Annex C. Pandemic Influenza Laboratory Preparedness Plan. Date of Latest Version: October 2006

Transcription

1 Annex C Pandemic Influenza Laboratory Preparedness Plan Date of Latest Version: October 2006 Summary of Significant Changes: Provides more details regarding laboratory preparedness Uses new Pandemic Phase terminology and identifies activities pertaining to each phase.

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3 C Pandemic Influenza Laboratory Preparedness Plan Table of Contents Interpandemic Period: Canadian Phases 1.0 and Testing Surveillance and Data Collection Communication Pandemic Preparedness Pandemic Alert Period: Canadian Phases 3.0 and Testing Phase Phase Surveillance and Data Collection Communication Pandemic Alert Period: Canadian Phases 4.0 and 5.0, Canadian Phases 4.1 and 5.1, and Canadian Phases 4.2 and Testing Surveillance and Data Collection Communication Other Pandemic Period: Canadian Phase 6.0, and Canadian Phases 6.1 and Testing Surveillance and Data Collection Communication Post-Pandemic Period in Canada Annex C i

4 Appendices A. Nasopharyngeal Swab Procedure B. Members of the Pandemic Influenza Laboratory Preparedness Network C. List of Acronyms ii The Canadian Pandemic Influenza Plan for the Health Sector

5 The Pandemic Influenza Laboratory Preparedness Network (PILPN) has developed this document in accordance with the defined phases of the new Canadian Pandemic Influenza Plan for the Health Care Sector. Laboratory testing, laboratory-based surveillance and data collection, communication issues and pandemic preparedness are addressed from the perspective of the Canadian phases. The document provides general guidelines and facilitates a consistent approach to laboratory testing for influenza during the Interpandemic Period and Pandemic Period. Interpandemic Period Canadian Phases 1.0 and 2.0: No new influenza A virus subtypes have been detected in humans 1. Testing Maintain routine laboratory diagnostic services for influenza: Virus isolation in cell culture Direct antigen detection (immunofluorescent assay [IFA], enzyme immunoassay [EIA], rapid point of care [POC] testing) Reverse transcriptase polymerase chain reaction (RT-PCR). Serology is of limited usefulness in diagnosis of acute influenza. The PIPLN supports the use of rapid detection methods in conjunction with cell culture, viral isolation, as well as nucleic acid amplification tests (NATs), such as RT-PCR, or nucleic acid sequence-based amplification (NASBA) to aid in the timely diagnosis, particularly in outbreak situations. The nasopharyngeal swab (NPS) is recommended as the preferred specimen because it leads to the best results in most direct antigen tests, such as IFA and rapid POC testing, as well as in cell cultures. Because of their poor sensitivity for antigen and culture-based assays, throat swabs are not recommended. However, throat swabs and nasopharyngeal (NP) washings may be acceptable or recommended by the manufacturers of specific rapid detection kits. Nasal swabs may be an acceptable alternative in children particularly when a NAT, such as RT-PCR, is used as the diagnostic test. This is likely true in adult patients, however there is little published data to support this. Specimens should be collected as soon as symptoms develop because viral shedding is maximal at the time of onset of illness and generally decreases to undetectable levels by 5 days in immunocompetent adults. Viral shedding may last longer in children and immunocompromised patients; hence, collection after 5 days of illness may still be useful in this setting. Because the suboptimal positive predictive value during periods of low influenza activity, diagnosis by rapid POC tests must be interpreted with caution and confirmed by IFA, viral culture or RT-PCR. Complete details regarding World Health Organization (WHO) Annex C 1

