Upson Family Medical Center, Llc

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on July 31, 2025. 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 deficiencies were cited: D2016 - 42 CFR 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 CFR 493.1445 Condition: Moderate Complex 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 proficiency testing (PT) desk review using the Centers for Medicare and Medicaid Services Casper report 155 and review of the laboratory's PT reports, 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 -- laboratory failed to maintain overall satisfactory performance in the Specialty of Hematology resulting in a second subsequent unsuccessful occurrence for the analyte of White Blood Cell Differential (WBC Diff) in four out of five events, and the initial unsuccessful occurrence for the analyte of hemoglobin (HGB) in two of three events. Refer to D 2130 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 proficiency testing (PT) desk review using the Centers for Medicare and Medicaid Services Casper report 155 and review of the laboratory's PT reports, the laboratory failed to maintain overall satisfactory performance in the Specialty of Hematolgy resulting in a second subsequent unsuccessful occurrence for the analyte of White Blood Cell Differential (WBC Diff) in four out of five events (1st and 2nd event, 2024, and 1st and 2nd event, 2025), and the initial unsuccessful occurrence for the analyte of hemoglobin (HGB) in two of three events (2nd event, 2024 and 1st event, 2025. Findings: 1. Review of the CASPER 155 report revealed the following scores: a. WBC Diff: 2024 Event 1 score 60% 2024 Event 2 score 0% 2025 Event 1 score 33% 2025 Event 2 score 0% b. HGB 2024 Event 2 score 0% 2025 Event 1 score 0% 2. Desk review of the laboratory's PT reports from WSLH confirms the laboratory scores for WBC Diff and HGB and an overall score of (67%) in the Specialty of Hematology. 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: The laboratory director failed to provide overall management and direction of the laboratory to ensure successful participation in proficiency testing (PT) in the specialty of Hematology for the analytes of WBC Diff and HGB. 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: The laboratory director failed to ensure PT was tested as required under subpart H resulting in the unsuccessful occurrences in the Specialty of Hematology for the analytes of WBC Diff and HGB. Refer to D2130 -- 2 of 3 -- D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) (e)(4)(iv) An approved

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on November 30, 2023. At the time of the review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments (CLIA) of 1988, 42 CFR 493.1 through 42 CFR 493.1780. The following condition deficiencies were cited: D2016 - 42 CFR 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 CFR 493.1403 Condition: Moderate Complex 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 review of the Centers for Medicare and Medicaid Services (CMS) 155 report and review of Wisconsin State Laboratory of Hygiene (WSLH) and American 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 -- Academy of Family Physicians (AAFP) proficiency testing reports, the laboratory failed to successfully participate in proficiency testing (PT) for white blood cell differential (WBC Diff) in four consecutive testing events (2022 event 3 and 2023 events 1, 2 & 3), resulting in the non-initial unsuccessful participation for WBC Diff. 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 CMS 155 report and review of AAFP and WSLH PT evaluation reports, the laboratory failed to demonstrate satisfactory performance in four consecutive testing events, resulting in a non-initial unsuccessful participation for WBC Diff. Findings: 1. A review of CMS 155 report disclosed the laboratory failed WBC Diff on the following: 2022 AAFP Event 3 Score 67% 2023 WSLH Event 1 Score 53% 2023 WSLH Event 2 Score 0% 2023 WSLH Event 3 Score 60% 2. A review of the laboratory's AAFP and WSLH PT evaluation reports confirmed the laboratory failed WBC Diff 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 CMS 155 report and review of the AAFP and WSLH PT evaluation reports, the laboratory director failed to to provide overall management and direction for sucessful participation in proficiency testing. 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 155 Report and review of the PT evaluation reports from AAFP and WSLH, the laboratory director failed to ensure successful proficiency testing performance. Refer to D2130 -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on January 12, 2023. 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: 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 laboratory proficiency testing (PT) reports and testing personnel (TP) interview, the laboratory failed to maintain satisfactory performance in two of three testing events (1st and 3rd events of 2022), resulting in the first unsuccessful performance for automated white blood cell differential (WBCD) lymphocyte count. Findings: 1. Review of the laboratory PT reports disclosed the laboratory failed WBCD-lymphocyte count on the following: 2022 Event 1 lymphocte Score 60% 2022 Event 3 lymphocyte Score 40% 2. Interview with TP #1 (CMS 209 form) on 1/12/23 in the clinical supervisor's office at 11:00 AM, confirmed the findings. 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 review of the American Academy of Family Physicians (AAFP) 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 (PT) documents for 2021 events 2 and 3 and 2022 events 1, 2, and 3 for hematology and testing personnel (TP) interview, the laboratory failed to provide

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on September 19, 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: 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 review of the Casper 096 report and staff interview, the laboratory failed to enroll in Proficiency Testing (PT) for 2018. Findings include: 1. Review of the Casper 096 report revealed no reported scores for 2018. 2. Interview with staff #4 (CMS 209 form) on 9/19/18 at 10:15 AM in the breakroom, confirmed the lab did not participate in PT for the year of 2018. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of 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 7 -- proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of the Casper 096 report and staff interview, the laboratory failed to maintain a copy of the proficiency testing (PT) records. Findings include: 1. Review of the Casper 096 report revealed test scores for 2017, but no documents were retrievable at the time of the survey 2. Interview with staff #4 (CMS 209 form) on 9/19 /18 at 10:15 AM in the breakroom, confirmed the lab did not have the PT records for the year of 2017. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of the procedure manual (SOP) and staff interview, the laboratory failed to establish and follow written policies and procedures to assess laboratory personnel competency. Findings include: 1. SOP review revealed the laboratory failed to establish and follow a six-procedure policy and procedure for assessing laboratory personnel competency. 2. An interview with Staff #4 (CMS 209) in the breakroom on 9/19/18 at approximately 11::00 a.m. confirmed the SOP did not contain a six- procedure competency policy and procedure. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of laboratory procedure manual (SOP) and staff interview, the laboratory failed to establish and follow written policies and procedures for Quality Assessment (QA) . Findings include: 1. Review of the SOP revealed the lack of QA policies and procedures . 2. Interview with staff #4 (CMS 209 form) on 9/19/18 at 11 AM in the breakroom, confirmed the lab did not have written QA policies and procedures. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) -- 2 of 7 -- 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 review of the procedure manual (SOP) and staff interview, the laboratory failed to establish and follow written policies and procedures for all tests, exams, and assays performed by the lab. Findings include: 1. SOP review revealed the laboratory failed to establish and follow written policies and procedures for analyzer or computer downtime, Quality Assurance, personnel training or competency, Proficiency testing, safety, eyewash maintenence,