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 the laboratory's policies and procedures, review of 2020, 2021, and 2022 API (American Proficiency Institute) and CAP (College of American Pathologists) proficiency testing records, review of 2020, 2021, and 2022 TheraTest verification records, and interview with the GS (general supervisor) 12/13/22, the laboratory failed to enroll in an HHS (Health and Human Services) approved proficiency testing program for the ANA (antinuclear antibodies) and RF (rheumatoid factor) testing performed. Findings: Review of the laboratory's "General Quality Assessment Policy" revealed on page 4 "... The CLIA reportable tests (Antinuclear Antibody Screen and Rheumatoid Factor IgM) are done through CAP or other accredited proficiency testing agencies. ...". On page 5, the policy states "The TheraTest Proficiency Testing Program, which is not HHS (Health and Human Services) approved, has two events per year. ...". Review of 2020, 2021, and 2022 API and CAP proficiency testing records revealed the laboratory was not enrolled for ANA and RF. Review of 2020, 2021, and 2022 TheraTest verification records revealed the laboratory participated for ANA and RF. During interview at approximately 2:50 p.m., the GS confirmed the laboratory had not participated in proficiency testing for their ANA and RF testing. She stated she was unaware the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- laboratory was required to enroll in an HHS-approved proficiency testing program for ANA and RF. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, review of 2020, 2021, and 2022 API and CAP proficiency testing records, and interview with the GS 12/13 /22, the laboratory failed to verify the accuracy of the QuantiFERON-TB Gold test at least twice a year in 2020. Findings: Review of 2020, 2021, and 2022 API proficiency testing records revealed the laboratory enrolled in the mycobacteriology module from API for 2020. The module the laboratory enrolled in was for mycobacteriology cultures and was not the correct test system the laboratory uses for the QuantiFERON- TB Gold testing performed. Review of 2020, 2021, and 2022 CAP proficiency testing records revealed the laboratory enrolled in proficiency testing for the QuantiFERON- TB Gold in 2021, but there was no documentation of CAP enrollment for 2020. There was no documentation that the laboratory performed any other activity to verify the accuracy of the Quantiferon-TB Gold in 2020. During interview at approximately 2: 55 p.m., the GS confirmed that they did not perform any activity to verify the accuracy of the QuantiFERON-TB Gold in 2020. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)