OSHA Instruction CPL 2-2. 36 November 30, 1983 Office of Occupational Medicine

Subject: Hepatitis B Risks in the Health Care System

A. Purpose. This instruction provides a description of the hazard of hepatitis B infection to workers in the health care delivery system and recommends work practice techniques to reduce those risks of that hazard.

B. Scope. This instruction applies OSHA-wide.

C. Reference. OSHA Instruction CPL 2.58, October 1, 1983, and CPL 2.59, November 9, 1983

D. Action. As part of OSHA's outreach program, Regional Administrators and Area Directors shall ensure that copies of Appendix A are mailed to all major health care facilities listed in Appendix B in their respective areas. Appendix C is a letter that could be used as a vehicle to convey this document to those facilities. In conjunction with Area Offices being Full Service Resource Centers, copies of Appendix A shall be made available from the Area Office to members of health care facilities upon request.

E. Federal Program Change. This instruction describes a change in the Federal program for which a State response is not required. Each Regional Administrator, however, shall:

1. Ensure that this change is promptly forwarded to State designees.

2. Explain the technical content of this change as well as the Region's plans for implementing it to the State designee.

3. Encourage States to adopt similar program initiatives where such initiatives are not already in place by taking the action described in D and mailing Appendix A to the identified major health care facilities.

F. Background. OSHA has become aware that a significant risk of contacting hepatitis B exists among the various occupations involved in health care delivery. In order to help both employers and employees recognize and prevent this disease, OSHA has developed a field instruction describing the disease, the high-risk workers, and recommending work practices and procedures currently available.

OSHA INSTRUCTION CPL 2-2.36 NOV 30 1983 OFFICE OF OCCUPATIONAL MEDICINE

G. Mailing. The National Office will furnish either lists or labels of establishments' name and addresses for this mailing for some of the facilities indicated in Appendix B. These mailing lists and additional copies of Appendix A will be sent to the Regional Offices in approximately 4 weeks. However, some of these facilities are not identified by SIC codes and Regional Administrators/Area Directors should try and identify these facilities to the extent possible and add them to the above lists

Thorne G.Auchter Assistant Secretary

DISTRIBUTION: National, Regional and Area Offices All Compliance Officers State Designees 7(c)(1) Project Managers NIOSH Regional Program Directors

OSHA INSTRUCTION CPL 2-2.36 NOV 30 1983 OFFICE OF OCCUPATIONAL MEDICINE

Office of Occupational Medicine Directorate of Technical Support Occupational Safety and Health Administration U.S. Department of Labor

OSHA INSTRUCTION CPL 2-2.36 NOV 30 1983 OFFICE OF OCCUPATIONAL MEDICINE

Preface

I wish to thank Ed Jones, M.D. for his invaluable assistance drawing up this document. I am grateful to the following for their comments and suggestions which have been used wherever possible:

Janice Hutchinson, M.D. - V.A.H. Mark A. Kane, M.D., M.P.H. - C.D.C. John C. Petricciani M.D. - F.D.A. Leonard B. Seeff, M.D. - V.A.H. Donald E. Widman, M.D. - J.C.A.H. Hyman J. Zimmerman M.D. - G.W. University Medical School

Ralph E. Yodaiken, M.D. MPH. Director, Office of Occupational Medicine

OSHA INSTRUCTION CPL 2-2.36 NOV 30 1983 OFFICE OF OCCUPATIONAL MEDICINE

INTRODUCTION

Hepatitis B infection represents a significant occupational hazard to all workers who contact blood or body fluids from patients infected with the hepatitis B virus. This communication will:

- provide a brief explanation of hepatitis B,

- cite examples of those workers within the health care delivery system who are at increased risk of acquiring the infection,

- list suggested work practices to limit exposure to hepatitis B,

- describe the hepatitis B virus vaccine which may be recommended to you by your employer to prevent a hepatitis B virus infection, and

- describe immune globulins and their use.

HEPATITIS

Hepatitis is an inflammation of the liver which can be caused by various toxins, medications or infectious agents. Most infectious hepatitis is caused by viruses; some of these viruses are identified by the letters "A" and "B" and one or more are grouped under the designation "non A/non B". The hepatitis B virus is frequently shortened to HBV and the infection caused by this virus is called hepatitis B.

