Family Medicine Associates Of Lincoln County, Pllc

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 desk review of CMS (Centers for Medicare and Medicaid Services) Casper reports 153D and 155D on 7/30/25 and desk review of 2025 API (American Proficiency Institute) proficiency testing results 9/3/25, the laboratory failed to achieve satisfactory performance for Glucose on 2 consecutive test events, resulting in unsuccessful participation in proficiency testing. Findings: See the deficiency cited at D2096. 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 -- (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 desk review of CMS Casper reports 153D and 155D on 7/30/25 and desk review of 2025 API proficiency testing results 9/3/25, the laboratory failed to achieve satisfactory performance for Glucose on 2 consecutive testing events, resulting in unsuccessful performance. Findings: Desk review of CMS Casper reports 153D and 155D and 2025 API proficiency testing results revealed the laboratory received a score of: 1. 60% for Glucose on the 2025 Chemistry-Core 1st Event. 2. 20% for Glucose on the 2025 Chemistry-Core 2nd Event. 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 desk review of CMS Casper reports 153D and 155D on 7/30/25 and desk review of 2025 API proficiency testing results 9/3/25, the laboratory director failed to provide overall management and direction to ensure successful proficiency testing participation. Findings: See the deficiency cited at 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 desk review of CMS Casper reports 153D and 155D on 7/30/25 and desk review of 2025 API proficiency testing results 9/3/25, the laboratory director failed to ensure successful participation in proficiency testing as required in Subpart H. Findings: See the deficiency cited at D2096. -- 2 of 2 --

Summary Statement of Deficiencies D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) (b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, review of the laboratory's critical value list, review of 2023, 2024, and 2025 American Proficiency Institute (API) proficiency testing (PT) records, and interview with testing personnel (TP) 5/1 /25, the laboratory failed to test the proficiency sample in the same manner as patient specimens are routinely tested. Findings: Review of the laboratory's Proficiency Testing policy revealed "The surveys are handled in the same manner as patient samples.....Raw data printouts of PT samples must be kept with the PT records." Review of the laboratory's "Critical Value List" revealed the following ALERT VALUE parameters for Glucose: less than 50 milligrams/deciliter (mg/dl) or greater than 500 mg/dl. The "Critical Value List" stated to repeat testing for all specimens with results occurring within the listed parameters. Review of the 2025 API Chemistry Core 1st event proficiency testing records revealed that sample CH-04 contained a glucose level of 46 mg/dl, which was critically low according to the laboratory's Critical Value list. There was no repeat testing documentation found with the results for PT sample CH-04. During an interview at approximately 2:30 p.m., TP #1 verified there was no documentation of repeat testing, and confirmed the repeated critical results should be stapled to the original results. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems 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 -- activities specified in 493.1252 through 493.1289 for at least 2 years. In addition, retain the following: This STANDARD is not met as evidenced by: Based on review of 2024 and 2025 Coulter AcT diff hematology records, the absence of records, and interview with the technical consultant (TC) 5/1/25, the laboratory failed to retain calibration records for 2022 and 2023 for the Coulter AcT diff hematology analyzer. Findings: Review of 2024 and 2025 Coulter AcT diff calibration records revealed the instrument was calibrated 3/10/24, 10/28/24, and 5/1 /25. There were no 2022 or 2023 calibration records available for review. During interview at approximately 11:15 a.m., the TC stated they were unable to locate 2022 and 2023 Coulter AcT diff calibration records. 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 laboratory's policies and procedures, review of personnel records, and interview with the TC on 5/1/25, the laboratory failed to follow the established Competency Evaluation procedure found in the Quality Assessment Policy. Findings: Review of the Quality Assessment Policy revealed a Competency Evaluation procedure that stated, "Competency evaluations shall be the responsibility of the Lead Tech and/or Technical Consultant. The first year they shall be done every six months. Thereafter, they will be done on an annual basis.....All competencies will be documented." Review of personnel records for TP #1 revealed annual competency evaluations performed in December 2023 and December 2024, but there were no records of a competency evaluation in 2022. Review of personnel records for TP #3 revealed annual competency evaluations performed in December 2023 and December 2024, but there were no records of a competency evaluation in 2022. During an interview at approximately 10:45 a.m., the TC confirmed there were no other competency records available for review. -- 2 of 2 --

Summary Statement of Deficiencies D6026 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(8) 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)(8) Ensure that reports of test results include pertinent information required for interpretation. This STANDARD is not met as evidenced by: Based on review of manufacturer's instructions, review of a random patient test report, and interview with staff on 4/16/19, the laboratory director failed to ensure that the laboratory's Prostatic Specific Antigen (PSA) test reports included the identity of the assay used. Finding: The laboratory performed Prostatic Specific Antigen (PSA) testing using the Access Hybritech PSA intended for use on the Bachman Coulter Access 2 immunoassay analyzers. The manufacturer's product insert (A85067c, REF 3720) for this test reads in the section entitled, "WARNING: ...The concentration of PSA in a given specimen determined with assays from different manufacturers can vary due to differences in assay methods and reagent specificity. The results reported by the laboratory to the physicians must include the identity of the PSA assay used...". Review of a random computer generated patient report (#11489) revealed that the test report did not include the method used for PSA. During interview at approximately 2: 00 p.m., the laboratory manager and the technical consultant confirmed that the PSA method was not included in patient test 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 1 --