Dermatology Associates Of South Jersey, Llc

Summary Statement of Deficiencies 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: a) Based on surveyor review of the Procedure Manual (PM), Biannual Assessment (BA) and interview with the Office Manager (OM), the laboratory failed to have a procedure for BA at the time of survey. The OM confirmed on 11/10/22 at 11:40 am the laboratory did not have a procedure for BA. b) Based on surveyor review of the Procedure Manual (PM), observation of Staining Station (SS) and interview with the Office Manager (OM), the laboratory failed to have a procedure for Hematoxyilin- Eosin (HE) staining at the time of survey. The OM confirmed on 11/10/22 at 12:30 pm that the laboratory did not have the aforementioned procedure. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- This STANDARD is not met as evidenced by: Based on surveyor review of the Test Report (TR) and interview with the Office Manager (OM), the laboratory failed to include the name and address of the laboratory where the Technical Component (TC) for Mohs testing was performed from 9/18/17 to the date of survey. The OM confirmed on 11/10/22 at 12:00 pm that the TC laboratory name and address was not on the Mohs TR. Note: This was previously cited on 9/26/19. -- 2 of 2 --

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 Laboratory Director (LD), the laboratory failed to document Hematoxylin and Eosin (H&E) control slide reaction from 9/18/17 to the date of survey. The findings include: 1. The laboratory did not document H&E stain QC reaction for reading of biopsy slides. 2. The laboratory did not document H&E stain QC reaction for Mohs testing from 1/4/19 to 9/20/19. 3. The laboratory read and reported around 2500 patients slides. 4. The LD confirmed on 9/26/19 at 1:30 pm that the laboratory did not document H&E QC stain reaction. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- acceptability. This STANDARD is not met as evidenced by: Based on surveyor review of the Test Report (TR) and interview with the Laboratory Director (LD), the laboratory failed to include the name and address of the laboratory where the Technical Component (TC) for Mohs testing was performed from 9/18/17 to the date of survey. The LD confirmed on 9/26/19 at 1:45 pm that the TC laboratory name and address was not on the Mohs TR. -- 2 of 2 --