Source: accessed 5/17/07 http://www.pandemicflu.gov/plan/healthcare/maskguidancehc.html

Recommendations for Health Care Settings

Surgical mask and respirator use is one component of a system of infection control practices to prevent the spread of infection between infected and non-infected persons where pandemic influenza patients might receive health care services (e.g., hospitals, emergency departments, out-patient facilities, residential care facilities, emergency medical services, home health care delivery). During an influenza pandemic, surgical masks and respirators—along with other forms of personal protective equipment (e.g., gloves, gowns, and goggles)—should be used by health care personnel in health care settings in conjunction with Standard and Droplet Precautions, respiratory hygiene, cough etiquette, vaccination, and early diagnosis and treatment. Different types of surgical masks and respirators are described in Appendix B.

Recommendations

1. National Institute for Occupational Safety and Health (NIOSH)-certified respirators (N-95 or higher) are recommended for use during activities that have a high likelihood of generating infectious respiratory aerosols, [c] including the following high-risk situations:[d]

• Aerosol-generating procedures (e.g., endotracheal intubation, nebulizer treatment, and bronchoscopy) performed on patients with confirmed or suspected pandemic influenza
• Resuscitation of a patient with confirmed or suspected pandemic influenza (i.e., emergency intubation or cardiac pulmonary resuscitation)
• Providing direct care for patients with confirmed or suspected pandemic influenza-associated pneumonia (as determined on the basis of clinical diagnosis or chest x-ray), who might produce larger-than-normal amounts of respirable infectious particles when they cough

In the event of actual or anticipated shortages of N-95 respirators:

• Other NIOSH-certified N-, R-, or P-class respirators should be considered in lieu of the N-95 respirator.
• If re-useable elastomeric respirators are used, these respirators must be decontaminated according to the manufacturer’s instructions after each use.
• Powered air purifying respirators (PAPRs) may be considered for certain workers and tasks (e.g., high-risk activities). Loose-fitting PAPRs have the advantages of providing eye protection, being comfortable to wear, and not requiring fit-testing; however, hearing (e.g., for auscultation) is impaired, limiting their utility for clinical care. Training is required to ensure proper use and care of PAPRs.

2. Use of N-95 respirators for other direct care activities involving patients with confirmed or suspected pandemic influenza is also prudent. Hospital planners should take this into consideration during planning and preparation in their facilities when ordering supplies. In addition, several measures can be employed to minimize the number of personnel required to come in contact with suspected or confirmed pandemic influenza patients, thereby reducing worker exposure and minimizing the demand for respirators. Such measures include the following:

• Establishing specific wards for patients with pandemic influenza
• Assigning dedicated staff (e.g., health care, housekeeping, janitorial) to provide care for pandemic influenza patients and restricting those staff from working with non-influenza patients
• Dedicating entrances and passageways for influenza patients

Planning assumptions and projections suggest that shortages of respirators are likely in a sustained pandemic (22). Therefore, in the event of an actual or anticipated shortage, hospital planners must ensure that sufficient numbers of respirators are prioritized for use during the high-risk procedures described in Recommendation 1. This will require careful planning as well as real-time supply monitoring to ensure that excess respirators are not held in reserve while health care personnel are conducting activities for which they would otherwise be provided respiratory protection. Conversely, excessive use of respirators could result in their unavailability for high-risk procedures. Decision guidance for determining respirator wear should consider factors such as duration, frequency, proximity, and degree of contact with the patient. Occupational health and safety professionals can assist with making these site- and activity-specific decisions. For example, a nurse entering a room with a suspected or confirmed pandemic influenza patient to obtain vital signs should wear an N-95 respirator. A housekeeper entering multiple rooms of confirmed or suspected influenza patients to mop floors or clean patient equipment should be similarly protected. Work activities such as those performed by a receptionist at the entrance of a hospital should be designed to prevent exposure of the worker to large numbers of potentially infected patients. In such situations, the use of transparent barriers or enclosures is preferable to the use of respirators.
If supplies of N-95 (or higher) respirators are not available, surgical masks can provide benefits against large droplet exposure, and should be worn for all health care activities for patients with confirmed or suspected pandemic-influenza.

3. Negative pressure isolation is not required for routine patient care of individuals with pandemic influenza. If possible, airborne infection isolation rooms should be used when performing high-risk aerosol-generating procedures. If work flow, timing, resources, availability, or other factors prevent the use of airborne infection isolation rooms, it is prudent to conduct these activities in a private room (with the door closed) or other enclosed area, if possible, and to limit personnel in the room to the minimum number necessary to perform the procedure properly.

