With your Host Heidi Loynes, BSN, RN

Why is Vaccine Management Important?

• Vaccines prevent serious, sometimes fatal diseases

• Vaccines that are not properly stored and handled can result in: ˗ Failure to protect children and adults from serious

diseases˗ Monies lost to replacing vaccine and possible

revaccination˗ Loss of the patients’ trust in your clinical judgment˗ Potential liability to providers

Storage and Handling• Proper vaccine storage and handling has been an

important factor in preventing and eradicating vaccine-preventable diseases (VPD)

• Yet, each year, storage and handling errors result in revaccination of many patients and significant loss due to wasted vaccine

• Patients can lose confidence in vaccines and providers if they have to be revaccinated because the vaccines they received may have been compromised

Disclosure:• Vaccines For Children (VFC) providers

should consult with your local health department to ensure you are meeting all the mandatory storage and handling requirements

RULES• The team has 30 seconds to

answer questions• If they are stuck:

˗ “Call out a friend”, twice – 1 person in audience

˗ Shout out, twice – the whole audience

• The information comes from publications of the Centers for Disease Control Prevention (CDC), The Vaccine Storage and Handling Toolkit and the Immunization Action Coalition (IAC)

http://www.thecomedynetwork.ca/Shows/CashCab

Let’s Go!

Question 1:Which statement best defines cold chain management? A.Checking that vaccines are potent and effective when used.B.Maintaining appropriate storage and handling conditions at every link in the cold chain.C.Minimizing exposure to excessive heat or cold.D.Checking vaccines for physical evidence of lost potency before administration.

Answer:

B –Maintaining appropriate storage and handling conditions at every link in the cold chain.

$50

Maintaining the Cold Chain

Vaccine Manufacturing

Vaccine Distribution

Vaccine Arrival to Provider Facility

Vaccine Storage and Handlingat Provider Facility

Vaccine Administration

• Excessive heat, cold or light exposure can damage vaccine

• To maintain the cold chain:˗ Vaccines must be stored

appropriately

˗ Know manufacturer’s storage and handling recommendations for each vaccine and have a Vaccine Management Plan

Question 2 (True or False Question):Vaccine appearance is a reliable indicator that vaccines have been stored under appropriate conditions.

Answer:

False

Some vaccines may look normal when exposed to inappropriate storage conditions.

$50

You Will Not be Able to See the Difference

Properly Stored Vaccine Full Potency

Improperly Stored Vaccine Diminished Potency

Images Courtesy of CDC

• Vaccine appearance is not a reliable indicator that vaccines have been stored in appropriate conditions

• For example:˗ Inactivated vaccines, even when exposed to freezing

temperatures, may not appear frozen, giving no indication of reduced or lost potency

Question 3:CDC recommends that storage and handling training should be done:A.As part of new employee orientation.B.Annually, as a refresher for all staff involved in immunization and vaccine management activities.C.Whenever new vaccines are added to the inventory.D.Whenever recommendations for storage and handling of vaccines are updated.E.All of the above.

Answer:

E—All of the above.

$50

Question 4:Which staff need to be trained on vaccine storage and handling?A.Only staff members who administer vaccines.B.Only the primary and alternate (backup) vaccine coordinators.C.Only new staff during orientation.D.All staff members who receive deliveries and/or handle or administer vaccines.

Answer:

D—All staff members who receive deliveries and/or handle or administer vaccines.

$50

Vaccine storage and handling practices are only as effective and successful as the staff that

implement them!

Well-Trained Staff

• Everyone who handles or administers vaccines and/or receives deliveries should be familiar with vaccine management

• Training should occur:

˗ As part of new employee orientation

˗ Annually as a refresher

˗ Whenever new vaccines are added into inventory

˗ When recommendations are updated

Staff to Manage Vaccine

• Designate an onsite primary vaccine coordinator and back-up coordinator

˗ Back-up coordinator serves as alternate when primary is absent

• Primary coordinator is responsible for ensuring all vaccines are stored and handled correctly

˗ Some responsibilities include: temperature monitoring, ordering vaccines, daily physical inspection & organizing of storage units, ensuring staff are properly trained, etc.

• Both coordinators should be fully trained in routine and emergency policies and procedures

˗ All staff should KNOW storage and handling basics

• From front to back of office, including the provider

Knowledgeable Staff are Critical

• All staff who will store, handle and administer vaccines should: – Receive competency-based training

– Have knowledge and skills validated

• Integrate competency-based training into: – New staff orientation

– Annual education requirements

• Ongoing education: – Whenever vaccine administration

recommendations are updated

– When new vaccines are added to inventory

• Don’t forget to assess vaccine administration skills of temporary staff

“Skills Checklist for Immunization” www.immunize.org/catg.d/p7010.pdf

Question 5:

You need to store a vaccine that requires freezer temperatures between -58˚F to +5˚F (-50˚C to -15˚C). Which type of storage unit would be acceptable for storing these vaccines?

A.Freezer compartment of a household combination unit.B.A cooler.C.Stand-alone freezer unit.D.Dormitory-style refrigerator with internal freezer area.

Answer:

C –Stand-alone freezer unit.

$75

~Storage and temperature monitoring equipment is an insurance policy to protect patient health and safeguard your facility~

• The refrigerator or freezer unit must:

˗ Be in good working order

˗ Be large enough to hold the year’s largest inventory• Plus water bottles in refrigerator or freezer

˗ Be able to maintain required temperatures

˗ Be dedicated to vaccine storage• No food or beverages in units

˗ Have a certified calibrated thermometer in center of each storage unit

Vaccine Storage Unit Basics

Image Courtesy of CDC

• The best units for storing vaccines are:˗ Stand-alone refrigerators and freezers that

are a pharmaceutical grade or purpose-built unit

• Why? ˗ Intended to store medication/other

biologics

˗ Better at maintaining temperatures

˗ Nearly all the internal space in the unit can be used

˗ Good temperature recovery when unit is opened to get vaccines

˗ Self-sealing doors to prevent door being left ajar

Stand-Alone Storage Units

Example of Under-Counter Pharmaceutical Stand-Alone Unit

Example of Full-Sized Pharmaceutical Stand-Alone Unit

Household Combination Units

• Not recommended for use because known to have temperature issues

• You run the risk of vaccine exposed to out-of-range temperatures

• Why change units?˗ Studies found freezer cannot

maintain proper temperatures

˗ Increased risk of freeze damage to refrigerated vaccines

Commercial Units

• May use commercial grade units but intended for food storage

• Tend to have temperature variations

• Better option than household combination unit

˗ Temps more stable than household combo units

Example of a Household

Combination UnitExample of a Commercial

Grade Unit

Unstable Storage Units

Combination Household Unit Freezer Section

Do not store any vaccine in a dormitory-style or bar-style combined refrigerator/freezer unit under any circumstances!!!

Combination Household Unit With One Outside Door

“Dormitory” Style Unit

Freezer

Question 6:Each facility should have a temperature monitoring device (Digital data logger preferred) for: A.Each vaccine storage unit.B.Each emergency transport unit.C.At least one backup temperature monitoring device in case a primary device malfunctions or is out for calibration testing.D.A and BE.All the above.

Answer:

E—All the above.

$75

• Every vaccine storage unit must have a temperature monitoring device

˗ Less expensive than replacing vaccines wasted due to inaccurate temperature readings

• Thermometers must:

˗ Be calibrated

˗ Have a Certificate of Traceability and Calibration Testing

˗ Be in good working order

˗ Have probe placed in center of the storage unit

Temperature Monitoring Equipment

Digital Data Logger

• Recommended to use a digital data logger with a detachable probe in glycol, glass beads, sand or Teflon® in center of each storage unit˗ Meeting CDC’s and MDHHS standards:

• Alarm for out-of-range temperatures• Low-battery indicator• Current, minimum, and maximum temperature display• Recommended uncertainty of +/- 1°F (+/-0.5°C)• Logging interval (or reading rate) that can be

programmed; CDC recommends interval at least every 30 minutes

• Why?˗ Gives a more accurate reading of actual vial temperature˗ Gives detailed continuous monitoring & recording of temperatures˗ Can download temperatures without removing probe from unit

• All VFC providers are required to use a data logger and have a back-up thermometer

Example of a Digital Data Logger

Question 7:Regarding temperature monitoring, CDC recommends:A.Reviewing and recording unit temperature at least 2 times each workday (morning and end of day).B.Post on a log, on or near each storage unit.C.Download and review stored temperature log data at least once a week.D.Keep logs and downloaded data at least 3 years or according to state record retention requirements.E.All the above.

Answer: E—All the above.

$75

MUST Read Temperatures

• Temperatures must be recorded twice a day for each storage unit on a temperature log; along with recording min/max temperatures every AM

˗ Ensures that temperature was good at the beginning of your work day and at the end of your work day

˗ Recommended to check temps at least 30 to 60 minutes before clinic closes• Allows time to solve temperature

issues before you leave for the day Source: Centers for Disease Control and Prevention

More Points to Remember

• Keep temperature logs for at least 3 years

• Why?˗ If out-of-range temperatures have been documented,

you can determine how long and how often this has been occurring

˗ You can track recurring problems as the storage unit ages

˗ Great way to demonstrate why you need a new refrigerator or freezer

˗ Useful to be able to look back at the record to help determine if a unit is developing a problem

Question 8:Maintaining stable temperatures in the storage unit is critical. Ensure storage unit works well and maintains temperatures by: (pick all that apply) A.Placing water bottles along walls, top shelf, floor, and door of refrigerator.B.Placing water bottles along walls, back, floor, and door of freezer.C.Placing storage unit in standard indoor room with temperatures at 20°C to 25°C (68°F to 77°F).D.Packing vaccines tightly in the storage unit.E.Removing bins and drawers in storage unit.

Answer: A, B, C and E

$75

• Place water bottles* along walls, top shelf, floor, and door of refrigerator (also along walls, back, floor, and door of freezer)˗ Label “Do Not Drink”

• Allow for cold air circulation by ensuring space around vaccines˗ Avoid packing too tightly

• Ensure storage unit doors are tightly closed and sealed

• Do not store food and beverages in unit(s)

• Remove bins and drawers in storage unit if present

Stabilizing Temperatures

Image Courtesy of CDC*Immunization Storage Tip

• Ensure good air circulation around outside of unit˗ Place in a well-ventilated room˗ Need to allow for space on all sides of unit

• Leave space between the unit, ceiling, and any walls

˗ Ensure nothing is blocking cover of the motor compartment• Usually located at the back or side of unit

• Studies find most units work best when placed in standard indoor room temperatures 20°C to 25°C (68°F to 77°F)

• Check manufacturer-supplied owner’s manual for additional guidance on placement and spacing

Storage Unit Placement

Question 9:Which vaccine has been correctly stored in the refrigerator?A.Vaccine stored in a drawer inside the refrigerator.B.Vaccine that is stored in a labeled container/bin on the middle shelf, a few inches away from the wall.C.2 different vaccines stored in the same container/bin on the middle shelf.D.Vaccine that is stored in the refrigerator door next to the diluent.

Answer:

B—Vaccine that is stored in a labeled container/bin

$125

• Keep vaccine centrally located in the storage unit(s)

˗ 2 to 3 inches away from walls, ceiling, floor, and door

˗ Vaccines should never be stored in the deli, fruit, and vegetable drawers, or in the door

˗ Contact the unit manufacturer to determine if vaccine can be stored on the top shelf (under cooling vents)

• Diluent packaged with vaccine

˗ Store together in refrigerator

• Diluent packaged separate from vaccine

˗ Store at room temperature* or in refrigerator

• Never store diluents in freezer

Placement in the Unit Matters

Image Courtesy of CDC

*Room should be no warmer than 77˚F (25˚C)

• May use trays/open bins/uncovered containers to store vaccine boxes˗ Helps organize vaccine and diluent

• Keep all vaccines in their original boxes with lid on˗ Protects from light

• Never store loose vials or syringes outside of packaging˗ Decreases errors, exposes to light, and

difficult to track expiration dates

• Separate and clearly label ˗ By age: childhood, adolescent, adult

˗ By purchase type: Private or VFC

Further Storage Practices

Image Courtesy of CDC

DTaP Ages: 6 weeks through 6 years Use for: Any dose in the series

Route: Intramuscular (IM) injectionVFC vaccine

Example Vaccine Label

Resource regarding Storage Best Practices: https://www.cdc.gov/vaccines/hcp/admin/storage/index.html

Question 10:True or FalseDiluents are interchangeable, as most are only sterile water.

Answer:

False—Diluents vary by volume and ingredients. Use only the specific diluent provided by the manufacturer with the specific vaccine.

