ML17305B151: Difference between revisions

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| issue date = 10/25/1990
| issue date = 10/25/1990
| title = Responds to NRC 900926 Ltr Re Violations Noted in Insp Repts 50-528/90-36,50-529/90-36 & 50-530/90-36 & Proposed Imposition of Civil Penalty in Amount of $75,000.Requests That Civil Penalty Be Mitigated
| title = Responds to NRC 900926 Ltr Re Violations Noted in Insp Repts 50-528/90-36,50-529/90-36 & 50-530/90-36 & Proposed Imposition of Civil Penalty in Amount of $75,000.Requests That Civil Penalty Be Mitigated
| author name = CONWAY W F
| author name = Conway W
| author affiliation = ARIZONA PUBLIC SERVICE CO. (FORMERLY ARIZONA NUCLEAR
| author affiliation = ARIZONA PUBLIC SERVICE CO. (FORMERLY ARIZONA NUCLEAR
| addressee name =  
| addressee name =  
Line 15: Line 15:
| page count = 10
| page count = 10
}}
}}
See also: [[followed by::IR 05000528/1990036]]


=Text=
=Text=
{{#Wiki_filter:ACCELERATED
{{#Wiki_filter:ACCELERATED DISTRIBUTION DEMONSTI&TION SYSTEM R EGULATORY INFORMATI'3N       DISTRIBUTION SYSTEM (RIDS)
DISTRIBUTION
  .ESSION NBR:9011020165               DOC.DATE:   90/10/25   NOTARIZED: NO         DOCKET CIL:STN-50-528 Palo Verde Nuclear Station, Unit 1, Arizona Publi 05000528 STN-50-529 Palo Verde Nuclear Station, Unit 2, Arizona Publi 05000529 STN-50-530 Palo Verde'uclear Station, Unit 3, Arizona Publi 05000530 AUTH. NAME             AUTHOR AFFILIATION CONWAYPW.F.           Arizona Public Service Co. (formerly Arizona Nuclear Power RECIP.NAME             RECIPIENT AFFILIATION Document Control Branch (Document Control Desk)
DEMONSTI&TION
 
SYSTEM R EGULATORY INFORMATI'3N
==SUBJECT:==
DISTRIBUTION
Responds       to NRC   900926 50-528/90-36,50-529/90-36 ltr6 re50-530/90-36.Corrective violations noted in Insp Repts actions:
SYSTEM (RIDS).ESSION NBR:9011020165
DISTRIBUTION CODE: IE14D             COPIES RECEIVED:LTR     1   ENCL   I SIZE:
DOC.DATE: 90/10/25 NOTARIZED:
TITLE: Enforcement Action Non-2.790-Licensee               Response NOTES:STANDARDIZED PLANT                                                             05000528 Standardized plant.                                                           05000529 Standardized plant.                                                           05000530 RECIPIENT             COPIES            RECIPIENT        COPIES ID CODE/NAME             LTTR ENCL        ID  CODE/NAME      LTTR ENCL PD5 LA                       1      1      PD5 PD                1    '1 PETERSON,S.                   1      1      TRAMMELLPC~          1    1 TERNAL: AEOD/DOA                       1    '1      AEOD/DSP/TPAB        1    1 DEDRO                         1      1      NRR/DOEA/OEAB11      1    1 NRR/PMAS/ILRB12                            NUDOCS-ABSTRACT
NO DOCKET CIL:STN-50-528
            ~ I'%
Palo Verde Nuclear Station, Unit 1, Arizona Publi 05000528 STN-50-529
EG F           02 1
Palo Verde Nuclear Station, Unit 2, Arizona Publi 05000529 STN-50-530
1 1
Palo Verde'uclear
1 1
Station, Unit 3, Arizona Publi 05000530 AUTH.NAME AUTHOR AFFILIATION
1 OE FILE RGN5    FILE 03 01 1
CONWAYPW.F.
1 1
Arizona Public Service Co.(formerly Arizona Nuclear Power RECIP.NAME
1 1
RECIPIENT AFFILIATION
1 RGN2 DRSS/EPRPB              1     1 EXTERNAL: NRC PDR                        1     1     NSIC                  1     1 NOTES:                                    1     1 NOTE TO ALL "RIDS" RECIPIENTS:
Document Control Branch (Document Control Desk)SUBJECT: Responds to NRC 900926 ltr re violations
PLEASE HELP US TO REDUCE WASTE! CONTACT THE DOCUMENT CONTROL DESK, ROOM Pl-37 (EXT. 20079) TO ELIMINATEYOUR NAME FROM DISHUBUTION LISIS FOR DOCUMENTS YOU DON'T NEED!
noted in Insp Repts 50-528/90-36,50-529/90-36
TOTAL NUMBER OF COPIES REQUIRED: LTTR                 18  ENCL   18
6 50-530/90-36.Corrective
 
