Willow Creek Pediatrics

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 record review and interview with testing personnel, samples were not tested by personnel who routinely perform the testing in the laboratory. 1. Record review of Proficiency Testing from Merican Academy of Family Physicians (AAFP) showed the lab failed to test Proficiency Testing samples in the same manner at patient samples for 2 out of 3 attestation reports in 2021 and 3 out of 3 attestation reports in 2022 2. Interview with TP1 on 2/2/2023 at 3:30 p.m. confirmed that the laboratory failed to rotate test personnel for Proficiency Testing. 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. 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 the testing personnel the Laboratory Director did not sign any Proficiency Test attestation reports for the years of 2021 and 2022. 1. Record review of Proficiency Testing for the years of 2021 and 2022 showed the Laboratory Director failed to sign Proficiency Testing attestation reports for 3 out of 3 events in 2021 and 3 out of 3 events for 2022. 2. Interview with TP1 on 2/2/2023 at 3:30 p.m. confirmed that the laboratory director did not sign the proficiency testing attestation reports. 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 D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on patient test records review, quality control (QC) records review, lack of documentation, procedure manual review, and interview with the laboratory manager, the laboratory failed to follow their procedure to perform two levels of quality control each month and new lot number of test cartridges received for one of eleven tests reviewed. Findings include: 1. Patient test records review include the instrument print out for patient Number 536872 tested for total and direct bilirubin concentrations on 03/02/2019 using Piccolo cartridge lot number 8301AC3. 2. Q C records review failed to include documentation lot number 8301AC3 was checked using two levels of control prior to use. QC for February 2019 was performed using reagent cartridge lot number 8222BA3 and QC for March 2019 was performed using lot number 8222BA3. 3. Procedure manual review Individualized Quality Control Plan (IQCP) stated the laboratory performed reagent cartridge quality control monthly and with each new lot number of cartridges prior to testing patient samples. 4. In an interview with the laboratory manager on 11/05/2019 at approximately 3:45 P.M. the laboratory manager confirmed the lot number on the instrument printout did not have documentation qualify control was performed prior to performing 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 No Tags No deficiency details available. 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 --