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Document name: Tuberculosis Policy Document type: Policy What does this policy replace? This policy replaces one previously in place for Barnsley and is now a Trust-wide policy Staff group to whom it applies: All staff within the Trust Distribution: The whole of the Trust How to access: Intranet Issue date: February 2016 Next review: September 2018 Approved by: Executive Management Team February 2016 Developed by: Lead TB Nurse Director Leads: Director of Nursing Contact for advice: Health Integration Team / TB Service 01226 731686 Management of Tuberculosis and Measures for its Prevention and Control Section 1 1.1 2 2.1 3 4 4.1 4.2 4.3 4.4 4.5 4.6 4.7 4.8 4.9 4.10 4.11 4.12 4.13 4.14 4.15 5 5.1 5.2 5.3 5.4 5.5 6 6.1 Introduction Evidence Purpose Scope Definitions Duties Chief Executive Trust Board Executive Management Team Clinical Governance and Clinical Safety Committee TB Team Employees Practice Governance Coaches Infection Prevention and Control Consultants Chest Physicians Occupational Health Microbiology Health and Safety Health Protection Unit Managers Procedure and Guidance Mode of transmission Infection with TB and disease progression Latent TB infection Who is at risk of TB Common symptoms of TB Diagnosis Diagnosis active pulmonary TB Page 5 5 6 6 6 6 7 7 7 7 7 8 8 9 9 9 10 10 10 10 10 11 11 11 11 11 11 12 12 2 Section 6.2 7 7.1 7.2 7.3 7.4 7.5 7.6 7.7 7.8 7.9 7.10 7.11 7.12 7.13 7.14 7.15 7.16 7.17 7.18 7.19 8 8.1 9 9.1 9.2 9.3 9.5 9.6 10 11 11.1 Diagnosis of Non respiratory TB Treatment Treatment regimes Potential side effects Monitoring treatment regimens and treatment completion Directly observed treatment HIV / TB Admission to hospital and other in patient areas Risk Assessment Care of a service user residing in an Initial Accommodation Centre (Wakefield) Drug Resistance Care of the service user with suspected drug resistant TB Isolation Practice recommendations for TB service users admitted to hospital and in patient areas Care of a service user nursed in a single room Termination of Isolation Spirometry Care of service users attending outpatient departments Care of service user in their own home Discharge and transfer of a service user with TB Death Contact Tracing Assessment for contact tracing BCG Vaccination Maternity services Children’s services New Entrants BCG Contacts requiring BCG Other groups Terms and Acronyms Developmental Processes Identification of Need Page 13 14 14 15 16 17 17 17 17 18 18 19 20 20 20 21 22 22 22 23 23 23 24 24 24 25 25 26 26 26 28 28 3 11.2 11.3 11.4 Stakeholder involvement Equality Impact Assessment Dissemination and implementation arrangements (including training) 11.5 Implementation 11.6 Training 11.7 Monitoring compliance 11.8 Effectiveness of policy 11.9 Further advice and support 12 Review and revision arrangements (including version control) 12.1 Process of reviewing 12.2 Version control 13 References and further reading 14 Any other policies which should be referred to Appendix Equality Impact Assessment one Appendix Checklist for review and approval of two procedural document 29 29 29 29 29 29 30 30 30 30 30 30 31 32 34 4 Management of Tuberculosis and Measures for its Prevention and Control 1. Introduction Tuberculosis (TB) is caused by the bacterium Mycobacterium tuberculosis (M tuberculosis or M.TB). It is transmitted by inhaling the bacterium in droplets or aerosols produced during coughing/sneezing or by or aerosol producing procedures carried out on someone with infectious tuberculosis. People with respiratory tuberculosis, and who have bacteria in sputum, which can be seen on a simple microscopic examination are considered to be highly infectious, these service users are referred to as smear positive. People with other forms of tuberculosis i.e. those affecting sites other than the respiratory tract, are not generally considered to be as infectious. However, if the site is manipulated and aerosols are produced, transmission may still occur, especially if the sample is smear positive. The risk of becoming infected with TB varies depending on the length and intensity of exposure to the bacterium. The risk is greatest in those with prolonged, close exposure e.g. household contacts, those with added risk factors such as people who are immuno-compromised and staff who are carrying out close aerosol producing procedures e.g. intubation and suction. The incidence of Tuberculosis is influenced by risk factors such as exposure to, and susceptibility to, Tuberculosis and levels of deprivation (poverty, housing, nutrition and access to healthcare). The most important intervention in regards to the control of Tuberculosis is effective treatment. Hence, the completion of treatment is vital to reduce onward transmission of Tuberculosis and support successful clinical outcomes for service users, resulting in the reduction of the development of multi drug resistant Tuberculosis. The control of Tuberculosis requires targeted screening of high risk individuals and groups, identifying close contacts and effective treatment. Therefore the need to implement a clinically robust guidance is of paramount importance. 1.2 Evidence This local policy reflects the NICE guidelines 2011 (Including amendments January 2016) for Tuberculosis: clinical diagnosis and management of tuberculosis, and measures for its prevention and control and has been specifically written to cover the requirements for diagnosis and management within the South West Yorkshire Partnership NHS Foundation Trust. 5 2. Purpose To provide clinical staff of all disciplines working for or on behalf Yorkshire Partnership NHS Foundation Trust, with guidelines procedures that are based on NICE guidelines for the management infected cases and for the prevention of potential transmission to inclusion of staff members, service users and visitors. of South West and standard of Tuberculosis other, with the 2.1 Scope This policy is applicable to all staff in the Trust and is designed to provide guidance and support to staff in relation to the management, prevention and control of tuberculosis in order to ensure consistent practice across the Trust. Although there nationally accepted and evidence based standards for the management, prevention and control of tuberculosis identified within the policy it is inappropriate for the Trust to make a blanket statement in relation to these. The policy cannot anticipate any given situation, therefore professional judgement should be used to identify when a risk assessment is needed to protect those who have been compromised, are vulnerable / or at risk. The risk assessment process will enable staff to identify the level of vulnerability and the risks posed to each individual concerned resulting in appropriate action being taken. Professional judgement should derive from a robust disciplinary team discussion 3. Definitions This document is a policy, which clearly specifies its’ purpose and scope. 4. Duties The Trust has a duty and is committed to the management, prevention and control of tuberculosis by providing assurance systems and resources required to ensure safe working practice and the ongoing education and audit to ensure compliance. All staff are responsible for demonstrating compliance with this policy. The following specific duties apply: 4.1 Chief Executive The Chief Executive has overall accountability for reducing the risk of Tuberculosis infection by ensuring that there are arrangements and systems in place within the organisation to assist with its prevention and management. 