Although many people with hepatitis may feel or look ill, up to 50 percent of people with a hepatitis B infection will be unaware that they have contracted the virus. Hepatitis B is a frequent cause of sporadic hepatitis in the United States. Centers for Disease Control (CDC) surveys estimate that 200,000 new infections occur here each year and nearly 10 percent of those infected become "chronic carriers" of the hepatitis a virus. About 10,000 people are hospitalized each year with HBV infections.

OSHA INSTRUCTION CPL 2-2.36 NOV 30 1983 OFFICE OF OCCUPATIONAL MEDICINE

Acutely infected individuals and chronic carriers of this virus can be identified by laboratory tests that detect part of the protein that is on the surface of this virus. This protein is called the "hepatitis B surface antigen" (HBsAg) and can be detected in the blood and body fluids of infected individuals. A person is designated a "chronic carrier" when two blood tests at least 6 months apart are positive for the HBsAg.1 The infection in these carriers may be eradicated in a few years or it may continue for many years. All people who are "chronic carriers" or who are acutely infected with the virus should be considered potentially infectious. Many chronic carriers of the HBsAg have few or no symptoms, however up to 25 percent may develop chronic active hepatitis .2 This illness has a varied prognosis but can lead to cirrhosis and death. Chronic carriage of the surface antigen has also been associated with cancer of the liver (hepatoma),1

In addition to detection of the HBsAg, other laboratory tests are available to document current or past infection with the HBV. Anti-bodies are produced by the body's defense mechanisms in an attempt to eradicate the invading virus. One is produced against the HBsAg and is designated anti-HBs. Detection of this antibody in blood obtained from an individual indicates that the individual has been immunized against the HBV or that the individual has successfully eradicated an infection with this virus. This antibody usually persists indefinitely.

Another antibody is manufactured against a different antigen (protein) of the hepatitis B virus which is called the core antigen. This antibody is labeled anti-HBc and can also be detected in a blood sample from a person with a current or past infection caused by the HBV. This antibody may also persist indefinitely. The presence of anti-HBs in adequate titer in blood drawn from an individual ensures that

OSHA INSTRUCTION CPL 2-2.36 NOV 30 1983 OFFICE OF OCCUPATIONAL MEDICINE

the individual is incapable of acquiring or transmitting the HBV. The detection of anti-HBc alone cannot be used to differentiate between a current or past infection. Although the Work Practice recommendations in this communication are intended to limit exposure to the HBV, it is currently believed that the same methods could be used to limit exposure to the "non A/non B" hepatitis viruses.

Since the CDC estimates that 0.3 percent of the U.S population are chronic carriers of the HBsAg and 10,000 patients are admitted to hospitals each year with newly acquired HBV infections, the risk to workers in the health care delivery system is obvious. 2 All body fluids from acutely or chronically infected patients should be considered potentially infectious. Although feces classically has been considered infectious, contamination with blood is necessary for virus transmission. Saliva, semen and blood have been demonstrated to be capable of transmitting infection with the HBV.3 Workers within the health care delivery system who have no exposure to these fluids from infected individuals should not be at an increased risk of acquiring a hepatitis B virus infection. About 1 percent of patients admitted to large city hospitals are chronic HBsAg carriers.- Approximately 1 percent of all health care workers in a hospital setting are chronically infected with the HBV virus. 5 The long term risk of HBV infection in workers with frequent blood contact varies between 15 and 30 percent.6 The following are examples of the specialties and job categories that have been shown to be at increased risk of HBV infection: pathologists and pathology laboratory staff, surgeons and surgical residents, pediatricians, clinical laboratory staff and technicians, internists, dentists and dental technicians, emergency room staff, dialysis unit workers, operating and recovery room staff, IV therapy teams, intensive care unit nurses, hematology and oncology ward staff, blood bank personnel,

OSHA INSTRUCTION CPL 2-2.36 NOV 30 1983 OFFICE OF OCCUPATIONAL MEDICINE

obstetricians, gynecologists and family practitioners 5,7,8 Workers within the health care delivery system need to follow guidelines designed to reduce their risk of HBV infection.

The consequences of HBV virus infection in women of child bearing age deserve special attention. Many women who are acutely or chronically infected in the few months before and after delivery transmit this infection to their children. Many of these children become chronic carriers of the hepatitis B surface antigen. Although transmission to the newborn may not be prevented, chronic carriage of the HBsAg in these children can be dramatically reduced with prompt administration of HBIG (hepatitis B immune globulin).9 A pediatrician should be consulted regarding HBIG use and possible future hepatitis B virus vaccine administration. Preventing HBV infection in pregnant women who are working in a high risk setting is obviously a high priority.

