Hepatitis B vaccination and post exposure evaluation and follow-up

§1910.1030(f)

This paragraph provides a means to protect employees from infection caused by the hepatitis B virus by requiring employers to make the hepatitis B vaccination available to employees with occupational exposure to blood or OPIM. It also ensures that employees receive appropriate medical follow-up after each specific exposure incident.

1.  General — Paragraph (f)(1). This paragraph refers to the hepatitis B vaccination as both the hepatitis B vaccine and vaccination series. These are to be made available to all occupationally exposed employees. In addition, a post-exposure evaluation and follow-up procedures are to be made available to all employees who experience an exposure incident. While it is OSHA’s intent to have the employer remove, as much as possible, obstacles to the employee’s acceptance of the vaccine, the term “made available” emphasizes that the employee has the option to decline participation in the vaccination and follow-up programs.

Inspection guidelines: The compliance officer should examine the employer’s program to determine if the vaccination series and post-exposure follow-up procedures meet the requirements of paragraph (f)(1)(ii).

2.  Paragraph (f)(1)(ii)(A). The term “no cost to the employee” means, among other things, no “out of pocket” expense to the employee.

The employer may not permit the employee to use his/her healthcare insurance to pay for the series unless the employer pays all of the cost of the health insurance and unless there is no cost to the employee in the form of deductibles, copayments, or other expenses. Even partial employee contribution to the insurance premium means the employee could be affected by a rise in the total premium caused by insurance company reaction to widespread hepatitis B vaccinations and is therefore unacceptable. Likewise, any use of a spouse or other family member’s insurance plan to provide vaccination would not be considered “at no cost” to the employee.

The employer may not institute a program in which the employee pays the original cost of the vaccine and is reimbursed by the employer if she/he remains employed for a specified period of time.

An “amortization contract” which requires employees to reimburse the employer for the cost of the vaccination should they leave his/her employ prior to a specified period of time is similarly prohibited.

A waiver of liability for any harm caused by the vaccine is also prohibited.

3.  Paragraph (f)(1)(ii)(B). The term “reasonable time and place” requires the medical procedures and evaluations to be convenient to the employee. They must normally be offered during employees’ scheduled work hours. If participation requires travel away from the worksite, the employer must bear the cost.

4.  Paragraph (f)(1)(ii)(C). The Compliance Officer can contact the National Council of State Boards of Nursing, Inc. at the Board of Nursing Contact Information web site at http://www.ncsbn.org to obtain the most current lists of addresses and phone numbers for each State Board of Nursing, to determine if the State Board of Nursing allows licensed healthcare professionals other than physicians to carry out the procedures and evaluations required by paragraph (f). The National Commission on Certification of Physicians’ Assistants can clarify the role of physician assistants in these procedures. They can be reached at (770) 399-9971.

5.  Paragraph (f)(1)(ii)(D). This paragraph takes into consideration the changing nature of medical treatment relating to Hepatitis B. The CDC is the U.S. Public Health Service (USPHS) agency responsible for issuing guidelines and making recommendations regarding infectious agents. OSHA requires employers to follow the CDC guidelines current at the time of the evaluation or procedure. Copies of the current guidelines and other CDC documents can be obtained on CDC’s web site, http://www.cdc.gov. The hepatitis B vaccination must be given in the standard dose and through the standard route of administration as recommended in the USPHS/CDC guidelines.

The most current CDC guideline regarding Hepatitis B is “Updated U.S. Public Health Service Guidelines for the Management of Occupational Exposures to HBV, HCV, and HIV and Recommendations for Postexposure Prophylaxis” published in Morbidity and Mortality Weekly Report, Vol. 50, No. RR-11, June 29, 2001. It states that employees who have ongoing contact with patients or blood and are at ongoing risk for percutaneous injuries are to be tested for antibody to Hepatitis B surface antigen, one to two months after the completion of the three-dose vaccination series. Employees who do not respond to the primary vaccination series must be revaccinated with a second three-dose vaccine series and retested, unless they are HbsAg-positive (infected). Non-responders must be medically evaluated.

Inspection guidelines: It is important that the compliance officer investigate thoroughly whether the employer knows of the contents of the CDC guidelines. Evidence may include statements from supervisors or managers that they were aware of the guidelines; an interview with the employer, employer’s attendance at conferences or seminars where in-service training about the CDC guidelines was provided; knowledge of interactive webpages associated with the CDC guidelines; or actual copies of the MMWR.

