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Trust Guideline for the Management of Incidents which have the potential to transmit Blood Borne Viruses A clinical guideline recommended for use For Use in: By: For: Division responsible for document: Key words: Name and job titles of document author: Name and job title of document author’s Line Manager: Workplace Health & Wellbeing, Accident & Emergency Department, iCaSH Norfolk Trust Managers & Supervisors All Health Care Workers Any patient (bleed back incident) or Health Care Worker who may have been put at risk of blood borne virus transmission (Hepatitis B, Hepatitis C and HIV) Corporate Hepatitis B, Hepatitis C, HIV, Occupational Exposure, Source, Recipient, Risk Assessment, Post Exposure Prophylaxis (PEP) Blood Borne Viruses (BBV), Bleed Back Incident, needlestick, Blood and Body Fluid Exposure Incident, Inoculation injury, Other Potential Infectious Material (OPIM), Non Infectious Materials (NIM) Hilary Winch, Head of Workplace Health, Safety & Wellbeing Dr Mark Ferris, Specialty Doctor, Occupational Health Supported by: Portia Jackson, Highly Specialist Pharmacist HIV Dr J Evans, Consultant, iCaSH Norfolk Dr T Daynes, Consultant in Accident & Emergency Dr S Dervisevic, Consultant Virologist Assessed and approved by the: Chairs Action approval given 17/09/2015 and reported to Clinical Guidelines Assessment Panel (CGAP) 23/09/2015 Date of approval: 17/09/2015 Ratified by or reported as approved to (if applicable): Clinical Standards Group and Effectiveness Sub-Board To be reviewed before: This document remains current after this 17/09/2018 date but will be under review To be reviewed by: Workplace Health & Wellbeing Manager Reference and / or Trust Docs ID No: CA4003 id 1260 Version No: 5 Description of changes: Amendment made as GUM changed to iCaSH Compliance links: (is there any NICE related to guidance) If Yes - does the strategy/policy deviate from the recommendations of NICE? If so why? None This guideline has been approved by the Trust's Clinical Guidelines Assessment Panel as an aid to the diagnosis and management of relevant patients and clinical circumstances. Not every patient or situation fits neatly into a standard guideline scenario and the guideline must be interpreted and applied in practice in the light of prevailing clinical circumstances, the diagnostic and treatment options available and the professional judgement, knowledge and expertise of relevant clinicians. It is advised that the rationale for any departure from relevant guidance should be documented in the patient's case notes. The Trust's guidelines are made publicly available as part of the collective endeavour to continuously improve the quality of healthcare through sharing medical experience and knowledge. The Trust accepts no responsibility for any misunderstanding or misapplication of this document. Author/s: Dr Hilliard, Wendy Sharp, Hilary Winch Valid until: 17/09/2018 Document: Incidents with the potential to transmit Blood Borne Viruses guideline Copy of complete document available from: Trust intranet Date of issue: 17/09/ 2015 Guideline Ref No: CA4003 / V5 id 1260 Page 1 of 36 Trust Guideline for the Management of Incidents which have the potential to transmit Blood Borne Viruses Contents Quick reference pages:1. Management of Staff Blood and Body Fluid Exposure Incidents 2. Source Testing in Blood and Body Fluid Exposure Incidents 3. Blood Exposure Management - A&E Department 4. A&E Department Check List for Assessing High Risk Blood & Body Fluid Risk Incidents 5. A&E Department Hepatitis B Assessment Algorithm 6. A&E Department HIV Assessment Algorithm 7. Important Contact Numbers 8. Definitions Additional information on the following can be found in sections:Objective / Rationale Immediate management of a Blood or Body Fluid Exposure Incident Management responsibility Source consent and blood testing The Role of Workplace Health & Wellbeing Role of the Accident & Emergency Department Role of Integrated Contraception and Sexual health, Norfolk (iCaSH) Bleed Back Incidents Clinical audit standards Guideline development and consultation process Page 3 4 5 6 7 8 9 10 12 12 12 13 14 15 16 16 17 17 Appendices 1 - Patient Information leaflet for Post Exposure Prophylaxis (PEP) against HIV 2 - Drug Interactions 3 - Recipient consent form for PEP against HIV infection 4 - Patient consent form for Source Testing 5 - Parent/guardian consent form for Source Testing 6 - Advice Sheet for staff 7 - PEP Proforma 8 - Background information for Health Care Workers on Blood Borne Viruses. References Author/s: Dr Hilliard, Wendy Sharp, Hilary Winch Valid until: 17/09/2018 Document: Incidents with the potential to transmit Blood Borne Viruses guideline Copy of complete document available from: Trust intranet Date of issue: 17/09/ 2015 Guideline Ref No: CA4003 / V5 id 1260 Page 2 of 36 Trust Guideline for the Management of Incidents which have the potential to transmit Blood Borne Viruses Quick Reference Guide 1 - Management of Staff Blood and Body Fluid Exposure Incident Immediate Management: Bleed / Wash / Cover Inform "person in charge" of ward / department 17.00 -08.30 + Weekends & Bank Holidays Time of Incident? A&E assessment Staff member (recipient) attend with details of "source" "Person in Charge" to facilitate investigation of incident and source (Refer to source testing algorithm) 08.30 -17.00 Weekdays Contact Workplace Health & Wellbeing at earliest oppurtunity Who is the "Person in Charge"? The most senior staff member on shift where the source patient is being cared for at the time of the incident. If this person is also the recipient then they should contact the Operational Practitioner who will assume this role. It is the responsibility of the "person in charge" to ensure that the source testing process is undertaken - either by a nurse or a doctor. NB: If the source patient moves location shortly after the incident, then it is the responsibility of the original senior staff member to inform the new location and ensure source blood testing is commenced. Workplace Health & Wellbeing Telephone (01603) 287035 Int. x3035 Fax (01603) 287026 Author/s: Dr Hilliard, Wendy Sharp, Hilary Winch Valid until: 17/09/2018 Document: Incidents with the potential to transmit Blood Borne Viruses guideline Copy of complete document available from: Trust intranet Date of issue: 17/09/ 2015 Guideline Ref No: CA4003 / V5 id 1260 Page 3 of 36 Trust Guideline for the Management of Incidents which have the potential to transmit Blood Borne Viruses Quick Reference Guide 2 Source Testing after Blood & Body Fluid Exposure Incidents "Source" Identified? Inform Workplace Health & Wellbeing at earliest opportunity No/ Unable Yes Use Consent form Appendix 4 or 5 Consent for blood testing? Yes No/ Unable Document in hospital notes that patient is unable or unwilling to consent to blood borne virus testing Arrange for appropriate blood tests HIV serology Hepatitis B Surface antigen Hepatitis C antibodies When logging on ICE - select the blood and body fluid expsoure option Inform Workplace Health & Wellbeing at earliest opportunity Yes State on request - "source patient of occupational blood / body fluid exposure incident, written consent obtained" + label as URGENT sample Copy of consent form (Appendix 4 or 5) place in source patient notes (original copy) faxed to Workplace Health & Wellbeing Workplace Health & Wellbeing Telephone (01603) 287035 / int x3035 Fax Number (01603 ) 287026 Quick Reference Guide 3 Blood Exposure Incident Management - A&E Patient presents to A/E with Author/s: Dr Hilliard, Wendy Sharp, Hilary Winch needlestick / Blood exposure incident Valid until: 17/09/2018 Document: Incidents with the potential to transmit Blood Borne Viruses guideline Copy of complete document available from: Trust intranet Date of issue: 17/09/ 2015 Guideline Ref No: CA4003 / V5 id 1260 Page 4 of 36 Trust Guideline for the Management of Incidents which have the potential to transmit Blood Borne Viruses *On ICE/Symphony select Microbiology /Serology then Blood and Body fluid Exposure Incident option, this will advise on the bloods required for the recipient (staff member) Author/s: Dr Hilliard, Wendy Sharp, Hilary Winch Valid until: 17/09/2018 Document: Incidents with the potential to transmit Blood Borne Viruses guideline Copy of complete document available from: Trust intranet Date of issue: 17/09/ 2015 Guideline Ref No: CA4003 / V5 id 1260 Page 5 of 36 Quick Ref 4 - A&E Check List for Assessing a High Risk Blood & Body Fluid Exposure Incident NAME .............................................................…….ADDRESS ....................................…………………………………………………………. DOB……………………….…………JOB TITLE………………………………………………TEL. NO/BLEEP. ........................………………… TRUST .................…………………LINE MANAGER…………………………………DATE & TIME OF INCIDENT……………………………. LOCATION OF INCIDENT ...................................………………… DATE & TIME SEEN……………………………………………………….. Past Medical History including drug history ………………………………………………………………………… INCIDENT DETAILS……………………………………………………………………………………………………………………………………………………. ..............................................................................................................................................................……………………………………………………….. ...............................................................................................................................................................……………………………………………………….. Percutaneous injury Y / N Hollow bore needle? Y / N Gauge/type ................... Used for ...................................................................