Frequently Asked Questions About Collection Sites and Collection Procedures

This section provides the NRC staff's answers to the following questions related to collection sites and collection procedures, as it relates to fitness-for-duty:

Can a licensee request pre-access observed urine drug screens of employees without cause? According to 10 CFR 26.115, "collecting urine specimens must provide for donor's privacy" unless certain conditions are met.

No, 10 CFR 26.115(a) specifies the circumstances in which a urine specimen may or must be collected under direct observation. The rule prohibits collecting urine specimens under direct observation without cause.

Does the 1989 FFD rule, which is currently in effect, require collection sites to refrigerate specimens?

Section 2.7 in Appendix A to the 1989 FFD rule requires specimen refrigeration by licensee testing facilities but not collection sites. However, the final rule that was published in the Federal Register on March 31, 2008 (73 FR 16966), which must be implemented by March 31, 2009, requires refrigeration of urine specimens at collection sites under the conditions specified in 10 CFR 25.117(j).

Do "contractors" come under the same rules as "house" technicians for the new Part 26 (Fatigue Management)? More specifically, for health physics technicians, do both the "house" and contractor technicians come under the same work hour rules for outages greater than 60 days?

Yes, "house" and contractor technicians come under the same work hour rules for outages greater than 60 days. 10 CFR 26.201 addresses the applicability of Subpart I (Managing Fatigue) and explains that the work hour rules [which are found in Section 26.205(d)] apply to all individuals in Section 26.4(a), including the individuals in Section 26.4(a)(2). Section 26.4(a)(2) doesn't differentiate between contractors and "house" technicians; it identifies personnel who are granted unescorted access to nuclear power reactor protected areas and perform health physics or chemistry duties that are required as a member of the onsite emergency response organization minimum shift complement.

Section 26.137(d)(2)(i) states: (2) Requirements for performing initial pH tests are as follows: (i) Colorimetric pH tests that have a dynamic range of 2 to 12 and pH meters and must be capable of measuring pH to one decimal place.

It appears that this section had an additional "and" added to it from the wording in the proposed rule. The added "and" is in italics and is underlined. The proposed rule did not have this second "and" and was proposed as: (i) Colorimetric pH tests that have a dynamic range of 2 to 12 and pH meters must be capable of measuring pH to one decimal place. Is this second "and" correct?

The "and" included in the current § 26.137(d)(2)(i) after the phrase "colorimetric pH tests that have a dynamic range of 2 to 12 and pH meters" is incorrect. The requirement in § 26.137(d)(2)(i) is that either a colorimetric pH test with a dynamic range of 2 to 12 or a pH meter that can measure pH to one decimal place be used for initial pH testing. The NRC is working to correct the error in the rule.

Does the requirement in § 26.177(j) "Specimens must be shipped from the collection site to the HHS-certified laboratory or the licensee testing facility as soon as reasonably practical but, except under unusual circumstances, the time between specimen shipment and receipt of the specimen at the licensee testing facility or HHS-certified laboratory should not exceed 2 business days" require that the licensee only have to tract receipt of specimens that are under "suspect" between the time a specimen is shipped from the collection site to the HHS certified lab or the licensee testing facility that should not exceed 2 business days? What would be considered "except under unusual circumstances"?

Plus at the licensee collection site, after a specimen has been collected, is it correct to not require the need to refrigerate a specimen that:

1. The licensee testing facility is in the same location as the collection site and testing of the specimen is being conducted or is expected to be conducted within 24 hours.

2. The collection site is not in the same location as the licensee testing facility and the specimens are being transported to the licensee testing facility (either shipped or hand carried) and it is expected that this is completed within 24 hours.

In addition, is it correct to require specimen's that are suspected of having been substituted, adulterated, or tampered with in any way must be maintained cooled to not more than 6°C (42.8 °F) until they are shipped to the HHS-certified laboratory, even if they are expected to be shipped within 24 hours?

What would be considered "shipped"? The time a licensee has placed the appropriately packaged specimens in a shipment drop box for pick-up and/or hand picked-up by the carrier?

26.117(j) until they are shipped to the HHS-certified laboratory. Specimens must be shipped from the collection site to the HHS-certified laboratory or the licensee testing facility as soon as reasonably practical but, except under unusual circumstances, the time between specimen shipment and receipt of the specimen at the licensee testing facility or HHS-certified laboratory should not exceed 2 business days.

Collection site personnel shall arrange to transfer the collected specimens to the HHS-certified laboratory or the licensee testing facility. Licensees and other entities shall take appropriate and prudent actions to minimize false negative results from specimen degradation. Specimens that have not been shipped to the HHS-certified laboratory or the licensee testing facility within 24 hours of collection and any specimen that is suspected of having been substituted, adulterated, or tampered with in any way must be maintained cooled to not more than 6 [deg]C (42.8 [deg]F) until they are shipped to the HHS certified laboratory. Specimens must be shipped from the collection site to the HHS-certified laboratory or the licensee testing facility as soon as reasonably practical but, except under unusual circumstances, the time between specimen shipment and receipt of the specimen at the licensee testing facility or HHS-certified laboratory should not exceed 2 business days.

The phrase in § 26.117(j) "except under unusual circumstances" refers to unpredictable situations that would prevent a specimen from being shipped in a timely manner such as a weather event (e.g., a snow storm) that affected access to the collection site by the courier service or the delivery of the specimen to the testing facility. Section 26.117(j) applies to all specimen collections and is not limited to instances where a specimen is considered "suspect" by the collector.

Section 26.117(j) requires that each specimen be shipped within 24 hours of collection or maintained at a temperature not more than 6°C (42.8°F) until shipped. Refrigeration would not be necessary if a specimen was shipped to the licensee testing facility within 24 hours of collection. However, if a specimen is suspected by the collector of being substituted, adulterated, or otherwise subject to tampering, the specimen is to be maintained at 6°C (42.8°F) immediately after the collection has been completed and until shipment to the HHS-certified laboratory for testing.

The intent of the 24-hour shipment requirement is that a specimen be in transit to the testing facility within 24 hours of collection. Placing an appropriately packaged specimen in a shipment drop box does not ensure that a specimen will be in transport to a testing facility within 24 hours of collection.