Rule 360-34-.05 - Requirements of the Vaccine Protocol AgreementThe 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.Ga. Comp. R. & Regs. R. 360-34-.05
O.C.G.A §§ 26-4-5, 31-12-3.1, 43-34-5, 43-34-26.1.
Original Rule entitled "Requirements of the Vaccine Protocol Agreement" adopted. F. Sept. 14, 2015; eff. Oct. 4, 2015.Repealed: New Rule of same title adopted. F. Dec. 20, 2015; eff. Jan. 9, 2016.Amended: F. Jan. 26, 2023; eff. Feb. 15, 2023.Amended: F. Mar. 19, 2024; eff. Apr. 8, 2024.