10 CFR 26.117, Preparing Urine Specimens for Storage and Shipping

Preparing urine specimens for storage and shipping

a

(a) Both the donor and the collector shall keep the donor's urine specimen(s) in view at all times before the specimen(s) are sealed and labeled. If any specimen or aliquot is transferred to another container, the collector shall ask the donor to observe the transfer and sealing of the container with a tamper-evident seal.

b

(b) Both the collector and the donor shall be present (at the same time) during the procedures outlined in this section.

c

(c) The collector shall place an identification label securely on each container. The label must contain the date, the donor's specimen number, and any other identifying information provided or required by the FFD program. The collector shall also apply a tamper-evident seal on each container if it is separate from the label. The specimen bottle must be securely sealed to prevent undetected tampering.

d

(d) The donor shall initial the identification label(s) on the specimen bottle(s) for the purpose of certifying that the specimen was collected from him or her. The collector shall also ask the donor to read and sign a statement on the custody-and-control form certifying that the specimen(s) identified as having been collected from the donor is, in fact, the specimen(s) that he or she provided.

e

(e) The collector shall complete the custody-and-control form(s) and shall certify proper completion of the collection.

f

(f) The specimens and chain-of-custody forms must be packaged for transfer to the HHS-certified laboratory or the licensee's testing facility. If the specimens are not immediately prepared for transfer, they must be appropriately safeguarded during temporary storage.

g

(g) While any part of the chain-of-custody procedures is being performed, the specimens and custody documents must be under the control of the involved collector. The collector may not leave the collection site during the interval between presentation of the specimen by the donor and securing of the specimens with identifying labels bearing the donor's specimen identification numbers and seals initialed by the donor. If the involved collector momentarily leaves his or her workstation, the sealed specimens and custody-and-control forms must be secured or taken with him or her. If the collector is leaving for an extended period of time, the specimens must be packaged for transfer to the HHS-certified laboratory or the licensee testing facility and secured before the collector leaves the collection site.

h

(h) The specimen(s) sealed in a shipping container must be immediately transferred, appropriately safeguarded during temporary storage, or kept under the personal control of an authorized individual until transferred. These minimum procedures apply to the transfer of specimens to licensee testing facilities from collection sites (except where co-located) as well as to the shipping of specimens to HHS-certified laboratories. As an option, licensees and other entities may ship several specimens via courier in a locked or sealed shipping container.

i

j

(j) 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 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> 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°C (42.8 °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.

k

(k) Couriers, express carriers, and postal service personnel do not have direct access to the custody-and-control forms or the specimen bottles. Therefore, there is no requirement that such personnel document chain of custody on the custody-and-control forms during transit. Custody accountability of the shipping containers during shipment must be maintained by a tracking system provided by the courier, express carrier, or postal service.

Federal Register

[[[FR::http://frwebgate.access.gpo.gov/cgi-bin/getpage.cgi?dbname=2008_register&page=17201&position=1%7C 73 FR 17201 Mar. 31, 2008]]]

External Links

[[URL::http://www.nrc.gov/reading-rm/doc-collections/cfr/part026/part026-0117.html%7CNRC website 10 CFR 26.117]]

v t e Code of Federal Regulations
Title 10 Part 26 - FITNESS FOR DUTY PROGRAMS
10 CFR: 1 2 4 5 7 9 10 11 12 13 14 15 16 19 20 21 25 26 30 31 32 33 34 35 36 37 39 40 50 51 52 54 55 60 61 62 63 70 71 72 73 74 75 76 81 95 100 140 150 160 170 171
1, Administrative Provisions, Purpose 3, Scope 4, FFD program applicability to categories of individuals 5, Definitions 7, Interpretations 8, Information collection requirements: OMB approval 9, Specific exemptions 11, Communications 21, Program Elements, Fitness-for-duty program 23, Performance objectives 25, Reserved 27, Written policy and procedures 29, Training 31, Drug and alcohol testing 33, Behavioral observation 35, Employee assistance programs 37, Protection of information 39, Review process for fitness-for-duty policy violations 41, Audits and corrective action 51, Granting and Maintaining Authorization, Applicability 53, General provisions 55, Initial authorization 57, Authorization update 59, Authorization reinstatement 61, Self-disclosure and employment history 63, Suitable inquiry 65, Pre-access drug and alcohol testing 67, Random drug and alcohol testing of individuals who have applied for authorization 69, Authorization with potentially disqualifying fitness-for-duty information 71, Maintaining authorization 73, Management Actions and Sanctions To Be Imposed, Applicability 75, Sanctions 77, Management actions regarding possible impairment 81, Collecting Specimens for Testing, Purpose and applicability 83, Specimens to be collected 85, Collector qualifications and responsibilities 87, Collection sites 89, Preparing to collect specimens for testing 91, Acceptable devices for conducting initial and confirmatory tests for alcohol and methods of use 93, Preparing for alcohol testing 95, Conducting an initial test for alcohol using a breath specimen 97, Conducting an initial test for alcohol using a specimen of oral fluids 99, Determining the need for a confirmatory test for alcohol 101, Conducting a confirmatory test for alcohol 103, Determining a confirmed positive test result for alcohol 105, Preparing for urine collection 107, Collecting a urine specimen 109, Urine specimen quantity 111, Checking the acceptability of the urine specimen 113, Splitting the urine specimen 115, Collecting a urine specimen under direct observation 117, Preparing urine specimens for storage and shipping 119, Determining "shy" bladder 121, Licensee Testing Facilities, Purpose 123, Testing facility capabilities 125, Licensee testing facility personnel 127, Procedures 129, Assuring specimen security, chain of custody, and preservation 131, Cutoff levels for validity screening and initial validity tests 133, Cutoff levels for drugs and drug metabolites 135, Split specimens 137, Quality assurance and quality control 139, Reporting initial validity and drug test results 151, Laboratories Certified by the Department of Health and Human Services, Purpose 153, Using certified laboratories for testing urine specimens 155, Laboratory personnel 157, Procedures 159, Assuring specimen security, chain of custody, and preservation 161, Cutoff levels for validity testing 163, Cutoff levels for drugs and drug metabolites 165, Testing split specimens and retesting single specimens 167, Quality assurance and quality control 168, Blind performance testing 169, Reporting Results 181, Determining Fitness-for-Duty Policy Violations and Determining Fitness, Purpose 183, Medical review officer 185, Determining a fitness-for-duty policy violation 187, Substance abuse expert 189, Determination of fitness 201, Managing Fatigue, Applicability 203, General provisions 205, Work hours 207, Waivers and exceptions 209, Self-declarations 211, Fatigue assessments 401, FFD Programs for Construction, General 403, Written policy and procedures 405, Drug and alcohol testing 406, Fitness monitoring 407, Behavioral observation 409, Sanctions 411, Protection of information 413, Review process 415, Audits 417, Recordkeeping and reporting 419, Suitability and fitness evaluations 709, Recordkeeping and Reporting Requirements, Applicability 711, General provisions 713, Recordkeeping requirements for licensees and other entities 715, Recordkeeping requirements for collection sites, licensee testing facilities, and laboratories certified by the Department of Health and Human Services further results Appendices:

10 CFR 26.117, Preparing Urine Specimens for Storage and Shipping

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10 CFR 26.117, Preparing Urine Specimens for Storage and Shipping

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