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 record review and an interview with Testing Personnel (TP) #1, the laboratory failed to follow a written policy and procedure to assess competency of TP # 4, TP #5 and TP #6 as required in the personnel requirements in subpart M. This deficient practice had the potential to affect three out of 10 TP in the subspecialties of Bacteriology and Parasitology. Findings Include: 1. A review of the laboratory's CMS- 209 form, approved and signed by the Lab Director on 12/04/2024, found 10 individuals listed as TP. 2. A review of the laboratory's "Laboratory Personnel Policies" policy and procedure found the following statement: "...For new employees, after initial training, competency will be done at 6 months, then 6 months later (1 year anniversary) and annually thereafter ..." 3. A review of the laboratory's competency assessment data for TP #4, TP #5 and TP #6 found the following: TP #4: Initial 5-16- 22 8-18-22 8-18-23 TP #5: Initial 9-16-22 3-1-23 3-26-24 TP #6: Initial 11-28-22 4- 20-23 4-18-24 4. The surveyor requested competency assessment documentation for TP #4, TP #5 and TP #6 from TP #1 per the timeline in the "Laboratory Personnel Policies." An interview with TP #1, on 12/04/2024 at 2:10 PM, confirmed that the laboratory failed to follow the competency assessment policy for TP #4, TP #5 and TP #6 and was unable to provide the requested documentation on the date of the survey. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --