HEPATITIS B VACCINATION
Employees who fall under this standard are required by the institution to have a placement health review at Employee Occupational Health Services (EOHW). At the time of the health review, the employee will be provided with pertinent information about the hepatitis B vaccine and it will be determined whether or not the employee falls under the exemptions for offering the vaccine. If the employee is not exempt the vaccine will be offered. If the employee does not want to start the series at that time, he/she will be asked to read and sign the declination form and given instructions that the vaccine will be available to them should they change their mind. It is the employee’s department that is responsible for making certain the employee goes through this process within 10 working days of initial assignment.

POST EXPOSURE EVALUATION AND FOLLOW-UP
Exposure Definition
Significant exposure includes contamination by blood or other body fluids or high titers of  cell-associated or free virus via 1) percutaneous, e.g., needlestick; 2) permucosal, e.g., splash in eye or mouth; or 3) cutaneous exposure, e.g., nonintact skin, or involving large amounts of blood or prolonged contact with blood, especially when exposed skin is chapped, abraded, or afflicted with dermatitis.

Employee Exposure
A 24-hour hotline number is available at 115 and 684-8115 off-site for immediate evaluation of exposures by EOHW representatives. EOHW South staff will review the exposure. Hepatitis B virus (HBV) and human immunodeficiency virus (HIV) infection status of the source patient will be specifically  investigated but the presence of other bloodborne diseases will be evaluated and appropriate protocols instituted, as needed. Examples of these disease include hepatitis C, malaria, syphilis, babesiosis, brucellosis, leptospirosis, arboviral infections, relapsing fever, Creutzfeld-Jakob disease, HTLV-1, and viral hemorrhagic fever.

Documentation of the route(s) of exposure, the circumstances under which the exposure occurred, and personal protective equipment used, if any, will be documented on the A-016 form as well as information on the source patient. Copies of all reported blood and body fluid exposures are sent to Biological Safety Division, OESO, for follow-up. Employee will be informed of NC State and federal laws regarding confidentiality of the source patients testing and status of infectivity.

Hepatitis B Protocol
Check hepatitis B surface antigen (HBsAg) status of source patient.

I. Unvaccinated employee

A. Source known, HbsAg (+)

1. Administer single dose of hepatitis B immune globulin (HBIG) (0.06 ml/kg body weight) within 24 hours, if possible.

2. Start hepatitis B vaccine series.
Note: If exposure is >7 days, do not give HBIG; start hepatitis B vaccine  series if within reasonable proximity of exposure.

HBIG’s value >7 days post exposure is unclear.

B. Source known, HbsAg (-)

1. Start hepatitis B vaccine series.

C. Source known, HbsAg status undetermined

1. High risk that source is HbsAg (+) , e.g., patients with high risk of HBV carriage or patients with acute or chronic liver disease serologically undiagnosed).

a. Administer single dose of HBIG.
b. Start hepatitis B vaccine series.

2. Low risk that source HbsAg (+)

a. Start hepatitis B vaccine series; categorized as “unknown source”.

D. Source unknown

1. Start hepatitis B vaccine series; categorized as “unknown source.”

A. Source known, HbsAg (+)

1. Employee completed all 3 doses.

a. Test for antibody to hepatitis B surface antigen (anti-HBs) if employee has not been tested within last 24 months.

b. If antibodies adequate, no additional treatment indicated.
Note: adequate antibody level is >10 milliInternational Units (mIU/ml), approximately equivalent to 10 sample ratio units (SRU) by RIA, or positive by EIA

*10/91: Cl Chem Lab at DUMC currently using EIA).

c. If antibodies inadequate on testing or employee has previously not responded to vaccine, administer single dose of HBIG immediately (no later than 7 days post exposure) and a booster dose of hepatitis B vaccine or HBIG x2 if an employee has failed to respond to at least 4 doses of hepatitis B vaccine.

d. If antibodies inadequate on testing but employee is known to have had adequate antibodies in past, administer one booster dose of hepatitis B vaccine.

2. Employee completed 1 or 2 doses

a. Administer single dose of HBIG immediately and continue on schedule with vaccine series.

B. Source known, HBsAg (-)

1. No testing or treatment.

C. Source known, HBsAg status undetermined

1. High risk that source is HBsAg (+)

a. Employee has completed all 3 doses.
Follow II.A.1. above.

b. Employee has received 1 or 2 doses of vaccine
Follow II.A.2. above.

2. Low risk that source is HBsAg (+).

a. No testing or treatment; categorized as “unknown source”.

