What Every Nurse Should Know About Vaccine Distribution

What Every Nurse Should Know About Vaccine Distribution

Nurses all over the country have been giving vaccinations for the COVID-19 virus. As more and more settings are offering the vaccine, there are a number of risks that nurses need to be aware of before going to work and assisting with vaccine distribution.

Jennifer Flynn, CPHRM, Risk Manager, Nurses Service Organization (NSO), agreed to answer our questions about what nurses need to be aware of when they’re going to give COVID-19 vaccinations.

Overall, what do nurse need to be aware of in general?  

When assisting with a vaccination program, whether through your employer or volunteering, nurses need to ensure that vaccines are administered in appropriate settings with adequate patient safety and monitoring procedures. Nurses may require additional training to participate in administering vaccines. In general, nurses will want to educate themselves on vaccine specifics, as well as other considerations including but not limited to, contraindications for administration, potential adverse reactions, dosing requirements, storage and handling requirements, documentation requirements, administration requirements such as mixing with diluent, appropriate needle size and anatomic administration sites, and post-vaccination monitoring requirements. Providers will also want to be prepared for responding to adverse events, such as anaphylaxis.

What is informed consent and informed refusal? Why do nurses need to be aware of them? If someone refuses, what should they do?

Simply put, informed consent is a two-part process: the discussion and the documentation of that discussion. From a liability perspective, it helps to manage patient expectations—it can reduce the possibility of a misunderstanding. And, it can strengthen one’s legal defense in the event of a claim.

In order for patients to give informed consent, the verbal discussion allows the provider to explain the risks of the proposed treatment, benefits, and alternatives. In order to gauge the patient’s understanding, they should have the opportunity to ask questions before any written consent is obtained.

The signed informed consent form should be placed in the patient’s health care information record.

Persistent failure to heed medical advice can lead to less than desirable results for the patient, as well as potential liability exposure for providers. Health care providers can counter this risk by adopting a standardized refusal-to-consent form, which serves to confirm in writing that the provider fully disclosed to the patient the risks of forgoing the proposed test, treatment, or procedure. By signing the form, patients acknowledge that they have discussed the proposed course of care with their practitioner and understand that failure to follow medical recommendations can have serious or even life-threatening consequences. The completed refusal-to-consent form should be placed in the health care information record.

Prior to administering the vaccine, nurses should participate as witness or be aware that the facility has performed the informed consent process that it has been properly documented. Ensure the patient received the manufacturer’s fact sheet, inform the patient of the FDA’s Emergency Use Authorization status of the vaccine, known and potential benefits and risks, option to accept or refuse the vaccine and the risks associated with refusal, any available alternatives, obtain the patient’s written informed consent and document the content of the discussion, materials provided to the patient, and the signed consent form in the patient’s health care record.

Why do they need to have adequate documentation when giving the vaccine? Does this differ is they’re doing this vaccination directly for their employer (say a hospital or rehab center/nursing home) or doing the work for a vaccine center?

A carefully documented record may prove invaluable in defending against allegations of negligence. When assisting with a vaccination program, whether through your employer or volunteering, documentation for administering vaccines should include the date and time of administration, vaccine administered, dosage and lot number, route and site of administration, and post-vaccination monitoring information.

As a reminder, the health care record is a legal document and is an essential tool to understand:

  • The patient’s medical event. Document thoroughly including treatment decisions made, actions taken, the corresponding rationale and information given to the patient.
  • The nurse’s actions. Good recordkeeping involves accurately conveying what was heard, seen and thought, what treatment was performed, why that treatment was necessary, and what future care was required—based solely on written documentation. Include patterns of noncompliance.
  • Factually note:
    • What occurred
    • What the patient stated
    • What steps were taken to resolve or relieve the situation
    • Whether the patient responded favorably to those steps
    • The patient’s condition and mode of leaving following the appointment
    • The follow-up or referral instructions provided to the patient
  • If the record is deficient, the nurse’s credibility is weakened.

Because complete and accurate health care records are such an essential risk management measure, nurses should maintain proper documentation practices and follow their facility’s policies and procedures governing documentation.

Maintaining a consistent, professional patient health information record is essential to providing quality patient care, ensuring consistent communication among all professionals caring for the patient, and establishing the basis for an effective defense should litigation arise.

What are some tips for mitigating risk of malpractice?  

Know and comply with your state scope of practice requirements, nurse practice act, and facility policies, procedures, and protocols. Follow documentation standards established by nurse professional organizations and comply with your employer’s standards. Maintain clinical competencies aligned with the relevant patient population and healthcare specialty. Develop, maintain, and practice professional written and spoken communication skills. Emphasize ongoing patient assessment and monitoring.

Can you give me some general education and infection control best practices that nurses should know?

