Download guidance on exposure prone procedures

POLICY FOR THE PREVENTION
OF HEPATITIS B VIRUS
TRANSMISSION
IN OCCUPATIONAL AND
HEALTHCARE SETTINGS
Comments and proposed amendments
should be sent to:
[email protected]
November 2009
by noon of 15 February 2009
CONTENTS
1.
INTRODUCTION:
2
2.
EMPLOYER RESPONSIBILITIES:
2
3.
EMPLOYEE RESPONSIBILITIES:
2
4.
SIGNIFICANT EXPOSURE:
3
5.
EXPOSURE PRONE PROCEDURES:
3
6.
DETERMINING HBV RISK IN HEALTHCARE SETTINGS:
4
7.
POLICY IMPLEMENTATION:
5
8.
PROVISION OF IMMUNISATION SERVICES:
5
9.
SCHEDULING OF VACCINATIONS:
5
10.
VERIFICATION OF HBV PROTECTION:
5
12.
RECORD KEEPING:
6
13.
HIGH RISK EMPLOYEES:
6
14.
INTERMEDIATE RISK EMPLOYEES:
7
15.
LOW RISK EMPLOYEES:
7
16.
MINIMAL RISK EMPLOYEES:
7
17.
EXPOSURE INCIDENTS:
8
GUIDANCE ON EXPOSURE PRONE PROCEDURES
9
1
1.
Introduction:
1.1.
Hepatitis B is a disease that causes inflammation of the liver. It is caused by the Hepatitis B
Virus (HBV) and is usually spread by contact with infected blood or blood products.
1.2.
The vast majority of cases involve asymptomatic HBV carriers. HBV carriage in the Maltese
population is estimated at around 1%.
1.3.
HBV can also be spread in such ways as illicit injectable drug use, tattooing, and ear piercing. In
addition to its presence in blood, the Hepatitis B virus may be found in other body fluids such as
urine, tears, semen, vaginal secretions, and breast milk. As a result, transmission of the disease
can also occur through close interpersonal contact, including sexual contact.
1.4.
Prevention is the only real method of control. An effective and safe vaccine against Hepatitis B is
available.
2.
Employer responsibilities:
2.1.
It is responsibility of every employer (including self employed persons) to ensure safe and
healthy working conditions for employees who may be exposed or have the potential of
exposure to HBV and to minimise to the greatest extent possible transmission of HBV to clients
in its facilities.
2.2.
To this end, the employer should carry out a risk assessment exercise to identify the significance
of HBV exposure to employees and clients and take the necessary preventive measures to
mitigate such potential risk.
2.2.1. Such measures include

the obligation to offer HBV vaccinations to its personnel (free of charge to high and intermediate
risk employees) in advance of exposure and

the provision of protective equipment deemed to be necessary for HBV prevention through
expert advice and in accordance with the risk assessment and

offer a comprehensive service of professional advice and medical care for workers who may have
been exposed to HBV or any other blood borne virus.
3.
Employee responsibilities:
3.1.
Employees are under ethical and legal obligations to take all proper steps to safeguard their
health and that of their clients.
2
3.1.1. In the healthcare setting, this would include also ensuring that in the event of a client being
exposed to the infected health care worker's blood, information about the latter's status is
reported to the appropriate channels to consider what action might be necessary to protect
the client from transmission of infection.
3.2.
Staff who know themselves to be suffering from a Hepatitis B must have appropriate medical
assessment and should not rely upon their own evaluation of the risks they pose to clients.
Where Hepatitis B can pose a threat to clients or fellow employees, they are obliged to inform
their employer of their circumstance, who in turn will perform a risk assessment and act
accordingly.
3.3.
Workers who have any reasons to believe they may have been exposed to infection with a
blood-borne virus including HBV, in whatever circumstances, should promptly seek and comply
with confidential professional advice on whether they should be tested. Failure to do so may
breach their duty of care.
4.
Significant exposure:
4.1.
Significant exposure usually follows contact of mucous membrane (including conjunctival) and/or
broken skin with blood, body fluids or tissues of an infected person.
4.2.
