Program (FUSRAP) site did not find widespread contamination, probably due to the use of

the salt bath. For conditions related to dose, those likely compensable are lung cancers in

nonsmokers, and skin cancers are compensable. Kidney cancer may be compensable.

Ziemer: Will the methodology account for the greater chemical than radiological toxicity of

natural uranium? Yes, but that pertains to a Sub-part D claim, not this task.

Melius: So ORA U went through a number of the A WE sites to develop the site profiles?

Yes, and four more sites are still in development. Mr. Elliott added that these were chosen

according to the number of claims to date, in order to have the maximum impact of

addressing the "low hanging fruit" (e.g., this site had 300 claims) while building and testing

the models.

Griffon: How are the DOE site profiles likely to differ from those of the AWEs? Dr. Neton

said that most DOE sites will have personal monitoring data as well as processing data.

That can flesh out these profiles, which are now mostly based on whole-year data. Dr.

Toohey added that ORAU is creating look-up tables for processes and x-ray exposures, as

well as the minimum detectable limits for sites. For example, Hanford, Rocky Flats, the

NTS, etc., were major plutonium facilities. Those lookup tables are necessary to do dose

reconstructions for people who had biomonitoring done.

PubHc Comment

Ms. Jeannie Cisco (phone 740-289-2045) was employed at the Portsmouth Gaseous Diffusion

Plant (GDP), and is a compensation representative for the PACE Union Local 5-689. She works

in the PACE Medical Protection Program and assists the members' EEIOCP A claims. She

reported the concerns of claimants with the interview process. PACE advised the claimants to

prepare written answers before the phone interview to ensure that the most information could be

provided as accurately as possible. One person did so and spoke to the interviewer for about 3

hours in the first interview. He was pleased with the interviewer's patience and attention, but the

draft report was overly condensed and held inaccuracies. The interviewer was clearly not

familiar with the processes. When the person called to complain, he was told by the interviewer

that the computer only had so much space for answers per question asked. He then contacted

Ms. Cisco's office and they tried to condense his written answers. The second interview was 45

minutes long. Comments provided were included, but there were still incomplete sentences and

inaccuracies (e.g., coal recovery versus cold recovery).

Ms. Cisco urged that NIOSH tape interviews with the claimants' pemrlssion in order to ensure

max.imum accuracy. Clearly, she thought an audit to be needed by the ABRWH to ensure QC

and mid-course corrections as needed. She advised that the claimants be allowed to itemize the

records needed, and felt that the claim fonn is problematic for widows/widowers, whose spouses

were not allowed to discuss processes with their families.

Mr. Greg Malone, ofLoca1252 of the National Chemical Workers Union, represents the Center

for Worker Safety Information. This is funded by a DOE grant and conducts health and safety

training; he is a coordinator. He stated that asking an 80-year-old woman what her husband did

is contrary to the reality of the culture. In the 40s and 50s, anyone who said they worked at Oak

Ridge was not asked any other questions.

9
He had heard Dr. Tara O'Toole, a DOE Assistant Secretary, testify to Congress that DOE

monitoring results were "junk." He agreed, noting that Y-121s air monitoring was done 8-121

above the floor, and only in the mid-1980s was lowered to the breathing zone. After that, "the

counts went sky high." He also asked how the fact could be addressed that in the 1940s and

1950s, workers were routinely told to leave their dosimeters outside when working on a "hot"

job. He asked how the perception can be avoided that the "fox is still guarding the hen house?"

DOE is still providing the data and funding the process. In fact, in Mr. Malone's opinion, DOE

should be the one required to prove they did no hann, not the claimant that they did.

Dr. Ziemer recalled that one member of the public said at a previous meeting that claimants had

to provide the data, although it was clarified that they do not He appreciated the good points

raised, which have had been discussed by the Board before. The dose reconstruction processes

are trying to gather supplementary data to address those issues.

