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U.S. Department of Energy 

Office of Inspector General 

Office of Audit Services 

Audit Report 

Confirmatory Bioassay Testing at 

Selected Sites 

DOE/IG-0773 August 2007
Department of Energy 

Washington, DC 20585 

August 17, 2007 

MEMORANDUM FOR 

FROM: 

Inspector General 

S U BJ ECT: INFORMATION: Audit Report on "Confirmatory Bioassay 

Testing at Selected Sites" 

BACKGROUND 

The Department of Energy maintains a significant inventory of radioactive substances at 

facilities throughout the United States. To help ensure the safety of its workforce, the 

Department established a two-tiered approach to biological or "bioassay" testing of 

workers to determine whether and to what extent they may have absorbed radioactive 

material. The more intense process mandates biological testing and applies to the 

relatively few workers with significant exposure risk. When significant exposures are not 

expected - the situation at most sites and upon which this audit focused - the 

Department's contractors are required to develop a program to ensure that controls are 

effective in reducing exposures to radioactive substances. Specific components of the 

program are left to the discretion of the contractor. However, most rely on continuous air 

monitoring, radiological surveys, and confimlatory bioassay testing. 

Prior Office of Inspector General reviews have identified problems regarding the costeffectiveness and efficiency of the Department's bioassay monitoring program. Given the 

current emphasis on worker safety and the obvious dangers posed by excessive radiation 

exposure, we initiated this audit to determine whether contractor-developed bioassay 

programs were effectively administered. 

RESULTS OF AUDlT 

At selected sites, the confirmatory bioassay component of contractor-developed programs 

to monitor the effectiveness of radiological engineering and administrative controls was 

not functioning as intended. Specifically, our randomly selected samples revealed that: 

At the Oak Ridge National Laboratory, 16 of the 24 (about 67 percent) of the 

workers we sampled who regularly accessed radiological areas did not receive all 

scheduled tests, were either not tested at the prescribed frequency or were not 

tested for all of the radioactive isotopes to which they may have been exposed; 
Abo~~t 20 percent (9 of 34) of the radiological workers at the East Tennessee 

Technology Park were not tested at the frequency prescribed for all of the 

isotopes to which they may have been exposed; and, 

For over 20 percent (7 of 30) of the employees at the Nevada Test Site (N'TS), 

required documentation could not be provided indicating whether or not they 

were properly enrolled into the bioassay program. We also identified individuals 

at NTS that had either never been selected for testing despite being enrolled in 

the program or who were enrolled in the program but not tested as required. 

Further, we concluded that site-level safeguards for the bioassay component of the 

contractor-developed monitoring program were inadequate and that Federal reviews by 

the Department were not always sufficient. 

In contrast to the confirmatory bioassay program administration issues we identified, our 

audit revealed that individuals were being tested in accordance with site-level procedures 

at the Y- 12 National Security Complex and the Savannah River Site. Further, to the 

Department's credit, we noted that sites have developed radiation protection programs for 

bioassay monitoring and that many of the laboratories and analysis procedures were 

accredited under the Department of Energy Laboratory Accreditation Program. 

While these actions are noteworthy, without an improvement in the control process over 

personnel monitoring, Department and contractor en~ployees may be at risk for 

occupational exposures to radioactive material that might not be detected. As our audit 

demonstrated, opportunities exist to improve the reliability and effectiveness of the 

confirrnatory bioassay process employed by contractors. In that connection, we made 

several recommendations designed to ensure that monitoring and testing for radiological 

workers is appropriate. 

We also noted other matters for consideration (described in Appendix 1) pertaining to 

costs associated with providing bioassay services. In particular, we observed that the 

sites had not fully embraced cost reduction-related recommendations made in our report 

on 111- Vitro Bioassq Services at Department of Enera> Facilities (DOEIIG-0458, 

February 2000). 

MANAGEMENT REACTION 

The National Nuclear Security Administration (NNSA), as well as, the Offices of Science 

(Science) and Environmental Management (EM) provided comments on the report. The 

NNSA generally agreed with the report and concurred with the recommendations. 

Science and EM indicated that they would work with contractors to assure that local 

testing regimens are clearly stated and are being accomplished, however, they did not 

concur with the recommendations. Those offices noted that Federal regulation does not 

specifically require bioassay testing and that they would not compel employees to comply 

with contractor-established testing programs that were designed to help ensure the 

effectiveness of radiological controls if the employee chose not to do so. They based 
their position on the view that bioassay testing is a lagging indicator and that air 

monitoring, combined with radiation and contamination surveys, are the preferred options 

for verifying the effectiveness of protective controls. 

While the Office of Inspector General recognizes that bioassay testing for the class of 

individuals examined in this report was not specifically required by regulation, neither 

are air monitoring and radiation surveys. Rather, contractors are required to develop a 

program, based on site-level work environments, to verify that workers are adequately 

protected. Our review focused on whether the confirmatory bioassay testing component 

of contractor-developed protection programs - a component sanctioned and funded by 

the Department for many years at considerable cost - was functioning as intended. We 

found that it was not at the sites identified in the report. Management's comments are 

included in their entirety as Appendix 4. 

