Wellstar Urgent Care Atlanta

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) initial survey was completed on October, 15, 2025 - October, 15, 2025. 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: D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on facility policy review, a review of a chemistry analyzer user manual, facility document review, observation, and interview, the laboratory failed to maintain acceptable room temperatures according to manufacturer guidelines for 2 (March 2025 and June 2025) of 12 months reviewed for chemistry testing. Findings included: A facility policy titled, "[The Facility's Management Group Abbreviation] Quality Control and Quality Assurance," dated 07/22/2024, specified, "6. Daily temperature checks of refrigerators used for reagent storage are performed by individual testing departments. The departments are responsible for monitoring temperature and humidity log sheets. Log sheets are kept at the location site and are readily available for inspection." The facility's chemistry analyzer manufacturer's user manual for an I- Stat analyzer, revised 10/18/2021, included a policy titled, "Quality Control," which specified, "Ensure that cartridges are not exposed to temperatures exceeding 30 C 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 -- [degrees Celsius] (86 F [degrees Fahrenheit])." Facility documents titled, "[The Facility's Management Group Abbreviation] Temperature and Humidity Log," for the timeframe from October 2024 through October 2025, revealed the following dates the room temperature was documented outside the acceptable parameters according to the I-Stat analyzer user manual: - 03/20/2025- The room temperature was documented as 33 degrees Celsius. - 06/20/2025- The room temperature was documented as 38 degrees Celsius. - 06/27/2025- The room temperature was documented as 33 degrees Celsius. An observation of the laboratory on 10/15/2025 at 10:50 AM revealed the laboratory utilized an I-STAT chemistry analyzer and had an I-Stat test cartridge (Labeled with lot number H25163C, expiration date of 12/09/2025, refrigerator storage range of 2-8 degrees Celsius) unrefrigerated on the laboratory counter. During an interview on 10/15/2025 at 2:15 PM, Testing Personnel #1 stated that the temperature and humidity documentation logs corresponded to the room where the I- Stat test cartridge was observed on the counter for testing. During an interview on 10 /15/2025 at 11:05 AM, Testing Personnel #1 confirmed that the I-Stat test cartridges were "routinely taken out of the refrigerator and left on the laboratory counter for testing." -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on July 16, 2021. 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: D5485 CONTROL PROCEDURES CFR(s): 493.1256(h) If control materials are not available, the laboratory must have an alternative mechanism to detect immediate errors and monitor test system performance over time. The performance of alternative control procedures must be documented. This STANDARD is not met as evidenced by: Based on Chemistry Quality Control (QC) data review and staff interviews, the laboratory failed to perform QC on the Abbott I-Stat Chemistry analyzer, thereby failing to meet the laboratory's established (SOP) guidelines. Findings include: 1.) Quality Control documents review revealed NO (QC) data available at the time of survey during the month of June 2021. 2.) Interviews with the laboratory coordinator, office manager and TP #1(CMS 209) in the review room on 07/16/2021 at approximately 12:35 pm confirmed NO Chemistry (QC) was done in June 2021 due to lack of supplies. D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) 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. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical 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 -- consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on review of the employee competency assessments, and staff interview, the laboratory failed to provide Initial training documents for Testing Personnel (TP) rotating in the laboratory. Findings: 1. Review of the employee competency assessment records revealed, there was no documentation of initial training or 6 months evaluations for TPs #1 - 4 (CMS 209) from December 2020 to July 2021. 2. Interviews with the laboratory coordinator, Office Manager and TP #1 (CMS 209) on 07/16/2021 at approximately 12:40 pm in the review room, confirmed there were no initial training or 6 months review documents for the aformentioned Testing Personnel during the time of survey. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require