actions: DISTRIBUTION
a
CODE: IE14D COPIES RECEIVED:LTR
                                                          ~,
1 ENCL I SIZE: TITLE: Enforcement
Arizona Public Service Company P.O, BOX 53999 ~  PHOENIX, ARI2ONA 85072-3999 WILLIAMF. CONWAY                                                102-01877-WFC/TRB EXECUTIVEVICE PRESIDENT NUCLEAR                                                October 25, 1990 Director, Office of Enforcement U. S. Nuclear Regulatory Commission Attention: Document Control Desk Mail Station: Pl-37 Washington,        DC  20555
Action Non-2.790-Licensee
 
Response NOTES:STANDARDIZED
==Reference:==
PLANT Standardized
(1)   Letter from J.       B. Martin, Regional Administrator, NRC to W. F. Conway, Executive Vice President Nuclear, Arizona Public Service, dated September 26, 1990.
plant.Standardized
(2)   Letter from R. P. Zimmerman, Director, Division of Reactor Safety and Projects, NRC to W. F, Conway, Executive Vice President Nuclear, Arizona Public Service, dated August 23, 1990.
plant.05000528 05000529 05000530 RECIPIENT ID CODE/NAME PD5 LA PETERSON,S.
 
TERNAL: AEOD/DOA DEDRO NRR/PMAS/ILRB12
==Dear   Sirs:==
~I'%EG F 02 RGN2 DRSS/EPRPB
 
EXTERNAL: NRC PDR NOTES: COPIES LTTR ENCL 1 1 1 1 1'1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 RECIPIENT ID CODE/NAME PD5 PD TRAMMELLPC
Palo Verde Nuclear Generating Station (PVNGS)
~AEOD/DSP/TPAB
Units 1, 2, and       3 Docket No. STN 50-528 (License No. NPF-41)
NRR/DOEA/OEAB11
Docket No. STN 50-529 (License No. NPF-51)
NUDOCS-ABSTRACT
Docket No. STN 50-530 (License No. NPF-74)
OE FILE 01 RGN5 FILE 03 NSIC COPIES LTTR ENCL 1'1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 NOTE TO ALL"RIDS" RECIPIENTS:
Reply to Notice of Violation and Proposed Imposition       of Civil Penalty - $ 75,000 (Inspection Report Nos.
PLEASE HELP US TO REDUCE WASTE!CONTACT THE DOCUMENT CONTROL DESK, ROOM Pl-37 (EXT.20079)TO ELIMINATE YOUR NAME FROM DISHUBUTION
50-528/90-36, 50-529/90-36, and 50-530/90-36)
LISIS FOR DOCUMENTS YOU DON'T NEED!TOTAL NUMBER OF COPIES REQUIRED: LTTR 18 ENCL 18
File'0-070-026 As   directed by Reference (1), Arizona Public Service Company (APS) hereby responds to the Notice of Violation and Proposed Imposition of Civil Penalty (Notice). A restatement of the violations and APS's response are provided in Appendix A and Attachment 1, respectively, to this letter.
a
As stated in Attachment 1, APS agrees that the violations did occur as stated in the Notice. APS appreciates the significant nature of these violations and the appropriateness of a civil penalty. However, based on the discussion in the referenced letter, APS believes that NRC may not have considered all relevant facts in weighing the escalation and mitigation factors. APS is, therefore, providing additional information in this letter and requesting that NRC reconsider the amount of the proposed civil penalty.
~, Arizona Public Service Company P.O, BOX 53999~PHOENIX, ARI2ONA 85072-3999
It is important to keep in mind that subsequent reviews have shown that the violations had no actual and very little potential impact on the public health and safety.         The first violation involved four examples in which a licensed physician evaluated an operator's changed medical condition and determined that the operator was capable of performing his functions but APS failed to
WILLIAM F.CONWAY EXECUTIVE VICE PRESIDENT NUCLEAR 102-01877-WFC/TRB
                ~ ~
October 25, 1990 Director, Office of Enforcement
              ~   ~
U.S.Nuclear Regulatory
90ii020i65 801025   05000528 PDR   ADDCK Q                         PNU
Commission
 
