Archive for the 'Laboratory Systems and Standards' category

What Exactly Does the Shutdown Mean for Public Health?

As we face day three of the federal government shutdown, we are hearing more about the deeply felt impact on our federal partners.  While we can be grateful that local and state public health agencies are still hard at work, the federal portion of the continuum is minimally staffed and operating a bare-minimum of essential programs that ensure the public’s health and safety.  Below are some of the negative effects we are hearing from the Centers for Disease Control and Prevention (CDC), the United States Department of Agriculture (USDA), the Food and Drug Administration (FDA), and the Department of Health and Human Services (HHS).

What Exactly Does the Shutdown Mean for Public Health? | www.aphlblog.org

Reference Testing Services Will be Delayed or Absent

CDC provides highly specialized reference testing for rare pathogens and for rare instances of drug resistance. Although CDC will maintain many of these services, the number of staff performing these tests will be greatly reduced. The result will be a delay in delivery of potentially lifesaving test results.

For example, the Division of Tuberculosis Elimination performs sequencing to detect mutations associated with drug resistance to rapidly identify persons with drug resistant TB.  It is the only laboratory in the country that is currently utilizes this method (which provides a high level of detail) for public health investigations.  Delayed results will lead to delays in delivering optimal treatment to patients and mounting an appropriate public health response.

National Disease Surveillance Will Be Weakened

CDC collects data on infectious diseases from all 50 states, local jurisdictions and territories.  The compiled data tracks how diseases are spreading and helps scientists to identify multi-state outbreaks.  One of the best examples of this function is influenza surveillance.  Flu season is upon us; CDC monitors the flu virus strains that are circulating nationally, keeps track of any resistance to drugs, and determines how well this season’s flu shot will work against circulating strains, and sends national alerts to public health professionals when things look out of the ordinary.  It shares the data generated from this activity with state and local health departments, providing them with a “big picture” view of flu activity across the country. Armed with this information, they can prepare effectively for potential outbreaks in their area. But a prolonged government shutdown will reduce the clarity of the big picture view, since less data will be collected.

CDC Support of Local Outbreak Response will be Limited

CDC services like advanced testing and consultation to state and local public health programs facing cases or outbreaks of relatively rare diseases. Because these diseases are so rare, many jurisdictions rely heavily on subject matter expertise at CDC for advice and information when responding. Although CDC’s skeleton crew of staff will do its best to assist, state and local public health departments will be largely on their own when it comes to responding to outbreaks of relatively rare diseases like measles or mumps.

Food Safety Will be Negatively Impacted – More People Could Get Sick

  • If you and others who ate the same food become ill from certain types of foodborne bacteria, you may never know the cause of your illness, as CDC will not be analyzing all of the data submitted, and FDA and USDA will not be following up on those leads to track the source of the illness.  These are necessary steps to ensuring fewer people get sick.
  • CDC will delay assessing the proficiency of state and local laboratories that participate in PulseNet.  This bi-annual assessment may be pushed back for several weeks, even if the shutdown only lasts several days.
  • State and local scientists who want to begin submitting DNA fingerprints to PulseNet will not be allowed to, as CDC certification of new PulseNet participants will be on hold.
  • In normal operating status, state and local food regulators do not have enough resources to properly inspect all retail food establishments and restaurants.  With federal inspection personnel on furlough, even fewer establishments will be inspected to make sure that they are following the regulations.
  • CDC’s IT staff have been furloughed. PulseNet IT staff are not present to aid public health laboratories if they are unable to connect or submit data to the national databases. If the system fails, national outbreak detection could come to a halt. If communication list-serves fail, there are few remaining staff with the know-how to repair these critical national communication tools.

Select Agent Program Has a Delayed Response

Due to the absence of either an FY 2014 appropriation or a Continuing Resolution for HHS and USDA, the Federal Select Agent Program, which oversees the possession, use and transfer of biological select agents and toxins that have the potential to pose a severe threat to public, animal or plant health or to animal or plant products, is not fully staffed and thus unable to provide timely regulatory compliance support to state and local entities. These regulatory gaps could have serious implications for safety and security.

