B16375, Provides Commitment Results in Response to CAL 1-97-10

Provides Commitment Results in Response to CAL 1-97-10

ML20138B216
Person / Time
Site:	Millstone, Haddam Neck  File:Connecticut Yankee Atomic Power Co icon.png
Issue date:	04/22/1997
From:	Thayer J CONNECTICUT YANKEE ATOMIC POWER CO., NORTHEAST NUCLEAR ENERGY CO.
To:	NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM)
References
B16375, CAL-1-97-10, NUDOCS 9704290102
Download: ML20138B216 (15)

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/ [ Northerst Nuclear Energy unstone Noacar power smiion Northeet Ntricar Energy Cornpany P.O. Box 128 Waterford. CT 06385-0128 (860) 447-1791 i

Fax (860) 444-4277 The Northeast l'tditica Systern 1

l April 22,1997 i Docket No. 50-213 50-245 i 50-336 l 50-423 i B16375 l Re: CAL 1-97-010 U. S. Nuclear Regulatory Commission i ATTN: Document Control Desk l Washington, DC 20555 Haddam Neck Plant Millstone Nuclear Power Station, Units 1,2 and 3 Response to Confirmatory AcJon Letter l References (a): H. J. Miller and W. D. Travers, USNaC letter to B. D. Kenyon,

" Confirmatory Action Letter," dated March 7,1997.

(b): J. K. Thayer letter to USNRC, " Response to Confirmatory Action Letter," dated March 31,1997.

In our letter dated March 31,1997 [ Reference (b)], Connecticut Yankee Atomic Power l Company (CYAPCO) and Northeast Nuclear Energy Company (NNECO) committed to l conduct a review of currently licensad operators to determine the extent to which the  ;

submitted medical certifications (NRC Forms 396) accurately reflect the required I physical examinations and medical tests, and to submit the results of this review by April 23,1997. This commitment is reflected in Confirmatory Action Letter 1-97-010 ,

[ Reference (a)] as commitment #6. Summarized below is the results of our review.  !

l An independent medical study was conducted to determine the extent to which license applications submitted to the NRC for the Millstone Units and the Haddam Neck Plant  !

f have been based on correct and complete medical information, and that changes in the i E90042 *'

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. ,' B16375\Dage 2 medical status for licensed operators have been submitted as required by 10CFR55.

The medical study was performed on-site at Millstone Station and the Haddam Neck Plant from March 24 to March 28,1997, to perform a 100% review of licensed nuclear plant operators' medical records and related medical applications. The review encompassed January 1,1993, through March 1,1997. Overall, it was determined that both Millstone station and the Haddam Neck Plant medical facilities provide an excellent standard of compliance with ANSI 3.4 and NRC Form 396.

The independent medical review team was comprised of medical professionals led by Dr. Benjamin Hoffman, MD. Dr. Hoffman is a principalin Business Health Management (BHM). BHM provides medical services to Seabrook Nuclear Station. BHM, Dr. ,

Hoffman, and his associates have not previously been contracted to provide medical services to the Millstone Station or the Haddam Neck Plant. Attachment 1 to this letter provides the Executive Summary of the medical team's conclusions.

i The medical study had three objectives. Each objective is described below with the esults of the study and any interim compensatory action that have been taken.

Objective 1 100% review of currently licensed operators to determine the extent to which the medical certifications (NRC Form 396) accurately reflect the required physical examinations and medical tests.

l Results Three operators (out of approximately 170 reviewed) had developed medical conditions that were potentially disqualifying. In the first two cases, the potential disqualifiers were not noted on supplemental NRC Forms 396. In the third case, the appropriate restriction for corrective lenses was noted on the Form 396, but the operator did not meet the visual acuity acceptance criteria. The medical review team concluded that all three operators had adequately compensated medical conditions, and it was not necessary to place any restriction on their solo operation.

The medical review team recommended that potentially disqualifying conditions should l be identified to the NRC, along with the analysis and conclusions of the medical examiner.

( . Case #22 (RO/MP1). Onset of adult diabetes. Following the medical review team's 4

audit, the Millstone Medical Examiner prepared a letter describing the case facts,

analysis, and conclusion. Dr. Hoffman reviewed and concurred with the analysis i and conclusion that the operator did not require any medical restriction. A letter l

] describing the analysis of the medical condition will be submitted to the NRC by May 15,1997.

