Steven Vantine Educational Consultant, Immunization Branch Division of Communicable Disease Control, Center for Infectious Diseases California Department of Public Health, Immunization Branch Best Practices for Vaccine Storage and Handling

DisclosuresDisclosures Speaker has no financial conflict with manufacturers of any product named in this presentation. The use of trade names and commercial sources during this presentation is for identification only, and does not imply endorsement by the U.S. Department of Health and Human Services, the U.S. Public Health Service, the Centers for Disease Control and Prevention or the State of California, Immunization Branch.

Objectives VFC Program Requirements (the basics) Cold Chain & Inventory Management Temperature monitoring Proper vaccine storage and handling Consequences of improper vaccine storage Documentation

VFC Program Funding The program’s federal budget is almost $4 billion dollars California’s VFC Vaccine Budget: $500 M This make the VFC Program a highly visible program and part of the Federal Program Integrity Initiative Seeks to ensure the integrity of operations in all HHS programs, to reduce the risk of fraud, waste, and abuse

VFC Program Requirements

Designate a Vaccine Coordinator Put this information in writing (culpability) Annual Training Requirements Storing Vaccines (20 min) Monitoring Refrigerator Temperatures (17 Min) Monitoring Freezer Temperatures (15 min) Conducting a Vaccine Inventory (19 min) VFC Program Requirements (15 min) Vaccine Management Plan Screen for eligibility Record keeping

Annual Training Requirements Each clinic’s VFC Provider of Record and Vaccine Coordinator must complete annual EZIZ lessons to meet new federal education requirements on key program areas. Completion of EZIZ lessons will be tied in to annual VFC Recertification. Provider of Record must complete the lesson: 1. VFC Program Requirements Vaccine Coordinator must complete the following lessons: 1. Storing Vaccines (20 min) 2. Monitoring Refrigerator Temperatures (17 Min) 3. Monitoring Freezer Temperatures (15 min) 4. Conducting a Vaccine Inventory (19 min) 5. VFC Program Requirements (15 min)

EZIZ Lessons: Administering, Storing, and Monitoring Vaccines! Have you completed these lessons?

What is the ‘Cold Chain’? The vaccine cold chain is a temperature-controlled environment used to maintain and distribute vaccines in optimal condition. Monitor the temperature of your storage unit(s) regularly to assure that appropriate conditions are maintained. Take immediate corrective action when a storage unit temperature is outside the recommended range. If you are a VFC provider or have other vaccines purchased with public funds, contact your immunization program

What is the ‘Cold Chain’? NOT Vaccine appearance is NOT a reliable indicator that vaccines have been stored under appropriate conditions. Vaccine exposed to inappropriate temperatures that is inadvertently administered generally should be repeated. Contact your immunization program, vaccine manufacturer(s), or both for guidance.

Vaccine Manufacturer Vaccine Distribution Vaccine Arrival at Provider Facility Vaccine S & H at Provider Facility Vaccine Administration Manufacturer/Distributor Responsibility Provider’s Responsibility Cold Chain Flow Chart

Vaccine Potency What affects vaccine potency: - Light - Heat - Cold Once potency is lost, it cannot be restored. Each time vaccines are exposed to improper conditions, potency is reduced further. Eventually, if the cold chain is not properly maintained, potency will be lost, and the vaccines become useless.

Required Vaccine Storage Temperatures

Effect of temperature on vaccines Too cold (freezing 32°F. or below) Adjuvanted: Hep A Hep B diphtheria-tetanus-pertussis (DTaP, Tdap) Haemophilus influenzae type b (Hib) human papillomavirus (HPV) Pneumococcal Non-adjuvanted IPV Flu Too warm (above 46°F) Damage is gradual Vaccine manufacturers have conducted numerous stability studies, but most of the studies only show data to support vaccine viability when stored above the recommended temperature for up to 72 hours Source: Morbidity and Mortality Weekly Report: Notice to Readers: Guidelines for Maintaining and Managing the Vaccine Cold Chain; October 24, 2003 / 52(42); I NACTIVATED VACCINES AND TOXOIDS

Effect of temperature on vaccines Freezing 5°F. or below Lyophilized is freeze dried - undiluted, Lyophilized vaccines cannot be damaged by freezing Caution: DO NOT FREEZE DILUENT Too warm ( above 5ºF.) Damage is rapid or “quick” Varicella – does not tolerate any heat MMR also heat sensitive (store between - 58  F to 46  F). Although stable in either the refrigerator or freezer, we recommended to store in freezer. LIVE VACCINES

Thermometer Requirements Thermometer must meet the following specifications: Be accurate within +/- 1°F (+/-0.5°C). Be digital, with the digital display placed outside the unit to allow for temperature monitoring without opening the unit door. Must have a bio-safe, glycol-encased probe (or similar buffer solution), placed in proximity with vaccines. Must display current temperature, as well as the minimum and maximum temperatures, and have an out-of-range temperature alarm (visual or audible).

