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July 22, 1993

Ms. Anne M. Sturtz
Assistant General Counsel
VOCA Corporation
5555 ParkCenter Circle,
Suite 200
Dublin, Ohio 43017-2005

Dear Ms. Sturtz:

This is in response to your letter of November 9, 1992, to Mr. David Kennedy of our Columbus, Ohio, area office. You requested an interpretation of the Occupational Safety and Health Administration (OSHA) regulation, 29 CFR 1910.1030, "Occupational Exposure to Bloodborne Pathogens." Specifically, you inquired about the permissibility of a consent form with a waiver of liability. Your letter was referred to this office for response.

The consent form you enclosed with your November 9, correspondence cannot be used because the sentence which releases the employer from liability constitutes a violation of OSHA's requirement that the vaccine be offered at no cost to the employee. We concur with the Chicago Regional Office letter of January 6, which states that asking employees to waive possible future legal rights is considered a cost to employees.

Your letter stated that VOCA offers prescreening, free of charge, to employees who elect to participate in the vaccination program. This is allowed by the standard since your program is not a prerequisite for receiving the hepatitis B vaccine. Also permitted under the standard is the requirement for employees who receive the vaccine to sign an informed consent form, provided that the information is not biased. For example, a lengthy description of all potential side effects of the vaccine and no explanation of the benefits of receiving the vaccine (i.e., the health effects which may result from actual contraction of the disease) would not be acceptable.

The consent form you sent along with your November 9, letter is acceptable until the last sentence, which releases VOCA from all responsibility for reactions that may occur from the immunization.

The fact that OSHA prohibits the liability waiver does not mean that you are necessarily liable should an accident occur. OSHA does not have the authority to determine liability for injuries or illnesses; such liability is a matter of state worker's compensation or tort law. We do, however, have the responsibility to ensure that employees who have occupational exposure to blood or other potentially infectious materials are offered the hepatitis B vaccine at no cost.

In a telephone conversation you had with a member of my staff on April 27, you expressed VOCA's desire to be sure your employees make an informed decision before accepting the hepatitis B vaccine, and that they understand there could be contraindications. The bloodborne pathogens training, as required by paragraph (g)(2)(vii)(I), must include information on the hepatitis B vaccine, including information on its efficacy and safety. Since employees are required to receive this training before receiving the vaccine, they will have received the necessary information to make an informed decision. Further, you are required to keep on file the healthcare professional's written opinion, in which the person administering the vaccine has determined, through consultation with the employee and/or the employee's medical records, whether any contraindications can be determined for the employee. Complying with these two requirements should reassure you that your employees have been informed as to both the benefits and risks of the vaccine before they receive the first dose.

We hope this has been responsive to your concerns. Thank you for your interest in employee safety and health.

Sincerely,



Roger A. Clark, Director
Directorate of Compliance Programs




March 22, 1993

MEMORANDUM FOR:     ROGER CLARK, DIRECTOR
                   DIRECTORATE OF COMPLIANCE PROGRAMS

ATTENTION:          RUTH McCULLY, DIRECTOR OFFICE OF HEALTH
                   COMPLIANCE ASSISTANCE

FROM:               MICHAEL G. CONNORS REGIONAL ADMINISTRATOR

SUBJECT:            NATIONAL OFFICE RESPONSE VOCA CORPORATION

The package of materials labeled "#2" pertains to issues initially raised by VOCA with the Cincinnati Area Office and responded to by the Chicago Regional Office of Technical Support (after consultation with Ms. Jessica Sandler of the Office of Health Compliance Assistance). There do not appear to be any unresolved questions from this interaction, and the material is being sent for your background information only.

