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Interim Guidelines for Smallpox Response and Management in Scotland in the Post-Eradication era

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Interim Guidelines for Smallpox Response and Management in Scotland in the Post-Eradication era

VI Planning for outbreaks of smallpox
  1. Since smallpox no longer exists as a naturally acquired infection, the two most likely causes for its re-emergence would be:

  • A deliberate release of the organism. This may occur without warning and it is possible that many people would be exposed, either via infected person(s) or environmental release of smallpox virus. A criminal investigation would need to proceed in parallel with the public health response.

  • An accidental release in one of the two approved collaborating centres for smallpox. This is unlikely because both laboratories undergo frequent WHO inspections and have stringent safety and security procedures in place.

  1. A number of Alert Levels can be identified to assist planning according to the actions required (see Appendix 3). Alert Levels proceed in a stepwise fashion, except that level 0 may proceed directly to levels 1 or 2.

  • Alert Level 0:

Smallpox remains eradicated - no credible threat of a release.

  • Alert Level 1:

Heightened threat:

  • Case confirmed outside UK.

  • Virus identified outside the WHO approved collaborating centres.

  • Intelligence suggests a credible and imminent threat of a release in the UK.

  • Alert Level 2:

Case confirmed in Scotland and/or elsewhere in the UK.

  • Alert Level 3:

Outbreak occurring in Scotland and/or elsewhere in the UK.

  • Alert Level 4:

Large or multiple outbreak not controlled by ring vaccination.

  • Alert Level 5:

Outbreak controlled - no further cases occurring.

Diagnosis and response to initial cases

  1. Early recognition and appropriate management of initial cases is key to rapid implementation of outbreak containment measures. At Alert Levels 0 and 1, the aim will be to alert clinicians to the possibility of a case of smallpox, raise awareness of the presenting symptoms and signs, and encourage appropriate and rapid reporting of patients with suspicious illnesses for further assessment. Structures and processes for further assessment and management of these patients will also be required.

  2. Regional Smallpox Diagnosis and Response Groups and Teams (RSDRG and RSDRT) in Scotland

  3. Regional Smallpox Diagnosis and Response Groups in Scotland will be established at Alert Level 0, in the three regions used for Emergency Planning in Scotland, as an incident would fall within the Emergency Planning Response. The three Regions are:

  • West: Dumfries and Galloway, Ayrshire and Arran, Greater Glasgow, Lanarkshire and Argyll and Clyde;

  • East: Borders, Lothian, Forth Valley, Fife and Tayside;

  • North: Grampian, Highlands, Western Isles, Shetland and Orkney.

Each Group will be headed by the lead Director of Public Health (LDPH), supported by a SCIEH epidemiologist and will be accountable to the Scottish Executive Health Department (SEHD).

  1. RSDRGs in Scotland will be responsible for all aspects of planning for outbreaks of smallpox:

  • Maintain a 24 hour emergency response to suspected and probable cases of smallpox through RSDRTs (see below).

  • Co-ordinate vaccinations to be provided at Alert Levels 0 and 1 (see Section VIII) and monitor vaccine side effects.

  • Identify healthcare, emergency, laboratory and other essential personnel who will be vaccinated at Alert Levels 1 and 2.

  • Identify a Regional Smallpox Care Centre (see Appendix 6).

  • Identify a Regional Smallpox Vaccination Centre (see Appendix 8).

  • Train and co-ordinate a network of Smallpox Diagnostic Experts (see below)

  • Offer a resource for training clinicians in the recognition and reporting of patients with suspicious illnesses.

  • Distribute a UK National Standard Diagnostic Algorithm to clinicians through PCTs to aid the assessment of patients with suspicious illnesses - see Figure 10.

  • Develop multi-agency partnerships with the designated Category 3 laboratory in Scotland, RVL at Gartnavel General Hospital, Glasgow and with local emergency services across the Region to ensure that a co-ordinated response can be mounted to the first suspected or probable cases in Scotland or elsewhere in the UK.