….. Other sharp? ..........................................................…… Was the contamination fresh blood? Y/N Was the injury: Superficial (surface scratch)? Y / N Deep (with or without bleeding) Y / N Were gloves worn? Y / N if yes indicate below Single Pair Double Pair Mucocutaneous exposure Y / N Mucous membrane? Y/N Area ......................................…………………………………… Broken skin? Y/N Was the contaminate fresh blood Y / N (if N) give details Details…………………….…………………………………………. Approx volume of body fluid……………………………………… SOURCE DETAILS Is the source known Y N If N can source be traced to ward/dept if so where…………………………………………..................................... 1. Patient/s Name………………………………………………..DOB ....................................……………………...Hospital / NHS No………………………... Diagnosis ...................…………………………………………………………………………………………………………………………………………………… GP name and surgery address………………………………………………………………………………………………………………………………………… ……………………………………………………………………………………………………………………………………………………………………………… Senior Nurse in charge of patient……………………………………………………Tel/Bleep………………………………………………………………………. Clinician in charge of source case…………………………………………………..Tel/Bleep……………………………………….......................................... HIV Risk Assessment Table Section A Was the patient exposed to blood or Other Potential Infectious Material OPIM * Was the exposure to non-infectious body fluid?** Section B: Is the injury / exposure: Blood/OPIM* contact with healthy skin? Prolonged contact/heavy contamination with non–intact skin? Mucocutaneous exposure? E.g. eye, mouth Superficial or deep injury with solid instrument/ hollow bore needle with/without visible blood? Bite from patient causing abrasion or penetrating injury? Section C: Age of patient Patient under 16 years of age? Patient over 16 years? Section D: Is the source: HIV positive and NEVER had antiretroviral therapy (ART)? HIV positive on ART or taken in the past? High-risk history for HIV*** No High-risk history for HIV? If answer Yes: Go to section B Do not recommend PEP If answer Yes: Do not recommend PEP Go to section C Go to section C Go to section C Do not recommend PEP If answer Yes: Contact on call paediatrician Go to section D If answer Yes: Recommend PEP Recommend PEP. Contact GU consultant Recommend PEP Do not recommend PEP 1. PEP recommended? If yes proceed to question 2 2. Patient pregnant? If yes, discuss PEP with GU consultant 3. Is patient under 16 years old? If yes discuss PEP with paediatrician 4. Consent for PEP obtained? 5. PEP Info Given 6. Is the patient on any medication? If Yes, Check drug interactions table Hep B Immunisation Hep B immune Optimal response Poor Response Non-Responder Hep B Booster given Immunoglobulin administered Y Y Y Y N N N N Y N *OPIM: Amniotic fluid, vaginal secretions, semen, human breast milk, cerebrospinal fluid, peritoneal fluid, pleural fluid, pericardial fluid, synovial fluid, saliva in association with dentistry (likely to be contaminated with blood even when not visibly so, Unfixed tissues and organs, Exudate or tissue fluids from burns or skin lesions and any body fluid visibly blood stained **Non-Infectious body fluids: Urine, vomit, saliva & faeces which are not visibly blood stained ***High risk for HIV infection: Men who have sex with men, Intra Venous Drug User (IVDU), Men/ women in countries where heterosexual transmission is common (notably sub Saharan Africa), Infants born to HIV infected mothers or adults with HIV infected sexual partners, Commercial sex workers PHOTOCOPY FORM & PLACE WITH A&E RECORD GIVE COMPLETED FORM TO THE STAFF MEMBER TO GIVE TO OH/iCaSH Completed by name …………………………………………….……….Signature………………….Date………………… Author/s: Dr Hilliard, Wendy Sharp, Hilary Winch Valid until: 17/09/2018 Document: Incidents with the potential to transmit Blood Borne Viruses guideline Copy of complete document available from: Trust intranet Date of issue: 17/09/2015 Guideline Ref No: CA4003 / V5 id 1260 Page 6 of 36 Y N Y N Y N Y Y Y N N N Trust Guideline for the Management of Incidents which have the potential to transmit Blood Borne Viruses Quick Reference 5 - A&E Hepatitis B Assessment Algorithm Complete A&E Checklist (3.4) Exposure Risk? Hepatitis B Assessment Contact Workplace Health and Wellbeing at earliest opportunity High sAb = serum antibodies sAg = serum antigen Yes Person in charge to facilitate investigation of incident and source. (refer to Source Testing Algorithm) No / Unknown Low Hepatitis B vaccinated? No Take blood for storage; Workplace Health & Wellbeing to request tests for recipient sAb Source sAg positive? Hepatitis B Vaccination Source sAg positive? Yes Yes Hepatitis B Vaccination Hepatitis B Booster Vaccination & Consider Hepatitis B Immunoglobulin (Contact Consultant Microbiologist) No/ Unknown Consider Hepatitis B Immunoglobulin (Contact Consultant Microbiologist) HIV Assessment Author/s: Dr Hilliard, Wendy Sharp, Hilary Winch Valid until: 17/09/2018 Document: Incidents with the potential to transmit Blood Borne Viruses guideline Copy of complete document available from: Trust intranet Date of issue: 17/09/2015 Guideline Ref No: CA4003 / V5 id 1260 Page 7 of 36 Trust Guideline for the Management of Incidents which have the potential to transmit Blood Borne Viruses Quick Reference 6 A&E HIV Assessment Algorithm Hepatitis B assessment (QR 5) & A&E Checklist (QR4) completed Patient to contact their Occupational Health at earliest opportunity HIV Risk Assessment Yes HIV positive or high risk source? No / Unknown DO NOT recomend postexposure prophylaxis Staff? No Yes Patient to contact iCaSH at earliest opportunity Age of recipient? <16 yr Contact On-call Paediatrician >16 yr Pregnant? Yes Contact On-call Genitourinary Consultant @ iCaSH Commence post-exposure prophylaxis if indicated (after consultation with relevant specialist) No Source patient viral load known > 200 HIV RNA/ml or unknown Yes No Do not commence post-exposure prophylaxis Commence postexposure prophylaxis (if no contraindications) Staff? Yes No Patient to contact iCaSH at earliest opportunity Author/s: Dr Hilliard, Wendy Sharp, Hilary Winch Valid until: 17/09/2018 Document: Incidents with the potential to transmit Blood Borne Viruses guideline Copy of complete document available from: Trust intranet Patient to contact their Occupational Health at earliest opportunity Date of issue: 17/09/2015 Guideline Ref No: CA4003 / V5 id 1260 Page 8 of 36 Trust Guideline for the Management of Incidents which have the potential to transmit Blood Borne Viruses Quick Reference 7 Important Contact Numbers 24 Hour Action Line: 01603 287676 or ext: 3676 Workplace Health & Wellbeing: 01603 287035 or ext: 3035 Accident & Emergency Department: 01603 287324/5 or ext: 3324/5 Health & Safety Dept: 01603 287423 or ext: 3423 Trust Microbiology Department: 01603 284587 or ext: 4587(for urgent samples). Out of hours via NNUH Switchboard ICaSH Norfolk (integrated contraception and sexual health): 0300 300 3030 Quick Reference 8 - Definitions Author/s: Dr Hilliard, Wendy Sharp, Hilary Winch Valid until: 17/09/2018 Document: Incidents with the potential to transmit Blood Borne Viruses guideline Copy of complete document available from: Trust intranet Date of issue: 17/09/2015 Guideline Ref No: CA4003 / V5 id 1260 Page 9 of 36 Trust Guideline for the Management of Incidents which have the potential to transmit Blood Borne Viruses 1. Bleed Back Incident An incident in which the blood of a health care worker comes into contact with the blood or open tissues of a patient. The following are examples of when this could occur: Bleed back from a visible laceration to a Health Care Worker’s hand during an Exposure Prone Procedure (e.g. during surgery). Visible bleeding from a Health Care Worker from any site leading to significant bleed back into a patient’s open tissues or mucous membranes. In the unlikely event that an invasive device or product contaminated by use on one patient is accidentally reused on another patient. 2. Blood Borne Viruses (BBV) BBVs are viruses which can be present in blood or other body fluids and which have high potential for transmission to another person by direct contact with their blood or susceptible fluids. For practical purposes these are Hepatitis B (HBV), Hepatitis C (HCV), and Human Immunodeficiency Virus (HIV). 3. Occupational Exposure There are three types of exposure in health care settings associated with significant risk from blood or higher risk body fluids these are: Percutaneous injury (e.g. from needles, sharp instruments, bone fragments, significant bites which break the skin). Exposure of broken skin (e.g.abrasions, cuts, eczema). It is important to note that intact skin is a safe protective barrier against BBV transmission. Exposure of mucous membranes including eyes and mouth. 4. Post Exposure Prophylaxis (PEP) PEP is the treatment which may be advised and supplied to the recipient following a risk assessment from a known or high risk HIV or Hepatitis B exposure incident. The treatment for Hepatitis B is only recommended when the recipient does not have adequate immune protection. 5. Recipient The individual who has been exposed to the possibility of acquiring a blood borne infection as a result of an incident with the potential to transmit a BBV. 6. Source Author/s: Dr Hilliard, Wendy Sharp, Hilary Winch Valid until: 17/09/2018 Document: Incidents with the potential to transmit Blood Borne Viruses guideline Copy of complete document available from: Trust intranet Date of issue: 17/09/2015 Guideline Ref No: CA4003 / V5 id 1260 Page 10 of 36 Trust Guideline for the Management of Incidents which have the potential to transmit Blood Borne Viruses The individual who was the source of the blood or body fluid, which made contact with the recipient. The source will usually be a patient but may be a HCW as in a bleed back incident. 