November 9, 1990
Ms. Wanda L. Hurr Director of Legal Services Wisconsin Association of Nursing Homes, Inc. 14 South Carroll Street Suite 200 Madison, Wisconsin 53703
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Dear Ms. Hurr:
This is in response to your letter of October 10 addressed to William E. Funcheon, Jr., Assistant Regional Administrator for Technical Support in the Occupational Safety and Health Administration (OSHA) Chicago Regional Office. Your letter was referred to this office for response.
While your letter to Mr. Funcheon addresses the specific issue of payment for the cost of the screening test for the hepatitis B vaccine, the sample release form which you enclosed should also be addressed as a general matter.
Until a final standard addressing occupational exposure to bloodborne pathogens is promulgated, OSHA is enforcing a number of current standards which are applicable to the hazards of bloodborne disease. In addition to several general industry standards, we are enforcing the general duty clause, section 5(a)(1) of the Occupational Safety and Health Act of 1970 (OSH Act), which requires an employer to “furnish to each of his employees employment and a place of employment which are free from recognized hazards that are causing or are likely to cause death or serious physical harm to his employees.”
It is OSHA’s interpretation of section 5(a)(1) that the hepatitis B vaccine is a feasible method of preventing contraction of the disease. OSHA requires that the cost of the vaccine be borne by the employer. To provide the vaccine free-of-cost but to require that a pre-test be performed and paid for by the employee creates an impediment to acceptance of the vaccine and is inconsistent with OSHA’s intent which is to remove, as much as possible, obstacles to the employee’s acceptance of the vaccine.
We agree with you that if the employee prefers to determine his or her immune status prior to vaccination, there is no authority requiring employers to bear the cost of the prevaccination serologic testing. However, your sample release form is ambiguous in this regard and it is unclear whether or not you are, in fact, requiring employees to determine their immune status prior to vaccination. Such a requirement, at cost to the employee, would be viewed as a violation of section 5(a)(1) of the OSH Act.
In fact, the Centers for Disease Control (CDC) does not recommend routine prevaccination serologic testing for susceptibility to the hepatitis B virus, and states that the decision to test potential vaccine recipients for prior infection is primarily a cost-effectiveness issue which “should be based on whether the costs of testing balance the cost of vaccine saved by not vaccinating individuals who have already been infected” (Morbidity and Mortality Weekly Report, February 9, 1990). Such testing is usually cost-effective for groups with the highest risk of infections and marginally so for groups at intermediate risk.
Another principal objection to the sample release form is the waiver-of-liability provision. Under section 5(a)(1), all at risk employees have a right to receive free hepatitis B vaccine, regardless of whether they waive liability. If the liability waiver is deleted, it would not violate section 5(a)(1) to require employees to sign forms indicating consent to the vaccination and informing them of the benefits and risks of the vaccine and the procedures for obtaining the vaccine.
There are, however, a number of misconceptions in your release form concerning the safety and efficacy of the vaccine which we must point out. You state, for instance, that the vaccine “may produce immunity in 82-87% of recipients. The vaccines are prepared from plasma of individuals who are carriers of the hepatitis virus or from yeast derivatives using recombinant DNA technology”. In fact, plasma-derived vaccine is no longer being produced in the United States and the currently licensed recombinant hepatitis B vaccine series induces an adequate antibody response in more than 90% of healthy adults.
You also state that “studies involving the use of the vaccine in pregnant and nursing women have not been performed and the vaccine will be given in these situations only if clearly needed…”. While it is true that data are not available on the safety on the hepatitis B vaccine for the developing fetus, the CDC states that “because the vaccines contain only noninfectious HBsAg particles, there should be no risk to the fetus. In contrast, HBV infection of a pregnant woman may result in severe disease for the mother and chronic infection of the newborn. Therefore, pregnancy or lactation should not be considered a contraindication to the use of this vaccine for persons who are otherwise eligible” (Ibid.).
We understand that the lengthy description in your form of potential side effects from the vaccine stems from your concern regarding the issue of liability. With respect to the danger of the plasma-derived vaccine, it should be noted again that it is no longer being produced and is available only to hemodialysis patients, other immunocompromised hosts, and persons with known allergy to yeast.
