ML20036D282

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Summary of 960131 Meeting W/Representatives of WPPSS Representing Members of Utilities Service Alliance to Discuss Proposed Approach for WPPSS to Conduct Initial Screening Tests of Urine Specimens Sent by USA Members
ML20036D282
Person / Time
Site: Palisades, Fermi, Wolf Creek, Cooper, Columbia, Crystal River, Clinton, Big Rock Point, Fort Calhoun  File:Consumers Energy icon.png
Issue date: 02/01/1996
From: Liza Cunningham
NRC (Affiliation Not Assigned)
To: Crutchfield D
NRC (Affiliation Not Assigned)
References
NUDOCS 9602060390
Download: ML20036D282 (17)
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Text

{{#Wiki_filter:.: & $t4kl F A fa a549 p+. i UNITED STATES E NUCLEAR REGULATORY COMMISSION I WASHINGTON, D.C. 20565-0001 \\,.g.,/ February 1, 1996 MEMORANDUM TO: Dennis M. Crutchfield, Director I Division of Reactor Program Management / Office of Nuclear Reactor Regulation, / i FROM: LeMoine J. Cunningham, Chief 'g Safeguards Branch Division of Reactor Program anagement Office of Nuclear Reactor Regulation

SUBJECT:

SUPtiARY OF MEETING REGARDING ONSITE DRUG TESTING On January 31, 1996, the NRC staff conducted an open meeting with representatives of the Washington Public Power Supply System (WPPSS) representing the members of the Utilities Service Alliance (USA) to discuss a proposed approach for WPPSS to conduct initial screening tests of urine specimens sent to them by USA members. 1 USA is an association of utilities that have agreed to share resources to reduce costs. USA currently consists of the following utilities: 1. Wolf Creek Nuclear Operating Corp. - Wolf Creek (Carl Perry of Wolf Creek is current head of USA) 2. Consumers Power - Big Rock Point and Palisades 3. Detroit Edison - Fermi 4. Florida Power - Crystal River 5. Illinois Power - Clinton 6. Nebraska Public Power - Cooper i 7. Omr.ha Public Power - Ft. Calhoun 8. Washir.gton Public Power Supply - Washington Nuclear A list of the 12 attendees is attached. Joe Holder, WPPSS, was the presenter, assisted by Perry Robinson of Winston and Strawn. Walt Vogl, Division of i Workplace Programs, HHS, made several useful contributions (we'll work with l HHS on some of the issues that will come out of the proposal). Vince Taylor, Editor, " Drug Detection Report," attended, as did Hans Renner, NUS, and Nancy Chapman, Bechtel, who will pass on information to clients through newsletters. Also attachej is a series of slides used by Mr. Holder during his presentation. Some key points brought up during the discussion: i

Contact:

Loren L. Bush, NRR 415-2944 V01 - 6 kilb f gyprR-<; dpf 5 bm, g, {L a s ppg g.: g sr.g, S K i go2o g go no2ot om-m To orw ce g f . RETURN TO REGULATORY CENTRAL HLES6s

Denais M. Crutchfield

  • USA estimates the proposal would save the eight utilities a total of a

$180 K per year. Seven of the utilities, other than WPPSS, were reported to be currently paying $12 to $35 per screening test. t!PPSS claims they are able to do the screening test for $6. NOTE: These costs and the anticipated savings are probably misleading. As described in the footnote on page 3.12 of the Regulatory Analysis attached to SECY 95-262, testing costs can be calculated in several ways: (1) a flat fee for testing services regardless of the number of specimens, (2) a flat rate per specimen and pro-rate the GC/MS testing, or (3) charge separately for each scr;ening test and each GC/MS test. Furthermore, the seven utilities, other than WPPSS, will be reducing the number of specimens sent to the HHS-certified laboratory; the specimens being sent to the labs will include a much higher percentage of the specimens needing GC/MS testing, which will drive the costs of testing such specimens up considerably. The WPPSS testing facility is currently capable of conducting 31,000 screening tests per year. That capability can be increased (at least doubled) by upgrading, at no cost, the testing equipment. The WPPSS testing facility is currently doing 2,500-3,100 tests per year. They expect to process 12-14,000 per year under the proposed approach. A one shipment pilot program was conducted with Fermi shipping several vials of aliquots and a few performance blind specimens to WPPSS by Express Mail. It cost $3.50 and was received the next day. Shipment met postal requirements for biological specimens. No problems were encountered w'th the shipment. Test results and reports were accurate. Issues with the proposed chain-of-custody form, particularly during onsite testing, were discussed. Proposal should clearly describe procedures for ensuring the quality and consistency of results, shipping and receiving procedures, etc. Proposal should clearly indicate who has lead responsibility in matters such as investigating errors. Proposed changes now before the Commission, when final, may require a resubmission or amendment to the proposal. There was a lengthy discussion on the public policy issues and long-term implications of an approach that is neither onsite testing nor testing by an HHS-certified laboratory. a