The risk of infection following significant exposure from an HBV positive individual in a nonimmune worker can be as high as 30%.
4.3.
Exposure or potential exposure to HBV is defined in terms of actual or potential skin, mucous
membrane, parenteral contact with blood, body fluids, and tissues or potentially infectious fluids
and tissues associated with laboratory investigations of HBV.
4.4.
All clients should treated as being of the same infectious potential. In this way satisfactory
precautionary measures are taken when dealing with each and every case.
5.
Exposure prone procedures:
5.1.
Exposure prone procedures are defined as activities where there is a risk that injury to the
worker may result in the exposure of the client’s open tissues to the blood of the worker (bleedback).
5.1.1. These include healthcare procedures where the worker’s gloved hands may be in contact
with sharp instruments, needle tips or sharp tissues (e.g. spicules of bone or teeth) inside a
client’s open body cavity, wound or confined anatomical space where the hands or
fingertips may not be completely visible at all times. However, other situations, such as prehospital trauma care and care of clients where the risk of biting is predictable (e.g. such as
with a disturbed and violent client or a client having an epileptic fit) should be avoided. In
such cases health care workers are restricted from performing exposure prone procedures.
3
5.1.2. Guidance on what constitutes exposure prone procedures in the various healthcare
professions, specialties and occupations is included in Appendix 1.
6.
Determining HBV risk in healthcare settings:
6.1.
High Risk:
6.1.1. These are individuals whose work involves a continuous and inherent risk of significant
HBV exposure through exposure prone procedures and/or may result in a significant risk of
transmission of HBV to the patient if the worker him/herself is a HBV carrier.
6.1.2. These individuals are at a significant risk of acquiring hepatitis B from an infected patient if
the patient is a HBV carrier.
6.2.
Intermediate Risk:
6.2.1. Individuals whose works entails procedures or other job related tasks that:
6.2.1.1. Are not exposure prone but still involve a definite risk for significant HBV exposure to
the worker
6.2.1.2. These individuals are at a significant risk of acquiring hepatitis B from an infected
patient but the nature of their duties results in a negligible risk of transmitting the virus
to patients if they themselves are carriers.
6.2.1.3. Such occupations would include all employees having direct contact with patients and
who perform interventions with a potential of a needlestick injury or splash exposure
to the worker.
6.3.
Low Risk:
6.3.1. Individuals whose work entails procedures or other job related tasks that:
6.3.1.1. Involve no direct exposure to blood, body fluids, or tissues but may involve an
occasional potential risk of significant HBV exposure
6.3.1.2. These individuals have no patient contact but are at some risk of acquiring hepatitis B
indirectly through the course of their duties.
6.3.1.3. Such occupations would include domestics, maintenance workers, ward clerks etc.
6.4.
Minimal Risk:
6.4.1. Individuals whose works entails procedures or other job related tasks that:
6.4.1.1. Would not normally involve potential risk of significant HBV exposure in the normal
course of their work
6.4.1.2. Such occupations would include administrative, clerical and other staff who work
outside of the patient care setting.
4
7.
Policy Implementation:
7.1.
Every employer should designate a specific trained individual with responsibility to implement
this policy. This individual would be tasked with all related tasks, including:
7.1.1. Determine the individuals’ risk category
7.1.2. Provision of immunisation service according to the national schedule (vide para 9)
7.1.3. Sero-conversion testing
7.1.4. Confidential maintenance of relevant records
7.1.5. Post-exposure counselling and management
7.1.6. Formulate standard precautions for the workplace
8.
Provision of immunisation services:
8.1.
In keeping with this policy, Hepatitis B vaccinations shall be offered free of charge to all
employees who deemed to be at high or intermediate risk as per par. 6.
8.2.
Employees may decline to receive the vaccination.
8.2.1. In such circumstances a refusal form exonerating the employer from any form of liability
must be signed.
8.2.2. The employer nevertheless would have the option to prevent any employee from performing
exposure prone interventions listed in Appendix 1 that, in the absence of hepatitis B
immunity, may pose a risk to the employee as well as to patients and/or other workers.
9.