Dose Reconstruction Workgroup Report/Changes Made

Mr. Mark Griffon, Chair of the Dose Reconstruction Workgroup, reviewed the three documents

discussed by the workgroup and by the Board during the December conference call. The latest

draft (January 2003) reflected the changes made in the Workgroup and the conference call. He

outlined those that were major.

Attachment A, Request for Contract

. Page 3: A reference value will have to be added to Project Planning.

To Section H, "The review panel will present heir justification for contractor(s) selection to

the Board prior to the contract award" was added.

Section P, page 4: Definition of the technical panel members was left open except for one

advisory Board member. Also discussed was whether among the other members should be

a representative from other federal agencies as well as NIOSH. Mr. Elliott clarified that

one OCAS staff member will be on the review panel as well as others from other federal

agencies (not DOE) who are trained in contract procedures. Panel members other than the

Board member will not be identified, but their affiliation may be identifiable. Mr. Elliott

agreed to check on whether the latter is possible.

Attachment C

. Page 3, Section A: Text included the projected breakouts of expected cases to review rears

one through five.

Page 5, Section 2b: Mr. Elliott asked that the phrases added on re-interview be removed,

because that would require at least the Department of Health and Human Services (DHHS)

and possibly OMB clearance before the program could proceed. Even adding "pending OMB approval II would still require OMB and/or DHHS approval.

c Griffon: The ABR WH should commit to proceed with this, at least in principal, because

if not included here, it may not be done. The current plan is only to review the summary

form of the interview rather than whether the interview itself captures everything

10
accurately and sufficiently. Ziemer: Perhaps a third, non-specific, point could be

included, requiring the contractor to assist with other work in the future to evaluate the

process.

D Mr. Elliott appreciated Ms. Cisco's comments related to this question, and wished they

had been brought directly to NIOSH. The survey instrument and interview approach

were fully vetted in DHHS and were designed to capture all information, even

acknowledging the site secrecy that was cited in public comment. There are three

interview forms, and the one for survivors also asks about co-workers who could add

information. Among the process tools are a follow-up report, a final review by the

claimant, and their signing of the OCAS-l form. NIOSH welcomes an audit of all these

procedures, and can implement such new procedures after the OMB clearance is in place.

D Andrade: Taping the interviews seems advantageous. Would a comparison by an

auditing body of the tape to a transcript/report require OMB clearance? Elliott:

Whether OMB clearance is required depends on whether there are changes in the

questions, going back to the interviewee, etc. These considerations led to NIOSH's

decision to not tape.

D Andrade: Then, perhaps it would be more practical for both the interviewer and the

auditor to summarize what they thought they heard and compare those for accuracy.

Any discrepancies would prompt a follow-up phone call to the interviewee to straighten

that out. Mr. Elliott found this suggestion to have merit. This would be part of the

follow up to ensure that the information needed is in hand to pursue the claim, and not

require OMB clearance. Such methods are more practical than requiring a follow-up

audit to all interviews.

D Melius: However, the issue is that NIOSH chooses the contractor to review NIOSR If

the RFP does not specify follow-up interviews, but that task is added later, would that

require OMB approval? Any task requiring an additional burden or time commitment

from the public will require OMB approval.

D Ziemer: What constitutes an audit requires clarification; it is not a re-interview with

different questions. It must be ensured that the ABR WH does not end up doing the work

of the auditor or the agency itself. Mr. Griffon supported the generation of a transcript.

D Melius: The current QC plans, of having a supervisor liSten in occasionally and

informally, are not adequate. It is independent of the ABR WH' s process, but that process

still should be examined in more detail and improved. He was uncomfortable with

substituting that for this Board's review. He asked the Board to agree whether 1) the

interview process should be reviewed by the ABRWR and 2) how and when that should

be done (e.g., transcript, with or without follow up interview,. and after the record is

developed or at the time of the initial interview?) "and 3) how to implement that, while

allowing NIOSH to proceed with the RFP. For example, consideration is needed of

whether the contractor has the necessary expertise to oversee the interview process.

