Prague Regional Memorial Hospital

Summary Statement of Deficiencies D0000 The recertification survey was performed on 11/18,19,21/2024. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the chief executive officer, technical consultant, and laboratory manager during an exit conference performed at the conclusion of the survey. D3025 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103(d) Investigation of transfusion reactions. The facility must have procedures for preventing transfusion reactions and when necessary, promptly identify, investigate, and report blood and blood product transfusion reactions to the laboratory and, as appropriate, to Federal and State authorities. This STANDARD is not met as evidenced by: Based on a review of records, nursing policy, and interview with the laboratory manager, the facility failed to ensure written policies were followed for preventing transfusion reactions for one of four units of packed red-blood cells transfused. Findings include: (1) On 11/18/2024 at 11:55 am, the laboratory manager stated blood transfusions were performed by nursing staff; (2) On 11/21/2024, a review of the hospital policy titled, "Blood Product Administration" stated: (a) "Vital signs are taken immediately prior to infusing the blood" (b) "Every 15 minutes for the first hour, then" (c) "Every 30 minutes during the remainder of the transfusion" (3) A review of transfusion records for four units transfused, identified the policy had not been followed for one of the four units as follows: (a) Unit #W091024207629 - The transfusion started on 06/23/2024 at 08:00 pm. Vital signs had not been taken as follows: (i) 30 Minute Vital Signs - Not taken between 09:30 pm and 11:28 pm. (4) The records were reviewed with the laboratory manager who stated on 11/21/2024 at 02:10 pm, the vital signs had not been documented according to policy. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE 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): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant, the laboratory failed to review and evaluate proficiency testing results to identify biases for two of five Hematology proficiency testing events and to identify and address a failure for one of five Hematology proficiency testing events reviewed in 2023 and 2024. Findings include: BIASES (1) On 11/18/2024, a review of Hematology proficiency testing records for 2023 (first, second, and third events) and 2024 (first and second events) identified the following biases (biases were identified using the SDI (Standard Deviation Index) values assigned by the proficiency program) for two of five events: (a) First 2023 Event (i) MCH (Mean Corpuscular Hemoglobin) - five of five results exhibited a positive bias (aa) Sample DXH-01 - SDI of 2.7 (bb) Sample DXH-02 - SDI of 2.4 (cc) Sample DXH-03 - SDI of 2.1 (dd) Sample DXH-04 - SDI of 2.4 (ee) Sample DXH-05 0 SDI of 3.3 (b) Second 2024 Event (i) Hemoglobin - five of five results exhibited a positive bias (aa) Sample DXH-06 - SDI of 3.1 (bb) Sample DXH-07 - SDI of 3.9 (cc) Sample DXH-08 - SDI of 2.9 (dd) Sample DXH-09 - SDI of 3.2 (ee) Sample DXH-10 - SDI of 4.2 (2) There was no evidence in the records to prove the biases had been identified and addressed; (3) The records were reviewed with the technical consultant who stated on 11/18/2024 at 01:40 pm, the biases had not been addressed. FAILURE (1) During the review of Hematology proficiency testing records, the following failure was identified for one of five events: (a) Second 2024 Event (i) MCH - The laboratory received a score of 80%. The result for sample DXH-05 had failed. There was no documentation to prove that

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and from the proficiency testing provider. The laboratory was found out of compliance with the following CLIA Conditions: 493.803; D2016: Successful Participation 493.1407; D6000: Laboratory Director, Moderate Complexity 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 a desk review of proficiency testing scores obtained from the Casper 0155D report and proficiency testing Comparative Evaluation obtained from API (American Proficiency Institute) for the first 2023 and second 2023 events, the laboratory failed 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 -- to successfully participate in a proficiency testing program for the specialty of Hematology. Findings include: (1) The laboratory failed to achieve satisfactory performance for two consecutive testing events for the analyte PTT (Partial Thromboplastin Time). Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the Casper 0155D report and the proficiency testing graded evaluations obtained from API (American Proficiency Institute), the laboratory failed to achieve successful performance for the analyte PTT (Partial Thromboplastin Time) for two consecutive testing events. Findings include: (1) The laboratory received a score of 60% on the first 2023 event and a score of 60% on the second 2023 event. 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 a desk review of proficiency testing scores obtained from the Casper 0155D report and the proficiency testing graded evaluations obtained from API (American Proficiency Institute), the laboratory failed to achieve satisfactory performance for the analyte PTT (Partial Thromboplastin Time) in two consecutive events. The laboratory failed to achieve a passing score of 80% for the first 2023 event and second 2023 event. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(i) Ensure that 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 desk review of proficiency testing scores obtained from the Casper 0155D report and the proficiency testing graded evaluations obtained from API (American Proficiency Institute), the laboratory failed to achieve satisfactory performance for the -- 2 of 3 -- analyte PTT (Partial Thromboplastin Time) in two consecutive events. The laboratory failed to achieve a passing score of 80% for the first 2023 event and second 2023 event. Refer to D2130. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 08/22,23,24/2022. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory manager and technical consultant at the conclusion of the survey. 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 records, manufacturer's instructions, and interview with the laboratory manager and technical consultant, the laboratory failed to follow the manufacturer's instructions for implementing one of four coagulation reagents. Findings include: (1) On 08/22/2022 at 10:20 am, the laboratory manager stated the ACL Elite analyzer was used to perform patient PT/INR (Prothrombin Time /International Normalized Ratio) testing (the INR was calculated using the PT reference interval mean); (2) On 08/23/2022 at 10:30 am, the laboratory manager stated the HemosIL RecombiPlastIN PT reagent, lot #N0311118 was put into use on 07/30/2021; (3) A review of the manufacturer's instructions contained in the "Hemostasis Performance Verification Manual" for implementing new reagents, revealed the following: (a) Under the section titled, "Establishing a Normal Reference Interval" stated for a 20- donor study: (i) "Donors should be equally divided between male/female"; (ii) "Determine the mean, standard deviation (SD) and range once the data has been collected.....For non-Gaussian distributions, such as PT, a geometric mean is recommended". (b) Under the section titled, "Results" it stated "Examine the results to make sure there are no outliers....Rejection of outliers should be used with 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 -- caution. The presence of more than a few outliers may indicate that the assay needs to be repeated". (4) A review of the implementation records for the PT reagent lot change revealed the following: (a) Although 20 donors had been used, which consisted of 10 males and 10 females, the PT results for two of the donors were beyond the laboratory normal reference range, and therefore did not appear to be normal values: (i) The normal reference range had been calculated as 10.4-14.4 (ii) One of the donors used in the study had a PT result of 15.0 and one donor had a PT result of 15.8; (iii) There was no documentation the laboratory identified the outliers and followed the manufacturer's instructions on how to proceed. (5) The findings were reviewed with the laboratory manager and technical consultant. Both stated on 08/23 /2022 at 02:05 pm, the laboratory did not follow the manufacturer's instructions to identify outliers and had utilized the results when calculating the normal reference interval. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the laboratory manager and technical consultant, the laboratory failed to follow the manufacturer's instructions for performing maintenance procedures on the Beckman Coulter AU480 analyzer for one of four analyzers reviewed. Findings include: (1) On 08/22/2022 at 10:25 am, the laboratory manager stated Albumin, Alcohol, Alkaline Phosphatase, ALT (Alanine Aminotransferase), Ammonia, Amylase, AST (Aspartate Aminotransferase), BUN (Blood, Urea, Nitrogen), Calcium, CK (Creatine Kinase), Creatinine, Chloride, CO2, Direct Bilirubin, Glucose, HDL (High Density Lipoprotein), Lactate, LDL (Low Density Lipoprotein), Lipase, Magnesium, Phosphorus, Potassium, Sodium, Total Bilirubin, Total Cholesterol, Total Protein, Triglyceride, and Uric Acid testing were performed on the Beckman Coulter AU480 analyzer; (2) On 08/24/2022, a review of the manufacturer's maintenance requirements, as stated on the manufacturer's maintenance log revealed the following requirements: (a) Weekly (i) Clean Sample Pre-Dilution Bottle (ii) Perform a W2 (iii) Perform a Photocal (b) Monthly (i) Clean the Sample and Reagent Probe Wash Wells (ii) Clean the Mix Bar Wash Wells (iii) Clean the Wash Nozzle unit, and Check the Tube mounting Joints (iv) Clean the Deionized Water Tank, DI and Sample Probe Filters (c) ISE Maintenance Every Three Months (i) Replace the Roller Tubes for MID Solution Dispense and Mixture Aspiration (ii) Replace the Pinch Valve Tubing (3) A review of maintenance logs from July 2021 through July 2022 revealed maintenance had not been documented as performed as follows: (a) Weekly - Not documented as performed between: (i) 05/18/2022 and 06/01/2022 (ii) 01/19/2022 and 02/02/2022 (b) Monthly (i) Clean the Wash Nozzle Unit, and Check the Tube Mounting Joints; and Clean the Deionized Water Tank, DI and Sample Probe Filters had not been documented as performed between 09/27/2021 and 12/04/2021; (ii) Clean the Sample and Reagent Probe Wash Wells; and Clean the Mix Bar Wash Wells had not documented as performed between 10/12/2021 and 04/06/2022; (iii) Clean the Wash Nozzle Unit, and Check the Tube Mounting Joints; and Clean the Deionized Water Tank, DI and Sample Probe Filters had not been documented as performed between 12/04/2021 and 04/06/2022; (iv) Clean the Sample and Reagent -- 2 of 6 -- Probe Wash Wells; and Clean the Mix Bar Wash Wells had not documented as performed between 04/22/2022 and 06/29/2022; (v) Clean the Wash Nozzle Unit, and Check the Tube Mounting Joints; and Clean the Deionized Water Tank, DI and Sample Probe Filters had not been documented as performed between 04/06/2022 and 07/26/2022. (c) Every Three Months - Not documented as performed during the review period. (4) The records were reviewed with the laboratory manager and technical consultant. Both stated on 08/24/2022 at 01:20 pm, the maintenance had not been documented as performed as shown above. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the laboratory manager, the laboratory failed to perform function checks every six months as defined by the manufacturer for the iSTAT 1. Findings include: (1) On 08/22/2022 at 10:18 am, the laboratory manager stated the laboratory performed Blood Gas (pH, pCO2, and pO2) testing using the the iSTAT 1 analyzer and the CG8+ cartridge; (2) A review of the manufacturer's instructions contained in the "iSTAT 1 System Manual" on page 14-19 stated "Check thermal probes on each analyzer every six months"; (3) A review of records from February 2021 through the current date revealed no evidence the thermal probe checks had been performed between 02/01 /2021 and 02/25/2022; (4) The findings were reviewed with the laboratory manager who stated on 08/22/2022 at 04:25 pm, the thermal probe checks had not been performed every six months. 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 -- 3 of 6 -- calibration verification. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager and technical consultant, the laboratory failed to perform calibration verification procedures at least once every 6 months for 28 of 28 analytes. Findings include: (1) On 08/22/2022 at 10: 25 am, the laboratory manager stated Albumin, Alcohol, Alkaline Phosphatase, ALT (Alanine Aminotransferase), Ammonia, Amylase, AST (Aspartate Aminotransferase), BUN (Blood, Urea, Nitrogen), Calcium, CK (Creatine Kinase), Creatinine, Chloride, CO2, Direct Bilirubin, Glucose, HDL (High Density Lipoprotein), Lactate, LDL (Low Density Lipoprotein), Lipase, Magnesium, Phosphorus, Potassium, Sodium, Total Bilirubin, Total Cholesterol, Total Protein, Triglyceride, and Uric Acid testing were performed on the Beckman Coulter AU480 analyzer; (2) On 08/24/2022 at 01:30 pm, the laboratory manager confirmed that calibration procedures for the above analytes were performed less than three levels of calibrators. Since the calibration procedures included one or two levels, calibration verification procedures, using three or more levels of calibration materials that included a low, mid, and high value, were required every six months; (3) A review of calibration verification records performed from September through the current date revealed