The package of materials labeled "#1" pertains to issues initially raised by VOCA with the Columbus Area Office, responded to by the Chicago Regional Office of Technical Support and then forwarded to the National Office of Health Compliance Assistance when it became apparent that the company was seeking approval for a disclaimer form that would affect operations in four OSHA regions including ours. We have included all correspondence available from our files to assist you in this matter. Our response to VOCA would be essentially the same as enumerated in our original letter of July 9, 1992, however they seem to have added a wrinkle by using the mandatory declination form prescribed at Appendix A to 29 CFR 1910.1030 and the "consent" form attached as exhibit E to their letter of November 9, 1992, for those employees who elect to have the procedure. The company seems to be worried about medical liability to adverse reactions to the vaccine, which I believe we addressed in our January 6, 1993, letter to them (see package #2).

Your assistance in this matter will be greatly appreciated, as we suspect that it is just cloudy enough that a single, decisive response from the National Office is going to be needed to put this issue to rest once and for all. If you or your staff have any questions with regard to this matter please contact Mr. William Wiehrdt of my staff at 312-353-5977.

Attachments



August 4, 1992

Anne Sturtz
5555 Parkcenter,
Suite 200
Dublin, OH 43017

Dear Ms. Sturtz:

A copy of VOCA's specific consent form was sent to our Chicago Regional Office for clarification as to whether the form could be used. In accordance with the Region's decision, this consent form (see attached) can not be used. "The addition of a sentence(s) releasing the employer from liability would further constitute a violation of our agency's requirement due to the fact that employees at risk have a right to receive free hepatitis B vaccines regardless of whether or not they waive liability."

If you have any further questions, please contact our office.

Sincerely,



W. Art Thomas, Area Director

WAT/jmc

cc: David Freeland



August 12, 1992

W. Art Thomas, Area Director
U.S. Department of Labor
Occupational Safety
and Health Administration
Federal Office Building
Room 620 200 North High Street
Columbus, Ohio 43215-2497

RE: Clarification of Letter of August 4, 1992

Dear Mr. Thomas:

Thank you for your letter of August 4, 1992, regarding the form of specific consent we have been using for employees who elect to participate in the Hepatitis B Vaccination Program. I appreciate your comments about the consent form. I noticed that your letter references the Chicago Region's decision, as the basis for determining that the consent form is unacceptable. Please forward a copy of the Chicago Region's decision, regarding the consent form to me, for my files. Your letter has raised some questions regarding acceptable language for the consent form.

As you know, the standard prohibits the employer from requiring employees to undergo any kind of prescreening prior to administration of the vaccine. However, several physicians have advised us, that there are certain risks associated with the administration of the Hepatitis B Vaccine. In particular, the vaccine is contraindicated for women who are pregnant or breastfeeding, and persons with sensitivity to thimersol or mercury products, sensitivity to yeast, active infections or pulmonary/cardiac problems. Therefore, VOCA Corporation and its affiliates (hereinafter 'VOCA') have elected to offer prescreening, free of charge, to employees who elect to participate in the vaccination program. The decision to undergo prescreening is at the employee's option, and is not a prerequisite to participation in the vaccination program.

It is our understanding that although there are few documented cases of adverse reactions to the vaccine, the possibility exists that some employees will experience complications or adverse reactions. For example, some employees may not be aware that they are sensitive to thimersol, mercury or yeast, and may elect to receive the vaccine, without undergoing any prescreening. In addition, a female employee, in the early stages of pregnancy, may unwittingly elect to participate in the vaccination program, without undergoing any prescreening. In each case, the employee may suffer an injury or illness related to participation in the vaccination program. Your letter appears to suggest that VOCA would be liable for any adverse reactions employees might suffer as a result of the employee's failure to heed warnings regarding the risks associated with receipt of the vaccine.

It is our position that the company is not responsible for medical complications or adverse reactions which may occur, as a result of an employee's failure to heed warnings about possible complications which may result from receiving the vaccine.

Therefore, I enclose for your review a revised form of specific consent, which sets forth the company's position. Please review this form of specific consent and let us know if this language is acceptable. In addition, please clarify if it is the Department of Labor's position that the employer, is liable for employee injuries or illnesses which result from the employee's participation in the vaccination program and the employee's failure to heed warnings regarding possible risks of receipt of the Hepatitis B vaccine.

