urine drug testing guidelines 2022

Posted on November 7, 2022 by

Section 1.7What is a refusal to take a federally regulated drug test? The document may account for an individual specimen, aliquot, or batch of specimens/aliquots and must include the name and signature of each individual who handled the specimen(s) or aliquot(s) and the date and purpose of the handling. 11.22What statistical summary reports must an HHS-certified laboratory provide for urine testing? The Secretary of the U.S. Department of Health and Human Services. (2) Burden of Proof/Standard of Proof. You may also e-mail your questions to the Physical Qualifications Division at fmcsamedical@dot.gov or call and ask for a Specialist on (202) 366-4001. Certifying Technician (CT). Effective Date: 08.01.2022 This policy addresses the use of Brineura (cerliponase alfa) in pediatric patients with late infantile neuronal ceroid lipofuscinosis (LINCL). They are also used to decide whether a given health service is medically necessary. (e) The Secretary shall investigate the blind sample error. (2) If the donor states that they are unable to provide a urine specimen, the collector records the reason for not collecting a urine specimen on the Federal CCF, notifies the federal agency's designated representative for authorization of an alternate specimen to be collected, and sends the appropriate copies of the Federal CCF to the MRO and to the federal agency's designated representative. Applicable Procedure Codes: 77301, 77338, 77385, 77386, 77387, 77520, 77522, 77523, 77525, G6015, G6016, G6017. Unauthorized copying, use, and distribution of this information are strictly prohibited. One commenter disagreed that the cost increase for laboratories to add analytes to regulated testing will be minimal, stating that significant costs would be incurred for information technology (IT) development, as well as incremental costs for additional immunoassays (if required); for additional calibrators, controls, and internal standards; and for increased confirmatory testing costs (including data review and result certification) based on an expected increased positivity rate for opioids. Section 2.3How is each urine specimen collected? Employment Drug Testing Laws in 2022: A Complete Overview. The NCAA drug-testing program, along with clear policies and effective education, protects student-athletes who play by the rules by playing clean. Applicable Procedure Codes: 76376, 76377, 76801, 76802, 76805, 76810, 76811, 76812, 76815, 76816, 76817. Effective Date: 11.01.2022 This policy addresses epidural steroid injections for spinal pain. Effective Date: 03.01.2022 This policy addresses wearable air conduction, bone-anchored, semi-implantable hearing aids (SEHA), intraoral bone conduction, and laser or light based hearing aids, and totally implanted middle ear hearing systems. One commenter suggested that the wording be modified to clarify that employers are responsible for ensuring blind samples are sent to the laboratories, but that collectors are tasked with submitting the blind samples. False-Positive Results for Cannabinoid Immunoassays. Section 8.13How does the collector report a donor's refusal to test? Effective Date: 10.01.2021 This policy addresses sublingual immunotherapy. Section 14.1When may a split (B) specimen be tested? A licensed physician who reviews, verifies, and reports a specimen test result to the federal agency. (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. (a) The MRO must review all positive, adulterated, rejected for testing, invalid, and (for urine) substituted test results. The commonly prescribed antidepressant, trazodone, has been reported to cause false positives in 3,4-methylenedioxymethamphetamine (MDMA) UDSs. (b) When the HHS-certified laboratory or HHS-certified IITF reports a negative/dilute result for the primary (A) urine specimen, the MRO reports a negative/dilute result to the agency and directs the agency to immediately collect another specimen from the donor. (c) Public Notice. The three samples were then retested on different immunoassay platforms for PCP. (7) An initial pH meter test (if a pH screening test is used) or confirmatory pH meter test must have the following calibrators and controls when the result of the preceding pH test indicates that the pH is above the upper decision point in use: (iii) One control in the range of 10 to 10.8; and. For full access to this pdf, sign in to an existing account, or purchase an annual subscription. Applicable Procedure Codes: 11402, 11403, 11404, 11406, 11420, 11421, 11422, 11423, 11424, 11426, 11442, 19000, 20552, 20553, 27096, 31579, 57460, 62270, 62321, 64479, 64490, 64493, 64633, 64635. (a) PT samples used to evaluate drug tests will be prepared using the following specifications: (1) PT samples may contain one or more of the drugs and drug metabolites in the drug classes listed in Section 3.4 and must satisfy one of the following parameters: (i) The concentration of a drug or metabolite will be at least 20 percent above the initial test cutoff concentration for the drug or drug metabolite; (ii) The concentration of a drug or metabolite may be as low as 40 percent of the confirmatory test cutoff concentration when the PT sample is designated as a retest sample; or. (a) A laboratory or IITF that does not maintain its HHS certification must: (1) Stop testing federally regulated specimens; (2) Ensure the security of federally regulated specimens and records throughout the required storage period described in Sections 11.20, 11.21, 12.18, and 14.8; (3) Ensure access to federally regulated specimens and records in accordance with Sections 11.23, 11.24, 12.20, 12.21, and Subpart P; and. In one report, the investigators created dilutions of quetiapine tablets dissolved in water and demonstrated that false positives for TCAs were occurring at 7.0 g/mL using the Microgenics Tricyclics Serum Tox EIA immunoassay on the Roche Hitachi 911 platform (16). Effective Date: 04.01.2022 This policy addresses the use of Parsabiv (etelcalcetide) for the treatment of secondary hyperparathyroidism with chronic kidney disease. The case involved a patient who was admitted to the emergency department with an apparent overdose. One commenter noted that, per Sections 8.4(c) and 8.9(b), when a collector finds an adulterant or substitution product or observes an attempt to substitute a urine specimen, this prompts a direct observed collection, not a refusal to test. 