Burnett Medical Center

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was completed on November 24, 2025, the laboratory was found out of compliance with the CLIA regulations. The conditions not met: D2016 - 42 C.F.R. 493.803(a)(b)(c) Condition: Successful participation D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; 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 surveyor review of the federal Certification and Survey Provider Enhanced Reports and American Proficiency Institute proficiency testing reports, and interview with a laboratory supervisor (Staff A), the laboratory failed to successfully obtain an 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 -- 80% satisfactory testing event score for the Hemoglobin A1c test for two out of three consecutive testing events, the first and third events in 2025. See D2097. D2097 ROUTINE CHEMISTRY CFR(s): 493.841(g) (g) Failure to achieve an overall testing event score of satisfactory performance for 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 surveyor review of the federal Certification and Survey Provider Enhanced Reports (CASPER) and American Proficiency Institute (API) proficiency testing (PT) reports, and interview with a laboratory supervisor (Staff A), the laboratory failed to obtain satisfactory PT scores of at least 80% for two out of three consecutive events for the Hemoglobin A1c test (analyte 0420) in the Chemistry speciality in 2025, resulting in unsuccessful PT performance. Findings include: 1a. Review of "CASPER Report 0153D", created November 4, 2025, showed the laboratory had unsuccessful performance for Hemoglobin A1c testing (analyte 0420). 1b. Review of "CASPER Report 0155D", created November 4, 2025, showed the laboratory had unsatisfactory performance for Hemoglobin A1c testing in events one and three in 2025. Event one, score 60% Event three, score 40% 2a. Review of API "Performance Summary" reports showed the following scores for Hemoglobin A1c testing in 2025: First Event, score 60% Third Event, score 40% 2b. The API "Performance Summary 2025 Chemistry - Core - 3rd Event" report identified the Hemoglobin A1c testing performance as unsuccessful. 3. During a phone call with Staff A on November 24, 2025, at 9:50 AM, Staff A confirmed the laboratory received unsatisfactory scores for Hemoglobin A1c testing for two out of three consecutive PT events in 2025 and confirmed the laboratory's Hemoglobin A1c PT performance was unsuccessful. 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 American Proficiency Institute Proficiency Testing (PT) reports and interview with a laboratory supervisor (Staff A), the laboratory failed to obtain satisfactory PT scores for Hemoglobin A1c testing in the first and third events in 2025, two out of three consecutive events, resulting in unsuccessful PT performance. The laboratory director did not ensure personnel were reporting PT results accurately and proficiently to prevent unsuccessful PT performance. See D6004. 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 -- 2 of 3 -- 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 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: Based on proficiency testing (PT) desk review of American Proficiency Institute (API) PT reports and interview with a laboratory supervisor (Staff A), the laboratory failed to obtain satisfactory PT scores for the Hemoglobin A1c test for two out of three consecutive PT events in 2025, resulting in unsuccessful PT performance. The laboratory director did not ensure personnel reported PT results accurately and proficiently to prevent unsuccessful PT performance. Findings include: 1. Review of the API "Performance Summary" and "Comparative Evaluation" reports for the first and third PT events in 2025 showed following: -"2025 Chemistry - Core - 1st Event" report revealed the laboratory received unacceptable Hemoglobin A1c scores for samples GLY-02 and GLY-04 resulting in a score of 60% for Hemoglobin A1c. -"2025 Chemistry - Core - 3rd Event" report revealed the laboratory received unacceptable Hemoglobin A1c scores for samples GLY-11, GLY-14, and GLY-15 resulting in a score of 40% for Hemoglobin A1c. 2. During a phone call with Staff A on November 24, 2025, at 9:50 AM, Staff A confirmed testing personnel did not report PT results for Hemoglobin A1c accurately and proficiently in first and third PT events for Chemistry in 2025. -- 3 of 3 --

