Summary:
Summary Statement of Deficiencies D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on a review of the 2018 API (American Proficiency Institute) Proficiency Testing (PT) records and an interview with the previous Technical Consultant (with the current Technical Consultant present), the surveyor determined the laboratory failed to ensure proficiency testing results were submitted within the timeframes established by the PT program. This was noted on one of three of the 2018 Chemistry surveys reviewed. The findings include: 1. A review of the 2018 API PT records revealed the Event #2 Chemistry survey received a score of 0% for all analytes due to "Failure to participate". The instrument printouts revealed testing for the Event #2 survey was performed on 5/30/2018, however the results were not submitted before the established deadline on 6/8/2018. 2. During an interview on 11/21/2018 at 10:30 AM, the previous Technical Consultant explained it was the responsibility of the testing personnel to ensure the PT results are submitted before the deadline established by API. The Technical Consultant further stated the testing personnel had entered the results on the API website, however she had failed to hit the "submit" button afterwards. Although the testing personnel received a "reminder" e-mail, she was off on the date results were actually due. Thus the above noted findings were confirmed. . D6041 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(3) 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 -- (b) The technical consultant is responsible for-- (b)(3) Enrollment and participation in an HHS approved proficiency testing program commensurate with the services offered; This STANDARD is not met as evidenced by: Based on a review of the 2018 API (American Proficiency Institute) proficiency testing (PT) records and an interview with the previous Technical Consultant (with the current Technical Consultant present), the surveyor determined the Technical Consultant failed to ensure proficiency testing results were submitted by the testing personnel under their supervision within the timeframes established by the PT program. This was noted on one of three of the 2018 Chemistry surveys reviewed. (Refer to D5215.) SURVEYOR: Laura T. Williams, BS, MT (ASCP) Licensure and Certification Surveyor -- 2 of 2 --