Summary:
Summary Statement of Deficiencies 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 proficiency testing (PT) documentation and interview with the testing person (TP), the laboratory failed to verify the accuracy of all analytes tested at least twice annually. Findings: 1. The laboratory tested patient specimens using the TheraTest EL-anti-CCP/2 (cyclic citrullinated peptide) test kit and the TheraTest EL- ANA/9 test kit which is a multiplex immunoassay for the measurement of antinuclear antibodies in human serum. The EL-ANA/9 test kit detects antibodies against the following 9 nuclear antigens: single-stranded deoxyribonucleic acid (ssDNA), double- stranded DNA (dsDNA), Smith (Sm), ribonucleoprotein (RNP/Sm), Sjgren's syndrome (SSA and SSB), chromatin, schleroderma (Scl-70), and centromere. 2. The laboratory was enrolled in a PT program that included dsDNA, Sm, RNP/Sm, SSA, SSB, and centromere, but did not include ssDNA, Scl-70, nor chromatin. 3. The laboratory began testing patient specimens on 09/16/2020. 4. There were no records of the laboratory performing PT for anti-CCP. 5. The TP stated that the laboratory was enrolled in PT with TheraTest for ssDNA, Scl-70 and chromatin, but had not yet received a testing event. 6. During the exit interview at 3:30 PM, the TP confirmed that the laboratory had not verified the accuracy, via PT, of all tests performed on patient specimens. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(a) The laboratory must establish and follow written policies and procedures for an Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on review of the quality assessment (QA) policy and laboratory records and interview with the testing person (TP), the laboratory failed to ensure that communications and rejected specimens were documented and reviewed as described in the QA policy. Findings: 1. The "General Quality Assessment Policy" was reviewed. 2. The section titled "Complaint Investigations" stated that "Once a quarter, the Laboratory Director/Supervisor will review the Complaints and