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. |
