# Presentation: 139408

## 

Confirmatory Bioassay Programs
A Discussion of the August 2007 IG Report

Sandy Hyman
Idaho Cleanup Project
Ch2MHill-WGI, LLC

**Confirmatory Bioassay Programs**
**A Discussion of the August 2007 IG Report**
**Sandy Hyman**
**Idaho Cleanup Project**
**Ch2MHill-WGI, LLC**

## Inspector General Report

**“****Confirmatory Bioassay Testing at Selected Sites” (DOE/IG-0773, August 2007)**
- _[http://](http://ig.energy.gov/)__[ig.energy.gov](http://ig.energy.gov/)__[/](http://ig.energy.gov/)_

## Context

**Context of “confirmatory”**
- Second of a two tiered approach
- First tier is for “relatively few workers with significant exposure risk”
- Second tier is “confirmatory bioassay testing” which is one component of a program that the contractor **may** use “to ensure that controls are effective in reducing exposures to radioactive substances..... when significant exposures are not expected”.
- Specific components are at the **discretion** of the contractor.
- All of the site contractors audited required confirmatory bioassay testing as a part of their program.
**Context of audit**
- “Prior Office of Inspector General reviews have identified problems regarding the cost-effectiveness and efficiency of the Department’s bioassay monitoring program.......this audit [was] to determine **whether contractor-developed bioassay programs were effectively administered**.”

**Notes:**
In the cover letter to the secretary

Most contractors rely on confirmatory bioassay testing, continuous air monitoring, and radiological surveys.

DOE regulations state that site contractors must develop their own method to verify the radiological engineering and administrative controls are effective in preventing radiation exposure.

## Roll-up of Audit Results

**Contractors had not ensured that all personnel that had regular access to radiological areas were being monitored in accordance with established site level requirements.**
- Testing and methods used to track potential exposures did not conform to contractor developed procedures.
- Identified problems with the timing and sufficiency of tests and maintenance of work history and potential exposure records.
- Some workers were not tested at the prescribed frequency and some workers were not tested for all the potential hazards to which they may have been exposed.

## Break-down of Audit Results

**SRS & Y-12**
- Individuals were being tested in accordance with site-level procedures
**Oak Ridge National Laboratory**
- 16/24 of workers 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.
- Record keeping problems, missed appointments were not rescheduled or were delayed
**East Tennessee Technology Park**
- 9/34 of the radiological workers were not tested at the frequency prescribed for all of the isotopes for which they may have been exposed.
**Nevada Test Site**
- For 7/30 of the workers required documentation was not available to demonstrate whether or not they were enrolled in the  bioassay program (appeared to be inadequate radiological work history to support being enrolled in the bioassay program)
- Some workers were not selected for testing even though they were enrolled in the bioassay program

**Notes:**
ORNL – one individual (scientist) cancelled 29/31 scheduled appointments for bioassay testing

## IG Report 

**Cause(s)**
- Site level controls designed to ensure workers complied with bioassay requirements and methods used to select individuals for testing were not always effective.
- Site officials stated that much of the responsibility for compliance with the bioassay program requirements rested on the individual and few, if any, sanctions were applied if an individual did not comply.
- Bioassay program document states that full participation in the confirmatory program is not required but did not specify what was an acceptable level of participation
- IG was concerned that at least one individual from each Radiation Work Permit was not being tested therefore “...a risk exists that exposures could be undetected for a particular work activity”.

## IG Report 

**Cause(s)**
- Methodologies used to select individual workers for testing did not always ensure that all employees received needed tests.
- Process for selecting employees to participate was supposed to be based on employees with the greatest chance of exposure but was sometimes based on employee’s willingness to submit a sample.
- Process for selecting employees to participate based on a rotating basis vs. prescribed frequency in RWPs.
- Selection for participation into the bioassay program was based on an “informal” selection by the health physicist vs. actual Work Permit sign-ins therefore “individuals that have performed work in radiological areas might never be entered into the bioassay program”.

## IG Report 

**Cause(s)**
- Problems with the accuracy and maintenance of site-level bioassay databases contributed to selection, monitoring, and enrollment problems
- Work permit sign-ins were not always uploaded in a timely manner, therefore delaying scheduling of bioassay appointmentes (leading to delinquent bioassay monitoring)
- Some isotopes were not added to individual bioassay monitoring profiles for testing
- A corrupted personnel data file caused an employee that should have been considered for testing to be excluded from bioassay monitoring
- Employees were not automatically removed from bioassay program when monitoring was no longer necessary
- Database does not track historical changes

## IG Impact Statement(s)

- “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.”
- “...the lack of accurate exposure history may hamper the Department’s ability to accurately assess future health issues....(as demonstrated by the Department’s ) experience with the EEOICPA and potential legal issues surrounding incomplete occupational exposure data from past radiological work.  As of the end of FY2006, the estimated benefits payable to eligible individuals under the EEOICPA was $6.9 billion.”

## IG Recommendations

- 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
- 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
- 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
- Ensure that site-level bioassay requirements and/or procedures are validated through Federal management review activities

## Federal Reaction 

**National Nuclear Security Administration (NNSA)**
- “Generally agreed with the report and concurred with the recommendations”
**Office of Science & Office of Environmental Management **
- “....would work with the site contractors to assure that local testing regimens were clearly stated and are being accomplished, however, they did not concur with the recommendations”
- “....**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.”
- “.....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.”

## IG Response to Federal Reaction

- “While the Office of Inspector General recognizes that bioassay testing for the class of individuals examined in this report **was not specifically required by the 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.”
- The review focused on whether or not the confirmatory bioassay programs at the sites were functioning as designed and found they were not.

## EFCOG Discussion

- Why do we continue to rely on confirmatory bioassay programs as a part of our radiation protection programs to demonstrate the effectiveness of engineered and administrative controls?
- Costly to administer
- Approximately $800K / year for INL bioassay program
- Even with outsourcing analyses, still maintain 4.3 FTEs to provide technical oversight, pick up of samples, packaging and shipping, review and upload of data, and general administration of program
- Inherent difficulties associated with calculating dose
- Not very popular with employees
- Internal dose (regardless of the magnitude) is very personal to most employees
- Which site will offer up their program as the model of worker safety, regulatory compliance balanced with cost effectiveness? (Please call me at 208-351-9818).