Attachment 

cc: Deputy Secretary 

Administrator, National Nuclear Security Administration 

Acting Under Secretary of Energy 

Under Secretary for Science 

Chief of Staff 
REPORT ON CONFIRMATORY BIOASSAY TESTING AT 

SELECTED SITES 

TABLE OF 

CONTENTS 

Confirmatory Bioassay Testinq 

1. Details of Finding .............................................................. 1

2. Recommendations and Comments .................................... 8 

Appendices 

1. Other Matters for Consideration ..................................... 1 1 

2. Objective, Scope, and Methodology ............................... 13 

3. Prior Reports ................................................................. 1 5 

4. Management Comments .................................................. 16 
CONFIRMATORY BIOASSAY TESTING 

Background The Code of Federal Regulations requires biological testing 

and monitoring as part of a program to protect individuals 

from the harmful effects of radiation. Department of 

Energy (Department) regulations specify that site 

contractors must develop their own method to verify that 

radiological engineering and administrative controls are 

effective in preventing radiation exposure. Contractors are 

permitted to take actions such as performing air 

monitoring, conducting radiation and contamination 

surveys, and using bioassay monitoring to confirm the 

effectiveness of such controls. At each of the sites we 

reviewed, contractors had elected to use confirmatory 

bioassay testing as a part of their protective program and 

had developed site-level procedures outlining testing 

requirements. As part of their program, contractors 

describe specific isotopes to which an individual may be 

exposed and for which testing is required by preparing 

Radiological Work Permits (Work Permit) that govern the 

conduct of operations for each work areahask. Workers are 

required to "sign-in" on the Work Permit each time they 

enter the radiological area. 

Bioassay Program Our review found that the Department's site contractors 

Administration had not ensurcd that all personnel that had regular access to 

radiological areas were being monitored in accordance with 

established site-level requirements. In particular, testing 

and methods used to track potential exposures did not 

conform to contractor-developed procedures. 

Monitorinp Issues 

Although each of the sites visited had developed and 

implemented monitoring programs designed to protect 

workers, we identified problems with the timing and 

sufficiency of tests and the maintenance of work history 

and potential exposure records. While sites recognized the 

potential health consequences associated with exposure to 

radioactive material, we noted that some workers were not 

tested at the frequency prescribed by the site and others 

were not tested for all the potential hazards to which they 

may have been exposed. For example: 

At Oak Ridge National Laboratory (ORNL), over 65 

percent (16 of 24) of the employees in our sample were 

not tested in accordance with the site's monitoring 

requirements. While certain individuals were not tested 

because of database deficiencies, the majority had not 

Page 1 Details of Finding 
submitted to testing as scheduled despite being notified 

of the requirement. Cancelled or missed appointments 

were supposed to be rescheduled through the bioassay 

system; however, rescheduled appointments were often 

delayed or missed. For example, one individual only 

met two of seven required tests over a 14-month period. 

During this time period, the individual worked in areas 

where she was potentially exposed to isotopes such as 

iodine- 13 1, which may increase a person's risk for 

developing thyroid cancer. Although this particular 

individual did obtain some whole body radiation 

screenings (referred to as "counts") on a bi-monthly 

basis, she cancelled 29 of 3 1 scheduled appointments 

for bioassay testing over a 14-month period. According 

to a site official, this individual indicated that she did 

not submit to testing because she believed, based on her 

knowledge as a scientist, that the frequency of testing 

was unnecessary. 

In addition, we also found instances where individuals 

- even though they had been tested for certain 

constituents - were not tested for all of the isotopes to 

which they may have been exposed. For example, an 

individual was to be tested on a quarterly basis, 

beginning in April 2004, for technetium-99 (TC-991, 

which is excreted rapidly from the body. In 2004, three 

appointments for this test were scheduled, all of which 

were cancelled. Because of the rapid excretion of TC99, a late make-up test may not be sufficient to detect 

exposure. This individual continued to work in 

radiological areas where TC-99 was identified as an 

isotope of interest throughout 2004 and part of 2005. 

Our ability to determine the full extent that 

appointments were not kept - and the site's ability to 

monitor the performance of its workforce in that regard 

- was hampered by record keeping problems. For 

example, a bioassay official routinely changed status 

records for appointments from "unmet" to "cancelled" 

without maintaining supporting information. This 

matter came to our attention when site officials 

provided listings that were inconsistent with previously 

provided data. The employee responsible for the 

changes stated that he made them to "clean up the 

system." Additionally, it was noted that certain controls 

built into the system could be easily circumvented by 

Page 2 Details of ind ding 
inserting codes that could allow officials to skip 

entering information critical to identifying radiological 

intakes. 

