East Georgia Diagnostic Services, Inc

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification Survey was completed on October 30, 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: 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: A review of 2023 - 2025 Quality Assurance Records confirmed that the laboratory failed to enroll in an approved Proficiency Testing Program. THE FINDINGS INCLUDE: 1. A review of 2023 - 2025 Quality Assurance Records confirmed that the facility was not enrolled in an approved proficiency testing program. 2. An exit interview, with the General Supervisor, on October 30, 2025, at 1:00pm, confirmed that the laboratory failed to enroll in an approved Proficiency Testing Program. 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 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 -- failures in quality as they occur; This STANDARD is not met as evidenced by: A review of 2023 - 2025 Quality Control Records, 2023 - 2025 Personnel Records, 2023- 2025 Maintenance Records, 2023 - 2025 Temperature Records, and 2023 - 2025 Proficiency Records revealed that the Laboratory Director (LD) failed to perform the required quality assurance oversight. THE FINDINGS INCLUDE: 1. A review of the aforementioned 2023 - 2025 Records confirmed that the General Supervisor performed monthly QC overviews without a Letter of Delegation from the Laboratory Director. 3. An exit interview, with the General Supervisor, on October 30, 2025, at 1:00pm, confirmed that the Laboratory Director failed to perform the required quality assurance oversight. D6087 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(iii) (e)(3)(iii) Laboratory personnel are performing the test methods as required for accurate and reliable results; This STANDARD is not met as evidenced by: A review of 2023- 2025 Personnel Records confirmed that the Laboratory Director failed to conduct personnel competencies as required. THE FINDINGS INCLUDE: 1. A review of 2023- 2025 Personnel Records revealed that documentation of competencies performed on Testing Personnel #1 and on General Supervisor ( See CMS Form 209) were not completed. 2. An exit interview, with the General Supervisor, on October 30, 2025, at 1:00pm, confirmed that the Laboratory Director failed to perform personnel competencies as required. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification survey was completed on, June 26, 2023. Condition and Standard level Citations were found. 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: Condition D6076 493.1441 D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on review of the Policy and Procedure AP301APP3 Potential For Biohazard Exposure-Exercise Universal Precautions, the laboratory had no documentation demonstrating that Testing Personnel (TP) 1 and 2 have been monitoring for the Permissible Exposure Levels for Formaldehyde. Findings: 1. Review of the Policy and Procedure AP301APP3 Potential for Biohazard Exposure-Exercise Universal Precautions, page 1, paragraph 3. Definitions, Permissible Exposure Level (PEL), sixth bullet point, states exposure monitoring (every 6 months) Short Term Exposure Level (STEL), sixth bullet point states, Exposure monitoring (annual) Action Level (AL), second bullet point states, exposure monitoring (every 6 months) 2. Interview with TP-1, TP-2, on 06/26/2023 at approximately 4 pm, in the office, confirmed that there was no documentation showing that the monitoring had been performed. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by 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 2 -- 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 the review of the Policy / Procedure, and staff interview, the laboratory failed to follow the policy AP302APP3 Formaldehyde Program Potential for Biohazard Exposure-Exercise Universal Precautions. The laboratory failed to follow the Policy for monitoring the levels for Formaldehyde exposure for the Testing Personnel (TP) for 2022 to 06/26/ 2023. Findings: 1. There were no documents demonstrating the laboratory had performed the Formaldehyde Program to monitor the levels for exposure to Formaldehyde. 2. Interview with the TP-1 and TP-2, on 06 /26/2023, at approximately 4 pm, in the Laboratory Office, confirmed the above aforementioned statement. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on review of the Testing Personnel (TP) competency assessments and staff interview the Laboratory Director (LD), filling the Technical Supervisor (TS) job, failed to perform annual competencies on either of the TP-1 and TP-2 for the year 2022. The 2023 competencies were completed. Reference D6079 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: Based on review of the Testing Personnel (TP) competencies, and staff interview, the Laboratory Director(LD) failed to perform competency assessments for 2022. The LD had performed TP competencies in 2023. Findings: 1. Review of the Competency Assessments for the two TP, there was a competency assessment for TP-1 and TP-2 in 2023, but not for either TP-1 or TP-2 for 2021 2. Interview with the TP-1 and TP-2 on June 26, 2023 at approximately 4 pm in the office, confirmed to the aforementioned statement. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification survey was completed on, December 1 2021. Condition and Standard level Citations were found. 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: 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 Standard Operating Policies and Procedures (SOP), and staff interview, the laboratory failed to have a written policy for assessing the employee competency. Findings: 1. Review of the SOP documents, the laboratory did not have a policy for performing initial training, and annual employee competency assessment. 2. Interview with staff #2 (CMS 209 Personnel List) on December 2, 2021 at approximately 4pm, in the laboratory confirmed that there was not a procedure for training and annual employee competency assessment. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. 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 -- This CONDITION is not met as evidenced by: Observation during the lab tour, the histotech, was using expired stains, clairifier, High Purity Reagent Grade water, and 10% formalin for the processing of speciments and staining slides. Reference: D5417 D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Observation during the lab tour, and staff interview, the histotech was using expired stains, and reagents for processing specimens for processing and slide staining. Findings: 1. Observation during the lab tour confirmed that there were several bottles of stains and processing reagents on the storage shelf. Upon additional investigation, the following stains and reagents were being used after the expiration date: Hematoxylin - expired 11-1-2020 Eosin Y - expired 06/2020 Clarifier 1 - expired 06 /2018 High Purity Reagent Grade Water expired 06-05-2021 10% Buffered Formalin - expired 11/12/2021 2. Interview with the histotech, on December 1, 2021, in the laboratory confirmed the expiration dates on the above listed stains and reagents. D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on document review and staff interview, the laboratory did not have a record for documenting the acceptability of the slide stain used in the tissue processing for histology specimen slides. Findings: 1. Review of slide staining documents, the laboratory failed to have a record for documentation for the results of the pathologist review of the slide processing and staining for each day of processing. 2. Interview with the staff #2 (CMS209 Personnel List) on 12/01/2021, at approximately 3:30 pm in the laboratory, confirmed there was no documentaion of the slide and stain quality check. The facility processes slides only, the diagnostic reading of the slides is performed in another office. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on September 26, 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: D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on observation and staff interview, the laboratory failed to perform and document required equipment maintenance. Findings include: 1. Observation during the laboratory tour on September 26, 2019, at approximately 10:45 a.m. revealed there were no professional calibration records for the Nikon microscope for 2018 and 2019 thus far. 2. An interview with the lab director on September 26, 2019, in the office area at approximately 10:45 a.m. confirmed the lack of professional calibration documents for the Nikon microscope for the aforementioned time periods.. 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 --