Wellstar Sylvan Grove Hospital

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on August 12, 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 493.1403 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 CASPER 155 report and review of the American 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 -- Institute (API) reports, the laboratory failed to maintain satisfactory proficiency testing (PT) participation for Creatinine (Creat) in 2025 events 1 & 2, resulting in an initial unsuccessful participation for Creatinine. Refer to D 2096 D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (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 review of the Centers for Medicare and Medicaid (CMS) CASPER 155 report and review of American Proficiency Institute (API) reports, the laboratory failed to maintain satisfactory participation in two consecutive testing events ( 1st & 2nd events of 2025), resulting in an initial unsuccessful participation for Creat. Findings: 1. A review of Casper Report 155 revealed the laboratory failed Creat on the following: 2025 Event 1 Creat Score 60% 2025 Event 2 Creat Score 60% 2. A review of the laboratory's API Reports confirmed the laboratory failed Creat 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 CASPER 155 report and review of American Proficiency Institute (API) reports, the laboratory director failed to provide overall management and direction for proficiency testing performance. The laboratory director failed to ensure proficiency testing samples were tested as required. 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: Based on review of the CMS CASPER Report 155 and the American Proficiency Institute (API) 2025 events 1 & 2 PT evaluation reports, the laboratory director failed to ensure successful proficiency testing performance in Creat in two consecutive testing events (2025 events 1 & 2), resulting in the initial unsuccessful participation for Creat. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on July 2, 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] D6076 - 42 CFR 493.1445 Condition: High 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) CASPER 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 -- 155 report and review of the laboratory 's American Proficiency Institute (API) proficiency testing (PT) reports, the laboratory failed to maintain satisfactory participation in PT in the specialty of Immunohematology for Compatibility testing for 3 out of 5 events for event 3 of 2023, event 2 of 2024, and event 1 of 2025. Refer to D 2173 D2173 COMPATIBILITY TESTING CFR(s): 493.863(a) (a) Failure to attain an overall testing event score of at least 100 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of the CMS CASPER 155 report and review of the laboratory 's API proficiency testing (PT ) reports, the laboratory failed to maintain satisfactory participation in PT in 3 out of 5 events in the specialty of Immunohematology for Compatibility Testing . Findings include: 1. Desk review of the CMS CASPER 155 report revealed the laboratory failed Compatibility Testing on: 2023 Event 3 score: 80% 2024 Event 2 score: 40% 2025 Event 1 score: 40% 2. Desk review of the laboratory's proficiency testing reports from API confirms the laboratory failed Compatibility testing on the aforementioned events resulting in the non-initial unsuccessful performance. 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 CMS CASPER 155 report and review of the laboratory 's API PT reports, the laboratory director failed to provide overall management and direction for proficiency testing to ensure successful participation in PT for the specialty of Immunohematology for Compatibility Testing. Refer to D6089 and D6092. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(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 review of the CMS CASPER Report 155 and the API 2023 event 3, 2024 event 2, and 2025 event 1 PT evaluation reports, the laboratory director failed to ensure successful proficiency testing performance in Compatibility Testing in three of five testing events, resulting in the non-initial unsuccessful participation for Compatibility Testing. Refer to D 2173 D6092 LABORATORY DIRECTOR RESPONSIBILITIES -- 2 of 3 -- CFR(s): 493.1445(e)(4)(iv) (e)(4)(iv) An approved

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) survey was completed on February 26, 2025. The laboratory was not in compliance with all applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following standard level deficiency was cited: 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 American Proficiency Institute (API) proficiency testing (PT) records and interview with a laboratory technical supervisor (TS), the laboratory failed to document

