Phoenix Neurological Institute

Summary Statement of Deficiencies D6047 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b(8)(i) The procedures for evaluation of the competency of the staff must include, but are not limited to direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. This STANDARD is not met as evidenced by: Based on review of 2022 and 2023 competency documentation and interview with the testing personnel (TP) #1, the technical consultant (TC) failed to perform direct observation of 3 of 3 competency evaluations. Findings: 1. Review of 2022 and 2023 competency evaluations revealed the technical consultant failed to perform direct observation for 3 of 3 competencies for testing personnel of moderate complexity testing. 2. Interview with the TP #1 on July 14, 2023 at 9:00 AM confirmed the TC failed to perform competencies by direct observation for activated clotting time (ACT) and prothrombin time (PT). TP #1 stated, "the TC does not come onsite to perform the competencies, she delegates to a testing personnel." 3. The laboratory results approximately 50 ACT and PT patient 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 D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) 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 QC records i-Stat testing performed in 2020 and interview with the testing personnel, the laboratory failed to retain the i-Stat instrument printouts for the PT/INR quality control (QC) results for the testing performed on 04/23/2020. Findings include: 1. No QC records that includes instrument printouts of two levels of liquid controls and a simulator electronic control pass/fail were presented for review for the tesing date 04/23/2020. 2. Patient test reports reviewed included patient ID #1553 who was tested for PT/INR on 04/23/2020. 3. The testing personnel acknowledged that the printouts indicated above were missing. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) 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. 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 patient test reports (ID #1491 03/12/2020 and ID #1552 04/23 /2020) as indicated on the i-Stat instrument printouts and interview with the laboratory personnel, the testing personnel as indicated by the testing personnel's initials on the printouts for ACT testing did not have any documentation of initial training for ACT testing and had not been listed on the CMS-209 (Personnel Report) submitted by the laboratory during the survey. Findings include: 1. The two instrument printouts indicated above had the initials J.D. on them. There was no other evidence of the specific testing personnel that performed the test. The Operator ID as indicated on each printout was identical (#84014) on each printout regardless of whose initials were indicated on the printouts. 2. The initial training documents and competency assessment documents did not include any individuals with the initials J.D. 3. The laboratory personnel indicated that they were unaware that J.D. initialed the printouts. -- 2 of 2 --

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 information for the control reference number used for one out of three patient test results reviewed for testing performed under the specialty of Hematology and interview with the laboratory director, the laboratory failed to include the control reference number used on three out of the four controls tested (2 for ACT and 1 for PT/INR). Findings include: 1. The correct manufacturer's assay sheets for the controls listed above could not be determined since the QC thermal paper records were taped to sheets of blank paper in such a way that information was not evident including the control reference sheet numbers that indicated the manufacturer's assayed ranges for each control level for ACT and PT/INR controls. 2. Some of the thermal paper records were not copied and it was evident that some of the thermal records were smudged or were beginning to fade. 3. The laboratory director acknowledged that the control number for the QC assay sheets were missing for the controls that were ran on 07/12/2018. 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 -- D5785