Summary Statement of Deficiencies 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 surveyor review of laboratory procedures and competence evaluations and interview with the Technical Consultant, the policies and procedures did not address evaluation of consultant competence and the laboratory had not documented the evaluation of the competence of one of one General Supervisor in performed the responsibilities of a general supervisor. Findings include: 1. Review of laboratory procedures showed no evidence the laboratory had established a procedure for evaluation of the general supervisor in performing their responsibilities. 2. Review of competence evaluations showed no evidence the laboratory evaluated the General Supervisor's competence. 3. Interview with the Technical Consultant on July 17, 2024, at 10:00 AM confirmed the laboratory had not documented the evaluation of the performance of the General Supervisor's responsibilities and confirmed the procedures did not address evaluation of consultant competence. 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 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: Item 1: Based on surveyor review of laboratory records and interview with the general supervisor, the laboratory director did not review and approve the performance specification verification records on the Quidel Solana Group A Strep assay prior to reporting patient results. Findings include: 1. Review of the "Solana Group A Strep Assay" validation form showed the laboratory performed performance specification verification on April 4, 2022. 2. Interview with the general supervisor on September 8, 2022 at 8:20 AM stated the laboratory started patient testing on April 13, 2022. Further interview stated director did not review and approve the performance specification verification records for the Quidel Solana Group A Strep assay until April 26, 2022. 3. Interview with the general supervisor on September 8, 2022 at 8:20 AM confirmed the laboratory director did not review and approve the performance specification verification records on the Quidel Solana Group A Strep assay prior to reporting patient results. Item 2: Based on surveyor review of laboratory records and interview with the general supervisor, the laboratory director did not review and approve the performance specification verification records on the Alcor miniiSED erythrocyte sedimentation rate (ESR) analyzer prior to reporting patient results. Findings include: 1. Review of the "Alcor miniiSED" quality control and maintenance form showed the laboratory started patient testing on the analyzer on July 1, 2021. 2. 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 -- Review of the "Erythrocyte Sedimentation Rate (ESR) Correlation Data Analysis Report" showed the general supervisor, who is not delegated to approve performance specification verification data, signed the analysis on June 29, 2021. Further review showed the laboratory director reviewed and accepted the performance specification verification on January 25, 2022. 3. Interview with the general supervisor on September 7, 2022, at 2:05 PM confirmed the laboratory director did not review and approve the performance specification verification records on the Alcor miniiSED ESR analyzer prior to reporting patient results. This is a previous deficiency from July 18, 2014. D5545 HEMATOLOGY CFR(s): 493.1269(b)(d) (b) For all nonmanual coagulation test systems, the laboratory must include two levels of control material each 8 hours of operation and each time a reagent is changed. (d) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on survey review of coagulation records, observation of the Sysmex CA 600 coagulation analyzer and interview with the general supervisor, the laboratory failed to verify the accuracy of the new lot information used for calculating the International Normalized Ratio (INR). Findings include: 1. Review of the "QA New Lot Innovin Patient Comparison (Normal Range Validation)" records for the Sysmex CA 600 coagulation analyzer showed the current International Sensitivity Index (ISI) for Innovin lot number 549770B is 1.01 and the established Mean Normal Range (MNR) is 10.17 seconds. Further review showed the new lot was implemented on July 13, 2021. 2. Observation of the ISI and MNR data on September 8, 2022, at 12:12 PM revealed the IS value in the Sysmex CA 600 analyzer is 1.01 and the MNR is 9.9 seconds. 3. Interview with the general supervisor on September 8, 2022, at 12:25 PM confirmed the laboratory failed to verify the accuracy of the new lot information used for calculating the International Normalized Ratio (INR) for the Innovin lot in use since July 13, 2021. -- 2 of 2 --

