Pandmeic Planning and Preparedness Project H1N1 Influenza A Mass Immunization

Date:  April 19, 2010

Ensuring access to available vaccine by the general public proved to be a logistical and practical challenge in communities across the United States.  Despite existing plans for mass immunization/prophylaxis, there existed gaps in the ability to operationalize those plans in a timely and effective manner.  The following information is a description of the activities undertaken in Louisville, Kentucky, a metro community of more than 700,000 persons.

As was done by most communities, Louisville had devoted significant resources to development of plans aimed at emergency response when prophylaxis or immunization was needed following presence of a transmissible infection.  In accordance with planning scenarios, emergency plans focused largely on response to an anthrax release as response would be necessary within a matter of days and would need to address adult and pediatric prevention and treatment.  Emergency plans were developed including points of dispensing plans.  Implementation of these plans were exercised and included response across public and private sectors.  Evaluations were performed, after action reports filed, and improvements implemented.  Emergency planners expressed comfort with the existing plans although the need for continuous improvement was clear.

When the first cases of the novel H1N1 influenza A virus were recognized in California in April of 2009, the potential for mass immunization became part of regular community preparedness discussions.  In late summer, it was evident that vaccine would be available and the need for broad distribution and administration would be an integral part of the global response to this new pandemic. 

On a tangential note, over the course of the previous five years, planning had been underway at the University of Louisville (UL) with respect to pandemic preparedness.  Although the presumed virus was H5N1, planning assumptions included the need to ensure access to, and administration of, available vaccine to all university faculty, staff, students, and family members of faculty, staff and students.  With a student population of more than 20,000 and approximately 6,000 faculty and staff, it was assumed that plans should include the ability to immunize up to 60,000 individuals within a 3-4 day period.  Evaluation of existing university property identified the football stadium parking lot as the ideal location due to its central location, relative ease of access and egress.  Given that the targeted illness consisted of a respiratory illness with the capability of transmission via respiratory droplets and contact, plans involved use of a drive-thru method for vaccine administration.  Other methods were discussed, but the ability to transmit the illness within confined spaces was considered to be a modifiable risk factor for an immunization event.  University Planners chose to modify that risk by electing a drive-thru immunization method.  University planners had significant experience and success with other drive-thru immunization efforts although they had been on a much smaller scale (3000 doses per day).  Community influenza immunization drive-thru campaigns had been an annual event provided by the University of Louisville Hospital since 1995.  The venue for those events had been the UL Papa John Cardinal Stadium parking area so there was also significant experience with that particular site.  By May of 2009, plans were in development for a large drive-thru event predicated upon the expected availability of large quantities of vaccine, both injectable and intranasal.

In early October, communication from the Centers for Disease Control and Prevention indicated that large quantities of vaccine would soon be available for the general public.  The plan for the drive-thru component was outlined in detail and there was the expected level of skepticism among UL leadership.  UL planners had anticipated that and had approached the Director of the Logistics and Distribution Institute at UL, Dr. Sunderesh Heragu.  Dr. Heragu was asked to assist with development of a model with simulation that could be used to visualize the process and identify potential bottlenecks and vulnerabilities in the process.  Within days, a simulation was available following intense work by Dr. Heragu and a cadre of industrial engineering students and was used to demonstrate the process to UL leadership as a means of obtaining buy-in for this nontraditional approach. 

In mid-October, planners at UL were alerted that vaccine was apparently not as available as previously thought and first doses of vaccine would be targeted toward specific high risk groups and would be distributed to a network of providers and local hospitals.  Plans for a UL event were put on hold until more information was available from LMPHW.  

During the last week of October, UL planners were approached by LMPHW leadership regarding the possibility of a joint immunization effort targeting high risk individuals in the community.  This would be the first time H1N1 vaccine would be available outside provider or hospital networks.  During initial discussions, LMPHW leadership discussed challenges posed by the implementation of existing mass immunization plans.  The locations included in those plans had been visited and were found to be deficient and the plans were described as “not workable”.  Use of the UL plan was deemed as the only presently viable option.  Use of the simulation model was again part of the discussion and was instrumental in convincing LMPHW leadership that the drive-thru option was viable. 

At that time, planning for a joint mass immunization effort began.  It was expected with a large shipment of vaccine (injectable and intranasal) would be received by LMPHW within seven days.  A target date for the event was identified giving 11 planning days. 

It was determined that the event would provide a drive-thru and walk-up option and would be a joint project between LMPHW and UL.  An incident command structure was implemented to support this joint venture.  The incident commander was from LMPHW.  Members from the UL Department of Environmental Health and Safety and faculty and staff from the UL School of Public Health and Information Sciences were liaison members of the command structure.  UL planners were responsible for the drive-thru process and LMPHW planners were responsible for the walk-up process.  UL planners estimated that a two-day event would cost approximately $100,000 per day so the UL Provost provided approval for that amount to be available for planning purposes.  LMPHW allocated 10,000 doses for the event was the possibility of an additional 10,000 if needed. 

Use of simulation helped alter traffic flow within the drive-thru as well as traffic flow in areas adjacent to the stadium parking lot. Following visualization of the simulation, full support was provided by UL and LMPHW leadership and a memorandum of agreement was executed.  The dates of the event were set; November 11 and 12, 2010.

