A Woman's View

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation and interview with laboratory director on 10/29/2024, the laboratory failed to discard materials that had exceeded their expiration dates and were available for use in patient testing. Findings: 1. At approximately 3:00 P.M., the surveyor observed one (1) Vacuette Red Top blood collection tube with Lot Number B2303338 and expiration date 2024-08-30 in a tray in the Phlebotomy Collection Station inside the laboratory. 2. At approximately 3:00 P.M., the surveyor observed four (4) QFT LabCorp blood collection kits with Lot Number 2309280177 and expiration date 09/30/24 in a tray in the Phlebotomy Collection Station inside the laboratory. The expired blood collection tubes were given to laboratory director who, during an interview at 3:00 P.M., confirmed that they had exceeded their expiration dates. The expired tubes were immediately discarded in the laboratory's biohazard container. 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 D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of hematology records, the absence of records, and interview with the TC (technical consultant) 5/4/22, the laboratory failed to retain background records for the Medonic M-series hematology analyzer from 1/4/19 to 2/24/22. Review of 2019, 2020, 2021, and 2022 hematology records revealed there were no background records available for the Medonic hematology analyzer. The laboratory director was able to print a background report during the survey, but the report did not include any backgrounds prior to 2/25/22. During interview at approximately 3:40 p. m., the TC stated that they don't routinely print backgrounds. 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: Based on review of the laboratory's policies and procedures, review of 2019, 2020, 2021, and 2022 API (American Proficiency Institute) proficiency testing records, and interview with the TC (technical consultant) 5/4/22, the laboratory failed to ensure that all unacceptable and ungraded proficiency testng results were evaluated to determine the need for

Summary Statement of Deficiencies 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)