Vaccination Schedules :
9.1.
The standard Hepatitis B vaccine course involves three doses at 0, 1 & 6 months
9.2.
In cases where a more rapid response is needed, an accelerated vaccine course can be given
with a dose at 0, 1 & 2 months followed by booster at 1 year
10. Verification of HBV Protection:
10.1. In order to document vaccination effectiveness in developing the antibodies necessary to protect
the individual from the disease, a blood test and titre are necessary to determine protection.
10.2. Anti-HBs titres should be checked within 6 months following the last vaccination, preferably 8 -
10 weeks.
10.2.1. A titre that is more than 10 IU/ml indicates full seroconversion. Such individuals will NOT
normally need further boosters unless there is a specific indication.
5
10.2.2. A titre that is less than 10 IU/ml indicates non-response to the vaccine. A repeat vaccination
course with a double dose of the vaccine should be attempted. If non-response recurs, a
third attempt should be tried with double dose of another hepatitis B vaccine produced by a
different manufacturer.
10.2.2.1. Individuals who remain non-responsive should be counselled and, if relevant and
requested, granted transfer to duties which pose a lower risk of HBV acquisition.
10.2.2.2. Since a small proportion on non-responders are unable to mount an immune
response due to hepatitis B carriage, all non-responders will be offered and actively
encouraged to undertake testing for HBV markers to exclude such a possibility.
10.2.2.3. This testing is mandatory for individuals likely to perform high risk duties as detailed in
paragraph 6.
11. Non-seroconversion:
11.1. Individuals who show evidence of persistent non-response to HB vaccine will be offered
confidential assessment of their hepatitis B status through testing for viral markers.
11.1.1. This assessment is mandatory for individuals performing exposure prone procedures.
12. Record keeping:
12.1. A copy of the vaccinations given and any refusals must be kept by the designated officer.
12.2. These records must be maintained for thirty years past the last day of employment.
12.3. Such records are deemed to be highly confidential. They should be stored securely and not
made available to unauthorised third parties.
12.4. Records to be available to inspectors authorised by the superintendent of Public Health.
13. High risk employees:
13.1. All employees in this category are required to have received a full vaccination course (unless
otherwise indicated medically) and undertaken seroconversion studies to show immunity to HBV.
13.2. Evidence of sero-conversion or absence of hepatitis markers is a pre-requisite of new
employment and will need to be provided at the application stage.
13.3. Employees in this category who refuse vaccination, sero-conversion examination or (in the case
of non-responders) hepatitis status testing, may be transferred to alternative duties which do not
offer a significant risk of client/client exposure.
13.4. Non-seroconverters in the high-risk category who are HbsAg negative can perform all exposure
risk procedures but will be required to undertake regular testing for hepatitis markers.
6
13.5. Workers who are e-antigen positive should immediately cease to perform exposure prone
procedures once their status is known.
13.6. Hepatitis B infected workers should not continue to perform exposure prone procedures if 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.
13.7. Hepatitis B infected employees in the high-risk category who are e-antigen negative will be
asked to undertake viral load (hepatitis B virus DNA) testing on a yearly basis.
13.7.1. Health care workers whose viral load does not exceed 10 3 genome equivalents per ml need
not have their working practices restricted unless an investigation of a case of hepatitis B in
a client indicates the possibility of a transmission from the worker. Such individuals should
seek and receive appropriate occupational health advice.
13.7.2. Individuals in this category whose viral load exceeds 103 genome equivalents per ml should
cease to perform exposure prone procedures if their viral load is shown by testing to have
risen above the specified level.
13.8. Full assistance should be made available by the employer to staff who require modification of
their duties.
14. Intermediate risk employees:
14.1. Individuals in this category are required to have received a full vaccination course and show
evidence of immunity to HBV by the end of their probationary period of employment.
14.1.1. Failure to provide such documentary evidence may compromise their permanent
appointment.
14.2. Employees who give evidence of non-response will be encouraged to undertake confidential
assessment of their hepatitis B status.
15. Low risk employees:
15.1. Employees in this category are encouraged to receive hepatitis vaccine.
15.2. Sero-conversion testing will, unless otherwise determined, be performed only in the event of
significant exposure to HBV.
