Summary:
Summary Statement of Deficiencies D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(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 document review and interview with laboratory personnel. the technical consultant failed to assess the competency of 13 test personnel for a microscopic examination in 2018. Findings are as follows: 1. The laboratory performed microscopic examinations for ectoparasites (Scabies) as confirmed by the Histotechnician (HT), at 10:05 a.m., on date of survey, 3/7/19 2. Competency assessment requirements via twice annual peer-to-peer comparisons for the Scabies test were established in the following procedures: - Introduction: Policies & Procedures / 6.0 Proficiency Testing - Proficiency Testing Policy - KOH Procedure Manual / 14.0 Frequency & Record of Quality Control Analysis - Ectoparasites - Scabies Preparation Procedure Manual / 11.0 Frequency & Record of Quality Control Analysis 3. 13 Testing Personnel were identified on the CMS-209 Report as performing Scabies testing. Documentation of competency assessment of the Scabies testing in 2018 was found for only 7 of 26 required events in the laboratory records. The laboratory was unable to provide documentation of the remainder of the assessments upon request. The laboratory performed 75 scabies examinations in 2018 as indicated in the microscopic examination testing log. 4. In an interview on 03/7/19 at 10:20 a.m., the HT confirmed the above finding. *This is a repeat finding from the 07/25/17 survey* 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 --