Rules of the State Board of Health
Bureau of Communicable Disease

CHAPTER 420-6-2

Exchange of Immunization Information and Operation of the Alabama Immunization Registry

TABLE OF CONTENTS

420-6-2-.01                 Definitions
420-6-2-.02                 Purpose
420-6-2-.03                 Exchange of Immunization Information
420-6-2-.04                 Access to the Immunization Registry
420-6-2-.05                 Importation and Modification of Data in the Immunization Registry
420-6-2-.06                 Permitted Uses of the Immunization Registry
420-6-2-.07                 Prohibited Uses of the Immunization Registry
420-6-2-.08                 Confidentiality of Immunization Registry Information

420-6-2-.01   Definitions.

             (1)  Health care provider means a physician, nurse practitioner, physician=s assistant, nurse, or other health professional duly licensed and authorized to administer immunizations in Alabama.  The term includes the clinics, facilities, and hospitals where the licensed health professional practices.  

(2)  Department means the Alabama Department of Public Health including its county and area subdivisions. 

(3)  Immunization registry means the statewide, centralized computerized database created, owned, and maintained by the department and which contains immunization information consisting of identifying, locating, and immunization data about former or current Alabama residents.

(4)  Identifying data means non-locating data that serve to uniquely identify an individual.  Such data may include the immunization registry number, name (last name, first name, middle name, generation), date of birth, sex, race, social security number, place of birth (city, state or country), birth plurality, Medicaid number, mother’s name (last name, first name, middle name, maiden name), mother’s  date of birth, mother’s social security number, father’s name (last name, first name, middle name), father’s date of birth, and father’s social security number.

(5)  Locating data means data that indicate the location of the individual.  Such data include address (street, city, state, zip code), telephone numbers, and health care providers who administered immunizations to the individual.

(6)  Immunization data means data that indicate the type(s) of immunization received and date(s) of immunization.  The department will determine which immunization antigens are recorded in the immunization registry.

(7)  Immunization data user means those individuals and entities with a legitimate need to know immunization data and includes public and private health care providers and the health care facilities they represent; health care insurers; managed care organizations and similar entities; the Alabama Medicaid Agency; officials of public and private day-care centers, schools, and post-secondary educational institutions; and other state immunization registries and any future federal immunization registry that conform with the principles of this chapter.

(8)  Vaccines for Children means the federal entitlement program that supplies enrolled health care providers with free vaccine for eligible children.

Author:  Charles H. Woernle, M.D., M.P.H.
Statutory Authority:  Code of Alabama, 1975, '22-11B-1, et seq. and 22-2-2.
History: Original rule filed 10/15/97; Effective 12/5/97

420-6-2-.02   Purpose.

            The purpose of this chapter is to establish procedures whereby health care providers exchange information concerning the immunization status of an individual with authorized immunization data users. This chapter also governs the operation and use of the immunization registry, which is designed to provide information that identifies an individuals immunization status, thereby promoting the proper immunization of individuals and the proper functioning of immunization programs.

Author:  Charles H. Woernle, M.D., M.P.H.
Statutory Authority:  Code of Alabama, 1975, '22-11B-1, et seq. and 22-2-2.
History:  Original rule filed 10/15/97; Effective 12/5/97

420-6-2-.03  Exchange of Immunization Information.

(1)  Health care providers shall provide immunization data about an individual upon the request of an immunization data user, as provided herein.

(2) No immunization data user shall inquire about immunization data without a reasonable basis for believing that the health care provider has immunization data on the particular individual.

(3)  The request from the immunization data user may be presented by letter, telephone call, fax, other electronic means, or in person and in a manner that identifies the requester as an immunization data user.  The responding health care provider shall provide the data in a timely manner and form that facilitate achieving the appropriate immunization of the particular individual or enable the requesting  immunization data user to meet legal responsibilities.  Health care providers shall not refuse or delay the exchange of immunization data with immunization data users. 

(4)  Immunization data users shall not release immunization data obtained from health care providers except to other immunization data users, the individual, or his/her parents or legal guardians, or except upon presentation of a properly executed release.   Identifying and locating data shall be exchanged only to the extent required to confirm the identity of the individual about whom immunization data are sought.

(5)  Health care providers are strongly encouraged to submit data to the immunization registry, and immunization data users are strongly encouraged to access the immunization registry as a preferred means to exchange immunization data.

Author:  Charles H. Woernle, M.D., M.P.H.
Statutory Authority:  Code of Alabama, 1975, '22-11B-1, et seq. and 22-2-2.
History:  Original rule filed  10/15/97; Effective 12/5/97

420-6-2-.04  Access to the Immunization Registry.

(1)   The department will provide to immunization data users both electronic access to the immunization registry and access via telephone inquiry. 

(2)  Electronic access to the immunization registry is restricted to immunization data users who have been issued an identification code and password by the department.  Immunization data users will complete an enrollment form designed by the department that specifies the conditions under which the immunization registry can be accessed and the data used. Requested information may include the name of the enrolling health care provider, his/her title, social security number, license number, Medicaid provider number, organization name, reason why applicant needs to know immunization data, federal identification code, Vaccines for Children provider number, business location, mailing address, telephone number, fax number, E-mail address, and method of access to the registry.

(3)  By memoranda of understanding, the department may permit electronic access to the immunization registry via computer systems operated by other immunization data users.

