N.Y. Comp. Codes R. & Regs. Tit. 10 § 66-1.2 - Statewide immunization registry
(a)
(1)
Statewide immunization
information system shall mean the statewide (except New York City)
computerized database of immunizations developed and maintained by the New York
State Department of Health, known as the New York State Immunization
Information System ("NYSIIS" or "system").
(2)
Citywide immunization registry
(CIR) shall mean the immunization information system maintained by the
New York City Department of Health and Mental Hygiene, capable of collecting,
storing and disclosing the electronic and paper records of vaccinations
administered to persons less than 19 years of age and those persons 19 and
older with consent in accordance with the New York City Health Code. For the
purposes of this definition, the term New York City Department of
Health and Mental Hygiene shall mean such agency or
any successor agency responsible for the CIR.
(3)
Health care provider for
the purposes of this section shall mean any person authorized by law to order
an immunization or any health care facility licensed under article 28 of the
Public Health Law or any certified home health agency established under section
3606 of the Public Health Law.
(4)
Designees shall mean
individuals, acting under the authority of a health care provider or another
category of authorized user, who have been specifically delegated
responsibility to access NYSIIS or the CIR and perform the functions permitted
the primary authorized user.
(5)
Emancipated minors shall mean those children less than 18
years of age who by virtue of a court decision declaring them emancipated, or
who because they are otherwise emancipated under the law, are able to make
their own decisions regarding health care services.
(6) Registrants shall mean all individuals
for whom an immunization or exemption to immunization or blood lead analysis is
recorded in the system, at any time following January 1, 2008 for NYSIIS and
January 1, 1994 for the CIR. Registrants also include individuals born in New
York State (outside of New York City) on or after January 1, 2004 for NYSIIS or
born in New York City on or after January 1, 1996 for the CIR.
(7)
School, for the purposes
of this section, shall mean any agency or entity required by law or regulation
to verify immunization status for participants prior to or at selected times
during enrollment, including licensed day care facilities. Such verification is
an authorized delegation of public health authority for the purposes of
fulfilling this public health mandate related to verification of immunization
status.
(8) Authorized users of
NYSIIS and the CIR shall mean the following categories of users, who are
permitted access only to records of registrants falling within their
administrative or clinical responsibilities. An authorized user in a category
below may designate the ability to access the system to others where indicated.
(i) health care providers who order an
immunization, and their designees, including Regional Health Information
Organizations or other Health Information Technology entities as defined in 18
NYCRR section 504.9(h)(2);
(ii)
local health districts;
(iii)
commissioners of local social services districts and their designees;
(iv) the Commissioner of the Office of
Children and Family Services and his/her designees;
(v) schools;
(vi) third party payers;
(vii) WIC programs;
(viii) colleges;
(ix) professional and technical
schools;
(x) children's overnight
camps and summer day camps;
(xi)
registered professional nurses; and
(xii) pharmacists authorized to administer
immunizations pursuant to subdivision two of section sixty-eight hundred one of
the Education Law.
(b)
Mandated Reporting
(1) Mandated reporters to NYSIIS and the CIR
include any health care provider, as defined in section 66-1.2 who administers
an immunization or conducts a blood lead analysis of a sample.
(2) Mandated reporters must report any
immunization to a child less than 19 years of age to either NYSIIS or the CIR,
depending on the location of administration of the vaccine.
(3) Article 28 facilities or certified home
health agencies established under section
3606 of the Public Health Law in which
providers are responsible for administration of vaccines may, when agreed to by
the facility and the provider ordering the vaccination, assume reporting
responsibility for the authorized individuals administering vaccines within
their facilities.
(4) A person who
administers but does not order immunizations is not responsible for reporting
the immunizations to the system, unless acting as a designee of the health care
provider who ordered the immunization and under whose supervision the vaccine
was administered. The ordering health care provider remains responsible for
supervising his/her designee and ensuring that appropriate and timely reporting
occurs.
(5) When vaccines are
administered based on non-patient specific orders, the health care provider
ordering the immunizations shall ensure that required data elements for each
vaccination are submitted to NYSIIS or the CIR, depending on the location of
administration of the vaccine.
(c)
Information required to be
reported, methods of reporting, exceptions and timeliness of reporting.
(1) Information required to be reported to
NYSIIS or the CIR, to the extent available to the provider shall include: the
patient's name (first, middle and last); date of birth; gender; race;
ethnicity; address, including zip code; telephone numbers; birth order (if
multiple birth); birth state/country; mother's maiden name; mother's or other
responsible party's name (first, middle and last); vaccines for children
program eligibility; Medicaid number; and vaccine administration date, type,
lot number and manufacturer, except as noted in paragraph (3) of this
subdivision. A provider should report elements for any additional data fields
in NYSIIS or the CIR when available.