6 recommendations on the use of rapid testing for influenza, including a review of the currently available kits can be found at: avian_influenza/guidelines/ rapid_testing/en/index.html. The PILPN encourages provincial public health laboratories (PHLs) and local clinical laboratories to develop an influenza testing strategy for a pandemic situation. This should include the establishment of protocols to process and identify novel influenza subtypes that may be considered Risk Group 3 pathogens. Algorithms should include consideration of conventional culture, IFA, EIA and NAT options, depending on local expertise and anticipated resource availability. Ongoing development of NAT methods for the rapid detection of novel influenza subtypes can be undertaken using conventional or real-time RT-PCR methods. This may include the utilization of a universal detection protocol that would identify any influenza A virus using primers to a conserved region within the genome and subsequent subtyping using primers specific for avian subtypes with pandemic potential, i.e. H5, H7, H9, and human subtypes H1, H3. Other novel diagnostic protocols should be explored such as the development of protocols for the simultaneous detection and subtyping of defined influenza A viruses. The National Microbiology Laboratory (NML) and PHLs will share sequence information of newly emerging strains as soon as it is available and exchange details of recommended protocols and primers where appropriate. The NML will also provide the necessary reagents and controls that will be essential in developing these assays and to ensure quality assurance. Participation in the NML proficiency program for influenza is strongly suggested for all laboratories performing any type of influenza diagnosis. The NML will provide two influenza proficiency panels per year to any Canadian laboratories that wish to participate for the molecular identification of current influenza A strains. These will consist of specimens of ribonucleic acid (RNA) extracted from key strains of interest for RT-PCR quality control testing. The PILPN also encourages participation in other accredited proficiency programs, such as those of the College of American Pathologists. Up to 10% of all influenza isolates, including at least five early-season, five late-season and any unusual isolates, especially from a person presenting with a severe respiratory infection with an epidemiological link to an area of concern, must be sent to the NML for subtyping. These isolates must be submitted to the NML promptly, along with the results of any subtyping or genotyping performed locally. The NML will give priority to processing such specimens. Virus will be amplified in cell culture for subtyping by HAI and/or neutralization assays. For specimens that cannot be amplified by culture, the genotype will be determined after amplification of selected genes by RT-PCR and sequencing. The NML will undertake to report the subtype to the submitting laboratory within a few days of receipt. All laboratories performing viral isolation are expected to submit isolates for subtyping as described above unless otherwise directed by the NML. In accordance with the response plan outlined by the Pandemic Influenza Committee (PIC), the PILPN encourages each province and territory (P/T) to ensure that at least one laboratory within the P/T has the capability to determine the subtype influenza A virus and, if not, to establish appropriate alternate arrangements. This may include the development of nucleic acid sequencing protocols capable of determining the subtype of novel strains of influenza A. The NML will supply protocols, primers and reagents necessary to develop and evaluate these assays along with controls required for a quality assurance program. 2 The Canadian Pandemic Influenza Plan for the Health Sector

7 The NML currently performs testing for amantadine resistance on early-season and late-season isolates. Specimens can be submitted for this testing as agreed upon by the NML in conjunction with PHLs. Resistance is monitored by amplification and the sequencing of the gene encoding the M2 protein to identify the mutations associated with resistance, and by viral growth inhibition assay. The NML will undertake investigations related to surveillance for resistance to neuraminidase inhibitor drugs in emerging and currently circulating strains. The NML and selected PHLs will share subtyping and susceptibility testing technology as well as developments of rapid test(s) for detection of influenza, better subtyping and susceptibility testing methods. They will also serve as sites for training other appropriate laboratories in these methods. The NML will provide proficiency panels to assess the diagnostic sensitivity and specificity of tests available at PHLs and other viral diagnostic labs. The NML and PHLs will share reagent lots designed to diagnose circulating or evolving influenza agents. The NML will develop the capacity to produce and evaluate in-house reagents, such as monoclonal antibodies for IFA testing, which could be stockpiled and distributed to PHLs at the time of a pandemic. Testing protocols for immune response will be developed in cooperation with the Vaccine Development Group to test vaccine recipients for immune response in assessing efficacy of vaccine. Hemagglutination inhibition (HAI) and or EIA tests will be implemented using the antigens that are included in the most current vaccines. Enhancing the detection of the influenza vaccine immunological response in the population, measuring cross reactivity among strains, and tracking how immune response evolves in a population over time with the succession of circulating influenza strains and existing vaccination programs is expected to help define the longevity of the immune response and to improve approaches to measuring population-based vaccine-induced or natural immunity. The NML will undertake a leading role in this area of research and development. 2. Surveillance and Data Collection The PILPN encourages all PHLs and other laboratories that routinely test for influenza to submit data on influenza testing during the influenza season to the Public Health Agency of Canada (PHAC) on a weekly basis or more frequently if requested by PHAC. This data is reported on FluWatch and accessible through the Health Canada and Canadian Public Health Laboratory Network (CPHLN) surveillance tools, such as those available on the Canadian Laboratory Surveillance Network (CLSN). Enhanced surveillance using sentinel physicians, including laboratory testing, may be set up by PHAC in collaboration with local public health officials and PHLs. 3. Communication Each PHL will maintain an up-to-date list of laboratories that routinely test for influenza in their jurisdictions. Information from each laboratory including a contact name, fax and phone numbers, and address should be maintained in a data base so that up-to-date information regarding novel viral isolates and their diagnostic characteristics can be rapidly disseminated as pandemic phases progress. An up-to-date listing of all influenza testing laboratories will also be maintained by the NML and the CPHLN Annex C 3

