Wellstar Vining's Health Park Urgent Care

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on January 1/8/25. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) 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 review of the training & competency personnel documents and interview with a technical consultant (TC), the lab director (LD) failed to ensure all testing personnel (TP) were trained at each laboratory that they perform laboratory technical procedures. Findings: 1. Review of the training documents provided revealed the float and the PRN (as needed) TP (CMS form 209 page 2 of 3), 9 of 9 TP listed were trained under the location of WMG not the Wellstar Urgent Care Vinings Health Park (VHP) location. 2. CLIA regulations requires the completion of training and competency of all testining personnel per CLIA Certificate. 3. Interview with TC #3 (CMS 209 form page 3 of 3) on 1/8/25 at 1:30 pm, confirmed the aforementioned TP were trained under the WMG location to work at any Wellstar Medical Group laboratory. 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 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on August 30, 2022. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D5783

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on September 13, 2018. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on review of the daily lab logs and staff interview, the lab failed to monitor room temperature (RT), relative humidity (RH), or refrigerator temperature each day of use as required by the manufacturer of the hematology analyzer. Findings include: 1. Review of the daily lab logs for October 2017 thru December 2017 revealed the lab failed to monitor the RT and RH 92 of 92 days of operation of the Beckman Coulter ACT Diff 2 hematology analyzer. 2. Review of the daily lab logs for January 2018 thru May 26, 2018 revealed the lab failed to monitor the RT and RH 146 of 146 days of operation of the Beckman Coulter ACT Diff 2 hematology analyzer. No RT and RH was recorded 6/15/18. 3. Review of the daily lab logs for September 2017 revealed the lab failed to record the refrigerator temperature on 9/30 and 9/31. Review of the daily lab logs for October 2017 revealed the lab failed to record the refrigerator temperature on 10/01 and 10/02. 4. Interview with staff #10 (CMS 209 form) on 09/13 /18 in the practice manager's office at 11:30 AM, confirmed the aforementioned missed temperatures and humidity readings. 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 --