Regence Health Network, Inc

Summary Statement of Deficiencies D0000 An unannounced onsite investigation was conducted for complaint TX22003408 on July 26, 2023. The laboratory was surveyed and failed to meet the following conditions of the CLIA regulations found at CFR 42 493.1 through 493.1780: 493.801 Condition: Enrollment and testing of samples; 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director. D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based upon review of the Casper report 155 Individual Laboratory Profiles, proficiency testing records, electronic mail (email) and interview of facility personnel, the laboratory failed to avoid inter-laboratory communications of proficiency testing results prior to the final submission date for grading to the proficiency testing agency. (see D2011 and D2013) D2011 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(3) Laboratories that perform tests on proficiency testing samples must not engage in any inter-laboratory communications pertaining to the results of proficiency testing sample 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 -- (s) until after the date by which the laboratory must report proficiency testing results to the program for the testing event in which the samples were sent. Laboratories with multiple testing sites or separate locations must not participate in any communications or discussions across sites/locations concerning proficiency testing sample results until after the date by which the laboratory must report proficiency testing results to the program. This STANDARD is not met as evidenced by: Based upon review of Casper Reports 155 Individual Laboratory Profiles, proficiency testing records, Lab quality assurance policy and interviews of facility personnel found the laboratory failed to avoid communication of proficiency testing results with other laboratories prior to the submission deadline of the American Proficiency Institute (API) proficiency testing agency in one of three Chemistry Core testing events in 2022. The findings included: 1. Review of the API Performance Evaluations for the 2022 Chemistry Core 1st testing event (obtained through API) on June 12, 2023 found each of the three laboratories (45D0506643, 45D0664603 and 45D0506774) failed to submit acceptable results for two of five samples as follows: a. Sample HCG-02 - the laboratory reported a result of Positive with an expected result of Negative. b. Sample HCG-05 - the laboratory reported a result of Positive with an expected result of Negative. 2. Review of the 2022 Chemistry Core 1st event proficiency testing records for 45D0506643 included: a. Original submission forms (reviewed onsite during the recertification inspection conducted June 20, 2023) defined a deadline submission of Wednesday, 2/2/2022 11:59 PM ET and had the following results documented on the bubble sheet by Testing personnel: Sample HCG- 01 - positive result filled Sample HCG-02 - negative result filled Sample HCG-03 - positive result filled Sample HCG-04 - positive result filled Sample HCG-05 - negative result filled b. A copy of the original submission form (bubble sheet) included the following markings through the original results: Sample HCG-01 - positive result filled Sample HCG-02 - positive and negative results both filled with an (X) marked through the negative result. Sample HCG-03 - positive result filled Sample HCG-04 - positive result filled Sample HCG-05 - positive and negative results both filled with an (X) marked through the negative result. c. Review of the attestation statement found the testing personnel documented testing completed on 1/25/22 and the Laboratory Director signing on 02/16/2022. d. Review of the Submitted Result Forms (obtained from API) found: A. 2022 Chemistry Core 1st Event Submitted result form found the submission time stamp to be January 28, 2022 12:25 PM, with the following results: Sample HCG-01 - Positive Sample HCG-02 - Positive Sample HCG-03 - Positive Sample HCG-04 - Positive Sample HCG-05 - Positive 3. Review of the 2022 Chemistry Core 1st proficiency testing records for 45D0664603 included: a. The original submission forms defined a deadline submission of Wednesday, 2/2 /2022 11:59 PM ET and had the following results documented on the bubble sheet by testing personnel: Sample HCG-01 - positive result filled Sample HCG-02 - positive result filled Sample HCG-03 - positive result filled Sample HCG-04 - positive result filled Sample HCG-05 - positive result filled b. Review of the attestation statement found the testing personnel documented testing completed on 1-13-22 and the Laboratory Director signing on 01/28/2022. c. Review of the 2022 Chemistry Core 1st Event Submitted Result Forms (obtained from API) found the submission time stamp to be January 28, 2022 12:26 PM, with the following results documented: Sample HCG-01 - Positive Sample HCG-02 - Positive Sample HCG-03 - Positive Sample HCG-04 - Positive Sample HCG-05 - Positive 4. Review of a forwarded email sent by testing Person one on 07/26/2023 at 2:40 PM included the following: "From: [Testing Person 1 name], To: [Lab Coordinator name and email address]; Subject API's" with a -- 2 of 6 -- PDF attachment titled SHereford M22012511190." The attachment "SHereford M22012511190" included 2022 Chemistry Core 1st Event Attestation Statement" with two testing personnel's signatures attesting to testing the Serum HCG proficiency testing on 01/25/2022 and original result forms (bubble sheets) with Serum HCG PT results filled as: Sample HCG-01 - Positive Sample HCG-02 - Negative Sample HCG- 03 - Positive Sample HCG-04 - Positive Sample HCG-05 - Negative The original result forms did not include markings through results. These forms were filled by the testing personnel and submitted to the laboratory coordinator for entering and reporting to the PT company. 5. Review of the Lab Quality Assurance Policy (approved by the Lab director on 10/27/2021) found on page 4: "3.2 Proficiency testing (PT) a. Verify PT is performed in accordance with CLIA guidelines. b. Ensure PT is performed in the same manner as patient testing. c. Ensure a review of graded results is conducted and documented. Verify unsuccessful or unsatisfactory PT events are investigated and