8 secretariat. An up-to-date list will also be accessible to all PIPLN and CPHLN members on their respective secure sites. The CPHLN secretariat must set up enhanced communications to link the NML, PHLs and other viral diagnostic laboratories that test for influenza with provincial epidemiologists using the CLSN intelligence exchange centre, enabling , fax, phone and/or teleconference, and Web-casting communication capabilities for infectious disease outbreak and event management. Diagnostic expertise from PILPN will be solicited by CPHLN as is deemed necessary and appropriate. Each province will have an influenza surveillance committee in place to ensure good communication among the provincial laboratory, provincial epidemiologists and health units. The committee will deal primarily with influenza in the event of a pandemic, but it will deal with other surveillance issues at other times as required. The committee should include, at a minimum, a provincial epidemiologist, the provincial laboratory director or designate and the chief medical officer of health or designate. 4. Pandemic Preparedness As part of pandemic preparation, the PILPN encourages the NML to consider in-house production of alternate sources of reagents (e.g. antibodies) that could be distributed to diagnostic laboratories across the country during a pandemic when commercial reagents may be in short supply. As part of pandemic preparation the PILPN encourages PHLs and other local laboratories to assess how the pandemic will impact on other clinical laboratory functions and human resource (HR) issues. Although the true impact is difficult to accurately predict, one can expect that certain tests requests from physicians will increase (e.g. increased respiratory specimens) and others will decrease. Trying to anticipate this in advance may help in developing strategies to maximize workflow and efficiency. Strategies may include but are not limited to: a. Development of an inventory of currently provided services and the human resources required to maintain this level of service. b. Development of a list of essential services and the HR required to maintain these essential services. c. Anticipation of testing demands which will increase (e.g. respiratory culture) and those that may decrease (e.g. HIV viral load testing). d. Development of a prioritization strategy for lowering conventional workload and other services to determine which services will be restricted and in what order when faced with HR and resource problems. This will need to include the impact of each test and its volume. e. Development of a staffing strategy. Ideally staffing issues should be addressed prior to the pandemic so potential concerns can be addressed before HR problems develop. f. Anticipation of staff safety concerns. Staff will need reassurance that the environment they are working in is safe. The processing of specimens in a Biosafety Level (BSL) 2 laboratory should not be a concern because swabs for other BSL 3 pathogens (TB) can be readily processed in a BSL 2 laboratory in a HEPA-filtered biosafety cabinet. The main concern will be biosafety relating to viral amplification 4 The Canadian Pandemic Influenza Plan for the Health Sector

