Hospitals and Clinics Administration

Enterprise #0041

DATE: (Policy Approval Date)

TO: ☐ All Enterprise Workforce ☐ Department Specific

☐ Site Specific Workforce

FROM: Paul E. Lorenz

Chief Executive Officer, Enterprise

SUBJECT:

Standardized Procedure: Influenza (Flu) Vaccine Administration

SCOPE:

Location

(includes hospital and all inpatient and outpatient locations and subacute facilities of the hospital,

unless otherwise indicated)

☒ Enterprise Wide

☐ O’Connor Hospital ☐ Santa Clara Valley Medical Center ☐ St. Louise Regional Hospital

☐ Ambulatory ☐ Inpatient ☐ Subacute

Who May Perform This Procedure

☐ Everyone

☒ RN ☐ LVN ☐ Pharmacist ☐ Physician/Resident

☐ APP ☐ Other (specify)

DEFINITIONS:

- Thimerosal: Mercury-based preservative used in multi-dose vials)

- Abbreviations Used:

- 4: Quadrivalent (4 component)

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- AAP: American Academy of Pediatrics

- ACIP: Advisory Committee on Immunization Practices

- APP: Advanced Practice Provider

- BRN: Board of Registered Nursing

- CDC: Centers for Disease Control and Prevention

- EHR: Electronic health record

- HD: High Dose

- IIV: Inactivated Influenza Vaccine

- IM: Intramuscular

- IN: Intranasal

- LAIV: Live Attenuated Influenza Vaccine

- RIV: Recombinant Influenza Vaccine

- RN: Registered Nurse

- VIS: Vaccine Information Statement

POLICY:

The standard of care in our community is to offer the influenza vaccine to anyone 6 months of

age and older, who requests the vaccination (subject to vaccine availability), and who does not

have contraindications (as defined by the CDC’s ACIP).

The vaccine may be given when available, and throughout the flu season, typically beginning

October 1. It may be given earlier when available from the manufacturer. It is recommended

that vaccination should be offered by the end of October. The vaccine should not be given

too early in the season because antibody titers may begin to decline before the flu season

ends.

The list of influenza vaccines may be amended to add or remove approved vaccines when

necessary. The types of influenza vaccines are listed below. The specific influenza vaccines

that are available for the current influenza season is determined by Pharmacy Purchasing. Refer

to the package inserts for specific prescribing information.

o Inactivated vaccines

▪ Quadrivalent inactivated influenza vaccine

▪ High-dose inactivated influenza vaccine

o Recombinant influenza vaccine

o Live vaccines ▪ Quadrivalent live attenuated influenza vaccine (if available)

Vaccination should be deferred (postponed) for people with suspected or confirmed COVID-19,

regardless of whether they have symptoms, until they have met the criteria to discontinue their

isolation. While mild illness is not a contraindication to flu vaccination, vaccination visits for

these people should be postponed to avoid exposing healthcare personnel and other patients to the

Enterprise #0041 Standardized Procedure: Influenza (Flu) Vaccine Administration Page 3 of 12

virus that causes COVID- 19 (CDC, “Frequently Asked Influenza (Flu) Questions: 2021-2022

Season”, Page last reviewed: August 6, 2021).

LEVEL:

- Independent

SUPPORTIVE DATA:

This standardized procedure complies with the California BRN Standardized Procedure Guideline

and may be performed by RNs working in the acute care settings and ambulatory settings. Only RNs

who have been authorized through evaluation and approved in writing may perform this standardized

procedure. No direct supervision of the RN is required.

I. CONTENT:

A. ASSESSMENT:

1. For Ambulatory Care, complete the Immunization Questions in the EHR. For inpatient units,

notify provider of any exclusion criteria.

2. Assess patient’s allergy status- medication/food (i.e., egg allergy), latex,

formaldehyde, sulfite, and inclusion/exclusion criteria information.

3. Question patient regarding thimerosal sensitivity.

4. Obtain patient’s temperature.

5. Ascertain history of problems/reactions following previous immunization(s) with flu

vaccine.

