Summary:
Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. In addition, retain the following: This STANDARD is not met as evidenced by: Based on the review of the laboratory's protocol for retention of records, a total of 17 patient test records, lack of preventive maintenance (PM) records, and interviews with the office manager (OM) on March 11, 2026; it was determined that the laboratory failed to retain the PM records for the micrscopes used for testing. The findings include: 1. The laboratory's policy was to perform PM for the microscopes annually through their internal biomedical equipment department. 2. The surveyor reviewed a total of seventeen patient records that required the use of the micrscope for test performance. Sixteen out of seventeen were potentially affected due to lack of records from 8/16/2022 to 1/28/2026. The records as followed: Identifier Date of service Test 56551216 08/16/2022 KOH 23-931 12/08/2022 Mohs 23-088 01/27/2023 Mohs 56382214 02/01/2023 KOH and scabies 23-1106B 10/19/2023 Mohs 56661360 11/06 /2023 KOH 24-231 02/15/2024 Mohs 56537106 03/12/2024 KOH 24-1417 11/14 /2024 Mohs 60012805 12/06/2024 KOH and scabies 52671519 01/30/2025 scabies 25- 207 03/05/2025 Mohs 25-806 09/24/2025 Mohs 67703378 11/10/2025 KOH 54770816 01/13/2026 KOH 26-050 01/28/2026 Mohs 3. During an interview on March 11, 2026, at approximately 9:30 a.m., the OM confirmed that no PM records were available for review at the time of the survey. 4. According to the testing declaration form submitted at the time of survey, the laboratory performed and reported approximately 150 Mycology tests, 50 Parasitology tests and 1,000 Dermatopathology cases annually including the time when the laboratory failed to retain PM records for the microscopes. . 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 -- 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's Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing (PT) documentation from 2022 to 2025, lack of laboratory records, and an interview with the office manager on March 11, 2026, it was determined the laboratory failed to at least twice annually verify the accuracy of the tests performed in 2023. The findings include: 1. The surveyor reviewed the laboratory's proficiency testing documentation and found that they were enrolled with the WSLH PT program for 2022, 2024 and 2025, but missed 2023 for the Provider Performed Microscopy tests. 2. The office manager stated in an interview on March 11, 2026 at 11:50 a.m., that the laboratory was not enrolled in 2023 which was verified from an email they received from the WSLH PT program that stated "This site was actually not enrolled with WSLH PT in 2023. They were enrolled previously since at least 2018, and have been enrolled every year since 2023. It doesn't look like an order was ever placed for 2023, however, so no enrollment was processed nor samples sent". 3. Further findings included a lack of