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 review of the current, approved policies and procedures, lack of personnel training records, as well as interview with the laboratory director (LD), the LD failed to perform and document clinical consultant (CC), technical consultant (TC), and testing person (TP) competency assessments. FINDINGS: 1. There was no documentation of CC, TC, and TP competency evaluations. 2. Current, approved policies and procedures did not include written description of CC, TC, and TP job duties, responsibilities, and written instructions for performing competency evaluations. 3. LD confirmed the findings on April 3, 2024, at 11:00 A.M. Refer to D6079. D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) 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, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are 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 -- properly performed. This STANDARD is not met as evidenced by: Based on review of the current, approved standard operating policies and procedures, lack of CC, TC, and TP training records, as well as interview with the LD, the LD failed to perform and document personnel competency evaluations in compliance with applicable regulations. Refer to D5209. -- 2 of 2 --