Consent Form - Medical Student 1. Screening for Blood-borne Viral Diseases, 2. Assessment of Immunity to Rubella, Measles, Varicella and Tuberculosis 3. Smartcard Name Forenames____________________
Family name_______________________________________
Date of Birth (Day/Month/Year)_____________________________________ Your contact email address and phone number _____________________________________________________
Consent to being tested for hepatitis B, hepatitis C and HIV (bloodborne viruses) Hepatitis B, hepatitis C and the human immunodeficiency virus (HIV) are viruses that can be transmitted to patients from an infected health care worker during surgery or other procedures where there is opportunity for the worker’s blood to get into the patient e.g. after an accidental injury from a needle or surgical instrument. To minimise risk to patients the Department of Health require that all students be offered testing for evidence of infection with hepatitis B, hepatitis C and the human immunodeficiency virus (HIV). If you are found to be infected with hepatitis B, hepatitis C or HIV you will be offered counselling about the test result by the Occupational Health Service (OHS) and referred to your general practitioner for follow-up and specialist referral. You will be allowed to continue on your course but would not be allowed to assist with or undertake surgery or other ‘exposure-prone’ procedures on patients unless the infection can be eradicated or (in the case of hepatitis B) satisfactorily suppressed. Infection will not prevent you from qualifying or practicing as a doctor, except for the restriction on exposure-prone procedures. Undergoing testing for bloodborne diseases is additional to standard assessment for healthcare workers. It is not compulsory and your consent is required before you can be tested. If you do not agree, however, you will not be allowed to participate in or undertake Exposure Prone Procedures (EPPs). For those students who do not wish to participate in EPPs it is still a Department of Health requirement that new health care workers (including medical students) be offered testing for bloodborne viruses. As well, the General Medical Council expects medical students who could have been exposed to bloodborne virus risk to seek advice and be tested. Further information about this testing is included in the fact sheet in Appendix 1. For a definition of EPPs see Appendix 2. You should read both these documents, decide whether you agree to have a test, and then tick the relevant boxes below. I have read the information provided regarding hepatitis B, C and HIV ............................yes
no
I consent to being tested for hepatitis B antibodies and antigen ............................... yes
no
I consent to a blood test for hepatitis C antibodies .....................................................................yes
no
I consent to a blood test for HIV antibodies ....................................................................................yes
no
If you first require more information or have any queries you can discuss matters, in confidence, with a clinical member of staff from the OHS prior to testing (by telephoning 01865 282676) or on the day. Where indicated or requested a separate appointment at the OHS will be made.
Consent for rubella, measles, varicella and tuberculosis immunity assessment
Standard health checks for healthcare workers new to the NHS include; assessment of immunity to rubella, measles, varicella and tuberculosis. Immunity to rubella, measles and varicella is assessed through antibody response blood testing, history of infection and/or history of vaccination. Where there is no demonstrated effective immunity students may be required to receive an appropriate primary course or booster vaccination. Tuberculosis (TB) is a bacterial disease that may affect any part of the body. Almost all cases of TB in the UK are acquired via the respiratory route and infected healthcare workers may infect patients with whom they come in contact. In the case of TB, students are required to show evidence of previous immunisation (BCG scar) or to have their blood tested for immunity or infection. Students who are non-immune are required to have a BCG vaccination (unless medical contraindications exist). Those infected with TB will not be allowed patient contact until the infection has been effectively managed.
Have you ever suffered from rubella (German measles) ............................................. yes
no
Have you ever suffered from measles ................................................................................................yes
no
Have you received two MMR vaccinations …………………………………………………yes
no
no
I consent to my blood being tested for rubella antibodies .........................................yes
no
I consent to a BCG scar check and/or a blood test for TB.......................................................yes
no
Have you ever suffered from varicella (Chickenpox)
……………………… …………………...yes
NHS Smart Card Once you complete your assessment and any vaccination course, you may be issued with a NHS Smart Card (see Appendix 3) to securely hold your information and health clearance data. This can be used throughout your training and after you begin work as a doctor to pass on the information to NHS occupational health departments when necessary. Under the Data Protection Act, you have to give your explicit, informed consent before we can create a card for you. Read the information on the NHS Smart Card attached to this form and then tick the relevant box below. I agree to my bloodborne virus and immunisation status information being transferred to my NHS Smart Card ............................................................................................................................................yes no
Blood test consent I confirm that the information I have provided is correct to the best of my knowledge and belief, and that I consent to venepuncture, and my blood being subjected to the tests to which I have answered ‘Yes’. **Please note** With the exception of the rubella, measles, and varicella antibody tests, should any results be found to be positive you would be informed personally by an occupational health physician or nurse adviser.
