North Canyon Medical Center

Summary Statement of Deficiencies D0000 During an offsite paper revisit the laboratory was found to be in compliance with the CLIA regulations (42 CFR Part 493 effective April 24, 2003.) No deficiencies were cited. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of maintenance logs and interviews with the technical supervisor (TS) on 7/29/2024 and 7/30/2024, the laboratory failed to perform maintenance as required by the manufacturer in 2023 and 2024. The findings include: 1. A review of Cepheid GeneXpert maintenance logs identified that the laboratory failed to perform the quarterly maintenance of disinfection of the cartridge bay interior and the plunger rod for three of four quarters in 2023 and two of two quarters in 2024 as required by the manufacturer. 2. A review of the Capture CSW100 and Immucor Solid Phase Washer maintenance logs identified that the laboratory failed to perform monthly maintenance in 2023 and 2024 as required by the manufacturer for the following: Capture CSW100: replace exhaust filters and verification of fill check. Immucor Solid Phase Washer: decontaminate external surfaces, run maintenance decontamination, run day rinse DI, prime all buffers and verification of fill check. 3. An interview with the TS on 7/29/2024 at 3:50 pm and 7/30/2024 at 8:09 am confirmed the above findings. 4. The laboratory reports performing 1069 tests annually on the Cepheid and 720 immunohematology 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 D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on a review of laboratory policies and procedures and interviews with the laboratory manager on 3/22/2021 and 3/23/2021 the laboratory failed to have written procedures for all tests available to the laboratory personnel. The findings include: 1. A review of laboratory policies and procedures identified that the laboratory failed to have a procedure for the performance of quality control on the prepared plated medium from Becton, Dickinson and Company used in microbiology. 2. A review of laboratory policies and procedures identified that the laboratory failed to have a procedure for the performance of osmolality testing. 3. Interviews with the laboratory manager on 3/22/2021 and 3/23/2021 confirmed the above findings. D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. 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 a record review and an interview with the technical supervisor (TS) on 3/23 /2021, the laboratory failed to check each lot of prepared plated medium for its ability to support growth and/or inhibit growth. The findings include: 1. A review of microbiology quality control (QC) records identified that the laboratory failed to perform and document quality control (QC) to show the ability of the prepared plated medium to support growth on MacConkey II Agar lot number 1014081 (BD BBL), Trypticase Soy Agar with 5% Sheep Blood Agar lot number 1007815 (BD BBL), Chocolate II Agar lot number 1007679 (BD BBL) and Enterococcosel Agar lot number 1035657 (BD BBL). 2. A review of microbiology quality control (QC) records identified that the laboratory failed to perform and document QC to show the ability of the media to inhibit growth on selective media, MacConkey II Agar lot number 1014081 (BD BBL) and Enterococcosel Agar lot number 1035657 (BD BBL). 3. An interview with the TS on 3/22/2021 at 11:00 am confirmed that the laboratory failed to perform and document QC on prepared plated medium. -- 2 of 2 --

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 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: Based on proficiency testing desk review, the laboratory failed to successfully participate in proficiency testing for the analyte Compatibility Testing. Refer to D2181. D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) Failure to achieve an overall testing event score of satisfactory for two consecutive testing events or two out of three consecutive testing events is unsuccessful 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 -- performance. This STANDARD is not met as evidenced by: Based on proficiency testing (PT) desk review and the laboratory's graded results from the American Proficiency Institute (API), the laboratory failed to achieve an overall testing event score of satisfactory performance for two out of three testing events for Compatibility testing. Findings: Analyte Year Event Score Compatibility Testing 2017 2 80% Compatibility Testing 2017 3 0% -- 2 of 2 --