Information Notice 2004-20, Recent Issues Associated with NRC Medical Requirements for Licensed Operators

Recent Issues Associated with NRC Medical Requirements for Licensed Operators

ML042510509
Person / Time
Issue date:	11/24/2004
From:	Hiland P NRC/NRR/DIPM/IROB
To:
Trimble D C, DIPM/IEHB/IOHS, 415-1017
References
TAC M3722 IN-04-020
Download: ML042510509 (9)

UNITED STATES

NUCLEAR REGULATORY COMMISSION

OFFICE OF NUCLEAR REACTOR REGULATION

WASHINGTON, D.C. 20555-0001 November 24, 2004 NRC INFORMATION NOTICE 2004-20: RECENT ISSUES ASSOCIATED WITH NRC

MEDICAL REQUIREMENTS FOR LICENSED

OPERATORS

ADDRESSEES

All holders of operating licenses for nuclear power reactors and research and test reactors, except those who have permanently ceased operations and have certified that fuel has been

permanently removed from the reactor vessel.

PURPOSE

The U.S. Nuclear Regulatory Commission (NRC) is issuing this information notice (IN) to

highlight concerns related to the conduct and documentation of medical examinations for

applicants and holders of reactor operator and senior operator licenses (hereafter referred to

collectively as licensed operators). It is expected that recipients will review the information for

applicability to their facilities and consider actions, as appropriate, to avoid similar problems.

However, suggestions contained in this information notice are not NRC requirements; therefore, no specific action or written response is required.

DESCRIPTION OF CIRCUMSTANCES

The NRC depends on facility licensees to ensure that the personnel who perform and evaluate

licensed operator medical examinations understand the regulatory requirements, the applicable

medical standards, and the physical demands of the operators duties, thereby ensuring that the

examinations are performed correctly and any medical defects are accommodated with

compensatory license restrictions or, if necessary, by removal from licensed duties. Failure to

detect a disqualifying medical condition could adversely affect an operators ability to perform

assigned duties under stressful and demanding accident conditions, thereby distracting the rest

of the crew and increasing the possibility of operational errors that could endanger public health

and safety.

The NRC also depends, in large part, on facility licensees to ensure that their licensed

operators are familiar with and adhere to the individual license conditions specified in

Section 55.53. Licensed operators should understand that they are responsible for meeting all

the conditions of their license and for promptly informing their employer if they develop any

medical condition, such as needing to wear glasses or taking a prescription or over-the-counter

medication, that could affect their fitness to safely operate the facility.

BACKGROUND

The NRCs requirements related to the conduct and documentation of medical examinations for

operators are contained in Subpart C, Medical Requirements, of 10 CFR Part 55, Operators

Licenses. Specifically, Section 55.21, Medical examination, requires every operator to be

examined by a physician when he or she first applies for a license and every two years

thereafter. The physician must determine whether the operator meets the requirements of

Section 55.33(a)(1), i.e., the operators medical condition and general health will not adversely

affect the performance of assigned operator duties or cause operational errors that endanger

public health and safety.

Every time an operator applies for a license pursuant to Section 55.31, How to apply, or

Section 55.57, Renewal of licenses, an authorized representative of the facility licensee must

complete and sign Form NRC-396, Certification of Medical Examination by Facility Licensee, attesting, pursuant to Section 55.23, Certification, that a physician has conducted the required

medical examination and determined that the operators medical condition and general health

meet the requirements of Section 55.33(a)(1). The facility licensee must also certify which

industry standard (i.e., the 1983 or 1996 version of ANSI/ANS-3.4, Medical Certification and

Monitoring of Personnel Requiring Operator Licenses for Nuclear Power Plants, or the 1988 revision of ANSI/ANS-15.4, American National Standard for the Selection and Training of

Personnel for Research Reactors) or other NRC-approved method was used in making the

fitness determination.

The ANSI standards describe a number of specific operator health requirements and

disqualifying conditions. If an operators health does not meet the minimum standards, the

facility licensee must request a conditional license in accordance with Section 55.23(b) by

submitting the appropriate medical evidence with Form NRC-396. Pursuant to Section 55.33, Disposition of an initial application, and Section 55.57, as applicable, the Commission will

review the license application based on the facility licensees certification and include any

conditions in the license that might be necessary based on the supporting medical evidence.