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y.S. Nucl:ar Regulatory Commission B16375\ Pag 3 3 l

. Case #3 (SRO/MP2). Colon cancer. Following the medical review team's audit, the Millstone Medical Examiner prepared a letter describing the case facts, analysis, and conclusion. Dr. Hoffman concurred with the analysis and conclusion that there is no requirement for a medical restriction. A letter describing the analysis of the medical condition will be submitted to the NRC by May 15,1997.

. Case #87 (SRO/MP2). Visual acuity. The operator was examined on March 13, 1997, and the operator's visual acuity did not meet the acceptance criteria. The Medical Examiner accepted the physical examination in error. After the medical team identified the error, the operator was reexamined with a new corrective lens prescription. The April 2,1997 visual acuity exam was acceptable. The operator currently has a license restriction that requires corrective lenses.

Obiective 2 100% review of currently licensed operators' medical records to determine the extent to which medical restrictions, which were identified after Northeast Utilities submitted the i license [ applications) to the NRC, resulted, as appropriate, in a supplemental NRC l Form 396 being filed. l Results

. The medical review team reviewed approximately 170 licensed operators, and identified a number of cases at Millstone in which supplemental NRC Form 396 may l not have been submitted for restrictions requiring corrective lenses, restrictions which developed after the operator's initial NRC Form 396 was submitted. This condition affects approximately ten operators.

. Corrective Action

. As an interim compensatory corrective action, the Millstone Operations Managers i have issued the following directive to all Operations licensed operators: "If you wear ,

prescription corrective lenses, you are required to have the corrective lenses  ;

available when standing watch as a licensed operator." )

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. As a final corrective action, NNECO will submit a supplemental NRC Form 396 for l l

each case not currently docketed in which an operator wears prescriptive corrective lensas. This action will be completed by May 15,1997.

Objective 3 Determine the extent to which the process for licensed operator physicals is defined and documented in accordance with normal industrial medical standards and Millstone administrative procedures.

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U.S. Nuclear Regulatory Commission B16375\Page 4

( Results The medical review team identified a number of charts with missing documentation for

, examination and laboratory elements. One notable omission was urinalysis results l during 1993. This was a transition period based on new Clinical Laboratory j lmprovement Act (CLIA) regulations that were effective in 1993. The issue was .

corrected later in 1993, as evidenced by appropriate lab results being documented in the charts from 1994 to date.

The medical review team concluded that the interfaces, roles and responsibilities, and  ;

l process for the administration of operator medical certifications are not currently well i l defined in written administrative procedures.

Corrective Actions

. NU has committed to improve the operator licensing application and medical l certification process (reference the Corrective Action Plan, item 4.6.3.c, submitted in l our March 31st letter). This will be completed by June 10,1997.  ;

1 1 l . The Millstone Health Facility will develop a method to track all physical examination and laboratory elements on a routine basis to ensure that all examinations and laboratory work are completed and documented. This action will be completed by June 15,1997.

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. The Millstone Health Facility will assess the effectiveness of the corrective actions l outlined above. This assessment will be complete by September 15th,1998.  !

i The following are CYAPCO's and NNECO's commitments contained within this letter.

All other statements within this letter are for information on!y.

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! B16375-1 NNECO will submit updated NRC Forms 396 for Case #3 and Case #22, including letters describing the analyses of the medical conditions. This action will be completed by May 10 1997.

B16375-2 NNECO will submit a supplemental NRC Form 396 for each case not currently docketed in which an operator wears prescriptive corrective lenses. This action will be completed by May 15,1997.

, B16375-3 The Millstone Health Facility will develop a method to track all physical i l examination and laboratory elements on a routine basis to ensure that all examinations and laboratory work are completed and documented. This f action will be completed by June 15,1997.

B16375-4 The Millstone Health Facility will assess the effectiveness of the corrective actions. This action will be completed by September 15th,1998.

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U.S. Nuglear Regulatory Commission

. B16375\Page 5 l

Please contact Mr.W. J. Temple at (860) 437-5904 should you have any questions l regarding this matter.  !

