Kinnelon Dermatology Associates

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 Histotechnician (HT), the laboratory failed to verify the accuracy of Histopathology testing biannually from 12/16/24 to 9/23/25. The findings include: 1. Surveyor review of the BA records revealed the laboratory had incomplete BA records for the following cases: a) Case # 24-335 reviewed by the Laboratory Director (LD) on 12/18/24 b) Case # 24-68 reviewed by the LD on 5/15/24 c) Case # 24-121 reviewed by the LD on 5/15/24 2. The HT confirmed on 9/23/25 at 1:30 pm, the laboratory did not verify the accuracy of Histopathology testing biannually. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) (d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM), observation of the staining station and interview with the Histotechnician (HT), the laboratory failed to have staining procedures approved by the Laboratory Director (LD) from 2/15/24 to 9/23 /25. The finding includes: 1. The laboratory had two different Hematoxylin and Eosin (HE) staining procedures located in the PM and above the staining station. 2. Interview with the HT revealed the laboratory is using the staining procedure above 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 staining station and not the procedure in the PM. 3. There were no implementation or discontinuance dates on the HE procedures. 4. The HT confirmed on 9/23/25 at 1: 20 pm the laboratory did not have implementation or discontinuance dates on the HE procedures approved by the LD. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM), lack of Quality Assurance Electronic Medical Records (QAEMR) Map Logs and interview with the Histotechnician (HT), the laboratory failed to follow their procedure in the postanalytic systems for "Quality Assurance" from 2/15/24 to 9/23/25. The finding includes: 1. The PM stated "Every January and July EMR maps from the Biannual Assessment cases should be checked to make sure they were scanned and put into the patients chart. The findings and

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 survey review of the Procedure Manual (PM), Biannual Assessment (BA) records and interview with the Office Manager (OM) the laboratory failed to follow procedures for Biannual Assessment for Histopathology testing in the calendar years of 2022 and 2023. The findings include: 1. The PM states " Evaluation and review will be documented by the laboratory director on the BA form. If they do not agree then the slides will be sent to a third party." 2. The BA case # 22-275 shows non agreement for Slide # I2. There was no documented evidence the slides were sent to a third party for review. 3. There was no documented evidence that the Laboratory Director (LD) evaluated and reviewed the BA performed for 2 out of 2 events for 2022 and 1 out of 2 events for 2023. 4. The reviewing pathologist for BA events of 2022 and 2023 is not listed as a reviewing pathologist on the BA procedure. 5. The laboratory failed to have the credentials of the reviewing pathologist at the time of survey. 6. The OM confirmed on 10/10/23 at 11:00 am that the laboratory failed to follow procedures for BA for Histopathology. 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. 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 observation of Histopathology reagents, the Flammable Cabinet, and interview with the Office Manager (OM), the laboratory used and failed to dispose expired Histopathology reagents and dyes from 7/1/2020 to the date of survey. The findings include: 1. The Procedure Manual (PM) states " the expiration date is to be circled and the reagent is to be disposed of when the expiration date is reached." The following reagents were observed to be expired. a. one violet tissue marking dye lot 082181 expired on 7/1/2020. b. one black tissue marking dye lot 085357 expired on 8/31/21. c. one green tissue marking dye lot 085405 expired on 8 /31/21. d. one orange tissue marking dye lot 085400 expired on 8/31/21. e. two Submount 4oz. Mounting Media lot 1145 expired on 5/25/22. f. one CoverMount 4oz. lot 107975 expired on 10/31/22. g. one 95% Reagent Alcohol 1 gallon container lot 125677 expired on 7/31/23. 2. The laboratory performed approximately 500 Histopathology tests annually. 3. The OM confirmed on 10/10/23 at 10:30 am that the laboratory used and failed to dispose the expired reagents and dyes. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual, a lack of a Reagent Tracking Log and interview with the Office Manager (OM) the laboratory failed to establish policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic system from 6/25/19 to the date of survey. The finding includes: 1. The laboratory failed to have a procedure for tracking reagents and dyes used in Histopathology testing. 2. The OM confirmed on 10/10/23 at 11:15 am that the laboratory failed to establish written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems. -- 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) via telephone, the laboratory failed to evaluate competency accurately on one of one TP from 6/29/17 to the date of the survey. The findings include: 1. The laboratory failed to use the CA evaluation tools accurately as follows: a. Document review was used to assess: 1. Does not discuss patients results outside the laboratory 2. Performance of Mohs frozen sections 3. Insures adequate grossing of specimen 4. Cuts satisfactory cryostat specimens 5. Stains slides and coverslips adequately 6. Files Mohs frozen sections 7. Direct observation 8, Maintains reagents 9. Keeps reagents fresh and filtered. 10. Disposes of reagents properly 11. Maintains equipment 12. Assures appropriate maintenance of same 13. Contacts repair person when needed 14. Safety issues 15. Maintains universal precautions 16. Troubleshooting problem solving ability 17. Work completed in a timely manner 18. Slide quality b. Direct observation was used to assess: 1. Patient confidentiality. 2. Does not discuss patient results outside the laboratory 3. Assures appropriate maintenance of same 4. Keeps current safety regulations 5. QC records reviewed 2. One section of the CA indicated the TP was reviewed and achieved competency by direct observation and document review but did not state what was observed or reviewed. 3. Direct observation of instrument maintenance was not assessed. 4. The TP stated via telephone on 6/26/19 at 9:30 am the laboratory did not uses the CA evaluation tools accurately. D5401 PROCEDURE MANUAL 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 -- 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 via telephone (TP), the laboratory failed to follow the Quality Assurance (QA) procedure for Histopahology tests from 6/29/17 to 12/8/18. The finding includes: 1. The PM stated "All QC logs will be checked, signed and dated as each page is completed to make sure all the recorded data are within limits" but there was no documented evidence QC pages were signed when completed. 2. The TP confirmed via telephone on 6/26/19 at 9:30 am that the laboratory did not follow the PM. -- 2 of 2 --