Winter Haven Dermatology Pa

Summary Statement of Deficiencies D0000 44394 Winter Haven Dermatology clinical laboratory is not in compliance with 42 CFR part 493, Requirements for Laboratories. A CLIA recertification survey was conducted on 06/10/2021. 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 record review and interview, the laboratory failed to perform yearly maintenance on the Micromaster microscope for 2 out of 2 years (2019 and 2020) reviewed. Findings included: Review of the maintenance records for the Micromaster microscope revealed that maintenance was last performed on 12/12/2018 and was due for service on 12/12/2019. Interview via e-mail correspondence on 6/10/2021 at 4:08 PM with the Laboratory Director confirmed maintenance on the Micromaster microscope had not been performed since 2018. 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 D0000 An announced CLIA recertification survey was conducted at Winter Haven Dermatology on 04/18/19. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level 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 Office Manager the laboratory failed to record the humidity in the laboratory for 2 out of 2 (04/17-04/19) years reviewed. Findings Included: Review of manufacturer's instructions for the cryostat revealed that the laboratory must not have a humidity greater than 60%. Review of the laboratory logs revealed that the humidity was not recorded. Interview with the Office Manager on 04/18/19 at 10:11 AM confirmed that the laboratory did not record the humidity of the room where the cryostat was used. 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 --