Nj Certified Dermatology Pc

Summary Statement of Deficiencies D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on surveyor review of Quality Control (QC) records and interview with the Testing Personnel (TP), the laboratory failed to document Hematoxylin and Eosin (H&E) control slide reactions for Mohs testing in the calendar year 2019. The findings include: 1. The laboratory did not document H&E stain QC reactions in January, February, March, April and July of 2019. 2. The laboratory read and reported 32 patients slides in the above time period. 3. The TP #1 listed on CMS form 209 confirmed on 10/10/19 at 1:30 pm that the laboratory did not document H&E QC stain reaction. 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 CA correctly on the Testing Personnel from November 2017 to the date of the survey. The findings include: 1. The laboratory did not document when TP was observed. 2. The CA stated "follows Bi-Annual assessment procedures as outlined in the procedure manual" but this tool is not applicable for TP. 3. The TP confirmed on 5/22/18 at 1:20 pm that CA was not performed correctly. 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 --