  1. At Alert Level 0, each RSDRG will have between three and five Regional Smallpox Diagnosis and Response Teams depending on local circumstances and cross-cover arrangements, sufficient to allow one of these Teams to be on duty at all times to respond to suspected and probable cases of smallpox. They will be contactable through a single emergency telephone number maintained by the RSDRG.

  2. Each RSDRT will comprise five members: a Public Health Physician (who is team leader), a Medical Consultant (usually an ID Physician), a Public Health/Infection Control Nurse, a Clinical N urse with experience in acute emergency medicine, and arrangements for a Paediatrician. One individual in each role will be on duty at all times. All members of the team will be vaccinated against smallpox (see Section VIII). The equipment to be carried by Teams is listed in Appendix 4. They will be given training in smallpox management and additional general emergency medical training such as Advanced Life Support.

  3. At Alert Level 1, the number of RSDRTs per RSDRG will be increased to allow a response to multiple cases arising simultaneously.

  4. Smallpox Diagnostic Experts (SDE)

  5. Smallpox Diagnostic Experts will be Infectious Disease (ID) Physicians who, at Alert Level 0, will be vaccinated against smallpox (see Section VIII) and given advanced training in smallpox differential diagnosis so that they are able to assess patients with suspicious illnesses safely and accurately.

  6. ID Physicians in each Region will be invited by the RSDRG to become SDEs, and a network of SDEs will be established who will be trained and co-ordinated by the RSDRG.

  7. At Alert Levels 1 or 2, more general physicians and consultants from other specialties will be trained as SDEs.

  8. Procedure for assessment and management of initial cases

  9. Patients with suspicious illnesses may present at a variety of different sites as listed below (in addition, smallpox virus may be seen on routine EM of vesicular fluid - see paragraph 51). General and specific management in the event of each of these scenarios is described in Figures 1 to 7.

  • At a patient's home.

  • At a primary care centre.

  • At a hospital:

  • Accident and Emergency (A+E),

  • General Medical ward,

  • Intensive Care Unit (ICU), or

  • Infectious Disease (ID) Unit.

  • At a Port Health Control Unit.

  1. Clinicians will be offered training and a UK National Standard Diagnostic Algorithm (see Figure 10) will be distributed to all clinicians to assist them with the assessment of patients with suspicious illnesses.

  2. Diagnostic Algorithms will be distributed from the RSDRG via local Primary Care Trusts (PCTs) who will be responsible for adding contact details of local SDEs.

  3. Clinicians should assess these patients according to the Diagnostic Algorithm - see Figure 10. If they are unable to exclude the diagnosis of smallpox, they should contact their local SDE to request a further assessment.

  4. Whilst waiting for the SDE, the referring clinician should remain at the scene, isolate the patient as best as possible, and encourage close contacts of the patient also to remain close by.

  5. SDEs will visit the patient, at the site, to make a further assessment. They should use appropriate personal protective equipment including non-sterile gloves, disposable gowns, face and eye protection and shoe covers.

  6. There are three possible outcomes:

  1. Smallpox can be excluded. The patient can be handed back to the referring clinician for further management.

  2. Smallpox cannot be excluded. The patient is now a suspected case of smallpox. Responsibility for management transfers to the SDE. The SDE should contact the RSDRT to arrange laboratory investigation and further management. Appropriate treatment for other possible diagnoses should be initiated.

  3. The clinical features are strongly suggestive of smallpox and there is no other likely diagnosis. The patient is now a probable case of smallpox. Responsibility for management transfers to the SDE. The SDE should contact the RSDRT to arrange immediate transfer to isolation facilities, laboratory investigation and further management (see paragraphs 82 to 88. Note that patients should not be transferred out of an ICU.

  1. When they are contacted by an SDE, the RSDRT must immediately notify:

  • The Designated Category 3 Laboratory for Scotland, RVL Gartnavel Hospital, Glasgow (see Appendix 2) that they may expect specimens for EM - see paragraphs 77 to 78. The laboratory will in turn immediately notify a UK Reference laboratory (CPHL or CAMR).

  • The lead DPH, who will in turn notify:

  • Local police forces - that there is a suspected case, and that escort to and security at the scene may be required.

  • Local ambulance services - that a Category 3 infectious removal may be required - see Appendix 5.

  • Hospital isolation facilities - that a bed may be required - see paragraphs 82 to 84.

  • The local Consultant in Public Health Medicine (CPHM (CD&EH)).

  • The local Health Emergency Planning Officer.

  • The Scottish Centre for Infection and Environmental Health (SCIEH) and the SEHD.

  1. While awaiting the arrival of the RSDRT, and later while awaiting laboratory results, management of suspected or probable cases requires three key principles, irrespective of the site:

  1. Patient care. The patient should be kept comfortable, and supportive treatment should be provided. This may necessitate transfer to isolation facilities at any stage - see paragraphs 82 to 84.

  2. Infection control. Entry and exit of persons and fomites from the potentially contaminated area must be strictly controlled. This may require the assistance of the police to maintain a protective cordon. Potentially contaminated fomites should be placed in yellow clinical waste bags at the earliest opportunity.

  3. Preliminary identification of contacts. The interval should be used for:

  • Establishing the date from which the patient should be regarded as potentially infectious - this is 24 hours prior to the time when the fever was first recognised (see paragraph 28).

  • Obtaining a detailed account of the patient's movements while potentially infectious and during the incubation period. This is both in order to identify primary contacts, and to investigate potential sources of infection. (It is more difficult to get this information from the patient after admission to hospital).

  • Using this information to begin drawing up a list of primary contacts.

  • Contacts who are present at the site should be encouraged to stay there until smallpox can be excluded or confirmed. This if to facilitate infection control, and because they may then be given immediate vaccination by the RSDRT if smallpox is confirmed.

  1. On contacting the RSDRT, the SDE may request that they visit the patient at the site to arrange laboratory investigation and further management, or that they arrange immediate transfer to isolation facilities (see paragraphs 81 to 84). The referring clinician should ideally stay at the site to assist clinical and public health management and because they will require vaccination if the case is confirmed.

  2. Immediate transfer may be requested for probable cases of smallpox (unless already in ICU), or for suspected cases that are outside hospital but whose condition is causing concern or deteriorating.

  3. The RSDRT will attend the patient, travelling in their own private vehicles, with their allocated equipment and supplies. The RSDRT paediatrician will only be required if the patient is under 16 years old.

  4. The SDE may have elected to arrange transfer of the patient to isolation facilities before the RSDRT can arrive at the site. In this event:

  • The SDE should accompany the patient but must ensure that the referring clinician is able to maintain infection control measures at the site.

  • The RSDRT will split:

  • The Medical Consultant and clinical nurse (and Paediatrician if appropriate) will join the patient at hospital isolation facilities.

  • The Public Health Consultant and Communicable Disease Control Nurse will go to the site to ensure that infection control measures are maintained and begin contact identification and tracing.

  1. When they reach the patient and/or site, responsibility for management transfers to the RSDRT, and at least one member of the Team should stay with the patient and at the site until smallpox can be confirmed or excluded.

  2. After an assessment, the RSDRT will send diagnostic clinical specimens for EM (see Appendix 1). A minimum of four specimens of vesicle fluid should be sent to the Designated Category 3 laboratory in Scotland.

  3. One member of the RSDRT will personally transport specimens. On receipt of the specimens the designated laboratory in Scotland will immediately dispatch at least two of them to a UK Reference laboratory for confirmatory tests. Transport of specimens from the field to the designated Scottish laboratory and from there to the UK Reference laboratories may require a blue light escort for speed.

  4. If diagnoses other than smallpox are also considered possible, the RSDRT will send additional relevant specimens and initiate or continue appropriate treatments according to normal procedures.

