(1) Each home infusion therapy agency shall:

(a) provide clinical and laboratory data concerning each patient to any contracted party providing services to the patient;

(b) report, in a timely manner, any abnormal values to the prescribing practitioner and any contracted party providing services to the patient; and

(c) ensure that each patient complies with and adheres to the home infusion regimen.

(2) Each home infusion therapy agency, and any contracted party providing services to the patient, together, shall:

(a) design, document and follow a systematic process of medication use review on an ongoing basis;

(b) prepare and document a medication profile;

(c) monitor and assess each patient's ongoing drug therapy and at a minimum, document for each patient:

(i) the initial assessment, including appropriateness of the dose, frequency, route of administration, and relevant medical history;

(ii) the clinical progress notes and on-call and after hours activity;

(iii) the drug stability, and osmolarity and compatibility, when appropriate;

(iv) the clinical laboratory or clinical monitoring methods to detect side effects, toxicity, or adverse effects and whether the findings have been reported to the pharmacist and prescribing practitioner;

(v) the monthly clinical therapy summary for any patient receiving services 30 days or longer; and

(vi) the discharge summary of therapy at the end of treatment.

(3) 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 home care 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.

(4) Any sterile product administered for the first time must be administered under the supervision of a licensed health care professional to detect, monitor, and respond to adverse drug reactions.