Cascade 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 a proficiency testing (PT) desk review of the Centers for Medicare and Medicaid (CMS) PT data report (Report 155D), graded results from the American Proficiency Institute (API) and a telephone interview with the laboratory manager on 10/10/2024 at 9:35 AM, the laboratory failed to successfully participate in proficiency testing for the specialty routine chemistry for the analyte cholesterol, total 2 (two) out of 3 (three) events for 2024. Refer to: D2096 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 -- 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 the Centers for Medicare and Medicaid (CMS) Proficiency Testing (PT) data report (Report 155D), graded PT results from the American Proficiency Institute (API), and an interview with the laboratory manager on 10/10 /24, the laboratory failed to achieve satisfactory performance for two (2) out of three (3) PT events for the analyte cholesterol, total. The findings include: 1. A review of Report 155D and graded PT results from API identified that the laboratory failed to achieve satisfactory performance for events two (2) and (3) three in 2024 for the specialty of routine chemistry for the analyte cholesterol, total. Provider Analyte Year Event Score API cholesterol, total 2024 2 40% API cholesterol, total 2024 3 60% 2. An interview with the laboratory manager on 10/10/2024 at 9:35 AM confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies 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 the bioMrieux Vidas 3 maintenance logs and an interview with the laboratory manager on 8/27/2024, the laboratory failed to perform maintenance as required by the manufacturer in 2022, 2023 and 2024. The findings include: 1. A review of the bioMrieux Vidas 3 maintenance logs identified that the laboratory failed to have documentation of semi annual maintenance performance (cleaning the housing, front cover, vials, tubes, disposables rack, reagent strip sections and touch screen) for 2022 as required by the manufacturer. 2. A review of bioMrieux Vidas 3 maintenance logs identified that the laboratory failed to perform monthly maintenance (cleaning the SPR block) in October 2022, November 2022, December 2022, February 2023, June 2023 and January 2024. 3. An interview with the laboratory manager on 8/27/2024 at 11:32 am confirmed the above findings. 4. The laboratory reports performing 296 tests on the bioMrieux Vidas 3 annually. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or 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 -- baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on a direct observation, lack of documentation and an interview with the laboratory manager on 8/27/2024, the laboratory failed to calibrate the pipette used for chemistry testing. The findings include: 1. During the laboratory tour on 8/27/2024 a direct observation identified an MLA adjustable volume pipette (50,100, 200 ul). 2. A lack of laboratory calibration documents identified that the laboratory failed to calibrate the pipette since the last inspection in September 2022. 3. An interview with the laboratory manager on 8/27/2024 at 12:53 pm confirmed that the laboratory had not calibrated the pipette. 4. The laboratory reports performing 41,501 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 review of Quality Control (QC) documentation and an interview with the laboratory manager on 8/27/2024, the laboratory failed to successfully perform two levels of QC each day of patient testing for procalcitonin. The findings include: 1. A random record review of QC documents from the bioMrieux Vidas 3 for 2022, 2023 and 2024 identified that the laboratory failed to perform two levels of QC for procalcitonin on 1/25/2023, 12/18/2023 and 12/19/2023. The laboratory performed procalcitonin tests on one patient each of the preceding days (230250017, 233520003, 233530048). 2. An interview with the laboratory manager on 8/27/2024 at 12:40 pm confirmed the above finding. 3. The laboratory reports performing 70 procalcitonin tests annually. -- 2 of 2 --

Summary Statement of Deficiencies 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 proficiency testing (PT) records from American Proficiency Institute (API) and an interview with the laboratory manager on 9/20/2022, the laboratory failed to evaluate results that were less than 100% for 2021 and 2022. The findings include: 1. A review of chemistry 2021 event two PT records from API identified that the laboratory failed to evaluate the results for the following analytes; B-type natriuretic peptide (BNP) 60% and Creatine kinase-MB (CK-MB) 80%. 2. A review of hematology 2021 event two PT records from API identified that the laboratory failed to evaluate the results for the following analytes; urine sedimentation exam 50% and vaginal wet preparation (KOH) 0%. 3. A review of hematology 2022 event one PT records from API identified that the laboratory failed to evaluate the results for red cell count 80%. 4. An interview with the laboratory manager on 9/20 /2022 at 10:30 am confirmed that the laboratory failed to evaluated PT results for the above analytes. 5. The laboratory reports performing 43,605 tests annually. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). 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 -- 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 9/20/2022, the laboratory failed to evaluate the accuracy of analytes that were assigned an artificial score of 100% because it was ungraded by the PT provider. The findings include: 1. A review of Hematology 2021 event three PT records from API identified that the laboratory failed to evaluate an ungraded sample for vaginal wet preparation (KOH) that was given an artificial score of 100% due to lack of consensus. 