The following links and resources can help you learn more about COVID-19 vaccines and proactively prepare to implement a vaccine program. You may want to bookmark this page or check back often as information will be updated frequently.
NOTE TO RETIRED MEDICAL PROFESSIONALS:
In his January 4, 2021 “Update to New Yorkers”, Governor Andrew Cuomo announced that the State of New York is “identifying public facilities and convention centers to also be used as vaccination centers, and is recruiting retired nurses, doctors and pharmacists to support vaccine administrations”.
As part of MLMIC’s ongoing efforts to support our dedicated physicians throughout New York, we are pleased to extend medical professional liability coverage to retired physicians who were last insured with MLMIC and return to volunteer to provide vaccine administrations during the COVID-19 pandemic.
Posted January 20, 2021
The Federal Public Readiness and Emergency Preparedness Act, otherwise know as the PREP Act, provides for immunity for, among other things, the administration to or use by an individual of a covered countermeasure (such as a vaccine), if the person is a qualified person under NY State law. This includes licensed health professionals or other individuals authorized to prescribe administer or dispense the countermeasure by state law. The immunity is applicable, unless there is willful misconduct by the professional administering the vaccine.
Posted January 6, 2021
Yes, MLMIC will pay claims that an insured becomes legally obligated to pay, subject to all the terms, conditions, limits, and exclusions described throughout the policy. The CDC Provider agreement requires that the provider keep a medical record, submit vaccine administration data, store and handle the vaccine in compliance with the package insert, report adverse events to VAERS and provide a vaccination card to recipients. Compliance with the Provider Agreement will significantly reduce exposure to allegations of negligence.
Please stay current with CDC and state guidelines:
Posted January 13, 2021
The New York State Department of Health has issued a NYS COVID-19 vaccine consent form that that we recommend be used for both informed consent as well as a screening tool and information sheet for patients to read. Under NY State laws governing informed consent, the consent should be in written form and signed by the patient, unless there is a physical or mental disability which precludes the patient from signing the form. If that occurs, the patient who has capacity should be read the contents of the consent if feasible and give verbal consent in front of a witness as well as the person giving the inoculation. Alternatively, consent can be given by a legal guardian, a Health Care Proxy Agent (if the patient is determined to lack capacity) or other legal surrogate under NYS laws. All of this should be documented on the consent form by the provider. Because the vaccines are available under an emergency authorization (EUA) from the FDA, not all of the risks and complications may be known at this time, other than fever, pain, fatigue, and an occasional allergic or anaphylactic reaction. The patient should be advised of this as part of the consent discussion and monitored for either 15 minutes (if the patient has no history of allergic reactions and has had no untoward reaction during that 15 minutes that would requires longer observation) or for 30 minutes if the patient has a history of allergic reactions. Epinephrine should be immediately available at vaccination sites.
Both the Pfizer vaccine and the Moderna vaccine are available for distribution under an Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA). The FDA has authored “Fact Sheet for Recipients and Caregivers” which describes the risks and benefits of getting the COVID-19 vaccine. These documents were published to help educate patients and health care professionals, not as informed consent forms. However, because the Fact Sheets describe both the risks and the benefits associated with vaccinations, they may be used to assist with the informed consent process, as long as they conform to the appropriate New York state laws. The Fact Sheets also contain information that may be useful to the patient later, such as information about what to do in case of an adverse reaction.
Posted January 6, 2021
As with any vaccine, care should be taken prior to administration of the COVID-19 vaccine to assess for appropriateness, possible contraindications to inoculation as well as monitoring for side effects.
The CDC has provided recommendations as to the amount of time patients should be monitored in the office given their particular comorbidities. The link below discusses in detail the clinical considerations that should be reviewed prior to administration of the COVID-19 vaccine. A review of the monitoring time that should be incorporated into the visit, given the patient’s history of allergies to past vaccines or other vaccine components is included in Appendix B.
Posted January 6, 2021
In the event a patient does not return for the second dose of the vaccine, an attempt should be made to contact them and determine the reason. It may be that there is a practical reason, such as their work schedule prevents them from keeping their appointment and alternative times cannot be arranged. If the patient is refusing the second dose because of misbeliefs regarding the vaccine, attempt to re-educate the patient on the vaccine’s safety and the need for a second dose to protect themselves and those that they are around. If the patient continues to refuse a second dose or you are unable to contact him or her, send a letter to their home outlining the importance of receiving the second dose of the vaccine and the possible consequences of not receiving it. Consider sending the letter via certified/registered mail as well as routine postal delivery. A copy of the letter should be kept in the patient’s medical record. Additionally, the dates and times of all attempts to contact the patient, and any responses made by the patient should be documented in the patient’s medical record.
MLMIC has a Risk Management Tip which can assist you in addressing patient non-compliance.
For further assistance on addressing a patient’s non-compliance with the COVID-19 vaccine and other treatments you may also contact the law firm of Fager Amsler Keller & Schoppmann, LLP at (877) 426-9555.
Posted January 6, 2021
There are currently no federal or state mandates for COVID-19 vaccinations, however, healthcare employers may choose to make this vaccination a condition of employment.
According to a recent update to the EEOC Guidelines, under the ADA, employers are permitted to impose “a requirement that an individual shall not impose a direct threat to the health or safety of individuals in the workplace,” Here, that threat is an unvaccinated employee in this time of pandemic. Please note that employers who mandate vaccination for COVID-19 must provide a “reasonable accommodation” for employees who have a disability or sincere religious belief that forbids vaccinations.
Employers considering mandated vaccinations must design their policies and processes to comply with any federal, state and/or local regulations or requirements and document both informed consent or refusal in the employee file. Employers should also contact their business counsel for further assistance on this issue.
Please stay current with federal, state, local and EEOC guidelines and regulations:
AMERICAN HOSPITAL ASSOCIATION
AMERICAN MEDICAL ASSOCIATION
AMERICAN NURSES ASSOCIATION
AMERICAN PHARMACISTS ASSOCIATION
AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS
CENTERS FOR DISEASE CONTROL AND PREVENTION
CENTERS FOR MEDICARE AND MEDICAID SERVICES
IMMUNIZATION ACTION COALITION
NATIONAL ACADEMIES OD SCIENCES, ENGINEERING, AND MEDICINE
NATIONAL GOVERNORS ASSOCIATION
U.S. DEPARTMENT OF DEFENSE
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
U.S. FOOD AND DRUG ADMINISTRATION
WORLD HEALTH ORGANIZATION