Signature:
Date:
Your blood test results will be sent to your College address by default unless you request otherwise. College:
______________________________________________________________________________ ______________________________________________________________________________
I wish the results to be sent to the following address: Alternative address___________________________________________________________________________ ___________________________________________________________________________
APPENDIX 1 Information sheet: this aims to provide you with the information needed to decide whether to give informed consent to being tested for bloodborne viruses and to provide answers to the questions you may have about screening. Please Note: If you first require more information or have any queries you can discuss matters, in confidence, with a clinical member of staff from the OHS prior to testing (by telephoning 01865 282676) or on the day. Where indicated or requested a separate appointment at the OHS will be made. Why are medical students being offered additional health screening? The Department of Health has recently introduced requirements stating that all new health care workers, including medical students, who participate in exposure prone procedures (EPP), must undergo testing for hepatitis B, hepatitis C and HIV. This testing is being offered by Oxford University Medical School so that students can be compliant with these guidelines. Hepatitis B and C can cause a chronic infection of the liver, which over time can lead to cirrhosis and death from liver failure or cancer. A person may be a carrier of hepatitis B (have antigen) even though they appear to have a satisfactory antibody level. For this reason hepatitis B antibody and antigen are tested. Hepatitis B and C can sometimes be eradicated with medication. Human immunodeficiency virus infection is a chronic condition which over a period of years progressively damages a person’s immune system, eventually causing AIDS. There is no cure for HIV at present, but treatment with anti-viral drugs can suppress viral replication enough to prevent or slow down the damage to the immune system. A bloodborne virus carrier may be unaware that he or she is infected with a bloodborne virus. If a student who is infected with any of the viruses injured themselves during exposure prone procedures this could allow the virus to be transmitted to the patient. As new healthcare workers, under Department of Health requirements, medical students who wish to participate in EPP must first be tested under identity validated conditions for hepatitis B, C and HIV. If found to be a carrier of a bloodborne virus you must receive OHS advice. As part of this, you will not be allowed to assist with, or undertake, surgical procedures unless cleared of the infection. This restriction will be formalised by the Medical School. You will still be permitted to continue on the course and qualify as a doctor. The Department of Health recommends that all new healthcare workers, whether undertaking EPPs or not, should be offered the opportunity of having tests for hepatitis B, hepatitis C and HIV carrier status. Will I require rescreening? Routine re-screening of newly qualified doctors in the UK will not normally be required if they are new graduates of UK Medical Schools. However, students will still be bound by their professional obligations to inform the OHS if, after original screening, they may have been exposed to risk of contracting a BBV. Based on an individual risk assessment further testing could be required. Detectable antibodies to bloodborne viruses may not develop until some weeks after infection, so a test carried out in the first 3 months after an exposure may not be reliable. A test carried out after this time will be accurate. Examples (non exhaustive) of risk factors for bloodborne viral disease and carrier status include: • • • • • •
You have ever injected drugs using equipment shared with someone else You have been accidentally exposed to blood of a person infected with hepatitis B, hepatitis C or HIV (e.g. a needlestick injury) Blood transfusions where blood is not effectively screened for bloodborne viruses You have had unprotected penetrative sex (i.e. without using a condom) You have had a tattoo or body piercing in places with poor procedures for sterilising equipment or materials. Medical or dental treatment in countries where hepatitis B, C or HIV is common and where equipment may not be sterilised properly.
What are the advantages of being tested for bloodborne viruses? Advantages include: 1. You’ll be able to plan your career. If you are negative, the whole range of medical carers will be open to you. You will be able to participate in exposure prone procedures. Exposure prone procedures can form an important part of medical training and, although not mandatory, the UK medical schools believe that students should not be denied the opportunity to undertake them. EPPs comprise part of the normal work of a significant number of clinicians and there is, therefore, a national requirement for a substantial proportion of the postgraduate medical workforce to be competent in EPPs. 2.
If positive for infection, then some careers, particularly in surgical specialties, will not be open to you, unless you had treatment to eradicate the infection. Early diagnosis is of proven benefit. For hepatitis B and C, it is easier to treat an infection in the earlier stages. For HIV, once diagnosed, a person can be monitored and anti-viral treatment started before irreversible damage to the immune system occurs.
3.
You will be complying with your professional duty to get tested if you have been at risk.
4.
