Mcguiness Dermatology Center Of Flower Mound

Summary Statement of Deficiencies D0000 The Practice Manager was at the entrance conference conducted 12/02/2020. The survey process was discussed. An opportunity for questions and comments was given. The exit conference was held with the Practice Manager on 12/02/2020. The laboratory was found to be in substantial compliance for the specialties/subspecialties for which it was surveyed. The standard level deficiencies cited were discussed. The process for submitting the corrections was explained. CMS form 2567 will be emailed from the Texas State Health and Human Services Commission, Health Facility Compliance Arlington Group. 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 staff interview and review of the laboratory records from 2019 and 2020, it was revealed the laboratory failed to have documentation of performing twice annual accuracy assessments for histopathology slide interpretations for 2019 and 2020. Findings: 1. In an interview on 12/02/2020 at 09:45 hours in the breakroom, the facility Practice Manager explained that the laboratory did NOT perform any sort of specimen processing or staining. Patient specimens were submitted to a reference laboratory for processing, staining, and evaluation. Results were digitally transmitted back to the facility. These results included a diagnosis and a digital image of the prepared slide. The facility laboratory director reviewed the digital image of the slide. 2. Review of laboratory records from 2019 and 2020 revealed the laboratory failed to have documentation of performing twice annual accuracy assessments for 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 -- histopathology slide interpretations. The laboratory was asked to provide documentation of twice annual accuracy assessment. No documentation was provided. This confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies 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 record review and interview with the Office Manager the laboratory failed to perform competency assessments on 4 out of 4 Testing Personnel who performs KOH (Potassium Hydroxide) and Scabies testing. Findings Included: Review of the CMS 209 revealed 4 Testing Personnel who performed the KOH and Scabies testing. Record review revealed no documentation of competency assessments for all 4 Testing Personnel. During an interview on 11/05/18 at 3:08 PM the Office Manager confirmed that no competency assessments had been performed on the 4 Testing Personnel. 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 with the Office Manager the laboratory failed to verify the accuracy of the KOH (Potassium Hydroxide) and Scabies testing for 2 out of 2 years (2016-2017) reviewed. Findings Included: Review of peer review records revealed no peer review was performed for KOH or Scabies testing from 10 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 -- /2016 to 10/2018. During an interview on 11/05/18 at 1:43 PM the Office Manager confirmed that there was no peer review documented for the KOH or Scabies testing. -- 2 of 2 --