2. A review of Hematology 2022 event two PT records from API identified that the laboratory failed to evaluate an ungraded sample for vaginal wet preparation that was given an artificial score of 100% due to lack of consensus. 3. An interview with the laboratory manager on 9/22/2021 at 10:30 am confirmed that the laboratory did not evaluate the accuracy of ungraded PT results that were given an artificial score of 100%. 4. The laboratory reports performing 43,605 tests annually. 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) records for the Siemens epoc and the Quidel triage and an interview with the laboratory manager on 9/20/2022, the laboratory failed to perform QC 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 testing performed on the epoc and the triage. 2. A review of QC for blood gas testing on the epoc and D-dimer, troponin and B-type natriuretic peptide (BNP) testing on the triage identified that the laboratory failed to test QC each day of patient testing. 3. An interview with the laboratory manager on 9/20/2022 at 12: 32 pm confirmed that the laboratory did not have an IQCP for the epoc and the triage and only performed QC on new kit lots. -- 2 of 2 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review of the laboratory's competency assessment documentation, the CMS-209 personnel form, and an interview with the General Supervisor (GS) on 04/02 /2021, the laboratory failed to have the Technical Supervisor (TS) evaluate the competency of testing personnel performing moderate and high complexity testing. The findings include: 1. A record review of testing personnel competency assessment documentation revealed that 3 of 3 testing personnel performing moderate and high complexity testing did not have annual competency assessed by the TS designated on the CMS-209 form. 2. An interview with the GS on 04/02/2021 at 11:30 AM confirmed that the GS performed the competency assessments, with no delegation, for 2 of 3 moderate complexity testing personnel, and no competency assessments for 1 of 3 high complexity testing personnel. 3. The laboratory reports performing 42,300 moderate and high complexity tests 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 D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a proficiency testing (PT) record reviews and an interview with the laboratory manager, the laboratory director and the testing personnel failed to sign the American Proficiency Institute (API) attestation statements for the specialty of Hematology and Chemistry since the last survey on January 20, 2016. Findings: 1. A review of API PT records from 2017 event 1 through 2018 event 2, revealed the laboratory director and the testing personnel who performed the tests, failed to sign the attestation statements for complete blood counts with cell identification, chemistry, and microscopic fungal and urine examinations. 2. An interview on October 3, 2018 at 9:35 AM, with the laboratory manager, confirmed the laboratory director and the testing personnel who performed the testing events failed to sign the attestation statements from 2017. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a record review of personnel documents and the procedure manual, and an 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 -- interview with the laboratory manager, the laboratory failed to establish and follow written policies and procedures to evaluate the competency of testing personnel performing complete blood counts, chemistry, and microscopic examinations since the last survey on January 20, 2016. Findings: 1. A review of documents for the testing personnel competency assessments and laboratory procedures and policies manual, revealed the laboratory failed to establish in writing and document the competency evaluations for 3 out of 3 testing personnel listed on the CMS-209 Personnel Report form. 2. An interview on October 3, 2018 at 9:15 AM, with the laboratory manager, confirmed the laboratory failed to establish and follow written policies and procedures to assess the competency of testing personnel. D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: Based on a record review and an interview with the laboratory manager, the laboratory failed to have a written or electronic request for an ordered test from an authorized provider on April 24, 2018. Findings: 1. A review of a patient's laboratory records on April 24, 2018 revealed the laboratory failed to have an order from an authorized provider for a urine analysis on a patient's urine specimen prior to reporting the results. 2. An interview on October 3, 2018 at 11:15 AM, with the laboratory manager, confirmed the laboratory failed to have an order from an emergency room provider for a urine test prior to reporting the laboratory results. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on a record review and an interview with the laboratory manager, the laboratory failed to have a written procedure for the microscopic evaluations of urine sediment examinations since the last survey on January 20, 2016. Findings: 1. A review of the laboratory's procedure manual on October 3, 2018, revealed the laboratory failed to have a written procedure for the microscopic evaluation of urine sediment exams since the last survey. 2. An interview on October 3, 2018 at 10:05 AM, with the laboratory manager, confirmed the laboratory failed to have a written procedure for the microscopic evaluations of urine sediments performed by the laboratory testing personnel. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, -- 2 of 6 -- storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)