Weiser Memorial Hospital

Summary Statement of Deficiencies D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of the laboratory's policies and procedures, a lack of quality control (QC) documents for the AmniSure ROM assay and an interview with the laboratory manager on 8/29/2024, the laboratory failed to perform QC as established by the laboratory and specified by the manufacturer in 2022, 2023 and 2024. The findings include: 1. A review of the laboratory's policies and procedures identified that the laboratory established QC frequency based on the manufacturer's recommendation in their Individualized Quality Control Plan (IQCP) for the AmniSure ROM assay as external QC performed with each new lot and monthly. 2. A lack of documents for QC testing for the AmniSure ROM assay identified that the laboratory failed to ensure QC was performed by labor and delivery at least once per month as established in the IQCP since the last inspection (10/6/2022). 3. An interview with the laboratory manager on 8/29/2024 at 12:13 pm confirmed the above findings. 4. The laboratory reports performing 11 AmniSure ROM assays annually. 5. This is a repeat deficiency for failure to perform QC for the AmniSure ROM Assay from the previous inspection (10/6/2022). D5447 CONTROL PROCEDURES Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- CFR(s): 493.1256(d)(3)(i)(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 quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of Quality Control (QC) documentation and an interview with the laboratory manager on 8/28/2024 the laboratory failed to successfully perform two levels of QC for each day of patient testing for ferritin in 2023. The findings include: 1. A random record review of QC documents from the Vitros 5600 for 2023 and 2024 identified that the laboratory failed to perform two levels of QC for ferritin on 12/14 /2023. The laboratory performed one patient ferritin test (10021887) on 12/14/2023. 2. An interview with the laboratory manager on 8/28/2024 at 2:27 pm confirmed the above finding. 3. The laboratory reports performing 152 ferritin tests annually. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on a review of patient test reports and an interview with the laboratory manager on 8/29/2024, the laboratory failed to clearly indicate the name of the performing laboratory for the reported tests. The findings include: 1. A review of laboratory patient test reports for chemistry and toxicology testing identified that the laboratory failed to clearly indicate the name of the performing laboratory when testing was performed by a reference laboratory. 2. An interview with the laboratory manager on 8 /29/2024 at 12:54 pm confirmed the above finding. 3. The laboratory reports performing 125,286 tests annually. -- 2 of 2 --

Summary Statement of Deficiencies D2003 ENROLLMENT CFR(s): 493.801(a)(2)(ii) For those tests performed by the laboratory that are not included in subpart I of this part, a laboratory must establish and maintain the accuracy of its testing procedures, in accordance with 493.1236(c)(1) This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) records from American Proficiency Institute (API), and an interview with the laboratory manager on 10/6/2022, the laboratory failed to enroll in proficiency testing to verify the accuracy of testing for the AmniSure Rom assay in accordance with 493.1236(c)(1). The findings include: 1. A review of proficiency testing records from API identified that the laboratory failed to ensure the verification of testing accuracy for the AmniSure Rom assay biannually for 2021 and 2022. 2. An interview with the laboratory manager on 10/6/2022 at 9:13 am confirmed that the laboratory failed to ensure the verification of testing accuracy for the AmniSure Rom assay biannually for 2021 and 2022. 3. The laboratory reports performing 11 AmniSure Rom Assays annually. 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 lack of Cepheid GeneXpert maintenance logs and an interview with the laboratory manager on 10/6/2022, the laboratory failed to perform maintenance as 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 -- required by the manufacturer. The findings include: 1. A lack of Cepheid GeneXpert maintenance logs identified that the laboratory failed to perform daily, weekly, monthly and quarterly maintenance as required by the manufacturer since begining testing in January of 2021. 2. An interview with the laboratory manager on 10/6/2022 at 9:00 am confirmed that the laboratory failed to document maintenance on the Cepheid GeneXpert. 3. The laboratory reports performing 268 tests annually on the Cepheid GeneXpert. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of the laboratory's policies and procedures, quality control (QC) documents for the Triage, lack of QC documents for the AmniSure ROM assay and interviews with the laboratory manager and labor and delivery charge nurse on 10/5 /2022 and 10/6/22 respectively, the laboratory failed to perform QC once each day of patient testing. The findings include: 1. A review of the laboratory's policies and procedures identified that the laboratory failed to have an Individualized Quality Control Plan (IQCP) for D-Dimer testing performed on the Triage and the AmniSure ROM assay. 