Summary:
Summary Statement of Deficiencies D0000 An announced CLIA initial survey was conducted at INPATIENT RESEARCH CLINIC, LLC from 09/03/2025 to 09/05/2025. The laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiency: D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on laboratory records review and staff interview, the laboratory failed to do Initial competency evaluation for one out of one Testing Personnel (TP). Findings included: 1-Review of FORM CMS 209 signed by the Laboratory Director (LD) on 08 /27/2025 revealed that the LD was Clinical Consultant (CC), Technical Consultant (TC) and there was one testing personnel (TP#1). 2-Review of Procedure Manual signed by the LD on 02/07/2025, revealed that the Procedure Manual had a policy "STAFF ORIENTATION, TRAINING AND COMPETENCY", this policy defined the " Initial Training". "Initial training on individual analyzers, equipment, test methods and kits must be documented. Document initial training competency 3- Review of personnel records for TP#1 revealed that the Initial Competency and Checklist were not documented. 3-During an interview on 09/03/2025 at 12:30 PM TP#1 confirmed that there was no Initial Competency. 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 --