North Bend Medical Center

Summary Statement of Deficiencies D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on review of the policies and procedures presented during survey and interview with the technical consultant (TC #2), the laboratory failed to ensure the laboratory was following the Oregon State Regulation for reporting Reportable Conditions as specified by State/Local Law OAR 333-018-0013. Findings include: 1. Upon review of the laboratory's procedure manual, no procedure or policy for reporting reportable conditions to the Oregon Health Authority (OHA) or local County Health Department could be produced. 2. OAR 333-018-0013 requires laboratories report Reportable Conditions to their state or local health authority. 3. A request for written evidence of reporting reportable conditions to OHA or the local County Health Department could not be produced. 4. Interview with the TC #2 on 08/20/2025 at 11:30am confirmed there was no written record of reportable conditions reported to OHA or local County Health Department, nor was there an approved procedure for doing so in this laboratory. 5.The laboratory reports performing 6333 reportable condition analytes per year, of which 196 were positive. D5801 TEST REPORT CFR(s): 493.1291(a) (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 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 -- 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 the laboratory's procedure manual and interview with the technical consultant (TC#2), the laboratory failed to have a written procedure for reporting "reportable conditions" to the State or County as specified by State/Local Law OAR 333-018-0013. Findings include: 1. Upon review of the laboratory's procedure manual presented during the survey, no procedure for reporting "reportable conditions" to the State or County could be produced. 2. Upon request for written documentation of reportable conditions that had been reported to the State or County in 2024 and 2025, no written log or other document of reporting could be produced. 3. Interview with TC #2 on 8/20/2025 at 11:30am confirmed there was no written document for reportable conditions. 4. The lab reports performing 6333 reportable condition analytes per year, of which 196 were positive. D6033 TECHNICAL CONSULTANT-MODERATE COMPLEXITY 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: Findings include: 1. See D6046 D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. The procedures for evaluation of the competency of the staff must include, but are not limited to-- This STANDARD is not met as evidenced by: Based on the lack of written annual competency assessments for 2024 for seven (7) out of twelve (12) testing personnel (TP) performing moderate complexity testing, the two (2) Technical Consultants (TC's #1 & #2) listed on the CMS 209 form submitted during survey, failed to ensure annual competency assessments for all TP performing moderate complexity testing in Hematology, Chemistry, Endocrinology, Immunology /Serology and Microbiology were performed. Findings include: 1. Upon review of the CMS 209 form, it was noted that there were two (2) persons listed as a Technical Consultant (TC #1 & TC #2) for moderate complexity testing in Chemistry, Endocrinology, Immunology/Serology and Microbiology. 2. TC #1 oversees the specialties in Chemistry, Endocrinology and Immunology/Serology. 3. TC #2 oversees the specialty Microbiology, which includes Virology, Mycology and Parasitology sub-specialties. 4. Upon request for competency assessments for all TP in 2024, it was revealed that seven (7) out of twelve (12) TP lacked any record of competency assessment in any moderate complexity testing performed in this lab. 5. -- 2 of 3 -- Interview with both TC #1 and TC #2 at 12:00 pm on 08/20/2025 confirmed that there were no 2024 annual competency assessments for the seven (7) individuals who lacked written documentation of competency assessment for all moderately complex tests in 2024. 6. The laboratory reports performing 1,100,128 moderate complexity assays annually. D6108 LABORATORY TECHNICAL SUPERVISOR CFR(s): 493.1447 The laboratory must have a technical supervisor who meets the qualification requirements of 493.1449 of this subpart and provides technical supervision in accordance with 493.1451 of this subpart. This CONDITION is not met as evidenced by: Findings include: 1.See D6120 D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (b)(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on review of testing personnel (TP) annual competency assessment forms, review of the Quality Assurance Program (QAP) policy and interview with the technical specialist (TS) the TS failed to complete 2024 and 2025 annual competency assessments on seven (7) out of seven (7) testing personnel (TP) performing high complexity testing. Findings include: 1. Based on review of the written competency assessments for the seven (7) TP listed on the CMS 209 as performing high complexity testing, it was noted that seven (7) out of the seven (7) TP did not have competency assessments for white blood cell manual differentials in 2024 and 2025. 2. Upon request for written evidence of competency for white blood cell manual differentials, none could be produced for seven (7) TP out of seven (7) TP in 2024 and 2025. 3. The laboratory's policy titled "Quality Assurance Program" (QAP) in sub- section four (4) of the QAP: Staff competencies - Annual and Biannual Competencies, states, "competency assessments would be performed annually." 4. Interview with the TS on 08/20/2025 at 10:15am confirmed the laboratory did not perform the annual competency assessment for seven (7) out of seven (7) TP in 2024 and 2025. 5. The laboratory reports performing 73 white blood cell manual differentials annually. -- 3 of 3 --