6 4.2 Trust Board Trust board is responsible for the signing and approval, dissemination and implementation of this policy. 4.3 Executive Management Team The Executive Management Team is responsible for approving the contents of the policy. 4.4 Clinical Governance and Clinical Safety Committee The Clinical Governance and Clinical Safety Committee is responsible for the dissemination and implementation of this policy on behalf of the Trust Board 4.5 Tuberculosis Service Team The team consists of Lead Nurse Tuberculosis, Tuberculosis Specialist Nurse, and Clerical Officer. The Tuberculosis Service Team is responsible for working with the Service Managers, Practice Governance Coaches / Modern Matrons other health care professionals to improve the care of service users. In order to achieve this they will: Develop, disseminate, implement and review this policy as required Audit compliance with this policy Provide training as identified to educate and monitor staff awareness of the policy content Ensure that Directors of the Business Delivery Units are made aware of issues as they arise within their care groups Deliver quarterly reports in order to monitor practice with the inclusion of all incidents reported via the DATIX system Provide other timely reports as required to Trust Board, Executive Management Team, the Clinical Governance and Clinical Safety Committee, Business Delivery Units, Modern Matrons and any other relevant groups which will include lessons learnt. Provide specialist tuberculosis advice to management, clinicians and practitioners and any other relevant agencies. Liaise with other TB Specialist Nurses Work closely with both the acute hospital and Public Health England TB Nurse to perform Chest Clinic with the Chest Physician in charge of TB management Give support to service users, carers and family whilst having treatment. Carry out contact tracing and refer to Chest Physician as indicated. Act as a resource on TB for other professionals 7 Provide education sessions as required, including attending community health events The TB Specialist Nurses to liaise with Public Health England, Consultant in Communicable Disease Control in relation to Outbreaks and Incidents Collation of all notifiable cases of tuberculosis COHORT review process Specialist advice and support to all staff within the trust. Comply with the Tuberculosis policy 4.6 Employees will: Co-operate and assist with the implementation of this Policy, and its associated procedures. Bring to the notice of management, any problems or failings associated with the control of Tuberculosis Attend training as required. Make themselves aware of, and follow safe systems of work and control methods (including personal protective equipment) provided for their safety and the safety of others. Promptly report all incidents concerning the risks of exposure to Tuberculosis in accordance with the Trusts’ Policy and procedure on reporting incidents. Report to the Occupational Health Department if they consider they are at risk of transmitting Tuberculosis to service users. Be responsible for liaising with appropriate personnel when service users are discharged or transferred. Comply with the Tuberculosis policy. 4.7 Practice Governance Coaches will: Ensure that the policy is integrated into clinical practice. Liaise and work closely with the TB Specialist Nurse to control Tuberculosis. Advise service users and carers to contact TB Specialist Nurse for TB related information if required Participate in audit monitor practice and compliance with standards. Comply with the Tuberculosis policy 4.8 Infection Prevention & Control Team will: Promote good infection control practices in line with the policy. Provide information, advice and training to enable managers and users to undertake risk assessments as required in association with the TB Nurse Report on incidents to the Infection Prevention and Trust Action Group Play an active role in outbreak management associated to Trust premises, in coordination with TB Specialist Nurse and the Health Protection Unit. 8 Communicate and liaise with the appropriate personnel (especially TB Specialist Nurse) on the care and management of positive individuals. Liaise with the TB Specialist Nurse and Occupational Health in the screening of contacts. Liaise with TB Specialist Nurse if any laboratory results show possible TB infection. Comply with the Tuberculosis policy. 4.9 Consultants will: Refer all suspected or confirmed cases of Tuberculosis to the chest physicians for treatment and follow up. Ensure that service users with Tuberculosis receive appropriate clinical care and management. Comply with the Tuberculosis policy 4.10 Chest Physicians will: Be responsible for the diagnosis and clinical management. Be responsible for the clinical follow up of cases of TB. Advise all service users on TB treatments of the benefits of having a HIV test. Are responsible for completing notification forms to the HPU. Work closely with the TB Specialist Nurse to facilitate contact tracing and service user support. Be the key members of local TB Working Groups. Be the key members of Outbreak Control Team. Discuss options for organising care for people with MDR TB with specialists. Comply with the Tuberculosis policy 4.11 Occupational Health Department will: Formulate and regularly review OHD policies for the protection of staff. Provide pre-employment health assessment for prospective employees and for those on change of post. Provide protection by way of BCG (Bacillus Calmette-Guerin) immunisation appropriate to risk, following NICE Guidance. Provide further medical screening when advised by the TB Specialist Nurse for staff who have been exposed to a significant risk of TB. Provide information and advice to staff on the protection/prevention of TB. Arrange further medical investigations and referral to a Consultant Respiratory Physician as appropriate, for employees who develop symptoms suggestive of TB. Advise managers and employees on current guidelines and the Trust’s reporting procedures. 9 Work closely with the Consultant Communicable Disease Control, TB Specialist Nurse, Infection Prevention and Control Team and managers of the Trust. Maintain records of exposure, treatment and follow up of staff. Comply with the Tuberculosis policy 4.12 Microbiology Laboratory: The service level agreement with the laboratories will specify that the labs will; Advice on appropriate sample for diagnosis and screening Report any positive to the Infection Prevention and Control Team, consultant in charge and the Health Protection Unit as soon as possible. Provide TB Specialist Nurse with details of patients who have laboratory results that could indicate TB infection. Comply with the Tuberculosis policy 4.13 Health and Safety will: Record all exposure incidents reported via the Datix system. 4.14 Health Protection Unit (South &West Yorkshire) will: Collaborate with the Trust in reviewing its local guidance on the management and protection of service users and staff from TB. Collate all notified cases of TB. 4.15 Managers will: Ensure staff comply with the policy. 5. Procedure and Guidance 5.1 Mode of transmission People who have active infectious (open) pulmonary or laryngeal TB expel small respiratory droplets when coughing and sneezing. These small droplet nuclei, carried by air currents can be inhaled by susceptible people. 