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 office manager (OM) and laboratory director (LD), the laboratory failed to establish safety procedures to ensure protection from physical, chemical, and biochemical materials. The findings include: 1. Based on the survey on July 22, 2025, at approximately 12:20 p.m. the laboratory failed to provide a written policy and procedure for laboratory safety. 2. Based on the observations during the laboratory tour where the Mohs processing and staining of samples took place, it was found that the laboratory lacked an eye wash. 3. The OM and LD affirmed by interviews July 22, 2025, at approximately 12:45 p.m. that the laboratory lacked safety procedures and eyewash in the Mohs processing area. 4. Based on the laboratory's annual testing volume declaration signed by the laboratory director on 07/21/2025, the laboratory processed and reported annually approximately 100 Mohs patients' test samples. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: 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 -- Based on the surveyor's review of the laboratory's policies and procedures, peer review records, six (6) randomly selected patient records, and interviews with the office manager (OM); the laboratory failed to verify the accuracy of any test or procedure performed at least twice annually for the years 2023 and 2024. The findings include: 1. The laboratory's policy and procedure for proficiency testing stated that two cases are sent to another facility to verify the accuracy of results for Dermatopathology. However, only one case per year was available for review for the years 2023 and 2024. Therefore, the accuracy of patient results could not be assured. 2. The OM confirmed by interview the day of the survey July 22, 2025, at approximately 11:30 a.m., that the laboratory failed to verify the accuracy of the dermatopathology Mohs procedure at least twice per year as stated in #1. 3. The laboratory's testing declaration form submitted at the time of the survey stated that 100 tests Dermatopathology Mohs were processed and reported annually during the time that laboratory failed to verify the accuracy of the Mohs test results. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's policies and procedures, preventive maintenance (PM) documentation, six (6) patient records, and interviews with the laboratory's office manager (OM); the laboratory failed to follow an established policy and procedure in place for the preventive maintenance (PM) as defined by the manufacturer, with at least the frequency recommended for the laboratory's equipment prior to patient testing for the microscope. The findings include: 1.The laboratory failed to provide PM documentation for the year 2023 for the microscope according to manufacturer's requirements, to be performed annually. 2. No