ML18095A558
| ML18095A558 | |
| Person / Time | |
|---|---|
| Site: | Salem, Hope Creek  |
| Issue date: | 05/15/1990 |
| From: | Albert R, Bush L, Della Ratta A, Keimig R, Pirtle G, Ratta A NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I) |
| To: | |
| Shared Package | |
| ML18095A556 | List: |
| References | |
| 50-272-90-10, 50-311-90-10, 50-354-90-07, 50-354-90-7, NUDOCS 9011050375 | |
| Download: ML18095A558 (16) | |
See also: IR 05000272/1990010
Text
U. S. NUCLEAR REGULATORY COMMISSION
REGION I
.
.
50-272/90-10
50-311/90-10
Report Nos.
50~354/90-07
50-272
50-311
Docket Nos. 50-354
License Nos. NPF-57
Licensee:
Public Service Electric & Gas Company
Facility Name:
Artificial Island Nuclear Generating Station
..
Inspection At:
Hancocks Bridge, New Jersey
Inspection Conducted:
March 12-15, 1990
Type of Inspection:
Initial, Fitness-for-Duty.
Inspectors:*
Inspector
L. Bush, Jr., Chief~ Program Development
and R~view Section, NRR/RSGB
A. Della Ratta;afe9Uards Auditor
- ~-£>Q~**
Approved by:*
Approved by:
G. L. Pirtle, Plant Protection
Analyst, Rill
~q}.~!~C> .
- .
R. R. Keimig, Chief, Site uards Section
Div
ion of Radiation Safety and Safeguards*
?
.
Bush, Jr., Chief, Program Development
Review Section; NRR/RSGB
.9011050375 901019
.
ADOCK 05000272.
G
PNU
CS-.;_IV-CJ D
date*
.. date
s I *~lqd
c:tate
-*~aazo
. 'date
Inspection Summary:
Initial, Fitness-For-Duty Inspection (Combined Inspection
Report Nos. 50-272/90-10, 50-311/90-10 and 50-354/90-07)
Areas Inspected:
Written policies and proc~dures; program administration;
'training, key program processes and onsite testing facility.
Findings:
Based upon selective examinations of key elements of PSE&G 1 s
fitness-for-duty program, the objectives of 10 CFR Part 26 are being met.
Management support for th.is program was evidenced by the qua 1 ity of the
facilities and the staff who administered the program.
However, there were
some .weaknesses in the implementation which can be expected for a new
program.
The more significant of these are as follows:
1.
Although policies were included in staff procedures provided the
individuals affected by the FFO program, there was no written policy on
drugs which met the requfrements of 10 CFR 26.20(a).
By letter dated
April 17, 1990, PSE&G forwarded to the NRC a written policy statement
that met the requirements.
(Reference paragraph 4).
This is a non-cited
violation.
2.
The licensee permitted flexibility in scheduling random tests, foll6wing
a supervisor to *request postponement of the test until later in the day
if it would be a significant inconvenience or an interruption of
important work.
This program feature has the potential for abuse that
could result in a delay of 8-12 hours in testing. (Reference paragraph
7a).
This is an unresolved item.
3.
Several corporate and contractor personnel who have infrequent unescorted
access were not subject to random testing while not working at the site
and are not routinely rescreened after more than 60 days absence.
(Reference paragraph 7a).
This is an unresolved item pending evaluation
of corrective action initiated by the licensee.
4.
The licensee did not collect specimens between 7:00 p.m. and 6:00 a.m. on
weekdays.
This predictable gap in scheduling diminishes the deterrent
- effect of random testing.
(Reference paragraph 7b).
This is an
unresolved item.
5.
Custody of blood specimens was not properly mai~tained. The licensee
took immediate corrective action by ensuring that technicians followed
procedures.
(Reference paragraph 7b).
Areas Inspected:
Written policies and procedures; program ~dministrat1on*
training, key program processes and ons1te testing facility.
Findings:
Based upon selective examinations of key elements of PSE&
s
fitness-for-duty program, the objectives of 10 CFR Part 26 are bein met.
Management support for this program was evidenced by the quality
the
facilities and the staff who administered th_e program.
However, there were
some weaknesses in the implementation which can be expected fo -a new program.
The more significant of these are as follows:
1.
Although policies were included in staff procedures
ovided the individuals
affected by the FFD program, there was no written P,
icy on drugs which
met the requirements of 10 CFR 26. 20(a).
By lett
dated April 17, 1990,
PSE&G forwarded to the NRC a written policy sta ment that met the requirements.
(Reference paragraph 4.) This is a non~cited
olation.
2.
The licensee permitted flexibility in sched ing random tests, allowing a
supervisor to request postponement of the est, until later in the day if
it would be a significant inconvenience r an interruption of important
wotk.
This program feature has the po
ntial for abuse that could result
in a delay of 8-12 hours in testing. (Reference paragraph 7a.) This is an
unresolved item.
-
3.
Several corporate and contractor personnel who have infrequent unescorted
access were not subject to ran m testing while not working at the site
and are not routinely rescree ed after more than 60 days absence.
(Reference
paragraph 7a.) This is an
resolved item pending evaluation of corrective
action initiated by the l * ensee.
4.
The licensee did not c lect specimens over the weekends and between 7:00
p.m. and 6:00 a.m. o weekdays.
This predictable gap in scheduling diminishes
the deterrent effec of random testing.
(Reference paragraph 7b.) This
is a non-cited
ation.
5.
Custody of blo
specimens was not properly maintained.
The licensee took
ective action by changing the procedure. _(Reference paragraph
a non-cited violation.
- - -1
DETAILS
1.
Key Persons Contacted
The following personnel attended the exit meeting on March 15, 1990:
Licensee
D. Coles, Medical Services Supervisor
G. Connor, General Manager-Nuclear Services
T. Crimmins, Vice President Nuclear Engineering
-B. Espinosa, Manager-Nuclear Human Resources and
Administrative Services
R. Fisher, Screening Supervisor
J. Fleming, Senior Staff Engineer-QA
A. Giardino, Manager-QA Programs and Audits
W. Grau, Senior Staff Engineer-Licensing
E. Hall, Employee Relations Manager
M. Ivanick, Senior Security Regulatory Coordinator
L. Krajewski, Site Access Administrator
J. Lawrence, Legal Intern
R. Mack, Medical Director-Nuclear
R. McCarthy, Psychological Services Administrator
S. Miltenberger, Vice President CNO
P. Moeller, Manager-Site Protection
B. Preston, Manager-Licensing and Regulations
L. Reiter, Manager-Nuclear Engineering_ Projects
D. Renwick, Nuclear Security Manager
C. Rokes, Licensing Engineer
C. Sauder, .Personnel Affairs Manager
8. Thomas, Associate Engineer
M. Walton, Medical Administrator-Nuclear
N. Wetterhahn, Attorney
J. Zupko, Jr., General Manager-QA/NSR
USN RC
T. Johnson, Senior Resident Inspector
R. Keimig, Chief, Safeguards Section~Region I
S. Pindale, Resident Inspector
G. Tracy, Resident Inspector
The inspectors also interviewed other licensee and contractor personnel
who did not attend the exit meeting.
The following Battelle personnel, who are under NRC contract, participated
in the inspection:
N. E. Durbin, Research Scientist
J. Olson, Senior Research Scientist
4
2.
Entrance and E~it Meetings
The inspectors met with the licensee representatives; as indicated above,
at the Salem/Hope Creek site on March 13, 1990, to summarize the scope and *
purposes of th~ inspection and on March 15, 1990, to present the inspectiori
findings.
3.
- Approach
The inspect ion team evai uated .the 1icensee 1 s Fitness-for-Duty (FFD) Program
using an NRC draft Temporary Instruction,* Fitness,..For-Duty:
Initial
Inspection of Program .Implementatfon. *This evaluation included a revi~w
of the licensee's written policies and procedures and program_implementation,
as required by 10 CFR 26, in the areas of: management support; selection
and notification for testing; collection and processing of specimens; chemical
. testing for illegal drugs and alcohol; FFD training and worker awareness;
the e~ployee assistance program; management actions including sanctions;
appeals; audits; and maintenance and protection of records; The review of
the program imp 1 ementat ion i nvolVed i ntervi.ews with key FFD program personne 1
and a sampling of the licensee's employees and contractor employees with.
unescorted plant access, a review of relevant program records, and observation
of k.ey processes, such as specimen collection and onsite screening processes ..
