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 a record review and an interview with the technical supervisor, the laboratory failed to establish and document the competency assessment for the technical supervisor since the last survey on April 11, 2016. Findings: 1. A review of personnel documents and laboratory procedures and policies, revealed the laboratory failed to establish in writing and document the competency for the technical supervisor listed on the CMS-209 Personnel Report form. 2. An interview on April 9, 2018 at 1:30 PM, with the technical supervisor, confirmed the laboratory failed to establish and assess the competency for the technical supervisor since the last survey. 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 technical supervisor, the laboratory failed to verify the accuracy of parathyroid hormone (PTH) at least twice annually since the last survey on April 11, 2016. Findings: 1. A record review of proficiency testing from American Proficiency Institute and the laboratory's testing reports for PTH, revealed the laboratory failed to document the accuracy of PTH at 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 -- least twice annually since the last survey on April 11, 2016. 2. An interview on April 9, 2018 at 3:45 PM, with the technical supervisor, confirmed the laboratory failed to document the accuracy of PTH at least twice annually. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on a record review and an interview with the technical supervisor, the laboratory failed to establish and document unscheduled maintenance and