5.2 Infection with Tuberculosis and disease progression. Once inhaled, the bacteria reach the lung and grow slowly over several weeks. The body’s immune system is stimulated, which can be shown by a tuberculin skin test (Mantoux). The majority of exposed persons will kill off the inhaled bacteria, and be left only with a positive skin test as a marker of exposure. In a small number of cases a defensive barrier is built round the infection, this results in the bacteria not being killed, but instead lying dormant. This is called latent Tuberculosis infection, in such cases the person is not ill and is not considered to be infectious. Reactivation of the latent 10 infection can occur at any time, and may be many years later, becoming active tuberculosis disease. 5.3 Latent Tuberculosis Latent TB is defined as infection with Mycobacterium tuberculosis, where the bacteria are alive but not currently causing active disease. The purpose of treating those patients identified as having latent TB is to kill any dormant bacteria in order to reduce the likelihood or prevent later reactivation of tuberculosis into active disease. Treatment for Latent TB infection should be considered for certain individuals once active TB disease has been excluded, this will require a respiratory consultant review by chest X-ray and physical examination. 5.4 Who is at Risk of TB? Whilst anyone may catch TB certain groups are recognised at being at an increased risk. These are generally: Close contacts of infectious cases Those who have lived or travelled to places where TB is still common (endemic) Those who have visitors from places where TB is common (endemic) Those who live in ethnic minority communities originating from places where TB is common (endemic) Those with immune systems weakened by Human Immuno-deficiency Virus (HIV) infection or other medical problems. The very young and elderly as their immune systems are less robust Those with chronic poor health as a result of lifestyle, such as homelessness and/or substance misuse e.g. drugs and alcohol 5.5 What are the common symptoms of TB? TB is mostly found in the lungs (pulmonary) but can affect any part of the body, such as brain, lymph node and bones. TB symptoms in other parts of the body/systems can be extremely varied, but may include pain and swelling in the affected area. Typical Symptoms of Pulmonary TB include: Chronic cough / Haemoptysis Loss of appetite Weight loss Extreme lethargy Intermittent fever Drenching night sweats 11 6 Diagnosis 6.1 Diagnosis of Active Pulmonary TB Sputum For individual’s suspected of having pulmonary Tuberculosis three sputum samples taken on three consecutive days are required. These should preferably be obtained in the morning as these yields the highest number of organisms if present. The specimen request form and sample must be labelled with high-risk stickers. Samples will be tested for Acid Alcohol Fast Bacilli (AAFB) which if positive is suggestive of infection with mycobacterium (although TB cannot be confirmed at this point). Sputum samples will then be cultured to determine the species of mycobacteria, at which point TB will be confirmed, however, as the organism is slow growing, culture results can take several weeks. Spontaneous sputum should be obtained where possible; however bronchoscopy and lavage may be considered where clinically indicated. In children who are not able to expectorate sputum, gastric washings may be considered. Advice can be sought from the Consultant Medical Microbiologist as to the significance of any bacterial growth identified on sputum. All sputum specimens confirmed as AAFB positive on microscopy or culture will be faxed from the Microbiology laboratory directly to the TB specialist nurse to action. Sputum and Bronchial washings from known or suspected TB patients MUST be treated as high-risk samples i.e. danger of infection or high-risk labelling on both the sample and request form and MUST NOT UNDER ANY CIRCUMSTANCES BE TRANSPORTED BY AN AIR TUBE SYSTEM Chest X-Ray A posterior-anterior chest x-ray should be taken, and if suggestive of TB further investigation should be carried out by referral to either respiratory consultant or paediatrician. Management of Contacts Treatment and follow up of contacts of patients with active pulmonary TB infection should not be delayed whilst awaiting culture results, but should be based on other microbiological results (AAFB positive) and clinical findings. Culture only confirms the mycobacterium species and indicates which drugs Where x-ray or sputum specimen results are suggestive of TB then urgent referral to the respiratory Consultant or Paediatrician should be made. Enhanced surveillance TB is a notifiable disease and therefore patients suspected or confirmed with pulmonary TB must be notified to Public Health England. 12 Notification to Public Health England (notification and data collection form for enhanced tuberculosis surveillance) is the statutory responsibility of the doctor who makes a provisional or definite diagnosis of Tuberculosis under the Public Health (Infectious Disease) Regulations 1988. Notification should not wait until confirmation of culture results, notification must be sent at time of clinical diagnosis. Notifications must be sent initially to the TB Nurse Specialist who will then complete the relevant database online and forward them on to the Consultant in Communicable Disease Control at Public Health England 6.2 Diagnosis of active non respiratory TB: Specimens Where there is a clinical indication of active non respiratory TB infection samples from biopsy or aspiration should be sent for TB culture. These may include: lymph node biopsy Aspiration sample (any fluid) Tissue sample Bone biopsy Autopsy sample All lymph node specimens and other tissue samples should be divided and part sent in formalin for histology and part sent in saline to microbiology for TB stain and culture. Chest X-Ray Chest X-Rays are also required to exclude or confirm co existing respiratory TB disease Additional Tests The Mantoux Tuberculin Skin Test (TST) and gamma interferon blood tests (T spot) can identify people exposed to TB or who may have latent TB infection. Enhanced surveillance Active Non respiratory TB is a notifiable disease and therefore patients suspected or confirmed with non -pulmonary TB must be notified to Public Health England. 7 Treatment Once a diagnosis of active tuberculosis is suspected the clinician responsible for care should refer the person with TB urgently to a physician/paediatrician with experience and training in the treatment of people with TB. If there are clinical signs 13 and symptoms consistent with a diagnosis of TB, treatment should be started without waiting for culture results. The treatment regime will be determined by the treating physician based on clinical and microbiological assessment and in accordance with NICE guidelines, TB treatment is currently free of charge (DOH 2007) and this is achieved by providing a prescription obtained from the hospital pharmacy. If an FP10 prescription is necessary the patient will have to pay for the medication if they are not exempt. (This will be the exception). Prior to commencing medication in adults diagnosed with TB the following are required as a base line: Visual acuity Liver function blood test and urea and electrolyte Abnormalities with either may require adjustment to service users’ doses of medication. 7.1 Treatment Regimes The standard regime of Six month, four drug regimens should be used to treat Active respiratory TB in: Adults not known to be HIV positive Adults who are HIV positive Children The standard drug regime (as per NICE guidelines) is also applicable for patients with: Active peripheral lymph node TB Active spinal TB (with no direct spinal cord involvement) TB other bone and joint. (Please refer to NICE guidelines for further recommended treatment regimes) The majority of bacteria are sensitive to Rifampicin Isoniazid Pyrazinamide Ethambutol The standard NICE recommended regime is six months of Isoniazid and Rifampicin, supplemented by Pyrazinamide and Ethambutol for the first two months. Occasionally this standard regime is amended by the hospital consultant or TB nurse to support concordance. Fixed dose combination tablets are recommended for 14 adults. The medication should be taken all together first thing in a morning on an empty stomach wherever possible. Although currently low in the UK, drug resistance is on the increase worldwide, with approximately 1% of cases occasionally Being resistant to both Rifampicin and Isoniazid. These isolated cases are referred to as Multi-drug Resistant TB (MDR TB), and are recognised as being more difficult to treat. For those service users in whom samples have been sent for culture, the sensitivity tests are required prior to the change to the continuation phase of treatment. 7.2 Potential side effects of Treatment: Staff should be aware of these in order to inform, advise and support the patients in the their care. (Please see most current British National Formulary [BNF] for full details). Rifampicin Gastro intestinal symptoms including anorexia, nausea, vomiting and diarrhoea Alterations to Liver function tests (contra-indicated in jaundice/hepatic disorders) Urticaria and rashes Menstrual disturbance (contraindications if patient is taking oral contraceptives, advise to use barrier method of contraception) urine saliva and other body secretions coloured orange-red Isoniazid Gastro intestinal symptoms as above Peripheral neuritis with high doses (pyridoxine prophylaxis is given to those at increased risk such as diabetics, alcohol dependent, malnourished and pregnant and breast feeding mothers) Patients with Hepatic impairment caution is needed Pyrazinamide Aggravate or cause Gout Hepatotoxicity including fever, anorexia etc Ethambutol Caution needed in renal impairment Potential side effect of optic neuritis, red/green colour blindness Visual acuity check before commencement of treatment 15 7.3 Monitoring adherence to treatment regimens and treatment completion To promote adherence, service users should be involved in treatment decisions at the outset of treatment for active TB Disease or latent TB infection. Service user verbal consent should be obtained to share relevant information with other health care professionals and recorded on System One. The importance of adherence and potential impact on outcome and possible consequences of non-compliance must be explained and emphasised to the patient. Consent is not required to inform public health England as TB is a notifiable disease The service user should be informed that they will be allocated a named key worker/ TB Nurse Specialist who will continue to support them throughout the course of their treatment. Service user’s individual beliefs must be respected and their dignity maintained at all times. Service users who are diagnosed with TB still do feel that a stigma exists with a diagnosis of Tuberculosis and will need much individual support. They are often worried about how family and friends react as well as the transmission to those closest to them. Correct information in a timely manner is essential to avoid unnecessary anxiety. If you are unable to answer questions directly and accurately you should contact the TB Nurse Specialist for advice. 7.4 Directly observed therapy (DOT) Directly observed therapy is the supervised swallowing of medication to support concordance. Directly observed therapy (DOT) is rarely necessary with any requirement being risk assessment by treating clinician and TB specialist nurse. It is likely to be considered for those who have adverse risk factors, in particular street or shelter dwelling homeless people with active TB and patients with likely poor adherence due to lifestyle etc. or those with a history on non-adherence 7.5 HIV and TB Staff should refer to the British HIV Association (BHIVA) treatment guidelines for TB/HIV 2011, which were drawn up by the BHIVA guidelines writing committee to help physicians manage adults with HIV/TB co infection. Starting antiretroviral therapy in service users who have TB is a balance between potential overlapping toxicities, drug interactions and possible immune reconstitution versus the risk of further immune suppression with its associated increase in morbidity and mortality. Mantoux testing is not recommended in HIV/TB co-infected patients or as a routine screening test for tuberculosis in HIV infected service users as, there are high numbers of false negative rates, especially in those with low CD4 counts. Gamma interferon testing (T Spot) appears to have a better sensitivity than tuberculin skin tests but is currently not recommended as routine. All patients 16 diagnosed with active TB should be offered a HIV test, where accepted this should be a direct referral from chest clinic or the TB Nurse. Positive results are referred to the Genito-Urinary Medicine Consultant with the consent of the service user .The offer and outcome of offer should be documented in the service users’ clinical notes. 7.6 Admission to hospital and other inpatient areas It is important to prevent unnecessary hospitalisation as treatment can proceed in a service users’ home, considering that the household contacts will be picked up by the contact tracing process and that the infectiousness declines rapidly once treatment begins. Service users who are considered infectious may be required to stay at home for a minimum of two weeks of treatment in order to isolate themselves from and prevent new contacts. 7.7 Risk Assessment Service users admitted to hospital or other inpatient units who are suspected of having respiratory TB must be admitted to a single room with Respiratory Infection Control Precautions as per individual Trust’s Transmission Based Isolation Policy. Service users with a productive cough must be nursed in a single room, until all three sputum results are available and cleared by the Infection Prevention and Control Team. Service uses who are an inpatient and who are diagnosed smear positive (with no risk factors for MDRTB) must be cared for in a single room until they have completed at least two weeks of the standard treatment and an appropriate risk assessment has been carried out by responsible consultant. The risk assessment must be documented in the medical notes and the infection and prevention and control team should be consulted prior to any move from the cubicle. Service users who are smear positive (with no risk factors for MDRTB) and who are deemed fit enough for discharge should remain in the cubicle until the point of discharge from the hospital. If a service user is suspected of TB after admission to hospital, they must be allocated to a cubicle as priority. Contact the Infection prevention and control team along with bed management team. Service users who are smear positive pulmonary TB must be isolated as soon as possible and before the exposure of other service users reaches 8 hours. For those who are suspected or diagnosed with active pulmonary TB, who are smear positive and who have been nursed with other service users in a bay area for more than 8 hours should be identified and referred to infection and prevention and control nurse as soon as possible on the same day. 7.8 Care of service users residing in an Initial Accommodation Centre (Wakefield) Initial Accommodation Health Care Nurses to identify service users at risk or suspected TB at point of initial assessment. To refer to TB Specialist Nurse for 17 further assessment and screening as appropriate and dependent on the findings undertake baseline bloods LFT / U&E /FBC/ HIV/Vitamin D request a CXR if symptomatic request sputum samples and discuss isolation and contact screening with initial accommodation staff. To be referred to the consultant. TB Specialist nurse to discuss with consultant infectivity risk, contact screening and establish if a delayed dispersal is required. The TB nurse will then make the necessary arrangements and liaise with the UKBA / Home Office. On dispersal TB nurse to refer on to appropriate TB Service 7.9 Drug resistance Drug resistance is an important issue in the management of TB, as it may prolong the period during which patients are infectious to others as well as compromising the effectiveness of treatment. .A clinical risk assessment for drug resistance must be made by the medical team responsible for the service users care (advice and support is available from the Medical Microbiologist, the Infection prevention and Control Team, the TB Nurse Specialist or the Consultant for Communicable Disease Control, based at Public Health England in Sheffield). The risk assessment for resistance is based on the following risk factors: History of prior TB drug treatment; prior TB treatment failure Contact with a known case of drug-resistant TB Birth in a foreign country, particularly high incidence countries as defined by the public health England www.phe.gov.uk HIV infection Residence in London Age profile, with the highest rates of resistance being between 25 and 44 years of age. Gender higher incidence of resistance in male gender. If after clinical risk assessment, there is considered to be a significant risk of drug resistance, urgent molecular tests for Rifampicin resistance should be performed on smear positive material. This will be arranged through microbiology. 7.10 Care of the service user with suspected drug resistance TB Service users with suspected or known MDR TB who are admitted to hospital must be nursed in a continually monitored negative pressure room. The infection prevention and control team must be contacted as a priority as, such patients will require urgent transfer to a neighbouring facility (currently only available at Royal Hallamshire Hospital Sheffield or Sheffield children’s hospital for Barnsley service users St James in Leeds for Wakefield patients).The reason for transfer must be explained to the service user and their carer(s)/relatives. 18 Service users at increased risk of drug resistance should be closely monitored and if there is no clinical improvement, or if cultures remain smear or culture positive after the fourth month of treatment, then drug resistance should be suspected. Referral to Consultant Microbiologist is necessary and transfer to the appropriate hospital. For service users known to have or suspected of having MDR TB, staff and visitors must wear an FFP3 mask during contact while ever the patient is considered infectious. These masks require training prior to use, to ensure appropriate and adequate fit Before discharge, any service users who have been identified as drug resistant need secure arrangements to be made for the supervision and administration of all anti-TB treatment. Liaison with the TB Nurse Specialist in a timely manner to arrange directly observed Therapy (DOT) is necessary 7.11 Isolation There are three levels of isolation for infection prevention and control in an inpatient setting: 1. Negative pressure rooms, which have air pressure continuously or automatically measured as defined by NHS Estates. These must be used for Service users with suspected or confirmed MDR TB and are currently only available at the Royal Hallamshire Hospital and Sheffield children’s hospital. 2. Single rooms that are not negative pressure but are vented to the outside – used for: Smear positive service users with a productive cough Suspected respiratory TB service users until a full risk assessment has been carried out by the clinician responsible for their care in conjunction with Microbiology 3. Beds on a ward, for which no particular engineering standards are required (these must not be used for service users with a productive cough, unless proven to be smear negative and as directed by the Infection Prevention and Control Team. 7.12 Practice recommendations for TB service users admitted to hospital and to inpatient areas Inform the admitting ward/area. Service user to be isolated in a cubicle until an assessment of the service user has been carried out and advice obtained from Infection Prevention and Control Team. Children admitted with TB of any site must be admitted to a cubicle as a visitor may be an undiagnosed and unidentified index case of infectious Tuberculosis. 19 Inform infection Prevention and Control Nurses. Inform TB Services 01226 731686. 7.13 Care of a patient nursed in a single room when respiratory precautions are required Service users can find isolation a very stressful experience and if personal protective equipment is required then the service user requires adequate explanation and reassurance. Consult with the Infection Prevention and Control Nurses for assessment/advice. Service users to remain in the room with the door closed. If respiratory infection control precautions apply, the sign must be displayed clearly at the entrance to the side room (Green isolation sign). Masks: Service users visiting other departments who are identified as infectious must wear a FFP2 mask (duck billed). Linen from patients who are coughing and assessed as an infection risk must be handled as ‘infected’. Close household contacts should be allowed to visit with no precautions unless drug resistance is suspected. Visitors of newly diagnosed service users should, as far as is possible, be limited to those who have already been in close contact with the service user before diagnosis as these people will be followed up routinely as contacts. Others, who are immuno-compromised or children under two years should not visit unless the situation deems absolutely necessary. Individual risk assessment is required and masks may be required. Any visitors of a child with TB must be screened as part of contact tracing and kept separate from other service users until they are excluded as the source case. One of the visitors could potentially be the source of TB and hence a risk to others on the ward. After assessment by Infection prevention and Control Team, health care workers may not be required to wear masks or gowns unless: MDR TB is suspected Aerosol generating procedures are being performed (e.g. use of BiPAP, CPAP etc.) They have very close prolonged contact with the service user where coughing directly into the face is anticipated. This should be an individual risk assessment and in consultation with infection prevention and control team and TB specialist nurse. 20 Service users with respiratory immunocompromised service users TB must be separated from 7.14Termination of Isolation The decision to terminate isolation should be taken by the supervising physician in conjunction with the Infection Prevention and Control Team/TB Nurse Specialist. There is evidence that the vast majority of service users with uncomplicated pulmonary TB will be non–infectious after two weeks of compliance with two weeks of appropriate anti-TB therapy. Results of sputum samples and response to treatment should be taken into account. 7.15 Spirometry Service users requiring spirometry will be assessed on an individual basis and spirometry will be performed through a filter as per medical physics guidelines. Carbon monoxide monitoring for the benefit of smoking cessation will not be permitted. 7.16 Care of service users attending outpatient departments Service users who attend clinic prior to commencing treatment for TB and who are suspected as having pulmonary TB should be segregated from other patients by sitting the patient in a private room(reassurance and explanation is required to alleviate anxiety. For the baseline eye test prior to treatment the patient must wear a FFP2 mask (duck billed). For any procedures such as bronchoscopy the patient should be last on the list. 7.17 Care of service users in their own home Often service users are cared for in their home and precautions are not usually necessary unless drug resistance is suspected or the individual is particularly infectious. All household contacts will be screened in a timely manner according to their individual needs as assessed by the TB Nurse Specialist. Health care workers may not be required to wear masks at home visits after an assessment has been carried out by Infection Prevention and Control or TB Specialist Nurse unless: MDR TB is suspected Aerosol generating procedures are being performed They have very close prolonged contact with the service user where coughing directly into the face is anticipated. This should be an individual risk assessment by the healthcare worker (the service user can be asked to wear the mask during a visit from a health care professional if individual risk assessment deems it appropriate) 21 Infectious case service users should be advised to stay at home until they have received 2 weeks continuous compliant anti-TB drugs. They should be educated about the risks of spreading infection and advised about disposal of tissues (these should not be thrown directly into the bin, but firstly into a plastic bag etc) and to cover the mouth when coughing and turn away from contacts. Disposal of tissues etc must be followed by rigorous hand washing. They should be advised not to make any new contacts until they are non-infectious to others 7.18 Discharge and transfer of a service user with tuberculosis The TB Nurse must be contacted prior to discharge (tel. 01226 731686) If Directly Observed Therapy (DOT) is required the TB Nurse must be given notice and the patient not discharged until the service has been arranged. If a service user is to leave using the ambulance service then an assessment by Infection prevention and Control Nurse is required for infection risk and the relevant Inter-Healthcare Transfer Form to be completed. The ambulance service must be informed at the time of booking that the patient has Tuberculosis and their infection status at time of transfer – patients still considered to be infectious must wear FFP2 masks (duck billed)for the duration of the journey and must travel alone. The room must be terminally cleaned in line with the Trust Decontamination Policy following discharge, where service user’s results are unknown or have been proven to be AAFB positive. Service users visiting other departments who are identified as infectious must wear a FFP2 mask (duck billed). If service users are to attend other departments, the receiving department must be informed so that they can take the necessary precautions to prevent exposure to susceptible service users in awaiting area/department. Service users with infectious TB must be placed last on the operating/procedure list to facilitate cleaning and change of any equipment. 7.19 Death If a service user with known or suspected TB (of any type and from anybody site) dies, the mortuary and/or undertaker must be informed. The body must be placed in a black heavy-duty cadaver bag suitable for “danger of infection”. Under no circumstances must routine body pouches be used. The TB nurse must be informed of any patient who dies and who has a confirmed diagnosis of Tuberculosis, as contact tracing will be required. 22 8 Contact tracing Contact tracing is performed by the TB Nurse Specialist after an individual is diagnosed with Tuberculosis (the index case). Individual assessment of contacts by the TB specialist looks at the infectivity of the index case, the contacts exposure to the index case and the susceptibility of the individual contact. Identification of those who require a BCG vaccination is also considered. Contacts that require screening are referred to the nurse led contact clinic or referred to the Paediatrician with special interest in TB and are seen in the children’s outpatients department in accordance with specific pathway. 8.1 Assessment for contact tracing Contact tracing should not be delayed until notification. Screening is offered to the household contacts of any person with active TB, irrespective of site of infection For people with sputum smear-positive TB, other close contacts should be assessed. Casual contacts of people with TB, which include the majority of workplace contacts. Staff caring for a service users with TB do not usually require screening but for those who are considered to have had a significant exposure to an infectious case of Tuberculosis please refer to occupational health services staff policy “Control and prevention of tuberculosis in healthcare” 2007. The need for Contact tracing service users exposed to TB will assessed by the Infection prevention and Control Team in collaboration with department manager and TB specialist nurse. The assessment would take into account: The infectivity of the index case The length of time before appropriate infection control precautions were introduced Whether other patients were known or suspected to be unusually susceptible to infection The proximity of the contact with the index case Any specific features (e.g. Drug resistance) If associated cases of Tuberculosis disease are identified then the screening of other casual contacts may be appropriate. Latent TB infection if identified in contacts may require chemo prophylaxis. This is offered on an individual assessment in line with NICE guidelines. 