Citation guidelines: Paragraph (f)(1)(ii)(D) should be cited if the employer failed to provide vaccinations, evaluations, or follow-up procedures for Hepatitis B in accordance with the CDC recommendations that were current at the time these procedures took place. Any additional requirements (such as obtaining a written healthcare professional’s opinion) specified in paragraph (f) must also be met.

6.  Paragraph (f)(1)(iii) requires that all laboratory tests be conducted by an accredited laboratory. The Compliance Officer must determine by means of employer documentation (e.g., certificate) that the laboratory is accredited by a national accrediting body (e.g., American Association of Blood Labs, College of American Pathologists, Joint Commission on Accreditation of Healthcare Organizations, etc.) or equivalent State agency which participates in a recognized quality assurance program.

7.  Hepatitis B vaccination — Paragraph (f)(2). The Compliance Officer should determine whether or not all occupationally exposed employees have had the hepatitis B vaccination series made available to them after the training required by paragraph (g)(2)(vii)(I) and within 10 working days of their initial assignment. The term “made available” includes the healthcare professional’s evaluation and arranging for the administration of the first dose of the hepatitis B vaccination series to begin within the 10 days. This includes all employees with occupational exposure, regardless of how often the exposure may occur. Part-time and temporary employees are included in this coverage. The vaccine does not have to be made available if the employer documents the exemption(s) set forth in paragraph (f)(2). It does not have to be administered if the employer can produce the signature of the employee on the mandatory declination form (See Appendix A of §1910.1030.)

8.  Paragraph (f)(2)(i) states the circumstances under which an employer is exempted from making the vaccination available. If, (a) the complete hepatitis B vaccination series was previously received (three vaccine shots or in the case of a non-responder, six), or (b) antibody testing shows the employee to be immune, or (c) the vaccine cannot be given for medical reasons, the series does not have to be made available. If the employer claims one of these exemptions, it must be documented in the employee’s medical record in accordance with paragraph (h)(1)(ii)(B).

Current USPHS guidelines recommend post-vaccination screening for antibody to HBsAg (anti-HBs) for certain healthcare workers. See discussion of (f)(1)(ii)(D). Periodic antibody tests thereafter are not currently recommended.

Citation policy for first aid providers. Citations should be issued when designated first aid providers, who have occupational exposure, are not offered the hepatitis B vaccine before they are exposed unless the following conditions are in place:

a.    The primary job assignment of such a designated first aid provider is not the rendering of first aid or other medical assistance, and

b.    Any first aid rendered by such person is rendered only as a collateral duty, responding solely to injuries resulting from workplace incidents, generally at the location where the incident occurred.

Note

This exception does not apply to designated first aid providers who render assistance on a regular basis, for example, at a first aid station, clinic, dispensary or other location where injured employees routinely go for assistance; nor does it apply to any healthcare, emergency, or public safety personnel who are expected to render first aid in the course of their work. These employees must be offered the vaccine prior to exposure.

c.    The employer’s exposure control plan must specifically address the provision of the hepatitis B vaccine to all unvaccinated first aid providers who render assistance in any situation involving the presence of blood or OPIM (regardless of whether an actual “exposure incident” as defined by the standard occurred) and the provision of appropriate post-exposure evaluation, prophylaxis, and follow-up for those employees who experience an “exposure incident.” The plan must include:

1.     Provision for a reporting procedure that ensures that all first aid incidents involving the presence of blood or OPIM will be reported to the employer before the end of the work shift during which the incident occurred. The report must include the names of all first aid providers who rendered assistance, regardless of whether personal protective equipment was used and must describe the first aid incident, including time and date.

The description must include a determination of whether or not, in addition to the presence of blood or other potentially infectious materials, an “exposure incident,” as defined by the standard, occurred. This determination is necessary in order to ensure that the proper post-exposure evaluation, prophylaxis, and follow-up procedures required by paragraph (f)(3) of the standard are made available immediately, whenever there has been an “exposure incident” as defined by the standard.

2.     A report that lists all such first aid incidents, that is readily available, upon request, to all employees and to the Assistant Secretary.

