Lesson 6. Pathogens and Transmission

Estimated Time: 1 period

Objective

Define a pathogen and describe how it gets transmitted

EQ: What exactly is a pathogen and how do we contract/transmit them?

Bridge

We have identified many different ways that people can develop diseases: through poor nutrition, toxic substances, microorganisms, organ malfunction/failure, cancer, allergies, genetics, and poor hygiene. You have also been able to make connections that one of these can lead to another one occurring. For example, if you come down with the flu which is a microorganism, this can lead to your lungs not working properly (organ malfunction) and the reason you came down with the flu in the first place was that you were not careful to keep your hands clean before you ate (poor hygiene).

From this list of things that can lead to disease, which one do you think doctors treat the most often? Why?

Mini Lesson

Share out responses from the bridge. They can answer anything they want as long as they are willing to back it up. Ideally, most of the students will come up with microorganisms, although you may have to remind them that microorganisms include viruses, bacteria, fungi, parasites, etc. Where other diseases may be more deadly than the microorganisms, these are definitely the most common. Someone that comes down with or is born with diabetes, depending on the type, will always have diabetes, will always need to be treated for diabetes to keep their condition stable, and there is a good chance that diabetes or the side effects of having diabetes will be one of the causes of death. However, you will come down with several diseases caused by microorganisms over the course of your life and depending on what kind of microorganism it is, what kind of medical care is available concerning that microorganism, and how your body responds to fighting off that microorganism, will decide how minor or how severe that microorganism is to you.

These microorganisms are what inspired the study of pathology and the development of vaccines in the world, and why treatment of these contagious diseases were one of the first things that doctors were able to deal with…. It was much harder to fix genetic disorders when you don’t know about DNA than it was to kill something that was alive and after the invention of the microscope, they could now be seen.

We have a lot of microorganisms that live in harmony with us: there is bacteria that live on our skin, in our noses, and in our digestive tract that help us break down food or serve as a first line

of defense against disease. But our body is constantly under attack from these other living organisms. We call these other microorganisms that can potentially cause disease pathogens. These pathogens like viruses, fungi, bacteria and other living organisms that can make us sick make antigens which are nothing more than chemicals that our bodies recognize as not being part of us or not being something we can use to survive. All of these pathogens attack and hurt or destroy specific cells in our bodies. Sometimes they will take over the cells and use them to reproduce more of themselves (retroviruses), sometimes they just outright kill our cells (many bacteria), and sometimes they attach to our cells and steal the nutrients and use it as a source of nourishment (fungi and parasites). So when we become infected, guess what happens? Immune response!

So how is it that we get these pathogens anyway?

Work Period

Students will be dealing with several different artifacts….. you can set these up as stations or give each group the artifacts and let them work at their tables. As a group, they need to determine as many transmission vectors from the 16 artifacts as they can and how the preventions are related to the transmission vectors. The artifacts range from wash your hands after you go to the bathroom warnings to journal articles about a specific disease to public service announcements to journal entries made during epidemics in history and others.

As they work with the artifacts, have them classify them as a transmission vector, transmission action, or prevention. I would also tell them that there are only 4 transmission vectors to help them put together the big picture (water, air, blood/body fluids, animal). At the end, have them explain how understanding both transmission and prevention is key for protecting someone from communicable/infectious/contagious disease (use the terms interchangeably so they understand that they all mean the same thing).

Summary

Answer the EQ

Closing

There have been instances in history of some very severe diseases such as Ebola (and several science fiction movies and books!) that will infect a person and they will be dead within hours. Is this a realistic timeframe for a person to contract a disease and die from it? Why or why not? Why is it that these severe diseases have not wiped out the planet?

SPED and ELL Modifications: 1. Offer graphic organizers for both discussion pieces2. Pair students to come up with ideas for the work period3. Prerecord all the readings so that students can replay and listen to as much as needed and

if it is done on iPads they can translate all the articles to native language for greater understanding.

Apps and Internet Activities: Video Editor App: A great project to do with the artifacts is to create a virtual story book of each artifact. Have students chose one of interest to them- and summarize the importance- they show the picture and explain while recording. Each student artifact summary is done on the same iPad and VideoEditor App can be used to string them together.

Independent Practice

Reading with questions about different pathogens

Artifact 1. From the American Red Cross

Controlling the Spread of Contagious Diseases: Quarantine and Isolation

People can be infected with dangerous diseases in a number of ways. Some germs, like those causing malaria, are passed to humans by animals. Other germs, like those that cause botulism, are carried to people by contaminated food or water. Still others, like the ones causing measles, are passed directly from person to person. These diseases are called "contagious."

Contagious diseases that pose a health risk to people have always existed. While the spread of many of these diseases has been controlled through vaccination and other public health efforts, terrorist acts worldwide have raised concerns about the possibility of a biological attack. That makes it important for people to understand what can and would be done to protect the public from the spread of dangerous contagious diseases.

