Summary:
Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification survey conducted at your facility on June 3, 2025. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. 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 a review of the 2023 and 2024 laboratory records for the twice per year verification of accuracy for Wet Mount and KOH testing, and an interview with the Senior Clinic Manager, the laboratory failed to ensure that twice per year verification of accuracy was performed for each provider performing Wet Mount and KOH testing in the laboratory. Findings include: 1. Testing personnel number two on the CMS-209 form did not have documentation of a second accuracy check in 2024. 2. Testing personnel number three on the CMS-209 form did not have documentation of a second accuracy check in 2024. 3. Testing personnel number four on the CMS-209 form did not have documentation of any accuracy checks in 2024. 4. Testing personnel number five on the CMS-209 form did not have documentation of a second accuracy check in 2024. 5. An interview with the Senior Clinic Manager on June 3, 2025 at approximately 10:00 AM confirmed these findings. The laboratory performs approximately 25 mycology and parasitology tests annually. D5433 MAINTENANCE AND FUNCTION CHECKS 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 -- CFR(s): 493.1254(b)(1) (b)(1)(i) Establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(1)(ii) Perform and document the maintenance activities specified in paragraph b(1)(i) of this section. This STANDARD is not met as evidenced by: Based on the laboratory's policies and procedures, lack of maintenance records, and an interview with the Senior Clinic Manager, the laboratory failed to ensure maintenance for the microscope was performed and documented. Findings include: 1. A review of the laboratory director approved policy titled "Laboratory Microscopes" states that "Microscopes are clean, adequate, optically aligned, and properly maintained with records of preventative maintenance at least annually". 2. There was no documentation of annual maintenance performed on the microscope that is used for Wet Mounts and KOH testing. 3. An interview with the Senior Clinic Manager on June 3, 2025 at approximately 10:30 AM confirmed these findings. The laboratory performs approximately 25 mycology and parasitology tests annually. D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) (e)(12) Ensure that prior to testing patients specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results; This STANDARD is not met as evidenced by: Based on a review of the roster provided on the CMS-209 form, a lack of documented initial training, an interview with the Senior Clinic Manager, the laboratory director failed to ensure that all testing personnel had documented initial trainings prior to performing Wet Mount and KOH. Findings include: 1. Testing personnel four (TP4) listed on the CMS-209 had no documentation of initial training for Wet Mount and KOH testing. TP4 was hired in December 2023. 2. An interview with the Senior Clinic Manager on June 3, 2025 at approximately 10:00 AM confirmed these findings. The laboratory performs approximately 25 mycology and parasitology tests annually. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (b)(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on a review of the roster provided on the CMS-209 form, a lack of annual competency assessments, an interview with the Senior Clinic Manager, the technical supervisor failed to ensure that all testing personnel had documented semi annual and -- 2 of 3 -- annual competency assessments. Findings include: 1. Testing personnel two listed on the CMS-209 had no annual competency assessments for Wet Mount and KOH testing in 2023 and 2024. 2. Testing personnel three the CMS-209 had no annual competency assessments for Wet Mount and KOH testing in 2023 and 2024. 3. Testing personnel four the CMS-209 had no semi annual or annual competency assessments for Wet Mount and KOH testing in 2024. 4. Testing personnel five the CMS-209 had no annual competency assessments for Wet Mount and KOH testing in 2023 and 2024. 5. An interview with the Senior Clinic Manager on June 3, 2025 at approximately 10:00 AM confirmed these findings. The laboratory performs approximately 25 mycology and parasitology tests annually. -- 3 of 3 --