16. Minimal risk employees:
16.1. Hepatitis vaccine will not normally be provided to employees in this category unless otherwise
indicated following a risk assessment.
7
17. Exposure incidents:
17.1. Exposure incidents including accidental injuries caused by "sharps" must be dealt with
immediately.
17.2. Free bleeding should be encouraged, but under no circumstances should the wound be sucked.
The wound is washed liberally with saline or soap and water, without scrubbing, and then
covered with a waterproof dressing. Similarly, contaminated skin, conjunctivae or mucous
membranes should be washed immediately. This applies to all situations at all times.
17.3. Any incident, however small, MUST be reported PROMPTLY to the designated officer entrusted
with occupational health responsibilities who is in turn obliged to make the necessary risk
assessment and take the necessary actions.
8
APPENDIX
GUIDANCE ON EXPOSURE PRONE PROCEDURES
THAT WOULD CONSTITUTE HIGH-RISK ACTIVITIES
Accident and Emergency
Work at A&E and pre-hospital trauma care includes exposure prone procedures (EPPs) especially
when caring for acute trauma patients with open tissues because of the unpredictable risk of injury
from sharp tissues such as fractured bones. Other EPPs which may arise in an A&E setting would
include:
• rectal examination in presence of suspected pelvic fracture;
• deep suturing to arrest haemorrhage;
• internal cardiac massage.
Hence staff who cannot perform EPPs should not be allowed to work in this setting.
Anaesthetics
Procedures performed purely percutaneously are not exposure prone, nor have endotracheal
intubation nor the use of a laryngeal mask been considered so. The only procedures currently
preformed by anaesthetists which would constitute EPPs are:
• the placement of portacaths (very rarely done) which involves excavating a small pouch under the
skin and may sometimes require manoeuvres which are not under direct vision;
• the insertion of chest drains in accident and emergency trauma cases such as patients with multiple
rib fractures.
The insertion of a chest drain may or may not be considered to be exposure prone depending on how
it is performed. Procedures where, following a small initial incision, the chest drain with its internal
trochar is passed directly through the chest wall (as may happen e.g. with a pneumothorax or pleural
effusion) and where the lung is well clear of the chest wall, would not be considered to be exposure
prone. However, where a larger incision is made, and a finger is inserted into the chest cavity, as may
be necessary e.g. with a flail chest, and where the health care worker could be injured by the broken
ribs, the procedure should be considered exposure prone. Modern techniques for skin tunnelling
involve wire guided techniques and putting steel or plastic trochars from the entry site to the exit site
where they are retrieved in full vision. Therefore skin tunnelling is no longer considered to be
exposure prone (see also Arterial cutdown).
9
Arterial Cutdown
Although the use of more percutaneous techniques has made arterial or venous cutdown to obtain
access to blood vessels an unusual procedure, it may still be used in rare cases. However, as the
operator’s hands are always visible, it should no longer be considered exposure prone.
Biting
Staff working in areas posing a significant risk of biting should not be treated as performing EPPs.
Based on the available information, it can be tentatively concluded that even though there is a
theoretical risk of transmission of a blood borne virus from an infected health care worker to a biting
patient, the risk remains negligible. Since there is no documented case of transmission from an
infected health care worker to a biting patient, individuals infected with blood-borne viruses should not
be prevented from working in or training for specialties where there is a risk of being bitten.
Bone Marrow transplants
Not exposure prone.
Cardiology
Percutaneous procedures including angiography/cardiac catheterisation are not exposure prone.
Implantation of permanent pacemakers (for which a skin tunnelling technique is used to site the
pacemaker device subcutaneously) may or may not be exposure prone. This will depend on whether
the operator’s fingers are or are not concealed from view in the patient’s tissues in the presence of
sharp instruments during the procedure
Dentistry and orthodontics (including hygienists)
The majority of procedures in dentistry are exposure prone, with the exception of:
• examination using a mouth mirror only;
• taking extra-oral radiographs;
• visual and digital examination of the head and neck;
• visual and digital examination of the edentulous mouth;
• taking impressions of edentulous patients; and
• the construction and fitting of full dentures.
