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 review of waived testing supplies and an interview with the office manager, the laboratory failed to keep records and documentation for the waived pregnancy test and for the Multistix 10 SG urinalysis strips. Findings: At approximately 10 AM on August 20, 2018 it was confirmed by the office manager that the laboratory did not have the following records for the waived testing performed in the laboratory: 1. There was no package inserts available for the urine pregnancy test therefore it was impossible to determine if any QC was required by the manufacturer and to determine the proper steps the laboratory is required to follow to perform the pregnancy test properly. 2. The laboratory had no pregnancy testing record logs, to include the lot numbers and expiration dates. 3. There was no package inserts available for the Clarity Urocheck 10 SG urinalysis strips and there were no documentation of lot numbers and expiration dates. 4. For Fecal Occult Blood the laboratory had no documentation of lot numbers and expiration dates. 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 lack of Quality Assurance (QA) records and an interview with the office manager, the laboratory failed to verify the accuracy of interpretation of the KOH, wet mount and fern tests at least twice per year for calendar year 2017 and up to survey date. FINDINGS: 1. The office manager confirmed on August 20, 2018 at approximately 9:30 AM that the accuracy of interpretation of the KOH, wet mount and fern testing was not performed at least twice yearly in calendar year 2017 and up to survey date. 2. Approximately 200 patients' KOH, wet mount and fern slides were interpreted and reported in calendar year 2017 and up to survey date. 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)