Optum Medical Care Pc

Summary Statement of Deficiencies D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API) Proficiency Testing (PT) records for calendar years 2019, 2020, 2021 and confirmed in an interview with the practice manger, the laboratory failed to retain the signed attestation forms for the hematology API PT challenges for the 2019, 2020 and 2021 events. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Base on review of the 2019, 2020 and 2021 API PT summary reports and an interview with the practice manager the laboratory failed to review and evaluate the API hematology PT results. FINDINGS: 1. The API PT summary records did not include evidence of review and evaluation of the PT results for al 2nd event of 2019, 1st & 3rd events in 2020 and 1st & 2nd events of 2021. 2. The laboratory had scored 100% for all the events but did not sign the summary report as reviewed and evaluated. 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 --

Summary Statement of Deficiencies D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on a review of proficiency test records and an interview with the laboratory nurse manager/testing person, the laboratory failed to perform PT testing in the same manner as patient specimen testing. Findings Include: It was confirmed by the laboratory nurse manager/testing person on February 5, 2019, at approximately 1:00 pm that PT specimens are always performed by the nurse manager/testing person, whereas patient specimens are performed by five of five testing personnel. 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 --