(2) Methods of reporting. All data elements
reported to NYSIIS or the CIR must be submitted electronically except as
provided in paragraph (3) of this subdivision.
(i) Direct online entry of immunization
information into NYSIIS. Authorized users with read/write access and their
designees may submit information directly to the statewide system using their
individual access accounts.
(ii)
Health care providers with existing electronic information systems compatible
with NYSIIS. Such providers may request, on an individual or group basis,
permission to download information from current systems into a
department-prescribed file format for transfer directly to NYSIIS. The provider
is responsible for the costs/programming needed to effect these data transfers,
ensuring that transfers are completed on a timely basis and updating
provider-specific data systems when changes are made to these
systems.
(iii) Historical
immunization information previously submitted to a regional registry. Health
care providers who have submitted immunization records to one of the regional
immunization registries (Healthy Shot or Immunization Registry and Information
Source ["IRIS"]) may authorize submission of this regionally-archived
immunization history information to the statewide system.
(iv) Submission of immunization information
to NYSIIS or the CIR. Providers must submit immunization information to NYSIIS
or the CIR, dependent upon the IIS operating in the area in which they
practice, not the IIS appropriate to the patient's area of residence. Exchange
of information between IIS's will be the responsibility of NYSIIS and the
CIR.
(3) Exceptions to
reporting requirements to NYSIIS.
(i)
Hospitals participating in the statewide perinatal data system are exempted
from entering immunization information directly into NYSIIS for newborns during
their initial hospital stay. Information submitted through the statewide
perinatal data system will populate NYSIIS's required information fields.
Hospitals located in New York State, outside of New York City, are required to
report to NYSIIS all other immunizations administered to children less than 19
years of age while under their care.
(ii) A provider may submit incomplete
immunization electronic files or may manually enter incomplete immunization
information into the statewide system in fulfillment of requirements for
submission of historical immunization information. Required information for
immunizations administered after January 1, 2008, which is missing shall be
entered when it becomes available to the provider.
(4) Timeliness of reporting. Providers
ordering immunizations must submit immunization information to NYSIIS or the
CIR within 14 days of administration of the immunization. Providers must also
submit information regarding immunizations not previously reported for each
registrant. For NYSIIS only:
(i) Providers
must submit any missing information requested by NYSIIS within 14 days of the
issuance of the request.
(ii) For
individuals exempt from administration of vaccines, providers must submit
patient information, including the reason that such immunization may be
detrimental to the child's health, as defined in subdivision (l) of section
66-1.1 of
this Subpart, to the statewide immunization information system within 14 days
following the in-person clinical interaction that occurs at or after what would
normally have been the due date for administration of an age-appropriate
immunization to that child, according to current national immunization
recommendations
(d)
Allowable access levels and
permitted uses of NYSIIS and/or CIR data by authorized users specific to the
organization they are representing.
(1)
Allowable access levels.
(i) Read/write
access. Only health care providers providing services to the registrant and
State and local Department of Health staff may compile reports, read
immunization information, enter immunization information and change
immunization information, with limitations as specified below. Health care
providers who have been granted a time-limited deferral on electronic data
submission to NYSIIS may access the information by phone or via written
request.
(ii) Read-only access.
Authorized users not listed in subparagraph (i) of this paragraph (such as
schools) are permitted read-only access to NYSIIS and/or the CIR. Read-only
access allows the user to view records of only those children under their
administrative responsibility and to compile reports based on data aggregated
from those records.
(2)
Permitted uses of NYSIIS or CIR data. All requests for use of NYSIIS
information by an authorized user which are not included in the allowable uses
for that person as noted in subparagraphs (i)-(x) of this paragraph are
prohibited without the approval of the commissioner of the State Department of
Health; or, for requests for CIR information, without the approval of the
commissioner of the New York City Department of Health and Mental Hygiene or
his or her designee. Approval is contingent on ongoing adherence to the terms
and conditions of the user agreements. Allowable uses of the data for
particular categories of users include:
(i)
Health care providers or their designees may access NYSIIS or CIR data for the
provision of care and treatment, either temporary or longer term, to a
particular registrant. The information can be used either on a patient-specific
basis or to generate reports specific to their practice to determine
immunizations received by a specific group of registrants, review of practice
coverage, generation of reminder and recall notices, quality improvement,
vaccine inventory and accountability inclusive of Vaccines for Children (VFC)
Program inventory and accountability, vaccine ordering, VFC re-enrollment, and
printing a copy of the immunization record for the registrant or the
registrant's parent or guardian, as appropriate.
(a) If other child health status or test
results information becomes available through NYSIIS or the CIR that may be
useful in determining the course of treatment for the child, such information
will be made available on an as-needed and authorized basis to health care
providers.
(ii) Schools
may access NYSIIS or CIR data for verifying immunization history for students
entering or registered in that school or school system or may run
school-specific reports that aggregate available data. Access will be limited
to data for registrants enrolling or already enrolled in a particular school or
school system.
