This
document represents the April 5, 2001
recommendations made by the National
Immunization Program’s Technical Working
Group (TWG) on the minimum technical
functions of immunization registries.
These standards were identified through
a process that involved an October
1997 survey of immunization program
managers and registry developers regarding
the technical functions that "at
a minimum, state- and community-based
immunization registries must"
implement. Functions that were identified
by >= 75% of respondents were discussed
at breakout sessions at the 1997 Program
Managers meeting to ensure consensus.
Since that time, the core functions
have been renamed "immunization
registry minimum functional standards."
In November
1999, the TWG recommended that the
minimum functional standards be used
as a basis for voluntary registry certification.
Though a certification body has not
yet been identified to assume this
responsibility, the TWG reviewed the
functional standards in preparation
for registry certification. As a result
of this review, two standards were
separated (Standard #5 and Standard
#6) and two standards were merged (Standard
#6 and former Standard #7-- Disaster
recovery).
These
standards were approved by the National
Immunization Program on May 15, 2001.
Note: These standards
only apply to records available in
a population-based immunization registry
(one that is designed to contain all
children in the catchment area) that
is operating in compliance with state/local
laws and/or policies. For example,
in a state where explicit consent is
required by law or policy, these standards
only apply to records where explicit
consent has been obtained.
Standard
#1
Electronically store data
on all NVAC-approved core data elements
Definition The registry’s
computer database contains fields for
all NVAC-approved core data elements.
These elements are: patient name (first,
middle, and last); patient birth date;
patient sex; patient birth state/country;
mother’s name (first, middle, last,
and maiden); vaccine type; vaccine
manufacturer; vaccination date; and
vaccine lot number.
Note: The core data
elements comprise the basic set of
data that registries will exchange
with each other. They are designed
to standardize a set of patient demographic
and vaccine event elements that are
considered core to record exchange
between registries. The mother's name
element refers to current legal mother
(who may or may not be birth mother).
To receive credit for the patient and
mother names, at least a surname and
one other name element must be valued.
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Standard
#2
Establish a registry record within
6 weeks of birth for each newborn
child born in the catchment area
Definition Identifying
information from a population-based
data set (e.g., vital statistics) is
regularly sent to or retrieved by the
registry in a computer file format
that requires little, if any, manipulation
by registry staff for the data to be
entered into the immunization registry.
Such information is available in the
registry within 6 weeks of birth.
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Standard
#3
Enable access to and retrieval
of immunization information in the
registry at the time of encounter
Definition
The registry provides a means by which
providers can access and retrieve immunization
records prior to or at the time of
a scheduled encounter.1
Note:
this standard accommodates registries
that do not operate continuously (e.g.,
closed Sundays and holidays) and those
that send and receive non-electronic
records in order to allow access to
users without electronic capabilities.
For example, providers can request
and receive the immunization record(s)
needed from the registry prior to the
scheduled encounter (can include printed
patient lists, flags on charts, fax
or phone requests).
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Standard
#4
Receive
and process immunization information
within 1 month2 of
vaccine administration
Definition
The registry receives and processes immunization
information within 1 month of vaccine(s)
administration (e.g., can include fax
or phone requests)3.
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Standard
#5
Protect the confidentiality of
health care information
Definition The registry
has written confidentiality policies
and procedures in place and implemented,
including administrative and technical
practices to protect health care information4.
The policies and procedures are consistent
with applicable state and local laws,
and Federal law (HIPAA or other privacy
law) when implemented, and with the
recommended specifications and guidelines
outlined in the updated “Community
Immunization Registries Manual: Chapter
II: Confidentiality,” except where
they conflict with applicable legislation.
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Standard
#6
Ensure security of health care
information
Definition The registry
has written security policies and procedures
in place and implemented, including
administrative and technical practices
and physical safeguards to protect
health care information. The
policies and procedures are consistent
with applicable state and local laws
and with Federal law when implemented.
Note: Appendix D of
the
“Community
Immunization Registries Manual: Chapter
II: Confidentiality” will serve
as the current recommended specifications
and guidelines; however, HIPAA implementation
may result in a change in the minimum
specification.
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Standard
#7
Exchange
immunization records using Health Level
Seven (HL7) standards
Definition
The registry has a function, at the
central level, that creates, receives,
and properly processes the HL7 messages,
as specified in NIP's Implementation
Guide for Immunization Data Transactions
using Version 2.3.1 of the Health Level
Seven (HL7) Standard Protocol,
June 1999.
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Standard
#8
Automatically
determine the routine childhood immunization(s)
needed, in compliance with current
ACIP recommendations, when an individual
presents for a scheduled immunization
Definition The registry
has an automated function, accessible
at the provider level, that determines
needed routine childhood immunizations,
in compliance with current ACIP recommendations,
given an individual's immunization
history to date.
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Standard
#9
Automatically identify individuals
due/late for immunization(s) to
enable the production of reminder/recall
notifications
Definition The registry
has an automated function that produces
a list of individuals who, as of a
given date, are due or late for immunizations
according to the registry's algorithm
(see Functional Standard #8). The output
from this function gives the ability
to produce reminder or recall notices.
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Standard
#10
Automatically
produce immunization
coverage reports by providers, age
groups, and geographic areas
Definition The registry
has an automated function to assess
immunization coverage (e.g., % of children
"age-appropriately" immunized)
as of a given date for an individual
provider's practice, for the registry's
entire catchment area, and for subgroups
within a practice or the catchment
area (e.g., children of a certain age).
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Standard
#11
Produce official immunization records
Definition The registry
has an function that allows authorized
users to produce an individual's immunization
history that is accepted as an official
immunization record.
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Standard
#12
Promote accuracy and completeness
of registry data
Definition
The registry has developed and implemented
a data quality protocol to combine
all available information relating
to a particular individual into a single,
accurate immunization record.
1The
standard as currently defined will
serve as the interim minimum during
the initial phase of registry certification;
however, the standard will change in
2005 to :
"Electronically access immunization
information in the registry at the
time of encounter."
2For the purposes of this calculation,
one month equals 30 days.
3The standard as currently defined
will serve as the interim minimum during
the initial phase of registry assessment;
however, the standard will change in
2005 to: "Receive and process
immunization information on the day
of vaccine administration."
4Health care information in this
document refers to patient demographics,
as well as medical conditions, care
or services related to the health of
the patient. |
