South Jersey Dermatology Center

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on surveyor review of the Biannual Assessment (BA) records and interview with the Office Manager (OM), the laboratory failed to verify the accuracy of Histopathology testing twice annually in the calendar year 2020. The OM confirmed on 7/27/21 at 1:00 pm that the laboratory did not perform BA for Histopathology testing twice in 2020. 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 D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on surveyor review of the laboratory's Quality Assurance (QA) Plan and interview with the Chief Executive Officer (CEO), the laboratory failed to maintain the Quality Assessment (QA) plan from 4/20/16 to the date of the survey. The finding includes: 1. The QA plan stated the Laboratory Director reviews all quality control charts and logs on a monthly basis but there was no documented evidence of review on any records. 2. The CEO confirmed on 4/10/18 at 10:35 am the QA plan was not maintained. 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 --