Benewah Community Hospital

Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) 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 the laboratory maintenance logs and an interview with the laboratory manager on 2/27/2025, the laboratory failed to perform maintenance as required by the Siemens Dimension EXL200 manufacturer in 2023, 2024 and 2025. The findings include: 1. A review of the laboratory maintenance logs identified that the laboratory failed to have documentation of weekly maintenance for the Dimension EXL200 as required by the manufacturer. The laboratory failed to document Cleaning HM Wash Probes and the R2 Reagent Probe weekly since February 2023. 2. A review of the laboratory maintenance logs identified that the laboratory failed to have documentation of monthly maintenance for the Dimension EXL200 as required by the manufacturer. The laboratory failed to document Cleaning the Clot Check Drain on the IMT Port, Replacing IMT Pump Tubing, Cleaning the IMT System, Replacing Instrument Air Filters, Styletting HM Wash Probes, Replacing HM Pump Heads on wash station, Cleaning the R1, R2 and R3 (if RMS equipped) Drains since February 2023. 3. An interview with the laboratory manager on 2/27/2025 at 11:36 am confirmed that the above findings. 4. The laboratory reports performing 86,400 tests on the Dimension EXL200 annually. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) (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 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 -- limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on a review of calibration verification records, instrument documents for the Abbott i-STAT and an interview with the laboratory manager on 2/27/2025, the laboratory failed to verify the reportable range at least once every six months for blood gas analytes, troponin and prothrombin time (PT) in 2023 and 2024. The findings include: 1. A review of records for the Abbott i-STAT test system identified that the laboratory failed to perform verifications of the reportable range for the blood gas, troponin and PT analytes at least once every six months in 2023 and 2024. 2. An interview with the laboratory manager on 2/27/2025 at 12:52 pm confirmed the above finding. 3. The laboratory reports performing 1,125 i-STAT tests annually. D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) (c) Blood shall be stored in a clean and orderly environment in a manner to prevent mix-ups. Expired blood must not be in the routine inventory. Unacceptable units must be segregated from routine inventory. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the alarm system must be documented. This STANDARD is not met as evidenced by: Based on a review of laboratory policies, temperature logs and an interview with the laboratory manager on 2/27/2025, the laboratory failed to perform alarm checks on the immunohematology refrigerator and freezer in 2023, 2024. The findings include: 1. The laboratory policies, "Alarm Check For Jewett Freezer" and "Alarm Check For Blood Bank refrigerator" state alarm checks will occur quarterly. 2. A review of laboratory temperature logs identified that the laboratory failed to perform alarm checks on the immunohematology refrigerator and freezer quarterly in 2023, 2024. 3. An interview with the laboratory manager on 2/27/2025 at 4:14 pm confirmed the above finding. 4. The laboratory reports performing 400 immunohematology tests annually. -- 2 of 2 --

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 review of calibration verification documentation and an interview with the technical supervisor on 02/08/23 the laboratory failed to verify the reportable range for Hemoglobin A1C (HbA1C) and electrolytes (sodium, potassium, and chloride). The findings include: 1. A review of calibration verification documentation identified that the laboratory failed to perform calibration verifications on electrolytes and HbA1C in 2022. 2. An interview with the technical supervisor on 02/08/23 at 09:24 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 -- confirmed the above findings. 3. The laboratory reports performing 83,900 chemistry tests annually. D5447 CONTROL PROCEDURES 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 random review of Quality Control (QC) documentation and an interview with the technical supervisor on 02/08/23, the laboratory failed to perform two (2) levels of QC each day of testing for creatinine and aspartate aminotransferase (AST). The findings include: 1. A random record review of QC from the Dimension EXL identified that the laboratory failed to have an acceptable level 3 control for creatinine (12 patients resulted) on 11/24/2021 and a level 1 control for AST (4 patients resulted) on 2/5/2022. 2. An interview with the technical supervisor on 02/08/23 at 09:58 am confirmed the above findings. 3. The laboratory reports performing 83,900 chemistry tests annually. -- 2 of 2 --