If, at any time during the term of an operators license, the operator develops a permanent

physical or mental condition that causes the operator to fail to meet the requirements of

Section 55.21, the facility licensee must notify the Commission, in accordance with 10 CFR

50.74(c), within 30 days of learning of the diagnosis. If a conditional license is requested, the

facility licensee must, again, provide medical certification on Form NRC-396, as described in

Section 55.23.

For additional information on this subject, refer to NRC IN 91-08, Medical Examination for

Licensed Operators (issued February 5, 1991), IN 94-14, Failure to Implement Requirements

for Biennial Medical Examination and Notification to the NRC of Changes in Licensed Operator

Medical Conditions (issued February 24, 1994), and IN 94-14, Supplement 1 (issued April 14,

1997).

DISCUSSION

Given the importance of the operators role in maintaining reactor safety, the NRC staff

becomes concerned whenever inspection results, facility audits, and other indicators suggest

that facility medical programs may not be receiving sufficient management oversight to ensure that the

fitness of licensed operators is being maintained at the required level. The following recent

examples indicate a potential problem in this area:

• The checklist that one facility used to track the ANSI testing requirements specifically

noted discrepancies for a number of operators, but the examining physician

nevertheless signed the overall physical examination as satisfactory. One operator was

noted to have disqualifying cardiovascular conditions (arrhythmia and peripheral

vascular insufficiency) and an unsatisfactory electrocardiogram that should have

warranted a no-solo license restriction, but when the inspectors questioned the

physician who had completed the checklist, he simply changed the unsatisfactory

conditions to satisfactory in front of the inspectors without evaluating the medical record.

Other examples included a skin condition affecting the ability to wear protective clothing, abnormalities related to the endocrine system, blood, and blood-forming organs, and

various laboratory tests.

• While following up on concerns raised by an NRC inspector, a facility licensee found

that some tests specified in the ANSI standard (e.g., nose sensitivity and neurological

testing) had not been completed for any of its licensed operators. The facility licensee

implemented immediate corrective action by testing its operators before they were

allowed back on shift.

• During an audit of its medical records, a facility licensee discovered that two of its

recently licensed operators had preexisting medical conditions (histories of myocardial

infarction and coronary heart disease) that had not been reported on their original

NRC-396 forms. The facility licensee submitted new NRC-396 forms with the required

medical evidence but again failed to recommend any license conditions to

accommodate the operators medical defects, which preclude solo operation of a

nuclear power plant per the ANSI standard. Upon review, the NRC amended both

operators licenses to include no-solo license restrictions.

• As a follow-up corrective action, the facility licensee audited the medical records at other

sites and identified two additional operators who had potentially disqualifying medical

conditions but did not have restrictions on their licenses. The licensees root cause

review of this problem identified a company-wide flaw in the training provided to doctors

and nurses contracted to perform the medical evaluations. The licensee found that the

doctors had been trained that the site nurse or licensed nurse practitioner would inform

the doctors if there were any requirements for a regulatory restriction based on the

results of the physical exam. However, the nurses were not trained to point out the

regulatory restrictions to the doctors and did not question the doctors decisions when

no regulatory restrictions were recommended.

• Several other facility licensees, while performing routine or reactive audits of their

licensed operators medical records, have recently identified various medical conditions, including heart attacks and poor vision, that should have been reported to the NRC

pursuant to 10 CFR 55.25. The most egregious case involved an operator who should

have been restricted from solo operation since suffering a heart attack in 1996; the

facility licensee was unable to determine why the condition went unreported. * In one instance, as the result of an unclear facility procedure, a licensed operator waited

for seven months before informing the site nurse that his personal physician had

prescribed a medication that could adversely affect his ability to perform licensed duties.

The site nurse compounded the problem by waiting another month before informing

facility management so the operator could be removed from licensed duties and the

NRC could be notified.

