New Report Finds Program’s Improper Storage of Immunizations a Threat to Children

AcuTemp Thermal Systems

2900 Dryden Road
Dayton, OH USA 45439
Phone: +1.937.312.0114
Fax: +1.937.312.1277
http://acutemp.com

Dayton, Ohio, USA, June 11, 2012

The Vaccines for Children Program (VFC) provides immunizations to children whose families are unable to afford them.  The program ensures that children are better able to acquire necessary, often life-saving vaccinations protecting babies, young children, and adolescents from over a dozen diseases.  The VFC vaccinations are endorsed by the Advisory Committee on Immunization Practices (ACIP) administered by the Centers for Disease Control and Prevention (CDC) that purchases and distributes the vaccines to private and public healthcare members.  Because of the CDC’s work, approximately 80 million vaccines have been distributed to over 40 million children of low-income homes at a cost of approximately $3.6 billion.

Recently, an investigation by the Department of Health and Human Services' Office of the Inspector General (HHS OIG) has brought great scrutiny and concern to the program’s operations after its report found that many of the program’s doctors are improperly storing vaccines, putting their efficacy in question.  The new government report obtained exclusively by ABC News found that many of the approximately 44,000 offices and clinics participating in the program do not store their vaccines at suitable temperatures and that their improper storage represents a major breakdown in the program’s management process.  During the investigation, the VFC visited the offices of 45 providers in five states that offer free immunizations as part of the program to verify that their operations meet the HHS OIG’s requirements for delivery and storage.  Over three-quarters of the immunization providers were storing vaccines at a temperature either higher or lower than specifications.  More broadly, it was found that not one of the providers properly managed the vaccines according to all of the VFC program requirements, falling short with both on-site storage and the delivery of vaccines to and between individual clinics and their satellite sites.

In response to the report, the HHS OIG recommended that the CDC take the necessary steps to ensure that those taking part in the VFC program “do their jobs.”  Dwayne Grant, the regional inspector general for the Office of Inspector General in Atlanta, stressed the importance of the CDC working closely with the grantees and providers to ensure that vaccines are properly stored during transport and at on-site environments.  While there has been a consensus that the VFC program has helped protect many children from preventable diseases, those involved also acknowledge there are issues with the transport logistics and storage management processes that are designed to ensure the safety of these temperature-sensitive products.  A root cause analysis of the investigation’s findings has identified equipment changes and selection at the end stages of the cold chain process as the key factors in the development of the current problems.  Increased quantities and variations in prescribed vaccines have placed a heavier burden on storage requirements during the delivery to and storage within provider locations.

Those taking part in the investigation emphasize how important it is that these issues have come to light, and point out that everyone involved must take part in the solution.  First and foremost, they stress that parents must continue to get their children immunized.  In addition to this, they feel it is the parent’s responsibility to question their doctors as to where vaccines are stored and how they are transported and handled.  Doctors also have an extremely important role to play in addressing these issues.  Not only must they take greater responsibility for the monitoring and maintenance of vaccine storage temperatures while on-site, they must also insist that those transporting temperature-sensitive vaccines are doing their part to ensure proper temperature ranges during transport.  According to Dr. William Schaffner, chair of preventive medicine at Vanderbilt University Medical Center:

 We want every dose given to every child to provide the optimum protection as it's intended,[to accomplish this] the temperature has to be monitored throughout the entire time, from the time it leaves the manufacturer to the time it spends in transit to the time it's delivered to the clinic and it's used in the clinic.

It is in the design and delivery of solutions for the transport stage of the logistical cold chain process that AcuTemp has become a global leader.  AcuTemp offers both active and passive transport solutions that meet HHS OIG’s requirements by replacing what some pediatricians describe as the “large Styrofoam containers” that are used throughout the program’s current operations. AcuTemp AX27L mobile refrigeration units are energy efficient, precisely controlled, and transportable.  Designed to safely store or transport critical vaccines, drugs, specimens, and other bio-medical materials to the point of use, the units are capable of running up to five days on battery power only and are certified for in-flight operation.  The AcuTemp AX27L has become an essential component in vaccine and drug distribution around the world.  Furthermore, the AcuTemp AX27L can be used in conjunction with the AcuTemp PX1L portable carrying case and AcuTemp PXC coolant packs for a complete distribution system.  These units are built with AcuTemp’s ThermoCor high performance insulation technology that has an R Value up to 45 per inch thickness (0.00312 W/mK) – the highest in the industry, and can maintain crucial vaccines, drugs and other bio-medical payloads at required temperatures for up to 60 hours in refrigeration mode with no power while ensuring integrity at point of use.  The AcuTemp PXC Coolant Packs are made of a phase change material that enables the packs to maintain specified temperatures for long periods.  These AcuTemp solutions are an extremely reliable, cost-effective way to ensure the safety of temperature-sensitive materials.

About AcuTemp The AcuTemp mission is to enhance the efficiency and effectiveness of the temperature-controlled supply chain.  The company’s product offerings make previously unachievable commercial and industrial applications possible.  Its users benefit from reductions in power consumption, the additional available transporting space of a decreased footprint, a great increase in achievable hold times, and an overall reduction in operating costs through higher thermal efficiency.

 
Pharma/Biotechnology

Pharmaceutical companies are under relentless pressure to reduce pharmaceutical shipping costs and ensure their products are handled properly throughout the cold chain. To meet the industry’s stringent requirements, AcuTemp develops insulated shipping containers that provide the Peace of Mind™ of uncompromised hold time performance while offering a low total cost of ownership.

Medical Device

AcuTemp’s ability to adapt to unusual insulated packaging requirements affords our medical device customers with the benefit of having fully customized insulated shipping containers. Not only do medical devices come in all shapes and sizes, they also have very specific thermal management requirements and may require very specific protective packaging strategies.

Public Health

With a reputation of superior hold time performance, AcuTemp insulated shippers, carrying cases, and mobile refrigerator/freezer units are entrusted to maintain exacting temperature ranges in the transport of vaccines, drugs, specimens and other bio-medical materials. Some of the world’s largest organizations rely on AcuTemp insulated containers to provide precise temperature control and superior hold time performance throughout the cold chain distribution cycle.

Military Medical

AcuTemp’s mobile refrigerated units are designed with specific military applications in mind. When it comes to providing reliable thermal management in the delivery of biologics and medicines in the harshest of conditions, even on the field of battle, AcuTemp delivers. Designed in accordance with the military’s strict standards (such as MIL-STD 810F), our actively powered insulated containers provide the superior hold time performance necessary for the potentially life-saving applications in which they are used.

Transportation Logistics

Designed to meet the most stringent air cargo shipping protocols, AcuTemp’s versatile cold chain solutions enable freight forwarders, airlines, 3PLs and logistics providers to ship temperature critical materials around the world with greater assurance than with any other thermal management provider.

 

 

Advisor