3.     Provision for the bloodborne pathogens training program for designated first aiders to include the specifics of this reporting procedure.

4.     Provision for the full hepatitis B vaccination series to be made available as soon as possible, but in no event later than 24 hours, to all unvaccinated first aid providers who have rendered assistance in any situation involving the presence of blood or OPIM, regardless of whether or not a specific “exposure incident,” as defined by the standard, has occurred.

5.     Unless all the requirements of this de minimis policy are met, paragraph (f)(2)(i) should be cited for failure to provide the hepatitis B vaccine.

Note

For industries not covered by §1910.1030 or §1915.1030, failure to provide appropriate evaluation of first aid incidents (including the determination of whether an exposure incident occurred) and adequate follow-up of exposure incidents (including the provision of the hepatitis B vaccine series free of charge) should be considered for a possible 5(a)(1) citation.

9.  Paragraph (f)(2)(ii). Prevaccination screening for antibody status cannot be required of an employee, although if an employer wishes, he/she can make it available at no cost to employees. An employee may decline the prescreening, and the employer must still make the vaccination series available to the employee.

10.  Paragraph (f)(2)(iii). The signing of the hepatitis B vaccine declination form by the employee, at the time the vaccination is made available, does not relieve the employer from the requirement to provide the vaccine at a later date if the employee so chooses.

11.  Paragraph (f)(2)(iv). Employers must ensure that employees who decline the vaccine sign a declination form. The language in the declination form is set forth in §1910.1030, Appendix A. An employer’s form which conveys the same information as Appendix A, although in different words, should be considered a de minimis violation. However, any additions to that language should be made for the sole purpose of improving employee comprehension. Forms must not add language that would discourage employee acceptance of the vaccine or add liability concerns.

If the employer has added information that requires the employee to provide confidential medical information, regardless of whether it is physically on the declination form or on a separate form, a citation of (h)(1)(iii) should be considered.

The standard does not make reference to consent forms for employees accepting the vaccine. Medical informed consent forms are acceptable. However, any waiver of liability for any harm caused by the vaccine violates paragraph (f)(1)(ii)(A), which requires that the vaccine be provided at no cost. Consent forms which require the employee to release his or her test results to the employer violate the confidentiality requirements in paragraph (f)(5)(iii). Consent forms on which the hazards of the vaccine are clearly exaggerated violate paragraph (g)(2)(vii)(I).

12.  Paragraph (f)(2)(v). At the time of this publication, the provision of routine boosters of the hepatitis B vaccine is still being assessed. There is no requirement to provide boosters unless the USPHS recommends it at a later date.

13.  Post-exposure evaluation and follow-up paragraph (f)(3). This paragraph requires the employer to make immediately available a confidential medical evaluation and follow-up to an employee reporting an exposure incident.

Bloodborne pathogens are defined by the standard (see the Definitions paragraph of this Directive), to include more than just HIV and HBV. The standard applies to any pathogenic microorganism present in human blood that can cause disease in humans. Paragraph (f)(3) is not specific to HIV and HBV. This paragraph requires that the employer provide post-exposure evaluation and follow-up to employees for bloodborne pathogens, such as hepatitis C (HCV), as recommended by the CDC. The current CDC recommendations for HBV, HIV and HCV are found in the “Up-dated U.S. Public Health Service Guidelines for the Management of Occupational Exposures to HBV, HCV, and HIV and Recommendations for Postexposure Prophylaxis” in Vol. 50, No. RR-11, published in the June 29, 2001 MMWR.

Note

Employees who do not fall within the scope of this standard may still experience a specific exposure incident at work that is unrelated to the performance of their job duties. An example is “Good Samaritan” assistance, voluntarily performed, to an injured co-worker or a member of the public. In such a case, OSHA strongly encourages employers of these employees to offer them the follow-up procedures set forth in this paragraph.

Inspection guidelines: The compliance officer should determine if the employer’s plan ensures immediate and confidential post-exposure and follow-up procedures in accordance with the current CDC guidelines. As advised in paragraph (f)(1)(ii)(D), the compliance officer should document the employer’s awareness of CDC guidelines. At sites where an exposure incident has occurred it should be determined if the procedures were properly followed through interviews, incident report reviews, and, if necessary, medical records reviews.

