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 interview with testing personnel (TP) A, the laboratory failed to document the annual competency assessment on 2 out of 2 (A, B) testing personnel for 2017 and 2018 period. Findings include: Review of employee documentation showed that the laboratory failed to have documentation of annual competency assessment on 2017 and 2018 for TP A and B. During an interview on 01 /16/2019 at 10:30 AM, with TP A, she confirmed that there was no competency assessment documented for the period of reference. 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. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to verify the accuracy of the reading and interpretation of the Hematoxylin and Eosin (H&E) Stain and fungal cultures at least twice annually for 1 out of 2 years reviewed (2017- 2018). Findings include: Review of laboratory's peers review records showed that there was no peer review documented for H&E stain for year 2018. Review of fungal cultures revealed only one verification. During an interview with Testing Person A at 11:00 a. 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 -- m. on 01/16/2019, she confirmed that there was no documentation of the accuracy verification for H&E stain for 2018 and for fungal cultures only one done on 2018. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of