IN CARING FOR PATIENTS INFECTED WITH THE HEPATITIS B VIRUS

The following recommendations have been abstracted and modified largely from CDC guidelines.10,11

1. INPATIENT IDENTIFICATION: Although hospitals may design their own identification system, many hospitals are currently using a CDC recommended, category specific, classification system. Under this system some infectious patients, including all those infected with the hepatitis B virus, will be identified by a pink card displayed on the door or near the bed of the individual. It will be titled -"Blood/Body Fluid Precautions" and list some work practice information that is essential in caring for the patient. If the hospital has adopted the CDC's alternate recommendation of a disease-specific identification system, a different card will be displayed and will probably contain the phrase "Hepatitis B".

OSHA INSTRUCTION CPL 2-2.36 NOV 30 1983 OFFICE OF OCCUPATIONAL MEDICINE

2. GLOVES: They are indicated for patient contact or procedures in which blood, body fluid or saliva will be handled. Gloves should always be worn when the worker's hands are abraded or active dermatitis is present.

3. GOWNS: They should be worn when contamination of skin or clothing with blood, body fluid or saliva is likely.

4. BAGGING OF ARTICLES: Objects that are likely to be contaminated with infectious material should be placed in an impervious bag. If puncture,or outside contamination of the bag is likely, a second bag should be added. Bags should be clearly labeled to designate contaminated articles or infectious waste.

5. REUSABLE EQUIPMENT: Sterilization or, if impossible, decontamination, is necessary. A recommended information source is the CDC Guideline for Hospital Environmental Control: Cleaning, Disinfection and Sterilization of Hospital Equipment.

6. HANDWASHING: Hands should be washed after caring for infected patients, after removing gloves or immediately after possible contact with blood, body fluid or saliva.

7. NEEDLES AND SYRINGES: Disposable syringes should be used whenever possible. Needles should not be recapped or bent. They should be placed in a labeled, puncture resistant container dedicated solely for this disposal purpose.

8. NEEDLE STICK EXPOSURE: All needle sticks involving needles potentially contaminated with HBV should be immediately reported to your supervisor or to the person responsible for infection control. These exposures should be assessed for the potential of HBV transmission and the appropriateness of immune globulin administration. This will be discussed in more detail later in this communication. Known exposure of a worker's eyes, mouth or broken skin to HBV infected saliva should be reported and assessed in the same fashion.

OSHA INSTRUCTION CPL 2-2.36 NOV 30 1983 OFFICE OF OCCUPATIONAL MEDICINE

9. LINEN: Obviously contaminated linen should be placed in a laundry bag in the infected area and handled as described above in bagging of articles. This marked linen should not be sorted before cleaning and laundry employees personnel should wear gloves while handling this material.

10. REUSABLE DISHES, UTENSILS AND TRAYS: Obviously contaminated equipment should be bagged and labeled. Dishwashers handling these items should use gloves.

11. DRESSINGS AND PAPER TISSUES: All contaminated disposable items should be bagged, labeled and disposed of in accordance with local regulations.

12. LAB SPECIMENS: They should be clearly labeled and if the outside of the specimen container is contaminated, disinfection or bagging may be necessary. In most cases laboratory employees should use gloves and lab coats or aprons while performing tests on these specimens.

13. ROOM CLEANING: This should be done in a fashion similar to the recommendations from the CDC.

14. BLOOD SPILLS: They should be cleaned immediately with detergent and water. A solution of 5.25 percent sodium hypochlorite diluted between 1:10 and 1:00 with water may be indicated for disinfection following the initial cleanup.

15. EXAMINATIONS AND PROCEDURES: Gloves should be worn at all times during examination of the oropharynx, gastrointestinal tract and genitourinary tract. Hands should be washed when the gloves are removed. Instruments and material from these examinations such as dental instruments, X-ray film containers placed in the mouth, gastroscopes, cystoscopes, sigmoidoscopes etc. should be considered infectious and handled only with gloves. Disinfection or sterilization of reusable items will obviously be necessary.