$125

Diluents• Use only the

manufacturer-supplied diluent to reconstitute a vaccine

˗ Inspect vaccine and diluent vials for damage or contamination

˗ Check the expiration dates for the vaccine and diluent

• Also, check the expiration date on injection equipment, on the alcohol prep wipes, syringe, and needle www.immunize.org/catg.d/p3040.pdf

Question 11:One of the most common reasons that refrigerators are out of temperature range is: A.Power outage B.The thermometer is broken C.Storage unit was unplugged D.Staff don’t shut the refrigerator doorE.The refrigerator thermostat is not working

Answer:D—Believe it or not, staff not shutting the refrigerator door is one of the most common reasons a refrigerator is out of temperature range!

$125

Leaving the Door Open

• Inadvertently leaving the refrigerator/freezer door open or having inadequate seals

• Vaccine is lost every year because storage unit doors were left open

• Remind staff to completely close the door

• Check the seals on the doors on a regular schedule

Source: Centers for Disease Control and Prevention

Question 12:

True or FalseOnce the protective cap is removed from the vaccine, single dose vial or prefilled syringe, it must be used by the end of the clinic day.

Answer:

True

$125

“Activated Vaccine”

• Only open a single-dose vial when ready to use˗ Once protective cap is removed, vaccine should be used

˗ If not used, discard it at end of workday

• Once a manufacturer-filled syringe is activated (i.e., syringe cap removed or needle attached), vaccine should be used or discarded at end of workday

Images Courtesy of CDC

Question 13:It is flu season. Mike and his 3 year old son need their flu shots. You have Inactivated flu vaccine (IIV) which is given intramuscular (IM).Which is the recommended site for an IM injection for a 3 year old?A.Gluteus muscle (buttock)B.Vastus lateralis muscle (anterolateral thigh)C.Deltoid muscle (upper arm)D.Back of the upper arm

Answer:

C—Deltoid muscle (upper arm)

$200

Administration Route

• Route: Intramuscular injection (IM)

˗ Vaccines: HepA, HepB, Hib, DTaP, DT, Flu, HPV, IPV, MenACWY, MenB, PCV13, PPSV23, Td, Tdap, RZV

• Technique:

˗ Spread the skin of the site taut between the thumb and forefinger, isolating the muscle

˗ Insert the needle fully into the muscle at a 90° angle and inject

Image Courtesy of CDC

** Use professional judgement when choosing needle length Aspiration is NOT recommended

IM Injections: Children and Adults• For children 3 through 18 years of age, use the deltoid muscle in the

upper arm

˗ If the muscle mass is not adequate, use the vastus lateralis muscle

• For adults 19 years of age and older, use the deltoid muscle in the upper arm

Images Courtesy of CDC

45

Shoulder Injury Related to Vaccine Administration (SIRVA)

• Occurs after incorrect administration of a vaccine intended for IM injection in the deltoid muscle (upper arm) – Inflammatory reaction

– Causes shoulder pain and limited range of motion

• How do we prevent this?– Technique (visualize the muscle)

– Train

– Observe

– Check-off

Image Courtesy of CDC

http://www.immunize.org/catg.d/p7010.pdf

Question 14:It is now Mike’s turn to get his flu shot. Mike weighs 200 pounds. What needle length should you use?

A.2 -inchB.1.5-inchC.5/8-inchD.All of the above are okay to useE.None of the above

Answer:

B—1.5 inch needle

$200

Needle Length• For adults, the deltoid muscle is recommended for routine

intramuscular vaccinations˗ The anterolateral thigh also can be

used

• Needle lengths:˗ For men and women who weigh

130-152 lbs (60-70 kg), a 1-inch needle is sufficient

˗ For women who weigh 152-200 lbs (70-90 kg) and men who weigh 152-260 lbs (70-118 kg), a 1- to 1.5-inch needle is recommended

˗ For women who weigh >200 lbs (>90 kg) or men who weigh >260 lbs (>118 kg), a 1.5-inch needle is recommended www.immunize.org/catg.d/p3085.pdf

Resource General Best Practice Guidelines: www.cdc.gov/vaccines/hcp/acip-recs/general-recs/administration.html

Question 15:“Take action” when it comes to temperature monitoring; this means? (pick all that apply): A.Remove all vaccines that are out of range and discard them. B.Call the state/local VFC program (or manufacturer for private vaccines) for guidance. C.Notify the practice’s vaccine coordinator to get the refrigerator temperature back in range. D.Thaw any vaccines that were frozen for 45 minutes.

Answer:

B and C

$200

Ensure You Act on Compromised Vaccine

• Vaccine could be compromised due to out-of-range temps

˗ Or compromised due to equipment failure, power outages, natural disasters or by being left out on the counter

• For suspected compromised vaccine, immediately follow the Emergency Response Plan & Worksheet

˗ Separate the vaccines & store appropriately

• Label “DO NOT USE” –place vaccine in clearly labeled bag

• DO NOT automatically throw away any vaccine

• If viability is in question contact vaccine manufacturer

˗ Always get the name of the person you are talking with

• Required to contact LHD if Vaccines for Children (VFC) vaccines involved

˗ Encouraged to contact LHD for private stock

Question 16:Which of the following containers is the BEST option for emergency vaccine transport? A.Any container as long as it contains dry ice.B.Portable vaccine refrigerators and portable vaccine freezers.C.Lunch containers D.Soft-sided collapsible coolersE.Hard-sided cooler.

Answer:

B –Portable vaccine refrigerators and portable vaccine freezers. CDC recommends this.

$200

• Vaccines should only be transported when absolutely necessary

• Frozen varicella-containing vaccines should never be transported except in an emergency

• Improper packing for transport is as risky for vaccines as a failed storage unit

• If vaccines must be transported, limit amount to what is needed for that workday

• Move vaccine to an appropriate storage unit and monitor temperatures at least 2 times during the workday (hourly if must be kept in portable storage unit)

Transporting Vaccines

Image Courtesy of CDC

See next slide on how to pack a refrigerated pack-out!

Packing Refrigerated Vaccines for Transport • CDC discourages routine transport

of vaccines˗ If necessary, recommended to use

portable refrigerator unit˗ If not available, use qualified

containers/pack-outs

• Important:˗ Use “Conditioned” frozen water

bottles, a hard sided cooler and insulating materials

˗ Place thermometer in cooler˗ Assess temperatures hourly &

document on temperature log˗ Respond to out-of-range

temperatures immediately˗ Keep a copy of temperature log for

3 years

www.michigan.gov/immunize or www.aimtoolkit.org

Transporting Varicella-Containing Vaccine

• To maintain varicella-containing vaccine viability, these vaccines should not be transported

• If transport is necessary

˗ Use a portable freezer type unit, monitor temperatures and contact LHD

• As a last option may use a refrigerated pack-out, which will likely damage vaccines

• If temperature is out of range, contact your LHD for VFC vaccine and the manufacturer for private vaccine

Review the “Guidance for Transporting Merck Varicella Vaccines” at www.michigan.gov/immunize or www.aimtoolkit.org

• Stand-alone refrigerators and freezers that are a pharmaceutical grade or purpose-built unit are meant to store vaccines

• A digital data logger is recommended: ˗ In every vaccine storage unit˗ For each emergency transport unit you have˗ Having at least one backup digital data logger in case a

primary device malfunctions or is out for calibration testing• VFC providers are required to have at least one backup certified

calibrated thermometer (digital data logger)

• Proper equipment helps ensure that the vaccine temperature is maintained and the vaccine is protected

• Training staff is one of the most important steps you can take in order to ensure proper vaccine storage and handling!

Key Points on Storage & Handling

Resources• Storage and Handling Toolkit:

www.cdc.gov/vaccines/hcp/admin/storage/toolkit/index.html• General Best Practice Guidelines: www.cdc.gov/vaccines/hcp/acip-recs/general-

recs/index.html• Educational modules, You Call the Shots:

www.cdc.gov/vaccines/ed/youcalltheshots.htm• Educational Webinars, Pink Book: www.cdc.gov/vaccines/ed/webinar-

epv/index.html• CDC Storage and Handling: www.cdc.gov/vaccines/hcp/admin/storage/index.html• CDC Vaccine Administration: www.cdc.gov/vaccines/hcp/admin/admin-

protocols.html• Immunization Action Coalition: www.immunize.org• Michigan Education Information: www.Michigan.gov/immunize

Thank you for all that you do

AND for playing IMMUNIZATION

CASH CAB!