Similarly, at the East Tennessee Technology Park 

(ETTP), over 20 percent (9 of 34) of employees in our 

sample were not tested for isotopes as specified in the 

site's Work Permits. These individuals were not 

scheduled or tested at the frequency prescribed in 

applicable Work Permits. For example, four of these 

individuals were not scheduled in a timely manner, and, 

as a result, over 25 percent of required tests for uranium 

isotopes were at least three weeks delinquent. Testing 

for uranium isotopes, in this case, was required to be 

conducted monthly. While site officials told us that 

these individuals were eventually tested and that the 

testing provided adequate protection, we noted that 

testing intervals in each case exceeded scientifically 

determined test intervals contained in each Work 

Permit. The calculated intervals - which site officials 

believed to be accurate - considered factors such as 

radiation decay and bodily excretion rates. 

Twenty-three percent (7 of 30) of the employees in our 

sample at the Nevada Test Site (NTS) were tested for 

exposure to radiological hazards even though the site 

could not provide docun~entation supporting the need 

for them to be enrolled in the bioassay program. For a 

number of individuals in our sample, NTS was unable 

to provide docunlentation that would support entry into 

the bioassay program even though it was specifically 

required by site level policies. An NTS official stated 

that "it would be a research project" to reconstruct an 

individual's radiological work history. Without such 

history, NTS cannot ensure that these and other 

individuals should have been tested at all, at the 

required frequency, or for all the potential isotopes to 

which they may have been exposed. Since the 

completion of our field work, NTS officials informed 

us that they were now taking actions to revise existing 

procedures to formalize their enrollment process. 

Certain other individuals at NTS were not tested even 

though they were assigned to the bioassay program. 

We identified two radiological workers that were not 

selected by health physicists for testing during the 

three-year period we reviewed. Another employee we 

Page 3 Details of ind ding 
evaluated was not tested at the required frequency for 

all the isotopes as prescribed by the bioassay testing 

plan to which he or she was assigned. 

Site Level Controls These conditions occurred because site-level controls 

designed to ensure that workers con~plied with bioassay 

requirements and methods used to select individuals for 

testing were not always effective. In addition, the database 

systems used for tracking participants and identifying them 

for testing were not properly maintained. Further, 

Departmental monitoring of the bioassay program at the 

sites we visited was insufficient. 

Controls and Sanctions 

During the course of our audit work, we identified 

weaknesses in the controls used to in~plen~ent sie-level 

confirmatory bioassay progranls. In particular, site 

officials stated that much of the responsibility for 

compliance with bioassay program requirements rested on 

the individual worker and few, if any, sanctions were 

applied if an individual did not comply. For exanlple, at 

ORNL, site officials indicated that there were no work 

restrictions for not submitting required confirmatory 

bioassay samples and we identified a number of employees 

that routinely cancelled bioassay appointments. Of these, 

one individual cancelled 19 consecutive bioassay 

appointments in a seven-month period. During this time, 

this employee was still able to perform radiological work. 

We also noted inconsistencies in the design and conduct of 

the bioassay program at ORNL that could lead to a 

breakdown in the implementation of their program. 

Specifically, an ORNL bioassay program document states 

that fill1 participation is not required for the confirmatory 

bioassay program, and an isolated failure by a few 

individuals to submit samples does not constitute a 

programmatic failure. However, this document does not 

detail what an acceptable percentage of non-participation 

would be and site officials would not articulate what they 

believed to be the appropriate level of participation. Site 

officials also told us that they could not demonstrate that at 

least one individual from each Work Permit was being 

tested. Without this validation, a risk exists that exposures 

could be undetected for a particular work activity. 

Page 4 Details of Finding 
Finally, a 2005 Benchmarking study of the ORNL Internal 

Dosimetry Program completed by the Savannah River Site 

as part of a peer review, noted issues similar to those we 

found - that a significant fraction of routine urine bioassays 

were not being submitted. Since confirmatory bioassay at 

ORNL is used to verify that engineering and administrative 

controls were effective in the protection of personnel from 

radiological hazards, the study noted that noncompliance 

by a large fraction of the workforce makes this claim 

difficult to defend. ORNL's program docurnentation also 

acknowledges the importance of its confimiatory testing 

program by noting that a large fraction of significant 

exposures have been detected through the bioassay 

program. 

Selection Process and Program Enrollment 

Methodologies used to select individual workers for testing 

did not always ensure that all employees received needed 

tests. At NTS, bioassay sampling for select projects was 

not based on a statistical methodology. Instead, those that 

have the greatest chance of exposure are supposed to be 

selected for testing by health physicists. While this 

approach was acceptable, site officials told us that, at times, 

they selected individuals based on their willingness to 

submit to testing rather than on their exposure time. Using 

this discretionary approach, and as illustrated by our 

findings at the site, individuals may never be selected for 

testing and the site may not be accurately reporting 

employee doses and/or exposure. 

