Wagoner Community Hospital

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 API (American Proficiency Institute) Performance Summaries and Comparative Evaluation records, the laboratory failed to successfully participate in a 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 -- proficiency testing program for two of two consecutive testing for Digoxin, resulting in unsuccessful performance. Refer to D2118 D2118 TOXICOLOGY CFR(s): 493.845(f) (f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of proficiency testing scores obtained from the CASPER 0155D report and API (American Proficiency Institute) Performance Summaries and Comparative Evaluation records, the laboratory failed to achieve satisfactory performance for the analyte Digoxin for two of two consecutive testing events in 2025. Findings include: (1) A review of the CASPER 0155D report identified the following unsatisfactory scores for Digoxin: (a) First Event 2025 - 40% (b) Second Event 2025 - 60% (2) A review of the proficiency testing scores from API 2025 confirmed the above findings. 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 API (American Proficiency Institute) Performance Summaries and Comparative Evaluation records, the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the CASPER 0155D report and API (American Proficiency Institute) Performance Summaries and Comparative Evaluation records, the laboratory director failed to ensure successful performance in an HHS approved proficiency testing program for the analyte Digoxin in two of two consecutive testing events in 2025. Refer to D2118. -- 2 of 2 --

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 493.1441; D6076: Laboratory Director, High 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 API (American Proficiency Institute) Performance Summaries and Comparative Evaluation records, the laboratory failed to successfully participate in a 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 -- proficiency testing program for two of three consecutive testing events for Compatibility Testing, resulting in unsuccessful performance. Refer to D2181. D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) (e) Failure to achieve an overall testing event score of satisfactory 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 a review of proficiency testing scores obtained from the CASPER 0155D report and API (American Proficiency Institute) Performance Summaries and Comparative Evaluation records, the laboratory failed to achieve satisfactory performance for Compatibility Testing for two of three consecutive testing events in 2024 and 2025. Findings include: (1) A review of the CASPER 0155D report identified the following unsatisfactory scores for Compatibility Testing: (a) Second 2024 Event - 40% (b) First 2025 Event - 40% (2) A review of the proficiency testing scores from API for 2024 and 2025 confirmed the above findings. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the CASPER 0155D report and API (American Proficiency Institute) Performance Summaries and Comparative Evaluation records, the laboratory director failed to provide overall management and direction for two of three consecutive events in 2024 and 2025, resulting in unsuccessful performance. Refer to D6089. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under subpart H of this part; This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the CASPER 0155D report and API (American Proficiency Institute) Performance Summaries and Comparative Evaluation records, the laboratory director failed to ensure successful performance in an HHS approved proficiency testing program for Compatibility Testing in two of three consecutive testing events in 2024 and 2025. Refer to D2181. -- 2 of 2 --

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 API (American Proficiency Institute) Performance Summaries and Comparative Evaluation records, the laboratory failed to successfully participate in a 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 -- proficiency testing program for two of three consecutive testing events in the subspecialty of Routine Chemistry for the analyte Total Bilirubin. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of proficiency testing scores obtained from the CASPER 0155D report and API (American Proficiency Institute) Performance Summaries and Comparative Evaluation records, the laboratory failed to achieve satisfactory performance for the analyte Total Bilirubin for two of three consecutive testing events between 2024 and 2025, resulting in unsuccessful performance. Findings include: (1) A review of the CASPER 0155D report identified the following unsatisfactory scores for Total Bilirubin: (a) Second 2024 Event - 40% (b) First 2025 Event - 20% (2) A review of the proficiency testing scores from API for 2024 confirmed the above findings. 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 API (American Proficiency Institute) Performance Summaries and Comparative Evaluation records, the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the CASPER 0155D report and API (American Proficiency Institute) Performance Summaries and Comparative Evaluation records, the laboratory director failed to ensure successful performance in an HHS approved proficiency testing program for the analyte Total Bilirubin in two of three consecutive testing events between 2024 and 2025. Refer to D2096. -- 2 of 2 --

