(1) Each home infusion therapy agency must employ an administrator who shall:

(a) organize and direct the home infusion therapy agency's ongoing functions;

(b) be responsible for ongoing oversight of the home infusion therapy agency's quality assessment system, including the establishment of policies and procedures which address the safe control, accountability, distribution, and administration of infusion products;

(c) employ qualified personnel and ensure adequate staff

education and evaluation; and

(d) be familiar with and assure compliance with the rules

of this subchapter.

(2) For a pharmacy which is licensed as a home infusion therapy agency, the pharmacist-in-charge may serve as the administrator.

(3) All services provided by the home infusion therapy agency and its employees must be provided in accordance with state laws, regulations, and home infusion therapy agency policies and procedures.

(4) The home infusion therapy agency must maintain, at all times, a pharmacist-in-charge (or designee) and a Montana licensed nurse that are both accessible and physically able to respond 24 hours a day, seven days per week.

(5) The home infusion therapy agency shall document in the employee record:

(a) all professional employee orientation;

(b) competency assessments;

(c) specialized training required within the respective professions; and

(d) a current license.

(6) The pharmacist-in-charge may be assisted by supportive personnel. Supportive personnel must work under the immediate supervision of a licensed pharmacist and have specialized training in the field of home infusion therapy. The duties and responsibilities of these personnel must be consistent with their training and experience.

(7) The licensed health care professional providing skilled nursing services shall:

(a) provide those services in accordance with the plan of care;

(b) dictate or write clinical notes at the time of service. Clinical notes must be signed, recorded, and incorporated into the patient's medical record within three working days of providing the service;

(c) assist in coordinating all services provided; and

(d) notify the pharmacist, the prescribing practitioner, and the home infusion therapy agency's personnel responsible for the care of the patient, of any significant changes in the patient's condition.