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on December 16, 2024. 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 493.1403 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 CASPER 155 report and review of the American 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 -- Institute (API) reports, the laboratory failed to maintain satisfactory proficiency testing (PT) participation for Compatibility testing in 2023 event 3, resulting in an initial unsuccessful participation. Refer to D 2173 D2173 COMPATIBILITY TESTING CFR(s): 493.863(a) Failure to attain an overall testing event score of at least 100 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid (CMS) CASPER 155 report and review of American Proficiency Institute (API) reports, the laboratory failed to maintain satisfactory participation in the 3rd event of 2023 resulting in an initial unsuccessful participation for compatibility testing. Findings: 1. A review of Casper Report 155 revealed the laboratory failed Compatibility testing on the following: 2023 Event 3 Score 80% 2. A review of the laboratory's API Report confirmed the laboratory failed compatibility testing with the aforementioned score. 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 CMS CASPER 155 report and review of American Proficiency Institute (API) report, the laboratory director failed to provide overall management and direction for proficiency testing performance. The laboratory director failed to ensure proficiency testing samples were tested as required. Refer to D6089 D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure 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 CASPER Report 155 and the American Proficiency Institute (API) 2023 event # 3 PT evaluation report, the laboratory director failed to ensure successful proficiency testing performance in compatibility testing. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on January 27, 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: 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 observation and staff interview, the laboratory failed to ensure protection from physical hazard as required. Findings include: 1. Observation of the laboratory revealed that there were no Exit signs present in the laboratory, during the laboratory tour on January 27, 2021 at approximately 3:15 P.M. 2. An interview with the laboratory manager and head nurse on January 27, 2021 at approximately 3:20 P.M. confirmed that the Exit signs were not present at the time of the inspection. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. 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 -- (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on October 23, 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: D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on review of the Beckman/Coulter LH500 (LH500) hematology procedure manual, and LH500 Quality Control (QC) documents, and staff interview, the laboratory failed to establish the frequency of performing Quality Control (QC) as required by the State Licensure Requirements for Hematology analyzers. Findings: 1. Review of the LH500 procedure manual showed that the Laboratory did not have a frequency listed for performing QC for the Hematology Analyzer. QC must be performed each shift of patient testing per State of Georgia Laboratory Regulatory Requirements. 111-8-10-.14 Quality Control for Hematology. Instruments used in hematological examination of specimens shall be recalibrated, retested or reinspected, as appropriate, each day of use. Each procedure shall be recalibrated or rechecked each shift of use with standards or controls covering the entire range of expected values, unless required more frequently by the manufacturer or federal laboratory regulations. Tests such as the hematocrit and one-stage prothrombin time test shall be run in duplicate except as specified in published guidelines. Standard deviation, coefficient of variation, or other statistical estimates of precision shall be determined by the laboratory. All control materials used to satisfy the control requirement must have documented established limits. Authority: O.C.G.A. 31-22-1 et seq.. 2. Review 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 -- of a universal example of LH500 QC showed the following: a. March 2017 - 58 QC runs for 31 days - showed 33 QC runs were performed greater than 8 hours apart b. July 2017 - 80 QC runs for 30 days - showed 54 QC runs were performed greater than 8 hours apart c. April 2018 - 78 QC runs for 31 days - showed 34 QC runs were performed greater than 8 hours apart d. July 2018 - 82 QC runs for 31 days - showed 42 QC runs were performed greater than 8 hours apart 3. Interview with the Laboratory Manager, and Laboratory Administrator, on October 23, 2018 at approximately 3:30 pm in the Conference Room, confirmed the above forementioned statement. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the Laboratory Policy and Procedure manuals, and staff interview, the current Laboratory Director failed to approve, date and sign the Laboratory Policy and Procedure manuals. Findings: 1. Review of the Policy and Procedure manuals for Hematology, Chemistry, Urinalysis, Coagulation, Blood Bank, and Miscellaneous Testing, showed that the current Laboratory Director had not reviewed, approved, and signed the procedure manuals. 2. Interview with Lab Manager on October 23, 2018, at approximately 11:19 am in the conference room, confirmed that the current Laboratory Director had not approved and signed any of the Laboratory Department Policy and Procedure Manuals. 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: -- 2 of 3 -- Based on review of the calibration documents for the Beckman Coulter LH500 Hematology Analyzer (LH500), and staff interview the laboratory failed to calibrate the LH500 at least once every 6 months. Findings: 1. Review of the calibration documents for the LH500, the laboratory calibrated the LH500 in January 2017, and September 2018. There was no documentation of calibrations performed between January 2017, and September 2018. (July 2017, January 2018, July 2018). 2. Staff interview with Lab Manager, on October 23, 2018 at approximately 3 pm in the conference room confirmed that there was not documentation for calibrations on the LH500 between January 2017 and September 2018. D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) (c) Blood and blood products storage. Blood and Blood products must be stored under appropriate conditions that include an adequate temperature alarm system that is regularly inspected. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the alarm system must be documented. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on the review of the Blood Bank Refrigerator, Laboratory Refrigerator, and Laboratory Freezer temperature monitor graphs, and staff interview, the laboratory failed to change the temperature monitor graph papers from 3-29-18 to 7-2-18. Findings: 1. Review of the Blood Bank Refrigerator, Laboratory Refrigerator, and the Laboratory Freezer termperature monitor graphs, graph paper was placed on the temperature monitor recorder device on May 29, 2018 and was not removed until 7-2- 2018. There were no other graphs available between May 29, 2018 and July 2, 2018. Review of the graphs show that the recorder went around on the same graph numerous times. 2. Interview with the laboratory Manager, and the Laboratory Administrator, on October 23, 2018 at approximately 4pm in the blood bank area, confirmed the above forementioned statement. -- 3 of 3 --