(1) Each home infusion therapy agency, in consultation with any contracted parties, if applicable, shall develop and implement a system of reviewing and evaluating the appropriateness and effectiveness of patient services and the correction of deficiencies. At a minimum, the quality assessment system must:

(a) consist of an annual review of overall provider functions and a semiannual review of selected patient clinical records; and

(b) be reviewed and evaluated by a team composed of, at a minimum, a pharmacist-in-charge, a licensed health care professional, and a licensed health care professional not affiliated with the home infusion therapy agency. The evaluation will be ongoing, including sampling not initiated

solely in response to a problem.

(2) The annual review of provider function must be an organized, effective and documented evaluation. At a minimum, the evaluation must include a review of the:

(a) administrative policies and procedures;

(b) personnel policies;

(c) safety management;

(d) emergency preparedness policies;

(e) clinical program policies and procedures; and

(f) durable medical equipment maintenance and procedures.

(3) The semiannual review of patient clinical records must be:

(a) both concurrent and retrospective; and

(b) performed against preset criteria of practice for each discipline providing care. Criteria of practice must include:

(i) the appropriateness of the level of care provided to protect the health and safety of patients;

(ii) the timeliness of the provision of care;

(iii) the adequacy of the care to meet the patient's needs; and

(iv) the appropriateness of the specific services provided.

(4) Each home infusion therapy agency, in consultation with any contracted parties, if applicable, shall develop and implement a quality assessment plan. The plan must include:

(a) a method for reporting results and a mechanism for taking follow up action;

(b) patient and caregiver and licensed health care professional satisfaction surveys; and

(c) methods to document medication errors and incident reporting and adverse drug reactions.

(5) Each home infusion therapy agency, in consultation with any contracted parties, if applicable, shall establish, document, and audit at regular, planned intervals, quality control procedures. Quality control procedures must be evaluated on an ongoing basis. At a minimum, quality control procedures must include:

(a) drug or product recall procedures;

(b) documentation of storage, stability, and expiration dates;

(c) documentation of equipment functioning and maintenance (such as daily refrigerator temperature logs, records for cleaning, maintenance and calibration of infusion devices) ;

(d) certification of laminar flow hoods and biological safety cabinets by an independent contractor, according to national sanitation foundation standard 49, for operational efficiency at least every 12 months. Appropriate records must be maintained to document certification;

(e) documentation of assessment of sterile technique performed by pharmacy personnel; and

(f) procedures for suspected microbial contamination of sterile products.