Summary:
Summary Statement of Deficiencies D2021 BACTERIOLOGY CFR(s): 493.823(b) (b) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing (PT) records and an interview with the Testing Personnel (TP) on December 19, 2025, it was determined that the laboratory failed to participate in the second bacteriology testing event of 2025. The findings included: 1. It was the practice of the laboratory to perform moderate complexity testing for Chlamydia and Gonorrhea detection. The laboratory enrolled in the American Proficiency Institute (API) proficiency testing (PT) program for this specialty. 2. According to the API evaluation report, the laboratory did not participate in the second event of 2025 and received unsatisfactory scores of 0% for the specialty of bacteriology. 3. On December 19, 2025, around 10:00 am, the TP confirmed the laboratory did not participate in the testing event and received unsatisfactory proficiency scores. 4. The laboratory's testing declaration form, signed by the laboratory director on December 10, 2025, stated that the laboratory performed approximately 1000 bacteriology tests annually. 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 --