Pariser Dermatology Specialists Ltd

Summary Statement of Deficiencies D0000 An announced on-site CLIA recertification survey was conducted at Pariser Dermatology Specialists LTD (Norfolk) on February 7, 2024 by the Virginia Department of Health's Office of Licensure and Certification. The survey also included a follow up interview with the laboratory's main histopathology supervisor on 2/8/24. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiency cited is as follows: D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on a tour, review of procedures, Chemical Inventory List, lack of documentation, and interviews, the laboratory failed to establish a written/approved safety protocol for fume/exhaust hood maintenance to ensure adequate ventilation checks for eighty-five (85) hazardous chemical reagents utilized to process/prepare tissue histopathology samples during twenty-two (22) of 22 months of review (timeframe April 2022 to the date of the inspection on February 7, 2024). Findings include: 1. During a tour of the main histopathology laboratory on 2/7/24 at 3:00 PM the inspector noted more than fifty chemical reagents stored in the laboratory's chemical cabinets and on staining stations. The inspector requested to review the chemical reagent inventory list. A provided Chemical Inventory List outlined eighty- eight (88) chemicals. The inspector noted that 85 of the 88 were labeled by manufacturers as hazardous. (*See Chemical Inventory List.) 2. Review of the laboratory's procedures revealed no written/approved fume hood maintenance protocol. The inspector noted that the laboratory had a pre-purchased Dermopathology CLIA guide. The guide included a table of contents that listed fume 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 -- hood maintenance. The pre-purchased fume hood template had not been updated and was left blank. The inspector inquired regarding the laboratory's protocol to verify safe levels of fume ventilation while utilizing the 85 hazardous chemicals. The supervisor provided a follow up statement on 2/8/24 at 4:00 PM, "We do not have a written policy but we will write a policy that specifies how the fume hood exhausts are being monitored to ensure we verify adequate fume ventilation." 3. Exit interviews with the practice manager, operations manager, pathology laboratory supervisor, and regional managers on 2/7/24 at 4:45 PM, and pathology laboratory supervisor on 2/8 /24 at 4:00 PM confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Pariser Dermatology Specialists LTD (Norfolk) on April 20-21, 2022 by the Virginia Department of Health's Office of Licensure and Certification. The inspector noted that the laboratory performs SARS-CoV-2 (COVID-19) testing and was in compliance with the applicable COVID-19 reporting requirements. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiency cited is as follows: D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of the Clinical Laboratory Improvement Amendments Application for Certification form (CLIA 116), tour, review of equipment user manual, maintenance logs, lack of documentation, and interviews, the laboratory failed to document daily and weekly histopathology preventative maintenance procedures according to the Leica CV5030 manufacturer's instructions for fourteen (14) of 14 months reviewed (February 2021 to the date of the survey on April 21, 2022). Findings include: 1. Review of the CMS 116 form on 4/20/22 revealed that the laboratory indicated two new histopathology laboratory equipment which included a Leica CV5030 Robotic Coverslipper (Serial Number RS485). 2. During a facility tour (pathology section) on 4/21/22 at approximately 11:00 AM, the inspector noted the Leica CV5030 Robotic Coverslipper, outlined above, in use in the histopathology specimen processing lab room. The inspector inquired regarding the date the laboratory installed the CV5030 equipment. The laboratory manager provided the installation date of February 2021. 3. Review of the Leica CV5030 user manual revealed the following preventative maintenance instructions: Daily - remove 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 -- adhesive residue and broken glass, check plastic container/refill with 5ml solvent, check level of glass vial in dispenser rest/park position, fill loading bath with solvent, prime dispenser needle with coverslip mountant and check flow, inspect cover slip catch tray; Weekly - replace all the solvent in the loading bath, rinse the dispenser group with solvent, check the brush of dispenser needle cleaner, replace any dirty/hard brushes; As Necessary (PRN) - fill coverslipping mounting bottle, replace carbon filter (no later than after every three months), check transfer station and clean as necessary (transfer arm, discharge chute) 4. Review of the laboratory's histopathology instrument maintenance logs revealed no documentation for the maintenance outlined above. The inspector requested to review documentation of the daily, weekly, and PRN tasks outlined by the manufacturer for the Leica CV5030 for the 14 months since installation in February 2021. No documentation was available for review. 5. An exit interview with the Clinical Operations Manger, Pathology Lab Manager, and Moh's Tech, on 4/21/22 at approximately 12:30 PM, the above listed findings were confirmed. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Pariser Dermatology Specialists LTD on November 6, 2019 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: A. Based on a tour, review of microtome user manual, instrument maintenance logs, and interviews, the laboratory failed to document annual preventative maintenance according to the manufacturer's instructions for two (2) of three (3) tissue section processors during the twenty-four (24) months reviewed. Findings include: 1. During a facility tour at approximately 11:00 AM, the inspector noted 3 Sakura AccuCut SRM 200 Rotary Microtome instruments in use in the histopathology specimen processing lab room (instruments were tagged/identified as A, B, and C). 2. Review of the Sakura Microtome user manuals revealed "Care of the Instrument" maintenance checklist instructions that stated: "Have the instrument inspected yearly by a qualified service technician authorized by Sakura Finetek as preventative maintenance (PM)". 3. Review of the laboratory's Sakura instrument maintenance logs for microtome A, B, and C revealed: Microtome A installation service was performed on 02/25/19. The inspector requested to review documentation of a yearly PM for microtome "B"-serial number (SN) 03597 and "C"- SN 14290194 for the timeframe of November 2017 to 11 /6/19. No records were available. The laboratory manager stated, at approximately 12: 30 PM, "we do not have yearly PM's scheduled for the instrumentation but we do call for service on an as needed basis". 