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 API (American Proficiency Institute) Performance Summaries and Comparative Evaluation records, the laboratory failed to successfully participate in a 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 -- proficiency testing program for two of three consecutive testing events in the subspecialty of Routine Chemistry for the analyte Albumin. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of proficiency testing scores obtained from the CASPER 0155D report and API (American Proficiency Institute) Performance Summaries and Comparative Evaluation records, the laboratory failed to achieve satisfactory performance for the analyte Albumin for two of three consecutive testing events in 2024, resulting in unsuccessful performance. Findings include: (1) A review of the CASPER 0155D report identified the following unsatisfactory scores for Albumin: (a) First 2024 Event - 40% (b) Third 2024 Event- 40% (2) A review of the proficiency testing scores from API for 2024 confirmed the above findings. 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 API (American Proficiency Institute) Performance Summaries and Comparative Evaluation records, the laboratory director failed to provide overall management and direction of the laboratory services. 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 API (American Proficiency Institute) Performance Summaries and Comparative Evaluation records, the laboratory director failed to ensure successful performance in an HHS approved proficiency testing program for the analyte Albumin in two of three consecutive testing events during 2024. Refer to D2096. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 03/30,31/2022 and 04/01/2022 The laboratory was found out of compliance with the following CLIA regulation: 493.1409; D6033: Technical Consultant The findings were reviewed with the director of laboratory services 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, observation, and interview with the director of laboratory services, the laboratory failed to follow the manufacturer's instructions for implementing coagulation reagents for one of two lot numbers. Findings include: (1) On 03/30/2022 at 10:30 am, the director of laboratory services stated: (a) The Sysmex CA-660 analyzer was used to perform PT/INR (Prothrombin Time/International Normalized Ratio) and PTT (Partial Thromboplastin Time) testing (the INR was calculated using the PT reference interval mean); (b) The following reagent lot numbers were put into use in 05/29/2021: (i) PT - Innovin reagent, lot #549770 (ii) PTT - Actin FSL reagent, lot #562663 (iii) Ci-Trol 1 control, lot #564821 (iv) Ci-Trol 3 control, lot #556537 (2) A review of the manufacturer's instructions contained in the "Lot Roll-Over Procedure" for implementing new reagents stated, "The following recommendations should be used as a guideline when converting to new lots of reagents for Hemostasis analyzers. These procedures should be followed each year before new lots of reagents are put into use on the existing Hemostasis system". In addition, the manufacturer required the following: (a) Section titled "Verification of Reference Range" (i) "20 Normal Individuals * 10 males; 10 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 -- females * Medication History: no aspirin, no hormones, no herbal supplements * 20 is the minimum requirement for statistical validity"; (ii) "Assay samples on current and new lot number reagents simultaneously or within 10 minutes of each other. This data can be used in Section II"; (iii) "Calculate mean and 2 SD range"; (iv) "MNPT for INR calculation should be the geometric mean". (b) Section titled, "Method Correlation" (i) "40 samples: 20 normal, 20 abnormal"; (ii) "Normal samples (Section I) may be used for the Method Correlation and Verification of Reference Range"; (iii) "Abnormal samples should span the Reportable Range of assay"; (iv) "Assay samples on current and new lot number reagents simultaneously or within 1 our of each other"; (v) "Calculate Linear Regression statistics". (c) Section titled "Quality Control" (i) "Assay new lot number of QC material with the new lot of reagent in PTN and APTT protocols"; (ii) "Collect a minimum of 30 data points"; (iii) "Calculate the mean, 2 SD and 3 SD range". (3) A review of the records for the lot changes revealed the following: (a) PT - Innovin reagent, lot #549770 (i) Normal Range Study - Three of the 10 male participants were taking aspirin and two of the 10 female participants were taking aspirin (ii) Method Correlation - The records showed the laboratory had used 15 normal samples, instead of 20 as required by the manufacturer (b) PTT - Actin FSL reagent, lot #562663 (i) Normal Range Study -Three of the 10 male participants were taking aspirin and two of the 10 female participants were taking aspirin (ii) Method Correlation - The records showed the laboratory had used 15 normal samples, instead of 20 as required by the manufacturer. (c) Quality Control (QC) (i) Ci-Trol 1, lot #564821 - The records showed the laboratory had used 20 data points to establish QC ranges for PT and 20 data points to establish QC ranges for PTT instead of 30 data points as required by the manufacturer. (ii) Ci-Trol 3, lot #556537 - The records showed the laboratory had used 20 data points to establish QC ranges for PT and 20 data points to establish QC ranges for PTT instead of 30 data points as required by the manufacturer. (4) The findings were reviewed with the director of laboratory services who stated on 03/30/2022 at 12:15 pm, the manufacturer's instructions had not been followed for the reagent lot changes as specified above. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on a review of records, written procedures, and interview with the director of laboratory services, the laboratory failed to ensure the reportable ranges had been utilized for two of two new test methods. Findings include: DIESSE MINI-CUBE ANALYZER (1) On 03/30/2022 at 09:45 am, the director of laboratory services stated the laboratory began performing automated ESR (Erythrocyte Sedimentation Rate) testing using the Diesse Mini-Cube on 10/11/2021; (2) A review of the performance specification records for the new test system revealed the following: (a) The laboratory had demonstrated a reportable range of 0-80; (b) Documentation in the records showed the laboratory had approved using the manufacturer's reportable range -- 2 of 6 -- of 0-140. (3) On 03/30/2022 at 02:00 pm, the findings were reviewed with the director of laboratory services who stated the laboratory was using the manufacturer's reportable range of 0-140 instead of the reportable range that had been demonstrated by the laboratory. G3+ AND ISTAT 1 ANALYZER (1) On 03/30/2022 at 09:50 am the director of laboratory services stated the laboratory began performing Blood Gas (pH, pCO2, pO2) testing using the G3+ cartridge and iSTAT 1 analyzer on 03/25 /2022; (2) On 03/31/2022, a review of the performance specification records for the new test system revealed the following reportable ranges had been demonstrated by the laboratory: (a) pH - 6.550-7.914 (b) CO2 - 18.8-100.2 mmHg (c) pO2 - 66-407 mm Hg (3) A review of the procedure titled, "iSTAT G3+" showed the following manufacturer's reportable ranges being used by the laboratory: (a) pH - 6.5-8.20 (b) CO2 - 5-130 mm Hg (c) pO2 - 5-800 mm Hg (4) On 03/31/2022 at 01:45 pm, the findings were reviewed with the director of laboratory services who stated the laboratory was using the manufacturer's reportable ranges instead of the reportable ranges that had been demonstrated by the laboratory. 39088 Based on a review of records, manufacturer's instructions, and interview with the director of laboratory services, the laboratory failed to ensure the reportable ranges had been utilized for two of two new test methods. Findings include: (1) On 03/30/2022 at 10:45 am, the director of laboratory services stated the laboratory began performing chemistry testing using the Vitros 5600 on 03/07/2021; (2) On 03/31/2022, a review of the performance specification records for the new test system revealed the following reportable ranges had been demonstrated by the laboratory: (a) Alkaline Phosphatase - 26 - 1473.5 U/L (b) Aspartate Aminotransferase - 16.3 - 793.2 U/L (c) Ammonia - 6 - 478.7 umol/L (d) B12 - 63.8 - 983 mcg (e) CKMB - 0.22 - 343 IU/L (f) Creatine Kinase - 37.9 - 1516.4 IU/L (g) Glucose - 30 - 589 mg/dL (h) Glycated Hemoglobin - 5.9 - 10.4% (i) Lipase 31.8 - 1886.3 U/L (j) Total Bilirubin - 0.93 - 18.3 mg/dL (k) Triglycerides - 34.6 - 520.8 mg/dL (3) A review of the manufacturer's reportable range showed the following manufacturer's reportable ranges being used by the laboratory: (a) Alkaline Phosphatase - 20 -1500 U/L (b) Aspartate Aminotransferase - 3 - 750 U/L (c) Ammonia - 9 - 500 umol/L (d) B12 - 159 - 1000 mcg (e) CKMB - 0.22 - 400 IU/L (f) Creatine Kinase - 20 -1600 IU/L (g) Glucose - 20 -625 mg/dL (h) Glycated Hemoglobin - 4 - 14% (i) Lipase 10 -2000 U/L (j) Total Bilirubin - 0.1 - 27 (k) Triglycerides - 10 - 525 mg/dL (4) On 03/31/2022 at 01:45 pm, the findings were reviewed with the director of laboratory services who stated the laboratory was using the manufacturer's reportable ranges instead of the reportable ranges that had been demonstrated by the laboratory. 