Northeast Georgia Diagnostic Assoc And Clinic, Llc

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on September 13, 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 condition level deficiencies were cited: D2016 - 42 C.F.R. 493.803 Successful participation [proficiency testing] D6000 - 493.1403 Laboratory Director, Moderate Complexity 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 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 -- 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 three consecutive events (3rd event of 2021, 1st and 2nd events of 2022), resulting in the second unsuccessful participation for General Immunology including: Rhematoid Arthritis/Rheumatoid Factor (RA/RF). D2084 GENERAL IMMUNOLOGY CFR(s): 493.837(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 desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's American Association of Bioanalysts (AAB) proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in three consecutive testing events (3rd event of 2021, 1st and 2nd events of 2022), resulting in the second unsuccessful performance for Rhematoid Arthritis/Rheumatoid Factor (RA/RF). Findings include: 1. A review of Casper Reports 153 and 155 disclosed the laboratory failed RA/RF on the following: 2021 Event 3 RF/RA Score 60% 2022 Event 1 RF/RA Score 60% 2022 Event 2 RF/RA Score 40% 2. A review of the laboratory's proficiency testing reports from American Association of Bioanalysts (AAB) confirmed the laboratory failed RA/RF for the following: 2021 Event 3 RF/RA Score 60% 2022 Event 1 RF/RA Score 60% 2022 Event 2 RF/RA Score 40% 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's American Association of Bioanalysts (AAB) proficiency testing (PT) reports, the laboratory director failed to provide overall management and direction for ensuring immunology proficiency testing were tested as required under Subpart H. 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; -- 2 of 3 -- 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 American Association of Bioanalysts (AAB) proficiency testing (PT) reports, the laboratory director failed to ensure immunology proficiency testing was tested as required under Subpart H. The laboratory failed to maintain satisfactory performance in three consecutive testing events (3rd event of 2021, 1st and 2nd events of 2022), resulting in the second unsuccessful performance for RA/RF. Refer to D2084 -- 3 of 3 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on May 25, 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 two consecutive events (3rd event of 2021 and 1st event of 2022), resulting in the first unsuccessful occurrence for General immunoology # 065 including: RA/RF # 225. Findings include: Refer to D 2075 D2075 GENERAL IMMUNOLOGY CFR(s): 493.837(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. 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 two consecutive testing events (3rd event of 2021 and 1st event of 2022), resulting in the first unsuccessful performance for RA/RF, analyte # 225. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte # 225 RA/RF on event 3 of 2021 with a score of 60% and event 1 of 2022 with a score of 60%. 2. Desk review of the laboratory's proficiency testing reports from American Association of Bioanalysts (AAB) confirmed the laboratory failed RA/RF on Event 3 of 2021 and Event 1 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: 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 director failed to ensure the laboratory maintained satisfactory performance in two of three consecutive events (1st and 3rd events of 2018), resulting in the first unsuccessful occurrence for human chorionic gonadotropin (HCG), analyte # 555. Findings include: 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 proficiency testing desk review using the Centers for Medicare and -- 2 of 3 -- 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 consecutive events ( 3rd event of 2021 and 1st event of 2022), resulting in the first unsuccessful occurrence for RA/RF, analyte # 225. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte # 225 , RF/RA on event 3 of 2021 with a score of 60% and event 1 of 2022 with a score of 60%. 2. Desk review of the laboratory's proficiency testing reports from American Association of Bioanalysts (AAB) confirmed the laboratory failed RA/RF on Events 3 of 2021 and event 1 of 2022, resulting in the first unsuccessful performance. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on January 25, 2021. 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 153 and 155 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 two out of three events (Events 1 & 2 of 2020), resulting in the first unsuccessful occurrence for NA analyte #0475 in the specialty of Routine Chemistry. Findings include: Refer to D2096 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 desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 153 and 155 and review of the laboratory's proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two out of three events (Events 1 & 2 of 2020), resulting in the first unsuccessful occurrence for NA analyte #0475 in the specialty of Routine Chemistry. 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte #0475 NA, on Events 1 & 2 of 2020 with a score of 0% for both events. 2. The criteria for acceptable performance for the specialty of Routine Chemistry is 80%. 3. Desk review of the laboratory's proficiency testing reports from the Medical Laboratory Evaluation (AAB) confirmed the laboratory failed analyte #0475 NA for Events 1 and 2 of 2020 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: 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 American Association of Bioanalysts (AAB) proficiency testing (PT) reports, the laboratory director failed to ensure the laboratory maintained satisfactory performance in two out of three consecutive events (Events 1 & 2 of 2020), resulting in the first unsuccessful occurrence for #0475 NA (Sodium) in the specialty of Routine Chemistry. The findings include: 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; -- 2 of 3 -- 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 American Association of Bioanalysts (AAB) proficiency testing (PT) reports, the laboratory director failed to ensure the laboratory maintained satisfactory performance in two out of three consecutive events (Events 1 & 2 of 2020), resulting in the first unsuccessful occurrence for #0475 NA (Sodium) in the specialty of Routine Chemistry. The findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte #0475 NA, on Events 1 & 2 of 2020 with a score of 0% for both events. 2. The criteria for acceptable performance for the specialty of Routine Chemistry is 80%. 3. Desk review of the laboratory's proficiency testing reports from the American Association of Bioanalysts (AAB) confirmed the laboratory failed analyte #0475 NA for Events 1 and 2 of 2020 resulting in the first unsuccessful performance. -- 3 of 3 --