Summary:
Summary Statement of Deficiencies D0000 Based on an unannounced validation revisit, the laboratory was found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780. A standard level deficiency remains uncorrected. __________________________________________ Based on an announced validation inspection, the laboratory was found NOT to be in compliance with the CLIA regulations found at 42 CFR 493 CLIA requirements. The conditions not met were: D5024 - 42 C.F.R. 493.1215 Condition: Hematology; D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director; D6033 - 42 C.F.R. 493.1409 Condition: Laboratories performing moderate complexity testing; technical consultant. D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on observation, review of manufacturer's instructions, and interview, the laboratory failed to record the open date on a vial of QwikCheck Reagent Strips for Semen Analysis used for Leukocytes and pH testing on one (1) of one (1) open vial reviewed. Findings follow. A. During a tour of the laboratory on May 21, 2024 at 1550 hours surveyor observed an open vial of QwikCheck Reagent Strips for Semen Analysis, Lot 23B10_080323, showed on the label "open vial expiration = 90 days" and had a space to record the open date. No open date was recorded on the vial. B. Interview with testing personnel #5 on May 21, 2024 at 1550 hours in the laboratory acknowledged the date should have been documented on the vial and confirmed they only used one or two strips per day. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 11 -- D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review competency evaluations, proficiency testing, accuracy assessments, validation records, manufacturer's instructions, calibration verifications, quality control (QC) records, test reports, comparison of test results,