Clinical Discovery Institute Llc

Summary Statement of Deficiencies D0000 A recertification survey was conducted from 11/05/2024 to 11/20/2024.CLINICAL DISCOVERY INSTITUTE clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. 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 record review and staff interview, the laboratory failed to retain Quality Control (QC) record for one out of five testing days reviewed. Findings included: 1- Review of five patient reports and QC records for a Complete Blood Cell count (CBC): Patient (P)#1 (12/01/2022), P#2 (03/01/20243, P#3 (10/16/2023), P#4 (02/28 /2024) and P#5 (09/09/2024), revealed that for P#1 the laboratory could not provide the QC records for that testing date. During an interview on 11/05/2024 at 12:35 PM, the Director of Research and Quality Systems (DRQS) explained that the laboratory could not locate the record for that day and the analyzer used for that test was not in use anymore (ACT5 Diff), the laboratory is currently using a different analyzer, the Sysmex XN 40. The surveyor agreed to give time to the laboratory to locate the record, during a call with the DRQS on 11/20/2024 at 1:30 PM she confirmed that the laboratory could not locate the record of reference. 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 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 review of CMS 209 Laboratory Personnel Report, review of College of American Pathologist (CAP) proficiency testing (PT) records and interview with Testing Personnel (TP) A the laboratory failed to have all testing personnel (TP) rotate through the testing of PT for the hematology specialty for 2 out of 2 years (2017 - 2018) reviewed. Findings include: Review of CMS 209 signed and dated by the Laboratory Director (LD) had 3 testing personnel listed (TPA, TP B and TP C). Review of CAP PT records found that TP C did not perform PT in 2017-2018 and TP B during 2018. During an interview on 2/26/2019 at 10:30 AM the TP A confirmed that TP C and TP B missed to participate in PT during the years of reference 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 --