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 the lack of documentation and interview with the laboratory director (LD), technical supervisor (TS), and testing personnel on February 6, 2020 at approximately 11:45 am, as specified in the personnel requirements in subpart M, the laboratory failed to establish and follow written policies and procedures to assess testing personnel competency. Findings include: a. The laboratory had two (2) testing personnel. b. Two out of two of the testing personnel listed on the CMS-209 Form, did not have documentation of training or competency for the tests performed at the laboratory. c. This deficient practice was affirmed by interview with the LD and the TS on February 6, 2020 at approximately 11:45 am. d. The laboratory reportedly performs approximately 4,770 tests annually. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) 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)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and 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 -- proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on the lack of laboratory personnel competency evaluation, the lack of laboratory written policies and procedures for assessing individual performances, and interview with the technical supervisor; the Laboratory Director failed to ensure that policies and procedures are established and followed for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures, and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. See D5209 and D6120. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on the review of personnel training and competency assessments documentation on February 6, 2020, the technical supervisor failed to evaluate the competency of all testing personnel and assure that the staff maintain their competency to perform test procedures and report test results promptly, accurately, and proficiently. See D5209. -- 2 of 2 --