Dermatology Center Of Washington Township Pc

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 surveyor review of the Procedure Manual (PM), observation of Staining Station (SS) and interview with the Testing Personnel (TP), the laboratory failed to follow the PM for "Mohs Tissue Procedure" from 1/4/24 to the date of the survey. The findings include: 1. The PM stated step i "Eosin working solutions 2 dips" but the SS had 100% alcohol 2. The TP confirmed on 9/11/24 at 1:30 pm that the laboratory did not follow the PM. 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 Histology reagents and interview with the Testing Personnel (TP), the laboratory failed to discard expired Histopathology reagents from 3/31/24 to the date of survey. The findings include: 1. Avantik Tissue marking dyes were expired as follows: a) Blue marking day lot # 145362 expired 3/31/24 b) Red marking dye lot # 145595 expired 3/31/24 2. Approximately 500 patients were tested 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 -- with expired reagent. 3. The TP confirmed on 9/11/24 at 1:30 pm that the laboratory used expired reagents. -- 2 of 2 --

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 surveyor review of the Procedure Manual (PM), and interview with the Testing Personnel (TP), the laboratory failed to have a procedure for Biannual Assessment (BA) on the date of survey. The TP confirmed on 1/4/23 at 1:00 pm that the laboratory did not have the aforementioned procedure. 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 Log (QCL) and interview with the Testing Personnel (TP), the laboratory failed to document Hematoxylin and Eosin (H&E) control slide reaction from 10/28/21 to the date of survey. The findings include: 1. The laboratory did not document H&E stain Quality Control reaction on 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 -- the QCL for reading of Moh's slides. 2. The laboratory read and reported approximately 1900 patient slides. 3. The TP confirmed on 1/4/23 at 12:40 pm that the laboratory did not document H&E QC stain reaction. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(12) 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 surveyor review of the Procedure Manual and interview with the Testing Personnel (TP), the Laboratory Director (LD) failed to establish a Competency Assessment (CA) procedure with the required elements for Moh's testing from 3/28 /2018 to the date of the survey. The TP confirmed on 1/4/23 at 1:40 pm that a CA procedure was not established. -- 2 of 2 --

Summary Statement of Deficiencies D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on surveyor review of Personnel Records (PR) and interview with the Testing Personnel (TP), the Laboratory Director (LD) failed to ensure that the education record for one of four TP was available on the date of the survey. The TP #4 listed on CMS from 209 confirmed 4/22/21 at 10:00 am that all education records were not available. 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 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 Biannual Assessment (BA) procedure, Procedure Manual (PM) and interview with the Office Manager (OM), the laboratory failed follow the BA procedure for the Calendar year 2017. The finding includes: 1. PM stated to perform BA twice a year but the laboratory performed once in calendar year 2017. 2. The OM confirmed on 3/28/18 at 10:30 am that the BA procedure was not followed. 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 --