Summary:
Summary Statement of Deficiencies 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: Through review of the CMS 209 form, lack of documentation and interviews with laboratory staff, it was determined the laboratory failed to assess employee competency as directed in personnel requirements. Survey findings follow: A) Review of the CMS 209 form submitted by the laboratory revealed that the laboratory staff member (#1 on the CMS 209 form) was listed as the technical consultant for specialties 1 and 2, the laboratory staff member ( #16 on the CMS 209 form) was listed as technical consultant for specialty 9, the laboratory staff member (# 26 on the CMS 209 form) was listed as technical consultant for specialty 8, the laboratory staff member (# 28 on the CMS 209 form) was listed as technical consultant for specialty 7, and the laboratory staff member (# 33 on the CMS 209 form) was listed as general supervisor. B) Upon request, the laboratory was unable to provide documentation of competency determinations for the positions and personnel identified above, four of four technical consultants and one of one general supervisor. C) In an interview at 11: 30 a.m. on November 28, 2023 the laboratory staff member (# 33 on the CMS 209 form) confirmed that competency determinations have not been performed on personnel designated as technical consultants or general supervisor based upon their position responsibilities. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Obervation, review of policy and procedure manuals, and interview showed the laboratory was not following their written policy and procedure. Findings follow: 1 - A) Review of the policy and procedure manual revealed "Clinical Laboratory: Standardized