Attention:
~"
Document Control Desk Mail Station: Pl-37 Washington, DC 20555 Reference:
NRC Document   Control Desk                                           102-01877-WFC/TRB Page 2                                                                  October 25, 1990 report such changes in the operator's medical conditions to the NRC.'n each case the physician had evaluated the condition in light of the operator's duties and imposed restrictions, as necessary, on his work activities. There is no information to suggest the operators failed to conduct themselves in accordance with those restrictions or that the condition affected the operators'erformance.         The principal failure was that the medical department did not recognize either the need to advise APS's licensing department of the condition or the specific requirements of the applicable standard. The second violation involved 15 instances in which a licensed physician performing physical examinations of operators omitted one or more tests required by the applicable standard, but an APS representative certified that the examinations had been performed in accordance with that standard.           In each of these cases the operator was subsequently found to be medically qualified based on a physical examination which completed the requirements of the applicable standard. As a result, although there had been some possibility that an incapacitating medical condition could have been overlooked in the previous incomplete examinations, that did not occur.
(1)Letter from J.B.Martin, Regional Administrator, NRC to W.F.Conway, Executive Vice President Nuclear, Arizona Public Service, dated September 26, 1990.(2)Letter from R.P.Zimmerman, Director, Division of Reactor Safety and Projects, NRC to W.F, Conway, Executive Vice President Nuclear, Arizona Public Service, dated August 23, 1990.Dear Sirs: Palo Verde Nuclear Generating
The NRC should reconsider the escalation of the       civil   penalty because the NRC's consideration of the applicable       factors appears   to be based on a misunderstanding of     the actual sequence   of events. The pertinent events are as follows:,
Station (PVNGS)Units 1, 2, and 3 Docket No.STN 50-528 (License No.NPF-41)Docket No.STN 50-529 (License No.NPF-51)Docket No.STN 50-530 (License No.NPF-74)Reply to Notice of Violation and Proposed Imposition
        ~     In response to suggestions from the     NRC   inspector in   May 1990, the APS   medical department reviewed the medical records of       PVNGS licensed operators. The review identified a number of discrepancies, including an operator whose changed physical condition had not been reported to the NRC in accordance with NRC requirements, a number of operators whose biennial physical exam had been outside the required two year frequency and six operators whose medical certifications were based on physical exams that did not meet all of the applicable requirements. These findings were reported to NRC (LER 90-09), and the'APS Quality Assurance (QA) organization issued a Corrective Action Report (CAR) documenting the deficiencies.
of Civil Penalty-$75,000 (Inspection
To assure   that the potentially significant issues were reviewed first, APS decided to have QA review     these issues in two stages.
Report Nos.50-528/90-36, 50-529/90-36, and 50-530/90-36)
First, a QA monitoring review was   initiated to   assure currently
File'0-070-026
      'ne   of the four examples, concerning an operator with diabetes mellitus, involved an error in a 1988 license renewal application, rather than a changed medical condition. The individual's initial license application in 1986 had disclosed this medical condition, and the individual's initial operator license in 1986 and amendment in 1987 was appropriately conditioned.
As directed by Reference (1), Arizona Public Service Company (APS)hereby responds to the Notice of Violation and Proposed Imposition
 