9. BCG vaccination 9.1Maternity Services 23 BCG vaccination will be given by suitably qualified midwifes to appropriate neonates identified at an increased risk during the ante-natal assessment, while an inpatient on the postnatal ward. Missed BCG babies are referred to the Paediatric with special interest for TB, (Barnsley) and will receive an appointment for the children’s outpatient clinic, or to TB Specialist Nurse in Wakefield who will arrange an appointment in the community clinic. BCG vaccination is offered to selected neonates who: Were born in an area with high incidence of TB as defined by the HPA Have one or more parents or grandparents who were born in a high incidence country Have a family history of TB in the past five years Routine BCG vaccination for children aged 10-14 is no longer recommended as part of the UK routine immunisation programme 9.2 Children’s Services Healthcare workers should opportunistically identify unvaccinated children older than 4 weeks and younger than 16 years at increased risk of TB and who would have qualified for neonatal BCG (High risk as above). Children up to the age of 12 years are referred to Paediatrician with special interest in TB. Children over 12 years are referred to the nurse led contact tracing clinic Mantoux testing is not routinely done before BCG vaccination in children younger than 6 years unless there is a history of residence or prolonged stay (more than a month) in a country with a high incidence of TB. 9.3 New Entrants and BCG BCG should be offered to Mantoux-negative new entrants who are: From high incidence countries and are previously unvaccinated, and are aged 35 years or younger Currently the screening service is only available to new entrants who are registered at The Health Integration Team. Any new entrants identified as requiring BCG are referred to either the Paediatrician with special interest in TB or the Respiratory Consultant with special interest in TB in Barnsley. In Wakefield referral to TB service Nurse Led Clinic 9.4 Health Care Workers and BCG Please refer to Workplace Health and Wellbeing immunisation procedure. BCG should be offered to healthcare workers irrespective of age, who: 24 Are previously unvaccinated and Will have contact with service users or clinical materials and Are mantoux (or interferon-gamma) negative Staff who have any concerns should contact the Workplace Health and Wellbeing department. 9.5 Contacts Requiring BCG This will be identified during contact tracing procedures. BCG should be offered to mantoux–negative / IgRA negative contacts of people with pulmonary TB if they are previously unvaccinated and are: Aged 35 or younger Aged 36 and older and a healthcare or laboratory worker who has contact with service users or clinical materials 9.6 Other Groups BCG should be offered to previously unvaccinated, mantoux-negative people less than 35 years as per Department of Health, Immunisation against infectious disease 2006 ‘Green Book’ Veterinary and other staff such as abattoir workers Prison staff working directly with prisoners Staff at care homes for elderly people Staff at hostels for homeless people and facilities accommodating refugees and asylum seekers Previously unvaccinated, tuberculin-negative individuals under 16 years of age who were born in or who have lived for a prolonged period (at least three months) in a country with an annual TB incidence of 40/100,000 or greater. 10 Terms and Acronyms Terms Index case Any person who lives in the same household as the index case (sharing bedroom, bathroom, kitchen or sitting room- e.g bedsits with some shared facilities). Contacts with a cumulative total exposure to a smear positive case of TB exceeding 8 hours within a restricted area equivalent to a domestic setting (this may include partners who do not live in the same household). Casual Contact Will include the majority of workplace contacts and people who spend less than 8 cumulative hours with the index case. 25 Contact Tracing Is screening to find associated cases, to detect people infected without evidence of disease (latent TB), and to identify those not infected who may benefit from BCG vaccination. Where recent infection has occurred (e.g. clinical disease in children) contact tracing is done to find a source of infection and co primary cases (other index cases). Smear positive Laboratory diagnosis of Acid and Alcohol Fast Bacilli by Ziehl Neilson or Auramine phenol staining on Microscopy. Smear negative When a microscopy sample is stained by Ziehl Neilson or auramine phenol and Acid and Alcohol Fast Baccilli are not seen. Culture positive Acid and Alcohol fast Baccilli are identified on culture. Drug Sensitivity Dependant on the species of mycobacterium identified, the reference laboratory will provide confirmation of drug sensitivity and resistance. Respiratory TB TB present within the respiratory system - more easily transmitted to others. Non Respiratory TB TB present within other sites of the body - less easily transmitted to others. Latent TB Infection with Mycobacteria of the M Tuberculosis complex, where the bacteria are alive, but not currently causing active disease. Acronyms / Abbreviations Drug regimens are often abbreviated to the number of months a phase of treatment lasts followed by the letters for the drugs administered in that phase: H ISONIAZID R RIFAMPICIN Z PYRAZINAMIDE E ETHAMBUTOL S STRPTOMYCIN For example: 2HRZE / 4HR is the standard regime AAFB Acid and Alcohol Fast Bacilli BCG Bacillus Calmette-Guerin vaccine 26 DIPC Director of Infection Prevention and Control HAART Highly active anti-retroviral therapy HIV Human Immunodeficiency Virus IGRA Interferon Gamma Assay IPCN Infection Prevention and Control Nurse IPCDC Infection Prevention and Control and Decontamination Committee MDR-TB Multi Drug Resistant Tuberculosis PA Posterior-anterior STH Sheffield Teaching Hospitals TB Tuberculosis ZN Ziehl Neilson 11 Developmental Processes 11.1 Identification of need The need for a revised Tuberculosis policy or procedure may be prompted by changes in national legislation, policy or guidance. It may also be identified within theTrust either as a result of learning from experience, such as incidents or complaints, or as a result of an identified risk. New policies may also be required as a result of the development of a new service or a new way of working. To reduce organisational risk, the policies of Barnsley BDU, needed to be harmonised with those of SWYPFT to recognise service provision changes. This policy is intended to meet the needs of the organisation as a whole. 11.2 Stakeholder involvement The organisation recognises that policies need to be developed in consultation and communication with a range of stakeholders. The following list identifies some of the individuals or groups who have been consulted in the development of this policy. Stakeholder Executive Management Team Public Health Level of involvement Approval Commissioning, development, consultation, dissemination, 27 implementation and monitoring Infection Prevention and Control Team Consultation, dissemination, implementation. Drugs and Therapeutic Committee Consultation, dissemination, implementation Business Delivery Units, Practice Consultation, dissemination, monitor Governance Coaches, Managers Staff side Consultation 11.3 Equality Impact Assessment The Trust aims to ensure its policies and procedures promote equality both as a provider of services and as an employer. Please see Appendix 1 for quality impact assessment 11.4Dissemination and implementation arrangements (including training) This policy is available in read only format via the document store and web page on the Trust intranet and internet. Staffs are informed of any changes to the policy via the weekly update. 11.5 Implementation Advice to assist with the implementation of this policy is available from the TB Team. 11.6 Training The TB Team will offer training to staff, other services and agencies in a variety of formats in order to accommodate the diversity of services. 11.7 Monitoring compliance Regular COHORT reviews in place to audit all compliance and effectiveness. 11.8 Effectiveness of the policy Any incidents of known non-compliance will be highlight through the Datix incident reporting system. 