Laboratory Biosafety Plan Template For Biosafety Level 1 And 2: Fill & Download for Free

Out of three questions, first two questions are answered here Surbhi Tripathi's answer to What is the Nipah virus, and how is it transmitted?The last question which is most important one to answer is about government's measures on NiV. As India is one of the member state of World Health Organisation so the preparedness for NiV is recommended by WHO will be apt to apply in India:Surveillance, Prevention and Control ofNipah Virus Infection: A Practical HandbookPage No. 18–354. OUTBREAK OR EMERGENCY PREPAREDNESS AND RESPONSE FOR NiV4.1. PreparednessPreparedness in terms of technical and logistical management of a Nipah outbreak is essential in countries with recurrent outbreaks. The best response to a Nipah outbreak is being able to detect cases as early as possible and prevent further infections.4.1.1. Enhancing surveillance during the NiV transmission seasonSurveillance should be intensified during the Nipah season from January through May, when most Nipah outbreaks have been identified. This will increase the possibility of identifying NiV infection and understanding the characteristics of the virus. Blood, CSF, urine and throat swabs are collected from suspected patients and sent to the reference laboratories.4.1.2. Awareness building in hospitals and raising community awareness• Encourage and train health-care workers to maintain standard infection control precautions, e.g., personal hygiene, use of personal protective equipment(PPE), and manage encephalitis or neurological patients appropriately.• Disseminate information to communities through multimedia, leaflets, posters and meetings (group, community and market) encouraging people:o to stop consumption of raw date palm sap;o not to eat fruit partially eaten by bats;o cover the mouth and nose while caring for unconscious patients;o wash hands with soap and water before and after feeding and taking care of patients.4.1.3. Infection control in health-care settings should be in place• Implement standard infection control precautions.• Acquire and maintain PPE stock and other equipment needed in epidemiological investigations and outbreak response.4.1.4. Planning for outbreak response: some major components4.1.4.1. Formation of a multisectoral team 20Since NiV infection is a zoonosis and outbreaks may be associated with multiple factors such as animal reservoirs, sociocultural practices, food habits and possible human-to-human transmission, a multidisciplinary team is needed, and preparation should be done for pre-outbreak, outbreak and post-outbreak phases.A multisectoral team should be built up at national and local levels for the monitoring, evaluation and response to unusual acute public health events and outbreak response, including Nipah outbreaks. The team should have a holistic, multidisciplinary approach consisting of public health personnel, clinicians and laboratory personnel. The multisectoral team may consist of the following professionals (depending on the evolving and country-specific situation) who would bring relevant expertise in outbreak investigation and response:• epidemiologist• microbiologist• anthropologist and/or social scientist• veterinarian• ecologist.National or subnational level – Rapid Response Team (NRRT): The NRRT should be assigned from institutes at the national/provincial level and partner institutes.District/provincial level – District Rapid Response Team (DRRT): The DRRT consists of the head of health services at the district/provincial level and clinical and laboratory expertise, and other expertise from the public health department.4.1.4.2. Evaluate and ensure the supplies for sample collection, storage and shipment of samples:• Assess PPE in stock;• Assess sample collection instruments;• Assess sample storage capacity in the laboratory;• Evaluate laboratory capacity for NiV testing (e.g., biosafety, quality, skills, human resources and consumables for NiV virus testing);• Evaluate hospital capacities for isolation facilities and ability to treat Nipah patients in Nipah-prone areas.4.2. Alert and outbreak investigationThe outbreak investigation should lead to formulation of an appropriate public health intervention as soon as the source and mode of transmission are known. In the meantime, control measures mitigating known risk factors should be implemented as soon as NiV transmission is suspected.4.2.1. Investigation of a suspected case or cluster of suspect cases:4.2.1.1. Standard Operating Procedures (SOPs) for sample collection and transportation in place:• Surveillance physician will take verbal consent from patient or patient’s family member;• Collect 5 ml venous blood;• If possible, collect 3 ml extra-CSF when appropriate;• Aliquot 1 ml serum and 1 ml CSF samples in 1.8 ml cryovial tube. Try to aliquot serum and CSF samples in three cryovial tubes;• Label the cryovial tube with: type of samples (serum/CSF), patient name and identification number, and date of sample collection;• Store the serum and CSF samples in liquid nitrogen if possible, or −20°C freezer for short-term storage if liquid nitrogen is not available;• Ship samples in