However, taking impressions from dentate or partially dentate patients would be considered exposure
prone, as would the fitting of partial dentures and fixed or removable orthodontic appliances, where
clasps and other pieces of metal could result in injury to the dentist.
10
Ear, Nose and Throat Surgery (Otolaryngology)
ENT surgical procedures generally should be regarded as exposure prone with the exception of
simple ear or nasal procedures, and procedures performed using endoscopes (flexible and rigid)
provided
fingertips
are
always
visible.
Non-exposure
prone
ear
procedures
include
stapedectomy/stapedotomy, insertion of ventilation tubes and insertion of a titanium screw for a bone
anchored hearing aid.
Endoscopy
Simple endoscopic procedures (e.g. gastroscopy, bronchoscopy) have not been considered exposure
prone. In general there is a risk that surgical endoscopic procedures (e.g. cystoscopy, laparoscopy –
see below) may escalate due to complications which may not have been foreseen and may
necessitate an open EPP. The need for cover from a colleague who is allowed to perform EPPs
should be considered as a contingency.
General Practice
See Accident and Emergency, Biting, Minor Surgery, Midwifery/Obstetrics, Resuscitation
Gynaecology
Open surgical procedures are exposure prone. Many minor gynaecological procedures are not
considered exposure prone, examples include dilatation & curettage (D& C), suction evacuation of
uterine contents , colposcopy, surgical insertion of depot contraceptive implants/devices, fitting
intrauterine
contraceptive devices (coils), and vaginal egg collection provided fingers remain visible at all times
when sharp instruments are in use.
Performing cone biopsies with a scalpel (and with the necessary suturing of the cervix) would be
exposure prone. Cone biopsies performed with a loop or laser would not in themselves be classified
as exposure prone, but if local anaesthetic was administered to the cervix other than under direct
vision i.e. with fingers concealed in the vagina, then the latter would be an exposure prone procedure.
Haemodialysis/Haemofiltration
See Renal Medicine
Intensive Care
Intensive care does not generally involve EPPs on the part of medical or nursing staff
11
Laparoscopy
Mostly non-exposure prone because fingers are never concealed in the patient’s tissues. Exceptions
are, exposure prone if main trochar inserted using an open procedure, as for example in a patient
who has had previous abdominal surgery. Also exposure prone would be a situation where the rectus
sheath is closed at port sites using J-needle, and fingers rather than needle holders and forceps are
used. In general there is a risk that a therapeutic, rather than a diagnostic, laparoscopy may escalate
due to complications which may not have been foreseen necessitating an open exposure prone
procedure. Cover from colleagues who are allowed to perform EPPs would be needed at all times to
avoid this eventuality.
Midwifery/Obstetrics
Simple vaginal delivery, amniotomy using a plastic device, attachment of fetal scalp electrodes,
infiltration of local anaesthetic prior to an episiotomy and the use of scissors to make an episiotomy
cut are not exposure prone.
The only exposure prone procedures, if undertaken by midwives, would be repairs following
episiotomies and perineal tears.
Minor Surgery
In the context of general practice, minor surgical procedures such as excision of sebaceous cysts,
skin lesions, cauterization of skin warts, aspiration of bursae, cortisone injections into joints and
vasectomies do not usually constitute EPPs.
Needlestick/Occupational Exposure
Health care workers need not refrain from performing exposure prone procedures pending follow up
of occupational exposure. The combined risks of contracting an HBV infection from the source
patient, and then transmitting this to another patient during an exposure prone procedure is so low as
to be considered negligible. However in the event of the worker being diagnosed HIV positive, such
procedures must cease in accordance with this guidance.
Nursing
General nursing procedures do not include EPPs. The duties of operating theatre nurses should be
considered individually. Theatre scrub nurses do not generally undertake exposure prone
procedures. However, it is possible that nurses acting as first assistant may perform EPPs
12
Obstetrics/Midwifery
Obstetricians perform surgical procedures, many of which will be exposure prone according to the
criteria.