At ETTP, a decision was made to change bioassay 

monitoring protocols for over 100 Work Pennits. This 

modified approach monitors workers on a rotating basis 

rather than the prescribed frequency calculated during the 

developnlent of the Work Permits. According to a site 

official, "the major driving force" for the change in the 

bioassay monitoring protocol was to reduce monitoring 

costs. Using this approach, ETTP realized a cost savings of 

about $7,000 per employee annually. While we recognize 

that this modified approach, if adequately justified, is an 

acceptable method, it was inconsistent with the project-byproject requirements established in each of the 11 7 existing 

Work Permits that were affected. ETTP stated that, based 

on a review of several years of bioassay and air sampling 

results, they believed that the same level of safety 

assurance was achieved with the new methodology. Site 

Page 5 Details of Finding 
officials, however, could not provide analytical evidence to 

support the change and told us that they did not perform a 

con~parison of existing requirements to the new modified 

requirements for all affected Work Permits. 

Weaknesses in how individuals were entered into or 

removed from the bioassay program also existed at several 

sites. At NTS, for example, a site official stated that entry 

into the bioassay program was an informal process based 

solely on the assignment of individuals to particular 

bioassay plans by the Health Physicist for the project rather 

than on actual Work Permit sign-ins. Since Work Permit 

sign-in records were not used to establish enrollment or 

testing requirements, individuals that have performed work 

in radiological areas might never be entered into the 

bioassay program. Site officials also told us that removal 

from the program was a manual process and that there is no 

fonnal protocol to ensure that individuals are removed 

when testing is no longer necessary. 

Bioassay Database Systems 

Problems with the accuracy and maintenance of site-level 

bioassay databases also contributed to selection, 

monitoring, and enrollment problems. For example: 

At ETTP, Work Permit sign-ins were not always 

being uploaded in a timely manner, delaying 

scheduling of bioassay appointments - a problem 

that lead to delinquent bioassay monitoring for a 

number of individuals in our sample. Site officials 

informed us that this delay was discovered and 

corrected in September 2005 and only affected logins over a one month period. However, many of the 

delays identified in our review dated back to 

January 2005, thereby indicating that these delays 

had been ongoing for at least nine months before 

being identified. 

At ORNL, some isotopes were not added to 

individual bioassay monitoring profiles for testing. 

Site officials indicated that they were unable to 

determine whether or not the problem we 

discovered was an isolated incident. 

At NTS, a corrupted personnel data file caused an 

employee in our sample that should have been 

Page 6 Details of Finding 
Protection of 

Workers 

considered for testing to be excluded from bioassay 

monitoring. While a repair was attempted, the 

repair failed and went undetected until it was 

rediscovered by NTS officials while researching 

questions for this review. 

At both NTS and ORNL, database systems did not 

automatically remove participants from the bioassay 

program when monitoring was no longer necessary. 

Also, we found that a number of manual overrides of the 

bioassay database were performed at ORNL. These 

overrides were performed at the discretion of the internal 

dosimetrist who indicated, as previously noted, that they 

were periodically done to "clean up the system." ORNL's 

database does not track historical changes and, therefore, 

does not always accurately reflect an individuals' 

monitoring history, as required. 

Reviews at the Federal Level 

Our review also revealed that Federal monitoring of sitelevel bioassay programs was inadequate. Specifically, the 

federal positions that provide management and review of 

the radiological protection programs at NTS and Y-12 had 

been vacant for over two years. During the time these 

positions were vacant, there was no evidence of formal or 

informal assessments being conducted at the Federal field 

level in this area. Once the position was filled at Y-12, a 

number of assessments were conducted in the area of 

radiological protection, which identified nine weaknesses. 

Exposure to radiation is not a guarantee of harm. However, 

more exposure means more risk, and radiation exposure 

poses some risk of adverse health effect. Without an 

improvement in the control process over personnel 

monitoring, Department and contractor employees may be 

at increased risk for occupational exposures that might not 

be detected. Failure to provide an accurate total dose for 

employees may have an adverse impact on the health and 

welfare of workers. Also, if assessments at the Federal 

level are conducted more frequently, findings and 

opportunities for improvement related to radiological 

protection could be identified earlier and the risk of 

potential exposures caused by ineffective engineering or 

administrative controls could be reduced. 

Page 7 Details of Finding 
Finally, the lack of accurate exposure history may hamper 

the Department's ability to accurately assess future health 

issues. This lack of adequate exposure evidence is 

highlighted by the Department's experience with the 

Energy Employees Occupational Illness Compensation 

Program Act (EEOICPA) and potential legal issues 

surrounding incomplete occupational exposure data from 

past radiological work. As of the end of Fiscal Year 2006, 

the estimated future benefits payable to eligible individuals 

under the EEOICPA was $6.9 billion. 

RECOMMENDATIONS We recommend that the Administrator, National Nuclear 

Security Administration; the Under Secretary for Science; 

and the Assistant Secretary for Environmental 

Management, require field sites under their purview to: 

1. Ensure that restrictions are in place and develop a 

mechanism to enforce restrictions for those that 

have not complied with local testing regimens, 

including the creation of penalties for Work Permit 

violations; 

2. Develop mechanisms at the field project level to 

enable sites to accurately track an individual's 

radiological work activities and periodically 

perform a comparison of Work Permit sign-ins with 

work assignments; 

3. Correct existing deficiencies, verify and validate the 

effectiveness of system controls for bioassay 

program databases, and ensure that data entry into 

the database system is timely and accurate; and, 

4. Ensure that site-level bioassay requirements and/or 

procedures are validated through Federal 

management review activities. 

