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 the laboratory's American Proficiency Institute (API) proficiency testing (PT) records and interview with the laboratory liaison, the laboratory director and testing personnel failed to sign two of four PT attestation statements in 2022 and 2023. The findings include: 1. Review of the laboratory's proficiency testing records revealed the following: - Events not signed by laboratory director: 2022 2nd Event and 2023 2nd Event - Event not signed by testing personnel: 2023 2nd Event 2. Interview with the laboratory liaison on 10.25.2023 at 2:15 p.m. confirmed laboratory director and testing personnel failed to sign attestation statements for two of four PT events in 2022 and 2023. D3027 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(1) Test requisitions and authorizations. Retain records of test requisitions and test authorizations, including the patient's chart or medical record if used as the test requisition or authorization, for at least 2 years. This STANDARD is not met as evidenced by: Based on review of patient test reports, lack of patient test requisitions and interview with the laboratory liaison, the laboratory failed to retain records of test requisitions for three of three patients reviewed in 2022 and 2023. The findings include: 1. Review Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- of the patient test reports revealed the following: -patient number 6641 had documented test results for Complete Blood Count and Urine Microscopy on 06.27.2022 -patient number 7280 had documented test results for Complete Blood Count and Urine Microscopy on 09.11.2023 -patient number 6823 had documented test results for Complete Blood Count and Urine Microscopy on 10.07.2023 2. No patient test requisitions could be provided for surveyor review for the Complete Blood Counts and Urine Microscopy tests for patients 6641, 7280, and 6823. 3. Interview on 10.25.2023 at 2:15 p.m. with the laboratory liaison affirmed the laboratory documents patient orders on a charge sheet and once orders are completed and charges filed, charge sheets are shredded which confirmed the laboratory failed to retain records of test requisitions for three of three patients reviewed in 2022 and 2023. 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 observation of the laboratory, review of patient test reports, review of laboratory records and interview with the laboratory liaison, the laboratory failed to verify the accuracy of urine microscopic testing twice a year in 2022 and 2023. The findings include: 1) Observation of the laboratory on 10.25.2023 at 11:05 a.m. revealed a microscope on the counter in use for patient testing for urine microscopy. 2) Review of patient test reports revealed urine microscopic patient testing was performed in 2022 and 2023. 3) Review of the laboratory records revealed no documentation that twice per year verification of accuracy had been done for urine microscopy in 2022 or 2023. 4) Interview with the laboratory liaison on 10.25.2023 at 2:15 p.m. confirmed the laboratory performed urine microscopic testing and no records were present for verifying the accuracy twice a year in 2022 and 2023. 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)