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Information for Travelers to Affected Areas Avian Influenza A (H5N1) Virus Update

Source:  http://www.cdc.gov/travel/other/avian_influenza_se_asia_2005.htm
                             Accessed 5/17/07

Current Situation     Phase 3 (Pandemic Alert).
CDC Recommendations
CDC has not recommended that the general public avoid travel to any of the countries affected by H5N1 viruses. Persons visiting H5N1-affected areas can reduce their risk of infection by observing the following measures.
Before travel to an area affected by H5N1 virus, follow these routine precautions
Visit CDC's Travelers’ Health Website to educate yourself and others who may be traveling with you about any disease risks and CDC health recommendations for international travel in areas you plan to visit.
Be sure you are up-to-date with all your routine vaccinations, including seasonal influenza vaccine, and see your doctor or health-care provider, ideally 4–6 weeks before travel, to get any additional vaccinations, medications or information you may need.
Assemble a travel health kit containing basic first aid and medical supplies. Be sure to include a thermometer and alcohol-based hand gel (containing at least 60% alcohol) for hand hygiene. See Travelers’ Health Kit in Health Information for International Travel for other suggested items.
Identify in-country health-care resources in advance of your trip.
Check your health insurance plan or get additional insurance that covers medical evacuation in case you become sick. Information about medical evacuation services is provided on the U.S. Department of State web page, Medical Information for Americans Traveling Abroad.

During travel to an H5N1-affected area:
Avoid all direct contact with birds, including domestic poultry (such as chickens and ducks) and wild birds.
Avoid places such as poultry farms and bird markets where live birds are raised or kept.
Avoid touching surfaces contaminated with poultry feces or secretions.
As with other infectious illnesses, one of the most important preventive practices is careful and frequent handwashing. Cleaning your hands often with soap and water removes potentially infectious material from your skin and helps prevent disease transmission. Waterless alcohol-based hand gels (containing at least 60% alcohol) may be used when soap is not available and hands are not visibly soiled.

During travel to an H5N1-affected area (continued):

All foods from poultry, including eggs and poultry blood, should be cooked thoroughly. Egg yolks should not be runny or liquid. Because influenza viruses are destroyed by heat, the cooking temperature for poultry meat should be 74°C (165°F).
If you become sick with symptoms such as a fever plus a cough, sore throat or have trouble breathing, or if you develop any illness that requires prompt medical attention, a U.S. consular officer can assist you in locating medical services and informing your family or friends. Inform the health-care provider of any possible exposures to avian influenza, such as exposures to ill or dead birds. See Seeking Health Care Abroad in Health Information for International Travel for more information about what to do if you become ill while abroad. You should defer further travel until you are free of symptoms, unless traveling locally for medical care.
To help stop the spread of germs,
Cover your mouth and nose with a tissue when you cough or sneeze.
If you don't have a tissue, cough or sneeze into your upper sleeve, not your hands.
Put your used tissue in the waste basket.
Clean your hands after coughing or sneezing by washing them with soap and water (or by using an alcohol-based hand cleaner with at least 60% alcohol when soap and water are not available).
You may be asked to put on a surgical mask to protect others.
Note: Some countries have instituted health monitoring techniques, such as temperature screenings, at ports of entry for travelers arriving from areas affected by the H5N1 virus. Please consult the embassy of your travel destination country if you have any questions.
After your return from an H5N1-affected area
Closely monitor your health for 10 days.
If you become ill with a fever plus a cough, sore throat or have trouble breathing during this 10-day period, consult a health-care provider. Before you visit a health-care setting, tell the provider the following: 1) your symptoms, 2) where you traveled, and 3) if you have had direct contact with poultry or close contact with a severely ill person. This way, he or she can be aware that you have traveled to an area reporting H5N1.
Do not travel while ill, unless you are seeking local medical care. Limiting contact with others as much as possible can help prevent the spread of an infectious illness.
Date: February 2, 2007 Content Source: National Center for Infectious Diseases, Division of Global Migration and Quarantine

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Quarantine, Isolation and Other Legal Issues from the SARS Experience: Concerns for Local Health Officials

By Susan Allan, MD, JD, MPH, Health Director, Arlington, Virginia

The experiences of the communities that lived through severe acute respiratory syndrome (SARS) last year are instructive and sobering. The public health and other officials from the countries that were affected by SARS last year have been generous in sharing details of their experience and their lessons learned. I have had the opportunity to participate in several conferences and meetings with officials from Toronto, Singapore, Taiwan, and Hong Kong. From Toronto in particular, I have heard from and spoken with not only their public health officials, but also their legal counsel, chiefs of police for the city and for the province, and private emergency room and infectious disease physicians. A number of more extensive articles have recently been published regarding the range of legal and policy issues raised by the SARS experience; these articles are a valuable reference for anyone wanting to go deeper into these issues. In this brief article, I will attempt to summarize the major legal, policy, and resource issues that seem to have the greatest significance for local public health agencies. Because the social, legal, and health care systems of Toronto are most similar to those of the United States, I will draw most heavily from their experience.

The scale of the response to SARS in these affected countries was astounding, but one of the lessons learned is that they cannot provide firm information on numbers quarantined or isolated. For Taiwan, estimates have ranged from 80,000 to 130,000 people quarantined. Estimates for number quarantined in Toronto have ranged from 23,000 to 29,000 during the three months of the outbreak, with as many as 7,000 under quarantine at any one time. The total number of actual SARS cases in Toronto was 375, so the number of people quarantined was vastly greater than the number of people who ultimately became ill. Because the early experience with SARS in a hospital in Vietnam had suggested a possible fatality rate of 50 percent, these countries felt they needed to take drastic measures initially, until later experience with the disease provided more information about modes of transmission and showed a lower, but still significant, fatality rate.

An important point to note is that the vast majority of both quarantined and isolated individuals complied voluntarily and were never taken through any kind of legal process or court order. They were given directives from their health department staff, private physician, in some cases from their employer (hospitals, for example), but were not actually issued a formal order of quarantine or isolation unless they were noncompliant.
The vast majority were compliant with instructions they were given—Toronto only issued  27 legal orders. They believe that they were able to achieve this high level of compliance with voluntary quarantine in large part because of the extensive efforts to ensure that the community at large understood what was needed and why, and also because of the very labor intensive monitoring and support systems they developed for those in quarantine. These included placing telephone calls to the individuals twice daily;
maintaining logs of symptoms (especially temperature and respiratory symptoms); ensuring that people had the supplies needed to remain in their homes, such as food and medications; providing someone to talk with about their fears and anxieties, etc. The logistical burden was extensive. They also set up a community hotline staffed by public health nurses, which fielded approximately 300,000 telephone calls in total. Although there are legal and epidemiologic distinctions between quarantine and isolation, for the most part the communities handled the logistics of quarantine and outpatient isolation very similarly. (Inpatient “isolation” was generally a matter of providing infection control while treating severely ill patients in a hospital setting, which presented medical treatment and hospital management challenges that will not be discussed further here.) Most often, they would "isolate" or "quarantine" people to their own homes, with instructions on how to keep separate from the rest of the household and how to maintain specific infection control practices. This made the quarantine or isolation much easier for the government to manage, since no separate facility needed to be maintained and the family could help provide much of the routine support, whether the individual was well or sick. People might be "quarantined," then become
moderately symptomatic and remain in the home, unless they actually needed to be hospitalized due to the severity of illness. In most of the affected communities, they did provide some sort of a facility for people who were "advised" to be quarantined but preferred not to stay at home and potentially put their families at risk.
 
Some current and proposed state laws in the U.S. describe different procedures for issuing quarantine orders and isolation orders. For small numbers of affected individuals, it may not be unduly burdensome to shift from a quarantine order to an isolation order for those who become ill while in quarantine. Quarantine laws are being drafted that more explicitly could apply quarantine to large groups of people, while isolation laws generally are crafted to apply only to specifically identified individuals. In a situation with thousands who need to be quarantined, it may be more practical to create a process to extend the quarantine order once someone becomes symptomatic without necessarily going through a second process to obtain an isolation order. On the other hand, requiring an individual hearing for isolation orders may be a practicable approach if the isolation order would be necessary only for those not voluntarily complying, which is likely to be a much smaller number. Because the period of isolation for someone who is ill could end up much longer than the quarantine period, it may be appropriate from a civil rights perspective to have a more individualized procedure for isolation orders.
When people have the right of appeal, or to have a hearing pertaining to a quarantine or isolation order, there may be a practical question of how to provide counsel to large numbers of people within the short timeframes that would be involved. Existing systems for appointing counsel may quickly be overwhelmed, or the laws may be written so that there is no right to have counsel provided in these circumstances.

Most existing laws do not address the issue of what to modify in terms of a quarantine or isolation order for a whole facility or group of people, e.g., when initially the whole hospital was quarantined, and later it is determined that the quarantine or isolation can be limited to the emergency room or the intensive care unit. Toronto developed the concept of “work quarantine”, which was applied to healthcare and EMS workers, in order to permit those systems to continue to operate while large numbers of their workers were in quarantine. At one point, Toronto had about 400 of the 875 paramedics operating under “work quarantine”—they were permitted to go to work, using appropriate PPE and other infection control precautions; and could drive straight home,
where they maintained appropriate distance and other separation measures from others in the household. But they were restricted from engaging in any other activities or going any place else. It is not clear whether a work quarantine option exists under the laws of most of the U.S. states.

During the SARS outbreak, Toronto passed several laws relating to employment rights and compensation. They passed legislation to protect employees who were home on voluntary quarantine or isolation from intimidation or dismissal by their employers. However, in some cases employers lost so much business during that period that they needed to lay off employees. Toronto also made provisions to compensate people for
lost wages or income due to quarantine or isolation. Because formal quarantine and isolation orders were issued so rarely, question arouse how to prove that an employee had been directed to stay away from work or that a business had been directed to close, rather than having made a personal decision to stay away from work due to fear of being infected by others. Toronto also passed laws prohibiting inappropriate discrimination by an employer or business based on a false belief that a person presented a risk to others.

Law enforcement agencies in Toronto and other affected communities faced a number of challenges. Typically, state and local laws require that someone from a branch of law enforcement serve notice of an individual order of quarantine or isolation. This can present a significant workload for a law enforcement department that is likely already to be stretched by responding to the public crisis. Law enforcement also assisted with monitoring those in quarantine who appeared to be noncompliant, and helped send a
message to the community that these orders were to taken seriously. In Toronto, there was one criminal investigation of an individual who infected a coworker with SARS when he failed to comply with a quarantine order. The prosecution was dropped because the index case subsequently died.

Legal and security issues arose regarding restricting visitors to patients who were in isolation or who were in the two quarantined hospitals. Some cases were quite tragic, when family members were not allowed to visit their sick or dying relatives. On some occasions, public health and law enforcement authorities prohibited certain kinds of public gatherings. For example, a public funeral was prohibited when some family members had been a source of infection to others while attending an earlier funeral of a family member and many members of the family were still in quarantine or isolation.
Certain church services were cancelled for a period of time when the church had previously been a site of disease transmission and members were being monitored for symptoms. Although the number of deaths did not turn out to be overwhelming, officials sought the authority to require cremation of bodies if needed, even if against the family’s wishes or religious beliefs.

To effectively use quarantine and isolation as tools to control a disease outbreak, it is essential that cases of diseases be reported promptly to public health authorities.Toronto officials are concerned that the existing requirements for physicians to report diseases and consequences for failure to report may not be strong enough for situations such as SARS, where identifying and managing every single case is critical. They do not
believe they have found a good answer to this problem. Poor reporting of diseases is already a concern of many local health departments in this country.

From this brief overview of some of the legal and policy issues related to quarantine, isolation and response to a disease outbreak, it is clear that such situations could present challenges for which many of our current laws, plans and resources are not adequate. The legal and public health authorities from Toronto have spoken out clearly and emphatically that the middle of an epidemic is not the best time to be rewriting laws and developing plans. We would do well to heed their message.

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Laboratory Testing of Persons with Suspected Infection with Avian Influenza A (H5N1) Virus in the United States

Updated Interim Guidance
CDC HEALTH UPDATE
Distributed via Health Alert Network
Wednesday, June 07, 2006, 19:50  EDT (7:50  PM EDT)
CDCHAN-00246-2006-06-07-UPD-N
 ……

Current Situation:

The avian influenza A (H5N1) epizootic (animal outbreak) in Asia has expanded to wild birds and/or poultry in parts of Europe, the Near East and Africa. Sporadic human infections with H5N1 continue to be reported and have most recently occurred in China, Egypt, Indonesia, Azerbaijan, Cambodia, and Djibouti. In addition, rare instances of probable human-to-human transmission associated with H5N1 viruses have occurred, most recently in a family cluster in Indonesia. So far, however, the spread of H5N1 virus from person to person has been rare, inefficient, and unsustained. The total number of confirmed human cases of H5N1 reported as of June 7, 2006 has reached 225. The case fatality rate for these reported cases continues to be approximately 50 percent. As of this date, H5N1 has not been identified among animals or humans in the United States.

The epizootic in Asia and parts of Europe, the Near East and Africa is not expected to diminish significantly in the short term and it is likely that H5N1 infection among birds has become enzootic in certain areas. It is expected that human infections resulting from direct contact with infected poultry will continue to occur in affected countries. Since no sustained human-to-human transmission of influenza H5N1 has been documented anywhere in the world, the current phase of alert, based on the World Health Organization (WHO) global influenza preparedness plan, remains at Phase 3 (Pandemic Alert).*  In addition, no evidence for genetic reassortment between human and avian influenza A virus genes has been found. Nevertheless, this expanding epizootic continues to pose an important and growing public health threat. CDC is in communication with WHO and other national and international agencies and continues to monitor the situation closely.

Reporting and Testing Guidelines:

CDC recommends maintaining the enhanced surveillance efforts practiced currently by state and local health departments, hospitals, and clinicians to identify patients at increased risk for avian influenza A (H5N1). Guidance for enhanced surveillance was first described in a HAN update issued on February 3, 2004 and most recently updated on February 4, 2005.

Testing for avian influenza A (H5N1) virus infection is recommended for:

A patient who has an illness that:

• requires hospitalization or is fatal; AND
• has or had a documented temperature of ≥38°C (≥100.4° F); AND
• has radiographically confirmed pneumonia, acute respiratory distress syndrome (ARDS), or other severe respiratory illness for which an alternate diagnosis has not been established; AND
• has at least one of the following potential exposures within 10 days of symptom onset:

A)         History of travel to a country with influenza H5N1 documented in poultry, wild birds, and/or humans,† AND had at least one of the following potential exposures   during travel:

• direct contact with (e.g., touching) sick or dead domestic poultry
• direct contact with surfaces contaminated with poultry feces;
• consumption of raw or incompletely cooked poultry or poultry products;
• direct contact with sick or dead wild birds suspected or confirmed to have influenza H5N1;
• close contact (approach within 1 meter [approx. 3 feet]) of a person who was hospitalized or died due to a severe unexplained respiratory illness;

B)         Close contact (approach within 1 meter [approx. 3 feet]) of an ill patient who was confirmed or suspected to have H5N1;

C)         Worked with live influenza H5N1 virus in a laboratory.

Testing for avian influenza A (H5N1) virus infection can be considered on a case-by-case basis, in consultation with local and state health departments, for:

• A patient with mild or atypical disease‡ (hospitalized or ambulatory) who has one of the exposures listed above (criteria A, B, or C); OR
• A patient with severe or fatal respiratory disease whose epidemiological information is uncertain, unavailable, or otherwise suspicious but does not meet the criteria above (examples include: a returned traveler from an influenza H5N1-affected country whose exposures are unclear or suspicious, a person who had contact with sick or well-appearing poultry, etc.)

Clinicians should contact their local or state health department as soon as possible to report any suspected human case of influenza H5N1 in the United States.

Specimen Collection and Testing Guidelines:

• Oropharyngeal swab specimens and lower respiratory tract specimens (e.g., bronchoalveolar lavage or tracheal aspirates) are preferred because they appear to contain the highest quantity of virus for influenza H5N1 detection, as determined on the basis of available data. Nasal or nasopharyngeal swab specimens are acceptable, but may contain less virus and therefore not be optimal specimens for virus detection.
• Detection of influenza H5N1 is more likely from specimens collected within the first 3 days of illness onset. If possible, serial specimens should be obtained over several days from the same patient.
• Bronchoalveolar lavage is considered to be a high-risk aerosol-generating procedure. Therefore, infection control precautions should include the use of gloves, gown, goggles or face shield, and a fit-tested respirator with an N-95 or higher rated filter. A loose-fitting powered air-purifying respirator (PAPR) may be used if     fit-testing is not possible (for example, if the person has a beard). Detailed guidance on infection control precautions for health care workers caring for suspected influenza H5N1 patients is available.||
• Swabs used for specimen collection should have a Dacron tip and an aluminum or plastic shaft. Swabs with calcium alginate or cotton tips and wooden shafts are not recommended.§ Specimens should be placed at 4°C immediately after collection.
• For reverse-transcriptase polymerase chain reaction (RT-PCR) analysis, nucleic acid extraction lysis buffer can be added to specimens (for virus inactivation and RNA stabilization), after which specimens can be stored and shipped at 4°C. Otherwise, specimens should be frozen at or below -70°C and shipped on dry ice.  For viral isolation, specimens can be stored and shipped at 4°C. If specimens are not expected to be inoculated into culture within 2 days, they should be frozen at or below -70°C and shipped on dry ice. Avoid repeated freeze/thaw cycles.
• Influenza H5N1-specific RT-PCR testing conducted under Biosafety Level 2 conditions is the preferred method for diagnosis. All state public health laboratories, several local public health laboratories, and CDC are able to perform influenza H5N1 RT-PCR testing, and are the recommended sites for initial diagnosis.
• Viral culture should NOT be attempted on specimens from patients suspected to have influenza H5N1, unless conducted under Biosafety Level 3 conditions with enhancements.
• Commercial rapid influenza antigen testing in the evaluation of suspected influenza H5N1 cases should be interpreted with caution. Clinicians should be aware that these tests have relatively low sensitivities, and a negative result would not exclude a diagnosis of influenza H5N1. In addition, a positive result does not distinguish between seasonal and avian influenza A viruses.
• Serologic testing for influenza H5N1-specific antibody, using appropriately timed specimens, can be considered if other influenza H5N1 diagnostic testing methods are unsuccessful (for example, due to delays in respiratory specimen collection). Paired serum specimens from the same patient are required for influenza H5N1 diagnosis: one sample should be tested within the first week of illness, and a second sample should be tested 2-4 weeks later. A demonstrated rise in the H5N1-specific antibody level is required for a diagnosis of H5N1 infection. Currently, the microneutralization assay, which requires live virus, is the recommended test for measuring H5N1-specific antibody. Any work with live wild-type highly pathogenic influenza H5N1 viruses must be conducted in a USDA-approved Biosafety Level 3 enhanced containment facility. Visit http://www.cdc.gov/flu/h2n2bsl3.htm for more information about procedures and facilities recommended for manipulating highly pathogenic avian influenza viruses.

Laboratory testing results positive for influenza A (H5N1) in the United States should be confirmed at CDC, which has been designated as a WHO H5 Reference Laboratory. Before sending specimens, state and local health departments should contact CDC’s on-call epidemiologist at (404) 639-3747 or (404) 639-3591 (Monday – Friday, 8:30 AM - 5:00 PM) or (770) 488-7100 (all other times).

Department of Health and Human Services at www.pandemicflu.gov
World Health Organization at
World Organization for Animal Health (OIE) at http://www.oie.int/eng/en_index.htm

*For the current WHO Pandemic Phase, see http://www.who.int/csr/disease/avian_influenza/phase/en/index.html.

† For a listing of influenza H5N1-affected countries, visit the CDC website at http://www.cdc.gov/flu/avian/outbreaks/current.htm; the OIE website at http://www.oie.int/eng/en_index.htm; and the WHO website at http://www.who.int/csr/disease/avian_influenza/en/.

‡ For example, a patient with respiratory illness and fever who does not require hospitalization, or a patient with significant neurologic or gastrointestinal symptoms in the absence of respiratory disease.

|| Interim recommendations for infection control in health-care facilities caring for patients with known or suspected avian influenza are available at  http://www.cdc.gov/flu/avian/professional/infect-control.htm.

• Specimens can be transported in viral transport media, Hanks balanced salt solution, cell culture medium, tryptose-phosphate broth, veal infusion broth, or sucrose-phosphate buffer. Transport media should be supplemented with protein, such as bovine serum albumin or gelatin, to a concentration of 0.5% to 1%.

Information regarding Laboratory Biosafety Level Criteria can be found at http://www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4s3.htm.

##This Message was distributed to State and Local Health Officers, Public Information Officers, Epidemiologists, State Laboratory Directors, Weapons of Mass Destruction Coordinators and HAN Coordinators, as well as Public Health Associations and Clinician organizations##

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Summary of Ethical Guidelines in Pandemic Influenza

[Note: Excerpts from a CDC requested document from the Ethics Subcommittee to address ethical considerations in:

• vaccine and anti-viral drug distribution prioritization and
• development of interventions that would limit individual freedom and create social distancing(in discourse on pandemic influenza, often referred to as non-pharmaceutical interventions). ]

I. General Ethical Considerations
• Identification of clear overall goals for pandemic planning is essential to making difficult choices. Historically, the organizing principle for resource (antiviral and vaccine) distribution in inter-pandemic years has been the minimization of serious influenza-associated complications, including hospitalization and death. Individuals most at risk of experiencing the serious negative health consequences of hospitalization or death if infected are given priority in receiving influenza vaccinations. The recommendations of two federal advisory committees, the Advisory Committee on Immunization Practices (ACIP) and the National Vaccine Advisory Committee (NVAC) reflect this principle.3
However, in pandemic influenza management a second principle – that of preserving the functioning of society – should receive greater priority in decision making than preventing serious complications. Those individuals who are essential to the provision of health care, public safety and the functioning of key aspects of society should receive priority in the distribution of vaccine, antivirals and other scarce resources. Engagement of diverse stakeholders will be essential in affirming this priority, determining who is considered key to the functioning of society, and establishing a distribution strategy that allows for decisions to be made when resources are limited. In any prioritization proposal, it must be clearly acknowledged that maintaining the functioning of society may result in a lack of resource availability to those at high risk of severe medical complications due to pre-existing medical conditions or advanced age.
Affirming this second principle (preserving the functioning of society) raises important conceptual questions about who is valued and how particular services and functions are determined to be “key.” These questions are set in important historical and social contexts involving individuals’ ability to attain “essential” positions given societal barriers and obstacles. Discussion of these questions, while very important in ordinary times, takes on a lower priority when confronted with the urgent demands of preserving society.
There is a commitment to transparency throughout the pandemic influenza planning and response process. The reasoning behind choices made is fully articulated (in language appropriate to particular audiences) and the values and principles justifying those decisions are clearly identified and open for examination. This commitment to clarity and openness, which is based on a deep respect for all individuals and communities involved, exists in balance with the understanding that those with the authority and responsibility of making decisions must often make decisions in a timely manner.
• Public engagement and involvement are essential to build public will and trust and should be evidenced throughout the planning and response process. The public is seen as a partner with other experts, with particular attention to vulnerable or historically marginalized members of society. Clear mechanisms must be created for public involvement in planning and for feedback throughout the process.
• Public health officials have a responsibility to maximize preparedness in order to minimize the need to make allocation decisions later. (Examples of maximizing preparedness include shortening the time for virus recognition orvaccine production, increasing the capacity to produce vaccines or antivirals and increasing the supplies of antivirals.) Proactive planning of response strategies for a pandemic, including the training of staff, is required. This necessarily entails consideration of the full context in which choices are made. Enhancing the available range of prophylaxis and treatment options should decrease the need to focus on scarcity of resources and allocation during a pandemic. Preparedness also includes determining and articulating what rules will govern public health decision making in advance of the time that decision making must commence. Though every specific choice or contingency cannot be foreseen, comprehensible foundational guidelines and procedural action plans provide coherence and direction and build trust.
• Sound guidelines should be based on the best available scientific evidence. There is no need to establish rules for the equitable distribution of goods that will not work or to implement public health interventions that are ineffective. This is equally true for vaccines and antivirals as it is for ‘social distancing’ measures. Because the scientific basis for efficacy of particular interventions continues to be studied and models projecting the course of a pandemic are being investigated, sound scientific evidence for proposed interventions may not currently exist. The current knowledge basis should serve as a foundation for ethical guidelines and a commitment to ongoing scientific and ethical evaluation of interventions should be made.
• The United States recognizes its membership in the global community, and the pandemic planning process acknowledges the importance of working with and learning from preparedness efforts globally. This recognition is not based simply on the potential of global involvement to benefit U.S. citizens (an “instrumental” reason), but on a deep recognition of the common good4 and our interdependence globally. Mechanisms for global involvement and criteria for determining the scope of impact of U.S. decisions should be explicit.
• Balancing of Individual Liberty and Community Interests Pandemic influenza planning, like other public and community health activities, is a cooperative and shared responsibility that balances community and individual interests. During the course of a pandemic, the functioning of society may be threatened. Our moral tradition embodies an understanding that it may be ethically acceptable (or perhaps even ethically mandatory) to suspend some (but not all) ordinary moral rules in such circumstances. For example, limits on individual freedom or choice may be necessary to protect individuals as well as entire communities during pandemic influenza. Yet, individual liberty should be restricted with great care and only when alternative approaches to realizing the goal of weathering the pandemic are not likely to be effective. Suspensions of 4ordinary moral rules should be anticipated and the conditions calling for such suspensions should be specified
Guiding principles in determining these restrictions include:

