Scientific & Technical Review

Panel Final Report for

2021-S-0028

Standard for Use of Serological

Testing Methods Associated with

Forensic Investigations

Organization of Scientific Area Committees (OSAC) for Forensic Science
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STRP Final Report

2021-S-0028

Standard for Use of Serological Testing

Methods Associated with Forensic

Investigations

Organization of Scientific Area Committees (OSAC) for Forensic Science

August 3, 2022

Disclaimer:

This report was produced by an independent Scientific and Technical Review Panel (STRP). The

views expressed in the report do not necessarily reflect the views or policies of the U.S.

Government. Visit the OSAC website for more information on OSAC’s STRP process.

Scientific & Technical Review Panel Members

• Dawn Boswell , University of North Texas Health Science Center (UNTHSC) - Center

for Human Identification

• Rolando Carol, Auburn University at Montgomery

• Mark Lancaster, Battelle

• Melissa LaVigne, Tampa Bay Regional Operations Center

• Jennifer Mihalovich, Oakland Police Department Criminalistics Division (Retired) •

Shawn O’Toole, Denver Police Department

• Mark Stolorow, National Institute of Standards and Technology (NIST) •

Jessica Trout, Baltimore County Police Department
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Report Summary:

The Scientific and Technical Review Panel (STRP) for “Standard for Use of Serological Testing

Methods Associated with Forensic Investigations” is an independent panel appointed by the

National Institute of Standards and Technology (NIST). A STRP is established with a range of

experts to consider how well a standard meets the needs of the forensic science, law

enforcement, and legal communities, and to recommend improvements to the standards under

review. The STRP appreciates the efforts of Christie Smith, Human Forensic Biology

Subcommittee member, while serving as the subcommittee liaison to this STRP during the

review process.

The STRP began its review process with a kickoff meeting on August 26, 2021 and concluded

with this STRP final report. The panel reviewed the draft standard and prepared comments for

the Human Forensic Biology Subcommittee.

Report Components:

The STRP reviewed this draft standard against OSAC’s STRP Instructions for Review which

include the following content areas: scientific and technical merit, human factors, quality

assurance, scope and purpose, terminology, method description and reporting results. The details

below contain a brief description of each reviewed content area and the STRP’s assessment of

how that content was addressed in the Draft OSAC Proposed Standard.

1. Scientific and Technical Merit: OSAC-approved standards must have strong scientific

foundations so that the methods practitioners employ are scientifically valid, and the

resulting claims are trustworthy. In addition, standards for methods or interpretation of

results must include the expression and communication of the uncertainties in measurements

or other results.

1.1 Consensus View – The STRP believes the proposed standard adequately

addresses the scientific and technical merit of serological testing methods

associated with forensic investigations. The standard recognizes the importance of
using validation studies and scientific literature when developing and performing

serological analytical procedures. The use of controls, contamination prevention,

and the limitations of testing procedures are all recognized. While the standard

gives guidance on minimal requirements for documentation and interpretation of

serological testing, it still leaves discretion for laboratories to develop internal

policies for case-specific issues such as presumptive testing and sampling of

items. One issue the subcommittee may want to consider addressing is the utility

of semi-quantitative opinions when describing color-changing serological tests,

such as “weak” or “strong” positives. These are subjective terms and may lead to

downstream inferences in the DNA analysis.

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1.2 Minority View – None

2. Human Factors: All forensic science methods rely on human performance in acquiring,

examining, reporting, and testifying to the results. In the examination phase, some standards

rely heavily on human judgment, whereas others rely more on properly maintained and

calibrated instruments and statistical analysis of data.

2.1. Consensus View – Generally, the draft adequately addresses most issues related

to human factors and performance. Specifically, this draft acknowledges the

importance of education, experience, training, competency testing, and technical

and administrative review required for serological testing. Further, the draft

recognizes the potential influence of subjectivity and bias during documentation

and interpretation and encourages mitigating actions such as requiring report

evaluation by a second qualified analyst who is not the report author.

Additionally, this draft standard acknowledges the imperfect nature of human

memory and automaticity and suggests that all written analytical procedures be

readily available to those in the lab.

Documenting serological testing in a reproducible way for later review presents

unique challenges. While defining needed specificity relating to documentation

can be problematic given varied laboratory practices, the STRP recommends

including some additional guidance about documenting examinations to

strengthen these areas of the standard. For example, additional guidance

suggesting more detailed and specific documentation in relation to location

selection and the orientation of selected samples position in the overall item

being sampled would be useful. This information provides assurance that

sufficient records will exist so another qualified individual can evaluate what was

tested and interpret the test results, and it also enables future stakeholders to

make decisions about additional testing requests. While the standard already

incorporates some details of potential considerations for sufficient and detailed

documentation including “written notes, photography, drawing, photocopying or

scanning”, providing additional considerations about methods and specificity of

documentation (especially location) might be helpful.
Other potential impacts of bias, specifically on report interpretation and

evaluation, could be reduced further but would likely require unrealistic and/or

impractical modifications.

