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10.34.35.00.htm 10.34.35.00. Title 10 MARYLAND DEPARTMENT OF HEALTH Subtitle 34 BOARD OF PHARMACY Chapter 35 Infusion Pharmacy Services in an Alternate Site Care Environment Authority: Health-Occupations Article, §12-205, Annotated Code of Maryland
10.34.35.01.htm 10.34.35.01. 01 Definitions.. A. In this chapter, the following terms have the meanings indicated.. B. Terms Defined.. 1) “Alternate site care environment” means the location where the patient is receiving infusion therapy other than an inpatient hospital setting.2) “Compounding worksheet” means a document or electronic record which:. a) Specifies instructions for a specific compounded parenteral medication;. b) Documents the manufacturer’s:. i) Ingredients;. ii) Lot numbers; and.
10.34.35.02.htm 10.34.35.02. 02 Permit Holder Responsibilities.. The permit holder shall:. A. Develop and maintain a policy and procedure manual which establishes the pharmacy’s policies and standard operating procedures related to the provision of infusion therapy services;B. Ensure that an annual review of the policy and procedure manual is performed by a qualified clinician or clinicians to assure that the policies and procedures meet the current standards of practice and regulatory requirements;
10.34.35.03.htm 10.34.35.03. 03 Supervising Pharmacist Responsibilities.. The supervising pharmacist or the supervising pharmacist's designee shall ensure compliance with:. A. State and federal regulations;. B. Infusion pharmacy practice standards:. 1) As set forth in this chapter; and. 2) As established by nationally recognized professional organizations and accrediting bodies as appropriate;C. The infusion pharmacy’s policies and procedures manual;. D. An established training program; and.
10.34.35.04.htm 10.34.35.04. 04 Pharmacist Responsibilities.. A. A pharmacist in an infusion pharmacy shall adhere to the policies and procedures set forth in Regulation .06 of this chapter.B. A pharmacist shall:. 1) Provide infusion therapy services in accordance with:. a) Orders issued by a licensed authorized prescriber of record; and. b) Where applicable, protocols issued by a licensed authorized prescriber of record.. 2) Perform and document initial and ongoing assessments of the appropriaten
10.34.35.05.htm 10.34.35.05. 05 Support Personnel.. A. Pharmacy Technicians.. 1) A pharmacist working in an infusion pharmacy may delegate pharmacy acts to a pharmacy technician in accordance with COMAR 10.34.34.2) A pharmacy technician working in an infusion pharmacy may not perform delegated pharmacy acts as set forth in COMAR 10.34.34.03.3) A pharmacy technician working in an infusion pharmacy shall:. a) Communicate immediately to the pharmacist reported changes in:. i) Patient condition;.
10.34.35.06.htm 10.34.35.06. 06 Minimum Requirements for Policies and Procedures.. The policies and procedures shall:. A. Be congruent with State regulations and standards of care from accrediting bodies and professional organizations; andB. 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;.
10.34.35.07.htm 10.34.35.07. 07 Training Requirements.. 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;.
10.34.35.08.htm 10.34.35.08. 08 Performance Improvement Program.. A. The performance improvement program shall consist of:. 1) A committee which:. a) Consists of representation of personnel and varied areas of job responsibility; and. b) Is responsible for analysis of data, reporting trends and corrective actions; and. c) Meets at least quarterly;. 2) Quality assurance and performance improvement monitoring parameters;. 3) Documentation requirements for:. a) Established monitoring parameters;.
10.34.35.09.htm 10.34.35.09. 09 Discontinuation of Infusion Therapy.. A. If not addressed in the initial order, the infusion pharmacy shall verify an end of therapy order.B. The infusion pharmacist shall:. 1) Communicate with the licensed authorized prescriber of record or agent of the prescriber of record to verify:a) An end of therapy order, if not addressed in the initial order; and. b) Parenteral infusion access device disposition, including orders for removal or line maintenance; and
10.34.35.10.htm 10.34.35.10. 10 Reference Materials.. A. An infusion pharmacy shall maintain an adequate reference library to enable it to prepare and dispense infusion therapy properly.B. In addition to the requirements of COMAR 10.34.07.03, an infusion pharmacy’s reference library shall include:1) Material Safety Data Sheets (MSDSs). 2) IV compatibility references;. 3) Stability and extended stability references;. 4) Websites and electronic references authored by established medical publi
10.34.35.9999.htm 10.34.35.9999. Administrative History Effective date: March 1, 2012 (38:23 Md. R. 1421).
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