- to manage blood exposure
incidents for both health care workers and patients. Health boards or
NHS trusts should designate medical staff to assess incidents and to
consider the need for hepatitis B immunoprophylaxis. Independent contractors
should ensure that they have similar arrangements in place for staff
and patients.
4. Medical
Directors of NHS trusts are asked to ensure this circular is brought to
the attention of occupational health physicians, consultant microbiologists
and virologists, and clinical directors of community dental services.
Executive Nurse Directors are requested to bring this circular to the
attention of Heads of Midwifery Services/senior midwives of NHS trusts
and occupational health nurses.
5. Directors
of Public Health are asked to arrange for copies of this guidance to be
distributed to all General Medical Practitioners in their area as soon
as bulk supplies reach them. Bulk supplies of the circular are also being
sent under separate cover to Primary Care Trusts and Island Health Boards
who are asked to distribute copies of the circular to all dental practitioners
on their lists and all community dentists in their area. Medical Directors
of NHS Trusts are also asked to circulate copies to hospital dentists
in their area.
6. Occupational
Health Departments will be contacted separately by the Department regarding
this guidance.
Yours sincerely
Sir David Carter
Chief Medical Officer
ANNEX A
Background
and Other Information
Previous
guidance and scope of new guidance
- Protecting health care
workers and patients from hepatitis B, issued in August 1993, recommends
that health care workers infected with hepatitis B who carry the e-antigen,
a marker indicating high infectivity, should not perform exposure prone
procedures. The recommendations about the immunisation of health
care workers, the testing of staff who undertake exposure prone procedures,
and the restriction of working practices of health care workers who
are e-antigen positive outlined in Protecting health care workers
and patients from hepatitis B and in its addendum issued under cover
of MEL(1996)93 in November 1996 still apply. However, this circular
supplements the recommendations applying to the management of hepatitis
B infected health care workers without the e-antigen (e-antigen negative)
who perform exposure prone procedures, or clinical duties in renal units.
The 1993 guidance booklet will be revised later this year and will include
this new recommendation about hepatitis B infected health care workers
without the e-antigen who perform exposure prone procedures.
- This guidance applies to
all health care workers in the NHS who carry out exposure prone procedures,
including independent contractors such as general dental and medical
practitioners (and relevant staff), independent midwives, students and
visiting health care workers. NHS Trusts that arrange for NHS patients
to be treated by private sector hospitals should ensure that this guidance
is observed by health care workers who perform exposure prone procedures
on NHS patients.
Transmissions
to patients from hepatitis B infected health care workers without the
e-antigen
- The 1993 guidelines have
done much to reduce the risk to patients. However, since those guidelines
were issued, there have been several incidents in which hepatitis B
infected health care workers without the e-antigen have been associated
with transmission of infection to their patients. It is now known that
some hepatitis B infected individuals carry a genetic variant of the
hepatitis B virus, which is unable to produce the e-antigen, but is
still capable of assembling infectious viral particles. It is thus necessary
to introduce further tests to assess infectivity.
Use of
viral load tests and restriction on practice of hepatitis B infected
health care workers without the e-antigen
- The Advisory Group on Hepatitis
(AGH) has reviewed the 1993 guidelines and has recommended that the
restrictions placed upon hepatitis B infected health care workers who
are e-antigen positive should remain. Therefore, testing for e-markers
should still be carried out. However, in addition, the AGH has recommended
that hepatitis B infected health care workers who are e-antigen negative
and who perform exposure prone procedures1 should have their
viral loads measured, and that those with viral loads exceeding 10³
genome equivalents per ml should not perform exposure prone procedures.
- Not all currently available
assays have a dynamic range capable of detecting viral loads at this
level and, therefore, testing is to be undertaken with a commercial
amplification based assay. Arrangements have been made for two designated
laboratories to undertake this testing and to interchange specimens
to ensure consistency of results. At present, only test results from
the designated laboratories will be used to determine whether a hepatitis
B infected health care worker who is e-antigen negative is to be allowed
to perform exposure prone procedures. In accordance with good laboratory
practice, two different serum samples will be taken from each health
care worker a week apart and will be tested in the two designated laboratories.
Annex B to this circular contains detailed guidance on sampling and
testing.
- Hepatitis B infected health
care workers who are e-antigen negative and whose viral loads do not
exceed 10³ need not be restricted from performing exposure prone procedures
or from any other areas of work. However, these health care workers
should have their viral loads re-tested regularly at 12 monthly intervals
because research has shown that viral loads may fluctuate over time.
If the viral load rises above 10³ genome equivalents per ml, they should
cease performing exposure prone procedures. In addition, hepatitis B
DNA testing should be carried out immediately if a health care worker
becomes immunosuppressed for any reason, or has symptoms suggestive
of a reactivation of hepatitis B, or if investigation of a case of hepatitis
B in a patient indicates the possibility of a transmission from a health
care worker.
