Southeast Medical Group

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the laboratory's proficiency testing provider, AAB-MLE (American Association of Bioanalysts Medical Laboratory Evaluation). The laboratory was found to be out of compliance with CONDITION LEVEL DEFICIENCIES, as follows: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; 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 off-site proficiency testing (PT) desk reviews of the CASPER Reports 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 -- 0153D and 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and PT evaluation reports from the AAB-MLE (American Association of Bioanalysts Medical Laboratory Evaluation), the laboratory failed to successfully participate (achieve scores of 80% or greater) in proficiency testing for Hematocrit, a regulated analyte in the specialty of Hematology. The laboratory failed two consecutive PT events, 2025 Event #2 and Event #3 in 2025, resulting in initial unsuccessful proficiency testing performance. Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) (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 off-site proficiency testing (PT) desk reviews of the CASPER Reports 0153D and 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and PT evaluation reports from AAB-MLE (American Association of Bioanalysts Medical Laboratory Evaluation), the laboratory failed to successfully participate (achieve scores of 80% or greater) in proficiency testing for Hematocrit, resulting in initial unsuccessful performance. The findings included: 1. Based on review of the CASPER Reports 153D and 155D, Individual Laboratory Profile reports, the laboratory received the following failing scores, resulting in unsatisfactory performances for two consecutive events, as follows: A. 2025-Event #2: Hematocrit: 60% B. 2025-Event #3: Hematocrit: 40% 2. A review of the laboratory's proficiency testing results from AAB-MLE confirmed the above findings. 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 off-site proficiency testing (PT) desk reviews of the CASPER Reports 0153D and 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and proficiency testing evaluation reports from the AAB- MLE (American Association of Bioanalysts Medical Laboratory Evaluation), the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. 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 off-site proficiency testing (PT) desk reviews of the CASPER Reports -- 2 of 3 -- 0153D and 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and PT evaluation reports from AAB-MLE (American Association of Bioanalysts Medical Laboratory Evaluation), the laboratory director failed to ensure the laboratory had successful participation in an HHS approved proficiency testing program for Hematocrit for two consecutive AAB-MLE PT events, resulting in initial unsuccessful participation for the analyte. Refer to D2130. -- 3 of 3 --

Summary Statement of Deficiencies 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 a review of the MLE (Medical Laboratory Evaluation) Proficiency Testing (PT) records and an interview with Administration Manager, the laboratory failed to ensure the Laboratory Director and Testing Personnel signed the attestation statements for four of six Hematology events reviewed in 2023 and 2024. The findings include: 1. A review of the MLE PT records revealed no signatures by the Laboratory Director or Testing Personnel on attestation statements for the following surveys: a) 2023 Hematology 1st Event. b) 2023 Hematology 2nd Event. c) 2024 Hematology 1st Event. d) 2024 Hematology 2nd Event. 2. During an interview on 7/8/2024, at 10:15 AM, the Administration Manager confirmed the above findings. 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 reviews of the MLE (Medical Laboratory Evaluation) PT (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) records,

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on a review of the Procedure Manual and an interview with the Office Administrator, the laboratory failed to have a written procedure for the Emerald Cell Dyn Hematology analyzer. The findings include: 1. A review of the Procedure Manual revealed a lack of written procedures for the Emerald Cell Dyn Hematology analyzer. 2. During an interview on 09/01/2022 at 4:00 PM, the Office Administrator confirmed the laboratory did not have any other procedures available. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on a review of Testing Personnel records and an interview with the Office Administrator, the Technical Consultant failed to implement and document evaluations that included the six minimal regulatory requirements for assessment of competency on the Emerald Cell Dyn Hematology analyzer. This was noted for ten out of ten Testing Personnel from December 2020 to the date of the current survey (09 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 -- /01/2022). The findings include: 1. A review of Testing Personnel records revealed the competency assessments did not include the six minimal regulatory requirements for assessment of competency as specified by CLIA. The aforementioned document only included a statement deeming the Testing Personnel competent, with the signature of the employee and the Laboratory Supervisor. 2. During an interview at 10: 48 AM on 09/01/2022, the Office Administrator stated, "The yearly evaluations are completed based on a review of the Emerald training checklist". -- 2 of 2 --

Summary Statement of Deficiencies 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 a review of the CMS (Centers for Medicare and Medicaid Services) CASPER reports and the MLE (Medical Laboratory Evaluation) Proficiency Testing (PT) evaluations, the surveyor determined the laboratory failed two consecutive testing events for Total Bilirubin (Chemistry testing), Events #2 and #3, 2021. These failures result in an initial unsuccessful PT participation. The findings include: 1. A review of the CASPER reports (#153 and #155) revealed the laboratory scored 40 % (percent) for Total Bilirubin for Event #2, 2021 and 20 % for Event #3, 2021. 2. The surveyor reviewed the MLE PT evaluations and confirmed the above noted scores. 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 a review of the CMS (Centers for Medicare and Medicaid Services) CASPER reports and the MLE (Medical Laboratory Evaluation) Proficiency Testing (PT) evaluations, the surveyor determined the laboratory failed to satisfactorily perform for two consecutive testing events for Total Bilirubin (Chemistry testing), Events #2 and #3, 2021. These failures result in an initial unsuccessful PT participation. The findings include: 1. A review of the CASPER reports (#153 and #155) revealed the laboratory scored 40 % (percent) for Total Bilirubin for Event #2, 2021 and 20 % for Event #3, 2021. 2. The surveyor reviewed the MLE PT evaluations and confirmed the above noted scores. -- 2 of 2 --