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 personnel records review (yars 2021-2023) and laboratory director interview on June 6, 2023 at 11:30 AM, it was determined that the laboratory failed to follow the established schedule for personnel competence evaluation. The findings include: 1. The laboratory schedule for testing personnel and clinical consultant competence evaluation showed that it must be performed every year. 2. The laboratory did not perform the annual evaluation of the clinical consultant- MD #10738 since year 2021. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on personnel records review (years 2021-2023) and laboratory diretor interview on June 6, 2023 at 11:30 AM, it was determined that the laboratory failed to follow the established schedule for clinical consultant evaluation. The findings include: 1. The laboratory schedule for clinical consultant competence evaluation showed that it 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 -- must be performed every year. 2. The laboratory did not perform the clinical consultant competence evaluation since year 2021. 3. The director confirmed on June 6, 2023 at 11:30 AM that the competence evaluation were not performed as established. -- 2 of 2 --