MANAGEMENT 

REACTION 

The National Nuclear Security Administration (IVNSA), as 

well as the Offices of Science (Science) and Environmental 

Management (EM) provided comments on the report. The 

NNSA generally agreed with the report and concurred with 

the recommendations. 

Science and EM indicated, in their consolidated comments, 

that they would work with contractors to assure that local 

testing regimens are clearly stated and are being 

Page 8 Recommendations and Comments 
AUDITOR 

COMMENTS 

accomplisl~ed; however, they did not agree with the basic 

tenet of the report and did not concur with any of the 

recommendations. Those Offices noted that Federal 

regulation does not specifically require bioassay testing, 

that such testing is optional, and that they would not 

compel employees to comply with contractor-established 

testing programs designed to help ensure the effectiveness 

of radiological controls if the employee chose not to do so. 

They based their position on the view that bioassay testing 

is a lagging indicator and that air monitoring, combined 

with radiation and contamination surveys, are the preferred 

options for verifying the effectiveness of protective 

controls. 

According to Science and EM, since bioassay monitoring is 

not exclusively required and is not the preferred method for 

verifying the effectiveness of engineering controls, 

recommendations 1 and 2 are not necessary. Management 

partially agreed with recommendation 3 and agreed to work 

with contractors to assure that the site-level procedures 

referenced in the report are clearly stated and are being 

accomplished. Science and EM believed that 

recommendation 4 was only applicable to IVIVSA. 

Management's comments are included in their entirety as 

Appendix 4. 

NNSA's comments and planned actions are responsive to 

our recommendations. We do not, however, consider the 

consolidated comments submitted by the Offices of Science 

and Environmental Management to be responsive. 

While the Office of Inspector General recognizes that 

bioassay testing for the class of individuals examined in 

this report is not specifically required by Federal 

regulation, neither are air monitoring and radiation surveys. 

Rather, contractors are required to develop a program, 

based on site-level work environments, to verify that 

workers are adequately protected. Our review focused on 

whether the confirmatory bioassay testing component of 

contractor-developed protection programs - a component 

sanctioned and funded by the Department for many years at 

considerable cost - was functioning as intended. We found 

that it was not functioning properly at the sites identified in 

the report. Each site had developed technical basis 

documentation and site-level procedures that outlined their 

Page 9 Comments 
bioassay programs and our recommendations were nleant 

to address issues with the implementation of these site-level 

requirements. 

We disagree with Science and EM that recommendation 4 

is only applicable to NNSA. The intent of this 

recommendation was to ensure that Federal management 

reviews over radiological protection, including bioassay 

monitoring, occur at all field sites. We believe that 

confirmatory bioassay programs at the Department's sites 

would benefit from such reviews and could help ensure that 

contractors are implementing site-developed bioassay 

programs. 

To address management's comments and to clarify that we 

evaluated the sites based on their contractor-developed 

procedures, we made revisions to the report as necessary. 

Page 10 Comments 
Appendix I 

OTHER MATTERS FOR CONSIDERATION 

The sites we evaluated during this audit could not identify how much they spent to 

implement their bioassay programs and could be paying more than necessary. The actual 

costs associated with providing bioassay services could not be determined and the sites' 

methods for collecting and analyzing costs of the bioassay program were ineffective. 

Each site had developed a unique method for tracking the costs of the bioassay analyses that, 

in many cases, did not capture the total costs associated with monitoring. Each of the three 

sites that used in-house programs could only provide allocated budget amounts rather than 

cost per analysis figures. Our examination revealed that the cost elements considered in the 

budget allocations differed from site to site and we were unable to determine what was 

included in each of the elements. For example, the Y-12 National Security Complex budget 

included labor, subcontracts, organizational burden, and supplies, while the Savannah River 

Site included only labor, non-labor, and services purchased from other site organizations. 

For the two sites that used contracted services, substantially different rates for analyses of the 

same isotope were to be paid. For example, in 2005, the Nevada Test Site's price for a 45- 

day turnaround was $140 per analysis for Americium, whereas, the East Tennessee 

Technology Park's price, on average, was approximately $320 per analysis. However, 

neither of these prices reflected the full cost of testing. For example, officials at both sites 

indicated that additional costs to collect and deliver the sanlples to the contract laboratory 

had been incurred, however, they were not included in the cost of providing bioassay 

services. 

The Department of Energy (Department) could not ensure it was administering its bioassay 

program in the most cost-effective manner because it had not required sites to perform a 

make-or-buy study, nor had it established a listing of cost elements that needed to be 

considered when conducting such studies. For example, only one of the sites could provide a 

documented, comprehensive cost analysis that could be used to determine the most 

economical method of providing bioassay services. The other sites either had not con~pleted 

a cost analysis or had conducted very limited reviews based on the support provided. 