6. Question patient regarding acute respiratory symptoms, or other active infections.

Patients with a minor illness (e.g., mild upper respiratory tract infection or allergic

rhinitis), with or without fever may still receive the influenza vaccine.

B. INCLUSION CRITERIA:

1. All persons 6 months of age and older who do not have contraindications.

C. EXCLUSION CRITERIA:

1. Anaphylaxis hypersensitivity to eggs, latex, or other vaccine components. For a list of vaccine

components, refer to the manufacturer’s package insert or go to:

https://www.fda.gov/vaccines-blood-biologics/vaccines/vaccines-licensed-use-united-states

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2. Patients experiencing severe allergic reaction (e.g., anaphylaxis, respiratory distress, chest

pain, angioedema, lightheadedness, recurrent emesis) from a previous influenza vaccine.

3. Patients experiencing hives from a previous influenza vaccine, notify provider.

4. Individuals known to be sensitive to thimerosal.

5. Asymptomatic or *symptomatic patients with suspected or confirmed COVID-19, until

criteria to discontinue isolation has been met (2 weeks from beginning of symptoms).

*COVID-19 symptoms may include:

• Fever (greater than or equal to 100F / 37.8C)

• Chills or rigor

• New onset of difficulty breathing

• New or worsening cough

• New onset loss of smell or taste

• Sore throat

• Aching throughout the body / myalgias

• Vomiting or diarrhea

• Severe, constant chest pain or pressure

• Extreme difficulty breathing

• Severe, constant lightheadedness

• Disoriented or unresponsive

D. PRECAUTIONS (CONDITIONS TO REPORT AND CONSULT WITH PROVIDER):

1. Patient/parent reports an allergy or history as identified on the Flu Immunization questions.

2. Patient reports any reaction to eggs.

3. Patient gives a history of reaction after receiving a previous flu vaccine.

4. Patient has a history of Guillain-Barré Syndrome (GBS).

5. Patient has no vaccine history, is unable to answer for self, or no family member is present to

address medical history.

6. Platelet count is less than 20,000, including patients undergoing chemotherapy and/or radiation

therapy.

7. Any patient requests a booster vaccine.

8. Patient reports a history of sulfite allergy.

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9. Clinic patient / parent / guardian requests the live attenuated influenza vaccine nasal spray.

The nasal spray must be ordered by the provider.

10. Notify provider immediately of any allergic reaction (which usually occurs immediately).

Complete an occurrence report.

E. PLAN/TREATMENT: (Initiated when patient meets B AND no positive findings from C and

D.)

1. Provide the patient with current VIS for the vaccine prior to administration, in the

patient’s native or preferred language, available at: http://www.immunize.org/vis/

2. Administer influenza vaccine. Refer to the U.S. Food & Drug Administration for the

most complete and updated prescribing information, including (but not limited to)

indications, contraindications, and precautions. Package inserts for US-licensed

vaccines are available at: https://www.fda.gov/vaccines-blood-

biologics/vaccines/vaccines- licensed-use-united-states

3. The AAP advises that influenza vaccine can be administered simultaneously (but at

a different site and with a different syringe) with other routine, vaccinations in

children.

4. IIVs and RIV4 may be administered concomitantly or sequentially with other inactivated

vaccines or with live vaccines. Injectable vaccines that are given concomitantly should be

administered at separate anatomical sites.

5. Flu vaccines and COVID-19 vaccines can be given at the same time. Separate injection

sites by 1 inch or more, if possible, if administering the influenza vaccine with the COVID-

19 vaccine.

6. If patient develops anaphylaxis, activate Anaphylaxis Standardized Procedure, where

applicable, and notify provider.

7. Adult inpatient hospital units will give the influenza vaccine if temperature less than

38˚ C/ 100.4˚ F, without antipyretics.

8. Age/weight appropriate acetaminophen dose for fever

9. Observe all patients for 15 minutes following influenza vaccine administration

to decrease the risk for injury should syncope occur.