7. Risk Assessment The process by which the need for PEP is determined, based on the characteristics of the potential transmission incident and the evidence on the previous behaviour of the source, which carries the potential risk of BBV infection. 8. Other Potential Infectious Material (OPIM) Amniotic fluid, vaginal secretions, semen, human breast milk, cerebrospinal fluid, peritoneal fluid, pleural fluid, pericardial fluid, synovial fluid, saliva in association with dentistry (likely to be contaminated with blood even when not visibly so, Unfixed tissues and organs, exudate or tissue fluids from burns or skin lesions and any body fluid visibly blood stained. 9. Non – Infectious body fluids Urine, vomit, saliva and faeces which are not visibly blood stained. 1. Objective and Rationale This guidance is aimed at all Health Care Workers (HCW), subcontracted HCWs, Health Care students (including work experience) on Trust premises. This guideline is to be used in the event of a potential occupational exposure to Blood Borne Viruses (BBV) or other potential infectious material (OPIM), particularly those contaminated with blood. It is essential that all staff and managers familiarise themselves with this guideline since urgent action may be required in the event of an exposure. Author/s: Dr Hilliard, Wendy Sharp, Hilary Winch Valid until: 17/09/2018 Document: Incidents with the potential to transmit Blood Borne Viruses guideline Copy of complete document available from: Trust intranet Date of issue: 17/09/2015 Guideline Ref No: CA4003 / V5 id 1260 Page 11 of 36 Trust Guideline for the Management of Incidents which have the potential to transmit Blood Borne Viruses HCWs are potentially at risk from Blood Borne Viruses (BBV) including Hepatitis B virus (HBV), Hepatitis C virus (HCV) and Human Immunodeficiency Virus (HIV) through exposure to blood or other higher risk body fluids. The greatest risk of transmission is from inoculation injuries but transmission is known to have occurred following splashing onto mucous membranes or damaged skin. Incidents with the potential to transmit BBV comprise percutaneous injury (i.e. needlesticks), exposure of broken skin, or exposure (often splashes) of the mucous membranes including those of the eyes and mouth. These incidents are a medical emergency, as prophylactic medication may need to be made available at short notice. Every effort should be made to avoid blood and body fluid exposure incidents by the adoption of safe systems of work. Please refer to the Trust policy for the Prevention and Management of Needlestick and Sharps Injuries within the Trust. 2. Immediate Management of a Blood or Body Fluid Exposure Incident First Aid Treatment Bleed it Wash it Cover it Report it – Via Datix as well as undertaking actions in Quick Reference Guide 1 3. Manager Responsibility It is a manager’s responsibility to ensure all staff are informed of the risk of acquiring a BBV through occupational exposure. 3.1 Line Manager To ensure the exposed member of staff has followed the appropriate guidance and contacted Workplace Health & Wellbeing or the A&E department depending on the time of incident (See quick reference 1). To ensure that the incident has been reported on Datix (incident reporting system). To investigate all blood and body fluid exposure injuries and to ensure safe working practices are adhered to at all times. To consider if a specific exposure incident was due to poor practice or negligence, which may require guidance, training or even in certain cases disciplinary procedures. Where the Line Manager is in charge of the source patient they must follow the guidance outlined in 3.2. Author/s: Dr Hilliard, Wendy Sharp, Hilary Winch Valid until: 17/09/2018 Document: Incidents with the potential to transmit Blood Borne Viruses guideline Copy of complete document available from: Trust intranet Date of issue: 17/09/2015 Guideline Ref No: CA4003 / V5 id 1260 Page 12 of 36 Trust Guideline for the Management of Incidents which have the potential to transmit Blood Borne Viruses A case may arise where the Line Manager is not in charge of the source patient as they have moved to another location. If this occurs the Line Manager must liaise with the person now in charge of the source patient to implement the source testing process. 3.2 Person in charge of the department or ward where incident occurred or who is in charge of the source patient (See Quick Reference 2) To ensure all first aid measures have been undertaken and that the recipient has contacted Workplace Health & Wellbeing or the A&E department as appropriate. (See Quick Reference 1). Obtain consent as soon as possible from the source patient for BBV blood testing (see section 4), as the purpose of this assessment is to ascertain whether the recipient requires URGENT referral for PEP for possible HIV and HBV exposure. Post Exposure Prophylaxis (PEP) should be started for maximal effectiveness preferably within ONE HOUR of the exposure / injury If the incident occurs at night and the recipient is the person in charge of the department or ward where the source patient is being nursed then they must contact the operational practitioner who will take on the role of the person in charge of the source patient. NB: Staff working at Cromer / external locations should in the first instance contact Workplace Health & Wellbeing or the A&E department by telephone to assess the need to travel to Norwich for further treatment. 4.Source Consent & Blood Testing (See Quick Reference 2) Consent MUST be gained from the source patient for blood tests to be undertaken using the appropriate Patient Consent Form – (Appendix 4 or 5), even if an appropriate sample (taken in a plain orange-topped tube) is already available in the laboratory. The following blood tests MUST be requested: Hepatitis B Surface Antigen Hepatitis C Antibodies HIV Antigen and Antibodies BBV testing must not be undertaken without the patient’s informed consent as otherwise there may be a breach of the Human Tissue Act 2004 which may result in disciplinary proceedings from the Trust or the member of staff’s professional organisation (e.g. GMC, NMC). If the source patient is unable to give informed consent due to physical or psychological illness, unconsciousness or death, advice must be obtained from the Clinician in charge of the source patient in liaison with an Occupational Health Physician. Workplace Health & Wellbeing will undertake the initial risk assessment as if the incident occurred from an unknown source. The Hepatitis B,C and HIV blood tests should be requested on ICE, select microbiology/serology and the Blood and Body Fluid Exposure Incident option (hard copy if Author/s: Dr Hilliard, Wendy Sharp, Hilary Winch Valid until: 17/09/2018 Document: Incidents with the potential to transmit Blood Borne Viruses guideline Copy of complete document available from: Trust intranet Date of issue: 17/09/2015 Guideline Ref No: CA4003 / V5 id 1260 Page 13 of 36 Trust Guideline for the Management of Incidents which have the potential to transmit Blood Borne Viruses ICE not applicable state URGENT source test and “source patient of occupational blood/body fluid exposure incident, written consent obtained”). The patients name and date of birth should be used as identification. When requesting the HIV tests on ICE, when the requester has reached the ‘reason for request screen’ they should click ‘other’ and then type in ‘Source patient of blood / body fluid injury’ The Trust Microbiology department should receive the sample within 24 hours of the incident and must be informed by telephone on ext 4587 that this is an URGENT source test request. If the incident occurs at night then a message must be left on the answer machine to alert Microbiology of the urgency of the request for the morning. The test results should be requested for Workplace Health & Wellbeing and not recorded in the patient’s notes. Once the blood sample has been taken, Workplace Health & Wellbeing must be contacted on ext: 3035 or 01603 287035 with the following information: Name, Date of Birth and contact number of Recipient Name and Hospital Number of Source patient Managers name and contact number For an incident occurring between 17.00 and 08.30 Monday to Friday and at any time during a weekend or on a Bank Holiday, fax the completed ‘Source consent form’ to Workplace Health & Wellbeing (01603 287026). NB: the original source consent form must be filed in patient’s hospital notes. 