http://www.kirklees.nhs.uk/fileadmin/documents/New/Your_health/Infection_prevention___control/Polici

MANAGEMENT OF CLINICAL SHARPS INJURIES AND EXPOSURE TO BLOOD AND HIGH RISK BODY FLUIDS

Prepared by:

Kirklees Infection Control Team

Responsible Area: Approval Information:

Public Health Date Approved: COMMITTEE:-

Lead Director:

Dr J Hooper

Infection Control Team PEC 13 February 2008

Version No. Approved:

Three

Review Date:

September 2009

Reference to Standards for Better Health Domain

Department of Health 2004 Standards for Better Health First domain Safety

Core/Development standard

Core Standard C4e

Performance indicators

1.To reduce incidence of cross infection

History of Document

Version 1: November 2002 – superseded Version 2: September 2005 - superseded Version 3 September 2007

CONTENTS Section No. 1.

General Information

1

2.

Associated Policies and Procedures

2

3.

Training

2

4.

Safe Practices for the Prevention of Injury

2

5.

Section 2 - What is the risk of infection after exposure

5

6.

Section 3 - Immediate action following injury - who takes responsibility for what?

Section 4 - First Aid

6

Section 5 - Responsibilities for treating the injured health care worker Section 6 - Assessing the incident and the extent of exposure

8

7.

8.

9.

10.

Page No’s

7

10 12

11.

Section 7 - Guidelines for approaching the source patient (adult and child) for permission to test for HIV, HBC, HCV Section 8 - Establishing the infectivity risk of the source patient

12.

Section 9 - Responsibilities for obtaining source blood

15

13.

Section 10 - Management of exposure to Hepatitis B virus

17

14.

Section 11 - Management of exposure to HIV

20

15.

Section 12 - Management of exposure of Hepatitis C virus

21

16.

Section 13 - Management of the non-significant injury

22

17.

Section 14 – Management of Exposure to Blood Borne Infections References

23

18

14

24

NICE Guidance Once NICE guidance is published, health professionals are expected to take it fully into account when exercising their clinical judgement. However, NICE Guidance does not override the individual responsibility of health professionals to make appropriate decisions according to the circumstances of the individual patient in consultation with the patient and/or their guardian or carer.

1.

GENERAL INFORMATION These guidelines refer to the following injuries or exposures involving: needles or sharp objects that have been in contact with blood or high risk body fluids*; splashing of blood or high risk body fluid* on skin that is broken, abraded, chapped, or has dermatitis or open sores; contamination of eyes, nose or mouth with blood or high risk body fluids*; a human bite that breaks the skin. *High-risk body fluids include blood and blood stained fluids. (Semen and vaginal secretions are also high-risk body fluids but have not been reported in the literature as a source of occupational exposure).

Because of the risks of blood borne diseases, caused by Hepatitis B virus (HBV), Human Immunodeficiency virus (HIV) and Hepatitis C Virus (HCV) and other agents, it is necessary for all health care workers (HCWs) to take precautions to protect themselves and others from blood contact. In particular, HCWs should take action to prevent needlestick and other similar injuries detailed above.

Needlestick injuries cause considerable concern and uncertainty among those injured and their families. For HBV there is effective vaccination; there is also prophylactic treatment for those who are not vaccinated. For HIV there is no vaccine or cure yet available; however, there is post exposure prophylaxis (PEP) – IMMEDIATE ACTION IS REQUIRED. There is currently no vaccine or post exposure prophylaxis for HCV, but it is recognized that early diagnosis and treatment can influence the progression of the disease.

Testing source patients for HBV, HCV and HIV is the most effective way of providing reassurance to those injured, as the vast majority of patients will not be infectious. In practice, there has been reluctance on the part of clinicians to seek patients’ consent to have this done yet patients have usually been found willing to co-operate with this arrangement if approached in a sensitive manner.

In the event of a needlestick or similar injury occurring, it is important for all staff to know: • what action to take • who has responsibility to ensure proper assessment; • where to go for treatment of the injury and follow-up.

• how to report the incident so that systems can be revised and future injuries reduced or avoided.

This guidance has been prepared for HCWs but the principles can be applied to other groups of workers who are injured, such as the police, cleansing workers and also members of the general public. These individuals will be less likely to have been immunised against HBV. Needles encountered outside hospitals should be regarded as being at high risk of transmitting HBV. Many needlestick and similar injuries can be prevented if proper care is taken and appropropriate prevention strategies are adopted by both individuals and health care institutions.

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2.

ASSOCIATED POLICIES AND PROCEDURES • • • • • •

PCT Universal Precautions Guidelines PCT Waste Management Guideline Incident Reporting Health and Safety COSHH Consent Policy

3

TRAINING

4.

Training on Management of Clinical Sharps Injuries exposure to blood and high risk body fluids is delivered to healthcare professionals at a variety of training sessions such as • Mandatory training • Induction training • As part of the Department of Health Essential Steps Programme SAFE PRACTICES FOR THE PREVENTION OF INJURY It is not always possible to know who is infected by certain bacteria of viruses, therefore when dealing with blood and body fluids the same procedure of universal precautions apply in all dealings with blood and body fluids.

The possibility of infection is best prevented by avoiding sharps and contamination injuries, by covering broken or abraised skin surfaces with an adhesive dressing and by wearing appropriate personal protection equipment for procedures where splash contamination is possible. a)

The Sharps Box • • • • • • • • •

b)

Safe Practices • • •

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At the beginning of the relevant procedures, ensure that a sharps bin is immediately to hand.

Select a bin with a capacity suitable for the intended use.

All sharps bin must comply with British Standards 7320 and UN 3291 Standards.

If not already done, assemble the bin carefully, following the manufacturer’s instructions.

Complete the assembly label on the front of the bin At the end of the procedure, close the sharp bin using the temporary closure mechanism.

Position the sharp bin in a secure location that precludes theft or injury to patients, visitors or other staff.

They should not be stored on the floor. They should be located at shoulder height for the average person.

Should not be stored near direct sunlight or radiators.

Always take a sharps bin to the task, rather than the sharp object to the bin.

Sharps and needles should not be passed from hand to hand.

Use a needle-holder to hold suture needles.

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• • • •

• • • c)

Needle forceps or other suitable device must be used when the needle is disposable from a reusable syringe eg local anaesthetic in dentistry.

Do not attempt to locate the position of a sharp instrument without visual control.

Needles must not be re-sheathed by hand and must not be bent or broken prior to disposal.

Needles must not be detached from the syringe. Needle and syringe should be disposed of as one unit except when there is a need to decant blood from the syringe directly into a specimen container. In such a case, the needle may be removed, using the “needle remover”, if provided on the sharps box.

All sharp objects, whether contaminated with blood, or not, must be discarded directly into a sharps bin. Do not leave sharps or needles lying around.

Always carry used sharps bins by the handle.

Do not attempt to retrieve items from sharps bins.

Accountabilities and Responsibilities The Chief Executive is the accountable officer regarding all infection, prevention and control arrangements but delegates the responsibility to the PCT Board and the Director of Infection, Prevention and Control. The Board ensures that the arrangements which the PCT has in place to prevent and control infection are effective. The Board will use the Assurance Framework to gain assurances that all risks regarding safe disposal of Sharps are being managed. Procedures will be constantly reviewed to support the reduction in the incidence of Sharps injuries or the use of safer devices.

It is the responsibility of the individual user to dispose of sharp objects safely under the remit of the Health and Safety at Work Act 1974 and the COSHH Regulations 2002 require actions to be taken to control the risk of hazardous substances, including biological agents. This responsibility is personal and cannot be delegated to others.

Line managers must ensure that the healthcare worker has received the appropriate first aid attention and appropriate Occupational Health department has been informed of the incident and that an incident form has been completed.

The departmental manager is responsible for preventing unauthorised access to sharps bins. It is essential that the bins are kept away from patients and members of the public, particularly young children.

d)

Personal protection • • •

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Gloves must be worn for venepuncture and other invasive procedures.

Aprons must be worn whenever there is a risk of body contamination with blood or body fluids.

Goggles and/or masks must be worn when ever there is the Page 3 of 24

risk of splashes contaminating the eyes or the mouth of the HCW and in high risk situations such as occurs with the use of high speed drills in dentistry. e)

Disposal of sharps bins • • • • • •

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Sharps containers should not be filled beyond three quarters capacity Lock sharp bins securely when full and label with date and location Where available, full sharps bins should be disposed of directly into the large clinical waste wheelie bins. Alternately, store full sharps bins in a secure location to await collection.

Do not place used sharps bins in yellow bags for disposal Place damaged and overfilled sharps containers into a larger secure container for disposal Full sharps bins must be disposed of by incineration

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SECTION 2 WHAT IS THE RISK OF INFECTION AFTER EXPOSURE? Hepatitis B Virus (HBV) Health care workers who have received Hepatitis B vaccine and have developed immunity to the virus are at no risk of infection. The risk of infection following a significant percutaneous injury has been estimated at 1 in 3 for a Hepatitis B e antigen positive source. There is currently no evidence on the risk of transmission of Hepatitis B following mucocutaneous exposure.

Hepatitis C Virus (HCV) The risk of infection following a significant percutaneous injury has been estimated at 1 in 30 for a Hepatitis C PCR positive source. There is currently no evidence on the risk transmission of Hepatitis C following mucocutaneous exposure.

Human Immunodeficiency Virus (HIV) The risk of infection following a significant percutaneous injury has been estimated at 1 in 300 for HIV positive source.

After a mucocutaneous exposure the average risk is estimated at less than 1 in 1,000.

There is no risk of transmission where intact skin is exposed to HIV infected blood.

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SECTION 3 IMMEDIATE ACTION FOLLOWING INJURY – WHO TAKES RESPONSIBILITY FOR WHAT? When an incident occurs.

Injured Health Care Workers (HCWs) must: • • •

Apply first aid (See Section 4); Report to line manager immediately; Contact appropriate Occupational Health department as soon as possible. Mid Yorkshire Hospitals NHS Trust and Calderdale and Huddersfield Foundation Trust Occupational Health Services currently provide an Occupational Health Service only to those directly employed staff who were part of the former North Kirklees, South and Central Huddersfield Primary Care Trusts. From April 2008 Mid Yorkshire Hospitals NHS Trust Occupational Health Service will provide the service to all directly employed staff of Kirklees PCT.

•

Occupational Health Services for General Medical Practitioners and their staff or General Dental Practitioners and their staff is provided by Kirklees Employee Healthcare during normal working hours.

• Accident and Emergency if out of normal working hours (Weekends and Bank Holidays) NB: If there is a high index or suspicion that the infecting blood is HIV positive, reporting to Occupational Health or A&E must be done immediately, as time is critical to the success of prophylaxis in these cases. A risk assessment needs to be made urgently by someone other than the exposed worker about the appropriateness of starting PEP. Complete incident form.

•

Non HCWs and HCWs without an Occupational Health Department will: • •

Apply first aid (See Section 4); Report to A&E at all times.

The Line Manager responsible for the injured HCW must: • • • • • •

Ensure that first aid has occurred; Refer injured HCW to Occupational Health Department or A&E as soon as possible (see above); Ensure that all steps for care of the HCW are taken and follow-up is completed; Ensure that a incident form is completed and forwarded to the appropriate authority; Investigate the cause of the injury; Adopt any appropriate preventative strategies, e.g. safe sighting of sharps boxes or other measures that will reduce the likelihood of further injuries. Liaise with the infection control team.

Community Infection control nurses 01924 512159 01484 466177

Occupational Health and Accident & Emergency Departments: •

The further course of action to be taken will depend on the circumstances and the risk

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assessment of the incident

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SECTION 4 FIRST AID - Immediately following any exposure whether or not the source is known to pose a risk of infection.

Make sure proper First Aid has been carried out.

A. Puncture/sharps wounds • • •

Encourage free bleeding of accidental puncture wounds by gentle squeezing.

Wounds should NOT BE SUCKED. Wash thoroughly with soap and water but without scrubbing. Antiseptics and skin washes should not be used.

Dry and apply adhesive dressing.

B. Eye contamination • •

Irrigate the eye(s) for several minutes with water /saline for irrigation or warm tap water.

Wearers of contact lens should immediately remove them from the affected eye(s) and irrigate copiously with water, before and after removal. The lens should not be replaced until advice is sought.

C. Contaminated skin •

Wash contaminated skin with soap and warm water. DO NOT SCRUB THE AREA.

D. Mucosal contamination • Treat mucosal surfaces such as mouth or nose by rinsing with warm water or saline.

Water used for rinsing the mouth must not be swallowed.

DO NOT USE BLEACH ON THE INJURY •

It is a caustic agent

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SECTION 5 RESPONSIBILITIES FOR TREATING THE INJURED HEALTH CARE WORKER • • •

Ensure first aid has been carried out (Section 4).

Assess the significance of the injury (Section 6).

Ask whether infecting material or source patient, if identified, is known to be high risk for blood borne viruses.

a) High risk situation for HIV infection (Section 11): Significant injury together with infecting blood stained fluid that is known / highly suspected of being HIV positive :•

•

•

• • •

A significant injury is one with the potential to transmit a blood borne virus. There are three types of exposure in health care settings associated with significant risks.

These are • Percutaneous injury • Exposure of broken skin • Exposure of mucous membranes including the eye If infecting blood stained fluid is known to be positive for HIV and the injury is significant e.g. penetration of skin, contamination of mucous membrane, offer HIV post exposure prophylaxis (PEP) and refer to Occupational Health or if out of hours Accident and Emergency Department.

If the infecting blood stained fluid is not known to be HIV positive, but there is a high index of suspicion that this is likely, and the injury is significant, the first dose of HIV PEP should also be offered to the infected worker without awaiting confirmation of the status of the infecting blood. Refer to Occupational Health or if out of hours Accident and Emergency Department.

Ensure that baseline sample from HCW for storage has been taken, and that it has been sent to the Laboratory.

The HCW should be informed the baseline samples will be retained indefinitely.

Arrange joint counselling and long term support with Genito Urinary Medicine clinic (GUM) and/or Occupational Health Services.

b) Low risk situation for HIV infection (Section 11) e.g. Source patient is known / highly suspected of being positive for HIV, but the contamination consists of urine on intact skin :• • • • •

HIV PEP is not recommended in these circumstances unless the HCW is insistent even when given informed advice, in which case refer to Occupational Health.

Counsel and support.

Take baseline sample from injured HCW for storage and send to Pathology Laboratory.

The HCW should be informed the baseline samples will be retained for 2 years.

