Ocmulgee Physicians Laboratory

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification Survey was completed on November 20, 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: D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) (d)(3)(i) Each quantitative procedure, include two control materials of different concentrations; This STANDARD is not met as evidenced by: A review of 2023 - 2025 Quality Control Records confirmed that the laboratory failed to include the required control levels for all test procedures when processing test samples as required by CLIA Regulation 493.1256(d)(3)(i). THE FINDINGS INCLUDE: 1. A review of 2023 - 2025 Quality Control Records revealed the lack of quality control documentation for the Erythrocyte Sedimentation Rate (ESR) testing by the Westergren method. 2. An interview with testing personnel confirmed that quality controls were not performed for ESR testing. 3. A review of the 2023 - 2025 Quality Control records revealed that quality controls for the Polymerase Chain Reaction (PCR) testing were performed once per week, as opposed to running with each testing run as required. 4. A review of the Quality Controls SOP confirmed that an Individualized Quality Control Plan (IQCP), to support the deviation from regulatory requirements, was not established. 6. An exit interview, with Laboratory Staff, on November 20, 2025, at 2:30pm, in the Lab Office, confirmed that the laboratory failed to include the required control levels for all test procedures when processing test samples. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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 -- (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 the 2023 - 2025 Quality Control Records and the 2023 - 2025 Quality Assurance Records confirmed that the Laboratory Director failed to establish and to maintain quality control and quality assessment programs to assure the quality of laboratory services provided. THE FINDINGS INCLUDE: 1. A review of the 2023 - 2025 Quality Assurance Records confirmed that the Laboratory Director had not performed the required quality assurance oversight of the laboratory quality control and quality assessment programs. 2. An exit interview, with Laboratory Staff, on November 20, 2025, at 2:30pm, in the Lab Office confirmed that the Laboratory Director failed to establish and to maintain quality control and quality assessment programs to assure the quality of laboratory services provided. D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(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, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 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 the 2023 - 2025 Personnel Records confirmed that Laboratory Director failed to complete annual competencies for the General Supervisor and the Technical Supervisor for years 2023 - 2025 or establish the required letters of Delegation for shared duties. THE FINDINGS INCLUDE: 1. A review of the 2023- 2025 Personnel Records revealed that the annual competencies for the General Supervisor and the Technical Supervisor were not completed in years 2023 - 2025. 2. A review of the 2023 - 2025 Quality Assurance Records confirmed that Testing Personnel performed the quality assurance programs. The required Letters of Delegation from the Laboratory Director was not available on the date of survey 3. An exit interview, with Laboratory Staff, on November 20, 2025, at 2:30pm, in the Lab Office confirmed that the Laboratory Director failed to complete annual competencies for the General Supervisor and the Technical Supervisor for years 2023 - 2025 or establish the required letters of Delegation for shared duties. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification survey was completed on October 28, 2021. 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: D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on review of the calibration documents for the CellDyn Ruby (Ruby) 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 -- hematology analyzer, and staff interview the laboratory failed to calibrate the Ruby at least every 6 months. Findings: 1. Document review for the Ruby hematology analyzer, showed that the calibration was performed on the following days: 04/12 /2021 08/14/2020 - eight months 09/19/2019 - 11 months 05/30/2019 2. Interview with the lab manager and Technical Consultant, in the office on October 28, at approximately 4:30 pm confirmed the aforementioned statement. D6036 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413 The technical consultant is responsible for the technical and scientific oversight of the laboratory. This STANDARD is not met as evidenced by: Based on review of the calibration documents for the CellDyn Ruby (Ruby) hematology analyzer, and staff interview the Technical Consultant (TC) failed to verify that the calibration of the Ruby was performed at least every 6 months. Findings: 1. Document review for the Ruby hematology analyzer, showed that the calibration was performed on the following days: 04/12/2021 08/14/2020 - eight months 09/19/2019 - 11 months 05/30/2019 2. Interview with the lab manager and Technical Consultant, in the office on October 28, at approximately 4:30 pm confirmed the aforementioned statement. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on May 22, 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 consecutive events ( 3rd event of 2017 and 1st event of 2018), 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 -- resulting in the first unsuccessful occurrence for hemoglobin (HGB) # 795. Findings include: 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 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 consecutive events ( 3rd event of 2017 and 1st event of 2018), resulting in the first unsuccessful occurrence for hemoglobin (HGB) # 795. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte #795 HGB on event 3 of 2017 with a score of 60% and event 1 of 2018 with a score of 60%. 2. Desk review of the laboratory's proficiency testing reports from API confirms the laboratory failed HGB on events 1 of 2017 and 1 of 2018 resulting in the first unsuccessful performance. -- 2 of 2 --