The purpose of this IN is to remind facility licensees (1) that licensed operators and the

personnel who perform and interpret their medical examinations need to be familiar with the

regulatory requirements and guidelines; (2) that any time a licensed operator fails to meet any

of the medical standards outlined in the applicable version of ANSI/ANS-3.4, the failure must be

reported to the appropriate NRC regional office on Form NRC-396; and (3) that Form NRC-396 must include a copy of all supporting medical information and, if deemed necessary, the

specific recommended wording for the conditional license to be issued to the affected operator.

CONTACT

S

This information notice requires no specific action or written response. Please direct any

questions about this matter to the technical contact(s) listed below or to the appropriate Office

of Nuclear Reactor Regulation (NRR) project manager.

/RA/

Patrick L. Hiland, Chief

Reactor Operations Branch

Division of Inspection Program Management

Office of Nuclear Reactor Regulation

Technical Contacts: David C. Trimble, NRR Richard J. Conte, RI

301-415-2942 610-337-5183 E-mail: dct@nrc.gov E-mail: rjc@nrc.gov

James H. Moorman, RII Roger D. Lanksbury, RIII

404-562-4637 630-829-9631 E-mail: jhms2@nrc.gov E-mail: rdl@nrc.gov

Anthony T. Gody, RIV Patrick M. Madden, NRR

817-860-8159 301-415-1188 E-mail: atg@nrc.gov E-mail: pmm@nrc.gov

Attachment: List of Recently Issued NRC Information Notice

ML042510509 DOCUMENT NAME: C:\MyFiles\Checkout\cdp edit MEDICAL ISSUES RIS 2004-XX.wpd

OFFICE IROB:DIPM TECH EDITOR SC:IOHS:DIPM OE PMAS

NAME SGuenther PKleene DCTrimble CNolan DLMcCain

DATE 09/09/2004 09/01/2004 09/09/2004 10/04/2004 10/05/2004 OFFICE OCIO OGC (NLO) OGC (SBREFA) CRGR IROB:DIPM

NAME BShelton CHolzle AWMarkley

DATE 10/05/2004 10/18/2004 10/18/2004 11/09/2004 11/10/2004 OFFICE A:SC:OES:DIPM C:IROB:DIPM

NAME THBoyce PLHiland

DATE 11/22/04 11/24/2004

Attachment LIST OF RECENTLY ISSUED

NRC INFORMATION NOTICES

_____________________________________________________________________________________

Information Date of

Notice No. Subject Issuance Issued to

_____________________________________________________________________________________

2004-19 Problems Associated with 11/04/2004 All holders of operating licenses

Back-up Power Supplies to for nuclear power reactors, Emergency Response except those who have

Facilities and Equipment permanently ceased operations

and have certified that fuel has

been permanently removed from

the reactor vessel.

2004-18 Recent Safety-related Event at 10/26/2004 All licensees authorized to

Panoramic Wet-source- possess and use sealed sources

storage Irradiator in panoramic wet-source-storage

irradiators, and irradiator vendors.

2004-17 Loose Part Detection and 08/25/2004 All holders of operating licenses

Computerized Eddy Current for pressurized-water reactors

Data Analysis in Steam (PWRs), except those who have

Generators permanently ceased operations

and have certified that fuel has

been permanently removed from

the reactor.

2004-16 Tube Leakage Due to a 08/03/2004 All holders of operating licenses

Fabrication Flaw in a for pressurized-water reactors

Replacement Steam Generator (PWRs), except those who have

permanently ceased operations

and have certified that fuel has

been permanently removed from

the reactor.

2004-15 Dual-Unit Scram at Peach 07/22/2004 All holders of operating licenses

Bottom Units 2 and 3 for nuclear power reactors except

those who have permanently

ceased operation and have

certified that fuel has been

permanently removed from the

reactor vessel.

Note: NRC generic communications may be received in electronic format shortly after they are

issued by subscribing to the NRC listserver as follows:

To subscribe send an e-mail to <listproc@nrc.gov >, no subject, and the following

command in the message portion:

subscribe gc-nrr firstname lastname

______________________________________________________________________________________

OL = Operating License

CP = Construction Permit