# COMAR Title 10 — Maryland Department of Health

## Subtitle 34 — Board of Pharmacy

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

#### Regulation .07 Training Requirements.

*COMAR 10.34.35.07*

A. Personnel shall be trained in the following areas where appropriate:

  (1) Patient rights and responsibilities;

  (2) Patient safety;

  (3) Performance improvement program;

  (4) Universal precautions which are incorporated by reference in COMAR 10.06.01.01-1;

  (5) Warehouse and equipment orientation;

  (6) Waste management;

  (7) Handling hazardous substances;

  (8) Policies and procedures;

  (9) Recognizing signs of patient abuse and neglect;

  (10) Recognizing signs of IV drug abuse;

  (11) Customer service and cultural sensitivity training;

  (12) Emergency policies and procedures which support the continuum of patient care during natural or manmade disasters; and

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

B. A pharmacist shall be trained and evaluated in the following areas, including but not limited to:

  (1) Clinical management of therapies and disease states managed by the infusion pharmacy services, including but not limited to:

    (a) Specific dosing and monitoring protocols;

    (b) Care planning;

    (c) Lab value ranges; and

    (d) Side effects;

  (2) Pump use and programming;

  (3) Parenteral infusion access devices and therapy-specific appropriateness by device;

  (4) Supplies by therapy and device;

  (5) Accurate set-up of compounding worksheet instructions;

  (6) Pharmacist functions on computer systems;

  (7) Documentation;

  (8) If performing sterile compounding, COMAR 10.34.19;

  (9) Medication storage;

  (10) IV compatibility and stability;

  (11) Calculations to ensure:

    (a) IV dose appropriateness; and

    (b) Compounding accuracy, if applicable; and

  (12) On-call requirements and procedures for handling after-hours care.

C. A pharmacy technician obtaining clinical information shall be trained and evaluated in the following areas, including but not limited to:

  (1) Pharmacy technician functions on computer systems;

  (2) Parenteral infusion access devices

  (3) Supplies specific to therapy and device

  (4) Storage and shipping protocols;

  (5) Pharmaceutical calculations for IV compounding, if applicable;

  (6) Patient triage forms — therapy-specific training and communication with the pharmacist as specified in Regulation .05A(3)(a) of this chapter; and

  (7) Documentation of:

    (a) Communication with patients or caregiver; and

    (b) Delivery scheduling.

D. Unlicensed personnel shall be trained and evaluated in the following areas as applicable:

  (1) Insurance pre-authorization;

  (2) Billing;

  (3) Delivery procedures;

  (4) Supplies;

  (5) Picking and packing of supplies;

  (6) Drug storage;

  (7) Shipping protocols; and

  (8) Cleaning, testing, and maintenance of patient-use equipment according to manufacturers’ specifications.