Clinical Skin Center Of Northern Virginia, The

Summary Statement of Deficiencies D0000 An announced off-site CLIA recertification survey was conducted for The Clinical Skin Center of Northern Virginia on January 26, 2022 by the Virginia Department of Health's Office of Licensure and Certification. The survey included an entrance interview on January 7, 2022 and virtual record review conducted on January 21 and 24, 2022. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. The specific deficiency is as follows: 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: A. Based on a review of the laboratory's "Chemical Log Sheet", MOHS/Frozen Section accession log and interview, the laboratory failed to ensure the Schiff's Reagent used in the staining of frozen section specimens was within manufacturer's expiration date while staining nine (9) patients from August 13, 2021 until August 27, 2021. Findings include: 1. A review of the laboratory's "Chemical Log Sheet" revealed the following: a. 1 gallon of Mercedes Schiff's reagent (lot number 103203 /expiration date 07/31/2021) was received on 11/05/2020 with an open date of 05/28 /2021; b. 1 gallon of Mercedes Schiff's reagent (lot number 2116916/expiration date 06 /22/2022) was received on 08/26/2021 with an open date of 09/03/2021. There were no other lots of Schiff's reagent listed with "Open Dates" on the laboratory's "Chemical Log Sheet". 2. A review of the laboratory's "MOHS/Frozen Section Accession Log" revealed 9 Frozen Section patient specimens were stained from 08/01 /2021 until 09/03/2021 while using the expired Schiff's reagent (lot number 103203 /expiration date 7/31/2021). 3. In an exit interview with Mohs Technician A on January 26, 2022 at approximately 10:00 AM, the findings were confirmed. B. Based 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 -- on a review of the laboratory's "Chemical Log Sheet", MOHS/Frozen Section accession log, and interview, the laboratory failed to ensure the 10% Potassium Hydroxide (KOH) solution used for the softening of patient nail specimens was within manufacturer's expiration date while processing six (6) patient specimens from October 29, 2021 until November 19, 2021. Findings include: 1. A review of the laboratory's "Chemical Log Sheet" revealed the following: a. 1 bottle of Mercedes 10% KOH solution (lot number 9301/expiration date 10/28/2021) received on 03/23 /2020 with an open date of 01/08/2021; b. 1 bottle of Mercedes 10% KOH solution (lot number 0275/expiration date 10/01/2022) received on 01/26/2021 with an open date of 11/19/2021. There were no other lots of KOH solution listed with "Open Dates" on the laboratory's "Chemical Log Sheet". 2. A review of the laboratory's "MOHS/Frozen Section Accession Log" revealed six (6) nail specimens were processed from 10/29/2021 until 11/19/2021 with the expired 10% KOH solution (lot number 9301/expiration date 10/28/2021). 3. In an exit interview with Mohs Technician A on January 26, 2022 at approximately 10:00 AM, the findings were confirmed. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at The Clinical Skin Center of Northern Virginia on September 4, 2019 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. The specific deficiencies are as follows: D5427 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(c) (c) Documentation. The laboratory must document all activities specified in this section. This STANDARD is not met as evidenced by: Based on a tour, review of the laboratory's performance validation/verification records, patient test logs, and interviews, the laboratory failed to document the validation of the Vector PNI IHC (CK) Immunohistochemical (IHC) stain kit prior to reporting twenty-two (22) patient results using the new IHC staining kit from June 12, 2019 to the date of survey on September 4, 2019. Findings include: 1. During a tour of the laboratory at approximately 10:00 AM, the surveyor noted IHC reagents for the Vector PNI IHC (CK) IHC kit (lot ZE1121 exp. 9/20) in use for patient IHC staining for the detection of CK. The surveyor asked when the laboratory began using the Vector PNI IHC kit in the laboratory. TP F stated they began patient testing for CK in June 2019. 2. Review of the laboratory's performance validation/verification documentation records revealed a lack of documentation of the validation of the new Vector PNI IHC (CK) IHC stain kit. The inspector requested to review documentation that the laboratory had performed validation of the new IHC stain kit prior to patient testing. The laboratory provided no documentation of the new IHC stain validation for review. 3. In an interview with TP B, TP F, TP G and Mohs Technician (MT) A at approximately 1:15 PM, TP B stated they performed the validation but they did not have the documentation. 