Very truly yours, CONNECTICUT YANKEE ATOMIC POWER COMPANY  !

NORTHEAST NUCLEAR ENERGY COMPANY A W

g. Thayer, Recafvery Officer l Nuclear Engineering and Support Services j Attachment (1)  :

cc: H. J. Miller, Region I Administrator G.W. Meyer, Chief of Operator Licensing, NRC Region I F. J. Miraglia, Deputy Director, NRR W.D. Travers, PhD., Director, Special Projects Office {

W.D. Lanning, Deputy Director, inspections, Special Projects Office i P. F. McKee, Deputy Director, Licensing and Oversight, Special Projects Office J. P. Durr, Branch Chief Inspections, Special Projects Office j M.B. Fairtile, NRC Project Manager, Haddam Neck Plant  :

W.J. Raymond, Senior Resident inspector, Haddam Neck Plant S. Dembek, NRC Project Manager, Millstone Unit 1 T.A. Eastick, Senior Resident inspector, Millstone Unit 1 D.G. Mcdonald, Jr., NRC Senior Project Manager, Mil! stone Unit 2 ,

D.P. Beaulieu, Senior Resident inspector, Millstone Unit 2 J.W. Andersen, NRC Project Manager, Millstone Unit 3  :

A.C. Cerne, Senior Resident inspector, Millstone Unit 3 l

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. l Docket No. 50-213  !

50-245 50-336 j 50-423 B16375 l i

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Attachment 1 )

1 Haddam Neck Plant j Millstone Nuclear Power Station, Units 1,2 and 3 j Executive Summary of Medical Review Team Findings l

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WTITTUTT5T5UU555535TT3 Executive Summary INDEPENDENT INVESTIGATION OF OPERATOR LICENSE MEDICAL RECORDS CONTENTS q

INTRODUCTION...............................................................................................................................................1 P U R POS E . . . . . . . . . . . . . . . . . . . . . . . . .... . ........ . .. ..... ........... .... ............................................................................1 PROCEDURE....................................................................................................................................1 FINDINGS........................................................................................... ................................................2 MILLSTONE REGULATORY COMPLIANCE ....... ............... .. ... . .. .... ... .. ... ... ................. . ... .. .. ... ....... .... .... ... ..... 2 CLIN lC al STANDARDS OF CARE AT MILLSTONE....... .... .. .. . . ..... ... . ..... . ...... .. ..... . . ...... ......... .. .. ..... ........... ...... 3 CONNECTICUT YANKEE REGULATORY COMPLIANCE.... .... . ... ... ... .. . .. ........... ......... .. .. ..... .. .. ........ ... .......... .... 3 CLINICAL STANDARDS OF CARE AT CONNECTICUT YANKEE...... . .......... .............. ....... . .......... ...... ... ......... ..... .. ..... .... 3

SUMMARY

. .............................................................. ... . ..... ...... ....... .... .. .. .... .. .. .... ..... . ....... ....... 4 MILLSTONE.. ..

.. . ..... .. ... .. ......... .... .................. .... .. ... ..... .. ... .. ........ ........ ....... .. ... .. ........ . . . .. ...... ... 4 CONNECTICUT YANKEE.. .. . .... . ............ ......

...... . ... . ......... ... ..... ... ... .... .............. .. ..... .... ... . . .. . .. .... .. .. ... 4 ADDENDUM A: AUDIT TEAM PERSONNEL ADDENDUM B: REVIEW INSTRUMENT ADDENDUM C: ALL FINDINGS

INTRODUCTION PURPOSE An independent audit team conducted an investigation at Millstone and Connecticut Yankee to determine the extent to which

. operator licenses submitted to the NRC have been based on correct and complete medicalinformation, j

. changes in medical status for licensed operators have been submitted as required by 10CFR55, and

. the process for licensed operator physicals has been defined and documented in accordance with standard 9 industrial medical practice.

Mr. Carl Clement, Manager, General Services, commissioned this study.

PROCEDURE From March 24 to March 28,1997, a team of occupational health professionals (see Addendum A) went on-site at t Millstone and Connecticut Yankee to perform a 100% review oflicensed nuclear plant operators' medical records i and related medical applications (NRC 396 Forms).

