The Statewide Immunization Registry

1
The Statewide Immunization Registry

• Key Points from the Statute and some Proposed
  Regulatory Enhancements
• Barbara A. Brustman, EdD

2
Public Health Law 2168 Basics

• Enacted in August, 2006, effective 12/1/06.
• Mandates development of a statewide immunization
  registry in NYS outside of NYC.
• Mandated start date of 1/1/08.
• Recognizes existence of a NYC-wide registry,
  which will continue as a separate registry.

3
Public Health Law 2168 Who Must Report
Information to the Registry?

• Any health care provider who
• Is authorized by law to order or administer an
  immunization AND
• Administers an immunization to a child 18 years
  of age or younger after 1/1/08.
• Health care providers include not only
  individuals but Article 28 facilities and
  Certified Home Health agencies (CHHAs).

4
Regulatory Enhancements Proposed

• The health care provider who ORDERS the
  immunization assumes primary responsibility for
  ensuring that the immunization information is
  entered into the registry.
• This responsibility can be delegated to either
  the person administering the vaccination or
  another staff person.
• All such individuals must apply for access to the
  registry under the authority of the person
  ordering the immunization.

5
PHL 2168 What Information Must be Reported?

• Specifies reports of immunizations performed
  after 1/1/08.
• For children under the age of 19, and over the
  age of 19 at the discretion of the commissioner,
  and with the consent of the individual.
• Also specifies that past immunization history be
  reported whenever this is missing from the
  registry.
• Information on patients exempt from immunizations
  must also be entered.

6
Proposed Regulations What information must be
reported?

• The minimum data elements for an immunization
  registry from the CDC national standard data set
• Patient name first, middle, last
• Patient date of birth
• Patient gender
• Mothers name first, middle, last and maiden
• Vaccine type, lot number and manufacturer and
  date of administration
• PLUS, 1 recommended data element patient
  address, for follow-back purposes.

7
Proposed Regulations Past Immunization History

• To minimize provider burden, it is being proposed
  that alternative means of entering past
  immunization history be accepted, e.g.,
• Information already submitted to one of the
  upstate regional immunization registries.
• Downloads from existing provider electronic data
  systems.

8
PHL 2168 Required timeliness of reporting

• The law specifies that immunizations must be
  reported within 14 days of administration.
• Historical data must be reported at the same
  time, if not already in the registry.

9
Proposed Regulatory Enhancements to Timely
Reporting

• Reports must be made electronically within the 14
  day timeframe.
• Earlier entry of historical immunization
  information from existing regional registries
  (Healthy Shots or IRIS) may be permitted to
  prevent backlogs in entry after 1/1/08.

10
Proposed Regulations Will some patients already
be entered in the registry?

• Patients who are currently entered in one of the
  existing regional applications, will also be in
  the web-based registry.
• Patients who were born in NYS outside of NYC
  after 1/1/04 These patients should already be
  entered into the registry from information taken
  from the birth certificate.
• If a patient is seen by multiple providers, one
  of the others may have already entered this
  patient into the registry, and you may find these
  patients when you search the registry for a
  unique match.

11
Proposed Regulations Possible Variations in
mandated Start Date

• We are proposing at this point that there may be
  some leeway in the 1/1/08 electronic submission
  deadline for all immunizations, with prior DOH
  approval
• If you are actively working on programming for
  ongoing electronic downloads from your electronic
  data system to the registry You must notify DOH
  in writing.
• If you cannot obtain internet access by 1/1/08
  You must notify DOH in writing.
• If DOH has not yet made interactive training
  available in your region (either face-to-face or
  webinar) and you are having difficulty with
  submission of data.

12
Possible Start Date Deferrals

• While the start date for the registry is 1/1/08,
  and we would be happy if everyone started on that
  date, our expectations for full state start-up
  are (somewhat) reality-based.
• For providers who prefer to download from their
  existing systems, deferrals will be granted
  following written request to DOH stating their
  intention to submit via this method and the date
  they expect to begin transfer. File
  specifications will be made available in early
  fall of 2007.

13
Possible Start Date Deferrals

• Training-related deferrals
• If the on-line training is not available as of
  12/1/2007 as planned, and regional training has
  not been made available in your area, there will
  be a deferral of your start date until regional
  training has been held.
• If on-line training is available, but you have
  problems with submission, you may defer your
  start date until 1 week after interactive
  (face-to-face or webinar) training is held in
  your region, whether you attend or not.

14
Proposed regulations Variation in minimum data
to be reported

• One exception to reporting the minimum data set
  is proposed
• Information for vaccinations routinely
  administered to newborns during their initial
  hospital stay is downloaded from the Statewide
  Perinatal Data System (SPDS) NO ADDITIONAL
  REGISTRY input will be required for newborns.
  All required information will be taken from the
  SPDS/birth certificate files.
• Until vaccine lot number and manufacturer are
  available on the SPDS, these fields will be
  exempted from collection for the initial hospital
  stay only.
• These fields may be available on the SPDS by
  1/1/08, but it is not guaranteed.