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 -- 3 of 6 -- 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 records and interview with the director of laboratory services, the laboratory failed to perform calibration verification procedures at least once every 6 months for one of six analytes. Findings include: (1) On 03/30/2022 at 09:57 am, the director of laboratory services stated the laboratory began performing Vitamin B12 testing using the Ortho Vitros 5600 analyzer on 01/04/2021; (2) On 04/01/2022, a review of 2022 calibration records revealed the calibration procedures for Vitamin B12 had been performed with two levels of calibrators therefore, 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 analyzer records from January 2021 through March 2022 revealed that calibration verification had not been performed after 01/04/2021; (4) The records were reviewed with the director of laboratory services who stated on 04/01/2022 at 12:30 pm, calibration verification procedures had not been performed every six months. D5559 IMMUNOHEMATOLOGY CFR(s): 493.1271(e)(f) (e) Investigation of transfusion reactions. (e)(1) According to its established procedures, the laboratory that performs compatibility testing, or issues blood or blood products, must promptly investigate all transfusion reactions occurring in facilities for which it has investigational responsibility and make recommendations to the medical staff regarding improvements in transfusion procedures. (e)(2) The laboratory must document, as applicable, that all necessary remedial actions are taken to prevent recurrences of transfusion reactions and that all policies and procedures are reviewed to assure they are adequate to ensure the safety of individuals being transfused. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on a review of written policies and interview with the director of laboratory services, the laboratory failed to ensure that written policies provided safety for individuals being transfused for 10 of 10 units of packed red blood cells. Findings include: (1) On 03/30/2022 at 11:10 am, the director of laboratory services stated: (a) The laboratory stored units of packed red blood cells in the blood bank refrigerator. The units were to be used for patient transfusions; (2) A review of the hospital policy titled, "Blood Product Administration" under the section titled, "ADMINISTRATION OF PACKED RED BLOOD CELLS, AUTOLOGOUS, AND DIRECTED DONOR BLOOD", stated: (a) "12. After initiation vital signs will be documented as follows:" (i) "a. Once within the first 15 minutes"; (ii) "b. Every hour until completion of infusion," (iii) "c. There will then need to be a vital sign 1 hour post transfusion. The vital signs will be recorded on the blood request form and in the nurse's notes. The unit number and time of transfusion will be recorded in the electronic record.". (3) A review of patient records for 10 units of PRBCs (Packed Red Blood Cells) that had -- 4 of 6 -- been transfused between 10/07/2021 through 03/01/2022 for five patients, revealed the following: (a) Vitals on the blood request forms were documented as "BEFORE", "DURING" AND "AFTER" but did not include a time the three vitals were taken during infusion for 10 of 10 units; (i) Patient #1 - Transfused with one unit of PRBCs (unit #W091021346317) on 10/07/2021; Transfused with one unit of PRBCs (unit #W091021331639) on 10/07/2021; (ii) Patient #2 - Transfused with one unit of PRBCs (unit #W091021368295) on 11/18/2021; Transfused with one unit of PRBCs (unit #W091021389089) on 11/18/2021 (iii) Patient #3 - Transfused with one unit of PRBCs (unit #W0910214156008) on 12/04/2021; Transfused with one unit of PRBCs (unit #W091021448478) on 01/29/2022 (iv) Patient #4 - Transfused with one unit of PRBCs (unit #W091021404643) on 12/04/2021; Transfused with one unit of PRBCs (unit #W091022120171) on 03/01/2022; (v) Patient #5 - Transfused with one unit of PRBCs (unit #W0910214374440) on 01/29/2022; and Transfused with one unit of PRBCs (unit #W091021452778) on 012/29/2022. (4) The findings were reviewed with the director of laboratory services who stated on 04/01/2022 at 11:45 am the vitals had been taken but not documented and the written policy and procedure for blood administration had not been followed as indicated above. D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the technical consultant failed to provide technical oversight in accordance with 493.1413 of this subpart. Findings include: (1) The technical consultant failed to ensure the individual who performed the duties and responsibilities of the technical consultant, met the qualifications. Refer to D6035. D6035 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 (a) The technical consultant must be qualified and must possess a current license issued by the State in which the laboratory is located, if such licensing is required. (b) The technical consultant