F. PATIENT EDUCATION/FOLLOW-UP:

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1. Advise patient about risks of vaccination as compared with risk of influenza and its

complications.

2. Advise patient that it takes approximately 2 weeks for the immune system to

develop protection from the date of vaccine administration.

3. Inform patient that the vaccine cannot cause influenza, but that fever, malaise, and

myalgia may begin 6 to 12 hours after vaccination and last 1 to 2 days.

4. Instruct patient to take acetaminophen, for fever, as appropriate for age, (unless

contraindicated) and to apply ice compresses to the injection site to minimize

discomfort.

G. DOCUMENTATION:

1. Complete the Flu Immunization questions in the MAR.

2. Document the following information in the EHR:

a. Temperature including route

b. Vaccine name, dosage; lot #; manufacturer name; expiration date VIS edition date given

c. Body site where injection given (include preference right / left deltoid; right / left

anterolateral thigh)

d. Document patient’s decision to not receive, or if patient/parent declines vaccination

e. Document the exclusion criteria, if applicable

f. Document patient instructions provided

g. Document any physician/provider notifications, reasons for notification, and any follow

up / interventions.

II. REQUIREMENTS OF RN:

A. EDUCATION AND TRAINING

1. Orientation and competency validation to the standardized procedure.

B. EXPERIENCE

1. Minimum of completion of orientation

C. INITIAL EVALUATION

1. Completion of orientation and competency validation to the standardized procedure.

Competency validation will be documented and maintained in the learning management

system.

D. ON-GOING EVALUATION

1. Annual review of competency.

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III. DEVELOPMENT & APPROVAL OF THE STANDARDIZED PROCEDURE:

A. METHOD

1. Developed and approved by authorized representatives of Administration, Medical Staff,

Pharmacy, and Nursing

B. REVIEW

1. Annual

REGULATORY

REFERENCES:

Business and Profession Code, Nursing Practice Act (NPA), Section 2725.

Accessed from:

https://leginfo.legislature.ca.gov/faces/codes_displayText.xhtml?lawCode=BPC

&division=2.&title=&part=&chapter=6.&article=2.

Board of Registered Nursing, Title 16, California Code of Regulations, Section

1474. Accessed from:

https://govt.westlaw.com/calregs/Document/IB5F41390D48E11DEBC02831C6

D6C108E?viewType=FullText&originationContext=documenttoc&transitionTy

pe=CategoryPageItem&contextData=(sc.Default).

Medical Board of California, Title 16, California Code of Regulations, Section

1379. Accessed from:

https://govt.westlaw.com/calregs/Document/I324910A0D48D11DEBC02831C

6D6C108E?viewType=FullText&originationContext=documenttoc&transitionT

ype=CategoryPageItem&contextData=(sc.Default)&bhcp=1.

Centers for Medicare and Medicaid Services (CMS) State Operations Manual

Appendix A for Hospitals, Regulations and Interpretive Guidelines for

Hospitals, §482.24(c)(3). Accessed from: https://www.cms.gov/Regulations-

and-Guidance/Guidance/Manuals/downloads/som107ap_a_hospitals.pdf

CLINICAL

REFERENCES:

Centers for Disease Control and Prevention, Symptoms of COVID-19.

Updated Feb. 22, 2021. Accessed 08/13/21 from:

https://www.cdc.gov/coronavirus/2019-ncov/symptoms-

testing/symptoms.html

Centers for Disease Control and Prevention, Frequently Asked Influenza (Flu)

Questions: 2021-2022 Season. Accessed 08/11/21 from: Frequently Asked

Influenza (Flu) Questions: 2021-2022 Season | CDC

Centers for Disease Control and Prevention, Summary Document for

Interim Clinical Considerations for Use of COVID-19 Vaccines Currently

Authorized in the United States, 08/09/2021. Accessed 08/11/21 from:

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https://www.cdc.gov/vaccines/covid-19/downloads/summary-interim-

clinical-considerations.pdf

Immunization Action Coalition, Vaccine Information Statements.

