Middle Georgia Pediatrics Llc

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on September 15, 2025. At the time of the review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 42 CFR 493.1780. The following condition deficiencies were cited: D2016 - 42 CFR 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 CFR 493.1403 Condition: moderate Complex Laboratory Director D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid Services (CMS) CASPER 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 -- 155 report and review of the laboratory 's American Proficiency Institute (API) proficiency testing (PT) reports, the laboratory failed to maintain satisfactory participation in PT in the specialty of Microbiology and the subspeciality of Bacteriology. Refer to: D 2028 D2028 BACTERIOLOGY CFR(s): 493.823(e) (e) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid Services (CMS) CASPER 155 report and review of the laboratory 's American Proficiency Institute (API) proficiency testing (PT )reports, the laboratory failed to maintain satisfactory participation in PT in the specialty of Microbiology subspeciality of Bacteriology, resulting in the initial unsuccessful performance for Bacteriology. Findings: 1. Desk review of the CMS CASPER 155 report revealed the laboratory failed bacteriology : -- 2024 Event 3 Score 60% -- 2025 Event 2 Score 0% 2. Desk review of the laboratory's proficiency testing reports from API confirms the laboratory failed the aforementioned testing on the above listed events resulting in the unsuccessful performances. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on review of the CMS CASPER 155 report and review of the laboratory 's API PT reports, the laboratory director failed to provide overall management and direction for proficiency testing to ensure successful participation in PT for the specialty of Microbiology and subspeciality of Bacteriology. Refer to D6016 D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on review of the CMS CASPER Report 155 and the API PT evaluation reports, the laboratory director failed to ensure the proficiency testing samples are tested as required under Subpart H of this part. Findings: 1. Desk review of the CMS CASPER 155 report revealed the laboratory failed bacteriology: -- 2024 Event 3 Score 60% -- -- 2 of 3 -- 2025 Event 2 Score 0% 2. Desk review of the laboratory's proficiency testing reports from API confirms the laboratory failed the aforementioned testing on the above listed events resulting in the unsuccessful performances. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A recertification survey was performed on November 13, 2024. The facility was found to be NOT in compliance with the CLIA conditions and standards for specialties /subspecialties for 42 CFR. CONDITION LEVEL: D6000 - Laboratory Director Responsibilities - 493.1407(d) D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on the review of the Quality Control (QC) for the Sysmex XN-330, Hematology Analyzer (Sysmex), the Laboratory Director failed to provide overall management and direction. The LD failed to document review of the QC documents for the Sysmex from 1/10/2023 thru the date of survey, 11/13/2024. This a CONDITION level citation. REFERENCE: D6020 .Laboratory Director Responsibilities 493.147 (e) (5) D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that the quality control program is established and maintained to assure the quality of laboratory services provided. 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 the review of the Quality Control (QC) for the Sysmex XN-330, Hematology Analyzer (Sysmex) and staff interview, the Laboratory Director (LD) failed to provide overall management and direction. The LD failed to document review of the QC documents for the Sysmex from 1/10/2023 thru the date of the survey date, 11/13/2024. Findings: 1. Review of the Sysmex QC documents from January 2023 thru November 2024, the LD failed to document review of the QC documents 2. Staff interview with the Office Manager and Lab supervisor, on 11/13 /2024, at approximately 3pm, in the breakroom, confirmed the statement above. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey was performed on November 30, 2022. An entrance conference was held with the laboratory representatives. The survey process was discussed, along with review of the survey forms that was sent to the facility, previous to the survey. An opportunity for questions and comments was given. Noted deficiencies and plans of correction were discussed with the laboratory representatives at the exit conference. The laboratory representatives were given an opportunity to provide evidence of compliance with the noted deficencies, and no such evidence was provided prior to survey exit. The facility was found to be NOT in compliance with the CLIA conditions for specialties/subspecialties for 42 CFR. 493.1230 General Laboratory Systems 493.1403 Condition: Laboratory Director, (Moderate Complexity) This is a REPEAT Citation NOTE: The CMS-2567 (Statement of Deficiencies) is an official , legal document,. All information must remain unchanged except for entering the

