Ga. Comp. R. & Regs. R. 360-34-.05 - Requirements of the Vaccine Protocol Agreement
The protocol agreement must:
(1) Contain the current names, addresses,
telephone numbers, and professional license numbers of the physician and the
pharmacist or nurse;
(2) Contain a
provision for immediate consultation with the physician or an alternate
physician;
(3) Require the
pharmacist or nurse to take a complete case history and determine whether a
patient has had a physical examination within the past year;
(4) Provide that no vaccine shall be
administered to a patient with any condition for which the vaccine is
contraindicated;
(5) Require the
pharmacist or nurse to provide the vaccine recipient with the appropriate and
current Vaccine Information Statement (VIS) as provided by the federal Centers
for Disease Control and Prevention;
(6) Require the pharmacist or nurse to
provide written information to the vaccine recipient developed by the
Department of Public Health on the importance of having and periodically seeing
a primary care physician;
(7)
Require the pharmacist or nurse to retain documentation of each dose
administered with such documentation to include the following:
(a) the administering pharmacist's or nurse's
name, address, telephone number and professional license number;
(b) the name, dose, manufacturer, and lot
number of the vaccine;
(c) the
vaccine recipient's name, address, date of birth, and telephone
number;
(d) the date of
administration and injection site;
(e) the signed and dated consent form that
acknowledges receipt of the VIS, consents to the administration of the vaccine
and authorizes the pharmacist or nurse to notify the vaccine recipient's
primary care provider of the vaccine administered to the vaccine recipient;
and
(f) any adverse events or
complications that occur;
(8) Require the pharmacist or nurse to make
documented reasonable efforts to obtain the name of the vaccine recipient's
primary care provider and to notify such primary care provider of the vaccine
administered by the pharmacist or nurse within 72 hours of the
administration;
(9) Require the
pharmacy or nurse to administer the vaccine to a patient in a private room,
area with a privacy screen or other interior area in which the patient's
privacy can be maintained unless there is a declared public health emergency or
where immunizations are being administered for purposes of training for a short
period of time;
(10) Prohibit the
administration of the vaccine to a patient while the patient is in his or her
personal vehicle;
(11) Require the
pharmacist, nurse, or his or her designee to check the Georgia Registry of
Immunization Transactions and Services prior to administration of the vaccine
and to enter the patient's vaccine information in the vaccination registry
within the time designated by the Department of Public Health; provided,
however, that a pharmacist, nurse, or his or her designee shall not be required
to check the Georgia Registry of Immunization Transactions and Services during:
(a) A public health emergency, as defined in
Code Section
31-12-1.1, for any vaccine
administered to address the cause of the threat of an illness or health
condition or the infectious agent or biological toxin which resulted in such
public health emergency; or
(b) A
vaccination event for influenza that is anticipated to serve 75 or more
patients;
(12) Require
that the vaccine recipient remain under observation for not less than 15
minutes immediately subsequent to the administration of the vaccine;
(13) Contain procedures to follow in the
event of an adverse event or complication;
(14) Provide for prioritization of vaccine
recipients in the event of a limitation in the supply of the vaccine;
(15) Require that the pharmacist or nurse
maintains individual liability insurance coverage in an amount not less than
$250,000 to cover claims arising from the administration of vaccines, or has
individual coverage from his/her employer's liability insurance in an amount
not less than $250,000 to cover claims arising from the administration of
vaccines;
(16) Require that the
pharmacist or nurse maintain a copy of the proof of insurance with the name of
the insurer and policy number onsite at his or her primary location;
(17) Require that the pharmacist or nurse
post proof of the vaccine protocol agreement, including a list of the vaccines
authorized to be administered, in a conspicuous location within the pharmacy or
other setting in which the vaccine is being administered;
(18) Require the submission of a signed and
notarized affidavit by the pharmacist or nurse to the physician attesting to:
(a) the maintenance of liability
insurance;
(b) current
certification in Basic Cardiac Life Support, and for pharmacists, verification
of completion of immunology training;
(c) the maintenance of a copy of the vaccine
protocol agreement; and
(d) the
identification of the locations where the pharmacist or nurse will be
administering vaccinations pursuant to the protocol;
(19) Provide that the pharmacist cannot
delegate the administration of the vaccine to another individual except a
pharmacy intern or a qualified pharmacy technician under his/her direct
supervision, provided that approval of such authorization of qualified pharmacy
technicians is included in the vaccine protocol agreement between the physician
and pharmacist, and that the nurse cannot delegate the administration of the
vaccine except a registered professional nurse may delegate the administration
to a licensed practical nurse under the direct on-site supervision of the
registered professional nurse; and
(20) Provide for the expiration, renewal, or
revision of the protocol on at least a biennial basis.
Notes
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
No prior version found.