5. The Role of Workplace Health & Wellbeing To provide advice, support and treatment (during the hours of 0830 and 1700, Monday to Friday) and review all staff who have been involved in a blood or body fluid exposure incident in line with internal Workplace Health & Wellbeing procedures and best practice. To liaise with the person in charge of the source patient to ensure that arrangements have been made for a blood sample to be tested for BBV. To liaise with the Clinician in charge of the source patient prior to Workplace Health & Wellbeing advising the recipient about further management. To advise the recipient of the source patient’s results once the source patient has been informed by the Clinician in charge of their care. If the source results are positive, an urgent appointment will be made for the recipient to see an Occupational Health Physician at the earliest opportunity. All source patient results will be released to Workplace Health & Wellbeing as long as the source blood sample request has been clearly marked as indicated in section 4 - “Source patient of occupational blood/body fluid exposure incident, written consent obtained”. Author/s: Dr Hilliard, Wendy Sharp, Hilary Winch Valid until: 17/09/2018 Document: Incidents with the potential to transmit Blood Borne Viruses guideline Copy of complete document available from: Trust intranet Date of issue: 17/09/2015 Guideline Ref No: CA4003 / V5 id 1260 Page 14 of 36 Trust Guideline for the Management of Incidents which have the potential to transmit Blood Borne Viruses NB: If the patient has been discharged or the results are positive, the Clinician in charge of the patient at the time of the incident will be responsible for advising the GP of the results and will be requested to advise the patient and arrange referral to the appropriate specialist. To provide information and training on the management of exposure incidents mandatory and induction training for the Trust, and provide any other training when requested, on all aspects of the management of blood and body fluid exposure incidents. To undertake ongoing audit of source testing and blood borne exposure incidents. To provide the Trust with advice about the management of blood and body fluid exposure incidents. To report all high risk HIV, Hepatitis B or C blood and body fluid exposure incidents to Public Health England (previously HPA) / Health & Safety Executive (under RIDDOR Regulations) 6. Role of the Accident & Emergency Department To provide emergency care for all HCWs in accordance with current Department of Health (DoH) guidance and best practice. To manage the member of staff in accordance with internal A&E protocols and procedures (see quick reference guides 3, 4, & 5). To triage as requiring urgent medical attention since HIV Post Exposure Prophylaxis should ideally be given within one hour of exposure. However it can be commenced up to 72 hours afterwards (and on occasions longer) To provide HIV and Hepatitis B prophylaxis when indicated. Hepatitis B Immunoglobulin is only available from Microbiology and therefore the Consultant Microbiologist On Call will need to be contacted to discuss the case and supply if indicated. To provide advice to managers when the Workplace Health & Wellbeing department is closed. If an occupational injury to instruct the recipient to telephone their Occupational Health on the next working day for any further treatment or advice. If the member of staff is employed by Norfolk and Norwich University Foundation Trust they should contact Workplace Health & Wellbeing on (01603 287035 ext: 3035) To undertake the initial management of any blood and body fluid exposure incident sustained by a member of the public and to refer them to the Integrated Contraception and Sexual Health clinic (iCaSH clinic) if HIV PEP has been commenced (either for blood or sexual exposure). For those members of the public who have attended A&E where HIV PEP has not been commenced or who only require Hepatitis B follow up they should be referred to their Primary Care Service. Author/s: Dr Hilliard, Wendy Sharp, Hilary Winch Valid until: 17/09/2018 Document: Incidents with the potential to transmit Blood Borne Viruses guideline Copy of complete document available from: Trust intranet Date of issue: 17/09/2015 Guideline Ref No: CA4003 / V5 id 1260 Page 15 of 36 Trust Guideline for the Management of Incidents which have the potential to transmit Blood Borne Viruses 7. Role of Integrated Contraception and Sexual Health (iCaSH) To provide any follow up management for members of the public in the event of a high risk blood and body fluid exposure incident where HIV PEP has been commenced. To provide consultant advice via telephone for the Occupational Health Physician when Post Exposure Prophylaxis (PEP) is indicated, but either due to health condition of source patient or recipient of incident cannot prescribe the standard PEP starter pack. To take a referral of an occupational health patient following a blood exposure incident when PEP is likely to be indicated, but WHWB do not have a doctor present to assess and prescribe. This would include a consultation and baseline bloods. WHWB would be responsible for necessary follow up consultations and employee support. To advise WHWB on the activity undertaken so that appropriate follow up can take place (as per agreed SLA) In the event where the source patient is identified as HIV positive, to advise WHWB on the most appropriate choice of HIV PEP, taking into account previous treatment of the source patient, and any other medical conditions or medications taken by the exposed worker. To advise Pharmacy and A&E on the most appropriate constituents of HIV PEP Starter packs. 8. Bleed Back Incident Definition– see quick reference 8 In the rare event of a ‘bleed back’ incident, it is important that both the HCW and the exposed patient have access to appropriate clinical management following the incident. Following a ‘bleed back' incident the HCW must attend Workplace Health & Wellbeing for counselling and blood testing for BBVs (under a code number) following appropriate consent to do so. If the HCW tests negative for BBVs the DoH have indicated that there is no need to inform the patient about the incident as this would avoid causing the patient unnecessary anxiety. If the HCW tests positive for any BBV, the patient should be notified of an ‘intra operative episode’ without revealing which member of the clinical team is infected. PEP should only be recommended to a patient following a positive test in the HCW for HIV or Hepatitis B (except in very exceptional circumstances e.g. high likelihood of BBV infection). If the HCW tests positive, the patient will be followed up with baseline blood test for (storage) and further testing, as appropriate,. It is the responsibility of the Clinician in charge of the patient to advise their GP that further blood tests are required. HIV test results should, ideally be available within eight hours of the exposure incident to maximise the benefit of PEP for the patient if indicated. However, if the ‘bleed back’ incident occurs at the weekend or on a bank holiday and the microbiology lab is not able to Author/s: Dr Hilliard, Wendy Sharp, Hilary Winch Valid until: 17/09/2018 Document: Incidents with the potential to transmit Blood Borne Viruses guideline Copy of complete document available from: Trust intranet Date of issue: 17/09/2015 Guideline Ref No: CA4003 / V5 id 1260 Page 16 of 36 Trust Guideline for the Management of Incidents which have the potential to transmit Blood Borne Viruses supply the result within an eight hour period, if the source (HCW) has high risk factors for HIV infection then the recipient (patient) should be informed of the incident and commenced on PEP until the result has been received. Where PEP for HIV (or Hepatitis B) is required for an exposed patient the Clinician responsible for that patient will be advised by a the Occupational Health doctor. The iCaSH Norfolk Consultant should be contacted to confirm the appropriate HIV treatment regimen. Any HCW (particularly if involved in EPP) who believes they may have been exposed to infection with HIV, Hepatitis B or Hepatitis C should inform Workplace Health & Wellbeing, as to whether they should be tested for these BBV infections. Failure to do so may breach the duty of care to patients. Therefore HCWs are under continual obligation to report their own BBV infections risks. 9. Clinical Audit Standards To ensure that this document is compliant with the above standards, the following monitoring processes will be undertaken: All high risk blood & body fluid exposure incidents were reported to the HSE, Public Health England and the Health & Safety Committee and managed appropriately according to the guidelines. Employees receive appropriately timed follow up testing via WHWB 10. Guideline Development and Consultation Process Guidelines were drawn up by the authors following a review of published literature (see references). Discussions took place with colleagues in Microbiology, A&E, iCaSH Norfolk, Health & Safety and Infection Control. Appendix 1 HIV POST-EXPOSURE PROPHYLAXIS (PEP) FOLLOWING OCCUPATIONAL EXPOSURE Department of Workplace Health and Wellbeing You have had an injury/exposure that may have put you at risk from Human Immunodeficiency Virus (HIV) infection. This information is aimed at hospital staff but will equally apply to a member of the public. It is important that you read the following information before deciding whether or not to take prophylactic treatment. What are the risks of acquiring HIV following a potential exposure? The risk of acquiring HIV infection following occupational exposure to HIV-infected blood is extremely low. Studies have indicated that the average risk after percutaneous exposure (e.g. needlestick injury) to HIV-infected blood in a healthcare setting is about 3 per 1,000 injuries (0.3%). This risk is lower after mucous membrane exposure (e.g. exposure of the eye) or broken skin (e.g. Author/s: Dr Hilliard, Wendy Sharp, Hilary Winch Valid until: 17/09/2018 Document: Incidents with the potential to transmit Blood Borne Viruses guideline Copy of complete document available from: Trust intranet Date of issue: 17/09/2015 Guideline Ref No: CA4003 / V5 id 1260 Page 17 of 36 Trust Guideline for the Management of Incidents which have the potential to transmit