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 review of the Proficinecy Testing events from College of American Pathologists (CAP) and American Association of Bioanalysts (AAB) for the years 2022 and 2023, the laboratory failed to ensure that each testing event attestation form was signed and dated by each testing personnel (TP) and the Laboratory Director (LD). Findings include: 1. Of the PT specialties reviewed, the following PT events failed to have a signed and dated attestation by both the TP and the LD in 2022. a. Syphilis - Three (3) out of three (3) events in 2022 b. Rheumatoid Factor - Two (2) out of three (3) events in 2022 c. Coagulation - Three (3) out of three (3) events in 2022 d. Hematology with Auto Differential - Two (2) out of three (3) events in 2022 e. Blood Bank (Immunohematology) - Three (3) out of three (3) events in 2022 2. Of the PT specialties reviewed, the following PT event failed to have a signed and dated attestation by both the TP and the LD in 2023. a. Viral Markers - One (1) out of one (1) event in 2023 3. Of the total PT events reviewed, fourteen (14) out of sixteen (16) attestations were not signed and dated by the TP and the LD. 4. The Laboratory Manager and the Technical Specilist (TS) confirmed there were no signed and dated attestation statements for these PT events during interview 3/20/2023 at appproximately 3:00 pm. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing 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 -- performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of the Proficinecy Testing (PT) events from College of American Pathologists (CAP) and American Association of Bioanalysts (AAB) for the years 2022 and 2023 and interview with the Lab Manager and the Technical Supervisor (TS), the laboratory failed to ensure that each testing event was reviewed, signed and dated by each testing personnel (TP) for that event and the Laboratory Director (LD). Findings include: 1. Of the PT specialties reviewed, the following PT events failed to have a signed and dated PT review by both the TP and the LD in 2022. a. Syphilis - Three (3) out of three (3) events in 2022 b. Rheumatoid Factor - Two (2) out of three (3) events in 2022 c. Coagulation - Three (3) out of three (3) events in 2022 d. Hematology with Auto Differential - Two (2) out of three (3) events in 2022 e. Blood Bank (Immunohematology) - Three (3) out of three (3) events in 2022 2. Of the PT specialties reviewed, the following PT event failed to have a signed and dated review by both the TP and the LD in 2023. a. Viral Markers - One (1) out of one (1) event in 2023 3. Sixteen (16) out of sixteen (16) PT testing events reviewed during survey for 2022 and 2023 had no evidence of review by either the TP and / or the LD. 3. The Laboratory Manager and the TS confirmed there were no signed and dated reviews for these PT events during interview 3/20/2023 at appproximately 3:00 pm. 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 review of laboratory records for all specialties on this CLIA certificate and interview with the Laboratory Manager, the Technical Supervisor (TS) and two (2) testing personnel (TP), the Laboratory Director (LD) failed to fulfill the duties of Laboratory Director in a high complexity CLIA laboratory. Findings include: Please see D6091, D6092, D6094, D6106 and D6107 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 D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on review of personnel records and discussions with the staff the laboratory failed to provide the necessary documentation of education of the testing personnel . Findings include: 1. The surveyor requested and the laboratory failed to provide copies of diplomas or transcript of records of 4 out of 5 new testing personnel (TP) that were hired on 05/23/2017, 08/14/2017, 11/20/2017 and 04/02/2018 at the time of survey. 2. The Laboratory Manager and the Quality Assurance and Compliance Officer concurred with these findings on 02/20/2019 at 11:30. 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 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: Proficiency Testing desk review of the American Association of Bioanalysts (AAB) proficiency testing (PT) shows laboratory had unsuccessful participation for the 2nd and 3rd event of 2017 for Rheumatoid Factor in General Immunology. Refer to D2084. D2084 GENERAL IMMUNOLOGY CFR(s): 493.837(f) Failure to achieve satisfactory performance for the same analyte or test in two 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 -- consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Proficiency testing (PT) desk review of the American Association of Bioanalysts (AAB) PT shows unsatisfactory performance of two consecutive events for the analyte Rheumatoid Factor (RF). Findings include: 1 AAB 2nd event 2017 RF - 60%. 2. AAB 3rd event 2017 RF - 40%. -- 2 of 2 --