Similar issues with costs were identified in In-Vitro Bioussu~v Services rzt Depurtrneizt of 

Eizergy Fcrcilities, (DOEIIG-0458, February 2000). The report found that bioassay analyses 

had not been obtained at the lowest prices available and recommended that the Department 

establish a cost schedule - a standard set of cost elements - to be used in determining the 

 no st efficient way of obtaining bioassay services and also assure that sites maintain 

sufficient cost records to evaluate program cost against the cost schedule. While the 

Department did develop a standard cost schedule in response to our recommendation, it was 

only applied to make-or-buy analyses and, as we noted, the majority of the sites we reviewed 

had not conducted such analyses. It is unclear whether the Department fully addressed the 

recon~mendation to require site contractors to maintain sufficient cost records. However, we 

believe that had the recommended actions been taken, managers would have a better idea 

how they compared to other sites and benchmarks could have been established. 

Page 11 Other Matters for Consideration 
Appendix I (continued) 

SUGGESTION FOR IMPROVEMENT 

The Department should revisit the recommendations made in our previous report and 

implement standard cost elements that would enable the sites to compare and analyze the cost 

of bioassay services and would perniit the preparation of comprehensive cost-benefit 

analyses. All sites that have the need for bioassay services should be required to analyze the 

costs of bioassay services using standard cost elements and maintain sufficient cost records. 

Page 12 Other Matters for Consideration 
Appendix 2 

OBJECTIVE To determine whether contractor-developed confirmatory 

bioassay programs were being administered in an effective 

manner. 

SCOPE We conducted the audit from January 2006 to May 2007 at 

Department's Headquarters in Germantown, Maryland; the 

Savannah River Site (SRS) in Aiken, South Carolina; the 

Nevada Test Site (NTS) in Nye County, Nevada; the East 

Tennessee Technology Park (ETTP), the Y-12 National 

Security Complex (Y-12), and Oak Ridge National Laboratory 

(ORNL) in Oak Ridge, Tennessee. 

In addition, we conducted audit work at the Tonopah Test 

Range in Tonopah, Nevada, and the Yucca Mountain Project in 

Nye County, Nevada. However, neither of these sites have 

routine bioassay programs, therefore, we did not include any of 

the inforn~ation from these sites in the report. 

To accomplish the audit objective, we: 

Selected a discovery sample of employees with routine 

access to radiological areas at selected sites; 

Analyzed bioassay requirements, appointments and test 

results for selected en~ployees; 

a Reviewed applicable Federal regulations, Department 

Orders, and other guidance related to bioassay 

monitoring; 

Obtained and reviewed internal dosimetry technical 

basis documents and site-level policies and procedures 

related to bioassay monitori~lg at selected sites; 

Obtained and reviewed Radiation Protection Programs 

at selected sites; 

Obtained and reviewed Noncompliance Tracking 

System reports and Radiological AwarenessIEvent 

Reports for selected sites; 

Page 13 Objective, Scope, and Methodology 
Appendix 2 

Held discussions with officials from SRS, NTS, ETTP, 

Y-12, and ORNL regarding the Department's bioassay 

monitoring program; and, 

Held discussions with Headquarters officials regarding 

site bioassay monitoring programs and programmatic 

responsibilities. 

The audit was performed in accordance with generally 

accepted Government auditing standards for perfomlance 

audits and included tests of internal controls and compliance 

with laws and regulations to the extent necessary to satisfy the 

audit objective. Accordingly, the audit included reviews of 

Department and regulatory policies, procedures, and 

performance measures related to the Department's Bioassay 

Program. We assessed performance measures in accordance 

with the Government Performunee and Results Act of 1993 and 

concluded that the Department had not established 

performance measures related to bioassay monitoring 

programs. Because our review was limited, it would not 

necessarily have disclosed all internal control deficiencies that 

may have existed at the time of our audit. We obtained and 

reviewed the computer processed data made available to us in 

order to achieve our audit objective. We validated the 

reliability of such data, to the extent necessary to satisfy our 

audit objective, by tracing it to source documents or other 

supporting information. Also, since bioassay databases formed 

the basis of most of the testing, we evaluated the input controls 

over these systems. 

Management waived an exit conference. 

Page 14 Objective, Scope, and Methodology 
Appendix 3 

PRIOR REPORTS 

Office of Inspector General Reports 

In- Vitro Bioassay Services at Departnzent of Enei-gy Facilities (DOEIIG-0458, 

February 2000). The report found that the Department of Energy's (Department) 

contractors did not obtain bioassay analyses at the lowest prices available. 

