This table of contents is a navigational tool, processed from the (a) An HHS-certified laboratory must use the following criteria to reconfirm a substituted result when testing a split (B) urine specimen: (1) The creatinine must be measured using the laboratory's confirmatory creatinine test with a cutoff concentration of less than 2 mg/dL; and. (b) PT samples used to evaluate specimen validity tests shall satisfy, but are not limited to, one of the following criteria: (1) The nitrite concentration will be at least 20 percent above the cutoff; (2) The pH will be between 1.5 and 5.0 or between 8.5 and 12.5; (3) The concentration of an oxidant will be at a level sufficient to challenge a laboratory's ability to identify and confirm the oxidant; (4) The creatinine concentration will be between 0 and 20 mg/dL; or. The appellant and the respondent each participate in developing the file for the reviewing official and in submitting written arguments. A physician who is a trained MRO will have the knowledge necessary to identify another physician with appropriate expertise for the medical evaluation. (c) A primary (A) specimen is reported positive for a specific drug or drug metabolite when both the initial drug test is positive and the confirmatory drug test is positive in accordance with Section 3.4. (c) The resealed specimen and split specimen and the Federal CCF are sealed in a leak-proof plastic bag, and are sent to an HHS-certified laboratory under chain of custody within one day after completing the drug and specimen validity tests. The Department agrees with the commenter and has changed the term opiates to opioids where appropriate to refer to oxycodone, oxymorphone, hydrocodone, and hydromorphone in addition to codeine, morphine, and 6-acetylmorphine (6-AM). Effective Date: 08.01.2022 This policy addresses the use of Cabenuva (cabotegravir/rilpivirine) for the treatment of a human immunodeficiency virus type-1 (HIV-1) in patients who are virologically suppressed. (a) An HHS-certified IITF must control access to the drug testing facility, specimens, aliquots, and records. (19) The collector failed to check the specimen temperature box and the Remarks line did not have a comment regarding the temperature being out of range. (b) The Secretary shall consider the following factors in determining whether revocation is necessary: (1) Unsatisfactory performance in analyzing and reporting the results of drug and specimen validity tests (e.g., an HHS-certified laboratory reporting a false positive result for an employee's drug test); (2) Unsatisfactory participation in performance testing or inspections; (3) A material violation of a certification standard, contract term, or other condition imposed on the HHS-certified laboratory or IITF by a federal agency using the laboratory's or IITF's services; (4) Conviction for any criminal offense committed as an incident to operation of the HHS-certified laboratory or IITF; or. 3.8What criteria are used to report a urine specimen as dilute? To receive reimbursement for controlled substance and drugs of abuse testing, the service reported on the claim MUST match the service ordered by the physician. In subpart D, a trainer is required to document the training of an individual to be a collector [Section 4.3(a)(3)] and the documentation must be maintained in the collector's training file [Section 4.3(c)]. 16.15Is there a review of the final administrative action? Office of Drug & Alcohol Policy & Compliance. Applicable Procedure Codes: J1442, J1447, J2506, J2820, JQ5101, Q5108, Q5110, Q5111, Q5120, Q5122, Q5125. The regulations do not authorize the DOT to certify service agents. The 400 sample limit was added to reduce the burden on large agencies based on the Department's review of agencies' blind testing programs. If not, correct the error or revert back to the previous version until your site works again. Although the cross-reactivity is low, it remains significant given the high concentrations of these compounds that are commonly found in urine relative to the low cutoff (5 g/L) of the buprenorphine immunoassay (29). (b) The collector, in the presence of the donor, pours the urine from the collection container into two specimen bottles to be labeled A and B. The Department requested comments on costs and benefits. Applicable Procedure Code: J2357. (c) Review File and Briefs. The commenter cited the additional time and cost (evaluation of donor for shy bladder) as well as the fact that the collector may not know the agency's policy on alternate specimen types. Effective Date: 10.01.2022 This policy addresses the use of Korsuva (difelikefalin) for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis. Please direct any questions regarding coding to the payer being billed. The authors acknowledge the generous funding provided by Waters Corporation for the University of California, San Diego (UCSD) clinical chemistry fellowship program. (h) The collector seals the specimens (Bottle A and Bottle B) in a package and, within 24 hours or during the next business day, sends them to the HHS-certified laboratory or IITF that will be testing the Bottle A urine specimen. Effective Date: 09.01.2022 This policy addresses the use of C1 esterace inhibitors (human), C1 esterace inhibitors (recombinant), and plasma kallikrein inhibitors (human) for the treatment and prophlaxis of hereditary angioedema (HAE). The laboratory may convert hardcopy records to electronic records for storage and then discard the hardcopy records after 6 months. (b) Staff under the direct, personal supervision of the MRO may review and report negative and (for urine) negative/dilute test results to the agency's designated representative. For these analytes, the immunoassay test is not specific for the target analyte for the confirmatory test. edition of the Federal Register. Until the ACFR grants it official