If you have been worrying about possibly being infected, a test can give you certainty. If negative, it can provide you with peace of mind. If positive, you can start to take control of your problem.
5.
If you turn out to be infected, you can take steps to limit the risk of transmission to others, including sexual partners.
What are the disadvantages of being tested? There are some potential disadvantages to being tested for these infections, which you should be aware of. These include 1.
Discovering that you are infected with bloodborne viruses can be stressful.
2.
If you are infected you may have difficulty obtaining life insurance. NB Insurance companies do not impose higher premiums simply because a person has had a test for HIV or hepatitis.
3.
Some countries will not grant visas to foreign nationals infected with HIV.
4.
You may encounter prejudicial behaviour from others if they discovered you were HIV or hepatitis C positive.
5.
If you have had unsafe sex in the past, a negative test may give a false sense of security and tempt you to continue this risky behaviour.
6.
If you have been at risk of exposure in the past 12 weeks, a test now may be falsely negative. You should defer testing until 12 weeks after your last risk.
7.
Tests can yield false positive results. However, this risk is very small.
What will happen if I do not agree to be tested? Testing is voluntary. If you do not agree to be tested, the OHS will inform the medical school that you are not cleared for participation in exposure prone procedures. What will happen if I am not cleared for participation in exposure prone procedures? The medical school is required to have robust procedures in place for ensuring that students who have not received health clearance do not participate in exposure prone procedures. As well, a responsibility lies with the students to ensure that they and their patients are not put at risk. If you have not been cleared, whether through declining testing or because of a positive result, the medical school will be advised arrange for you to be counselled about the limitations that you should place on your practice. This restriction will be formalised by the Medical School and you will be required to agree to conformity with the list of restrictions on your clinical training. How will the testing be carried out? The Department of Health has strict requirements for the management and quality control of testing. These include: validation of identity by photographic proof at the time the sample is taken; taking of blood in standardised conditions; and use of an accredited laboratory, (e.g. one holding full or provisional accreditation status issued by Clinical Pathology Accreditation UK Ltd)
which is experienced in performing the necessary tests and which participates in appropriate external quality assurance schemes. All these conditions will be met by the service provided by the Oxford University OHS. Special arrangements have been made to ensure that all current clinical students can be offered testing promptly and efficiently, so that you do not face limitations on your activities during clinical rotations. Times and location will be notified to you closer to the date. What pre-test counselling will be offered? The principal method of pre-test counselling will be the provision of the written information contained in this fact sheet. This is consistent with current BBV screening practices in other sectors of the health service, such as antenatal care. However, as already stated, if you first require more information or have any queries you can discuss matters, in confidence, with a clinical member of staff from the OHS prior to testing (by telephoning 01865 282676) or on the day. Where indicated or requested a separate appointment at the OHS will be made. What post-test counselling will be offered? Individuals whose tests are negative will be informed in writing. No further counselling will be offered but is available upon request. A copy of the laboratory report will be provided in addition to a complete set of immunisation/blood test details since the commencement of your entry into the Medical School. You will receive the results of the blood tests as soon as the OHS are able to collate them, although due to the time it takes for the laboratory to process the samples this will not normally be for 8 -10 weeks after the blood test. Students who test positive for a BBV will be offered the guidance of an Occupational Health Physician who will facilitate referral to an appropriate specialist, in full consultation with the student’s General Practitioner. What should I do if I am concerned that I may have risk factors placing me at higher risk of a positive test? If you believe that you are at higher risk of having a bloodborne virus infection, you may undertake screening as planned. However, you may wish to seek advice and personal counselling from the OHS, and/or from another health professional, prior to testing. If you have had exposure to risk within the preceding twelve weeks, you should contact the OHS for advice. Can I undertake testing for health clearance through an alternative route? In order to meet the administrative and quality standards required by the Department of Health, only testing managed by the University of Oxford OHS will be accepted for health clearance. Testing all medical students in the required timeframe will require significant additional resources and it is therefore expected that students will attend for testing as scheduled. If you have a scheduling clash, you will be able to contact the medical school to arrange an alternative time. If you wish to be tested, but believe there is a reason why you should not participate in the scheduled screening, you should contact the OHS for advice on alternative arrangements. Why do I need to be tested for hepatitis B if the Occupational Health Service has already tested me for this? The DOH guidelines require photo identity validated samples for health clearance: Hepatitis B testing will have to be repeated to meet this requirement. Who will have access to test results? Any employing/hosting NHS Trust Human Resource department will be aware of your EPP status either by you agreeing to the NHS Trust occupational health department being allowed access to your ‘Smart Card’ data, or by the NHS Trust requesting your EPP status from either the University OHS or the Medical School. References and further reading. Health clearance for tuberculosis, hepatitis B, hepatitis C and HIV: New healthcare workers (Department of Health): http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_073132 Hepatitis B infected healthcare workers and antiviral therapy: http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_073164
APPENDIX 2
Definition of Exposure-prone procedures (EPPs) 1.
