February 19, 1998

Mr. Phillip Pampinella
Assistant Administrator
Fort Myers Nursing Agency
3949 Evans Ave.
Fort Myers, FL 33901

Dear Mr. Pampinella;

This letter is in response to your letters of October 29, 1997, to Senator Connie Mack and Senator Bob Graham, concerning the potential expense involved in the administration of Hepatitis B vaccine. Both letters were forwarded to my office for reply. You expressed in your letter that when or if an employee keeps missing her scheduled shots in the series, an employer would have to start the series over and over again, which could increase the employer's potential liability from $156 to $500 or more per employee.

As was explained during your phone conversation, it appears that you have been misinformed on the procedures to follow if an employee misses a scheduled appointment for his or her second or third shot in the vaccination series. It is not required or even recommended to restart the vaccination series if an employee misses the scheduled date for a shot. Even though the usual frequency of the shots in the vaccination series is at 0, 1 and 6 months, the U.S. Public Health Service (USPHS) provides for some flexibility in scheduling. Current USPHS recommendations indicate that in the case of an interrupted series, the next immunization in the series should be given as if the interruption had not occurred, providing sufficient time has elapsed since the previous immunization was received. This permits a certain flexibility and there should be little or no added financial burden to a reasonably diligent employer if an employee misses a date for a shot. The employer should simply reschedule the missed shot as soon as possible. The employer has the responsibility of following current USPHS guidelines, which are published by the Center of Disease Control and Prevention (CDC).

It should be noted that the bloodborne pathogens standard requires that the Hepatitis B vaccine be administered at a convenient time and place. In written comments to the bloodborne pathogen docket, nurses noted that they were more likely to receive the immunization if it were conveniently located at their worksite and offered at a convenient time such as during their normal workshift. Employers evaluating their employees' incomplete vaccination series should take the above considerations into account.

You also stated in your phone conversation another problem was that the vaccine had a very short shelf life and had to be thrown away if not used art the time of the appointment. This information also seems to be false. We have spoken to one manufacturer of the vaccine and they have assured us that the shelf life of their single dose vials is usually 36 months.

I hope this clarifies OSHA's position on the Hepatitis-B vaccination series. If you have any further questions, please contact Craig Moulton in the Office of Health Compliance Assistance on (202) 219-8036, ext. 39.

Sincerely,

John B. Miles Jr.
Director
Directorate of Compliance Programs