status, the XML One commenter agreed with MRO certification/training entities submitting the delivery method and content of the MRO examination as applicable along with other required documents. You may need to scroll to find it. Drug Testing Drug Section 14.5Who receives the split (B) specimen result? (ii) The observer's responsibility for maintaining the integrity of the collection process, ensuring the privacy of individuals being tested, ensuring that the observation is done in a professional manner that minimizes the discomfort to the employee so observed, ensuring the security of the specimen by maintaining visual contact with the collection container until it is delivered to the collector, and avoiding conduct or statements that could be viewed as offensive or inappropriate. Section 11.14What must an HHS-certified laboratory do to validate a confirmatory drug test? Collection Site. What does this mean for the employees? . ODAPC does not develop or maintain a list of qualified service agents. 11.24What HHS-certified laboratory information is available to a federal employee? One commenter requested that the Department provide the justification and data used to determine the cutoff levels for the added opioids. Use the PDF linked in the document sidebar for the official electronic format. Section 11.11What must an HHS-certified laboratory do to validate an initial drug test? Effective Date: 10.01.2021 This policy addresses unicondylar spacer devices for treating knee joint pain or disability from any cause. (n) HHS-certified laboratories may transmit test results to the MRO by various electronic means (e.g., teleprinter, facsimile, or computer). Three commenters recommended that the CCF be revised to address the addition of the oral fluid specimen matrix. Many cross-reactivities exist with other analytes, potentially causing a false-positive result in an initial drug screen. (2) When there is any reason to believe that a donor may have adulterated or substituted the specimen, another specimen must be obtained as soon as possible under direct observation in accordance with Section 8.10. Transmissions of the reports must ensure confidentiality. Applicable Procedure Code: 96549. The DOT regulations do not address hiring, termination, or other employment actions. One commenter stated that the Department should add a requirement for MRO training on what constitutes a refusal to test. [FR Doc. A federal employee who is the subject of a drug test may provide a written request through the MRO and/or the federal agency requesting access to any records relating to the employee's drug test results or a documentation package (as described in Section 12.20) and any relevant certification, review, or revocation of certification records. As the name suggests this class of compounds is based on a three-ringed organic framework, which is further modified to obtain desired pharmacological effects. False positives for PCP from tramadol overdose were also noted in two patients using the Syva EMIT II Plus immunoassay (TableVI) (54). The Department has revised Sections 4.4(b), 8.1(b), and 8.10 to allow the donor to be observed by a person whose gender matches the donor's gender, which is determined by the donor's gender identity (defined in Section 1.5). 16.14What are the requirements for a written decision? If your blog is showing the wrong domain name in links, redirecting to another site, or is missing images and style, these are all usually related to the same problem: you have the wrong domain name configured in your WordPress blog. Effective Date: 10.01.2022 This policy addresses vitamin D testing. External Service Provider. The following privacy requirements apply when a donor is providing a urine specimen: (a) Only authorized personnel and the donor may be present in the restricted access area where the collection takes place. Because of the importance of timeliness for these expedited procedures, all written communications between the parties and between either party and the reviewing official shall be by facsimile, secured electronic transmissions, or overnight mail. (b) Calibrators and controls must total at least 10 percent of the aliquots analyzed in each batch. Effective Date: 11.01.2022 This policy addresses surgical repair for treating athletic pubalgia. Drugs and/or metabolites described at or prior to the year 2000 as causing false-positive TCA results include carbamazepine (14) and cyclobenzaprine (15). The same commenter requested medical referral information on the employer's actions when a donor could not provide a urine specimen and then could not provide an oral fluid specimen. The observer selection process is described in Section 8.10(b). Effective Date: 11.01.2022 This policy addresses home traction therapy. Section 11.2What are the responsibilities of the responsible person (RP)? documents in the last year, 23 Applicable Procedure Codes: 0342T, 36511, 36512, 36513, 36514, 36516, 36522, S2120. If an alternate specimen is authorized, the collector may begin the collection procedure for the alternate specimen (see Section 8.7) in accordance with the Mandatory Guidelines for Federal Workplace Drug Testing Programs using the alternative specimen. The information presented in these policies and guidelines is believed to be accurate and current as of the date of publication and is provided on an "AS IS" basis. L. 100-71 and allowed urine drug testing only. The regulations only require that you meet the qualification and training outlined in 49 CFR Part 40 and maintain the necessary documents to prove your qualifications. Effective Date: 10.01.2022 This policy addresses the use of intravenous (IV) and subcutaneous (SC) immune globulin (IG) products. The opiate immunoassay that does not have sufficient cross-reactivity would be acceptable as an initial test under these Guidelines when the lowest-reacting