Hamzavi Dermatology

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 record review and interview with the Office Manager, the laboratory failed to verify the accuracy of its Potassium Hydroxide (KOH) and Scabies preparations for 2 (December 2018 to December 2020) of 2 years. Findings include: 1. A review of the laboratory's records revealed a lack of verification of accuracy testing for KOH and Scabies preparations between December 2018 and December 2020. 2. An interview on 12/17/20 at 1:31 pm with the Office Manager confirmed the laboratory did not perform verification of accuracy testing for KOH and Scabies preparations. 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 D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: . Based on document review and interview, the laboratory failed to follow the manufacturer's operator's manual to monitor and record the humidity readings in the laboratory for 22 of 22 months reviewed to ensure reliable Leica CM 1510S cryostat operation. Findings include: 1. On March 8, 2018 at 10:34 a.m., document review of the maintenance log for the room temperature revealed there was no monitoring and documenting of the humidity for 22 (April to December 2016, 2017, and January to February 2018) of 22 months reviewed in 2016, 2017, and 2018. 2. During the interview on March 8, 2018 at 10:34 a.m., one of the Mohs' processing techs confirmed the humidity readings were not monitored and documented each day of patient testing. 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 --