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. (3) The electronic report provided by the HHS-certified laboratory or HHS-certified IITF does not contain all the data elements required for the HHS standard laboratory or IITF electronic report for a specimen being reported drug positive, adulterated, invalid result, or (for urine) substituted. 9.18May a laboratory or IITF that had its HHS certification revoked be recertified to test federal agency specimens? How Can I Become a Collector for DOT Drug Testing? The analytical value (e.g., drug or drug metabolite concentration) used as the decision point to determine a result (e.g., negative, positive, adulterated, invalid, or, for urine, substituted) or the need for further testing. Applicable Procedure Codes: 90283, 90284, J1459, J1554, J1555, J1556, J1557, J1558, J1559, J1561, J1566, J1568, J1569, J1572, J1575, J1599, J3590. The Guidelines contain a number of recordkeeping requirements that SAMHSA considers not to be an additional recordkeeping burden. 12.10What must an HHS-certified IITF do to validate an initial drug test? 3.3May any of the specimens be used for other purposes? Two commenters disagreed with the added cross-reactivity requirements, noting this section should not attempt to provide equivalence between immunoassay and other initial testing technologies. The Department received no substantive data or evidence through public comments in favor of changing the estimated costs and benefits provided in the Department's May 2015 Federal Register Notice for the UrMG, and therefore, has retained the analysis and estimates provided in that notice below. (a) The collector secures the restroom being used for the monitored collection so that no one except the employee and the monitor can enter the restroom until after the collection has been completed. Two commenters requested clarification on the collection/testing scenario where the federal agency authorizes collection of an oral fluid specimen, but the contracted laboratory does not perform oral fluid testing. Collector. This varies by browser, if you do not see a box on your page with a red X try right clicking on the page, then select View Page Info, and goto the Media Tab. The person who assumes professional, organizational, educational, and administrative responsibility for the day-to-day management of the HHS-certified IITF when the responsible technician is unable to fulfill these obligations. Applicable Procedure Codes: 43647, 43648, 43881, 43882, 64590, 64595, 72195, 72196, 72197, 76496, 91117, 91120, 91122, 91132, 91133. Effective Date: 09.01.2022 This policy addresses vaccines/immunizations. Applicable Procedure Codes: 22899, 27299, 64625, 64628, 64629, 64633, 64634, 64635, 64636, 64999. Effective Date: 06.01.2022 This policy addresses surgery of the hip and femoroacetabular impingement (FAI) syndrome. The Department agrees and has revised Section 15.3(a)(5) to include employee identification number in addition to Social Security Number.. (e) The collector must ensure that all the information required on the Federal CCF is provided. RewriteCond %{REQUEST_FILENAME} !-d One of these commenters suggested the Department develop separate requirements for initial test methods using an alternate technology or, alternatively, require the combined cross-reactivity of low-reacting compounds (e.g., hydrocodone and hydromorphone for an opiate assay; MDA and MDEA for an amphetamines assay) to be equal to or greater than the cutoff. (c) Each initial drug test using an alternate technology must be re-verified periodically or at least annually. (b) In addition, an HHS-certified laboratory reports a primary (A) specimen as dilute when the creatinine concentration is equal to or greater than 2 mg/dL but less than 20 mg/dL and the specific gravity is greater than 1.0010 but less than 1.0030. The Guidelines will continue to require that the donor be allowed reasonable attempts to provide a urine specimen as described in Sections 8.5 and 8.6, and allow collection of an authorized alternate specimen (i.e., oral fluid). documents in the last year, 271 Share sensitive information only on official, secure websites. Applicable Procedure Codes: 90963, 90964, 90965, 90966, 90967, 90968, 90969, 90970, 90989, 90993, 99512, S9335. Effective Date: 06.01.2022 This policy addresses certain elective procedures that are typically performed in an office setting but may be performed in an ambulatory surgical center in certain circumstances. Sample. Published by Oxford University Press 2014. (2) Completed a train the trainer course given by an organization (e.g., manufacturer, private entity, contractor, federal agency). A presumptive positive amphetamine result was considered if the sample was found to be above the cutoff concentration of the lowest calibrator for the assay, which is 1.0 g/mL (1). Applicable Procedure Code: 93580. The meaning of this section remains the same. (a) The list of HHS-certified laboratories and IITFs is published monthly in the Federal Register. Seven commenters specifically agreed with the addition of these drugs to the Guidelines. The MRO reports to the agency a reconfirmed result [specify