Laboratory Systems & Standards: Building the Foundation for Quality Testing

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.

Yet Another Multi-state Salmonella Outbreak Proves Need for PulseNet

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.

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.

Clinical Learning in a Virtual World

by Dorelle Engel, product line specialist, On-Demand Products

Take it with you! APHL’s Department of Continuing Education and Training has released an outstanding new online course in CD format entitled Red Blood Cell Morphology. The course can be used as a review for hematology technicians, clinical lab scientists, technologists and pathologists. To those new to the field, this course is an invaluable training tool in identification of normal and abnormal red blood cell morphology. In addition to course content, scenarios were developed to provide real-life simulations in a hematology lab setting. These 10 different scenarios include both case studies and bench work situations. Patient history and lab results are presented and the viewer can examine virtual blood smears for each activity. Several practice questions are provided for each scenario, challenging the learner’s comprehension. APHL CD format allows for training at the convenience of the laboratorian. This basic course offers 2 contact hours through the ASCLS P.A.C.E.® Continuing Education Program.

In addition to our On-Demand line up of programs, APHL strives to provide and encourage high quality Continuing Education and Training Programs using a variety of different presentation formats, including seminars, hands-on laboratory workshops, teleconferences and webconferences. Check out the link to APHL’s Featured Training and all our program offerings!

The Michigan Laboratory System Advisory Group Experience

By Patty Clark, M.P.H., Michigan Department of Community Health Bureau of Laboratories

The first meeting of the Michigan Laboratory System Advisory Group (LSAG) met in November, 2009. The LSAG was formed as a direct result of the Michigan Laboratory System Improvement Program (LSIP) held last March. The intent of the LSAG is to provide a forum where Lab System partners can meet, discuss issues affecting system partners, and participate in workgroups by interest and need to solve common problems. During the LSAG meeting, a brainstorming session created a list of areas where system partners felt there was need for improvement. The items on this list were prioritized by voting as high, medium, or low priority. At this point, system partners were asked for input as to how they would like to see the group move forward. Some partners voiced a concern that we had not captured all data from the original LSIP meeting in our priority voting and all were confused as to how to proceed. The intent to get buy-in from partners by involving them in the decision making process resulted in confusion and the inability to move the group forward. We ended the meeting assuring partners we would revisit the LSIP documentation, review the brainstorming and priority lists, and get back to them with a comprehensive list from both the LSIP and the LSAG. My suggestion for others planning such a meeting is to provide more direction and ask for opinions from the group rather than expecting the group to make decisions, at least in the initial meetings.