The review encompassed January 1,1993, through March 1,1997. An audit checklist and evaluation instrument was developed prior to the audit using an Excel spreadsheet (see Addendum B).

This review instrument was developed to assess compliance with ANSI 3.4 (Medical Certification and Monitoring .

of Personnel Requiring Operator Licenses for Nuclear Power Plants,1983) and compliance with proper filing of the NCR 396 Form.

The review was performed in the following sequence:

LevelI All medical charts were initially assessed to determined if they contained all the necessary  ;

documents for review. If these were not available, Millstone or Connecticut Yankee medical staff were asked to obtain the missing documents.

LevelII All charts were reviewed by two physician's assistants and one physician (Dr. Schmitz).

Level 111 Any chart having an incompletely documented physical examination or inadequately filed NRC 1 396 Form was further reviewed by Dr. Hoffman. q

. See Addendum C for all findings. To maintain confidentiality, operators' names have been indicated by numbers.

April 2,1997 Executive Summary Independent Investigation of Operator License Medical Reports Page1 of4  :

prepared for Northeast Utilities System by Business Heahh Managem nt. Occupational Heahh + Rehabilitation Inc

5555566666666666 Ettttt4555&&&4%%%Etttt%%M FINDINGS Overall, the NRC 396 Forms were properly completed and fded on an every six-year basis, except as noted, as MILLSTONE requd by tk E.

REGULATORY W ypes oMngs were nd on se au&

CO31PLIANCE Finding 1 -ANSI 3.4 requires vision assessment biennially. Changes in vision that require corrective lenses must be noted on the 396 even in non-licensing years. The documentation provided with the medical charts indicated that the NRC was not notified of an indeterminate number (approximately 10) oflicensed operators who had a change in vision that required corrective lenses in a non-licensing year. For each of these operators, an NRC 396 Form should have been submitted with the appropriate annotation of" corrective lenses required for licensed duties."

One operator's visual acuity did not meet required standards in a non-licensing year. No disqualification or changes in the NRC 396 Form were fded, and the chart contains no documentation regarding assessment of this issue. Once this fmding was brought to the attention of the medical department (April 1997, one month after the exam), the medical department contacted the licensed operator who informed them he had been to an eye specialist for refraction since the time of the exam. His repert vision exam at the Millstone Medical Department revealed adequate visual acuity with corrective lenses, consistent with ANSI 3.4 vision standards. The NRC 396 Form is currently being amended for filing.

Finding 2 -ANSI 3.4 requires that "a history or other indication of any disqualifying condition shall be disqualifying unless adequate supplemental findings demonstrate that no disqualifying condition exists. Such a demonstration shallinclude at least the specific narrative entries by the designated medical examiner and relevant aspects of medical history and examination." In addition, 10CFR55 reinforces this requirement.

It is the opinion of this audit team, based on 10CFR55 and ANSI 3.4, that any potentially disqualifying condition that is adequately compensated should be noted on the NRC 396 Form and adequate demonstration of compensation, including supporting documents from the operator's personal physician, should be attached. The NRC's medical consultant reviews the licensee's medical examiner's opinion and documentation and makes the fmal determination.

Two operators had medical conditions that were potentially disqualifying, but not noted on the NRC 396 Form. It is the opinion of the audit team that both operators had adequately compensated medical conditions and it was unnecessary to place any restriction on their solo operation. The site physician exercised proper medical judgment and adequately documented the reasons for his decisions in the charts. Nonetheless, the NRC 396 Forms should have been filed with the expectation th^< G NRC Medical Consultant would have approved the license application.

Independent Investigation of Operator License Medical Reports April 2,1997 Executive Summary Page 2 of 4 prepared fer Northeast Utilities System by Business Health Managementoccupational Health + Rehabilitation Inc

b l5 5 5 5 5 5 5 t E E E t & & 5 5R FINDINGS (CONTINUED)

Three findings were noted regarding clinical standards of care:

CLINICAL STANDARDS OF Finding 1 -The ANSI 3.4 requires certain exam and laboratory elements biennially. Occasionally, CARE AT documentation for exam or lab elements were missing from a chart. In particular, in 1993 many of MILLSTONE the operators' exams did not include a urinalysis. This problem was corrected in 1994. Although this test is a routine component of biennial exams, all of these operators underwent a urinalysis in 1992 and 1994. Since Millstone performed annual comprehensive examinations on alllicensed operators, a great deal of redundant and overlapping medical information is documented for each operator. In the opinion of the audit team, none of the findings that may have resulted from missing exam components noted from 1993-1997 likely would have impacted an operator's '

performance or resulted in amended NRC 396 findings. A checklist in the form of a spreadsheet or database computer program should be developed to track all physical examination and laboratory elements on a routine basis (annually is recommended) to ensure that all exams and lab work are completed and documented.