must-- (b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(1)(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (b)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (b)(2)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine are qualified to serve as the technical consultant in hematology); or (b)(3)(i) Hold an earned doctoral or master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (b)(3)(ii) Have at least one year of -- 5 of 6 -- laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(4)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (b)(4)(ii) Have at least 2 years of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible. Note: The technical consultant requirements for "laboratory training or experience, or both" in each specialty or subspecialty may be acquired concurrently in more than one of the specialties or subspecialties of service, excluding waived tests. For example, an individual who has a bachelor's degree in biology and additionally has documentation of 2 years of work experience performing tests of moderate complexity in all specialties and subspecialties of service, would be qualified as a technical consultant in a laboratory performing moderate complexity testing in all specialties and subspecialties of service. This STANDARD is not met as evidenced by: Based on a review of records and interview with the director of laboratory services , the laboratory failed to ensure the individual who performed the duties and responsibilities of the technical consultant, met the qualifications for one of seven competency evaluations. Findings include: (1) On 03/30/2022, a review of records for seven persons performing moderate complexity testing in 2020 and 2021 revealed the following for one of seven testing persons: (a) Testing Person #5 - The 02/26/2021 evaluation and 07/02/2021 evaluation had been performed by the director of laboratory services (this person had earned an associate's degree in applied clinical laboratory science). (2) The findings were reviewed with the director of laboratory services who stated on 03/30/2022 at 01:45 pm, the evaluations had been performed by an individual who did not meet the qualifications of a technical consultant. -- 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 evaluation obtained from the proficiency testing provider, the laboratory failed to successfully participate in a proficiency testing program for the subspecialty of Routine Chemistry. Findings include: (1) The laboratory failed to achieve satisfactory performance for two consecutive testing events for the analyte LDH (Lactate Dehydrogenase). Refer to D2094 and D2096. 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 -- D2094 ROUTINE CHEMISTRY CFR(s): 493.841(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 the proficiency testing provider, the laboratory failed to achieve a successful performance for the analyte LDH. Findings include: (1) The laboratory failed to achieve satisfactory performance on the first and second 2021 events. 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. The laboratory was found out of compliance with the following CLIA regulations: 1. 493.803: D2016: Successful Participation 2. 493.807: D2017: Reinstatement of Nonwaived Laboratories 3. 493.1441: D6076: Laboratory Director, High 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, the laboratory failed to successfully participate in a proficiency testing program for the subspecialty of Compatibility Testing. Findings include: (1) 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 -- laboratory failed to achieve satisfactory performance for three of four proficiency testing events for Compatibility Testing. Refer to D2181. D2017 REINSTATEMENT OF NONWAIVED LABORATORIES CFR(s): 493.807(a)(b) (a) If a laboratory's certificate is suspended or limited or its Medicare or Medicaid approval is cancelled or its Medicare or Medicaid payments are suspended because it fails to participate successfully in proficiency testing for one or more specialties, subspecialties, analyte or test, or voluntarily withdraws its certification under CLIA for the failed specialty, subspecialty, or analyte, the laboratory must then demonstrate sustained satisfactory performance on two consecutive proficiency testing events, one of which may be on site, before CMS will consider it for reinstatement for certification and Medicare or Medicaid approval in that specialty, subspecialty, analyte or test. (b) The cancellation period for Medicare and Medicaid approval or period for suspension of Medicare or Medicaid payments or suspension or limitation of certification under CLIA for the failed specialty, subspecialty, or analyte or test is for a period of not less than six months from the date of cancellation, limitation or suspension of the CLIA certificate. This CONDITION is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the Casper 0155D report, the laboratory failed to