2. A review of QC for D-Dimer testing on the Triage identified that the laboratory failed to perform QC each day of patient testing. 3. A lack of documents for QC testing for the AmniSure ROM assay identified that the laboratory failed to ensure QC was performed each day of patient testing. 4. An interview with the laboratory manager on 10/5/2022 at 9:42 am confirmed that the laboratory did not have an IQCP for D-Dimer testing performed on the Triage and only performed QC once per month. 5. An interview with the labor and delivery charge nurse on 10/6 /2022 at 11:30 am confirmed that the laboratory did not have an IQCP for AmniSure ROM assay and did not perform QC. D5545 HEMATOLOGY CFR(s): 493.1269(b)(d) (b) For all nonmanual coagulation test systems, the laboratory must include two levels of control material each 8 hours of operation and each time a reagent is changed. (d) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on a record review of Sysmex CA 620 coagulation quality control (QC) documentation, patient logs, and an interview with testing personnel 1 (TP1) on 10/5 /2022, the laboratory failed to include two levels of QC material every 8 hours of patient testing. The findings include: 1. A random record review of prothrombin time -- 2 of 4 -- (PT) and partial thromboplastin time (PTT) QC identified that the laboratory failed to document two levels of QC every 8 hours when patient testing occurred for three days in July 2021, four days in October 2021, one day in December 2021 and two days in January 2022. 2. A review of the laboratory's patient results identified three patient PT /INRs reported on 7/3/2021, one patient PT/INR and PTT reported on 7/14/2021, one patient PT/INR and PTT reported on 7/15/2021, one patient PT/INR and PTT reported on 10/1/2021, one patient PT/INR reported on 10/2/2021, one patient PT/INR and PTT reported on 10/7/2021, one patient PT/INR and PTT reported on 10/14/2021, one patient PT/INR reported on 12/31/2021, one patient PT/INR reported on 1/1/2022, two patient PT/INRs reported on 1/14/202. 3. An interview with TP1 on 10/5/2022 at 12:42 pm confirmed that QC was not documented every 8 hours of patient testing on the above dates. 4. This is a repeat deficiency from the previous inspection on 4/21 /2021. 5. The laboratory reports performing 975 PT/INR and PTT tests annually. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) 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)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; This STANDARD is not met as evidenced by: Based on a record review of the Cepheid test verifications, BioFire test verification and an interview with the laboratory manager on 10/5/2022, the laboratory director failed to ensure that the instrument verifications were adequate. The findings include: 1. A record review of the new test verification of Xpert C. difficile, performed on the Cepheid, identified that the laboratory director failed to review and approve the verification results for accuracy and precision to ensure that they were adequate before beginning patient testing in January 2021. 2. A record review of the new test verification of Xpert MRSA/SA SSTI, performed on the Cepheid, identified that the laboratory director failed to review and approve the verification results for accuracy and precision to ensure that they were adequate before beginning patient testing in January 2021. 3. A record review of the new test verification of Xpert Xpress SARS- CoV-2, performed on the Cepheid, identified that the laboratory director failed to review and approve the verification results for accuracy and precision to ensure that they were adequate before beginning patient testing in June 2021. 4. A record review of the new test verification of Xpert Xpress SARS-CoV-2/Flu/RSV, performed on the Cepheid, identified that the laboratory director failed to review and approve the verification results for accuracy and precision to ensure that they were adequate before beginning patient testing in December 2021. 5. A record review of the new test verification of BioFire Respiratory 2.1 (RP2.1) Panel, performed on the BioFire FilmArray Torch System, identified that the laboratory director failed to review and approve the verification results for accuracy and precision to ensure that they were adequate before beginning patient testing in January 2021. 6. An interview with the laboratory manager on 10/5/2022 at 4:34 pm confirmed the above findings. 