D. Source unknown

1. Employee may be tested for anti-HBs, if desired. No further testing treatment; categorized as “unknown source”.

Exposure Definition
Significant occupational exposure includes contamination by blood or other body fluids or high titers of cell-associated or free virus via 1)percutaneous route, e.g., needlestick; 2)mucosal contact, e.g., splash in eye or mouth; 3)cutaneous exposure, e.g., nonintact skin, or involving large amount of blood or  prolonged contact with blood, espcially when exposed skin is chapped, abraded, or afflicted with dermatitis.

Employee Exposure
Employee must inform EOHW of exposure. EOHW staff will review the type of exposure, employee status, patient source requesting HIV ab testing as necessary, make a decision on risk, and counsel the exposed employee offering the appropriate post-exposure prophylaxis (PEP). This includes research lab personnel who have exposures to high titers of cell-associated or free virus. Other blood and body fluid (B/BF) exposure protocols will be instituted, as indicated.

Patient source is HIV infected, HIV ab neg but risk behaviors present or unknown

Baseline encounter

Evaluate type of exposure, employee status, patient source (see risk guidelines, Appendix A).

Counsel employee: risk of exposure, patient source information, and offer/recommend PEP as appropriate (see guidelines, Appendix A)

HIV ab (saved)

3 months post-exposure

HIV ab

6 months post-exposure

HIV ab

• Patient source HIV ab negative with no known risk behaviors
• Baseline encounter
• HIV ab offered
**Some risk behaviors include: any STD (presumptive or documented) now or within recent years (including HB); IVDU; multiple sexual partners, bisexual, or sexual partners of the previous; sexual abuse/possibility of sexual abuse; TB.

Specimens for HIV ab are submitted anonymously to the ID lab. The specimen is labeled with a code
number known only to EOHW staff. The employee is counseled privately by EOHW staff on the results of all HIV testing.

Infected Employee
The purpose of these guidelines is to respond to those issued by the Centers for Disease Control (CDC) (7/12/90) concerning health care workers (HCW) who have active infection with Hepatitis B virus (HBV) and/or Human Immunodeficiency Virus (HIV) (see HBV Protocol).

*HCW’s infected with HIV shall inform EOHW of their status.

*Those who come to the attention of EOHW will be assessed individually as to risk of transmission in patient care setting. A confidential occupational assessment will be conducted by a committee made up of the chairperson of the HICC, the director of EOHW, and a member of the clinical faculty to be designated by the Chief of the medical staff. The function of the committee is to assure that no patient is exposed to undue risk from a HCW known to have tested positive for HIV. Infected HCW’s will be notified of their responsibility to report to the State Health Director via State law.

*Information concerning health status and work activities will be confidentially collected from appropriate resources and presented confidentially to the assessment committee. Decisions of this committee on any need for a change in work activities will be based on current clinical standards of care. It is the function of the assessment committee to advise EOHW regarding a change in work activities. Implementation of recommendations made by the committee will be administered through and according to policies of EOHW.

*HCW’s with HIV infection will be reassessed periodically (based on health status and job risk) for their ability to safely continue their work activities.

*The work status of physician and non-physician HCW’s will be communicated to the Chancellor for Health Affairs by the director of EOHW. Information regarding specific cases will include recommendations for changes in the work status but will be strictly confidential. Medical records are not shared with management.

Hivprot2.wpe 6/90;3/92;6/92;7/96
Appendix A: HIV PEP Guidelines
When patient source is known to be HIV infected, PEP will be discussed with the employee per the following guidelines. If the source patient or the patient’s HIV status is unknown, initiating PEP will be decided on a case by case basis, based on the exposure risk and likelihood of HIV infection in known or possible source patients. PEP is not justifiable for exposure with negligible risk.

Exposure
High Risk = BOTH larger volume of blood, e.g., deep injury with large diameter hollow needle previously in source patient’s vein or artery, especially involving an injection of source patient’s blood, AND blood containing a high titer of HIV, e.g., source with acute retroviral illness or end stage AIDS, concentrated HIV from research laboratory.

Increased Risk = EITHER exposure to larger volume of blood OR blood with a high titer of HIV.

No Increased Risk = NEITHER exposure to larger volume of blood NOR blood with a high titer of HIV, e.g., solid suture needle injury from source patient with asymptomatic HIV infection.

Skin Exposures: Risk is increased for exposures involving a high titer of HIV, prolonged contact, an extensive area, or an area in which skin integrity is visibly compromised. For skin exposures without increased risk, the risk for drug toxicity outweight the benefit of PEP.

Body Fluids
In addition to blood, other potentially infectious body fluids include semen, vaginal secretions, cerebrospinal, synovial, pleural, peritoneal, pericardial, and amniotic fluids.