Laboratory Response Network Anticipates Delays

Because the CDC is operating with minimal staff throughout, the Laboratory Response Network, which is the nation’s premier system for responding to potential bioterrorism, chemical terrorism and other public health emergencies, is down to just a few staff with anticipated delays in responding to requests for assistance from state and local public health laboratories and no support for daily reagent shipments.

The larger impact is the lack of federal support for state and local public health. While these state and local agencies continue to conduct routine surveillance and monitor the nation’s health, they rely on their federal counterparts to provide the big picture of disease spread, potential releases of biological threats as well as scientific guidance and methodologies to detect novel threats, like the MERS-coronavirus.

Newborn Screening Laboratory Quality Assessment Delayed

Closing CDC has delayed the fourth quarter assessment of newborn screening laboratory quality. If the delay is extended, then these laboratories will not be able to rely on the assistance of CDC to maintain their compliance with Clinical Laboratory Improvement Amendments, the federal law known as CLIA. Newborn screening depends upon high complexity laboratory operations that are governed by the requirements of CLIA, which include an independent external review to provide quality assurance – and is provided by CDC in the case of newborn screening.

The shutdown will force newborn screening laboratories to seek out non-traditional sources for external review, establish a working relationship with them – possibly at some expense, and pursue activities to meet the CLIA quality assurance requirements. This will not only be inefficient, cumbersome and potentially costly, it will also result in a greater degree of uncertainty because it has never been done.

As CDC’s website details, “The Newborn Screening and Molecular Biology Branch, Division of Laboratory Sciences, operates the Newborn Screening Quality Assurance Program (NSQAP). NSQAP is a voluntary, non-regulatory program to help state health departments and their laboratories maintain and enhance the quality of test results. The program is operated in partnership with APHL. The program provides services to more than 85 domestic newborn screening laboratories, 31 manufacturers of diagnostic products, and laboratories in 67 countries. NSQAP has been the only comprehensive source of essential quality assurance services for dried-blood spot testing for more than 33 years.”

The shutdown will add an unnecessary burden and additional complexity to one of the most successful public health programs in the United States.

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One World. One Health… and the Vector at Our Back Door

You don’t have to explain to public health laboratorians that the health of humans, animals and the environment are inextricably linked. HIV/AIDS, SARS, 2009 H1N1, West Nile Virus: laboratorians know the inner workings of these enterprising pathogens that travel (from jungle, field or suburban neighborhood, etc.) to animal hosts (chimpanzees, bats, birds, field mice, etc.) and on to us.

One World One HealthAnd they know that more of these smart bugs are coming our way. Population growth, climate change, deforestation, diminishing species diversity and changes in land use are all interfering with established patterns of interaction among people, animals and the environment. Vectors that were once in a distant forest are now at our back door. Already the majority of emerging infectious diseases affecting humans (approximately 75%) are of animal origin.

This dynamic has broad implications for public health as well as human medicine, veterinary medicine and environmental science. In a world where the interface between animals, humans and the environmental is in flux, it’s perilous for health and science professionals of any stripe to operate in professional silos. To protect the health of all species, those of us in public health must join with our colleagues in veterinary science, human medicine and environmental science to adopt a holistic approach to disease surveillance, detection and control. To put it simply, we must be about one health, not several.

At the 2012 APHL Annual Meeting, “one health” will be center stage. Participants will have the opportunity to meet leaders in the One Health movement – including James Hughes, MD; Lisa Conti, DVM, MPH; and Terry McElwain, DVM, PhD – and discuss actions required to operationalize One Health objectives. Here are a few questions to get you started with these discussions. How can we:

  • Expand and improve national and global surveillance networks, particularly those that capture the animal-human interface?
  • Enhance sentinel event coordination to detect and reduce environmental health threats?
  • Build efficient global reporting and sample submission systems to support surveillance systems?
  • Communicate the benefits of investment in surveillance? (Too often disease surveillance is viewed as an old-school public health function, one that’s not sexy enough to warrant sustained investment.)
  • More effectively employ animals as sentinels for human health—and humans as sentinels for animal disease risk?

