evidence 

Notes:

186 
 Appendix 6

Procedures for the Serological Identification of Biological Substances on Evidentiary Materials 

Routine Procedures 

Procedure for the Presumptive Identification of Blood 1 2 3 4 5 6 7 8 9 10 N/A 

18 Reagents and Supplies 

19 Quality Control Procedures 

20 Test Procedure 

21 References 

Procedure for the Confirmatory Identification of Blood 1 2 3 4 5 6 7 8 9 10 N/A 

22 Reagents and Supplies 

23 Quality Control Procedures 

24 Test Procedure 

25 References 

Procedure for the Preparation of Dried Bloodstains 1 2 3 4 5 6 7 8 9 10 N/A 

26 Reagents and Supplies 

27 Quality Control Procedures 

28 

Preparation of Dried Bloodstains from 

Coagulated Whole Blood 

29 

Preparation of Dried Bloodstains from 

Anticoagulated Whole Blood 

30 Reference 

Procedure for the Presumptive Identification of Semen 1 2 3 4 5 6 7 8 9 10 N/A 

31 Reagents and Supplies 

32 Quality Control Procedures 

33 Test Procedure 

34 References 

Procedure for the Extraction of Suspected Semen Stains Prior to 

OneStep ABACard PSA Test 1 2 3 4 5 6 7 8 9 10 N/A 

35 Reagents and Supplies 

36 Quality Control Procedures 

37 Questioned Stain Extraction Procedure 

38 Reference 

Procedure for Human Semen Identification by the OneStep 

ABACard PSA Test 1 2 3 4 5 6 7 8 9 10 N/A 

39 Reagents and Supplies 

40 Quality Control Procedures 

41 Test Procedure 

187 
 Appendix 6

42 Interpretation of Results 

43 Disposal 

44 References 

Non-Routine Procedures 

Procedure for the Origin Determination of Stains 1 2 3 4 5 6 7 8 9 10 N/A 

45 Reagents and Supplies 

46 Quality Control Procedures 

47 Test Procedure 

48 Interpretation of Results 

49 Disposal 

50 References 

Procedure for Evaluating the Specificity of Anti-Species Antisera 

1 2 3 4 5 6 7 8 9 10 N/A

51 Reagents and Supplies 

52 Quality Control Procedures 

53 Test Procedures 

54 Interpretation of Results 

55 References 

Procedure for the Presumptive Identification of Blood Using 

Luminol 1 2 3 4 5 6 7 8 9 10 N/A

56 Reagents and Supplies 

57 Quality Control Procedures 

58 Test Procedure 

59 Interpretation of Results 

60 References 

Procedure for the Calibration of OneStep ABACard Tests for the

Detection of p30 1 2 3 4 5 6 7 8 9 10 N/A

61 Detection of p30 

62 Reagents and Supplies 

63 Preparation of p30 Standard Solutions 

64 Tests of the p30 Standard Solutions 

65 Interpretation of Results 

66 Reference 

Procedure for the Microscopic Identification of Spermatozoa 

1 2 3 4 5 6 7 8 9 10 N/A

67 Reagents and Supplies 

68 Quality Control Procedures 

69 Test Procedures 

70 References 

188 
 Appendix 6

Procedure for the Staining of Smear Slides with 

Kernechtrotpicroindigocarmine for the Microscopic Identification 

of Spermatozoa 1 2 3 4 5 6 7 8 9 10 N/A 

71 Reagents and Supplies 

72 Quality Control Procedures 

73 Test Procedures 

74 References 

Procedures for the Detection of Amylase in Saliva Stains 1 2 3 4 5 6 7 8 9 10 N/A

75 Reagents and Supplies 

76 Quality Control Procedures 

77 Test Procedures 

78 Interpretation of Results 

79 References 

80 Radial Diffusion Template 

Procedure for the Detection of Urea in Urine Stains 1 2 3 4 5 6 7 8 9 10 N/A 

81 Reagents and Supplies 

82 Quality Control Procedures 

83 Test Procedures 

84 Interpretation of Results 

85 References 

86 Radial Diffusion Template 

Laboratory Setup 1 2 3 4 5 6 7 8 9 10 N/A

87 Dedicated Equipment and Supply Items 

88 Dedicated Laboratory Space 

89 Equipment Calibration 

Notes:

189 
 Appendix 6

Impact/Risk Assessment Forms, Phase 2 

 = Lab Wide = Unit Specific

Instructions: rate each of the following major sections for impact and risk. 