9 and manipulation of viral cultures. Laboratories that do not have a BSL 3 laboratory will need to implement non-culture methods. Laboratories that do not possess BSL 3 capability will not be able to culture virus safely and will need to shift to non-culture methods such as antigen detection methods (IFA, direct fluorescent-antibody assay [DFA]) or NATs (RT-PCR or NASBA). g. Consideration of materials and supplies needed during the intrapandemic and interpandemic periods and anticipation of shortages. Both influenza and non-influenza related supplies should be included. Plans should be made to allow for up to 16 weeks of interrupted supply chains. h. Consideration of use of high throughput instruments to facilitate increasing the test volume (e.g. automated nucleic acid extraction). i. Consideration of appropriate means of streamlining specimen accessioning. j. Consideration of possible changes in the testing schedule to maximize workflow and personnel. k. Education of the laboratory staff about the necessity of annual influenza vaccination (strongly encourage vaccination). Laboratories will participate in regular disaster drills at the request of the national PIC to test the plan and identify areas that need further attention. Pandemic Alert Period Canadian Phase 3.0: Sporadic human infections with a new subtype outside Canada Canadian Phase 3.1: Sporadic human infections with a new subtype in Canada 1. Testing Phase 3.0 Diagnostic testing services capacity and approach will continue as in Phases 1.0 and 2.0. The NML will give priority to reagent preparation for the identification of the new strain in readiness for Phase 3.1. The NML will distribute NAT and conventional culture protocols as appropriate. In preparation of Phase 3.1, PHLs and other viral diagnostic laboratories that provide influenza testing are encouraged to review their requirements for reagents and other supplies by the following: Completion of an inventory of present capacity Determination of the minimum diagnostic requirements needed to make a timely diagnosis of the pandemic strain, e.g. by RT-PCR Confirmation and assurance that enough supplies are available to maintain the ability to diagnose influenza and that these supplies will last at least throughout the first wave of the pandemic Increasing inventory of swabs, viral transport media kits and other reagents needed for influenza diagnostics Annex C 5

10 Phase 3.1 The PHLs and other viral diagnostic laboratories will be on high alert and will focus on: Enhanced laboratory-based surveillance for the emerging new subtype Viral isolation by culture if appropriately equipped Implementation or augmentation of RT-PCR assays or other NATs There is expected to be an increased demand for testing with emphasis on the identification of the hemagglutinin (HA) type of the viruses identified. Viral isolation is encouraged in order to facilitate detection of emergence of new subtypes within Canada. RT-PCR will be particularly useful for rapid detection and HA type determination. All influenza A isolates must be typed and, if not, conventional circulating strains must be forwarded for further testing to the NML. The PHLs will play a critical role in tracking the potential spread of the pandemic strain. Any positive influenza findings obtained from a case with severe respiratory infection and epidemiological links with avian influenza need to be confirmed by the NML and rapidly characterized because the new subtype may be co-circulating with epidemic human strains. The use of commercially available rapid POC tests for the diagnosis of a new subtype is not recommended because of the lack of information on the clinical accuracy of such rapid tests. These tests may be able to rapidly identify and differentiate influenza A and B infections, but currently they do not differentiate different HA subtypes of influenza A and cannot differentiate human from avian influenza virus. Any findings in direct antigen or rapid POC tests obtained on patients suspicious for avian influenza must be confirmed by culture and/or RT-PCR. The NML will evaluate the efficacy of POC tests to detect any new subtype and share this information with all influenza testing laboratories. The NML will supply proficiency panels to ensure quality assurance. Although the NPS is the ideal specimen for human influenza, it has been recently reported that the recovery of the current H5N1 viruses infecting humans in Asia is better from throat specimens than from nasal specimens. Because the optimal specimen type and timing of collection are unknown for avian influenza infections in humans, particularly as they continue to evolve, the PILPN encourages laboratories to consider the collection of different types of respiratory specimens, including NP swabs, NP aspirate, nasal washings, throat swabs and sputa, on multiple different days. In addition, cases of H5N1 have been isolated in the stool of infected patients; hence, consideration should be given to testing stool specimens in patients who have significant gastrointestinal symptoms. The biosafety level required for processing these specimens will be assessed by the Office of Laboratory Security, Centre for Emergency Preparedness and Response (CEPR), in consultation with the CPHLN and international partners, such as WHO and the United States Centers for Disease Control and Prevention (CDC), and the directives disseminated to all influenza testing laboratories. 2. Surveillance and Data Collection As in Phases 1.0 and 2.0, with heightened laboratory-based surveillance as determined by the NML and PIC. 6 The Canadian Pandemic Influenza Plan for the Health Sector