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Item 1: Based on surveyor review of proficiency testing (PT) and other laboratory records and interview with the technical consultant, the laboratory did not verify the accuracy of potassium hydroxide (KOH) testing performed on skin samples twice annually in 2019 or 2020. Findings include: 1. Review of PT records from 2019 and 2020 showed no evidence of evaluation of KOH testing of skin samples. 2. Review of other laboratory records showed no evidence of accuracy verification of KOH testing of skin samples. 3. Interview with the technical consultant on December 1, 2020 at 10: 55 AM confirmed the laboratory performed KOH testing of skin samples. Further interview confirmed the laboratory had not developed a process to verify the accuracy of this testing twice annually. Item 2: Based on surveyor review of proficiency testing (PT) and other laboratory records and interview with the general supervisor, the laboratory did not verify the accuracy of body fluid cell differentials twice annually in 2019 or 2020. Findings include: 1. Review of PT records from 2019 and 2020 showed no evidence of evaluation of body fluid cell differentials. 2. Review of other laboratory records showed the laboratory performed three body fluid cell differentials on patient samples in 2020. Further review showed no evidence of accuracy verification of body fluid cell differentials. 3. Interview with the general supervisor on December 2, 2020 at 11:15 AM confirmed the laboratory performed body fluid cell differentials. Further interview confirmed the laboratory had not developed a process to verify the accuracy of this testing twice annually. This is a repeat deficiency previously cited on June 9, 2010. D5449 CONTROL PROCEDURES 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 -- CFR(s): 493.1256(d)(3)(ii)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor review of immunohematology quality control records and laboratory procedures, and interview with the general supervisor, the laboratory did not test a negative control material with Search-Cyte Reagent Blood Cell II each day of patient testing since August 27, 2018 and did not test Anti-D reagent with a negative control material since August 12, 2019. Findings include: 1. Review of the immunohematology "Daily / Weekly QC Log" from the week of August 5, 2019 showed the Search-Cyte Reagent Blood Cell II was only tested with Anti-D reagent for a positive reaction. The instructions on the form (revised August 27, 2018) did not identify a negative control material for Search-Cyte Reagent Blood Cell II. Review of the immunohematology "Daily / Weekly QC Log" from the week of November 9, 2020 (revised August 12, 2019) showed only positive reactions for Search-Cyte Reagent Blood Cell II and Anti-D reagents. The instructions directed testing personnel to test the Search-Cyte Reagent Blood Cell II with Anti-D and Anti-c reagent; both reactions were expected to be positive. The form also directed testing personnel to test Anti-D reagent with Search-Cyte Reagent Blood Cell I and II and showed both expected results as positive. 2. Review of the laboratory procedure, "Rh (D) blood grouping", showed the Quality Control section stated, the Anti-D reagent "should be confirmed each day of testing with red blood cells known to be negative and positive for the relevant antigen". 3. Interview with the general supervisor on December 2, 2020 at 11:30 AM confirmed the laboratory's quality control program did not ensure testing personnel tested Anti-D reagent (since August 12, 2019) and Search-Cyte Reagent Blood Cells II (since August 27, 2018) with a negative control material each day of testing. This is a repeat deficiency previously cited on June 9, 2010. D5785

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on surveyor review of manufacturer's instructions and laboratory records, observation of the coagulation analyzer, and interview with the general supervisor, the laboratory did not ensure the correct ISI (International Sensitivity Index) and mean patient value were entered in the analyzer for calculation of the INR (International Normalized Ratio) when the extended channel is used. Findings include: 1. Review of the manufacturer's instructions and laboratory records showed Innovin lot 549704 is in use. The manufacturer's instructions showed the ISI for this lot was 1.03 and laboratory records showed the mean patient value was 9.9 seconds. 2. Observation of the coagulation analyzer on August 29, 2018 at 10:15 AM showed the values entered for the PTX (Prothrombin Time Extended) mode were for lot 539230 with an expiration date of April 18, 2015. The entered ISI was 1.04 and the mean patient value was 9.7 seconds. 3. Interview with the general supervisor on August 29, 2018 at 10:15 AM confirmed the current ISI and mean patient values were not entered into the coagulation analyzer for the PTX mode. Further interview confirmed the PTX mode is used for some patient tests. This is a repeat deficiency cited on June 9, 2010 and July 9, 2008. D5781