The rating should reflect the highest level of impact or risk of 

procedures/protocols contained within the section. Put N/A if the section is 

informational only. If the sections listed below contain subsections that cover

too broad an impact or risk range to be assessed as a whole (>3 values), an 

itemized assessment of each subsection should be completed. 

# of FBI Laboratory Division Quality Assurance Manual 

Sections 1 2 3 4 5 6 7 8 9 10 N/A

1 Authorization and Approval Hierarchy 

2 Laboratory Quality System 

Laboratory Policies 1 2 3 4 5 6 7 8 9 10 N/A

3 Court Testimony Policy 

Operational Practices 1 2 3 4 5 6 7 8 9 10 N/A

4 Practices for Corrective Action 

5 Practices for Court Testimony Monitoring 

6 Practices for Document Control 

7 Practices for Instrument Calibration and Maintenance 

8 Practices for Internal Audits 

9 Practices for Laboratory Security 

10 Practices for Open Proficiency Testing 

11 Practices for Scientific or Technical Casework Conflict Resolution 

12 Practices for Validating Technical Procedures 

13 Practices for Writing Standard Operating Procedures 

Notes:

DNA Analysis Unit I Quality Assurance Manual 

1 2 3 4 5 6 7 8 9 10 N/A

14 Mission Statement 

15 Goals and Objectives 

16 Organization and Management 

17 Authority and Accountability 

18 

Job Descriptions, Personnel Qualifications and Training/Continuing 

Education 

190 
 Appendix 6

1 2 3 4 5 6 7 8 9 10 N/A

19 Facilities (Security) 

20 Documentation System 

21 Standard Operating Procedures 

22 Report Writing 

23 Case Assignment, Documentation and Review 

24 Quality Control of Reagents and Materials 

25 Instrument Calibration and Maintenance 

26 Validation 

27 Court Testimony Monitoring 

28 Addressing Complaints 

29 Proficiency Testing 

30 Audits 

31 Corrective Action 

32 Environmental Health and Safety 

Notes:

Short Tandem Repeat Analysis Protocol 

1 2 3 4 5 6 7 8 9 10 N/A

33 Scope: Principles of Forensic STR Typing Tests 

34 Reagents and Supplies and Equipment 

35 Reagents and Supplies for Extraction 

36 Reagents and Supplies for Quantitation 

37 

Reagents and Supplies for Profiler Plus / Cofiler 

Amplification and Detection by ABI Prism 310 

38 Equipment 

39 Special Quality Control Measures 

40 Guidelines for Control Samples 

41 Equipment 

42 

Quality Control of Critical Supplies and 

Reagents 

43 Extraction 

44 Whole Blood or Bloodstains 

45 Vaginal Swabs or Semen Stains 

46 Saliva Stains 

47 Envelope Flaps or Stamps 

48 Cigarette Butts 

49 Tissues 

50 Hairs 

191 
 Appendix 6

51 Bone 

52 Teeth 

53 Quantification by Quantiblot 

54 Amplification 

1 2 3 4 5 6 7 8 9 10 N/A

55 STR Typing by Capillary Gel Electrophoresis 

56 Setting up the Instrument 

57 Setting up a Run 

58 Genescan Analysis 

59 Genotyper Analysis 

60 Before Applying Genotyper 

61 Using a template file 

62 Examining data 

63 Interpretation 

64 Designation of Profiler Plus ID and Cofiler Alleles 

65 Preliminary Evaluation of Data 

66 Interpretation of Control Samples 

67 Interpretation of Specimens 

68 

Application of Population Frequency Data to 

Profiler Plus ID and Cofiler Typing Results 

69 Source Attribution 

70 Minimum Allele Frequency 

71 Allele Frequencies 

72 Report Writing 

73 Laboratory Set-up 

74 

DNA Extraction and Non-amplified DNA 

Laboratory 

75 PCR Set-up 

76 Amplified DNA Analysis 

77 References 

78 Safety 

Notes:

Miscellaneous Procedures 

1 2 3 4 5 6 7 8 9 10 N/A

79 Procedure for Monitoring Ultra-Violet Light Intensity 

80 Procedure for Pipette Calibration 

81 Procedure for One Point Thermometer Calibration 

Notes:

192