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 laboratory procedure manuals and interview with Office manager, the laboratory failed to establish a complete procedure to assess the competency of 5 of 5 testing personnel (TP) performing Microscopic urinalysis examinations, 3 of 4 TP performing Microscopic Histology examinations and 4 of 4 clinical consultant competency in 2018 and 2019. Findings include: 1. On the day of survey, 10/30/2019, the laboratory failed to provide a complete written policy to assess the competency of 5 of 5 testing personnel (TP) performing Microscopic urinalysis examinations, 3 of 4 TP performing Microscopic Histology examinations and 4 of 4 clinical consultant competency in 2018 and 2019. 2. The office manager could not provide competency assessments records for 5 of 5 TP performing Microscopic urinalysis examinations, 3 of 4 TP performing Microscopic Histology examinations and 4 of 4 clinical consultant competency in 2018 and 2019. 3. 6029 Microscopic urinalysis examinations were performed in 2018. 4. 73 Microscopic Histology examinations were performed in 2018. 5. The office manager confirmed the findings above on 10/30/2019 around 10: 15 am. **** Repeat Deficiency**** D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- This STANDARD is not met as evidenced by: Based on review of records and interview with the office manager, the laboratory failed to perform at least twice annually, accuracy verification of microscopic urinalysis examinations performed in 2018. Findings Include: 1. The CMS 2567