4. Review of patient test logs revealed that the laboratory reported 22 patient PNI CK IHC stain results using the Vector PNI IHC (CK) stain kit 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 -- from June 12, 2019 to the date of the survey on September 4, 2019. 5. In an exit interview with the TP F at approximately 2:00 PM, the above findings were confirmed. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Clinical Skin Center of Northern Virginia on February 1, 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: D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of the laboratory's immunology proficiency testing (PT) records, Hitachi CLA-1 analyzer documentation, and interviews, the laboratory failed to rotate proficiency testing among personnel performing patient immunology testing in 2016 and 2017. Findings include: 1. Review of the laboratory's 2015, 2016, and 2017 American Proficiency Institute (API) immunology PT documentation revealed that the laboratory is enrolled as customer number 69032 and that testing personnel A performed seven (7) of seven (7) events reviewed. (See Personnel Code Sheet) 2. Review of the laboratory's Hitachi CLA-1 Luminometer Allergen Specific IgE analyzer documentation revealed that testing personnel (TP) A and B received initial training from the manufacturer's field service engineer in calendar year 2015 as operators and that patient data logs, quality control runs, and calibration verification studies were performed by both TP A and B in 2016 and 2017. 3. During a facility tour at approximately 2:30 PM, the inspector interviewed the laboratory director regarding the testing personnel who utilize, operate, and report results from the Hitachi CLA-1 analyzer. The laboratory director stated that "TP A is the primary testing personnel and TP B is our back up operator". 4. In an exit interview with the laboratory director, clinical consultant, office manager, and primary testing personnel Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- on 2/1/18 at approximately 4:30 PM , it was confirmed that the laboratory failed to rotate immunology proficiency testing among all personnel responsible for performing patient testing on the Hitachi CLA-1 assay in 2016 and 2017. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a review of the laboratory's 2015, 2016, and 2017 immunology proficiency testing (PT) documentation, and an interview, the laboratory failed to retain attestation statements signed by the laboratory director and testing personnel for three (3) of seven (7) events reviewed and failed to retain documentation of the analyzer results for seven (7) of seven (7) events reviewed. Findings include: 1. Review of the laboratory's American Proficiency Institute (API) immunology PT documentation (customer number 69032), a total of seven (7) events, revealed no signed attestation statements for: 2017 Event 1 2017 Event 2 2017 Event 3 and revealed no Hitachi CLA-1 Luminometer instrument result print outs were retained for: 2015 Event 3 2016 Event 1 2016 Event 2 2016 Event 3 2017 Event 1 2017 Event 2 2017 Event 3. The inspector requested to review the attestation documentation and analyzer result print outs for the immunology events listed above. No documentation was available for review. 2. In an exit interview with the laboratory director, clinical consultant, office manager, and primary testing personnel on 2/1/18 at approximately 4:30 PM , it was confirmed that the laboratory failed to retain copies of the API attestation statements and the Hitachi CLA-1 analyzer result print outs for the PT events outlined above in 2015, 2016 and 2017. 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 facility tour, review of manufacturer's package insert, analyzer patient report documentation, and interviews, the laboratory failed to ensure that the immunology test reagents were within the manufacturer's expiration dates prior to reporting twelve (12) patient allergen panel results on 11/16/17. Findings include: 1. During a facility tour at approximately 2:30 PM on 2/1/18, which included the immunology specimen processing area, the inspector noted one (1) box of Hitachi -- 2 of 4 -- CLA Allergen Test Reagent (Lot Number 47A06639), expiration date of 10/31/17, stored in the refrigerator. The test kit had six (6) of twenty (20) tests remaining for use. The primary testing personnel stated, "I need to pull that out and dispose of it". 2. Review of the Hitachi CLA reagent manufacturer's package insert revealed storage instructions to "Store kit components at 2-8 degrees Celsius. When stored as directed, the kit components can be used until the printed expiration date". 3. Review of the laboratory's Hitachi CLA-1 analyzer patient report documentation from January 2017 to the date of the survey, revealed that CLA Allergen Test Reagent kit (Lot Number 47A06639, expiration date of 10/31/17) was utilized on 11/16/17 to report: Cassette A : Patient Slot 3 Cassette A : Patient Slot 4 Cassette A : Patient Slot 5 Cassette B : Patient Slot 1 Cassette B : Patient Slot 2 Cassette B : Patient Slot 3 Cassette B : Patient Slot 4 Cassette B : Patient Slot 5 Cassette A2: Patient Slot 1 Cassette A2: Patient Slot 2 Cassette A2: Patient Slot 3 Cassette A2: Patient Slot 4 a total of twelve (12) patient allergen panel results. 