of Civil Penalty (Notice).A restatement
4' ip t NRC Document Page 3 Control Desk                                       102-01877-WFC/TRB October 25, 1990 licensed operators'ompliance with the requirement for biennial medical examinations. Second, a more comprehensive review of the historical medical records would be performed during a full QA audit of the Training and Qualification program that was already scheduled for October 1990. APS decided to retain this audit schedule so that the audit could also assess the effectiveness of APS's programmatic corrective actions.
of the violations
            ~     The NRC   inspection in July 1990 identified additional   examples of the same types of problems that APS had previously identified and reported to the NRC. Consequently, the corrective actions that APS took were not significantly affected by this NRC inspection.
and APS's response are provided in Appendix A and Attachment
Indeed, APS believes that the additional examples identified by the NRC inspector would have been identified in the activities required to resolve the CAR and in the scheduled QA audit.
1, respectively, to this letter.As stated in Attachment
Reference   (1) appears to criticize the initial QA review for being limited and for failing to identify certain deficiencies. Reference (1) also states that "as of the date of the enforcement conference a comprehensive independent review of this program had not been made nor had a date for such a review been determined." These observations are not justified, since the initial QA review was intentionally limited in scope to focus on the question of whether, within the previous two years, each of the licensed operators had received a medical examination meeting the ANSI/ANS 3.4-1983 standard.         This scope was appropriate because     it directly addressed the area of concern expressed by the NRC inspector and the area most likely to have current safety significance.
1, APS agrees that the violations
The CAR and the scheduled QA audit were specific documented processes that constituted a significant portion of the APS process for 'performing a comprehensive review of this area and for resolving the identified concerns.
did occur as stated in the Notice.APS appreciates
Thus, a comprehensive independent review of this program had been scheduled (this audit is currently in progress) and its schedule documented on the overall APS QA audit schedule. Although APS mentioned this fact at the enforcement conference,     it apparently was not fully recognized by the NRC staff.
the significant
APS recognized the importance of this issue and acted promptly to implement comprehensive programs to control, not only the operator medical examinations, but all facets of licensed operator qualification.           regional has reviewed these programs and concluded in Reference implemented, the programs appear to be appropriate to NRC (2) that  ifmanagement properly correct the deficiencies which APS and the NRC have identified.
nature of these violations
 
and the appropriateness
tg NRC Document Control Desk                                   102-01877-WFC/TRB Page 4                                                          October 25, 1990 APS respectfully requests that based on the information provided above, the NRC reconsider the escalation and mitigation factors and reduce the amount of the civil penalty.
of a civil penalty.However, based on the discussion
Should you have any questions or comments relative to the Reply to the Notices of Violations, this letter, or any other matter, I would appreciate the opportunity to respond to them.
in the referenced
Very truly yours, WFC/TRB/dmn Attachment CC:    J. M. Taylor J. B. Martin C. M. Trammell J. R. Newman A. C. Gehr D. H. Coe}}
letter, APS believes that NRC may not have considered
all relevant facts in weighing the escalation
and mitigation
factors.APS is, therefore, providing additional
information
in this letter and requesting
that NRC reconsider
the amount of the proposed civil penalty.It is important to keep in mind that subsequent
reviews have shown that the violations
had no actual and very little potential impact on the public health and safety.The first violation involved four examples in which a licensed physician evaluated an operator's
changed medical condition and determined
that the operator was capable of performing
his functions but APS failed to~~~~90ii020i65
801025 PDR ADDCK 05000528 Q PNU  
~"  
NRC Document Control Desk Page 2 102-01877-WFC/TRB
October 25, 1990 report such changes in the operator's
medical conditions
to the NRC.'n each case the physician had evaluated the condition in light of the operator's
duties and imposed restrictions, as necessary, on his work activities.
There is no information
to suggest the operators failed to conduct themselves
in accordance
with those restrictions
or that the condition affected the operators'erformance.
The principal failure was that the medical department
did not recognize either the need to advise APS's licensing department
of the condition or the specific requirements
of the applicable
standard.The second violation involved 15 instances in which a licensed physician performing
physical examinations
of operators omitted one or more tests required by the applicable
standard, but an APS representative
certified that the examinations
had been performed in accordance
with that standard.In each of these cases the operator was subsequently
found to be medically qualified based on a physical examination
which completed the requirements
of the applicable
standard.As a result, although there had been some possibility
that an incapacitating
medical condition could have been overlooked
in the previous incomplete
examinations, that did not occur.The NRC should reconsider
the escalation
of the civil penalty because the NRC's consideration
of the applicable
factors appears to be based on a misunderstanding
of the actual sequence of events.The pertinent events are as follows:,~In response to suggestions
from the NRC inspector in May 1990, the APS medical department
reviewed the medical records of PVNGS licensed operators.
The review identified
a number of discrepancies, including an operator whose changed physical condition had not been reported to the NRC in accordance
with NRC requirements, a number of operators whose biennial physical exam had been outside the required two year frequency and six operators whose medical certifications
were based on physical exams that did not meet all of the applicable
requirements.
These findings were reported to NRC (LER 90-09), and the'APS Quality Assurance (QA)organization
issued a Corrective
Action Report (CAR)documenting
the deficiencies.
To assure that the potentially
significant
issues were reviewed first, APS decided to have QA review these issues in two stages.First, a QA monitoring
review was initiated to assure currently'ne of the four examples, concerning
an operator with diabetes mellitus, involved an error in a 1988 license renewal application, rather than a changed medical condition.
The individual's
initial license application
in 1986 had disclosed this medical condition, and the individual's
initial operator license in 1986 and amendment in 1987 was appropriately
conditioned.  
4'  
t ip NRC Document Control Desk Page 3 102-01877-WFC/TRB
October 25, 1990 licensed operators'ompliance
with the requirement
for biennial medical examinations.
Second, a more comprehensive
review of the historical
medical records would be performed during a full QA audit of the Training and Qualification
program that was already scheduled for October 1990.APS decided to retain this audit schedule so that the audit could also assess the effectiveness
of APS's programmatic
corrective
actions.~The NRC inspection
in July 1990 identified
additional
examples of the same types of problems that APS had previously
identified
and reported to the NRC.Consequently, the corrective
actions that APS took were not significantly
affected by this NRC inspection.
Indeed, APS believes that the additional
examples identified
by the NRC inspector would have been identified
in the activities
required to resolve the CAR and in the scheduled QA audit.Reference (1)appears to criticize the initial QA review for being limited and for failing to identify certain deficiencies.
Reference (1)also states that"as of the date of the enforcement
conference
a comprehensive
independent
review of this program had not been made nor had a date for such a review been determined." These observations
are not justified, since the initial QA review was intentionally
limited in scope to focus on the question of whether, within the previous two years, each of the licensed operators had received a medical examination
meeting the ANSI/ANS 3.4-1983 standard.This scope was appropriate
because it directly addressed the area of concern expressed by the NRC inspector and the area most likely to have current safety significance.
The CAR and the scheduled QA audit were specific documented
processes that constituted
a significant
portion of the APS process for'performing
a comprehensive
review of this area and for resolving the identified
concerns.Thus, a comprehensive
independent
review of this program had been scheduled (this audit is currently in progress)and its schedule documented
on the overall APS QA audit schedule.Although APS mentioned this fact at the enforcement
conference, it apparently
was not fully recognized
by the NRC staff.APS recognized
the importance
of this issue and acted promptly to implement comprehensive
programs to control, not only the operator medical examinations, but all facets of licensed operator qualification.
NRC regional management
has reviewed these programs and concluded in Reference (2)that if properly implemented, the programs appear to be appropriate
to correct the deficiencies
which APS and the NRC have identified.  
tg NRC Document Control Desk Page 4 102-01877-WFC/TRB
October 25, 1990 APS respectfully
requests that based on the information
provided above, the NRC reconsider
the escalation
and mitigation
factors and reduce the amount of the civil penalty.Should you have any questions or comments relative to the Reply to the Notices of Violations, this letter, or any other matter, I would appreciate
the opportunity
to respond to them.Very truly yours, WFC/TRB/dmn
Attachment
CC: J.M.J.B.C.M.J.R.A.C.D.H.Taylor Martin Trammell Newman Gehr Coe
}}

