Southeast Medical Clinic

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 an off-site desk review of the laboratory's 2024 American Proficiency Institute (API) proficiency testing (PT) records and an email with the laboratory director, it was determined the laboratory failed to attain a score of at least eighty (80) percent of acceptable responses for the analyte White Blood Cell (WBC) Differential in two (2) out of three (3) Hematology testing events resulting in unsuccessful PT performance. Refer to D2130 D2130 HEMATOLOGY CFR(s): 493.851(f) 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 -- (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 an off-site desk review of the laboratory's 2024 American Proficiency Institute (API) proficiency testing (PT) records and an email with the laboratory director, it was determined the laboratory failed to attain a score of at least eighty (80) percent of acceptable responses for the analyte White Blood Cell (WBC) Differential in two (2) out of three (3) Hematology testing events resulting in unsuccessful PT performance. Findings include: 1. Desk review of the laboratory's 2024 API PT records revealed analyte scores of less than eighty percent for WBC Differential. a. 2024 Event 1 = 28% b. 2024 Event 3 = 16% 2. In an email correspondence with the laboratory director on January 7, 2025, it was confirmed the laboratory was unsuccessful in the PT events listed above. -- 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 an off-site desk review of the laboratory's 2023 and 2024 American Proficiency Institute (API) proficiency testing (PT) records and a phone interview with the laboratory director, it was determined the laboratory failed to attain a score of at least eighty (80) percent of acceptable responses for the specialty of Bacteriology in two (2) out of three (3) Bacteriology testing events resulting in unsuccessful PT performance. Refer to D2028. D2028 BACTERIOLOGY CFR(s): 493.823(e) 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 -- Failure to achieve an overall testing event score of satisfactory performance for 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 an off-site desk review of the laboratory's 2023 and 2024 American Proficiency Institute (API) proficiency testing (PT) records and a phone interview with the laboratory director, it was determined the laboratory failed to attain a score of at least eighty (80) percent of overall testing event score for the specialty of Bacteriology in two (2) out of three (3) Bacteriology testing events resulting in unsuccessful PT performance. Findings include: 1. Desk review of the laboratory's 2023 and 2024 API PT records revealed Bacteriology scores of less than eighty percent for the following events: a. 2023 API Bacteriology 2nd event: 0% b. 2024 API Bacteriology 1st event: 0% 2. In a phone interview with the laboratory director on 4/3 /2024 at 2:00 PM, it was confirmed that the laboratory was unsuccessful in the PT events listed above. -- 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 an off-site desk review of CMS CASPER 155 Report, the laboratory's 2021 and 2022 American Proficiency Institute (API) proficiency testing (PT) records, and an email with the laboratory director on August 9, 2022 it was determined that the laboratory failed to attain a score of at least eighty (80) percent of acceptable responses for Total Bilirubin (TBili) in two (2) out of three (3) chemistry testing events. See 2096 D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 -- 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 an off-site desk review of CMS CASPER 155 Report, the laboratory's 2021 and 2022 American Proficiency Institute (API) proficiency testing (PT) records, and an email with the laboratory director on August 9, 2022 it was determined that the laboratory failed to attain a score of at least eighty (80) percent of acceptable responses for Total Bilirubin (TBili) in two (2) out of three (3) chemistry testing events. Findings include: 1. Desk review of the laboratory's 2021 and 2022 API PT records revealed TBili scores of less than eighty percent for the following Chemistry events: a. 2021-3 - score of 60% b. 2022-2 - score of 40% 2.In an email with the laboratory director on 8/9/2022, it was confirmed that the laboratory was unsuccessful in the PT events listed above. -- 2 of 2 --

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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: (1) Water quality. (2) Temperature. (3) Humidity. (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 review of the manufacturer's package insert, interview with the laboratory director, and observation, the laboratory failed to follow the manufacturer's instructions to store serum for Direct and Total Bilirubin testing away from fluorescent lights to prevent photodegradation prior to testing. Findings include: 1. The refrigerator used to store Direct and Total Bilirubin specimens has a glass door allowing for room light illumination and internal fluorescent lights that were continuously on. 2. Direct and Total Bilirubin testing is routinely performed three days a week, and the serum samples stored in the refrigerator prior to testing were not protected from the room light or the refrigerator's fluorescent lights. 3. The laboratory performs approximately 3,500 Direct and Total bilirubin tests annually. 4. The laboratory director confirmed these findings 2/15/2022 at 12:30 pm. 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 --