that calibration verification had not been performed every six months during the review period as follows: (a) Albumin, Alcohol, Alkaline Phosphatase, ALT, Amylase, AST, BUN, Calcium, CK, Creatinine, Chloride, CO2, Direct Bilirubin, Glucose, HDL, Lactate, LDL, Lipase, Magnesium, Phosphorus, Potassium, Sodium, Total Bilirubin, Total Cholesterol, Total Protein, Triglyceride, and Uric Acid had not been performed between: (i) 09/24/2020 and 05 /13/2021 (due 03/2021) (ii) 05/13/2021 and 12/15/2021 (due 01/2022) (iii) 12/15/2021 and 07/14/2022 (due 06/2022) (b) Ammonia had not been performed between: (i) 09 /25/2020 and 12/08/2021 (due 03/2021) (ii) 12/08/2021 and 07/15/2022 (due 06/2022) (4) The records were reviewed with the laboratory manager and technical consultant. Both stated on 08/24/2022 at 02:20 pm, calibration verification had not been performed every six months as stated above. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of records, quality control package inserts, and interview with the laboratory manager and technical consultant, the laboratory failed to have control procedures that monitored the accuracy and precision of the testing process; and that would detect immediate errors that would occur due to test system failure, adverse environmental conditions, and operator performance for CKMB (Creatine Kinase -- 4 of 6 -- Isoenzyme) testing for ten of ten months and PSA (Prostate Specific Antigen) testing for seven of seven months. Findings include: (1) On 08/22/2022 at 10:15 am, the laboratory manager stated the Beckman Coulter Access 2 analyzer was used to perform CKMB and PSA testing; (2) On 08/23/2022 at 10:40 am, the laboratory manager stated the following: (a) Two levels of QC materials were performed each day of patient testing; (b) When new lot numbers of control materials were put into use, the laboratory established means for each analyte and utilized historic two SD (Standard Deviation) ranges; (c) The following control materials were currently in use: (i) CKMB testing - Bio-Rad Liquichek Cardiac Markers Plus controls LT, level one lot #67651 and level three lot #67653; (ii) PSA testing - Bio-Rad Liquicheck Immunoassay Plus control, level one lot #85271 and level three lot #85273. (3) A review of QC records (Levey-Jennings graphs and cumulative calculated data; and QC package inserts) from November 2021 through the current date revealed the following: (a) CKMB - The current lot numbers were in use from November 2021 through the current date. The laboratory was using ranges as wide as the package insert guideline ranges for one of two levels of QC materials (the package insert stated the guideline ranges were listed as a three SD range): (i) Level Three - The laboratory was using a range of 48.88-68.08 which was as wide as the package insert guideline range of 49.2-68.4. (b) PSA - The current lot numbers were in use from February 2022 through the current date. The laboratory was using ranges wider or as wide as the package insert guideline ranges for two of two levels of QC materials (the package insert stated the guideline ranges were listed as a three SD range): (i) Level One - The laboratory was using a range of 0.0132-0.772 which was wider than the package insert guideline range of 0.374-0.529; (ii) Level Three - The laboratory was using a range of 22.45-32.17 which was as wide as the package insert guideline range of 24.0-33.7. (4) The records were reviewed with the laboratory manager and technical consultant. Both stated on 08/23/2022 at 03:40 pm, the laboratory was using ranges wider or as wide as the package insert guideline ranges and the ranges were currently being used to determine patient acceptability. D5449 CONTROL PROCEDURES 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 a review of records and interview with the laboratory manager and technical consultant, the laboratory failed to perform a negative and positive control material one of ten days of patient qualitative serum pregnancy testing. Findings include: (1) On 08/22/2022 at 10:15 am, the laboratory manager stated the following: (a) The OSOM hCG Combo test kit was used to perform patient qualitative pregnancy testing; (b) Negative and positive QC (quality control) materials were performed each day of patient testing. (2) A review of QC and patient testing records for testing performed from April 2021 through August 2022 revealed negative and positive QC materials had not been documented as performed each day of patient testing for one of ten days of testing. The specific day was 06/06/2022; (3) The records were reviewed with the -- 5 of 6 -- laboratory manager and technical consultant. Both stated on 08/22/2022 at 02:33 pm, negative and positive QC materials had not been documented as performed on 06/06 /2022. -- 6 of 6 --

