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.

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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.

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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.

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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.

Do:

  • 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.
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Don’t:

  • 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.
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