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Sharps, Needlestick Injury and Body Fluid Exposure Management Policy and Procedure Inclusive of HIV Post-Exposure Prophylaxis Please be advised that the Trust discourages the retention of hard copies of policies and procedures and can only guarantee that the policy on the Trust Intranet is the most up to date version Document Type: Policy / Procedure Version: 4 Date of Issue: November 2014 Review Date: November 2017 Lead Director: Service Transformation and Workforce Post Responsible for Update: Lead Nurse Occupational Health Approving Committee: SICC Approved by them in the minutes of: 4th November 2014 Distribution to: All Trust staff via the Trust Intranet Contents: Heading Heading (Insert Title) Number Page Number Contents / Risk rating 2 1 Introduction / Purpose 4 2 General Document 4 3 Definitions 19 4 Associated Documents 20 5 Duties 20 6 Consultation and Communication with 23 (Sharps Injury Management Policy) Stakeholders 7 Implementation 23 8 Education and training 24 9 Monitoring and review 25 10 References / Bibliography 26 11 Appendices 1. Out Of Hours Risk Assessment Questionnaire 2. Situations when HIV post exposure chemoprophylaxis (PEP) should be considered following non-sexual/occupational exposure 3. HIV post exposure chemoprophylaxis information sheet 4. Patient information sheet Truvada and Raltegravir 5. Flowchart-Sharps injury treatment 6. Flowchart-immediate actions following inoculation injury or accidental exposure to blood or body fluid. 27 Risk Rating Who will be affected by this procedure? Is there an existing risk assessment related to this procedure? If No is one required? If Yes does it require updating? Trust Employees / Patients / Contractors Yes Yes Yes – December 2010 No Yes – Date completed A Consequence (1-5) B Likelihood of Occurrence (1-5) C Risk rating Sharps, Needlestick Injury and Body Fluid Exposure Management Policy and Procedure: Page 2 of 40 (A x B = C) Raw Risk Rating (No control measures in place) 5 3 15 Final Risk Rating (Control measures in place) 5 1 5 Name: Keith Williamson Date: 24.10.14 Sharps, Needlestick Injury and Body Fluid Exposure Management Policy and Procedure: Page 3 of 40 1 Introduction / Purpose This policy and associated procedure sets out the standards for minimising the risk of transmission of blood borne viral infections (i.e. hepatitis B, C and HIV) following staff accidental body fluid exposure. Purpose: To ensure that all employees are aware of their responsibilities following exposure to body fluids, and that no one suffers ill-health due to contracting blood borne virus via occupational injury with contaminated sharp or body fluid To provide a clear framework for the management of body fluid exposure including post exposure chemoprophylaxis (PEP) To provide information regarding the prevention of exposure to body fluids, and the protection of employees It is the policy of the Trust that no one will be discriminated against on grounds of age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion or belief, sex or sexual orientation. The Trust will provide interpretation services or documentation in other mediums as requested and necessary to ensure natural justice and equality of access. 2 General Document Principles 2.1 Sharps Injury Management Policy Potential routes of exposure: Percutaneous Exposure: The skin of the recipient is cut or penetrated via needle or other sharp object e.g. scalpel, blade, trochar, bone fragment or tooth, which is contaminated by blood or other body fluids. Mucocutaneous Exposure: Blood or other body fluid contaminates the eyes, the inside of the nose or mouth, or an area of non-intact skin of the recipient. Exposures to low risk body fluids e.g. urine, vomit, faeces, sputum and saliva (except when associated with dentistry) are not normally considered a risk unless visibly blood stained. Exposure of unbroken skin or mucous membranes to blood or body fluids has not been associated with blood borne virus transmission. Injuries with unused needles or sharps should be cleaned, a waterproof dressing applied and an incident form completed; in this circumstance there is no reason to inform Occupational Health or report to ED out-of-hours. It is recognised that healthcare workers may be exposed to sources of infection outside their employment. This procedure will be followed in such circumstances to minimise the onward transmission of infection to others. Body fluids, which may transfer infection: Blood Saliva, associated with dentistry. Sharps, Needlestick Injury and Body Fluid Exposure Management Policy and Procedure: Page 4 of 40 Cerebral-spinal fluid. Pericardial fluid. Peritoneal fluid. Pleural fluid. Synovial fluid. Unfixed human tissue and organs. Exudate or tissue fluid from burns/wounds. Vaginal fluid. Semen. Amniotic fluid. Human breast milk. Any other body fluid if visibly blood stained Protection of Staff: Exposure to blood borne viruses has been risk assessed by the Trust and an immunisation programme is available to all qualifying Trust employees. Immunisation is available to all staff via the Occupational Health Department. During the recruitment of healthcare workers, all clinically based employees are required to complete a health declaration form, which includes a job risk assessment section. The recruiting manager completes this; the job risk assessment identifies employees who are potentially exposed to blood borne viruses and they will be offered immunisation. Those healthcare workers who undertake procedures which pose a risk of infecting patients will be required to prove they are not an infection risk prior to undertaking such procedures by means of a blood sample result which has been tested in a UK laboratory (It maybe necessary for a blood sample to be obtained and tested prior to performing exposure prone procedures). Those employees who are an infection risk will not be allowed to carry out exposure prone procedures, until considered and extensive advice has been obtained surrounding the particular situation and the necessary steps taken to minimise the risk of transmission. Refer to viral hepatitis and Aids/HIV employment policies if positive for blood borne viruses. Immediate post exposure action to be taken by the health care worker: Any healthcare worker who has had an exposure to a needle stick/sharp or body fluid exposure should: Wash the site with soap and water, no scrubbing. (Antiseptics and skin wash should not be used) Irrigate exposed eyes, mouth or broken skin with saline/ water (eyes should be cleaned pre and post removal of contact lenses) attend ED if assistance required). Gently encourage free bleeding of puncture wounds, milk the wound do not suck the wound. Report the injury to the person in charge and complete an incident form. Establish source and risk assess (Manager). 2.2. Essential aspects of post exposure risk assessment: Donor Patient: Sharps, Needlestick Injury and Body Fluid Exposure Management Policy and Procedure: Page 5 of 40 It is essential that full and thorough risk assessment of the donor patient be undertaken by the most senior medical/nursing person available (Risk Assessment of the donor patient should not be undertaken by the recipient/injured health care worker) The decision on whether any post-exposure prophylaxis is administered depends on risk assessment of the source of the injury and must include as a minimum: o o o o o o o o o Donor’s age Donor’s sex Diagnosis Race Sexual orientation Sexual promiscuity Intravenous drug abuse both past and present Country of origin or return form areas with high prevalence of HIV infection in the community e.g. Sub-Saharan urban Africa. Medical history of liver disease, jaundice and hepatitis Recipient health care worker: Of equal importance as the risk assessment of the donor patient for active/potential of blood borne virus infection is the completion and thorough risk assessment of the recipient healthcare worker. Risk assessment of the recipient healthcare worker will be performed by the Occupational Health Department and in the event of the injury occurring outside of office hours then by the Emergency Department. Healthcare workers must not complete their own risk assessment and equally should not ask a colleague to do it; treatments other than first aid must not be administrated at departmental level. Failure to comply with this stipulation could have potentially life threatening consequences and may result in disciplinary sanctions. Essentially the risk assessment must include: Nature of injury i.e. bite, scratch, puncture wound, splash injury Deepness of injury Visible blood on injury device Injury from needle or device from source patient’s artery/vein Timescale since injury First aid measures employed Hepatitis B immunity status of the recipient healthcare worker Health status of recipient healthcare worker, i.e. hepatic disease, pregnancy etc. 2.3 Mandatory blood sampling (at time of injury): In all circumstances where exposure has been assessed to have occurred then the following blood samples must be obtained: Donor patient: Consensual bloods should be obtained for: Hepatitis B surface antigen Hepatitis C antibody HIV 1&2 antibodies and P24 antigen Sharps, Needlestick Injury and Body Fluid Exposure Management Policy and Procedure: Page 6 of 40 Donor patients should be informed that the test does not form part of their clinical notes and they will receive feedback if they are discovered to have carrier status. Donor patients should be informed that the test is similar to testing that is undertaken when donating blood and does not require declaration on life insurance policy applications. Donor patients must be informed that the results of their tests will be made known to the Occupational Health department and to the recipient if any tests return positive. Recipient healthcare worker: Consensual blood should be obtained for storage only If the Hepatitis B antibody status is unclear then this must be requested at this juncture 2.4. Prevention of exposure to blood and body fluids: Prior to commencement of hands on patient care all health care workers must: Wash hands before and after patient contact and before putting on and after removing gloves; gloves must be changed between patient contacts. Use gloves where there is likelihood of exposure to body fluids (including venepuncture) Surgeons should ‘double glove’ except for exceptional circumstances. Use waterproof plasters and gloves to cover all breaks in skin especially where contact with body fluids is anticipated. Use goggles, visors, masks and gowns and aprons to avoid splash injuries in to eyes, mouth, body and clothing where provided and instructed. Seek advice from the Occupational Health department for skin conditions such as dermatitis/eczema. Spillages of body fluids should be dealt with by following the appropriate infection control policy; appropriate use of personal protective equipment and use of spillage kit where available. Wear appropriate footwear in locations where blood spillages may occur or sharp instruments or needles are being handled. To help reduce the risk of sharps injuries and body fluid exposure healthcare staff must: Take particular care when handling sharps no hand-to-hand transfers or procedures directed towards the hand. Be vigilant and acknowledge fatigue, which may affect concentration. Take the sharps bin to the point of use before starting the procedure. Use gloves to prevent percutaneous exposure to blood. Never become distracted from the task in hand. Never re-sheathe, bend or break needles before disposal. It is the sharps users’ responsibility to dispose of the sharp in a recognised container. Carefully remove needle and apply obturator when transporting arterial blood for analysis. Intravascular guide wires and chest drain trocars must be disposed of in the appropriate sized sharps bins. Avoid unnecessary use of sharps e.g. collection of urine samples from catheter bags using needles. Use needle free devices where it is reasonably practicable to do so Use safer sharps where it is reasonably practicable to do so providing the device does not: o Compromise patient care o And is reasonably practicable to do so 2.5 Safe use of containers for sharps disposal: Sharps, Needlestick Injury and Body Fluid Exposure Management Policy and Procedure: Page 7 of 40 Trust staff must: Only use sharps containers approved by the Infection Prevention & Control team and those that comply with British Standard (7320) Never force anything in to a sharps container Never attempt to retrieve anything from a sharps container. Never place sharps containers in a public place or on the floor. Label sharps bin on assembly and closure. Ensure temporary closure of sharps bins during any transportation Secure and replace sharps bins when they are 3/4 full or approaching that level, never overfill. Thoroughly dispose of giving sets in sharps bins approved for that purpose. Responsibility for the preparation use and storage of used containers rests with the manager in accordance with national policy Use needle free devices or safer sharps device where provided and reasonably practicable to do so. Responsibility for the collection of used sharps bins for incineration rests with the Support Services Manager. 2.6 Procedure for sharps injury and body fluid management, including post-exposure chemoprophylaxis 2.6.1 Protection against hepatitis B, management and risk assessment: The action needed to be taken in the immediate post exposure period to protect the recipient health care worker against Hepatitis B is dependent on the vaccination status of the health care worker and the Hepatitis B surface antigen level of the donor (both if known). This will be managed by the Occupational Health Department and out of hours it will be dealt with by the Emergency Department using the designated exposure risk assessment and procedure form (appendix D) All staff dealing directly with patients and/or body fluids or likely to come in to contact with blood/body fluids in the execution of their routine duties should be immunised against hepatitis B virus. Each member of staff who has been immunised has a responsibility to know their Hepatitis B antibody status after completion of the course. The titre level falls over a period of years and staff members should have a one off booster at 5 years. Response to Hepatitis B vaccination: Knowledge of the recipient healthcare worker’s response to Hepatitis B vaccine is required to perform a satisfactory assessment of risk. Response to vaccination will be: a. Nil/ non-responder: non-responders are particularly susceptible to Hepatitis B infection so should be extra vigilant to avoid inoculation injuries. Will have titre levels less than 10 units/ml. b. Poor responder: titre levels greater than 10 units/ml and less than 100 units/ml are recognised as having a degree of protection, but will be at high risk from Hepatitis B ‘e’ antigen positive patients. c. Satisfactory responder: will have titre levels greater than 100 units/ml and will be considered immune to Hepatitis B virus and following a booster dose after 5 years are considered immune for life. Sharps, Needlestick Injury and Body Fluid Exposure Management Policy and Procedure: Page 8 of 40 Hepatitis B post exposure prophylaxis: HBV status of person exposed. Less than 2 doses of Hep B vaccine pre-exposure. More than 2 doses of Hep B vaccine pre-exposure. Hepatitis B antibodies unknown. Known responder to Hep B vaccine. Antibodies unknown. Known nonresponder to Hep B vaccine. Source Hep B antigen positive. Accelerated course of Hep B vaccine& Hepatitis B Immunoglobulin x1. (HBIG) 1 dose of Hep B vaccine followed by 2nd dose 1 month later. Source Hep B antigen negative. Start a course of Hep B vaccine. Give booster dose of Hep B vaccine if recipient has not had 5-year booster. Consider booster dose of Hep B vaccine if recipient has not had 5-year booster. HBIGx1** and booster dose Hep B vaccine. No HBIG required. Consider booster of Hep B vaccine. Source Unknown. Accelerated course of Hep B vaccine. * Complete the course of Administer 1 dose Hep B vaccine. Hep B vaccine as a booster within 48 hours. Consider booster dose of Hep B vaccine if recipient has not had 5- year booster. HBIGx1** required if high risk Consider booster Of Hep B vaccine. *Accelerated course of Hepatitis B vaccine is given at 0, 1 and 2 months with a booster dose at 12 months for anyone remaining at risk from Hepatitis B virus. **If hepatitis B immunoglobulin is required this can be obtained from Public Health England laboratory following discussion with the on-call microbiologist. Hepatitis B immunoglobulin should be given as soon as possible preferably within 12-hours, ideally with 48-hours however no later than 1 week. Dose for adults over 10-years of age is 500 iu. 2.6.2 Protection against hepatitis C, management and risk assessment: Currently there is no vaccine or recognised post exposure prophylaxis against Hepatitis C virus therefore universal precautionary measures need to be adopted as detailed in the policy section of this document. If the source patient is found or known to be Hepatitis C positive then the healthcare worker must attend Occupational Health for follow-up. Treatment in the early stages of Hepatitis C infection has been shown to be effective therefore both the source patient and the recipient healthcare worker should be referred to an appropriate specialist if Hepatitis C positive. A positive Hepatitis C RNA (ribonucleic acid polymerase chain reaction) test in an individual with Hepatitis C antibodies indicates that they have active disease and are capable of infecting others exposed to their body fluids. A negative Hepatitis C RNA test in an individual with Hepatitis C antibodies indicated that they are unlikely to have active disease and therefore unlikely to infect others exposed to their body fluids. Sharps, Needlestick Injury and Body Fluid Exposure Management Policy and Procedure: Page 9 of 40 Hepatitis C Positive Donor Patient: If the donor patient is Hepatitis C positive, then the donor’s blood will be need to be checked for Hep C RNA. The recipient healthcare worker will be tested at 6 and 12 weeks in cases where the donor is Hep C RNA positive and if there is evidence of acquisition they will be referred to a Consultant Hepatologist for advice and counselling. Source Unknown: In the event that the source/donor patient cannot be tested for whatever reason then management of the recipient should be based on a risk assessment. Clinical information about the incident and/or source will be reviewed. If due to the incident it is considered that the recipient is at high risk of becoming infected with Hep C virus then the healthcare worker may be managed as if the source was known to be Hep C RNA positive (this would normally only be if the source was known to be or highly suspected to be an intravenous drug user) Summary: (Investigations and follow-up of recipient healthcare workers when donor patient is known to be Hepatitis C infected) Obtain serum/EDTA for HCV-RNA (viral load) at 6 and 12 weeks Obtain serum/ EDTA for genome detection at 6 and 12 weeks Obtain serum for antibodies-HCV at 12 and 24 weeks. Hepatitis C virus status of source unknown: Perform a risk assessment of incident and clinical details. If source considered high risk then treat incident as if an infected source as above. If source considered low/unknown risk then obtain base line serum/EDTA sample for storage and serum for anti-HCV at 24 weeks. Genotyping of the source and the recipient will help establish if transmission of Hep C virus from patient to healthcare worker has occurred. 2.6.3 Human immunodeficiency Virus (HIV), Management and Risk Assessment: There is no risk of HIV transmission when intact skin is in contact with HIV infected blood, regardless of viral load. Currently there is no vaccination against HIV but post-exposure prophylaxis is available. Department of Health studies have shown there is a low chance of HIV transmission following percutaneous or mucutaneous injury from a known HIV infected source. However, some factors are associated with increased risk of HIV transmission: Deep injury Blood on the device from which the injury occurred Sharps, Needlestick Injury and Body Fluid Exposure Management Policy and Procedure: Page 10 of 40 Injury from a needle or device that had been in the source patient’s artery or vein. Terminal HIV infection in the source patient Fresh blood on the device, HIV is affected by UV light and drying The initial risk assessment should be based on the potential for viral transmission, i.e. the type of body fluid involved, the route and severity of exposure. For example some occupational exposures after careful assessment may not be considered to be significant and do not pose any risk of HIV transmission. In such circumstances post-exposure prophylaxis should not be given. HIV Exposure Circumstances: High risks of HIV cross-infection Post-exposure prophylaxis would be recommended for percutaneous exposures involving all of the following: (reference appendix 2) Deep injury. Visible blood on injury device Injury with needle or device that has been in a donor patient’s artery/vein Terminal HIV related illness in donor patient High viral load; a recent infection with HIV that has resulted in seroconversion or one with late stage HIV infection or with a measured HIV viral load of greater than 50,000 copies/ml. Or donor patient suspected to be infected i.e. Positive HIV antibody test. On antiretroviral drugs but refuses test. Source patient is unable to give history/consent (unconscious, mentally impaired) but history from medical notes/family etc. strongly suggests HIV infection. Current or remote history of immune deficiency which is acquired plus one of the following risk factors: 1. 2. 3. 4. 5. 