successfully participate in a proficiency testing program for Compatibility Testing. Findings include: (1) The laboratory failed to successfully participate in proficiency testing for Compatibility Testing. Refer to D2181. D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) Failure to achieve an overall testing event score of satisfactory 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 a desk review of proficiency testing scores obtained from the Casper 0155D report, the laboratory failed to achieve satisfactory performance for Compatibility Testing in three of four proficiency testing events. Findings include: (1) The laboratory received the following scores: (a) A score of 80% was received on the Third 2019 Event; (b) A score of 80% was received on the Second 2020 Event; (c) A score of 80% was received on the Third 2020 Event. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: -- 2 of 3 -- Based on a desk review of proficiency testing scores obtained from the Casper 0155D report, the laboratory demonstrated non-initial unsuccessful participation for Compatibility Testing. The laboratory failed to achieve a passing score of 100% for the Third 2019 Event, Second 2020 Event, and the Third 2020 Event. Refer to D6091. D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) The laboratory director must ensure all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D0000 The recertification survey was performed on 11/09,10/2020. The findings were reviewed with the laboratory director, laboratory manager, chief nursing officer, and infection control/quality director during an exit conference performed at the conclusion of the survey. The laboratory was found out of compliance with the following CLIA regulations: 493.1447; D6108: Technical Supervisor 493.1409; D6033: Technical Consultant 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, the laboratory failed to review and evaluate proficiency testing results for 7 of 27 events. Findings include: BIASES (1) On 11/09/2020, surveyor #2 reviewed 2018, 2019, and 2020 proficiency testing records and identified the following biases (the biases was identified using the SDI (Standard Deviation Index) values assigned by the proficiency program): (a) First 2019 Chemistry Core Event (i) Glucose- 3 of 5 results exhibited a positive bias (aa) BG-02 - SDI of 2.0 (bb) BG-03 - SDI of 4.9 (cc) BG-04 - SDI of 3.0 (ii) Phosphorus- 3 of 5 results exhibited a positive bias (aa) CH-03 - SDI of 2.7 (bb) CH-04 - SDI of 2.0 (cc) CH-05 - SDI of 2.0 (b) Second 2019 Chemistry Core Event (i) Troponin I - 3 of 5 results exhibited a positive bias (aa) CH-07 - SDI of 2.3 (bb) CH-08 - SDI of 2.0 (cc) CH-10 - SDI of 2.6 (c) First 2020 Chemistry Core Event (i) Glucose - 4 of 5 results exhibited a positive bias (aa) BG-02- SDI of 2.0 (bb) BG-03- SDI of 2.3 (cc) BG-04- SDI of 2,7 (dd) BG-05- SDI of 2.4 (ii) Digoxin - 5 of 5 results exhibited a positive bias (aa) CH-06 - SDI of 2.6 (bb) CH-07 - SDI of 2.4 (cc) CH-08 - SDI of 4.1 (dd) CH-09 - SDI of 3.4 (ee) CH-10 - SDI of 2.1 (iii) Salicylates - 4 of results exhibited a positive bias (aa) CH-06 - SDI of 2.7 (bb) CH-07 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 16 -- - SDI of 2.8 (cc) CH-08 - SDI of 2.2 (dd) CH-10 - SDI of 2.5 (iv) Gentamicin - 5 of 5 results exhibited a positive bias (aa) CH-06 - SDI of 2.8 (bb) CH-07 - SDI of 2.6 (cc) CH-08 - SDI of 2.8 (dd) CH-09 - SDI of 2.2 (ee) CH-10 - SDI of 2.6 (d) Third 2020 Chemistry Core Event (i) Ionized Calcium - 4 of 5 results exhibited a positive bias (aa) BG-12- SDI of 2.9 (bb) BG-13- SDI of 3.0 (cc) BG-44- SDI of 2.8 (dd) BG-55- SDI of 2.7 (ii) Salicylates - 5 of 5 results exhibited a positive bias (aa) CH-11 - SDI of 2.7 (bb) CH-12 - SDI of 3.6 (cc) CH-13 - SDI of 3.1 (dd) CH-14 - SDI of 2.7 (ee) CH- 15 - SDI of 3.0 (iii) Total Protein - 3 of 5 results exhibited a negative bias (aa) CH-11 - SDI of -2.4 (bb) CH-13 - SDI of -2.3 (cc) CH-14 - SDI of -2.4 (e) Second 2020 Hematology Event (i) MCHC - 3 of 5 results exhibited a negative bias (aa) XE-02 - SDI of -2.3 (bb) XE-04 - SDI of -2.9 (cc) XE-05 - SDI of -2.3 (2) Surveyor #2 further reviewed the records and could not locate documentation verifying the biases had been identified and addressed; (3) Surveyor #2 then reviewed the records with the laboratory manager, and asked if the biases had been addressed. The laboratory manager stated on 11/09/2020 at 01:15 pm the biases had not been addressed. FAILURES (1) On 11/09/2020, surveyor #2 reviewed 2018, 2019, and 2020 proficiency testing records for testing performed in the respiratory therapy department. The following failures were identified, in which

