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, staff interview, and policy review, the laboratory failed to twice annually verify the accuracy of 2 of 2 non-regulated analytes (wet preparation and urine microscopic examination) in 2022. The laboratory performed approximately seven wet preparations and 90 urine microscopic examination patient tests in 2022. Findings include: 1. Reviewed at 12:15 p.m. on 07/10/23, the laboratory's test menu listed wet preparations and urine microscopic examinations available for patient testing. 2. Reviewed at 12:20 p.m. on 07/10/23, the 2022 proficiency testing records indicated the laboratory did not participate in proficiency testing for wet preparations and urine microscopic examinations. 3. Reviewed at 12:30 p.m. on 07/10/23, the 2022 verification records failed to include evidence of a second accuracy verification in 2022 for wet preparations and urine microscopic examinations. 4. Upon request, the laboratory failed to provide evidence of a second accuracy verification in 2022 for wet preparations and urine microscopic examinations. 5. During interview at 1:05 p.m. on 07/10/23, the laboratory director (#1) confirmed the laboratory performed patient testing for wet preparations and urine microscopic examinations in 2022 and did not verify the accuracy of these tests a second time in 2022. 6. Review of the following policies/procedures occurred on 7/10/23: - "Wet Mount," dated 01/01/97, stated, ". . . Quality Control for outlying clinics: Quality Control . . . will be checked at least twice a year by reviewing and identifying photos from proficiency surveys with known results. The Laboratory Technical consultant will provide the survey photos and evaluate for correct identification. . . ." - "Urine Microscopic Examination Procedure," dated 02/08/93, stated, ". . . Quality Control . . . will be checked at least twice a year by reviewing and identifying photos from proficiency surveys with known results. 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 -- The Laboratory Technical consultant will provide the survey photos and evaluate for correct identification. . . ." -- 2 of 2 --