Arrange joint counselling and long-term support with Genito Urinary Medicine Clinic.

c) All injuries associated with infecting blood known to be Hepatitis B positive (Section 10):• • •

Assess the injured employee’s immunity to Hepatitis B. On the basis of careful risk assessment, consider further Hepatitis B vaccine and the possibility of prophylaxis using Hepatitis B immunoglobulin.

Take baseline sample from injured HCW for storage and sent to Pathology Laboratory.

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• •

Arrange return for long-term care, counselling and follow up tests.

Refer for further clinical care as necessary.

d) All injuries associated with infecting blood known to be Hepatitis C positive:• • • •

Counsel and support.

Take baseline sample from injured HCW for storage, and send to Path Lab. Arrange return for long term counselling and follow up tests @ 6 weeks, 3 and 6 months.

Refer for further clinical care as necessary.

e) Action when the status of the infecting blood is unknown, but can be ascertained:• • • • • •

Make an initial assessment of risk on the basis of the information available (Section 6) and act accordingly.

If the exposure is considered to be high risk, liaise with the source patient’s General Practitioner, to make a risk assessment, and to seek permission and arrange for the source patient to be tested for blood borne viruses (Section 7 & 8).

If consent is given, phone laboratory, discuss tests required (usually Hepatitis B, C and HIV), check when results will be known and to whom they are to be given.

If test is positive for one of the blood borne viruses, treat as above.

If test is negative for blood borne viruses, reassure HCW and support as necessary.

Arrange longer-term follow-up with the appropriate agency, as necessary.

f) Action when the status of the infecting blood is unknown and cannot be ascertained:• • • •

Make a risk assessment on the basis of the available information (Section 6).

Treat the infecting blood as Hepatitis B & C positive and proceed as at (c) or (d) above.

Reassure the HCW regarding the low risk of infectivity with HIV. Counsel, support.

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SECTION 6 ASSESSING THE INCIDENT AND THE EXTENT OF EXPOSURE The risk of viral transmission following an exposure incident is associated with the following: a) A viral source The contaminating body fluid from the source patient must be infected with one of the blood borne viruses. b) The mechanism of infection The virus in the contaminating body fluid must enter the body of the injured party. c) The vehicle for viral transmission: Although blood borne viruses can be found in many body fluids, for a number of reasons, the greatest risk of infection following injury occurs when the virus is transmitted via:• • •

infected blood; infected serum; or infected plasma.

d) The route of entry into the body: Four factors are associated with increased risk of Occupational acquired HIV Infection • Deep injury • Visible blood on the device which caused the injury • Injury with a needle which has been placed in a source patient’s arterial vein • Terminal HIV related illness in the source patient. e) Any action which facilitates a breach of intact skin e.g.

• • • f)

Scratches and puncture injuries caused by needles, sharps and teeth which are contaminated with infected blood.

Eczema, dermatitis at area of contamination with infected body fluid.

Abrasions, cuts.

Some factors which increase the risk of transmission: The risk of transmitting infection is increased if the incident is associated with the following:• • • • •

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Penetrating injuries from needles, instruments, bone fragments significant bites which break the skin.

Wide/hollow bore needles.

Significant amount of blood contamination.

Large areas of broken skin.

The quality of the blood e.g. freshness and dilution factor.

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• • • •

Lack of barriers to the transfer of body fluid.

High viral load.

Non-immune recipient Needle previously in donor’s vein or artery

ASSESSING THE RISK OF TRANSMITTING INFECTION AND HENCE THE NEED FOR PROPHYLAXIS Blood borne viruses are known to have different rates of infectivity (Section 2) a) Questions to ask: • • •

Could the exposure be described as a needlestick/sharps injury /bite with skin penetration or the contamination of broken skin, eczematous skin or mucous membrane?

Was it associated with the transfer of blood or blood stained body fluid to the injured site?

Did the infecting blood or body fluid come from a person known or suspected of having a blood borne viral infection?

If yes to all of the above, this constitutes a high-risk exposure for HBV, HCV and HIV and warrants prophylaxis and follow-up. b) The risk of transmission increases if any of the following factors are present:• • • •

Deep or penetrating injury Wide / hollow bore needle Contamination of large areas of broken skin Transfer of significant amount of blood?

c) Contamination of intact skin WITHOUT skin penetration constitutes negligible risk and PEP is NOT warranted. The potential side effects and toxicity of taking PEP outweigh the negligible risk of transmission. d) Body fluids and materials which may pose a risk of HIV transmission if significant occupational exposure occurs:Amniotic fluid, Cerebrospinal fluid, Human breast milk, Pericardial fluid, Pleural fluid, Peritoneal fluid, Saliva in association with dentistry (likely to be contaminated with blood, even when not obviously so), Synovial fluid, Unfixed human tissue and organs, Any other body fluid if visibly bloodstained, Exudative or other tissue fluid from burns or skin lesions.