If you have any questions, or require additional information, do not hesitate to contact me.

Sincerely yours,



Anne M. Sturtz
Assistant General Counsel

Enclosure

cc: David Freeland

AMS/ss



January 6, 1993

Anne M. Sturtz Assistant
General Counsel
VOCA Corporation
5555 Parkcenter Circle,
Suite 200
Dublin, Ohio 43017-3586

Dear Ms. Sturtz:

This is in response to your December 2, 1992 letter requesting further clarification of the hepatitis B vaccination requirements of OSHA's Bloodborne Pathogens Standard. While I believe that your questions have already been answered by this office in previous correspondence, I will readdress your concerns. Enclosed are the actual U.S. Public Health Service (USPHS) recommendations regarding the administration of the vaccine, as well as a copy of the Bloodborne Pathogens Standard and the OSHA Act. It is recommended that you review all three documents to assist you in understanding OSHA's requirements for offering the hepatitis B vaccine. It is also suggested that you discuss them with a licensed physician or healthcare practitioner who is knowledgeable and can explain the technical aspects of the recommendations. You may also contact the Centers for Disease Control's Hepatitis B Vaccine Hotline at 404-332-4555.

The issues you raise will be addressed in the order in which they were stated, but before I address your individual concerns, I believe a brief explanation of OSHA's hepatitis B vaccine regulation is necessary. OSHA relies on the USPHS to provide the medical specifics on the use of the hepatitis B vaccine as they have the expertise and experience in this field. In the future, the recommendations may change as knowledge about the benefits and risks of the vaccine is acquired. It is important to note that the USPHS recommendations are for the general public, which consists of persons of all ages and a wide range of health situations, that is healthy newborns, immune-suppressed adults, etc. The recommendations are not directed specifically at the U.S. work force, although the U.S. work force does consist of a diversity of ages and individual health situations. In requiring employers to make the vaccine available to employees, OSHA expects that the USPHS guidelines will be followed.

The first issue you raise concerns the administration of booster doses of the hepatitis B vaccine. Your statement that we implied "that the standard requires an employer to ensure that an employee participating in the voluntary vaccination program receive optimal protection from the vaccine, by administering booster doses to employees who fail to receive the second and third doses of the vaccine in a timely fashion." is unclear. I do not believe that my November 12, 1992 letter, which quoted the actual USPHS recommendations, mentioned booster shots. The specific section of the USPHS recommendations that apply to vaccine doses which are not administered in the recommended intervals is on page B-12.

"Vaccine doses administered at longer intervals provide equally satisfactory protection, but optimal protection is not conferred until after the third dose. If the vaccine series is interrupted after the first dose, the second and third doses should be given separated by an interval of 3-5 months. Persons who are late for the third dose should be given this dose when convenient. Post vaccination testing is not considered necessary in either situation."

What this means is that although the 0, 1, 6-month interval is most desirable for conferring immunity, and these are the time intervals that OSHA requires employers to follow, immunity is not completely compromised by not strictly adhering to this 0, 1, 6- month recommendation. The need for post vaccination screening is addressed on page B-14 of the recommendations.

"Available data show that vaccine-induced antibody levels decline steadily with time and that up to 50% of adult vaccinees who respond adequately to vaccine may have low or undetectable antibody levels by 7 years after vaccination. Nevertheless, both adults and children with declining antibody levels are still protected against hepatitis B disease."