2.2. Minority View – None

3. Quality Assurance: Quality assurance covers a broad range of topics. For example, a

method must include quality assurance procedures to ensure that sufficiently similar results

will be obtained when the methodology is properly followed by different users in different

facilities.

3.1. Consensus View – The STRP believes that the appropriate quality assurance

topics are covered in this draft standard. The standard requires the important

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aspects of quality assurance including, but not limited to: using approved

validated methods and proper controls; monitoring of analytical procedures,

including annual review and approval of documents; monitoring of personnel,

including proficiency testing and competency testing; and monitoring of records

of testing, including technical and administrative reviews and discrepant

conclusions during review. The standard also addresses requirements for

laboratory facilities, equipment, including maintenance and calibration, reagents

and chemicals, including handling, use and storage.

3.2. Minority View – None

4. Scope and Purpose: Standards should have a short statement of their scope and purpose.

They should list the topics that they address and the related topics that they do not address.

Requirements, recommendations, or statements of what is permitted or prohibited do not

belong in this section.

4.1. Consensus View – The STRP believes the proposed standard adequately defines

the scope and purpose of the standard. The scope is broad and defines minimum

requirements allowing a wide range of laboratories to successfully meet the

standards. The STRP agrees that while the use of conventional serological

testing has declined as the sensitivity of DNA analysis methods has increased,

there is still a need for quality assurance requirements when performing and

documenting forensic serological methods to evaluate body fluids.

4.2. Minority View – None

5. Terminology: Standards should define terms that have specialized meanings. Only rarely

should they give a highly restricted or specialized meaning to a term in common use among

the general public.

5.1. Consensus View – The draft appropriately defines terms with specialized
meaning as they relate to serological testing. The standard accounts for and

incorporates terminology in the approved OSAC Lexicon. It also attempts to

promote consistency by considering the terminology used in guidance provided

by other relevant organizations. The STRP recommends using OSAC preferred

terms when available. The STRP also recognizes that there is some

inconsistency in terms and concerns about their use that exist and should be

resolved. In particular, the Human Factors group expressed meritorious concern

about the use of “conclusions” that warrant resolution by the OSAC generally.

The OSAC should work to resolve that Human Factors groups’ concern while

recognizing the laboratory’s need to continue to use certain terminology in some

instances. It should also explore other areas of needed resolutions to promote

clarification and standardization.

Recognizing that the adoption of the instant recommendation may result in

inconsistencies in terminology, the STRP still recommends removing the word

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“unintentional” in the definition of contamination. The subcommittee’s initial

exclusion of that word is more appropriate.

5.2. Minority View – None

6. Method Description: There is no rule as to the necessary level of detail in the description of

the method. Some parts of the method may be performed in alternative ways without

affecting the quality and consistency of the results. Standards should focus on standardizing

steps that must be performed consistently across organizations to ensure equivalent results.

Alternatively, standards can define specific performance criteria that are required to be

demonstrated and met rather than specifying the exact way a task must be done. For example,

it may be enough to specify the lower limit for detecting a substance without specifying the

equipment or method for achieving this limit of detection.

6.1. Consensus View – The standard does not address exact methods employed in

serology testing but rather provides guidance as to how analytical procedures are

developed and implemented. The STRP considers that the proposed standard

meets the Method Description requirement. This opinion is based on the fact

that the standard provides terms and definitions (section 3) encompassing

processes used in methods (i.e. confirmatory tests, controls, material

modification, performance checks, and presumptive tests). The standard

provides data on Analytical Procedures (Section 4.3) including that they are

based on validation studies and scientific literature and gives guidance

information needed in the procedure (i.e. 4.3.2 a – presumptive or confirmatory

test, 4.3.2 d – equipment, reagents and chemicals, 4.3.2 h – deviations from

procedures, 4.3.2 j – interpretations, 4.3.2 k – limitations, and 4.3.2 m –

reporting). Additionally, the standard addresses the monitoring of the analytical

procedure (Section 4.3.3), the approval of analytical procedures (Section 4.3.4)

and the material modification of analytical procedures (Section 4.3.6).
The STRP does recommend drafting additional standards to further guide the

development and implementation of specific serological testing procedures.

6.2. Minority View – None

7. Reporting Results: Methods must not only be well described, scientifically sound, and

comprehensive but also lead to reported results that are within the scope of the standard,

appropriately caveated, and not overreaching.

7.1. Consensus View – The methods “must ... lead to reported results that are within

the scope of the standard...” However, the scope of this standard specifically

states “This document does not address details of validation, training, evidence

handling, sample collection and preservation, reporting of analyses, testimony,

and safety.” Therefore, evaluating Reporting Results is beyond the scope of this

standard. However, the STRP strongly recommends the OSAC Human Forensic

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Biology Subcommittee draft best-practice documents for specific forensic

serological methods and reporting and testimony.

7.2. Minority View – None
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