Southeast Medical Group

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (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 American Association of Bioanalysts-Medical Laboratory Evaluation (AAB-MLE) Proficiency Testing (PT) records and an interview with the Practice Manager (PM), the laboratory failed to ensure the Laboratory Director (LD), or designee and the Testing Personnel (TP/Analyst) signed the attestation statements for three of the four PT Hematology events reviewed in 2025-2026. The findings include: 1. A review of the AAB-MLE PT records revealed the LD and TP/Analyst failed to sign the attestation statements for the following PT Hematology events A) 2025 M1, missing LD signature B) 2025 M2, missing LD and TP/Analyst signatures C) 2026 M1, missing LD and TP/Analyst signatures 2. PM confirmed the above findings during exit conference on 06-23-2026 at 1:45 PM. 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 a review of the American Association of Bioanalysts-Medical Laboratory Evaluation (AAB-MLE) Proficiency Testing (PT) records and an interview with the Practice Manager (PM), the Laboratory Director (LD) failed to document review 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 4 -- evaluation of PT performance. The surveyor noted three out of three events in 2025 had no documentation of review by the LD. The findings include: 1. A review of the AAB-MLE PT records revealed no documentation of review on the returned evaluations by the LD, or designee, for the following events, 2025 Hematology, M1, M2 and M3 Events. 2. The PM confirmed the above findings during the exit conference on 06-23-2026 at 1:45 PM. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, 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 analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on observation during the lab tour, reviews of the Quality Control (QC) labels on the QC vials, the Temperature and Humidity logs, the Abbott Cell Dyn Emerald maintenance logs and QC records, the laboratory: 1. failed to record on the vials the open expiration date for the three levels of QC. 2. failed to ensure documentation of the daily room temperature during patient testing and refrigerator temperatures were within manufacturer's acceptable limits. 3. failed to perform maintenance of the analyzer as per manufacturer's requirement. 4. failed to retain documentation to monitor the accuracy and precision of test performance over time. Findings include: 1. Refer to D5415 2. Refer to D5413. 3. Refer to D5429. 4. Refer to D5441. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on reviews of the Temperatures and Humidity logs, the Abbott Cell-Dyn 18 Plus Control labels on the vials and an interview with the Practice Manager (PM), the laboratory failed to ensure the Room Temperature and Humidity where the Hematology analyzer was in operation and the Refrigerator Temperature where the Hematology Quality Control materials were stored were documented and were within manufacturer's acceptable limits on the day of patient testing. The Room Temperature and Humidity were missing documentation for 14 out of 26 testing days in December 2024 and the Refrigerator Temperature was outside the manufacturer's acceptable limits for 21 days out of 75 testing days from January-March 2026. The findings include: 1. A review of the Temperature and Humidity logs revealed no -- 2 of 4 -- documentation of the Humidity, Room and Refrigerator temperatures for the following days in 2024; a) December 5-6 b) December10-11 c) December 13-14 d) December 19-21 e) December 23-27 2. A further review of the Temperature and Humidity logs revealed the Refrigerator Temperature was outside the manufacturer's acceptable limits for the following days: A) January 2026; 6 days, B) February 2026; 12 days, E) March 2026; 3 days. 3. A review of the Abbott Cell-Dyn 18 Plus Control vials revealed the manufacturer's required storage temperature of 2-10 degrees Celsius. 4. PM confirmed the above findings during exit conference on 06-23-2026 at 1:45 PM. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) Identity and when significant, titer, strength or concentration. (c)(2) Storage requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on surveyor's laboratory tour observation, review of manufacturer's package inserts and confirmed in an interview with the Practice Manager (PM), the laboratory failed to label Abbott Cell-Dyn 18 Plus Quality Control (QC) materials with revised expiration dates for 3 of the 3 QC vials upon opening. Findings Included: 1. During the laboratory tour of the facility with the PM on 6-23-2026 at 9:10 AM, the surveyor observed the following Abbott Cell-Dyn 18 Plus controls for the Cell-Dyn Emerald analyzer, stored in the laboratory refrigerator. Levels L, N and H Lot Number: L6089, N6089, H6089 Expiration Date: 07-17-2026 Open Expiration Date: Not written The surveyor inquired if the above QC vials were currently being used prior to patient testing. PM confirmed the QC vials were currently in use. 2. Review of manufacturer's package insert for the Abbott Cell-Dyn 18 Plus controls revealed the following instructions, "8 Consecutive-Day Open-Tube Stability. 3. PM confirmed the above findings during exit conference on 06-23-2026 at 1:45 PM. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) 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 a review of the Abbott Cell- Dyn Emerald analyzer maintenance logs, the Abbott Cell- Dyn Emerald Operator's Manual and an interview with the Practice Manager (PM), the laboratory staff failed to document the semi-annual maintenance. The surveyor noted the first of the two semi-annual maintenances due in March 2026 was not performed and documented. The findings include: 1. A review of the Abbott Cell Dyn Emerald Maintenance logs revealed a place to document semi-annual maintenance for the analyzer. However, there was no documentation of performance in the past eight months after the analyzer was installed in September 2025. 2. A review of the Abbott Cell Dyn Emerald Operator's Manual revealed the following manufacturer's semi-annual maintenance specifications, on Section 9: Service and -- 3 of 4 -- Maintenance, page 9-14, "Lubricating the Pistons, for optimal operation...". 3. PM confirmed the above findings during exit conference on 06-23-2026 at 1:45 PM. 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. This STANDARD is not met as evidenced by: Based on review of Abbott Cell Dyn Emerald Hematology Quality Control (QC) records and an interview with Practice Manager (PM), the laboratory failed to retain documentation to monitor the accuracy and precision of test performance over time. The surveyor noted three of the three Abbott Cell-Dyn 18 Plus QC levels had no Levey-Jennings charts available for review in May 2026. The findings include: 1. A review of Abbott Cell Dyn Emerald QC records revealed no evidence of the L-J charts or peer group data comparison was available for review from May 1-22, 2026. 2. PM confirmed the above findings during exit conference on 06-23-2026 at 1:45 PM. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; and This STANDARD is not met as evidenced by: Based on a review of the validation records for the Abbott Cell Dyn Emerald Hematology analyzer, the Abbott Cell Dyn Emerald operation manual and an interview with Practice Manager (PM), the Laboratory Director (LD) failed to review and approved the validation procedures to verify the manufacturer's performance specifications before patient testing effective September 2025. The findings include: 1. A review of the validation records for the Abbott Cell Dyn Emerald Hematology analyzer revealed no evidence of LD review and approval for the following studies when the analyzer went live for patient testing 09-30-2025. A) Precision B) Accuracy C) Linearity or Reportable Range D) Carry-Over E) Method Comparison 2. PM confirmed the above findings during exit conference on 06-23-2026 at 1:45 PM. -- 4 of 4 --

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 --