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: During an onsite recertification survey on 01/23/2018, based on procedure manual review, proficiency testing review, and testing personnel review, the laboratory failed to ensure that proficiency testing (PT) samples for calcium (Ca) testing were routinely tested the same number of times as patient samples for 1 of 10 PT events reviewed from 2016 to 2017 (2016, Event 3). Findings include: 1. The procedure manual stated that all panic values would be rerun to ensure accuracy. The laboratory procedure defined the following as panic values: a. Ca less than 6 or greater than 14 2. Review of the American Proficiency Institute (API) proficiency testing events from 2016 to 2017 revealed the following proficiency testing events with critical value that was reported and not repeated according to laboratory policy. a. 2016, Event 3: i. sample CH-13- Ca 5.1 3. Testing personnel confirmed during an onsite interview on 01/23 /2018 at 3:30pm that the laboratory failed to ensure that proficiency testing samples were routinely tested the same number of times as patient samples. 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 --