Chapter 360-34 VACCINE PROTOCOL AGREEMENTS
As used in this Chapter, the following definitions
apply:
(1) |
'Administer'
means the provision of a unit dose of vaccine by a pharmacist or
nurse pursuant to a vaccine order contained in a vaccine protocol
agreement with a physician. |
(2) |
'Adverse event' means an event
that is a negative consequence of the administration of vaccine by a
pharmacist or nurse that results in an unintended reaction, injury,
or illness, which may or may not have been preventable. |
(3) |
'Board' means the Georgia
Composite Medical Board. |
(4) |
'Nurse' means a registered
professional nurse as defined in paragraph (9) of Code Section
43-26-3.
The term shall also mean a licensed practical nurse as defined in
paragraph (5) of Code Section
43-26-32
who is regularly employed by a physician who actively engaged in the
private practice of medicine. |
(5) |
'Pharmacist' means an
individual licensed under Chapter 4 of Title 26 to engage in the
practice of pharmacy in the State of Georgia. |
(6) |
'Pharmacy intern' means a
pharmacy intern as defined in paragraph (19) of Code Section
26-4-5. |
(7) |
'Physician' means an individual
holding a current license to practice medicine and surgery in this
state and whose principal place of practice is located in this
state. |
(8) |
'Vaccine'
means a specially prepared antigen which upon administration to a
person will result in immunity to influenza, pneumococcal disease,
shingles, or meningitis. No live attenuated virus shall be
administered pursuant to a vaccine protocol unless the patient or his
or her parent, if a minor, has signed an informed consent that he or
she does not have a contraindication to this vaccine, and such
informed consent lists the contraindications to the
vaccine. |
(9) |
'Vaccine
order' means a prescription drug order, contained in a vaccine
protocol agreement, issued by a physician for a group of patients
that meet a certain criteria and to be administered by a pharmacist
or a nurse. A vaccine order shall also mean a prescription drug
order, contained in a vaccine protocol agreement, for epinephrine
issued by a physician for a group of patients that meet a certain
criteria and to be administered by a pharmacist or a nurse only upon
the occurrence of an actual or perceived anaphylactic adverse
reaction to the administered vaccine provided that the vaccine
protocol agreement sets forth the signs and symptoms that warrant the
administration of epinephrine. |
(10) |
'Vaccine protocol agreement'
means a written document mutually agreed upon and signed by a
physician and a pharmacist or by a physician and a nurse, by which
document the physician prescribes a vaccine and epinephrine, if
determined appropriate by the physician, by means of a vaccine order
for administration by a pharmacist or a nurse. |
In order for a physician to be eligible to enter into
a vaccine protocol agreement, the physician must:
(1) |
Hold a current license to
practice medicine in the State of Georgia; |
(2) |
Have his/her principal place of
practice in the State of Georgia; |
(3) |
Be registered with the
vaccination registry established by the Georgia Department of Public
Health ("DPH") O.C.G.A. Section
31-12-3.1,
commonly known as the Georgia Registry of Immunization Transactions
and Services ("GRITS"); |
(4) |
Not be employed by the
pharmacist(s) or nurse(s) with whom he/she is entering into the
vaccine protocol agreement; |
(5) |
Not be an employee of a
pharmacy that also employs the pharmacist(s) or nurse(s) with whom
he/she is entering into the vaccine protocol agreement; and |
(6) |
Be available for immediate
consultation or have designated another qualified physician as an
alternate physician who is available for immediate
consultation. |
In order for a pharmacist to be eligible to enter
into a vaccine protocol agreement, the pharmacist must:
(1) |
Hold a current license to
practice as a pharmacist in the State of Georgia; |
(2) |
Hold a current certification in
Basic Cardiac Life Support; |
(3) |
Have completed a course of
training in immunization administration approved by the Georgia State
Board of Pharmacy; |
(4) |
Have completed a training program recognized by the Centers for
Disease Control and Prevention in the basics of immunology which
focuses on practice implementation and legal and regulatory issues,
composed of (a) at least 12 hours of self-study and an assessment
exam; (b) at least eight hours of a live seminar with a final exam;
and (c) a hands-on assessment of intramuscular and subcutaneous
injection technique; and |
(5) |
Have individual liability
insurance coverage in an amount not less than $250,000 to cover
claims arising from the administration of vaccines, or have
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. |
In order for a nurse to be eligible to enter into a
vaccine protocol agreement, the nurse must:
(1) |
Hold a current license to
practice as a registered professional nurse; or be licensed to
practice as a licensed practical nurse while regularly employed by
the physician in the protocol; |
(2) |
Hold a current certification in
Basic Cardiac Life Support; and |
(3) |
Have individual liability
insurance coverage in an amount not less than $250,000 to cover
claims arising from the administration of vaccines, or have
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. |
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 provide each new vaccine recipient with a personal immunization
card on card stock paper containing the vaccine recipient's name, the
pharmacist's or nurse's name and phone number, the name and dosage of
the vaccine, the location of the injection on the vaccine recipient
and the date of administration of the vaccine in a format made
available by the Department of Public Health. In the event the
patient already has an immunization card, the pharmacist or nurse
shall update the card; |
(8) |
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; |
|
(9) |
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; |
(10) |
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; |
(11) |
Prohibit the administration of
the vaccine to a patient while the patient is in his or her personal
vehicle; |
(12) |
Require the
pharmacist or nurse to enter the patient's vaccine information in
Georgia Registry of Immunization Transactions and Services ("GRITS")
within the time designated by the Department of Public
Health; |
(13) |
Require that
the vaccine recipient remain under observation for not less than 15
minutes immediately subsequent to the administration of the
vaccine; |
(14) |
Contain
procedures to follow in the event of an adverse event or
complication; |
(15) |
Provide for prioritization of vaccine recipients in the event of a
limitation in the supply of the vaccine; |
(16) |
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; |
(17) |
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; |
(18) |
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, local
health department, or other setting in which the vaccine is being
administered; |
(19) |
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; |
|
(20) |
Provide that the pharmacist
cannot delegate the administration of the vaccine to another
individual except a pharmacy intern under his/her direct supervision,
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 |
(21) |
Provide for the expiration,
renewal or revision of the protocol on at least a biennial
basis. |
(1) |
The
physician shall not enter vaccine protocol agreements with more than
ten (10) pharmacists and/or nurses except as provided in O.C.G.A.
