Nj Certified Dermatology, Pc

Summary Statement of Deficiencies D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on surveyor review of the Final Report (FR), Mohs Maps (MM) and interview with the Laboratory Manager (LM), the laboratory failed to ensure test results were transcribed accurately for Histopathology tests from 6/19/24 to 10/9/24. The finding includes: 1. Review of the MM and FR revealed the pre operations sizes on the FR did not match the pre operation sizes on the MM for five out of five patients test records from 6/19/24. 2. The LM confirmed on 10/9/24 at 1:10 pm that the laboratory did not transcribe results accurately on the FR. 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 Competency Assessment (CA) records and interview with the Testing Personnel (TP), the laboratory failed to perform CA for all Testing Personnel (TP) in the calendar year 2020. The finding includes: 1. One out of three TP did not have a CA performed in the calendar year 2020. 2. The TP #3 as listed on CMS form 209 confirmed on 12/16/21 at 12:45 pm that the CA was not performed. D5781

Summary Statement of Deficiencies D6084 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(2) The laboratory director must ensure that the physical plant and environmental conditions provide a safe environment in which employees are protected from physical, chemical, and biological hazards. This STANDARD is not met as evidenced by: Based on the lack of a Flammable Cabinet, observation of flammable reagents, and interview with the General Supervisor (GS) the Laboratory Director (LD) failed to provide a safe environment from physical and chemical hazards from September 2018 until the date of survey. 1) Xylene and alcohol reagents where kept in a cabinet under a sink. 2) Xylene and Alcohol reagents are "fire and explosion hazards" as stated by the manufacture. 3) The GS confirmed at 1:00 pm on 4/5/19 that the LD failed to provide a safe environment from physical and chemical hazards. 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 --