Summary:
Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation and interview with laboratory staff, the laboratory had supplies available for use after their expiration date. Findings follow: A) During a tour of the laboratory on 3/13/26 at 11:17 am, 4 (of 4) iScreen Urine Drug Tests (DX drug screen square cup), REF: ABTDUAW1127028, lot: W512402010, expiration date 2/27/26, were observed in the laboratory, available for use beyond the expiration date. B) In an interview on 3/7/26 at 11:17 am the lab director confirmed that the items, identified above, had exceeded their expiration date and were available for use in the laboratory. D5805 TEST REPORT CFR(s): 493.1291(c) (c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Through a review of Laboratory test reports and interview with staff it was determined the available laboratory test reports failed to include the address of the laboratory where the test was performed. Survey findings include: A) A review of laboratory test reports (one of one) revealed the laboratory results report failed to include the address of the laboratory where testing was performed. B) In an interview at 9:06am on 3/13/2026 the laboratory director confirmed the available laboratory test report did not include the laboratory address. -- 2 of 2 --