Northwest Medical Center

Summary Statement of Deficiencies 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 review of the College of American Pathologists (CAP) chemistry proficiency testing (PT) results for 2025 and 2024 and phone interview with the technical supervisor (TS) #2 on April 10, 2025 at 9:10 AM , the laboratory failed to successfully participate in PT. Refer to D-tag 2096, unsatisfactory performance in two consecutive PT events for PCO2 (partial pressure of carbon dioxide) blood gas. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 -- (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 review of the College of American Pathologists (CAP) chemistry proficiency testing (PT) results for 2025 and 2024 and phone interview with the technical supervisor (TS) #2 on April 10, 2025 at 9:10 AM, the laboratory failed to achieve satisfactory performance for PCO2 (partial pressure of carbon dioxide) blood gas in two consecutive testing events. Findings: 1. Review of the CAP chemistry PT results for the third event of 2024 showed the laboratory obtained an unsatisfactory score of 0 percent for the analyte PCO2 blood gas. 2. Review of the CAP chemistry PT results for the first event of 2025 showed the laboratory obtained an unsatisfactory score of 60 percent for the analyte PCO2 blood gas. 3. Phone interview with the technical supervisor (TS) #2 on April 10, 2025 at 9:10 AM confirmed the laboratory failed to achieve satisfactory performance for PCO2 blood gas in two consecutive testing events. -- 2 of 2 --

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of procedures, review of d-dimer patient results, quality control (QC) records, and interview with the technical supervisor (TS) #2, the laboratory failed to follow the procedure for d-dimer controls for one of twenty-one patient results. Findings: 1. Review of the "D-Dimer ACL Elite-COAG" procedure states "Controls must be tested each time reagents are placed on instrument and patient testing is performed." 2. Review of twenty-one patient results from March 6, 2023 to date November 14, 2023 were performed. 3. Review of the of the quality control records showed on March 27, 2023 the d-dimer QC was not performed with each patient test performed. 4. Interview with TS #2 on November 14, 2023 at 12:00 PM confirmed the laboratory failed to follow procedure for running d-dimer controls. 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 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 must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the Abbott i-STAT 2022 and 2023 quality control (QC) records, review of individualized quality control plan (IQCP), and interview with technical supervisor (TS) #2, the laboratory failed to follow the IQCP for 3 of 22 months. Findings: 1. Review of QC from January 2022 to October 2023 showed no QC was performed for July 2022, September 2022 and March 2023 for EG7+, CG4, and Chem 8 cartridges. 2. Review of IQCP states, "complete QC on each new shipment of cartridges and once every month." 3. Interview with TS #2 on November 14, 2023 at 12:00 PM confirmed the laboratory failed to follow the IQCP for the Abbott i-STAT system. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on the review of employee annual performance evaluations and interview with the technical supervisor (TS) #2, the TS failed to perform annual performance evaluations for 1 of 5 testing personnel (TP). Findings: 1. Review of employees competencies showed the TS failed to perform the annual performance evaluation for TP #2 in 2022. 2. Interview with TS #2 on November 14, 2023 at 12:00 PM confirmed the TS failed to perform the annual performance evaluation for TP #2. -- 2 of 2 --

Summary Statement of Deficiencies 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 review of the manufacturer's instructions, lack of humidity logs for 2020 /2021 and to date January 25, 2022, observation of calibrator materials stored in freezer, 2021 temperature logs and interview with technical supervisor (TS) #3, the laboratory failed to follow manufacturer's instructions for monitoring and documenting humidity and acceptable temperature range for storage of reagents in freezer. Findings: 1. Review of the Sysmex XS-1000i instruction for use states "operate at humidity 30 percent to 85 percent". 2. Review of laboratory logs showed no documentation for humidity in 2020, 2021 and to date January 25, 2022. 3. Review of the manufacturer's instructions for storage of Siemens calibrators LOCI THY CAL, LOCI NTP and CKI/MBI CAL state "must be stored at minus 25 degrees Celsius (C) to minus 15 degrees Celsius". 4. Observation of the laboratory freezer #1 showed 2 boxes of LOCI THY calibrator (lot number IED020, expiration date: 2022 06-01), 2 boxes of LOCI NTP calibrator (lot number IHD009, expiration date: 2022 08-01) and 2 boxes of CKI/MBI calibrator (lot number ICD011, expiration date: 2022 03-01) currently stored in freezer #1. 5. Review of the 2021 laboratory's temperature chart for freezer #1 showed a defined acceptable range of minus 10 degrees C to minus 20 degrees C. For 25 of 365 testing days the laboratory failed to meet the manufacturer's required minus 25 degrees C to minus 15 degree C temperature range. 6. 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 3 -- with TS #3 on January 25, 2022 at 11:00 AM confirmed the laboratory failed to follow manufacturer's instructions for monitoring and documenting humidity and to maintain an acceptable temperature range for the storage of chemistry reagents. 