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 review of laboratory records and interview with a laboratory representative; the laboratory failed to perform bi-annual evaluations for vaginal wet mount testing with and without potassium hydroxide (KOH) in 2019. Findings Include: 1. Review of proficiency testing records revealed the laboratory failed to enroll in vaginal wet mounts with and without KOH reagent in 2019 with the American Proficiency Institute. 2. Interview with the laboratory representative on 10-22-2019 at 10:30 am confirmed the laboratory dropped enrollment with the American Proficiency Institute for vaginal wet mounts with and without KOH. 3. Review of PT documentation found no bi-annual verification documentation for vaginal wet mounts with and without KOH for 2019. 4. Interview with the laboratory representative at 2:00 pm confirmed the laboratory initiated a new "CAL" proficiency testing program for vaginal wet mounts with and without KOH. 5. Review of documentation for the "CAL" program found no documentation for the laboratory except a completion certificate that is specific to an individual. Personnel take the assessment until a passing score is achieved but no documentation is retained other than a completion certificate. What is assessed and how the laboratory performed is not retained and documented. 6. The "CAL" program is not tied to each CLIA number but to an individual therefore there was way to ensure bi-annual verification of vaginal wet mounts with and without KOH were completed for the Peoria, Illinois laboratory location. 7. Interview with the laboratory representative on 10-22-2019 at 1:15 pm confirmed 1,626 vaginal wet mounts had been performed in 2018 through 2019. 8. Interview with the laboratory representative on 10-22-2019 at 2:00 pm confirmed the surveyor's findings. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iv) Ensure that an approved