liquid nitrogen tank or ice pack to assigned centre for laboratory diagnosis;• Store samples in −70°C freezer for longer-term storage;• A list of potential national or international reference laboratories should be pre-established. There can be several for different purposes: a frontline laboratory would be the WHO Collaborating Centre for laboratory diagnosis of viral diseases with BSL 3 or BSL 4 facilities (see list of WHO Collaborating Centres and other institutions for laboratory diagnosis, surveillance and response in Appendix 4).4.2.1.2. Templates of data collection instruments pre-developed and in place for quick useThese templates should include the following:• line listing of all cases;• case reporting form;• questionnaire for case-control studies or other relevant studies;• forms for sample collection.4.2.1.3. SOP for activating and conducting outbreak investigation teamsThis SOP is commonly country-specific as the process relies on the administrative structures and capacity or resources of a given country. Therefore a country-based manual or protocol for outbreak investigations should be in place in at-risk countries forNipah outbreaks. A more generalized national SOP manual for all emerging or re-emerging infectious diseases of international concern could be developed focusing on a mechanism of response and roles and responsibilities of different parties.The following are some of the key components to prepare a team for outbreak investigation:1) National or Subnational Rapid Response Team (RRT) Should an outbreak of NiV virus disease be suspected and/or reported, the National RRT should be activated and should meet together to:(1) Plan and conduct the investigation;(2) Request further technical support if needed (e.g., further analysis and interpretation, risk communication, initiate control).2) Administrative SOP for field work in place: administrative clearance, organize supplies, travel arrangements:• approval/permission from competent authority;• arrangement for accommodation;• arrangement for security, if needed;• arrange vehicle;• supplies:o medicineso sample collection instrumentso PPEo disinfectants, hand sanitizero basic medical and investigation equipment, e.g., stethoscope, thermometer, GPS instrument, etc.3) SOP for rapid mobilization of additional or experts teamsIf the NiV outbreak is confirmed, an experienced Nipah outbreak investigation team comprising an epidemiologist, clinician, veterinarian and anthropologist or social scientist can move to the field within 24 hours of outbreak reporting.4.2. 1.4. Nipah outbreak investigationThe overall objective of investigating Nipah outbreaks is to control the outbreak and prevent future outbreaks. Any Nipah (or suspicion of) outbreaks should be investigated as the disease is of public health concern with potentially devastating consequences.The specific objectives include the following:• to determine the extent of the outbreak;• to characterize the populations at greatest risk and to identify specific risk factors;• to provide practical recommendations to strengthen control and prevention measures.Key steps when conducting Nipah outbreak investigationStep 1: Activate preparation plan for outbreak investigation (details above).Step 2: Confirm the outbreak.One of the first tasks of the initial investigation team is to verify that a suspected cluster of cases is indeed a real outbreak with common cause. Some will be unrelated cases of the same disease, and others will turn out to be real cases of AES or ALRI but of unrelated diseases. This step consists of confirming the diagnosis through visiting the outbreak affected areas to (1) examine the patients and/or review the medical charts to describe and understand the clinical presentation; (2) collect blood, CSF and throat swab samples at the time of admission/ first contact, and follow-up serum samples 2 weeks after the onset of illness for testing.A Nipah outbreak is defined as the identification of at least one laboratory-confirmed case.Step 3: Define and identify cases.The investigators should develop or adapt standardized case definitions appropriate to the outbreak context (see details in standard case definitions). Testing for NiV infection should be performed when there are: (i) clusters of AES due to an unknown agent or (ii) patients with AES due to an unknown agent living in or near NiV zones.Patients with AES should also be tested for NiV infection when they are exposed to a cluster of unexplained neurological/pulmonary illness in animals, such as horses and pigs.Step 4: Case-findingIn many outbreaks, including Nipah outbreaks, the first cases that are recognized are usually a small proportion of the total number. Retrospective and prospective case-findings are crucial to determine the true magnitude and geographical extent of the outbreak.Active case-finding should be conducted:Among close contacts:• A close contact is defined as “a patient or the person who came in contact with a Nipah case (confirmed or probable cases) AND stayed in the room or veranda or vehicle for at least 15 minutes”.