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 a review of the laboratory policies and procedures, a review of personnel files for all staff, lack of documentation, and interviews with staff, it was determined the laboratory failed to follow written procedures for competency assessment. Survey findings follow: A. A review of the Laboratory Policy and Procedure Manual revealed that the Personnel Assessment Policy states that competency assessments will be performed at six months and annually after that. B. Through a review of the personnel files for employees #1, #2, #3 and #5, it was determined that there was no documentation of competency assessment in 2017 for four of four laboratory employees. C. In an interview, at 9:34 a.m. on 9/4/2018, the technical consultant (personnel #1 on the form CMS-209) stated that the 2017 competency assessments were not available. D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Through a review of personnel files for all staff, lack of documentation, and interviews with staff, it was determined the laboratory director failed to give testing personnel written authorization to perform testing without direct supervision. Survey findings follow: A. Through a review of the personnel files for the two employees listed as testing personnel (#3 and #5 from the form CMS-209), it was revealed that the files did not include a written authorization, from the director, to perform testing. C. In an interview, at 9:43 a.m. on 9/4/2018, the technical consultant (personnel #1 on the form CMS-209) confirmed, that written authorizations to test are not available for two of two testing personnel. -- 2 of 2 --