D Dr. Andrade strongly suggested, if supervisors will be listening in randomly, that the

supervisor and interviewer independently transcribe their summary of the interview

(while redacting Privacy Act material). This should allow the OMB process to be

completed quickly.

D Dr. Anderson thought that this would not require altering the Task Order. He suggested

extending Task #1 with "or other evaluation mechanisms which would not increase the

11
time needed," or whatever the exclusionary phraseology would be. An independent

auditor sitting in on the interview would not affect the claimant's time, nor would tape

recording it. Those suggestions, or some other language (along with these meeting

minutes), should indicate to the contractor the basis on which to estimate. He thought

Item #1 to be overly restrictive and not even include auditing the independent record. If

the only way to properly audit is a re-interview, that can be approached at another time.

D Dr. Ziemer expected that an independent listening-in by a Board member, separate from

the audit and before the dose reconstruction itself is done, could focus on the process

rather than the particular case, to identify shortcomings in the process.

D Melius: Include a task for the contractor to develop a process. for submission to the

Board. to evaluate the interview process. Mr. Elliott responded that this is not the Task

Order itself, but just a description for the bidders. The proposal would not have to bid on

it, but would need to factor in the required expertise of technical personnel to respond to

that. Once the Board has a technical consultation contractor in place, then the Task

Orders will be developed and negotiated with the contractor.

Resolution of the question. Dr. Ziemer suggested, to general agreement, deleting the

last half of the sentence and inserting a period after "history of information" in PageS,

2.Bl. This was to be done by Mr. Griffon after this document review.

Page 6, Section B; page 7, Section C: The numbers of cases projected were deleted. The

estimated dose reconstruction reviews for individuals, but not site profiles, were inserted.

Dr. Neton noted the need, for the procurement, to provide numbers for all years if numbers

are provided for year one. Those could be reinserted before this meeting's end, as Mr.

Griffon had already estimated them.

Mr. Elliott advised also for Page 7, C-4, Task Orders, after sentence one, inserting the

critical staff needs expected (e.g., for evaluation of survey instruments or for an expert

on program evaluation), or "See attachment A, Personnel Requirements."

Attachment A: Technical Evaluation Criteria

. Section A, Personnel, should be edited as just discussed.

Section E was modified in terms of the time allowable since DOE work was done, and key

personnel are defined at the bottom of page 4.

Roessler: The work history (page 4, paragraph 2), "while performing with NIOSHt ORAU

or "teaming partners,t is too vague and should be more specific. Make this the "two

primary teaming partners;" the procurement officer can name the corporations or insert the

contract numbers. For example, ORAU has contracts for similar work not pertaining to this

project at all.

0 Mr. Griffon stated that the original intent was to be more restrictive about work with

NIOSH or ORAU, as with DOEt to ensure the project's credibility to the public.

0 Dr. DeHart objected that such excluded work could be one lecture delivered at ORAU

four years earlier, or someone doing work with funding channeled through ORAUt but

not actually done directly for or by them (e.g., training done oversees).

12
a It was agreed that the emphasis should be on disclosure. For example, insert "If work

was done and those doing the work are included on staff, provide justification of why

they are included."

a Mr. Elliott cautioned that this could exclude people who otherwise could develop a great

proposal. Mr. Griffon thought that the justification should resolve that, but the minimum

requirement could block out such people.

a Dr. DeHart asked if experts testifying for employees of AWEs would also be exclud~

being concerned about excluding experts on only one, side. His experience with

compensation claims indicated that experts can disagree based on the same data, so

excluding an entire viewpoint would skew objectivity. While the problem pertaining to

individual claim cases had been resolved by the Board (experts just could not review any

case in which they had testified), the problem facing class action suits still required

resolution.