Summary Statement of Deficiencies D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based upon review of laboratory policies and procedures, review of proficiency testing (PT) records for the years 2022 and 2023 (three events per year), review of instrument printouts and interview of facility personnel, the laboratory failed to test proficiency specimens in the same manner as patient specimens in three of five proficiency events for Hematology. The findings included: 1. Review of the laboratory policy titled Critical Tests and Critical Results found under the heading Definition:"The organization defines critical tests and critical results and values: "WBC less than 3.0 or greater than 18.0 RBC less than 2.5 or greater than 6.5 Hemoglobin less than 7 or greater than 20 Hematocrit less than 30 or greater than 55 Platelet count less than 80 or greater than 600" Continued review found under the heading Procedure: "Repeat the test and enter both on the report on all critical values..." 2. Review of the policy titled Lab Quality Assurance Policy found on page 4 under Proficiency Testing (PT): "Verify PT is performed in accordance with CLIA guidelines. Ensure PT is performed in the same manner as patient testing. Ensure a review of graded results is conducted and documented. Verify unsuccessful or unsatisfactory PT events are investigated and

Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Review of manufacturer's instructions, patient final reports, personnel records and interview of facility personnel found the laboratory failed to follow the manufacturer's instructions when using the Sofia SARS Antigen FIA test kits for testing patients as defined by the manufacturer under the Emergency Use Authorization (EUA). The findings included: 1. Review of the manufacturer's instructions for the Sofia SARS Antigen FIA found on page 19 under the heading CONDITIONS OF AUTHORIZATION FOR LABORATORY " Authorized laboratories using the Sofia SARS Antigen FIA must include with the test result reports, all authorized Fact Sheets." Further review found: " all operators using your product must be appropriately trained in performing and interpreting the results of your product, use appropriate personal protective equipment when handling this kit, and use your product in accordance with authorized labeling." 2. Review of patient results found no fact sheets included with the final report for three of three patient reports reviewed. 3. Review of personnel records found no documentation of training for five of five testing personnel. Interview of Testing person one on the CMS Laboratory Personnel Report conducted September 22, 2021 at 10:02 AM confirmed that the Fact Sheets were not included with the patient test results for SARS COV-2 testing, and the laboratory failed to document training for five of five testing personnel. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) 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 -- Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of the laboratory's CBC QC records from 11/1/2020 to 9/22/21 and confirmed in an interview the laboratory failed to retain 6 of 7 assay sheets for QC lots of Horiba Minotrol-16 Hematology Reference Control for a minimum of 2 years. The findings were: 1. Review of the laboratory QC records found the laboratory failed to retain assay sheets for 6 of 7 quality control lots used between 11/1/20 and 9/22/21. MX430 Exp: 2021-09-05 MX429 Exp: 2021-07-05 MX428 Exp: 2021-05-05 MX427 Exp: 2021-03-05 MX426 Exp: 2021-01-05 MX425 Exp: 2020-11-05 2. An interview with the lab coordinator on 9/23/21 at 9:35 PM in the conference room confirmed the laboratory discarded the previous CBC QC lot assay sheets when new CBC QC lot put in use. Key: CBC=Complete Blood Count QC=Quality Control 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 laboratory's verification records, the laboratory's procedures, CMS 116 application, and confirmed in an interview the laboratory failed to verify four of four required performance specifications, accuracy, precision, reportable ranges, and reference range, for the Horiba ABX Micro 60 hematology analyzer. The findings were: 1. Review of the laboratory's verification records for Horiba ABX Micros 60 (SN# 904CS98713) revealed the laboratory did not verify the performance specifications for: Accuracy Precision Reportable Ranges Normal values (Reference Range) 2. Review of the CMS 116 application signed by the CEO on 09/13/21 revealed the CBC annual volume was 3,600. 3. An interview with the lab coordinator on 9/22/21 at 10:00 am in the break room confirmed the above performance specifications were not verified. Key: CMS=Center of Medicare and Medicaid Service CEO=Chief executive officer CBC=Complete Blood Count D5783