1. E-mail: carmstrong@vhha.com Hospital Considerations: Smallpox Response Teams Carl W. Armstrong, MD VP & Senior Medical Advisor Virginia Hospital & Healthcare Association

2. Background HRSA cooperative agreement for BT VDH contract with VHHA VHHA task force established Regional planning (six regions) Hospital planning committee in each region

3. Administrative Issues Hospitals should thoughtfully set policy for phase I as it sets a precedent for phase II Liability protection of hospitals & staff Employee medical costs Employee lost wages Education / Informed consent

4. What Will Hospital Policy Be For: Leave granted to get vaccine & F/U? Need for furlough? Sick leave? Employee duties affected by accepting vaccination? Employee duties affected by declining vaccination? Expectations of employee if local smallpox case occurs?

5. Liability: Basis for Protection Section 304 –According to CDC, does not protect hospitals & staff if vaccine not administered there HHS letter & Guidance 1/16/03 –Promises to extend protection to non-vaccinating hospitals with response teams through future language in Sec. Declaration Sec. HHS Declaration –Not yet issued

6. Liability: Basis for Protection Federal SB6 –Recently introduced in the 108th Congress, it claims, as a sense of the Congress, that Sec. 304 protection only includes hospitals that have their own staff administer the vaccine. It also asserts that the vaccinated health care worker him/herself is not covered by the Act. State SB897 –Recently introduced in the 2003 General Assembly, provides liability protection for Virginia hospitals even if only designating team

7. Prof. Edward P. Richards, LSU Law School, 2003 Liability: Bottom Line Under the Department of Justice's opinion, reflected in the Secretary's letter, this provision should provide complete immunity for tort claims against health care workers and their institutions, but with the CDC and a group of Senators [SB6] claiming otherwise, there are certain to be courts who will reject this immunity. At this point, the only way to clarify the immunity provisions will be further legislation by Congress.

8. Liability: Options for Hospitals Trust in Sec. HHS & move forward Await language in Sec. Declaration –Should happen soon Await clarification from Congress –May take a while, if it happens at all

9. Compensation for Injury Section 304 –Does not establish federal no fault compensation for injured vaccinee –Claimant can only sue federal government –Payment only made if negligence proven Federal SB6: –President should guarantee medical care, compensation for injuries, and other protections for individuals who are vaccinated...

10. Compensation for Injury Workers compensation –Eligibility for coverage currently uncertain –Might cover medical costs –Might cover a portion of lost wages State HB2728 –Would mandate coverage, if passed

11. Compensation for Injury Employee Health Insurance Policy –Likely most would cover medical expenses if workers comp is denied –Some may claim this is not a covered benefit –Some have yet to determine policy –Insurers, too, are concerned about the precedent set for phases II & III

12. Education / Informed Consent A fully informed potential volunteer should know about (among other things): –Uncertainty of vaccine benefit –Organizational policies relevant to employees on smallpox team –Status of coverage for medical expenses –Status of coverage for lost wages