Peninsula Dermatology Skin Cancer Surgery Center

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Peninsula Dermatology Skin Cancer Surgery Center (Williamsburg) on December 3, 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: 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 a lab tour, review of the laboratory Quality Assurance (QA) manual, laboratory temperature logs, and an interview, it was determined that the laboratory failed to monitor temperatures for seven (7) days out of the twenty three months reviewed. Review timeframe included January 2023 through November 2024. Findings include: 1. During a laboratory tour on 12/3/24 at approximately 1:15 pm, the inspector noted two Avantik-QS11 Cryotstats (Serial numbers 56219 and 60277) and a slide warmer in-use. 2. Review of the laboratory's QA manual revealed an established policy for the MOHS tech to monitor and document laboratory temperatures daily. 3. Review of the temperature logs for January 2023 through November 2024 revealed no documentation that temperatures were recorded on 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 -- following days: 9/20/23, 9/22/23, 9/28/23, 11/3/23, 11/17/23, 6/21/24, 8/30/24, a total of 7 days. 4. An interview with the Lab Director and Clinical Assistant director on 12 /3/24 at approximately 5 PM confirmed the above findings. D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on a review of procedures, quality control (QC) records, patient logs, and interview, the laboratory failed to document daily Hematoxylin and Eosin (H&E) stain acceptability for five (5) days with thirty six (36) patient Mohs slides stained/ processed during the twenty three months reviewed. Review timeframe January 2023 - November 2024. Findings include: 1. Review of the laboratory's Quality Control procedure revealed that a control slide is made and evaluated each day a frozen section is prepared. 2. Review of the QC records from January 2023 through November 2024 revealed no control slide documented for the following five dates: 2/8 /23, 5/26/23, 10/27/24, 8/30/24, and 11/22/24. 3. Review of the patient logs revealed the following number of patient Mohs slides stained/ processed/evaluated on the five days with no QC documentation: 2/8/23 - 10 patients, 5/26/23 - 8 patients, 10/27/23 - 4 patients, 8/30/24 - 7 patients, and 11/22/24 - 7 patients. A total of 36 patients slides. 4. An interview with the Lab Director and Clinical Assistant director on 12/3/24 at approximately 5 PM confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Oyster Point Dermatology, INC on November 19, 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 deficiency cited is 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 procedure manuals, and interviews, the laboratory failed to follow their policy for labeling fourteen (14) MOHS slides using patient accession number, patient last name and first initial, and lesion letter/specimen number for one (1) of 1 observed case on the date of the survey, November 19, 2018. Findings include: 1. During a laboratory tour, at approximately 2:30 PM on 11/19/18, the inspector observed Patient A's MOHS case in progress in the laboratory processing area. The inspector noted that each of the 14 slides of the observed case were labeled with one partial patient identifier (abbreviated patient last name "JENK") and lesion lettering. The inspector requested to view Patient A's MOHS map that correlated with the 14 tissue slides labeled as "JENK". The primary testing personnel (TP) provided the map which revealed no unique patient identifier that matched the lettering on the slides ("JENK"). (See Patient Code Sheet attached) 2. Review of the MOHS procedure manual revealed a policy titled "Procedure for Labeling Mohs Slides" (Revision Date 1/31/13) that stated "To provide consistent labeling of slides for each Mohs case, each slide is labeled with the following: MOHS case number, patient last name and first initial, stage number, and slide number." 3. In an interview 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 -- with the laboratory director, office 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 last name and first initial) throughout the testing/resulting process as outlined above. -- 2 of 2 --