- An algorithm showing the
sequence of testing of hepatitis B infected health care workers who
perform exposure prone procedures is at Annex C.
Timescale
for Implementation
Initial
implementation phase
- Initial assessments of
viral load should be completed by 1 July 2001 at the latest for all
hepatitis B infected health care workers who are e-antigen negative
and who perform exposure prone procedures. During this initial implementation
phase, these health care workers should not be restricted from carrying
out exposure prone procedures whilst awaiting viral load test results.
Ongoing
implementation
- After the initial implementation
phase, health care workers previously tested and found to have viral
loads which do not exceed 10³ genome equivalents per ml need not be
restricted from carrying out exposure prone procedures whilst awaiting
subsequent viral load test results, provided samples have been taken
and despatched for repeat testing within 12 months from the date of
the preceding test. In all other circumstances, hepatitis B infected
health care workers without the e-antigen should not perform exposure
prone procedures until satisfactory test results have been provided.
Security
of samples
- As for other tests of hepatitis
B markers performed on health care workers who perform exposure prone
procedures, it is important that those commissioning tests for hepatitis
B viral loads should ensure that samples tested are from the health
care worker in question. Where feasible, samples should be taken by
the occupational health doctor or nurse. Where this is not feasible,
samples should be taken by a person expressly acting on behalf of occupational
health. Health care workers should not provide their own specimens.
- On request, occupational
health departments may wish to arrange testing for hepatitis B infected
health care workers without the e-antigen who are currently not employed.
Trusts are not expected to meet the costs of testing for these individuals,
unless such testing forms parts of pre-employment assessment. If it
does not, trusts may wish to seek reimbursement of the testing costs
from individual health care workers. Hepatitis B infected health care
workers without the e-antigen who are currently not employed will need
to be cleared for the performance of exposure prone procedures before
applying for locum work or other substantive posts. Occupational health
departments will also wish to make arrangements, via health boards,
to provide a similar service for practitioners and staff in the general
medical services and general dental services who perform exposure prone
procedures.
Health
care workers who have taken interferon or antiviral drugs
- Health care workers without
the e-antigen who are supplying a blood sample for testing should be
asked if they are currently being treated, or have been treated within
the last 12 months, with interferon or antiviral therapy. The AGH has
advised that hepatitis B infected health care workers should not continue
to perform exposure prone procedures whilst on interferon or antiviral
therapy. Those who have undergone a course of such treatment need to
show that they have a viral load that does not exceed 10³ genome equivalents
per ml one year after cessation of treatment before a return to unrestricted
working practices can be considered. Rarely, hepatitis B infected health
care workers may lose the hepatitis B surface antigen (HBsAg) spontaneously.
In both cases, the UK Advisory Panel for Health Care Workers Infected
with Blood-borne Viruses is available to provide advice. Any infected
health care worker returning to unrestricted working practices would
be subject to the same 12 monthly re-testing as recommended for
other unrestricted hepatitis B infected health care workers without
the e-antigen.
Health
care workers who refuse to be tested
- Hepatitis B infected health
care workers without the e-antigen who refuse to have their viral load
tested should not be allowed to carry out exposure prone procedures
in future.
Advice
to hepatitis B infected health care workers
- Arrangements should be
made to provide individual health care workers with access to a consultant
occupational health physician. Occupational health departments should
explain to health care workers the purpose of the new testing arrangements
and how they might affect continued performance of exposure prone procedures.
After testing, occupational health departments should inform health
care workers of the results of their tests and the implications for
their working practice.
- All hepatitis B infected
health care workers should be given accurate and detailed advice on
ways of minimising the risks of transmission in the health care setting
and to close contacts. Hepatitis B infected health care workers who
are e-antigen negative and whose viral loads exceed 103 genome
equivalents per ml should not perform exposure prone procedures. Hepatitis
B infected health care workers who are e-antigen negative and whose
viral loads do not exceed 103 should be advised that they
can continue performing exposure prone procedures, but that their viral
loads will have to be re-tested regularly at 12 monthly intervals because
research has shown that viral loads in some infected individuals may
fluctuate over time. Occupational health departments should refer hepatitis
B infected health care workers for specialist clinical assessment, if
this has not already taken place. Occupational health departments will
be able to contact the designated laboratory for their area should they
have any queries about individual test results. Details of contacts
are given in Annex B.
Confidentiality
- It is extremely important
that hepatitis B infected health care workers receive the same right
of confidentiality as any patient seeking or receiving medical care.
Occupational health physicians who work within strict guidelines on
confidentiality, have a key role in this process, and the close involvement
of occupational health departments in revising local procedures for
managing hepatitis B infected health care workers is strongly recommended.
