Summary:
Summary Statement of Deficiencies D0000 A Certification Survey was performed on September 1, 2019 at Darrell C Robinson OBGYN, CLIA ID # 19D0983864. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to ensure the Laboratory Director signed the attestation statement for two (2) of four (4) proficiency testing (PT) events reviewed. Findings: 1. Review of the laboratory's College of American Pathologists (CAP) proficiency records for 2018 and 2019 revealed the Laboratory Director did not sign the attestation statement for the following events: a) CAP VS-B 2018 b) CAP VS-C 2018 2. In interview on September 19, 2019 at 09:20 am, Personnel 3 stated the laboratory discontinued testing for Candida sp., Bacterial vaginosa, and Trichomonas vaginalis in August 2018. Personnel 3 further stated that the laboratory overlooked getting the Laboratory Director's signature on the above events. 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 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 -- 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)