Blood Borne Viruses eczema) and it has been considered that there is no risk of HIV transmission when intact skin is exposed to HIV-infected blood. Why should I take PEP? Although the risk of acquiring HIV in a healthcare setting is extremely low, a very small number of healthcare workers have become infected from an occupational exposure. Taking prophylactic treatment may significantly reduce this risk but cannot eliminate it. PEP is not a cure for HIV; rather PEP may prevent HIV from entering the cells in your body and so prevent you from becoming infected with HIV. How do I make a decision when I do not know if the source was infected with HIV? In many cases it will not be possible to find out whether the source (i.e. the person you sustained the injury from/were exposed to) is HIV-positive when you are making the decision to start PEP. You must discuss whether your exposure has put you at significant risk of HIV infection with the prescribing doctor. The Department of Health (DoH) recommends PEP for healthcare workers who have had a significant occupational exposure to blood or other potentially infectious material from a patient or other source known to be HIV infected or considered to be at high risk of infection. A significant exposure is defined as: Percutaneous injury (e.g. from needles, instruments, significant bites which break the skin) Exposure of broken skin (e.g. eczema, cuts, abrasions) Exposure of mucous membranes, including the eye The DoH does NOT recommend PEP: After an exposure through any route with low risk materials e.g. saliva, urine, faeces or vomit unless visibly bloodstained (e.g. saliva associated with dentistry) If a risk assessment has concluded that HIV infection of the source is highly unlikely Where the source is known to be HIV-negative If the source is known to have an undetectable viral load (<200 copies HIV RNA/mL). However, PEP should be offered to those who are anxious about the risk of infection. Where a risk assessment suggests that HIV infection of the source is a potential risk, a request will be made to test the source for HIV. However, it may not always be possible, or appropriate, to perform a test. In this case it will be up to you to decide whether to continue treatment after further discussion with your occupational health department (if occupational injury) or Integrated Contraception and Sexual Health (iCaSH) Consultant. You will need to balance the relative risk of transmission against the possibility of side effects of the medication. If you decide not to start treatment you can still discuss this with an iCaSH Clinician or your occupational health physician at a later date, although commencing PEP is generally not recommended beyond 72 hours post exposure. If it is not possible to trace the source of my injury/exposure, should I still consider taking PEP? In the majority of cases where the source of the exposure is completely unknown, the risk of HIV is so low that PEP should not be recommended. If you would still prefer to take treatment then you should discuss this with the prescribing doctor. You can always stop treatment at a later date after further discussion with your occupational health service or an iCaSH clinician (0300 300 3030) What is the recommend PEP regimen? Author/s: Dr Hilliard, Wendy Sharp, Hilary Winch Valid until: 17/09/2018 Document: Incidents with the potential to transmit Blood Borne Viruses guideline Copy of complete document available from: Trust intranet Date of issue: 17/09/2015 Guideline Ref No: CA4003 / V5 id 1260 Page 18 of 36 Trust Guideline for the Management of Incidents which have the potential to transmit Blood Borne Viruses The current guidance from the DoH is to use the combination of Truvada® (tenofovir disoproxil and emtricitabine) and raltegravir (Isentress®), taken as follows: Medicine Truvada® tablets (Tenofovir disoproxil 245mg + emtricitabine 200mg) Raltegravir 400mg tablets Morning Take ONE tablet Evening - Take ONE tablet Take ONE tablet TWELVE HOURS apart However, in some situations, for example if you are pregnant, it may be appropriate to use alternative medications. In addition, if the needlestick injury/exposure was from a known HIV patient currently on treatment for HIV, your prophylactic regimen may be different and you should contact the local HIV specialist team to discuss the options. It is important to be aware that these drugs are not licensed for this indication. This medication should be started as soon as possible after exposure (preferably within ONE hour) and it should be continued for 28 days. PEP is generally not recommended beyond 72 hours post exposure. How should I take this medication? It is important that the tablets are taken at the same time each day and try to leave 12 hours between the morning and evening doses of raltegravir. Swallow the tablets whole with plenty of water. It is important that they are not chewed, crushed or split as this may affect how the medicine works. They can be taken with or without food. You may drink moderate amounts of alcohol (i.e. within normal recommended safe limits) while taking this medication This pack contains FIVE days supply only, but PEP will normally need to be continued for 28 days. You must arrange an appointment with your occupational health service or the iCaSH clinic as soon as possible for further supplies and advice. What are the possible side effects of the Truvada ® and raltegravir? The most common side effects of Truvada® and raltegravir are nausea, diarrhoea, headache, dizziness and insomnia. These usually settle if you keep taking the medication as directed, but medication to prevent sickness or diarrhoea, or simple painkillers, may help. However, if you experience side effects, speak to your occupational health doctor or iCaSH Norfolk as it may be possible to prescribe alternative medication. Serious side effects are rare and include allergic reactions. The medication may also cause liver and kidney problems and thinning of the bones, but this usually only occurs with long-term treatment (i.e. lasting several years). What should I do if I forget the take the tablets or miss a dose? It is very important that you do not miss any doses of this medication since this could reduce the it’s effectiveness. If you do forget to take a dose, take it as soon as you remember and take the next dose at the normal time. However, do not take two doses at once if you have missed a dose altogether; just take the next dose at the usual time. I am taking other medication; can I still take PEP? Truvada® and raltegravir can interact with other medicines and it is important that you tell the prescribing doctor all the medication you currently take. This includes anything you buy ‘over-theAuthor/s: Dr Hilliard, Wendy Sharp, Hilary Winch Valid until: 17/09/2018 Document: Incidents with the potential to transmit Blood Borne Viruses guideline Copy of complete document available from: Trust intranet Date of issue: 17/09/2015 Guideline Ref No: CA4003 / V5 id 1260 Page 19 of 36 Trust Guideline for the Management of Incidents which have the potential to transmit Blood Borne Viruses counter’ at a pharmacy, such as any herbal or complementary medications, and also any recreational drugs. It is also important that you check with a doctor or pharmacist before starting on any new medicines whilst taking Truvada® and raltegravir. Are Truvada® and raltegravir safe to take in pregnancy and breastfeeding ? You must tell your doctor if you are, or could be, pregnant. If you are uncertain, a pregnancy test is recommended. If you are pregnant, or at risk of pregnancy, then a different combination of medicines may be prescribed. You should not breast feed while taking these medicines. Do I need to take any other precautions whilst on PEP? You should take precautions to avoid becoming pregnant, or fathering a child (e.g. using a condom/femidon) while taking these medicines and until your follow-up with the iCaSH clinic is complete (i.e. until you have results of the 6-month blood test to confirm your HIV status) You should also avoid taking part in any procedure which could place others at risk of blood borne infections. This should be discussed with your occupational health service or with the iCaSH clinic If you need any further information, or have any questions, please contact your occupational health service (for NNUH employees Workplace Health and Wellbeing on 01603 287035or Ext. 3035 if calling internally) or the iCaSH Norfolk on 0300 300 3030. Appendix 2: Drug Interactions Antiretroviral medication may have potentially serious interactions with other prescription or non-prescription drugs. This can affect patient safety and the effectiveness of PEP. The following tables give information on potential drug-drug interactions with raltegravir and Truvada®, and the appropriate action to take. Please note that this list is not exhaustive and any decision to delay PEP treatment or prescribe an alternative drug combination should be made under the direction of a specialist clinician. Please contact the Pharmacist at iCaSH Norfolk on 0300 300 3030 or Medicines Information (Bleep 0500) or the on-call Pharmacist (out-of-hours only) for further information regarding the appropriate management of drug-drug interactions. Key: Safe to give Truvada®/raltegravir Caution. Give Truvada®/raltegravir but see warning notes and seek further specialist advice as necessary at the earliest opportunity. Do not give Truvada®/raltegravir. Speak to iCaSH Consultant as soon as possible. Author/s: Dr Hilliard, Wendy Sharp, Hilary Winch Valid until: 17/09/2018 