# COMAR Title 10 — Maryland Department of Health

## Subtitle 34 — Board of Pharmacy

### Chapter 35 — Infusion Pharmacy Services in an Alternate Site Care Environment

#### Regulation .06 Minimum Requirements for Policies and Procedures.

*COMAR 10.34.35.06*

The policies and procedures shall:

A. Be congruent with State regulations and standards of care from accrediting bodies and professional organizations; and

B. Address:

  (1) Personnel:

    (a) Training and Orientation;

    (b) Duties; and

    (c) Qualifications;

  (2) Security of the facility;

  (3) Standards of patient care;

  (4) Infection control;

  (5) Initial and ongoing home safety assessments;

  (6) The provision of patient or caregiver education including, but not limited to:

    (a) Drug and therapy administration-specific information and precautions;

    (b) Reporting adverse drug reactions;

    (c) Reporting side effects;

    (d) Infusion pharmacy contact information;

    (e) Emergency measures related to:

      (i) Changes in patient condition requiring medical intervention; and

      (ii) Events which may delay or prevent delivery of pharmaceuticals or nursing care; and

    (f) Equipment use and safety.

  (7) Patient care operations, including but not limited to:

    (a) If applicable, pharmacist checking procedures related to order entry and compounding accuracy;

    (b) Therapy-specific monitoring parameters for:

      (i) Laboratory testing;

      (ii) Appropriate frequency of testing; and

      (iii) Patient follow-up; and

    (c) Pump, or other patient-use equipment, between-patient cleaning, testing, and preventive maintenance, which include specific:

      (i) Procedures and documentation of cleaning, testing and preventive maintenance for patient equipment according to manufacturer’s guidelines; and

      (ii) Frequencies for all equipment maintenance activities;

  (8) Delivery arrangements;

  (9) Patient confidentiality and the Health Insurance Portability and Accountability Act, 45 CFR Parts 160 and 164; and

  (10) Availability of a pharmacist on call after-hours to respond to:

    (a) Pharmacy related patient or caregiver inquiries; and

    (b) Medication or supply needs.