  5. Further specific management depends on the location of the patient, and is described in Figures 1 to 7. The on duty RSDRT will attend and commence clinical and public health management of suspected or probable cases. If they are required to spend long periods at the site whilst awaiting results, if their workload becomes excessive, or if additional suspected or probable cases arise, they may call for support from other RSDRTs in the same or adjacent regions.

  6. EM results will be available within 6 hours of receipt of specimens from anywhere in Scotland. There are three potential EM results:

  1. Organism other than smallpox detected (eg. VZV or HSV) - this may be regarded as a negative result. The SDE and RSDRT should refer the patient to appropriate local services.

  2. No organism detected - this should be regarded as an equivocal result, and the diagnosis of smallpox should not be excluded until there has been confirmation by a UK Reference laboratory.

  3. Orthopox particles detected - this should be regarded as a provisionally positive result, indicating a probable case, pending a confirmation by the UK Reference laboratory.

Further action in the event of initial probable cases

  1. The patient will be transferred to isolation facilities if this has not already happened. Ideally, one of the UK High Security Infectious Disease Units (Newcastle) should be used. However, it may be necessary to use an alternative ID unit if:

  • The patient's life will be put at risk by a prolonged ambulance transfer.

  • There are large numbers of initial probable or confirmed cases and the high security units are full.

  1. RSDRGs should therefore examine local hospital isolation facilities to determine which ones might be used for the care of initial probable cases of smallpox. Facilities should meet the minimum specifications outlined in Appendix 5.

  2. The patient will be transferred in an ambulance, using standard procedures for a Category 3 infectious removal, accompanied by the RSDRT Medical Consultant, Clinical Nurse, and Paediatrician if appropriate (see also Appendix 6). A police escort is likely to be required. One relative or friend (a parent if the case is a child) may also accompany the patient.

  3. After the ambulance crew have delivered the patient to the isolation facilities, they will park in a secure area, wipe the vehicle with disinfectant (0.1% hypochlorite) and then lock it. They will then remove and dispose of protective clothing, and shower and change where these facilities are available. They will then leave their contact details with RSDRT before going off shift pending PCR results. If PCR is positive they will be vaccinated immediately. The vehicle will require decontamination - see Appendix 15. It should not be reused until smallpox has been excluded or decontamination has been completed.

  4. The RSDRT Public Health Physician and/or Communicable Disease Control Nurse will remain at the site to ensure that infection control measures are maintained, continue contact identification and tracing, and begin vaccinating contacts if the case is confirmed.

  5. Diagnosis of a probable case will lead to mobilisation of a public health response including preparation of Smallpox Care Centres and Smallpox Vaccination Centres, contact tracing (see Section VII) and deployment and distribution of vaccine supplies (see Appendix 11). However, vaccination should be deferred until confirmation by PCR.

  6. PCR results will be available within 12 hours of dispatch of specimens from anywhere in the UK. A positive PCR is required for confirmation of initial cases. However, in a case with strongly suggestive clinical features and no other diagnosis, smallpox should not automatically be excluded on the basis of a negative PCR result. The case should be reviewed and laboratory tests repeated if necessary.

  7. Further action in the event of initial confirmed cases

  8. Until further staff can be immunised, care of the initial confirmed cases, first at hospital isolation facilities and then at Smallpox Care Centres will have to be carried out by RSDRT members supported by SDEs.

  9. The site will need to be evacuated and sealed until it can be decontaminated (see Appendix 15).

  10. Scottish and Regional Smallpox Outbreak Co-ordination Centres (SSOCC and RSOCC) will be convened to co-ordinate the public health response and monitor the epidemiological picture in Scotland. A UK NSOCC will alert international authorities and co-ordinate the overall UK response and monitor the UK epidemiological picture (see paragraphs 109-117 for further details).

  11. Major incident control plans will be initiated with a response at regional Scottish and UK level as described in Deliberate Release of Biological and Chemical Agents in Scotland (SEHD May 2002).