Vaginal secretions Semen However the risk of sero-conversion after contamination with these fluids is thought to be less than with blood and, at the time of writing this policy, sero-conversion has only ever occurred when the contaminating fluid has been blood or blood stained.

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PEP should not be offered after exposure through any route with low risk materials – urine, vomit, saliva, faeces, unless they are visibly blood stained.

Risk assessment is not always clear cut, therefore, if in doubt, seek advice from the Consultant in Genito-Urinary Medicine or the Consultant Microbiologist.

An urgent preliminary risk assessment therefore should assess if it is appropriate to recommend that the exposed worker takes the first dose of PEP. When offering PEP it is important to take into account any views of the exposed HCW. It is recommended that, for optimal efficacy, PEP should be commenced as soon as possible after the incident and ideally within the hour. However it may still be worth considering starting PEP even if up to 2 weeks have elapsed since the exposure.

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SECTION 7 GUIDELINES FOR APPROACHING THE SOURCE PATIENT (ADULT AND CHILD) FOR PERMISSION TO TEST FOR HIV, HBC, HCV This situation must be handled sensitively. The patient should NOT be approached by the injured person, but by an experienced clinician directly involved in the patient’s care. eg General Practitioner There is no single approach, which will cover every interview, but it is recommended that the following points are observed: A. The discussion should take place in a location where proper privacy is maintained.

B. The patient should be informed that an employee has been injured in an accident involving their blood and that injuries of this kind can cause considerable anxiety and worry to health care workers because infections such as Hepatitis B, Hepatitis C and HIV can be transmitted in this way.

C. All patients should then be asked if they would be willing to consider allowing a sample of their blood to be taken for testing for HBV, HCV and HIV as a negative result gives most reassurance to the injured employee.

In asking this question it is important that undue pressure is not put on the patient to comply with this request. It should be made clear that the decision lies entirely with the patient. The outcome of the discussion should be recorded in the patient’s notes. A refusal from the patient must not have an effect on the overall management of that patient and this must be explained clearly to the patient.

D. If the request raises serious anxiety for the patient, for any reason, then the services of a trained counsellor should be offered and this can be arranged on the next working day.

E. If the consent to take blood is granted:-

obtain permission for results to be given to a third party i.e. Occupational Health, GUM, ICN and the injured person; ask if there is any objections to the report being filed within the clinical notes.

F. Phone the laboratory and arrange for testing to be carried out. It does not have to be done in the night and can wait for the next morning.

G. Complete blood form with a) the name of person authorizing blood tests and b) the specific tests requested (i.e. Hepatitis B surface antigen, Hepatitis C antibody and HIV 1 and 2 antibody). Ensure that the form is filled in correctly and that it is signed by a responsible member of the clinical team. (NB. Specimens accompanied by forms that are not completed correctly and signed will not be processed by the laboratory) H. Arrange for results to be phoned back to a named individual. Advise the patient that he/she will be informed by the results by a named person, usually within 72 hours, a positive test must always be repeated.

I.

Relay results to source patient, Occupational Health and GUM. It is not necessary to pass on the name of the source patient to a third party.

J. If the patient does not consent to testing, or if there are other good reasons for not testing, patients should be asked if they would mind answering some personal questions, which would help to clear up the concern.

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Emphasise that the questions are very personal and may very well not apply to them, but they are now asked routinely, for example, by the Blood Transfusion Service before accepting blood donations.

K. If the patients agree, ask them the questions detailed in Section 8.

L. When the source patient is unconscious when the injury occurs consent should be sought once the patient has regained full consciousness. If the patient is unable to give or withhold consent, or does not regain full consciousness within 48 hours. In such cases you may test an existing blood sample. If there is good reason to think that the patient has HIV and testing would be in the patient’s interest, but you must consult an experienced colleague first. It is possible that a decision to test an existing sample may be challenged in the courts. Be prepared to justify your decision.

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SECTION 8 ESTABLISHING THE INFECTIVITY RISK OF THE SOURCE PATIENT A

When the source blood is traced to an individual who is already known to be positive for HIV, hepatitis C or hepatitis B surface antigen (HbsAg) further confirmation will not be needed.

B

Needles discovered in the street or the park should be considered as high risk of transmitting hepatitis B and hepatitis C but not HIV.

C

If a source patient is identified, consider guidelines in Section 7 and ask patients to indicate if they come into any of the categories within the list below either by showing them the list or reading it to them.

D

Anyone answering yes to any of the questions and a baby of any high-risk women, should also be considered high risk. Remember residents of institutions for the mentally impaired or anyone from an endemic area are high risk for hepatitis B unless previously immunized.

List of questions to determine the risk category of the source patients’ blood 1.

2.

3.

4.

5.

6.

7.

8.

Have you ever given blood? If yes, when last donated? Continue to ask the following: Have you ever been told that you are positive for HIV/AIDS, HBV or HCV? (For men only) have you ever had sex, even safe sex with another man?

Have you ever injected yourself with drugs? (This includes body-building drugs, but excludes prescription drugs, such as insulin).