It is OSHA’s perception that your form could just as easily, and certainly should, include a list of the health effects and costs of infection with the hepatitis B virus. Since it does not, your presentation of the issue appears to be one-sided and could be construed as an attempt to dissuade employees from accepting the vaccine.
I hope this information is helpful to you.
Sincerely,
Patricia K. Clark Director Directorate of Compliance Programs
DATE: October 17, 1990 MEMORANDUM FOR: Patricia K. Clark Director Directorate of Compliance Programs THROUGH: Leo Carey Director Office of Field Programs FROM: Michael G. Connors Regional Administrator SUBJECT: Request For Clarification On HBV/HIV Issues
We are forwarding a letter from Wanda L. Hurr, Director of Legal Services at the Wisconsin Association of Nursing Homes regarding pre-test costs for HBV vaccines. The Regional Office believes that the issue(s) posed in this letter are of National significance and therefore, we respectfully request that you answer directly to the correspondent with a copy to our office.
The documents enclosed are:
1. Letter from Wanda L. Hurr, addressed to William E. Funcheon, Jr., ARA For Technical Support, Region V, dated October 10, 1990 (4 pages);
2. Letter from William E. Funcheon, Jr. to Wanda L. Hurr, dated October 2, 1990 (3 pages);
3. Letter from Gerald Cunningham, Milwaukee Area Office Area Director, addressed to William E. Funcheon, Jr., dated September 12, 1990 (1 page);
4. Letter from William E. Funcheon, Jr. to Gerald Cunningham, dated October 3, 1990 (2 pages);
5. Letter from Kathy Schallock, Nurse Consultant for the American Medical Services, Inc. to Gerald Cunningham, dated September 5, 1990 (1 page);
6. NIOSH Publication, No. 89-108;
7. Sample Release Form For Hepatitis B Vaccine, as redrafted by Susan Hurr, Legal director for the Wisconsin Association of Nursing Homes.
If you need further information, please contact Arthur Gomez, Region V Coordinator For Bloodborne Pathogens in the Technical Support Unit, at FTS 353-2220.
Sample Release Form Hepatitis B Vaccine
Vaccines providing protection against the HepatitiS B virus are licensed by the FDA. Clinical studies indicate that administration of the vaccine, in three doses over several months, may produce immunity in 82-87% of recipients. The vaccines are prepared from plasma of individuals who are carriers of the hepatitis virus or from yeast derivatives using recombinant DNA technology.
The Center for Disease Control (CDC) and the Occupational Safety and Health Administration (OSHA) have issued statements recommending vaccinations for health care workers who perform procedures that involve inherent at-risk potential for mucous membrane or direct skin contact with blood, bodily fluids, or tissues; or a potential for direct contact through spills or splashes of blood or bodily fluids.
While most long term care employees are less at risk for hepatitis infection than hospital based employees, some long term care employees may face potential exposure if the employee has direct contact with the bodily fluids of patients who harbor the Hepatitis B virus. The (facility)________________________, under the direction of its Medical Director, is prepared to offer and administer the vaccine without charge (except for the preliminary blood tests) to those employees in high risk positions who request it. Studies involving use of the vaccine in pregnant and nursing women have not been performed and the vaccine will be given in these situations only if clearly needed and at the written recommendation of your personal physician.
Prior to the administration of the vaccine a blood test, at the employee’s expense, may be performed to determine prior infection with Hepatitis B. Individuals whose test indicates prior exposure will not benefit from the vaccine and therefore will not be vaccinated.
The vaccine is given on a completely voluntary basis. Your decision to receive the vaccine is purely a personal decision. If you have further questions or concerns about the vaccine, please contact your personal physician before requesting the vaccination.
I understand that I have been given the option by (facility)_____________, of receiving the Hepatitis B vaccine series without charge to me. I, the undersigned employee, both request that the vaccine be administered and consent to the administration of the vaccine. I fully realize that administration of the vaccine may possibly result in immediate complications including, but not limited to: injection sight reactions consisting of soreness, pain, tenderness, pruritus, erythema, ecchymosis, swelling, warmth and nodule formation. Other adverse reactions may include feelings of fatigue/weakness headache, fever, malaise, nausea, diarrhea, pharangitis upper respiratory infection, sweating, achyness, sensation of warmth, light-headedness, chills, flushing, vomiting, abdominal pains/cramps, dyspepsia, diminished appetite, rhinitis (runny nose), influenza, cough, vertigo/dizziness paresthesia, non-specified rash, angioedema, urticaria, arthralgia, myalgia, back, neck and shoulder pain, lymphadenopathy, insomnia/disturbed sleep, earache, dysuria and hypotension.
Other complications that have been reported included hypersensitivity with a wide variety of symptoms including fever, dermatologic reactions, nose bleeds, chest discomfort, heart palpitations, bronchial spasm, and serum sickness like symptoms with a delayed onset of days to weeks after vaccination. Other reactions reported include Bell’s Palsy, muscle weakness, and optical neuritis.
Adverse effects of the plasma-derived Hepatitis B vaccine may include the above as well as the following: neurological disorders such as myelitis, acute radiculoneuropathy including Guillain-Barre syndrome and herpes zoster, thrombocytopenia, tinnitus and visual disturbances.
I also understand that anytime a medication is given by injection, unknown and potential serious allergic complications may occur.
Though I fully understand the risks of receiving these injections, I hereby release and forever discharge the (facility)________________ , its officers and directors, its medical and nursing staff, agents, employees and any other persons connected with the administration of the vaccine from any and all liabilities, claims, damages and causes of actions that may arise from the administration of the vaccine series and/or its possible complications. This release is to be binding upon my spouse, as well as my heirs, legal representatives and assigns.
I have fully read all of the terms of this release and understand that this is a complete release and bars any and all claims and resulting in the administration of the vaccine series and any possible complications regardless of whether specifically described herein.
After reading the above information about Hepatitis B vaccine, please read and sign the following release indicating your decision regarding the vaccine.
_____ I do not wish to receive the vaccine. _____ I have already been given the vaccine on __________, 19____. _____ I wish to receive the vaccine.
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I hereby certify that I have fully and completely read and understand the above information regarding the administration of the Hepatitis B vaccine series.
_______________________________________ (Employee Signature, Date) _______________________________________ (Witness Signature, Date) _______________________________________ (Witness Signature, Date) _______________________________________ (Medical Director Signature, Date) UNITED STATES DEPARTMENT OF LABOR Occupational Safety and Health Administration 230 South Dearborn Street, Room 3244 Chicago, Illinois 60604 (312) 353 – 2220
October 17, 1990
Wisconsin Association of Nursing Homes, Inc. 14 South Carroll Street Suite 200 Madison, WI 53703
ATTENTION: Wanda L Hurr Director of Legal Services RE: Your letter of October 10, 1990.
Dear Ms. Hurr:
Please be advised that your letter regarding vaccination costs, forms, etc. has been sent to our National Office for further disposition.
Thank you for your interest in safety and health in the workplace.
Sincerely,
William E. Funcheon, Jr. Assistant Regional Administrator Technical Support
Wisconsin Association of Nursing Homes, Inc. 14 South Carroll Street – Suite 200 (on the Capital Square) Madison, Wisconsin 53703 Area Code (608)257-0125 FAX: (608)257-0025
October 10, 1990
Mr. William E. Funcheon, Jr. Assistant Regional Administration Technical Support United States Department of Labor Occupational Safety and Health Administration 230 South Dearborn Street Room 3244 Chicago, IL 60604
Dear Mr. Funcheon:
Thank you for your letter dated October 2, 1990, regarding the sample release form which was distributed from the Association in September.
