Summary:
Summary Statement of Deficiencies D0000 An on-site validation survey was conducted on March 09, 2026 with the following standard level deficiencies cited. 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 review of the laboratory's policy, competency assessment documentation and interview with Technical Consultant (TC) #1, according to the Centers for Medicare and Medicaid Services (CMS) 209 Form, the laboratory failed to establish and follow a policy for consultant competency assessment for three of three Technical Consultants (TC). Findings Included: 1) Review of the laboratories policy titled 'Hawaii Pacific Health Straub Benioff Medical Center POCT Quality Assurance' did not state written policies or procedures to assess consultant competency. 2) The laboratory was asked to provide documentation of consultant competency assessment for three TCs. No documentation was provided. 3) In an interview on 3/09/2026 at 11: 45 AM in the conference room, TC#1 confirmed the laboratory did not have an established policy to perform competency assessments for the consultant roles, and did not have consultant competencies on file. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, Proficiency Testing (PT) records, and interview with Technical Consultant (TC) #1, according to the Centers for Medicare and Medicaid Services, the laboratory failed to document