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(1) The home infusion therapy agency shall develop a policy and procedure manual for the organization and operation of the home infusion therapy agency. A copy of the manual must be kept current at all times, and be readily available at all times, and to all who request it.

(2) The manual must include an organizational chart delineating the lines of authority, responsibility, and accountability for the administration and patient care services of the agency.

(3) The manual must specifically detail the storage, stability, handling, compounding, labeling, dispensing, and delivery of all sterile pharmaceuticals and address requirements relating to:

(a) security measures, which ensure that the premises where sterile pharmaceuticals are present are secured, and which prevent access to patient records by unauthorized personnel;

(b) sanitation, including the methodology of cleaning biological safety cabinets and laminar flow hoods, and of inspecting filters for deterioration and microbial contamination;

(c) the annual certification of safety cabinets and laminar floor hoods;

(d) the orientation of personnel;

(e) the duties and qualifications of staff;

(f) record keeping requirements;

(g) medication profiles;

(h) the administration of parenteral therapy to include infusion devices, drug delivery systems, and monitoring;

(i) the pharmacy patient evaluation and documentation;

(j) prescription processing;

(k) clinical services;

(l) drug and product selection;

(m) 24-hour emergency access to a pharmacist;

(n) the handling of antineoplastic agents, a description of which must include protective apparel to be worn by compounding personnel;

(o) drug destruction, returns, and proper waste management;

(p) equipment management, including tracking, cleaning, and testing of infusion pumps;

(q) end product testing;

(r) a quality assessment program;

(s) a risk management program including incident reports,

adverse drug reactions, product contamination, and drug recalls;

(t) education and training of the patient or the patient's caregiver;

(u) emergency drug and supply procurement;

(v) guidelines for handling investigational drug administration;

(w) reference materials; and

(x) an emergency preparedness plan.

History: 50-5-103, MCA; IMP, 50-5-103, 50-5-213, MCA; NEW, 1996 MAR p. 2587, Eff. 10/4/96; TRANS, from DHES, 2002 MAR p. 185; AMD, 2009 MAR p. 1668, Eff. 9/25/09.

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