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Immunization for Healthcare Personnel and Patients

Richard A. Van Enk, Ph.D., CICDirector, Infection Prevention and Epidemiology,

Bronson Methodist Hospitalvanenkr@bronsonhg.org

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ObjectivesYou will be able to:

1. Describe how vaccines work, identify the differences between vaccine types, state duration of immunity offered by vaccines, and describe how to assess immunity to vaccine-preventable diseases

2. List the vaccine-preventable diseases that all healthcare workers should be immune to prior to beginning work and annually

3. Design and implement a healthcare worker immunization program and serve as a resource for a hospital or healthcare system patient immunization program

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Introduction

• “Sanitation and vaccination have made the two greatest contributions to the health of mankind.”

• After infection surveillance, managing an effective immunization program for staff and patients is one of the most important things we do to prevent infections

• Most infection preventionists do not give immunizations, but immunization programs and processes are our responsibility (in the Joint Commission IC section)

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Vaccine Basics• A vaccine is an FDA-approved drug used to stimulate

the production of immunity in the patient, usually against one or more infectious diseases– The vaccine has antigenic similarity to the microorganism,

fools the body into thinking it is the pathogen– The vaccine cannot cause the disease, but must cause an

immune response, which is often confused with the disease

– The vaccine produces a primary immune response in the patient (on the first dose)

– Subsequent doses boost the immune response (because some immune responses wane over time)

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Vaccine basics

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Vaccine basics

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Vaccine basics• The primary immune response after first exposure

to an antigen is mostly immunoglobulin M, it is slow, low level, and it may not prevent the infection

• The secondary response on the second exposure consists of IgG, is faster, it kills or inactivates the pathogen better (more avid), it reaches much higher levels in the body, and it usually prevents the infection

• The purpose of immunization is to get the primary response over so if the patient encounters the disease, they give a secondary response

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Two main types of vaccines

• Live attenuated– Living, whole microorganisms (viruses or bacteria)– Replicate in the patient, producing stronger

immune response– Produce a more complete immune response;

contains many antigens– Can have more side effects – Examples:

• Viruses: MMR, Chickenpox, Shingles, Smallpox, live influenza, rotavirus

• Bacteria; Typhoid

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Two main types of vaccines

• Non-living (killed whole cell, toxoid, subunit, recombinant and others)– The vaccine is not alive, does not replicate in the

patient– Contains whole dead cells or pieces of the

microorganism that are immunogenic, usually proteins or carbohydrates on the microbial surface

– Often fewer side effects but less immunogenic, the body does not see as many antigens as a live vaccine

– Examples; tetanus/diphtheria/pertussis, influenza, meningococcal, pneumococcal, hepatitis B

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Other vaccine terms

• Toxoid vaccines are made of non-toxigenic forms of a microorganism’s toxin

• Recombinant vaccines are made by taking the genes from the pathogen’s virulence factors and making the proteins in another host

• Conjugate vaccines couple polysaccharide antigens with a protein to make them more immunogenic

• Multivalent vaccines include more than one strain of the same pathogen in the vaccine (mono, tri, quadrivalent…)

• Combination vaccines combine more than one pathogen in a single administration (without interfering with each other)

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Other vaccine terms• Vaccine series are when you give the same vaccine in 2 or

3 doses at defined intervals• Multidose vials contain vaccine for more than one

administration, you draw each dose up with a new syringe• Single dose vaccines come preloaded in a syringe or in a

single dose vial• Preservatives are required in multidose vials because the

vial is opened after the first dose is removed. The most common preservative is thimerosal

• Adjuvants are chemical additives that enhance vaccine immunogenicity

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Routes of administration

• Intramuscular injection (injectable) is most common– Note the needle size (1 or 1 ½ inch for adults)

• Oral vaccines for intestinal diseases– Polio, rotavirus, typhoid

• Intranasal vaccines for respiratory diseases– Live intranasal influenza vaccine

• Intradermal– New influenza vaccine

• Subcutaneous– Varicella, MMR, meningococcal

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Spacing of immunizations and the immunization schedules

• The ACIP determines the optimal time to give each vaccine– When is the patient likely to be exposed?– When will the patient make an immune response?– Are booster doses required, how many and when?– If only some people are at risk, which patients should receive

each vaccine if not everyone?– Can vaccines be given in combination?

