3.2 Revˆetements cycliques
3.2.2 D´emonstration du th´eor`eme III.B
tween 35ºF and 46ºF for at least 3 to 5 days.
Assemble packing supplies
1. Cooler. Use hard plastic Igloo-type coolers.
Attach a “Vaccines: Do Not Freeze” label to the cooler.
2. “Conditioned” cold packs. Condition frozen gel packs by leaving them at room temperature for 1 to 2 hours until the edges have defrost-ed and packs look like they’ve been “sweating.” Cold packs that are not conditioned can freeze vaccine. Do not use dry ice.
3. Thermometer. Prepare the thermometer by placing it in the refrigera-tor at least 2 hours before you pack the vaccine.
4. Packing material. Use two 2-inch layers of bubble wrap.
Not using enough bubble wrap can cause the vaccine to freeze.
Pack vaccine
Spread conditioned cold packs to cover only half of the bot-tom of the cooler.
Spread “conditioned” cold packs to cover only half of the bubble wrap.
Make sure that the cold packs do not touch the boxes of vaccine.
Completely cover the vaccine with another 2-inch layer of bubble wrap.
Fill the cooler to the top with bubble wrap. Place the thermom-eter’s digital display and the Return or Transfer of Vaccines Report form on top. It’s ok if temperatures go above 46ºF while packing.
Stack layers of vaccine boxes on the bubble wrap. Do not let the boxes of vaccine touch the cold packs.
Completely cover the cold packs with a 2-inch layer of bubble wrap.
Then, place the thermometer/
probe on top of the bubble wrap directly above a cold pack.
1. Cold packs
2. Bubble wrap
3. Vaccine
& Thermometer
4. Bubble wrap
6. Form & display 5. Cold packs
As soon as you reach the destination site, check the vaccine temperature. If the vaccine is:
• Between 35ºF and 46ºF, put it in the refrigerator.
2. Ensure the vaccine is kept at appropriate temperatures. Make sure the refrig-erator/freezer is working properly or move the vaccines to a unit that is.
Do not discard the affected vaccines. Mark the vaccines so that the potentially compromised vaccines can be easily identified.
3. Notify the local or state health department or call the manufacturer (see manufacturers’ phone numbers below).
4. Record action taken.
2. Temperature of freezer: current______ max.______ min.______
3. Air temperature of room where refrigerator is located:______
4. Estimated amount of time the unit’s temperature was outside normal range:
refrigerator _______ freezer ________
5. Vaccines in the refrigerator/freezer during the event (use the table below)
* Using a recording thermometer is the most effective method of tracking the refrigerator and freezer temperatures over time. Visually checking thermometers twice a day is an effective method to identify inconsistent or fluctuating temperatures in a refrigerator and freezer.
Other Conditions
1. Prior to this event, was the vaccine exposed to temperatures outside the recommended range? Y N 2. Were water bottles in the refrigerator and ice packs in the freezer at the time of this event? Y N 3. Other: _____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
Manufacturers
Crucell Vaccines Inc. (800) 533-5899 CSL Biotherapies, Inc. (888) 435-8633 GlaxoSmithKline (888) 825-5249 MedImmune, Inc. (877) 633-4411 Merck & Co., Inc. (800) 672-6372 Novartis Vaccines (800) 244-7668 Pfizer Inc. (800) 438-1985 sanofi pasteur (800) 822-2463 Other Resources
Vaccines Stored in Refrigerator
Vaccine, manufacturer,
and lot # Expiration
date # of doses # of affected vials
Vaccines Stored in Freezer
Vaccine, manufacturer,
and lot # Expiration
date # of doses # of affected vials
Action taken
Action taken
Checklist: Importance of Vaccine Administration, Storage & Handling
http://www.cdc.gov/vaccines/recs/vac-admin/providers-role-vacc-admin-storage.htm#storage The United States currently has the safest, most effective vaccines in its history. Federal regulations require that vaccines undergo years of testing before they can be licensed. Once in use, vaccines are monitored continually for safety and efficacy. As an immunization provider, you also play a key role in helping to ensure the safety and efficacy of vaccines through proper 1) Vaccine storage and handling;
2) Vaccine administration; 3) Timing and spacing of vaccine doses; 4) Observation of precautions and contraindications; 5) Management of vaccine side effects; 6) Reporting of suspected side effects; and 7) Communication about vaccine benefits and risks.
