Summary:
Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on review of laboratory records, lack of documentation and interview with the technical supervisor (TS), the laboratory failed to enroll in a Centers for Medicare and Medicaid (CMS) approved proficiency testing (PT) program for the subspecialty of virology (SARS-CoV-2, Respiratory Syncytial Virus (RSV), Influenza A, and Influenza B) in 2023 and 2024, affecting more than 12,239 patient tests. Findings include: 1. Review of the "Prism Health Lab List of Laboratory Test Performed" revealed the following tests: a. COVID-19 PCR Test Specimen Type: Anterior Nasal Swab, Saliva b. Influenza A PCR Test Specimen Type: Anterior Nasal Swab, Saliva c. Influenza B PCR Test Specimen Type: Anterior Nasal Swab, Saliva d. Respiratory Syncytial Virus (RSV) PCR Test Specimen Type: Anterior Nasal Swab, Saliva 2. Review of laboratory records revealed the reported number of patient test results in 2023 and 2024 for the following tests: - Swab COVID - 19 tests: 11,428 - Swab COVID - 19, Influenza A, Influenza B tests: 294 - Swab COVID - 19, Influenza A, Influenza B, RSV tests: 398 - Swab RSV - 63 - Saliva COVID - 19, Influenza A, Influenza B, RSV tests: 56 3. Review of the "Prism Health Lab