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 the surveyor's observation during the laboratory tour, review of the laboratory's policy and procedure, and interviews with the Mohs Tech CLS, (MT- CLS) the laboratory failed to establish safety procedures to ensure protection from physical, chemical, and biochemical materials. The findings include: 1. Based on the surveyor's review of policies and procedures on the day of the survey, August 28, 2025, at approximately 12:45 p.m. the laboratory failed to provide a written policy and procedures for laboratory safety. 2. Based on the surveyor's observations during the laboratory tour where processing of samples for Mohs procedure took place, it was found that the laboratory did not have either biological or chemical spill kits. 3. The MT-CLS affirmed by interviews August 28, 2025, at approximately 1:00 p.m. that the laboratory lacked safety procedures and spill kits in the sample processing and testing area as stated in #2. 4. Based on the laboratory's annual testing volume declaration signed by the laboratory director on 07/16/2025 the laboratory processed and reported annually approximately 65 patients' test samples. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(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. (b)(2) Microscopic 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 -- examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)