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 Compatibility Testing. Findings include: The laboratory failed to achieve satisfactory performance for two of three testing events for Compatibility Testing. Refer to D2179 and D2181. 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 -- D2179 COMPATIBILITY TESTING CFR(s): 493.863(d) (1) For any unsatisfactory 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 unsatisfactory 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 Compatibility Testing. Findings include: (1) The laboratory failed to achieve satisfactory performance on the Third 2019 Event and the Second 2020 Event. Refer to D2181. 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. 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 Routine Chemistry. Findings include: (1) The laboratory failed to achieve satisfactory performance for two consecutive testing events for the analyte PCO2 Blood Gas. Refer to D2094 and D2096; 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 -- D2094 ROUTINE CHEMISTRY CFR(s): 493.841(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 a successful performance for the analyte PCO2 Blood Gas. Findings include: (1) The laboratory failed to achieve satisfactory performance on the First 2018 and Second 2018 events. NOTE: The only acceptable

Summary Statement of Deficiencies D0000 The survey was performed from 02/26/18 - 03/01/18. The findings were reviewed with the laboratory director, technical consultant, general supervisor, and the chief executive officer at the conclusion of the survey. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on a review of records, manufacturers' instructions, and interview with the technical consultant and the general supervisor, the laboratory failed to ensure the manufacturers' required environmental specifications were met for the analyzers used for patient testing. Findings include: (1) On the first day of the survey, the technical consultant stated to the surveyor the laboratory performed moderate complexity testing, which included the following examples: (a) Coagulation testing - PT/INR (Prothrombin Time/International Normalized Ratio), APTT (Activated Partial Thromboplastin Time), and D-dimer using the Sysmex CA600 analyzer (b) CBC testing (i.e. WBC-White Blood Count, RBC-Red Blood Count, Hemoglobin, Hematocrit, Platelet Count, etc.) using the Sysmex XT-4000i analyzer (2) On the second day of the survey, the surveyor reviewed the manufacturer's instructions (operation manuals) for the analyzers listed above and identified the required humidity ranges: (a) Sysmex CA600: 30-80% (b) Sysmex XT-4000i: 30-85% (3) The surveyor then reviewed humidity records from 12 months (April, May, June, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- November, and December 2016; January, February, July, October, November, and December 2017; and January 2018) and identified the humidity was lower than the manufacturers' required range, as follows: (a) 2016: 1 of 5 months reviewed: (i) November: 6 of 30 days (aa) Day 20 - The humidity was 29.2% (bb) Day 21 - The humidity was 26.2% (cc) Day 22 - The humidity was 28.5% (dd) Day 24 - The humidity was 28.9% (ee) Day 29 - The humidity was 29.1% (ff) Day 30 - The humidity was 26.7% (b) 2017: 5 of 6 months reviewed: (i) January: 7 of 31 days (aa) Day 7 - The humidity was 25.6% (bb) Day 26 - The humidity was 26.5% (cc) Day 27 - The humidity was 26.8% (dd) Day 28 - The humidity was 25.6% (ee) Day 29 - The humidity was 25.8% (ff) Day 30 - The humidity was 27.3% (gg) Day 31 - The humidity was 26.6% (ii) February: 2 of 28 days (aa) Day 25 - The humidity was 26.3% (bb) Day 27 - The humidity was 22.8% (iii) March: 1 of 31 days (aa) Day 9 - The humidity was 29.4% (iv) October: 2 of 31 days (aa) Day 30 - The humidity was 26.8% (bb) Day 31 - The humidity was 26.3% (v) November: 10 of 30 days (aa) Day 11 - The humidity was 27.8% (bb) Day 19 - The humidity was 27.3 (cc) Day 20 - The humidity was 26.9% (dd) Day 22 - The humidity was 26.7% (ee) Day 23 - The humidity was 23.4% (ff) Day 24 - The humidity was 25.3% (gg) Day 25 - The humidity was 25.5% (hh) Day 26 - The humidity was 25.5% (ii) Day 27 - The humidity was 25.5% (jj) Day 28 - The humidity was 27.4% (4) The surveyor reviewed the findings with the technical consultant and the general supervisor, who stated to the surveyor the laboratory failed to ensure the manufacturers' humidity requirements had been met as listed above. NOTE: D5413 was cited on the previous recertification survey performed 03/02/16-03/04/16. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the technical consultant and the general supervisor, the laboratory failed to ensure expired testing materials were not used. Findings include: (1) On the first day of the survey, the technical consultant stated to the surveyor, the laboratory performed patient Blood Bank testing, which included: (a) ABO/Rh typing (b) Antibody Screen testing (c) Compatibility testing (2) On the second day of the survey, the surveyor reviewed Blood Bank QC (Quality Control) and patient testing records from 04/01/16 through 02/22/18 and identified documentation showed expired testing materials had been used on days of patient testing: (a) Anti-D Reagent, Lot #DB30541, with the manufacturer's expiration date, 12/11/16 had been used to perform QC and patient testing on 12/12/16 and 12/13/16; (b) Ortho Coombs Control Cells, Lot #K398, with the manufacturer's expiration date, 02/21/17 had been used to perform QC and patient testing on 02/22/17; (c) Ortho Coombs Control Cells, Lot #K404, with the manufacturer's expiration date, 03/21/17 had been used to perform QC and patient testing on 03/22/17; (d) Blood bank Saline, Lot #817476, with the manufacturer's expiration date, 04/28/17 had been used to perform QC and patient testing on 05/03 /17; (e) Reagent Screening Cells 1 and Cells 2, Lot #S013, with the manufacturer's expiration date, 01/16/18 had been used to perform QC and patient testing on 01/22 /18. (3) The surveyor reviewed the records with the technical consultant and the general supervisor, who stated to the surveyor expired testing materials had been used -- 2 of 5 -- as indicated above; (4) Examples of patient Crossmatch testing performed using the expired materials were: (a) Patient #1 - Testing performed on 12/12/16 and 12/13/16 (b) Patient #2 - Testing performed on 02/22/17 (c) Patient #3 - Testing performed on 03/22/17 (d) Patient #4 - Testing performed on 05/03/17 (e) Patient #5 - Testing performed on 01/22/18 NOTE: D5417 was cited on the previous recertification survey performed 03/02/16-03/04/16. 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 technical consultant and the general supervisor, the laboratory failed to follow the manufacturer's instructions for performing maintenance procedures. Findings include: (1) On the first day of the survey, the technical consultant stated to the surveyor the laboratory used the Sysmex CA-600 analyzer to perform PT/INR (Prothrombin Time /International Normalized Ratio), APTT (Activated Partial Thromboplastin Time), and D-dimer testing; (2) The surveyor reviewed the manufacturer's maintenance requirements as stated on the manufacturer's maintenance logs. The following was identified: (a) Weekly: Clean instrument interior/exterior (b) Yearly: Replace Rinse Filter (3) The surveyor then reviewed maintenance records for 15 months (June 2016 through January 2018). There was no documentation which proved the weekly and yearly maintenance had been performed: (a) Weekly: Had not been documented as having been performed: (i) Between 07/14/16 and 07/28/16 (ii) Between 08/03/16 and 08/14/16 (iii) Between 09/15/16 and 09/26/16 (iv) Between 11/30/16 and 12/20/16 (v) Between 12/28/16 and 01/08/17 (vi) Between 04/21/17 and 04/30/17 (vii) Between 05 /25/17 and 06/16/17 (b) Yearly: Had not been documented as having been performed: (i) Between 06/02/16 and 02/27/18 (4) The surveyor reviewed the records with the technical consultant and the general supervisor, who stated to the surveyor the laboratory failed to perform the manufacturer's required maintenance procedures as listed 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 technical consultant and the general supervisor, the laboratory failed to ensure function checks for cuvette temperatures on the Dimension EXL 200 chemistry analyzer were acceptable. Findings include: (1) On the first day of the survey, the technical consultant stated to the surveyor the laboratory performed patient chemistry (i.e., Albumin, Glucose, Potassium, TSH (Thyroid Stimulating Hormone), Digoxin, -- 3 of 5 -- Uric Acid, etc.) testing using the Dimension EXL 200 analyzer; (2) On the fourth day of the survey, the surveyor reviewed the manufacturer's instructions for performing daily function checks on the analyzer. The instructions required the cuvette temperatures be read daily and documented. In addition, the manufacturer's acceptable cuvette temperature range was 36.8 to 37.2 degrees Centigrade (C); (3) The surveyor then reviewed the cuvette temperature records from 11 months (June, July, August, September, October, and December 2016; January, June, September, and December 2017; and January 2018). The surveyor identified the cuvette temperatures were unacceptable on 17 of the 184 days reviewed in 2016, as follows: (a) July - On 3 of 31 days, the temperatures were unacceptable: (i) 36.7 degrees: Days 15,27,29 (b) August - On 6 of 31 days, the temperatures were unacceptable: (i) 36.6 degrees: Days 6,7,20,28 (ii) 36.7 degrees: Days 21,27 (c) September - On 6 of 30 days, the temperatures were unacceptable: (i) 36.7 degrees: Days 17,18,23,27,28,30 (d) October - On 1 of 31 days, the temperature was unacceptable: (i) 36.7 degrees: Day 3 (e) December - On 1 of 31 days, the temperature was unacceptable: (i) 36.7 degrees: Day 9 (4) The records were reviewed with the technical consultant and the general supervisor, who stated to the surveyor the temperatures were not being maintained within the manufacturer's acceptable range. NOTE: D5431 was cited on the previous recertification survey performed 03/02/16-03/04/16. D5785