My Dermatologist

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: . Based on observation and interview with laboratory personnel, the laboratory failed to ensure a stain used for viral microscopic examinations and a stain used for histopathology tissue processing were not used after the expiration date had been exceeded. Findings are as follows: 1. The laboratory performed Tzanck microscopic examinations and Mohs Histopathology slide examination as confirmed by Histotechnician 1 during review of the Laboratory Personnel Report (From CMS-209) at 10:30 a.m. on 01/07/21. 2. Instruction not to use reagents after the expiration date was established in the Tzanck (Cytodiagnostic) Smear and the Mohs Surgery procedures located in the CLIA Manual New 3-ring binder. 3. One bottle of expired Fungal Tzanck Stain was observed adjacent to the microscope and available for use during a tour of the laboratory at 10:05 a.m. on 01/07/21. See below for detailed information. Stain Exp. Lot number Tzanck 02/19/16 4050 4. One open bottle and one unopened bottle of expired Vintage Plus Hematoxylin stain were observed in the flammable liquid storage cabinet and available for use during the tour. See below for detailed information. Stain Exp. Lot number Hematoxylin 09/01/20 078985 5. In an interview at 10:05 a.m. and 10:15 a.m. on 01/07/21, the Clinic Administrator confirmed the above finding. 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 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 document review and interview with laboratory personnel, the laboratory failed to perform and document activities used to verify the accuracy of Microbiology and Histopathology test procedures at least twice annually in 2017. Findings are as follows: The laboratory performed Microscopic Examinations for parasites and viruses under the specialty of Microbiology and Mohs Micrographic Surgery testing under the subspecialty of Histopathology as confirmed by the Histotechnician (HT) during a tour of the laboratory on 09/06/18 at 10:05 a.m. Microscopic Examinations 1. The Scabies, Hair Shaft and Tzanck procedures located in the CLIA Manual included a twice annual verification of accuracy requirement for these microscopic examinations. 2. Documentation of the 2017 microscopic examination verifications for Scabies and Tzanck testing was not found in laboratory records. One microscopic examination verification performed in 2017 was found for Hair Shaft testing. The laboratory was unable to provide the missing verification documents upon request. See below for 2017 patient testing volume. Test Patients Scabies 6 Hair Shaft 7 Tzanck 1 3. In an interview on 09/06/18 at 12:10 p.m., the Laboratory Director confirmed the above finding. Mohs Micrographic Surgery 1. The Mohs Surgery procedure located in the CLIA Manual indicated 5 Mohs cases would be sent out for verification annually. 2. Documentation of the 2017 Mohs Micrographic Surgery verification was not found in laboratory records. The laboratory was unable to provide verification documentation from 2017 upon request. 3. In an interview on 09/06/18 at 12:05 p.m., the Laboratory Director confirmed Mohs Micrographic Surgery accuracy had not been verified in 2017. 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 --