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: Item 1 Based on surveyor review of the submitted Centers for Medicare and Medicaid Services (CMS) Form CMS-209 (Laboratory Personnel Report), competency evaluation records and interview with the program lead, staff A, the laboratory did not establish and follow written policies and procedures to assess the competence for one of one technical consultant that was not the laboratory director. Findings include: 1. Review of the Form CMS-209 submitted for survey showed one technical consultant, staff B, that was not the laboratory director. 2. Review of the competency evaluation records showed no evidence the laboratory director evaluated the competence of staff B in performing their assigned consultant responsibilities. 3. Interview with staff A on March 10, 2025, at 10:40 AM confirmed the laboratory had not established procedures to evaluate competency for the technical consultants and the laboratory director had not evaluated the competency of the technical consultants for their delegated responsibilities. Item 2 Based on surveyor review laboratory procedures and interview with the program lead, staff A, the laboratory did not establish a procedure defining five of the six elements required to assess competency of testing personnel. Findings include: 1. Review of "Quality Assurance Plan" procedure stated "Must have director observation to be signed off on." Further review of laboratory procedures showed no evidence of a procedures for assessing testing personnel competence that identified the following elements: Monitoring the recording and reporting of test results; Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records; Direct observations of performance of instrument maintenance and function checks; Assessment of test 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 -- performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and Assessment of problem-solving skills. 2. Interview with staff A on March 10, 2025, at 11:10 AM confirmed the laboratory had not established a procedure defining the required elements used to assess the competency of testing personnel. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) (d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on survey review of laboratory procedures and interview the project lead, staff A, the laboratory director did not sign and date three of six new procedures. Findings include: 1. Review of the laboratory procedures showed the following procedures: Acadian Health Quality Assessment: signed by the laboratory director and technical consultant Quality Assurance Plan: signed by the laboratory director and technical consultant Acadian Health Quality Control Plan: signed by the laboratory director and technical consultant EPOC CLSI Procedure Manual with epoc NXS Host: signed by the technical consultant, not signed by the laboratory director