This form was drafted by me, with the assistance of a board certified family practitioner. The purpose of this sample release form was to give Wisconsin nursing homes some guidance regarding the issue of informed consent, in order to allow the administration of the hepatitis-B vaccinations to employees. In the guidelines and Proposed Rules regarding “Bloodbourne Pathogens”, OSHA has not addressed a concern that is of grave concern to the health care industry. Though it is clear OSHA is requiring free-of-charge administration of the HBV-Vaccine to all at-risk employees, the Administration has ignored the potential liability ramifications for these facilities.
In Wisconsin, as in most other states, medication, such as the Hepatitis-B vaccination, cannot be administered in the absence of a physician’s order. Even with a physician’s order, the law has long mandated that no medication is ever given to an individual, without the informed consent of the individual. The purpose of distributing the sample release form was dual: To provide information to potential vaccinees, and to limit potential liability of facilities for providing this vaccination, in the event of untoward effects or reactions from the medication.
While I appreciate your comments and agree that the language in your first recommendation is clearer than the second paragraph, line 4 of the sample form, I have serious concerns about the other comments.
Specifically, in paragraph three, I believe that the language “is prepared to offer and administer the vaccine without charge … to those employees in high-risk positions who request it.” read alone, is taken out of context. The sample form clearly states that the vaccine is given on a voluntary basis and on the second page, sixth paragraph, line one, the document states “I, (the employee) understand that I have been given the option by
________________(facility) of receiving the Hepatitis-B vaccine series without charge to me.”
There is nothing in this form indicating that it is the responsibility of the employee to request the vaccine. In fact, I have counseled many facilities that it is the facility’s responsibility to inform all employees of the facility’s obligation to provide the vaccine. After the facility advises employees, only those employees who request that the vaccine be given will be vaccinated. I disagree that this form, which will be given to all employees who are at risk for Hepatitis-B exposure, shifts responsibility in any way from the employer to the employee.
It also appears from your comments regarding the fourth paragraph that you have reviewed the first draft of this document. For your information, I enclose the second draft which was sent to all of our member facilities. It states that “prior to the administration of the vaccine, a blood test, at the employee’s expense, may be performed to determine prior infection with Hepatitis-B.” I strongly disagree with your statement that the pre-test cost is to be paid by the employer, not the employee.
Our office has been working with OSHA since the beginning of the rule-making process on “occupational exposure to bloodbourne pathogens” and the Association provided testimony in Chicago during the hearings. I see nothing in the documents you cited, nothing in the Federal Register of Tuesday, May 30, 1989 (Proposed Rules Relating to Occupational Exposure to Bloodbourne Pathogens), nothing in the OSHA instruction CPL2-2.44B from the Office of Health Compliance Assistance, nor in the NIOSH publication 108-89, indicating that this pre-test cost is to be paid by the employer. In fact, at a recent convention sponsored by our Association, this question was brought up and at a panel discussion of HCFA and the Bureau of Quality Compliance officials with the Wisconsin Division of Health and members of the panel, without disagreement, advised all attendees that this pre-test cost is to be borne by the employee, as there are no regulations nor directives requiring that this cost be also borne by the employer.
I agree that the directive, and proposed regulations, clearly require employers to bear the cost of the vaccine. It is our position that any at risk employee may choose to have the vaccine, regardless of whether a pre-test was done. If, however, the employee chooses to undergo a pre-test, I can find no authority requiring employees to bear this cost as well. If I am overlooking any regulation which contradicts this position, please let me know.
Though I certainly agree with your comments regarding the fifth paragraph, again, the purpose of this sample form was to give employers some guidance in providing informed consent for the administration of the vaccine. The Association has been very active in providing our members with updated material relating to employer obligations, which include draining and education provisions of the standard.
In summary, when the entire sample release form is read as a whole, I do not believe that the document in any way “lessens or clouds” the intent of the standard by using language that implies employees must request the vaccine. As written, employers clearly have an obligation to give employees an option, and after that is done, the employee may request the vaccine, free of charge.
Also, as the second draft of the form was written, employees have the option of having a pre-test, so that they might choose to forgo the vaccine if the blood test indicates that the vaccine is not necessary because of previous exposure or a previous vaccination. This form does not mandate that the employee undergo the pre-test, but, if the employee chooses, I see absolutely no basis for requiring that the cost be borne by the employer.
