Skin And Cancer Associates Llp

Summary Statement of Deficiencies D0000 A recertification survey was conducted on February 27, 2024. SKIN AND CANCER ASSOCIATES LLP clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. 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 review of peer review records and interview, the laboratory failed to maintain documentation to verify accuracy of the reading and interpretation of the Hematoxylin and Eosin (H&E) stain at least twice annually for 2022 and 2023. Findings: Review of peer review records revealed the peer review was done on 09/09 /2022 and 10/06/2023. On 02/27/2024 at 10:57 AM, the Laboratory Consultant stated peer review was only done once each year. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D0000 An announced recertification survey was conducted on 9/25/19 at Skin & Cancer Associates, LLP. Skin & Cancer Associates, LLP is not in compliance with Code of Federal Regulations (CFR) 42, Part 493, Laboratory Requirements. 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. (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 with laboratory personnel, the laboratory did not document humidity in the room that the cryostat was used. The findings included: Review of quality control records for 2018 and 2019 on 9/25/19 revealed that room humidity was only documented in January, February, and June of 2018. The operator's manual for the cryostat specified that the instrument needed to be operating in no more that 60% humidity. During an interview with the Risk Manager at 10:39 a.m., on 9/25/19, he acknowledged that the histotechnician had not been documenting the room 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 1 --