Document: Incidents with the potential to transmit Blood Borne Viruses guideline Copy of complete document available from: Trust intranet Date of issue: 17/09/2015 Guideline Ref No: CA4003 / V5 id 1260 Page 20 of 36 Trust Guideline for the Management of Incidents which have the potential to transmit Blood Borne Viruses AntiCo-administered Drug Retroviral Drug Raltegravir Antacids Anti-coagulants Antiepileptics Antimicrobials Action Notes Aluminium &/or magnesium containing Calcium-carbonate containing Warfarin Carbamazepine Phenobarbital/ Primidone Phenytoin Rifampicin Rifabutin H2-receptor blockers HCV antivirals Famotidine Boceprevir Telaprevir Hormonal Contraceptives Methadone Estrogenand/or progesterone-based Multivitamin preparations containing polyvalent cations Orlistat Proton-pump inhibitors St John’s Wort Omeprazole Anti-Retroviral Interacting Drug Drug Truvada® (tenofovir/ Adefovir emtricitabine) Acetazolamide Analgesics Aspirin (NSAIDS) Celecoxib Diclofenac Ibuprofen Mefenamic acid Naproxen Piroxicam Antibacterials Amikacin Cefotaxime Gentamicin (IV/IM) Neomycin Streptomycin Tobramycin If required, suggest switching to calciumcontaining antacid Potential for raltegravir plasma concentrations. If co-administration unavoidable, seek advice from pharmacist & consider need for therapeutic drug monitoring of raltegravir Plasma concentration of raltegravir . Consideration should be given to doubling raltegravir dose to 800mg BD. Seek advice from pharmacist Potential for raltegravir plasma concentrations. Suggest withholding multivitamin preparations whilst taking raltegravir Potential for raltegravir plasma concentrations. Suggest withholding orlistat whilst taking raltegravir. Action Notes Co-administration of tenofovir with adefovir contra-indicated Truvada® is renally excreted; co-administration with drugs that renal function or compete for active tubular secretion may plasma concentration of Truvada® and/or plasma concentration of other renally excreted drugs ( risk of side effects/toxicity). If concurrent use unavoidable, monitor renal function closely and monitor for side effects/toxicity of either drug. Author/s: Dr Hilliard, Wendy Sharp, Hilary Winch Valid until: 17/09/2018 Document: Incidents with the potential to transmit Blood Borne Viruses guideline Copy of complete document available from: Trust intranet Date of issue: 17/09/2015 Guideline Ref No: CA4003 / V5 id 1260 Page 21 of 36 Trust Guideline for the Management of Incidents which have the potential to transmit Blood Borne Viruses Vancomycin Antifungals Amphotericin Flucytosine Antiprotozoals Antivirals Pentamidine (IV) Aciclovir Cidofovir Famciclovir Foscarnet Ganciclovir Valaciclovir Frusemide Hydralazine Cimetidine Diuretics H2-receptor antagonists Immunosuppressants Penicillamine Cytotoxics HCV antivirals Immunomodulating drugs Probenecid Ciclosporin Mycophenolate Sirolimus Tacrolimus Carboplatin Cisplatin Dacarbazine Ifosfamide Mesna Methotrexate Oxaliplatin Capecitabine/ fluorouracil Boceprevir Ribavirin Simeprevir Sofosbuvir Telaprevir Interferon alfa/ pegylated interferon alfa-2a Interleukin 2 (aldesleukin) Monitor for fluorouracil-associated adverse effects Monitor for tenofovir-associated adverse effects Monitor for treatment-associated toxicities, including hepatic decompensation and anaemia Monitor for tenofovir-associated adverse effects Author/s: Dr Hilliard, Wendy Sharp, Hilary Winch Valid until: 17/09/2018 Document: Incidents with the potential to transmit Blood Borne Viruses guideline Copy of complete document available from: Trust intranet Date of issue: 17/09/2015 Guideline Ref No: CA4003 / V5 id 1260 Page 22 of 36 Trust Guideline for the Management of Incidents which have the potential to transmit Blood Borne Viruses APPENDIX 3 - RECIPIENT CONSENT FORM FOR POST EXPOSURE PROPHYLAXIS AGAINST HIV INFECTION 1. I consider that I have/have not* had a significant exposure to blood or body fluids potentially infected with HIV. 2. I have considered the advice offered and have read the patient information leaflet and have decided to take/not to take* Post Exposure Prophylaxis. *Delete as appropriate 3. I have been made aware of, and have considered, the toxic effects of these drugs and I am aware that some of the long term side effects are unknown. 4. I am aware that the drugs may significantly reduce the chance of becoming infected with HIV but cannot eliminate it. 5. I have provided information on all medication I take (including that which has not been prescribed by a doctor) and have been advised not to start any new medication without discussing this with a doctor or pharmacist. 6. FEMALE STAFF ONLY (delete whichever is inappropriate) a) I am not aware that I am pregnant and, if unsure, have been advised to test appropriately. I will also take suitable contraceptive precautions whilst on treatment. b) I am, or could be, pregnant and have listened to the advice offered by A&E, Workplace Health & Wellbeing or iCaSH Norfolk. 7. I am aware of the importance of practising safer sex (use of condom/femidom) and of the importance of avoiding taking part in procedures which could put others at risk of HIV, until further results are available. 8. a) NHS trust staff and other Health Care Workers where support is provided through an Occupational Health Department: I agree to be followed up confidentially by an Occupational Health advisor on the NEXT DAY followed by the Occupational Health doctor within the next FIVE days. I will contact them as soon possible. b) All other: I agree to be followed up confidentially by the iCaSH Norfolk within the next FIVE days. I will contact them as soon as possible. Signed by patient………….………………………. Date (dd/mm/yyyy) ……………………… Name (please print) ……………………... Date of Birth ………… Employer A & E: Please send this form confidentially to either Occupational Health (if NNUH staff member) or iCaSH clinic, 1a Oak street, Norwich, NR3 3AE Author/s: Dr Hilliard, Wendy Sharp, Hilary Winch Valid until: 17/09/2018 Document: Incidents with the potential to transmit Blood Borne Viruses guideline Copy of complete document available from: Trust intranet Date of issue: 17/09/2015 Guideline Ref No: CA4003 / V5 id 1260 Page 23 of 36 Trust Guideline for the Management of Incidents which have the potential to transmit Blood Borne Viruses APPENDIX 4 Source Patient Consent Form for Source Testing following a Blood Exposure Incident Incident date:…………………………………………………... Location:…………………………………………. Introduction It can be very frightening for health care staff when blood or body fluids contaminate them at work. Very rarely blood contains viruses, which can be contagious if they come into contact with damaged skin or through an accidental sharps injury (e.g. from a needle) or even from splashes to the eyes or mouth The Help We Need When a member of staff is contaminated with blood or body fluids they themselves may require treatment. In deciding which treatment is best we need your help in allowing us to check your blood for three important viruses, Hepatitis B, C and HIV. It is Trust policy for us to approach ALL patients in this situation. The chance of any of these viruses being present in your blood is extremely rare. However, should this be the case, your Doctor will tell you and, if necessary, arrangements will be made for further care. Negative results will be confirmed in writing to you. People often worry that if they have a HIV test, this will affect any later request for life insurance etc. The position of the Association of British Insurers is that insurance companies should not ask whether you have had an HIV test. They should only ask if you have had a positive HIV test or are receiving treatment for HIV/Aids. Therefore a negative HIV test taken purely because someone may have been exposed to your blood should have no impact on a future request for insurance. Thank you for your assistance. CONSENT Name ………………………………………… Hosp/NHS No:……………………DOB…./……/…… Address……………………………………………………………………………………………………. Home telephone Number…………………………..Ward number (if applicable)………………… GP Name …………………………………………………………………………………………………… Address ……………………………………………………………………………………………………. Have read this form and give consent to a blood sample being taken or a previous appropriate sample used and tested for the Blood Borne Viruses: Hepatitis B Virus, Hepatitis C Virus and Human Immunodeficiency Virus (HIV) I understand that this request is being made only as part of the management of an incident of an individual who has been accidentally exposed to my blood or other body fluid. I consent to the results of these tests being made known to the injured member of staff and information recorded in their Occupational Health record, also for my General Practitioner/Consultant to be informed. OR I do not consent to these blood samples being taken. (Delete whichever statement does not apply) NB: you may withdraw your consent to this blood test at any time Signature:………………………………………………….. Date (dd/mm/yyyy)………………………… This form needs to be retained in the patients hospital records/case notes & a copy faxed to Workplace Health & Wellbeing on 01603 287026. APPENDIX 5 Parent/Guardian Consent Form for Source Testing following a Blood Exposure Incident Author/s: Dr Hilliard, Wendy Sharp, Hilary Winch Valid until: 17/09/2018 Document: Incidents with the potential to transmit Blood Borne Viruses guideline Copy of complete document available from: Trust intranet Date of issue: 17/09/2015 Guideline Ref No: CA4003 / V5 id 1260 Page 24 of 36 Trust Guideline for the Management of Incidents which have the potential to transmit Blood Borne