Dermatology Group Of Arkansas

Summary Statement of Deficiencies D5803 TEST REPORT CFR(s): 493.1291(b) Test report information maintained as part of the patient's chart or medical record must be readily available to the laboratory and to CMS or a CMS agent upon request. This STANDARD is not met as evidenced by: A review of patient final reports, lack of documentation, and interviews with laboratory staff, determined the laboratory failed to retrieve test report information maintained as part of the patient chart or medical record. As evidenced by: A. Upon request of ten randomly selected patients reports, the laboratory failed to generate one out of ten patient final reports. Records selected: (In 2022 1.M22-22, 2.M22-25, 3. M22-322, and 4.M22-778; In 2023 5.M23-0011, 6.F23-023, and 7.M23-1160; In 2024 8.M24-011, 9.M24-123 and 10.M24-487. B. In an interview on 4/19/2024 at 1137, the testing personnel #1 (as listed on CMS form 209) confirmed the laboratory could not retrieve patient test information for M24-011. C. In an interview on 4/26/2024 at 0911, the laboratory directory (as listed on CMS form 209) confirmed the laboratory could not retrieve patient test information for M24-011. 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 D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Through a review of the policy and procedure manual and a review of the laboratory stain maintenance log for 2021 and 2022, and interviews with laboratory staff, it was determined the laboratory failed to follow written procedures for the change of Hematoxylin and Eosin in the stain line. Survey findings include: A. A review of the policy and procedure manual and the stain maintenance log revealed the following policies for changing Hematoxylin and eosin in the stain line: from the policy and procedure manual "The hematoxylin and eosin are changed as needed during the week, but fresh is always set up monthly"; from the stain maintenance log "Change Hematoxylin 3 weeks" and "Change Eosin 3 weeks and top off daily with fresh Eosin" B. A review of documented stain maintenance for 2021 and 2022 revealed the following times that stains were not changed according to the policy in the policy and procedure manual (monthly): Hematoxylin and Eosin documented changed on 2/22 /2022 and not again until 4/26/2022. C. Through a review of stain maintenance documentation for 2021 and 2022 it was determined the on the following dates the stains were not changed according to the written instructions on the stain maintenance log (3 weeks); change documented on 7/13/2021 and then on 8/17/2021 (5 weeks); change documented on 1/4/2022 and then on 2/1/2022 (4 weeks); stain changed on 2 /22/2022 and then on 4/26/2022 (9 weeks); and change documented on 5/3/2022 and again on 5/31/2022 (4 weeks). D. In an interview, at 11:10 on 6/22/2022, the laboratory director confirmed the stain maintenance wasn't documented as required by the written instructions in the policy and on the maintenance log. 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 D5219 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(2) At least twice annually, the laboratory must verify the accuracy of any test or procedure listed in subpart I of this part for which compatible proficiency testing samples are not offered by a CMS-approved proficiency testing program. This STANDARD is not met as evidenced by: Through a review of the Proficiency Testing policy, a review of documentation of the laboratory's proficiency testing, and interviews with laboratory staff, it was determined the laboratory failed to follow their written procedures for Proficiency Testing and failed to verify the accuracy of the frozen section histopathology at least twice annually. Survey findings include: A. The Proficiency Testing policy states, "Proficiency Testing in the Mohs Micrographic Cutaneous Oncology, this laboratory has instituted an External Quality Control Program. Semi-annually, the tech or Risk Manager will send two cases containing the original slides, label it with only the surgical case number, and send it out for a microscopic examination by a Board Certified Dermatolpathologist." B. A review of documentation labeled "Quality assurance, proficiency testing" revealed the external quality control samples were submitted once in 2018 (dated June 2018), once in 2019 (dated 5/20/2019), and once in 2020 (dated 2/9/2020) instead of twice annually as required. C. During an interview at 10:20 on 3/10/2020, laboratory employee #2 (as listed on the form CMS-209) confirmed the proficiency testing was documented annually. 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 --