  12. Rapid health alerts will be sent out for enhanced surveillance for other cases - see Section IX. This will include activation of the NHS Helpline and as appropriate NHS24 advice algorithms.

  13. Designated Smallpox Care Centres (see Appendix 6) will be activated at the earliest opportunity, as these will be required to receive new patients once the high security beds are occupied. They will be need to be opened within 24 hours of confirmation of the first case.

  14. Designated Smallpox Vaccination Centres will also be activated as soon as possible. These will be required for vaccination of contacts of cases.

  15. Vaccination of contacts will proceed. Further healthcare, laboratory, emergency and other essential staff, including a large number of additional RSDRTs and SDEs, will be vaccinated to allow a response to multiple cases arising simultaneously.

  16. Cases arising in hospital

  17. Cases may be detected in A+Es, general hospital wards, ICUs or ID units. The procedures for managing such cases is summarised in Figures 3 to 6. Contacts in the hospital may be particularly susceptible to infection due to immunosuppressive disorders or treatments, or general ill health. Attack rates in hospital outbreaks of smallpox have been high.

  18. If a patient with a suspicious illness is recognised, the Hospital Infection Control Team and Trust Management should be informed as early as possible. Hospital air conditioning systems should be turned off immediately and remain off until smallpox has been excluded or decontamination completed. This may necessitate deployment of alternative cooling facilities.

  19. The Hospital Infection Control Team should assist the RSDRT in identifying all areas that the patient has passed through in order to guide implementation of infection control measures. The RSDRT has executive authority, through the lead DPH, to implement whatever infection control measures are deemed necessary, including closure of the hospital.

  20. Identification of contacts will require consideration of airflows within the hospital. Tracing of contacts will include other inpatients, discharged patients who were in contact with the case during their hospital stay, visitors to the hospital, and staff. Vaccination should be prioritised to those who have had the closest and most prolonged contact with cases.

  21. Inpatient close contacts will require cohort observation, with strict infection control procedures observed to avoid spreading infection from any secondary cases that develop. Special consideration for the management of sick inpatient contacts will be required, bearing in mind contraindications to vaccination. Note also that early symptoms of smallpox may be masked by other underlying medical disorders.

  22. It may be necessary to close large areas of the hospital to admissions, and restrict access to essential staff only, until all inpatient contacts are free of disease for 16 days after their last exposure to infection, since secondary cases may arise elsewhere in the building during the incubation period.

  23. Depending on the structure of the hospital, and airflow within it, consideration may be given to vaccinating all patients, visitors, staff and others who have been present in the building with an infectious case.

  24. At Alert Level 0, Hospital Infection Control Teams should examine their hospitals' plans to determine airflows so that they are prepared for contagious pathogens. In the event of a case of smallpox, this will enable risk areas to be determined rapidly, allowing vaccination to be prioritised and disruption to be kept to a minimum.

  25. Decontamination may necessitate prolonged closure of large areas of the hospital. Alternative facilities for healthcare provisions will be required.

  26. Cases arising at Port Health Control Units

  27. It is unlikely that a case will present at an airport since by the time the clinical features of smallpox are apparent, the patient is likely to be too ill to travel. It is possible that a case could present at a seaport. The procedures for managing such cases is summarised in Figure 7.

  28. In the event of a case presenting at a port it would be possible to hold both the case and contacts against their will, as the Port Medical Officer (PMO) can advise the immigration authorities that passengers should not be allowed to enter the country.

  29. Figure 7 assumes that the Infectious Disease (Aircraft) Regulations or the Infectious Disease (Ships) Regulations have not resulted in prior notification of the case to the Port Health Authorities and the case has presented at the health control unit. If there is prior notification to Port Health Authorities, then the PMO should board the aircraft or ship, and no one should be allowed to leave until an assessment has been made and the diagnosis confirmed or excluded. If the diagnosis is confirmed then all those on the same plane should be treated as category A contacts. Contacts on a ship may be category A or B depending on proximity and duration of exposure.

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Page updated: Friday, June 24, 2005