Immunization Registry Functional Standards

Standard #1

Minimum

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).

Ideal

Electronically store data on all NVAC-approved core data elements and these additional fields: vaccine expiration date; additional identifiers such as Medicaid identifier; relationship to patient such as legal guardian, birth mother or custodial mother; provider's reason for not giving a recommended vaccine such as denied or deferred (vaccine is still needed); and provider's reason for not giving a recommended vaccine such as previously given or positive titer (vaccine is not needed).

Definition: The registry's computer database contains fields for all NVAC-approved core data elements and all additional fields specified.

Standard #2

Minimum

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.

Ideal

Establish a registry record within 4 weeks of birth for each newborn child born in the catchment area

Definition: Identifying information from the provider of the immunization given at or around birth is 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 4 weeks of birth.

Standard #3

Minimum

Enable access to immunization information in the registry at the time of encounter

Definition: The registry provides a means by which providers can access immunization records prior to or at the time of a scheduled encounter. This will serve as the interim minimum during the initial phase of registry assessment; however, the ideal standard listed below will become the minimum in 2005.

Note: This standard accommodates registries that do not operate constantly (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).

Ideal

Electronically access immunization records in the registry at the time of encounter

Definition: The registry provides a means by which providers can electronically access immunization records at the time of encounter. Specifically, the registry does not require advance notice for inquiries and can process them in "real time".

Standard #4

Minimum

Receive and process immunization information within 1 month 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). This will serve as the interim minimum during the initial phase of registry assessment; however, the ideal standard listed below will become the minimum in 2005.

Ideal

Receive and process immunization information on the day of vaccine administration

Definition: The registry receives and processes immunization information on the day of vaccine(s) administration.

Standard #5

Minimum

Protect the confidentiality of medical information

Definition: The registry has written confidentiality policies and procedures in place and implemented, including administrative and technical practices to protect medical information. The policies and procedures are consistent with applicable state and local laws, 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.

Standard #6

Minimum

Ensure the security of medical information

Definition: The registry has written security policies and procedures in place and implemented, including administrative and technical practices and physical safeguards to protect medical 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.

Ideal

Because this standard is absolute, no ideal is specified.

Standard #7

Minimum

Recover lost data (disaster recovery)

Definition: The registry's full database is backed-up regularly (at least daily) and backup media is stored securely in a separate location. In addition, the registry has a regularly tested (at least annually) disaster recovery plan for providing basic system functions and ensuring access to registry data in an emergency (e.g., natural disaster or computer failure).

Ideal

Because this standard is absolute, no ideal is specified.

Standard #8

Minimum

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 Unsolicited Vaccination Record Update (VXU) HL7 message type, 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.

Note: The VXU will serve as the interim minimum through 2001 during the initial phase of record exchange among registries; however, the VXR will be added to the minimum in 2002, and the use of all four messages will become the minimum in 2003.

Ideal

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 Query for Vaccination Record (VXQ), Response to Vaccination Query Returning Multiple PID Matches (VXX), Response to Vaccination Query Returning the Vaccination Record (VXR), and Unsolicited Vaccination Record Update (VXU) HL7 message types, 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.

Standard #9

Minimum

Automatically determine the immunization(s) needed, in compliance with current ACIP recommendations, when an individual presents for a scheduled encounter.

Definition: The registry has an automated function, accessible at the provider level, that determines needed immunizations, in compliance with current ACIP recommendations, given an individual's immunization history to date.

Ideal

Automatically determine in real-time the immunization(s) needed, in compliance with current ACIP recommendations, when an individual presents for an encounter

Definition: The registry has an automated function, accessible at the provider level, that determines in real-time the needed immunizations, in compliance with current ACIP recommendations, given an individual's immunization history to date.

Standard #10

Minimum

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 #9). The output from this function gives the ability to produce reminder or recall notices.

Ideal

Because this standard is absolute, no ideal is specified

Standard #11

Minimum

Automatically produce immunization coverage reports by providers, age groups, and geographic areas.

Definition: The registry has an automated function to measure immunization coverage (% 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). "Age-appropriate" should be defined according to current ACIP recommendations implemented in the registry's algorithm.

Ideal

Automatically produce immunization coverage reports by providers, age groups and geographic areas

Definition: The registry has an automated function to allow providers to measure immunization coverage (% of children "age-appropriately" immunized) as of a given date for an individual provider's practice, the registry's entire catchment area, and for subgroups within a practice or the catchment area (e.g., children of a certain age). "Age-appropriate" should be defined according to current ACIP recommendations implemented in the registry's algorithm.

Standard #12

Minimum

Produce authorized immunization records

Definition: The registry has a function that allows authorized users to print an individual's immunization history that serves as an "official immunization record."

Ideal

Produce and electronically transmit authorized immunization records

Definition: The registry has a function that allows authorized users to print and/or electronically transmit an individual's immunization history that serves as an "official immunization record."

Standard #13

Minimum

Consolidate all immunization records from multiple providers, using deduplication and edit checking procedures to optimize accuracy and completeness

Definition: The registry has a method in place to combine all available information relating to a particular individual into one complete immunization record.

Ideal

Consolidate all immunization records from multiple providers, using deduplication and edit checking procedures to optimize accuracy and completeness

Definition: The registry has a method in place to combine all available information relating to a particular individual into one complete immunization record. The registry also has a process in place that allows for a measure of accuracy and can show a demonstrable reduction in the rate of duplicate records. The provider is electronically notified of data errors.