Summary Statement of Deficiencies D5447 CONTROL PROCEDURES 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 random record review of Quality Control (QC) documentation and an interview with the laboratory manager on 5/12/2021, the laboratory failed to successfully perform two levels of QC daily for each quantitative procedure. The findings include: 1. A random record review of QC from the Siemens Dimension EXL identified that the laboratory did not have an acceptable result for level 1 total bilirubin QC on 6/6/2020. The laboratory performed and released six (6) patient total bilirubin tests on 6/6/2020. 2. An interview with the laboratory manager on 5/12/2021 at 3:28 pm confirmed that the laboratory failed to have two acceptable QC levels for total bilirubin on 6/6/2020. D6086 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(ii) The laboratory director must ensure that 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 record review of instrument verifications and an interview with 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 2 -- laboratory manager on 05/12/2021, the Laboratory Director (LD) failed to ensure that verification procedures that were used for verification of the Sysmex CA-640 were adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method before their use in patient testing. The findings include: 1. A record review of the Sysmex CA-640 verification performed in June 2019, identified that the Laboratory Director failed to approve verification of performance of prothrombin time, partial thromboplastin time and D-dimer testing before implementation of patient testing. 2. An interview with the laboratory manager on 5/12 /2021 at 11:20 am confirmed that the Laboratory Director failed to approve and sign the performance verification of the Sysmex CA-640 before patient testing was implemented. -- 2 of 2 --

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on the Siemens Dimension prostate-specific antigen (PSA) reagent instructions, patient test report review, and an interview with the laboratory manager, the laboratory failed to follow the manufacturer's instructions to include the test method for PSA on the patient's test reports since the last survey on February 27, 2017. Findings: 1. A review of the Siemen TPSA reagent instruction sheet revealed the laboratory failed to include the identity of the PSA assay to physicians for patient's PSA test results. 2. The laboratory performs approximately 325 PSA tests a year. 3. An interview on February 25, 2019 at 11:10 AM, with the laboratory manager, confirmed the identity of the PSA assay was not included on patient test reports. 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 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 -- 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 perform and document calibration verification procedures for D- dimer tests since July 2018 and blood gas analytes at least once every 6 months since May 2018. Findings: 1. A record review revealed the laboratory failed to perform and document calibration verification procedures for blood gas assays performed on the I- Stat and D-dimer assays performed on the Siemens Stratus. 2. The laboratory performs approximately 40 blood gas tests and approximately 150 D-Dimer tests a year. 3. An interview on February 25, 2019 at 1:05 PM, with the laboratory manager, confirmed the laboratory failed to perform and document calibration verification procedures. 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 record review and an interview with the laboratory manager, the laboratory failed to establish the number, type, and frequency of quality control testing materials used to monitor and detect immediate errors for D-dimer tests performed on the Siemens Stratus test system since the last survey on February 27, 2017. Findings: 1. A review of the laboratory's Individualized Quality Control Plan (IQCP) for D-dimer tests performed on the Stratus revealed the laboratory failed to identify the number, type, and frequency of quality control testing materials used to monitor the performance of the tests over time. 2. The laboratory performs approximately 150 D-Dimer tests a year. 3. An interview on February 25, 2019 at 1: 00 PM, with the laboratory manager, confirmed the laboratory failed to establish and identify the number, the type, and the frequency of quality control testing materials for D-dimer in the IQCP. -- 2 of 3 -- 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 record review and an interview with the laboratory manager, the laboratory failed to include the source of microbiology culture specimens on the patient's final report from the time reviewed between December 2018 and February 2019. Findings: 1. A review of patient #348859 for a gram stain revealed the report failed to include the source of the specimen on the final report. 2. A review of 2 out of 2 patient test records for microbiology cultures referred to a reference laboratory, revealed the source of the specimen was not indicated either in the laboratory information system or on the patient's final report. 3. The laboratory performs approximately 40 gram stains per year and refers approximately 100 cultures out per year to a reference laboratory. 4. An interview on February 25, 2019 at 12:15 PM, with the laboratory manager, confirmed the patient's final microbiology results failed to include the source of the specimen in the laboratory information system or on the reference laboratory's final report. -- 3 of 3 --