PEP should be initiated promptly, preferably within a few hours post-exposure. Efficacy is questionable 24-36 hours post-exposure but will consider initiating even at 1-2 wks post exposure if at
highest risk. PEP should be administered for 4 weeks, if tolerated.
 




Guide to PEP

Exposure Type	Source Fluid	PEP	Meds Regimen
Percutaneous	Blood Highest Risk	Recommend	zdv+3tc+idv
	Increased Risk	Recommend	zdv+3tc, +idv*
	No Increased Risk	Offer	zdv+3tc
	Fluid containing visible blood, other potentially infectious fluid or tissue
	Other blood fluid,  e.g., urine	Not Offer	___________________
Mucous  Membrane	Blood	Offer	zdv+3tc, +idv*
Skin,  increased risk	Fluid containing  visible blood, other potentially infectious fld or tissue	Offer	zdv, +3tc
	Other blood fluid, e.g., urine	Not Offer	___________________
	Blood	Offer	zdv+3tc, +idv*
	Fluid containing  visible blood, other potentially infectious fluid or tissue	Offer	zdv, +3tc
	Other blood fluid,  e.g., urine	Not Offer	___________________


 
• Baseline Encounter
• Employee will be informed: 1) That knowledge about efficacy and toxicity of PEP is limited, 2) For agents other than ZDV, data are limited regarding toxicity in persons without HIV infection or who are pregnant; 3) About  adverse/side effects, and 4) That any or all drugs for PEP may be declined by the exposed employee.
• PAS (counseling service) will be notified
• Medical/exposure history
• Consent form for PEP protocol, if appropriate
• Lab work: Stat pregnancy test for fertile females, complete blood count, renal and hepatic chemical function tests, if on PEP
• HIV ab
•  1 week post exposure, if on PEP
•  Medical history/counseling
•  PE, studies, drug/dosage changes as clinically indicated.
•  5 weeks post exposure, if on PEP
•  Medical history
•  Lab work: Complete blood count, renal and hepatic chemical function tests.
•  PE, other studies, as clinically indicated.
•  3 months postexposure
•  HIV ab
•  6 months postexposure
•  HIV ab


Hepatitis C Exposure Protocol

Exposure Definition
Significant occupational exposure includes blood or other body fluid contamination via percutaneous route, e.g., needlestick, mucosal contact, e.g., splash in eye or mouth; or cutaneous exposure, e.g., nonintact skin.

Employee Exposure
EOHW South staff will review the exposure. Other blood or body fluid (B/BF) exposure protocols will be instituted, as indicated.

Check HCV status of patient source with appropriate patient consent.

Source is anti-HCV negative:

• Notify employee.
• No further follow up.
Patient source is anti-HVC reactive, has diagnosis of Hepatitis C, or status unknown:

1. Baseline anti-HCV and liver panel (ALT) done on employee

a. If positive at baseline, evaluated by EOHW MD for liver status, work related status (including review of past reported blood/body fluid exposures).

b. If negative, repeat anti-HCV and liver panel (ALT) at 3 months and 6 months post exposure; if negative, no further follow up.

c. If positive for either anti-HCV or ALT at any point of the exposure testing repeat anti-HCV and liver panel (ALT); if still positive do PCR, evaluated by EOHW MD for liver status, work related status.

Infected Employee
A. Employee infected from occupational exposure at Duke University

1. Every 6 month follow up by EOHW for review of liver status; if liver abnormalities develop, consultation with specialty medical service.

B. Employee infected outside of Duke University

1. HCW’s infected with HCV shall inform EOHW of their status.

2. Periodic follow-up by EOHW based on risk of communicability.

A and B:
*Those who come to the attention of EOHW will be assessed individually as to risk of transmission in patient care setting. A confidential occupational assessment will be conducted by a committeee made up of the chairperson of the HICC, the director of EOHW, and a member of the clinical faculty to be designated by the Chief of the medical staff. The function of the committee is to assure that no patient is exposed to undue risk from a HCW known to be HCV infected.

*Information concerning health status and work activities will be confidentially collected from appropriate resources and presented confidentially to the assessment committee. Decisions of this committee on any need for a change in work activities will be based on current clinical standards of care. It is the function of the assessment committee to advise EOHW regarding a change in work activities. Implementation of recommendations made by the committee will be administered through and according to policies of EOHW.

*The work status of physician and non-physician HCW’s will be communicated to the Chancellor for Health Affairs by the director of EOHW. Information regarding specific cases will include recommendations for changes on the work status. Medical records are not shared with management.

Healthcare Professional’s Written Opinion
The employee will be provided within 15 days of the completion of the evaluation the following
attached memo.
 
 

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Last Updated: January 24, 2001
Safety@mc.duke.edu