Exposure-prone procedures (EPPs) are those invasive procedures where there is a risk that injury to the worker may result in the exposure of the patient’s open tissues to the blood of the worker. These include 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 patient’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 pre-hospital trauma care, should be avoided by healthcare workers who are restricted from performing EPPs.
2.
When there is any doubt about whether a procedure is exposure-prone or not, expert advice should be sought in the first instance from a consultant occupational health physician, who may in turn wish to consult the UK Advisory Panel for healthcare Workers Infected with Blood-borne Viruses (UKAP). Some examples below of advice given by UKAP may serve as a guide, but cannot be seen as necessarily generally applicable, as the working practices of individual healthcare workers vary.
3.
Procedures where the hands and fingertips of the worker are visible and outside the patient’s body at all times, and internal examinations or procedures that do not involve possible injury to the worker’s gloved hands from sharp instruments and/or tissues, are considered not to be exposure-prone, provided that routine infection-control procedures are adhered to at all times.
4.
Examples of procedures that are not exposure-prone include: • • • • • •
5.
taking blood (venepuncture); setting up and maintaining IV lines or central lines (provided that any skin-tunnelling procedure used for the latter is performed in a non-exposure-prone manner, i.e. without the operator’s fingers being at any time concealed in the patient’s tissues in the presence of a sharp instrument); minor surface suturing; the incision of external abscesses; routine vaginal or rectal examinations; simple endoscopic procedures.
The decision whether an HIV, hepatitis B or hepatitis C infected worker should continue to perform a procedure, which itself is not exposure-prone, should take into account the risk of complications arising which necessitate the performance of an EPP; only reasonably predictable complications need to be considered in this context.
Appendix 3
Once you begin clinical studies, you will need to carry information about your immunisation and health clearances so that you can prove you can demonstrate that you have complied with control of infection requirements for working with patients of the hospitals where you will train. When you complete your immunisations, you may be issued with an NHS Personal Data Card (OHSC or ‘Smart Card’) that can securely hold this data. Apart from your personal details and photograph, the details held will be your immunisation records and confirmation that you have undergone the required testing clearing you for working safely with NHS patients, including whether you are cleared for exposure prone procedures. Your ‘Smart Card’ can be used throughout your training and, when you qualify, enable us to pass on the information to the relevant hospital occupational health department when you begin work as a doctor. This should remove the need for you to repeat all the blood tests you have at the start of medical school each time you start a new job. The card provides access to a DoH database, and also stores both personal information and clinical data. It works in a very similar manner to a bank ‘hole in the wall’ card, having a personal PIN access code. The Medical School and employing/hosting NHS Trust Human Resource departments will not have access to your test results. However, the Medical School will be automatically informed by the University OHS whether or not you are cleared to participate in exposure prone procedures (EPP). Any employing/hosting NHS Trust Human Resource department will be aware of your EPP status either by you agreeing to the NHS Trust OHS being allowed access to your ‘Smart Card’ data, or by the NHS Trust requesting your EPP status from either the University OHS or the Medical School. Under the provisions of the Data Protection Act 1998 it is necessary to obtain your informed, written consent to join the ‘Smart Card’ scheme. If you agree, you will be consenting to your personal and occupational health immunisation data held by the University of Oxford OHS, also being stored on the NHS OHSC system so that it will be available to hospital Trusts for use when you attend their hospitals for clinical training, and when you enter postgraduate medical training as a pre-registration house officer (PRHO). The data is fully encrypted to industry-standard. Access to the ‘HR’ area would be restricted to authorised NHS Trust and Medical School staff, and records can be only be updated by authorised personnel. As a student your occupational health information will only be available to The University OHS, and an employing NHS Trust occupational health department with your consent. You will always be entitled to view and verify your own records on the system, and request a printed copy. You can give consent by ticking the ‘yes’ box in Section 7 of the health declarations & consents form Once you are working as a doctor you will have a professional responsibility to keep your card details up to date. The following link gives you further details on the background to the scheme, how it works, the data contained on the card and who benefits: http://www.nhsemployers.org/practice/smart-cards.cfm