• It is best to stick to the schedule– It is possible to immunize early but you may have to repeat the

dose– Immunizing later leaves the patient more vulnerable

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Example of an immunization schedule

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Spacing of immunizations and the immunization schedules

• If a patient misses a scheduled immunization, you can make it up, you never have to start over

• The rule for children is you can give it up to 4 days before their recommended birthday

• Some parents ask about alternative schedules or pick and choose which vaccine their children get– They incorrectly believe that too many immunizations

“overwhelm” the immune system– This leaves children with partial immunity

• Some vaccines do interfere with each other, so check the schedule (two live vaccines)

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Other vaccine issues• Interchangeability– You can use combination and monovalent vaccines from

the same manufacturer interchangeably– If you want to switch to another manufacturer of the

same vaccine, check to see if they are interchangeable– It is best to complete a series with the same vaccine, but

if you can’t, give what you have• Unknown immunization status– If you cannot get a patient’s immunization records, re-

immunize– Do not depend on someone’s memory– Be sure to put your records in MCIR!

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The Vaccine Information Statement

• We are required to give each immunized patient a Vaccine Information Statement (VIS) prior to administration

• In Michigan, the VIS is different than the national forms because there is an informed consent at the bottom that allows us to enter the record into MCIR

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Contraindications and precautions

• A contraindication is a condition that increases the risk of a serious adverse event; the vaccine should not be given to that patient at that time (some are temporary)– Example; live virus vaccines in pregnancy

• A precaution or warning is a condition that may cause a non-serious reaction or reduce the vaccine’s effect, but the benefit may outweigh the risk and the vaccine may be given– Requires a conversation with the patient

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Contraindications and precautions• One of the biggest barriers to immunization is

when people confuse contraindications and precautions

• Can you immunize these patients?– History of Guillain-Barre Syndrome– History of seizures– Presence of fever– Presence of an infection– Patient is in the hospital– Patient is immunocompromised– Patient had a local reaction before

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Managing vaccine adverse reactions• Local

– Redness, swelling, soreness at the injection site– Common with all vaccines

• Systemic• Allergic (anaphylactic)

– Begins within seconds, requires epinephrine– Extremely rare

• Syncope (fainting)– Most common in adolescents– Observe patients for 15 minutes after injection

• Must be reported to the FDA Vaccine Adverse Event Reporting system (VAERS) if “clinically significant”– http://vaers.hhs.gov/index

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Vaccine storage and handling

• Must follow the manufacturer specifications• Note that some vaccines are stored in a refrigerator and

some frozen• Equipment must have a continuous temperature

monitor system (and be monitored)• Vaccine stored outside the temperature range should

not be administered• Do not administer expired vaccine• Once vaccine is removed from a multi-dose vial, it must

be used that day or discarded; do not put it back in the vial

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Immunization of healthcare personnel

• All healthcare personnel should be up to date on their recommended immunizations as a condition of employment

• It is an infection prevention function and responsibility to ensure that all personnel meet these requirements even if you do not do it– The infection prevention committee must supervise

• Document completely in the occupational medical record at hire– Don’t clear them for hire until completed

• Note that some vaccines are annual or at certain times after hire

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Vaccines for healthcare personnel

All personnel• Hepatitis B• Influenza (annually)• Measles• Mumps• Rubella• Tetanus/diphtheria/pertussis

(pertussis currently once)• Varicella

Certain personnel• Hepatitis A (food service,

mother/baby, pediatrics)• Meningococcal (laboratory,

every 5 years)• Typhoid fever (laboratory)• Polio (laboratory)

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Documentation of immunity for healthcare personnel

• New process; physician or parent documentation of disease is no longer acceptable– Often wrong; both ways

• The only acceptable documentation is either proof of immunization or serologic proof of immunity– Note that the serology test is the immune status test, not a

quantitative serology test for diagnosis of disease• In the absence of medical documentation, it is usually

better and cheaper to immunize rather than do serologic tests to determine immune status

• Keep all documentation in the occupational medical record• Decide what to do about older staff

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Other vaccines recommended for adults

