Dermatology Institute & Laser Center

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 the lack of Biannual Assessment (BA) records and interview with the Office Manager (OM), the laboratory failed to verify the accuracy of Histopathology testing in the calendar years 2022. The OM confirmed on 3/21/24 at 11:30 am that the laboratory did not perform BA for Histopathology. 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: A) Based on surveyor review of the Procedure Manual (PM), and interview with the Office Manager (OM), the laboratory failed to follow the procedure for "Proficiency Testing" for histopathology testing. The findings include: 1. The PM states "List of board certified dermatologists for this office" as "Dr Armin Bijal" and "Dr Marc Jacobson" 2. There was no documented evidence that the aforementioned doctors participated in the "Proficiency testing" procedure. 3. The OM confirmed on 3/21/24 at 11:00 am, the laboratory failed to follow the PM. B) Based on surveyor review of the Procedure Manual (PM), observation of Staining Station (SS) and interview with 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 Office Manager (OM), the laboratory failed to follow the PM for Hematoxyilin- Eosin (HE) staining from 9/15/22 to the date of the survey. The findings include: 1. The PM stated two dips of "95% Alcohol" after Eosin dip., the SS had one 2. The PM stated for steps fourteen, fifteen and sixteen as three changes of "100% Alcohol" the SS had two. 3. The OM confirmed on 3/21/24 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 Office Manager (OM), the laboratory failed to discard expired Histopathology reagent from 10/16/19 to the date of survey. The findings include: 1. Adventek Tissue marking dyes were expired as follows: a) Blue marking day lot # 115434 expired 1-31-2023 b) Yellow marking dye lot # 121748 expired 5-31-2023 c) Red marking day lot # 123231 expired 5-31-2023 2. Approximately 200 patients were tested with expired reagent. 3. The OM confirmed on 3/21/24 at 12:30 pm that the laboratory used expired reagents. -- 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 Practice Owner (PO) the laboratory failed to follow its policies and procedures for assessing the competency of TP who perform Histopathology testing at the date of survey. The findings include: 1. The CA was not performed on one out of one TP in the calendar years, 2020, and 2021. 2. The laboratory CA policy stated that testing personnel are evaluated annually. 3. The PO confirmed on 9/15/22 at 1:20 pm the laboratory did not follow the CA procedure. 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 Practice Owner (PO), the laboratory failed to follow all procedures written for Moh's tests from July 2020 to the date of the survey. The findings include: 1. There was no documented evidence the below mentioned procedure were followed: a. "C. Annually: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- Have preventative maintenance services performed on the MOHS pathologist Microscope". 2. The PO confirmed on 9/15/22 at 1:30 pm that the laboratory did not follow the PM. 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: a. Based on the lack of Temperature Logs (TL) and interview with the Practice Owner (PO), the laboratory failed to monitor and document Room Temperature (RT) and Humidity where Histopathology tests were performed from 8/2/19 to the date of survey. The PO confirmed on 9/15/22 at 1:30 pm that the laboratory did not document RT and Humidity. b. Based on the lack of Temperature Logs (TL) and interview with the Practice Owner (PO), the laboratory failed to to monitor and document temperature range for the Cryostat used in Histopathology tests from 8/2/19 to the date of the survey. The PO confirmed on 9/15/22 at 1:40 pm that the laboratory did not document temperature range for the Cryostat. 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 Practice Owner (PO), the laboratory failed to document Hematoxylin and Eosin (H&E) control slide reaction from 8/2/19 to the date of survey. The findings include: 1. The laboratory did not document H&E QC reaction for reading of Histopathology slides. 2. The laboratory read and reported approximately 450 patients. 3. The OM confirmed on 9/13522 at 1:20 pm that the laboratory did not document H&E QC stain reaction. D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) The laboratory director must ensure all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

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 the Automated Staining Station (ASS) and interview with the Office Manager (OM), the laboratory failed to follow Mohs Staining Procedure from June 2017 to the date of the survey. The findings include: 1. The ASS in the laboratory did not correspond with the staining procedure in the PM. a) The PM stated Staining Container (SC) # 5 was for Scott's Bluing reagent but ASS had water. b) The PM stated SC # 7 was for water but ASS had Bluing Solution.. c) The PM stated SC # 10 was for 95% Alcohol but ASS had Eosin. d) The PM stated SC # 11 was for 100% Alcohol but ASS had 95% Alcohol. 2. The OM confirmed on 8/2/19 at 10:00 am that PM procedure did not match with ASS. Note: This deficiency was previously cited 3/23/18. The

Summary Statement of Deficiencies D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual and interview with the Laboratory Director (LD), the laboratory failed to establish a written procedure for Biannual Assessment (BA) from June 2017 to the date of survey. The LD confirmed on 3/23/18 at 12:00 pm that a BA procedure was not established. 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 the Automated Staining Station (ASS) and interview with the Laboratory Director (LD), the laboratory failed to follow Mohs Staining Procedure from June 2017 to the date of the survey. The findings include: 1. The ASS in the laboratory did not correspond with the staining procedure in the PM. a) The PM stated Staining Container (SC) # 7 was for Scott's Bluing reagent but it was not on the ASS. b) The ASS had SC # 9 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 3 -- 95% alcohol but it was not in the PM. c) The PM had SC # 10 and 11 for 95% alcohol but there was no alchol in # 10 and 11 on ASS. d) The ASS had four 100% alcohol in SC # 10, 11, 12 and 13 but the PM stated three SC. e) The PM had Histoclear in SC # 15 but there no SC label for histoclear on ASS. 2. The LD confirmed on 3/23/18 at 12: 45 pm that PM procedure did not match with ASS. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on surveyor observation of the Staining Station and interview with the Laboratory Director (LD), the laboratory failed to label all staining jars used for Mohs testing from June 2017 to the date of the survey. The LD confirmed on 3/23/18 at 12: 35 pm that the staining jars were not labeled. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on surveyor review of the laboratory records and interview with the Laboratory Staff (LS), the laboratory failed to establish a maintenance protocol for automated stainer and Fume Hood when protocols were not provided by the manufacturer from June 2017 to the date of survey. The LS confirmed on 3/23/18 at 12:20 pm that the laboratory did not establish maintenance protocol. D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) The laboratory director must ensure all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require