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 policy and procedure, lack of proficiency testing (PT) records, and an interview with the office managers; it was determined that the laboratory failed to verify the accuracy of any test or procedure performed at least twice annually for the years 2023, 2024, and 2025. The findings include: 1. The laboratory was missing a protocol to conduct proficiency testing for all provider performed microscopy (PPM) tests that included potassium hydroxide (KOH) and scabies test at least twice annually. 2. The laboratory lacked proficiency testing records for all providers performing PPM tests for the years 2023, 2024, and 2025. 3. Both office managers affirmed by an interview on September 9, 2025, at approximately 10:00 a.m., that the laboratory missed to perform proficiency testing for all providers as mentioned in the statements above. 4. The laboratory's testing declaration form submitted at the time of the survey stated that 150 tests for KOH and 50 scabies test samples annually including the time when proficiency testing were not performed for the years 2023, 2024, and 2025. Thus, the reliability and accuracy of patient tests reported cannot be assured. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under subpart H of this part; 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 -- This STANDARD is not met as evidenced by: Based on surveyor's review of patient records, lack of proficiency testing (PT) records, and interviews with the office managers on September 9, 2025; it was determined that the laboratory director failed to ensure that PT was performed for the years 2023, 2024, and 2025 as required under subpart H of this part. See D5217. -- 2 of 2 --