Dermatology Of Boca Llc

Summary Statement of Deficiencies D0000 A recertification survey conducted on 1/23/2023 found the DERMATOLOGY OF BOCA LLC clinical laboratory not in compliance with 42 CFR Part 493, Requirements for Laboratories. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on observation, record review and interview, the laboratory failed to have annual maintenance performed on the Leica CM 1510S cryostat, required by the manufacturer, and also failed to have annual maintenance performed on the microscope, during the year 2021. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding 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 -- condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on observation, record review and interview, the laboratory failed to include in the Mohls test reports the (c)(2) name and address of the laboratory location where the test was performed. -- 2 of 2 --

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on record review and interview with the histology technician 1, the laboratory failed to document the room humidity for 2 out of 2 years reviewed. Findings include: Review of the cryostat manual Leica CM1510S indicated a requirement for room humidity not above 60 %. Quality control records of histopathology room revealed that: there was no documentation of the humidity during 2017 and 2018. During an interview on 03/26/19 at 10:30 a.m., the histology technician 1 confirmed that there was no record of room humidity for the years of reference. 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 --