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 policy and procedure, review of testing personnel (TP) records, and review of 2016 and 2017 American Proficiency Institute (API) hematology proficiency testing records 02/28/18, the laboratory failed to ensure hematology proficiency samples were tested by all testing personnel who routinely test patient specimens. Review of laboratory policy and procedure revealed the statement; "API proficiency testing will be done by all personnel who perform tests in the laboratory. Per CLIA recommendation, the testing will be rotated among the testing personnel." Review of personnel records revealed four testing personnel; TP #1, TP #2, TP #3 and TP #4, perform hematology testing on the Beckman Coulter Act Diff analyzer. Review of 2016 and 2017 API hematology proficiency testing records revealed TP #3 tested all samples for the 6 API hematology events of 2016 and 2017. 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: 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 -- Based on review of laboratory policy and procedure, review of 2016 and 2017 testing personnel (TP) competency records, and interview with laboratory director 02/28/18, the technical consultant (laboratory director) failed to evaluate and assure the competency for 3 of 7 testing personnel who perform urine microscopic testing. Review of laboratory policy and procedure entitled, "Education and Training", revealed the statement; "All employees will be evaluated yearly on lab skills and competency by laboratory director and documented." Review of 2016 and 2017 testing personnel competency records revealed no documentation of competency evaluations for urine microscopic testing for TP #6, TP #7, and TP #8. During interview with laboratory director at approximately 1045 am, the laboratory director confirmed that all testing personnel perform urine microscopic testing including the doctors, physician assistants and nurse practitioners. -- 2 of 2 --