Summary:
Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on observation of the phlebotomy area located within the laboratory and interview with the technical supervisor #2, the laboratory failed to store glucose tolerance testing supplies appropriately and failed to provide a safe environment in which laboratory personnel and patients are protected from physical,chemical and biological hazards. Findings: 1. Observation of the laboratory showed one phlebotomy chair located directly within the laboratory next to testing analyzers. Venous blood draw and throat culture swab collection procedures occurred while testing personnel performed specimen testing. 2. Observation of 2 bottles of glucose tolerance drink for patient consumption was located in the laboratory cabinet. 3. Interview with the technical supervisor #2 on January 4,2019 at 11:30 AM confirmed the laboratory failed to ensure laboratory personnel and patients were protected from physical, chemical and biohazard materials. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- (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)