Summary:
Summary Statement of Deficiencies D0000 A remote survey conducted 2/24/21 - 2/26/21 found Dermatology Group of Florida Pa not in compliance with 42 CFR Part 493, Requirements for Laboratories 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 unanswered email requests for additional information, the facility failed to verify the accuracy of the Mohs skin cancer histopathology slides at least twice annually for one of two years reviewed (2020). The findings include: The facility failed to respond to an email request for additional documentation of twice annual verification of accuracy of the reading of the Mohs surgery skin specimen slides read in the laboratory during the last year. The record review of the peer review received indicated peer review was performed in January 2020. An email request was sent to the laboratory on 2/24/21 at 11:52 am requesting documentation of peer review occurring twice in 2020. The response from the laboratory on 2/24/21 at 12:19 pm stated, "They started doing Mohs in 2020." An email was sent to the laboratory on 2 /25/21 at 3:22 pm stating, "The CMS 116 obtained at the time of survey in July 2019 states MOHs was being performed. Please send the requested information before 12: 00 pm tomorrow, 2/26/21." At time of survey exit on 2/26/21 at 2:00 pm, there had been no response to the documentation request. D5609 HISTOPATHOLOGY CFR(s): 493.1273(e)(f) (e) The laboratory must use acceptable terminology of a recognized system of disease nomenclature in reporting results. (f) The laboratory must document all control 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 -- procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on a record review and unanswered email requests for additional information, the laboratory failed to provide complete Histopathology quality control documentation of reagent lot numbers and expiration dates for 17 of 17 months reviewed (August 2019- January 2021). The findings include: The 2/24/21 record review of quality control documentation received from the facility on 2/8/21, showed there was no record of lot numbers and or expiration dates for the Hematoxylin and Eosin (H and E) staining reagents that were used on patient skin sample histopathology slides during processing, as required. An email request was sent to the laboratory on 2/24/21 at 11:52 am requesting documentation of lot numbers and expiration dates for the H and E stains used in 2019, 2020, and 2021. The response from the laboratory on 2/24/21 at 12:19 pm stated, "They started doing Mohs in 2020." An email was sent to the laboratory on 2/25/21 at 3:22 pm stating, "The CMS 116 obtained at the time of survey in July 2019 states MOHs was being performed. Please send the requested information before 12:00 pm tomorrow, 2/26/21." At time of survey exit on 2/26/21 at 2:00 pm, there had been no response to the documentation request. -- 2 of 2 --