4. In an exit interview with the laboratory director, clinical consultant, office manager, and primary testing personnel on 2/1/18 at approximately 4:30 PM, it was confirmed that the laboratory failed to ensure that the CLA Allergen Test Reagent kit reagents were not used beyond the manufacturer's expiration dates prior to reporting the twelve (12) patient results identified above on 11 /16/17. 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 facility tour, review of manufacturer's package inserts, maintenance records, patient logs, and an interview, the laboratory failed to establish maintenance protocols for two (2) of two (2) thermometers located in the immunology specimen processing area used to monitor Hitachi CLA IgE Assay reagent and patient sample storage. Findings include: 1. During a facility tour of the immunology specimen processing area on 2/1/18 at approximately 2:30 PM, the inspector noted a Thomas Scientific Thermometer Serial Number 150561211 with a manufacturer's calibration expiration date of 7/24/17 in the refrigerator. The digital thermometer was in use to monitor the following Hitachi reagents stored in the refrigerator: CLA IgE Assay Allergen Test Chambers CLA IgE Assay Wash Buffer Concentrate CLA IgE Assay IgE Antibody Solution CLA IgE Assay Photoreagent A CLA IgE Assay Photoreagent B CLA IgE Assay Photoreagent C CLA IgE Assay Photoreagent D During the tour, the inspector also noted a Thomas Scientific Thermometer Serial Number 112003272 with a manufacturer's calibration expiration date of 12/27/13 in the laboratory's freezer in use to monitor approximately 20 (twenty) patient specimens and two (2) CLA IgE Positive and Negative Control Serum vials. 2. Review of the two Thomas Scientific meters' manufacturer's package inserts revealed the statement "Digital Humidity and Temperature Meters can be affected by aging, temperature, shock, and contamination." 3. Review of the laboratory's equipment maintenance records from October 2015 to the date of the survey, revealed no calibration documentation for -- 3 of 4 -- thermometer Serial Number 150561211 or Serial Number 112003272. The inspector requested to review written maintenance protocols for confirming the accuracy of the expired thermometers calibrations. No documentation was available for review. 4. Review of the laboratory's Hitachi CLA IgE Assay patient log sheets from October 2015 to the date of the survey on 2/1/18 revealed: 2015: 1476 patient allergen tests were resulted (41 patients; 36 panels each) 2016: 4320 patient allergen tests were resulted (120 patients; 36 panels each) 2017 to date of the survey: 2844 patient allergen tests were resulted (79 patients; 36 panels each) 5. In an interview with the laboratory director, clinical consultant, office manager, and primary testing personnel on 2/1/18 at approximately 4:30 PM, it was confirmed that the laboratory failed to establish and follow maintenance protocols to confirm the accuracy of two (2) of two (2) digital thermometers utilized to monitor the storage requirements of the Hitachi CLA IgE Assay reagents and patient samples while reporting two hundred forty (240) patient panels from October 2015 up to the date of the survey on 2/1/18. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD 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 interviews, the technical consultant failed to assess Hitachi CLA-immunology testing competency for two (2) of two (2) testing personnel in 2016 and 2017. Findings include: 1. Review of the CMS Form 209: Laboratory Personnel Report revealed that there are seven (7) testing personnel (TP) and that the laboratory director also performs the duties of technical consultant. 2. During a facility tour at approximately 2:30 PM, the inspector asked which testing personnel utilize, operate, and report results from the Hitachi CLA-1 analyzer. The laboratory director stated "TP A is the primary testing personnel and TP B is our back up operator". (See Personnel Code Sheet) 3. Review of the laboratory personnel files revealed no Hitachi CLA-1 competency assessments in calendar year 2016 or 2017 for: Testing Personnel A, Testing Personnel B. The inspector requested to review the TP competency documentation. The documentation was not available for review. 4. In an interview with the laboratory director, clinical consultant, office manager, and primary testing personnel on 2/1/18 at approximately 4:30 PM it was confirmed that the laboratory failed to document immunology Hitachi CLA-1 analyzer competency assessments for two (2) of two (2) TP in 2016 and 2017. -- 4 of 4 --