Latest revision as of 09:25, 29 October 2019

Responds to NRC 900926 Ltr Re Violations Noted in Insp Repts 50-528/90-36,50-529/90-36 & 50-530/90-36 & Proposed Imposition of Civil Penalty in Amount of $75,000.Requests That Civil Penalty Be Mitigated
ML17305B151
Person / Time
Site: Palo Verde  Arizona Public Service icon.png
Issue date: 10/25/1990
From: Conway W
ARIZONA PUBLIC SERVICE CO. (FORMERLY ARIZONA NUCLEAR
To:
NRC OFFICE OF ENFORCEMENT (OE), NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM)
Shared Package
ML17305B152 List:
References
102-01877-WFC-T, 102-1877-WFC-T, NUDOCS 9011020165
Download: ML17305B151 (10)


Text

ACCELERATED DISTRIBUTION DEMONSTI&TION SYSTEM R EGULATORY INFORMATI'3N DISTRIBUTION SYSTEM (RIDS)

.ESSION NBR:9011020165 DOC.DATE: 90/10/25 NOTARIZED: NO DOCKET CIL:STN-50-528 Palo Verde Nuclear Station, Unit 1, Arizona Publi 05000528 STN-50-529 Palo Verde Nuclear Station, Unit 2, Arizona Publi 05000529 STN-50-530 Palo Verde'uclear Station, Unit 3, Arizona Publi 05000530 AUTH. NAME AUTHOR AFFILIATION CONWAYPW.F. Arizona Public Service Co. (formerly Arizona Nuclear Power RECIP.NAME RECIPIENT AFFILIATION Document Control Branch (Document Control Desk)

