We all
make mistakes. Refrigerator doors get left open. Employees forget to check data
loggers. Paperwork gets tossed out. So how do you avoid these mistakes and why
should you care?
According
to the CDC, the average cost per dose of Measles, Mumps and Rubella (MMR)
vaccine is $19.75, with a private sector cost of $56. In volume, this
investment can add up to thousands in losses, create a health risk, or reduce
the shelf-life of the product. Even with the best of intentions, unexpected
problems do occur. So how do you plan for this risk? Let's start with knowing
where the problems occur, and a few precautions to take. Below are some of the
most common errors that result in vaccine destruction and what you can do about
it:
Mess up #1: Leaving the refrigerator door
open. This happens more than you think. Shift
changes, people in a hurry, and faulty doors can all cause the incident to
happen multiple times during a 24 hour period. Obviously, temperature
fluctuations will affect the vaccine if exposure occurs, but remember that it
is not just a single fluctuation that can cause the issue, but the total amount
of time it was exposed. For example, a door opened 15 times at two minutes each
over a 24-hour period, means the the door was open for 30 minutes. If the
temperature in the refrigerator drops 5 degrees each time, you are opening
yourself up for contamination and invalidation of the vaccine. The fix: We also
recommend you check the seals on the doors, the internal temperature of the
refrigerator and ice formation daily. If possible, [Kevin Koh1] maintain a temperature log.
Mess up #2: Discarding temperature logs. You may have procedures in place, but documentation can
still get misplaced or even intentionally thrown away. The fix: Temperature
logs should be stored locally along with documentation until the current batch
of vaccine is used up. After this period, archiving data can provide proof of
storage conditions in case the information is needed. Most current data loggers
allow for download of data via USB and storage on a computer. More advanced cold
chain solutions, like loggers can send the data to the Internet for
long term access and alert you if irregularities occur.
Mess up #3: Designating only one person to inventory,
store and dispense vaccinations. Look to expanding the number of parties
accountable for these tasks in order to provide backup. Just make sure you
document and train on these changes. What to document: a detailed checklist of
storage norms, temperature controls, purchase history, expiratory dates and
what to do in emergencies. Train them on dealing with proper inspection,
logging, disposal, and how to deal with power outages, floods and other emergencies.
Mess up #4: Not taking action on too-low
temperatures. Cold chain solutions and practices tend to
prioritize protecting vaccines from heat damage, however, the CDC estimates
that between 14% and 35% of refrigerators or transport shipments were found to
have exposed vaccine to freezing temperatures, and freeze-sensitive vaccines
represented more than 31% of the US 439 million UNICEF spent on all vaccines in
2005. Increased awareness of this danger is the first step. The second is an
action plan as soon as a variation is noticed. Procedures should note that when
freezing has occurred, reporting and inspection is warranted. If the problem
cannot be remedied, then the affected vaccine should be labeled clearly as 'DO
NOT USE' and then be quarantined. Contact your state immunization program, the
VFC Program Coordinator, or vaccine manufacturer for additional information on
each vaccine's proper storage conditions.
Mess up #s 5 and 6: Recording or checking
temperatures just once a day. Let's
separate recording temperatures from checking them. Fix number one: Today's cold
chain solutions, like data loggers can do more, for less money than ever
before. Recording levels can be set to high and low triggers, have audible or
visual alarms, and even communicate with your cell phone. With functionality
increasing, while costs are decreasing, you have no excuse for not updating
your data loggers. If not set for continuous monitoring, set your data logger
for a minimum of three measurements per day times a day. The cheapest type is
min/max thermometer. The highest end is a wireless data logger that sends
readings to the cloud for remote access. These are multiple types in-between.
Regardless of the type you use, these thermometers should be calibrated every
year to assure their accuracy. Fix number two: procedures for checking your
data loggers in the cold chain. Whether they happen at shift change or on
regular time intervals, you need to make sure you document and train on when
checks should occur.
Mess up # 7: Storing food and vaccines in the
same refrigerator. You should have a separate
refrigeration unit designated only for medical items and vaccines versus your
staff's lunch. Cross-contamination of food with medication and vice-versa is a
legitimate concern. In addition, storing food items will negatively influence
the temperature in the chiller. Remember, that storing vaccines with your
staff's TV dinner means the refrigerator is opened and closed every time
someone wants to eat or drink something. It also poses a security risk to your
facility by allowing non-medical staff to access the unit. Spend the $75 to get
a dorm-style refrigerator for your staff to use with lunch, and leave the other
unit for your temperature controlled product.
Mess up # 8: Thinking that all areas of a
refrigeration unit have a consistent temperature. Temperatures can vary considerably from top rack to the
freezer. IF you are using a conventional refrigerator, vegetable bins, areas
near the floor, walls, door and the cold air vent can all vary considerably.
The fix: Use a calibrated data logger or thermometer to judge temperatures in
different parts of the unit and make sure that the vaccine is stored in the
right area of the unit.
Mess up #9: Incidents don't happen at my
place. OK, should this mess up really be a number
nine on the list, or number one? Thinking that your facility is fool-proof,
audit-proof, or accident-proof is a mistake all of us have to learn the hard
way. Facilities flood. Employees make mistakes. Old style cold chain solutions
fail. And procedures have holes. The fix: Call in the pros, even if you think
you have “dotted the i's” and “crossed the T's”. Generally, we recommend you
have a contingency plan ready for your vaccines in case the power breakdown or
if the necessary personnel are missing, but generalities won't find the holes.
Have your site audited by a third party that can map temperatures in your
facility, establish compliant procedures, calibrate your data loggers, and look
for the holes you missed. You'd be surprised what a small investment can find.
I hope you find this list
helpful and welcome your feedback. Am I missing anything? Please let us know
and we'll add it for others in your field.