Thermometer Requirements Back-up thermometer: A minimum of one back-up thermometer (practices with multiple vaccine storage units may need more than one back-up thermometer) Must be available for use when primary thermometers are being calibrated or fail Needs to comply with VFC required specifications Needs to be placed in an easily accessible location

Thermometer Display RESET Press RESET to clear the MIN/MAX reading MODE Pressing MODE only shows LO/HI which are the alarm parameters

Thermometer Specifications digital and have a biosafe glycol- encased probe. External digital display to monitoring temperature without opening unit Display current, minimum and maximum temperatures. Be within +/-.5°C accuracy (+/-1°F). Temperature reset button Audible alarm

Thermometers that are Not Recommended Fluid-filled biosafe liquid thermometers Bi-metal stem thermometers Food thermometers Household mercury thermometers Reasons these are NOT recommended for monitoring temperatures. have significant limitations in temperature monitoring can be difficult to read and only indicate the temperature at the precise time they are read temperature fluctuations outside the recommended range may not be detected.

VFC DDL Policy Workgroup

Digital Data Loggers A digital data logger (DDL), also known as a “continuous temperature monitoring device” or just a “data logger,” is an electronic device that reads and records temperatures and then stores them in its internal memory. Temperatures recorded by a data logger can be viewed on a computer and saved as an electronic or paper file.

Digital Data Loggers

Information from a digital data logger helps clinic staff: Know the exact times and for how long vaccines are stored at specific temperatures; See how a storage unit’s temperatures increase and decrease during clinic operations; Continuously monitor temperatures even when the clinic is closed. Some data loggers have advanced, remote alert capabilities to notify clinic staff of excursions during non- business hours; Prevent unnecessary vaccine losses when excursion time frames cannot be precisely determined.

Minimum DDL Requirements The logger you buy must meet these technical specifications: Accuracy of +/-1°F (+/-0.5°C) Visual or audible alarm for out-of-range temperatures Low battery indicator Memory storage of at least 4,000 readings Current, minimum, and maximum temperature display User-programmable logging interval (or reading rate) Certificate of Calibration Buffered temperature probe immersed in one of the following: a vial filled with liquid (e.g. glycol, ethanol, glycerin); a vial filled with loose media (e.g. sand, glass beads); or a solid block of material (e.g. Teflon®, aluminum)

Minimum DDL Requirements A buffered probe is a temperature probe immersed or inserted in one of the following: A vial filled with liquid (e.g., glycol, ethanol, glycerin) A vial filled with loose media (e.g., sand, glass beads) A solid block of material (e.g., Teflon®, aluminum) If a temperature probe is obtained separately from a vial with fluid buffer material, vials filled with 15 mL to 60 mL of fluid are able to provide sufficient thermal buffering. A vial containing less than 15 mL of fluid buffer material can be suitable as long as the probe and buffer vial are sold as a system designed to achieve proper immersion (the smaller volume of buffering media will work to monitor temperature). Probes that are permanently imbedded in buffer are acceptable as long as the temperature monitoring system for the entire unit may be calibration-tested.

Configuration Settings

Responding to Temperature Excursions Steps when using a DDL What to report What to submit to VFC with incident report: Summary page only?

VFC – Job Aid IMM-1206

Calibration of DDLs Units must be calibrated in accordance with VFC Program requirements. Period for calibration is still 1-2 years. Back-up DDLs should have a different calibration schedule so that the backup is available when the primary is sent for calibration.

Thermometer Calibration & Certification Primary and back-up thermometers must be calibrated annually Calibration should be conducted by an ILAC/MRA accredited laboratory. Thermometers must be accurate within, +/-1°F (+/-.5°C) as indicated in calibration measurement results must be replaced. A valid Certification of Calibration must be kept on file and be readily available for review during VFC visits.

thermometer identification Calibration date and next date due Accredited Laboratory Name Measurement Results Conformance with ISO Standards Certificate #

Temperature Monitoring Temperatures for each unit must be read and documented twice each workday, at the beginning of the day and before closing. Additionally, minimum and maximum temperatures must also be read and documented at the beginning of each workday. Thermometer temperatures must be cleared after each daily MIN/MAX readings. Temperatures must be recorded on VFC-provided temperature logs, even if using a continuous temperature-recording device or digital data logger. Temperature logs must be posted in a visible location. Temperature logs must be maintained for three years. Temperature Logs are available through the VFC Program. Use these new logs to document CURRENT, MINIMUM and MAXIMUM readings. They can be downloaded on

2016 Temperature Logs Start using January 2016

Temp Monitoring Resources Temp Logs still contain: Temp logs display days 1 – 15 and 16 – 31 Temperature ranges are displayed in color and include step-by=step action to take in the event of too warm and too cold temps A quality assurance component for the practice on-site supervisor to verify the temps were recorded correctly A section to document names and initials of staff who monitor and record temperatures No more documentation page (providers will report temp excursions online through S.H.O.T.S.) Temp logs are available to download from

Vaccine Storage Requirements Most practices will need a separate refrigerator and freezer, but low and medium volume providers already enrolled in the VFC Program may continue to use household refrigerator/freezer combination units IF they meet all the required specifications.