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and from the proficiency testing provider. 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 a desk review of proficiency testing scores obtained from the Casper 0155D report and the proficiency testing graded evaluations obtained from American Proficiency Institute, the laboratory failed to successfully participate in a proficiency testing program for the specialty of Hematology. Findings include: (1) The laboratory failed to achieve satisfactory performance for two consecutive testing events for Prothrombin Time. Refer to D2128 and D2130. 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 -- D2128 HEMATOLOGY CFR(s): 493.851(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the Casper 0155D report and the proficiency testing graded evaluation obtained from American Proficiency Institute, the laboratory failed to achieve successful performance for Prothrombin Time testing. Findings include: (1) The laboratory failed to achieve satisfactory performance on the third event in 2021 and the first event in 2022. Refer to D2130. NOTE: The only acceptable

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and from the proficiency testing provider. 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 a desk review of proficiency testing scores, the laboratory failed to successfully participate in a proficiency testing program for the subspecialty of Toxicology. Findings include: (1) The laboratory failed to achieve satisfactory performance for two of three testing events for the analyte Blood Alcohol. Refer to D2116 and D2118. 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 -- D2116 TOXICOLOGY CFR(s): 493.845(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the Casper 0155D report and the Proficiency Testing Performance Evaluations for 2020 and 2021 obtained from the laboratory, the laboratory failed to achieve a successful performance for the analyte Blood Alcohol. Findings include: (1) The laboratory failed to achieve satisfactory performance on the second event in 2020 and the first event in 2021. NOTE: The only acceptable

Summary Statement of Deficiencies D0000 The recertification survey was performed on 01/20,21,22/2021. The findings were reviewed with the laboratory manager and technical consultant #2 at the conclusion of the survey. The laboratory was found out of compliance with the following CLIA regulations: 493.1210; D5016: Routine Chemistry 493.1403; D6000: Laboratory Director D5016 ROUTINE CHEMISTRY CFR(s): 493.1210 If the laboratory provides services in the subspecialty of Routine Chemistry, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1267, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the laboratory failed to ensure the requirements were met for the subspecialty of Routine Chemistry for Blood Gas testing. Findings include: (1) The laboratory failed to perform one sample of control material each 8 hours of patient blood gas testing using a combination of control materials that included both low and high values on each day of blood gas testing for 33 of 33 days of patient testing. Refer to D5537. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager and technical Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- consultant #2, the laboratory failed to review and evaluate proficiency testing results for 4 of 22 events. Findings include: FAILURES (1) On 01/20/2021, the surveyor reviewed 2019 and 2020 proficiency testing records and identified the following failures: (a) Second 2020 Hematology Event (i) Urinalysis- The laboratory failed the results for 1 of 1 samples (UA-01); (2) The surveyor could not locate evidence in the records proving the failures had been addressed; (3) the surveyor reviewed the records with the laboratory manager and technical consultant #2, and asked if

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database. 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 a desk review of proficiency testing scores, the laboratory failed to successfully participate in a proficiency testing program for the subspecialty of Hematology. Findings include: (1) The laboratory failed to achieve satisfactory performance in two of three testing events for the analyte RBC (Red Blood Cell). Refer to D2128 and D2130. 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 -- D2128 HEMATOLOGY CFR(s): 493.851(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing scores, the laboratory failed to achieve successful performance for RBC (Red Blood Count). Findings include: (1) The laboratory failed to achieve satisfactory performance on the Second Event of 2019 and the First Event of 2020. Refer to D2130. NOTE: The only acceptable

