Information Notice 2001-02: Summary of Fitness-for-Duty Program Performance Reports for Calendar Years 1998 and 1999
NUCLEAR REGULATORY COMMISSION
OFFICE OF NUCLEAR REACTOR REGULATION
WASHINGTON, D.C. 20555-0001
March 28, 2001
|NRC INFORMATION NOTICE 2001-02: ||SUMMARY OF FITNESS-FOR-DUTY PROGRAM PERFORMANCE REPORTS FOR CALENDAR YEARS 1998 AND 1999 |
All holders of operating licenses for nuclear power reactors, and licensees authorized to possess or use formula quantities of strategic special nuclear material (SSNM) or to transport formula quantities of SSNM.
The U.S. Nuclear Regulatory Commission (NRC) is issuing this information notice (IN) to provide lessons learned and summarize the data submitted by licensees to the NRC in their fitness-for-duty (FFD) program performance reports for calendar years 1998 and 1999. It is expected that recipients will review the information for applicability to their facilities and consider actions, as appropriate. However, suggestions contained in this information notice are not NRC requirements, therefore no specific actions or written response is required.
Description of Circumstances
Since the fitness-for-duty rule (10 CFR Part 26) was published, licensees have submitted program performance reports to the NRC, as required by 10 CFR 26.71(d). In the past, the NRC summarized and analyzed the data submitted by the licensees and published an annual volume, NUREG/CR-5758, "Fitness for Duty in the Nuclear Power Industry—Annual Summary of Program Performance Reports." In 1998, the NRC issued IN 98-39 to convey this information for the years 1996 and 1997. This IN provides similar information for 1998 and 1999 FFD statistics are provided in Attachment 1.
Lessons learned, management initiatives and problems, and associated corrective actions reported by licensees in 1998 and 1999 are summarized below.
(1) Certified Laboratories
Some licensees continue to experience problems with laboratory performance or have identified potential weaknesses. Licensees also continue to investigate and review adulterant detection strategies to be used by laboratories.
- A licensee assessor noted that a laboratory's quality control blind samples were potentially identifiable. The laboratory is certified by the U.S Department of Health and Human Services (HHS). The laboratory gives the licensee chain-of-custody forms with preprinted numbers and bar codes. However, because the laboratory's blind samples are not processed with the licensee's chain-of-custody forms, the blind sample specimen chain-of-custody forms are out of sequence with the rest of the samples in the tray. The laboratory generates chain-of-custody forms for the blind samples, using the laboratory's next sequential numbers. As an interim corrective action, the laboratory is now mixing samples from different sources in the trays so that the non-sequential chain-of-custody forms for the blind samples will be less conspicuous. The laboratory is trying to design a better solution.
- One licensee reviewed the potential impact of ingestion of hemp seed oil products on tetrahydrocannabinol test results, disseminated its findings to the plant personnel, and incorporated them into FFD training.
- One licensee used Intoxilizer 5000 to verify that over-the-counter substances such as gum, Nyquil, Listerine, etc., do not cause false positive test results.
- One licensee laboratory reported that Klear is an effective adulterant for the marijuana metabolite but is easily detected if the specimen is tested for nitrites. Urine Luck made by Spectrum Laboratory is more difficult to detect but is also a less effective adulterant. Two blind specimens were spiked with marijuana metabolite. Urine Luck was introduced into one of the specimens. Onsite immunoassay screening found both specimens positive for marijuana. The HHS-certified laboratory confirmed both specimens positive, although the quantitation level for the specimen containing Urine Luck was slightly lower (189 ng/ml versus 206 ng/ml). The laboratory did not detect the presence of Urine Luck, not having done the additional adulterant testing it would have done if the screening and confirmation testing were contradictory. The specimens were retested a month later and found with quantitation levels of 163 ng/ml and 193 ng/ml, respectively. The laboratory will do more research to determine if Urine Luck is an effective adulterant for specimens having lower levels of the marijuana metabolite and to determine whether Multistix 10 SG effectively detects this adulterant.
- Other licensees reported they had started testing for the adulterants nitrate, pyridininium chlorochromate, and glutaraldehyde. One laboratory uses Test Sure, manufactured by SmithKline, to test for the following conditions and adulterants: pH, specify gravity, bleach, creatinine, glutaraldehyde, nitrate, and pyridine.