Occupational health notes are separate from other hospital notes. Occupational
health physicians are ethically and professionally obliged not to release
information without the consent of the individual. There are occasions
when an employer may need to be advised that a change of duties should
take place, but hepatitis B status itself will not normally be disclosed
without the health care workers consent. Where patients are, or have
been, at risk, however, it may be necessary in the public interest for
the employer to have access to confidential information.
Duties
of other health care workers
- Health care workers who
know, or have good reason to believe (having taken steps to confirm
the facts as far as practicable), that a hepatitis B infected health
care worker has not followed advice to modify their practice, should
inform an appropriate person in the health care workers employing or
contracting authority (e.g. a consultant occupational health physician,
trust medical director or director of public health), or where appropriate,
the relevant regulatory body. Such cases are likely to arise very rarely.
Wherever possible the health care worker should be informed before information
is passed to an employer or regulatory body.
Management
of blood exposure incidents
- Implementation of these
additional restrictions on the working practices of hepatitis B infected
health care workers will minimise the risk of transmission of hepatitis
B from infected health care worker to patient. However, there may
be occasions when a patient may accidentally be exposed to the blood
of a hepatitis B infected health care worker in circumstances which
may or may not involve exposure prone procedures. Appropriate management
of such potential exposure incidents will further reduce the risk of
hepatitis B infection for patients.
- Health care workers are
under ethical and legal obligations to take all proper steps to safeguard
the interests of their patients. This would include ensuring that in
the event of a patient being exposed to the infected health care workers
blood, information about the latters status was reported to the appropriate
person to consider what action might be necessary to protect the patient
from transmission of infection. The General Medical Councils guidance
Good Medical Practice and Serious Communicable Diseases
state that doctors who have a serious communicable disease and continue
in professional practice must have appropriate medical supervision and
should not rely upon their own assessment of the risks they pose to
patients. Statements from the General Dental Council and the United
Kingdom Central Council for Nursing, Midwifery and Health Visiting also
emphasise the duties of health care workers to safeguard the well-being
of their patients.
- As recommended in Guidance
for clinical health care workers: protection against infection with
blood-borne viruses, each employer should draw up a policy on the
management of blood exposure incidents for both patients and staff.
Each health board (which employs relevant staff) or NHS trust should
designate one or more doctors to whom health care staff, or any other
person present in the health care setting, may be referred immediately
for advice if they have been exposed, or have exposed others, to potentially
infected blood. Local policies should also specify who will be responsible
for provision of post-exposure prophylaxis and for the follow-up of
any staff or patients who have been exposed. Dental and medical practitioners
in primary care should ensure that similar procedures are in place for
themselves and their staff.
Patient
notification exercises
- The AGH does not recommend
that the finding that a health care worker has a viral load above 10³
genome equivalents per ml should in itself, trigger a patient notification
exercise. Patient notification, with the offer of serological testing,
should be undertaken only if there is evidence to suggest that transmission
of infection from a health care worker to patient may have taken place,
and should be considered if a review of surveillance data, or other
local information, points to this possibility. Local responsibility
for considering the need for patient notification exercises should rest
with the Director of Public Health. HeaHIf a patient notification exercise
is considered necessary the UK Advisory Panel for Health Care Workers
Infected with Blood-borne Viruses should be consulted.
Redeployment,
retraining and compensation issues
- It is expected that relatively
small numbers of health care workers will be affected by the new restrictions
and their retraining/redeployment needs will vary. Employers should
make every effort to arrange suitable alternative work and retraining
opportunities in accordance with good general principles of occupational
health and management practice. NHS employers already assist and support
cases where staff retraining and redeployment is necessary for a variety
of reasons. Postgraduate medical and dental deans also play an important
role in retraining or redeployment programmes for doctors and dentists,
not only within the training grades, but often within the career grades
too. Local employers are best placed to support staff displaced because
of the new restrictions, and to ensure that the process is handled sympathetically
and sensitively. Medical Directors will have an important contribution
to make. Local NHS trusts will want to consider the training and development
needs of the non-medical workforce (e.g. midwives) using training and
development opportunities available within the Trust and through consortia.
- The NHS Injury Benefits
Scheme and the Industrial Injuries Disablement Benefit Scheme provide
benefits where hepatitis B has been occupationally acquired. Occupational
health services locally should provide health care workers with advice
in cases where entitlement to benefits for occupationally acquired infection
is under consideration. Details of the NHS Scheme can be obtained from
Mrs Fiona Kay, The Scottish Public Pension Agency, St Margarets
Way, 151 London Road, Edinburgh, EH8 7TG. Leaflets and advice on
the Industrial Injuries Disablement Scheme can be obtained from local
Benefits Agency Offices.
