Chapter 360-34 VACCINE PROTOCOL AGREEMENTS

Rule 360-34-.01 Definitions

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.

Rule 360-34-.02 Qualifications for Physician to enter a protocol

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.

Rule 360-34-.03 Qualifications for a Pharmacist to enter a protocol

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.

Rule 360-34-.04 Qualifications for a Nurse to enter a protocol

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.

Rule 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 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.

Rule 360-34-.06 Limitations of the Vaccine Protocol Agreement

(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.

Rule 360-34-.07 Filing of Vaccine Agreements with the Board

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.

Rule 360-34-.08 Template

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.

Rule 360-34-.09 Exemptions

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.

Rule 360-34-.10 Penalties

(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.

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