In response to recent regulatory changes established by the Centers for Medicare & Medicaid Services (CMS), the Healthcare Facilities Accreditation Program (HFAP) has revised 11 standards in its Acute Care Hospital manual. The revisions address the new and revised CMS interpretive guidelines for Pharmacy Services, and one requirement that impacts Nursing Services.
The HFAP is providing these ‘pre-publication’ requirements to allow HFAP accredited facilities the time necessary to begin implementation strategies while the standards undergo the final approval process. Information that is new or revised is provided in BOLD print.
HFAP anticipates its new requirements will be finalized in April or May 2016. Upon final approval, an electronic message will be sent to clients to announce the effective date of the changes.
Summary of Revisions:
Standard 25.00.00 Condition of Participation: The expectations to demonstrate compliance for this Condition-level requirement have been expanded. The pharmacy services must include either a pharmacy that is directed by a pharmacist, or, when appropriate, a drug storage area that is competently supervised.
Standard 25.00.04 Pharmacy Management & Administration: Pharmacy services must ensure safe and appropriate procurement, storage, preparation, dispensing, use, tracking and control, and disposal of medications throughout the inpatient and outpatient services using accepted professional principles, such as the USP/NF.
Several policies and procedures that minimize drug errors are identified and required including: Weight-based dosing for pediatric populations, Monitoring drug alerts and/or recalls, and standardization of communication practices.
Standard 25.00.05 Management: This requirement clarifies the expectations and job description of the pharmacy director.
Standard 25.01.01 Medication Control & Distribution: Policies and practices relating to the safe dispensing of medications must be in accordance with accepted standards of practice; specific policy requirements are identified.
Standard 25.01.02 Supervision of Pharmacy Activities: The hospital must adopt and implement written policies and procedures to ensure all medications are prepared by authorized personnel. This regulation identifies extensive and specific requirements for COMPOUNDED PREPARATIONS.
Standard 25.01.03 Security of Medications: CFR reference information is provided regarding the self-administration of medications.
Standard 25.01.07 Inventory Management System: This regulation introduces the concept of “Beyond-use-date” (BUD) relating to outdated drugs. The hospital must maintain and implement policies and procedures that provide clear and consistent direction to pharmacy staff regarding how to determine the BUD information, even if this information is not available from the manufacturer.
Standard 25.01.09 Automatic Stop Medication Orders: This standard recognizes that hospitals with an electronic health records may have time and dose parameters automatically built into the CPOE screens.
Standard 25.01.12 Informational Resources: Through this regulation, the pharmacy is responsible to serve as a resource for medication-related information to the healthcare practitioners in order to minimize adverse drug events. Specific requirements are identified.
Standard 25.01.31 Pharmacy Services: This standard will be scored to cite shortcomings in the Pharmacy that are serious, yet, do not rise to a CMS Condition-level deficiency.
Standard 16.01.01 Preparation and Administration of Drugs: This Nursing Service requirement has been expanded to ensure staff adherence to accepted standards of practice to prevent healthcare-associated infections related to medication preparation and/or administration. Standards of practice related to compounded sterile preparations (CSPs) are required. Also, the concept of “Beyond-Use-Date” (BUD) is introduced with several requirements established.
Background
For more information on the new and revised CMS interpretive guidelines for Pharmacy Services, see CMS Revises Interpretive Guidelines for Hospital Pharmacy Services, Expands Guidance Related to Compounding of Medications