4.
Written Policies and Procedures
the licensee has recently undertaken significant changes in its Fitness-
for-Duty policy and programs iri order to comply with the requirements under
The NRC was notified that the program had been fully implemented
by letter on January 3, 1990.
The inspection team compared the licensee's
written poiicies*and procedures to. those required under 10 CFR 26 to assure
that the required policies and prdcedures had been ~eveloped, that their
content was in compliance with the rule, and.that their quality and level
of detail provided for an effettive program.
The inspection team had the
following observations:
.o
While the licensee had communicated its drug policy through training,
higher level management and implementing p_rocedures, licensee staff
could not produce a copy of an off;cial*policy statement on the use
of illegal drugs on the part of individuals covered by the rule, as
required by 10 CFR 26.20(a), "Written *policy documents must be in
sufficient detail to provide affected individuals*with information*
on what is expected of them, and what consequences may result from a
lack of adherence to the polfcy.
11 The licensee issued a policy on
alcohol in November 1989, which made reference to a corporate policy*
on drugs, as a!l'lended by.the Nuclear DiviSion. The corporate policy
which had been issued in 1985~ did not cover the policies that al_l *
licensees committed to develop in response to the NRC's Policy Statement
published in the Federal Register on August 14, 1986.
The expected *
.
0
0
0
0
5
.
.*
written policies appeared to be included in written procedures developed
by the various staff elements administering the FFD program, however,
these documents are not pro.vided to the affected individuals.
The
licensee agreed to develop a written policy statement that included
all applicable aspects of 10 CFR 26, which.was forwarded to the NRC
by letter dated April 17, 1990. Although this was a v1olati0n of 10
CFR 26.20(a), the violation is not being cited because the criteria
specified in Section V.A. of the Enforcement Policy were satisfied.
Procedures were not developed to a reasonably consistent level of
quality. Specifically, higher order procedures (Vice President -
Nuclear ADP-12 and NC-NA-AP.ZZ-0042) assigned responsibilities and
established broad program objectives which covered the several areas
required by the rule.
However, detailed implementing procedures for
the appropriate departments, in some cases, were not available, as
required by Section 8.2.2 of Procedure VPN-ADP-12.
Examples include
elements of the selection and notification process, the appeals process
(in draft format), and the process for evaluating program performance.
Interviews disclosed that no specific procedures had been developed
by the Nuclear Employee Relations Manager to address the assigned FFD
program implementation functions, including those relative to the FFD
appeal process as described in Section 3.7 of Procedure NC-NA-AP.ZZ-0042.
Additionally, no specific procedure had been developed by the Personnel
Affairs Manager for the FFD appeal process, as described in Section
3.11 of the above procedures.
In some of these *reai, the licensee
expressed an iritention to develop detailed procedures in the near
future.
A detailed review appears warranted to assure that departmental
procedures have been prepared to assure responsibilities assigned by
the higher tier documents are addressed.
The licensee's procedure (NC-NA-AP.ZZ-0042) did not clearly reflect
the requirement that the licensee will notify the NRC of certain per-
formance problems in its Department of Health and Human Services
(HHS)-certified laboratory, as required by 10 CFR 26, Appendix A,
2.8.(e)(4) and (5).
The li~ens~e stated that it w6uld revise its
procedures to address thi~ issue.
In some cases, existing procedures *nd current practices were not
clear. These include the procedure to use security staff to conduct
"for cause testing during the back ~hift (generally limited to breath
analysis testing) and Section 5.14.1.3 of Procedure NC-NA-AP.ZZ-0042
which mandates that misuse of prescription and over-the-counter drugs
will result in the same sanctions as use of illegal drugs.
In practice,
the Medical Review Officer (MRO) uses judgement as to whether "misuse"
warrants imposition of a sanction.
While most staff members involved in the FFD program were found to be
performing their jobs at a high level of proficiency, the possibility
of inadvertent errors in the discharge of these duties i~ increased
6
-- by the lack of detailed procedures for some functions.
The inspectors
. found that Section 8.2.2 of Vice President - Nuclear Procedure ADP-12,
Revision 1, requires that appropriate procedures for the. FFD program -
-be developed and ut i.l i zed by those departments with specific program
responsibilities.
5.
Program Administration
- Following are the inspectors' findings wi~h respect to the administration
of key elements of the licensee's FFD program. -
a.
D~lineated Respon~ibilities
Overall program responsibilities have been clearly de_l ineated by the
licensee's primary FFD program procedures (NC-NA-AP.ZZ-0042).
In
general, major FFD program functions have been assigned to appropriate
-staff elements.
b. -
Management Awareness of Responsibilities
With the exception of the licensee's responsibility to report to the
NRC performance problems at the HHS-certified -laboratory, managers of_
the program functioris appeared to be aware of their resporisibilities,
as described in procedure NC-NA-AP.ZZ-0042.
c.
Program Resources
Program resources currently appear adequate.
FFD program staff with
assigned program functions report that upper management, both at th~
site and-corporate levels, have been very supportive in providing the
necessary program resources.
The licensee staff reported very li.tt le_
additional impact because of the rule requirements. -The exception is
the Medical Department where both work.load and staff have expanded
su~~tantially~ - While resources in the ~edical Depaftment appear to
be keeping up with demand, the occurrence:of.three scheduled outages
in 1990 and the resulting increase in the number of. drug and alcohol
screens may place a strain on the staff. The licensee plans to increase
its FFD staff to cope with the work.load. The.::physical _facilities
available for the -FFD program are new, spacious,:0well-maintained, and
excellent housekeeping practices were noted. -The c;msite . .FFD testing
.area, the laboratory facility for preliminary-screening te-sts, the
medical support area, the facilities for the Medical Review Officer
(MRO), the several classrooms, and security's access processing
operations are all located in one building. This ~ontributes to timely --
and efficient coordination of operations amorig the various personnel
responsible for implementing most elements of ~he program.
The
facilities av'ailable to support the FFD program may well be a model
for other utilities.
-
7
The laboratory facility was adequate* in size, locked at all times,
and visitor access controlled and recorded on an access log.
Physical
security upgrades were planned to compensate for some structural
vulnerabilities identified during a February 1990 audit by the'
licensee.* The security upgrade project is schedule .to be completed
by .the end of Apri 1 1990.
d.
Management Monitoring of Program Performance
It appears that management monito.ri ng of program performance will be
adequate, with the following:
0
0
The fitness-for-:-duty program administrator was also the manager
of Nuclear Human Resources and Administrative Service~. * While
it is desirable to assign management responsibilities to
someone with the authority to take action to assure program*
- success, the inspectors had som~ concerns that the progra~
administrator was at a level with so many disparate*
responsibilities that the ad~inistrator was not sufficiently
aware cif the day~to-day operation of th~ program to be able t~
effectively monitor and coordinate program perf6rmance and
identify pro.gram weaknesses.
.
.
'
.
.
A strategy for assessing program performance and.analyzing
- .*program performance data has not yet been developed.
While the
medical department has begun to trend and analyze data from the
chemical testing program, workload pres~ures and other factors
have inhibited the staff from pursuing ~ts plan to d~velop an
approach designed to identify program weaknesses, as required
by 10 CFR 26.7l(d).
.
'
'
'
e. *
Measures Undertaken to Meet Perfor.mance Objectives of the Rule
The licensee has provided more than adequate resources and personnel
to meet the performance objectives of the.FFD rule.
However, some.
areis of concern were identified:
0
0
0
Although the se~rching of persons, packages, and vehicles entering
the protested area ~ontributes to achieving the performanc~ objective
of a drug-free workplace, as stated in 10 CFR.26.lO(c), the licensee
does not specifically conduct searches of the workplace for drugs,
which could further contribute to achievin~ that performance
. objective.
The licensee has not yet devised a method of random testing of
personnel granted unescorted access who are seldom onsite.
