Champaign Urbana Public Health District

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records, lack of documentation, and interview with the technical consultant (TC); the laboratory failed to ensure attestation statements were completed for five of five PT events for Vaginal Wet Preparation (KOH) testing in 2022 and 2023. Findings Include: 1. Review of the American Proficiency Institute (API) PT records for 2022 and 2023 revealed a lack of attestation statements for five of five routine Vaginal Wet Preparation (KOH) PT testing events in 2022 and 2023. 2. On survey date 01/16/2024, at 11:20 am, an interview with the TC confirmed these findings. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of the laboratory records, lack of documentation, and interview with the technical consultant (TC); the laboratory failed to have a competency policy /procedure in place to assess employee competency as required per 493.1235. Findings Include: 1. Review of the laboratory's policy and procedure manual 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 -- identified the laboratory failed to have a competency assessment policy/procedure in place as required per 493.1235. 2. On survey date 01-16-2024, at 11:17 am, the TC confirmed the laboratory failed to have a competency policy/procedure in place to assess employee competency. -- 2 of 2 --

Summary Statement of Deficiencies D2011 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(3) Laboratories that perform tests on proficiency testing samples must not engage in any inter-laboratory communications pertaining to the results of proficiency testing sample (s) until after the date by which the laboratory must report proficiency testing results to the program for the testing event in which the samples were sent. Laboratories with multiple testing sites or separate locations must not participate in any communications or discussions across sites/locations concerning proficiency testing sample results until after the date by which the laboratory must report proficiency testing results to the program. This STANDARD is not met as evidenced by: Based on record review, manuals, and an interview with the testing personnel (TP#1), the laboratory failed to ensure inter-laboratory communications are not engaged when testing proficiency testing (PT) sample(s) until after the date by which the laboratory must report proficiency testing results to the program for the testing event in which the samples were sent, during the years of 2019 and 2020. Findings include: 1. The laboratory procedures manual and American Proficiency Institute (API) PT attestation statements for the years of 2018, 2019, and 2020 were reviewed. 2. The laboratory's PT policy and procedure and API-PT program instructions TP to test PT samples in the same manner and same number of times that it routinely tests patients samples. 3. Routinely, when a patient is ordered a fungal preparation (Potassium Oxide - KOH Prep) or a Wet Mount Prep, it is performed by 1 (one) TP. 4. The API-PT attestation statements revealed the following: *Event 1 of 2019 - 5 TP signed and recorded their PT results for the same 2 PT sample on 02/21/2019; *Event 2 of 2019 - 7 TP signed that they tested the same 2 PT sample on 06/20/2019; *Event 3 of 2019 - 7 TP signed that they tested the same 2 PT sample on 11/26/2019; *Event 1 of 2020 - 7 TP signed that they tested the same 2 PT sample on 02/14/2020; *Event 2 of 2020 - 7 TP signed that they tested the same 2 PT sample on 03/17/2020. The results for 5 out of 5 PT 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 -- events listed above were reported prior to the PT program reporting deadline. 5. The laboratory failed to ensure one TP should perform 1 PT sample like they handle patients, and failed to ensure inter-laboratory communications are not engaged among the non-participating TP until after PT program reporting deadline has passed. 6. On a Recertification survey conducted on 10/30/20 at 1:00PM , the TP#1 confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with testing personnel (TP) #3; the laboratory test reports failed to include all the required test report information for 5 of 5 vaginal wet prep test reports reviewed. Findings Include: 1. Review of 5 of 5 patient test reports (Patient IDs: P1, P2, P3, P4, and P5) for vaginal wet prep testing failed to indicate the following: a. The address of the laboratory location where the test was performed. 2. 2 of 5 patient test reports (Patient IDs: P3 and P4) for vaginal wet prep testing failed to indicate the following: a. Specimen source. 3. During survey date 04-12-2018, at 12:30 pm, the above findings were confirmed by TP#3. 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 --