Coosa Family Care Llc

Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of the American Proficiency Institute (API) Proficiency Testing (PT) records and an interview with the Testing Personnel (TP), the Laboratory Director failed to document review and evaluation of PT performance. This was noted for three out of three events in 2025. The findings include: 1. A review of the API PT records revealed no documentation of review on the returned evaluations by the Laboratory Director, or designee, for the following events: a) 2025 Microbiology, First Event. b) 2025 Microbiology, Second Event. c) 2025 Microbiology, Third Event. 2. TP confirmed the above findings during the exit conference on 04-15-2026 at 1:05 PM. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of the AirClean and WVR PCR workstations maintenance logs, and an interview with the Testing Personnel (TP), the laboratory failed to document quarterly maintenance for the hood equipments. This was noted for six out of six possible maintenances reviewed from July, 2024 through December, 2025. The findings include: 1. A review of the laboratory's PCR Workstation maintenance logs 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 -- revealed no documentation of the quarterly (every 3 months) maintenance for the AirClean and VWR PCR workstations.. 2. A further review of the PCR workstations maintenance logs revealed a place to document the quarterly maintenance to replace the filter. 3. TP confirmed the above findings during the exit conference on 04-15- 2026 at 1:05 PM. -- 2 of 2 --

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 a review of the American Proficiency Institute (API) proficiency test records and an interview with Testing Personnel #1, the laboratory failed to implement a mechanism to verify the accuracy of non-regulated analytes in the specialty of Microbiology. This was noted for four of twenty analytes reviewed in 2023 and 2024. The findings include: 1. A review of the API proficiency records revealed the following analytes did not have documented accuracy verification or proficiency testing performed since 3/8/22: a) Haemophilus influenzae b) Moraxella catarrhalis c) Streptococcus pneumoniae d) Staphylococcus aureus 2. During an interview on 7/31 /2024 at 12:01 PM, Testing Personnel #1 said the analytes listed above had accuracy verification performed when sending split samples to another laboratory bi-annually. The laboratory began using API and thought all analytes were included in the Microbiology panel. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; 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 a review of the American Proficiency Institute (API) proficiency test records and an interview with Testing Personnel #1, the Laboratory Director failed to implement a mechanism to verify the accuracy of non-regulated analytes in the specialty of Microbiology. This was noted for four of twenty analytes reviewed in 2023 and 2024. The findings include: Refer to D 5217. . -- 2 of 2 --