Citation guidelines: The word “immediately” is used in the standard to emphasize the importance of prompt medical evaluation and prophylaxis. An exact time was not given in the standard because the time limit on the effectiveness of post-exposure prophylactic measures can vary depending on the infection of concern. OSHA requires the post-exposure evaluation and follow-up to be given as soon as possible after exposure. Where medical practice is an issue, and the compliance officer believes that access to care was delayed or denied or the employer was not following accepted post-exposure procedures, the Regional Bloodborne Pathogens Coordinator shall be contacted. A health care professional in the Directorate of Technical Support will be consulted if necessary. The employer must have established a system that maintains the confidentiality of the employee’s identity and test results. If the employer has contracted with a clinic or other healthcare facility to provide the follow-up programs, the confidentiality requirements must be part of the contract.

The boundary between employer and healthcare professional may be blurred in a medical setting in which, for example, the physician is both the employer and the evaluating healthcare professional or where the employer’s certified medical laboratory analyzes the serological samples. In such cases, the compliance officer should ensure that requirements for consent and confidentiality have been followed. The medical information is to be confined to the medical department and not to be discussed with or revealed to others (e.g., the personnel department, supervisors, or other healthcare professionals who do not need the information to comply with the standard).

The employer should be cited for violating paragraph (f)(3) provisions (except (iv)) for not providing a confidential medical evaluation and follow-up, e.g., testing. Failure to provide post-exposure prophylaxis should be cited under (f)(3)(iv).

14.  Paragraph (f)(3)(i). Documentation of the circumstances surrounding an exposure incident will help the employer and the Compliance Officer determine, for example, if PPE is being used or if training is lacking. Percutaneous injuries are primarily associated with the following activities: disposing of needles; administering injections; drawing blood, including use of capillary tubes; recap-ping needles; and handling trash and dirty linens.

Following an exposure incident, such as a needlestick or other sharps injury, employers are required to document, at a minimum, “the route(s) of exposure, and the circumstances under which the exposure incident occurred,” as per paragraph (f)(3)(i). The documentation of circumstances surrounding an incident by the employer allows identification and correction of hazards. To be useful, the documentation must contain sufficient detail about the incident. There should be information about the following: engineering controls in use at the time, work practices followed, a description of the device in use, protective equipment or clothing that was used at the time of the exposure incident, location, procedure being performed when the incident occurred, and the employee’s training. Additional information might also include a comparison of similar occurrences and recommendations to avoid future incidents, although this information is not mandatory. The Compliance Officer should request copies of the employer’s documentation on exposure incidents to determine if they are in compliance with paragraphs (c)(1)(ii)(C) and (f)(3)(i).

Inspection and citation guidelines: The goal of the employer should be to implement a method or device that prevents exposure incidents from recurring. Evaluating the circumstances around an exposure incident as required by paragraph (f)(3)(i) provides the employer with data necessary to make effective decisions about engineering controls and work practices that will reduce the risk of exposure. The compliance officer should review the documentation of incidents available in the facility. The compliance officer should request the Exposure Control Plan and review the procedures for evaluating the circumstances surrounding exposure incidents.

15.  Paragraph (f)(3)(ii). This paragraph requires the employer to identify the source individual in an exposure incident, unless this is infeasible. The employer must document in writing the identity of, or infeasibility of identifying, the source individual. Examples of when it may not be feasible to identify the source individual include: incidents of needlesticks caused by unmarked syringes left in laundry, or those involving blood samples which are not properly labeled, as well as incidents occurring where State or local laws prohibit such identification.

16.  Paragraph (f)(3)(ii)(A). This paragraph requires testing of the source individual’s blood after consent is obtained. The employer must ask for consent from the source individual or anyone legally authorized to give consent on his/her behalf. If legally-required consent is not obtained, the employer must establish this. This fact should be documented in writing, unless there is other clear evidence that consent could not be obtained. The compliance officer should ensure that the employer’s plan includes this provision.

For those jurisdictions that do not require consent of the individual, available blood may be used for testing rather than redrawing a specimen. The term “if available” applies to blood samples that have already been drawn from the source individual. OSHA does not require redrawing of blood specifically for HBV and HIV testing without the consent of the source individual.