(This is discussed in more detail in paragraph 7a).
The licensee's practices.did not include certain actions that
could be taken in response to confirmed positive test results.
These actions could include an attempt to identify the sources
of the drugs consumed, and a review of previous w6rk.
d.
e.
7
The laboratory facility was adequate in size, locked at all times,
and visitor access controlled and recorded on an access log.
Phys
security upgrades were planned to compensate for some structural
vulnerabi.lities identified during a February 1990 audit by the .icensee.
The security upgrade project is scheduled to be completed by
e .end
of April 1990.
Management Monitoring of Program Performance
It appears that management monitoring of program
adequate, with the following:
0
0
The fitness-for-duty program administrator
s also the manager
of Nuclear Human Resources and Administri ve Services. While
it is desirable to assign management res onsibilities to someone
with the authority to take action to a ure program success, the
inspectors had some concerns that the program administrator was
at a level with so many disp~rate r ponsibilities that the
administrator was not sufficientl.Y. aware of the day-to-day operation
of the program to be able to eff tively monitor and coordinate
program performance and identif program weaknesses.
A strategy for assessing pr ram performance and analyzing program
performance data has not y
been developed.
While the medical
department has begun to
end and analyze data from the chemical
testing program, worklo ~ pressures and other factors have inhibited
the staff from pursui
- its plan to develop an approach designed
to identify program eaknesses, as required by 10 CFR 26.7l(d).
Measures Undertaken
eet Performance Objectives of the Rule
The licensee hasp~ vided more than adequate resources and personnel
to meet the perfo ance objective of the FFD rule.
However, some
areas of concer were identified:
0
0
Althoug
the searching of persons, packages, and vehicles entering
- the pr, tected area contributes to achieving the performance
obje ive of a drug-free workplace, ;as'..st_ated in 10 CFR 26.lO(c),
th licensee does not conduct searches*of~he workplace with
d ug detection dogs which could contribute .*to achieving that
erformance objective.
The licensee has not yet devised a method of random testing of
personnel granted unescorted access who are seldom onsite. (This
is discussed in more detail in paragraph 7~).
The licensee's practices did not include certain actions that
could be taken in response to confirmed *positive test results.
These actions could include an attempt to identify the sources
of the drugs consumed,. and a review of previous work.
8
f.
Sanctions
The licensee's procedures establish sanctions as set forth by the FFD
rule; except for sanctions on misuse of legal drugs.
Acco~ding t6
. Section 5.14.1.3 of the licensee's nuclear admini~trative procedure
NC-NA-AP.ZZ-0042, the misuse of legal dr'ugs shall be subject to the
same _sanctions as those for illegal drugs.
However, the Medical Review
Officer stated that he exercises judgment as to what constitutes
enforceable misuse of legal drugsr The "shall" in the procedure is
appropriately "may" in practice; the licensee should mak.e the
. appropriate revision to that procedure ...
As permitted by the FFD rule, PSE&G permi.ts contractor employees who*
have been denied access based upon the first cbnfirmed positive test *
to regain their unescorted access status on the condition that they .
. provide evidence of rehabilitati~n and abstinence, are free of substances,
and undergo follow-up testing for three years..
g.
Employee Assistance Program
The licensee's implemented Employee Assistance Program (EAP) appeared
adequate in meeting the requirements of the rule.
In some cases, the
licensee has gone beyond normal ~xpectations, in"that insurance coverage
is provided for employees who lack-the coverage and need rehabilitation
treatment, and EAP services are provided for "permanent" contractors.
The staff and adequate facilities were available on si.te to address
FFD referra 1 s.
6.
Training
Thj licensee's FFD training pro~ram did not achieve some of the desired
objectives. The inspectors' evaluation was based on comments by resident
inspectors who attended the training, and on iriterviews with licensee and
contractor personnel, as follows:
a.
Program Awareness
.While personnel interviewed were aware.of FFD .testing, they did not
appear to understand fully the scope of the prrigram and its intended
~ositive impact on the work.place.*
b.
Worker Perceptions
It appeared the licensee. had not adequately *allayed employees' ap-
prehension toward false positives.
Nor did it appear that the licensee
provided information to assure that test ~esults would be valid and
reliable, and that any employee could be tested randomly at any time.
The workers conveyed to the inspectors:
..
.*
0
0
0
9
Strong convictions, particularly by contracto.r employees, that
employment would be terminated because of a false positive.
A perception that consumption of poppy seeds was a means of
circumventing the program.
A perception that the large volume of peop°le tested reduces
the odds of being randomly selected for an ~mmediate retest.
c.
Supervisor and Escort Understanding of Responsibil~ties
Supervisors and escorts appeared knowledgeable of their functions,
b1Jt there were concerns expressed that training on*drug recognition
and behavioral observation needed to be more indepth.
Supervisors may n6t be sufficiently sensitive to va~ious impairing
conditions of the workers and to the potential adverse impacts on the
work schedules when these conditions are ignored.
Some examples:
0
Although several work~rs had reported taking prescription or
over-the-counter medication which caused drowsiness (such as
codeine), these individuals apparently were put to work in
potentially hazardous situations.
7.
Key Program Proce*sses *
a.
Selection and Notification for Testing
Selection for random testing was conducted by use of a computer
generated list .. The computer software is designed to prevent access
to or tampering with the random selection process and, once the
selection process is initiated, the computer is not affected by
manipulation. Additiona*l.ly, names could not be added to or deleted.
from the random selection process once it was init~ated ..
Notification of personnel selected for testing was accomplished by a
FFD staff member, a medical t'erk who contacted FFD co6rdinators for
the appropriate dep~rtment and advised them of the personnel scheduled
for chemical testing arid made an appointment for the te~t~ .The supervisor
is permitted to request postponement of the test until later in the
day if it would be:a significant inconvenience or an interruption of
important work.
The FFD coordinators, supervisors and the Medical
Clerk coordinated to reschedule the test for later the same day.
However, abuse of this program feature could result in .a delay of 8
to 12 hours1.388889e-4 days <br />0.00333 hours <br />1.984127e-5 weeks <br />4.566e-6 months <br /> in the test - sufficient time to avoid detection of the
abuse of some substances, .particularly alcohol. In addition, the current
- FFD program does not limit the .time between when a person *1s advised
he or she was selected for testing and his or her scheduled test time.
i
10
In practice, the staff attempts to limit the time between notification
and the test. However, the program, as currently administered, could
~llow a person to be advised at 7 p.m; that he or she has been selected
for FFD testing and the actual testing could conceivably not occur
. until 6 a.ni. or later the following day.* This vulnerability has been
somewhat compensated for byattempting to test personnel on back.shifts
either before going to work. or after work.
This issue is considered
an un~esolved item (272/90-10-01; 311/90-10-01~ 354/90-07-01).
Approximately 1000 personnel authorized unescorted access (issued a * .
key card badge) areassigned to various.categories of jobs or locations
that are not onsite and infrequently have access.
Collection of specimens
is generally limited to when they are onsite, and therefore these
individuals are seldom tested when randomly selected.
The 11predictabil.ity
11
of testing under this approach -~ignificantly redu~es the det~rrent
effect of random testing because it allows the personnel involved to
perceive a means to avoid random testing.~ As the licensee's program
is implemented, personnel having infrequent access could be chemically
tested at a lower frequency than the onsite workers.* In addition,
other categories of personnel ~ay perceive that testing criteria is
inequitable.
The licensee's February 1990.Quality Assurance audit
issued a finding pertaining to this observatibn; corrective actions
were being considered and weres.cheduled for resolution by March 31,
1990.
Subsequent to the inspection, the inspectors were informed*
that the licensee had taken corrective action. this* issue is considered
an unresolved item (2-72/90-10-02; 311/90-10-02; 354/90-07-02).
Provisions had been established to accomplish "for cause" testing of
. backshift personnel when needed.
Testing for alcohol abuse would be
performed by designated and trained security force personnel.
Laboratory
. personnel would be called in to collect and test urine specimens and
- to draw blood if requested by the individual for further confirmatory
testing for alcohol ~buse. Sufficient breath analysis equipment was
available onsite to perform initial and confirmatory tests.
