Pariser Dermatology Specialists

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Pariser Dermatology Specialists on October 10, 2024 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific deficiencies cited are as follows and include the Condition under 42 CFR part 493 CLIA Regulation: D6168 -42 CFR. 493.1487 Condition Testing Personnel. D6168 TESTING PERSONNEL CFR(s): 493.1487 The laboratory has a sufficient number of individuals who meet the qualification requirements of 493.1489 of this subpart to perform the functions specified in 493. 1495 of this subpart for the volume and complexity of testing performed. This CONDITION is not met as evidenced by: Based on a review of the CLIA Laboratory Personnel Report Form, available testing personnel (TP) files, lack of documentation, and interview, the laboratory failed to retain education record to document qualifications of one of three TP identified as responsible for high complexity histopathology testing procedures during the review timeframe of January 2023 to October 10, 2024. See D6171. D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located or have earned a doctoral, master's or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; (b)(2)(i) Have earned 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 -- an associate degree in a laboratory science, or medical laboratory technology from an accredited institution or-- (b)(2)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes-- (b)(2)(ii)(A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, include either-- (b)(2)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(2)(ii)(A)(2) 24 semester hours of science courses that include-- (b)(2) (ii)(A)(2)(i) Six semester hours of chemistry; (b)(2)(ii)(A)(2)(ii) Six semester hours of biology; and (b)(2)(ii)(A)(2)(iii) Twelve semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(2)(ii)(B) Have laboratory training that includes either of the following: (b)(2)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES, the CAHEA, or other organization approved by HHS. (This training may be included in the 60 semester hours listed in paragraph (b)(2)(ii)(A) of this section.) (b)(2)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing. (b)(3) Have previously qualified or could have qualified as a technologist under 493.1491 on or before February 28, 1992; (b) (4) On or before April 24, 1995 be a high school graduate or equivalent and have either-- (b)(4)(i) Graduated from a medical laboratory or clinical laboratory training program approved or accredited by ABHES, CAHEA, or other organization approved by HHS; or (b)(4)(ii) Successfully completed an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); (b)(5)(i) Until September 1, 1997-- (b)(5)(i)(A) Have earned a high school diploma or equivalent; and (b)(5)(i)(B) Have documentation of training appropriate for the testing performed before analyzing patient specimens. Such training must ensure that the individual has-- (b)(5)(i)(B)(1) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; (b)(5)(i)(B)(2) The skills required for implementing all standard laboratory procedures; (b)(5)(i)(B)(3) The skills required for performing each test method and for proper instrument use; (b)(5)(i)(B)(4) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(5)(i)(B)(5) A working knowledge of reagent stability and storage; (b)(5)(i)(B)(6) The skills required to implement the quality control policies and procedures of the laboratory; (b)(5)(i)(B)(7) An awareness of the factors that influence test results; and (b)(5)(i)(B)(8) The skills required to assess and verify the validity of patient test results through the evaluation of quality control values before reporting patient test results; and (b)(5)(i)(B)(8)(ii) As of September 1, 1997, be qualified under 493.1489(b)(1), (b)(2), or (b)(4), except for those individuals qualified under paragraph (b)(5)(i) of this section who were performing high complexity testing on or before April 24, 1995; (b)(6) For blood gas analysis-- (b)(6) (i) Be qualified under 493.1489(b)(1), (b)(2), (b)(3), (b)(4), or (b)(5); (b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b)(6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution; or (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (l) to perform tissue examinations. This STANDARD is not met as evidenced by: Based on a review of the CLIA Laboratory Personnel Report Form (CMS-209 Form), available testing personnel (TP) files, lack of documentation, and interview, the laboratory failed to retain education record for one (1) of three (3) TP identified as qualified to perform high complexity histopathology testing procedures on the date of -- 2 of 3 -- the inspection (review timeframe: January 2023 to October 10, 2024). Findings include: 1. Review of the laboratory's CMS 209 form revealed that the lab director identified 3 histopathology TP responsible for high complexity Mohs pathology patient tissue processing/grossing during the review timeframe of 1/18/23 to 10/10/24. 2. Review of the available Mohs Laboratory Histotech personnel records for TP A revealed TP A was added as a new testing personnel on May 8, 2023 with initial training for patient tissue processing/grossing dated 5/8/23. (See Personnel Code Sheet attached). The inspector requested to review education records for TP A. No record was available for review. 3. An interview with the Operations Manager on 10 /10/24 at noon confirmed the above findings. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Pariser Dermatology Specialists on February 2-3, 2021 by the Virginia Department of Health's Office of Licensure and Certification. The remote survey included record review on 02/02/2021 with virtual interviews and tour on 02/03/21. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific deficiency cited is 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 the policy manual, manufacturer's package insert, patient logs, and an interview, the laboratory failed to follow the manufacturer's instructions for culture incubation time for nine (9) of eighty-nine (89) patient culture results reviewed between January 16, 2019 to January 29, 2021. Findings include: 1. Review of the laboratory's Dermatology Procedure Manual revealed a Fungal Culture policy that outlined that the laboratory utilizes Accuderm's ACU-DTM Dermatophyte Test Medium to detect dermatophytes from patient cutaneous sources. The policy stated "The culture must be interpreted by a provider within 10-14 days of inoculation. Any culture that has not been interpreted within 14 days must be repeated". 2. The Accuderm's 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 days due to the possibility of false positives". 