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 a review of training and competency records, the Centers for Medicare and Medicaid Services (CMS) 209 personnel form and an interview with testing personnel 1 (TP1) on 12/03/2020, the laboratory failed to follow written policies and procedures to assess employee competency. The findings include: 1. The CMS-209 identifies six (6) testing personnel performing moderate complexity testing. A training and competency record review revealed that two (2) of the six (6) testing personnel were hired since the previous inspection, 6/27/2018, and did not have documentation of initial training and competency for complete blood count testing (CBC). Testing person start date TP2 8/2018 TP3 5/2020 2. An interview with testing personnel (TP1) on 12/03/2020 at 9:10 am, confirmed that initial training and competency for two (2) of the six (6) testing personnel for CBC testing had not been documented. 3. The laboratory reports performing 2200 CBC tests annually. 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 --