Viruses Incident date: ………………………………………. Location:……………………………………….. Introduction It can be very frightening for health care staff when blood or body fluids contaminate them at work. Very rarely blood contains viruses, which can be contagious if they come into contact with damaged skin or through an accidental sharps injury (e.g. from a needle) or even from splashes to the eyes or mouth. The Help We Need When a member of staff is contaminated with blood or body fluids they themselves may require treatment. In deciding which treatment is best we need your help in allowing us to check your blood for three important viruses, Hepatitis B, C and HIV. It is Trust policy for us to approach ALL patients or Parents/Guardians in this situation. The chance of any of these viruses being present in your child’s blood is extremely rare. However, should this be the case, your Dr will tell you and if necessary arrangements will be made for further care. Negative results will be confirmed in writing to you. People often worry that if they have a HIV test, this will affect any later request for life insurance etc. The position of the Association of British Insurers is that insurance companies should not ask whether the child had an HIV test. They should only ask if you have had a positive HIV test or are receiving treatment for HIV/Aids. Therefore a negative HIV test taken purely because someone may have been exposed to your blood should have no impact on a future request for insurance. Thank you for your assistance PARENT/ GUARDIAN CONSENT Child……………………………………………Hosp/NHS No:…………………….DOB…./……/…… Name………………………………………Relationship to child………………………………………. Address…………………………………………………………………………………………………….. Home telephone Number…………………………..Ward number (if applicable)…………………. GP Name …………………………………………………………………………………………………… Address ……………………………………………………………………………………………………. I have read this form and give consent to a blood sample being taken from the above child or a previous appropriate sample used and tested for the Blood Borne Viruses: Hepatitis B Virus, Hepatitis C Virus and Human Immunodeficiency Virus (HIV) I understand that this request is being made only as part of the management of an incident of an individual who has been accidentally exposed to the above child’s blood or other body fluid. I consent to the results of these tests being made known to the injured member of staff and information recorded in their Occupational Health record, also for my General Practitioner/Consultant to be informed. OR I do not consent to these blood samples being taken. (Delete whichever statement does not apply) NB: you may withdraw your consent to this blood test at any time Signature:………………………………………………………………….... Date (dd/mm/yyyy)…………………… This form needs to be retained in the patients hospital records/case notes & a copy faxed to Workplace Health & Wellbeing on 01603 287026 Author/s: Dr Hilliard, Wendy Sharp, Hilary Winch Valid until: 17/09/2018 Document: Incidents with the potential to transmit Blood Borne Viruses guideline Copy of complete document available from: Trust intranet Date of issue: 17/09/2015 Guideline Ref No: CA4003 / V5 id 1260 Page 25 of 36 We recognise this may be an anxious time for you therefore if you have any concerns please write them down and discuss them with an Occupational Health Adviser. Useful Telephone Numbers ICaSH Norfolk 0300 300 3030 A&E Dept: 01603 287325 Information for staff who have experienced a blood/body fluid exposure incident Preventing Blood/Body fluid exposure incidents Never re-sheath a needle Always ensure sharps bins are assembled correctly Always ensure you have a sharps bin next to you when you carry out a procedure on a patient Temporarily close your sharps bin between use Do not fill the sharps bin to more than 75% of its capacity or above the fill line Sharps should never be passed hand to hand Use appropriate Personal Protective Equipment, gloves mask or goggles Level 1 , 20 Rouen Road, Norwich, NR1 1QQ Tel: 01603 287035 - Fax: 01603 287026 Cover cuts and grazes with waterproof dressings U/Draft/WS Source Testing Guideline (12) 26 This advice leaflet has been given to you because you have experienced a blood/body fluid exposure incident. If I have been supplied PEP what happens now? When you contact Workplace Health & Wellbeing they will ensure that the relevant blood tests are taken and The Accident & Emergency Department will have already provide you with additional advice regarding the risks completed an initial assessment and advised you on any further associated with Hepatitis B and C. medication, which is called Post Exposure Prophylaxis or PEP. You must ensure you have read your PEP information Further Information sheet and taken the medication as directed. If you You can obtain further information about Blood Borne Viruses in experience any nausea or other side effects please let section 3.7 of the Trust Guideline for the Management of the Occupational Health Adviser know. Incidents which have the potential to transmit Blood Borne Viruses (found on the Trust Intranet). You will also be seen by Workplace Health & Wellebing within the next working day to discuss ongoing What else do I need to do? medication. You are now required to contact Workplace Health & Wellbeing for further advice and assessment between the following times: Will the patient’s blood be tested for Blood Borne Viruses? Monday – Friday excluding Bank Holidays Yes – If the patient is able to provide informed consent 08.30 – 17.00 the source patient will be requested to have their blood 01603 287035 or ext: 3035 tested to check they are not a carrier of a Blood Borne Virus. You will be advised of the results. Author/s: Dr Hilliard, Wendy Sharp, Hilary Winch Valid until: 17/09/2018 Document: Incidents with the potential to transmit Blood Borne Viruses guideline Copy of complete document available from: Trust intranet Date of issue: 17/09/2015 Guideline Ref No: CA4003 / V5 id 1260 Page 27 of 36 Trust Guideline for the Management of Incidents which have the potential to transmit Blood Borne Viruses Appendix 7: PEP PROFORMA Please complete and send to either Workplace Health & Wellbeing (for NNUH Trust staff) or iCaSH Norfolk, 1a Oak Street, Norwich, NR3 3AE depending on the patient. If the details are unknown, please write unknown. Patient Details Name Date of Birth Date of Consultation Past Medical History Drug History Menstruation & Pregnancy (go straight to Risk Exposure if not applicable) Date of Last Menstrual Period Method of Contraception Pregnancy testing Has a pregnancy test been done? Yes No If YES, state result: Positive Risk Exposure Negative Type of Injury Time & Date of Exposure Source Post Exposure Prophylaxis (PEP) Has PEP been recommended? Yes No If yes, state recommended treatment: ………………………….. ……………………………………………………………………….. If no, state reason: ………………………………………………… ……………………………………………………………………….. Time of 1st dose: Author/s: Dr Hilliard, Wendy Sharp, Hilary Winch Valid until: 17/09/2018 Document: Incidents with the potential to transmit Blood Borne Viruses guideline Copy of complete document available from: Trust intranet Date of issue: 17/09/2015 Guideline Ref No: CA4003 / V5 id 1260 Page 28 of 36 Trust Guideline for the Management of Incidents which have the potential to transmit Blood Borne Viruses Investigations (to be completed by Workplace Health & Wellbeing or iCaSH Norfolk) (Please tick/sign as appropriate) Investigation Date 3 to 28 days Baseline 12 weeks after PEP completion HIV Hepatitis A IgG *NR WHWB / A&E Hepatitis B Hepatitis C ** Syphilis NR WHWB / A&E STI screen * NR WHWB / A&E Full Blood Count ***** *** ***** ***** ***** ***** Liver function tests U&E Glucose Lipids Urinalysis/uPCR Pregnancy test * ** *** **** ***** N/R WHWB / A&E ***** MSM without history of vaccination HCV RNA at 28-42 days in those with known HCV status HCV RNA in those with known HCV exposure If symptoms If appropriate Appendix 8 - Background Information for Health Care Workers (HCW) on Blood Borne Viruses Author/s: Dr Hilliard, Wendy Sharp, Hilary Winch Valid until: 17/09/2018 Document: Incidents with the potential to transmit Blood Borne Viruses guideline Copy of complete document available from: Trust intranet Date of issue: 17/09/2015 Guideline Ref No: CA4003 / V5 id 1260 Page 29 of 36 Trust Guideline for the Management of Incidents which have the potential to transmit Blood Borne Viruses Human Immunodeficiency Virus (HIV) Source: Found in almost all body fluids. Only blood and blood products, semen, vaginal secretions, donor organs and tissues and breast milk have been implicated in transmission. UK Population Transmission: Men who have sex with men. Injecting drug users. Men and women who have lived as adults in countries where heterosexual transmission is common e.g. South, East or Central Africa (notably Sub Saharan Africa). Infants with HIV infected mothers or adults with HIV infected sexual partners. Occupational Transmission: To HCW ‘Average’ transmission risk for blood related sharps injury is 0.3%, for mucous membrane exposure is 0.09% (likely even lower for non-intact skin exposure). Risk also greater for patients with terminal HIV illness, but viral load assessment of source patient is not established as a means for assessing risk of transmission. From HCW Transmission has occurred from Health Care Workers undertaking exposure prone procedures, but only very rarely. Immunisation: Unavailable. Post-exposure prophylaxis: If source is known to be infected or considered to be at risk but not yet tested a 4 week course of anti-HIV drugs is indicated. High likelihood of side