• The hospital may choose to provide to staff through employee health or recommend they receive it from their primary care provider– Pneumococcal (pneumonia)– Tetanus/diphtheria following wound– Human papillomavirus– Zoster– Hepatitis A

• Make sure your employee insurance covers all routine immunizations

• It is worth it to provide it to your personnel

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Special issues for healthcare personnel

• Pregnancy– Do not give a vaccine that is contraindicated (live virus

vaccines), but pregnancy is temporary, so you can immunize after delivery

– Other vaccines are not contraindicated, and may be strongly indicated (influenza, Tdap)

– Coordinate with the obstetrician so you don’t give it twice• Staff with immunocompromising or chronic medical

conditions– Almost all vaccines can be given, may need to wait until

after the chemotherapy, may need to repeat all the childhood vaccines, may need to give higher dose

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Special issues for healthcare personnel

• Mandatory immunization– It is absolutely legal and ethically justified for

healthcare personnel to be required to be immune to vaccine-preventable diseases for the purpose of reducing the risk of infection to patients, themselves and other personnel

• Relationship of the employer to the employee’s physician– Most often their opinion is not helpful– Do your own assessment; do not ask the employee

to get the opinion of their physician

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Patient immunization programs

• The infection preventionist must ensure that their patients are immunized

• Never miss an opportunity to immunize– Inpatients should be screened on admission and any missing

immunizations administered before discharge (this is easy in Michigan because of MCIR)

– Inpatient screening and immunization rates should be tracked and performance reported to administration

– Some are required by external agencies (pneumococcal vaccine for Medicare patients, influenza by Joint Commission)

– Outpatient practices are tracked externally by payers; acquire these data and report them

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Patient immunization programs

• Patient immunization programs are complex because they involve many stakeholders; pharmacy, nursing, information technology, Quality Improvement, physicians

• The best programs are standing orders; never require a physician order to give a required immunization– Some surgeons still think that their patients should

not be immunized perioperatively, but that is not true; try to change them

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Advisory Committee on Immunization Practices (ACIP)

• http://www.cdc.gov/vaccines/acip/• http://

www.cdc.gov/vaccines/hcp/patient-ed/conversations/downloads/vacsafe-acip-color-office.pdf

• A subcommittee sponsored by the CDC• 15 expert members, 30 professional organizations • Meets twice per year, in June and October• Reviews current and new vaccines• Makes national recommendations• The source of the annual immunization schedules

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American Academy of Pediatrics Committee on Infectious Diseases

• Produces the “Red Book” about every 3 years

• Started as “Immunization Procedures” booklet in 1938

• Focuses on pediatrics• Now includes all infectious

diseases, including diagnosis and control, including immunizations

• Usually follows ACIP and FDA and others, but not always; they are independent

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The Michigan Care Improvement Registry

• http://www.mcir.org/• http://

www.mcir.org/forms/MCIR%20Brochure%20FINAL%202-13-2007.pdf

• A statewide registry for all immunization records

• Began in 1998 to contain pediatric records, expanded to adults in 2006

• Extremely useful for patient management and epidemiology

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References; print

• Decker, M. D., D. J. Weber and W. A. Schaffner. Vaccination of healthcare workers, pp. 1112-1127. In: Mayhall, C. G., Hospital Epidemiology and Infection Control, fourth edition. 2012. Lippincott Williams and Wilkins, Philadelphia, PA.

• D. J. Haiduven and G. A. Poland. Immunization in the Healthcare Worker, pp. 107-1 to 107-37. In: APIC Text of Infection Control and Epidemiology, 3rd edition. 2009. Association for Professionals in Infection Control and Epidemiology, Washington, DC.

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References, links• General Recommendations on Immunization– http://www.cdc.gov/mmwr/pdf/rr/rr6002.pdf

• Immunization of Health-care Personnel– http://www.cdc.gov/mmwr/pdf/rr/rr6007.pdf

• Vaccine Guidelines and Recommendations for Emergency Situations– http://

www.cdc.gov/vaccines/hcp/acip-recs/recs-emergency.html

• Archived ACIP Recommendations– http://

www.cdc.gov/vaccines/hcp/acip-recs/recs-archived.html#comprehensive