UL planners implemented the existing plan and established a ten lane drive-thru consisting of five separate tents (two lanes running through each tent).  An additional tent was identified for use in distribution of consent forms.  Signage was developed and graphic representations of the drive-thru process were developed.  Workers were identified including UL School of Nursing and Bellarmine University School of Nursing students and faculty.  Medical students from the  UL School of Medicine were also included.  Competency-based training was implemented for all workers.  Multidose vials of vaccine were taken to the UL Hospital pharmacy so pharmacy personnel could draw vaccine into individual syringes.  This was done to improve efficiency in the drive-thru process and enable a color-coding system designed to minimize error.  Using standard pharmacy practices, syringes were prefilled.  As multidose vials are consistently overfilled, using these standard practices resulted in an increase in the available doses of vaccine. 

For the processes of vaccine administration, the drive-thru workforce included 10 nurses in every tent.  Two registered nurses experienced in mass vaccine via drive-thru were available and acted as vaccine specialists and process managers.  School of Nursing faculty were also stationed in each tent.  Double-check procedures were reviewed as part of competency-based training. 

Communication processes both operational and external were developed with the assistance of the public information specialist with LMPHW, UL and the local Emergency Management Agency personnel.  Information shared with the media outlets provided directions on the vaccination process, the required consent forms and maps to the site. This same information was place on LMPHW and UL web sites. 1610 am radio capabilities were provided that enabled a continuous loop of information regarding the immunization process in the geographic area around the stadium. 

Operational communications relied on 800 mhz radios, short distance business radios and cellular phones. Onsite security was provided by UL.  The Jefferson County Sheriff’s office provided additional security at the site and Louisville Metro police controlled traffic on adjacent public streets and off UL property. All of the internal communications were integrated allowing information to move freely between different agencies and geographical locations.

At the end of the first day, more than 12,000 doses had been administered with more than 65% administered via drive-thru.  In an effort to maintain traffic flow, individuals preferring drive-thru immunization were redirected to the walk-up tent.  As the first day exceeded all expectation, additional doses of vaccine were released by LMPHW so the total number of available doses was between 19,000 and 20,000.   The second day of the drive-thru was a busy as the first day.  All available doses of vaccine had been administered by 2pm.  During those two days, a total of 19,079 vaccines were administered with 12,613 (66.1%) being administered via a ten lane drive-thru.  There were no identified adverse events reported during or within 90 days of the immunization event.  There were three needlestick injuries experienced by three nursing students.  Two occurred during activation of the needle safety device and one immediately following injection to an active child.  Four vaccine errors were identified.  Three doses of intranasal vaccine were administered to individuals with identified contraindications and one child received an incorrect vaccine dose.  All were reported to the medical director who determined no additional followup was needed. 

The drive-thru averaged about 1000 doses administered per hour which translated to about 100 doses per lane, per hour.  Throughput times were gathered periodically during both days and there was a general wait time of approximately 30-45 minutes for the drive-thru.  LMPHW environmental safety personnel monitored carbon monoxide levels in every tent periodically throughout both days.  Levels were non-detectable for all checks except one.  That level was minimal and not actionable.  It is noteworthy that both days were a comfortable but cool temperature with a heavy breeze on November 11th and a lighter breeze on November 12th.       

In an effort to enable access to immunization by targeted individuals who lacked personal transportation, public bus service was arranged with continuous pickup and return to six government centers.  The total number of people utilizing this public transportation option was 445 in 75 round trip routes.  This represented 2.3% of the total people vaccinated.  According to the Transit Authority of River City (TARC) web site, the operating cost on a per mile basis is $2.58.  Using the round trip distance to each of the six government sites, the cost per trip ranged from $20.64 to $79.98.   The number of individuals transported from the six sites ranged from 18-103 with a cost/person ranging from $2.29 to $15.68.  The average cost to transport individuals from the government sites to the POD was $6.58 per person.  These costs were in addition to the costs for immunization.    There were no negative events occurring on the bus or as part of the process.

Following the event, extensive efforts were made to capture all costs associated with the event.  UL captured all personnel, equipment and supply costs and they were provided to LMPHW leadership for reimbursement from available federal funds.  Total UL costs were $100,962.73.  Total LMPHW costs were $127,177.08.  When calculating the cost per dose, the cost was approximately $13.35 per immunization administered.  When comparing costs of the drive-thru to costs for walk-up, the cost per dose for the drive-thru was $5.58 and the cost per dose for walk-up was $29.61.

Limitations to this comparison primarily involve volume and workforce.  Costs would go down if volume to the walk-up process increased.  Drive-thru workforce consisted largely of nursing students for which there were no costs assigned.  If registered or licensed practical nurses were used instead, and an average hourly rate of $25 was paid, the cost per dose of vaccine would increase approximately $2 per dose.  It is important to note that use of nursing students required more time as they were not a fast with immunization as non-students and therefore the throughput time could have increased and more doses administered.  This could result in a lower cost/dose.

In summary, the drive-thru process was deemed a success.  Planners and participants concluded that the process was sustainable and could have continued had additional doses of vaccine been available.  LMPHW received a tremendous amount of positive media coverage and comments from the general public were overwhelmingly positive and supportive.  All documents have been maintained and work is in progress for development of a toolkit that would enable other communities of any size to implement a drive-thru immunization event.

  

The Challenge

The task of assuring the security of our homeland involves protecting the citizens of the United States, the nation's critical infrastructure and key assets. This is necessary to sustain the nation's vitality against terrorism and other threats. This protection must originate at the community level. It requires discovering, developing and deploying new technology that will support first responders and key decision makers in local communities.

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The Strategy

Through management of the Kentucky Critical Infrastructure Protections Program (KCI), the National Institute for Hometown Security (NIHS) provides an ongoing, integrated program dedicated to developing new technologies and devices. NIHS works through qualified academic institutions to accomplish the technological objectives.