11 3. Communication Information such as subtype, optimal cell lines to use, usefulness of direct antigen testing, antiviral susceptibility, morbidity, mortality, etc., from WHO, CDC, NML or laboratories from areas affected by the new subtype will be rapidly disseminated to PHLs by CPHLN secretariat by various means, i.e. CLSN intelligence exchange centres, fax, , telephone, etc., depending on the circumstances. Using the laboratory database compiled in the Interpandemic Period, PHLs will ensure that other influenza testing laboratories in province are kept informed. The CPHLN secretariat will coordinate meetings and/or teleconferences of the PILPN and PHLs as required. Education sessions to update staff will be held on aspects of testing, safety, HR issues and other changes in laboratory protocols that can be expected, as the pandemic phases progress. Communications will be prepared in advance of the ensuing pandemic to outline for clients the changes to testing that are anticipated with the onset of the pandemic. This will include alternative strategies that are available to help reduce the workload of the laboratory. Pandemic Alert Period Canadian Phases 4.0 and 5.0: Limited human-to-human transmission confirmed. Small or large localized clusters of cases outside Canada. Canadian Phases 4.1 and 5.1: Limited human-to-human transmission. Small or large sporadic clusters of cases in Canada Canadian Phases 4.2 and 5.2: Small or large localized cluster(s) with limited human-to-human transmission are occurring in Canada but human-to-human spread is still localized, suggesting that the virus is becoming increasingly better adapted to humans but may not yet be fully transmissible. 1. Testing During Phases 4.0 and 5.0, the PHLs and other viral diagnostic laboratories will be on high alert and follow the protocol as in Phase 3.1: Enhanced laboratory-based surveillance for the emerging new subtype Viral isolation by culture RT- PCR (or other NAT) During Phases 4.2 and 5.2, a dramatic increase is expected in the demand for testing, especially in affected areas. Increased testing by culture will be required to detect the pandemic strain in suspected cases. RT-PCR will be particularly useful for rapid detection and HA type determination. Isolates from identified clusters will be tested for HA type and forwarded to the NML for strain characterization. The PHLs will play a critical role in tracking the potential spread of the pandemic strain. Annex C 7

12 Additional supplies of appropriate cell lines may be required. The NML in consultation with the WHO will review the primers used in molecular testing to ensure they are effective in identifying the pandemic strain. The NML and PHLs will share information and reagents for identification of the pandemic strain, advise on cell lines, use of rapid test methodologies and the biosafety level required, etc. The PHLs and other laboratories will be encouraged to review inventory of reagents and order necessary reagents and cell lines (e.g. more viral transport swabs and/or media, influenza antigen tests, antisera for IFA testing) as well as to review personal protective equipment, testing algorithms for influenza based upon availability of reagents, cell lines, kits, etc. The biosafety level required will be reassessed by the Office of Laboratory Security, CEPR, in consultation with the CPHLN and international partners, such as WHO and CDC, and the directives will be disseminated to all influenza testing laboratories. Rapid subtyping of isolates will be performed by the NML and designated PHLs. Once reference antisera are available, subtyping will be done using HAI and neutralization assays and only by laboratories with the appropriate BSL containment facilities as dictated by the BSL requirements of the novel strain. Other laboratories will rely on RT-PCR for rapid subtyping using previously established protocols. Note that supplies, including cell lines, test kits and reagents, may be in short supply as other North American laboratories ramp up their testing. The PHLs and other laboratories currently producing their own cells (for example, MDCK) might act as suppliers or provide seed stocks and the protocols for their propagation to other PHLs in need. Because the supply of antivirals may be limited, diagnostic laboratories will play a central role in their optimal use. The use of rapid diagnostics, such as DFA, NATs or rapid POC tests, may become an integral part of this strategy. The PILPN will provide guidance regarding the effectiveness of rapid POC tests and the implementation of these strategies. Although the onset of the pandemic is expected to strain the diagnostic capabilities of laboratories, it will be important to continue quality assurance activities, such as the participation in proficiency panels distributed by the NML. The NML will be responsible for providing guidance and materials required. Agreements will need to be established to outline how the PHLs would best redirect testing capacity to help track the spread of the pandemic and to standardize how laboratories will triage critical from non-critical respiratory testing. This will be necessary so at least some capacity will be available to track the evolution of the outbreak. 2. Surveillance and Data Collection As in Phases 1.0 to 3.0, with heightened surveillance as determined by the PHAC, the NML and PIC. 3. Communication The NML will be responsible for rapid communication of relevant information concerning the evolution of the pandemic to the PHLs and other viral diagnostic laboratories. This will include information concerning the occurrence of small or large clusters in different locations through the CLSN intelligence exchange centres, or by fax, or telephone 8 The Canadian Pandemic Influenza Plan for the Health Sector

13 as appropriate, and the provision of updates on the activity of new virus, cell lines, direct test methods, etc. The PHLs will rapidly communicate via the NML their first isolate of pandemic strain as well as any other local influenza activity. The PHLs will also ensure other influenza testing laboratories in the province are kept informed. 4. Other The PHLs and other viral diagnostic laboratories should also review strategies developed to reduce the impact on clinical laboratory. They should: a. Review the testing prioritization list. b. Review alternative testing strategies. Ensure supply of reagents available for testing: i. E.g. urine dip sticks for screening urines ii. E.g. order urine dipsticks for GPs to encourage in-office testing. c. Prepare any reagents that will be needed for the next several months e.g. media. d. Begin prioritization exercise. e. Implement specimen deferral, rejection and test minimization strategies. f. Readjust testing schedules as appropriate. Pandemic Period Canadian Phase 6.0: Increased and sustained human-to-human transmission in the general population outside Canada Canadian Phases 6.1 and 6.2: Widespread, sporadic or localized pandemic in Canada 1. Testing Depending on the extent and duration of the pandemic, the demand for testing will reach an unprecedented level, which may overwhelm diagnostic abilities, and the PHLs and other viral diagnostic laboratories. The laboratories will continue to function as in Phases 4.2 and 5.2 with focus on: Rapid testing RT- PCR (or other NATs) Reduction of emphasis on viral culture in areas where the pandemic is established All viral diagnostic laboratories will be under considerable pressure to provide rapid testing service to facilitate rapid case confirmation. The PHLs will need to redirect resources to give priority to influenza testing. However, if at this point the pandemic is established, laboratories within the affected regions may consider scaling down routine testing because clinical diagnosis will prove sufficiently accurate. This will depend on local conditions and available resources, etc. Rapid testing methodologies, including RT-PCR (or other NATs), may be preferred to standard cultures. The PHLs will focus on tracking the spread and trend of the pandemic and monitoring antiviral resistance, depending on available resources. Annex C 9