OSHA INSTRUCTION CPL 2-2.36 NOV 30 1983 OFFICE OF OCCUPATIONAL MEDICINE

INACTIVATED HEPATITIS B VIRUS VACCINE

The following is a brief description of this new vaccine. A more detailed description of the vaccine and its uses, as recommended by the CDC, can be found in reference. 1

This preparation is a suspension of inactivated HBsAg particles of a specific size. These particles are obtained from the blood of donors known to be infected with the HBV. No viable infectious agents are known to survive the vaccine preparation process which includes several procedures that inactivate representative viruses of all known types. The healthy adult vaccines requires a series of three vaccine injections with the second and third injections being given at 1 and 6 months after the first. With proper administration, the vaccine is about 90 percent (80-95 percent) effective in preventing infection in susceptible vaccinees. It is possible that immunity produced by this vaccination will decrease with time and boosters will have to be given to ensure protection.

Vaccinees have been carefully monitored by the CDC in an effort to record all potential side effects. As of March 1, 1983, the vaccine had been administered to over 200,000 people. There have been 62 illnesses that occurred in vaccinees that might represent natural background illness or vaccine side effects. Six of these illnesses were defined as serious. This meant that they met one of the following criteria: lasted 14 or more days, caused permanent disability, were life threatening, or required hospitalization or intensive medical care.

The majority of serious illnesses involved the central nervous system. 12 One major concern has been that this vaccine is prepared from plasma donated by some individuals who are at increased risk of

OSHA INSTRUCTION CPL 2-2.36 NOV 30 1983 OFFICE OF OCCUPATIONAL MEDICINE

developing Acquired Immune Deficiency Syndrome (AIDS). If an infectious agent were the cause of AIDS, it is extremely unlikely that it could survive the vaccine preparation process 14, is Unfortunately, the correct incidence of all side effects will not be known until more individuals have received the vaccine and have been followed medically for a significant period of time.

Based upon cost effectiveness, it appears that administration of this vaccine would be acceptable in populations with attack rates as low as 1 or 2 percent per year. 13 The cost effectiveness of screening for prior HBV infection before vaccine administration varies with the cost of the vaccine and screening tests and the prevalence of this infection in the group being considered for vaccination. In general, screening of workers in the health care delivery system would not be justified economically. Some employers might elect to screen workers for anti-HBs regardless of cost considerations. This would identify those workers who are already immune to HBV infection and would be subjected to potential risks with no expected gain if vaccinated.

Immune globulins can modify infection with the HBV in various situations after exposure has occurred, Immune globulins are sterile solutions of antibodies obtained from the blood of donors. Immune globulin (IG) prepared in the United States contains antibodies to the hepatitis B virus. Hepatitis B immune globulin (HBIG) contains the same antibodies (anti-HBs) but in a much higher concentration. Whether IG or HBIG should be given and in what concentration depends upon an accurate assessment of the probability and mode of exposure and the potential adverse reactions to immune globulins. A significant lapse in time between exposure and administration of IG or HBIG would be expected to decrease its effectiveness.

OSHA INSTRUCTION CPL 2-2.36 NOV 30 1983 OFFICE OF OCCUPATIONAL MEDICINE

Acute exposure to blood or body fluids containing the HBsAg, either by cut, needle stick or mucous membrane ( eye, mouth) exposure, is the most important indication for consideration of administration of HBIG or IG. Many other exposures to potentially infectious body fluids also warrant assessment. Reference 9 covers this subject in detail and contains the latest CDC recommendations on the subject. Workers whose serum already contains HBsAg, anti-HBs or anti-HBs are not usually considered at risk to acquire a new HBV infection and typically do not receive immune globulins. Evidence that some "chronic carriers" can acquire a second HBV infection has recently been published. 6 When required, immune globulins should be given immediately to maximize effectiveness. If a needlestick exposure has occurred to blood from a person who has a high likelihood of HBV infection, immune globulin should be immediately administered to the exposed individual after blood for the appropriate laboratory tests (noted above) has been obtained. Blood from the source of the exposure should be checked for the HBsAg. Follow-up HBIG administration should be accomplished if indicated by these tests.

CONCLUSION

It is clear that many health care workers are at substantial risk of HBV infection. Appropriate work practice in the care of all patients, especially those with a current HBV infection, should reduce the incidence of HBV infections in this group of workers. All needle stick exposures should be quickly reported so that immune globulin administration may be considered. However, OSHA, through dissemination of this notice, is not rendering any judgment on the safety or advisability of this or any other medical treatment. Instead OSHA seeks to make the affected

OSHA INSTRUCTION CPL 2-2.36 NOV 30 1983 OFFICE OF OCCUPATIONAL MEDICINE

public aware that immune globulin administration and the HBV vaccine are available and their use should be considered. Whether the HBV vaccine should be offered to an individual worker depends upon many factors, including his/her job description, the risk of HBV acquisition in this job at his/her particular health facility, and his/her susceptibility to HBV infection. Because these particulars will vary significantly from one facility to another, the decision will have to be made by the appropriate personnel at each health care location.