Operating Department Assistant/Technician
General duties do not normally include exposure prone procedures.
Ophthalmology
With the exception of orbital surgery which is usually performed by maxillo-facial surgeons (who
perform many other EPPs), routine ophthalmological surgical procedures are not exposure prone as
the operator’s fingers are not concealed in the patient’s tissues. Exceptions may occur in some acute
trauma cases, which should be avoided by EPP restricted surgeons.
Optometry
The training and practice of optometry does not require the performance of EPPs.
Orthopaedics
Exposure prone procedures include:
• Open surgical procedures;
• Procedures involving the cutting or fixation of bones, including the use of K-wire fixation and
osteotomies;
• Procedures involving the distant transfer of tissues from a second site (such as in a thumb
reconstruction);
• Acute hand trauma;
• Nail avulsion of the toes for in-growing toenails and Zadek’s procedure (this advice may not apply to
other situations such as when nail avulsions are performed by podiatrists).
Non-exposure prone procedures include:
• Manipulation of joints with the skin intact;
• Arthroscopy, provided that if there is any possibility that an open procedure might become
necessary, the procedure is undertaken by a colleague able to perform the appropriate open surgical
procedure;
• Superficial surgery involving the soft tissues of the hand;
13
• Work on tendons using purely instrumental tunnelling techniques that do not involve fingers and
sharp instruments together in the tunnel;
• Procedures for secondary reconstruction of the hand, provided that the operator’s fingers are in full
view;
• Carpal tunnel decompression provided fingers and sharp instruments are not together in the wound;
• Closed reductions of fractures and other percutaneous procedures.
Paediatrics
Neither general nor neonatal/special care paediatrics has been considered likely to involve any EPPs.
Paediatric surgeons do perform EPPs.
Paramedics
In contrast to other emergency workers, a paramedic’s primary function is to provide care to patients.
Paramedics do not normally perform EPPs. However, paramedics who would be restricted from
performing EPPs should not provide pre-hospital trauma care. This advice is subject to review as the
work undertaken by paramedics continues to develop.
Pathology
In the event of injury to an EPP restricted pathologist performing a post mortem examination, the risk
to other workers handling the same body subsequently is so remote that no restriction is
recommended.
Podiatrists
Routine procedures undertaken by podiatrists who are not trained in and do not perform surgical
techniques are not exposure prone. Procedures undertaken by podiatric surgeons include surgery on
nails, bones and soft tissue of the foot and lower leg, and joint replacements. In a proportion of these
procedures, part of the operator’s fingers will be inside the wound and out of view, making them
exposure prone procedures
Radiology
All percutaneous procedures, including imaging of the vascular tree, biliary system and renal system,
drainage procedures and biopsies as appropriate, are not EPPs.
14
Renal Medicine
Obtaining vascular access at the femoral site in a distressed client may constitute an exposure prone
procedure as the risk of injury to the HCW may be significant. This is more likely to be a problem for
haemofiltration (often performed in an emergency) than for haemodialysis (more likely to be instigated
electively and clients less likely to be distressed than those who need haemofiltration). The working
practices of those staff who supervise haemofiltration and haemodialysis circuits do not include
exposure prone procedures. However clinical duties in renal units are regarded as equivalent in risk
and therefore covered by this policy.
Resuscitation
Resuscitation performed wearing appropriate protective equipment does not constitute an EPP. The
Resuscitation Council (UK) recommends the use of a pocket mask when delivering cardio-pulmonary
resuscitation. Pocket masks incorporate a filter and are single-use.
Surgery
Open surgical procedures are exposure prone. This applies equally to major organ retrieval because
there is a very small, though remote, risk that major organs retrieved for transplant could be
contaminated by a health care worker’s blood during what are long retrieval operations while the
patient’s circulation remains intact. It is possible for some contaminated blood cells to remain
following pre-transplantation preparatory procedures and for any virus to remain intact since organs
are chilled to only 10°C.
Volunteer health care workers (including first aid)
The important issue is whether or not an infected health care worker undertakes EPPs. If this is the
case, this guidance should be applied, whether or not the health care worker is paid for their work.
15