Summary:
Summary Statement of Deficiencies D0000 An announced recertification survey was conducted on 08/24/2022 at Seymour M Bigayer DPM PA, a clinical laboratory in West Palm Beach, Florida. Seymour M Bigayer DPM PA was not in compliance with Code of Federal Regulations (CFR) 42, Part 493, Laboratory Requirements. 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: Based on record review and interview, the laboratory failed to verify the accuracy of fungal cultures using dermatophyte test medium (DTM) at least twice annually in 2021. The finding included: Review of the "Quality Control Log" showed that the verification of the fungal cultures using dermatophyte test medium (DTM) was performed only once in 2021. According to the Clinical Laboratory Improvement Amendments (CLIA) Application for Certification signed and dated by the Laboratory Director on 8/20/22, the laboratory had an estimated annual test volume of 286. On 8 /24/22 at 1:52 p.m., the Laboratory Director confirmed the proficiency testing for the DTM testing was only done once in 2021 D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to report the temperature of the refrigerator and the room temperature each day of testing from 6/14/20 to 8/24 /22. The findings included: Review of "Refrigerator Temperature Control Log" showed the refrigerator temperature was recorded only 85 times from 6/14/20 to08/24 /22. Review of the patient test results notebook showed the room temperature was recorded 72 times from 6/14/22 to 8/24/22. Review of the laboratory's procedure titled "Quality Assurance" noted "Refrigerator temperatures will be monitored on a bi- monthly basis" and "Room will be monitored on a bi-weekly basis." On 8/24/22 at 1: 55 p.m., the Laboratory Director stated the temperatures were not recorded daily and that he did not know they needed to record the temperatures of the refrigerator and the room temperature every date the facility was open. -- 2 of 2 --