analyte, hydromorphone, is used to establish a decision point. An inclusive literature review was conducted for five predefined drugs of abuse classes and a miscellaneous drug class that included several different drugs. If the suspension and proposed revocation are upheld, the revocation will become effective immediately and the public will be notified by publication of a notice in the Federal Register. Our literature search of recent interferences revealed that quetiapine (5), usually prescribed as an atypical antipsychotic (16), was the only recent drug found to yield false-positive TCA results (Figure1). (2) If the donor is unable to provide a legitimate explanation or if the MRO determines that time and temperature fail to account for the pH in the 9.09.5 range, the MRO reports a test cancelled result with the reason for the invalid result and directs the federal agency to immediately collect another urine specimen from the donor using a direct observed collection. The semiannual statistical report contains the following information: (9) Number of specimens tested positive by each initial drug test; and. The Department of Health and Human Services (HHS or Department) has revised the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Guidelines), 73 FR 71858 (November 25, 2008) for urine testing. In this notice, the Secretary revised the standards for certification of laboratories engaged in urine fluid drug testing for federal agencies and the use of urine testing in federal drug-free workplace programs. Effective Date: 11.01.2022 This policy addresses computerized dynamic posturography (CDP) testing. 3.9What criteria are used to report an invalid result for a urine specimen? It is particularly troublesome that a false-positive buprenorphine screening test could be caused by heroin use, which potentially yields large quantities of morphine in urine. Accordingly, the Secretary has determined that the Guidelines do not contain policies that have federalism implications. (b) Each individual working in an HHS-certified IITF must be properly trained (i.e., receive training in each area of work that the individual will be performing, including training in forensic procedures related to their job duties) before they are permitted to work independently with federally regulated specimens. 12.8What are the IITF chain of custody requirements for specimens and aliquots? The MRO may convert hardcopy records to electronic records for storage and discard the hardcopy records after six months. (4) Perform one or more specimen validity tests for oxidizing adulterants on every specimen. Reimbursement Policy: Urine Drug Screening/Testing Effective Date: November 30, 2013 Last Revised Date: January 19, 2022 Purpose: To provide guidelines for the reimbursement of urine drug testing. Toxicol, 37, 255-264. The MRO reports reconfirmed to the agency. (c) If a split (B) urine specimen cannot be tested by a second HHS-certified laboratory (e.g., insufficient specimen, lost in transit, split not available, no second HHS-certified laboratory available to perform the test), the MRO reports to the federal agency that the test must be cancelled and the reason for the cancellation. Effective Date: 06.01.2022 This policy addresses implantable miniature telescope (IMT), conjunctival incision with posterior extrascleral placement of a pharmacologic agent, laser photocoagulation, and radiation therapy. Applicable Procedure Code: J1428. (d) The requirements for measuring the nitrite concentration are that the nitrite test must have a calibrator at 200 mcg/mL nitrite, a control without nitrite (i.e., certified negative urine), one control in the range of 200 mcg/mL to 250 mcg/mL, and one control in the range of 500 mcg/mL to 625 mcg/mL. (d) An individual may not collect specimens for a federal agency until the individual's training as a collector has been properly documented. Only essential documents should be submitted to the reviewing official. (d) To avoid a potential conflict of interest, a collector must not be related to the employee (e.g., spouse, ex-spouse, relative) or a close personal friend (e.g., fiance). Applicable Procedure Codes: E0637, E0638, E0641, E0642, E8000, E8001, E8002. The hiring official must be a trained collector. Applicable Procedure Codes: J1950, J1951, J1952, J3315, J3316, J9155, J9202, J9217, J9226. Applicable Procedure Codes: E2500, E2502, E2504, E2506, E2508, E2510, E2511, E2512, E2599. .). urine specimen collector, breath alcohol technician (BAT), screening test technician (STT), medical review officer (MRO), substance abuse professional (SAP), consortium/third-party administrator (C/TPA), or laboratory)? Applicable Procedure Code: 27599. An HHS-certified laboratory reports a primary (A) specimen as adulterated when: (a) The pH is less than 4 or equal to or greater than 11 using either a pH meter or a colorimetric pH test for the initial test on the first aliquot and a pH meter for the confirmatory test on the second aliquot; (b) The nitrite concentration is equal to or greater than 500 mcg/mL using either a nitrite colorimetric test or a general oxidant colorimetric test for the initial test on the first aliquot and a different confirmatory test (e.g., multi-wavelength spectrophotometry, ion chromatography, capillary electrophoresis) on the second aliquot;Start Printed Page 7942. Before any test result can be reported, it must be certified by a certifying scientist or a certifying technician (as appropriate). Niflumic acid standards were added to DFU at 13 concentrations ranging from 1.25 to 1,000 g/mL. The Federal CCF may be paper or electronic. This means an MRO may be an employee of the agency or a contractor for the agency; however, an MRO shall not be an employee or agent of or have any financial interest in the HHS-certified laboratory for which the MRO is reviewing drug testing results.