Banner Health Physicians West Llc

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 review of the CMS (Centers for Medicare and Medicaid Services) 209 Laboratory Personnel Report, review of personnel records, policy and procedure review, and staff interview, the laboratory failed to ensure a policy and procedure had been established to assess the responsibilities of the technical consultant. The laboratory employed two technical consultants. The findings were: 1. Review of the CMS 209 Laboratory Personnel Report showed 2 laboratory personnel were listed as technical consultants (TC). 2. Review of the personnel files for TC #1 and TC #2 showed no evidence a competency assessment had been completed for the position of technical consultant as required. 3. Review of the laboratory's policies and procedures failed to include a procedure for assessing the competency of the TC. 4. Interview with TC #1 on 12/4/24 at 9:58 AM confirmed a policy and procedure and not been established. 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 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, 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)

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 proficiency testing record review and staff interview, the laboratory failed to ensure all of the proficiency specimens included in an "Event" were analyzed by one analyst for 7 of 7 American Proficiency Institute (API) proficiency testing events from January 2019 to March 2021 for the specialty of hematology. The findings were: 1. Review of the hematology API proficiency testing attestation statements from January 2019 through March 2021 showed each event contained 5 unknown samples. The following concerns were identified: a. 2019 Event 1 showed sample #1 and #2 were performed by TP (testing personnel) #1 and sample #3, #4, and #5 were performed by TP #2. b. 2019 Event 2 showed sample #6, #7, and #8 were performed by TP #3 and sample #9 and #10 were performed by TP #4. c. 2019 Event 3 showed sample #11 and #12 were performed by TP #2 and sample #13, #14, and #15 were performed by TP #1. d. 2020 Event 1 showed sample #1, #2, and #3 were performed by TP #3 and sample #4 and #5 were performed by TP #4. e. 2020 Event 2 showed sample #6, #7, and #8 were performed by TP #1 and sample #9 and #10 were performed by TP #2. f. 2020 Event 3 showed sample #11, #12, #13 were performed by TP #1 and sample #14 and #15 were performed by TP #2. g. 2021 Event 1 showed sample #1 was performed by TP #5, samples #2, #3, and #4 were performed by TP #1, and sample #5 was performed by TP #6. 2. Interview with the technical consultant on 5/19/21 at 10:20 AM confirmed the laboratory split the hematology samples between testing personnel for the purpose of evaluating competency. 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 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 complete blood count quality control records review, lack of documentation, and interview with staff, the laboratory failed to monitor quality control (QC) accuracy and precision performance over time to detect issues such as test system failure, changes in environmental conditions, and operator performance for complete blood count (CBC) testing performed from the tests beginning in July 2017 to the day of survey. The laboratory performed approximately 4200 CBC tests per year. Finding include: 1. Laboratory quality control records review failed to include documentation the laboratory monitored quality control results performance over time. 2. The laboratory failed to document quality control results were plotted against the determined tests statistical mean and standard deviation through Levy Jennings (L/J) graphs or other statistical monitoring methods for identification of accuracy and precision issues and of test results shifts and/or trends. 3. In an interview conducted on 02/01/2019 at approximately 2:00 P.M., staff stated they did not have a method 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 2 -- evaluate quality control performance over time to monitor shifts and trends in results that are not observed from daily QC testing. The laboratory CBC instrument includes the option to print L/J graphs for QC monitoring features. D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on patient test records review, lack of documentation, and interview with staff, the laboratory failed to ensure maintenance of a record system that included the identity of the personnel who performed complete blood count (CBC) testing reviewed from October 2017 to January 2019 for 5 of 5 testing personnel. The laboratory performed approximately 4200 CBC tests per year. Findings include: 1. Patient test records review included the handwritten initials of the testing personnel performing CBC tests on instrument printouts as the laboratory method to identify testing personnel. 2. The laboratory failed to document the identity of the personnel to whom the handwritten initials matched. 3. In an interview with staff on 02/01/2019 at approximately 1:45 P. M., staff confirmed they did not have a system to record the testing personnel's initials with a direct link to the testing person's name. Staff stated two of the testing personnel who initialed CBC test results for patient number H68818 tested on 10/19/2017 and patient number F61380 tested on 01/26/2018 included initials for an employee who no longer worked in the laboratory. The initials were identified by current testing personnel who worked with the testing personnel present in 2017 and early 2018. -- 2 of 2 --