Southeastern Dermatology Group Pa

Summary Statement of Deficiencies 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 a review of the accuracy verification records and interviews with the Laboratory Director and Office Administrator, the surveyor determined the laboratory missed performing one of two accuracy verifications for Histopathology on MOHS Surgical procedures in 2021, and the first half of 2022. The findings include: 1. A review of the "Quarterly Peer Review" procedure revealed the laboratory opted to send out four cases per quarter to a pathologist in Panama City, Florida (FL) for verifications of accuracy in Histopathology on MOHS Surgical procedures. 2. A review of the Accuracy Verification /"Quarterly Peer Review" records revealed the following: A) In 2021, 1st and 2nd quarter cases were sent out and reviewed by the FL pathologist on 10/13/2021. The Laboratory Director signed his review of the results on the day of the survey (6/22/2022). B) The was no documentation of accuracy verification of cases from the second half of 2021 or the first half of 2022. 3. During an interview with the Laboratory Director on 6/22/2022 at approximately 1:00 PM, the surveyor reviewed the above noted findings. During the exit summation with the Office Administrator at 1:30 PM, the surveyor noted a year (June 2021-June 2022) since the laboratory had sent out cases slides for accuracy verification. The Administrator stated she had recently sent out slides, and would forward the results to the surveyor, however as of 6/27/2022, no additional accuracy verification records were received at the Alabama CLIA State Agency office. SURVEYOR ID#32558 Licensure and Certification Surveyor 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 D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on a review of the MOHS Quality Assurance (QA) documentation and interviews with the MOHS Tech, the surveyor determined the Laboratory Director (also the Testing Personnel) failed to document reviews (as indicated by his signature and date) of the returned "Proficiency Testing" results, and further failed to determine if