Grover C Dils Medical Center

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification survey conducted at your facility on August 5, 2026. The findings and conclusions of any investigation by the Division of Healthcare Purchasing and Compliance shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) (b)The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on a review of instrument printouts and laboratory records for American Proficiency Institute (API) Proficiency Testing (PT) 2025 Chemistry Core test events two and three, API PT 2026 Chemistry Core test event one, an interview with the laboratory supervisor on August 5, 2026, at approximately 12:00 PM, email correspondence received from the laboratory supervisor on August 18, 2026, at 12:12 PM PDT, and a telephone conversation on August 21, 2026, at approximately 9:45 AM PDT, the laboratory failed to ensure that proficiency testing specimens were tested in the same manner as patient samples for test results outside the assay range for High Sensitivity Troponin I (TNHI) for three of the six test events reviewed. Findings include: 1. The laboratory supervisor indicated that proficiency testing Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- specimens are not diluted when results exceed the assay's upper range, and that patient specimens are diluted when High Sensitivity Troponin I results fall above the upper limit of the assay's analytical measurement range (AMR) (4.0 - 25,000 pg/mL). 2. The printouts revealed an error code of "assay range" indicating that the results were outside of the analytical measurement range of the instrument for TNHI. The laboratory failed to resolve the error code for the following proficiency test events: a. The laboratory reported TNHI results of 27,000 pg/mL for 2025 API Chemistry Core Event 2 sample CM-06. The instrument print outs indicated results of 27.298 ng/mL or 27,298 pg/mL which is above the AMR. b. The laboratory reported TNHI results of 69,816 pg/mL for 2025 API Chemistry Core Event 3 sample CM-12. The instrument print outs indicated results of 69.816 ng/mL or 69,816 pg/mL which is above the AMR. c. After receiving the PT evaluation, the laboratory re-ran sample CM-12 and obtained a result of 35.857 ng/mL (35,857 pg/mL) with the same ' assay range ' error code. The laboratory did not correct the error code or document any dilutions performed. d. The laboratory reported TNHI results of 34,283 pg/mL for 2026 API Chemistry Core Event 1 sample CM-01. The instrument print outs indicated results of 34.283 ng/mL or 34,283 pg/mL which is above the AMR. 3. There was no documentation of dilution and re-running of the PT samples with the Troponin I (CTNI) diluent in accordance with the manufacturer's instructions prior to reporting the results, as the laboratory indicated they did with patient samples. 4. The laboratory supervisor confirmed during an interview conducted on August 5, 2026, at approximately 11:45 AM that the High Sensitivity Troponin I PT results outside the high end of the analytical range were not manually diluted and repeated to ensure that the results were accurate and reliable. 5. The laboratory supervisor confirmed via email correspondence received on August 18, 2026, at 12:12 pm PDT, and during a telephone conversation on August 21, 2026, at approximately 9:45 am PDT that PT specimens are not diluted if they are outside the assay range high prior to reporting the results to API. The supervisor stated in both the email correspondence and during the telephone conversation that patient specimens are diluted when the High Sensitivity Troponin I results are outside the upper end of the assay range. According to the submitted CMS-116 form, the laboratory performs 5,835 chemistry tests annually. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) (a )Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (a)(1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (a)(2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (a)(2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (a) (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (a)(3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on a review of manufacturer ' s instructions, instrument printouts and laboratory records for the American Proficiency Institute (API) Proficiency Testing (PT) 2024 Chemistry Core test event three through 2026 Chemistry Core test event two, a review of a patient report and the corresponding instrument print out from January 16, 2025 -- 2 of 6 -- (the date of the 2025 Chemistry Core Test Event one), an interview and a telephone conversation with the laboratory supervisor, the laboratory failed to follow the manufacturer's calibration frequency requirements for multiple analytes across six of six API Chemistry Core PT events and related patient testing. Findings include: 1. A review of the retained instrument printouts and performance evaluations for API PT Chemistry Core events from 