The Centers for Disease Control and Prevention (CDC) is the U.S. government agency responsible for identifying, tracking and controlling the spread of disease. With the help of the CDC, state and local health departments have created emergency preparedness and response plans. In addition to early detection, rapid diagnosis and treatment with antibiotics or antivirals, these plans use two main traditional strategies—quarantine and isolation*1*—to contain the spread of illness. These are common health care practices to control the spread of a contagious disease by limiting people's exposure to it.

The difference between quarantine and isolation can be summed up like this: quarantine applies to those who have been exposed to a contagious disease but

who may or may not become ill. isolation applies to persons who are known to be ill with a contagious disease.

When someone is known to be ill with a contagious disease, they are placed in isolation and receive special care, with precautions taken to protect uninfected people from exposure to the disease. When someone has been exposed to a contagious disease and it is not yet known if they have caught it, they may be quarantined or separated from others who have not been exposed to the disease. For example, they may be asked to remain at home to prevent further potential spread of the illness. They also receive special care and observation for any early signs of the illness.

When would quarantine and isolation be used and by whom?

If people in a certain area were potentially exposed to a contagious disease, this is what would happen: State and local health authorities would let people know that they may have been exposed and would direct them to get medical attention, undergo diagnostic tests and stay at home, limiting their contact with people who have not been exposed to the disease. Only rarely would federal, state or local health authorities issue an "order" for quarantine and isolation.

However, both quarantine and isolation may be conducted on a voluntary basis or compelled on a mandatory basis through legal authority.

States have the authority to declare and enforce quarantine and isolation within their borders. This authority varies widely, depending on state laws. It derives from the authority of state governments granted by the U.S. Constitution to enact laws and promote regulations to safeguard the health and welfare of people within state borders.

Further, at the national level, the CDC may detain, medically examine or conditionally release persons suspected of having certain contagious diseases.*2* This authority applies to individuals arriving from foreign countries, including Canada and Mexico, on airplanes, trains, automobiles, boats or by foot. It also applies to individuals traveling from one state to another or in the event of "inadequate local control."*3*

The CDC regularly uses its authority to monitor passengers arriving in the United States for contagious diseases. In modern times, most quarantine measures have been imposed on a small scale, typically involving small numbers of travelers (airline or cruise ship passengers) who have curable diseases, such as infectious tuberculosis or cholera. No instances of large-scale quarantine have occurred in the U.S. since the "Spanish Flu" pandemic of 1918-1919.

Based on years of experience working with state and local partners, the CDC anticipates that the need to use its federal authority to involuntarily quarantine a person

would occur only in rare situations—for example, if a person posed a threat to public health and refused to cooperate with a voluntary request.*4*

For more information, contact one of the following:

Centers for Disease Control and Prevention (www.bt.cdc.gov)Your local American Red Cross chapter (www.redcross.org)Your state or local health department (www.cdc.gov/doc.do/id/0900f3ec80226c7a)

Definitions

Infectious disease: a disease caused by a microorganism and therefore potentially infinitely transferable to new individuals. May or may not be communicable. Example of non communicable is disease caused by toxins from food poisoning or infection caused by toxins in the environment, such as tetanus.

Communicable disease: an infectious disease that is contagious and which can be transmitted from one source to another by infectious bacteria or viral organisms.

Contagious disease: a very communicable disease capable of spreading rapidly from one person to another by contact or close proximity.

_____________________________________1 The CDC applies the term "quarantine" to more than just people. They also use it to refer to any situation in which a building, conveyance, cargo or animal might also be thought to have been exposed to a dangerous contagious disease agent and is closed off or kept apart from others to prevent disease spread.

2 The list of diseases for which quarantine is authorized must first be specified in an Executive Order of the President, on recommendation of the Secretary of Health and Human Services. Since 1983, this list has included cholera, diphtheria, infectious tuberculosis, plague, smallpox, yellow fever and viral hemorrhagic fevers. It was amended in April 2003 to include SARS.

3 Title 42 United States Code Section 264 (Section 361 of the Public Health Service [PHS] Act) gives the Secretary of the Department of Health and Human Services (HHS) responsibility for preventing the introduction, transmission and spread of contagious diseases from foreign countries into the United States and from one state or possession to another. This statute is implemented through regulations found at 42 CFR Parts 70 and 71. Under its delegated authority, CDC, through the Division of Global Migration and Quarantine, is empowered to detain, medically examine or conditionally release persons suspected of carrying specified contagious diseases.

4 For more information, see the CDC's "Fact Sheet on Legal Authorities for Isolation/Quarantine" and "Questions and Answers on Legal Authorities for quarantine and isolation."