Dennis M. Crutchfield

  • Since the proposed approach is not "onsite. testing," except for WPPSS, the staff decided subsequent to the meeting that another term was needed.

" Centralized Second Party Testing" was chosen. Attachments:

1. Federal Register Notice
2. List of Attendees
3. Copy of Slides

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j I JANUARY 31,1996 SUPPLY SYSTEM MEETING WITH NRC STAFF CONCERNING INITIAL SCREENING TESTS I o l i l l l 4 I i

AGENDA I. INTRODUCTION Purpose of Meeting Overview of Utilities Service Alliance (USA) Potential Cost Savirtgs to USA Members r I II. PROPOSED ALTERNATIVE Summary of Current Capabilities of Supply System Analytical Laboratory Proposed Overall Process for Initial Screening Tests' Ress.snsibilities of USA Members and Supply System Analytical Laboratory ( USA " Protocol" to Ensure Testing is Consistent with IIIIS Guidelines III. REGULATORY APPROACII Use of Exemptions Justification Availab'c 1 SL 'bE 2 t

~.. _ _ _ . I. INTRODUCTION Purpose of Meeting: l T Brief the NRC Stafron the proposal of members of the Utilities Service Alliance to utilize the Supply System Analytical Laboratory for initial screening tests of urine specimens Discuss administrative and related details of the proposed testing in relation to the overall Part 26 scheme Discuss the regulatory approach 4 SLIDE 3 t m. _____________m_____,__-,,......,4..,-.,.... ,m,. -,w, .4.,

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1. INTRODUCTION (CONT'D)

Overview of Utilities Service Alliance (USA): USA has estallished a Memorandum of Understanding (MOU) MOU sets forth purpose and function of USA A primary purpose is to provide for common support services at reduced costs Consistent with "CBLA" efforts by NRC and nuclear utilities USA focus currently on Fitness-for-Duty area To reduce costs ofinitial screening tests SLIDE 4 l . ~ ___._-.__,i

1. INTRODUCTION (CONT'D)

P Potentia! Cost Savines to USA Members Potentis' for significant cost savings for initial screening tests Current costs (range) Costs assumed by NRC when Part 26 originally published - $20 per initial screen Cost savings not available if USA nwmbers must use IIIIS-certified labs for initial screening tests SLIDE 5 i i . - -. -, - - -.. ~,. . - - - -. -. ~. - -.......,. ,--n--.,.

l. \\ II. PROPOSED AI TERNATIVE 1 i Summary of Current Capabilities of Supply System Analytical Laboratory-Part 26 Experience Supply System Analytical Laboratory is " licensee's testing facility" for WNP-2 Operates in accordance with Part 26, including NRC Guidelines Demonstrated effectiveness: SALF, NRC inspections ("exce!!ent" performance) Certified per C; 1A (Clinical and Laboratory improvement Act) Ilas provided commercial drug screening services since 1997 Tmployees are non-bargaining " EMIT" (Euryme Multiplied Immunoassay Technique) testing capability Ampic throughput capacity " Pilot" Program with Fermi to verify feasibility of proposed alternative i i SLIDE 6 ~-

II. PROPOSED ALTERNATIVE (CONT'D) AS ILLUSTRATED IN TIIE CllART BELOW, TIIE PROPOSED ALTERNATIVE COMPRISES ONLY A PORTION OF EXISTING TESTING PRACTICES INVOLVING OFF-SITE LABS FOR INITIAL TESTING. Tile PROPOSAL DOES NOT AFFECT INITIAL ON-SITE COLLECTION OR SUBSEQUENT SECOND-SCREEN AND CONFIRMATION ATlillS-CERTIFIED LAB. TYPICAL PART 26 TESTING GOVERNED BY CUPRENT PROPOSED ALTERNATIVE I ELEMENTS PRACTICES utility enliects specimens / scal / label utility package for shipment / ship utility chain-of-custody: collect / ship utility use of overnight couriers lab receives / inspects packages lab report discrepancies, etc. lab performs initial testing lab reports resuits/rctains documents second screening and confirmatory tests at lillS-certified lab SLIDE 't

II. PROPOSED ALTERNATIVE (CONT'D) TIIE FOLLOWING TWO SLIDES IIIGIILIGIIT RESPONSIBILITIES OF ALLIANCE MEMBERS AND TIIE SUPPLY SYSTEM ANALYTICAL LABORATORY, AS CURRENTLY ENVISIONED. RESPONSIBILITIES OF ALLIAPI ' MEMBERS initial collection of specimens prevent subversion of testing label and package ship to Supply System Analytical Laboratory prevent sample degradation in transit preserve samples at initial collection site pending receipt of results ofinitial testing at Supply System Analytical Laboratory receipt of results ofinitial testing and related recordkeeping safeguard unconfirmed positive results forward of samples for second screening and confirmatory tests at IIIIS-certified laboratory SLIDE 8

II. PROPOSED ALTERNATIVE (CONT'D) RESPONSIRILITIES OF SUPPLY SYSTEM ANALYTICAL LABORATORY perform testing in accordance with Part 26 and related NRC guidelines, as well as Supply System Fitness for Duty Instructions (i.e., as a " licensee's testing facility" as that term is defined in Part 26) supply shipping sampic containers, labeling and packing materials to Alliance members supply specimen identification forms to Alliance members supply related instructions to Alliance members for packaging and shipping g receipt inspection of packaged samples from Alliance members maintain and document proper chain-of-custody during initial testing, to include obtaining associated chain-of-custody information from courier personnel maintain confidentiality of results prevent subversion of testing j prevent false negatives l report results to Alliance members - retain records for all tested specimens for a period of at Icast two years audits SLIDE 9 l L

t l l II. PROPOSED ALTERNATIVE (CONT'D) l l USA IS MINDFUL OF THE NEED TO ADDRESS SPECIFIC CIIALLENGES OF THE PROPOSED-AL l'ERNATIVE. i IIIIS Guidelines - factors related to muL.'nttest sites chain of custody forms need for having two separate laboratory forms potential for mixups and lost sample:. in transit potential for reporting delays potential for reports based only on initial screening tests s Additional Concerns: prevention of sample degradation assurance of continued protection of employee rights SLIDE 10

II. PROPOSED ALTERNATIVE (CONT'D) 1 USA " PROTOCOL" WILL ADDRESS IIIIS GUIDELINES AND RELATED ISSUES AND WILL PROMOTE COORDINATION AND EFFICIENCY BY USA MEMBERS. Protocol designed to provMe a uniform administrative interface between USA members and Supply System Protocol would describe circumstances ofinitial screening tests by Supply System i Protocol will addres IIIIS Guidelines Protocol used in conjunction with Supply System FFD Procedures and Instructior.s Protocol emphasizes Part 26 requirements will be impicmented as before Protocol provides that Supply System audit results will be made available to USA members i SLIDli 11

III. DISCUSSION OF REGULATORY APPROACH Use of Exemptione Part 26 does not appear to contemplate use of a " licensee's testing facility" for initial screening tests ~ for other licensee

v Supply System Analytical Laboratory is not IIIIS-certified Exemption (s) may be needed Justification Available Part 26 already applicable to Supply System Analytical Laboratory (JSA " Protocol" in conjunction Supply System and Alliance member Part 26 ccmpliance 1111S Guidelines addressed Cost savings /CBLA criteria SLIDE 12

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