Alan Hinman



EpiVac Pink Book Netconference

Vaccine Storage and Handling; Vaccine Administration–2018

Tina Objio

Dr. Andrew Kroger: Welcome to the 2018 EpiVac Pink Book Netconference Webinar Series. Today’s topic is Vaccine Storage and Handling and Vaccine Administration 2018. I’m Andrew Kroger; I’m a medical officer in the Immunization Services Division of the National Center for Immunization and Respiratory Diseases or NCIRD at the CDC and I’ll be the moderator for today’s session.

Here are the learning objectives. At the conclusion of this session, the participant will be able to describe the different forms of immunity; describe the different types of vaccines; for each vaccine-preventable disease, identify those for whom routine immunization is recommended; for each vaccine-preventable disease, describe characteristics of the vaccine used to prevent the disease; describe an emerging immunization issue; locate resources relevant to current immunization practice; and implement disease detection and prevention health care services—for example, smoking cessation, weight reduction, diabetes screening, blood pressure screening, and immunization services to prevent health problems and maintain health.

Today’s topic is Vaccine Storage and Handling and Vaccine Administration for 2018, which is based on the fifth and sixth chapters of the CDC textbook, Epidemiology and Prevention of Vaccine-Preventable Diseases or the Pink Book. It will be presented by Tina Objio, a nurse educator in the Communication and Education Branch in the Immunization Services Division in CDC NCIRD.

Continuing Education or CE credit is available through Training and Continuing Education Online System at getCE. If you are watching this version live, the course number is WC2645-071118. CE credit for the live course expires August 16th, 2018. If you’re watching an enduring or archived course, the course number is WD2645-071118. CE credit for the enduring course expires June 1st, 2019. A course access code is required for this webinar. Please make note of this code; course access codes will not be given outside of the course presentation. Instructions are available in the Resource Pod.

In compliance with Continuing Education requirements, all presenters must disclose any financial or other associations with the manufacturers of commercial products, suppliers of commercial services, or commercial supporters, as well as any use of unlabeled products or products under investigational use. CDC, our planners, content experts, and their spouses or partners wish to disclose they have no financial interest or other relationships with the manufacturers of commercial products, suppliers of commercial services, or commercial supporters. Planners have reviewed content to ensure there is no bias. Presentations will not include any discussion of the unlabeled use of a product or a product under investigational use. CDC does not accept any commercial support.

If you have a question, please enter your question into the QA Pod. We will answer selected questions during the question and answer session following Tina’s presentation. And so I will now turn the microphone over to Tina. You may begin.

TINA OBJIO: Thank you, Dr. Kroger. Good afternoon, everyone. I am pleased to be here with you today presenting Vaccine Storage and Handling and Vaccine Administration. If you’re following along in the 13th Edition of Epidemiology and Prevention of Vaccine-Preventable Diseases, the Pink Book, there’ve been some updates since the Pink Book was published, so there’s some information on these presentation slides that’s more current. These slides and a resource page are posted on the web page for this program.

Let’s start with vaccine storage and handling, which is chapter five on page 63 for those following along in the Pink Book. It’s critical that the vaccine storage and handling cold chain, which is a temperature-controlled supply chain or environment, is maintained from the time a vaccine is manufactured until it’s administered. As you can see in the image on this slide, the majority of the responsibility for maintaining the vaccine cold chain occurs at the provider level, so it’s essential to have a well-trained staff, reliable storage and temperature monitoring equipment, and accurate vaccine inventory management.

Here’s an image of CDC’s 2018 Vaccine Storage and Handling Toolkit. This is CDC’s most comprehensive and current source of recommendations and best practices for vaccine storage and handling. Also on this slide are links to CDC’s General Best Practice Guidelines for Immunization and FDA’s website for information on vaccines licensed for use in the U.S. You can find the manufacturers’ package insert for each vaccine from this FDA page.

Every facility should have plans with standard operating procedures or SOPs for daily management of their vaccine supply. And also, emergency procedures that spell out what to do to protect vaccines in the event of an emergency. If you do not have these SOPs in place, there’s more detail in CDC’s Storage and Handling Toolkit to help you develop them. Be sure to keep plans and SOPs near the vaccine storage units and ensure that your staff is familiar with the contents and their potential roles or activities. Remember that things can go wrong outside of normal operating hours. Be sure that custodial and security staff know who to contact in the event of an after-hours emergency.

There should be one person in your facility who takes primary responsibility for vaccine storage and handling management and there should also be at least one back-up person who can take over in the absence of the primary coordinator. The primary coordinator and back-up coordinator are not the only people who should be familiar with how to store and handle vaccines. Storage and handling training should be provided to all staff who handle or administer vaccines during their orientation, during annual refresher training, and any time recommendations change or new vaccines are added to your inventory.

Routine vaccine orders are generally made on a monthly basis, so conduct an inventory of vaccines and diluents before placing an order to avoid overstocking.

Another issue that can sometimes cause problems and expensive loss of vaccines is improperly handling vaccine deliveries. Arrange deliveries when the vaccine coordinator or back-up person is available and notify them immediately when the shipment arrives. Examine deliveries as soon as they arrive and then store the vaccines at the proper temperatures right away. Examine the shipping container and its contents for any evidence of damage and cross-check the contents with the packing list to be sure they match. Check heat and cold temperature monitors or indicators if they are included in the shipping container. You will need to follow instructions on the monitors for reading and reporting any problems. If a monitor indicates a possible temperature excursion during shipping, the vaccines in question should be properly stored, separate from other vaccines, and marked. “Do Not Use.” Then, according to your facility’s policies, consult the immunization program, distributor, or vaccine manufacturer for guidance.

In addition to well-trained staff, you need the appropriate equipment. CDC recommends using purpose-built units, sometimes called pharmaceutical-grade units, designed to either refrigerate or freeze. A secondary option is a stand-alone household unit. We know from studies that have been done these types of units are the best at maintaining the required temperature ranges for vaccines.

Vaccines stored in the freezer should maintain temperatures between 50 degrees Celsius and -15 degrees Celsius or -58 degrees Fahrenheit and +5 degrees Fahrenheit. The thermostat should be at the factory-set or midpoint temperature setting to assure appropriate frozen storage temperatures.

Refrigerated vaccines should be stored at temperatures between 2 degrees Celsius and 8 degrees Celsius or 36 degrees Fahrenheit and 46 degrees Fahrenheit. The thermostat should be set at midrange to achieve a temperature of about 5 degrees Celsius or 40 degrees Fahrenheit, which will decrease the likelihood of temperature excursions.

It’s important to remember that when vaccines are exposed to temperatures outside the recommended ranges, the losses can be very costly, not only in vaccines and replacement, but also in staff resources and confidence in your facility if patients have to be recalled for revaccination. So it’s less costly in the long run to use good equipment that will maintain the appropriate temperatures. If you must use a household-grade combination refrigerator/freezer unit, you should only use the refrigerator compartment for storing vaccines. These units have cold spots and temperature fluctuations and air circulating from the freezer could expose refrigerated vaccines to freezing temperatures. If you are using a household combination refrigerator/freezer, leave the freezer on at the factory-set or midpoint temperature setting to maintain proper temperatures in the refrigerator.

Water bottles should also be placed in the refrigerator to help stabilize temperature that can be destabilized by frequently opening and closing unit doors or power failure. Do not use the freezer compartment of a household combination refrigerator/freezer to store vaccines. Use a separate stand-alone freezer to store frozen vaccines.

We used to always have concern about vaccines getting too warm, but actually, more damage can be done if refrigerated vaccines are exposed to freezing temperatures. CDC does not recommend using dormitory-style units at all—not even for temporary storage. And VFC does not allow them to be used. Studies have shown that these dormitory-style units cannot reliably and consistently maintain the recommended temperatures for both refrigerated and frozen vaccines. That little freezer area where the green arrow is pointing is not sufficient to maintain the appropriate freezer temperature for frozen vaccines, but it can expose refrigerated vaccines to freezing temperatures. But not all small storage units are dormitory- or bar-style units; compact purpose-built units for biologics can be used to store vaccines. Just make sure the storage unit has enough space to store the largest inventory you might have at the busiest point in the year without crowding—for example, during flu season or back-to-school immunizations.

An accurate temperature history that reflects actual vaccine temperatures is critical for protecting your vaccines. Every vaccine storage unit must have a temperature monitoring device or TMD and investing in a reliable device is less expensive than replacing vaccines wasted due to inaccurate temperature readings. For monitoring the temperature in your storage unit, CDC recommends using a continuous temperature monitoring device called a “digital data logger” or “DDL” with a buffered probe. The DDL should have a current, valid certificate of calibration. This certificate is required for providers who have vaccines purchased with public funds. Calibration testing should be done every one to two years or according to the manufacturers’ recommendation to ensure that the device is continuing to record accurate temperatures.

We often get questions about which temperature monitoring device CDC recommends; of course, CDC does not recommend or endorse any specific product or manufacturer. However, we do have a list of recommended features that can be used as a starting point when you’re looking at different products. And your organization may have additional needs or preferences like ease of use or technology compatibility, so you can certainly add to the basic feature list recommended in the toolkit when you’re searching for a new DDL. This slide and the Storage and Handling Toolkit contain a list of the recommended features for a temperature monitoring device and many of the state immunization programs can also provide guidance on selecting a device. The most important thing is to be sure that your staff is trained on how to set up and properly use whatever type of device you have.

If you’re using a DDL, check and record storage unit minimum and maximum temperatures at the start of each workday. This is a requirement for Vaccines for Children or VFC providers. The min/max temperatures recorded should be those obtained since the last workday when the min/max temperatures were reset. If your device does not display min/max temperatures, then check and record the current temperature a minimum of two times, at the start and the end of the workday.

A temperature monitoring log sheet should be placed on each storage unit door or nearby and the following information should be recorded: temperature, date, time, and the initials of the person recording the information. If a reading is missed, leave that entry space blank on the log. This information, along with the room temperature, can be very helpful if there has been a temperature excursion and you’re seeking guidance on whether the vaccine can still be used.

Also, check the current temperature each time vaccines are accessed in the storage unit. These checks also provide an opportunity to inspect the storage unit, reorganize any misplaced vaccines, and remove any expired vaccines.

Review storage unit temperature readings and review continuous DDL software or website information for changes and temperature trends that might require action. File this information so it can be analyzed for long-term trends or recurring problems. Temperature data should be kept for threeyears unless state statutes or rules require a longer period. If there appears to be any fluctuation in temperature, troubleshoot the problem based on additional information provided in the Vaccine Storage and Handling Toolkit, manufacturer manuals, or your office storage and handling SOPs.

Always be sure to take immediate action if there’s a temperature excursion. A temperature excursion is any temperature reading outside ranges recommended in the manufacturer’s package insert. However, do not immediately discard the vaccines. Store them properly, separate from any vaccines that are not in question, and mark “Do Not Use” on the vaccines that are in question. Then, according to your policies, contact the immunization program, the vaccine manufacturer, or both for guidance.

The Immunization Action Coalition has a vaccine storage troubleshooting record, shown here on the top right, that you may use to document an excursion and the corrective action taken.

The document on the bottom right is a tool that can be found in the resources section in the back of the Vaccine Storage and Handling Toolkit. This is a great step-by-step tool describing how to handle temperature excursions.

When preparing to store a particular vaccine, always check the manufacturer’s package insert for storage and handling information specific to that product. Avoid storing vaccines near walls, coils, cooling vents, the top shelf, the ceiling, the floor, or back of the unit because these areas are more likely to have variations in temperature. Keep vaccines and diluents in the original packaging with the lids closed until ready to use. This will help maintain the temperature, avoid unnecessary exposure to light, and may help prevent administration errors. Arrange vaccines and diluents in rows by same type with rows separated by two to three inches; this will promote good air flow around the vaccines. You can store vaccines and diluents in their original packaging in clearly labeled storage bins to help keep things organized and separated. Store pediatric and adult formulations on different shelves and do not store sound-alike and look-alike vaccines next to each other. For example, don’t put DTaP and Tdap right next to each other. Using labels with vaccine type, age and gender indications or that are color-coded can also help prevent administration errors. We’ve included a link to a website with vaccine label examples that you may find helpful.

Do not store vaccines in the doors or deli, vegetable, or fruit crisper drawers. And as a side note, your temperature monitoring device’s buffered probe should not be placed in any of these locations either. It should be placed with your vaccines so that it will accurately reflect the temperature of the vaccines. And do not freeze diluents. We have included a link to a helpful job aid, shown on the right, about proper storage of various diluents. The manufacturer package insert for each product also contains product storage information. Also, if you’re a VFC provider, consult your state program for guidelines on storing VFC vaccines and privately purchased vaccines.

Be proactive and take preventative measures to protect your vaccines. Plug the storage unit directly into the wall. Plug only one unit into an outlet. Use a plug guard or safety-lock plugs that you don’t have to worry about anyone unplugging your unit like custodial staff. Install a temperature alarm to alert you if a problem occurs when the facility is closed. Label circuit breakers and electrical outlets so that workers who may be in the building will not disrupt power to your storage unit. And post warning signs that include emergency contact information in case something happens when the facility is closed. Do not use power outlets with built-in circuit switches or power outlets that can be activated by a wall switch. And do not use multioutlet power strips.

Use water bottles in the refrigerator and freezer to help maintain the correct temperatures. Never store personal food and beverages in the same unit with vaccines. If other biologics must be stored in the same unit, store them below the vaccines to avoid spillage and contamination of your vaccines. Inspect your storage units daily to make sure the thermometer and vaccines are in place and there are no concerns about damage. And most importantly, take immediate corrective action when there’s a problem.

Unfortunately, we hear too often about administration of expired vaccine. Check all vaccine and diluent expiration dates a minimum of weekly. Rotate stock so that the vaccines and diluents with the soonest expiration dates are used first so that you can avoid waste. Get expired vaccines out of your storage unit so that somebody doesn’t accidentally administer a dose from one of these vials. If you are a health care provider, you are individually responsible to check the expiration date of anything you are preparing to administer. Some vials have an expiration date that includes the month, day, and year; others only have the month and year. If month, day, and year are included, then the vaccine can be used until the end of the day noted on the product. If only the month and year are given, the vaccine can be used through the last day of that month.

Of course, this only applies as long as the vaccine is stored and handled properly and is normal in appearance. There are exceptions to the expiration date printed on the product. Once a vaccine is reconstituted, the clock is ticking. The package insert will indicate the beyond use time or date, which is referred to as the B-U-D or BUD. It may be 30 minutes, 8 hours, 24 hours, or in the case of a multidose vial, it could be a number of days. Also, the expiration date may change for a multidose vial once it’s opened; for example, there are some influenza vaccines that must be used within 28 days once the vial stopper is punctured.

And a third exception may occur if there’s a temperature excursion; the manufacturer may say that the vaccine can still be used, but they will shorten the expiration date. Any time there is a change in the date, it should be noted on the product along with the initials of the person making the change.

And there’s one other precaution that does not relate directly to the expiration date; package inserts will likely indicate the number of doses that may be taken from a multidose vial. Once that number of doses is withdrawn, the vial should be discarded, even if there’s residual and the expiration date has not been reached.

We get a lot of questions about moving vaccines. Two common reasons that people would need to plan for movement of vaccines are off-site or satellite immunization clinics like a flu vaccine clinic and emergency transport like power outage after a major weather event. Be sure to follow the Vaccine Storage and Handling Toolkit guidance for the set of circumstances that apply when creating your organization’s SOPs.

Although there is some overlap, there are also some differences in the recommendations between emergency transport and off-site, satellite vaccine transport. Vaccines that will be used at an off-site or satellite facility should be delivered directly to that facility. If that is not possible, transport of vaccines should only be done using a portable vaccine refrigerator with a temperature monitoring device placed with the vaccines.

If a portable refrigerator is not available, qualified containers and pack-outs can be used with a temperature monitoring device in each container. A qualified container and pack-out is a type of container and supplies specifically designed for use when packing vaccines for transport. The container and supplies are qualified through laboratory testing under controlled conditions to ensure they achieve and maintain desired temperatures for a set amount of time.

If you must transport vaccines, transport only what is needed for the workday. The total time for transport and workday should be a maximum of eight hours. If you must transport vaccines in non-commercial vehicles, use the passenger compartment—not the truck. Immediately upon arrival at an off-site, satellite facility, vaccines should be stored in an appropriate storage unit with a temperature monitoring device. If the device displays min/max temperatures, they should be checked and recorded. If the device does not display min/max temperatures, then the current temperatures should be checked and recorded a minimum of two times, at the start and end of the workday.

If vaccines cannot be stored in an on-site storage unit, they should be kept in the portable vaccine refrigerator during the clinic with a calibrated temperature monitoring device as close as possible to the vaccines. The temperature should be read and recorded at least hourly. The container should be kept closed as much as possible. No more than one multidose vial or ten doses should be removed at a time by each person administering vaccine. There is more detail on transport in the Storage and Handling Toolkit and we’ve developed an emergency transport job aid that is posted on our website. You can see the first page of this job aid on the slide. Please note that the system described in this job aid is specific to emergency transport.

When you remove the dust cover and expose the rubber diaphragm or stopper on a single-dose vial, you should use that vaccine or discard it at the end of the workday because you can’t always tell if the diaphragm or stopper has been punctured by someone else once the cover is off. And remember, single-dose vials do not contain a preservative; they are meant for single entry and single use for a single patient.

When using manufacturer-filled syringes, the syringe is activated and the sterile seal is broken once the cap is removed from the needle or when a needle is added to the syringe. It should be used that day or discarded at the end of the workday because like single-dose vials, manufacturer-filled syringes do not contain a preservative and should be used—not stored—once the sterile seal is broken.

And when preparing vaccines, do not draw vaccine into a syringe until you’re ready to use it. Predrawing increases the risk for administration errors, wasting vaccine, and possible growth of microorganisms in the vaccine. General-use syringes are not designed for storage. Consider using manufacturer-filled syringes for large immunization events because they are designed for both storage and administration. Again, more detail is available in the Storage and Handling Toolkit.

You should contact your immunization program or vaccine manufacturer for policies about disposition of unopened vials, expired vials, unused doses, and potentially compromised vaccine. Open vials, activated manufacturer-filled syringes, vaccine predrawn by a provider, and broken vials and syringes are not returnable and should be appropriately discarded. You also should check with your immunization program or state environmental agency about proper disposal of empty vaccine vials.

Let’s move on to vaccine administration; if you are following along in the Pink Book, this is chapter six, which begins on page 79.

Not only is it critical that vaccines are stored and handled properly, but they must also be administered correctly to ensure the vaccination is as safe and effective as possible. Vaccinators should follow professional standards for medication administration and the guidance provided by vaccine manufacturers. CDC also has a web page for providers on evidence-based safe injection practices. Improper administration of vaccines can prevent the vaccines from providing optimal protection and may even lead to adverse reactions and injuries.

All personnel including temporary staff who will administer vaccines should receive comprehensive, competency-based training on vaccine administration during their orientation, at annual updates, and when there are new recommendations or new vaccines added to the facility’s inventory. Knowledge and skills should be assessed before someone is allowed to administer vaccines to patients. If you need an immunization skills checklist, we have included a link to one on the Immunization Action Coalition website.

The patient’s immunization history should be reviewed at every health care visit. When the patient arrives, providers should obtain a complete immunization history and compare the patient’s immunization record to the medical record and immunization information system or registry data, if one is available. Use the current immunization schedule based on the age of the patient to determine all recommended vaccines that are needed.

Also, assess for any vaccines that are indicated based on health status, occupation, or other risk factors. If a documented immunization history is not available, administer the vaccines that are indicated. With the exception of self-report for influenza and pneumococcal polysaccharide vaccine or PPSV23, providers should only accept written, dated records.

All patients should be screened for contraindications and precautions prior to administering any vaccine, even if the patient has previously received that vaccine. If you do not have screening questionnaires, we have included links to screening forms available on the Immunization Action Coalition website.

Use vaccine information statements and other resources to discuss vaccine benefits and risks and disease risks with parents and patients. After-care instructions should include information and strategies for dealing with side effects and for determining when medical attention should be sought. We’ve also included links to a few resources that can be used with parents when providing after-care instructions.

When determining patient positioning and restraint, consider the patient’s comfort and safety as well as their age, activity level, and the site where you will be administering the vaccine. If you can get the parent involved, this has been shown to increase a child’s comfort. Encourage parents to hold their child while the vaccine is being administered, but if the parent is uncomfortable, have someone else assist. This slide shows some suggested positioning techniques; studies have shown that children are less fearful and experience less pain if they’re sitting up rather than lying down when vaccines are administered. This seems to reduce anxiety, which, in turn, reduces the perception of pain.

All providers who administer vaccines to older children, adolescents, and adults should be aware of the risk for syncope or fainting after vaccination, which could lead to patient injury. So make sure the person who is being vaccinated is always seated or lying down. Be aware of symptoms that precede fainting like weakness, dizziness, and if the patient looks pale. And of course, provide supportive care and take appropriate measures to prevent injuries if the person does faint. The Advisory Committee on Immunization Practices or ACIP also recommends that providers consider observing the patient with the patient seated or lying down for 15 minutes after vaccination.

The pain associated with vaccine injections is a source of distress for children, their parents, and those administering the injections. If not addressed, this pain can lead to preprocedural anxiety in the future, needle fears, and avoiding health care, including not adhering to vaccination schedules. It’s estimated that up to 25% of adults have a fear of needles, with most fears developing in childhood, and about 10% of the population avoids vaccination and other needle procedures because of needle fears.