Although discounts were available under Department-wide subcontracts, two of 

the Department's contractors issued their own subcontracts for bioassay analyses 

with rates that were higher than the Department-wide rates. Also, three 

contractors paid substantially different rates for similar or identical analyses 

performed by the same subcontractor. These conditions occurred because the 

Department did not require contractors to use the Department-wide subcontracts 

and consolidate requirements into a single, cost-effective basic ordering 

agreement. As a result, the Department incurred unnecessary costs of about 

$495,000 during FYs 1998 and 1999. The report also noted that the audit team 

could not determine if the Department obtained bioassay analyses at the lowest 

prices available for 74 percent of the analyses reviewed because the three inhouse laboratories were not required to capture the actual cost of specific analyses 

performed. 

Audit of the Department of Energy's Conzmercial Laboi-atory Quality Assurance 

Evaluation Program (DOEIIG-0374, June 1995). The audit found that the 

Department's method of perfonning quality assurance evaluations of commercial 

analytical laboratories was not cost effective or efficient. Contractors at many of 

the Department's sites conducted multiple evaluations of the same conlmercial 

laboratory. In addition, methods used to perfom1 evaluations and report results 

varied among contractors. Finally, quality assurance evaluation results were not 

communicated to other contractors. These problems occurred because the 

Department's quality assurance policy guidance did not require development and 

implementation of a coordinated comn~ercialaboratory quality assurance 

program. The Department did not require contractors to coordinate efforts, 

develop unifonn standards and methods, or to conlmunicate the results of their 

evaluations to other contractors. 

Page 15 Prior Reports 
Appendix 4 

Department of Energy 

Off ice of Science 

Washington, DC 20585 

July 70, 2007 

MEMORANDUM FOR RICKEY R. IIASS 

ASSISTANT INSPECTOR GENFRAL 

FOR FIKANCIAL, TECHNOLOGY AND 

CORPORATE AUDITS 

OFFICE OF INSPECTOR GENERAL 

FIIOM 

OFFICE O G 

I 

SUBJECT: Response to Inspector General's Draft Repofi, "Confirmatory 

Bioassay Testing at Selected Sites" 

Thank you for the opportunity to review and comment on the draft report, "Confirmatory 

Bioassay Testing at Selected Sites." The following is a consolidated response developed 

bctwcen the Office of Science and the Office of Environmental Management. 

Bioassay programs for DOE contractors include testing that is mandatory, in compliance 

with DOE requirements, as well as testing that is discretionary and not required by DOE. 

The DOE requires mandatory bioassays for radiological workers who are likely to receive 

a committed effective dose equivalent of 100 millirem per year. This DOE requirement 

is found in 10 CFR 835.402. For perspective, there are only a small number of 

radiological workers who fall into this category, where bioassays are required by DOE. 

In addition to this mandatory bioassay testing requirement, DOE contractors are also 

required to verify the effectiveness of engineering and process controls for containing 

radioactive materials and reducing radiation exposures. This requirement is found in 

10 CFR 835.40I(a). To meet this requirement, contractors have the option of performing 

air monitoring in the workplace, radiation and contamination SUNeyS, and optional 

bioassays for additional employees who are not expected to receive a committed effective 

dose equivalent of 100 millirem per year. Of those options, additional employee 

bioassays arc not considered the first choice because they are a lagging indicator, and 

such bioassays are not required by DOE. 

The vast majority of employees who submit bioassay samples fall into this latter category 

of workers for whom testing is optional and discretionary, and not required by DOE. For 

the employees who are required to have bioassays, DOE enforces a very strict standard of 

care. For employees who are not required to have bioassays, DOE does not have any 

Page 16 Management Comments 
Appendix 4 (continued) 

reason to require that they continue with the testing if they choose not to, especially in 

light of the fact that the preferred alternative for verifying the effectiveness of 

engineering controls is to perform air monitoring in the workplace along with other 

radiation and contamination surveys. 

Management Response: 

DOE agrees that it is important to enforce a very strict standard of care for radiological 

workers who are monitored because they are expected to receive a committed effective 

dose equivalent of 100 millirem per year, and DOE expects its contractors to rigorously 

and proactively ensure that suitable restrictions are in place and enforced. 

The issues identified in this report relate to monitoring that is discretionary and not 

related to compliance with the DOE requirements for bioassay programs, as specified in 

10 CFR 835.401 (a) and 10 CFR 835.402. DOE will work with the contractors to assure 

that the discretionary procedures in the "local testing regimens" referenced in the report 

are clearly stated in site procedures and are being accomplished. 

Attached are the DOE responses to each audit recommendation. If you have any 

questions related to this response, please contact Barry Parks at 301 -903-9649 or 

barry .parks@science.doe.gov. 

Attachment 

cc: Joni Boone, EM-43 

Richard Speidel, NA-66 

Merley Lewis, CF- 1.2 

Robert Goldsmith, EM-62 

Robyne Johnston, HS- 1.23 

Page 17 Management Comments 
Appendix 4 (continued) 

Attachment 

SC and EM Management Response to Recommendations: 

Recommendation 1: Ensure that restrictions are in place and develop a mechanism to 

enforce restrictions for those that have not complied with local testing regimens, 

including the creation of penalties for Work Permit violations. 

