Pariser Dermatology Specialists, Ltd

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at Pariser Dermatology Specialists, LTD on 08/20/24 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 the review of policy and procedures (P&P), patient histology slides, Mohs surgery maps and interviews, the lab failed to follow the established P&P for patient labeling of Mohs histopathology tissue slides for one of eight random samples selected for review at the date of survey on 08/20/24. Findings include: 1. Review of P&P "Labeling/Accessioning of Slides and MMS Maps" revealed the following statement: "Slides are to be labeled "A" for the first slide, "B" for the second slide, "C" on the third slide, etc. for each additional slide. The first section is placed on the outermost edge of the slide furthest from the frosted edge. As additional sections are taken, they are placed adjacent until reaching the frosted end of the slide." 2. Review of eight random tissue slides and corresponding Mohs surgery maps revealed a discrepancy for Case number WB24-547 on 04/22/24 between the Mohs map and the patients' histology slide for "Stage III section 5 and 6". The Mohs map showed Stage III sections 5 and 6 as written written by the Mohs surgeon. The two corresponding patient slides for that stage was marked as II 3, 4 5 and II 3, 4 A. In an interview with the histotechnologist on 08/20/24 at approximately 1500, they confirmed that the slides were not labeled as written on the Mohs map for Stage III sectioning. 3. An exit 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 -- interview with the operations manager and the histotechnologist on 08/20/24 at 1530 confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Pariser Dermatology Specialists, LTD -Williamsburg on September 22, 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: 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 six (6) of fifty-four (54) patient culture results reviewed between December 15, 2020 to the date of the survey on September 22, 2022. 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 "Exam the culture for up to 14 days for color change and/or growth". 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. Interpretation of the test is questionable after fourteen days due to the possibility of false positives". 3. The inspector selected 54 random patient case numbers from the DTM patient logs 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 -- (timeframe of 12/15/20 to 09/22/22) 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 2984330 on 12/16/20 incubated eighteen (18) days; Case number 3513570 on 04/28/21 incubated twenty-three days; Case number 1142540 on 11/19/21 incubated 18 days; Case number 1541910 on 01/04 /22 recorded as result read retroactively on 01/04/21; Case number 3631140 on 01/04 /22 recorded as being read retroactively on 01/04/21; Case number 3982860 on 07/12 /22 incubated sixteen days; a total of 6 patient results were recorded outside of the manufacturer's recommended incubation time. 4. An exit interview with the operation managers on 09/22/22 at approximately 1:00 PM confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Pariser Dermatology Specialists-Williamsburg on August 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: 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 laboratory's policy manual, patient test logs, and interviews, the laboratory failed to follow their written policy for labeling MOHS slides using patient accession number, patient name, and layer/specimen number for thirteen (13) of thirteen (13) months reviewed while processing one thousand one hundred (1,100) patient cases. Findings include: 1. During a laboratory tour, the inspector observed three (3) patient MOHS slides in the testing processing area. The inspector noted that each slide was labeled with one patient identifier. The inspector asked the primary testing personnel (TP) to describe the process of labeling the MOHS slides. The testing personnel stated: "We write an accession or case number and each layer number on our slides." 2. Review of the policy manual revealed a procedure for labeling and accessioning of MOHS slides that stated: "Slides are labeled in pencil on the frosted end of the slide and will contain the patient accession number, patient name, and each layer/specimen number". 3. Review of the patient test logs from July 2017 to the date of the survey on August 23, 2018 revealed one thousand one hundred (1,100) MOHS cases listed by patient case number. The inspector requested the following five (5) random case numbers to be pulled 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 -- review: Case slide 235, processed on 10/26/17, did not have a patient name on the slides. Case slides WB18-008, WB18-009, WB18-010, WB18-011, processed on 1/18 /18, did not have patient names on the slides. The inspector and the TP reviewed the laboratory's written procedure for labeling of slides at approximately 12:00 PM, and the primary TP stated: "We have never written the patient's name on our slides. The policy does state that we will write the name but we have not followed that policy". 4. In an interview with the operations manager at approximately 12:30 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 and patient name) during the thirteen (13) of thirteen (13) months reviewed while processing one thousand one hundred (1,100) patient cases. 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 Dermatophyte Test Media (DTM) package insert, DTM patient logs, and an interview, the laboratory failed to follow the manufacturer's instructions for incubation time for three (3) of twenty (20) random patient tests reviewed from March 1, 2018 to August 23, 2018. 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 (14) days due to the possibility of false positives". 3. The inspector selected twenty (20) random patient case numbers from the DTM patient logs from the timeframe of March 1, 2018 to the day of the survey on August 23, 2018. Review of the selected patient DTM culture results revealed the following case number entries having incubation periods exceeding fourteen (14) days: Case number 5074000 on 03/30/18 incubated twenty-four (24) days; Case number 1906090 on 06/13/18 incubated fifteen (15) days; Case number 2013990 on 06/28/18 incubated nineteen (19) days; a total of three (3) of the twenty (20) patient results were recorded outside of the manufacturer's recommended incubation time. The inspector requested to review the repeat cultures for the case numbers listed above. No repeat culture results were available for review. 4. In an interview with the operation manager at approximately 12:30 PM , it was confirmed that the laboratory did not follow the manufacturer instructions for DTM incubation for the three (3) of twenty (20) patent case numbers as outlined above. D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 -- 2 of 3 -- The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), laboratory personnel files, and interview, the technical consultant failed to perform annual Potassium Hydroxide (KOH) competency assessments for six (6) of six (6) testing personnel in 2017 (Cross reference D6054). D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on a review of Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), laboratory personnel files, and an interview, the technical consultant (TC) failed to perform annual Potassium Hydroxide (KOH) competency assessments for six (6) of six (6) testing personnel in 2017. **REPEAT DEFICIENCY Findings include: 1. Review of the CMS Form 209 revealed that there are six (6) testing personnel performing KOH patient testing and that the lab director (LD) performs the duties of TC. (See Personnel Code Sheet.) 2. Review of the laboratory personnel files revealed no record of KOH annual competency assessments or split sample documentation in calendar year 2017 for: Testing personnel A, Testing personnel B, Testing personnel C, Testing personnel D, Testing personnel E, Testing personnel F. The inspector requested to review the 2017 annual competency documentation. The documentation was not available for review. 3. In an interview with the operations manager at approximately 12:30 PM, it was confirmed that the laboratory failed to document KOH competency assessments for the six (6) testing personnel outlined above in calendar year 2017. -- 3 of 3 --