Frequently Asked Questions About Audits
This section provides the NRC staff's answers to the following questions related to audits, as it relates to fitness-for-duty:
Is it necessary to review the laboratory's completed U.S. Department of Health and Human Services (HHS) inspection records in order to determine which items of the HHS inspection records are acceptable to the utility? If so, what records or reports are provided to the HHS-certified laboratory, and how does a licensee obtain these documents?
Yes, licensees and other entities who are subject to the rule must review HHS inspection reports and records as one portion of the auditing activities required under §26.41 of the March 31, 2008, rule. These reviews are necessary in order to ensure the continuing effectiveness of the FFD program, including ensuring that corrective actions are taken to resolve any problems identified by the HHS certification inspections.
In addition, §26.41(c)(2) requires, in part, that licensees and other entities "review the HHS certification inspection records and reports to identify any areas in which the licensee or other entity uses services that the HHS certification inspection did not address." The intent of this provision is to ensure that licensees and other entities audit "any areas" that the HHS inspection did not evaluate where the HHS-certified lab is providing services to licensees and other entities that are outside the scope of the HHS certification inspection. Accordingly, audits performed by licensees and other entities must review the inspection records and audit any areas in which licensees and other entities use services that the HHS certification inspection did not address.
The discussion on page 17030 of the March 31, 2008, Federal Register notice (73 FR 16966 ), states, "The NRC has added §26.41(d)(2) to ensure that licensees' and other entities' contracts with C/Vs and HHS-certified laboratories permit the licensee or other entity to obtain copies of and take away any documents that auditors may need to assure that the C/V, its subcontractors, or the HHS-certified laboratory are performing their functions properly and that staff and procedures meet applicable requirements." Therefore, through §26.41(d)(2), the NRC has ensured that access to these inspection reports will enable licensees and other entities to meet the requirements of §26.41(c)(2).
Is it acceptable to verify that the lab is certified by the U.S. Department of Health and Human Services (HHS) and audit the laboratory program and procedures for effective implementation for only the differences in cutoff levels and any additional drugs that are not listed in the tables in Subpart G, §26.163, and the corrective actions from any finding from the HHS inspection?
The discussion of §26.41(c)(2) on page 17030 of the March 31, 2008, Federal Register Notice (73 FR 16966 ) states, "If a licensee or other entity chooses to implement more stringent cutoff levels or a broader panel of drugs than required under the final rule, the licensee or other entity is required to ensure that annual audits of the HHS certified services related to those cutoff levels and drug tests are performed." Nonetheless, cutoff levels and a broader panel of drugs were used as examples, not the total definition of "any areas" in §26.41(c)(2). For example, if a licensee or other entity relies on the HHS-certified laboratory to test dilute urine specimens that were collected for-cause for drugs at the limits of detection (LOD), the audit would evaluate this service. Therefore, it is sufficient for a "licensee to verify that the lab is HHS-certified and audit the laboratory program and procedures for effective implementation for only the differences in cutoff levels and any additional drugs that are not listed in the tables in Subpart G, § 26.163, and the corrective actions from any finding from the HHS inspection," if those are the only two services not covered by the HHS inspection. In addition, as noted in the response to the previous question, if the HHS inspection identified problems, the licensee’s or other entity’s audit would also be required to verify that appropriate corrective actions have been taken to resolve the problems identified.
What if the licensee does not require the HHS-certified lab to conduct special analyses of a dilute specimen [§26.163(a)(2) states "at the licensee discretion..."] and the specimen does not confirm at the cut-off level, so in reality it is negative, but still dilute? Section 26.185(g)(5) states that an MRO review is not required for specimens that the HHS-certified laboratory reports as negative and dilute. The licensee or other entity may not take any administrative actions or impose any sanctions on a donor who submits a negative and dilute specimen. Under the 1989 FFD rule, licensees were able to re-collect under observed conditions for a dilute specimen, but this is not allowed in the 2008 FFD rule. In addition, the Statements of Consideration (SOC) for the 2008 FFD rule indicate that testing the specimen at the level of detection (LOD) (special analysis) is how the MRO can determine the results of this type of test. Licensees, at their discretion, can allow this to happen, but by saying that it "may" be done does not mean that it must be done. How does a dilute specimen with no special analysis that is negative get resolved? Or is §26.185(g)(5) the answer: no MRO review and no further action?