The sele~tion and notificatio~ proc~ss files contained, among other
things, copies of the random selection list, record of telephone calls
made for notification and scheduling purposes~ and written verifications
pertaining to reasons for not testing a person who was randomly selected.
The files reviewed were generally complete, accurate, and well maintained.
However, in some cases, the form. used to obtain written verification
from management of the reasons why.a selected person was excused from
random testing was not received by the medical department until a
- week or more after the scheduled test date.
More timely responses
appear warran~ed to allow followup on any problems encountered with
persons excused from testing situations.
.-
.:*.1
11
b.
Collection and Processing of Specimens
The inspectors evaluated collection and processing of specimens by
observing another fnspector, who was subjected to the breathalyzer
and who actually gave a ~rine sample, so through th~ sc~eening
process.
Those specimens were properly identified, positively
contra ll ed, and processed according to the 1 i censee' s procedures and
the rule.
However, while p*rocessing the simulated blood specimen provided* by
the inspector, the*chain-of-custody was not ~roperly maintained, in
that the onsite testing laboratory technician had t~mpor<J.rY custody
without signing the chain-of-custody form.
The licensee took
immediate corrective action by ensuring that technicians foll.owed
procedures to.take the blood specimen directly to secure storage
pending shipment to the HHS-c.ertifi ed laboratory.
The licensee does not te~t between 7~00 p.m. and 6:00 a.m. on
weekdays.
The licensee had explored the possibility of testing
during off-hours, but the effort was not cons*idered productive for
- several reasons:
a.
It required three people to admini~ter the testing, roughly
equivalent to the number of workers tested.
b.
The people on these shifts may be tested early or late during
their shift; plus they rotate shifts and are subject to *
behavioral observation.
c.
No positives have resulted, to date,' and there is a
low-positive rate for the entire workforce.
This predictable gap in scheduling diminishes.the deterrent effect
of random_ testing.
This issue is ~onsidered an unresolved item
(50-272/90-10-03; 50-311/~b-10-03; 50-354/90-07-03).
c.
Dev~lopment, Use~ and Storage of Records
A system of files and procedures to protect personal information
contained in FFD related records had bee~~evel6ped. Such rec6rds
.were used and stored in an- appropriate manner. *Medical-related records
were routinely stored within a fire retardant storage rbom in.the
medical services area which was routinely_ locked durin~ non-working
hours_
Acceis to such records .was limited tb medical and clerical
staff members who had job-related "need-to-know" **responsibilities.
Results of quality control and confirmatory tests-from the HHS
laboratories were routinely delivered by express mail to the Laboratory
' ~
11
b.
-Collection and Processing of Specim~ns
c.
The inspectors evaluated collection and processing of specimens b
observing anoth~r inspector, who was subjected to the br~athaly r
and who actually gave a urine sample, go through the screening recess.
Those specimens were properly identified~ positively ctintrol d, and
proce~sed according to the licensee's procedures and the rue.-~
However, while processing the simulat~d blood speci~eri R ovided by
the inspector, the chain of custody was not properly m ntained,-in
that* the onsite testing laboratory technician had te orary custody
without signing the chain-of-custody form.
The lie nsee took immediate
corrective action by changing the procedure to ta
the- blood specimen
directly to secure storage pending ~hipment to
e~HS-certified __
laboratory. -Although this is a violation of S tion 2.4(d) of Appendix
A to 10 CFR Part 26, ihe violation is not be" g cited becaus~ the
Criteria specified in Section V.A. of the E orcement Policy were
satisfied.
_The licensee does not test between 7:0
pm and 6:00 am on.weekdays
and over the week.ends.
The licensee ad explored the possibility of
testing during the off-hours, but t
effort was not considered
productive for several reasons:
a.
It .required three
equivalent to the
administer the testing, r6ughly
of workers tested.-
b.
The people on these s ifts maY be tested e*arly or late during*
their shift~ plus t
y rotate shifts and are subject to behavioral
c.
observation.
No positives
rate for the
e resulted, to date, and there is a low-positive
tire work. force.