Best practices for vaccine storage Store only vaccine in CDC/VFC Approved vaccine storage units. Separate the VFC vaccine supply from privately purchased vaccine. Place vaccine in breathable plastic mesh baskets and clearly label baskets by type of vaccine. Keep vaccines 2-3 inches from walls of the storage unit. Rotate vaccines (those expiring first should be placed in front) Transfer short-dated vaccine If you have vaccine that will expire in 4 months or less, contact other VFC Providers to see if they can use the vaccine prior to the expiration date. Needs VFC Approval before transfer. Place thermometer probe towards the center of the vaccine storage unit Clear your MIN/MAX thermometer 2x/day after documenting temperatures

What NOT to do…  No vaccine in doors, along walls  No vaccine in solid plastic trays or containers.  No food or lab specimens in refrigerator.  No vaccine in drawers or on floor of refrigerator.  Never plug into outlet controlled by wall switch.  DO NOT IGNORE OUT OF RANGE TEMPERATURES

What’s wrong with this picture?

Temperature Monitoring: Provider Requirements “A storage unit is only as effective as the temperature monitoring system inside.” “A thermometer costing a few dollars is not worth the risk of damaging thousands of dollars worth of vaccines because of inaccurate readings. In the long run, it is better to invest in a better-quality, more reliable calibrated thermometer because it is more cost-effective than replacing vaccine.”

Temperature Monitoring Temperatures for each unit must be read and documented twice each workday, at the beginning of the day and before closing. Additionally, minimum and maximum temperatures must also be read and documented at the beginning of each workday. Thermometer temperatures must be cleared after each daily MIN/MAX readings. Temperatures must be recorded on VFC-provided temperature logs, even if using a continuous temperature-recording device or digital data logger. Temperature logs must be posted in a visible location. Temperature logs must be maintained for three years. Temperature Logs are available through the VFC Program. Use these new logs to document CURRENT, MINIMUM and MAXIMUM readings. They can be downloaded on

Both of these providers documented similar out of range temperatures for at least 6 months Clinic refrigerator repeatedly dropped below freezing over a 17-month period in 2005 and 2006

Associated Press (01/21/05) Almost 3,900 people in Tennessee's Jefferson and Fayette counties must receive new vaccinations against influenza, hepatitis B, polio, pertussis, diphtheria, tetanus, and pneumonia after storage errors resulted in ineffective vaccines. East Tennessee regional director for the state Department of Health Dr. Paul Erwin says that the vaccinations were stored below freezing for a period of time when they were not supposed to be stored that way. Erwin notes that the ineffective vaccines are not dangerous, and patients requiring new vaccinations are being notified via certified mail.

Things to consider… How many patients do you immunize each day, week, month, or year? What if you had to recall all those patients that were immunized with non-viable vaccines? How will you explain to parents why their children must repeat the vaccine doses? Will your patients maintain their trust in you that you are providing quality care? Consider the costs, staff resources and patient time involved with having to revaccinate Avoid a situation like this and TAKE ACTION RIGHT AWAY if you notice out-of-range temperatures!

Storage and Handling Problem Protocol Notify your facility manger Contact the VFC Central Office and discuss the problem. You will be asked to go online to the VFC’s new “Storage & Handling Online Triage System” (S.H.O.T.S.) Follow the online instructions Mark the affected vaccines as “DO NOT USE UNTIL FURTHER NOTICE”. Store the vaccines in a properly working refrigerator or freezer while waiting for resolution. Do NOT use the vaccine until its efficacy has been determined.

S.H.O.T.S. S.H.O.T.S. – Storage and Handling Online Triage System The SHOTS can be accessed through the provider’s account at MyVFCvaccines.org

S.H.O.T.S. If excursion occur, providers will document the excursions on SHOTS SHOTS will keep track of the excursions and provide instructions to: Whether or not to use vaccines Contact manufacturers for further guidance Return spoiled vaccines to McKesson as directed

S.H.O.T.S.

EZIZ: One EZ Stop for IZ Resources!

Documentation

Documentation Under the “Proprietary Patient Medicine Act” (federal law) there are specific documentation requirements: Record the name of the medication Date and time the medication was administered Record the dose Record the route of administration (IM, SQ, oral, intranasal Record the manufacturer’s Record the vaccine lot # Chart the patient's reaction

PATIENT SAFETY 8 RIGHTS FOR MEDICATION ADMINISTRATION 1.Right patient 2.Right medication 3.Right dose 4.Right route 5.Right time 6.Right documentation 7.Right reason 8.Right response

Questions? Remember that your local county immunization coordinator, State Immunization Branch Staff and VFC Field Staff are here to help! Contact the representative in your area if you have any questions or need assistance.

Why we do what we do...

Steven J. VanTine Educational Consultant, Immunization Branch Division of Communicable Disease Control, Center for Infectious Diseases California Department of Public Health, Immunization Branch Office: