Summary:
Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and confirmed by testing personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 2: 30 pm on 4/30/2021, the laboratory director failed to attest to the routine integration of samples into the patient workload by signing attestation statements for six out of six PT events from 1/1/2019 - 12/31/2020. The findings include: 1. For 2019 PT first event, the laboratory director failed to sign the hematology/coagulation, chemistry, microbiology, and immunology attestation statements. 2. For 2019 PT second event, the laboratory director failed to sign the hematology/coagulation, chemistry, microbiology, and immunology attestation statements. 3. For 2019 PT third event, the laboratory director failed to sign the hematology/coagulation, chemistry, microbiology, and immunology attestation statements. 4. For 2020 PT first event, the laborator director failed to sign the hematology/coagulation attestation statements. 5. For 2020 PT second event, the laboratory director failed to sign the hematology /coagulation, chemistry, microbiology, and immunology attestation statements. 6. For 2020 PT third event, the laboratory director failed to sign the hematology/coagulation, chemistry, microbiology, and immunology attestation statements. D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- 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 -- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and confirmed by laboratory testing personnel identifier #1 (refer to Laboratory Personnel Report) at approximately 2:30 pm on 04/30/2021,the laboratory failed to evaluate the accuracy of ungraded analytes for two out of six PT testing events from 1/1/2019 - 12/31/2020. The findings include: 1. For 2019 PT first event, the laboratory did not evaluate the accuracy of the ungraded analytes: alanine aminotransferase, sample CH-01; urine sediment, sample US-02; and vaginal wet preparation, sample VKP-01. 2. For 2020 PT first event, the laboratory did not evaluate the accuracy of the ungraded analyte alanine aminotransferase, sample CH-01. -- 2 of 2 --