Confirmatory Bioassay Programs

1

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

2
Inspector General Report

• Confirmatory Bioassay Testing at Selected Sites
  (DOE/IG-0773, August 2007)
• http//ig.energy.gov/

3
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
  Departments bioassay monitoring program.this
  audit was to determine whether
  contractor-developed bioassay programs were
  effectively administered.

4
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.

5
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

6
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.

7
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 employees 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.

8
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

9
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 Departments ability to accurately
  assess future health issues.(as demonstrated by
  the Departments ) 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.

10
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 individuals
  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

11
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.

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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.

13
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).