Summary Statement of Deficiencies D0000 The recertification survey was performed 09/17/18 through 09/20/18. The laboratory was found to be in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory manager and the hospital chief executive officer at the conclusion of the survey. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on a review of records, written policy, and interview with the laboratory manager, the laboratory failed to follow its policy for performing calibration procedures. Findings include: (1) On the first day of the survey, the laboratory manager stated to the surveyor, on 06/09/17 the laboratory began using the Beckman Coulter AcT 5 diff CP analyzer to perform CBC (Complete Blood Count) testing; (2) On the second day of the survey, the surveyor reviewed the laboratory's written policy, "Calibration Frequency" for the calibration procedure on the Beckman Coulter AcT 5 diff CP analyzer. The policy stated, "Calibrate during installation before analyzing samples, after major service has been performed on the instrument, at least every 6 months, or when instructed by a Beckman Coulter representative"; (3) The surveyor then reviewed records which showed the laboratory performed a calibration procedure on 06/03/17 during the implementation of the new analyzer and on 02/09 /18, but could not find documentation a calibration procedure had been performed each 6 months between 06/03/17 and 02/09/18 as required by the laboratory's written 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 -- policy; (4) The surveyor reviewed the findings with the laboratory manager, who stated to the surveyor calibration materials could not be obtained and the calibration procedure had not been performed each 6 months. D5479 CONTROL PROCEDURES CFR(s): 493.1256(e)(5)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (5) Follow the manufacturer's specifications for using reagents, media, and supplies and be responsible for results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of records, manufacturers' instructions, and interview with the laboratory manager, the laboratory failed to follow the manufacturers' specifications for control materials. Findings include: BECKMAN COULTER ACCESS 2 ANALYZER (1) On the first day of the survey, the laboratory manager stated to the surveyor the laboratory began using the Beckman Coulter Access 2 Immunoassay analyzer on 07/06/17 to perform Troponin I testing; (2) The laboratory manager also stated to the surveyor, the laboratory used 2 levels (Level 1 and Level 3) of Bio-Rad Liquichek Cardiac Markers Plus Control materials each day of patient testing to monitor acceptability of the testing; (3) On the second day of the survey, the surveyor reviewed the manufacturer's instructions (package insert) for the QC (Quality Control) materials. Under "Assignment of Values" it stated, "The mean values and corresponding +/- 3SD ranges in the Assignment of Values Data Charts (available separately) were derived from replicate analyses and are lot specific for this lot of product. Data from Unity Interlaboratory Program are included in the determination of some ranges. The tests listed were performed by the manufacturer and/or independent laboratories using manufacturer supported reagents and a representative sampling of this lot of product. It is recommended that each laboratory establish its own acceptable ranges and use those provided only as guides."; (4) The surveyor then reviewed QC records of the 4 lot numbers used from 07/06/17 through 08/07/18. The surveyor identified the laboratory utilized the manufacturer's mean and assay limits from the package insert of the Bio-Rad Liquichek Cardiac Markers Plus Control QC materials and did not follow the manufacturer's specifications to establish its own mean and limits of acceptability, for 4 of the 4 QC lot numbers used: (a) Level 1, Lot #29861 and Level, Lot #29863 (i) Used from 07/06/17-03/28/18 (ii) Used from 05/01/18-05/31 /18 (iii) Used from 07/01/18-07/31/18 (b) Level 1, Lot #23681 and Level 3, Lot #23683 (i) Used from 04/01/18-04/30/18 (ii) Used from 06/01/18-06/30/18 (iii) Used from 08/01/18-08/07/18 (5) The surveyor reviewed the findings with the laboratory manager who stated to the surveyor, the laboratory used the package insert means and limits for the QC materials