Have you ever lived in, or visited Africa or any Far Eastern country, and had sex with men or women living there or received hospital treatment?

Have you ever received a blood transfusion outside the United Kingdom? If yes, where and when?

Have you been a sex worker at any time?

Have you ever had sex with a person in the above groups?

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SECTION 9 RESPONSIBILITIES FOR OBTAINING SOURCE BLOOD a) Clinical Manager/ supervisor covering the area where the source of blood is located:• •

• •

•

Locate source patient if possible.

Arrange for member of the medical team responsible for source patient to seek source patient’s consent to have blood test for HIV/HBV/HCV blood borne viruses (BBVs) to be carried out and for permission to give that result to a third party i.e.

Occupational Health and GUM. Arrange for transport of specimens to laboratory (taxi if rapid results required) and prompt return of report. Phone lab and organise to which member of the clinical team the result should be phoned.

Inform Occupational Health Department during normal working hours or Accident & Emergency outside these hours whether or not a source patient has been identified and, if so, the “AT RISK” status and blood test results. It is not necessary to identify the name of the source patient, but may be helpful for Occupational Health Services.

If the incident occurs when the laboratory is closed, tests can be processed the next morning.

N.B. If the source patient prefers, a coded identification should be used. The patient should give approval for testing under his or her own name. b) Clinician in charge of the source patient • • • • • • • •

Confirm details of injury Consult guidelines on approaching source patient and establish risk status (Sections 7 and 8).

Seek source patient’s consent for testing and for reporting result to a third party.

Offer the services of a trained counsellor if the request causes serious anxiety for the patient.

Take blood, if patient is agreeable, and send it to the laboratory.

Advise the patient’s GP that the incident has occurred.

Inform source patient of the results.

Inform Occupational Health and GUM as per arrangement made with source patient.

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SECTION 10 MANAGEMENT OF EXPOSURE TO HEPATITIS B VIRUS Action should be taken after establishing the injured person’s immunity. In most circumstances, this will be done without waiting for the results of the blood test from the source patient.

A. A high proportion of NHS staff will have been immunised with Hepatitis B vaccine.

Within the Primary Care Trust all vaccinated staff are offered a post vaccination antibody test to assess their level of immunity. This result may be available from:- The Occupational Health Department record B. In cases where the exposure is considered significant (Section 6), the use of Hepatitis B immunoglobulin (HBIG) and or Hepatitis B Vaccine may be required. There is a need for action as soon as possible – within 24 hours for maximum protection.

Accident and Emergency Departments and Occupational Health Departments should have ready access to stocks of Hepatitis B vaccine. Hepatitis B immunoglobulin (HBIG) has to be ordered from the Public Health Laboratory.

All HCW’s must be referred back to the relevant Occupational Health Department.

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C. See table below for details of immunisation required.

HBV prophylaxis for reported exposure incidents Significant exposure

Non-significant exposure

HBV status of person exposed ≤ 1 dose HB vaccine pre-exposure

HBsAg positive source Accelerated course of HB vaccine* HBIG x 1

Unknown source Accelerated course of HB vaccine*

HBsAg negative source Initiate course of HB vaccine

Continued risk

No further risk

Initiate course of HB vaccine

No HBV prophylaxis.

Reassure

≥ 2 doses HB vaccine pre-exposure (anti-HBs not known)

One dose of HB vaccine followed by second dose one month later

One dose of HB vaccine

Finish course of HB vaccine

Finish course of HB vaccine

No HBV prophylaxis.

Reassure

Known responder to HB vaccine (anti-HBs > 10mlU/ml)

Consider booster dose of HB vaccine

Consider booster does of HB vaccine

Consider booster dose of HB vaccine

Consider booster dose of HB vaccine

No HBV prophylaxis.

Reassure

Known nonresponder to HB vaccine (anti-HBs < 10mlU/ml 2-4 months postimmunisation)

HBIG X 1 Consider booster dose of HB vaccine

HBIG X 1 Consider booster dose of HB vaccine

No HBIG Consider booster dose of HB vaccine

No HBIG Consider booster dose of HB vaccine

No prophylaxis Reassure

A second dose of HBIG should be given at one month

A second dose of HBIG should be given at one month

* An accelerated course of vaccine consists of doses spaced at zero, one and two months.

A booster dose may be given at 12 months to those at continuing risk of exposure to HBV. Source: PHLS Hepatitis Subcommittee (1992) Primary Immunisation For pre-exposure prophylaxis in groups at high risk and for post-exposure prophylaxis, an accelerated schedule should be used, with vaccine given at zero, one and two months. For those who are at continued risk, a fourth dose is recommended at 12 months. An alternative schedule at zero, one and six months for those 11 – 15 years of age can be used for pre-exposure prophylaxis where rapid protection is not required and there is a high likelihood of compliance. Where compliance with a more prolonged schedule is difficult to achieve (e.g. in IDUs and genito-urinary medicine clinic attenders), higher completion rates for three doses at zero, one and two months have been reported. Improved compliance is likely to offset the slightly reduced immunogenicity where compared with the zero-, oneand six-month schedule, and similar response rates can be achieved by opportunistic use of a fourth dose after 12 months.