2024 through 2026 revealed that the following analytes were performed and reported for the following events with expired calibrations: a. HBA1C: 2024 Event 3; 2025 Event 2 b. Vitamin D: 2024 Event 3; 2025 Events 1, 2, 3; 2026 Events 1, 2 c. Blood Urea Nitrogen: 2024 Event 3; 2025 Event 1 d. Phosphorus: 2024 Event 3; 2025 Event 1 e. Thyroid Stimulating Hormone: 2024 Event 3 f. Acetaminophen: 2024 Event 3; 2025 Event 3; 2026 Event 1 g. Salicylate: 2024 Event 3 h. Lipase: 2025 Event 1; 2026 Event 1 i. Amylase: 2025 Events 1, 2; 2026 Event 2 j. Cholesterol: 2025 Event 1 k. Carbon Dioxide: 2025 Event 1 l. Glucose: 2025 Event 1 m. Triglycerides: 2025 Events 1, 2 n. Total Bilirubin: 2025 Event 1 o. High Sensitivity Troponin I: 2025 Event 2; 2026 Events 1, 2 p. Ethanol: 2025 Event 2 q. Ferritin: 2025 Event 2 r. Free T4: 2025 Event 2; 2026 Event 2 s. Total Iron Binding Capacity: 2025 Event 2 t. High Density Lipoprotein: 2026 Event 1 u. Total Prostate Specific Antigen: 2026 Event 1 v. Creatine Kinase: 2026 Event 1 w. N- Terminal Pro-Brain Natriuretic Peptide: 2026 Event 2 2. The manufacturer's instructions from Siemens indicate the following calibration frequencies: a. Every 7 days Vitamin D (VITD) b. Every 21 days High Sensitivity Troponin I (TNIH) c. Every 30 days Hemoglobin A1c (A1C) Blood Urea Nitrogen (BUN) Thyroid Stimulating Hormone (TSHL) Free T4 (FT4L) N-Terminal Pro-Brain Natriuretic Peptide (LNTP) d. Every 45 days Lipase (LIP) e. Every 90 days Acetaminophen (ACTM) Carbon Dioxide (ECO2) Glucose (GLU) Triglycerides (TGL) Total Bilirubin (TBI) Ethanol (ETOH) Total Iron Binding Capacity (IBCT) Total Prostate Specific Antigen (TPSA) Creatine Kinase (CKI) f. Every 3 months Phosphorus (PHOS) Amylase (AMY) Cholesterol (CHOL) Ferritin (FERR) High Density Lipoprotein (AHDL) Salicylate (SAL) 3. A patient test report and instrument print out for a Comprehensive Metabolic Panel and Lipid Panel performed on January 16, 2025, on the same day as the API 2025 Chemistry Core PT Event 1 revealed that the calibrations for the following tests were expired: Cholesterol, Triglycerides, Carbon Dioxide (CO2), Glucose, Blood Uren Nitrogen (BUN), and Total Bilirubin. The results were reported for the patient's test order. 4. The findings were confirmed during an interview with the laboratory supervisor conducted on August 5, 2026, at approximately 3:30 PM and a telephone conversation with the laboratory supervisor on August 21, 2026, at 9:45 AM PDT. According to the submitted CMS-116 form, the laboratory performs 5,835 chemistry tests annually. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. This STANDARD is not met as evidenced by: Based on a review of the director approved quality assessment policy, a review of the laboratory semi-annual quality assessment between the dates of reports, a review of instrument printouts and laboratory records for the American Proficiency Institute (API) Proficiency Testing (PT) 2024 Chemistry Core test event three through the 2026 Chemistry Core test event two, a review of a patient report and the -- 3 of 6 -- corresponding instrument print out from January 16, 2025 (the date of the 2025 Chemistry Core Test Event 1), an interview and a telephone conversation with the laboratory supervisor, the laboratory failed to ensure that the director approved quality assessment policy and procedure was effective to detect and correct the failure to ensure that the calibration procedures for multiple analytes were performed in accordance with the manufacturer's instructions, and the failure to ensure that troubleshooting was performed to resolve error codes associated with test results from the Siemens Dimension EXL 200 prior to reporting proficiency testing results. Findings include: 1. A review of the instrument printouts for the API PT Chemistry Core 2024 test event three, 2025 events one, two and three, and the 2026 events one and two, and a review of a patient report and the corresponding instrument print out from January 16, 2025 (the date of the 2025 Chemistry Core Test Event 1) revealed that the laboratory failed to ensure that calibrations were current and not expired prior to reporting PT and patient results for multiple analytes. A review of the printouts and the manufacturer ' s instructions revealed that the calibrations were expired at the time of reporting. (Refer to D5437) 2. A review of the semi-annual Quality Assurance Reports between the dates of July 2024 and July 2026 revealed that four of four reports incorrectly stated that the calibration for the Siemens Dimension EXL 200 was 100% in compliance. 3. A review of the instrument printouts for the API PT Chemistry Core 2025 events two and three, and the 2026 test event one revealed that the laboratory failed to resolve the high assay range error codes for the High Sensitivity Troponin I (TNHI) prior to reporting the PT results. (Refer to D5781) 4. A review of the director approved quality assessment policy revealed that the established policy and procedure was not effective to detect and correct the failure of the laboratory to follow the manufacturer's instructions for the calibration of analytes prior to reporting results and resolution of error codes prior to reporting proficiency testing results. 