10 CFR 26.131, Cutoff Levels for Validity Screening and Initial Validity Tests

Cutoff levels for validity screening and initial validity tests

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(a) Each validity test result from the licensee testing facility must be based on performing either a validity screening test or an initial validity test, or both, on one or more aliquots of a urine specimen. The licensee testing facility shall forward any specimen that yields a questionable validity screening or initial validity test result to the HHS-certified laboratory for further testing. Licensee testing facilities need not perform validity screening tests before conducting initial validity tests of a specimen.

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(b) At a minimum, the licensee testing facility shall test each urine specimen for creatinine, pH, and one or more oxidizing adulterants. Licensees and other entities may not specify more stringent cutoff levels for validity screening and initial validity tests than those specified in this section. If tests or observations indicate one or more of the following from either a validity screening test or an initial validity test, the licensee testing facility shall forward the specimen to the HHS-certified laboratory for additional testing:

(1) Creatinine is less than 20 milligrams (mg) per deciliter (dL);

(2) The pH of the specimen is either less than 4.5 or equal to or greater than 9, using either a colorimetric pH test with a dynamic range of 2 to 12 or pH meter that is capable of measuring pH to one decimal place (for initial validity tests), or colorimetric pH tests, dipsticks, and pH paper (for pH validity screening tests) that have a narrow dynamic range;

(3) Nitrite or other oxidant concentration is equal to or greater than 200 micrograms (mcg) per mL or equal to or greater than 200 mcg/mL nitrite-equivalents using either a nitrite colorimetric test or a general oxidant colorimetric test;

(4) The possible presence of an oxidizing adulterant (e.g., chromium (VI), pyridine (pyridinium chlorochromate)) is determined using either a general oxidant colorimetric test (with a cutoff equal to or greater than 50 mcg/mL chromium (VI)-equivalents) or a chromium (VI) colorimetric test (chromium (VI) concentration equal to or greater than 50 mcg/mL);

(5) The possible presence of halogen (e.g., bleach, iodine, fluoride) is determined using a general oxidant colorimetric test (with a cutoff equal to or greater than 200 mcg/mL nitrite-equivalents or equal to or greater than 50 mcg/mL chromium (VI)-equivalents), a halogen colorimetric test (halogen concentration equal to or greater than the limit of detection (LOD)), or the odor of the specimen;

(6) The possible presence of glutaraldehyde is determined using either an aldehyde test (aldehyde present) or the characteristic immunoassay response is observed on one or more drug immunoassay tests;

(7) The possible presence of a surfactant is determined by using a surfactant colorimetric test with a cutoff equal to or greater than 100 mcg/mL dodecylbenzene sulfonate-equivalent or a foam/shake test; or

(8) The specimen shows evidence of adulterants, including, but not limited to, the following:

(i) Abnormal physical characteristics;

(ii) Reactions or responses characteristic of an adulterant obtained during the validity screening or initial test; or

(iii) A possible unidentified interfering substance or adulterant, demonstrated by interference occurring on the immunoassay drug tests on two separate aliquots (i.e., valid immunoassay drug test results cannot be obtained).

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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 26.131, Cutoff Levels for Validity Screening and Initial Validity Tests

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10 CFR 26.131, Cutoff Levels for Validity Screening and Initial Validity Tests

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