When assisting with a vaccination program, whether through your employer or volunteering, the location should permit physical distancing between individuals who are in line to receive the vaccine in conformity with CDC guidelines. Patient appointments should be designated appointment times. Consider the creation of dedicated vaccination areas or specified hours for those at higher or severe risk associated with COVID-19. Implement strategies to manage patient flow, and limit crowding or long lines by using unidirectional signage. Limit the overall number of individuals permitted in vaccination or monitoring areas.

Anything else that is important for nurses to know?

I think it is also important for nurses to know “Do’s and “Don’ts” of what to do if they have received a legal summons/paperwork or State Board of Nursing complaint.


  • Contact your Risk Manager, your employer, and your insurance carrier immediately!
  • Secure and sequester the file to prevent alteration—Do not add or delete any information in the patient’s chart!
  • Comply with all investigations.
  • Give copies of records to patients when they request them.


  • Try to resolve legal/regulatory situations on your own (without legal or Risk Management guidance).
  • Call patient to discuss a legal/regulatory matter without talking to your attorney first.
  • Talk to anyone about the case other than your Risk Manager, your employer, your insurance carrier, and your attorney.
Informed Consent and Informed Refusal in Managing Patient Expectations

Informed Consent and Informed Refusal in Managing Patient Expectations

Insights from the new Nurse Practitioner Claim Report: 4th Edition from CNA and Nurses Service Organization (NSO) show that the majority of claims against nurse practitioners developed from a failure involving core competencies, such as diagnosis, medication prescribing, or treatment and care management. Allegations related to failure to diagnose and improper prescribing/managing of controlled drugs occurred most frequently.

What the report also found was that in many claims, the nurse practitioner met the standard of care, but the patient was nonetheless dissatisfied, often due to a lack of communication or understanding. The informed consent discussion represents the first step in managing patient expectations, thus reducing the possibility of a misunderstanding and mitigating the risk of a consequent lawsuit.

Additionally, documenting the informed consent process provides the best defense in the event a patient alleges that the proposed treatment, other options, or the potential for injury were not adequately explained to them. Refer to state statutes for guidance on the informed consent process, as there is considerable variance among states. This is especially true when it comes to caring for minors or cognitively impaired patients, and emergency situations.

The informed consent process involves two main components:

  • Discussion, providing the patient with sufficient information about and time to consider:
    • The nature of the proposed treatment, including rationale, anticipated benefits and prognosis.
    • Alternatives to the proposed treatment, including specialty referral options or no treatment at all. This should also include an explanation of why, according to one’s professional judgment, the recommended treatment is preferable to alternatives.
    • Foreseeable risks, including potential complications of the proposed treatment and risks of refusing it.
  • Documentation of the discussion and the outcome of the discussion in the healthcare information record, which often includes the use of a written informed consent form in addition to the verbal component.

The informed refusal process is similar to, but goes beyond, the process for informed consent. Refusal of care increases the potential liability exposure for the nurse practitioner, but nurse practitioners can help minimize their liability exposure by being aware of their consequent responsibilities and documenting the informed refusal process.

Nurse practitioners who continue caring for a patient after they decline treatment recommendations must be aware of their responsibility to:

  • Continue to examine and diagnose the patient for the duration of the practitioner-patient relationship and as long as the patient continues to refuse treatment.
  • Continue to inform the patient about the condition and its associated risks, while the practitioner-patient relationship is in place, the condition exists, and the patient continues to refuse treatment.
  • Continue to inform the patient how their refusal of treatment may affect treatment of other conditions or problems, when discussing these conditions.

After discussing the potential consequences of refusal with the patient, nurse practitioners should complete a comprehensive progress note and document the refusal using a written form, which should be incorporated into the patient health care information record. Progress notes should document:

  • The individuals present during the discussion.
  • The treatment discussed.
  • The risks of not following treatment recommendations, listing the specific risks mentioned.
  • The brochures and other educational resources provided.
  • The questions asked and answers given by both parties.
  • The patient’s refusal of the recommended care.
  • The patient’s reasons for refusal.
  • The fact that the patient continues to refuse the recommended treatment.

As the data proves, it is imperative for nurse practitioners to protect their patients and their practice by documenting all phases of medical treatment, discussing (and documenting) the nature of all proposed treatments with patients as well as educating them about the need for follow-up, and signs and symptoms that should prompt a follow-up call.

In addition, today’s nurse practitioners must continuously evaluate and enhance their patient safety and risk management practices by remaining current regarding their clinical practice, medications, biologics, and equipment utilized for the diagnosis and treatment of acute and chronic illnesses and conditions related to one’s specialty and obtain regular continuing education.

Disclaimer: This article is provided for general informational purposes only and is not intended to provide individualized business, risk management or legal advice.  It is not intended to be a substitute for any professional standards, guidelines or workplace policies related to the subject matter.

This risk management information was provided by Nurses Service Organization (NSO), the nation’s largest provider of nurses’ professional liability insurance coverage for over 550,000 nurses since 1976. Reproduction without permission of the publisher is prohibited. For questions, send an e-mail to [email protected] or call 1-800-247-1500. www.nso.com.