For an introduction to the “one health” concept, see the websites of the One Health Initiative and CDC’s One Health Office.

And a parting thought: When was the last time you took your state veterinarian or your colleague in environmental science to lunch? It’s a small step, but remember: One Health is collaborative; you can split the check.

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Building and Sustaining an Efficient Laboratory through the Laboratory Efficiencies Initiative

Apr 26 2012 :: Published in Laboratory Systems and Standards

This week is National Medical Laboratory Professionals Week and National Environmental Laboratory Professionals Week.  APHL is honoring the many individuals working public health and environmental laboratories around the world.  Stay tuned for blog posts this week featuring the work of many of those unsung heroes working to protect the public’s health.
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By Sadira Daher, Senior Specialist, Quality Systems, APHL

State Public Health Laboratories have been facing serious financial cutbacks. Many laboratories have had to reduce staff by nearly 25%, affecting testing services. Lab directors are concerned about having difficulty maintaining services, which could potentially hinder the state’s outbreak investigation, emergency response, surveillance and public health prevention programs.

In response to these hardships, APHL and CDC developed the Laboratory Efficiencies Initiative (LEI). The goal of LEI is to help labs maintain their public health testing services despite decreased funding in an effort to build a sustainable public health laboratory system in the United States.

Public Health Laboratory, Richmond, VA

Through LEI, representatives from public health labs, APHL and CDC have met to begin implementing a framework for an efficient data gathering and reporting process; to identify models to improve purchasing of laboratory equipment and supplies; and to provide input on ideas on methods of improving the delivery of public health laboratory services.

Many laboratories already have processes in place to improve efficiencies. Some examples include participation in Lean activities and the creation of a group of laboratories as a consortium with neighboring states. The laboratories within the consortium stay in touch through scheduled periodic conference calls where they can exchange ideas and discuss processes and practices that have been working well.

The consortium has also been useful for education and training. The labs have set up training workshops together and have shared their programs with other states through a variety of modalities. They are keeping track of what is going on in their region through this increased communication.

The strengthening relationships between the labs have made it easier for them to share services as necessary. For example, when a lab had unexpected problems with some of its equipment, it could easily send specimens for testing to a neighboring state.

Another laboratory used Lean to identify inefficiencies in its receiving process for newborn screening specimens. The laboratory addressed the problems and was able to decrease turn-around time. On the first day of implementing the new process, a newborn screening sample arrived after what had previously been the cut-off time for processing, but because the new more efficient system was in place, it was processed.  The test returned an abnormal result which was able to be reported to the baby’s pediatrician a day earlier than if they had used their previous process.

An important part of the LEI is the sharing of experiences and lessons-learned with other public health laboratories.

 

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Kansas L-SIP Assessment Experience

Jun 28 2011 :: Published in Laboratory Systems and Standards

By Bertina Su, MPH, Specialist, Laboratory Systems & Standards, APHL

On May 17, Kansas became the 26th state to complete a Laboratory System Improvement Program (L-SIP) assessment and the second to use the updated L-SIP assessment tool. Approximately 60 representatives from different parts of the state public health laboratory system met for a one-day meeting to identify system strengths and find opportunities to partner with one another to address gaps.  

Laboratory Improvement Manager Dennis Dobson found that all the preparation for the event paid off, “The real joy comes on the morning of the meeting, because now things have all come together for the assessment. Seeing all the people arriving and the interactions that take place confirms that you are having success from the very beginning.”   

During the assessment, participants divided into three breakout groups, each addressing a different section of the assessment tool. They shared personal experiences and expertise, and evaluated system performance for each Essential Service. While it was valuable to capture the system ratings as a baseline measure, Dobson stressed the importance of, “the realization that we are part of network, parts of which we were unaware of, and that we have more strengths than we recognized before the day began. Networking is far more important than the score that is voted upon at the end of each Essential Service.”

Action items resulting from the discussion included development of a mission statement for the Kansas public health laboratory system and workforce issues. Based on the closing session and written evaluations, the assessment was received positively. This positive assessment extended to non-laboratory partners. A member of the highway patrol commented, “I wish that every state agency would do this.”

To learn more about how a state public health laboratory system can create a culture of improvement via L-SIP, please contact Tina Su at bertina.su@aphl.org.

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Confronting Measles — Part 2

By Travis Jobe, Senior Specialist, Laboratory Systems & Standards - Vaccine-Preventable Diseases, APHL

So where do the public health labs enter the story on measles?

One of the key components for identifying measles cases is laboratory diagnostics.  This can be especially important when immunized persons become sick with measles but don’t present with typical symptoms due to their partial immunity.  However, the limited number of assays available to public health laboratories for measles diagnostics limits their abilities to detect the disease.  Also, because a laboratory rarely gets a chance to run the test on real cases, it may be hard to be confident in any given assay’s performance.  The APHL Recovery Act-funded Vaccine-Preventable Diseases (VPD) project has attempted to confront the question of performance of measles serology assays by offering public health laboratories the opportunity to participate in a pilot proficiency testing-like exercise.  Anyone who hasn’t worked in a diagnostic laboratory probably doesn’t know what proficiency testing, or PT, is.  But, essentially, PT is a panel of positive and negative samples sent to a laboratory to test and see if they get the correct results.  PT is a vital part of the work that public health laboratories perform to assure that they are competent in the results they report – results that impact the treatment of people like you and me.

Thirty-five public health laboratories from 30 different states participated in this measles serology PT exercise.  As it turns out, the results did point out some variances in the assays public health laboratories use for measles serology testing.  It just goes to show that not all assays may work perfectly for laboratory diagnosis, which shouldn’t be news to anyone in the medical or public health field.  But as long as the laboratorians themselves know about and understand these limitations, the proper interpretation of laboratory results can be communicated to the epidemiologists and doctors who are confronting the measles cases – real patients – directly.  Travelers with measles continue to return to the US this year from Europe and other areas of the world with ongoing measles outbreaks.  The laboratories that participated in the PT exercise are already putting to use this increased knowledge of their assays’ performance as they are called upon to perform the testing for these cases.  This includes the public health laboratories of Minnesota, California, New York, Pennsylvania, Washington, Texas, Florida, New Mexico, and New Jersey – just to name a few of the states that have seen imported measles this year.

For the general public, not only does the public health response prevent further illness by limiting disease transmission, it also helps to save further expenses – real money.  In the US, the cost to society is estimated to be well over $100,000 per measles case!  This includes not just the cost of treating the sick patient but of protecting the public from further spread of disease.  This doesn’t even include the cost to businesses for parents’ time off to attend to sick children and other private-sector expenses.  Nor does it include the costs of raising and supporting individuals permanently injured by the disease.  By immunizing the population and responding quickly to imported measles cases, further costs – and potentially deadly or debilitating illness – can be prevented.  Laboratories are but one link in the chain of the public health response.  Confidence in the performance of laboratory assays is a key component of that link.

At the same time, not all public health laboratories can be expected to perform all tests for measles – or any other disease for that matter.  No laboratory has unlimited resources, and public health labs are faced with limitations coming from federal, state, and local budget constraints.  So, in the public health laboratory community, we need to work together to support each other where needed.  Of course, the US Centers for Diseases Control and Prevention (CDC) have historically provided the extra support and reference testing services that public health laboratories rely on.  But with current fiscal cutbacks, laboratories cannot always count on that to be the case.

To discuss these issues is more depth, with a specific focus on measles testing included, APHL’s VPD project hosted a meeting of experts in March to discuss various national laboratory capacity models that may help confront the challenges of VPD testing.  The meeting participants noted that currently many public health laboratories utilize a shared-services model for mutual support; but they also acknowledged the lack of sustainability of this type of model.  Having a national laboratory capacity model where each public health laboratory can maintain the baseline testing capability that they desire, while having the ability to access additional non-CDC reference services for complex testing and surge capacity, was seen by the meeting participants to be an acceptable, if not urgently needed, solution.  The existence of public health laboratory resource centers for this type of support for reference testing, additional PT programs, and subject matter expertise, are seen as universal needs for all types of VPD testing.  This type of collaborative national effort to confront existing VPD testing challenges can help public health laboratories support each other and maintain a level of preparedness that will allow them to be ready to respond to many emerging public health threats, such as importation of measles.

The World Health Organization has targeted measles for worldwide elimination.  For this disease to begin a comeback in the US due to a lack of relatively small investments would be an embarrassment and a national shame.  Elimination of measles is not a goal of just some poor countries overseas where the disease is still endemic.  We in the public health system in the US are all part of this effort as well, whether we realize it every day or not.  Now is not the time to be complacent by cutting back funding for prevention and control efforts, because to do otherwise would risk catastrophic situations and massive inputs of resources.  Of course, by resources, I mean money – money that state governments currently cannot afford to spend on preventable situations.

APHL and the VPD project are doing their part within their role to maintain vigilance against measles.  I hope that my efforts in this project help make our roles be successful.  Now, I don’t expect my grandmother from Arkansas, or the street vendors I encountered in Livingstone, Zambia, to understand all the work that I do calculating standard deviations for PT results, reviewing laboratory testing algorithms, or analyzing the factors of various laboratory capacity models for public health laboratory resource centers.  But I hope they do understand the value that these efforts have on society as a whole, helping to keep us all healthy – and happily ignorant of this devastating disease.

As I said, I have never seen a case of measles.  With the continued great efforts of all my colleagues in the public health field, I hope I never do.

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Confronting Measles — Part 1

By Travis Jobe, Senior Specialist, Laboratory Systems & Standards - Vaccine-Preventable Diseases, APHL

I have never seen a case of measles.  I would bet most Americans today haven’t.  Yet, ironically, it’s a disease those of us in the public health field work against every day.

I get the sense Americans tend to think of measles as a relatively minor disease that – before the era of immunizations – was just a regular, ordinary childhood right-of-passage; just like many in my generation experienced chickenpox.  Chickenpox may have sickened most kids in the US before immunizations began in the mid-1990s, but serious complications were rare – less than 1% of cases.  Measles is another story.  While it’s true that measles may have been a regular right-of-passage through childhood, ordinary it wasn’t.  Measles is a bad, nasty disease.  Over one-quarter of measles cases can have complications such as diarrhea or pneumonia, many of which require hospitalization.  Before vaccine was available in 1963, measles sickened millions and killed hundreds of children every year in this country alone.

For perspective, take a country like Zambia, in southern Africa, that struggles with funding and infrastructure to provide adequate public health services.  An outbreak of measles in that country just last year (2010) sickened thousands of children, with a fatality rate of anywhere between 1-4%, depending on the region and what report you may read.  That’s hundreds of deaths in one year in a country of under 14 million people in an area just slightly larger than Texas (which has nearly 25 million people by comparison).  It seems inconceivable that a disease like measles could ever cause such death in the US.  Plus, these numbers don’t even consider the numbers of children permanently injured by the virus, causing deafness, blindness, or other neurological damage.  But this is not much different than what was experienced in the US during the pre-immunization era.

I have a personal family story that can attest to this.  As a child in the 1920s, my grandmother traveled from California by train with her mother and siblings to the Ozarks of northwestern Arkansas to visit relatives.  She and her brother and sister contracted measles either on the train or from their cousins in Arkansas, barely surviving the next few weeks before making the trip back home to California.  The fear this disease struck in the minds of my ancestors is clear from their written recollections, and the fact that none died was a huge relief to them after their weeks of uncertainty.

Whereas diseases historically spread to distant geographic regions by boat, then train, today disease transport routes have been rapidly expanded by airplanes.  In fact, two years ago I visited Victoria Falls in Zambia – the town of Livingstone, to be precise – only a couple plane rides away (and roughly 30 hours) to return from there to the US.  It’s not improbable that a traveler – amidst Zambia’s outbreak – could have crossed paths with a measles infected person before flying hone.  Thousands of people do arrive in the US every day on plane rides from overseas.  One can easily be in some far off corner of the world where there is an outbreak of measles and be back in small town America in a matter of a couple days – before you would even know you were sick.  And the reality is: it happens all the time.  In fact, there were 13 imported cases of measles in the US in just the first 2 months of this year alone.  That’s about 2 people per week!

One of those measles cases was a woman traveling back from London who decided to stop for a few days in Washington, DC, where I live, while on her way back to New Mexico.  Turns out, as I heard on the radio one morning, she had stopped for lunch at the Potbelly sandwich shop in my neighborhood just a few days earlier on the weekend.  As you’d expect, the District of Columbia epidemiologists were asking anyone who may have been exposed to be aware of the signs and symptoms of measles illness.  Twenty minutes later, as I walked past that same Potbelly on my way to work, I thought about the hundreds of other people walking by: going to school, commuting to their government jobs downtown, heading to the airport.  Any one of them could have been exposed to measles over the weekend.  But the risk of anyone, including myself, getting ill was essentially zero.  Why?  Because we’re vaccinated and thereby immune.  And as the radio broadcast proves, the District of Columbia public health department is well-organized at actively trying to identify cases and stop any further disease transmission before an outbreak can even start.  Not outwardly apparent, but that’s our public health system at work.

So where do the labs come in?  Click here for Part 2 of this post.

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Notes from the President: Preventive Laboratory Services

By Dr. Patrick Luedtke, M.D., President, APHL, Director, Unified State Laboratories, Utah Department of Health

Notes from the President will be a regular series.

Currently public health laboratories focus on infectious disease. Recently an APHL member and fellow lab director asked me for my thoughts on branching out to testing related to chronic disease prevention. I have given a good deal of thought to how public health labs will or could fit into a new prevention-based health system, which seems to be bounding down the healthcare highway toward us at a high rate of speed. While I certainly have no solutions, I have no shortage of ideas and concerns.

It seems to me the roles of public health laboratories in a prevention-based health system could be made to fit into four broad categories:

1. Provision of test results

Public health laboratories could begin or continue providing a panel of prevention-based testing that perhaps focuses on CDC director Dr. Thomas Frieden’s “winnable battles.” Testing could include fasting blood sugars, lipid panels, and others. Some of APHL’s local laboratory members already perform this testing on a regular basis. For others, it seems to me adoption of this type of testing would be quite dependent on local/state politics.

2. Prevention-focused research

I envision public health laboratories could play a meaningful role in prevention-focused research.  For example, we are approaching 80 million American adults with hypertension, 95% of whom have no known cause for their high blood pressure.  Additionally, it is well known that high blood levels of calcium and potassium as well as low levels of sodium produce significant decreases in many with high blood pressure. That being said, very little is known about body-burden of select metals/chemicals at birth and the resulting development of hypertension.  The same could be said of other common diseases of public health import.  Therefore, given the public health laboratory’s role in newborn screening (NBS), it is not a stretch to imagine an expansion of the NBS panel to include heavy metals, other select chemicals, etc. with the aim of identifying “at-birth risks” for chronic disease development.

3. Regulatory systems

It seems to me that traditional public health laboratory roles of oversight in the clinical lab arena will likely not change substantially in the future. In fact, they may expand as point-of-care testing increases and direct access testing labs proliferate.

4. Health outcomes partnering

I believe public health laboratories have an opportunity to move from the old “program evaluation” and internal “quality improvement initiative” paradigms to become active members in systems that focus predominantly on the final impact an intervention has on patient outcome. This is an area that clinical medicine is rapidly moving into, and an area I feel that public health laboratories need to seriously study.

– The opinions expressed here represent those of the author and not APHL.

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Laboratory Systems & Standards: Building the Foundation for Quality Testing

Apr 21 2010 :: Published in Laboratory Systems and Standards

In honor of Laboratory Professional Week, APHL would like to highlight some of the activities that it conducts on behalf of members. The Laboratory Systems and Standards (LSS) program works with public health and laboratory partners to build the foundation for quality testing: comprehensive standards and integrated public health laboratory systems.

Vaccine-Preventable Disease Project

As the incidence of Vaccine-Preventable Diseases (VPD) decreases in the US, the capacity and capability of state and local public health laboratories to perform VPD testing has declined, becoming increasingly inconsistent. While some labs are quite proficient in VPD testing, others are eliminating testing altogether. However, timely and accurate diagnosis of VPDs is essential to identify and control outbreaks and to provide the information needed to improve vaccines and vaccination programs. To address gaps in testing capacity for VPDs, APHL was recently awarded funding through the American Recovery and Reinvestment Act of 2009 (ARRA) to provide training programs and quality improvement activities for VPD testing in public health laboratories. The association is partnering with CDC to develop and present these programs.

The first initiative is a series of teleconferences targeted to public health laboratorians. To date, CDC subject matter experts have presented new diagnostic testing methods for several VPDs, including Bordetella pertussis (whooping cough), Streptococcus pneumoniae, measles virus and mumps virus. The mumps educational teleconferences have been especially timely in light of the ongoing mumps outbreak in the northeastern United States. State public health lab staff are being trained in the new mumps assay developed at CDC. Access to this assay will enhance patient diagnosis and epidemiological investigations in participating states.

In response to a recent survey of public health labs’ training needs for VPDs, more trainings and quality improvement activities are planned, including hands-on workshops, proficiency testing exercises and assay comparison studies. By working together on these activities, APHL and CDC look forward to helping public health laboratories to improve their capability to quickly and accurately detect cases of VPDs.

Voluntary Accreditation Program

“Continuous quality improvement” is part of the laboratorian’s credo. Assays and equipment must meet precise quality standard before they can be utilized in the laboratory. Now APHL is developing voluntary standards specific to public health laboratories that will be used to assess the quality of the laboratory itself and specifically its operations and functions. These new standards will not supplant CLIA, but be used as a complement to the federal regulation.

The accreditation program will be voluntary, and will integrate standards from existing domestic and international sources as well as those outlined in the Core Functions of Public Health Laboratories.

Incorporation of the public health laboratory standards will be proposed to the Public Health Accreditation Board (PHAB) for incorporation into their accreditation process. Accreditation will signify that the laboratory has met agreed-upon standards of quality and that it ascribes to them as a measure of its services.

APHL is convening a Think Tank with PHAB at the end of April to discuss how the program should look, be structured, and what elements should be included in such a partnership. Information from the Think Tank will be shared with membership on the APHL web site and through reports in Lab Matters.

Laboratory System Improvement Program (L-SIP) Assessment

To make it easier for labs to find quality improvement and performance-related materials, APHL provides a one-stop-shop for resources to improve the quality of state public health laboratory systems. One of those tools is the Laboratory System Improvement Program (L-SIP) assessment tool. During an L-SIP assessment, representatives of the state public health laboratory system and partners convene to assess the performance of state public health laboratory system. This program provides a user-friendly process, including a performance assessment tool for assessing and establishing a baseline measure of performance.

Most recently, South Dakota has scheduled our Laboratory System Improvement Assessment for April 29th. We have closely followed the recommendations of the APHL L-SIP Assessment Tool User’s Guide, a document that walks the coordinators through the assessment preparation process and includes sample materials such as letters to participants and agendas. For this lab and the others who utilize the L-SIP assessment tool, they find that it offers a means for strengthening relationships with public health, clinical and other laboratories and partners that comprise the broader laboratory system, as well as a framework for continuous improvement of public health laboratory systems.

