Pariser Dermatology Specialists

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Pariser Dermatology Specialists LTD (Suffolk) on April 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 deficiencies cited are as follows: D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on a review of policy/procedures, manufacturer's package insert, patient logs, and an interview, the laboratory failed to follow the manufacturer's instructions for culture incubation period for twelve (12) of forty (40) randomly selected patient Fungal culture results reviewed from 2020 and 2021 logsheets. Findings include: 1. Review of the laboratory's Dermatology Procedure Manual revealed a Fungal Culture policy that outlined that the laboratory utilizes ACU-DTM Dermatophyte Test Medium to detect dermatophytes from patient cutaneous sources. The policy stated "Examine the culture for up to 14 days." 2. The DTM manufacturer's package insert defined the patient incubation period of up to fourteen (14) days and instructions to disregard any color change in the medium after the 14 days of incubation. The package insert instructions stated "Reading should be made within fourteen days. Color interpretation of the test is questionable after fourteen (14) days due to the possibility of false positives". 3. The inspector selected 40 random patient account numbers from the 2020 and 2021 DTM patient logs for review. Review of the 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 -- randomly selected patient DTM culture results revealed the following entries having incubation periods exceeding fourteen (14) days: 2011090 on 08/11/20 incubated twenty (20) days; 707500 on 09/16/20 incubated fifteen (15) days; 3581790 on 12/21 /20 incubated fifteen (15) days; 3207690 on 01/06/21 incubated fifteen (15) days; 3804070 on 03/03/21 incubated twenty-one (21) days; 2163880 on 04/06/21 incubated twenty (20) days; 2497160 on 04/08/21 incubated eighteen (18) days; 3080910 on 04 /09/21 incubated seventeen (17) days; 3837130 on 04/09/21 incubated seventeen (17) days; 2934690 on 11/10/21 incubated nineteen (19) days-culture A; 2934690 on 11/10 /21 incubated nineteen (19) days-culture B; 933510 on 11/10/21 incubated eighteen (18) days; a total of 12 of 40 patient results reviewed were recorded outside of the manufacturer's recommended incubation time. 4. An exit interview with the office Clinical Operations Manager on 4/21/22 at approximately 3:30 PM, confirmed the above findings. 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 a tour, review of policy and procedure manual, patient test logs, and interviews, the laboratory failed to ensure that their Potassium Hydroxide (KOH) 10% and fungal stain reagent, stored in the nursing station microscopy area, were within the manufacturer's stated expiration dates for two (2) of 2 lot numbers of reagents while reporting thirty-two (32) patient Tissue Fungal Exam KOH results from September 30, 2021 to the date of the survey on April 21, 2022. Findings include: 1. During a laboratory tour of the nursing station microscopy area on 4/21/22 at approximately 2:15 PM, the inspector noted the following 2 expired reagents: Medical Chemical Company Potassium Hydroxide 10%, Lot Number 0084-00 (manufacturer's printed expiration date 09/30/2021); HealthLink Fungal Black E Stain, Lot Number 9296 (manufacturer's printed expiration date 10/23/2021). The laboratory inspector noted substantial particulate matter afloat in the reagent bottles and inquired if the expired KOH and fungal stain reagents were being used for patient testing. The operations manager and lead nurse confirmed with statement: "Yes, they are still being used. We will reorder today". 2. Review of the laboratory's policy and procedure manual revealed a Potassium Hydroxide (KOH) Examination procedure that included a Reagents Storage, Use, and Handling protocol that stated: "Do not use the KOH 10% and KOH with Chlorazol Black E reagents after expiration date". 3. Review of the laboratory's Tissue Exam Fungal KOH test logs revealed 32 patient results were reported while utilizing the expired reagents (timeframe 9/30/21 to 4/21 /22). 4. An exit interview with the office Clinical Operations Manager on 4/21/22 at approximately 3:30 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 on January 14, 2020 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. The specific deficiency cited is as follows: 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 the microscope utilized for histopathology patient testing during the twenty-two (22) months reviewed. Findings include: 1. During a facility tour at approximately 1:00 PM, the inspector noted the following microscope in the histopathology MOHS specimen processing area: Olympus Model BX43F Serial Number (SN) 7C50581 (labeled with a maintenance sticker that stated "service due January 2021"). The inspector noted the following microscope in the nurse station work areas: Accuscope Model 3004 SN 060235. 2. A review of the laboratory's equipment maintenance logs (timeframe: March 2018 to date of inspection) revealed no record of preventative maintenance for the Olympus Model BX43F SN 7C50581. The inspector requested to review the written maintenance protocols for the microscope utilized for histopathology patient testing listed above. No documentation was available for review. The laboratory manager stated, at approximately 3:00 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 -- "We have protocols for Tidewater Medical Sales and Service to come in to perform yearly maintenance checks on the microscopes but our records indicate that they checked and PM'd only the Accuscope microscope that we use for wet prep exams. I will email our maintenance contact to make sure we have added the MOHS microscope to that annual PM protocol". The histotechnologist stated, at approximately 3:00 PM, "We had Tidewater Service come in last week to service the microscope in the MOHS lab but he did not leave any records". 3. In an exit interview with the practice manager and histotechnologist at approximately 3:30 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 Specialist (Suffolk) on March 6, 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: 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 calendar years 2016 and 2017. Findings include 1. The review of the procedure manual revealed that 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 in 2016 and 2017. The documentation was not available for review. 2. An interview with the laboratory director at approximately 3:45 PM confirmed that the laboratory failed to verify the accuracy of dermatological Wet Preps and KOH microscopic examination for 2016 and 2017. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. 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 the review of the CMS Application for Certification Form (CLIA 116), CMS Laboratory Personnel Form (CLIA 209), policy and procedure manual and interview, the laboratory director failed to document approval and date of review for the written policies and procedures at the date of survey on March 6, 2018. Findings include: 1. Review of the CLIA 116 and CLIA 209 forms revealed that there was a change in laboratory director. The inspector reviewed a signed document from the previous laboratory director assigning laboratory directorship to the current laboratory director for the Mohs histological test system on July 17, 2017. 2. Review of the policy and procedure manual for the Mohs histological test system revealed no documentation of approval and date of review of the written policies and procedures by the current laboratory director. 3. An interview with the laboratory director at approximately 3:45 PM confirmed that the current laboratory director failed to review and approve the policy/procedure manual. 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 the review of Dermatophyte Test Media (DTM) quality control (QC) records, patient test logs, and an interview, the laboratory failed to document before or concurrent with use the ability of the DTM to grow, inhibit growth and produce the expected biochemical response for the twelve (12) of twenty-four (24) months reviewed. Findings include: 1. Review of DTM QC records revealed there was no QC documentation from January 1, 2016 through December 31, 2016. The inspector requested to review DTM QC records for 2016. The records were not available for review. 2. Review of the patient DTM test logs revealed sixty-eight (68) patient cultures reported from January 1, 2016 through December 31, 2016. 3. An interview laboratory director at approximately 3:45 PM confirmed the laboratory failed to document DTM QC from January 1, 2016 through December 31, 2016. -- 2 of 2 --