Current through Register Vol. 6, March 22, 2024
(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.
