Summary:
Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a surveyor's review of Proficiency Testing (PT) records from the Wisconsin State Laboratory of Hygiene (WSLH) reports and confirmed in an interview with the office manager/testing person at the time of this survey, the laboratory failed to evaluate, perform and document remedial action for the PT score 0% for hematology for the first event in 2017. D6017 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(ii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(ii) Ensure that results are returned within the timeframes established by the proficiency testing program. This STANDARD is not met as evidenced by: Based on a surveyor's review of WSLH PT records and an interview with the office manager/testing person, the laboratory director failed to return the CAP PT test results within the required timeframe established by the PT program for the first event in 2017. Refer to D5211 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 --