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 a record review and an interview with the laboratory manager, the laboratory failed to verify the accuracy of body fluid crystals at least twice annually since the last survey on June 29, 2016. Findings: 1. A record review revealed the laboratory failed to document the accuracy of body fluid crystals, used for the detection of crystals in synovial and body fluids, at least semiannually since the last survey on June 29, 2016. 2. An interview on April 5, 2018 at 11:30 AM, with the laboratory manager, confirmed the laboratory failed to perform and document the accuracy of crystals in body fluid at least semiannually since the last survey. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on a record review of personnel documents and an interview with the laboratory manager, the laboratory manager failed to evaluate and document the competency of testing personnel at least semiannually during the first year of patient testing on the Medonic M analyzer used to test complete blood counts (CBCs) since the last survey on June 29, 2016. Findings: 1. A record review of personnel 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 -- documents, revealed 1 out of 2 testing personnel listed on the CMS-209 Personnel Report form failed to have competency assessment performed at least semiannually during the first year of patient testing. 2. An interview on April 5, 2018 at 10:00 AM, with the laboratory manager, confirmed the laboratory manager failed to assess competency at least semiannually on 1 testing person in 2016. -- 2 of 2 --