Additional information that addresses standards for immunization practices for children and adolescents and adults can be found in the 2003 American Journal of Preventive Medicine article by Poland et al available at
http://download.journals.elsevierhealth.com/pdfs/journals/0749-3797/PIIS074937970300120X.pdf that supports the need to ensure that healthcare professionals review and administer vaccines in accordance with patient (in this instance, the healthcare personnel) needs.
Vaccine Storage
To achieve the best possible results from vaccines, carefully follow the recommendations for storage, handling, and administration found in each vaccine’s package insert. Here are other steps you can take to help monitor and ensure vaccine safety:
Quality Monitoring Element Yes No NA Followup and/or corrective action Proper vaccine storage unit(s) are available
in which to store vaccines
A properly calibrated thermometer or temperature recording device is inside each storage compartment
Cold chain procedures are in place to ensure that vaccine storage and handling guidelines are being followed
Vaccines are inspected upon delivery and refrigerator and freezer temperatures are monitored to assure maintenance of the cold chain.
Vaccine stock is rotated so the oldest vaccines are used first.
If errors in vaccine storage and
administration occur, there is evidence that corrective action is immediately taken to prevent them from happening again
Quality Monitoring Element Yes No NA Followup and/or corrective action Administration of vaccine is performed to
ensure that it is never administered later than the expiration date
If reconstituted, the vaccine is administered within the prescribed time period following that reconstitution
Vaccines are drawn into syringes
immediately prior to administration (unless pre-drawn in the pharmacy under USP 797 standard conditions)
If vaccines are mixed in the same syringe, it has been specifically approved for such mixing by the Food and Drug Administration (FDA)
The vaccine and administration information, including lot numbers and injection sites, are noted in the employee’s health record If errors in vaccine administration occur, appropriate notification is immediately performed to ensure patient safety
Timing and Spacing
The timing and spacing of vaccine doses are two of the most important issues in the appropriate use of vaccines. To ensure optimal results from each immunization, follow the currently recommended immunization schedules. Use the following checklist to help monitor and ensure vaccine timing and spacing:
Quality Monitoring Element Yes No NA Followup and/or corrective action All needed vaccines are administered as
recommended, even if it means giving multiple doses at the same time Use of combination vaccines have been considered to minimize missed doses or timing errors (e.g., MMR, MMRV)
Administration records are maintained in a manner that provides all necessary
information (e.g., dates of administration) and are organized in a way that promotes
adherence with followup dosing and scheduling
An electronic process is utilized to maintain vaccine information and calculate next dose due dates
Observe Valid Contraindications and Precautions
Contraindications and precautions to vaccination indicate when vaccines should not be given. A contraindication is a condition in a patient that increases the chance of a serious, adverse reaction. In general, a vaccine should not be administered when a contraindication is present. A precaution is a condition in a patient that may increase the chance of a serious side effect or render a vaccine less effective. Normally, vaccination is deferred when a precaution is present. However, situations may arise when the benefits of vaccination outweigh the risk of a side effect, and the provider may decide to vaccinate the patient. Most precautions and some contraindications are temporary and the vaccine may be given at a later time.
