Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Valley Skin Specialists (DBA - River Ridge Dermatology Roanoke) on July 22, 2025 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations and included a follow up off-site interview with the primary histotechs on 7/23/25. Valley Skin Specialists (DBA - River Ridge Dermatology Roanoke) was not in compliance with applicable Standards under 42 CFR part 493 CLIA Regulations. Specific deficiencies cited are as follows: D3043 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(7) (a)(7) Slide, block, and tissue retention-- (a)(7)(i) Slides. (a)(7)(i)(A) Retain cytology slide preparations for at least 5 years from the date of examination (see 493.1274(f) for proficiency testing exception). (a)(7)(i)(B) Retain histopathology slides for at least 10 years from the date of examination. (a)(7)(ii) Blocks. Retain pathology specimen blocks for at least 2 years from the date of examination. (a)(7)(iii) Tissue. Preserve remnants of tissue for pathology examination until a diagnosis is made on the specimen. This STANDARD is not met as evidenced by: Based on a review of twice annual accuracy verification records (proficiency testing), lack of documentation, procedures, and interviews, the laboratory failed to follow their established protocol for storage/retention of patient histopathology slides for one (1) of ten (10) randomly selected mohs patient cases reviewed on the date of the inspection July 22, 2025. Findings include: 1. During a review of the laboratory's proficiency testing documentation, the inspector requested to review the pathology report, slides, and mapping records of 10 randomly selected mohs histopathology cases resulted by the laboratory during the timeframe of 7/25/23-7/22/25. The review revealed two missing slides for the following patient case: Accession # RM24-150, MRN175890. The inspector noted that the histopathology mohs mapping record 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 2 -- the accession number outlined above indicated four slides were processed and evaluated by the laboratory (2 slides stage I of six tissue sections, 2 slides stage II of four tissue sections). The inspector noted that the stage I slides were missing. The inspector requested to review the stage I slides for the case outlined above. The primary histotech testing personnel were unable to locate the missing slides during the inspection on 7/22/25. 2. Review of the laboratory's procedures revealed a protocol (titled: Storage of Diagnosed Slides) that stated, "In this facility, diagnosed slides will be stored in the following manner: slides will be transferred to permanent slide file, making sure that rows and drawers are labeled as to contents with lab accession number and year. Slides are kept on location for 10 years." 3. An interview on 7/22/25 at 3:00 PM and 7/23/25 at 2:00 PM with the primary histotech personnel confirmed the above findings. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) (e)(5) Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur; This STANDARD is not met as evidenced by: Based on a review of twice annual accuracy verification records (proficiency testing), lack of documentation, procedures, and interviews, the laboratory director (LD) failed to ensure that quality assessment protocols were established to document/assure patient histopathology slides sent out for mohs peer review were returned for storage /retention during the twenty-four (24) of 24 months reviewed (survey timeframe: July 25, 2023 - July 22, 2025). *Cross Reference D3043. Findings include: 1. A review of 10 randomly selected cases included in the laboratory's proficiency testing documentation for the 24 month survey timeframe revealed two missing slides for case Accession # RM24-150, MRN175890. The inspector inquired regarding the missing slides for the RM24-150 case and asked to review them. The primary histotech testing personnel were unable to locate the missing slides during the inspection on 7/22/25. 2. Review of the laboratory's procedures revealed a protocol (titled: Storage of Diagnosed Slides) that stated, "In this facility, diagnosed slides will be stored in the following manner: slides will be transferred to permanent slide file, making sure that rows and drawers are labeled as to contents with lab accession number and year. Slides are kept on location for 10 years." 3. The inspector inquired to review a LD approved Quality Assessment policy that included the recording of twice annual peer review slides being checked out and returned for the 10 year storage /retention per the policy outlined above. The primary histotechs stated on 7/22/25 at 2: 30 PM, "Our lab director reads over the sent out peer review findings for agreement, but we have not been recording dates and number of that the slides are returned. We do not currently have a QA check for that." 4. An interview with the primary histotechs on 7/22/25 at 3:00 PM confirmed the above findings. -- 2 of 2 --