4. In an exit interview with the laboratory manager 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 -- and practice manager, at approximately 2:00 PM, the above listed findings were confirmed. B. Based on a tour, review of users manual, instrument maintenance logs, and interviews, the laboratory failed to document slide dryer's cleaning and temperature maintenance checks according to the manufacturer's maintenance instructions in the twenty-four (24) months reviewed. Findings include: 1. During a facility tour at approximately 11:00 AM, the inspector noted one (1) Quincy Lab Model GC Series Lab Oven in use for patient tissue slide drying in the histopathology specimen processing room. 2. Review of the Model GC Series Lab Oven users guide revealed a highlighted "Periodic Oven Maintenance" section on page 4 that stated: "Operation safety requires periodic cleaning and chamber temperature accuracy verification. Periodically check/clean the rear air intake vents. Keep the intake and exit ports clear of obstruction, dust, and dirt. Once a year, check the oven chamber temperature against a known accurate temperature measurement device. Calibrate the control as necessary". 3. Review of the laboratory's instrument maintenance logs revealed no record of the Model GC Series Oven cleaning or temperature verification maintenance outlined above (timeframe of review: November 2017 to 11/6/19). The inspector requested to review the maintenance documentation. No records were available. The laboratory manager stated, at approximately 1:00 PM, "We have not performed the maintenance. We use the unit to dry slides prior to immunohistochemistry (IHC) staining. We were not instructed to do those maintenance procedures when the unit was installed". 4. In an exit interview with the laboratory manager and practice manager, at approximately 2:00 PM, the above listed findings were confirmed. 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 a tour, review of maintenance logs, and interviews, the laboratory failed to establish maintenance protocols for three (3) of five (5) microscopes utilized for histopathology patient testing during the twenty-four (24) months reviewed. Findings include: 1. During a facility tour at approximately 11:00 AM, the inspector noted the following three (3) microscopes in the histopathology specimen processing area: Nikon model E600 Serial Number (SN) 117796, Olympus Model BX43 SN 4H41210, Nikon YS2-T Serial# 148792. The inspector noted the following 2 microscopes in the nurse station work areas: Accuscope EXC 120 Series SN 1209016, Accuscope EXC 120 Series SN 070039. 2. A review of the laboratory's equipment maintenance logs (timeframe: November 2017 to date of inspection) revealed no record of preventative maintenance for the Nikon E600 SN 117796, Olympus BX43 SN 4H41210, or Nikon YS2-T SN 148792. The inspector requested to review the written maintenance protocols for the 3 microscopes utilized for histopathology patient testing listed above. No documentation was available for review. The laboratory manager stated, at approximately 12:00 PM, "We have protocols for Tidewater Medical Sales and Service to come in to perform yearly maintenance checks on the microscopes but they -- 2 of 3 -- checked and PM'd only the Accuscope microscopes. We have not added the other microscopes to that annual PM protocol". 3. In an exit interview with the laboratory manager and practice manager, at approximately 2:00 PM, the above listed findings were confirmed. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on a review of the laboratory's policies and procedures and an interview, the laboratory director (LD) failed to ensure that a quality assurance (QA) policy for the histopathology test procedures performed in the specimen processing room was established and maintained during the twenty-four (24) months reviewed. Findings include: 1. Review of the laboratory's policy and procedure manuals revealed no written and approved QA policy to include preanalytical, analytical, and post analytical quality measures for the histopathology specimen processing testing room during the timeframe of November 2017 to 11/6/19. The inspector inquired of laboratory QA protocols to correct problems such as missed required histopathology instrument/equipment maintenance utilized in the specimen processing room. The laboratory manager stated "We do not have a written QA policy. We do keep a

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Pariser Dermatology Specialists on January 23, 2018 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: 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: A. Based on a review of the procedure manual and an interview, the laboratory failed to verify the accuracy of Potassium Hydroxide (KOH) and dermatological Wet Preparations (Preps) microscopic examinations in 2016 and 2017. Findings include 1. The laboratory performs dermatological Wet Preps and KOH microscopic slide examinations, which are categorized as moderately complex and non-regulated tests. The inspector requested to review the documentation of twice a year accuracy checks for the aforementioned tests for 2016 and 2017. The documentation was not available for review. 2. An interview with main testing personnel at approximately 3:30 PM confirmed that the laboratory failed to verify the accuracy of dermatological Wet Preps and KOH microscopic examination for 2016 and 2017. B. Based on a review of the procedure manual and an interview, the laboratory failed to verify the accuracy of Dermatophyte Test Medium (DTM) cultures in 2016. Findings include: 1. The laboratory performs DTM cultures, which are categorized as moderately complex and non-regulated tests. The inspector requested to review the documentation of twice a year accuracy checks for 2016. The documentation was not available for review. 2. An interview with main testing personnel at approximately 3:30 PM confirmed that the laboratory failed to verify the accuracy of DTM cultures in 2016. 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 -- D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review, patient test logs, and an interview, the laboratory failed to document quality control for DTM (dermatophyte) test medium for twenty-one (21) of twenty-four (24) months reviewed. Findings include: 1. Review of quality control (QC) records for DTM cultures revealed QC documented from October 11, 2017 to the date of survey, January 23, 2018. The inspector requested to review the QC documentation for DTM cultures for January 2016 up to October 11, 2017. No other records were available for review. 2. Review of patient DTM test logs revealed four hundred eighty-one (481) patient cultures reported from January 2016 to October 11, 2017. 3. An interview with primary testing personnel at approximately 3:30 PM confirmed that the laboratory failed to document DTM QC for twenty-one (21) of twenty-four (24) months reviewed. -- 2 of 2 --