Associated
Documentation
- Protecting health care
workers and patients from hepatitis B (August 1993) and its Addendum
(issued under cover of MEL (1996) 93 (November 1996);
- Guidance for clinical
health care workers: protection against infection with blood-borne viruses
(issued under cover of SODH/CMO(98)12, May 1998);
- Guidance on the management
of AIDS/HIV infected health care workers and patient notification (issued
under cover of MEL(1999)29, March 1999).
ANNEX B
TESTING
ARRANGEMENTS FOR HEPATITIS B INFECTED HEALTH CARE WORKERS WITHOUT THE
e-ANTIGEN WHO CARRY OUT EXPOSURE PRONE PROCEDURES
Designated laboratories
- Two laboratories in the
UK have been designated to carry out the testing to ensure consistency
of results. Specimens in Scotland should be sent to the Regional Virus
Laboratory, Gartnavel General Hospital, 1053 Great Western Road, Glasgow
G12 0YN. Contact names are Dr Sheila Cameron (Tel:0141-211-0080) or
Dr Bill Carman (Tel:07775-783743) Fax:0141-211-0082.
Specimens
- Two samples of a minimum
of 10ml of clotted blood should be taken from the health care worker
a week apart, and should be sent separately as soon as possible after
sampling to the designated laboratory. The first sample should not
be stored and the two samples then sent together. A suggested standard
laboratory request form, which should be photocopied locally, is attached
at Appendix (i). Each sample should be packaged and despatched separately
in accordance with current Post Office regulations. The aim should be
for samples to arrive within 24 hours of despatch and on a working day,
taking account of national and local holidays in the receiving laboratory.
Those despatching samples should telephone or fax the designated laboratory
to say that samples have been sent. The designated laboratory will confirm
receipt of the sample by fax.
Testing
- The two samples from each
health care worker will be tested for hepatitis B viral load in both
laboratories using a hepatitis B virus DNA quantitative polymerase chain
reaction assay. The designated laboratory will arrange testing in the
second laboratory and will provide results to the occupational health
department.
- Until further notice, only
test results from the designated laboratories will be used to determine
whether a hepatitis B infected health care worker who is e-antigen negative
can continue to perform exposure prone procedures.
Results
- The designated laboratories
will be able to provide test results within four weeks of receipt of
sample.
Re-testing
- Occupational health departments
should make the necessary arrangements to recall health care workers
for re-testing so that a specimen is taken and despatched within 12 months
from the date on which the first of the samples was taken for the preceding
test. If this has not been done, these health care workers should not
be allowed to perform exposure prone procedures until satisfactory
test results have been provided. Health care workers should be advised
when their next test is due so that those who move jobs can approach
their new occupational health department to arrange further testing.
Previous employers should also include details of the next test due
in the occupational health record as it would be helpful to new employers
if they ask for it to be passed on.
Testing
costs and payment
- The unit cost of testing
service is £400 per health care worker. Such testing is exempt from
value added tax. Payment should be made on receipt of an invoice from
the designated laboratory. NHS trusts and health boards (who employ
relevant staff) are expected to fund these tests for their employees
and health care workers undergoing a pre-employment assessment. Trusts
may wish to seek reimbursement of the testing costs from individual
health care workers who are currently not employed (unless they are
being tested for pre-employment assessment), and practitioners and staff
in the general medical services and general dental services.
ANNEX C
INVESTIGATION
OF HEPATITIS B INFECTED HEALTH CARE WORKERS
(HEPATITIS B SURFACE ANTIGEN (HBsAg) POSITIVE) WHO PERFORM
EXPOSURE PRONE PROCEDURES
Test for HBsAg
|
___________________________________________
| |
HBsAg positive HBsAg negative: no restriction
|
Test for e-markers
|
________________________________________________________________
| | |
HBeAg positive: anti-HBe No e-markers
practice positive |
restricted | |
|_______________________________|
|
|
Test for HBV DNA using genomic amplification
assay at designated laboratory
|
|
____________________________________________
| |
HBV DNA exceeding 10³ HBV DNA not exceeding 10³
genome equivalents per ml: genome equivalents per ml:
practice restricted practice not restricted but
subject to annual testing
Any
hepatitis B infected health care worker associated with transmission of
infection to a patient should cease performing exposure prone procedures.
APPENDIX
(i)
SUGGESTED
STANDARD LABORATORY REQUEST FORM FOR HEPATITIS B
VIRAL LOAD TEST
Request
for HBV viral load testing in accordance with Health Department Letter
isuued
August 2000
Name of health
care worker:
. Ref No:
Age
Grade
Has this health
care worker been treated with interferon or antiviral therapy within the
last twelve months? YES/NO*
If yes, the
health care worker should be advised as set out in paragraph 12
of the MEL.
*(Only send
samples for testing if the health care workers claims that the circumstances
in paragraph 12 of the guidance can be met please give details).
..
Occupational
Health Department:
.
Address:
.
Requesting
physician:
. Signature:
.
Date:
.
|
