Dermatology Center Of North Jersey

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 Assessments (BA) records and interview with the Mohs Technician, the laboratory failed to verify the accuracy and reliability of Mohs testing twice annually from 6/3/24 to 1/9/25. The findings include: 1. There were no statements of agreement from the Reviewing Pathologist and the Referring Pathologist documented on BA performed from 6/3/24 to 1/9/25. 2. The Mohs Technician confirmed on 1/9/25 at 10:30 am, there were not statements of agreement from the pathologists perfoming the BA. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (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), lack of reagent tracking logs and interview with the Mohs technician, the laboratory failed to follow all procedures for "Quality Control Policies and Documentation" from 5/10/23 to 1/9/25. The findings include: 1. The PM states "Reagent lot numbers and expiration dates must be recorded." 2. There was no documented evidence the procedure was 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 -- followed. 3. The Mohs technician confirmed on 1/9/25 at 10:35 am, the laboratory did not follow the PM. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

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: Based on the lack of a Procedure Manual (PM), and interview with the Testing Personnel (TP), the laboratory failed to have a procedure for Histopathology Biannual Assessment (BA) on the date of survey. The TP confirmed on 5/10/23 at 2:00 pm that the laboratory did not have the aforementioned procedure. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on surveyor observation of the Flammable Cabinet and interview with the Testing Personnel (TP), the laboratory used expired Hematoxylin reagent and red tissue marking dye for Histopatholgy testing on 5/10/23. Approximately 8 patient were testing. The TP confirmed on 5/10/23 at 1:30 pm that the laboratory used expired reagent. D6093 LABORATORY DIRECTOR RESPONSIBILITIES Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control 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 Procedure Manual and interview with the Testing Personnel (TP), the Laboratory Director failed to maintain a Quality Control (QC) program for Hematoxilyn and Eosin (H&E) stain reaction on the date of survey. The TP confirmed on 5/10/23 at 1:45 pm that a QC program was not maintained. 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 the lack of a laboratory Procedure Manual (PM) and interview with the Testing Personnel (TP) , the Laboratory Director (LD) failed to ensure a Quality Assurance (QA) program was established to assure quality of laboratory services for Histopathology tests provided on the date of survey. The TP confirmed on 5/10/23 at 1:45 pm that a QA program was not established. D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. This STANDARD is not met as evidenced by: Based on the lack of a Procedure Manual (PM) and interview with the Testing Personnel (TP) , the Laboratory Director (LD) failed to establish a Competency Assessment (CA) procedure with all the required elements for Testing Personnel on the date of survey. The LD confirmed on 5/10/23 at 1:00 pm that a CA procedure was not established. D6106 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(14) The laboratory director must ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on lack of a Procedure Manual (PM) and interview with the Testing Personnel (TP), Laboratory Director (LD) failed to have an approved PM for Histopathology testing from on the date of survey. The TP confirmed on 5/10/23 at 1:10 pm that the LD did not ensure an approved PM was available. -- 3 of 3 --

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), observation of the Automated Staining Station (ASS) and interview with the Testing Personnel (TP), the laboratory failed to follow Mohs Staining Procedure from 5/3/18 to the date of the survey. The finding includes: 1. The ASS in the laboratory did not correspond with the staining procedure in the PM. 2. The PM stated five dips for 100% alcohol but the ASS had four. 3. The TP #2 listed on CMS form 209 confirmed on 6/3/21 at 12:15 pm that PM procedure did not match with ASS. Note: This is a repeat deficiency Based on surveyor review of the Procedure Manual (PM) and interview with the Office Manager (OM), the laboratory failed to follow the PM for Quality Control (QC) of Stains by Pathologist from January 2020 to the date of the survey. The finding includes: 1. The PM stated the pathologist will review the Hematoxylin and Eosin (H&E) stain and note review on the Technical Labs Slide Stain Log worksheet. 2. The Technical Labs Slide Stain Log worksheeet was not found in the laboratory. 3. The OM confirmed on 6/3/21 at 12:45 pm that the laboratory did not follow the PM. 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 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 -- 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 Office Manager (OM), the laboratory failed to document Hematoxylin and Eosin (H&E) control slide reaction from January 2020 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 read and reported approximately 300 patient slides. 4. The OM confirmed on 6/3/21 at 1:40 pm that the laboratory did not document H&E QC stain reaction. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control 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 Procedure Manual and interview with the Office Manager (OM), the Laboratory Director failed to maintain a Quality Control (QC) program for Hematoxilyn and Eosin (H&E) stain reaction from January 2020 to the date of survey. The OM confirmed on 6/3/21 at 1:40 pm that a QC program was not maintained. -- 2 of 2 --

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 a CA on one out of two TP for the calendar year 2017 and 2016. The TP #1 listed on CMS form 209 confirmed on 5/3/18 at 1:05 pm that the CA was not performed. 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), observation of the Automated Staining Station (ASS) and interview with the Testing Personnel (TP), the laboratory failed to follow Mohs Staining Procedure from 5/3/16 to the date of the survey. The finding includes: 1. The ASS in the laboratory did not correspond with the staining procedure in the PM. a) The PM stated three dips for 100% alcohol but the ASS had two. 2. The TP #1 on CMS form 209 confirmed on 5/3/18 at 12:45 pm that PM procedure did not match with ASS. 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 --