11.9 Further advice and support Please contact Health Integration Team / TB Service 01226 731686 12 Review and revision arrangements (including version control) 12.1 Process for reviewing the policy The review date for this policy will be September 2018 and three yearly thereafter unless otherwise indicated by an identified need for change. 28 12.2 Version control This policy has been revised from its previous format and is version 1. 13 References and further reading BHIVA treatment guidelines for TB/HIV infection, 2011 http://www.bhiva.org/documents/guidelines/TB/HIV_954_online_final .pdf Department of Health Health Clearance for tuberculosis, hepatitis b, hepatitis and HIV: New Health care workers http://www.dh.gov.uk Department of Health (2009) The Health and Social Care Act (2008). A Code of Practice for the NHS on the prevention and control of healthcare associated infections and related guidance (update July 2015) http://www.dh.gov.uk Department of Health 2007 The NHS (Charges for Drugs and Appliances) Regulations (the Charges Regulations) 2007 http://www.dh.gov.uk Immunisation against infectious disease (Green Book) DOH 2011 chapter 32 NICE. Tuberculosis: clinical diagnosis and management of Tuberculosis and its measures for its prevention and control, March 2011 www.nice.org.uk South West Yorkshire Partnership NHS Foundation Trust -Patient group directive for BCG vaccination South West Yorkshire Partnership NHS Foundation Trust Patient Specific Direction for Mantoux Tuberculin skin test Public Health England. Collaborative TB strategy for England 2015-2020 Public Health England January 2015 http://www.gov.uk/phe 14 Any other policies which should be referred to This document should be read in conjunction with Infection Prevention and Control Policy Isolation Policy Confidentiality Policy Occupational Health Policy Health and Safety Policy 29 Appendix One Equality Impact Assessment Tool 8 Taking into account the Evidence based Answers information gathered above, &Actions. Where negative impact could this policy / has been identified please explain procedure/strategy affect any what action you will take to of the following group remove or mitigate this impact. unfavourably: To be completed and attached to any policy document when submitted to the Executive Management Team for consideration and approval. 1 2 3 4 5 Equality Impact Assessment Questions: Name of the document that you are Equality Impact Assessing Describe the overall aim of your document and context Who will benefit from this policy / procedure / strategy Who is the overall lead for this assessment? Who else was involved in conducting this assessment? Have you involved and consulted service users, carers and staff in developing this policy / procedure / strategy? Evidence based Answers and Actions Tuberculosis Policy The overall aim of the policy is to provide staff with clear and practical evidence based information that can be translated into working practice within the context of the Health and Social care Act (2008). NICE Guidance (2011) Management of Tuberculosis and Measures for its Prevention and Control and other external standards. All staff Director of nursing, Clinical Governance and Safety Lead Tuberculosis Nurse The Executive Management Team was consulted on the original development of the policy. Feedback form Infection Prevention and Control Team. What did you find out and how have you used this information? It was identified that staff required clear, practical evidenced based information; which needed to be easily accessible. 6 What equality data have you used to inform this equality impact assessment? 7 What does this data say? Information gathered from nurse led New entrant screening highlights an increase in positive results and a requirement for further assessment for individuals from Eastern Europe High proportion of positive results which need a central focus 30 8.1 Race Yes 8.2 8.3 8.4 8.5 8.6 8.7 8.8 8.9 8.10 Disability Gender Age Sexual orientation Religion or Belief Transgender Maternity and Pregnancy Marriage and civil partnerships Carers *SWYFT Trust requirement* No No No No No No No No No 9 What monitoring arrangements are you implementing or already have in place to ensure that this policy/procedure/strategy This policy aims to provide staff with clear and practical evidence based information relating to Tuberculosis prevention and management of this. 9a Promotes equality of opportunity for people who share the above protected characteristics; Eliminates discrimination, harassment and bullying for people who share the above protected characteristics; Promotes good relation between different equality groups Public Sector Equality Duty “Due Regard” Have you developed as action plan arising from this assessment? 9a 9c 9d 10 11 Assessment / Action plan approved by 12 Once approved you must forward a copy of this Assessment and Inclusion Team: [email protected] Target areas with high population of European Workers Yes the development of Satellite clinics and And health events target in areas with a high population of Eastern European workers Signed: Bev Jones Date: 02/11/2015 Title: Team Leader / Lead TB Nurse Please note that EIA is a public document and will be published on the web. Failing to complete an EIA could expose the Trust to future legal challenge 31 Appendix two Checklist for the Review and Approval of procedural Document To be completed and attached to any policy document when submitted to EMT for consideration and approval. Title of document being reviewed: 1 2 3 4 5 6 7 Title Is the title clear and unambiguous? Is it clear whether the document is a guideline, policy, protocol or standard? Is it clear in the introduction whether this document replaces or supersedes a previous document? Rationale Are reasons for the development of the document stated? Development Process Is the method described in brief? Are people involved in the development identified? Do you feel a reasonable attempt has been made to ensure relevant expertise has been used? Is there evidence of consultation with the stakeholders? Content Is the objective of the document clear? Is the target population clear and unambiguous? Are the intended outcomes described? Are the statements clear and unambiguous? Evidence based Is there type of evidence to support the document identify explicitly? Are key references cited? Are the references cited in full? Are supporting documents referenced Approval Does the document identify which committee/ group will approve it? If appropriate have joint Human resources /staff side committee or equivalent approved the document? Dissemination and Implementation Is there an outline /plan to identify how Yes Comments /no/unsure Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes yes yes N/A Yes 32 8 9 10 11 this will be done? Does the plan include the necessary training /support to ensure compliance? Document control Does the document identify where it will be held? Have archiving arrangements for superseded documents been addressed? Process to monitor compliance and effectiveness Are there measurable standards or KPIs to support monitoring of compliance with the effectiveness of the document? Is there a plan to review or audit compliance with the document? Review date Is the review date identified? Is the frequency of review identified? If so is it acceptable? Overall responsibility for the document Is it clear who will be responsible for the implementation and review of the document? yes Yes no Previous Barnsley PCT Policy currently archived Yes Yes Yes Yes Yes Date of Assessment: 09/11/2015 33