North Atlanta Pediatric Associates Pc

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on Aug. 14, 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: D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) (a )Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (a)(1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (a)(2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (a)(2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (a) (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (a)(3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on the lack of the Horiba Micros 60 calibration documents and staff interview, the laboratory failed to calibrate the Horiba Micros 60 analyzer at the frequency required by the manufacturer. Findings: 1. A review of the available calibration documents presented revealed no calibration was performed on February 2024 or Aug. 2024. The Horiba Micros 60 was calibrated only on dates 8/1/23 and 4/30/25. 2. An interview with testing personnel #1 (see CMS 209) on 8/14/25 at 12:30 pm in the lab director's office, confirmed the aformentioned finding. D6018 LABORATORY DIRECTOR RESPONSIBILITIES 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 -- CFR(s): 493.1407(e)(4)(iii) (e)(4)(iii) All proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratorys performance and to identify any problems that require

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on May 16, 2023. 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: D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on review of the laboratory policy and procedure manual (SOP) and staff interview, the laboratory failed to ensure a policy for the eyewash station and perform maintenance. Findings include: 1. SOP review revealed the laboratory failed to establish an eyewash procedure for safety of the testing personnel. 2. The laboratory failed to perform eyewash maintenance for 2021, 2022 (January- December), and thus far 2023. 3. During an interview with Testing Personnel #1 (CMS-209) on May 16, 2023 in the Laboratory Director's office, confirmed there was not an eyewash procedure present, during the time survey. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. 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 laboratory policy and procedure manual (SOP) review and staff interview, the laboratory failed to establish and follow the required 6-step criteria competency for 11 out of 11 Testing Personnel (TP). Findings include: 1. Competency document review revealed the laboratory was performing competency, but failed to follow the required 6-step criteria policy and procedure for all Testing Personnel (TP) listed on the CMS-209 form. 2. During an interview with Testing Personnel #1 (CMS-209) on May 16, 2023 at 12:50 PM, in the Laboratory Director's office, confirmed that competency was performed for all Testing Personnel (TP), but the laboratory failed to follow the required 6-step criteria for competency. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (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 review of the laboratory's testing personnel competency assessment checklist and staff interview, the Technical Consultant failed to ensure the competency assessment policy and procedure for testing performed, in the speciality of hematology and chemistry, met the 6 required criteria, and failed to perform the assessment on 11 out of 11 testing personnel.. The Findings include: 1. Competency document review revealed the Technical Consultant (TC) failed to perform the 6 required criteria for hematology and chemistry for 11 out of 11 Testing Personnel. 2. During an interview with Testing Personnel #1 (CMS-209) on May 16, 2023 at 12:50 PM in the Laboratory Director's office, confirmed the Technical Consultant failed to perform the 6 required criteria for competency. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on May 16, 2019. 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: D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of patient reports and staff interviews, the laboratory failed to include all required components on the facility's result reports. Findings include: 1. Review of 3 patient reports (SM ran 4/9/19, HWF ran on 5/1/19, and JKM reported 5 /13/19) revealed a second unique patient identifier was not printed on the report. 2. Review of 3 patient reports (SM ran 4/9/19, HWF ran on 5/1/19, and JKM reported 5 /13/19) revealed the performing lab was not identified on the report. 3. Interview with staff #3 (CMS 209 form) and the clinical manager on 5/16/19 at approximately 1 PM in the employee breakroom confirmed the missing required information on the patient reports. 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 --