Athens Heart Center, Pc

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on January 7, 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: 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 proficiency test (PT) documents review and staff interview, the laboratory director failed to attest that (PT) samples were ran in the same manner as patient samples by not signing attestation documents in a timely manner in 2023 and 2024. Findings: 1. American Proficiency Institute (API) (PT) documents review revealed the laboratory director (LD) failed to sign attestation statements, confirming that PT samples were integrated into the daily sample processing workflow in a timely manner as follows: Chemistry event 1 2023 - results submitted 1/31/2023, LD signed 8 /13/2023 - 7 months later. Hematology event 2 2023 - results submitted 3/29/23, LD signed 8/13/2023 - 5 months later. Chemistry event 2 2023 - results submitted 6/5 /2023, LD signed 6/28/2024 - 12 months later. Immunology event 2 2023 - results submittes 8/15/2023, LD signed 6/28/2024 - 10 months later. Chemistry event 3 2023 - results submitted 8/28/2023, LD signed 6/28/2024 - 8 months later. Hematology event 3 2023 - results submitted 11/9/2023, LD signed 6/28/2024 - 7 months later. Chemistry event 1 2024 - results submitted 1/19/2024, LD signed 6/29/2024 - 5 months later. Hematology event 3 2024 - results submitted 11/12/2024, LD signed 12 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 -- /6/2024 - 3 weeks later. 2. An interview with the laboratory manager (TP #3 CMS 209) in the review room at approximately 1:30 PM on 01/07/2025 confirmed the above findings. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on proficiency test (PT) documents review and staff interview, the laboratory director failed to review and evaluate proficiency testing (PT) results of the American Proficiency Institute (API) by not signing (PT) Evaluation documents in a timely manner in 2023 and 2024. Findings: 1. American Proficiency Institute (API) (PT) documents review revealed the laboratory director failed to review and sign (PT) results evaluation statements in a timely mannar for the following (PT) events: 2023 - Events #1 Hematology evaluation forms were signed 8/13/2025 (4 months later). There were no signatures for the remaining evaluation forms for Events #2 and #3 for Chemistry, Immunology and Hematology in 2023. 2. The American Proficiency Institute (API) (PT) events #1, #2 and #3 for Chemistry, Immunology and Hematology had no review signatures in 2024. 4. An interview with the laboratory manager (TP #3 CMS 209) in the review room at approximately 1:45 PM on 01/07 /2025 confirmed the above findings. D6005 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(c) 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. (c) The laboratory director must be accessible to the laboratory to provide onsite, telephone or electronic consultation as needed. This STANDARD is not met as evidenced by: Based on (PT) documents review and interview with the laboratory manager, the Laboratory director failed to ensure that ALL Quality Assurance (QA) guidelines were followed to identify and fix problems in the laboratory in 2023 and 2024 as required by Clinical Laboratory Improvement Amendments (CLIA). Findings: 1. American Proficiency Institute (API) and Quality Assurance (QA) documents review revealed the lab director, who is also the technical consultant (TC) , did NOT review and sign-off on (PT) attestation and evaluation documents in a timely manner from 2023 -2024. 2. An interview with the laboratory manager in the review room on 01/07 /2025 at approximately 12:35 PM, confirmed the laboratory director failed to ensure proper oversight of the laboratory's (QA) activities in 2023 and 2024. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A proficiency testing (PT) desk review was completed on August 22, 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 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 PT desk review using the Centers for Medicare and Medicaid Services (CMS) CASPER 155 Report and review of the American Proficiency Institute (API) 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 -- PT reports, the laboratory failed to successfully participate in 2 consecutive testing events, resulting in the initial unsuccessful performance for Chloride (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 review of the CMS CASPER 155 Report and the API 2022-2023 PT evaluation reports, the laboratory director failed to ensure successful proficiency testing performance in 2 consecutive testing events for CL, resulting in the initial unsuccessful performance for CL. Findings include: 1. Desk review of CASPER 155 reports disclosed the laboratory failed CL with the following scores: 2023 event 1 = 40% 2023 event 2 = 60% 2. Desk review of the laboratory's proficiency testing reports from API, confirmed the laboratory failed the aforementioned analytes. 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 evaluation 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 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 CMS CASPER 155 Report and the API 2022 and 2023 PT evaluation reports, the laboratory director failed to ensure successful PT participation in two consecutive testing events. Refer to D2096 -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on November 11, 2022. 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: 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 Test (PT) document review and staff interview, the laboratory failed to have successful performance in two out of three consecutive Chemistry testing events in 2022. (Refer to D 2096). 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 -- 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 Test (PT) document review and staff interview, the laboratory failed to have successful performance in two out of three concecutive Chemistry testing events in 2022. Findings include: 1. Review of American Proficiency Institute (API) PT documents revealed the laboratory failed to have successful performance in the following events: 2022 - Events #s 2 and 3, the laboratory scored 0% for (Sodium - Chemistry analyte) concecutively on both events. 2. An interview with the laboratory manager and Testing Personnel (TP#2 CMS 209), in the review room, at approximately 1:00 PM, on 11/17/2022, confirmed the unsuccessful PT findings in 2022. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the 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 record review and interview with the lab manager, the laboratory director who is also the Technical Consultant (TC), failed to ensure that annual competency assessments were completed for all testing personnel (TP) in 2021. Findings include: 1. A review of the training and competency records revealed that the laboratory director, who is also the (TC), failed to complete and sign the competency assessement form for TP ( #2 CMS 209) in 2021 as specified in the laboratory procedure manual. 2. An interview with the laboratory manager (TP #2 CMS 209) , on 11/17/2022, at approximately 1:05 PM, in the review room, confirmed that the technical consultant and lab director did not ensure that all annual competencies for testing personnel were completed and signed in 2021. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was January 7, 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: D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on proficiency test (PT) document review and staff interview, the laboratory director (LD) failed to ensure the laboratory was enrolled in an HHS approved PT program for the testing performed as required. Findings include: Refer to D2003 for details. D2003 ENROLLMENT CFR(s): 493.801(a)(2)(ii) For those tests performed by the laboratory that are not included in subpart I of this part, a laboratory must establish and maintain the accuracy of its testing procedures, in accordance with 493.1236(c)(1) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- This STANDARD is not met as evidenced by: Based on proficiency test (PT) document review and staff interview, the laboratory director (LD) failed to ensure the laboratory was enrolled in an HHS approved PT program for the testing performed as required. Findings include: 1. American Proficiency Institute (API) document reviewed revealed the lack of PT documents for brain natriuretic peptide (BNP) for the following Chemistry PT: 2019 - Events Two and Three; 2020 -- Events One, Two, and Three. 2. An interview with Staff #3 (CMS 209) in a medical office on 1/7/2021 at approximately 11:30 a.m. confirmed the lack of BNP PT enrollment for the aforementioned PT events. 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 proficiency test (PT) document review and staff interview, the laboratory director (LD) and testing personnel (TP) failed to attest to the integration of PT samples into the patient workload as required. Findings include: 1. American Proficiency Institute (API) PT document review revealed the LD and TP did not sign the 2020 Hematology/Coagulation attestation statement for Event 3. 2. An interview with Staff #3 (CMS 209) in a medical office on 1/7/2021 at approximately 11:45 a.m. confirmed the aforementioned lack of attestation statement signatures. D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on policy and procedure manual (SOP) review, proficiency test document review, and staff interview, the laboratory failed to monitor and evaluate the overall quality of the general laboratory systems and correct identified problems as required. Findings include: For details refer to D5221 and D5291. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on proficiency test (PT) document review and staff interview, the laboratory -- 2 of 5 -- failed to document evaluation and verification activities as required. Findings include: 1. American Proficiency Institute (API) PT document review revealed

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on August, 08 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: D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (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 (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (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 review of Hematology calibration documents and an interview the laboratory coordinator, the laboratory failed to perform calibrations on the Abacus 3CP CBC analyzer at least once every 6 months in 2017 and 2018. Findings include: 1. A review of hematology calibration records revealed calibrations were not performed in July 2017 and January 2018 as data dictated. 2. Calibrations were performed once in 2017 (1/5/17) and once in 2018 (3/7/2018). 3. An interview with the laboratory coordinator at approximately 11:25 AM on August 08, 2018 in the review room confirmed that the calibrations were not performed at least every 6 months in 2017 and 2018. 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 -- D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on Quality Control (QC) document review and an interview with the laboratory coordinator, the laboratory failed to monitor Quality Control values for the Abacus 3CP Hematology Analyzer over time to check the accuracy and precision of test performance. Findings include: 1. QC review revealed no evidence of long term monitoring of Hematology QC available to review i.e. (Levy-Jennings charts or eQC) in 2017 and 2018. 3. An interview with the laboratory coordinator on August 08, 2018 at approximately 11:50 AM in the review room confirmed QC for the Abacus 3CP Hematology Analyzer was not monitored for accuracy and precision. D6049 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(iii) The procedures for evaluation of the competency of the staff must include, but are not limited to review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. This STANDARD is not met as evidenced by: Based on review of the laboratory's maintenance records and an interview with the laboratory coordinator, the Technical Consultant (TC) who is also the laboratory director failed to review maintenance records in 2017, 2018. Findings include: 1. Review of maintenance logs including refrigerators, Humidity, room temperature, eye wash and problem logs revealed logs were not reviewed and signed on a monthly basis by (TC). 2. An interview with the laboratory coordinator on August 08, 2018 at approximately 11:40 am in the review room confirmed maintenance logs were not reviewed and signed by the (TC) who is also laboratory director. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the 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 review of testing personnel (TP) documents and interview with the -- 2 of 3 -- laboratory coordinator , the Technical Consultant(TC) failed to perform or sign off on annual competencies on all testing personnel in 2017 and 2018. Findings include: 1. Review of testing personnel documents revealed the technical consultant failed to sign off or perform annual competencies on TP #1 and #2 (CMS 209 form). 2. An interview with the laboratory coordinator at approximately 11:39 AM on August 08, 2018 in the review room confirmed the (TC) did not sign off or perform annual competencies for the aforementioned testing personnel. -- 3 of 3 --