5. The findings were confirmed during an interview with the laboratory supervisor conducted on August 5, 2026, at approximately 11:45 AM, via email correspondence received on August 18, 2026, at 12:12 pm PDT and a telephone conversation on August 21, 2026, at approximately 9:45 am PDT. According to the submitted CMS-116 form, the laboratory performs 5,835 chemistry tests annually. D6014 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(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: Based on a review of manufacturer's instructions, instrument printouts and laboratory records for the American Proficiency Institute (API) Proficiency Testing (PT) 2024 Chemistry Core test event three through 2026 Chemistry Core test event two, a review of a patient report and the corresponding instrument print out from January 16, 2025 (the date of the 2025 Chemistry Core Test Event 1), an interview and a telephone conversation with the laboratory supervisor, the laboratory director failed to ensure that the manufacturer ' s calibration frequency requirements for multiple analytes across six of six API Chemistry Core PT events and related patient testing. Findings include: 1. A review of the retained instrument printouts of the instrument printouts and performance evaluations for the API PT 2024 Chemistry Core test event three, 2025 Chemistry Core test events one, two and three, 2026 Chemistry Core test events one and two revealed that the laboratory director failed to ensure that the laboratory performed calibration procedures according to the manufacturer's instructions for the -- 4 of 6 -- Dimension EXL 200 chemistry analyzer tests as detailed in D5437. 2. The instrument printouts and the performance evaluations for the API PT 2024 Chemistry Core test events reviewed revealed that the following analytes were performed and reported for the following events with expired calibrations: a. HBA1C: 2024 Event 3; 2025 Event 2 b. Vitamin D: 2024 Event 3; 2025 Events 1, 2, 3; 2026 Events 1, 2 c. Blood Urea Nitrogen: 2024 Event 3; 2025 Event 1 d. Phosphorus: 2024 Event 3; 2025 Event 1 e. Thyroid Stimulating Hormone: 2024 Event 3 f. Acetaminophen: 2024 Event 3; 2025 Event 3; 2026 Event 1 g. Salicylate: 2024 Event 3 h. Lipase: 2025 Event 1; 2026 Event 1 i. Amylase: 2025 Events 1, 2; 2026 Event 2 j. Cholesterol: 2025 Event 1 k. Carbon Dioxide: 2025 Event 1 l. Glucose: 2025 Event 1 m. Triglycerides: 2025 Events 1, 2 n. Total Bilirubin: 2025 Event 1 o. High Sensitivity Troponin I: 2025 Event 2; 2026 Events 1, 2 p. Ethanol: 2025 Event 2 q. Ferritin: 2025 Event 2 r. Free T4: 2025 Event 2; 2026 Event 2 s. Total Iron Binding Capacity: 2025 Event 2 t. High Density Lipoprotein: 2026 Event 1 u. Total Prostate Specific Antigen: 2026 Event 1 v. Creatine Kinase: 2026 Event 1 w. N-Terminal Pro-Brain Natriuretic Peptide: 2026 Event 2 3. The findings were confirmed during an interview with the laboratory supervisor conducted on August 5, 2026, at approximately 3:30 PM and a telephone conversation with the laboratory supervisor on August 21, 2026, at 9:45 AM PDT. According to the submitted CMS-116 form, the laboratory performs 5,835 chemistry tests annually. 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 a review of instrument printouts and laboratory records for the American Proficiency Institute (API) Proficiency Testing (PT) 2025 Chemistry Core test events two through the API PT 2026 Chemistry Core test event two, an interview with the laboratory supervisor August 5, 2026 at approximately 12:00 PM, email correspondence received from the laboratory supervisor on August 18, 2026 at 12:12 pm PDT and during a telephone conversation on August 21, 2026 at approximately 9: 45 am PDT, the laboratory director failed to ensure that the proficiency testing samples are tested in the same manner as patient samples for test results outside the assay range for High Sensitivity Troponin I (TNHI) tests. Findings include: 1. The laboratory supervisor indicated that proficiency testing specimens are not diluted when results exceed the assay ' s upper range, and that patient specimens are diluted when High Sensitivity Troponin I results fall above the assay's reporting limit (4.0 - 25,000 pg/mL). 