effects. Used only on advice of occupational physician. Hepatitis B Virus (HBV) Source: Found in virtually all body fluids. Blood, semen and vaginal fluid mainly implicated in transmission. May survive in dried blood at room temperature for at least 1 week. UK Population transmission: Unprotected sexual intercourse Author/s: Dr Hilliard, Wendy Sharp, Hilary Winch Valid until: 17/09/2018 Document: Incidents with the potential to transmit Blood Borne Viruses guideline Copy of complete document available from: Trust intranet Date of issue: 17/09/2015 Guideline Ref No: CA4003 / V5 id 1260 Page 30 of 36 Trust Guideline for the Management of Incidents which have the potential to transmit Blood Borne Viruses Inoculation of infected blood - shared injecting equipment amongst drug users. From infected mother to baby perinatally. Occupational Transmission: To HCW Sharps injury, splash onto mucous membrane (eyes or mouth), splash onto broken skin Risk of clinical hepatitis for sharps injury up to 30% for e-antigen positive source, 6% for e-antigen negative source, although the risk of developing serological evidence of infection may be substantially higher in both groups. In a given incident risk depends on viral load of source patient (not routinely assessed) and the extent of contact with the infected fluid. From HCW Transmission has occurred from HCW undertaking exposure prone procedures and those working in renal dialysis units. Workplace Health & Wellbeing will test the HCW (as the Source Patient) for levels of infectivity. Immunisation: Available and effective. Post-exposure prophylaxis: For non-immune recipients If source known to be infected specific HB immune globulin (HBIG). For all occupational incidents, whether known infected source or not, unprotected individuals should be given accelerated course of vaccination. Protection from HBIG or post exposure vaccination alone up to 75%, increasing up to 95% if combined. Hepatitis C Virus (HCV) Source: Blood mainly implicated in transmission. Data on environmental viability limited. UK Population Transmission: Inoculation of infected blood - shared injecting equipment amongst drug users. Main risk group. Unprotected sexual intercourse (low risk). From infected mother-to-baby perinatally (low risk). Is identified in individuals without obvious high risk factors. Occupational Transmission: Author/s: Dr Hilliard, Wendy Sharp, Hilary Winch Valid until: 17/09/2018 Document: Incidents with the potential to transmit Blood Borne Viruses guideline Copy of complete document available from: Trust intranet Date of issue: 17/09/2015 Guideline Ref No: CA4003 / V5 id 1260 Page 31 of 36 Trust Guideline for the Management of Incidents which have the potential to transmit Blood Borne Viruses To HCW Sharps injury, splash onto mucous membrane (eyes or mouth), splash onto broken skin. ‘Average’ incidence of anti-HCV seroconversion for sharps injury 1.8%. Actual risk depends on viral load of source patient. Risk seems very low if source has undetectable virus on PCR test. Transmission rare from mucous membrane exposure to blood and no transmission in HCW documented from intact or non-intact skin exposures to blood. High risk of infection in intravenous drug users. From HCW Transmission has occurred from HCW undertaking exposure prone procedures Immunisation: Not available. Post-exposure prophylaxis: No evidence to support an effective PEP regime. Early treatment of established infection may result in higher ‘cure’ rate. Author/s: Dr Hilliard, Wendy Sharp, Hilary Winch Valid until: 17/09/2018 Document: Incidents with the potential to transmit Blood Borne Viruses guideline Copy of complete document available from: Trust intranet Date of issue: 17/09/2015 Guideline Ref No: CA4003 / V5 id 1260 Page 32 of 36 Trust Guideline for the Management of Incidents which have the potential to transmit Blood Borne Viruses Author/s: Dr Hilliard, Wendy Sharp, Hilary Winch Valid until: 17/09/2018 Document: Incidents with the potential to transmit Blood Borne Viruses guideline Copy of complete document available from: Trust intranet Date of issue: 17/09/2015 Guideline Ref No: CA4003 / V5 id 1260 Page 33 of 36 Trust Guideline for the Management of Incidents which have the potential to transmit Blood Borne Viruses Monitoring Compliance / Effectiveness Table Element to be monitored (For NHSLA documents this must include all Level 1 minimum requirements) Lead Responsible for monitoring Appendix 9 . Monitoring Tool / Method of monitoring Frequenc y of monitorin g Lead Responsible for developing action plan & acting on recommendation s Reporting arrangements (Title needed & name of individual where appropriate) (Committee or group where monitoring results and action plan progress are reported to) Any blood and body fluid exposure incidents from a positive HIV, Hep B, C source will be reported by WHWB to HSE, Public Health England Karen Carpenter Audit 3 yearly Karen Carpenter WHWB Clinical Governance All NNUH staff who commence PEP will be followed up in line with these guidelines by WHWB Mark Ferris Audit 2 yearly Mark Ferris WHWB Clinical Governance Sharing and disseminating lessons learned & recommended changes in practice as a result of monitoring compliance with this document The Lead responsible for developing the action plans will disseminate lessons learned via the most appropriate committee e.g. Clinical Safety Executive Sub-Board, Non-Clinical Safety Executive Sub-Board, Workforce Executive Sub-Board, Executive Board or Trust Board. REFERENCES Children’s HIV Association (HIVA) (2005) www.bhiva.org/chiva/ UK guideline for the use of post-exposure prophylaxis for HIV following sexual exposure (2011) http://www.bashh.org/documents/4076.pdf?WebsiteKey=f0a15fa5-2171-4d81-af9b110c7068d66b&hkey=faccb209-a32e-46b4-8663-a895d6cc2051&=404%3bhttp%3a%2f %2fwww.bashh.org%3a80%2fBASHH%2fGuidelines%2fGuidelines%2fBASHH %2fGuidelines%2fdocuments%2f4076.pdf Author/s: Dr Hilliard, Wendy Sharp, Hilary Winch Valid until: 17/09/2018 Document: Incidents with the potential to transmit Blood Borne Viruses guideline Copy of complete document available from: Trust intranet Date of issue: 17/09/2015 Guideline Ref No: CA4003 / V5 id 1260 Page 34 of 36 Trust Guideline for the Management of Incidents which have the potential to transmit Blood Borne Viruses EAGA guidance on HIV post-exposure prophylaxis Change to recommended regime for post exposure prophylaxis (sept 2014) https://www.gov.uk/government/publications/eaga-guidance-on-hiv-post-exposureprophylaxis EAGA guidance on HIV post-exposure prophylaxis Recommendation for HIV post-exposure prophylaxis (PEP) following occupational exposure to a source with undetectable HIV viral load. https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/275060/EA GA_advice_on_PEP_after_exposure_to_UD_source_Dec13.pdf Department of Health (Revised 2008) HIV Post exposure prophylaxis: Guidance from the UK Chief Medical Officer’s Expert Advisory Group on AIDS; Department of Health Publications, London. Department of Health (2002) Getting ahead of the curve: a strategy for combating infectious diseases (including other aspects of health protection); Department of Health Publications, London Expert Advisory Group on AIDS (2014) Change to recommended regimen for postexposure prophylaxis (PEP). Department of Health, London Health and Safety Executive. (1995) A guide to the Reporting of Injuries, Diseases and Dangerous Occurrences; HSE Books, Sudbury. Jackel et al (2001), Treatment of Acute Hepatitis C with Interferon Alfa-2b, N. Eng. J Med Nov 15 (20); 345: pg;1452-1457. Norfolk and Norwich University Hospital NHS Trust Guidelines: The Management of Isolation Procedures (2005), Guideline Reg No B1, Infection Control Manual pg 6. NHS Employers - The Management of health, safety and welfare issues for NHS staff 2005, Chapter 18. Blood Borne Viruses. www.nhsemployers.org/employment MSD (2005) Summary of product characteristics, Indinavir, Crixivan Summary of Product Characteristics Public Health Laboratory Service data (2005), www.phls.co.uk Bibliography: Centre for Disease Control and Prevention (2001), Updated US Public Health Service guidelines for the management of Occupational Exposures to HBV, HCV and HIV and recommendations for Post exposure Prophylaxis. MMWR June 29, Vol 50 No: RR11 1-43. Hawkins D et al (2005). Guidelines for Management of HIV infection in pregnant women and prevention of Mother to child transmission of HIV. HIV Med Jul; 6 Suppl 2: pg. 107-48. Author/s: Dr Hilliard, Wendy Sharp, Hilary Winch Valid until: 17/09/2018 Document: Incidents with the potential to transmit Blood Borne Viruses guideline Copy of complete document available from: Trust intranet Date of issue: 17/09/2015 Guideline Ref No: CA4003 / V5 id 1260 Page 35 of 36 Trust Guideline for the Management of Incidents which have the potential to transmit Blood Borne Viruses Tokars JI, Marcus R, Culver DH, et al (1993). Surveillance of HIV infection and Zidovudine use among health care workers after occupational exposure to HIV infected blood. Ann Intern Med June 15; 118(12) : 913-9 Care worker exposures to HIV and recommendations for post exposure prophylaxis, MMWR 1998; 47 (No. RR-7) Department of Health 1996, Guidelines for pre test discussion on HIV testing, Department of Health Publications, London. Author/s: Dr Hilliard, Wendy Sharp, Hilary Winch Valid until: 17/09/2018 Document: Incidents with the potential to transmit Blood Borne Viruses guideline Copy of complete document available from: Trust intranet Date of issue: 17/09/2015 Guideline Ref No: CA4003 / V5 id 1260 Page 36 of 36