Concierge Dermatology & Skin Surgery

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 record review and interview, the laboratory failed to follow their "Quality Assurance Program" procedure for daily temperature checks, maintenance, and quality control for three out of ten days reviewed when patient testing was performed. Findings: 1. Procedure "Quality Assurance Program" under section "Control Procedures" on page three states "The control procedures set forth in the procedure manual will be followed for each test." Procedure for "Mohs Surgery" states in section 6.1.5 "In this laboratory, this is accomplished by reviewing and recording the staining of a designated slide (QC slides are stored in a container unstained from a previous day's case) each day Mohs is performed." 2. Procedure "Quality Assurance Program" under section "Equipment Quality control for Cryostats" states " 1) Room temperature and humidity is checked and recorded daily. 2) Cryostat temperature range is -20 degrees C to -30 degrees C." and "5) Interior and exterior are cleaned daily using 100% reagent alcohol, while wearing gloves and recorded in the cryostat maintenance log." 3. Procedure "Quality Assurance Program" under section "Equipment Quality Control for the Thermo Scientific" states "1. Stain and reagent solutions are changed daily or as needed and recorded." 4. Review of quality records and logs on ten days of patient testing revealed the following: a. On 03/08/2021, the laboratory did not complete quality control for Hematoxylin and Eosin stain. b. On 11/20/2020, the laboratory did not complete the "Maintenance Record for Cryostats". c. On 11/18 /2019, the laboratory did not complete quality control for Hematoxylin and Eosin stain, the "Maintenance Record for Cryostats", the "Cryostat Temperature Log", the 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 -- "Stainer Maintenance Log", and the "Room Temperature and Humidity Log". 5. The laboratory completed a "

Summary Statement of Deficiencies D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: . Based on observation and interview with office manager, the laboratory failed to label inking reagents used for specimen grossing with the expiration dates for the current lots in use. Findings include: 1. An observation by the surveyor during the laboratory tour on 8/20/19 at 9:07 am revealed aliquoted inking reagents without expiration dates affixed on the storage containers. 2. A review of the laboratory's "Preparation and Labeling" procedure revealed a section stating, "All reagents are to be labeled with the following information: reagent, dilution (if any), date of preparation, date received and opened, technician (initials), and temperature for storage (if not room temperature)." 3. During the interview on 8/20/19 at 9:07 am, the office manager confirmed the inking reagents were missing expiration dates on the storage containers. 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 --