Review of Methods and Procedures

After a short lunch break, the discussion continued. Mr. Griffon noted that Task #1 in

Attachment C had originally been to review methods and procedures, but this was rolled into the

individual dose reconstruction review component. That was done because this review mostly

pertained to the individual case audit process rather than that overall, particularly in the initial

absence of real data/cases. It remains in the individual case approach. But he had reconsidered,

since this also pertains to the path taken by NIOSH/ORAU. It would add value by independently

reviewing the methods and procedures to establish an early baseline. The only intent is to

establish a baseline and set an early understanding of how NIOSH/ORAU are approaching

things. The EEOICPA statute itself also calls for review of the methods and a sampling of the

cases, but this should be carefully bound to avoid great expense.

He suggested that this overall review be reinserted into Task #1, to enable a cost effective initial

review. Aside from the individual case reviews, this could serve as the baseline of the NIOSH

and contractor dose reconstruction process and allow resolution of any basic disagreements

before many cases are adjudicated. It was currently a component of Item A, or it could be on

page 4 under C-3. A handout distributed at this meeting proposed an 8-item methodology to

review NIOSH and the contractor's methods/procedures (ee Attachment #2 to this report).

Discussion with Mr. Griffon included:

. Andrade: The tasks as stated are quite general. The Board could appear to be second

guessing what the experts themselves had developed. and the IREP and methods to address

individual cases had been shown to be as claimant-friendly as possible. Finally, many if

not most of the methods in the current processes had been presented to the ABR WH, many

members of which also are experts, who agreed that these were the best methods for the

analyses. This may go beyond the realm of auditing and approach second guessing. On the

other hand, Mr. Griffon pointed out that reinserting it could also eliminate any second

guessing since is done up front. He also clarified that this was not intended to second guess

IREP or any other underlying level of the current approach. . Ziemer: The procedures and questionnaires for the work history phone interviews have not

yet been reviewed either. His sense was that the workgroup was not questioning the

13
approaches used, but whether those already described were being used. Mr. Griffon

responded that the internal/external implementation guidelines address how, for example, a

missed dose would be handled. This does not preclude individual case approaches that

might have to differ, but would be only a generic review of the protocols (e.g., one question

may be whether it is always sensible to assign an Minimum Detectable Activity (MDA)

model).

Melius: Any review process involves some second guessing, but the Board should not

revisit issues already addressed. This should be a carefully specified review of the

application of the developed guidelines and procedures. Any identified vagueness or areas

of potential uncertainty or disagreement could then be brought by the contractor back to the

Board for resolution. This could be helpful to the overall review process, ensuring

consistent application of these procedures, and would be more efficiently done up front.

Roessler: Clarity on the intent is necessary, to avoid interpretation by potential bidders that

this could invite assessment of whether the proper ICRP guidelines are being used. But Mr.

Griffon responded that, while the use of the proper ICRP model could be assessed, whether

or not to use an ICRP model would not be. But these tasks also were deliberately broadly

defined, as they only serve as place holders, since this work is not something that would be

bid on in Attachments D and E. Nonetheless, it will need to be carefully bound in any

actual Task Order.

DeHart: Agreed, the bidding contractor will have to understand the methodologies and

procedures to bid. But should this be called an audit or report? Dr. Ziemer noted that a

review for familiarity differs from an audit review.

Anderson: Add these issues to the first paragraph; especially the last part: '"to achieve

consistent application of the requirements of 42 CFR 82." Then, just drop the listed tasks.

Elliott: This was addressed in the early Board deliberations and in the workgroup, and the

scope of work's items for the three reviews (basic, advanced, and blind reviews), call for

address of any deficiencies. Additionally, a single review will not be sufficient. As the

A WE technical guideline is developed, the review contractor will have to do several

"snapshots in time" based on accumulated experience.

Dr. Neton agreed. The program is essentially keeping one step ahead of the dose

reconstruction process; every possible scenario cannot be predicted. This is not a mature

program that can be reviewed for a full fleshing-out of tables, etc. No contractor has ever

done this kind of work, which is very different from regulatory-based or research dose

reconstructions, although those can give the bidders some idea of the procedure. The first

pass-through will look at a small set of the ultimate overall number of procedures, and the

Board can pick the cases for review (low- versus high dose, etc.) and "road test" those.

