Summary:
Summary Statement of Deficiencies D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) records and an interview with Testing Personnel (TP) #1, the surveyor determined the laboratory failed to ensure testing on PT samples was performed the same number of times as patient specimens. This was noted on seven of twenty-five surveys reviewed. The findings include: 1. A review of 2016 - 2018 API (American Proficiency Institute) PT records revealed TP #1, #2 and a previous testing personnel ran PT samples more than once as follows: A) 2016 Event #2 Hematology: all five specimens ran by TP #1 and then by TP #2 on 7/22 /2016 (submission cutoff date-8/5/16) B) 2016 Event #2 Microbiology: all five Clostridium difficile specimens ran by TP #1 on 5/25/16 and a previous testing personnel on 6/2/16 before the submission cutoff date of 6/3/16 C) 2017 Event #2 Chemistry: all five specimens ran by TP #1 on 5/24/17 and then by TP #2 on 5/23/17 before the submission cutoff date D) 2017 Event #3 Chemistry: all five specimens ran by TP #1 on 8/30/17, TP #2 and a previous testing personnel on 8/31/17 before the submission cutoff date E) 2017 Event #3 Hematology: survey specimens #11, #12 and #14 were run twice, and specimens #13 and #15 were run three times by the testing personnel before the submission cutoff date F) 2018 Event #1 Hematology: all five specimens ran twice by TP #2 before the submission cutoff date of 3/30/18 G) 2018 Event #2 Hematology: all five specimens ran twice by TP #2 before the submission cutoff date 2. In an interview on 8/15/2018 at 12:10 PM, when asked how many times patient samples are routinely run, TP #1 stated "Once". TP #1 was then asked why they were not treating PT specimens in the same manner as patient samples, TP #1 explained they had misunderstood the regulations requiring all testing personnel to perform proficiency testing. The surveyor clarified the regulations explaining surveys Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- should be "rotated" among all personnel who perform patient testing. Thus, the above noted findings were confirmed. . D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on a review of the 2016 - 2018 API (American Proficiency Institute) Proficiency Testing (PT) records and an interview with Testing Personnel #1, the laboratory failed to document