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 review of the performance specifications for the new Abbott i-stat analyzer signed into effect: November 4, 2021 and interview with the technical supervisor (TS) #3, the laboratory failed to verify performance specifications prior to initiating patient testing. Findings: 1. Review of the performance specifications for the Abbott i-stat analyzer showed the laboratory failed to verify that the manufacturer's reference intervals (normal ranges) were appropriate for the laboratory's patient population for the analytes: pCO2, pO2, pH, SO2, sodium, potassium, chloride, ionized calcium, total CO2, hematocrit, hemoglobin, lactate, HCO3 and troponin for both venous and arterial specimens prior to the beginning of patient testing in November 2021. 2. Review of patient results from November 14, 2021 to date January 25, 2022 showed 49 results were reported for the analytes: pCO2, pO2, pH, SO2, sodium, potassium, chloride, ionized calcium, total CO2, hematocrit, hemoglobin, lactate and HCO3. No troponin patient results were reported. 3. Interview with the TS #3 on January 25, 2022 at 9:45 AM confirmed the laboratory failed to verify that the Abbott i-stat manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. 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 review of chemistry quality control (QC) records from January 1, 2021 to date January 25, 2022 and interview technical supervisor (TS) #3, the laboratory failed to include two control materials of different concentrations each day of patient testing for troponin. Findings: 1. Review of Abbott i-STAT QC during the period of January 1, 2021 and January 25, 2022 showed two acceptable levels of QC were not performed when patient specimens were assayed for troponins. 2. Interview with the -- 2 of 3 -- TS #3 on January 25, 2022 at 10:30 AM confirmed the laboratory failed to perform two control materials of different concentrations each day of patient testing for troponin. -- 3 of 3 --

Summary Statement of Deficiencies 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 review of manufacturer's instructions, documentation of freezer temperatures, observation of quality control (QC) material stored in the freezer and interview with the laboratory manager, the laboratory failed to follow the manufacturer's instructions for storage of control material for 2 of 44 testing days. Findings: 1. Review of the manufacturer's instructions for Bio-Rad liquid unassayed Multiqual control showed controls must be stored at minus 20 degrees Celsius (C) to minus 70 degrees C. 2. Review of the laboratory's temperature chart showed a defined acceptable range of minus 20 degrees C to minus 30 degrees C. On July 9, 2019 and August 3, 2019 the laboratory failed to meet the manufacturer's required minus 20 to minus 70 degree C range. 3. Observation of the laboratory freezer showed 17 boxes of Bio-Rad Multiqual unassayed controls currently in use in the laboratory. 4. Interview with the laboratory manager on August 13, 2019 at 3:00 PM confirmed the laboratory failed to properly monitor the freezer and store QC materials and supplies per manufacturer's instructions. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) 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 -- 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 review of the calibration records for the Siemens Dimension chemistry analyzer for the analytes of sodium, potassium, and chloride, and on interview with the laboratory manager which confirmed the laboratory failed to perform at least a three point calibration(a minimal, mid-point, and maximum) verification every six months. Findings: 1. Review calibration records for 2017, 2018 and to date for the Siemens Dimension chemistry analyzer for the analytes: sodium, potassium, and chloride, revealed the laboratory failed to perform a calibration including, at least, a minimal, midpoint, and maximum value for each analyte, every six months. 2. Interview with the laboratory manager on August 13, 2019 at 3:00 PM confirmed the laboratory failed to perform at least a 3 point calibration of the electrolytes on the Siemens Dimension analyzer every six months. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on observation of hematology staining for WBC manual differentials and interview with the laboratory manager the laboratory failed to check staining material each day of use. Findings: 1. Observation of hematology stain showed the laboratory failed to document stain used for manual white blood cell (WBC) differentials on each day of use. 2. Interview with the laboratory manager on August 13, 2019 at 3:00 PM confirmed the laboratory failed to check the staining material on each day of use. D5537 ROUTINE CHEMISTRY -- 2 of 5 -- CFR(s): 493.1267(b)(d) For blood gas analyses, the laboratory must perform the following: (b) Test one sample of control material each 8 hours of testing using a combination of control materials that include both low and high values on each day of testing. (d) Document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of blood gas controls and interview with the laboratory manager the laboratory failed to perform one sample of control material each 8 hours of testing using a combination of control materials that include both low and high values for one of thirteen days. Findings: 1. Review of i-Stat controls and patient testing showed a patient was resulted on August 9, 2019 and no controls were documented. 2. Interview with the laboratory manager on August 13, 2019 at 3:00 PM confirmed the laboratory failed to perform one sample of control material each 8 hours of testing using a combination of control materials that include both low and high values on August 9, 2019. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on review of chemistry instrument patient printouts and final test reports generated by the laboratory information system (LIS) August 12, 2019 and interview with testing personnel #1, the laboratory failed to ensure the electronic system in place accurately transmitted test results from the point of data entry to final test report destination. Findings: 1. Review of instrument printout for patient (C) printed on August 12, 2019 showed the chemistry instrument obtained an invalid BUN result of 11 mg/dl flagged as "abnl (abnormal) assay" 2. Review of the final report showed the invalid BUN result for patient (C) interfaced with the LIS and reported on August 12, 2019. No documentation was available to show the laboratory repeated the BUN test to obtain and report a valid result. 3. Interview with testing personnel #1 on August 13, 2019 at 10:30 AM confirmed the laboratory failed to have a system in place to detect instrument results flagged as "abnl assay" transmitted to the LIS. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. -- 3 of 5 -- This STANDARD is not met as evidenced by: Based on review of coagulation records and two of two selected test reports for August 2019 and interview with the technical supervisor, the laboratory failed to ensure pertinent reference intervals (normal values) as determined by the laboratory were available for patient prothrombin time testing. Findings: 1. Review of coagulation records showed the laboratory established patient prothrombin time normal values of 9.1-12.1 seconds for recombiplastin lot # N0587977 in use since April 2019. 2. Review of patient prothrombin time normal values included on two test report from August 12, 2019 and generated by the laboratory information system (LIS) revealed normal values of 9.7-12.5 seconds. 3. Interview on August 13, 2019 at 11:00 AM, the technical supervisor confirmed the laboratory failed to update normal values for prothrombin time testing in the LIS. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on review of the blood bank quality control (QC) program, QC records for May, June, July 2019, patient blood bank testing and transfusion records for May 2019 and interview with testing personnel # 8, the laboratory director failed to maintain the blood bank QC program. Findings: 1. The blood bank QC program states," Blood bank reagents used for ABO grouping, Rh typing, antibody detection and compatibility determinations must be tested for potency and specificity each day of use, preferably before use, but at least concurrently with first daily (patient) use. Quality control records must fall within stated limits as stated in the QC procedure. All reactions must be documented in the Quality Control Log." 2. Review of QC records for May, June and July 2019 revealed the laboratory did not document blood bank QC on May 14, 2019. Patient records revealed the laboratory performed ABO grouping, Rh typing, antibody detection and compatibility testing for Patient (A) on May 14, 2019. Transfusion records showed Patient (A) received two units of packed red blood cells on May 14, 2019. 3. Interview on August 13, 2019 at 10:00 AM with testing personnel confirmed the laboratory failed to document blood bank QC before or concurrent with patient testing on May 14, 2019. Interview confirmed the QC program did not identify/detect the failure May 14, 2019. Based on review of the chemistry QC program, QC and patient records for August 2019 and interview with the technical supervisor, the laboratory director failed to maintain the chemistry QC program. Findings: 1. The chemistry QC program states, " Two levels of control are run daily, if patient tests are ordered. QC results will be transmitted to the LIS (labortory information system) and stored in designated files. LIS will flag outliers and maintains action log." 2. Review of serum QC1 records generated by the LIS revealed the laboratory obtained three consecutive flagged results for Lipase testing on August 10, 2019. The QC records showed the laboratory obtained a flagged outlier result of 236 at 03:31 AM, obtained a flagged outlier result of 239 U/L at 3:49 AM and obtained a flagged outlier result of 239 U/L at 3:59 AM. The laboratory defined acceptable lipase limts of 216 -232 U/L for serum QC1. The laboratory did not obtain serum QC results within defined limits of acceptablility on August 10, 2019. Review of patient records revealed the laboratory tested and reported one patient lipase result -- 4 of 5 -- on August 10, 2019. 3. Review of QC records for August 11, 2019 revealed the laboratory did not perform two levels of lipase QC Review of patient records revealed the laboratory tested and reported four patient lipase results on August 11, 2019. 4. Review of QC records for August 12, 2019 revealed the laboratory did not perform two levels of lipase QC. Review of patient records revealed the laboratory tested and reported one patient lipase result on August 12, 2019. 5. Interview with the technical supervisor on August 13, 2019 at 10:45 AM confirmed the QC program did not identify/detect the QC failures August, 10, 11 and 12, 2019. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on review of the blood bank quality assessment (QA) program, QC records for 2019 and interview with testing personnel # 8, the laboratory director failed to ensure the written blood bank QA program was maintained and followed. Findings: 1. The blood bank QA program states," QC is performed daily when patient testing is performed. QC results are recorded in the Blood Bank QC logbook. QC results are reviewed monthly by supervisor." 2. Review of QC records revealed the laboratory did not document daily blood bank QC before or concurrent with patient testing on May 14, 2019. (Refer to #D6093) 3. The laboratory did not have documentation to show the supervisor reviewed monthly blood bank QC during 2019. 4. Interview with the technical supervisor on August 13, 2019 at 11:00 AM confirmed the QA program was not maintained and followed to idetify/detect failures in blood bank quality. -- 5 of 5 --