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: . Based on document review and interview with laboratory personnel, the laboratory failed to verify the accuracy of a non-regulated Hematology analyte at least twice annually in 2017 and 2018. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by the General Supervisor (GS) during a tour of the laboratory on 07/02/19 at 8:25 a.m. 2. The Fern Test microscopic examination procedure was included in the Laboratory Policy Manual.. 3. Twice annual Fern Testing verification of accuracy records were not found for 2017 or 2018. The laboratory was unable to provide documentation of verifications upon request. 4. In an interview on 07/02/19 at 4:00 p.m., the GS confirmed the accuracy of the Fern Test microscopic examination had not been verified twice annually in 2017 and 2018. 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 5 -- 493.1253. (7) Control procedures. (8)