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on May 19, 2022. At the time of the review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory failed to maintain satisfactory 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 -- performance in four (4) consecutive events ( Events 1, 2, 3 of 2021 and 1st event of 2022), resulting in the third unsuccessful occurrence for Bacteriology #05. Findings include: Refer to D 2028 D2028 BACTERIOLOGY CFR(s): 493.823(e) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in 4 consecutive events (1st, 2nd, & 3rd events of 2021 and 2022 event 1), resulting in the third unsuccessful performance for Bacteriology #05 (throat culture). Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte # 05 on: - event 1 of 2021 with a score of 67% - event 2 of 2021 with a score of 60% - event 3 of 2021 with a score of 60% - event 1 of 2022 with a score of 60% 2. Desk review of the laboratory's proficiency testing reports from American Proficiency Institute (API) confirmed the laboratory failed Bacteriology #05 on the aforementioned events of 2021 and 2022 resulting in the 3rd unsuccessful performance. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: The laboratory director failed to maintain compliance with successful bacteriology #05 proficiency testing (PT) for 4 consecutive events resulting in the 3rd unsuccessful PT occurrence for Bacteriology (throat culture). Refer to D6016 D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a desk review of the Centers for Medicare and Medicaid Casper Report 155 (CMS 155) and the laboratory's 2021, 2022 proficiency testing (PT) evaluation -- 2 of 3 -- reports, the laboratory director failed to ensure the laboratory maintained satisfactory performance for 4 consecutive proficiency testing events for bacteriology resulting in the third unsuccessful PT occurrence for Bacteriology (throat culture). The findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte Bacteriology #05 (throat culture) on: -event 1 of 2021 with a score of 67% - event 2 of 2021 with a score of 60 - event 3 of 2021 with a score of 60% - event 1 of 2022 with a score of 60% 2. Desk review of the laboratory's proficiency testing reports from American Proficiency Institute (API) confirmed the laboratory failed Bacteriology #05 on Events 1, 2, and 3 of 2021 and 2022 event 1, resulting in the 3rd unsuccessful performance. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on March 2, 2022. At the time of the review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 February 12, 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: D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of the Proficiency Testing(PT) documents from American Proficiency Institute (API), the laboratory failed to complete an attestation statement for 2019 Hematology/Coagulation 3rd event, and 2019 Microbiology 1st event. A signed attestation statement certifies that as closely as possible, these proficiency testing samples were tested in the same manner as patient specimens. Findings: 1. Review of the 2019 PT documents from API, the Hematology /Coagulation 3rd event had not be signed by the LD or TP. The 2019 Microbiology 1st event showed that the LD did not sign the required attestation statement to confirm that the PT samples were tested in the same manner of patient specimens. 2. An interview with staff #1 (CMS form 209) on February 12, 2021, in the facility breakroom, confirmed that the attestation statements were not completed. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing 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 -- performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of the Proficiency Testing (TP) documents from the American Proficiency Institute (API), the Laboratory Director (LD) failed to sign the Performance Evaluation after reviewing the PT results. The 2019 Microbiology 1st event, Hematology / Coagulation and Microbiology 3rd event, and 2020 Microbiology 1st event were not signed by the LD as being reviewed. Findings: 1. A review of the API PT Performance Review for 2019 confirmed that the LD failed to sign the Performance Review as being reviewed for Microbiology 2nd Event, Hematology 3rd event, and Microbiology 3rd event. In 2020, the LD failed to sign the Performance Review for Microbiology 1st event. 2. An interview with staff #1 (CMS 209 form), on February 12, 2021, at approximately 4:15 pm, confirmed that the above mentioned Performance Review documents were not signed by the LD. D6024 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(7) 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)(7) Ensure that all necessary remedial actions are taken and documented whenever significant deviations from the laboratory's established performance specifications are identified, This STANDARD is not met as evidenced by: Based on review of the Daily Temperature Logs(Temp Logs), the laboratory failed to provide

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on August,22, 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: 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 the Electronic Medical Record(EMR) report and staff interview, the EMR report does not have the units of measure when printed. Findings: 1. Review of the EMR report, shows that the report does not have the units of measure for each analyte result. 2. Interview with staff #1 (CMS 209 form) on August 22, 2018, at approximately 2:15pm in the breakroom, confirmed that the EMR report does not have the units of measure for each analyte result printed. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the 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 -- performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on testing personnel records, and staff interview, the technical consultant (TC) failed to perform competencies for all 9 of the testing personnel for the year 2017. Findings: 1. Based on review of the testing personnel records, the TC failed to perform competencies for all 9 of the testing personnel during the 2017 year. 2. Interview with staff #1(CMS 209 form) on August 22, 2018 at approximately 2:40, in the break room, confirmed that the TC failed to perform annual competencies for all 9 of the testing personnel. D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on testing personnel record review, and staff interview, the laboratory failed to provide documentation of a high school diploma or equivalent, or higher education for one out of 10 testing personnel. Findings: 1. Review of testing personnel records, one out of 10 personnel did not have a copy of their high school diploma or equivalent in their file. 2. Interview with staff #1(CMS 209 form), on August 22, 2018 at approximately 2:30 pm in the break room, confirmed that one employee did not have a copy of their high school diploma in their personnel file. -- 2 of 2 --