Summary:
Summary Statement of Deficiencies 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 a record review and an interview with the laboratory director, the laboratory failed to verify the accuracy of potassium hydroxide (KOH) and histopathology microscopic examinations at least twice annually since the last survey on August 2, 2016. Findings: 1. A record review revealed the laboratory failed to document the accuracy of KOH and histopathology microscopic examinations at least twice annually since the last survey. 2. An interview on June 12, 2018 at 2:20 PM, with the laboratory director, confirmed the laboratory failed to document the accuracy of KOH and histopathology microscopic examinations at least twice annually since the last survey. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on a personnel record review and an interview with the laboratory director, the 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 -- laboratory director who is the technical supervisor failed to assess the competency of the testing personnel performing potassium hydroxide (KOH) testing since the last survey on August 2, 2016. Findings: 1. A review of personnel records revealed the laboratory failed to perform competency assessments for 2 out of 2 testing personnel listed on the CMS-209 Personnel Report form performing KOH. 2. An interview on June 12, 2018 at 2:15 PM, with the laboratory director, confirmed the laboratory failed to perform and document the competency assessment on the two testing personnel performing KOH examinations since the last survey. -- 2 of 2 --