This predictabl
gap in scheduling dimini~hes the deterrent effect
of random tes ng.
Although this is a violation of 10 CFR 26.24,
the violatio is not cited because the criteria in Section -V.A. of
the Enforc ent Policy were satisfied.
Use
and Stora e of Records
A sy
em of files and procedures to protect personal information
co
ained in FFD related records had been developed.
Such records
w re used and stored in an appropriate manner. - Medical-related records
ere routinely stored within a fire retardant storage room in the
medical services area which was routinely locked during non-working
hours.
Access to such records was limited to medical and clerical
staff members who had job-related "need to know" responsibilities.
Results of quality control and confirmatory tests from the HHS
laboratories were routinely delivered by express mail to the Laboratory
it::, ..
- 12
Supervisor or by electronic transmission to a terminal loca-ted within
the secured laboratory facility.
The Laboratory Supervisor collects
the results of the onsite testing and the laboratory report, which
are then provfded to the MRO *. Adequate controls were also implemented -
for computer-related information~ Passwords we~~ required for access*
to the data, and personnel with access -capabilities had a work-related
need for such access. Interviews disclosed that the computer programmer
had been subject to the same type of psychological evaluation and *
-
background irivestigation as the FFD st~ff members.
-
The Quality Assurance department noted in its February 1990 aud-it
-'that some FFD related records (such as continuous behavioral observation
records) _needed to be included and/oridentified as part-of the FFD
-
record files. - The audit findings were scheduled_ to be resolved.by
March 31, 1990.
-
-
One practice noted during the inspection detracted from the generally
stringent controls for FFD-related-records.
By practice, presumptive
positive test reiults noted during the i~itial onsite screening test_
(pre-atcess) were given to a nurse for storage in her desk until the
confirmatory test results were received from the HHS laboratory. A
clerk within the Medical Department was aiso advised of the presumptive
positive test results for applicants for unesco_rted access so an
administrative- hold could be placed on issuing a security badge (the
reason -for the administrative hold did not appear in the ~omputer
data.) Since a presumptive positive is identified only as an
administrative hold and there are many other reasons for administrative
hold, the licensee's staff believed that individual rights were
proteeted.
Retaining presumptive. positive test results within the
laboratory until confirmatory test results are received appears to be
a more appropriate control of access to the information, provides a
more secure storage location, and prevents subsequent administrative
action on such *presumptive positive test results.
d.
Audit Program*
The licensee had completed Quality Assurance._(QA) audits of the_ FFD
progra*m implementation and audits of the-*two_:HHS~laboratories that
are used to perform testing services and redundant .-quality checks_.
The scope and depth of the audits were excellent and.:addressed all
major elements of the FFD program. *Audit findings were techn1cal ly
correct and well defined.
Initial responses to*the audit findings
were scheduled to be completed by March 31, 1990.
The audit findings
we~e generally consistent with the observations of the NRC team
members.
I
r
- - - - - - - - - -
-
8.
13 .
Onsite Testing Facility -
The onsite testing facility was centrally located~ modern, spacious,
well-equipped, and adequately staffed by persons who. displayed a high
level of proficiency. Aside from- s6me minor concerns, such as a
_
- considerable amount of personnel traffic, some of which criss-crossed
during the specimen collection process, the facility more than adequately
meets the intent of the FFD rule.
a.
Written Procedures_
-
.
Written procedures had been.developed for key functions and processes.
The testing facility procedures were not reviewed by the inspectors,
therefore no conclusions are made coric~rning thei~ adequacy or
whether they meet regul ato*ry requirements.
- b.
Practices
Practices were in accordance with the general intent of the FFD rule.
c.
Quality Controls
The inspecto~~ verified that the\\ltcense~ followed the blind performance
test procedures.
The quality tontrol measures met the intent of the
FFD rule.
To help assure that test rejults are valid, the li~en~ee splits all
urine specimens and the litensee sends all presumptive positive
preliminary tests and blind performance test specimens to two separate
HHS-certified l_aboratories for further testing.
d.
Security
The licensee self-identified a physical security weakness that exists
in the testing facility, and has initiated corrective action, as
described in paragraph Sc, above.