Management Response: DOE agrees that it is important to enforce a very strict 

standard of care for radiological workers who are monitored because they are expected to 

receive a committed effective dose equivalent of 100 millirem per year, and DOE expects 

its contractors to rigorously and proactively ensure that suitable restrictions are in place 

and enforced. However, DOE non-concurs with this recommendation, because it is not 

related to compliance with the DOE requirements for bioassay programs, as specified in 

10 CFR 835.401 (a) and 10 CFR 835.402. The procedures in the "local testing regimens" 

referenced in the report are strictly discretionary on the part of the contractor and are not 

required by DOE. The ability for DOE to enforce compliance with either statutory or 

contractual requirements is already in place through the use of civil penalties andlor 

contractual fee reductions. Any Work Permit violations which result in noncompliance 

with DOE requirements would be managed with these existing enforcement mechanisms. 

Because there is no issue with meeting DOE requirements, no corrective actions will be 

taken. 

Recommendation 2: Develop mechanisms at the field project level to enable sites to 

accurately track an individual's radiological work activities and periodically perform a 

comparison of Work Permit sign-ins with work assignments. 

Management Response: DOE is committed to ensuring that accurate records are kept 

for documenting occupational doses, and contractors are expected to comply with DOE 

requirements as set out in their Radiological Protection Program. However, DOE nonconcurs with this recommendation, because there are a number of acceptable mechanisms 

for accomplishing this goal. As long as the contractors can demonstrate compliance with 

the DOE requirements for bioassay programs in 10 CFR 835.401 (a) and I0 CFR 835.402, 

there is no benefit for specifying the exact mechanisms for doing so. No corrective 

actions will be taken for this recommendation. 

Recommendation 3: Correct existing deficiencies, verify and validate the effectiveness 

of system controls for bioassay program databases, and ensure that data entry into the 

database system is timely and accurate. 

Management Response: DOE expects its contractors to take proactive measures to 

ensure that databases and other recordkeeping and scheduling tools maintain accurate 

dosimetry records, for those workers being monitored as required by 10 CFR 835.40I(a) 

and 10 CFR 835.402. DOE partially concurs with this recommendation, on the basis that 

all of the database issues identified in the report are in regard to bioassays that are strictly 

discretionary on the part of the contractor and are not required by DOE. 

Page 18 Management Comments 
Appendix 4 (continued) 

Action Plan: The issues identified in this report relate to monitoring that is discretionary 

and not related to compliance with the DOE requirements for bioassay programs, as 

s~ecified in 10 CFR 835.401(a) and 10 CFR 835.402. DOE will work with the >, 

contractors to assure that the discretionary procedures in the "local testing regimens" 

referenced in the report are clearly stated in site procedures and are being accomplished. 

Estimated Completion Date: DOE will complete this action plan within one year from 

issuance of the report. 

Recommendation 4: Ensure that site-level bioassay requirements and/or procedures are 

validated through Federal management review activities. 

Management Response: This recommendation was specific to NNSA sites and 

NNSA's response is under a separate cover. No corrective action will be taken for EM 

and SC sitcs. 

Page 19 Management Comments 
Appendix 4 (continued) 

Department of Energy 

National Nuclear Securlty Admlnldration 

Washington, DC 20585 

FROM: 

SUBJECT: 

MEMORANDUMM FOR Rickey R. Hass 

Assistant Inspector (ieneral 

Director 

Policy and Internal Controls Management 

Revised Comments to Draft Confirmatory 

Bioassay Testing R~port; AO6PT015/2006- 

020 16 

The National Nuclear Security Administration (N\ISA) appreciates the 

opporhmity to provide revised comments to the h.spector General's (IG) 

drafl report, "Confirmatory Bioassay Testing at Sclected Sites." NNSA's 

original comments stated that we did not agree wrth the premise of this 

report as we understood it. After discussions with several of your 

auditors, NNSA is revising its comments to the draf? report. 

NNSA appreciates the IG commenting on the facl that the Y-12 complex 

is testing individuals in accordance with its site-1c:vel procedures. These 

site-level procedures are above and beyond what is required in the Code of 

Federal Regulations for bioassay programs. l'herein is the premise for this 

report as we now understand it, to determine wheher the site specific 

confirmatory bioassay programs are being administered in an effective 

manner. 

NNSA generally agrees with the report and its cc:~rresponding 

recommendations. NNSA will further evaluate what its next steps should 

be to implement corrective measures andlor monitor efficient operations. 

Wc will provide quarterly status reports, as necessary, until such time as 

the IG and NNSA agree that corrective actions ue complete. 

Should you have any questions about this response, please let me know 

cc: Frank Russo, Senior Advisor, Environment, Safety and Health 

Karen Boardman, Director, Service Ccntr:r 

David Boyd, Senior Procwement Executive 

Page 20 Management comments 
1G Report No. DOEIIG-0773 

CUSTOMER RESPONSE FORM 

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