Summary:
Summary Statement of Deficiencies 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 surveyor's review of the Siemens Multistix 10SG vial and Henry Schein urine hCG kit package inserts, lack of laboratory quality control (QC) records and an interview with the office manager, the laboratory failed to test QC material for the Siemens 10 SG Multistix and failed to document the lot number and the expiration date of each vial of Multistix and each kit of Henry Schein urine hCG opened. FINDINGS: 1. The office manager confirmed on March 10, 2020 at approximately 10: 30 AM, that the laboratory failed to follow the manufacturer's instruction for Siemens 10 SG Multistix which requires positive and negative external controls to be performed when a new vial of test strips is opened. 2. The laboratory failed to document the lot number and the expiration date of each vial of Multistix and each kit of urine pregnancy opened. 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: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- Based on the lack of twice yearly verification and confirmed at survey with the office manager, the laboratory failed to verify the accuracy for KOH and Wet Mount tests at least twice per year. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on lack of written standard operating procedures (SOP) and confirmed at survey with the office manager, the laboratory failed to establish written policies /procedures for the KOH and wet mount tests. 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)