We are looking forward to convening our system partners later this month to discuss our state public health laboratory system and what we can do to improve it.

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Yet Another Multi-state Salmonella Outbreak Proves Need for PulseNet

Feb 17 2010 :: Published in Food Safety, Laboratory Systems and Standards

The latest large-scale foodborne disease outbreak—involving Salmonella-tainted Italian salami products—has sickened at least 225 people in 44 states and Washington, DC. More than 50 are suffering illness severe enough to require hospitalization.

Coming on the heels of several high-profile, multi-state outbreaks involving everything from spinach to peanut butter, the latest incident raises questions about the safety of the food supply.

A quick review of the current outbreak reveals several trends.

1) The outbreak involves a collection of food items: about two dozen different ready-to-eat salami products. (Recall that a 2008-2009 Salmonella outbreak was linked to more than 400 different peanut-butter-containing foods).

2) The volume of products recalled is immense: more than 1.25 million pounds of meat.

3) The suspected source of the bacterium is an imported food item: the black pepper used to flavor the salami products.

In short, the food chain has become increasing convoluted and global in nature. Foods travel farther distances to reach consumers, and one product may contain ingredients sourced from several distinct producers (who may be based in the US or abroad, potentially in countries with more lax food safety regulations than the US). All of these factors increase the risk for contamination.

While APHL has no formal role in preventing food contamination, the association has played a pivotal role in detecting it so fewer people suffer illness. Laboratory-based surveillance—using the APHL/CDC PulseNet system—enables outbreaks to be identified much more swiftly than would otherwise be the case (including the ongoing salami-related outbreak), and undoubtedly detects small outbreaks that would otherwise go unnoticed. In the absence of more stringent food-safety regulations, PulseNet offers some assurance that tainted food products will be brought to the attention of state and federal authorities. In fact, the PulseNet system has proven so effective that there has been great interest in expanding it internationally.

APHL has also provided substantive input into the Guidelines for Foodborne Disease Outbreak Response recently released by the Council to Improve Foodborne Outbreak Response. These guidelines are important because they provide a model and benchmarks for the kind of multi-disciplinary and multi-agency collaboration essential to contain an outbreak. The recent Salmonella outbreak, for example, involves ingredients regulated by two different federal agencies: the USDA, which regulates meat, and the FDA, which regulates pepper.

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APHL Working to Ensure Power for Laboratory Services in Haiti

When the electrical grid comes back on-line in Haiti, the country’s laboratory system will be able to ramp up services quickly thanks to measures put in place before the magnitude 7.0 temblor January 12.

Even before the devastating earthquake, electrical power in Haiti was unreliable, with routine outages and serious voltage and frequency variations that compromised laboratory testing. Outages can lead to the loss of valuable testing reagents that must be stored at controlled temperatures, while “dirty power” is damaging to a wide range of laboratory equipment, including instruments used for diagnostic testing to support antiretroviral treatment for HIV-infected patients.

With funding from CDC’s Global AIDS Program and funding and technical assistance from the US Agency for International Development, APHL invested in site-specific technologies to improve the quality of the power received from the electric grid and provide continuous power during grid power outages. The core technologies include uninterruptible power supplies, generator back-up power with automatic transfer switches and no-contact inverter battery systems.

In addition, APHL has provided on-site maintenance and supervisory support visits with two-person teams comprised of one laboratory technologist and one service technician that travel to 16 supported sites throughout the country. Thankfully, Haiti’s national public health laboratory, the Laboratoire National de Santé Publique in Port-au-Prince, remains standing in the aftermath of the earthquake.

Although the massive relief effort has consumed all the country’s resources—with surviving laboratory staff understandably focusing on their homes and families—APHL is hopeful that conditions will improve enough to enable public health testing to resume in the not too distant future. At that point, the electrical support infrastructure will be a valuable help.

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