Code of Maryland Regulations
Title 10 - MARYLAND DEPARTMENT OF HEALTH
Part 4
Subtitle 34 - BOARD OF PHARMACY
Chapter 10.34.35 - Infusion Pharmacy Services in an Alternate Site Care Environment
Section 10.34.35.06 - Minimum Requirements for Policies and Procedures

Universal Citation: MD Code Reg 10.34.35.06

Current through Register Vol. 51, No. 19, September 20, 2024

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.

Disclaimer: These regulations may not be the most recent version. Maryland may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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