15
While not an exception to the required minimum
data set, per se

• DOH realizes that not all existing data systems
  contain all required data elements.
• We still encourage electronic transfer of
  available data.
• It will be possible to fill in missing data at a
  later date, and fulfill timely reporting
  requirements with the incomplete submissions.
• In fact, not all historical immunization
  information fields may be available you may be
  asked to provide an attestation to that effect at
  some point.

16
PHL 2168 Uses of Registry Data by Health Care
Providers

• Providers will be able to access registry data
  for their patients, with sufficient identifying
  information, to
• Determine the immunization status of a specific
  registrant.
• Print vaccination histories for
  parents/guardians.
• Review of practice coverage.
• Vaccine accountability.
• Determine if patients are due for or late for a
  recommended immunization, and generate reminder
  notices.
• Quality improvement.

17
Proposed Regulatory Enhancements Use of Registry
Information

• Registry data is proposed to be used to not only
  generate vaccination histories, but
• Reminder notices
• Recall notices
• Registry data may also be helpful with vaccine
  inventory
• Also, it is proposed that the registry will
  generate Vaccines for Children reports at some
  point
• Quality assurance activities

18
PHL 2168 Who else is Affected?

• Granted access to read-only information for
  children for whom they are responsible
• Schools, broadly defined to include licensed day
  care centers, etc.
• Local Health Departments (acting in their public
  health capacity, not as health care providers)
• HMOs and other 3rd party insurers
• Local Social Services Districts
• The Office of Children and Family Services

19
Proposed Regulations How will confidentiality be
protected?

• Application for access must be made by every
  individual who is authorized (belongs to one of
  the user categories cited) to view on-line
  information
• Access will be granted only to information on
  children
• Whose vaccination history they have need to view
• And for whom the requestor has sufficient
  identifying information to identify the
  appropriate individual
• Everyone with access must sign a confidentiality
  agreement

20
Confidentiality Proposed Regulations

• Every applicant for access to the registry must
  agree to
• View only records of children for whom they have
  clinical or administrative responsibility
• And access will be granted only if sufficient
  information is available to identify that
  particular child
• Not redisclose information from the registry,
  except health care providers who are required by
  law to give copies of the immunization history to
  the childs parents or guardians, on request

21
Applications for Access to the Registry

• Currently being designed.
• Will be made available on the DOH website and HPN
  site.
• Must be submitted specifically for the category
  of access granted by the legislation.
• No access beyond what is specified in the
  regulations will be granted.
• The Department (or in NYC the NYCDOHMH) must
  approve all applications for access.

22
Next Steps

• Data system for registry under development
• Training being planned for locations across the
  state
• Methods for informing providers via multiple
  venues are being developed

23
Regulations Development Process

• Draft regulations must be finalized and will go
  through multiple internal review steps
• Included in this
• Review and comment by key stakeholders
• Outreach to stakeholders will attempt to garner
  input from those most affected.

24
Regulations Development Process

• Once a draft of the regulations has been
  developed that
• Incorporates input from key stakeholders,
• Has received DOH, including our counsels office,
  and the Governors Office of Regulatory Reform
  approval
• The Regulations will be published for public
  comment by the Department of State for a period
  of 60 days

25
Regulations Development Process

• Once the 60 day public comment period is
  concluded, all comments must be reviewed and
  either result in changes or justification of why
  the changes are not being made
• If substantial changes are made, our counsels
  office re-reviews, as does GORR, and if they
  approve the changes
• A second public comment period of 45 days
  duration is held, after which the regulations may
  be adopted

26
What happens if the regulations are not in place
by 1/1/08?

• The law mandates that reporting begin on 1/1/08
• Draft regulations may be circulating well in
  advance of the start date, either published for
  public comment or available from key stakeholders
  If so, be careful to obtain the final copy to
  ensure you are in compliance, as changes may be
  made to draft versions!

27
What should you be doing NOW?

• HPN access will be required for each individual
  entering or accessing registry data.
• Requests for HPN access will take time, so the
  sooner you start with the application process,
  the better
• Registry access will also require a further
  approval step, and forms will be available
  on-line to be filled out at your convenience.

28
Who should you call if you have Questions?

• If you want to provide input on the drafting of
  the regulations, call me, Barbara Brustman, at
  518-473-1549 or bab04_at_health.state.ny.us.
• Immunization Registry Either the registry data
  system, details regarding downloading
  information, or program questions Mike Flynn or
  Pat Deyo, at 518-473-4437 or send an email to the
  Immunization Program mail log at
  Immunize_at_health.state.ny.us.