Artifact 2. Journal Article from a journalist during the “Black Death” in Europe

About the beginning of the year, it appeared in young children, male and female, either under the armpits, or in the groin by certain swellings, in some to the bigness of an Apple, in others like an Egg, and so they termed to be a Botch or Byle. In very short time, those infected parts were grown mortiferous. The disease would show itself by black or blue spots, which would appear on the arms of many, others on their thighs, and every part of the body. The Byle was an assured sign of near approaching death. All dyed within three days after the said signs were seen. Healthful persons speaking to the sick, coming to see them, or airing

clothes in kindness to comfort them, contracted the disease. Touching garments, or any food whereon the sick person fed, or anything else used in his service, seemed to transfer the disease from the sick to the sound. The quality of this contagious pestilence was not only of catching it one of another, either men or women, but it extended further, even in the apparent view of many, that the clothes, or anything else, wherein one died of that disease, being touched, or lain on by any beast, far from the kind or quality of man, they did not only contaminate and infect the said beast, were it Dog, Cat, or any other; but also it died very soon after.

Giovanni BoccaccioArtifact 3. Found outside an Event in Hong Kong

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Prevention and Management of respiratory tract infections in athletes

By Ola RonsenIntroduction    Athletes performing at high levels in their sports are most often members of a select group of people who are able to withstand the stress imposed by strenuous training and competition schedules without major illness or prolonged periods of fatigue (GLEESON, 2000; NIEMAN, 2000; RONSEN et aI., 2001). Nevertheless several studies suggest that athletes are at increased risk of respiratory tract infections (RTI) (GLEESON, 2000; NIEMAN et aI., 1989; NIEMAN et aI., 1990; PETERS, 1997). Exercise-induced suppression of certain immune functions during periods of strenuous training, increased exposure to foreign pathogens (microbes) while travelling and sharing the same training and living facilities with a team may contribute to this increased frequency or duration of RTI (GLEESON, 2000). Obviously, some sort of microbe (virus, bacteria, fungus, etc.) must be transmitted to the body at a certain point and have the ability to invade the respiratory tract for an RTI to occur. However, several environmental and physiological circumstances, such as heat and cold exposure, psychological stress, nutritional status and training load, are known to modulate the body's response to such pathogens and thus increase or decrease the course of the infection (PEDERSEN et aI., 1994).    A recent survey among 74 Norwegian athletes participating in the 2002 Olympic Winter Games and the 2004 Olympic Summer Games showed that more than 90% of the athletes reported one or more infectious episodes during the previous year (data to be presented at ISEI Congress in 2005). Respiratory tract infections and gastroenteritis were the most common diseases reported and the duration of symptoms was mostly inside one week. However, since many suffered several infectious episodes through the year, the average number of lost training days was 15 per year. Frequent absence from vital training sessions is highly undesirable for both athletes and coaches and will most likely have a negative impact on the performance level during parts of the season. The study also showed that on average one important competition per year was lost due to illness. Finally, there was a large degree of variability in the frequency and duration of infectious diseases reported by the athletes, with some never being sick while others missed more than 30 days per year of scheduled training due to illness. This, of course, highlights the need for preventive measures among the most illness susceptible athletes.    Prevention is always preferable and superior to treatment, even the best sports medicine based treatment. Therefore, all means and methods to avoid unnecessary and unprotected exposure to microbes should be practiced in athletic settings in order to avoid loss of training and competitions due to episodes of infection (RONSEN, 2003). Consequently, athletes and coaches need to be educated and guided with regard to important preventive measures for avoiding infectious diseases.    However, all contact with unknown sources of microbes is unavoidable in the normal life style of an athlete. This makes the correct management of infectious illnesses of paramount importance in order to limit the negative consequences of the infection. Management of RTI from a physician's standpoint should always be based on a thorough medical history, an evaluation of clinical signs and symptoms, a skilled

physical examination and a specific microbial diagnosis.  Athlete-based prevention and management of RTI    There is no single method or measure that completely eliminates the risk of contracting a RTI, but there are several effective ways of reducing the number of infectious episodes incurred over a period. Some of these measures are scientifically founded while others are supported mostly by clinical and personal experience. In essence, it is all about avoiding transmission of microbes from one person to another! It is important to underline that virus and bacteria causing RTI may be both received by and passed on from the same individual. This means that one should pay as much attention to preventing transmission of potentially contagious material from oneself to others as the opposite way, from others to oneself. Therefore, the "golden rule" of practising the same standard of hygiene when you are in contact with others as you expect others to practice towards you, should be the general objective of RTI prevention. A list of the most common preventive measures and practical guidelines against RTI infections, but also against any contagious disease, is given in Table 2.

     Even if one meticulously practices all the important preventive measures that athletes, coaches and medical support staff can put up against respiratory tract infections, it is everybody's experience that RTI, nevertheless, takes its toll, both on individual athletes and in teams. Therefore, it is crucial that all episodes of RTI, including the initial symptomatic phase are well managed and that the spread of microbes between members of a team or family is limited. For athletes on a training schedule, the obvious question when initial symptoms of RTI appears is about continuing, decreasing or stopping their regular exercise.   

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'Diagnosis: Dead Or Alive': Man Discovers Live Parasites Burrowing In His Chest Cavityhttp://www.huffingtonpost.com/2012/07/17/diagnosis-dead-or-alive-parasites-in-chest-cavity-video_n_1678853.html?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+HP%2FEntertainment+(Entertainment+on+The+Huffington+Post)

July 17, 2012

The most recent episode of "Diagnosis: Dead or Alive" (Mon., 10 p.m. ET on Discovery Fit & Health) profiled a man named Kurt's mysterious medical ailment. He had been suffering from strange lumps on his body and was coughing up blood. His lungs were filling with blood, and he was in danger of losing his life. Doctors were initially stumped as to what could be causing his symptoms.

His doctor ultimately discovered something he hadn't seen in 30 years of practicing medicine: Kurt had live parasites infecting his chest cavity. The lumps were the result of burrowing. The parasite is usually seen only in Southeast Asia, leading Kurt to suspect it may have come from imported crab at a sushi restaurant.

Luckily, doctors were able to treat him and eliminate the parasites through medication and Kurt lived to tell his harrowing story.

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You might have heard news reports about mad cow disease and wondered: What the heck is that? Mad cow disease is an illness also known as bovine spongiform encephalopathy (say: bo-vine spun-jih-form en-seh-fah-la-puh-thee), or BSE for short.

It's called mad cow disease because it affects a cow's nervous system, causing a cow to act strangely and lose control of its ability to do normal things, such as walk. An infected cow would act "mad," which sometimes means mentally ill.

A cow with BSE develops these problems because it has developed an infection. This infection causes its brain to waste away and become spongy. Researchers are not completely sure how cows get this kind of infection, but they believe it comes from certain kinds of food given to cows. Some of this food contains the remains of dead cows that had the infection. These remains, especially the brains and spinal cords, may contain BSE.Because BSE was a problem in the United Kingdom, the United States enacted rules to prevent live cows and some cow products from entering this country. The United States has had two cases of BSE in cows — one in 2003 and one in 2005. In both cases, the government took steps so that people wouldn't buy and eat the meat.

What Does This Have to Do With People?BSE is a concern because it can be transmitted to people if they eat meat that came from a cow with BSE. If a person eats BSE-infected beef, the person is at a higher risk for getting a human form of the disease, called Creutzfeldt-Jakob disease, or CJD. It is a very serious disease that affects the brain, but CJD is very rare in the United States. Only 1 in a million people get it. And it is not contagious, meaning a person can't catch it from someone who has it. Likewise, a cow that has BSE can't infect other cows.The discovery of the BSE cases in the United States increases concern about the human form of the disease, but it's still very unlikely that you or anyone you know will get the disease.

What's Being Done About BSE?Many people in the United States are working to prevent BSE-contaminated beef from getting to stores. There are rules against beef processors using the brains or spinal cords of the animal to make food products. In addition, there is a testing system in place designed to identify cows that may have the disease. There's also a recall system that allows companies to notify consumers and pull products off store shelves if there could be a problem with them.

What Should I Do?If you're worried about mad cow disease, tell the person who buys the food in your household about how you feel. Some cuts of meat carry less risk of transmitting the disease than ground beef, which is used to make hamburgers.Being a kid, you might be wondering about milk. Even though it comes from cows, BSE cannot be transmitted through milk or milk products.

~www.kidshealth.org

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DrugFacts: HIV/AIDS and Drug Abuse: Intertwined Epidemics Revised May 2012, provided b y www.drugabuse.gov , The National Institute on Drug Abuse, partial article

Drug abuse and addiction have been inextricably linked with HIV/AIDS since the beginning of the epidemic. The link has to do with heightened risk—both of contracting and transmitting HIV and of worsening its consequences.

No vaccine yet exists to protect a person from getting HIV, and there is no cure. However, HIV can be prevented and its transmission curtailed. Drug abuse treatment fosters both of these goals. HIV medications also help prevent HIV transmission and the progression of HIV to AIDS, greatly prolonging lives.

What Exactly Is HIV/AIDS?HIV stands for human immunodeficiency virus. This virus severely damages the immune system and causes acquired immune deficiency syndrome, or AIDS, a condition that defeats the body’s ability to protect itself against disease.HIV inflicts this damage by infecting immune cells in our bodies called CD4 positive (CD4+) T cells—essential for fighting infections. HIV converts the CD4+ T cells into “factories” that produce more of the HIV virus to infect other healthy cells, eventually destroying the CD4+ T cells.

How Is HIV Spread?HIV is transmitted by contact with the blood or other body fluids of an infected

person. This can occur during unprotected sex or through sharing injecting drug-use equipment. In addition, untreated infected women can pass HIV to their

infants during pregnancy, delivery, and breastfeeding.

How Do Drugs Affect HIV?Most people know that intravenous drug use and needle-sharing can transmit HIV; less known is the role that drug abuse in general plays. A person under the influence of certain drugs is more likely to engage in risky behaviors such as having unsafe sex with an infected partner. Indeed, the most common (but not only) way of contracting HIV is through unsafe sex. This includes “transactional” sex—trading sex for drugs or money.Drug abuse and addiction can also worsen HIV symptoms, causing greater neuronal injury and cognitive impairment, for example.

Because of the strong link between drug abuse and the spread of HIV, drug abuse treatment can be an effective way to prevent the latter. People in drug abuse treatment, which often includes HIV risk reduction counseling, stop or reduce their drug use and related risk behaviors, including risky injection practices and unsafe sex.

HIV infection is also disproportionately represented in the African American community. Over one-half of all newly diagnosed cases in the United States are in African Americans, followed by the White and Hispanic populations.

How Is HIV Treated?From the beginning of the HIV/AIDS epidemic in the early 1980s until the mid-1990s, HIV infection was almost guaranteed to result in death from AIDS. The number of deaths declined after 1996, when effective treatments were introduced.

With the Advent of HAART, More People Are Living with HIV Infection as Rates of AIDS-Related Deaths Decline HAART—highly active antiretroviral therapy—is a customized combination of different classes of medications that a physician prescribes to treat HIV. Although it cannot rid the body of the virus, HAART can control the amount of virus in the bloodstream (viral load), helping to delay the onset of symptoms and progression to AIDS, prolonging survival in people with HIV.

Why Is HIV Testing So Important?A person infected with HIV may look and feel fine for many years and may not even be aware of the infection. In fact, the Centers for Disease Control and Prevention estimates that 1.2 million people are infected with HIV in the United States and that one in five people infected are unaware of it. HIV testing is critical and can help prevent spread of the infection—among those most at risk (e.g., people who abuse drugs) and in general. Getting tested is not complicated. Some tests can even provide results in 20 minutes, although testing is not accurate until about 6–8 weeks after exposure to HIV. That time is needed for HIV antibodies to form in amounts detectable by a standard HIV test.Research shows that seeking out and testing high-risk populations and starting treatment for those who test positive prevents HIV transmission by decreasing viral load, infectivity (the ability to infect others), and subsequent illness—to the benefit of all.

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Water-borne diseases cause alarm in RajkotTNN Jul 23, 2002, 10.23pm IST

RAJKOT: High incidence dysentery and related complaints - 150 cases in ten days - has alarmed civic health officials.

Before July 10 daily four or five cases were reported. It was deemed normal. But the spurt in such cases after July 10 has made authorities to sit up.

The highest number of cases, 23, was reported on July 16. These cases were reported at municipal dispensaries, but authorities had no idea of the cases registered at private clinics.

Another cause for concern was that the cases occurred in almost all wards. Officials have asked the people to use boiled water.

The civic body has been supplying unfiltered water released from the Mahi project as the city gets more than its quota and much beyond the capacity of the filter plant. Many parts got dirty water which could have led to cases of dysentery. From January 116 cases of dysentery were recorded in the city.

Meanwhile, the civic body issued notices to five organisers of the mid-day meal scheme for supplying sub-standard food to children in the primary schools managed by the civic body.

Primary school committee vice-chairman Labhubhai Ahir had in a surprise visit to school number 62 found that the food quality was substandard. The services of a cook and four organisers have been discontinued.

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Drug-resistant TB spreading through Russian prisons

June 24, 1999

From Correspondent Steve Harrigan

MOSCOW CNN Russian medical officials said Thursday that a new strain of tuberculosis is turning a stay in a Russian jail into a death sentence for many people.

More than a million people are being held in Russian jails for a year, the time it typically takes for a trial. One in 10 has tuberculosis.

Russian doctors said partial treatment has allowed a new superstrain of drug-resistant tuberculosis to develop, and one-third of the infected prisoners have contracted that strain.

Health officials also warn that those who are infected could spread the drug-resistant tuberculosis worldwide.

Sixty-six percent will die. The problem is, before they die they will again contaminate, spread this disease to the other inmates, to the guards, to the medical personnel, said one doctor. Up to the year 2010, we can expect at least 2 million people here on the streets of Russia can carry this deadly superstrain, uncurable strain nearly.

To treat ordinary tuberculosis costs about 60. To treat a case of drug-resistant TB costs 250,000, money Russia doesn’t have.

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~Excerpt from The American Red Cross Biomedical Services Handbook

Protecting the Safety of Donors and Patients

Without the generosity of donors, who roll up their sleeves to give blood, the Red Cross could not support the many patients, families, hospitals and communities that rely on it in times of need. That is why the Red Cross is dedicated to providing a safe environment for those who give blood and a safe product for those who receive blood.

From the moment a potential blood donor walks into a Red Cross blood donation center, until the blood is shipped to hospitals and patients are monitored for adverse reactions, a sequence of steps are performed to ensure the safety of the blood donor and the patients who receive blood.

A comprehensive screening of the donor’s medical history is performed. A short physical exam is given. Blood is tested in one of five state-of-the-art Red Cross national testing labs. Blood is quarantined until results of tests are finalized. After distribution to hospitals, the Red Cross continually monitors and investigates any

reported adverse reactions.Many of these systems have overlapping effects or are redundant to provide layers of safety. All of these activities are managed under rigorous quality systems and are stringently regulated by the FDA.

Coordinating with the FDA to Improve Blood Safety

The Red Cross’ top priority is the safety of the blood it supplies. While the blood supply will never be without risk, the Red Cross is committed to making it as safe as it can possibly be.The Red Cross and other blood banks are working to minimize problems with blood products. While there is no data available to compare the overall success of individual blood banks, there is data to show that the Red Cross has a proportionately lower percentage of recall events when compared to the rest of the industry. A recall is where product that may not conform to safety standards is removed from the market.The Red Cross works continuously to improve blood safety by:

Creating a culture where everyone in the organization understands blood safety is the highest priority and reinforcing that with better training, increased supervision and accountability

Complying with Federal and State laws and regulations that set standards for operating blood banks, laboratories, and other facilities at which donors give blood, and where blood is prepared for distribution to hospitals and patients

Coordinating with the FDA, which regulates blood and the operations of blood banks, to achieve sustained compliance with an Amended Consent Decree which prescribes detailed standards for Red Cross operations

The Amended Consent Decree imposes stringent operating and reporting requirements on the Red Cross and financial penalties for non-compliance with laws, FDA regulations and Red Cross standard operating procedures.

To improve its performance in accordance with the applicable law and the Decree, the Red Cross has implemented system-wide changes to its operations. Three keys to this effort are:1. Biomedical Services Compliance Plan – a comprehensive plan with specific action steps to help achieve sustained compliance2. Standardization – a vigorous effort to help ensure Red Cross blood services operate in the same way in every location3. Technology and Process improvements – introduction of new technologies and systems to reduce the potential for human errorMeasurable Progress in Improving Blood SafetyAs a result of Red Cross efforts to continuously improve its blood services, the Red Cross has made great strides in improving our systems and processes, and there has been a steady and dramatic decrease in overall problems associated with blood collection since 2006.

Because of these renewed efforts, between July 2006 and March 2010 the Red Cross has demonstrated the following improvements:

47% reduction in overall problems 70% reduction in laboratory testing issues 52% reduction in recalls 63% reduction in storage, shipping and return issues 79% reduction in blood collection time and documentation issues

Artifact 16.New lab security report may signal need for pause

By LARRY MARGASAK Associated Press Writer

Oct. 16, 2008, 8:05PM

WASHINGTON — Another frightening new government report is heightening fears about the safety of U.S. biodefense laboratories that study some of the world's deadliest germs. The latest worry: Intruders could easily break into two of the labs due to lax security.

Now some lawmakers and members of a new citizen coalition are asking whether it's time for a timeout in the expansion of the Bush administration's biowarfare defense program.

The Bush administration decided after the Sept. 11, 2001, attacks that the nation needed to develop cures, drug treatments, vaccines and diagnostic tests to combat germs that could be used in a terrorist attack or accidentally released.

And, while U.S. officials say there are no known incidents where outsiders attacked anyone with germs from a U.S. lab, the FBI concluded last summer that a microbiologist at the Army's lab in Fort Detrick, Md., was responsible for anthrax attacks in 2001.

Two House lawmakers and members of a new citizen coalition — people "living in the shadow" of these labs — say the defensive biowarfare program has expanded too fast since Sept. 11, 2001. Security measures have not caught up, they said.

The latest government study, initially obtained by The Associated Press and released publicly Thursday, found that intruders could easily break into two laboratories handling organisms that could cause illnesses with no cure.

The AP identified the vulnerable lab locations as Atlanta and San Antonio. The Government Accountability Office did not identify the labs except to say they were classified as Biosafety Level 4 facilities — requiring the highest level of security. But the report included enough details for the AP — and others knowledgeable about such labs — to determine their locations.

In Texas, the Southwest Foundation for Biomedical Research features an outside window that looks directly into the room where the deadly germs are handled. The lab, which is privately run, also lacks sufficient security cameras, intrusion detection alarms or visible armed guards at its public entrances. Officials there said they will tighten security.

