Summary:
Summary Statement of Deficiencies D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on proficiency testing (PT) record review and an interview with the testing personnel, the laboratory failed to retain proficiency testing documents from the American Association of Bioanalysts (AAB) for the culture and identification of microorganism for 2016 and for the College of American Pathologist 2017 event 1. Findings: 1. A review of PT documents revealed the laboratory failed to retain all the proficiency records from AAB during 2016 and CAP testing from 2017 event 1. 2. An interview on June 11, 2018 at 5:00 PM, with the testing personnel, confirmed the laboratory was not able to make available the PT testing records for microbiology. 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 a records review and an interview with the laboratory testing personnel, the technical consultant failed to evaluate the competency of the 3 testing personnel performing potassium hydroxide (KOH) since the last survey on September 9, 2016. Findings: 1. A review of personnel records revealed the technical consultant failed to evaluate the competency assessments of the 3 testing personnel listed on the CMS-209 Personnel Report form. 2. An interview on June 11, 2018 at 5:40 PM, with 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 testing personnel, confirmed the technical consultant failed to perform competency assessments on the testing personnel. -- 2 of 2 --