Summary:
Summary Statement of Deficiencies D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on a review of the laboratory's policies and procedures manual, and an interview with the general supervisor (GS), the laboratory failed to establish policies and procedures to ensure laboratory safety from physical, chemical, biochemical, electrical, and biohazardous materials since the last recertification survey was conducted on January 27, 2022. Findings include: 1. Based on a review of the laboratory's policies and procedures manual, the laboratory failed to establish policies and procedures to ensure laboratory safety from physical, chemical, biochemical, electrical, and biohazardous materials. 2. An interview with the GS on October 16, 2024, at approximately 2:15 PM, confirmed the laboratory failed to establish policies and procedures to ensure laboratory safety from physical, chemical, biochemical, electrical, and biohazardous materials. 3. The laboratory performs approximately 7,800 tests annually. 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 5 -- (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)