Princeton Dermatology Associates

Summary Statement of Deficiencies 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 reagent from 10/16/19 to the date of survey. The finding include: 1. Gill 3 Hematoxylin reagent expired 11/30/22. 2. Eosin Working Solution reagent expired 10/16/19. 3. Approximately 300 patients were tested with expired reagent. 4. The TP confirmed on 3/1/23 at 12:30 pm that the laboratory used expired reagents. D5803 TEST REPORT CFR(s): 493.1291(b) Test report information maintained as part of the patient's chart or medical record must be readily available to the laboratory and to CMS or a CMS agent upon request. This STANDARD is not met as evidenced by: Based on the surveyor review of the Test Reports (TR) and interview with the Testing Personnel (TP), the laboratory failed to have one out of five TR available to review from 8/12/22 to the date of the survey. The TP confirmed on 3/1/23 at 1:00 pm not all patient TR were available to review. 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 Clinical Consultant (CC), the laboratory failed to perform CA correctly on two out of two Testing Personnel in the calendar year 2016 and 2017. The findings include: 1. The laboratory did not document when TP were observed, what records were reviewed and how assessment was done. 2. TP #2 listed on CMS form 209 did not have a CA for the calendar year 2016. 3. The CC confirmed on 5/17/18 at 10:20 am that CA was not performed correctly. 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), Biannual Assessment Records (BR) and interview with the Clinical Consultant (CC), the laboratory failed to follow their Quality Control (QC) procedure for Biannual Assessment (BA) in the calendar year 2017. The finding includes: 1. The PM stated under QC Documentation 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 -- 6.1.3 "Twice a year 3 cases shall be sent out to an outside physician" but a review of the BR revealed that one case twice a year was sent for BA. 2. The CC confirmed on 5 /17/18 at 10:10 am that the PM was not followed. 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 the Quality Control (QC) records, accession log and interview with the Testing Personnel (TP), the laboratory failed to record the reaction of a control slide for Hematoxylin and Eosin (HE) stains in September 2017. The finding includes: 1. A review of the accession log revealed that on 9/14/17 ten Mohs test were performed but the reaction of a HE QC was not documented. 2. The TP # 1 listed on CMS form 209 confirmed on 5/17/18 at 11:00 AM that QC was not documented on 9/14/17. -- 2 of 2 --