What this means is that post-vaccination screening is not always a useful tool in identifying if persons have not acquired immunity, because it is known that over time, almost half of immune adults who are tested will not show immunity. The best way to ensure a adequate development of antibody is to follow the USPHS recommendations. To answer your three questions regarding booster doses:

Answer to question no. 1(a):

The employer is required to pay for all booster doses required by the USPHS recommendations. Proper administration of the vaccine ensures that booster shots are not necessary. Enclosed is a letter from Dr. Craig N. Shapiro, Medical Epidemiologist for the CDC's Hepatitis Branch which discusses the issue of time intervals for the three-shot series. I believe this letter adequately addresses your concerns regarding the "timely" administration of the vaccine. However, in the event of an exposure incident the USPHS recommendations require, in some cases, that booster shots be administered. Please refer to Table 5 of the USPHS recommendations which lists the protocols for healthcare practitioners in evaluating employees after exposure incidents.

Answer to question no. 1(b):

The employer may require employees to undergo postvaccination screening if it is expected that they did not receive an optimal response to the vaccine because the vaccine was not administered in accordance with the USPHS recommendations.

Answer to question no. 1(c):

The employer is required to pay for booster shots if the USPHS recommendations indicate that a booster is necessary. Currently, the guidelines only recommend booster shots when, in the course of the healthcare practitioner's post-exposure incident follow-up procedures, blood tests indicate that the employee does not have adequate immunity. Please refer to Table 5 of the USPHS recommendations for further guidance.

The second issue you raise concerns the documentation of an employee's refusal to return for the remainder of the series. The employer is responsible for ensuring that all unvaccinated employees with occupational exposure receive the vaccine if they wish.

Answer to question no. 2(a):

While an employee who refuses to receive the vaccine in the time intervals recommended could be considered to be refusing the vaccine, OSHA would support the employee's attempts to be vaccinated at a subsequent date.

Answer to question no. 2(b):

OSHA does not require that the employer make extraordinary efforts to ensure completion of the series. However, we would look for good faith efforts on the part of the employer to ensure employee compliance. Documentation of written or verbal reminders to the employee would constitute a good faith effort. As you mention, we believe a completed declination form would also constitute documentation where an employee's failure to return for the second or third injections constitutes a refusal to complete the series.

Regarding the Medcom video, I would like to state again that OSHA does not approve, authorize or endorse any product or service. The informational literature provided in your correspondence will be forwarded to our Office of Public Information. Medcom will be contacted regarding their improper acknowledgment of OSHA as a contributor to the production of their training program.

Regarding your request for the legal basis of OSHA's position that asking employees to waive their future legal rights is considered a cost to employees, I offer the following.

Both legal suits and legal settlements result in monetary awards. That is, the right to file a suit is worth monetary benefits; therefore, giving up the right to file a suit is equivalent to giving up the right to obtain future monies. Asking an employee to waive future legal rights is a future cost to them.

Regarding your statement that "the standard prohibits the employer from requiring the employees to undergo any kind of prescreening prior to administration of the vaccine", I would like to point out that this is most definitely untrue. The standard requires a full evaluation of the employee by a licensed physician or healthcare practitioner who then must document in a written opinion whether the employee may or may not be vaccinated. Sections (f)(1)(ii)(C) and (D) state that "the employer shall ensure that all medical evaluations and procedures including the hepatitis B vaccine and vaccination series ... are ... performed by or under the supervision of a licensed physician or by or under the supervision of another licensed healthcare practitioner and provided according to recommendations of the USPHS current at the time these evaluations and procedures take place..."

What this means is that a licensed healthcare practitioner or physician, who understands the USPHS recommendations, must do a thorough evaluation of each and every employee to determine if the vaccine can indeed be administered to the employee and if any procedures above and beyond the three shot series needs to be done.

Regarding your statement that the early stages of pregnancy, active infections or cardiac/pulmonary problems are contraindications to the vaccine, please be advised that the USPHS recommendations do not state that these are contraindications. In fact, the recommendations specifically state that the vaccine should not be considered a contraindication for pregnant women.