Finally, while the Association has supported the intent of these proposed regulations and directives, we do not feel that this particular forum is the appropriate place to insert information about training and educational aspects of the standards.
The Wisconsin Association of Nursing Homes supports the provision of quality health services to health care employees. As such, we appreciate your comments and the efforts made by OSHA and the Department of Labor to promote safety for workers in Wisconsin and the United States.
Please feel free to contact me if you have any further questions.
Sincerely
Wanda L. Hurr Director of Legal Services
WLH:hsb
cc: Susan Wood
Gerald Cunningham ACCUPATIONAL SAFETY AND HEALTH ADMINISTRATION 230 S. DEARBORN STREET, ROOM 3244 CHICAGO, IL 60604 312-353-2220
DATE: October 3, 1990 MEMORANDUM FOR: Gerald Cunningham Area Director Milwaukee Area Office FROM: William E. Funcheon, Jr. Acting ARA Technical Support SUBJECT: HBV Release Form and Pre-Test Cost
In response to your letter of September 12, 1990 please be advised that OSHA has mandated the employer to provide the HBV vaccine free-of-charge and according to standard medical practice in at least three documents:
1. The proposed Bloodborne Pathogen Standard, 2nd page, Item 31
2. The OSHA Instruction CPL 2-2.44B.
3. The Department of Labor, informational sheet explaining to the public that the vaccine shall be offered free-of-charge to all employees found to be at-risk.
Arthur Gomez, our Region V Coordinator for the Bloodborne Pathogen Proposed Standard, has previously discussed the pre-testing cost issue with the National Office. We were advised that the charging of a pre-testing fee to an employee, to determine whether he/she needs or does not need the vaccine, is unacceptable to the agency. Otherwise, OSHA is mute on the subject of forms. We cannot approve nor disapprove any write-up which advises that, prior to the administration of the vaccine, a blood test (at employees expense) must be performed according to OSHA instructions. This form does not meet with the intent of the proposed standard whereas persons found at-risk must be offered the vaccine free-of-charge. Should the employer (or doctor) have any reason (clinical or otherwise) to do a titer analysis, it must be at the employer’s expense. The information presented in the form is not accurate and, in two instances, is contrary to OSHA requirements (See the 3rd and 4th paragraphs in the form.)
However, if an employee for reasons of his/her own, routinely or otherwise, were to request an anti-body test for hepatitis. This type of request could not be charged to the employer.
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Please advise the American Medical Services, Inc., that if they continue to use the form as presently written, they would not be within OSHA guidelines, nor would they be meeting the intent of the proposed standard.
UNITED STATES DEPARTMENT OF LABOR Occupational Safety and Health Administration 230 South Dearborn Street, Room 3244 Chicago, Illinois 60604 (312) 353 – 2220
October 2, 1990
Wisconsin Association of Nursing Homes, Inc. 14 South Carroll Street Suite 200 Madison, WI 53703
ATTENTION: Wanda L. Hurr Director of Legal Services RE: OSHA HBV Vaccine/Sample Release Form
Dear Ms. Hurr:
This letter is in regard to your letter of September 12, 1990, addressed to Ms. Susan Wood, which relates to the OSHA HBV vaccine/sample release form.
The OSHA Directive CPL 2-2.44B, dated February 27, 1990, Subsection M(5)(d)(1), page 20 (see below) clearly states that the employer’s responsibility is to provide Hepatitis B vaccinations free-of-charge to employees at-risk.
Hepatitis B Vaccination
The facility’s Infection Control policy regarding hepatitis B vaccinations shall address all circumstances warranting such vaccinations and shall identify employees at substantial risk of directly contacting body fluids. All such employees shall be offered Hepatitis B vaccinations free-of-charge in amounts and at times prescribed by standard medical practices.
OSHA has adopted Center For Disease Control (CDC) Guidelines for the prevention of transmission of HIV and HBV to Health Care and Public Safety Workers. The recent version of these Guidelines was published in February 1989 and also in the NIOSH Publication 108- 89 (pertinent pages enclosed). Section III. Employers Responsibilities, III.b, III.B.1, and III.B.2.a. of these guidelines also require providing Hepatitis B vaccine to employees.