drug(s)] and a failed to reconfirm result [specify drug(s) and specify adulterant]. For example, a hydrocodone dose may result in urine concentrations of only hydromorphone metabolite above the cutoff. In addition to any other authority specified in these procedures, the reviewing official and the presiding official, with respect to those authorities involving the oral presentation, shall have the authority to issue orders; examine witnesses; take all steps necessary for the conduct of an orderly hearing; rule on requests and motions; grant extensions of time for good reasons; dismiss for failure to meet deadlines or other requirements; order the parties to submit relevant information or witnesses; remand a case for further action by the respondent; waive or modify these procedures in a specific case, usually with notice to the parties; reconsider a decision of the reviewing official where a party promptly alleges a clear error of fact or law; and to take any other action necessary to resolve disputes in accordance with the objectives of these procedures. documents in the last year, 878 Effective Date: 07.01.2022 This policy addresses hospital outpatient facility infusion services for intravenous immune globulin (IVIG) and subcutaneous immune globulin (SCIG) therapy. All training must be documented. Section 8.14What are a federal agency's responsibilities for a collection site? Effective Date: 06.01.2022 This policy addresses wheelchair seating. The Department has evaluated these comments and agrees that all observed collections must be conducted in a professional manner that minimizes discomfort to the donor. (b) The collector is not required to be the same gender as the donor. Phone: 202-366-3784 The regulations do not authorize the DOT to certify service agents. {{configCtrl2.info.metaDescription}} Sign up today to receive the latest news and updates from UpToDate. Notice that the CaSe is important in this example. Calibrator. Effective Date: 10.01.2022 This policy addresses Saphnelo (anifrolumab-fnia) for the treatment of moderate to severe systemic lupus erythematosus (SLE). (c) If the donor declines to permit a collection to be monitored when required, the collector reports a refusal to test (i.e., as described in Section 8.13). Urine samples supplemented with 6.1 g/mL of naloxone or greater were opiate positive with the opiate CEDIA assay (28). The Department has evaluated the comments and has concluded that no change is needed. The Department has concluded that no change is needed. The MRO reports reconfirmed to the agency. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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). This bulletin provides complete details on recently approved, revised, and/or retired UnitedHealthcare Commercial Medical Policies, Medical Benefit Drug Policies, Coverage Determination Guidelines (CDG), and/or Utilization Review Guidelines (URG). on 1.5What do the terms used in these Guidelines mean? That is, the collector requests that the donor document the donor's gender on the Federal CCF and initial the annotation. When an error occurs more than once a month, the MRO must direct the collector, HHS-certified laboratory, or HHS-certified IITF (whichever is responsible for the error) to immediately take corrective action to prevent the recurrence of the error. Applicable Procedure Code: J1306. Effective Date: 04.01.2022 This policy addresses serum or urine collagen crosslinks or biochemical markers. Information about this document as published in the Federal Register. The Department has evaluated the comments and has concluded that no change is needed to the proposed cutoff (i.e., 4.0). Applicable Procedure Codes: 11981, 11982, 11983, J3490, J7999. Section 13.3What training is required before a physician may serve as an MRO? Effective Date: 05.01.2022 This policy addresses embolization of the ovarian or internal iliac veins. This notice does not trigger the requirement for a written statement under section 202(a) of the UMRA because the Guidelines do not impose a mandate that results in an expenditure of $100 million (adjusted annually for inflation) or more by either state, local, and tribal governments in the aggregate or by the private sector in any one year. A SAP qualified to act in the DOT drug and alcohol testing program must meet the SAP qualification requirements in 40.281. Final. (iii) If the employee has not provided a sufficient specimen (i.e., at least 45 mL) within three hours of the first unsuccessful attempt to provide the specimen, the collector records the reason for not collecting a urine specimen on the Federal CCF, notifies the federal agency's designated representative for authorization of an alternate specimen to be collected, and sends the appropriate copies of the Federal CCF to the MRO and to the federal agency's designated representative. Additionally, an MRO shall not derive any financial benefit by having an agency use a specific HHS-certified IITF or have any agreement with an HHS-certified IITF that may be construed as a potential conflict of interest.Start Printed Page 7962. Revised Mandatory Guidelines by the Secretary of Health and Human Services. Section 13.5What must an MRO do when reviewing a urine specimen's test results? The other commenter recommended not allowing methods other than immunoassay for urine initial testing. (e) The MRO must maintain records for a minimum of two years while maintaining the confidentiality of the information. 16.2What definitions are used for this subpart? (b) An HHS-certified laboratory or IITF is inspected by one or more inspectors. Publications describing interferences with UDS present differing degrees of evidence to support their claims. 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urine drug testing guidelines 2022