Regarding the issue you raise of VOCA's liability for any adverse medical reactions suffered by employees as a result of taking the vaccine, it is not in OSHA's jurisdiction to determine if VOCA is responsible for medical complications or adverse reactions which may occur as a result of possible complications which may result from receiving the vaccine. OSHA expects employers to take certain steps to ensure the safest and most effective vaccine possible, such as having employees evaluated by appropriate healthcare personnel prior to vaccination and by administering the vaccine in accordance with the USPHS recommendations. Because the vaccine is an OSHA requirement, that is, employees accept the vaccine in the course of their employment, it is very likely that Workman's Compensation laws apply to any injury or illness suffered as a result of receiving the vaccine. Please see Section 4(b)(4) of the OSHA Act which states that "Nothing in this Act shall be construed to supersede or in any manner affect any workman's compensation law or to enlarge or diminish or affect in any other manner the common law or statutory rights, duties, or liabilities of employers and employees under any law with respect to injuries, diseases, or death of employees arising out of, or in the course of, employment." There may be other laws that apply in such cases.

I hope this is informative. If you need further clarification, please do not hesitate to contact Leslie Ptak of my staff at 312- 353-2220.

Sincerely,



William Q. Wiehrdt
Assistant Regional Administrator
Technical Support

Enclosures



May 28, 1992

Susan E. Harwood, Ph.D. Director,
Office of Risk Assessment
U.S. Department of Labor
Occupational Safety and Health Administration
200 Constitution Avenue, N.W.,
Room N3718
Washington, D.C. 20210

Dear Dr. Harwood:

Thank you for your recent inquiry regarding clarification of the recommendations when the hepatitis B vaccine schedule is interrupted.

The Immunization Practices Advisory Committee (ICAP) recommendations (MMWR 1991; 40:7) state that "If the vaccination series is interrupted after the first dose, the second dose should be administered as soon as possible. The second and third dose should be separated by an interval of at least 2 months. If only the third dose is delayed, it should be administered when convenient."

Studies have shown that the third dose of vaccine can be delayed for 1 year or longer after the first dose and the response is excellent. There are data that show that the interval between the first and second dose can be as long as 3 months without affecting seroconversion or antibody titers. Beyond that time, there are no data. However, as a result of discussion with ACIP members and other hepatitis experts, a conclusion was reached that in the event of interruption of the series after the first dose, the series did not have to be restarted. Instead, the second dose should be given as soon as possible, followed by the third dose at least two months after the second (as stated above). If the delay between the first and second dose is longer than 3 months and there is concern about the response to vaccine, then post-vaccination testing can be considered to determine that the vaccine recipient responded to the series.

I hope this helps clarify the recommendations. Please feel free to call me if you have further questions.

Sincerely,



Craig N. Shapiro, M.D.
Medical Epidemiologist
Hepatitis Branch
Division of Viral and National
Center for Infectious Diseases

December 2, 1992

Mr. Michael G. Connors,
Regional Administrator
United States Department of Labor
Occupational Safety
and Health Administration
230 South Dearborn Street,
Room 3244
Chicago, Illinois 60604

Re: Administration of the Hepatitis B Vaccine 29 CFR 1910.1030

Dear Mr. Connors:

Thank you for your letter of November 12, 1992. I appreciate your quick response to my questions. Your letter has raised some new issues, which require additional clarification.

1. Administration of Booster Doses of the Hepatitis B Vaccine.

Your response to the question I raised regarding the administration of booster doses of the Hepatitis B Vaccine refers to the guidelines issued by the U.S. Public Health Service in 1990, regarding the administration of booster doses. As previously stated, Dr. Shaw has advised us that an employee's immunity may be compromised by failure to receive the vaccine in accordance with the manufacturer's instructions. Your response implies that the standard requires an employer to ensure that an employee participating in the voluntary vaccination program receive optimal protection from the vaccine, by administering booster doses to employees who fail to receive the second and third doses of the vaccine in a timely fashion. This is contrary to my understanding of statements made by Dr. Susan Harwood during a meeting l had with Assistant Secretary Dorothy Strunk and other representatives of the Department of Labor on August 31, 1992.

Please clarify:

(a) whether the standard requires an employer to pay for booster doses of the vaccine for employees who fail to receive the second and or third doses of the vaccine in a timely fashion?

