Dermatology Consultants Of Short Hills

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 Procedure Manual (PM), lack of Biannual Assessment (BA) records and interview with the Office Manager (OM), the laboratory failed to verify the accuracy and reliability of Histopathology testing twice a year from 1/1/24 to 5/6/25. The finding includes: 1. There was no documented evidence that a BA was performed from January 2024 to June 2024. 2. The BA from July 2024 to December 2024 was sent to the reviewing pathologist on 10/30/24. The laboratory did not receive the evaluation from the reviewing pathologist. 3. The OM confirmed 5 /6/25 at 1:10 pm, the laboratory did not verify the accuracy of Histopathology testing twice a year. *Note: This deficiency was previously cited on the previous survey performed on 4/19/23. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (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 Tissue Marking Dyes and Reagents, surveyor review of the Procedure Manual (PM)and interview with the Office Manage (OM) the laboratory used and failed to discard expired Tissue Marking Dye (TMD) used 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 -- Histopathology testing from 12/31/24 to 5/6/25. The findings include: 1. The PM states "do not use reagents after expiration date." 2. One Yellow TMD Lot# 162674 was observed to be expired on 12/31/24. 3. One Blue TMD Lot# 163941 was observed to be expired on 1/31/25. 4. Approximately fifty patients tests results were reported using the expired yellow TMD. 5. One patient tests results were reported using the expired blue TMD. 6. The OM confirmed on 5/6/25 at 1:20 pm, the laboratory used and failed to discard expired TMD for Histopathology testing. * Note this deficiency was cited on the previous survey performed on 4/19/23. -- 2 of 2 --

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 Procedure Manual (PM), lack of Biannual Assessment (BA) records and interview with the Office Manager (OM), the laboratory failed to verify the accuracy and reliability of Histopathology testing twice a year in the calendar year 2022. The finding includes: 1. There was no evidence that a BA was performed in 2022. 2. The OM confirmed on 4/19/23 at 1:00 pm that the laboratory did not verify the accuracy of Histopathology testing twice a year. 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 Office Manager (OM), the laboratory failed to follow the PM for Hematoxyilin-Eosin (HE) staining from 9/28/21 to the date of the survey. The findings include: 1. The PM stated step nine "100% Alcohol 10 seconds (3 Changes)" 2. The SS had two changes of 100% Alcohol at step 9. 3. The OM confirmed on 4/19/23 at 1:30 pm that the laboratory did not follow the PM. 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 -- 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 Office Manager (OM), the laboratory failed to discard expired Histopathology reagent from 6 /30/22 to the date of survey. The finding include: 1. Gill 3 Hematoxylin reagent Lot 112907 expired 6/30/22. 2. Approximately 200 patients were tested with expired reagent. 4. The OM confirmed on 4/19/23 at 2:30 pm that the laboratory used expired reagents. -- 2 of 2 --

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on surveyor review of temperature charts, observation of the room where Mohs testing was performed and interview with the Office Manager (OM), the laboratory failed to monitor and document the temperature where Mohs testing was performed from 5/2/18 to the date of the survey. The OM confirmed on 9/28/21 at 12:45 pm that the temperature was not monitored. 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 Mohs reagents and interview with the Office Manager (OM), the laboratory failed to discard an expired Mohs reagent from 5/2/18 to the date of survey. The findings include: 1. On the date of the survey the laboratory 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 -- had an expired reagent as follows: Avantik Eosin Y Stain Solution, 1 % (w/v) in Alcohol. Lot number J168-06, Expiration 6/25/21 2. Approximately 60 patients were tested with the expired reagent. 3. The OM confirmed on 9/28/21 at 12:15 pm that the laboratory used an expired reagent. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) 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 Files (PF) and interview with the Office Manager (OM), the Laboratory Director failed to have appropriate training documented for one out of two TP on the date of the survey. The OM confirmed on 9 /28/21 at 12:30 pm that training records were not available. -- 2 of 2 --

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 Assessment (BA) records and interview with the Office Manager (OM), the laboratory failed to perform BA twice a year for Histopathology tests in the calendar year 2016 and 2017. The finding includes: 1. A review of BA records revealed in 2016 BA was performed once and was not performed in 2017. 2. The OM confirmed on 5/2/18 at 10:45 am that BA was not performed twice a year. 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 Office Manager (OM), the laboratory failed to document the reaction of the QC slide for the Hematoxylin and Eosin stain used in Mohs Testing from 1/1/17 to the 5/1/18. The OM confirmed on 5/2/18 at 10:30 am that QC reactions were not documented. 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 -- 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. This STANDARD is not met as evidenced by: Based on surveyor review of the Final Report (FR) and interview with the Office Manager (OM), the laboratory failed to ensure that the FR included all the required information in 2018. The findings include: 1. A review of ten FR revealed four out of ten did not have the name and address of the laboratory where tests were performed. 2. One out of ten FR reviewed did not include all three stages removed. 3. The OM confirmed and stated on 5/2/18 at 11:45 am that FR did not have all the required information. -- 2 of 2 --