Melius: Take paragraph 1 and move it into the individual dose reconstructions, making it a

second or third paragraph under the existing item A. The Task Orders then could direct the

contractor to avoid unnecessary or too-early reviews and time/target the reviews most

appropriately.

Elliott: Change "determine" to "evaluate.." and later in the sentence, insert "whether"

before "there are sufficient procedures..."

Andrade: Or, insert a piece of last sentence into the provisions, addressing "whether the

procedures in place are sufficient to achieve consistent application of the provisions of 42

CFR." But this also is a secondary function, part of the audit. An audit is done by an

14
independent body to see how well the program is being done. The question is whether the

Board will hire someone to do an audit (which he favored) or some other function. If an

audit is done, he advised doing one comprehensive one, reviewing all the books rather than

just one dose reconstruction or procurement. Audits are based on data arriving after the fact

- e.g., reviewing two sets of transcripts of interviews in random fashion, choosing cases

that are reflective of the number of cases coming from different sites. This is not to be

confused with the QA function of the OCAS and ORAU supervisors. Finally, the OCAS

dose reconstruction team leader is responsible for consistency of approach. That should be

taken advantage of, ensuring that the Board is kept up to date. The focus should be on

issues that need address, not those handled in other ways.

Anderson: This seems to be only spot where cross-program consistency is addressed, such

that the procedures in place are documented and maintained in a continuing program that

will inform the address and resolution of any future ambiguity found. Drs. Andrade and

N eton agreed; these will be dynamic procedures that will develop over time. Being

fundamental and consistent with the legislation, they will probably not change wildly, but

some change is probable as specifics arise, not all of which can be documented.

Melius: If the contractor, in reviewing the procedures, raises an issue (e.g., the absence of a

procedure to deal with a specific in a consistent manner) that has not risen in the first 2000

cases, that should be just a point to note, not a deficiency in the audit.

Munn: In the absence of precise language, Ms. Munn agreed with Dr. Andrade that overly

prescriptive text should be avoided, which could establish criteria for a project that has

never been done before. It would be hard to identify how many actions the auditor might

be asked to undertake without defining what a full scale audit would involve.

Board Discussion/Working Session to Review All Documents

In a complete review of the documents, the Board commented on each section, as follows:

Requestfor Contract: No further changes were suggested to the document The following

Executive Session of the Board will insert the dollar amounts, and the Board member will be

appointed to panel along with the OCAS project officer (Dr. Neton).

Attachment C: Statement of Work

C.!: ~se of Contract: no changes

C.2: Backg!:ound and Need: no changes

C.3: Contract Tasks

Component # 1: Individual dose reconstructions

Section A: Dr. DeHart moved to insert after paragraph one, as a separate paragraph, text

then read by Mr. Elliott: "The contractor shall review all relevant dose reconstruction

methodologies and/or procedures employed by NIOSH and NIOSH contractors in

conducting individual dose reconstructions in SEC petitions. The contractor shall

15
evaluate whether the methodologies and procedures are consiftent with the requirements

under 42 CFR 82, and whether there are sufficient procedures to achieve consistent

application of the requirements in 42 CFR 82."

The motion was seconded by Dr. Melius. There was no further discussion other than Mr.

Griffon's remaining feeling that it may be confusing to place this under individual dose

reconstruction review. He still preferred this as a separate task. In a vote, the motion was

unanimously approved, including by Ms. Munn on the telephone link.

Other considerations were:

. DeHart: From where did the estimated case review numbers in C.3.A the current paragraph

2, now paragraph 3, come? Griffon: These came from discussions with Dr. Neton and

NIOSH staff, after which he adjusted the first year's expectations down considerably. Dr.

Neton added that, if this process parallels the ORAU ramp-up, the realistic number of cases

is expected to be less than the 8000 for year one.

