Action:
Amend Regulations Following Periodic Review
Action 6671
General Information
| Action Summary |
This regulatory action seeks to amend 12VAC5-71 - Regulations Governing Virginia Newborn Screening Services by repealing sections concerning Critical Congenital Heart Disease (CCHD) newborn screening and creating a new chapter (12VAC5-72) to house the CCHD newborn screening regulations in order to improve clarity of regulatory requirements. The action also provides minor updates to reflect current best practices and scientific information relevant to CCHD. Additionally, this action amends both 12VAC5-71 and the newly created 12VAC5-72 to provide stylistic updates to improve the clarity of the regulations and ensure compliance with the Virginia Register of Regulations Form, Style and Procedure Manual.
The existing Critical Congenital Heart Disease (CCHD) newborn screening regulations are housed alongside the dried blood spot newborn screening regulations in Chapter 71 of the Virginia Administrative Code. These regulations outline regulatory requirements for CCHD protocols, screenings, results reporting, care coordination, records, and screening refusals. VDH introduced the CCHD regulations in 2014 and the regulations became effective in 2016, but they have not been updated since that time.
While the dried blood spot and CCHD newborn screening regulations are currently housed in the same chapter, a separate regulatory chapter exists for the hearing newborn screening program. Because regulations for both dried blood spot newborn screening and CCHD newborn screening are included in 12VAC5-71 confusion from regulants, specifically with the Out-of-Hospital (OOH) birth community, has been reported. While dried blood spot regulations apply to all births (including OOH births and OOH birth providers), CCHD regulations do not apply to OOH births or birth providers. Promulgating CCHD regulations into their own chapter would provide consistency across the newborn screening programs and clarify roles and responsibilities of the health care providers for the different newborn screenings.
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| Chapters Affected |
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VAC |
Chapter Name |
Action Type |
| Primary |
12 VAC 5-71 |
Regulations Governing Virginia Newborn Screening Services |
Amend Existing Regulation
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| Other chapters |
| |
12 VAC 5 - 72 |
Regulations Governing Virginia Critical Congenital Heart Disease Newborn Screening Services |
Promulgate New Regulation
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| Executive Branch Review |
This action will go through the normal Executive Branch Review process.
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| RIS Project |
Yes [7747] |
| New Periodic Review |
This action will not be used to conduct a new periodic review.
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Stages
Stages associated with this regulatory action.
| Stage ID |
Stage Type |
Status |
|
10628
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Fast-Track
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DPB review in progress. |
Contact Information
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Name / Title:
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Rebecca Edelstein
/
Policy Analyst
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Address:
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109 Governor St.
Richmond, VA 23219
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Email Address:
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Rebecca.Edelstein@vdh.virginia.gov
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Phone:
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(804)240-1308
FAX: ()-
TDD: ()-
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