• Record contacts for potential follow-up if need be. They are to be followed up in case of occurrence of illness (up to 18 days). Serum specimens should be collected in case of symptom onseto in high-risk groups or in groups exposed to the sourceo through enhancing surveillance in the outbreak area and the at-risk areas for case-finding in the communityStep 5: Evaluate the outbreak in relation to ‘time, place and person’• establish a line-list of current and previous cases;• draw an epidemic curve;• analyse and interpret the data to identify potential sources of transmission.Step 6: Develop and evaluate hypothesesOnce step 5 has been done, investigators should have some hypotheses regarding the source and/or mode of transmission and the exposures that caused the disease. These hypotheses should be compared with established facts.Step 7: Refine hypotheses and carry out additional studiesIf step 6 is not conclusive, these hypotheses can be refined to look for new modes or vehicles of transmission and be evaluated through conducting case–control studies.Step 8: Implement control and prevention measures (see response section below)Step 9: Communicate findings and information about risks (i.e., outbreak report)• Develop an outbreak report and disseminate to concerned authorities.• Learning from the outbreak includes detailing:o new findingso major limitations during outbreak investigation• Resume the activities of pre-outbreak phase.4.3. Additional considerations with respect to Nipah outbreaksWhen the Nipah outbreak is confirmed, the investigation team needs to:• Immediately inform the local, regional and national authorities.• Inform the partners/stakeholders (notably those involved at local level): treating hospitals, patients’ relatives.• Declare the Nipah outbreak to WHO under the International HealthRegulation 2005 (IHR) via National IHR focal points (see detail below in the response section).Notification and assessment of Nipah outbreak and/or cases to WHO should be based on the following four criteria described in Annex II of IHR 2005. A "yes" to any of the four criteria would lead to notifying WHO under Article 6 of the IHR.• Is the public health impact of the Nipah outbreak and/or cases serious?• Are the Nipah outbreak and/or cases unusual or unexpected?• Is there a significant risk of international spread?• Is there a significant risk of international travel or trade restrictions?4.3.1. Conduct rapid risk assessmentSome of the major risk assessment questions should include the following:• What is the risk of occurrence of further cases from the detected outbreak?• What is the risk of spread of the infection?• What is the risk of major impact of the current outbreak on the health-care system?4.3.2. Evaluate the impact of control measuresEach outbreak should be thoroughly investigated, and lessons learnt from each outbreak should be evaluated and documented so that control measures can be reviewed and modified as required.4.3. 3. Develop further research with the objective of identifying determinants of infection or severity and determining modes and dynamics of infectionThe populations to be investigated would be those exposed to NiV:4.3.3.1. Health-care workers (HCWs)There is evidence of nosocomial transmission in India and Bangladesh, and one nurse was positive to Nipah IgM antibody in Malaysia (3, 4). HCWs are to be trained for infection control and prevention (see below). Surveillance should be in place to detect any suspected cases among HCWs. In addition, a study should be conducted to identify asymptomaticcases among HCWs who provided service to Nipah patients. Among these, positive cases should be subsequently compared with negative ones to determine risk factors for infection and understand the dynamics of transmission. Some components of the study could include:• Make a list of HCWs who provided care to Nipah patients.• Take consent from HCWs.• Interview at-risk HCWs using an exposure questionnaire, about 3 weeks after the last exposure to NiV-infected patients.• Collect 5 ml of blood for serology testing about 3 weeks after the last exposure to NiV-infected patients.4.3.3.2. Communities potentially exposed to NiVThe investigation should encourage involvement of multidisciplinary and multisectoral team using a one-health approach. For instance, investigators should have the support of microbiologists and their laboratories to conduct community-based seroprevalence surveys (detection of recent antibody response) to determine the extent of the outbreak via detecting subclinical and/or asymptomatic cases. Asymptomatic cases could be further compared with controls to identify risk factors for infection.Anthropologists or other social scientists with extensive community-based experience could help propose additional behaviour risk factors to be tested in a case–control study. Anthropologists should work with communication/health promotion specialists to develop communication messages combining both local explanatory models and biomedical models using local terms and languages, and deliver the message in such a way that it is meaningful to the community.Veterinarians and eco-health specialists should join the investigation to conduct studies collecting specimens from animals and the environment in the outbreak