- Inaccurate laboratory results for blind specimens continued to point out human error problems, particularly the use of incorrect cutoff levels and procedural weaknesses. The different Department of Transportation and NRC testing requirements contribute to the use of incorrect cutoff levels, and laboratories should be alert to develop safeguards against this error. The cause of inaccuracies at one laboratory was that the laboratory had no procedure to control parameter changes made by technologists on the screening instrument and to verify parameter settings. The laboratory corrected the problem by assigning passwords for the screening instrument (so that only approved personnel could change the instrument parameters) and by requiring another qualified technologist or supervisor to corroborate any changes before the instrument is used. In addition, the laboratory implemented a procedure to require a special quality control test of the instrument after instrument parameter changes, reagent changes, and calibration. The procedure involves spiking a sample at a concentration approximately twice as high as the highest calibrator.
- Several licensees reported that reviews of adulterant testing showed it to be useful and cost effective.
- Two licensees reported that the number of blind specimens they submitted to the laboratory was below the required 10% for one or more quarters of 1999. In one case, this was due to misunderstandings between the licensee and site FFD programs—administrative responsibilities for these programs were subsequently separated. No explanation was given for the second case.
- After establishing an onsite testing laboratory, one licensee suspended unescorted access for personnel who tested positive for cocaine and marijuana, pending results from the HHS-certified laboratory.
Several licensees reported working with laboratories to improve testing for specific adulterants. Licensees continued to report problems with laboratory performance.
- At one laboratory, a technician scanned the bar code identification on the specimen bottle lid rather than on the side of the bottle. Sample lids had been inadvertently switched, resulting in a sample identification error. The laboratory has eliminated retest bar codes on bottle lids to ensure that technicians scan the sides of specimen bottles.
- Several licensees reported that laboratories used incorrect cutoff levels or failed to test for the full list of substances.
- One licensee reported two blind specimens as negative for opiates when they should have been reported positive. The company that formulated the blind specimens said the blind specimen batches might not have been adequately mixed before they were prepared. In addition, the company was not performing gas chromatography/mass spectrometry on each specimen, only on the batches. The licensee has contracted with a new company to provide blind specimens.
(2) Random Testing
Licensees continued to report incidents in which employees who should have been included in the random testing pool were omitted.
- A licensee reported that it has reinstated a 100% random testing rate.
- Several licensees reported that workers had been improperly excluded from the drug testing pool for extended periods. For one licensee, an employee who returned to the site after a lengthy stint at the Institute of Nuclear Power Operations (INPO) was not put back into the random FFD testing pool because he had been "hardcoded" out of the system. This licensee is reviewing the process of hardcoding individuals out of the pool.
- One licensee reported that it enhanced its quarterly "repetitive task" process for verifying the integrity of the random testing pool.
- Licensees continued to improve their notification process by reducing the interval between notifying and testing employees and/or by keeping them under continuous observation during this time.
- One licensee analyzed the number of random screenings by day of week and the rate of failures for each weekday during 1998 and 1999. The number of random screenings was greatest on Monday and generally fell on each subsequent day of the week. Very few screenings were done on Saturday or Sunday. In 1998 no positive results were identified on Saturdays or Sundays. However, in 1999 the positive rate on these days was very high (Saturday tests had a 12.5% positive rate and Sunday tests a 15% positive rate). The analysis suggests potentially useful changes to the testing schedule.
Licensees continued to report incidents in which employees who should have been included in the random testing pool database were not included.
- A licensee that did weekly quality control checks of the random pool discovered a software program interface problem as a result of which contractors were omitted. One weekly check showed 110 contractors to have been omitted.
- Another licensee reported that a new contract worker had not been included in the random test pool for the first draw after being badged and starting work.
Several licensees reported having improved their FFD policies and procedures on the basis of their experience over the years.
- Another licensee reduced its marijuana cutoff value from 100 ng/ml to 50 ng/ml.
- One licensee introduced a lower cutoff value for alcohol testing for individuals in the followup program due to a previous positive test result for alcohol.
- One licensee reduced its testing list of drugs after finding that there had only been a single positive for barbiturates and benzodiazepines since its program was implemented in 1990.
