Summary:
Summary Statement of Deficiencies D0000 An Initial survey was performed on June 24, 2021 at Regional Urology, LLC, CLIA ID # 19D2075588. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were 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 record review and interview with personnel, the laboratory failed to ensure written policies and procedures to address competency for Technical Consultant were complete. Findings: 1. Review of the laboratory's policy and procedure manual revealed the laboratory did have a policy which includes competency assessment criteria; however, the policy did not include the frequency of performance assessment for personnel serving as Technical Consultant. 2. Review of the laboratory's CMS 209 form (Laboratory Personnel Report) revealed that Personnel 3 serves as Technical Consultant. 3. Review of personnel records for Personnel 3 revealed the Laboratory Director did perform a competency assessment for the duties as Technical Consultant. 4. In interview on June 24, 2021 at 3:08 pm, Personnel 1 confirmed the laboratory did not include the frequency at which the Technical Consultant has a competency assessment performed. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to establish complete policies and procedures. Findings: 1. Review of the laboratory's policy and procedure manual revealed the laboratory did not have written a policy and procedure to include: a) Twice a year verification for accuracy of the FastPack IP - Qualigen analyzers to include frequency, acceptability criteria, and