17.  Paragraph (f)(3)(ii)(C). This paragraph does not authorize the employer to be informed of the results of source individual or exposed employee testing. However, the results of the source individual’s testing must be made available to the exposed employee in accordance with applicable State and Federal laws and regulations concerning medical privacy and confidentiality.

18.  Paragraph (f)(3)(iii). The Compliance Officer must determine if the employer’s program offers covered employees all of the listed requirements in the event of an exposure incident. Counseling and evaluation of reported illnesses are not dependent on the employee’s electing to have baseline HBV and HIV serological testing.

19.  Paragraph (f)(3)(iii)(A). The consent of the employee must be obtained before the collection and testing of his or her blood.

20.  Paragraph (f)(3)(iii)(B). This paragraph allows employees the opportunity for future testing without the need for an immediate decision. Employees involved in an exposure incident have at least 90 days following baseline blood collection to decide if they wish to have their blood tested for HIV.

To the employee, HIV testing may present adverse ramifications, e.g., confidentiality, employment, prejudice, or lack of medical information. Therefore, the 90-day time frame allows for the opportunity to obtain knowledge about baseline serologic testing after exposure incidents, and to participate in further discussion, education or counseling. This opportunity will, instead of placing a demand on the employee to make an immediate decision, encourage employees to consent to blood collection at the time of exposure.

Employers are required to preserve the blood the employee consented to have drawn, if it was not tested for HIV initially, for at least the 90-day period. Compliance officers should check that if the employer contracts for post-exposure follow-up, the contractor has been informed of the 90-day requirement.

21.  Paragraph (f)(3)(iv). Employers must follow the current guidelines at the time of exposure to determine if post-exposure prophylaxis is medically indicated. See paragraph (f)(3) above.

Citation guidelines: Failure to offer post-exposure HIV prophylaxis where indicated under the current CDC guidelines should be cited as a violation of paragraph (f)(3)(iv). The guidelines leave decisions about prophylaxis up to the healthcare professional. However, in unusual circumstances involving gross misapplication of the CDC guidelines by the healthcare professional, the employer may be cited. In such cases consultation with the National office is appropriate.

22.  Information provided to the healthcare professional — Paragraph (f)(4). This paragraph requires the employer to provide information to the healthcare professional responsible for the employee’s hepatitis B vaccination and post-exposure incident follow-up.

Inspection guidelines: The Compliance Officer must determine if the employer’s plan includes providing a copy of this standard to the healthcare professional responsible for the employee’s hepatitis B vaccination. In the case of an exposure incident, the plan must provide for the transmission of the information required by paragraphs (f)(4)(ii)(A)-(C) and (E) to the healthcare professional. The information required by paragraph (f)(4)(ii)(D) must be provided only if available.

The employer does not have a specific right to know the actual results of the source individual’s blood testing, but must ensure that the information is provided to the evaluating healthcare professional. If the evaluating healthcare professional is also the employer, the information must still be in the employee’s record and be made available at the time of a post-exposure incident. All applicable laws and standards of confidentiality apply in this situation.

23.  Healthcare professional’s written opinion — Paragraph (f)(5). The employer is required to obtain a written opinion and provide it to the employee within 15 working days of completion of the original evaluation. The standard specifies the information which is to be included in the written opinion:

                       i.        For hepatitis B vaccination: whether hepatitis B vaccination is indicated for the employee, and if the employee received the vaccination;

                      ii.        For post-exposure evaluation and follow-up: that the employee has been informed of the results of the evaluation and told about any medical conditions resulting from exposure to blood or OPIMs requiring further evaluation or treatment.

                     iii.        All other findings or diagnoses shall remain confidential and shall not be included in the written report. The employer is afforded access to the limited information stated above. Any information regarding the results of the employee’s evaluation or medical conditions must be conveyed by the health care professional to the employee alone and not as part of the written opinion that goes to the employer.

24.  Paragraph (f)(5)(i) limits the healthcare professional’s written opinion to very specific information regarding the employee’s hepatitis B vaccine status, including indication for vaccine and whether such vaccination was initiated (i.e., the first shot had been given).

25.  Paragraph (f)(5)(ii) requires documentation that a post-exposure evaluation was performed and that the exposed employee was informed of the results as well as any medical conditions resulting from exposure which require further evaluation and treatment.