Several of the practice recommendations relating to the injection procedure can be implemented easily because they do not require planning or additional resources. Examples include positioning children upright, performing intramuscular injections rapidly without prior aspiration, injecting the most painful vaccine last when multiple vaccines are being administered, and providing tactile stimulation. A few practice recommendations such as breastfeeding or administration of sugar water for infants and application of topical anesthetics and psychological interventions require some planning or additional resources or both on the part of the health care providers and children and their families. Health care providers are encouraged to discuss these additional options with parents and children and to select the strategies best suited to individual children. Pain relief is enhanced when individual pain-relieving strategies are combined; therefore, health care providers are encouraged to use a mix of strategies. Here’s a job aid that can be shared with staff outlining these and other measures to decrease procedural pain.

I’m sure we all know that we need to take every precaution to prevent infection when performing any procedure, so just as a reminder, hand hygiene should be performed before preparing vaccines, between patients, and any time hands become soiled. Occupational Safety and Health Administration or OSHA regulations do not require gloves to be worn when administering vaccines unless the person administering the vaccine is likely to come into contact with potentially infectious body fluids or has open lesions on the hands. If gloves are worn, they should be changed and hands cleaned after removing gloves. CDC has additional information on hand hygiene in health care settings; the link is at the bottom of this slide.

And of course, puncture-proof biohazard containers should be used for discarding injection supplies. As discussed earlier, check with your state immunization program or environmental agency about proper disposal of vaccine vials.

When preparing vaccines, use a separate 1-milliliter or 3-milliliter sterile syringe and a separate needle for each injection; needle selection depends on the route, patient size, and the injection technique. Always inspect the vaccine and diluent vials for damage or signs of contamination. You should not only check the expiration dates on the vaccine and diluent, but syringes, needles, and even alcohol swabs likely have expiration dates.

We mentioned this earlier, but it’s worth repeating; always use only the diluents supplied by the manufacturer for that specific vaccine. Agitate the vial to be sure the vaccine is resuspended and thoroughly mixed and not discolored; you don’t want any precipitate or solids that did not dissolve floating around. If it looks suspicious, it should not be used. Be sure to check the manufacturer package insert, as it will normally contain a description of what the product should look like.

Only the number of doses indicated in the manufacturer’s package insert should be withdrawn from a vaccine vial. After the maximum number of doses has been withdrawn, the vial should be discarded, even if the expiration date has not been reached.

Here are a few “nevers” when preparing vaccines. Never combine vaccines into a single syringe, except when specifically approved by the FDA and packaged for that specific purpose. Never transfer vaccine from one syringe to another and never draw partial doses of vaccine from separate vials to obtain a full dose.

Rotavirus vaccines, oral typhoid vaccine, and a new oral cholera vaccine are the only U.S. licensed vaccines that are administered by the oral route. For children, oral vaccines should generally be given before administering injections or performing other procedures that might cause discomfort because it can be difficult to administer an oral vaccine if an infant or small child is crying. The rotavirus liquid should be administered slowly down the inside of the cheek, between the cheek and gum toward the back of the infant’s mouth.

Live, attenuated influenza vaccine is the only vaccine administered by the intranasal route. The images to the right show both oral vaccine administration for an infant, as well as live, attenuated influenza vaccine administration in a child. These images were taken from the vaccine administration resources page, which houses several short vaccine administration training videos. The link to this training is provided on the slide.

Subcutaneous injections are administered into the fatty tissue found below the dermis and above muscle tissue. The recommended sites are the thigh for infants younger than 12 months of age and the upper outer triceps of the arm for persons 1 year of age and older. If necessary, the upper outer triceps area can be used for infants; a 5/8”, 23- to 25-gauge needle should be used. To avoid reaching the muscle, the fatty tissue is pinched up and the needle is inserted at a 45-degree angle.

Intramuscular injections are administered into muscle tissue below the dermis and subcutaneous tissue. To avoid injection into subcutaneous tissue, the skin is spread taut between the thumb and forefinger, which isolates the muscle. Another technique used mostly for pediatric and geriatric patients is to grasp the tissue and bunch up the muscle; then the needle is inserted fully into the muscle at a 90-degree angle. Because there are no large blood vessels in the recommended sites, aspiration before injection of vaccines is not necessary. Also, some safety-engineered syringes do not allow for aspiration. The needle gauge is typically 22- to 25-gauge. The needle should be long to reach the muscle and prevent vaccine from seeping into subcutaneous tissue, but not so long that the needle would strike underlying nerves, blood vessels, or bones.

It’s important for the health care provider to be familiar with the anatomy of the area where the vaccine will be injected. For the majority of infants, the anterolateral aspect of the thigh or vastus lateralis muscle is the recommended site because it’s a large muscle. For the majority of infants, a 1”, 22- to 25-gauge needle is sufficient to penetrate the muscle. For a neonate, which is defined as the first 28 days of life, and for preterm infants, a 5/8” needle is usually long enough if the skin is stretched flat between the thumb and forefinger and the needle is inserted at a 90-degree angle.

For toddlers, the vastus lateralis muscle in the anterolateral thigh is the preferred site. The needle should be at least 1” long. The deltoid muscle can be used if there’s enough muscle tissue. A 5/8” needle is adequate for the deltoid muscle if the skin is stretched flat between the thumb and forefinger and the needle is inserted at a 90-degree angle.

The deltoid muscle is preferred for children 3 through 18 years of age. The needle size for deltoid injections can range from 22- to 25-gauge and from 5/8” to 1”, depending on technique. A 5/8” or 1” needle is required for most young children in this age range. In general, a 1” needle is needed for older children and adolescents. The vastus lateralis muscle in the anterolateral thigh is an alternative site if the deltoid sites cannot be used and a 1” or a 1¼” needle will be long enough for most older children and adolescents.

For adults, the deltoid muscle is recommended for routine intramuscular vaccinations, but the anterolateral thigh can also be used. There’s a chart in the Pink Book on page 96 based on gender and weight to assist in selecting needle length.

It’s important to use the route of administration recommended by the vaccine manufacturer. There are only two vaccines that can be administered by either the subcutaneous route or the intramuscular route; they are PPSV23, the pneumococcal polysaccharide vaccine, and IPV, the inactivated polio vaccine.

Shoulder injury related to vaccine administration is a vaccine administration error that we have seen an increase in reports to the Vaccine Adverse Event Reporting System and claims to the Vaccine Injury Compensation Program in recent years. In March 2017, shoulder injury related to vaccine administration was added to the Vaccine Injury Table. Shoulder injuries related to vaccine administration are injuries to the musculoskeletal structure of the shoulder, including the ligaments, bursa, and tendons. The injury is thought to occur as a result of the unintended injection of vaccine antigen and/or trauma from the needle going into and around the underlying bursa of the shoulder. Symptoms include shoulder pain and limited mobility after the injection. SIRVA is more common in adults than children. Follow proper injection technique and best practices when administering vaccines. Identify the site correctly using proper landmarks; use the correct needle length based on the age and size of the patient and injection technique. Here you can see an example of a job aid that describes prevention of shoulder injury related to vaccine administration. Please see CDC’s Vaccine Administration web page for additional vaccine administration information and materials.

Fluzone Intradermal is the only U.S. licensed vaccine that is administered by the intradermal route. This Fluzone formulation is not the same as intramuscular formulations of inactivated influenza vaccine. Other inactivated influenza vaccine formulations should not be administered by the intradermal route. The site of administration is the deltoid region of the upper arm. The patient should be seated with the arm bent at the elbow and the hand on the hip to ensure that the site of administration is prominent. The manufacturer prefilled microinjection syringe contains a 0.1 milliliter dose. The needle is inserted at a 90-degree angle into the deltoid region of the upper arm without aspirating. Because the needle is very short, as you can see in that bottom right image, the vaccine will be delivered just under the skin into the dermal layer. Do not administer this vaccine into the volar aspect of the forearm using the intradermal technique to administer a tuberculin skin test.

If multiple vaccines are administered at a single visit, it’s best to administer each vaccine at a different anatomic site, if possible. For infants and younger children, if more than two vaccines are injected in a single limb, the thigh is the preferred site because it’s a larger muscle. For older children and adults, the deltoid muscle can be used for more than one intramuscular injection. The injection sites should be separated by one to two inches. This way, if one of the vaccines causes a local reaction, you have a better chance of knowing which vaccine caused it. Vaccines that are most reactive, like tetanus-toxoid-containing and PCV13, should be administered in different limbs, if possible. If you have combination vaccines in stock, they can reduce the number of injections.

If a vaccine and an immune globulin preparation are administered at the same time, separate limbs should be used.

The location of all injection sites should be documented in the patient’s medical record. Health care providers should consider using a vaccination site map so that all persons administering vaccines routinely use the same anatomic site for each different vaccine. All vaccines administered should be documented in the patient’s permanent medical record. Health care providers who administer vaccines covered by the National Childhood Vaccine Injury Act are required to document date of administration, vaccine manufacturer, vaccine lot number, name and title of person who administered vaccine, and address of clinic or facility where permanent record will reside and date printed on the vaccine information statement. Best practice documentation also includes vaccine type, route, dosage, and site.

Let’s take a little bit of time to discuss vaccine administration errors. This graph reflects vaccination errors reported to the Vaccine Adverse Event Reporting System or VAERS. VAERS is authorized by National Childhood Vaccine Injury Act of 1986. It is jointly administered by CDC and FDA. VAERS is a national, postmarketing, passive reporting system for adverse events occurring after receipt of U.S. licensed vaccines.

There are a total of 63,759 vaccination errors reported to VAERS from 2000 to 2016. The red part of the columns shows what percentage of VAERS reports were related to vaccination errors out of all primary VAERS reports in the U.S. in each of the labeled years. As you can see, the number of reports received with errors has been increasing in recent years.

This table shows the number of vaccine administration error reports to VAERS by error group from 2000 to 2016 and the percentage of the total number of reports each group represents. The top three groups or types of errors were storage and dispensing, inappropriate schedule, and wrong vaccine. These were followed closely by incorrect dose and administration errors. This data on vaccine errors demonstrates the importance of proper vaccine storage, handling, and administration.

As hard as we try to prevent errors, we are human and we’re going to make mistakes sometimes. The first step to preventing errors is to establish a work environment that values reporting and investigating errors. This is critical to good risk management and quality improvement. You don’t want your staff to fear reporting an error.

Be familiar with and use best practice guidelines for storing and handling, preparing, and administering vaccines. If a temperature excursion occurs, isolate the affected vaccines and take immediate action to correct the situation. Promptly remove expired vaccines from your storage unit. Only administer vaccines that you have prepared and triple-checked. Be familiar with current recommended immunization schedules; recommendations change as new data becomes available and new vaccines enter the market. Immunization schedule recommendations can change fairly frequently because the Advisory Committee on Immunization Practices meets three times per year. After final approval, the most current vaccine recommendations will be posted on the ACIP web page under “recommendations.” And last, use standing orders when possible.

So what should you do if there’s an administration error? The patient or parent should be notified of the error. You want to assess the status of the patient and hopefully, there are no adverse events associated with the error. Of course, the patient or parent will want to know what is next. Do they have to be revaccinated? So be sure you know what action to take. Not all errors require revaccination, so consult available resources to find out if it is necessary or not; documentation is also important. Even if it was an error, the vaccine administered will need to be recorded. Other documentation will depend on your facility’s requirements for documentation related to an error. There may be an incident report that needs to be completed.

The Vaccine Adverse Event Reporting System, VAERS, accepts all reports, including reports of vaccination errors. Please report clinically important adverse events that occur after vaccination of adults and children, even if you are not sure whether the vaccine caused the adverse event. Also, report vaccination errors without health events. This information can sometimes reveal safety risks and guide future public health education needs.

This concludes the presentation.

For Continuing Education, the live course number is WC2645-071118. The expiration date for the live course is August 16th, 2018. For the enduring course, the course number is WD2645-071118. The expiration date for the enduring archived program is June 1st, 2019. The course access code is Handling, h-a-n-d-l-i-n-g. Please make note of this code; course access codes will not be given outside of the course presentation. Instructions are available in the Resource Pod.

For help with the online system, please dial 1-800-41-TRAIN; this corresponds to 1-800-418-7246 or you can e-mail ce@. This service is available 8:00 a.m. to 4:00 p.m. Eastern Time.

You can e-mail immunization questions to us at NIPINFO@ and we’ll try to respond to those as quickly as possible.

You can also call immunization questions into 1-800-CDC-INFO or 1-800-232-4636. This service is available 8:00 a.m. to 8:00 p.m. Eastern Time, Monday through Friday.

Additional resources you can use include the Pink Book, which you can see on the website listed on the screen. It’s available online or you can purchase a hard copy at the link for the Public Health Foundation Learning Resource Center. An online supplement to the Pink Book is available on the same web page as the Pink Book. You can see our CDC Vaccines and Immunization home page in the second bullet. Finally, our resource guide for health care personnel, entitled “CDC Immunization Resources for You and Your Patients,” is listed at the website you see here.

This concludes our program. Thank you very much for attending and have a great day from Atlanta.

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