32.1-46.01 - Virginia Immunization Information System.

§ 32.1-46.01. Virginia Immunization Information System.

A. The Board of Health shall establish the Virginia Immunization InformationSystem (VIIS), a statewide immunization registry that consolidates patientimmunization histories from birth to death into a complete, accurate, anddefinitive record that may be made available to participating health careproviders throughout Virginia, to the extent funds are appropriated by theGeneral Assembly or otherwise made available. The purposes of VIIS shall beto (i) protect the public health of all citizens of the Commonwealth, (ii)prevent under- and over-immunization of children, (iii) ensure up-to-daterecommendations for immunization scheduling to health care providers and theBoard, (iv) generate parental reminder and recall notices and manufacturerrecalls, (v) develop immunization coverage reports, (vi) identify areas ofunder-immunized population, and (vii) provide, in the event of a publichealth emergency, a mechanism for tracking the distribution andadministration of immunizations, immune globulins, or other preventivemedications or emergency treatments.

B. The Board of Health shall promulgate regulations to implement the VIISthat shall address:

1. Registration of voluntary participants, including, but not limited to, alist of those health care entities that are authorized to participate and anyforms and agreements necessary for compliance with the regulations concerningpatient privacy promulgated by the federal Department of Health and HumanServices;

2. Procedures for confirming, continuing, and terminating participation anddisciplining any participant for unauthorized use or disclosure of any VIISdata;

3. Procedures, timelines, and formats for reporting of immunizations byparticipants;

4. Procedures to provide for a secure system of data entry that may includeencrypted online data entry or secure delivery of data files;

5. Procedures for incorporating the data reported on children's immunizationspursuant to subsection E of § 32.1-46;

6. The patient identifying data to be reported, including, but not limitedto, the patient's name, date of birth, gender, telephone number, homeaddress, birth place, and mother's maiden name;

7. The patient immunization information to be reported, including, but notnecessarily limited to, the type of immunization administered (specified bycurrent procedural terminology (CPT) code or Health Level 7 (HL7) code); dateof administration; identity of administering person; lot number; and ifpresent, any contraindications, or religious or medical exemptions;

8. Mechanisms for entering into data-sharing agreements with other state andregional immunization registries for the exchange, on a periodic nonemergencybasis and in the event of a public health emergency, of patient immunizationinformation, after receiving, in writing, satisfactory assurances for thepreservation of confidentiality, a clear description of the data requested,specific details on the intended use of the data, and the identities of thepersons with whom the data will be shared;

9. Procedures for the use of vital statistics data, including, but notnecessarily limited to, the linking of birth certificates and deathcertificates;

10. Procedures for requesting immunization records that are in compliancewith the requirements for disclosing health records set forth in §32.1-127.1:03; such procedures shall address the approved uses for therequested data, to whom the data may be disclosed, and information on theprovisions for disclosure of health records pursuant to § 32.1-127.1:03;

11. Procedures for releasing aggregate data, from which personal identifyingdata has been removed or redacted, to qualified persons for purposes ofresearch, statistical analysis, and reporting; and

12. Procedures for the Commissioner of Health to access and release, asnecessary, the data contained in VIIS in the event of an epidemic or anoutbreak of any vaccine-preventable disease or the potential epidemic orepidemic of any disease of public health importance, public healthsignificance, or public health threat for which a treatment or vaccine exists.

The Board's regulations shall also include any necessary definitions for theoperation of VIIS; however, "health care entity," "health care plan," and"health care provider" shall be as defined in subsection B of §32.1-127.1:03.

C. The establishment and implementation of VIIS is hereby declared to be anecessary public health activity to ensure the integrity of the health caresystem in Virginia and to prevent serious harm and serious threats to thehealth and safety of individuals and the public. Pursuant to the regulationsconcerning patient privacy promulgated by the federal Department of Healthand Human Services, covered entities may disclose protected healthinformation to the secure system established for VIIS without obtainingconsent or authorization for such disclosure. Such protected healthinformation shall be used exclusively for the purposes established in thissection.

D. The Board and Commissioner of Health, any employees of the healthdepartment, any voluntary participant, and any person authorized to report ordisclose immunization data hereunder shall be immune from civil liability inconnection therewith unless such person acted with gross negligence ormalicious intent.

E. This section shall not diminish the responsibility of any physician orother person to maintain accurate patient immunization data or theresponsibility of any parent, guardian, or person standing in loco parentisto cause a child to be immunized in accordance with the provisions of §32.1-46. Further, this section shall not be construed to require theimmunization of any person who objects thereto on the grounds that theadministration of immunizing agents conflicts with his religious tenets orpractices, or any person for whom administration of immunizing agents wouldbe detrimental to his health.

(2005, cc. 643, 684.)