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 observations during the laboratory tour, review of the laboratory's policies and procedures, and interviews with the office manager (OM); the laboratory failed to have and follow written and approved laboratory safety procedures to ensure protection from physical, chemical, biochemical, and biohazardous materials. The findings include: 1. The laboratory failed to have a written Safety plan and procedures based on the laboratory's risk assessment to provide protection from physical, chemical, biochemical, and biohazardous materials as needed. 2. Surveyor observed during the laboratory tour that no eye wash station or eye wash portable bottle kit was found in the testing area. The fire extinguisher was located in a different room, not accesible to the laboratory. 3. The laboratory did not have a biological or chemical spill kit in the laboratory area where the Mohs procedure is performed. 4. The OM by interview on June 16, 2026, at approximately 12:00 p.m. affirmed that the laboratory did not have a written and laboratory director approved, signed, and dated Safety Plan and lacked an eye washing station and a chemical spill kit in the laboratory area. 5. The safety of laboratory testing personnel could not be assured at this time. 6. The annual testing declaration form submitted at the time of the survey stated 85 samples were processed and reported for Dermatopathology during the time when safety concern for all testing personnel could not be assured. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) 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 -- (a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on the review of the laboratory's policies and procedures, six (6) randomly selected patient test results for Mohs and Histopathology, and interviews with the laboratory's office manager (OM) and laboratory staff (LS) on June 16 2026; the laboratory failed to have CLIA compliant written procedures manuals for all tests, assays, and examinations performed by the laboratory available and followed by laboratory personnel. The findings included: 1. The laboratory lacked CLIA compliant written and LD approved, dated, and signed policies and procedures for: Mohs testing, microscope preventive maintenance, document retention, storage of slides, and laboratory safety policies. 2. Reliability of the laboratory tests' performance based on complete laboratory procedures to follow by testing personnel to ensure compliance with federal CLIA regulations could not be assured during this survey. 3. The OM and LS affirmed by an interview on June 16 , 2026, at approximately 11:45 a.m. that the laboratory failed to provide LD signed, dated, and approved laboratory policies and procedures for all the current tests and examinations performed in the laboratory. 4. According to the testing declaration form (CMS-116) submitted at the time of survey, the laboratory processed, tested, and reported approximately a total of 85 patient tests annually for Mohs and Histopathology, when the laboratory lacked written and approved policies and procedures manuals. 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 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)