14 Agreements will need to be established to outline how the PHLs can best redirect testing capacity to help track the spread of the pandemic and to standardize how laboratories will triage critical from non-critical respiratory testing. This will be necessary so at least some capacity will be available to track the evolution of the outbreak. Each laboratory will decide how to ensure the priority of influenza testing (e.g. restricted testing of other specimens, additional staffing, etc.). The PHLs and local laboratories are encouraged to review influenza testing protocols, availability of reagents and HR issues, and to implement the pre-developed strategies to reduce the impact of the pandemic on laboratory testing. Laboratories should review inventory of reagents and order necessary reagents and cell lines, more viral transport swabs, influenza antigen tests, antisera for IFA testing and laboratory personnel protective items, etc., as necessary. The NML in collaboration with the WHO will review the primers used in NATs to ensure that they are effective in identifying the potentially evolving pandemic strain. The NML will provide to the PHLs information or reagents for identification of the pandemic influenza virus, advice on cell lines, use of rapid test methodologies, biosafety level requirements, etc. Laboratories are encouraged to ensure that the new methods are sensitive and specific through participation in ongoing quality assurance programs. Problems encountered should be reported to the NML for investigation and/or sharing of information with PHLs and other viral diagnostic laboratories. Rapid subtyping of isolates by the NML and designated PHLs will be undertaken using culture and RT-PCR based methods. Susceptibility testing of strains will be done by the NML and participating PHLs who have the protocols in place for neuraminidase inhibitors and/or amantadine depending on the phenotypic characteristics of the pandemic strain. Specimens received by the NML will be tested periodically throughout the pandemic as part of surveillance and to monitor the development of antiviral resistance. In addition to surveillance testing, testing for antiviral resistance will be performed on specimens isolated from treatment failures in outbreak situations and immunocompromised hosts. Other testing will be done on specimens as determined by the NML in collaboration with PHLs or any submitting diagnostic laboratory. The biosafety level required will be reassessed by the Office of Laboratory Security, CEPR, in consultation with the CPHLN and international partners (e.g. WHO and CDC), and the directives disseminated to all influenza testing laboratories. As the pandemic progresses, the PILPN will provide guidelines on testing and updates on antiviral susceptibility of the pandemic strain and other co-circulating strains. 2. Surveillance and Data Collection Continued heightened surveillance, as in Phases 3.0 to The Canadian Pandemic Influenza Plan for the Health Sector

15 3. Communication As in Phases 1.0 to 5.0 The NML will be responsible for rapid communication of relevant information concerning the evolution of the pandemic to the PHLs and other viral diagnostic laboratories. This will include information concerning occurrence of small or large clusters in different locations through the CLSN intelligence exchange centres, or by fax, or telephone as appropriate, and the provision of updates on the activity of new virus, cell lines, direct test methods, etc. The PHLs will rapidly communicate via the NML their first isolates of pandemic strain as well as any other local influenza activity. The PHLs will ensure other influenza testing laboratories in the province are kept informed. The NML will collaborate with the provinces to notify bacteriology testing labs to prepare for an increase in testing for bacterial pneumonia (i.e. strategy for monitoring types of organisms, susceptibility patterns and the best antibiotics to use). Release communications outlining changes to testing anticipated with the onset of the pandemic will be prepared in advance and are to be sent to clients. Alternative strategies available to help reduce the workload of the laboratory may be included. As the pandemic progresses, the NML will keep the PHLs informed of influenza activity across the country, changes in susceptibility, other circulating strains, morbidity and mortality information, etc. Laboratories are encouraged to provide update education sessions for staff regarding testing, safety, HR issues, etc., and to prepare communications to physicians regarding reductions in service. Post-Pandemic Period in Canada This will mark a return to prepandemic activities. Any testing issues that arose during the pandemic will be reviewed to determine if there are any changes that can be implemented to the pandemic plan. Annex C 11

16 Appendix A: Nasopharyngeal Swab Procedure Nasopharyngeal swab procedure 1. Use the swab supplied with the viral transport media. 2. Explain the procedure to patient. 3. When you collect the specimens, wear gloves and a mask. Change gloves and wash your hands between each patient. 4. If the patient has a lot of mucus in the nose, this can interfere with the collection of cells. Either ask the patient to use a tissue to gently clean out visible nasal mucus or clean the nostril yourself with a Q-tip. 5. How to estimate the distance to the nasopharynx: Prior to insertion, measure the distance from the corner of the nose to the front of the ear and insert the shaft only half this length. 6. Seat the patient comfortably. Tilt the patient s head back slightly to straighten the passage from the front of the nose to the nasopharynx to make insertion of the swab easier. 7. Insert the swab provided along the medial part of the septum, along the floor of the nose, until it reaches the posterior nares; gentle rotation of the swab may be helpful. (If resistance is encountered, try the other nostril; the patient may have a deviated septum.) Image obtained from 12 The Canadian Pandemic Influenza Plan for the Health Sector

17 8. Allow the swab to sit in place for 5 10 seconds. 9. Rotate the swab several times to dislodge the columnar epithelial cells. Note: Insertion of the swab usually induces a cough. 10. Withdraw the swab and place it in the collection tube. 11. Refrigerate immediately. 12. Remove gloves. 13. Wash hands. 14. Attach completed requisition. 15. Transport to the laboratory. Annex C 13

