South Davis Community Hospital

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on direct observation and interview with testing personnel (TP), the laboratory failed to ensure the Lithium Heparin Separator tubes were not used past the expiration date. The laboratory performs approximately 5,000 tests per year. Findings include: 1. Direct observation of inventory storage on 4/19/2023 at 4:20 P.M. revealed 24 Lithium Heparin Separator tubes lot number B2212330 with an expiration date 2/03 /2023. 2. Interview with TP18 and TP24 on 4/19/2023 at 4:25 P.M. confirmed the 24 Lithium Heparin Separator tubes were expired and the laboratory used the tubes to collect patient specimens. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. 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 record review and interview with testing personnel (TP), the laboratory failed to list the address of the laboratory's location on the final test report. The laboratory performs approximately 5,000 iSTAT tests per year. Findings include: 1. Review of patient test reports on 4/19/2023 at 3:38 P.M. revealed no address listed on the final patient test report. 2. Interview with TP18 and TP25 on 4/19/2023 at 3:38 P. M. confirmed the laboratory failed to list the address of the laboratory in the final patient test report. 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 testing personnel (TP) competency record review and interview with staff, the laboratory failed to include direct observation of performing the iSTAT procedure for 48 out of 48 testing personnel since the last survey 9/17/2020. The laboratory performs approximately 5,000 tests per year. Findings include: 1. Record review of testing personnel competencies revealed lack of direct observation for performing iSTAT procedure for 48 out of 48 testing personnel since last survey on 9/17/2020. 2. Interview with TP18 and TP24 on 4/19/2023 at 1:48 P.M. confirmed testing personnel competency records lacked direct observation of the iSTAT test procedure. -- 2 of 2 --

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on proficiency testing records review and interview with staff, the laboratory failed to ensure proficiency testing samples were rotated among testing personnel routinely performing iSTAT arterial blood gas tests for 2 years of testing reviewed from September 2018 to September 2020 for 6 of 6 testing events. Findings include: 1. Proficiency testing record review included documentation the 2nd event of 2020 the attestation statement was not yet completed. The 1st event of 2020 included the same test persons at the 3rd event of 2019 and the 2nd event of 2019; the 1st event of 2019 did not include a signature by testing personal, the 3rd event of 2018 did not include the identity of testing personnel. 2. In an interview with staff on 09/17/2020 at approximately 5:00 P.M. staff confirmed proficiency tests were not rotated among testing personnel who routinely performed patient testing.. 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 D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on proficiency testing records review, lack of documentation, and interview with staff, the laboratory failed to attest the laboratory performed arterial blood gas testing the same as patient testing for 1 of 1 proficiency testing event performed since beginning testing in July 2018. Findings include: 1. Proficiency testing records reviewed included a blank attestation form for the 2nd proficiency testing event of 2018. 2. In an interview conducted on 10/19/2018 at approximately 3:00 P.M., the laboratory manager confirmed the laboratory director and testing personnel failed to attest the laboratory performed proficiency testing the same as patient specimens. 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 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 -- 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 test records review, lack of documentation and interview with staff, the laboratory failed to maintain an information or record system to document the date and time of specimen receipt into the laboratory for testing prior to September 2018 and the records and dates of all specimen testing including the identity of the personnel who performed the Troponin I and Chemistry 8+ testing for 2 of 8 specimens reviewed. The laboratory performed approximately 2 arterial blood gas tests per day. Findings include: 1. Patient test records available failed to include a record for the dates and times the laboratory received arterial blood gas testing for pH, partial pressure carbon dioxide (pCO2) and partial pressure oxygen (pO2), Troponin I, and chemistry panel 8+ assays between July 1, 2018 and September 18, 2018 and the records and dates of the testing performed. 2. Patient test records reviewed for 2 of 8 tests reviewed failed to include the identification of the personnel who performed Troponin I testing for patient 5409600 on 10/02/2018 and for patient 5197601 for Chemistry 8+ testing on 09/28/2018. 3. In an interview conducted on 10/19/2018 at approximately 1:00 P.M. the laboratory manager stated the laboratory did not have a system to record the date and time specimens were received into the laboratory and failed to record who performed 2 of 8 tests performed. -- 2 of 2 --