Dermatology Professionals Llc

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on record review of the laboratory's Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing (PT) records and confirmed through staff interview with the clinical services manager (CSM), the laboratory did not maintain a copy of all proficiency testing records in the specialty of Microbiology. Findings include: 1. Record review on 2/3/2023 of the laboratory's 2021, 2022 and 2023 to date WSLH PT records revealed: a. The attestation sheet was missing for 2021 KOH Event 2. b. The 2021 KOH Event 1 and 2022 KOH Events 1 and 2 attestation sheets were not signed by testing personnel (TP). 2. Record review on 2/3/2023 of the laboratory's 2022 KOH testing logs revealed, the laboratory did not document testing of WSLH PT KOH Event 1. 3. During staff interview with the CSM on 2/3/2023 at 10:30 AM, the CSM: a. Confirmed the attestation sheet for WSLH KOH 2021 Event 2 was missing. b. Confirmed the 2021 KOH Event 1 and 2022 KOH Events 1 and 2 attestation sheets were not signed by TP. c. Confirmed the 2022 KOH Event 1 results were not written on the laboratory log. d. Stated, "We have no way of knowing which TP performed the testing on KOH 2022 Event 1 and we do not always have TP sign the attestation 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 -- sheet." 4. The laboratory performs 25 KOH tests annually in the specialty of Microbiology. 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 of the laboratory's Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing (PT) records and staff interview with the clinical services manager (CSM), the laboratory failed to verify at least twice annually the accuracy of wet mounts to identify parasites in the specialty of Microbiology. *This is a repeat deficiency.* Findings include: 1. Record review on 2/3/2023 of the laboratory's 2021, 2022 and 2023 to date WSLH PT records revealed the laboratory did not have any documentation to verify the accuracy of scabies wet mount testing. 2. Record review on 2/3/2023 of the laboratory's 2021, 2022 and 2023 to date quality assurance records revealed the laboratory did not have any documentation to verify the accuracy of scabies wet mount testing. 3. Record review on 2/3/2023 of the laboratory's 2021, 2022 and 2023 patient testing logs revealed the laboratory performed 6 wet mount for scabies tests from 1/1/2021 through 2/3/2023. 4. Record review on 2/3/2023 of the laboratory's 'KOH & Wet Mount Manual Policy & Procedure' quality control section revealed: a. "PT is required; All Adult & pediatric Dermatology, pc labs have been enrolled with WSLH for our PT testing which are done biannually." b. "*Please refer to our WSLH Policy and Procedure." 5. Record review on 2/3/2023 of the laboratory's procedure manual revealed, the manual did not contain the procedure referenced in 4b above. 6. staff interview on 2/3/2023 at 10:00 AM with the CSM confirmed the laboratory did not verify the accuracy of wet mount scabies testing twice annually in 2021 and 2022 and has not performed accuracy testing in 2023 to date. 7. The laboratory has performed 6 scabies tests from 1/1/2021 through 2/3/2023 in the specialty of Microbiology. -- 2 of 2 --

Summary Statement of Deficiencies D0000 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 and interview on 4/30/2021, the laboratory failed to verify at least twice annually procedures it performs that are not included in subpart I of this part as evidenced by the following: 1. The surveyor reviewed the laboratory's quality assurance records for twice annual Potassium Hydroxide (KOH) preparations and wet mounts for scabies for calendar years 2019 and 2020. The review revealed that laboratory did not verify accuracy twice annually for wet mounts for scabies in 2019 or 2020 and verified accuracy of KOH preparations only once on 9/24/19. 2. The laboratory's Clinical Services Program Administrator confirmed through email interview on 4/30/21 at 10:55 AM that twice annual accuracy checks for scabies wet mounts were not performed in calendar years in 2019 and 2020 and that KOH preparation accuracy checks were performed only once in calendar year 2019. 3. The laboratory performs 24 KOH/wet mounts annually. This is a repeat deficiency. . 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 --

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the Dermatology Professionals, LLC laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. . 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. This STANDARD is not met as evidenced by: Based on a record review and interview with the laboratory director the laboratory failed to retain original patient test records for at least 2 years as evidenced by the following: MOHS Mapping Records: a) The facility scans the MOHS map into the patient's electronic medical record (EMR). b) A review of twelve (12) patient records for MOHS slide exams performed between 7/11/17 and 6/25/18 was performed. c) The review revealed the fact that the MOHS surgical maps in the patient's EMR were in black and white for all twelve (12) patient records reviewed, whereas the original hard copy maps that were scanned were color coded for marking and orientation purposes. d) According to the laboratory director interviewed on 7/24/18 at 9:40 am, the support staff scanned the mapping record for each patient into the computer and discarded the original. As a result, the computer scans, being the only record available, did not replicate the original colored mappings. e) As a result of these findings, the laboratory did not retain the MOHS mapping records, in their original form, for a minimum of 2 years. The laboratory performs 1366 procedures annually. . D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) 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 -- 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 procedure review and interview, the laboratory failed to have policies and procedures in place to verify the accuracy of KOH, wet preps, Tzanck smears as well as Histopathology skin slide exams twice annually. The laboratory director interviewed on 7/24/18 at 9:58 am confirmed that there was no established written policy and procedure for verifying the above listed procedures twice annually. . D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on procedure manual review and interview, the new laboratory director failed to approve, sign, and date all laboratory procedures as evidenced by the following: A review of the laboratory procedure for histopathology skin slide exams and Provider Performed Microscopy Procedures (PPMP) revealed that the laboratory director had not documented a review and approval of the procedure manual. The laboratory director confirmed in an interview on 7/24/18 at 9:55 AM that she had not documented a review and approval of the procedure manual. . -- 2 of 2 --