Banner Health Physicians West Llc

Summary Statement of Deficiencies D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on lack of documentation and staff interview, the laboratory failed to verify the statistical parameters of quality control material prior to use for 1 of 1 test system (Hematology) reviewed. The findings were: 1. There was no documentation the laboratory had verified new lot numbers of quality control material prior to being used on the Sysmex Poch-100i analyzer. 2. Interview with technical consultant #1 and technical consultant #2 on 2/16/24 at 11:01 AM confirmed the statistical parameters of the quality control materials had not been verified. 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 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 laboratory's environmental records, review of manufacturer's instructions, and staff interview, the laboratory failed to monitor humidity in the testing and reagent storage areas. The laboratory conducted approximately 8800 patient tests annually. The findings were: 1. Review of the daily environmental log showed the humidity level in the lab was not monitored. 2. Review of the instrument manual for the Alere Triage meter showed the relative humidity must be maintained between 10% and 85%. 3. Review of the Sysmex pocH-100i hematology analyzer instrument manual showed the relative humidity must be maintained between 30% and 85%. 4. Interview with the technical consultant on 1/18/22 at 5:10 PM confirmed the laboratory did not measure, monitor, or record relative humidity. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (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. 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 review of the CMS-209 Laboratory Personnel Report, review of policy and procedure, and staff interview, the technical consultant (TC) failed to ensure 6 of 6 testing personnel PA (physician assistant), #1, NP (nurse practitioner) #1, NP #2, NP #3, NP #4, and NP #5 were evaluated for competency in reading and reporting KOH (potassium hydroxide) and WP (wet prep) patient testing. The mid-level providers performed approximately 40 tests annually. In addition, the TC failed to ensure 1 of 1 technical consultant (TC #1) was evaluated for competency. The laboratory performed approximately 8800 patient tests annually. The findings were: 1. Review of the CMS- 209 Laboratory Personnel Report showed 6 testing personnel (PA #1, NP #1, NP #2, NP #3, NP #4, NP #5) were listed as testing personnel. Interview with the technical consultant on 1/18/22 at 1:15 PM revealed the mid-level providers performed KOH and WP patient testing for the laboratory. 2. Review of the laboratory's personnel records showed the mid-level providers participated in proficiency testing, however competency assessments had not been completed. PA #1 was hired in 8/2019; NP #1 was hired in 10/2016; NP #2, was hired in 2/2016; NP #3 was hired in 1/2000; NP #4 was hired in 10/2019; and NP #5 was hired in 11/2020. 3. Review of the laboratory's personnel records showed TC #1 was hired in 2/2020. There was no documentation any competency assessments had been completed for TC #1. 3. Interview with the technical consultant on 1/18/22 at 2:50 PM confirmed the competency assessments had not been completed. 4. Review of the policy titled "Competence Assessment Process" dated 5/30/20 showed "...2. The competence will be assessed at the following times: after initial training, after 6 months, and then at least annually thereafter. 3. Competency will be determined in the following ways: a. Recording and reporting of test results. b. Review of worksheets, QC (quality control) records, PT (proficiency testing) results, and maintenance results. c. Performance of assigned unknown specimens. d. Use of problem solving skills. e. Direct observation of test performance. f. Direct observation of instrument maintenance and function checks. g. Written exam and/or study module. h. Written cases or evaluations. i. Compliments or complaints. j. Other options as approved..." -- 2 of 2 --

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on Sysmex PoCH i100 operator's manual review, lack of documentation, instrument reagent log review, and interview with staff, the laboratory failed to follow the manufacturer's instructions to perform quality control with the change of diluent (D pack) reagent for two years of testing reviewed (January 2018 to January 2020). The laboratory performed approximately 2400 complete blood counts (CBCs) per year. Findings include: 1. The PoCHi 100 instrument manufacturer's operator's manual included instructions to perform quality control following reagent changes. 2. The laboratory lacked documentation of quality control performance following reagent changes prior to testing patient samples from January 2018 to January 2020. 3. The laboratory on board instrument reagent log recorded diluent reagent changes approximately every 3 to 5 days, (the lot number changing approximately once per month) and lyse reagent changed approximately once per month. 4. In an interview conducted on 01/28/2020 at approximately 1:10 P.M., testing staff stated they did not perform quality control when diluent or lyse reagents were changed prior to testing patient samples. 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 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 -- 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 lack of a record system, billing records review, and interview with staff, the laboratory failed to maintain a record system that includes the records and dates of all potassium hydroxide (KOH) preparation of vaginal specimen testing for two years reviewed from January 2018 to January 2020. The laboratory estimated they performed approximately 260 tests per year. Findings include: 1. The laboratory lacked a system for testing personnel to record the dates and identification of all KOH specimen testing. 2. Billing records review included approximately 45 tests performed over 2 years of testing reviewed. The billing record collected records only for tests that were directly billed for the KOH test code. 3. In an interview conducted on 01/28 /2020 at approximately 11:30 A.M., the technical consultant stated the laboratory KOH testing personnel did not have a record system to record the dates for all of the specimens they applied KOH reagent to reveal the presence or absence of fungal elements in vaginal fluid specimens. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with staff, the laboratory director failed to maintain the quality assurance plan to monitor the Individualized Quality Control Plan (IQCP) for D Dimer and Troponin I tests at least annually for 1 of 2 years reviewed (2019). The laboratory performed approximately 200 D Dimer and 200 Troponin I tests per year. Findings include: 1. The laboratory implemented an IQCP in 2018 for Troponin and D Dimer unit use cartridge tests to reduce quality control frequency to once per new shipment or lot number and every 30 days after evaluating the quality control history of conformance, reagent storage compliance, instrument function checks, and testing personnel competency. 2. In an interview conducted on 01 /28/2020 at approximately 11:00 A.M., the technical consultant confirmed the director had not review the IQCP to ensure reagents, environment, test systems, testing personnel and sample collections were monitored to ensure the frequency of control performance provided accurate and precise D Dimer and Troponin I tests. -- 2 of 2 --