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1. Centers for Disease Control. Inactivated Hepatitis B Virus Vaccine. MMWR 1982; 31:317-328.

2. CDC. Inactivated Hepatitis B Virus Vaccine, Recommendations of the Immunization Practices Advisory Committee. Ann. of Int. Med. 1982; 97:379-383.

3. Scott, R. M., Snitbhan, D., Barcroft, W. H., et al: Experimental Transmission of Hepatitis B Virus by Semen and Saliva. J Infect DIS 1980; 142:67-71.

4. Merck Sharp and Dohme: Hepatitis B: An Occupational Hazard for Health-Care Personnel.

5. Dienstag, J. L. and Ryan, D. M.: Occupational Exposure to Hepatitis B Virus in Hospital Personnel: Infection or Immunization. Am. J. Ep. 1982; 115:26-38.

6. Chin, J.: The Use of Hepatitis B Virus Vaccine. New Eng. J. Med. 1982; 307:678-679.

7. Denes AE et al: Hepatitis B Infection in Physicians. JAMA 1978; 239:210-212.

8. Maynard, J. E.: Nosocomial Viral Hepatitis. Am. J. Med. 1981; 70:440.

9. Centers for Disease Control. Immune Globulins for Protection Against Viral Hepatitis. MMWR 1981; 30:423-435.

10. Garner, J. S. and Simmons B. P.: CDC Guidelines for Isolation Precautions in Hospitals. Infection Control (special supplement) 1983; 4:245-325.

11. Williams, W. W.: CDC Guidelines for Infection Control in Hospital Personnel. Infection Control (special supplement) 1983; 4:329-349.

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12. Centers for Disease Control: Trends: Safety of Hepatitis B Virus Vaccine. JAMA 1983; 249:1812.

13. Mulley A. G., Silverstein, M. D. and Dienstag, J.L.: Indications for Use of Hepatitis B Vaccine, Based on Cost-Effectiveness Analysis. N. Eng. J Med 1982; 307:644-651.

14. Tabor E., Buynak, E., Smallwood, L.A. et al: Inactivation of Hepatitis B Virus by Three Methods: Treatment with Pepsin, Urea, or Formalin. J. Med. Virol. 1983; 11:1-9.

15. Hilleman, M.R, Buynak, E.B, Roehm, R.R et al: Purified and Inactivated Human Hepatitis B Vaccine: Progress Report. AM. Med. Sci. 1975: 401-404.

16. Gerety R.J. et al: Concomitant Hepatitis B Surface Antigen and Antibody in Thirteen Patients. Ann. Int. Med. 1983;99: 460-463.

OSHA INSTRUCTION CPL 2-2.36 NOV 30 1983 OFFICE OF OCCUPATIONAL MEDICINE

Name and Addresses Major Health Care Facilities SIC CODES Furnished

Hospitals 8062, 8069 Yes Nursing Homes 8051, 8059 Yes Hospices No

Emergency Care Facilities No (non-hospitals)

Dialysis Units (non-hospitals) No

Blood Donation and Bank Facilities 8091 Yes (non-hospitals)

Clinical Laboratories 8071 Yes

OSHA INSTRUCTION CPL 2-2.36 NOV 30 1983 OFFICE OF OCCUPATIONAL MEDICINE

Dear Health Care Professional:

The Occupational Safety and Health Administration (OSHA) is aware that a significant risk of contracting hepatitis B exists among the occupations involved in health care delivery. The Agency has developed the enclosed document, suitable for direct distribution to your employees, describing the disease, identifying the high-risk workers and recommending work practice techniques that can be implemented to help prevent this disease.

Local OSHA offices have recently assumed wider responsibilities for serving as a safety and health resource center for the communities they serve. Therefore, as your local OSHA contact I am providing this document to you for the information of your employees. In addition, I'd like to offer any assistance we might provide in this or any other safety and health topic of concern to you. Please feel free to contact me at:

(Regional/Area Office) (Address) (Telephone)

Sincerely,

(Name) (Title)

Enclosure

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