Indiana Immunization Coalition June 2013 Meeting

Indiana Immunization Coalition June 2013 Meeting

Identify 3 new recommendations for proper storage & handling of vaccines Describe the recommendations for the use of equipment used to monitor storage unit temperatures

Response to scientific studies conducted by NIST and recent OIG report CDC recommended for all public & private sector providers CDC recognizes cost may be a barrier Encouraged to move to implementing recommendations as soon as possible

S & H errors can result in: Loss of vaccines worth millions of dollars Reduced vaccine potency Inadequate immune response in patients Inadequate protection against disease Decreased patient confidence in provider when repeat vaccinations are required

Transport & Storage Equipment Trained Personnel Efficient Management Procedures

Use of stand-alone refrigerator and freezer units Discontinue use of dormitory-style storage units Use of digital thermometer with glycol-encased or temperature buffered probe to measure liquid temps Use of digital data loggers with detachable probe for 24 hour temp monitoring Routine maintenance of storage units Weekly review of vaccine expiration dates and rotation of stock http://www.cdc.gov/vaccines/recs/storage/interim.htm

Vaccine Cold Chain Vaccine Management Practices Storage & Handling Plans Vaccine Personnel Vaccine Storage Equipment Vaccine Storage Practices Temperature Monitoring Trouble-shooting Temp excursions Vaccine Preparation http://www.cdc.gov/vaccines/recs/storage/toolkit/storage-handling-toolkit.pdf

Stand-alone units (only refrigerate or freeze) are recommended Maintain temperatures better than combination refrigerator/freezer units Household, commercial or pharmaceutical grade

OK to use combination unit if using only the refrigerator Adjust thermostat to temps above 35 F (2 C). Place vaccines away from air vents Keep vaccines that are not sensitive to cold on top shelf (ie MMR) Do not use the Freezer compartment Defrost cycles cause temperature spikes above acceptable range

Small combination unit with 1 exterior door and icemaker compartment (freezer) Large temp gradients inside the unit Temperature stability issues Potential to freeze vaccines

Maintain required temps year round Large enough to hold year s largest inventory Dedicated to vaccines only Sufficient room to store water bottles (fridge) and frozen coolant packs (freezer)

Certified calibrated thermometers Digital thermometer with detachable probe in glycol-filled bottle Per CDC, thermometers with probes encased in glass beads are acceptable

Digital active display with detachable probe in glycol-filled bottle Conducts continuous monitoring of temps at programmed intervals (set by user) Alarm for out-of-range temps Low Battery indicator Temperature Min - Max display Accuracy is +/-1 F (+/- 0.5 C)

Place thermometers in the center of the storage compartment in proximity to stored vaccines

Refrigerated vaccines: 35º-46ºF (2-8ºC) Set the temperature mid-range to achieve an average of about 40ºF (5ºC). This temperature will provide the best safety margin. NEVER FREEZE REFRIGERATED VACCINES Freezer vaccines: HZV, VZV, MMRV, MMR* 5ºF (-15ºC) or colder The freezer compartment should maintain an average temperature of 5ºF (-15ºC). AUTO DEFROST OR FROST FREE UNITS ONLY

Only one person allowed to adjust temperatures on storage units Remove all drawers from household refrigerator units Place water bottles in refrigerator against walls or in doors Place ice packs in freezer

TEMPERATURE DOCUMENTATION Record temperatures twice daily with the min max temp reading in the morning Store temperature logs for 3 years

Recording is not enough. If temperature is outside of recommended range you must take immediate action! You must also document steps taken to correct the temperature. Have a back up Emergency Plan Review ISDH Storage & Handling Emergency Plans Policy

Avoid using power outlets with built-in circuit switches Use a safety-lock plug or an outlet cover to avoid unplugging Post a warning sign at the plug and on the refrigerator/freezer units Label the fuses and circuit breakers to alert people not to turn off the power to the storage units

Monthly Maintenance: Clean coils and motor Clean refrigerator and freezer units When cleaning unit transfer to packed nearby cooler Check the door seal Clean the drain pan (frost-free freezers only)

Keep vials in cartons with lids intact to protect from light Allow space between cartons for circulation of air and temperature stability Keep private and VFC stock separate Diluents with antigen and diluents packaged with vaccine should be stored with vaccine in refrigerator Store vaccine with similar packaging or product names in different locations of the storage unit

Never store food, drink, or lab specimens in refrigerator/freezer with the vaccines Do not store vaccines in doors or drawers; do not store on floor of refrigerator OK to store biologics or medicines on lower shelf of fridge unit

Providers should never allow a single dose of vaccine to expire in their storage unit

Always do a weekly inventory of all vaccines stored in your storage unit and make a note of any vaccines that will expire in the next 90 days. Move the short-dated or soon-to-expire vaccines to the front and use these doses first. VFC Providers: if unable to use the vaccine before it will expire, contact the Immunization Division for a vaccine transfer.

Each provider office should develop a routine vaccine management plan in addition to their emergency plan. ALL VFC providers must train their staff on this plan annually and must have a log documenting date and attendance at the training.

Purchased 500 data loggers with interface cradles One per provider VFC PIN (per request) Providers download temperature data weekly Purchased 250 freezers Targeted provider offices with single dial units or needing new storage units Shipped directly to clinic location from warehouse

Questions?

SEA 0415 (signed May 7, 2013) All providers must enter immunization records into CHIRP for individuals under the age of 19 years Includes a complete record for the immunization Effective July 1, 2015 39

HEA1464 (signed April 29, 2013) Pharmacist can administer additional immunizations under drug order, prescription or standing protocol signed by physician Pneumonia (PPSV23); tetanus, diphtheria, acellular pertussis (Tdap); human papilloma virus (HPV); and meningitis (MCV4 or MPSV4) Requires entry of all records into CHIRP Previously standing protocol only allowed for individuals 14 and older for influenza 40

Eligible Provider Locations Birthing hospitals, birthing centers and prenatal clinics Financial Eligibility Not privately insured or Medicaid eligible Uninsured patients only Risk Eligibility Pregnant women Parents, household members (who live in same dwelling) and family caregivers of an infant under 12 months (1 year) of age

9 new providers enrolled as of 6/30/13 Large community health centers Offer prenatal services in addition to primary care for children and adults Continuing to enroll providers throughout remainder 2013

THANK YOU!