How many other research facilities in the U.S. have BSL-3 or BSL-4 laboratories?

Most facilities in the United States with infectious disease research programs have BSL-3 laboratories. In addition, many hospitals have areas that can be operated at this level; these areas are used for isolating patients with highly contagious diseases.

BSL-4 labs have the most stringent safety and security requirements. There are currently only four operational BSL-4 laboratory suites in the United States: at the Centers for Disease Control and Prevention in Atlanta, GA; at the United States Army Medical Research Institute for Infectious Diseases at Fort Detrick in Frederick, MD; at the Southwest Foundation for Biomedical Research in San Antonio; and at the University of Texas at Galveston.

A small BSL-4 facility exists on the NIH campus in Bethesda, MD, but it is currently being operated only at a BSL-3 level for research on important emerging infectious diseases. There is also a small BSL-4 glovebox capability at Georgia State University in Atlanta, GA.

Cowboy BSL-4 in Texas Thumbs its Nose at the NIH Guidelines and the NIH Office of Biotechnology Activities

The Southwest Foundation for Biomedical Research (SFBR) in San Antonio, Texas (http://www.sfbr.org) has BSL-4 containment, thousands of primates, and some of the world's most dangerous viruses, such as Ebola and Lassa (1). Founded in 1941 by a Yale-educated oil tycoon whose other scientific endeavors included a search for the Abominable Snowman (a.k.a. Bigfoot) (2), SFBR is something of a receptacle for biomedical research that can't find a place at other institutions, especially those more squarely in the public eye. This is especially true of SFBR's relationship with the University of Texas System.

SFBR does dirty work for other labs, including dangerous experiments challenging animals with anthrax spores (3) and controversial projects such as sequencing indigenous peoples' DNA (4), testing their medicinal plants (5), and making genetically engineered monkeys (6).

If SFBR's official agenda wasn't controversial enough, it also conducts secret government biological projects that the public will never learn about. SFBR's biolabs are ringed with razor wire and have government clearance for classified research. "Many of the staff possess security clearances and have considerable experience in classified research and collaborations with national defense agencies." wrote its President in 2002 (7). SFBR also wants the Department of Homeland Security's proposed National Bio and Agro-Defense Facility (NBAF), a gigantic new 30 acre (12 ha) biodefense BSL-4 complex.

SFBR employs 400 and receives millions of dollars in federal biomedical grants every year, including participation in a National Institutes of Health (NIH) biodefense "Center of Excellence". It keeps the Bigfoot tradition alive with over 6,000 penned chimpanzees, baboons, macaques, and other primates, who alone receive about $6 million in NIH funding each year for their upkeep.

Despite its BSL-4 lab and extensive research involving biological weapons agents, SFBR refuses to comply with the NIH Guidelines on Research Involving Recombinant DNA Molecules, the allegedly obligatory federal system that requires the establishment and operation of Institutional Biosafety Committees (IBC) to ensure the safety of biotechnology research. In fact, SFBR cannot - or will not - produce any real evidence

that its IBC exists and fulfills its obligations.

BSL-4 Laboratories

Eyeball

Center for Disease Control and Prevention, Atlanta, GA

CDC Building 18, the Emerging Infectious Diseases Laboratory, is the premier biocontainment facility of its kind in the world today. Located on CDC’s Roybal Campus in Atlanta, GA, this 440,000 sf facility is the flagship facility for the HHS in their mission to protect all Americans from infectious disease.

Building 18 incorporates BSL-4/3Ag/3/2 laboratories and animal facilities, including specialized research in Q-fever, avian influenza and other high consequence agents. The laboratories directly support the CDC Bioterrorism Program, Division of Viral and Rickettsial Diseases, Special Pathogens Branch, Division of AIDS, STD and TB Laboratory Research, and the Division of Bacterial and Mycotic Diseases. The building also successfully balances ample office and amenity spaces with cutting edge laboratories to provide much-needed relief from the intensity of such research.

In addition, Building 18 contains forensic quality specimen receiving and analysis laboratories for CDC’s Bioterrorism Response and Preparedness program, which along with USAMRIID are the nation’s two Level D components of the laboratory response network. The laboratories are appropriate for drug efficacy studies, and the animal facilities are designed to AAALAC standards.

US Army Medical Research Institute for Infectious Diseases, Fort Detrick, MD

Southwest Foundation for Biomedical Research, San

Antonio, TX

Biosafety Level-4 Laboratory

A special advantage in their life-saving quest of the Department of Virology and Immunology’s state-of-the-art facilities include the nation’s only privately owned biosafety level four (BSL-4) maximum containment laboratory. This facility – which has proven especially beneficial in support of the nation’s biodefense efforts – allows Foundation scientists to safely study lethal pathogens for which there currently is no known treatment or cure.