OSHA does not certify nor approve any kind of sample Release Form or Consent Form, for the provision of vaccinations, in accordance with the proposed standard or other OSHA directives. However, the sample Release Form was reviewed, and the following comments are submitted for your consideration:
1. Second Paragraph, Line Four Should read “For contact with mucous membranes…”
2. Third Paragraph
Appears to lessen or cloud the intent of the standard which is that ALL EMPLOYEES FOUND AT-RISK MUST BE OFFERED THE VACCINE FREE-OF-CHARGE. The standard does not ask the employee found at-risk to request the vaccine. As written, it would appear to shift health/safety responsibility from the employer to the employee.
3. Fourth Paragraph
Reflects a misperception of the standard that never states that, prior to the administration of the vaccine, a pre-test must be made. If in some cases the employer has reason to believe that a pre-test is necessary (i.e., employees found at- risk is not sure that he/she has been vaccinated before), the employer then asks the consent of the individual at-risk to give a blood sample for a pre-test to determine whether the donor has, or has not had, a previous vaccination. Again, the pre-test cost is to be paid by the employer, not the employee.
4. Fifth Paragraph
Correctly states that receiving the vaccine is a personal decision. The paragraph does not counsel the employee about the training and education provision of the standard, which in this case becomes extremely important in order for the decision to be prudent, proper, and knowledgeable.
Thank you for your interest in safety and health in the workplace.
Sincerely,
William E. Funcheon, Jr. Assistant Regional Administrator Technical Support
Enclosures
U.S. DEPT. OF LABOR OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION 310 W. Wisconsin Ave., Suite 1180 Milwaukee, Wisconsin 53203 414/297-3315
DATE: September 12, 1990 TO: William Funcheon, ARA/Technical Support FROM: Gerald O. Cunningham, Area Director SUBJ: HBV PRE TEST COST Attached is a letter from American Medical Services Inc. which attached an instruction memo that talks about having employers pay for a HBV pre injection test. The author thinks this came from OSHA and the CPL 2-2.44B.
I checked and do not believe OSHA sent out such a letter. Please check through Washington and inform the author of your findings. Please copy this office on your findings. Thank you.
GOC/ck enclosure
American Medical Services Inc. REGIONAL OFFICES 1051 EAST OGDEN AVENUE MILWAUKEE, WISCONSIN 53202 TELEPHONE(414)274-0209
September 5, 1990
Gerald Cunningham, Director OSHA 310 W. Wisconsin Avenue, Suite 1180 Milwaukee, Wisconsin 53203
Dear Mr. Cunningham:
We are seeking clarification regarding the enclosed sample release form for the Hepatitis B vaccine. We received this sample with the February 27, 1990 OSHA Instruction CPL 2-2.44B.
In question is the fourth paragraph, page 1, which States “prior to the administration of the vaccine a blood test, at the employee’s expense, must be performed to determine prior infection with Hepatitis B”. Upon receiving the consent form from OSHA, our 11 Wisconsin nursing homes adopted this consent form without changes, feeling confident that we were following OSHA guidelines.
In recent weeks, the Milwaukee area Sanitarian with the Bureau of Quality Compliance, Tom Haupt, has questioned the validity of retiring employees to pay for the lab work prior to receiving the Hepatitis B vaccine. We are requesting a written confirmation that we are within OSHA guidelines if we continue to use this Hepatitis B consent form.
Thank you for your assistance.
Sincerely,
Kathy Schallock, R.N. Nurse Consultant
/cb encl,
CC: Tom Haupt
DISCLAIMER
Mention of company name or product does not constitute endorsement by the National Institute for Occupational Safety and Health.
Prepared under contract P.O. Number 90-5735 for the National Institute for Occupational Safety and Health.
This document may be requested from: NIOSH Attention: Publications 4676 Columbia Parkway Cincinnati, Ohio 45226 DHHS (NIOSH) PUBLICATION NO. 89-108
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