7. The laboratory reports performing 982 Cepheid and BioFire tests annually. D6072 TESTING PERSONNEL RESPONSIBILITIES -- 3 of 4 -- CFR(s): 493.1425(b)(3) Each individual performing moderate complexity testing must adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed. This STANDARD is not met as evidenced by: Based on a review of Sysmex CA 620 quality control (QC) documents, patient records, laboratory procedures and an interview with the laboratory manager on 10/5 /2022, the testing personnel failed to perform and document QC as stated in the laboratory procedure and required by federal regulations . The findings include: 1. A review of QC and patient records from the Sysmex CA 620, used for prothrombin time (PT) and partial thromboplastin time (PTT) testing, and a review of the "CA 620: Principle and Operation,"procedure identified that the testing personnel failed to perform and document QC every eight hours of patient testing as required by the laboratory procedure and federal regulations. See D5545 2. An interview with the laboratory manager on 10/5/2022 at 4:57 pm confirmed that the procedure and regulations were not followed by testing personnel. 3. The laboratory reports performing 975 of PT/INR and PTT tests annually. -- 4 of 4 --

Summary Statement of Deficiencies D5545 HEMATOLOGY CFR(s): 493.1269(b)(d) (b) For all nonmanual coagulation test systems, the laboratory must include two levels of control material each 8 hours of operation and each time a reagent is changed. (d) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on a record review of Sysmex CA 620 coagulation Quality Control (QC) documentation, patient coagulation log sheet, and an interview with the laboratory manager on 04/21/2021, the laboratory failed to include two levels of QC material each 8 hours of operation when patient testing occurred. The findings include: 1. A random record review of coagulation QC revealed that the laboratory failed to document 2 levels of QC every 8 hours that patient testing occurred on the following days: 01/18/2020, 05/06/2020, and 06/06/2020. 2. The laboratory's patient coagulation log sheet revealed that the laboratory failed to document QC on 01/18/2020 when a PT /INR and APTT patient sample was tested, on 05/06/2020 two patient samples were tested for PT/INR, and on 06/06/2020 two patient samples were tested for PT/INR and APTT. 3. An interview with the laboratory manager on 04/21/2021 at 1:30 PM confirmed that QC was not documented each 8 hours of operation, on the above dates, when patient testing occurred. 4. The laboratory reports performing 2,222 coagulation tests on the Sysmex CA 620 annually Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on a record review and an interview with the laboratory manager, the laboratory failed to document calibration verification procedures for electrolytes performed on the Siemens Dimension chemistry analyzer at least once every 6 months or as required by the manufacturer since the last survey on February 2, 2017. Findings: 1. A record review of calibration reports revealed the laboratory failed to perform calibration verification on electrolytes since the last survey. 2. An interview 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 -- on November 2, 2018 at 1:15 PM, with the laboratory manager, confirmed the laboratory failed to perform and document calibration verification activities on the electrolytes. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a record review and an interview with the laboratory manager, the laboratory failed to perform control procedures at least once each day of patient testing on the MedTox urine drug screen device and the i-Stat Blood Gas device since the last survey on February 2, 2017. Findings: 1. A review of the quality control records for the MedTox and i-Stat devices revealed the laboratory failed to perform quality control at least once each day of patient testing since the last survey. 2. An interview on November 2, 2018 at 1:25 PM with the laboratory manager, confirmed the laboratory failed to perform quality control each day of patient testing and did not write an Individualized Quality Control Plan for the test systems. D6125 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(v) The procedures for evaluation of the competency of the staff must include, but are not limited to assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. This STANDARD is not met as evidenced by: Based on a record review of personnel documents and an interview with the laboratory manager, the technical supervisor who is the laboratory manager failed to include assessment of test performance through blind testing or proficiency testing in the competency evaluations for testing personnel since the last survey on February 2, 2017. Findings: 1. A review of the personnel competency evaluations for 2017 and 2018 revealed the assessments failed to include the evaluations of test performances through blind testing or proficiency testing for 10 out of 10 testing personnel. 2. An interview on November 2, 2018 at 8:45 AM, with the laboratory manager, confirmed the competency assessment forms failed to include the evaluation of test performance through blind testing or proficiency testing. -- 2 of 2 --