(iii) Commissioners
of local social services districts and their designees may access NYSIIS or CIR
data with regard to children in their legal custody. Such information may be
used for quality assurance and accountability by local social services
districts.
(iv) The commissioner of
the Office of Children and Family Services and his/her designees may access
NYSIIS or CIR data with regard to children in his/her legal custody. Such
information may be used for ensuring appropriate care and treatment of children
for whom the Office of Children and Family Services maintains custody and
responsibility.
(v) Local health
departments may access immunization data in NYSIIS and the CIR for purposes of
outreach, quality improvement and vaccine accountability, epidemiological
studies and disease control within their own county. Local health department
staff may be granted access to immunization information in NYSIIS and the CIR
for registrants whose immunizations were administered within their own county
and for registrants residing in the county whose immunizations were
administered outside of the county.
(vi) Third party payers may access NYSIIS or
CIR data for the purpose of performing quality assurance, accountability and
outreach relating to enrollees covered by their plan. Third party payers must
request information from the appropriate registries.
(vii) The Commissioner of Health and the
commissioner of the New York City Department of Health and Mental Hygiene and
their designated staffs will have full read/write access to their respective
systems/registries in order to fulfill file maintenance and improvement
functions and may use the data in both NYSIIS and the CIR for purposes of
outreach, quality improvement and vaccine accountability, research,
epidemiological studies and disease control.
(a) The Commissioner of Health or the
Commissioner of the New York City Department of Health and Mental Hygiene or
his or her designee may provide, on request, registrant-specific information to
other State or city immunization systems and systems maintained by the Indian
Health Service and tribal nations recognized by the State or the United States
on a routine basis pursuant to a written agreement with each system requiring
such system to conform to national standards for maintaining the integrity of
the data, protecting the confidentiality of personal information and using the
data only for purposes permitted in this section.
(b) The Commissioner of Health or the
Commissioner of the New York City Department of Health and Mental Hygiene may
provide registrant-specific information to Federal health officials, State or
city immunization systems and systems maintained by the Indian Health Service
and tribal nations recognized by the State or the United States and others
identified by the commissioner of each respective immunization information
system, for activities necessary to protect public health, in accordance with
any written agreement required by such commissioner.
(c) The Commissioner of Health or the
Commissioner of the New York City Department of Health and Mental Hygiene may
provide institutes of higher education, medical research centers or other
institutions engaged in epidemiological research or other public health
research access to de-identified registrant information in NYSIIS or the CIR
for research purposes if approved by the Commissioner of Health or the
Commissioner of the New York City Department of Health and Mental Hygiene, as
appropriate.
(viii) WIC
programs for the purposes of verifying immunization and lead testing status for
those seeking or receiving services, as well as referral for immunizations or
lead tests as needed.
(ix) Colleges
may access NYSIIS or CIR data for verifying immunization history for students
entering or registered in that college or college system or may run
college-specific reports that aggregate available data. Access shall be limited
to data for registrants enrolling or already enrolled in a particular college
or college system.
(x) Professional
and technical schools may access NYSIIS or CIR data for verifying immunization
history for students entering or registered in that professional or technical
school or may run college-specific reports that aggregate available data.
Access shall be limited to data for registrants enrolling or already enrolled
in a particular professional or technical school.
(xi) Children's overnight camps and summer
day camps may access NYSIIS or CIR data for verifying immunization history for
children attending that overnight camp or summer day camp or may run
camp-specific reports that aggregate available data. Access shall be limited to
data for registrants attending a particular overnight or summer day
camp.
(xii) Any parent or guardian
of a registrant less than 18 years of age or the registrant himself/herself if
18 years or older or an emancipated minor, may receive a copy of an
immunization record at no cost from their local health department, the CIR or
NYSIIS.
(e)
Methods of accessing immunization data.
Each person seeking access to NYSIIS and/or the CIR must submit a completed application for access.
(f)
Maintenance of security and
confidentiality.
(1) Each person
accessing the statewide system must have a distinct password and system ID that
conform to industry standards, and with level and type of access tied to the
type of user, as defined in subdivision (d) of this section.
(2) Each person must understand and agree to
adhere to the confidentiality protocol developed by the department or the
NYCDOHMH prior to either submitting or obtaining data from NYSIIS or the
CIR.
(g)
Provision
of NYSIIS information to registrant's family/guardian.
(1) Mandated reporters to NYSIIS must provide
the parent or legal guardian of each registrant with a copy of an informational
brochure or letter from the department at the time of each registrant's initial
entry into the statewide system by that provider.
(2) If the parent/guardian speaks a primary
language other than English, mandated reporters to NYSIIS must make every
attempt to provide statewide system-related information comparable to the
department's brochure in the primary language of the parent or
guardian.
Notes
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