3. The inspector selected 89 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 -- random patient case numbers from the DTM patient logs (timeframe of 01/16/19 to 01 /29/21) for review. The review of the selected patient DTM culture results revealed the following case number entries having incubation periods outside the protocol of 14 days: Case number 460110 on 02/19/19 recorded as being read on 2/18/19; Case number 3185730 on 02/01/19 incubated fifteen (15) days; Case number 2929550 on 04 /03/19 incubated 15 days; Case number 3164430 on 05/28/19 incubated sixteen (16) days; Case number 2974830 on 10/21/19 incubated twenty-one (21) days; Case number 2098480 on 10/31/19 recorded as being read on 10/15/19; Case number 1872800 on 10/31/19 recorded as being read on 10/15/19; Case number 1017820 on 10 /31/19 recorded as being read on 10/15/19; Case number 2855960 on 1/12/21 incubated 15 days; a total of 9 patient results were recorded outside of the manufacturer's recommended incubation time. 4. In an exit interview with the operation manager on 02/03/21 at approximately 11:30 AM, the above findings were confirmed. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Pariser Dermatology Specialists on October 10, 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: D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on a laboratory tour, review of the policy manual, and interviews, the laboratory failed to follow their written policy for labeling MOHS slides using patient accession number, patient last and first name, date, and layer/specimen number for four (4) of (4) cases observed on the date of the survey, October 10, 2018. Findings include: 1. During a laboratory tour, at approximately 1:00 PM on 10/10/18, the inspector observed 4 patient MOHS cases with slides in the testing processing area. The inspector noted that for each of the 4 cases, the slides were labeled with one patient identifier (patient last name), the number 10/10, and a layer alphabet. 2. Review of the policy manual revealed a Slide Preparation, Completion, and Storage Procedure, Revision Date 2/25/17, that stated : "With Tissue Tek slide marker, write patient's last name, first initial, date, tissue layer, and section number on each slide". The inspector noted a procedure addendum for labeling and accessioning of MOHS slides that stated "Slides are labeled with Zebra EMR printed label that will contain the patient accession number, patient last and first name, date, and each layer /specimen number." 3. The inspector asked the primary TP and operations manager, at 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 -- approximately 2:00 PM, to describe the process of adding the zebra printer labels to the patient slides. The primary TP stated: "We do not have a zebra printer here at Newport News. We have not been following the policy of labeling with accession number and patient last and first name onsite. It is not until we print the labels at our main lab in Norfolk that we add the printed label with additional identifiers to the hand written labels before the slides are put in storage". 4. In an interview with the operations manager and lead TP at approximately 3:30 PM, it was confirmed that the laboratory failed to follow their written policy for labeling MOHS slides using two (2) positive unique identifiers (patient accession number, patient first and last name) at the time of tissue sample receipt onsite and through the testing/resulting as outlined above. 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 a laboratory tour, review of policies, and interviews, the laboratory failed to label the in use Hematoxylin and Eosin (H & E) reagents, at total of sixteen (16) containers, with appropriate identification on the date of the inspection, October 10, 2018. Findings include: 1. During a laboratory tour at approximately 1:00 PM on 10 /10/18, the inspector noted that the sixteen (16) H & E staining containers in use for staining slides for MOHS testing were not labeled with content name, lot number, open date or an expiration date. The inspector asked the primary testing personnel (TP) to describe the laboratory guidelines used to determine the staining order by hand staining. The TP stated: "Our containers are not labeled now because the label's adhesive fell off, but I am ordering new labels". 2. Review of the policy and procedure manual revealed a Frozen Section Staining policy that included instructions: "all slides are stained in this order by hand staining: 95% Alcohol for 2 minutes, Water (dip until clear), Hematoxlyin for 2 minutes, Water, Bluing Solution, Water, Water, 95 % Alcohol, Eosin, 95 % Alcohol, 95 % Alcohol, 95 % Alcohol, 100 % Alcohol, 100 % Alcohol, 100 % Alcohol, Citrisolve. Staining set up is in the weekly duties procedure". Review of the weekly duties procedure revealed a Quality Assurance (QA) statement: "Discard reagents that are unlabeled or those whose expiration date has passed". 3. During an interview with the primary TP and practice manager at approximately 3:30 PM, it was confirmed that, on the date of the survey, the laboratory failed to label 16 of 16 H & E staining reagents with the required identification of reagent name and expiration date. 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. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on a laboratory tour, review of policy and procedure manual, and interviews, the laboratory failed to ensure that their Potassium Hydroxide (KOH) 10% and fungal stain reagent, stored in the microscopy area, were within the manufacturer's stated expiration dates for two (2) lot numbers of reagents. Findings include: 1. During a laboratory tour of the microscopy area at approximately 1:15 PM on 10/10/18, the inspector noted the following 2 expired reagents stored beside the Olympus CH microscope: One (1) bottle of HealthLink Potassium Hydroxide (KOH) 10%, Lot Number 1425304, with manufacturer's printed expiration date of 7/2017; 1 bottle of HealthLink Fungal Black E Stain, Lot Number 400308, with manufacturer's printed expiration date of 9/10/2017. The laboratory inspector asked if the expired KOH and fungal stain reagents were being used for patient testing and the operations manager stated: "Yes, they are being used but 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 the expiration date". 3. During an interview with the primary testing personnel and operations manager at approximately 3:30 PM, it was confirmed that the laboratory failed to ensure that the 2 KOH Examination reagents, listed above, were not used beyond the expiration dates. -- 3 of 3 --