- One licensee changed its specimen collection procedures to include an observed collection if the urine sample fell outside the range of 93-98 degrees Fahrenheit and an oral temperature did not match the urine temperature.
- Some licensees have instituted a zero tolerance policy, denying an employee access after a first positive drug test result.
- More licensees now count the detection of adulterants as a positive test result and sanction employees accordingly.
- A licensee prepared the following policy statement on prescription marijuana and cocaine and communicated the statement to its employees:
"Certain drugs listed in the Controlled Substance Act such as marijuana and cocaine may be legally prescribed and used in certain states. However, federal regulations do not allow involvement with or possession or use of these drugs with or without a prescription by individuals assigned to [licensee name]."
- Several licensees found weaknesses in their FFD records management procedures. In two cases, the records management process was adequate but not appropriately documented in procedures. In another case, FFD records being prepared for shipment to another location for imaging were not stored in 1-hour fire rated cabinets, as required in the site-established procedures. In a fourth case, a licensee found that the logbook maintained by the FFD program did not satisfy the definition of a permanent, bound record book.
- One licensee found that its procedures failed to specify FFD program training required for personnel assigned to work in the FFD program.
- To enhance overall FFD at the site, one licensee now requires employees to report non-job-related injuries to a supervisor or manager before the start of work or training activities if the injury could impair the employees' ability to safely perform job assignments. The supervisor evaluates injured employees' fitness and accommodates them as necessary.
- At one site, a computer data entry error allowed a contract worker to enter a protected area before the worker passed a pre-access test. Appropriate FFD personnel were trained and the access authorization process modified to prevent this from happening again.
- One licensee introduced limits on how much time an employee may take to give a urine specimen and how much water he may drink beforehand.
- One licensee specified that requests for retesting be made within 72 hours.
- One licensee reported that an event at another licensee's site helped it identify and address a potential weakness at its own site. The event involved an FFD testing technician who recorded drug screen test results as negative before they were validated by the medical review officer (MRO). As a result, access was granted to a few individuals whose test results were later reported to be positive. To prevent this from happening at its own site, the licensee revised its procedures so that access authorization personnel can only accept reports that have been prepared by the MRO.
- One licensee updated its FFD procedures to include a precise formula by which to calculate blood alcohol concentration when an employee arrives at work.
- One licensee discovered that its pre-employment testing protocol implied breathalyzer testing irrespective of whether the candidate had yet been offered a job, leaving the licensee vulnerable to being found in violation of the Americans With Disabilities Act.
- One licensee initiated a standardized chain-of-custody form throughout its sites.
(4) Program and System Management
Licensees continued to report improvements in overall FFD program management.
- One licensee planed to merge FFD with Access Authorization to improve coordination and eliminate the potential for errors. This licensee is also trying to refine FFD performance indicators.
- A few licensees reported weaknesses in their behavioral observation programs because of insufficient training. Others reported improvements in their behavioral observation programs.
- FFD awareness activities continued to be reported (e.g., sending articles and newsletters to all employees, giving to all employees refrigerator magnets with the toll free employee assistance program telephone number).
- One licensee encouraged supervisors to complete refresher FFD training on time. The licensee now rigorously monitors overdue supervisor FFD training, sends an action request, and suspends unescorted access for a delinquent supervisor and for the workers who report to the supervisor.
- At one site it was discovered that supervisors who were not badged for unescorted access but who were required to report to the emergency operations facility did not have appropriate FFD training. Corrective actions were implemented to track FFD training requirements for nonbadged supervisors.
- Several licensees reported the value of canine searches in enhancing antidrug awareness at their sites, even the searches that typically did not discover drugs.
This information notice requires no specific action or written response. If you have any questions about the information in this notice, please contact the person listed below.
| ||/RA/ |
Ledyard B. Marsh, Chief
Events Assessment, Generic Communications and Non-Power Reactors Branch
Division of Regulatory Improvement Programs
Office of Nuclear Reactor Regulation
|Technical Contact: ||Garmon West, Jr., Ph.D. |
(ADAMS Accession Number ML010250419)
Page Last Reviewed/Updated Wednesday, March 24, 2021