18 Appendix B: Members of the Pandemic Influenza Laboratory Preparedness Network The Pandemic Influenza Laboratory Preparedness Network (PILPN) operates under the auspices of the Canadian Public Health Laboratory Network, and it is responsible for the preparation of this laboratory annex. PILPN members include: Dr. Greg Horsman Director, Provincial Laboratory Tel: Fax: Dr. Sam Ratnam Director Provincial Public Health Laboratory Tel: Fax: Dr. Todd Hatchette Director of Virology and Immunology Queen Elizabeth II Hospital Tel: Fax: Dr. Yan Li Chief, Respiratory Viruses National Microbiology Laboratory Tel: Fax: Dr. Tim Booth Director, Viral Diagnostics National Microbiology Laboratory Tel: Fax: Dr. Jody Berry Supervisor, Monoclonal Antibody and Bioforensic Development Section Tel: Fax: Dr. Michel Couillard Coordonnateur scientifique Laboratoire de santé publique du Québec Institut national de santé publique du Québec Tel: ext. 227 Fax: Dr. Anna Majury Regional Public Health Laboratory Kingston Tel / Ext. 129 Fax: Dr. Julie D Fox Associate Professor University of Calgary Microbiologist and Program Leader Provincial Laboratory for Public Health (Microbiology) Tel: Fax: J.Fox@provlab.ab.ca Dr. Kevin Fonseca Clinical Virologist Provincial Laboratory for Public Health Tel: k.fonseca@provlab.ab.ca Dr. Martin Petric Clinical Virologist Laboratory Services, BCCDC Tel: Fax: martin.petric@bccdc.ca 14 Canadian Pandemic Influenza Plan for the Health Sector

19 Disease Surveillance Liaison Jeannette Macey A/Head Disease Surveillance Immunization and Respiratory Infections Division, CIDPC Tel: Fax: Cel: Kerri Watkins Senior Epidemiologist Emerging Respiratory Immunization and Respiratory Infections Division CIDPC Tel: Fax: Cel: Hospital Liaison Dr. Max Chernesky Professor Emeritus Department of Pediatrics, and Pathology & Molecular Medicine McMaster University St. Joseph s Healthcare Tel Fax chernesk@mcmaster.ca Facilitator Anthony Ebsworth Provincial Laboratory Alberta A.Ebsworth@provlab.ab.ca Secretariat Support Dr. Theodore I. Kuschak Manager CPHLN National Microbiology Laboratory Tel: Fax: Theodore_kuschak@phac-aspc.gc.ca Annex C 15

20 Appendix C: List of Acronyms Organizations Canadian Laboratory Surveillance Network CLSN Canadian Network for Public Health Intelligence CNPHI Canadian Public Health Laboratory Network CPHLN Centre for Emergency Preparedness and Response CEPR Centre for Infectious Disease Prevention and Control CIDPC College of American Pathologists CAP Federal, provincial and/or territorial FPT National Microbiology Laboratory NML Pandemic Influenza Committee PIC Pandemic Influenza Laboratory Preparedness Network PILPN Provincial public health laboratories PHLs Province and/or territory P/T Public Health Agency of Canada PHAC United States Centers for Disease Control and Prevention CDC World Health Organization WHO Diagnostic and Scientific Terms Biosafety level BSL Direct fluorescent-antibody assay DFA Enzyme immunoassay EIA General practitioner GP Hemagglutinin HA Hemagglutination inhibition HAI High efficiency particulate air HEPA Human resource(s) HR Immunofluorescent assay IFA Nasopharyngeal NP Nasopharyngeal swab NPS Nucleic acid sequence-based amplification NASBA Nucleic acid test NAT Point of care POC Polymerase chain reaction PCR Reverse transcriptase polymerase chain reaction RT-PCR Ribonucleic acid RNA Tuberculosis TB 16 The Canadian Pandemic Influenza Plan for the Health Sector