SUBJECT:

Responds to NRC 900926 50-528/90-36,50-529/90-36 ltr6 re50-530/90-36.Corrective violations noted in Insp Repts actions:

DISTRIBUTION CODE: IE14D COPIES RECEIVED:LTR 1 ENCL I SIZE:

TITLE: Enforcement Action Non-2.790-Licensee Response NOTES:STANDARDIZED PLANT 05000528 Standardized plant. 05000529 Standardized plant. 05000530 RECIPIENT COPIES RECIPIENT COPIES ID CODE/NAME LTTR ENCL ID CODE/NAME LTTR ENCL PD5 LA 1 1 PD5 PD 1 '1 PETERSON,S. 1 1 TRAMMELLPC~ 1 1 TERNAL: AEOD/DOA 1 '1 AEOD/DSP/TPAB 1 1 DEDRO 1 1 NRR/DOEA/OEAB11 1 1 NRR/PMAS/ILRB12 NUDOCS-ABSTRACT

~ I'%

EG F 02 1

1 1

1 1

1 OE FILE RGN5 FILE 03 01 1

1 1

1 1

1 RGN2 DRSS/EPRPB 1 1 EXTERNAL: NRC PDR 1 1 NSIC 1 1 NOTES: 1 1 NOTE TO ALL "RIDS" RECIPIENTS:

PLEASE HELP US TO REDUCE WASTE! CONTACT THE DOCUMENT CONTROL DESK, ROOM Pl-37 (EXT. 20079) TO ELIMINATEYOUR NAME FROM DISHUBUTION LISIS FOR DOCUMENTS YOU DON'T NEED!

TOTAL NUMBER OF COPIES REQUIRED: LTTR 18 ENCL 18

a

~,

Arizona Public Service Company P.O, BOX 53999 ~ PHOENIX, ARI2ONA 85072-3999 WILLIAMF. CONWAY 102-01877-WFC/TRB EXECUTIVEVICE PRESIDENT NUCLEAR October 25, 1990 Director, Office of Enforcement U. S. Nuclear Regulatory Commission Attention: Document Control Desk Mail Station: Pl-37 Washington, DC 20555

Reference:

(1) Letter from J. B. Martin, Regional Administrator, NRC to W. F. Conway, Executive Vice President Nuclear, Arizona Public Service, dated September 26, 1990.

(2) Letter from R. P. Zimmerman, Director, Division of Reactor Safety and Projects, NRC to W. F, Conway, Executive Vice President Nuclear, Arizona Public Service, dated August 23, 1990.

Dear Sirs:

Palo Verde Nuclear Generating Station (PVNGS)

Units 1, 2, and 3 Docket No. STN 50-528 (License No. NPF-41)

Docket No. STN 50-529 (License No. NPF-51)

Docket No. STN 50-530 (License No. NPF-74)

Reply to Notice of Violation and Proposed Imposition of Civil Penalty - $ 75,000 (Inspection Report Nos.

50-528/90-36, 50-529/90-36, and 50-530/90-36)

File'0-070-026 As directed by Reference (1), Arizona Public Service Company (APS) hereby responds to the Notice of Violation and Proposed Imposition of Civil Penalty (Notice). A restatement of the violations and APS's response are provided in Appendix A and Attachment 1, respectively, to this letter.

As stated in Attachment 1, APS agrees that the violations did occur as stated in the Notice. APS appreciates the significant nature of these violations and the appropriateness of a civil penalty. However, based on the discussion in the referenced letter, APS believes that NRC may not have considered all relevant facts in weighing the escalation and mitigation factors. APS is, therefore, providing additional information in this letter and requesting that NRC reconsider the amount of the proposed civil penalty.

