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 surveyor's review of the laboratory's competency assessment policies, the testing personnel's competency records, and an interview with a license practical nurse (LPN) testing person, the laboratory failed to follow the laboratory's written competency assessment policies and failed to perform an annual competency evaluation for the two testing personnel in the 2018 calendar year. FINDINGS: The LPN/testing person confirmed on February 27, 2019 at approximately 11:30 AM, the laboratory failed to follow the laboratory's written competency assessment policies, that requires an annual evaluation for all laboratory testing personnel. a. the laboratory director failed to perform annual competency evaluations for the two testing personnel in the 2018 calendar year. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on surveyor's review of American Academy of Family Physicians (AAFP) Proficiency Testing (PT) reports for 2017 and 2018 and an interview with the LPN /testing person, the laboratory failed to review and evaluate all three PT summary Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- reports for the 2017 and 2018 test events. FINDINGS: 1. The LPN/testing person confirmed on February 27, 2019 at approximately 11:00 AM, the laboratory failed to review and evaluate all three PT summary reports for the 2017 and 2018 test events. a. The laboratory PT policy requires the laboratory director to review and evaluate all PT summary reports. b. There was no evidence of review of the for all three test events in 2017 and 2018 that were scored at 100%. 2. The laboratory failed to maintain the