Section
43-34-26.1(j). |
(2) |
The physician must be in the
same public health district as the pharmacists and/or nurses
identified in the protocol; or the nurses and/or pharmacists are
located in the same or contiguous county as the physician's
registration with the vaccination registry. |
(3) |
The physician shall have
verified that the pharmacist(s) or nurse(s) have had Basic Cardiac
Life Support training and any other training required by
law. |
(4) |
The physician
shall verify that the pharmacist or nurse administering the protocol
has policies and procedures for the handling and disposal of
contaminated equipment and supplies. |
(5) |
No vaccine protocol agreement
shall permit a pharmacist or nurse to administer a vaccine, including
the influenza vaccine, to any child under the age of 13 without an
individual prescription from a physician. |
(6) |
No vaccine protocol agreement
shall permit a pharmacist or nurse to administer a pneumococcal
disease vaccine or meningitis vaccine to a child under the age of
18. |
(7) |
No vaccine
protocol agreement shall permit a pharmacist or nurse to administer a
vaccine to a child under the age of 18 without consent from the
child's parent or legal guardian. |
The vaccine protocol agreement must be filed with the
Board within thirty (30) days of its execution and shall be renewable
as provided by the Board.
The Board's standard protocol template is available
at www.medicalboard.georgia.gov.
A physician may make further changes restricting the administration
of the vaccine from patients with certain medical
conditions.
The requirements of this Chapter shall not apply to
activities conducted within a hospital and its facilities,
physician's office, nursing home or other health care facilities
designated by the Department of Public Health.
(1) |
The Board may impose a fine of
up to $2,500 against any pharmacist or nurse who knowingly:
(a) |
Fails to maintain individual
liability insurance or fails to be individually covered by his/her
employer in an amount not less than $250,000 to cover claims arising
from the administration of vaccines; |
(b) |
Fails to provide proof of such
coverage to the physician entering into the vaccine protocol
agreement; or |
(c) |
Fails
to maintain a copy of the proof of insurance onsite at the primary
location. |
(d) |
Administers
a vaccine without a vaccine protocol agreement. |
|
(2) |
The Board may impose the
following sanctions against a pharmacist or nurse who fails to
provide a legible immunization card to a vaccine recipient as
provided by law:
(a) |
Upon the first
violation, the issuance of a warning; |
(b) |
Upon the second violation, a
fine up to $500; and |
(c) |
Upon a third or subsequent violation, the Board may prohibit the
pharmacist or nurse from administering vaccines for a period up to
one year. |
|
(3) |
The Board may impose the following sanctions against a pharmacist or
nurse who knowingly fails to post the vaccine protocol agreement as
provided by law:
(a) |
Upon the first
or second violation, the issuance of a warning; and |
(b) |
Upon the third or subsequent
violation, the Board may prohibit the pharmacist or nurse from
administering vaccines for a period up to six
months. |
|
(4) |
The
Board may impose a fine of up to $2,500 and may prohibit a pharmacist
or nurse from administering vaccines for up to one year if the
pharmacist or nurse knowingly administers a vaccine without a vaccine
protocol agreement as required by O.C.G.A. Section
43-34-26.1
and filed with the Board. |
(5) |
Sanctions imposed pursuant to
this Chapter shall not be contested cases. The Board shall issue a
citation with the identified offense and the sanction, including when
any fine is due, which citation shall be mailed to the pharmacist's
or nurse's address of record with the appropriate licensing board. A
pharmacist or nurse may request an appearance before the Board to
contest the finding or sanction within thirty (30) days after the
issuance of the sanction. Failure to request an appearance or pay any
fine imposes shall be considered a violation of a lawful order of the
Board. If an appearance is requested, the Board shall schedule the
appearance, and thereafter issue a decision on the imposition of
sanctions. |
(6) |
Nothing in
this rule prevents the Board from forwarding any investigation to the
professional licensing board of the licensed pharmacist or nurse for
further disciplinary action. |
(7) |
Nothing in this chapter shall
be construed to limit the authority of the Board to take disciplinary
action against any physician who is a party to a vaccine protocol
agreement for a violation of the law and rules. |