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 staff interview, the laboratory did not verify accuracy bi- annually for Uricult testing. Findings include: 1. Record review of the laboratory's test verification/accuracy records on 4/3/19, revealed the laboratory failed to verify the accuracy of the Uricult test at least twice annually for 2017 and 2018. 2. Staff interview with the laboratory director on 4/3/19 at 9:45 AM confirmed the laboratory did not have a system in place to verify the accuracy of Uricult testing bi-annually in 2017 and 2018. 3. The laboratory performs 110 Uricult tests annually. D6051 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(v) The procedures for evaluation of the competency of the staff must include, but are not limited to assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. This STANDARD is not met as evidenced by: Based on record review and staff interview, testing personnel did not test unknown samples to assess their knowledge and skills to maintain their competency in the specialty of microbiology. Findings include: 1. Record review of the college of American pathologists (CAP) throat culture attestation sheets on 4/3/19 revealed 3 of 6 testing personnel (TP) did not examine unknown samples including proficiency testing material to accurately assess their knowledge and skills in 2017 and 2018. 2. 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 -- Record review of TP competency records for Uricult testing on 4/3/19 revealed 6 of 6 TP did not examine unknown samples including proficiency testing material to accurately assess their knowledge and skills in 2017 and 2018. 3. Staff interview with the laboratory director on 4/3/19 at 10:00 AM confirmed 6 of 6 TP did not examined unknown samples including proficiency testing material to accurately assess their skills for the above in 2017 and 2018. 4. The Laboratory performs 520 throat culture and 110 Uricult tests annually. -- 2 of 2 --