. Dr. Andrade proposed again dropping the basic, advanced, and blind reviews, and instead

having the contractor conduct a complete audit to determine the adequacy and correct use

of the date and performance of the dose reconstruction. The points of the discussion

included:

- Anderson: A comprehensive audit might break the budget; doing a statistical sample

could accomplish the intent.

- Ziemer: The whole data base is available for audit and the ABRWH is the auditor, helped

by a contractors to determine whether sampling 2% or 50% is an adequate sampling size.

All the cases cannot be done.

- Andrade: Agreed; base it on the number of claims from each site. But do a

comprehensive study of each element of whatever cases are chosen. - Melius: After the first year, the Board can review whether the number audited is

satisfactory. This would start the process, and later on it can be determined how the

sampling will be done. This could be discussed during the selection process, but in the

meantime, this the personnel that might be needed could be indicated.

- Ziemer: Add: These percentages are subject to change by the advisory Board based on

its experience with the review process.

Item C, 5d: Change the text to data .. are" here and consistently throughout the document.

Advanced Review.

D B.1: End the sentence after the work "information" and drop the comparison ofNIOSH

OCAS work history with the interview report. No objections. Griffon: Less specificity

is acceptable here but he hoped, after this document was done, to discuss those specifics.

He will edit att-8chments D&E to reflect this change.

Component #2, maSH OCAS site and worker Rrofile reviews.

. Add an additional paragraph to cite the number of worker and site profile reviews (five and

5, respectively, in year one; 4 and 4 in years 2 and 3; and 3 and in year 5). This will total

-100/0 (32) of all covered facilities (-300). No objections . Again, correct the gram_mar to "are ... data appropriate"

16
Component #3, Review ofSEC Petitions (place marker, as no SEC rule is yet in place).

. Inserting the number of petition reviews per year of the contract was discussed, or text

about the number "to be detennined by the Board." However, this is not necessary in this

document; and since the process/procedure remains unknown, it was agreed by consensus

to drop the numben in the absence of the Rule.

Component #4, Task Orders

. Insert "See Attachment A" after "the required work" in paragraph one.

. Item f: delete "of is projection"o

Component #5:PreRaration of Reports: No changes

Dr. Melius moved to approve Attachment C and Mr. Espinosa seconded the motion. In a vote,

aU Board members were in favor of the motion and none were opposed or abstained.

Attachment D: Example of Basic Individual Dose Reconstruction Review

Mr. Griffon expressed concern that this attachment provides insufficient information for the

bidders to respond. Dr. Neton clarified that what is being evaluated is their approach, more than

the cost estimate (i.e., NIOSH assigned points to expertise of staff, approach, etc.). A bidders

conference call could be held to address any such questions, and they also can state their

assumptions (e.g., a 5-page versus a tOO-page report). The most qualified bidders will

understand the types of sites, and CDC's Procurement Office advises against including too much

information in order to be able to assess what the bidder intuitively or by experience knows.

Dr. Anderson moved to adopt Attachment D with no changes, and Dr. DeHart seconded the

motion, which passed unanimously with no abstentions.

Attachment E, Example of Advanced Individual Dose Reconstruction Review.

Dr. DeHart moved to accept Attachment E with the following edit: insert a period after

'infonnation' in B.l and dropping the rest of the sentence (as done for C3, Advanced Review).

Dr. Andrade seconded the motion, which was unanimously approved with no abstentions.

Attachment A: Technical Evaluation Criteria

A. Personnel changes discussed were:

. Add an Item 7 after "6) evaluating contradictory records", to state: "7) program evaluation

expertise related to health surveys" and then continue with "evidence of this..." Agreed to

by consensus.

Roessler: Does text at the end of paragraph 2 on DOE Q clearance conflict with Section

E's minimum of2 years of non-DOE work by key personnel. Mr. Gibson responded that

this pertains to U.S. government clearance after a background check. Dr. Andrade noted

that there are many different types ofQ clearances: DOE and their contractors are cleared

7