It is important to keep in mind that subsequent reviews have shown that the violations had no actual and very little potential impact on the public health and safety. The first violation involved four examples in which a licensed physician evaluated an operator's changed medical condition and determined that the operator was capable of performing his functions but APS failed to

~ ~

~ ~

90ii020i65 801025 05000528 PDR ADDCK Q PNU

~"

NRC Document Control Desk 102-01877-WFC/TRB Page 2 October 25, 1990 report such changes in the operator's medical conditions to the NRC.'n each case the physician had evaluated the condition in light of the operator's duties and imposed restrictions, as necessary, on his work activities. There is no information to suggest the operators failed to conduct themselves in accordance with those restrictions or that the condition affected the operators'erformance. The principal failure was that the medical department did not recognize either the need to advise APS's licensing department of the condition or the specific requirements of the applicable standard. The second violation involved 15 instances in which a licensed physician performing physical examinations of operators omitted one or more tests required by the applicable standard, but an APS representative certified that the examinations had been performed in accordance with that standard. In each of these cases the operator was subsequently found to be medically qualified based on a physical examination which completed the requirements of the applicable standard. As a result, although there had been some possibility that an incapacitating medical condition could have been overlooked in the previous incomplete examinations, that did not occur.

The NRC should reconsider the escalation of the civil penalty because the NRC's consideration of the applicable factors appears to be based on a misunderstanding of the actual sequence of events. The pertinent events are as follows:,

~ In response to suggestions from the NRC inspector in May 1990, the APS medical department reviewed the medical records of PVNGS licensed operators. The review identified a number of discrepancies, including an operator whose changed physical condition had not been reported to the NRC in accordance with NRC requirements, a number of operators whose biennial physical exam had been outside the required two year frequency and six operators whose medical certifications were based on physical exams that did not meet all of the applicable requirements. These findings were reported to NRC (LER 90-09), and the'APS Quality Assurance (QA) organization issued a Corrective Action Report (CAR) documenting the deficiencies.

To assure that the potentially significant issues were reviewed first, APS decided to have QA review these issues in two stages.

First, a QA monitoring review was initiated to assure currently

'ne of the four examples, concerning an operator with diabetes mellitus, involved an error in a 1988 license renewal application, rather than a changed medical condition. The individual's initial license application in 1986 had disclosed this medical condition, and the individual's initial operator license in 1986 and amendment in 1987 was appropriately conditioned.

4' ip t NRC Document Page 3 Control Desk 102-01877-WFC/TRB October 25, 1990 licensed operators'ompliance with the requirement for biennial medical examinations. Second, a more comprehensive review of the historical medical records would be performed during a full QA audit of the Training and Qualification program that was already scheduled for October 1990. APS decided to retain this audit schedule so that the audit could also assess the effectiveness of APS's programmatic corrective actions.

~ The NRC inspection in July 1990 identified additional examples of the same types of problems that APS had previously identified and reported to the NRC. Consequently, the corrective actions that APS took were not significantly affected by this NRC inspection.

Indeed, APS believes that the additional examples identified by the NRC inspector would have been identified in the activities required to resolve the CAR and in the scheduled QA audit.

Reference (1) appears to criticize the initial QA review for being limited and for failing to identify certain deficiencies. Reference (1) also states that "as of the date of the enforcement conference a comprehensive independent review of this program had not been made nor had a date for such a review been determined." These observations are not justified, since the initial QA review was intentionally limited in scope to focus on the question of whether, within the previous two years, each of the licensed operators had received a medical examination meeting the ANSI/ANS 3.4-1983 standard. This scope was appropriate because it directly addressed the area of concern expressed by the NRC inspector and the area most likely to have current safety significance.

The CAR and the scheduled QA audit were specific documented processes that constituted a significant portion of the APS process for 'performing a comprehensive review of this area and for resolving the identified concerns.

Thus, a comprehensive independent review of this program had been scheduled (this audit is currently in progress) and its schedule documented on the overall APS QA audit schedule. Although APS mentioned this fact at the enforcement conference, it apparently was not fully recognized by the NRC staff.

APS recognized the importance of this issue and acted promptly to implement comprehensive programs to control, not only the operator medical examinations, but all facets of licensed operator qualification. regional has reviewed these programs and concluded in Reference implemented, the programs appear to be appropriate to NRC (2) that ifmanagement properly correct the deficiencies which APS and the NRC have identified.

tg NRC Document Control Desk 102-01877-WFC/TRB Page 4 October 25, 1990 APS respectfully requests that based on the information provided above, the NRC reconsider the escalation and mitigation factors and reduce the amount of the civil penalty.

Should you have any questions or comments relative to the Reply to the Notices of Violations, this letter, or any other matter, I would appreciate the opportunity to respond to them.

Very truly yours, WFC/TRB/dmn Attachment CC: J. M. Taylor J. B. Martin C. M. Trammell J. R. Newman A. C. Gehr D. H. Coe