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PA Bulletin, Doc. No. 24-308

NOTICES

DEPARTMENT OF HEALTH

Fentanyl and Xylazine Detected in a Urine Drug Screening Performed under Act 43 of 2023

[54 Pa.B. 1268]
[Saturday, March 9, 2024]

 The act of December 14, 2023 (P.L. 378, No. 43) (Act 43) amended 35 Pa.C.S. (relating to health and safety) to require fentanyl and xylazine testing when a urine drug screening is conducted in an emergency department within an acute care hospital to assist in diagnosing a patient's condition. Xylazine testing is only required if testing is available as part of the urine drug screening panel. If the urine drug screening performed under Act 43 detects fentanyl or xylazine, the de-identified results shall be reported to the Department of Health (Department). Under Act 43, the Department is required, in consultation with stakeholders, to set the screening threshold for the reporting of test results and the manner of submission of test results and to thereafter transmit notice of the same to the Pennsylvania Bulletin for publication.

Screening threshold

 Emergency departments should use minimal threshold values as appropriately determined for tests used when reporting to the Department. After consulting with stakeholders, the Department determined that the following screening threshold shall apply. Under 42 CFR 493.1253 (relating to standard: Establishment and verification of performance specifications), laboratories are required to establish and verify test system performance specifications. Laboratories should follow manufacturer's instructions for waived tests. Laboratories should follow 42 CFR 493.1253 for nonwaived tests (Federal Drug Administration (FDA)-cleared, FDA-approved and laboratory developed tests).

Submission

 After consulting with stakeholders, the Department has determined that, effective June 1, 2024, de-identified test results for fentanyl or xylazine shall be submitted in aggregate form to the Department monthly on the Act 43 of 2023—Urine Drug Screening Reporting—Fentanyl and Xylazine Form, which will be available on the Department's web site. The emergency department conducting the urine drug screening is permitted to identify an appropriate reporter to submit this form to the Department. Reporting of a positive test result for fentanyl is not required if a health care practitioner determines that the positive result is due to a legally prescribed course of treatment for the patient.

 For additional information or for persons with a disability who wish for more information regarding this notice and require auxiliary aid, service or other accommodation to do so contact Raina Workman at (717) 547-3059. Speech and/or hearing-impaired persons use V/TT (717) 783-6514 or the Pennsylvania Hamilton Relay Service at (800) 654-5984 (TT).

DR. DEBRA L. BOGEN, 
Acting Secretary

[Pa.B. Doc. No. 24-308. Filed for public inspection March 8, 2024, 9:00 a.m.]

 


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