Summary:
Summary Statement of Deficiencies 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: Through a review of proficiency testing result reports, lack of documentation, and interviews with laboratory staff, it was determined the laboratory failed to verify the accuracy of KOH and Urine Formed Element examinations, at least twice annually. Findings follow: A) In a review of the proficiency test result report it was revealed that no proficiency tests for KOH and urine formed element examinations were presented. B) Upon request the laboratory was unable to provide documentation of twice annual evaluation of the accuracy of KOH and urine formed element examinations. C) In an interview, at 12:56 PM on 12/14/21, laboratory employee #3 (as listed on the form CMS-209) confirmed that the accuracy of KOH and urine formed element examinations had not been verified. 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 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 -- 493.1253. (7) Control procedures. (8)