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 and interview with the technical supervisor (TS); the laboratory failed to enroll in proficiency testing challenges in 2021 for antinuclear antibody (ANA) screen testing. Findings Include: 1. Review of the laboratory's policy and procedure manual identified the test menu, "DMG Hub Lab Testing Menu", which indicated the laboratory performs ANA screens. 2. Review of American Proficiency Institute (API) proficiency testing records revealed the laboratory failed to enroll in PT for ANA screens in 2021. 3. Interview with the TS, on 8-11-2021, at 9:53 am, confirmed the laboratory failed to enroll with API for ANA challenges. 4. Review of test volume records revealed from June of 2020 through June of 2021 that 9,000 ANA screens were performed. 5. During the survey on 8-11-2021, at 4:00 pm, the surveyor's findings were confirmed by the TS. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --