Internal Medicine Associates Of Middle Georgia Pc

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification Survey was completed on DECEMBER 2, 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: D2128 HEMATOLOGY CFR(s): 493.851(e) (e)(1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: A review of 2023 - 2025 API Proficiency Testing Records confirmed that

Summary Statement of Deficiencies D0000 A recertification survey was performed on November 17, 2023. The facility was found to be NOT in compliance with all applicable CLIA requirements for specialties /subspecialties for 42 CFR. D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Observation and staff interview during the tour of the laboratory confirmed that the laboratory failed to follow written policy on labeling of specimen tubes with two unique identifiers. Findings: 1. Observation during the tour of the laboratory, on November 17, 2023, there were 2 urine specimens, on the counter, that were not labeled with two unique identifiers. Sample #1 was labeled with a first initial and the last name, sample #2 was labeled with the first and last name. 2. Observation during the tour of the laboratory, on November 17, 2023 confirmed there were 3 SST tubes in the collection rack without two unique identifiers. The 3 SST tubes were labeled with the first and last name of the patient only. 3. Interview with Testing Personnel #1, (CMS 209 Laboratory Personnel Report) on November 17, 2023, in the laboratory, confirmed that the 2 urine specimens and the 3 SST tubes, were not labeled with two unique identifiers. 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 proficiency testing desk review was completed on January 05, 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 review of the Centers for Medicare and Medicaid (CMS) CASPER 155 report and review of College of American Pathologist (CAP) 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 maintain satisfactory proficiency testing (PT) performance for automated hemoglobin (HGB) in 2022 events 1, 2, and 3; hematocrit (HCT) and white blood cell count (WBC) in 2022 events 1, 2, 3, and 2023 event 1, resulting in the non-initial unsuccessful participation for HCT, HGB, and WBC. Refer to D 2130 D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 Report 155 and review of the College of American Pathologist (CAP) proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in three testing events (1st, 2nd, and 3rd events of 2022) resulting in the non-initial unsuccessful participation for automated hemoglobin (HGB). Four testing events (1st, 2nd, and 3rd events of 2022 and 1st event of 2023), resulting in the non-initial unsuccessful participation for automated hematocrit (HCT) and white blood cell count (WBC). Findings include: 1. A review of CASPER Report 155 revealed the laboratory failed HCT on the following: 2022 Event 1 HCT Score 60% 2022 Event 2 HCT Score 0% 2022 Event 3 HCT Score 40% 2023 Event 1 HCT Score 0% 2. A review of CASPER Report155 revealed the laboratory failed WBC on the following: 2022 Event 1 WBC Score 0% 2022 Event 2 WBC Score 40% 2022 Event 3 WBC Score 20% 2023 Event 1 WBC Score 20% 3. A review of CASPER Report155 revealed the laboratory failed HGB on the following: 2022 Event 1 HGB Score 20% 2022 Event 2 HGB Score 20% 2022 Event 3 HGB Score 0% 4. A review of the laboratory's proficiency testing reports from CAP confirmed the laboratory failed HCT, HGB, and WBC 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 College of American Pathologist (CAP) reports, the laboratory director failed to provide overall management and direction for PT performance. 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 -- 2 of 3 -- 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 review of the Centers for Medicare and Medicaid (CMS) CASPER Report 155 and the laboratory's College of American Pathologist (CAP) proficiency testing (PT) evaluation reports, the laboratory director failed to provide overall management and direction for PT performance. The laboratory director failed to ensure PT samples were tested as required. Findings include: 1. A review of CASPER Report 155 revealed the laboratory failed HCT on the following: 2022 Event 1 HCT Score 60% 2022 Event 2 HCT Score 0% 2022 Event 3 HCT Score 40% 2023 Event 1 HCT Score 0% 2. A review of CASPER Report155 revealed the laboratory failed WBC on the following: 2022 Event 1 WBC Score 0% 2022 Event 2 WBC Score 40% 2022 Event 3 WBC Score 20% 2023 Event 1 WBC Score 0% 3. A review of CASPER Report155 revealed the laboratory failed HGB on the following: 2022 Event 1 HGB Score 20% 2022 Event 2 HGB Score 20% 2022 Event 3 HGB Score 0% 4. A review of the laboratory's proficiency testing reports from CAP confirmed the laboratory failed HGB, HCT, and WBC with the aforementioned scores. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on August 3, 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 performance in two consecutive events (1st and 2nd events of 2022), resulting in 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 3 -- first unsuccessful occurrence for Hematology # 760 including: hematocrit (HCT) # 785, hemoglobin (HGB) # 795, white blood cell count (WBC) # 805. Findings include: Refer to D 2130 D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 two consecutive events (1st and 2nd events of 2022), resulting in the first unsuccessful occurrence for hematocrit (HCT) # 785, hemoglobin (HGB) # 795, white blood cell count (WBC) # 805. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte: #785 HCT on Event 1 of 2022 with a score of 60% and & Event 2 of 2022 with a score of 0% #795 HGB on Event 1 of 2022 with a score of 20% and & Event 2 of 2022 with a score of 20% # 805 WBC on Event 1 of 2022 with a score of 0% and & Event 2 of 2022 with a score of 40% 2. Desk review of the laboratory's proficiency testing reports from College of American Pathologists (CAP) confirmed the laboratory failed the aforementioned analytes 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 consecutive events (1st and 2nd events of 2022), resulting in the first unsuccessful occurrence for Hematology # 760 including: hematocrit (HCT) # 785, hemoglobin (HGB) # 795, white blood cell count (WBC) # 805. 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; -- 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 proficiency testing (PT) reports, the laboratory director failed to ensure the laboratory maintained satisfactory performance in two consecutive events (1st and 2nd events of 2022), resulting in the first unsuccessful occurrence for Hematology # 760 including: hematocrit (HCT) # 785, hemoglobin (HGB) # 795, white blood cell count (WBC) # 805. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte: #785 HCT on Event 1 of 2022 with a score of 60% and & Event 2 of 2022 with a score of 0% #795 HGB on Event 1 of 2022 with a score of 20% and & Event 2 of 2022 with a score of 20% # 805 WBC on Event 1 of 2022 with a score of 0% and & Event 2 of 2022 with a score of 40% 2. Desk review of the laboratory's proficiency testing reports from College of American Pathologists (CAP) confirmed the laboratory failed the aforementioned analytes resulting in the first unsuccessful performance. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification survey was completed on January 14, 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: D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review of the College of American Pathology (CAP) Proficiency Testing (PT) provider documents for the years 2020 and 2021 and staff interview, the Laboratory failed to verify the accuracy of the specialty of Hematology. Findings: 1. Review of the CAP PT documents for 2020 and 2021, for the specialty of Hematology, the facility received notes on the Evaluation that the submitted results were not graded due to "not enough participants to evaluate". Further investigation revealed that the Sample Kit was not correct for the testing of the Abbott Emerald, instead was listed as the Beckman/ Coulter AcT diff Hematology Analyzer. 2. Interview with staff #2 (CMS form 209)and the Laboratory Director, on January 14, 2022, at approximately 11:30 am, in the office confirmed the aformentioned statement. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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 -- 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)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification survey was completed on August 20, 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: D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of the proficiency test (PT) documents and staff interview, the lab failed to rotate PT among all testing personnel. Findings include: 1. Review of the College of American Pathologist (CAP) PT documents revealed staff #2 performed 4 of 5 testing events in 2018 - 2019 to date. 2. Interview with staff #2 (CMS 209 form) on 08/20/19 in the breakroom at approximately 1:30 PM, confirmed the aforementioned PT was performed by staff #2. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on Cell-Dyn Emerald maintenance document review and staff interview, 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 -- lab failed to perform and document maintenance per the procedure manual. Findings include: 1. Review of the 2018 Cell-Dyn Emerald maintenance logs revealed the monthly maintenance was performed in June 2018, but the Semi-Annual due was not performed/ documented. Review of the December 2018 maintenance logs revealed the Semi-Annual maintenance was performed but the monthly maintenance was not performed/ documented. 2. Interview with staff #2 (CMS 209 form) on 08/20/19 in the lab at approximately 1:30 PM, confirmed the aforementioned maintenance was not performed/ documented. -- 2 of 2 --