Summary:
Summary Statement of Deficiencies 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 the surveyor's review of the laboratory's policies and procedures, peer review records, eight (8) randomly selected patient records, and interviews with the office managers (OMs); the laboratory failed to verify the accuracy of any test or procedure performed at least twice annually for the year 2023. 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 year 2023. Therefore, the accuracy of patient results could not be assured. 2. The OM s confirmed by interview the day of the survey July 30, 2025, at approximately 12:30 p. 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 144 Dermatopathology Mohs samples were processed and reported annually during the time that laboratory failed to verify the accuracy of the Mohs test results. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (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. 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 -- This STANDARD is not met as evidenced by: Based on the lack of laboratory written policies and procedures for parasitology and preparation for the detection of Sarcoptes scabiei (scabies) and interviews with the laboratory managers (OMs) it was determined that the laboratory failed to have available and follow written procedures for parasitology test performed in the laboratory. The findings included: 1. On the day of the survey on July 30, 2025, at approximately 11:45 a.m. the laboratory failed to provide written policies and procedures for parasitology (scabies) microscopic test performed in the laboratory. 2. The OMs confirmed on 07/30/2025 at approximately 11:50 a.m. that the laboratory did not have written policies and procedures available for parasitology tests performed in the laboratory. 3. Based on the laboratory's annual testing volume declaration signed by the laboratory director on 07/01/2025, the laboratory processes and reports 5 parasitology samples annually. D5779