The BSL-4 full-suit lab has been certified by the Centers for Disease Control (CDC) and the U.S. Department of Agriculture (USDA) for work on human and animal pathogens. Access to the BSL-4 area is controlled. The lab satisfies safety and security requirements for numerous federal organizations. The laboratory contains Class IIB Biological Safety hoods, low-, high- and ultra-speed centrifuges equipped with both analytical and preparative scale rotors, low-speed centrifuges and microfuges, 4C refrigerators, -20C and -80C freezers.

Centre for Biodefense and Emerging Infectious Diseases BSL-4, University of Texas Medical Branch, Galveston, TX

\Galveston National Laboratory

Robert E. Shope, M.D. BSL4 Laboratory

John Sealy Pavilion for Infectious Diseases Research

The 2,140-square-foot UTMB BSL4 laboratory is devoted to the study of tropical and emerging infections and additionally will serve as a key component in the nation’s fight against bioterrorism. The maximum containment design for the facility includes approximately 10,000 additional square feet devoted to housing equipment to be used to sterilize and decontaminate all material leaving the lab, thus permitting scientists to safely study some of the most dangerous organisms on the planet. The plans for UTMB's BSL4 were approved in 2000. Construction was completed in 2003 and the facility was commissioned in 2004.

National Institute of Health Campus, Bethesda, MD

NIH Campus Building 10

NIH Campus Building 50

Georgia State University, Atlanta, GA

The Biology Department at Georgia State University is housed in three buildings:

* Kell Hall* The Natural Science Center* The Science Annex

Viral Immunology Center

The Viral Immunology Core (VIC) consists of four components centered around the needs and research interests of Georgia Research Alliance Eminent Scholar Dr. Julia Hilliard: the BSL3/BSL4 glove-box facility, the clinical diagnostic test laboratory, research and development laboratories, and the business office.

BSL3/BSL4: The glove-boxed facility allows Dr. Hilliard to carry out her Herpes B virus work as an NIH National Resource Center, and also supports her clinical diagnostic test operation. The BSL4 laboratory is one of only four in the country and the only one in a university setting. The facility is available to local skilled and experienced scientists to work within the biocontainment condition.

Clinical Diagnostic Laboratories: Consist of a combination of a highly sophisticated serological laboratory and an immunological laboratory that, together, perform more than 15,000 clinical tests a year. Research and Development Laboratory: Explores new frontiers and improves current techniques in the field of virology and vaccine development. Business Office: Manages facility user fees for the laboratories.

The major activities of the VIC include:

* Elucidation of host-virus interactions during alpha herpesvirus pathogenesis;

* Development of improved serological and virological test systems for the rapid detection of Herpes B virus (Herpesvirus simiae) and other simian herpesviruses;

* Maintenance of a diagnostic resource laboratory for worldwide use in emergency cases of zoonotic transmission of Herpes B virus infections in humans;

* Maintenance of a diagnostic resource laboratory for the detection of Herpes B virus infections in macaques to support the development of NIH-supported specific pathogen-free captive macaque colonies;

* Development of new anti-viral vaccine and drug therapies for prevention and treatment of zoonotic agents.

* High-throughput diagnostics using state-of-the-art robotic automation equipment from Beckman-Coulter.

A biosafety level is the level of the bio containment precautions required to isolate dangerous biological agents in an enclosed facility. The levels of containment range from the lowest biosafety level 1 (BSL-1) to the highest at level 4 (BSL-4). In the United States, the Centers for Disease Control and Prevention (CDC) have specified these levels. In the European Union, the same biosafety levels are defined in a directive.

Biosafety Level 4Biosafety Level 4 is required for work with dangerous and exotic agents that pose a high individual risk of aerosol-transmitted laboratory infections and life-threatening disease that is frequently fatal, for which there are no vaccines or treatments, or a related agent with unknown risk of transmission. Agents with a close or identical antigenic relationship to agents requiring BSL-4 containment must be handled at this level until sufficient data are obtained either to confirm continued work at this level, or re-designate the level. Laboratory staff must have specific and thorough training in handling extremely hazardous infectious agents. Laboratory staff must understand the primary and secondary containment functions of standard and special practices, containment equipment, and laboratory design characteristics.All laboratory staff and supervisors must be competent in handling agents and procedures requiring BSL-4 containment. The laboratory supervisor in accordance with institutional policies controls access to the laboratory.

There are two models for BSL-4 laboratories:1. A Cabinet Laboratory—Manipulation of agents must be performed in aClass III BSC; and2. A Suit Laboratory—Personnel must wear a positive pressure suppliedair protective suit.BSL-4 cabinet and suit laboratories have special engineering and designfeatures to prevent microorganisms from being disseminated into the environment.