(b) whether an employer is permitted to require employees who fail to receive the second and third doses of the vaccine in a timely fashion to undergo post- vaccination screening prior to administration of a booster dose of the vaccine, to determine whether a booster dose is medically necessary?

(c) whether the standard requires an employer to offer the vaccine without charge to employees, who have already received the series of shots, in a timely fashion, if the employee undergoes post-vaccination screening and discovers that the employee has lost immunity to Hepatitis B?

2. Documentation of Employee Refusal to Return for the Remainder of the Series.

You also indicated that an appropriate method for documenting employee refusal to return for the remainder of the series, would be use of the declination form. In the case outlined in my October 23, 1992, letter, the employee was asked if she wished to decline the vaccine by the facility nurse. However, the employee indicated that she still wished to participate in the vaccination program. The employee did receive the second injection of the vaccine at the Clinic, forty (40) days after the date the second injection of the vaccine should have been administered. Please clarify:

(a) whether willful refusal by an employee to receive the second and/or third dose of the hepatitis B vaccine within the prescribed time limits, constitutes a de facto declination of the vaccine?

(b) what steps an employer must take to ensure that employees electing to participate in the vaccination program receive the vaccine in a timely fashion?

I would also like to respond to your comment regarding the "Medcom" video which we use for training purposes. The promotional materials for the video and acknowledgments contained in the video and the materials accompanying the video indicate that OSHA was involved in the development of the video. I enclose for your reference copies of the cover of the manual which accompanies the video and a copy of the table of contents for the manual. Please note the acknowledgment at the bottom of the table of contents for the manual. In addition to the written acknowledgments, there is commentary at the beginning of the video acknowledging the assistance of the Occupational Safety and Health Administration and the Centers for Disease Control in developing the video.

I also would like to request clarification of the statement in your letter that "[a]sking employees to waive their future legal rights is considered a cost to the employee." I would appreciate an explanation of the legal basis for this statement. Your statement suggests that it is the Department of Labor's position that the employer, is liable for employee injuries or illnesses which result from the employee's participation in the vaccination program and the employee's failure to heed warnings regarding possible risks of receipt of the Hepatitis B vaccine. As you know, the standard prohibits the employer from requiring employees to undergo any kind of prescreening prior to administration of the vaccine. However, several physicians have advised us, that there are certain risks associated with the administration of the Hepatitis B Vaccine. In particular, the vaccine is contraindicated for women who are pregnant or breastfeeding, and persons with sensitivity to thimersol or mercury products, sensitivity to yeast, active infections or pulmonary/cardiac problems. Therefore, VOCA has elected to offer prescreening, free of charge, to employees who elect to participate in the vaccination program. The decision to undergo prescreening is at the employee's option, and is not a prerequisite to participation in the vaccination program.

It is our understanding that although there are few documented cases of adverse reactions to the vaccine, the possibility exists that some employees will experience complications or adverse reactions. For example, some employees may not be aware that they are sensitive to thimersol, mercury or yeast, and may elect to receive the vaccine, without undergoing any prescreening. In addition, a female employee, in the early stages of pregnancy, may unwittingly elect to participate in the vaccination program, without undergoing any prescreening. In each case, the employee may suffer an injury or illness related to participation in the vaccination program. Your statement appears to suggest that VOCA would be liable for any adverse medical reactions employees might suffer as a result of the employee's failure to heed warnings regarding the risks associated with receipt of the vaccine.

It is our position that the company is not responsible for medical complications or adverse reactions which may occur, as a result of an employee's failure to heed warnings about possible complications which may result from receiving the vaccine.

If you have any questions, or require additional information, do not hesitate to contact me.

Sincerely yours,



Anne M. Sturtz
Assistant General Counsel

Enclosure

cc: The Honorable Lynn Martin
The Honorable Dorothy L. Strunk
Arthur Gomez, Industrial Hygienist, Region V