Pariser Dermatology Specialists, Ltd

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Pariser Dermatology Specialists on March 4, 2021 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific deficiency cited is as follows: 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: Based on interviews, review of room temperature records, patient logs, and manufacturer's Dermatophyte Test Medium (DTM) package insert, the laboratory failed to record/monitor daily room temperature of the cabinet area utilized to incubate DTM culture medium on eight (8) days while reporting ten (10) patient results during the twenty-four (24) months reviewed. Findings include: 1. During the entrance interview on 3/4/21, the inspector noted that in the survey timeframe (February 2019 to the date of the survey) the laboratory performed DTM fungal cultures and confirmed with the office manager that the cultures were incubated in the nursing cabinet area. 2. The inspector reviewed the DTM room temperature records for the timeframe outlined above, and noted that the laboratory failed to to record the incubation room temperature on the following 8 days: 11/1-11, 2019 and 9/29/20. The inspector requested to review the temperature recordings for the dates outlined above. 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 confirmed on 3/4/21 at approximately 10:30 AM, that the laboratory failed to perform the temperature checks. 3. Review of the patient DTM logs for the 8 days outlined above revealed the following 10 patient cultures (by chart number) were incubated during the lapse in temperature monitoring: 3375370, 3397590, 2154060 (thumb and hand sample), 3410790, 3084220, 3655270, 3664950, 1659170, and 3647770. 4. Review of the Accuderm package insert revealed the following instructions: Incubate media at room temperature (15-30 C), aerobically, for up to fourteen days. Organisms differ in their requirements for humidity, temperature, atmosphere, and duration of incubation. The requirements must be observed in order to successfully culture the desired organism; variations of intended results may be due to improper specimen exposure to temperatures. 5. In an exit interview with the operation manager on 03/04/21 at approximately 3:30 PM, the above findings were confirmed. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Pariser Dermatology Specialists, LTD on February 12, 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: 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 procedures and policies, proficiency testing (PT) logs, and an interview, the laboratory failed to perform accuracy evaluations twice a year for fungal culture testing in calendar year 2017. Findings include: 1. Review of the laboratory's procedure manual revealed a dermatophyte culture PT policy that stated, "proficiency will be completed twice a year for providers using Acu-Derm test kits and DTM ATCC control samples following our procedure for fungal cultures". 2. Review of the laboratory's 2017 and 2018 Proficiency Testing Logs revealed one (1) DTM PT evaluation was documented during calendar year 2017 (dated 4/24/17). The inspector requested to review additional PT documentation of DTM fungal culture accuracy evaluations in calendar year 2017. No other records were available for review. 3. In an exit interview with the operation manager at approximately 3:30 PM, the above findings were confirmed. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic 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 -- systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on a review of the policy manual, ACU-DTM Dermatophyte Test Medium package insert, patient logs, problem logs, and an interview, the laboratory failed to: 1. follow the manufacturer's instructions for culture incubation time for seven (7) of eighteen (18) randomly selected patient fungal culture results in calendar years 2017 and 2018 (*REPEAT DEFICIENCY). See D 5411. 2. follow their