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 3 of 3 non-regulated analytes (urine sediment, vaginal wet preparation, and vaginal potassium hydroxide [KOH] preparation). The laboratory performed 42 urine microscopies (sediment), 143 vaginal wet preparations, and 143 vaginal KOH from 11/28/25 through 05/14/26. Findings include: 1. During interview at 9:00 a.m. on 06/11/26, testing personnel (#1) confirmed the laboratory used KOH while performing vaginal wet preparations. 2. Reviewed at 9:15 a.m. on 06 /11/26, the Non-Waived Laboratory Tests Performed document listed wet prep and urine microscopy patient testing volumes from 11/28/25 through 05/14/26. 3. Reviewed the morning of 06/11/26, the first event 2026 proficiency testing records indicated the laboratory did not participate in proficiency testing for urine sediment, vaginal wet preparation, and vaginal KOH preparation analytes. 4. Upon request, the laboratory failed to provide evidence of an alternative accuracy verification for urine sediment, vaginal wet preparation, and vaginal KOH preparation analytes. 5. Reviewed the afternoon of 06/11/26, the "Laboratory Policy," dated 12/21/20, stated, ". . . Proficiency Testing . . . 1. The laboratory will maintain enrollment in an approved proficiency program. . . ." The laboratory failed to provide a policy related to an alternative accuracy verification. 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 --