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: Based on surveyor review of competency assessment procedures and laboratory records, and interview with the technical consultant, the laboratory has not evaluated or developed procedures to assess the competency of the technical consultant to meet position requirements. Findings include: 1. Review of laboratory procedures showed no evidence of policies or procedures to assess the competency of the technical consultant in meeting the position responsibilities listed in Subpart M. 2. Review of laboratory records showed no documented evaluation of competency of the technical consultant. 3. Interview with the technical consultant on January 14, 2020 at 10:30 AM confirmed that the laboratory does not have a procedure to evaluate the competency of the technical consultant in meeting position responsibilities and the laboratory has not assessed the competency of the technical consultant. This is a repeat deficiency previously cited October 30, 2013 and November 16, 2017. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. 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 surveyor review of laboratory records and interview with the technical consultant, the laboratory does not have a process established for documenting general laboratory operation problems to allow monitoring and evaluation of the