Recently, an extension to the product licence for Engerix B® has been granted to allow for a very rapid immunisation schedule or three doses give at 0, 7 and 21 days. When this schedule is used, a fourth dose is recommended 12 months after the first dose. This schedule is licensed for use in circumstances where adults over 18 years of age are at immediate risk and where a more rapid induction of protection is required. This includes persons travelling to areas of high endemicity, IDUs and prisoners. In teenagers under 18 years of age, response to vaccine is as good or better than in older adults. Although not licensed for this age group, this schedule can be used in those aged 16 to 18 years where it is important to provide rapid protection and to maximise compliance (e.g. IDUs and those in prison).

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Fendrix速 is recommended to be given at zero, one, two and six months. Twinrix速 can also be given at 0, 7 and 21 days. This will provide more rapid protection against hepatitis B than other schedules but full protection against hepatitis A will be provided later than with a single dose of single hepatitis A vaccine. When this schedule is used, a fourth dose is recommended 12 months after the first dose.

Reinforcing immunisation The full duration of protection afforded by hepatitis B vaccine has yet to be established. Levels of vaccine-induced antibody to hepatitis B decline over time, but there is evidence that immune memory can persist in those successfully immunised. However, recent evidence suggests that not all individuals may respond in this way. It is, therefore, recommended that individuals at continuing risk of infection should be offered a single booster dose of vaccine, once only, around five years after primary immunisation. Measurement of anti-HBs levels is not required either before or after this dose.

Boosters are also recommended after exposure to the virus.

Response to vaccine and the use of additional doses Except in certain groups testing for anti-HBs is not recommended.

Those at risk of occupational exposure In those at risk of occupational exposure, particularly healthcare and laboratory workers, antibody titres should be checked one to four months after the completion of a primary course of vaccine.

Under the Control of Substances Hazardous to Health (COSHH) Regulations, individual workers have the right to know whether or not they have been protected. Such information allows appropriate decisions to be made concerning post-exposure prophylaxis following known or suspected exposure to the virus (see above).

Antibody responses to hepatitis B vaccine vary widely between individuals. It is preferable to achieve anti-HBs levels above 100mlU/ml, although levels of 10mIU/ml or more are generally accepted as enough to protect against infection. Some anti-HBs assays are not particularly specific at the lower levels, and anti-HBs levels of 100nIU/ml provide greater confidence that a specific response have been established.

Responders with anti-HBs levels greater than or equal to 100mIU/ml do not require any further primary doses. In immunocompetent individuals once a response has been established further assessment of antibody levels is not indicated. They should receive the reinforcing does at five years as recommended above.

Responders with anti-HBs levels of 10 to 100mIU/ml should receive one additional dose of vaccine at that time. In immunocompetent individuals, further assessment of antibody levels is not indicated.

They should receive the reinforcing dose at five years as recommended above.

An antibody level below 10mIU/ml is classified as a non-response to vaccine, and testing for markers of current or past infection is good clinical practice. In non-responders, a repeat course of vaccine is recommended, followed by retesting one to four months after the second course. Those who still have anti-HBs levels below 10mIU/ml, and who have no markers of current or past infection, will require HBIG for protection if exposed to the virus.

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SECTION 11 MANAGEMENT OF EXPOSURE TO HIV A. Combination therapy reduces the transmission of HIV. Combination therapy against HIV transmission [post exposure prophylaxis (PEP)] should be considered when:i.

HIV Post exposure Prophylaxis should be recommended to Healthcare workers if they have had significant occupational exposure to blood or another high risk body fluid from a patient or other source known to be HIV infected or considered to be at high risk of HIV infection but where the result of an HIV test has not or cannot be obtained.

ii

The needlestick injury or mucosal exposure is high risk (see Section 6).

If antiretroviral therapy is thought to be necessary time is of the essence and therapy should ideally be started within one hour of the injury. Nevertheless it may be worth considering PEP even if 2 weeks have elapsed since the exposure. When the source patient is of unknown HIV status but considered to have high risk factors, it may be appropriate to commence antiretroviral therapy prior to the result of an HIV test. In all instances the decision to commence combination therapy may be discussed with the Consultant in Genito-Urinary Medicine or the Consultant Microbiologist.

Recommended regimen for PEP •

One Combivir tablet (300 mg Zidovudine + 150mg Lamivudine) b.d.

Plus •

Two Kaletra film coated tablets (200 mg Lopinavir + 50 mg Ritonavir) b.d.

Once PEP is started, the injured HCW must be referred to the first available GUM clinic or Mid Yorkshire Hospital NHS Trust Occupational Health Service for long term care, counselling and support. At least 6 months should elapse after cessation of PEP before a negative antibody test is used to reassure the individual that infection has not occurred.