Author:  Charles H. Woernle, M.D., M.P.H.
Statutory Authority:  Code of Alabama, 1975, '22-11B-1, et seq. and 22-2-2.
History:  Original rule filed 10/15/97; Effective 12/5/97

420-6-2-.05  Importation and Modification of Data in the Immunization Registry.

(1)  Information in the immunization registry may be obtained from health care provider clinic records, billing data and information from health care insurers and the Alabama Medicaid Agency, department clinic records, and vital records.  The department may establish memoranda of understanding with health care insurers, managed care organizations or similar entities,  and the Alabama Medicaid Agency to establish procedures to permit the electronic importation of new or revised immunization information to which they are privileged.

(2)  Information from and related to birth certificates for births that occurred in Alabama on or after January 1, 1993, shall be provided by the Center for Health Statistics for inclusion in the immunization registry.  Unless specifically prohibited by law, immunization registry information derived from birth certificates shall include child=s name, date of birth, place of birth, sex, race, social security number, and plurality; mother=s name including maiden name, date of birth, social security number, and address; and father=s name, date of birth, and social security number.  The birth certificate number shall not be included in the immunization registry, but an identification number that can be linked to the birth certificate shall be maintained in the registry.  Changes made on birth certificates or to related information involving data items included in the immunization registry shall be forwarded by the Center for Health Statistics to the immunization registry to replace the original information from birth certificates.  Any original birth certificate information or related data in the registry shall be replaced by the changed information.  No record shall be kept in the immunization registry of the original information from the birth certificate, if that information has been changed on the birth certificate under Section 22-9A-12.  Information originating from or related to birth certificates contained in the immunization registry shall become immunization registry data subject to the laws and rules governing the immunization registry.  Other information from or related to birth certificates not included in the immunization registry may be used to assess immunization levels or to promote proper immunization of individuals identified in the registry, but that information shall not become part of the immunization registry.  The Center for Health Statistics shall also report to the immunization registry those individuals born on or after January 1, 1993, who have died in Alabama, and the fact of death shall be recorded in the immunization registry.

(3)  Immunization data can only be modified by the health care provider who administered that dose(s).  Immunization data users are encouraged to submit revised identifying and locating data as they are learned.  The department will establish procedures whereby data in the immunization registry can be changed.   Changes must be based on documents in the possession of the health care provider.  The department will have the right to validate changes made to records.  All changes to immunization records will be electronically archived and indicate the date and the health care provider submitting the changes.

Author:  Charles H. Woernle, M.D., M.P.H.
Statutory Authority:  Code of Alabama, 1975, '22-11B-1, et seq. and 22-2-2.
History:  Original rule filed 10/15/97; Effective 12/5/97

420-6-2-.06  Permitted Uses of the Immunization Registry.

(1)  Uses of the immunization registry include facilitating the exchange of immunization data; helping to remind individuals, their parents/legal guardians or health care providers that they are due or overdue  an immunization; and determining the proportion of a group of children that is appropriately immunized  by health care provider, geographic area, or other entity.

(2)  Immunization data users may either browse search based on submitted criteria that return a list of individuals in the immunization registry or uniquely select an individual and list his/her immunization data.

(3)  Data in the immunization registry may be used to issue the Alabama Certificate of Immunization, which may be computer generated if departmental specifications are met.  

(4)  The Alabama Medicaid Agency, health care insurers, managed care  organizations, and similar entities may utilize information in the registry to evaluate the extent individuals under their care are appropriately immunized.

(5)  The department may conduct surveys to identify children and geographic areas that represent underserved areas of need.  Researchers may submit proposals to receive immunization registry data, but such provided data shall not identify individual patients, health care  providers, or health care insurers.  Data may be provided in the form of paper reports and summaries or electronic files.  The department will establish procedures  to evaluate the suitability of research proposals. The department will consider such requests in light of its capacity and resources to respond.

Author  Charles H. Woernle, M.D., M.P.H.
History:  Code of Alabama, 1975, '22-11B-1, et seq. and 22-2-2.
Statutory Authority:  Original rule filed 10/15/97; Effective 12/5/97

420-6-2-.07  Prohibited Uses of the Immunization Registry. 

            Immunization data users shall not use the immunization registry to obtain information necessary to apply for a birth certificate, locate a child, determine the market share of competitors, engage in any commercial purpose, or enroll persons in lawsuits.  Immunization data users who engage in a prohibited use of the registry may be denied further access to the registry in addition to any other penalties provided by law. 

Author:  Charles H. Woernle, M.D., M.P.H.
Statutory Authority:  Code of Alabama, 1975, '22-11B-1, et seq. and 22-2-2.
History:  Original rule filed 10/15/97; Effective 12/5/97

420-6-2-.08  Confidentiality of Immunization Registry Information.

(1)  Immunization data users will consider information in the registry as confidential and thus only access it and provide it when there is a legitimate and professional need to know.  When an immunization data user accesses the registry, the only locating data accessible will be such data submitted by that immunization data user.

(2)  The identity of other health care providers will only be released to an inquiring health care provider upon receipt by the department of a written release of medical information signed by the individual or his/her parent or legal guardian. 

(3) The department can not otherwise release unique locating data to anyone except by subpoena.

Author:  Charles H. Woernle, M.D., M.P.H.
Statutory Authority:  Code of Alabama, 1975, '22-11B-1, et seq. and 22-2-2.
History:  Original rule filed 10/15/97; Effective 12/5/97