Advanced Dermatology Of The Midlands

Summary Statement of Deficiencies D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: Based on lack of written or electronic test requests and confirmed by laboratory personnel identifiers #1 and #8 (refer to the Laboratory Personnel Report) at 2:00 pm on 09/10/2024, the laboratory failed to have a written or electronic test request for two out of three patients (patient identifiers A and B) having potassium hydroxide (KOH) examinations performed in July 2024. The findings include: 1. Patient identifier A had a KOH examination performed on 07/16/2024. 2. Patient identifier B had a KOH examination performed on 07/19/2024. 3. At the time of the survey, personnel identifiers #1 and #8 confirmed that the laboratory did not have a written or electronic test request for KOH examinations performed on patient identifiers A and B from the dates listed above. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. 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 -- This STANDARD is not met as evidenced by: Based on review of patient test logs, patient electronic health records (EHR), and confirmed by laboratory personnel identifiers #1 and #8 (refer to the Laboratory Personnel Report) at 2:00 pm on 09/10/2024, the laboratory failed to have a system in place to ensure the accurate and reliable transcription of manual test results into the laboratory's EHR for one out of three patients (patient identifier A) having potassium hydroxide (KOH) examination testing performed in July 2024. The findings include: 1. Review of the laboratory's KOH log indicated that patient A had a KOH examination performed on 07/16/2024 with a negative result. 2. Patient A's EHR chart did not include a record of the KOH examination performed on 07/16/2024. 3. At the time of the survey, personnel identifiers #1 and #8 confirmed that the laboratory did not have a system in place to ensure the accurate and reliable transcription of KOH testing into the EHR. -- 2 of 2 --

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observations made during the survey, review of patient test logs and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 1:30 pm on 4/26/2023, the laboratory failed to ensure that the potassium hydroxide (KOH) reagent did not exceed its' expiration date when used on four out of four patients from 2/1/2023 - 4/26/2023. The finding include: 1. At the time of the survey, the KOH reagent expired on 1/31/2023. 2. The laboratory had performed KOH preparations on four patients from 2/1/2023 - 4/26/2023. 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: 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 -- Based on review of patient test reports and Mohs maps and confirmed by laboratory personnel #1 (refer to the Laboratory Personnel Report) at approximately 1:30 pm on 4 /26/2023, the laboratory failed to include the address of the testing facility on three out of five patient test reports reviewed from 1/1/2023 - 4/26/2023. The findings include: 1. The laboratory performed Mohs surgery, including the reading of Mohs slides, on 1/18/2023, 1/23/2023, and 1/26/2023. 2. The Mohs maps from each of the dates confirmed that the provider read the Mohs slides at Advanced Dermatology of the Midlands - Council Bluffs site. 3. At the time of the survey, the patient test reports did not have the correct address of the testing facility. -- 2 of 2 --