• Adopting the least restrictive practices that will allow the common good to be protected.
• Ensuring that restrictions are necessary and proportional to the need for protection.
• Attempting to ensure that those impacted by restrictions receive support from the community (e.g., job security, financial support for individuals and their families, provision of food and other necessities to those who are isolated or placed under quarantine, and/or protection against stigmatization or unwarranted disclosure of private information).

• Diversity in Ethical Decision Making Given numerous historical examples of abuse of individuals, particularly those who are considered vulnerable, in the name of the public good (e.g., involuntary sterilization of the mentally retarded, the U.S. Public Health Service Syphilis Study at Tuskegee, the internment of Japanese-Americans during World War II), public health officials must adequately acknowledge and respond to strong currents of suspicion and distrust of the healthcare system. This acknowledgement is, of course, a part of a much larger healthcare dialogue. Addressing this distrust should be a strong and enduring commitment and not viewed as merely instrumental to inducing individuals to comply with recommendations. Diverse public voices should be involved in determining the need for restrictions and in articulating the ethical justification for these restrictions.
• Fair Process Approach (Procedural Justice) We recommend an approach to justice that focuses on the procedures to be followed with the hope that good procedures will lead to fair outcomes. Following are the elements of an ideal procedural justice approach:

• Consistency in applying standards across people and time (treating like cases alike).
• Decision makers who are impartial and neutral.
• Ensuring that those affected by the decisions have a voice in decision making and agree in advance to the proposed process.
• Treating those affected with dignity and respect.
• Ensuring that decisions are adequately reasoned and based on accurate information.
• Communications and processes that are clear, transparent and without hidden agendas.
• Inclusion of processes to revise or correct approaches to address new information, including a process for appeals and procedures that are sustainable and enforceable.

The involvement of diverse voices in pandemic influenza planning and in creating a transparent procedure for decision making is essential. In addition to engaging citizens in general, this process would involve those who are primarily responsible for implementing the pandemic influenza plans (e.g., direct health care providers who would be asked to commit to providing care even in the face of personal risk or the competing needs of their own families.)
A balance between centralized, federal control and state and local community implementation of central guidelines must be effectively struck (see Section II-B, page 9, paragraph 2 for more discussion about the strong presumption in favor of centralized decision making during a pandemic). This process should be especially attentive to historically marginalized communities and those where sensitivity to cultural, racial, religious or other values must be incorporated.
Thoughtful preparation and attention to process will not provide guidance in all specific circumstances. The practice of attending to fair process may provide support for local decision makers addressing unanticipated questions. In addition, these decision makers must be authorized to utilize their best judgment in addressing and resolving particular issues.
Definitions

Social distancing refers to methods for reducing frequency and closeness of contact between people in order to decrease the risk of transmission of disease. Examples of social distancing include cancellation of public events such as concerts, sports events, or movies, closure of office buildings, schools, and other public places, and restriction of access to public places such as shopping malls or other places where people gather.

Common good refers to the interests of a group or collective that is defined by having in common certain attributes (e.g., location in a geographically-defined community, risk of a specific disease) that create a commonality of interests. Its use in this context reflects an understanding that in the case of an influenza pandemic, all human beings are part of a single collective that has a 'common good'.

Reference:

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In Case of Emergency Prescription Database

 Physicians can now gain immediate access to patients' medication histories during a disaster. 

www.ICERx.org (In Case of Emergency Prescription Database) 

This web portal is a secure, online resource with patients' comprehensive medication histories intended for licensed subscribers and pharmacists. This site is backed by AMA and represents a public health initiative launched through a collaboration of public and private organizations in response to lessons learned in the aftermath of Hurricane Katrina.

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Preparing for a pandemic influenza outbreak involves everybody. The threat of pandemic influenza is real, and America needs leadership from respected community members to prepare our towns and cities, reduce the impact of pandemic flu on individuals and families, and reduce or even prevent serious damage to the economy. ...

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