Finding 2 -The audit team noted a general problem with documenting the vision component of the exam.

Various forms associated with assessing vision often were unsigned or incomplete. It is recommended that the forms for documenting the visual exam be simplified and contained on one or two pages.

Finding 3 -The audit team discovered several charts in which the American Thoracic Society Standards for spirometry were not met (e.g., failure to provide three reproducible test curves). It is frequently the case that standards may not be met; however, documentation that explains why the standards are not being met must be provided in the chart.

CONNECTICUT The audit team found no issues with NRC 396 documentation or compliance with standards.

YANKEE REGULATORY CONIPLIANCE CLINICAL Several omissions of examination or laboratory elements were noted, but none were considered significant.

STANDARDS OF CARE AT The overall organization and documentation of the Connecticut Yankee charts were excellent.

CONNECTICUT YANKEE Executive Sununary Independent Investigation of Operator Ucense hiedical Reports Apnl 2,1997 prepared for Northeast Utilities System by Business Health hianagernent/ Occupational Heahh + Rehabilitation Inc Page 3 of 4

SUMMARY

Overall, the Medical Clinic provided an excellent standard of compliance with ANSI 3.4 and NRC 396. On two AIILLSTONE occasions, the on-site physician exercised judgment in not submitting a change in NRC 396. Only one operator license was initially in question, based on inadequate visual acuity. The visual acuity exam was repeated after the audit, and the operator met ANSI 3.4 Standards for visual acuity.

The audit team has three recommendations:

1. Develop a comprehensive system using a spreadsheet or database computer program to track

. the scheduling oflicensed operator exams,

. whether all exams and laboratory work are completed, and

. the proper illing of the NRC 396 Form, including revisions that occur in non-licensing years.

2. Licensed operators undergo medical evaluations only biennially, as recommended by ANSI 3.4

3. An internal quality assurance process should be developed to assess compliance with ANSI 3.4,10CFR55, and clinical standards of care on a routine basis (perhaps annually).

Overall, the Medical Clinic provided an excellent standard of compliance with ANSI 3.4 and NRC 396.

CONNECTICUT YANKEE The audit team has two recommendations:

1. Develop a comprehensive system using a spreadsheet or database computer program to track

. the scheduling oflicensed operator exams,

. whether all exams and laboratory work are completed, and

. the proper filing of the NRC 396 Form, including revisions that occur in non-licensing years.

2. An internal quality assurance process should be developed to assess compliance with ANSI 3.4,10CFR55, and clinical standards of care on a routine basis (perhaps annually).

April 2.1997 Executive Summary Independent lavestigation of Operator License Medical Reports Page 4 of 4 by Business Health Managementoccupational Health + Rehabilitation Inc prepared for Northeast Utilities System

I_S 4 4 O O O D D E & E B D & 5 & O & O O O O & O & O O O 006 CibbUbbU U U O OY ADDENDUM A: AUDITTEAM PERSONNEL Ben Hoffman, M.D., M.P.H., Project Director Steve Schmitz, M.D., M.P.H.

Tom Clayton, PA/C Wayne Estes, PA/C Jan Schwartz, OHN i Richard Scacheri I

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ADDENDUM C: ALL FINDINGS (See tollowing pages.)

Notes:

Explanation of missing exam data levels:

. MISSING EXAM DATA FOR 396 YEAR means that data is missing for an exam performed to file for the NRC 396 license.

. MISSING EXAM DATA BIENNIAL YEAR means that data is missing for an exam performed to conform with the ANSI 3.4 Standard.

. MISSING EXAM DATA means that data is missing from an exam performed during any year other than a 396 or biennial year.

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