listed above, and failed to follow the manufacturer's specifications to establish its own means and limits. BECKMAN COULTER AU480 ANALYZER (1) On the first day of the survey, the laboratory manager stated to the surveyor the laboratory began using the Beckman Coulter AU480 analyzer on 08/07 /17 to perform chemistry testing (e.g., Albumin, Glucose, CK (Creatinine Kinase), Potassium, Digoxin, etc.); (2) The laboratory manager also stated to the surveyor, the laboratory used 2 levels (Level 1 and Level 3) of Bio-Rad Liquid Assayed Multiqual control materials each day of patient testing to monitor acceptability of the testing; (3) On the third day of the survey, the surveyor reviewed the manufacturer's instructions (package insert) for the QC materials. Under "Assignment of Values" it stated, "The mean values and corresponding +/- 3SD ranges in the Assignment of Values Data -- 2 of 3 -- Charts (available separately) were derived from replicate analyses and are lot specific for this lot of product. Data from Unity Interlaboratory Program are included in the determination of some ranges. The tests listed were performed by the manufacturer and/or independent laboratories using manufacturer supported reagents and a representative sampling of this lot of product. It is recommended that each laboratory establish its own acceptable ranges and use those provided only as guides."; (4) The surveyor then reviewed the QC records from 5 months (September and December 2017; April, July, and August 2018) for the 4 lot numbers used since the analyzer was put into use. The surveyor identified the laboratory utilized the manufacturer's mean and assay limits from the package insert of the Bio-Rad Liquid Assayed Multiqual QC materials and did not follow the manufacturer's specifications to establish its own mean and limits of acceptability, for 4 of the 4 QC lot numbers used: (a) Level 1, Lot #45781 and Level 3, Lot #45783 (i) Used from 09/01/17-09/30/17 (ii) Used from 12 /01/17-12/31/17 (iii) Used from 04/01/18-04/30/18 (b) Level 1, Lot #45791 and Level 3, Lot #45793 (i) Used from 07/01/18-07/31/18 (ii) Used from 08/01/18-08/31/18 (5) The surveyor reviewed the findings with the laboratory manager who stated to the surveyor, the laboratory used the package insert means and limits for the QC materials listed above, and failed to follow the manufacturer's specifications to establish its own means and limits. ACL IL ELITE ANALYZER (1) On the first day of the survey, the laboratory manager stated to the surveyor the laboratory used the ACL IL Elite analyzer to perform PT/INR (Prothrombin/International Normalized Ratio) and PTT (Partial Thromboplastin Time) testing; (2) The laboratory manager also stated to the surveyor, the laboratory used 2 levels (Normal and Abnormal) of HemosIL control materials each day of patient testing to monitor acceptability of the testing; (3) The surveyor reviewed the manufacturer's instructions (package insert) for the QC materials. Under "Expected Values," it stated, "The reported ranges were determined over multiple runs of IL Coagulation Systems using specific lots of reagents. The mean of the control range determined in your laboratory may vary due to the lot of reagent used. Due to differences in reagents and instrumentation, each laboratory should establish its own Target Value and Acceptance Range (mean and standard deviation). However, any properly functioning coagulation system should yield mean values within the Acceptance Range on the package insert."; (4) The surveyor then reviewed the QC records from 11 months (March, June, August, and December 2017; February, March, April, May, June, July, and August 2018) for the QC lot numbers used during the review period. The surveyor identified the laboratory utilized the manufacturer's mean and assay limits from the package insert of the Normal and Abnormal QC materials and did not follow the manufacturer's specifications to establish its own mean and limits of acceptability, for 5 of the 5 QC lot numbers used during the review period: (a) Normal Control: (i) 03/01/18-08/06/18: Lot #N1166511 (ii) 08/07/18-08/31/18: Lot #N0670338 (b) Abnormal Control: (i) 03/01/18-04/28/18: Lot #N1166277 (ii) 05/01/18-05/31/18: Lot #N0965208 (iii) 06/01/18-07/24/18: Lot #N0965208 (iv) 07/27/18-08/31/18: Lot #N0871604 (5) The surveyor reviewed the findings with the laboratory manager who stated to the surveyor, the laboratory used the package insert means and limits for the QC materials listed above, and failed to follow the manufacturer's specifications to establish its own means and limits. -- 3 of 3 --