Family Physicians Of Evans

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification Survey was completed on August 14, 2025. 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: D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (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: A review of current Procedure Manual (SOP) confirmed that the SOP failed to contain step by step procedures for ALL technical testing operations that occur in the laboratory. THE FINDINGS INCLUDE: 1. A review of the laboratory SOP's revealed that ALL tests, assays, and examinations performed by the laboratory were not included in the Standard Operating Procedures. 2. A review of the laboratory SOP confirmed various log sheets for recording maintenance and temperatures were contained in the SOP however actual written step-by-step procedures for ALL laboratory operations were not available. 3. A review of the Laboraotory SOP revealed there were no Down Time, Maintenance, Temperature Monitoring, Specimen Handling & Storage, Quality Assurance or Quality Control Procedures. 4. An exit interview, with the Technical Consultant and the Testing Personnel, on August 14, 2025, at 2:00pm, confirmed that the SOP manual did not contain step by step procedures for ALL laboratory testing operations that occur in the laboratory. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) 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 -- (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: A tour of the laboratory environment and a review of the 2023 - 2025 Temperature Logs confirmed that reagents and collection tubes were not stored as required by the manufacturer. THE FINDINGS INCLUDE: 1. A review of the Freezer Temperature Reagent Storage Logsheet confirmed a temperature range of -20C - 0C. 2. A review of the BIO-RAD LiquiChek Immunoassay Plus Controls revealed a storage requirement of -70C - -20C however the BIO-RAD LiquiChek Immunoassay Plus Controls were stored in the Reagent Storage Freezer with a temperature range of -20C - 0C. 3. A review of the drawing room, used for storage of supplies, confirmed the temperature of the drawing room was not monitored. The following reagent and supplies were discovered: a. BD VACUTAINERS with temperature storage requirements of 4C - 25C; 4. An exit interview, with the Technical Consultant and the Testing Personnel, on August 14, 2025, at 2:00pm, confirmed that reagents were not stored as required by the manufacturer. 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: A tour of the laboratory confirmed that the laboratory failed to perform the preventive maintenance as required by the manufacturer. THE FINDINGS INCLUDE: 1. A review of the Clinical Pathology Laboratory's Centrifuge maintenance record and maintenance sticker revealed that the biannual speed calibration expired on 02/23 /2025. 2. An interview with the Technical Consultant confirmed that the speed calibration had not been performed after the expiration date of 02/23/2025. 3. An exit interview, with the Technical Consultant and the Testing Personnel, on August 14, 2025, at 2:00pm, confirmed that laboratory failed to perform the required biannual speed calibration, as required by the manufacturer. D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) 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. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel -- 2 of 4 -- meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: A review of 2023 - 2025 Maintenance Records, 2023 - 2025 Temperature Records, 2023 - 2025 Personnel Records, 2023 - 2025 Proficiency Testing Records, 2023 - 2025 Quality Control Records, and 2023 - 2025 Quality Assurance Records confirmed that the Laboratory Director failed to perform the required oversight for all laboratory operations. Refererece: D5401, D5413, D5417, D5429, D6020, and D6046. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) (e)(5) Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur; This STANDARD is not met as evidenced by: A review of 2023 - 2025 Maintenance Records, 2023 - 2025 Temperature Records, 2023 - 2025 Personnel Records, 2023 - 2025 Proficiency Testing Records, 2023 - 2025 Quality Control Records, and 2023 - 2025 Quality Assurance Records confirmed that the Laboratory Director failed to perform the required quality assurance assessment of laboratory operations to assure quality laboratory service. THE FINDINGS INCLUDE: 1. A review of the aforementioned records confirmed that quality assessment was conducted by the Technical Consultant and the Testing Personnel with no review by the Laboratory Director to identify failures. 2. An exit interview, with the Technical Consultant and the Testing Personnel, on August 14, 2025, at 2:00pm, confirmed that the Laboratory Director failed to perform the required quality assurance assessment of laboratory operations to assure quality laboratory services. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (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. The procedures for evaluation of the competency of the staff must include, but are not limited to-- This STANDARD is not met as evidenced by: A review of 2023 - 2025 Personnel Records confirmed that the Technical Consultant failed to perform personnel competency on two out of two testing personnel. THE FINDINGS INCLUDE: 1. A review of 2023 - 2025 Personnel Records confirmed that one out of two competencies were conducted by unqualified Testing Personnel. Testing Personnel 1 (See CMS- Form 209 Laboratory Personnel Report) performed the require six (6) month competency on Testing Personnel 2 (See CMS- Form 209 Laboratory Personnel Report). 2. A review of 2023 - 2025 Personnel Records revealed that a Letter of Delegation of Duties, from the Laboratory Director, for Testing Personnel 1 (See CMS- Form 209 Laboratory Personnel Report), was not available at -- 3 of 4 -- the time of inspection. 3. An exit interview, with the Technical Consultant and the Testing Personnel, on August 14, 2025, at 2:00pm, confirmed that the Technical Consultant failed to perform personnel competencies on two out of two laboratory testing personnel. -- 4 of 4 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification survey was completed on June 17, 2019. 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: D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on proficiency test (PT) document review and staff interview, the laboratory failed to examine the PT samples with the laboratory's regular patient workload by personnel who routinely perform the moderate-complexity laboratory testing. Findings include: 1. American Proficiency Institute (API) document review revealed Staff #3 (CMS 209) performed all of the Hematology PT sample testing for Events 1, 2, and 3 of 2018. 2. An interview in a medical office on 6/17/19 with the technical consultant at approximately 3:45 p.m. confirmed the aforementioned PT events were performed by the same testing personnel. 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 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on July 23, 2018. 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 deficiencies were cited: 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 desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two of three consecutive events (3rd event of 2017 and 2nd event of 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 -- 2018)), resulting in the first unsuccessful occurrence for chloride, analyte # 355. Findings include: Refer to D 2197 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two of three consecutive events (3rd event of 2017 and 2nd event of 2018)), resulting in the first unsuccessful occurrence for chloride, analyte # 355. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte #355 chloride on event 3 of 2017 with a score of 40% and event 2 of 2018 with a score of 0%. 2. Desk review of the laboratory's proficiency testing reports from American Proficiency Institute (API) confirmed the laboratory failed chloride on Event 3 of 2017 and Event 2 of 2018 resulting in the first unsuccessful performance. -- 2 of 2 --