Schweiger Dermatology, Pc - Millburn

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 complete procedure for Biannual Assessment (BA) on the date of survey. The findings include: 1) The BA procedure states the the reviewing pathologists for BA are Dr. Mark Jacobson and Dr. Paul CHU. 2) The BA for calendar year 2022 was not reviewed by the above mentioned pathologists. 3) The BA procedure does not include not the name and credentials of the current second and third party reviewing pathologists. 4) The TP confirmed on 2/7/23 at 12:00 pm that the laboratory did not have the aforementioned complete 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 reagents for Histopatholgy testing 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 -- from 1/26/23 to the ate of survey. The findings include: 1. Xylene Substitute XS-3 Lot # 146548 expired 1/26/23. 2. StatLab Marking Dye Lot # 4249 expired 1/31/23. 3. Approximately 10 patients were tested with the expired reagent. 4. The TP confirmed on 2/7/23 at 12:30 pm that the laboratory used expired reagent. 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 failed to ensure that the education records were available on the date of the survey. The finding includes: 1. Education records were not available for two out of three TP. 2. The TP confirmed on 2/7/23 at 1:00 pm that education records were not available. -- 2 of 2 --

Summary Statement of Deficiencies 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 Laboratory Consultant (LC), the laboratory failed to document Hematoxylin and Eosin (H&E) control slide reactions for Mohs testing in the calendar year 2019. The findings include: 1. The laboratory did not document H&E stain QC reactions from January through July of 2019. 2. The laboratory read and reported approximately 177 patients slides in the above time period. 3. The LC confirmed on 2/18/19 at 11:30 am that the laboratory did not document H&E QC stain reaction. 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: 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 -- Based on surveyor review of Personnel Records (PR) and interview with the Laboratory Consultant (LC), the Laboratory Director failed to ensure that the education record for one of four testing personnel was available on the date of the survey. The LC confirmed 2/18/20 at 10:00 am that all education records were not available. -- 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 CA correctly on six out of six TP in the calendar years 2016 and 2017. The findings include: 1. The laboratory did not document when testing personnel were observed, what records were reviewed and how assessment was done for Dermatopyte Test Medium (DTM). 2. Assessment of problem solving skills was not documented on CA for six out of six TP for DTM.. 3. CA was not performed for Mohs testing. 4. The TP # 4 listed on CMS form 209 confirmed on 3/22/18 at 10:20 am that the CA procedure was not performed correctly. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Testing Personnel (TP), the laboratory failed to review and evaluate coded Dermatophyte Screen PT results obtained from the Medical Laboratory Evaluation (MLE) for the 2017 - M3 PT event. The finding includes: 1. There was no review or 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 -- evaluation documented when the laboratory received "Not Graded" results for specimen DM-5. 2. The TP #2 listed on CMS form 209 confirmed on 3/22/18 at 10:15 am that the laboratory did not evaluate all PT results. 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 Testing Personnel (TP), the laboratory failed to perform BA twice a year for Histopathology in the calendar year 2017. The TP # 4 confirmed on 3/22/18 at 11:45 am that BA was not performed twice in 2017. 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 Records (TR) and interview with the Testing Personnel (TP) the laboratory failed to monitor and record the Temperature where Dermatophyte Test Medium (DTM) were incubated and stored from 1/6/16 to the date of the survey. The finding includes: 1. A review of the TR revealed DTM storage and incubator temperature was not monitored daily. 2. The TP #2 listed on CMS form 209 confirmed on 3/22/18 at 10:45 am that temperature was not monitored and recorded daily. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on surveyor review of the Personnel Files and interview with the Testing Personnel (TP), the Technical Consultant (TC) failed to evaluate the competency of six out of six Testing Personal (TP) in the calendar years 2016 and 2017. The finding includes: 1 . CA was evaluated by TP # 2 listed on CMS form 209 who had a high school diploma and was not qualified to perform CA 2. The TP #4 listed on CMS form 209 confirmed on 3/22/18 at 11:40 am that the TC did not perform CA. -- 2 of 2 --