Norton Children's Medical Group-Preston

Summary Statement of Deficiencies D0000 A recertification survey was conducted on 08/22/2024. The facility was found to not be in compliance with the laboratory requirements of 42 CFR Part 493 with standard deficiencies cited. 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: 1. Based on review of laboratory policy, American Proficiency Institute testing (PT) events (2023 Hematology Event 1:Chemistry Event 1, 2023 Hematology Event 2: Chemistry Event 2, 2023 Hematology Event 3:Chemistry Event 3, 2024 Hematology Event 1:Chemistry Event 1, 2024 Hematology Event 2:Chemistry Event 2), and confirmed in interview, the laboratory failed to have documentation of attestation forms for 8 of 10 PT events. 2. Review of the laboratory PT events revealed the following: a. 2023 Event 1 - No Chemistry attestation form; No signature of testing personnel for the Hematology attestation. b. 2023 Event 2 - No signature of testing personnel for the Hematology attestation. c. 2023 Event 3 - No attestation forms for Hematology and Chemistry. d. 2024 Event 1 - No attestation form for Hematology. e. 2024 Event 2 - No attestation forms for Hematology and Chemistry. 3. In an interview 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 -- on 8/22/2024 at 11:20 AM in the break room, the Technical Consultant (TC) was asked if attestation forms were produced for the PT events. The TC confirmed the attestation results were not produced for the 8 testing events. This confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies 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 record review and staff interview on 07/17/2018, the laboratory failed to perform and document maintenance procedures as required and recommended by the manufacturers of the Sysmex XP 300 Hematology analyzer. Findings include: The laboratory failed to perform weekly and monthly maintenance on the Sysmex XP 300 Hematology analyzer between August 1, 2017, and July 16, 2018. Interview with laboratory staff at 9:05 AM on 07/17/2018, determined the laboratory failed to establish a system to ensure maintenance procedures were performed and documented as required and recommended by the manufacturer. 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 --