2. The printouts revealed an error code of "assay range" indicating that the results were outside of the analytical measurement range of the instrument for TNHI. The laboratory failed to resolve the error code for the following proficiency test events: a. The laboratory reported TNHI results of 27,000 pg/mL for 2025 API Chemistry Core Event 2 sample CM-06. The instrument print outs indicated results of 27.298 ng/mL or 27,298 pg/mL. b. The laboratory reported TNHI results of 69,816 pg /mL for 2025 API Chemistry Core Event 3 sample CM-12. The instrument print outs indicated results of 69.816 ng/mL or 69,816 pg/mL. c. After receiving the PT evaluation, the laboratory re-ran sample CM-12 and obtained a result of 35.857 ng /mL (35,857 pg/mL) with the same ' assay range ' error code. The laboratory did not correct the error code or document any dilutions performed. d. The laboratory reported TNHI results of 34,283 pg/mL for 2026 API Chemistry Core Event 1 sample -- 5 of 6 -- CM-01. The instrument print outs indicated results of 34.283 ng/mL or 34,283 pg/mL. 3. There was no documentation of dilution and re-running of the PT samples with the Troponin I (CTNI) diluent in accordance with the manufacturer's instructions prior to reporting the results, as the laboratory indicated they did with patient samples. 4. The laboratory supervisor confirmed during an interview conducted on August 5, 2026, at approximately 11:45 AM that the High Sensitivity Troponin I PT results outside the high end of the analytical range were not manually diluted and repeated to ensure that the results were accurate and reliable. 5. The laboratory supervisor confirmed via email correspondence received on August 18, 2026, at 12:12 pm PDT, and during a telephone conversation on August 21, 2026, at approximately 9:45 am PDT that PT specimens are not diluted if they are outside the assay range high prior to reporting the results to API. The supervisor stated in both the email correspondence and during the telephone conversation that patient specimens are diluted when the High Sensitivity Troponin I results are outside the upper end of the assay range. According to the submitted CMS-116 form, the laboratory performs 5,835 chemistry tests annually. -- 6 of 6 --

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification survey conducted at your facility on August 12, 2024. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. 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 a review of the 2022 and 2023 American Proficiency Institute (API) Proficiency Testing (PT) records for Hematology and Coagulation, and an interview with general supervisor number one listed on the CMS-209 form, the laboratory failed to ensure that the ungraded educational challenges for the Blood Cell Identification and the ungraded vaginal wet preparation results were reviewed, and documented. Findings include: 1. A review of the 2022 API PT Hematology/Coagulation test event two report revealed that the laboratory failed to review and document the ungraded educational blood identification, and platelet estimate for sample DIF-02. The reported result for Neutrophil, segmented or band was 1%. The expected result was 41-71%. The reported result for the Platelet Estimate was increased. The expected result was Adequate/Normal. 2. A review of the 2022 API PT Hematology /Coagulation test event two report revealed that the laboratory failed to review and document the ungraded Vaginal Wet Preparation result for sample VA-02. 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 3 -- reported result was Trichomonas seen. The expected result stated to review the data summary. There was no documentation of a review of the data summary. 3. A review of the 2023 API PT Hematology/Coagulation test event one report revealed that the laboratory failed to review and document the ungraded educational blood identification for sample DIF-01. The reported result for Immature Cell was 29%. The expected result was 57-100%. The reported result for Lymphocyte was 49%. The expected result was 0-16%. The reported result for Unclassifed Cell was 3%. The expected result was 0-2%. 4. A review of the 2023 API PT Hematology/Coagulation test event one report revealed that the laboratory failed to review and document the ungraded educational blood identification for sample DIF-01. The reported result for Immature Cell was 29%. The expected result was 57-100%. The reported result for Lymphocyte was 49%. The expected result was 0-16%. The reported result for Unclassifed Cell was 3%. The expected result was 0-2%. 5. A review of the 2023 API PT Hematology/Coagulation test event two report revealed that the laboratory failed to review and document the ungraded platelet estimate for sample DIF-02. The reported result for the platelet estimate was increased. The expected result was Adequate/Normal. 6. The findings were confirmed during an interview with general supervisor number one listed on the CMS-209 form conducted on August 12, 2024 at approximately 4:30 PM. The laboratory performs approximately 4503 hematology tests and 321 microbiology tests annually. 