Atlanta Diabetes Associates

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on Aug. 12, 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 CASPER 155 report and review of the American Proficiency Institute (API) reports, the laboratory failed to maintain satisfactory proficiency 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 -- testing (PT) participation for Parathyroid hormone (PTH) in 2025 events 1 & 2, resulting in an initial unsuccessful participation. Refer to D 2108 D2108 ENDOCRINOLOGY CFR(s): 493.843(g) (g) 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 (CMS) CASPER 155 report and review of American Proficiency Institute (API) reports, the laboratory failed to maintain satisfactory participation in two consecutive testing events ( 1st and 2nd events of 2025), resulting in an initial unsuccessful participation for PTH. Findings: 1. A review of Casper Report 155 revealed the laboratory failed PTH on the following: 2025 Event 1 PTH Score 60% 2025 Event 2 PTH Score 20% 2. A review of the laboratory's API Reports confirmed the laboratory failed PTH with the aforementioned scores. 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 American Proficiency Institute (API) reports, the laboratory director failed to provide overall management and direction for proficiency testing performance. The laboratory director failed to ensure proficiency testing samples were tested as required. 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 American Proficiency Institute (API) 2025 events 1 & 2 evaluation reports, the laboratory director failed to ensure successful proficiency testing performance in 2 consecutive events (2025 events 1 & 2), resulting in the initial unsuccessful participation for PTH. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on July 31, 2024. 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 CASPER 155 report and review of the American Proficiency Institute (API) reports, the laboratory failed to maintain satisfactory proficiency 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 -- testing (PT) participation for Total Bilirubin (TBIL), Cholesterol (CHOL), High Density Lipoprotein (HDL), Creatinine (CREAT), Triglyceryde (TRIG) in 2023 event 3 and 2024 event 2, resulting in an initial unsuccessful participation for T.Bil, Chol, HDL, Creat, and Trig. Refer to D 2096 D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in 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 (CMS) CASPER 155 report and review of American Proficiency Institute (API) reports, the laboratory failed to maintain satisfactory participation in two of three testing events ( 3rd event of 2023 and 2nd event of 2024), resulting in an initial unsuccessful participation for T. Bil, Chol, HDL, Creat, Trig. Findings: 1. A review of Casper Report 155 revealed the laboratory failed T.Bil, Chol, HDL, Creat, Trig on the following: T.Bil Chol: HDL: Creat: Trig: 2023 Event 3 Score 0% 0% 0% 0% 0% 2024 Event 2 Score 40% 0% 0% 60% 40% 2. A review of the laboratory's API Reports confirmed the laboratory failed the aforementioned analytes with the aforementioned scores. 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 American Proficiency Institute (API) reports, the laboratory director failed to provide overall management and direction for proficiency testing performance. The laboratory director failed to ensure proficiency testing samples were tested as required. 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 review of the CMS CASPER Report 155 and the American Proficiency Institute (API) 2023 event 3 and 2024 event 2 PT evaluation reports, the laboratory -- 2 of 3 -- director failed to ensure successful proficiency testing performance in T BIL, Chol, HDL, Creat, and Trig in 2 out of 3 testing events, resulting in the initial unsuccessful participation for T BIL, Chol, HDL, Creat, and Trig. Findings: Refer to : D 2096 -- 3 of 3 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on March 20, 2024. 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 (CMS) CASPER 155 report and review of the American Proficiency Institute (API) reports, the 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 3 -- failed to successfully participate in proficiency testing (PT) for Blood Urea Nitrogen (BUN), Total Protein (TP), & Chloride (CL) resulting in the non-initial unsuccessful participation for BUN, TP, & CL. Refer to D 2096 D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in 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 the review of the CMS CASPER 155 report and American Proficiency Institute (API) proficiency testing (PT) reports, the laboratory failed to demonstrate satisfactory performance in three of four testing events for Blood Urea Nitrogen (BUN) and Total Protein (TP) and four of seven testing events for Chloride (CL). Findings: 1. A review of Report 155 revealed the laboratory failed to score at least 80% for the analytes BUN, CL, and TP during the following events: BUN 2023 Event 1 Score 60% 2023 Event 3 Score 0% 2024 Event 1 Score 0% TP 2022 Event 3 Score 0% 2023 Event 1 Score 40% 2023 Event 3 Score 0% CL 2022 Event 1 Score 40% 2022 Event 3 Score 0% 2023 Event 3 Score 0% 2024 Event 1 Score 20% 2. A review of the API reports revealed and confirmed the failed PT scores for the analytes BUN, CL, and TP. 