This presentation focuses on recent changes in vaccine storage and handling requirements for the State Childhood Vaccine Program. 1
Universal vaccine policy since 1989 All children have access to vaccines to prevent childhood diseases Federal and state dollars purchase vaccines DOH delivers vaccines to public and private providers Primary care providers are key to vaccine delivery system (promotes every kid having a medical home ) The right shot at right time achieved through CHILD Profile registry driving timely health notices and promotion materials to parents and providers 2
We are very fortunate in Washington to continue to provide all vaccines for all children less than 19 years of age. It takes the partnership of the CDC, who funds the Vaccines for Children Portion of the Program (about 63% of the funding for vaccines in Washington), the Washington Vaccine Association, which funds the remaining 37% of funding for vaccines. The providers throughout our state assure vaccine is available to children in their medical homes when they present for vaccination. State and local public health staff support quality assurance for vaccine storage and handling, enrollment in the program, best practices in program implementation and other aspects of assuring the infrastructure that supports the State Childhood Vaccine Program. In 2012 we distributed about three million doses of vaccines throughout the state. The vaccine was made available to providers and to children at no cost. The value of the vaccine distributed in 2012 was over $130 million. Rather than look at vaccine storage and handling as requirements to meet some reporting need, it s important for providers to view vaccine storage and handling as a best medical practice. Viable vaccine protects children from serious diseases, and assuring vaccine viability is what best practices in storage and handling are all about. Maintaining these best practices also assures Washington can continue to benefit from the federal Vaccines for Children Program if we meet these requirements, our participation in the program is not threatened. 3
Storage and handling is about protecting the health of children, and preventing life-threatening diseases. It s a life and death matter! If kids don t get viable vaccines, they are not protected from the diseases we re trying to prevent. If a child gets non-viable vaccine and they have to get revaccinated, or if they get a disease they ve been vaccinated against, the trust they have in their health care provider is damaged. Their concerns over vaccines may increase. A parent who is hesitant about vaccination may become a parent who resists or refuses vaccination. If children have to be recalled for vaccination, the clinic loses time and money. The amount of time it takes staff to recall children, explain to parents why the child is being recalled, rescheduled immunization visits, and juggle scheduling to fit extra kids in is significant. Time is money in the provider office. Additional costs may result from the provider having to pay for extra clinic hours, communication plans, postage (if they mail materials or recall cards out to patients). It also costs to replace the spoiled or wasted vaccines, and it may cost the provider to reimburse for the cost of vaccines to revaccinate children. If providers spoil vaccine they may be required to pay for the vaccine that was lost or to privately purchase vaccine to conduct the revaccination effort. 4
We believe that most providers are invested in making sure their patients are protected by assuring their vaccine is viable through best practices in storage and handling. Nationally some serious concerns were raised by an Office of Inspector General inspection of providers participating in the national Vaccines for Children Program. In May of 2012, the Office of the Inspector General went to 45 provider sites in 5 different states. They found some pretty significant problems with vaccine storage and handling. These findings led the CDC to make changes in storage and handling practices. The bottom line is that these findings put patients at risk practices that were not using best practices in storage and handling were putting patients at risk and in some cases were actually not protecting children against diseases even though they were vaccinating them. The issues that were found threatened the federal childhood vaccine program because of the huge financial investment in the vaccines (nearly $4 billion each year). 5
The certificate shows the thermometer s accuracy was measured against a National Institute of Standards and Technology (NIST) or American Society for Testing and Materials standard. When the provider buys a thermometer, they should ask for this certificate. They should find out how long the certificate is valid and when to recalibrate the thermometer. The provider should check the cost of recalibration -- it may cost less to buy a new certified thermometer. The provider should have your current certificate(s) on hand for the primary thermometer in each storage unit. : Federal law requires that providers give current VIS to patients each time they get a vaccine. It s easy to keep up-to-date on VIS forms by getting updates from the CDC e-mail distribution list: https://service.govdelivery.com/service/subscribe.html?code=uscdc_11_1 The CDC requires nine vaccine management policies documenting the provider s vaccine coordinators are and how you order, store, handle, transport and manage vaccine inventory. They require an emergency vaccine storage plan and its review schedule. In 2013 a policy is required for documenting staff training on vaccine storage and handling. Check to make sure you have these policies in place. Train your staff on the policies, update them at least once a year and keep them on hand for your compliance site visit. Templates for the policies are on our website. (Scroll down to VFC and AFIX Provider Resources): http://www.doh.wa.gov/publichealthandhealthcareproviders/publichealthsystemresourcesand Services/Immunization/SiteVisits.aspx Federal law requires the vaccine name, manufacturer, lot number, the VIS publication date, the date the VIS was given, the name and title of the person giving the vaccine, the address of the clinic where the vaccine was given and the VFC status of the patient. We check to make sure providers capture all of these things in the patient record, and follow-up on findings discovered during a compliance site visit. 6
CDC updated recommendation on storage units. In the next section, we ll cover various recommendations on these units. 7
We thought it would be good to start by reviewing the current recommendations. Most of these recommendations did not change. Stand alone refrigerators and freezers only have to maintain a single temperature range. It is easier for single purpose units (either refrigeration OR freezing) to maintain the correct temperature range for the vaccines that are stored in them. Laboratory grade refrigerators that are purpose built for temperature sensitive biologics and are sold by laboratory or medical supply companies. This type of unit is made for vaccines and gives the best possibility of vaccines being stored appropriately. We ve allowed combination refrigerator / freezer units to be used in the past. We required these combination units to have separate insulated doors for the refrigerator and freezer. In 2009 we stopped allowing providers to use dormitory style units for long term (over night) storage of vaccines). We allowed them to be used for day storage, if the vaccine was returned to the long term storage unit at the end of the day. 8
The major change in storage and handling requirements related to storage units is that dormitory style units will no longer be used for any vaccine storage. We must verify to CDC that no provider enrolled in the Washington State Childhood Vaccine Program is using a dormitory style refrigerators. For the last 3 years, we ve visited 50% of our providers (about 575 providers) each year. This means every provider receives a compliance site visit every other year. We are verifying this in two ways (1) the site visit review of the 50% of our providers receiving a compliance site visit this year, and (2) through written verification from all remaining providers. 9
Providers who are using dormitory style units for day use have a couple of options for making this change: They can purchase a small under counter purpose built or lab grade refrigerator; or a stand alone refrigerator only unit. They can store vaccine in their over night storage unit, and have staff get their vaccine from the long term (or overnight) storage unit for each vaccination. 10
The National Institutes of Standards and Technology tested the freezer and refrigerator compartments of combination refrigerator/freezers for temperature stability. They found that the freezer compartment does not keep temperatures cold enough for frozen vaccines. We recommend providers get a stand alone freezer for frozen vaccine storage. The refrigerator section of the refrigerator/freezer unit may still be used. Providers should be sure to follow all recommendations regarding temperature monitoring, placement of vaccines in the refrigerator, use of water bottles to stabilize temperature and other best practices in vaccine storage and handling to assure vaccine viability. Providers should not turn off the freezer section as it is important to maintaining the temperature of the refrigerator portion. Combination refrigerator/freezers use the cold air from the freezer to cool and maintain the temperature in the refrigerator section of the unit. There is no timeline for replacing combination refrigerator/freezers. At this point it is a recommendation, not a requirement. When providers need to replace their combination units, they should replace them with stand along refrigerators and freezers or laboratory grade storage units. 11
Another area identified for improvement during the OIG report, was the type of thermometer used and the way temperatures were monitored. This section of the presentation will address those changes. 12
The CDC requires that providers must have a current certificate of calibration for each thermometer used by the clinic/practice need to document the serial number and the date of expiration. 13
The CDC made several recommendations based on the findings from the OIG report. This list includes the characteristics a provider should look for when purchasing a thermometer for monitoring the storage temperatures of vaccines. 14
The CDC recommends digital data loggers because of their ability to continuously record temperatures, how they record the data, how temperatures are displayed and the ease with which providers can view and understand what is happening with the temperatures in their vaccine storage unit. The minimum and maximum temperature display allows the provider to know how the unit is performing not just the current temperature. This may help identify problems before they turn into storage incidents. Being able to reset this display allows the provider to review temperatures over a 24 hour period. Have a record of temperatures allows the provider to go back and review changes in the temperature and identify trends in temperature that may help warn of problems with how the unit is functioning. The CDC recommends that temperatures in continuously recording units chart the temperature every 15 minutes. 15
Although your clinic receives childhood vaccines at not cost, they are not free. A single dose of some publicly purchased vaccines can cost more than $100. Yes, a single dose! If you think about the number of doses of vaccine you receive each year, the cost is staggering! Taking care of your vaccine requires training and conscientious monitoring. It also warrants the use of high quality storage and monitoring equipment. We are privileged to be in a state that places a high value on the health of our children, and is willing to invest in the vaccine to protect them from vaccine preventable diseases. It s an investment worth making! A lab grade, under the counter refrigerator unit costs about the same as 10 doses of HPV vaccine. If a provider office had to pay to replace just 3 doses of HPV vaccine, it would cost as much as one of the fanciest data loggers available! If providers use equipment that doesn t meet the best practice standard, and they have a vaccine loss because of it, they may have to replace the vaccine that is lost if a vaccine incident occurs. Not only that, but they run the risks of the other costs associated with having to revaccinate children who received non-viable vaccine. 16
The requirements for monitoring the temperatures in vaccine storage units haven t changed. Providers should keep a posted temperature monitoring log, and staff should record the temperatures twice a day, noting the time the temperature was read, the temperature of the unit, the room temperature and the initials of the staff recording the temperature. Staff should be trained to act if a temperature drops out of the safe zone. CDC is recommending that once a day, preferably in the morning, providers record the minimum and maximum temperatures a unit reaches. We redesigned our temperature monitoring log to accommodate these once a day minimum and maximum readings. The CDC also recommends that continuously recorded temperatures be reviewed at least once a week, to determine if there are any trends that show the unit may be failing, or if any out of range temperatures occur at any time during the week. If providers find a temperature out of range, they should follow-up with their local health jurisdiction for assistance and direction. 17
Providers have always been asked to review their inventory each month and rotate short dated vaccine stock to the front of the storage unit so it can be used before it expires. Now, the CDC requires providers to review their inventory each week to identify short data vaccines and assure they are used before they expire. Providers who have vaccines that will expire within 3 months must contact their LHJ for help in transferring the stock to another provider so it can be used before it expires. Providers may also want to review expiration dates and rotate stock as new orders come in. The provider is not required to document stock rotation each week. They are required to complete their monthly report of vaccine usage. It is important that providers are able to easily distinguish between state supplied vaccine and privately This can be done by marking private stock, on privately purchased vaccine, labeling shelves, storing private stock on separate shelves, or in separate storage units. This is checked during the site visit. 18
We ve had several questions about emergency vaccine storage recently. We d like to start by just outlining some key elements: First, the reason for having a plan is to assure staff and providers know what to do before an emergency happens. The plan should include who and how vaccine would be removed and transported to a back-up storage facility if needed. The plan must include an option for how vaccine will be kept viable if the power goes out including the use of a generator on-site, or alternative storage off-site. 19
This is a snapshot of our guide for what to do when a storage incident occurs. It covers who to contact (LHJs, the power company, the equipment vendor etc.,) and what to do if there is a power outage.
This is a sample of our template for an Emergency Storage Plan. It s designed to tell staff what to do if there is an emergency, what information to have on hand, how to move vaccine if necessary. It can be used to practice so staff are ready if an emergency happens. The plans should be reviewed with all staff, and the date of the review should be recorded. The documentation will be reviewed during the provider compliance site visit. 21
This is a snapshot of the Vaccine Incident Report Form. It is required for any vaccine incident resulting in the loss of vaccine. The document has space to record the national drug code, lot number and expiration date and other information about the vaccines involved, and the number of doses affected. It also has a place to record what happened, and what action was taken to assure it doesn t happen again. The form includes instructions for returning non-viable, un-opened vaccines. Please note, single dose syringes (without needles) and vials can be returned. Open multidose vials should not be returned, but should be recorded on the form. 22
One of the areas the OIG report revealed as needing improvement was staff training. 23
Previously, providers were required to have 8 written plans. We provide templates for those plans on our website. For 2013 and moving forward, a new Vaccine Management Plan, called the Vaccine Storage and Handling Training Plan, is required for all practices. Our template provides information about how the training requirement will be met, and a place to record the names and dates of staff training. Staff are expected to receive training when hired and each year after that. 24
We ve made a lot of progress on formalizing training for state and local health staff over the last 3 years. We require state and local health staff to pass site visit training that focuses on vaccine storage and handling and the administration of the VFC Program. This year, we need to put a plan in place (literally, each provider will need a written plan) for assuring the primary and back-up vaccine coordinator (at least) are trained in vaccine storage and handling best practices, and that staff who screen for VFC eligiblity are also trained. We ll verify this for the CDC through the site visit process for 50% of the providers who ll get a site visit this year, and through a written verification from the remaining 50%. 25
Several areas related to record keeping have also been updated. 26
For several years we ve required providers to screen every child for their Vaccines for Children Status at each immunization visit. We ve required that the status be updated if it changed. Now the CDC is requiring that every child be screened and that their VFC status be documented at every immunization visit. Many providers may already be in compliance with this requirement. We will check for compliance with this item during the provider compliance site visits. At each visit, site visit reviewers will pull 10 patient charts, or review 10 electronic charts. They review the charts for completeness with the federally required data elements, including the whether or not the child s VFC status is documented. The goal is that 100% of charts show the screening. Missing federal chart documentation data is one of the most frequently missed items during the compliance site visit. Providers should assure accurate record keeping for their patient safety, and for meeting the federal requirement. 27
The Affordable Care Act resulted in a 2 year change in the allowable administration fee that can be charged for kids who are underinsured or uninsured. New $23.44 Centers for Medicare and Medicaid (CMS) cap. Don t charge an administration fee greater than $23.44 for patients who are uninsured or underinsured. Bill Medicaid and private insurance based on their guidelines. Medicaid determines the administration fee for children covered under Medicaid, and providers should contact Medicaid if they have questions about the administration fee. Medicaid has a web-site for information about their process: Private insurance determines the administration fees they allow for their members. Providers should contact private health plans for information about billing for their members. 28
Fraud = Intentional deception or misrepresentation Abuse = Unintentional practices Non-compliance on the Site Visit Questionnaire is the 1 st step to potential F&A This can include improper storage and handling of vaccines, especially if corrective actions are not implemented when problems are identified. Charging to high an administration fee for a VFC eligible child, using state supplied vaccine for populations it isn t intended for or failing to meet federal requirements may be identified as fraud or abuse. 29
Remember it s not just a requirement! It s a way to make sure kids are protected from serious diseases and death when the provider vaccinates them. Best practices in vaccine storage and handling are the best standard of medical practice related to immunizations. Protect children from bad diseases, maintain parent s trust, and assure your site visit goes off without a hitch! Protect your vaccine and protect the kids in your practice! 30
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