Lake Region Healthcare Barnesville

Summary Statement of Deficiencies D0000 . The Lake Region Healthcare Barnesville laboratory was found to be out of compliance with the regulations of the Clinical Laboratory Improvement Amendments of 1988 (42 C.F.R. part 493) upon completion of the recertification survey performed on December 12, 2025. The following standard-level deficiencies were cited: 493.1255 Calibration and calibration verification procedures. 493.1413 Technical consultant responsibilities . D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) (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 observation, document review, and interview with laboratory personnel, the laboratory failed to perform and document calibration verification at least once 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 -- every six months for one of two Chemistry test systems in 2025. Findings are as follows: 1. The laboratory performed moderate complexity Chemistry testing as confirmed by the Technical Consultant (TC) during a tour of the laboratory at 11:20 a. m. on 12/11/25. 2. An Abaxis Piccolo Xpress was observed as present and available for use during the tour. The laboratory performed moderate complexity Chemistry testing using the Piccolo in 2025 as indicated on the Form CMS-2567 provided by the laboratory on the date of survey. 3. Piccolo system calibration verification was required every six months as established in the Instrument Performance, Maintenance, and Test Calibrations procedure found in MediaLab. 4. Calibration verification was performed in September 2024 and September 2025. Documentation for calibration verification performed in March 2025 was not found in the CAL VER binder provided by the laboratory on the date of survey. 5. In an interview at 1:35 p.m. the TC indicated the March 2025 calibration verification had been missed. 6. In an email received at 12:39 p.m. on 12/12/25, the TC indicated the laboratory performed 78 Chemistry tests on patient samples between March 2025 and the next calibration verification performed in September 2025. . D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Thereafter, evaluations must be performed at least annually This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the Technical Consultant (TC) failed to assess competency for all moderate complexity test systems at least annually for two of four testing personnel (TP) in 2024. Findings are as follows: 1. The laboratory performed moderate complexity testing under the Microbiology, Chemistry, and Hematology specialties as indicated on the Form CMS-2567 provided by the laboratory on the date of survey. 2. The following moderate complexity test systems were observed as present and available for use during a tour of the laboratory at 11:20 a.m. on 12/11/25. See below. An Abaxis Piccolo Xpress Chemistry analyzer An Alere Triage Meter device used for Chemistry testing A Sysmex XN-430 Hematology analyzer An Alcor miniiSED Hematology analyzer A Zeiss Axiostar microscope used for Microscopic Urinalysis and KOH (potassium hydroxide) testing 3. 2024 annual competency documentation for TP 3 and TP4 was not found during review of laboratory records. The laboratory was unable to provide the missing documentation upon request. 4. In an interview at 9: 50 a.m., the TC indicated the 2024 competency assessment documents for TP3 and TP4 were not included in the competency assessment records. . -- 2 of 2 --

Summary Statement of Deficiencies D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to verify the accuracy of one 2021 non-graded proficiency testing (PT) results for a non-regulated analyte when the PT program did not obtain the agreement required for scoring. Findings are as follows: 1. The laboratory performed Vaginal Wet Preparation testing, which falls under the specialty of Microbiology, as confirmed by the Technical Consultant during a tour of the laboratory at 9:05 a.m. on September 8, 2023. 2. The laboratory performed PT using the American Proficiency Institute (API) provider. 3. One Vaginal Wet Preparation result from the 2021 Hematology/Coagulation PT 3rd event was not graded by API due to lack of consensus. See below. Sample ID Analyte VKP-03 Vaginal Wet Preparation 4. The API report referred the laboratory to the expected result data summary for evaluation of the non-graded test result. The data summary for the above sample was not present in laboratory records. Evaluation of the non-graded result was not found in laboratory records. The laboratory was unable to provide an evaluation of the non-graded result upon request. 5. Requirements for the evaluation of non-graded PT results was not included in the Proficiency Testing procedure found in the Lab Procedure Manual. 6. In an interview at 10:08 p.m. on September 8, 2023, the Technical Consultant confirmed the above finding. ** This is a repeat deficiency from the September 22, 2021 recertification survey** . 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 -- D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the laboratory failed to perform quality control (QC) activities as established in an Individualized Quality Control Plan (IQCP) four times in 8 months in 2023. Findings are as follows: 1. The laboratory performed Chemistry testing as confirmed by the Technical Consultant (TC) during a tour of the laboratory at 9:05 a.m. on September 8, 2023. 2. An Abaxis Piccolo Chemistry test system was observed as present and available for use during the tour. 3. Two levels of external control material was required every 31 days as established in the IQCP procedure found in the laboratory's IQCP for the Abaxis Piccolo. 4. The laboratory exceeded the 31 day QC performance time interval four times in the time frame reviewed, January 1, 2023, through September 8, 2023, as indicated in Monthly Piccolo QC log. QC was performed as follows: QC Done QC Due 01/12/23 N/A 02/21/23 02/12/23 03/06/23 OK 5/23/23 04 /06/23 07/06/23 06/23/23 08/16/23 08/06/23 5. In an interview at 11:25 a.m. on September 8, 2023, the TC confirmed the above finding. . -- 2 of 2 --

Summary Statement of Deficiencies D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to verify the accuracy of one 2020 non-graded proficiency testing (PT) results for a non-regulated analyte when the PT program did not obtain the agreement required for scoring. Findings are as follows: 1. The laboratory performed Chemistry testing as confirmed by Testing Personnel 1 during a tour of the laboratory at 12:05 p. m. on 09/22/21. 2. The laboratory performed PT using the American Proficiency Institute (API) provider. 3. One Urine Sediment result from the third 2020 Hematology /Coagulation PT event was not graded by API due to lack of consensus. See below. Sample ID Analyte US-06 Urine Sediment 4. The API report referred the laboratory to the expected result data summary for evaluation of the non-graded test result. The data summary for the above sample was not present in laboratory records. Evaluation of the non-graded result was not found in laboratory records. The laboratory was unable to provide an evaluation of the non-graded result upon request. 5. Requirements for the evaluation of non-graded PT results was not included in the Proficiency Testing procedure found in the Lab Procedure Manual. 6. In an interview at 2:45 p.m. on 09/22/21, the Technical Consultant confirmed the above finding. . 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 D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to verify the accuracy of non-graded proficiency testing (PT) results. Findings are as follows: 1. The laboratory performed Chemistry and Hematology testing as confirmed by Technical Consultant 1 (TC1) during a tour of the laboratory on 07/24 /19 at 9:00 a.m. 2. The laboratory performed PT using the American Proficiency Institute (API) PT provider. 3. The laboratory received non-graded results from API for the events and tests listed below. The Data Summaries from API with the expected results for these tests were not included in laboratory records. Event Sample ID Test* 2017 Chemistry-3 CH-11 to CH-15 LDL 2018 Hematology -1 BCI-01 BCID 2018 Hematology-2 BCI-10 BCID 2019 Hematology-1 US-02 USED 2019 Hematology-1 VKP-01 VWP 4. An evaluation of the non-graded PT results was not found during review of laboratory records. The laboratory was unable to provide evaluations upon request. 5. In an interview on 07/24/19 at 11:15 a.m., the GS confirmed the above finding. 6. This issue was also cited during the 08/31/17 survey. See D6014. *Note LDL - Low Density Lipoprotein BCID - Blood Cell Identification USED - Urine Sediment VWP - Vaginal Wet Preparation 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. 