Quality Monitoring Element Yes No NA Followup and/or corrective action Every healthcare worker patient is screened
for contraindications and precautions before being given a vaccine dose
Documentation of the discussion regarding the contraindication/precaution is
maintained
Many conditions are often inappropriately regarded as contraindications to vaccination. In most cases, the following are not contraindications:
• Mild acute illness (e.g., diarrhea and minor upper-respiratory tract illnesses, including otitis media) with or without low grade fever
• Mild to moderate local reactions and/or low grade or moderate fever following a prior dose of the vaccine
• Current antimicrobial therapy
• Convalescent phase of illness
• Recent exposure to an infectious disease
• Breastfeeding
Identify and collaborate with experts in immunization to identify concise communications regarding individual vaccines and their importance in disease prevention
Develop targeted communications regarding vaccines that focus on the most common questions from personnel
Coordinate communication methods so they include healthcare personnel who are employees as well as students, licensed independent professionals, and relevant external partners such as supply and
pharmaceutical vendors and representatives A copy of the most current Vaccine
Information Statement (VIS) is provided to all vaccines prior to the administration of each vaccine dose
If English is the second language, the VIS in the employee’s native language is provided, if available
Be Prepared to Manage Vaccine Side Effects
Most people experience no side effects, or only mild ones, following immunization. Mild side effects may include soreness, swelling, or redness at the injection site or mild fever. Severe side effects, such as severe allergic reactions, following vaccination are extremely rare.
Quality Monitoring Element Yes No NA Followup and/or corrective action Emergency protocols have been written and
are regularly reviewed
Personnel responsible for the immunization program are knowledgeable regarding the emergency protocols and have been deemed competent to apply those emergency interventions
Epinephrine and equipment for maintaining an airway are available for immediate use
Report Suspected Side Effects to VAERS
The Vaccine Adverse Event Reporting System (VAERS) is a national vaccine safety monitoring program.
VAERS collects information about adverse events (possible side effects) that occur after administration of U.S. licensed vaccines.
Quality Monitoring Element Yes No NA Followup and/or corrective action Those personnel responsible for the
administration of vaccines are aware of the selected events that require reporting to VAERS
Personnel are aware of the process for reporting vaccine events to VAERS
More information about VAERS, including reporting forms, can be obtained by calling the VAERS information line at 800-822-7967, or by visiting http://vaers.hhs.gov
• Healthcare Personnel Vaccination Recommendations in brief provided by the Immunization Action Coalition (IAC) http://www.immunize.org/catg.d/p2017.pdf
• Immunization of Health-Care Personnel, Recommendations of the Advisory Committee on Immunization Practices (ACIP) published on November 25, 2011 in the MMWR.
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr6007a1.htm?s_cid=rr6007a1
• Basics of vaccine administration adapted from
http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/D/vacc_admin.pdf
• Administering Vaccines to Adults: Dose, Route, Site, Needle Size, and Preparation
http://www.immunize.org/catg.d/p3084.pdf• How to Administer Intramuscular and Subcutaneous Vaccine Injections to Adults
http://www.immunize.org/catg.d/p2020a.pdf• How to Administer Intramuscular, Intradermal, and Intranasal Influenza Vaccines
http://www.immunize.org/catg.d/p2024.pdf• Vaccines with Diluents http://www.immunize.org/catg.d/p3040.pdf
• Guide to Contraindications and Precautions to Commonly Used Vaccines in Healthcare
Personnel http://www.immunize.org/catg.d/p3072a.pdf
of disease or immunity (HCP who have an “indeterminate” or “equivocal”
level of immunity upon testing should be considered nonimmune) or (b) appropriate vaccination against measles, mumps, and rubella (i.e., 2 doses of live measles and mumps vaccines given on or after the first birthday, separated by 28 days or more, and at least 1 dose of live rubella vaccine).
• Although birth before 1957 generally is considered acceptable evidence of measles, mumps, and rubella immunity, healthcare facilities should consider recommending 2 doses of MMR vaccine routinely to unvaccinated HCP born before 1957 who do not have laboratory evidence of disease or immunity to measles, mumps, and/or rubella. For these same HCP who do not have evidence of immunity, healthcare facilities should recommend 2 doses of MMR vaccine during an outbreak of measles or mumps and 1 dose during an outbreak of rubella.
Varicella
It is recommended that all HCP be immune to varicella. Evidence of immunity in HCP includes documentation of 2 doses of varicella vaccine given at least 28 days apart, history of varicella or herpes zoster based on physician diagnosis, laboratory evidence of immunity, or laboratory confirmation of disease.
Tetanus/Diphtheria/Pertussis (Td/Tdap)
All adults who have completed a primary series of a tetanus/diphtheria-containing product (DTP, DTaP, DT, Td) should receive Td boosters every 10 years. HCP of all ages with direct patient contact should be given a 1-time dose of Tdap, with priority given to those having contact with infants younger than age 12 months.
Meningococcal
Vaccination is recommended for microbiologists who are routinely exposed to isolates of N. meningitidis. Use of MCV4 is preferred for persons younger than age 56 years; give IM. Use MPSV4 only if there is a permanent contraindica-tion or precaucontraindica-tion to MCV4. Use of MPSV4 (not MCV4) is recommended for HCP older than age 55; give SC.
References
1. See Table 3 in “Updated U.S. Public Health Service Guidelines for the Manage-ment of Occupational Exposures to HBV, HCV, and HIV and Recommendations for Postexposure Prophylaxis,” MMWR, June 29, 2001, Vol. 50, RR-11.
For additional specific ACIP recommendations, refer to the official ACIP statements published in MMWR. To obtain copies, visit CDC’s website at www.cdc.gov/vac-cines/pubs/ACIP-list.htm; or visit the Immunization Action Coalition (IAC) website
Hepatitis B
Healthcare personnel (HCP) who perform tasks that may involve exposure to blood or body fluids should receive a 3-dose series of hepatitis B vaccine at 0-, 1-, and 6-month intervals. Test for hepatitis B surface antibody (anti-HBs) to document immunity 1–2 months after dose #3.
• If anti-HBs is at least 10 mIU/mL (positive), the patient is immune. No further serologic testing or vaccination is recommended.
• If anti-HBs is less than 10 mIU/mL (negative), the patient is unpro-tected from hepatitis B virus (HBV) infection; revaccinate with a 3-dose series. Retest anti-HBs 1–2 months after dose #3.
– If anti-HBs is positive, the patient is immune. No further testing or vac-cination is recommended.
– If anti-HBs is negative after 6 doses of vaccine, patient is a non-responder.
For non-responders: HCP who are non-responders should be considered susceptible to HBV and should be counseled regarding precautions to prevent HBV infection and the need to obtain HBIG prophylaxis for any known or probable parenteral exposure to hepatitis B surface antigen (HBsAg)-positive blood.1 It is also possible that non-responders are persons who are HBsAg positive. Testing should be considered. HCP found to be HBsAg positive should be counseled and medically evaluated.
Note: Anti-HBs testing is not recommended routinely for previously vac-cinated HCP who were not tested 1–2 months after their original vaccine series. These HCP should be tested for anti-HBs when they have an exposure to blood or body fluids. If found to be anti-HBs negative, the HCP should be treated as if susceptible.1
Influenza
All HCP, including physicians, nurses, paramedics, emergency medical tech-nicians, employees of nursing homes and chronic care facilities, students in these professions, and volunteers, should receive annual vaccination against influenza. Live attenuated influenza vaccine (LAIV) may only be given to non-pregnant healthy HCP age 49 years and younger. Inactivated injectable influenza vaccine (TIV) is preferred over LAIV for HCP who are in close contact with severely immunosuppressed persons (e.g., stem cell transplant patients) when patients require protective isolation.
Measles, Mumps, Rubella (MMR)
HCP who work in medical facilities should be immune to measles, mumps, and rubella.
• HCP born in 1957 or later can be considered immune to measles, mumps,