Accessed 08/11/21 from: Vaccine Information Statements - VISs - CDC

information sheets for patients (immunize.org)

U.S. Food and Drug Administration, Vaccines Licensed for Use in the United

States, Accessed 08/11/21 from: Vaccines Licensed for Use in the United States

| FDA

RELATED

POLICIES:

Nonapplicable

ATTACHMENTS:

1. Influenza Vaccine Administration Table

2. RN Standardized Procedure Authorization Listing

POLICIES REPLACED:

OCH: Influenza (Flu) Vaccine Administration (PolicyStat ID: 6815852) • Influenza Vaccination Program (PolicyStat ID 3888111) • Seasonal Influenza Plan (PolicyStat ID 2781113) • Influx of Infectious Patients (IC-106) (PolicyStat ID 2800096)

SLRH: Pneumococcal and Influenza Vaccine Screening and Administration for Adult and

Pediatric Patients (Policy Stat ID: 6810635)

• Immunization for Influenza Prevention (PolicyStat ID: 4347555)

VMC: Influenza (Flu) Vaccine Administration (VMC Policy: BRN 27.1)

Issued: 1/19/21

Revised: 8/21

Review By:

APPROVAL PATH:

Department or Committee Responsible Person Date

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Originating Department (i.e., Surgical

Services)

Person’s name Date

Collaborating Department (i.e.,

Anesthesiology)

Person’s name Date

Collaborating Department (i.e., Surgery) Person's Name Date

Collaborating Committee (i.e., Pharmacy &

Therapeutics)

Person’s name Date

Enterprise Interdisciplinary Practice

Committee

Person’s name Date

SCVMC Medical Leadership Council Person's Name Date

OCH Medical Leadership Council Person’s name Date

SLRH Medical Leadership Council Person's Name Date

Enterprise Medical Executive Committee Person’s name Date

Health & Hospital Committee Person’s name Date

Attachment 1, Influenza Vaccine Administration Table

Population Type of

Vaccine

Dose Route Instructions

6 months through 35 months IIV 0.5 mL IM A 2nd dose is recommended 4 weeks or more after the 1st dose if

patient has not received 2 doses in previous years (not necessarily

in the same season).

Thimerosal-free only

Administer in the anterolateral thigh.

Children ages 12 through 35 months may receive injection in

the deltoid.

2 years through 49 years LAIV* 0.2 mL IN With patient in an upright position, and breathing normally, depress

plunger rapidly until the dose-divider clip prevents further

depression.

Pinch and remove the dose-divider clip from the plunger.

Deliver the remaining vaccine into the other nostril.

NOTE: Dripping, sneezing, or swallowing may occur after

vaccination. Re-vaccination is not necessary.

3 years through 8 years IIV 0.5 mL IM A 2nd dose is recommended 4 weeks or more after the 1st dose if

patient has not received 2 doses in previous years (not necessarily

in the same season).

Administer in deltoid or anterolateral thigh.

9 years and older IIV 0.5 mL IM Administer in deltoid.

18 years and older RIV** 0.5 mL IM Administer in deltoid.

65 years and older IIV

IIV-high dose

0.5 mL IM Administer in deltoid.

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Population Type of

Vaccine

Dose Route Instructions

Adjuvanted**

Pregnant IIV or RIV** 0.5 mL IM Thimerosal-free only. Administer in deltoid.

*If available, for pediatric patients, must be ordered by the provider for pediatrics.

**Must be requested by the provider.

Attachment 2

RN STANDARDIZED PROCEDURE AUTHORIZATION LISTING

TITLE OF PROCEDURE: STANDARDIZED PROCEDURE: INFLUENZA (FLU) VACCINE

ADMINISTRATION

The following registered nurses have been validated for competency for the above RN standardized

procedure. Competency validation is performed annually.

NAME DATE VALIDATED BY: NAME/TITLE

1.

2.

3.

4.

5.

6.

7.

8.

9.

10.

THE ORIGINAL COMPLETED FORM IS TO BE PLACED IN THE MANAGER’S OFFICE.