Summary:
Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of laboratory procedure, review of Centers for Medicare and Medicaid Services (CMS) 209, review of 2018, 2019 and 2020 American Association of Bioanalysts (AAB) proficiency testing (PT) records and interview with technical consultant (TC) 3/6/20, the laboratory failed to ensure PT samples were tested by all TP who routinely test patient specimens. Findings: Review of laboratory procedure "Quality Assurance Program" revealed "Proficiency Testing (PT)...A. Proficiency samples are to be treated like patient samples and tested during routine work." Review of CMS 209 Laboratory Personnel Report submitted at time of survey revealed 7 TP routinely perform testing at the facility. Review of 2018, 2019 and 2020 AAB PT records revealed the laboratory participated in 5 PT events since the last quarter of 2018 until time of survey 3/6/20. Of the 5 PT events only 2 of 7 TP tested PT samples. TP#5 tested samples in 4 of the 5 PT events and TP# 4 tested samples in 1 of the 5 PT events. TP#1, TP#2, TP#3, TP#6 and TP#7 failed to participate in the PT events. Interview with TC at approximately 11:30 confirmed PT samples were not tested by all TP who routinely test patient specimens. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- This STANDARD is not met as evidenced by: Based on review of procedure manual, review of 2018, 2019 and 2020 laboratory competency records and interview with TC 3/6/20, the laboratory failed to establish and follow a procedure for the assessment of TC competency. Findings: Review of procedure manual revealed the LD had delegated the following to the TC: a. Write new procedures with the Lab Director signing off before implementing. b. Review procedures every two years and make any necessary changes. c. Review monthly QC for all waive and non-waived testing. d. Review Proficiency Testing results and provide