Summary:
Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review and interview with laboratory personnel, the laboratory failed to verify the accuracy of histopathology slides twice annually. Findings include: Review of proficiency testing records on 02/21/18 revealed that the laboratory verified the accuracy of Mohs surgery slides by peer review once in 2016 on 10/12/16 and then 08/19/17. During an interview with the histotechnician at 10:35 a.m. on 02/21 /18 , she confirmed that proficiency had been performed once in 2016. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on record review and interview with laboratory personnel, there was no documentation to indicate that the technical supervisor evaluated the performance of testing personnel annually. Findings include: Review of personnel information and 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 -- interview with the director at 11:40 a.m. on 02/21/18 revealed that there was no documented competency evaluation of the histotechnician for 2017. The last evaluation was dated 09/08/16. -- 2 of 2 --