B. If the source patient (or infecting body fluid) is:-

of unknown HIV status, or, after testing, is found to be HIV antibody negative with “high risk” factors,

PEP is not recommended, but injured workers must be counselled and supported in the Occupational Health Department. The injured worker should be followed up at 6 weeks, 3 and 6 months.

C. If the HIV antibody test in the source patient is negative and there are no other “high risk” factors, the injured party can be reassured.

D. Pregnancy does not preclude the use of HIV PEP. Expert advice should always be sought if PEP is considered for a pregnant HCW. Urgent pregnancy testing should be arranged for any female HCW who cannot rule out the possibility of pregnancy

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SECTION 12 MANAGEMENT OF EXPOSURE OF HEPATITIS C VIRUS There is no immunoglobulin or prophylactic treatment presently available for HCV. In all cases where there is:• • •

injury to a HCW: and contamination of the injury with blood or blood stained body fluid; and the source blood is known to be positive for, or considered to be “high-risk” for Hepatitis C.

The HCW should be referred to the appropriate Occupational Health Department for counselling, support and follow-up at 6 weeks, 3 and 6 months.

A baseline sample of blood must be taken at the time of the injury for storage.

If the injured person sero-converts at a later state, then specialist referral for monitoring liver function and assessment for antiviral therapies is essential.

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SECTION 13 MANAGEMENT OF THE NON-SIGNIFICANT INJURY. •

The injured person should be reassured

•

All persons who suffer injuries or accidents which carry a risk of infection with blood borne viruses, should have baseline blood taken at the time of the injury.

•

HCWs must be referred to the appropriate Occupational Health Department, where some HCWs may require further reassurance

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SECTION 14

Management of Exposure to Blood Borne Infections Management of Incidents with Blood/Other Body Post Exposure Procedure Needle stick injuries • • • • •

Remove object from skin Encourage wound to bleed Flush wound under warm running water Do Not suck the wound Cover wound with appropriate dressing

Incident involving broken skin, mouth or eyes •

Immediately irrigate affected area with copious amounts of water

Report incident to your Line Manager and complete an Incident Report Form as soon as possible

If the Source Person (SP) is known and they are in agreement pre test counselling should be given. Consent must be obtained for testing Hepatitis B&C and HIV. Send a 10ml clotted sample to the lab at Mid Yorks or CHFT, completing the request form for the tests with the SP’s name, date of birth, address and GP.

For All incidents Monday - Friday 8am – 4.30pm (excluding Bank Holidays Contact Occupational Health Dept CHFT 01484 342442 Mid Yorks 01924 212467 OHD will advise the recipient of any necessary action that needs to be taken

High risk exposure incidents must also be reported to OHD on next working day

Outside normal working hours High Risk Exposure • SP is known or suspected to be HIV positive or • SP is Hepatitis B positive and staff Hepatitis B status is unknown or the exposed person is non responder • Send exposed person to nearest A&E dept immediately (within 1 hour)if PEP required Factors to consider when assessing the SP for Hepatitis B or HIV infection • Is there a positive Hepatitis B and/or HIV result in medical records?

• Does the SP come from a country where blood-borne viruses are endemic i.e. Sub-Saharan Africa?

• Is the SP an IV Drug user?

• Is the SP a homosexual/bisexual man?

• Is the SP a sex worker • Has the SP had unprotected sex with a person who is HIV positive?

• Is the SP a current a past prisoner (with any of the above risk factors)?

• Is there a remote or current history of immune deficiency?

Low Risk Exposure

**IMPORTANT** YOU MUST READ THE PCT POLICY ON MANAGEMENT OF CLINICAL SHARPS INJURIES AND EXPOSURE TO BLOOD AND HIGH RISK BODY FLUIDS FOR FULL GUIDANCE. THIS CHART IS ONLY A QUICK GUIDE. Figure 1 – Management of Incidents * PEP – Post Exposure Prophylaxis Version No: Date Approved:

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18.

REFERENCES Department of Health HMSO London

2006

Immunisation against Infectious Disease

Department of Health February 2004 HIV Post-exposure prophylaxis Guidance from the UK Chief Medical Officersâ&#x20AC;&#x2122; Expert Advisory Group on AIDS : UK Health Departments. London Department of Health 2007 Up date to HIV Post Exposure Prophylaxis (PEP) Guidance from the Expert Advisory Group on AIDS following the recent recall of Viracept (Gateway Reference 8562) UK Health Departments London Extract from Exposure to Blood what health-care workers need to know.

From the Centres for Disease Control http;/www.cdc.gov.incidod/hip/BLOOD/exp_blood, htm Medical Devices Agency (2001) MDA SN2001 (19) Safe Use and Disposal of Sharps National Institute for Clinical Excellance (2003) Prevention of Healthcare Associated Infection in Primary and Community care. NICE London The Epic Project Development National Evidence-based Guidelines for preventing Health Care Associated Infections. Journal of Hospital Infection (2001) 47:S35-S37 (supplement)

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