Dermatology Center At Old Bridge

Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on lack of maintenance records and interview with the Testing Personnel (TP), the laboratory failed to perform and document annual maintenance on the microscope used in laboratory testing from 8/28/18 to the date of the survey. The TP #2 as listed on CMS form 209 confirmed on 8/30/21 at 12:30 pm there was no documented evidence that annual maintenance was performed on the microscope from 8/28/18 to the date of the survey. 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 D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on surveyor review of the Competency Assessment (CA) records and interview with the Testing Personnel (TP), the laboratory failed to perform and document CA on one out of one TP in the calendar year 2017. The TP confirmed on 8/28/18 at 10:00 am that CA was not done in 2017. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM), Maintenance Records and interview with the Testing Peronnel (TP), the laboratory failed to follow Microcope Maintenance Procedure (MMP) in the calendar yeay 2017. The finding includes: 1. The PM stated to perform preventive maintenance of microscope annually but the laboratory did not perform in 2017. 2. The TP confirmed on 8/28/18 at 10:30 am that the laboratory did not follow MMP. 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 --