As stated in the SOC for the final rule that was published in the Federal Register on March 31, 2008 (73 FR 16966 ), there are many reasons that an individual may produce a dilute urine specimen, the majority of which are the result of normal physiological processes, specific circumstances, or an individual's personal characteristics (e.g., body type, race, athleticism). Because dilute specimens are relatively common for these reasons, neither the HHS Guidelines nor the U.S. Department of Transportation Procedures for Transportation Workplace Drug and Alcohol Testing Programs permit further processing of negative and dilute specimens. The NRC chose not to require further processing of negative and dilute specimens for consistency with these other Federal agencies' programs. However, Part 26 permits licensees to direct the HHS-certified laboratory to perform drug testing of dilute specimens at the LOD and establishes requirements for that process. A licensee may choose not to subject negative and dilute specimens to drug testing at the LOD or, for example, may limit this type of testing to dilute specimens obtained from for-cause or follow-up tests only. If a licensee does not implement a policy and procedures for testing negative and dilute specimens at the LOD, then a specimen that yields "negative and dilute" test results from the HHS-certified laboratory is considered a negative test result and no MRO review or further action is required.
Is the licensee required to have a contract with the HHS laboratory who only performs retest for specimen "B" at Limit of Detection (LOD) for a specific metabolite? Are licensees required to audit that laboratory or the blind sample provider in addition to the primary HHS laboratory?
10 CFR Part 26 does not specifically require a licensee or its HHS-certified laboratory to have or maintain a contract with a second HHS-certified laboratory that performs retests of single specimens or testing of Bottle B of a split specimen. However, § 26.41(c)(1) specifies that “FFD services that are provided to a licensee or other entity by… HHS-certified laboratories must be audited on a nominal 12-month frequency.” The requirement does not differentiate between an HHS-certified laboratory used for a majority of specimen testing or a HHS-certified laboratory used only for retesting single specimens or for split specimen testing. Therefore, the licensee is required to audit the second lab.
Section 26.168(g) and (h) list the requirements that a blind performance test specimen manufacturer must meet in order to supply specimens for use in a licensee or other entity testing program. 10 CFR Part 26 does not contain any licensee or other entity auditing requirements pertaining to blind performance test specimen manufacturers but the licensee and other entity must ensure that the manufacturer provides specimens meeting § 26.168(g) and (h) requirements.
During a quality audit of the FFD/UAA program, it could not be determined if any FFD or Access records should be considered quality records. 10CFR26.713 does not make any indication as to the quality of the required records.
In response to your question, the only records required by 10 CFR 26 that qualify as Quality Assurance Records are those required by § 26.205(e)(4), which calls for licensees to record, trend, and correct under the licensee’s corrective action program, any problems identified in maintaining control of work hours consistent with the specific requirements and performance objectives of Part 26. This requirement is in keeping with the existing requirements in 10 CFR Part 50 Appendix B, Criterion XVII, “Quality Assurance Records.” Other records pertaining to fitness-for-duty and access authorization are not considered Quality Assurance Records. However, under 10 CFR 26.41, the NRC requires licensees and other entities to ensure that corrective actions are taken in response to any adverse findings resulting from an FFD audit.
Would a licensee be in compliance if clarification was added to a licensee procedure for its Quality Control program for the following two requirements: § 26.137(e)(6), at least one positive control, certified to be positive by an HHS certified laboratory, that appears to be a donor (normal sample) specimen to the laboratory analysts (e.g., licensee on-site testing technician) and § 26.137(d)(5), each analytical run performed to conduct initial validity testing shall include at least one quality control sample that appears to be a donor (normal sample) specimen to the laboratory analysts (e.g., licensee on-site testing technician)?
On March 31, 2009, the NRC issued an Enforcement Discretion Memorandum to address additional errors associated with §§ 26.137(d)(5) and 26.137(e)(6)(v) and to provide clarifying discussion regarding these requirements. For example, the current requirements in §§ 26.137(d)(5) and 26.137(e)(6)(v) incorrectly referenced licensee testing facility personnel as “laboratory analysts”. The correct position title is “licensee testing facility technicians.”
For initial drug testing, § 26.137(e)(6) specifies that quality control samples are not to be forwarded to an HHS-certified laboratory (other than for performance testing of samples). However, Section 26.137(d)(5) is silent with regard to additional testing of quality control samples at an HHS-certified laboratory. Is a licensee testing facility required to forward the quality control samples described in § 26.137(d)(5) to an HHS-certified laboratory for additional testing?A licensee testing facility is not required to send the control sample(s) described in § 26.137(d)(5) to an HHS-certified laboratory for additional testing.