settings.Zoonotic and environmental investigations during an NiV outbreak primarily aim to determine the primary reservoir, likely source of the virus, route of transmission and the extent of the spread of the virus in animals. Georeferenced positive specimens could be analysed with positive human cases to better understand the dynamics of transmission.4.4. ResponseAs soon as a Nipah outbreak is confirmed, national authorities should implement control measures based on known risk factors. The interventions should be based on a multisectoral approach and include/understand the following strategic objectives:1. Establishment of a coordination committee for outbreak prevention, and control activities and resources mobilization; the role of this committee is to ensure the general coordination of operations. It must clearly define the responsibilities of the various teams and the route of information during outbreak response operations.2. Setting up partnerships with the media to ensure media monitoring and better risk communication.3. Formation of a referral system with the principal objective of easing transfer of cases to the appropriate case-management health-care settings.a. Active detection for new Nipah cases and their transfer to the case-management ward.b. Follow up all contacts during 18 days after their last unprotected exposure to Nipah patient(s) or infected animal or tissue (e.g., laboratory) and their transfer to the case-management ward if they fall sick.4. Set up a social mobilization and medical education programme whose principal role is to inform the public and promote practices that decrease community transmission of the disease.5. At the foci zone, the medical team should ensure safe case management of Nipah patients by complying with the following guidelines:a. Respect patients and their families’ dignity and rights, in particular their right for information on disease and treatment,b. Set up a specific Nipah case-management ward that ensures biosafety of in-patient care,c. Set up infection prevention and control measures for safe patient care,d. Organize the safe transport of patients from their residence to the ward,e. The express consent of patients is necessary for any hospitalization. In the event of patient’s refusal to be hospitalized, the medical team should organize, temporarily, a patient’s care at home with his/her family support.f. Organize safe burials while respecting the funeral ceremony,g. Set up psychosocial support (patients, family, HCWs).6. Outside the foci zone, to prevent secondary foci, the medical team should reinforce standard infection prevention and control measures in health care in all health centres of the affected district and all hospitals catering to the outbreak zone.7. Establishment of links with the animal health sector to:a. Continue monitoring the cause of disease and death in domestic animals and wildlife.b. Test samples and alert public health authorities as needed.c. Control slaughtering/butchering activities of domestic animals and wildlife, at home, and in markets and slaughterhouses.8. Media and communicationa. Designate a spokesperson in the outbreak team.b. Designate a spokesperson at the national level who communicates with national media.c. Regularly update reports to be sent to assigned authority.d. Conduct regular meetings with press and community.e. Distribute information, education and communication material.4.5. In the aftermath of the outbreak (evaluation)4.5.1. Declare the end of the outbreakThe health ministry declares the end of the outbreak. The date of outbreak end is equal to twice the mean incubation period for Nipah counted from the last infectious contact with a confirmed or probable case.The national authorities should use the announcement of the end of the outbreak to acknowledge national and international field teams as well as the media. They should also formally present their solidarity and their empathy to the victims, their families and the affected populations.4.5.2. Writing a final report of the outbreak control activitiesThe report objective is to describe the activities undertaken during the epidemic as well as constraints and difficulties encountered. It should include technical aspects (final epidemiological analysis, clinical investigations, etc.), as well as administrative and financial aspects. The report should be published to achieve wider dissemination of findings and lessons learnt.4.5.3. Archive outbreak documents and files• Gather all the reports, files, photographs, videos and other documents related to the outbreak management.• Store all the documents in a place accessible for their later use.4.5.4. Evaluate the management of the outbreakThe evaluation of the management of the outbreak response will review the performance of the various components of the strategy: coordination, relationship to the media, surveillance system, social mobilization programme, clinical management and logistics.The aim of the evaluation is to determine lessons learnt to improve the future management of epidemics. This evaluation should be led by a team comprising national and technical partners.4.5.5. To resume activities of the pre-outbreak period