6. Homosexual/bisexual male who partakes/partook in unprotected anal intercourse. Intravenous drug user, both recent and remote. Haemophiliac receiving factor viii/cryoprecipitate prior to 1986 or from overseas Sex worker male/female. Recent arrival from or hospitalisation in urban sub-Saharan Africa. Unprotected sex with persons at high risk of HIV. Both males and females. Actions required: Refer the recipient healthcare worker to the Occupational Health Department between 8.30am and 4.30pm, Monday to Friday. Outside these hours managers should ensure that the recipient healthcare worker reports to nearest Emergency Department promptly so HIV post exposure chemoprophylaxis can be commenced without delay (if recommended following risk assessment). Managers should ensure that the recipient health care worker reports the incident to Occupational Health the next working day for follow-up. Moderate risk of HIV cross Infection: HIV post-exposure prophylaxis may be recommended after exposures involving the following: Sharps, Needlestick Injury and Body Fluid Exposure Management Policy and Procedure: Page 11 of 40 Other potentially infected body fluids i.e. amniotic fluid, vaginal secretions, semen, human breast milk, CSF, pleural/peritoneal/synovial and any other body fluid visibly blood stained, unfixed human tissues and organs, saliva associated with dentistry and exudate or other tissue fluid from burns or skin lesions. Mucous membranes splashes (to eyes and mouth) with HIV infected blood or blood strongly suspected to be HIV positive, i.e. donor patient from any listed in points 1-6 above. Strongly suspected: Includes donor patients with clinical symptoms indicative of HIV infection and those recently arrived from sub-Saharan Africa who have not yet been tested. It does not include one lifestyle factor such as Intravenous drug user or injuries from unknown sources. Actions required: Refer the recipient healthcare worker to Occupational Health department between 8.30am and 4.30pm, Monday to Friday. Outside of these hours’ managers should ensure that the recipient healthcare worker reports to the Emergency Department promptly so that HIV-post exposure chemoprophylaxis can be commenced promptly if risk assessment necessitates. Managers should ensure that the healthcare worker reports the incident to the Occupational Health department the next working day for follow-up. Low risk of HIV cross-infection: Circumstances where HIV prophylaxis should not be given: Intact skin exposed to HIV infected blood regardless of HIV viral load. Donor patient is proven to be HIV-negative. Actions required: No further actions required other than completion of accident form and reporting of the incident to Occupational Health department, to ensure no risk has occurred. 2.6.4 Illnesses that may be indicative of HIV/AIDS in donor patients: o o o o o o o o o o o o o o o o o Candidiasis: oesophageal, tracheal, bronchi or lungs. Coccidioidomycosis: extrapulmonary. Cryptococcosis: extrapulmonary. Cryptosporidiosis: with diarrhoea for excess of 1 month. Cytomegalovirus: retinitis, disease (not hepatic splenetic or nodal). Herpes simplex: ulcers greater than 1-month duration or bronchitis, pneumonitis, oseaphagitis. Histoplasmosis: disseminated/extrapulmonary. Isosporiasis: with diarrhoea for excess of 1 month. Kaposi’s sarcoma. Lymphoma: immunoblastic, primary in the brain. Mycobacterium avium complex: extrapulmonary Mycobacterium TB: pulmonary or extrapulmonary with positive Mantoux. Pneumocystis carinii, pneumonia. Pneumonia: excess of 2 episodes in 12 months. Progressive multifocal leucoencephalopathy. Salmonella: septicaemia recurrent. Toxoplasmosis: brain. Sharps, Needlestick Injury and Body Fluid Exposure Management Policy and Procedure: Page 12 of 40 Some of these illnesses may result from other causes of immunodeficiency. Example: immunosuppressive therapy, bone marrow transplantation, cytotoxic therapy, and leukaemia. If the answer is yes to any of the above then immediate specialist help is required. Contact Occupational Health department (during working hours) or A&E outside of office hours the on-call Microbiologist can also be contacted via switchboard. 2.7. Risk from discarded hypodermic needles/unidentified Donor: The risk from blood borne virus reduces with drying. The risk from blood borne virus reduces with time. The risk of blood borne virus reduces with exposure to UV light. Health Protection England does not recommend routine testing of needles or sharps for presence of blood borne virus in this type of injury. Therefore in the case of the source patient being unknown because devise was discarded then location of the sharp/device should be taken into account when considering the risk. I.e. Infectious Diseases Unit, needle exchange clinic, toilet or psychiatric or medical ward with known Intravenous drug user. Actions required: Hepatitis B vaccination is offered if not previously immunised or if last immunisation was in excess of 1-year. Blood should be taken from the recipient healthcare worker for storage. Normally Hep B immunoglobulin is not required or given. The risk from such incidents is considered low. The recipient healthcare worker must reports incident to Occupational Health who will arrange any follow-up including Hepatitis C antibody screen in 24 weeks from exposure. 2.8 Donor blood not available for testing: If donor is known but blood is not obtainable, the decisions as to whether any post-exposure prophylaxis depends on thorough risk assessment of the source of the injury. Including: Donor’s age Sex Diagnosis Race Sexual orientation Sex industry worker Intravenous drug user both present/past Country of origin or return from area with high prevalence of HIV infection in the community, e.g. sub-Saharan urban Africa. Past history of liver disease, jaundice, hepatitis. 2.9. Actions following inoculation/splash exposure: After sustaining an injury, the individual concerned should perform immediate first aid Actions involving the donor patient: Sharps, Needlestick Injury and Body Fluid Exposure Management Policy and Procedure: Page 13 of 40 A risk assessment of the donor patient must be carried out as soon as possible after the injury has occurred. This should ideally be carried out by the clinician responsible for the patent, but may also be performed by a responsible other e.g. Ward Sister/Manager. If the source is HIV positive/strongly suspected then the recipient healthcare worker MUST be risk assessed regarding commencing antiretroviral treatment immediately. Starter packs available via the Emergency Department/Occupational Health. The individual completing the risk assessment should obtain consent for blood from the donor patient. A sample of the donor patient’s blood should be obtained in an EDTA clotted tube and sent to Microbiology to test for Hepatitis B surface antigen, Hepatitis C antibodies, and HIV 1&2 antibodies and P24 antigen. The sample must be obtained with informed consent (from the donor or in the case of a minor then from their legal guardian) and this must be documented in the patient’s notes. Blood samples from unconscious patients must not be taken (Human Tissue Act 2004). In this circumstance decisions regarding PEP must be made on risk assessment only. The donor must be approached with extreme tact and sensitivity, permission must be sought and the circumstances explained. The test performed will be for the benefit of the recipient and the results will not be referred back to the donor patient’s notes unless requested by the donor patient. It should be explained that the tests performed are the same as for blood donors and therefore do not have to be declared to insurance companies. The fact of testing for HIV should not be suppressed or over emphasised. If any results return positive then the Consultant in charge of the patient’s care must take charge of the management of the feedback of results and any subsequent follow-up. Actions involving the recipient healthcare worker: If the donor patient is HIV positive with high viral load and the assessment of risk is high then the recipient healthcare worker must receive antiretroviral therapy immediately without delay. Starter packs are available via Emergency Department (ED) Leighton Hospital/Macclesfield Hospital or Pharmacy MCHFT/ECT. The recipient healthcare worker involved in the incident should provide a sample of blood in a 10ml-clotted EDTA tube to be sent to microbiology for storage. The healthcare worker must be informed that this baseline blood sample will be stored for 2 years. The Hepatitis vaccination history of the recipient healthcare worker should be ascertained and if appropriate the sample should be tested for Hepatitis B antibodies prior to storage. Blood samples can be sent from either Occupational Health or ED. If the recipient Healthcare worker has been successfully vaccinated against Hepatitis B no further treatment is required immediately. In circumstances where the recipient healthcare worker has no/ incomplete history of vaccination against Hepatitis B then a single dose of vaccine should be given within 48-hours. If the source is Hepatitis B surface antigen positive/strongly suspected then Hepatitis B immunoglobulin (HBIG) should be started preferably within 12-hours, ideally within 48-hours however no later than 1-week from injury. HBIG is available from Public Health England Laboratory, North West Region-0161 276 8788/8854 Sharps, Needlestick Injury and Body Fluid Exposure Management Policy and Procedure: Page 14 of 40 Injuries from unknown donors are usually classed as low risk. Action following exposure should involve all steps except obviously collection of donor bloods. All recipient healthcare worker exposures must report via telephone to the Occupational Health department as soon as possible, either immediately or if the injury occurred out-of-hours then the next working day. Blood sampling required: The Virology request form that accompanies the donor patient’s blood must include the following information: Clearly state that the blood sample is from a ‘Inoculation Injury donor patient’ Clearly states the donor patient’s name, hospital number, and ward and department. Clearly states the recipient’s healthcare workers Occupational Health number and Date of birth. Clearly states the date, time and nature of incident. Tests required are Hep B surface antigen, Hep C antibody & HIV antibodies. Results to be returned to Occupational health department. The Virology request form that accompanies the recipient healthcare worker’s blood must include the following information: Clearly state the blood sample is from an ‘Inoculation injury RECIPIENT healthcare worker’ Clearly states that sample is for STORAGE ONLY. Clearly states the name, ward and hospital number of donor. Clearly states the date, time and nature of accident. Clearly states STAFF in place of hospital number. Results to be returned to Occupational Health Department. If the donor patient has not been tested and the risk is deemed significant then the recipient healthcare worker should be tested as follows: Time Scale Hepatitis B At time of injury 6-Weeks Hepatitis C Hepatitis C (Source known positive or high risk) (Source unknown or low risk) 6mls Clotted Sample For Storage Surface antigen PCR (viral load) PCR and antibody 12-weeks 24-weeks HIV Surface antigen Surface antigen & surface antibodies* Antibody Antigen/antibody combined test. Antibody * Hepatitis surface antibody testing is only required at 6-months if Hepatitis B vaccination was commenced at time of injury. 2.10. Accidents during surgery/exposure prone procedures (EPP) What is an exposure prone procedure? Sharps, Needlestick Injury and Body Fluid Exposure Management Policy and Procedure: Page 15 of 40 Any procedure where the operator’s hand is in a body cavity in the presence of a sharp instrument / needle or bone spicule or tooth. Surgery Child birth Dentistry If exposure occurs from a Healthcare worker undertaking an exposure prone procedure to a patient (recipient), in this instance if the operator’s blood might have been inoculated into the patient, the operator is regarded as the donor and will need to be counselled appropriately and their blood is tested for blood borne agents. The patient will be reassured with the results of any tests and offered appropriate prophylaxis if indicated. It is Trust policy to test all new employees partaking in exposure prone procedures for mandatory Hepatitis B antibodies and surface antigen, Hepatitis C antibody, and since January 2007 HIV 1&2 antibodies, prior to starting employment, (Ref: Occupational Health Hepatitis Employment Policy and HIV Employment Policy). If for any reason the Healthcare workers blood borne virus status is unknown then bloods must be obtained for Hepatitis B surface antigen, Hep C antibodies and HIV antibodies without delay, Infection Prevention and Control must be informed immediately. Refer to United Kingdom Expert Advisory Group on AIDS. The consultant in-charge of patient’s care must be informed immediately. 2.11. Information and advice on HIV post exposure chemoprophylaxis (HIV-PEP): If a significant exposure has occurred and the donor patient is known to be HIV positive or risk assessment indicates ‘high risk’ then HIV- PEP should be commenced (Appendix 2). Best practice indicates that that the first dose should be given within 1 hour (HIV-PEP can be given up to 72 hours post-exposure but the effectiveness is reduced by time). Specialist advice needs to be sought if the donor patient is known to be HIV-positive or is unwilling to give consent for HIV testing. If the donor patient’s HIV status is uncertain or unknown but the source has been identified through risk assessment, as having risk factors for HIV then expert consideration needs to be given on whether to start PEP, pending further investigation. Specialist advise can be sought from Consultant Microbiologist, local GUM/Sexual Health Centre or out-ofhours GUM/ID on-call at Royal Liverpool Hospital 0161 706 2000. The recipient healthcare worker must not carry out the risk assessment on the possibility of the donor patient being HIV positive. Ideally the most senior member of the medical team caring for the donor patient (that is available) completes the risk assessment, or a competent other e.g. Senior Nurse, ward Manager/Sister, Nurse Practitioner or Modern Matron, in conjunction with a Consultant with specialist knowledge of HIV if required. If the risk assessment concludes that the donor patient is HIV positive then HIVPEP should commence immediately, ideally within 1 hour of the injury and the donor patient tested (subject to informed consent) for HIV. Based on the results of the donor patient testing the recipient health care worker. (Following advice from a specialist clinician) can make an informed decision on whether to continue with HIV-PEP. If the HIV status of the donor patient cannot be established, the recipient healthcare worker should be given the opportunity to decide whether to start and/or continue with HIV-PEP. Sharps, Needlestick Injury and Body Fluid Exposure Management Policy and Procedure: Page 16 of 40 This decision should be taken with advice from a specialist in HIV to include all knowledge of the donor patient, the risks of infection and the nature and severity of the exposure. The recipient healthcare worker must be advised on the potential for HIV-PEP to produce unpleasant and potentially serious side effects, and a copy of the Trust information sheet for healthcare workers commencing HIV-PEP should be given to the recipient healthcare worker, informed consent should be established before dispensing of medications. If on risk assessment the donor patient is considered to be highly unlikely to be HIV positive, then HIV-PEP is not normally recommended or commenced. However, there is still a requirement to test the donor patient for HIV and the recipient healthcare worker can be offered HIV-PEP in the event of a positive result. This universal approach to donor patient testing reduces the need to make difficult judgements and helps to avoid the possibility of discrimination. Ideally HIV-PEP should be commenced within 1 hour of potential exposure to HIV. However, the exact mechanisms of HIV infection are not currently fully understood, therefore if more than 1 hour has elapsed after exposure this does not automatically exclude starting HIV-PEP. The Department of Health states that the effectiveness of HIV-PEP diminishes with time and it should be commenced within a 72-hour window, but it is worth considering starting PEP up to 2 weeks following exposure. Specialist advice must be sought in this circumstance. If the recipient healthcare worker is female, consideration should be give to the possibility of pregnancy. For female healthcare workers who cannot rule out pregnancy advice from a specialist in HIV should be sought prior to commencing PEP. For further advice contact the Sexual Health department between 9am and 5pm Monday to Friday or outside these hours, the GUM/ID on-call at Royal Liverpool Hospital 0151 706-2000. Starter packs for HIV post exposure prophylaxis are available via the Emergency Department or pharmacy or on-call pharmacist contacted via switchboard. The prophylactic drugs act synergistically inhibiting the earliest stages of HIV infection by interfering with the initial cycles of HIV. This combination of drugs is one of the most potent cocktail of drugs available at present, but there are documented cases where the regimen has failed HIV post Exposure prophylaxis regime: The recommended starter pack regimen is: TRUVADA* RALTEGRAVIR (1 tablet once a day) for 3-5 days (1 tablet twice a day) for 3-5 days *An alternative to Truvada for patients with renal failure is Combivir (zidovudine+lamivudine) at a dose of 1 tablet BD in adults; please discuss with local/regional HIV team. This combination of drugs may have to be taken for up to 4 weeks Before commencing PEP, take bloods for: Full blood count Urea and electrolytes Liver function test, amylase Glucose and lipids Sharps, Needlestick Injury and Body Fluid Exposure Management Policy and Procedure: Page 17 of 40 EDTA blood sample to virology requesting ‘HIV test and save’ clearly stating pre-PEP, post inoculation injury. Ensure that STAFF is written on the form so any results are returned to Occupational Health to ensure confidentiality. The advantages of taking PEP: These drugs inhibit the growth of HIV in the laboratory. In studies those who took Azidothymidine (Zidovudine/AZT) after an injury with HIV infected blood had a reduced risk of getting infected with compared with those who did not take it. In some animal models using very high doses of the virus, AZT given early did reduce virus multiplication and in 2 studies actually prevented infection (relevance of animal experiments to human infection is unknown) Immediate combination therapy after significant exposure is now recommended in most centres caring for individuals with HIV in the UK, USA and Canada. The disadvantages of taking PEP: These drugs do have side effects. The combination of these drugs in the PEP packs have been specifically selected because they have relatively few side effects and are easy to take. However, common side effects (affecting 1-10 users in 100), when taking a combination of antiretroviral drugs may include: Diarrhoea Lack of strength and energy Nausea and vomiting, abdominal pain, wind Changes in body fat distribution- loss of fat from arms, legs and face and an increase in fat in the abdomen, breasts and back of the neck (buffalo hump). Anaemia (low red blood cell count) and neutropenia/leukopenia (low white blood cell count) may occur within 4-6 weeks due to treatment with Combivir. Please refer to the current British National Formulary (BNF), the Summary of Product Characteristics (SPC) and Patient information leaflet (PIL) for further information on adverse effects. The long-term side effects of taking these drugs are not known. These drugs can interact with other drugs the patient may be taking (whilst taking HIV-PEP the individual should be advised to inform the prescribing Doctor of all current medication that they are taking, and any medication that they have bought themselves. The effects of the drugs on the developing foetus are unknown. These drugs are not a guarantee that the person will not become infected with HIV. If the individual is already infected with HIV then the individual should not start PEP as it would be unnecessary and would have the potential for resistant virus to develop. Sharps, Needlestick Injury and Body Fluid Exposure Management Policy and Procedure: Page 18 of 40 If the healthcare worker decides to commence PEP then they must be advised to take adequate precautions to prevent pregnancy for 3 months. Using condoms is important, as it will protect any sexual partner if the individual has become infected with HIV through this incident. For further information contact the Sexual Health Service or on-call ID/GUM Consultant at Liverpool Royal Infirmary, between 9am and 5pm Monday to Friday. Any healthcare worker commenced on HIV post-exposure prophylaxis will be supported by the occupational health department via the Occupational Health Nurses and the Physician. The Occupational Health department will ensure that the necessary referral to a Specialist Physician in HIV medicine is completed and co-ordinate specialist counselling if necessary. Occupational Health staff will also be responsible for ensuring that follow-up testing at 12 -weeks to exclude HIV contamination of healthcare workers exposed to HIV positive blood is completed or 12weeks after completion of treatment if PEP was prescribed. The emotional impact of taking HIV post-exposure prophylaxis must not be under-estimated, and the Occupational Health department is responsible for ensuring that all necessary support is in place. 2.12. Out-of-Hours Management: The out-of-hours management of accidental inoculation incidents is the responsibility of the Emergency Department. During these hours they will assume the responsibility for risk assessment of the donor, recipient and administration of treatments including post exposure prophylaxis if indicated as necessary by risk assessment. The Emergency Department, nursing and medical staff will complete the out-of-hours profroma (Appendix) in full and will ensure that the Occupational Health Service received copies of the completed documentation for follow-up and audit purposes. 3 Definitions Blood borne viruses refer to a virus, which is transmitted through contact with body fluids i.e., blood, and saliva. Recipient refers to the person receiving the exposure to body fluids. Source refers to patient/client/person from which the body fluid came. HbAB Hepatitis B antibody HbIG Hepatitis B Immunoglobulin HIV Human Immunodeficiency Virus NSI Needlestick Injury BFC Body Fluid Contact HIV-PEP HIV Post Exposure Prophylaxis 3.1 Policy ‘A policy is a statement of Trust intent for a given issue and gives a clear position statement for the Trust’s customers and employees on its values and beliefs’ (Parsley & Corrigan 1999). A policy is a “must do”; there should be no deviation from the actions as defined in the policy. Any deviation must be discussed and approved by the Strategic Integrated Governance Committee. 3.2 Guideline A guideline is an overview of processes either clinical or non-clinical, to be undertaken in certain conditions. A guideline gives practical guidance as to how to deliver best practice Sharps, Needlestick Injury and Body Fluid Exposure Management Policy and Procedure: Page 19 of 40 but allows for professional initiative and informed decision making. Any deviation from a Trust guidance document, along with the reasons why, must be documented in the Health Records. 3.3 Clinical Pathway / Standard Operating Procedure (SOP) A Clinical Pathway / SOP is a working document detailing the current agreed working practice that takes account of all the areas that are applicable to the management of a process in an individual setting 4 Associated Documents U.K. Health Departments 1998. Guidance for Clinical Health Care Workers: Protection against Infection with Blood borne Viruses: Recommendations of the Expert Advisory Group on AIDS and the Advisory Group on Hepatitis (HSC 1998/063) AIDS/HIV infected Health Care Workers: Guidance on the management of infected Health Care Workers and Patient Notification: UK Health Departments November 1999. Health Service Circular (HSC) 2202/010 Hepatitis C Infected Health Care workers. Department of Health: Clearance for TB, Hep B, Hep C and HIV for New Healthcare Workers. 2007 Department of Health, Guidance from UK Chief Medical Officers Advisory Group on AIDS, HIV Post-exposure prophylaxis, 2008 Her Majesty’s Stationery Office, Human Tissue Act 2004. Health and Safety Executive, Health and Safety (Sharps Instruments in Healthcare) Regulations 2013 Mersey, Cheshire and North Wales HIV Managed Care Network, Guidelines for Post Exposure Prophylaxis for HIV Following Occupational or Sexual Exposure version 3 And with the following Policies/Procedures: Infection Prevention and Control and Occupational Health Infection Prevention and Control Good Practice guidelines Universal Precautions Protocol Safer Handling of Sharps Protocol Occupational Vaccination Policy HIV Employment Policy Hepatitis Employment Policy Counselling Policy and Supporting Emotional Wellbeing 5 Duties Duties within the Organisation Occupational Health Department The Occupational Health Clinical Lead Nurse is responsible for the review of this policy and ensuring it is implemented satisfactorily both during office hours and out-of-hours. The Occupational Health department will provide specialist knowledge and will instruct appropriately regarding any exposure incident and will instigate necessary treatments either directly or via third parties. Will assess initially via telephone the likely transmission of blood borne virus: Hepatitis B (Hep B), Hepatitis C (Hep C), and Human Immunodeficiency Virus (HIV) when an injury occurs. Sharps, Needlestick Injury and Body Fluid Exposure Management Policy and Procedure: Page 20 of 40 Offer advice on the appropriate follow-up and blood tests required for the recipient healthcare worker and the source patient. Arrange for any counselling of the recipient healthcare worker. Advise (where appropriate) clinicians on the testing requirements for the source and recipient and ensure results for both are cross-referenced and reported to Occupational Health. Ensure managing team of donor patient is informed of any Hep B, Hep C or HIV positive results so appropriate follow-up can be initiated. Manage the follow-up care for all potential exposures to Hep B, Hep C and HIV and refer to specialists for advice and treatment if necessary. Maintain all documentation relating to any injury and ensure confidentiality of all information. Maintain a database of all accidental inoculation injuries for the purpose of audit. Report all high-risk exposures that have resulted in post exposure prophylaxis under RIDDOR. Refer to Genitourinary Medicine (GUM)/ Infectious diseases (ID) specialists for high-risk potential exposures to HIV for specialist follow-up and care. Occupational Health will follow-up all recipient healthcare workers under the care of GUM/HIV/ID specialists teams to assess and monitor fitness for work. Ensure immediate HIV post exposure prophylaxis starter-packs are issued (in consultation with the Consultant Microbiologist) to recipient healthcare workers following high-risk exposure incidents. Ensure that Hepatitis B immunoglobulin is administered to high-risk hepatitis B exposures, according to risk assessment. Provide appropriate training for Accident and Emergency medical and nursing staff in the management of sharps injuries. Ensure that prevention and management of sharps injuries is included in induction and mandatory training. Responsibilities of Line Manager/person in charge at the time of the incident Ensure that all first aid recommendations have been followed. Ensure the incident reporting procedure is followed. Ensure the safe and correct disposal of ‘sharp’ causing the injury. Ensure the donor patient is informed of the incident. Ensure the donor patient’s contact details are made available to Occupational Health including, name, address, DOB, General Practitioner name and practice address. Sharps, Needlestick Injury and Body Fluid Exposure Management Policy and Procedure: Page 21 of 40 Under the guidance of Occupational Health, to organise donor patient blood sampling with appropriate consent. Ensure the recipient healthcare worker attends Occupational Health or Accident & Emergency (if out of hours) as soon as possible after incident. Assist with risk assessment in conjunction with Occupational Health and if necessary the Consultant Microbiologist. Responsibilities of all employees To follow first aid guidelines in the event of a body fluid incident immediately following the accident Immediately after all sharps injuries/body fluid contact, will consult with Occupational Health immediately or Accident and Emergency first, (if out of normal working hours) or nearest Accident and Emergency Department if out of area (Peripatetic staff) To report all accidental exposure to body fluids via the Incident Reporting Procedure. To contact Occupational Health, even if initially treated by Emergency Department To attend follow up appointments with Occupational Health. Emergency Department (ED) Outside of Occupational Health department working hours the Emergency department will assess, manage and implement this policy and associated procedure. Will provide immediate advice and care ensuring that recipient healthcare workers are referred on to Occupational Health for follow-up. Complete the Out-of-Hours Risk Assessment Questionnaire and Follow-up Checklist (appendix A) copies available in the Emergency Department or via the Intranet. Out-of Hours if post exposure chemoprophylaxis (HIV-PEP, HBIG) is indicated via completion of the risk assessment the ED doctor will prescribe and dispense the necessary medicines immediately. If Post Exposure Prophylaxis is administered will ensure that Occupational Health is informed the next working day for follow-up. Liaise with specialists in Infectious Diseases/Genitourinary Medicine / Microbiology as necessary. ED doctors and nurse practitioners will attend as required appropriate training in the management of accidental inoculation injuries and HIV post exposure prescribing. Trust Consultants/ senior medical staff/ Senior Nurse Be responsible for arranging and overseeing the testing of donor patients. Provide any necessary follow-up care associated with the donor patient. Sharps, Needlestick Injury and Body Fluid Exposure Management Policy and Procedure: Page 22 of 40 Facilitate risk assessment of donor patient with reference to actual or potential HIV and viral hepatitis infection. Admitting Consultants are obliged to inform the manager of an area if a patient poses an infection risk and the manager is responsible for the cascading of this information to all staff involved in patient care. A risk assessment must be carried out for each task. Genitourinary Medicine Clinic Provide specialist advice on request to the Occupational Health Department and ED for high-risk incidents. Provide follow-up care of recipient healthcare workers who have commenced HIV postexposure prophylaxis and those who have had a potentially high-risk exposure to HIV. Support Occupational Health regarding risk assessment and the suitability of post-exposure prophylaxis for HIV. Microbiologist/ Infection Prevention and Control Team Liaise with Occupational Health to ensure there is a robust system for managing accidental inoculation injuries. Provide clinical advice and support to the Occupational Health Department and the Emergency Department for the prescription and issue of Hepatitis B immunoglobulin before it is dispensed by pharmacy. Provide clinical advice and support regarding HIV post-exposure prophylaxis treatment. Ensure appropriate testing and storage of both recipient healthcare worker and donor patient blood samples (Microbiology Laboratory). The Infection control and Prevention Team will consider any policy and procedural changes as and when necessary. 6 Consultations and Communication with Stakeholders This Policy is based on an East Cheshire Policy that has been approved at Level 1 NHSLA. MCHFT Health and Safety Committee approved version 1 October 2010. Distributed for comments to: o NHSLA Lead o Health & Safety Lead o Strategic Infection Control Committee Membership o Service Manager & Associate Director of Infection Prevention & Control o Consultant Microbiologist o Pharmacy o Head of HR Management o Accident and Emergency Consultant o Accident and Emergency Matron o Staff side representative o Consultant in GUM Medicine Sharps, Needlestick Injury and Body Fluid Exposure Management Policy and Procedure: Page 23 of 40 [email protected] must be included in the consultation process for all policies Version 3 of this policy was sent for consultation to the members of the Strategic Infection Control Committee and the Consultant in Sexual Health, amendments were made to the policy following advice from the consultant in Sexual Health in accordance with PEP/PEPSE guidelines. 7 Implementation Implementation of this policy is a mandatory requirement for all Cheshire Occupational Health Service clinical staff and Accident and Emergency staff responsible for the post exposure management of inoculation incidents. All employees must follow this policy should they themselves or a colleague for whom they have management responsibility at the time receive an inoculation injury. Directors, managers and employees of the Trust and partner organisations must co-operate with Cheshire Occupational Health Service in the implementation of this policy, in-order to maintain a safe environment for employees protecting them from risk of blood borne virus infection from inoculation injuries. Implementation of this policy is required to ensure that the Occupational Health Service and the Trust meet their collective obligations under Health and Safety legislation, and applicable domestic and European law therefore reducing the chances of tribunal or legal proceedings. Implementation of this policy and associated Occupational Health policies and procedures should ensure essential functions of the Occupational Health Service in protecting public health are achieved (Therefore successfully meeting NHS Employers, NHS PLUS, NHS Litigation Authority and the Care Quality Commission requirements.) It also ensures the Trust is following best practice and anticipating the proposed European directive on prevention and management of inoculation injuries, This policy and procedure will be available on the Trust’s intranet and senior staff and managers will be alerted by the Trust’s communication processes when new policies are issued or existing polices are update and reissued. Due to the advisory and supportive function of the Cheshire Occupational Health Service the implementation of its policies, procedures and protocols is and on-going and consistent process. 8 Education and Training All Occupational Health Staff and Accident and Emergency staff responsible for the post exposure management of inoculation injuries are to adhere to this policy and carry out their responsibilities under it in order to achieve the objectives outlined in section 5 of this document. All staff will undertake mandatory and specialised training for on-going personal development. Training needs will be identified through Knowledge Skills Framework assessment. The Clinical Lead for Cheshire Occupational Health Service will communicate changes in practice to all Occupational Health clinical staff through monthly clinical meetings or more frequently if urgency dictates. The Occupational Health Clinical Lead will communicate changes in policy, which affect the out-of-hours management of exposure incidents, to the Accident and Emergency Department when necessary. Training for Trust staff in the application of this policy will be delivered in the following ways: Ad-hoc Clinical Updates: covering strategic and clinical aspects of Occupational Health, including national initiatives, National Institute for Clinical Excellence standards, Care Quality Commission requirements. Sharps, Needlestick Injury and Body Fluid Exposure Management Policy and Procedure: Page 24 of 40 Accredited Courses: All Cheshire Occupational Health Service and Emergency Department medical and nursing staff require current registration with their respective governing bodies (NMC/GMC). The consultant and senior nursing staff also hold additional specialist qualifications in the Occupational Health speciality. Practical Updates: Covering the practical application of policies and procedures and good Occupational Health delivery. (Including management of inoculation incidents including post exposure blood testing and prophylaxis) Yearly Training Needs Analysis: A yearly training plan is completed according to training needs identified via appraisal for the entire OH Service staff. The Occupational Health clinical team in the management of accidental inoculation injuries including post exposure prophylaxis will undertake a rolling programme of update training for Accident and Emergency staff. o 9 Continuing Professional Development: Occupational Health nursing staff will keep their training/development up-to-date as appropriate to satisfy the Nursing and Midwifery Council’s requirements for Post Registration Education and Practice in order to: Support clients and colleagues Enhance care Develop clinical practice Reduce risk Develop personally through education. Monitoring and Review The table below must be completed in the document to demonstrate effective monitoring of all documents. Monitoring and Audit Standard/process/issue required to be monitored Process for monitoring e.g. audit Responsible individual /group Total inoculation incidents. -Total high-risk inoculation incidents. -High-risk inoculation incidents where PEP administered. -Incidents where BBV transfer have occurred. -Total incidents where inappropriate management of incident has occurred. -Comparative analysis of inoculation incidents to identify areas of poor practice. Audit Lead Nurse Occupational Health Frequency of monitoring Annually Responsible committee Workforce Governance 9.1 Audit Proforma Sharps, Needlestick Injury and Body Fluid Exposure Management Policy and Procedure: Page 25 of 40 The MCHFT Audit proforma must be used to demonstrate effective monitoring and implementation of planned actions. This can be found on the intranet in frequently used forms/clinical audit. 10 References / Bibliography 1. Advisory Committee on Dangerous Pathogens, [1995], Department of Health. 2. British Medical Association, [2005] Code of Practice for the safe use and disposal of sharps, BMA, London. 3. Cardo DM, Culver DH Ciesielsik CA et al [1997] Case control of HIV seroconversion in healthcare workers after percutaneous exposure, New England Journal of Medicine, 1st Publish. 4. Centre for Disease Control [1996] Provisional Public Health Service Recommendations for Prophylaxis after Occupational Exposure to HIV. CDC Atlanta, USA. 5. Centre for Disease Control [1998] Public Health Service Guidelines for the management of Healthcare Workers Exposures to HIV and recommendations for post-Exposure Prophylaxis. 6. Department of Health [2006] Advice Chief Medical Officer Re HIV post-exposure Prophylaxis. 7. Department of Health [1990] HIV-The causative agents of AIDS and related conditions, Second revision of guidelines, Advisory Committee on Dangerous pathogens, DOH, London. 8. Department of Health, [2008] HIV post-exposure prophylaxis, Chief Medical Officer’s Expert Advisory Group on AIDS. 9. Department of Health [2004] HIV post-exposure prophylaxis 10. Guidelines for Clinical Health Care Workers: Protection against Infection and Blood borne viruses. Recommendations of the expert Advisory Committee on AIDS and the advisory group on Hepatitis [1998], UK Health Department, London. 11. Hawkins DA et al [2001] Seroconversion to HIV following a needlestick injury despite combination post-exposure prophylaxis, Journal of Infection Control. 12. Health Protection Agency [2005] North West Sharps Injury Procedure HPA. 13. Health & Social Care Act [2008], Hygiene code of practice, Department of Health. 14. Protection against Blood Borne Pathogens in the Workplace, HIV and Hepatitis [1995] 15. Ippolito G et al [2004] Occupational Human Immunodeficiency Virus Infection in Healthcare Workers: Worldwide cases through September 1997. Clinical infectious Disease 1999/2004 Sharps, Needlestick Injury and Body Fluid Exposure Management Policy and Procedure: Page 26 of 40 16. Jefferies DJ [1995] Viral Hazards to and from Healthcare Workers. Journal of Hospital Infection. 17. Jochimsen EM [1997] Failures of Zidovudine Post-Exposure Prophylaxis, American Journal of Medicine. 18. Safe Disposal of Clinical Waste [2004], Health Service Advisory Committee. 19. Safe use and disposal of sharps [2001] Medical Devices Agency Safety Notice. 20. Sharps injury and body fluid exposure procedure for Healthcare Workers [2005] Manchester N, C&S PCT. 21. www.departmentofhealth.co.uk 22. www.guidelines.gov/hepBprophylaxis 23. www.guidelines.gov/hepCprophylaxis 24. www.guidelines.gov/hivprophylaxis 25. www.hpa.co.uk 26. http://www.hse.gov.uk/pubns/hsis7.pdf 27. Mersey, Cheshire, and North Wales HIV Managed Care Network-Guidelines for post exposure prophylaxis for HIV following occupational or sexual exposure 28. Expert Advisory group on AIDS, Changes in recommended regimen for post-exposure prophylaxis (PEP) 11 Appendices 1 2 3 4 5 6 A B C Out of hours risk assessment questionnaire Situations when post exposure prophylaxis should be considered following nonsexual/occupational exposure HIV post exposure chemoprophylaxis information sheet Patient information sheet Truvada and Raltegravir Flowchart-Sharps injury treatment Flowchart-Immediate action following inoculation injury Version Control Document Communication / Training plan Equality Impact and Assessment Tool Sharps, Needlestick Injury and Body Fluid Exposure Management Policy and Procedure: Page 27 of 40 Appendix 1 Out of hours risk assessment questionnaire 1 Recipient’s Name: 3 Date of incident: 2 Date of Birth: / / 4. Has an incident form been completed 5. First Aid performed st Details of 1 aid performed: Time of incidents: / / Ward/department: YESNO Must always be completed YESNO 6. Nature of incident (marked (x) correct one) Sharp? Bite/scratch?(When skin is visibly broken) Blood splash to mucous membranes e.g. eyes/mouth? Contamination of broken skin with blood? Any of the above involving urine or body fluid that is visibly blood stained? If YES TO ANY OF THE ABOVE THEN CONTINUE WITH RISK ASSESSMENT IF NO THEN ENSURE INCIDENT FORM IS COMPLETED AND NO FURTHER ACTION IS REQUIRED. 7.Risk Assessment Name of donor: (if not known state) Hospital Number: Date of Birth / / Ward: From review of the donor patient’s clinical notes are they? HIV positive? YESNO (If yes discuss with consultant immediately) Hep B positive? YESNO (If yes discuss with consultant immediately) Hep C positive? YESNO(Recipient health care worker must contact occupational health next working day) Considering the donor patients clinical and lifestyle factor is there any suspicion that they could be blood borne virus positive? If yes then discuss with Consultant Advice sought form consultant? YESNO 8. Treatment HIV: HIV Post exposure prophylaxis given Hep B: Hep B immunoglobulin given Advised to seek OH input next day for immunisation/ Hep C follow-up YESNO YESNO YESNO 9. Blood Testing (See laminated example for form completion details) Donor PATIENT Obtain YELLOW topped sample from source patient with informed consent for: o o o Hep B surface antigens Hep C antibodies HIV 1&2 antibodies and P24 Antigen Completed YESNO RECIPIENT HEALTHCARE WORKER obtain YELLOW topped sample for: o Storage and Hepatitis B antibodies ONLY Completed YESNO 10. Follow-up Advised to contact Occupational Health at the earliest opportunity 2372 (Leighton) 1896 (Macclesfield) YESNO Copy Faxed to Occupational Health 01270273430 (Leighton) 01625 661896 (Macclesfield) YESN0 Name of person completing this Job Title: Signature: form: Sharps, Needlestick Injury and Body Fluid Exposure Management Policy and Procedure: Page 28 of 40 Appendix 2 Situations when post-exposure prophylaxis (PEP) should be considered Non-Sexual / Occupational Exposure Source HIV Status HIV Positive Unknown HIV Status Scenario Viral Load Viral load From HIGH risk From LOW Detectable Undetectable group/area prevalence group/ area Recommended Not Consider Sharing of injecting Not (Discuss) equipment Recommended Recommended Human Bite (with skin breakage and passage of blood) Needlestick from a discarded needle in the community Non intact skin or mucous membrane exposed to any bodily fluid (except urine, faeces, vomit or saliva unless it is blood stained) Skin penetration with any blood-stained sharp or blunt object, or instrument drawing blood Superficial injury with any sharp or blunt instrument- no blood drawn Discuss Not Recommended Not Recommended Not Recommended Not Recommended Not Recommended Not Recommended Not Recommended Recommended Not recommended Recommended (Discuss: if very anxious recipient) Not Recommended Recommended Not recommended Recommended (Discuss: if very anxious recipient) Not Recommended Not Recommended Not Recommended Not Recommended Not Recommended Bodily fluid or blood on intact skin Not Recommended Not Recommended Not Recommended Not Recommended Mucous membrane or Not broken skin exposed Recommended to urine, saliva, faeces or vomit that is not blood stained Not Recommended Not Recommended Not Recommended Sharps, Needlestick Injury and Body Fluid Exposure Management Policy and Procedure: Page 29 of 40 Appendix 3 HIV post exposure chemoprophylaxis information sheet FOLLOWING SIGNIFICANT OCCUPATIONAL EXPOSURE TO HIV INFECTION This should be read if you have had an injury involving blood with someone KNOWN TO BE HIV INFECTED or HIGH RISK and have been advised to commence taking antiretroviral to help protect you against catching HIV infection. During office hours you can contact Occupational Health extension 2372 or Sexual Health Department extension 2255 both will be happy to advise. If you have had an accident with blood or body fluids from a source that is KNOWN or HIGHLY SUSPECTED to be infected with human immunodeficiency virus (HIV) then you are advised to start taking antiretroviral as soon as possible after the exposure, preferably within the first hour. However if the individual is not definitely known to be infected with HIV, you should discuss the advisability of taking the drugs with the person prescribing and dispensing the medication. If you have had an occupational exposure then by the time you are reading this document, you should have: 1. Cleaned the wound thoroughly and apply waterproof dressing/plaster. 2. Reported the incident to your immediate supervisor on duty. 3. Assisted in the completion of a risk assessment of the incident. 4. Reported in person to the Occupational Health or Emergency Department. The reason for your taking the drugs is to reduce the risk of getting infected with HIV from this exposure incident; therefore you have to make a decision to take the drugs based on the risk of getting the infection versus the side effects from the drugs. The risks of becoming infected with HIV are low; HIV can be transmitted by accidental inoculation or splash injury. Overall only about 3 injuries per every 1000 result in transmission when the source is HIV antibody positive, This risk is marginally higher if deep injury has occurred and significant volumes of blood have been injected into the recipient. The risk is significantly lower if the injury is a splash to mucous membranes (i.e. eyes, mouth, etc.), 1 per every 1000 injuries and you cannot catch the infection through intact skin. What are the advantage/ rationale of taking antiretroviral drugs? 1. These drugs inhibit growth of HIV in the laboratory. 2. Individuals who took AZT after an injury with HIV infected blood had a reduced risk of becoming infected compared to those who did not take it. 3. Immediate combination therapy with these drugs after accidental exposure is now recommended in most centres caring for individuals with HIV in the UK, USA and Canada. 4. In some animal models using very high doses of virus, AZT given early did reduce virus multiplication, and in 2 studies did prevent actual infection, relevance to humans is unknown. Sharps, Needlestick Injury and Body Fluid Exposure Management Policy and Procedure: Page 30 of 40 What are the disadvantages of taking these drugs? 1. Peripheral neuropathy (tingling in the hands and feet); however more likely to occur in individuals who have been taking the drugs for excess of 24 weeks. Headache is a common side effect. 2. May reduce the number of white blood cells that fight infection. It can also cause stomach cramps, nausea and vomiting. 3. Main side effect is diarrhoea. In trials it was reported in 25% of patients taking it. If severe then it may be possible to control symptoms with anti-diarrhoeal medication. Some patients have reported developing a rash. 4. Long-term effects of taking the drugs are unknown. 5. These drugs can interact with other medicines. 6. Taking antiretroviral does not guarantee that you will not become infected with HIV. 7. If you are already infected with HIV then taking these drugs would not be necessary and could have the potential for resistant virus to develop. If there is a possibility you are pregnant you must not take these drugs. Your case will need to be discussed with a Consultant specialising in HIV treatments (alternative drug therapies are available). To be most effective the drugs need to be taken within a 1-HOUR of exposure as their effectiveness diminishes with time, HIV-PEP can be given up to 72-Hours post exposure. Inform the Doctor treating you if you believe that you may already have HIV infection. It must be emphasised that these drugs may be harmful, see side effects listed above. You agree for the doctor prescribing these drugs to perform baseline bloods, including HIV testing, full blood count, urea and electrolytes, liver function test, glucose and lipids. You are now being asked to make a decision on whether you wish to commence treatment. You are not being asked to decide whether you wish to start a full 4-week course of treatment. We are just asking whether you agree to take the first 24 to 72 hours worth. You must inform the Doctor treating you of any concerns you may have regarding the above points. YOU MUST MAKE THE DECISION NOW ON WHETHER YOU WISH TO HAVE THE FIRST DOSE OF HIV-PEP. Sharps, Needlestick Injury and Body Fluid Exposure Management Policy and Procedure: Page 31 of 40 Appendix 4 – Patient Information sheet (Truvada and Raltegravir) HIV Post-exposure prophylaxis: Drug information Truvada & Raltegravir Introduction You have been prescribed post-exposure prophylaxis (PEP/PEPSE) because you may have been exposed to the HIV virus. Prophylaxis means a preventative treatment. The treatment consists of a combination of two tablets. They are antiviral drugs that are effective against the HIV virus. Used together, there is evidence that they can reduce the risk of developing HIV infection following exposure to the virus. The names of your medicines are: “Truvada”, each tablet containing emtricitabine 200mg and tenofovir 245mg, blue capsule-shaped tablets, marked “GILEAD” and “701” “Raltegravir”, each tablet containing 400mg Raltegravir, (Isentress ®) pinkish capsule-shaped tablets marked ‘400’ You have been supplied with enough medication to last for 3-5 days. Arrangements will be made for you to collect the rest of your treatment to complete 28 days and attend for appropriate follow up. Taking your medicines For this treatment to be effective, it is important that you take your medicines properly. Treatment should start as soon as possible after potential exposure to HIV. Read the label on your medicines. They should be taken as follows: Medicine Morning Evening Truvada Take one tablet with your breakfast Nil Raltegravir Take one tablets with your breakfast Take one tablets after your evening meal, ideally 12 hours after breakfast dose Swallow the Raltegravir tablets whole with plenty of water while sitting or standing in an upright position. The Truvada tablets can be swallowed whole or can be disintegrated in approximately 100ml of water, orange juice or grape juice and taken immediately. Take the medicines at the approximate times indicated even if you have not actually had a meal. If you forget to take a dose, take it as soon as possible and then continue as before. If you have difficulty remembering to take them, use an alarm, e.g. on your mobile phone. You may drink moderate amounts of alcohol while taking these medicines (within normal recommended safe limits). Sharps, Needlestick Injury and Body Fluid Exposure Management Policy and Procedure: Page 32 of 40 Other medicines and medical problems With this treatment there is a risk of problems developing if you are taking other medication or if you have other medical problems (e.g. kidney or liver problems). You must tell your doctor about any and all medical problems you have, and about any medication you are taking, whether these are prescribed for you or bought over the counter including herbal products e.g. St John’s Wort. Do not start any new medication without discussing it with your doctor first. Just some of the drugs that are known to interact with these medicines include: warfarin (an anticoagulant) phenytoin, carbamazepine (used for treating epilepsy), rifampicin, erythromycin and clarithromycin (used for treating bacterial infections), quinidine (used to treat an irregular heart beat), methadone (used in the treatment of opiate dependence), simvastatin (used to lower cholesterol levels), dexamethasone, fluticasone proprionate (steroids), felodipine, nifedipine (heart medicines), ketoconazole, itraconazole (antifungals) and hormonal methods of contraception, including the combined pill and mini pill. You should not breast feed while taking these medicines. General advice Do not take more than the recommended dose. Do not give your medicines to others. Keep your medicines in a cool, dark, dry place, out of the reach of children. If at any point during the follow up period you develop an acute illness or symptoms comprising any of the following such as sore throat, fever, rash, myalgia, fatigue, malaise or enlarged lymph nodes, representing seroconversion illness you have to inform PEP clinic. Some of these symptoms may, however, be side effects of the antiretroviral medications. Side effects The commonest side effects of the medicines are dizziness, nausea (feeling sick), diarrhoea, headache, vomiting (being sick), and tiredness, weakness, and muscle aches. These usually settle if you keep taking the medicines as directed, but simple painkillers or tablets to prevent sickness or diarrhoea may help. Tell your doctor if the symptoms persist. Serious side effects are rare; they include allergic reactions, liver toxicity, pancreatic problems and reduced production of red blood cells, causing anemia, or white blood cells, which can make you prone to infections. Blood tests will be taken at 2 and 4 weeks to check for blood counts and liver problems. Tell your doctor if you are concerned about any new symptoms. Common side effects Can be caused by Feeling sick, stomach pains, wind, diarrhoea, digestive problems Headache, muscle aches Truvada, Raltegravir Truvada, Raltegravir Difficulty sleeping, abnormal Truvada, Raltegravir dreams, tiredness dizziness, Skin rash, itching Truvada, Raltegravir What you should do Keep on taking the tablets with food – it often settles. Tell your doctor if it persists or becomes distressing. Take a simple painkiller such as paracetamol or ibuprofen (Nurofen). Tell your doctor if it persists. Care required with driving or operating machinery. It may go away. Tell your doctor if it persists. Tell your doctor if it persists. Sharps, Needlestick Injury and Body Fluid Exposure Management Policy and Procedure: Page 33 of 40 Rare side effects Can be caused by What you should do Tiredness associated with shortness of breath Truvada, Raltegravir Tell your doctor – this could be due to anaemia. Fever associated with feeling unwell and other symptoms Jaundice (yellowing of the skin and eyes Truvada, Raltegravir Tell your doctor – this could be due to a low white cell count. Truvada, Raltegravir Tell your doctor – this could be due to liver toxicity. Pregnancy The available evidence is that the recommended drugs are safe after 12 weeks of pregnancy, but we have less information about the safety of the drugs in early pregnancy. You must tell your doctor if you could be pregnant. You should take precautions to avoid becoming pregnant or fathering a child while taking the medicines. The medication will reduce the effectiveness of hormonal contraception; these methods should not be relied on while you are taking the medication, and you should use a barrier method (condoms) in addition. Sharps, Needlestick Injury and Body Fluid Exposure Management Policy and Procedure: Page 34 of 40 Appendix 5 Sharps Injury Treatment Flowchart Significant Exposure to Blood or Visibly Blood-stained body fluid. 1st Aid procedures, Report to Occupational Health or A&E, ASAP. Identify source and complete accident form. Complete risk assessment of source and recipient Health care worker. Source Patient Recipient Health Worker Blood Investigations req. Hep B surface antigen, Hep C & HIV antibodies. (6 ml clotted) Hep B antibodies & storage. (6 ml clotted) Actions Required. Risk assess for potential Hep B, Hep C & HIV infection. Establish Hep B vaccination status. HCV-RNA= Hep C Viral load. HIV-PEP=HIV Post-Exposure Prophylaxis. Immune Status of Health Worker Less than 2 Hep B vaccines preexposure. No Risk from Source. Start/complete Hep B vaccine course. Low Risk Source. Start/complete Hep B vaccine Course. Unknown Source. Accelerated course Hep B Vaccination. 2 or more vaccines pre-exposure. Antibody status unknown. Known responder to Hep B vaccination. Hep B antibody> or= 100 iu/ml Known nonresponder to Hep B vaccine or Hep B antibody < 10 iu/ml. Hepatitis C virus. Complete course of vaccination. Complete course of vaccination. Booster dose of Hep B vaccine. No Action. No Action. No Action. (HCV) HIV High Risk Source. Hep B immunoglobulin & Accelerated course Hep B Booster dose, Hep B vaccine; repeat 1 month. Booster dose, Hep B vaccine, if 5-year booster not given. Booster dose, Hep B vaccine, if 5year booster not given. Booster dose Hep B vaccine. Hep B immune globulin & booster dose, Hep B vaccine Hep B immunoglobulin & booster dose, Hep B vaccine. No Action. 24-weeks. Bloods: HCV antibodies. 24-weeks. Bloods: HCV antibodies. No Action. No Action. No Action. 6&12-weeks, bloods for HCV RNA; at 12&24weeks HCV antibodies. HIV-PEP within 1hour. Sharps, Needlestick Injury and Body Fluid Exposure Management Policy and Procedure: Page 35 of 40 Appendix 6 Flowchart for immediate action following an Inoculation injury or accidental exposure to blood or body fluid to Healthcare Workers. Immediately stop and attend to injury. If the splash injury is to the eyes rinse with saline. (Remove contact lenses and rinse before and after removal) Encourage bleeding from puncture wound by gentle squeezing. Do not suck the wound. If splash injury is into mouth, rinse with water and spit several times. . Wash well with soap and water do not scrub wound. Apply waterproof dressing if appropriate Inform your manager, and complete an incident report. Contact Occupational Health immediately for advice and risk assessment; if OH closed then the employee must attend the Emergency Department. Doctor/Senior Nurse must assist OH or A&E with risk assessment by review of source patient’s clinical/social history Sharps, Needlestick Injury and Body Fluid Exposure Management Policy and Procedure: Page 36 of 40 APPENIDX A - Control Sheet This must be completed and form part of the document appendices each time the document is updated and approved. VERSION CONTROL SHEET Date dd/mm/yy 03.08.10 Version Author Reason for changes 1/2 Lead Nurse Occupational Health 10.09.2013 3 Lead Nurse Occupational Health 26.10.2014 4 Lead Nurse Occupational Health NHSLA Compliance Review bringing accidental inoculation injury management and PEP into 1 policy New policy format. Review following Health and Safety Executive Sharps Injury in Healthcare Regulations 2013 Changes in HIV post Exposure Chemoprophylaxis- scenarios for prescribing HIV PEP. Changes in PEP Changes in recommendation regarding prescribing PEP in circumstances of undetectable viral load Sharps, Needlestick Injury and Body Fluid Exposure Management Policy and Procedure: Page 37 of 40 APPENDIX B - Training needs analysis Communication/Training Plan (for all new / reviewed documents) Goal/purpose of the communication/training plan Target groups for the communication/training plan Target numbers Methodology – how will the communication or training be carried out? Communication/training delivery Funding Measurement of success. Learning outcomes and/or objectives Review effectiveness – learning outputs Issue date of Document Start and completion date of communication/training plan Support from Learning & Development Services Ensure that all actions following a body fluid contact incident are standardised Any member of staff involved in the management of body fluid contact incidents. All clinical and non-clinical staff exposed to body fluids as part of their job. Line Managers All clinical OH staff Dr’s and clinicians in Accident and Emergency All clinical staff and those who have exposure to body fluids in the course of their job 2-yearly mandatory update for all Trust staff Teaching sessions Included in Induction of any new members of staff Internal Occupational Health Specialists None required Monitor body fluid contact events audit actions taken following such events. Advise appropriate people accordingly. Annual report to the Health & Safety Committee Monitor consistency of actions following body fluid contact events Monitoring of attendance at induction and biennial mandatory updates. % of attendance reported to and monitored by Learning & Development For assistance in completing the Communication / Training Plan please contact the MCHT Learning and Development Services Sharps, Needlestick Injury and Body Fluid Exposure Management Policy and Procedure: Page 38 of 40 APPENDIX C - Form 1 Equality Impact Screening Assessment Please read the Guide to Equality Impact Assessment before completing this form. To be completed and form part of the policy or other document appendices when submitted to [email protected] for consideration and approval or to be completed and form part of the appendices for proposals/business cases to amend, introduce or discontinue services. POLICY/DOCUMENT/SERVICE………………………………………………… Sharps Injury and Body Fluid Exposure A Yes/ No Justification and Data Sources Does the document, proposal or service affect one group less or more favourably than another on the basis of: 1 Race, ethnic origins (including gypsies and travellers) or nationality no Employees who sustain an injury involving a patient originating or recently lived in a country of high prevalence of blood borne virus infection are at increased likelihood following risk assessment in the absence of blood test confirmation to require post exposure prophylaxis. 2 Sex no No discernible impact 3 Transgender no No discernible impact 4 Pregnancy or maternity no Pregnant women cannot receive post exposure chemoprophylaxis as defined in this policy; they would be referred to a consultant specialising in HIV regarding advice as to most appropriate chemoprophylaxis. 5 Marriage or civil partnership no No discernible impact 6 Sexual orientation including lesbian, gay and bisexual people no Employees who sustain an injury involving a patient who is a man who has unprotected sex with men, prostitutes or women who have had multiple sexual partners are more likely following risk assessment to require post exposure prophylaxis. 7 Religion or belief no No discernible impact 8 Age no No discernible impact 9 Disability - learning disabilities, physical disability, sensory impairment and mental health problems no No discernible impact, this policy document can be issued in other formats on request 10 Economic/social background no No discernible impact B Human Rights – are there any issues which may affect human rights 1 Right to Life no No discernible impact 2 Freedom from Degrading Treatment no No discernible impact Sharps, Needlestick Injury and Body Fluid Exposure Management Policy and Procedure: Page 39 of 40 3 Right to Privacy or Family Life no No discernible impact 4 Other Human Rights (see guidance note) no No discernible impact NOTES If you have identified a potential discriminatory impact of this document, proposal or service, please complete form 2 or 3 as appropriate. Date: 09.09.20-13 Keith Williamson Lead Nurse Occupational Health Name: ……………………………….. Signature: …………………………… Job Title:………………………… Sharps, Needlestick Injury and Body Fluid Exposure Management Policy and Procedure: Page 40 of 40