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 -- This STANDARD is not met as evidenced by: . Based on observation, document review and interview with laboratory personnel, the laboratory failed to ensure a Chemistry procedure (performance verification) was approved, signed, and dated by the laboratory director prior to use. Findings are as follows: 1. The laboratory performed Chemistry testing as confirmed by Technical Consultant 1 (TC1) during a tour of the laboratory on 07/24/19, at 9:00 a.m. 2. An Abbott Piccolo Xpress chemistry analyzer was observed as present and available for use during the tour of the laboratory. 3. Performance verification activities for the analyzer were acceptable and the laboratory began patient specimen testing in May 2018 as indicated in laboratory records. 4. The laboratory Director did not approve, sign, or date the performance verification documents prior to use of the analyzer. 5. In an interview on 07/24/19, at 12:00 p.m., TC1 confirmed the above finding. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: . Based on observation, document review and interview with laboratory personnel, the laboratory failed to ensure the reportable range obtained during performance verification of a new Chemistry analyzer was accurate in the procedure manual. Findings are as follows: 1. The laboratory performed Chemistry testing as confirmed by Technical Consultant 1 (TC1) during a tour of the laboratory on 07/24/19 at 9:00 a. m. 2. An Abbott Piccolo Xpress chemistry analyzer was observed as present and available for use during the tour of the laboratory. The laboratory completed performance verification (PV) activities and began testing patient specimens using this analyzer in May 2018 as indicated by TC1 and confirmed via laboratory records. 3. The reportable ranges listed in the Piccolo Blood Chemistry Analyzer - Specimen Processing procedure, located in the Lab Procedure Manual, for the analytes listed below did not reflect the actual reportable range values obtained by the laboratory during the PV. Analyte* Procedure PV Na 110-170 115-160 K 1.5-8.5 2.2-7.5 CO2 5.0-40 10-33 Cl 80-135 86-134 Glu 10-700 29-637 Ca 4.0-16.0 4.3-15.2 BUN 1.0-180 3-104 Crea 0.2-20 0.5-16 ALP 5.0-2400 24-1823 ALT 5.0-2000 16-1504 AST 5.0- 2000 21-1506 TBil 0.1-30 0.4-4.3 Alb 1.0-6.5 1.9-5.9 TP 2.0-14 3.3-10.0 4. In an interview on 07/24/19, at 12:10 p.m., TC1 confirmed the above finding and indicated the laboratory had included the manufacturer's analytical measurement ranges as the reportable ranges in the procedure. *Note Na - Sodium K - Potassium CO2 - Carbon Dioxide CL - Chloride Glu - Glucose Ca - Calcium BUN - Blood Urea Nitrogen Crea - Creatinine ALP - Alkaline Phosphatase ALT - Alanine Transaminase AST - Aspartate Aminotransferase TBil - Total Bilirubin Alb - Albumin TP - Total Protein D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) -- 2 of 4 -- Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the laboratory failed to perform quality control (QC) activities as established in the Individualized Quality Control Plan (IQCP) for a chemistry test. Findings are as follows: 1. The laboratory performed Chemistry testing as confirmed by Technical Consultant 1 (TC1) during a tour of the laboratory on 07/24/19, at 9:00 a.m. 2. A Biosite Triage Meter chemistry analyzer was observed as present and available for use during the tour of the laboratory. Troponin testing was performed on this analyzer. 2. Troponin QC performance was required with new lots and shipments of testing devices and every 30 days as established in the laboratory's IQCP for the test. 3. The time interval between Troponin QC performance exceeded that established in the IQCP on 6 occasions in the timeframe reviewed, 11/01/17 - 07/24/19, potentially affecting 38 patient test results (Pt). See below. QC date QC date Interval Pt 11/01/17 01/29/18 90 days 3 01/29/18 04/20/18 82 days 5 04/20/18 08/16/18 119 days 9 08/16 /18 01/15/19 153 days 10 01/15/19 04/29/19 105 days 7 04/29/19 none* 87 days 4 4. In an interview on 07/24/19, at 1:35 p.m., TC1 confirmed the above finding. *Note Date of survey, 07/24/19, used for calculation D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require