{
  "family": "public-comments",
  "checked": "2026-10-09",
  "scope": "A dated, selected snapshot, not an exhaustive live list. Deadlines can be extended, reopened, or close at a specified time. Always confirm the current official notice.",
  "id": "clia-virtual-access-personnel-proposal",
  "metaTitle": "CLIA Virtual Access and Personnel Proposal | America.co",
  "title": "CLIA virtual access and laboratory personnel proposal: comment by December 7",
  "description": "Find the CLIA virtual-access and personnel proposal, December 7 comment deadline, CMS-3478-P file code, and official CMS-2026-3235 docket.",
  "documentNumber": "2026-20613",
  "category": "Health systems",
  "noticeUrl": "https://www.federalregister.gov/documents/2026/10/08/2026-20613/clinical-laboratory-improvement-amendments-of-1988-clia-virtual-access-gynecologic-cytology",
  "actionUrl": "https://www.regulations.gov/docket/CMS-2026-3235",
  "actionLabel": "Open CMS’s CLIA proposal docket",
  "answer": "CMS proposes CLIA changes covering virtual access to laboratory data, digital images for gynecologic cytology proficiency testing, personnel qualifications, and related requirements. The notice lists December 7, 2026 for comments and file code CMS-3478-P. This is a proposal, not a determination of a laboratory’s compliance.",
  "facts": [
    {
      "label": "Listed comment deadline",
      "value": "2026-12-07; confirm cutoff at source",
      "sourceUrl": "https://www.federalregister.gov/documents/2026/10/08/2026-20613/clinical-laboratory-improvement-amendments-of-1988-clia-virtual-access-gynecologic-cytology"
    },
    {
      "label": "Docket or notice identifier",
      "value": "CMS-2026-3235",
      "sourceUrl": "https://www.federalregister.gov/documents/2026/10/08/2026-20613/clinical-laboratory-improvement-amendments-of-1988-clia-virtual-access-gynecologic-cytology"
    },
    {
      "label": "Agency",
      "value": "Centers for Medicare & Medicaid Services",
      "sourceUrl": "https://www.federalregister.gov/documents/2026/10/08/2026-20613/clinical-laboratory-improvement-amendments-of-1988-clia-virtual-access-gynecologic-cytology"
    },
    {
      "label": "Stage",
      "value": "Proposed rule",
      "sourceUrl": "https://www.federalregister.gov/documents/2026/10/08/2026-20613/clinical-laboratory-improvement-amendments-of-1988-clia-virtual-access-gynecologic-cytology"
    },
    {
      "label": "File code",
      "value": "CMS-3478-P",
      "sourceUrl": "https://www.federalregister.gov/documents/2026/10/08/2026-20613/clinical-laboratory-improvement-amendments-of-1988-clia-virtual-access-gynecologic-cytology"
    }
  ],
  "sections": [
    {
      "heading": "Virtual access is not one blanket permission",
      "paragraphs": [
        "The proposal’s general virtual-access discussion excludes the cytology subspecialty, while digital gynecologic cytology proficiency testing is a separate proposed change. Read the relevant section before combining those ideas."
      ],
      "sourceUrls": [
        "https://www.federalregister.gov/documents/2026/10/08/2026-20613/clinical-laboratory-improvement-amendments-of-1988-clia-virtual-access-gynecologic-cytology"
      ]
    },
    {
      "heading": "Make a focused technical contribution",
      "paragraphs": [
        "Identify which provision you are addressing, the laboratory workflow affected, a source for the evidence, and a practical implementation concern. Do not upload patient material to prove an example."
      ],
      "sourceUrls": [
        "https://www.regulations.gov/docket/CMS-2026-3235"
      ]
    }
  ],
  "steps": [
    "Confirm the current comment date and notice.",
    "Locate the exact provision rather than responding to the title alone.",
    "Refer to CMS-3478-P; the electronic docket is CMS-2026-3235.",
    "Choose one authorized route and retain the submission receipt."
  ],
  "caution": "Public comments are not a patient complaint or medical-care channel. Do not include patient identifiers, health records, or confidential business information. This page is not clinical or regulatory compliance advice.",
  "faq": [
    [
      "Are these already final laboratory requirements?",
      "The cited action is a proposed rule. Check any later final action and effective date at the official source."
    ],
    [
      "Are the file code and electronic docket the same?",
      "No. CMS-3478-P is the file code; CMS-2026-3235 is the Regulations.gov docket."
    ]
  ],
  "deadline": "2026-12-07",
  "publicationDate": "2026-10-08",
  "docket": "CMS-2026-3235",
  "documentId": "CMS-2026-3235-0001",
  "status": "open-at-check",
  "statusLabel": "Comment window listed open at the 2026-10-09 metadata check; confirm at source before acting",
  "sources": [
    {
      "title": "Published notice and submission instructions",
      "url": "https://www.federalregister.gov/documents/2026/10/08/2026-20613/clinical-laboratory-improvement-amendments-of-1988-clia-virtual-access-gynecologic-cytology",
      "asOf": "2026-10-09"
    },
    {
      "title": "Official Federal Register PDF on GovInfo",
      "url": "https://www.govinfo.gov/content/pkg/FR-2026-10-08/pdf/2026-20613.pdf",
      "asOf": "2026-10-09"
    },
    {
      "title": "Open CMS’s CLIA proposal docket",
      "url": "https://www.regulations.gov/docket/CMS-2026-3235",
      "asOf": "2026-10-09"
    }
  ],
  "related": [
    {
      "label": "Public comment opportunities",
      "url": "/public-comment-deadlines"
    },
    {
      "label": "How to comment on federal rules",
      "url": "/learn/how-to-comment-on-federal-rules"
    },
    {
      "label": "America.co editorial standards",
      "url": "/editorial"
    }
  ],
  "route": "/public-comments/clia-virtual-access-personnel-proposal",
  "file": "public-comments/clia-virtual-access-personnel-proposal.html"
}