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: Based on a review of the 2022 American Proficiency Institute (API) Proficiency Testing (PT) records for miscellaneous chemistry, and an interview with general supervisor number one listed on the CMS-209 form, the laboratory failed to verify the accuracy urine benzodiazepine and methadone twice annually during 2022. Findings include: 1. A review of the 2022 API PT records for miscellaneous revealed that the laboratory obtained a score of 67% for Methadone during the first test event of 2022. The laboratory obtained a score of 67% for Benzodiazepines during the second test event of 2022. 2. The findings were confirmed during an interview with general supervisor number one listed on the CMS-209 form conducted on August 12, 2024 at approximately 4:30 PM. The laboratory performs approximately 5835 chemistry tests annually. 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 a review of the manufacturer's package insert, observation of the Sysmex CA-600 programming for the INR calculation, and and interview with General -- 2 of 3 -- Supervisor numbers one and two on the CMS-209 form, the laboratory failed to ensure that the ISI was updated in the instrument when the current lot number of Dade Innovin reagent was placed in use for the Prothrombin Time (Protime) test. Findings include: 1. A review of the Dade Innovin package insert revealed that the ISI value for lot number 564657 for use on the Sysmex CA-600 coagulation instrument was 1.08. 2. Observation of the current programming in the Sysmex CA-600 analyzer revealed that the ISI in the instrument was 1.04. 3. The findings were confirmed during an interview with the General Supervisor numbers one and two conducted on August 12, 2024 at approximately 4:30 PM. The laboratory performs approximately 4503 hematology tests annually. -- 3 of 3 --

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification survey conducted at your facility on October 17, 2022. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. 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: Based on a review of the 2021 American Proficiency Institute (API) Proficiency Testing (PT) Immunology/Immunohematology results, a review of the director approved policy and procedure for Proficiency Testing, and an interview with the laboratory director and the laboratory supervisor, the laboratory failed to verify the accuracy of the SARS-CoV-2 antibody testing at least twice annually during 2021. Findings include: 1. The laboratory failed to obtain a passing score for the 2021 API Immunology/Immunohematology Proficiency Testing Events number 1 and 3 for the SARS-CoV-2 Antibody test. The laboratory received a score of 50% for both Event 1 and for Event 3. 2. The director approved procedure entitled, "Proficiency Testing" failed to include a provision for performing alternative proficiency testing in the event that the laboratory fails to obtain a passing score for two consecutive events, or two out of three events to verify the accuracy of analytes not listed in subpart I of 42 CFR 493, as required. 3. An interview with the laboratory director and the laboratory supervisor conducted on October 17, 2022 at approximately 12:00 PM confirmed the findings. The laboratory performs approximately 118 general immunology tests annually. 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 -- 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 a review of the laboratory records for calibration verification for the sodium, potassium and chloride analytes on the Siemens Dimension EXL chemistry analyzer, a review of the director approved policy, and an interview with the laboratory supervisor, the laboratory testing personnel, and the laboratory director, and email correspondence received from the laboratory, the laboratory failed to ensure that the calibration verification was performed every six months in 2021. Findings include: 1. A review of the calibration verification records for the sodium, potassium, and chloride revealed that the laboratory failed to perform calibration verification in December, 2021. The verification was performed on June 12, 2021, and May 23, 2022. 2. The director approved policy and procedure stated, " Recalibration or calibration verification and AMR validation, must be performed at least once every 6 months as specified under CLIA-88 regulations at 42CFR493.1255(b)(3)." (sic) 2. An interview with the laboratory director, the laboratory supervisor, and the laboratory testing personnel confirmed that the records could not be located at approximately 4: 45 PM on October 17, 2022. 3. An email received from the laboratory on October 18, 2022 at approximately 4:57 PM confirmed that the calibration verification was not performed in December, 2021. The laboratory performs approximately 4638 Chemistry tests annually. -- 2 of 2 --

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification survey conducted at your facility on March 1, 2021. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. D5781

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification survey conducted at your facility on July 9, 2018. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of