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 API reports, the laboratory director failed to provide overall management and direction for successful participation in PT. The laboratory director failed to ensure PT samples were tested as required. 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: -- 2 of 3 -- Based on review of the CMS CASPER Report 155 and the API 2022, 2023, & 2024 PT evaluation reports, the laboratory director failed to ensure successful PT participation. Refer to D 2096 -- 3 of 3 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on March 30, 2023. 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 CASPER 155 report and review of the American Proficiency Institute (API) reports, the laboratory failed to maintain satisfactory proficiency 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 -- testing (PT) participation for Total Protein (TP) in 2022 event 3 and 2023 event 1, resulting in an initial unsuccessful participation for TP. Refer to D 2096 D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in 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 (CMS) CASPER 155 report and review of American Proficiency Institute (API) reports, the laboratory failed to maintain satisfactory participation in two consecutive testing events ( 3rd event of 2022 and 1st event of 2023), resulting in an initial unsuccessful participation for Total Protein (TP) Findings: 1. A review of Casper Report 155 revealed the laboratory failed TP on the following: 2022 Event 3 TP Score 0% 2023 Event 1 TP Score 40% 2. A review of the laboratory's API Reports confirmed the laboratory failed TP with the aforementioned scores. 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 Centers for Medicare and Medicaid (CMS) CASPER 155 report and review of the American Proficiency Institute (API) reports, the laboratory director failed to ensure the laboratory maintained satisfactory performance in two consecutive testing events ( 3rd event of 2022 and 1st event of 2023), resulting in the initial unsuccessful participation in Total Protein (TP). Refer to D 6016 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 review of the Centers for Medicare and Medicaid (CMS) CASPER 155 report and review of the American Proficiency Institute (API) reports, the laboratory director failed to ensure the laboratory maintained satisfactory performance in two consecutive testing events ( 3rd event of 2022 and 1st event of 2023), resulting in the initial unsuccessful participation in chloride Total Protein (TP). Refer to D 2096 -- 2 of 2 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on January 11, 2023. 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 conditions 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: 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 -- The laboratory failed to maintain satisfactory proficiency testing (PT) performance for Chloride (CL) in 2022 events one and three resulting in the first unsuccessful occurrence for CL. Refer to D 2130 D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in 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 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 two of three events (1st and 3rd events of 2022) resulting in the first unsuccessful performance for chloride (CL). Findings : 1. Review of Casper Reports 153 and 155 disclosed the laboratory failed CL : - 2022 event 1 with a score of 40% - 2022 event 3 with a score of 0%. 2. Review of the laboratory's proficiency testing reports from American Proficiency Institute (API) confirmed the laboratory failed chloride on Events 1 and 3 of 2022 resulting in the first 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 Chloride (CL) proficiency testing (PT) for two of three events, resulting in the first unsuccessful performance for CL. 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 proficiency testing 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 director failed to ensure the laboratory maintained satisfactory performance in two of three events (1st and 3rd events of 2022), resulting in the first unsuccessful occurrence chloride (CL). Findings: 1. Review of Casper -- 2 of 3 -- Reports 153 and 155 disclosed the laboratory failed CL: - 2022 event 1 with a score of 40% - 2022 event 3 with a score of 0% 2. Review of the laboratory's proficiency testing reports from American Proficiency Institute (API) confirmed the laboratory failed CL on 2022 Events 1 and 3, resulting in the first unsuccessful performance. -- 3 of 3 --

Summary Statement of Deficiencies D0000 On June 01, 2022 an off site followup review was completed. The report revealed that