Docusign Envelope ID: 7A5B3479-9D4C-88D2-83E5-044BBCB62EF5
4.
5.
6.
Completes competency assessment at orientation and at least
once every three years, or more frequently as determined by the
organization (HR 11.04.01, EP 1).
Participates in ongoing education and training necessary to
maintain or increase competence, including 340B program and
data analysis training (HR 11.03.01).
Attends and completes all required health and safety classes,
updates, and health screenings/testing (NPG Goal 12).
Seeks out opportunities to learn and apply best practices.
Must be able to demonstrate the knowledge and skills necessary to
provide service based on the physical, psycho/social, educational,
safety, and related criteria appropriate to the age of the patients
served in his/her assigned service area.
7.
8.
1.
2.
Demonstrates awareness of and compliance with regulatory
standards; i.e., 340B federal requirements (HRSA Office of
Pharmacy Affairs), CMS Conditions of Participation — including
Pharmaceutical Services (42 CFR §482.25), Joint Commission
Accreditation 360 standards and National Performance Goals
(NPGs), Title 22, HIPAA, and other service specific regulations.
Performs all work in a manner consistent with 340B program
integrity requirements under section 340B of the Public Health
Service Act (42 U.S.C. §256b), including the prohibitions on
diversion to ineligible individuals and on duplicate discounts and,
as applicable to the hospital’s covered entity type, the group
purchasing organization (GPO) prohibition and orphan drug
exclusion.
Regulatory Compliance
Key Components: Joint
Commission Accreditation 360
standards and National
Performance Goals (NPGs),
CMS Conditions of
Participation, Title 22, OIG,
HIPAA, State/Federal laws,
hospital policies
3.
4.
Supports compliance with Joint Commission Medication
Management requirements as they apply to 340B purchasing,
inventory, and storage records, including management of drugs
and biologicals in accordance with federal and state law (MM
11.01.01), the medication formulary (MM 12.01.01), and medication
storage, records and disposition (MM 13.01.01).
Handles 340B claims, split-billing, and reporting data consistent
with Information Management requirements for privacy,
confidentiality, security, and integrity of health information (IM
12.01.01 and IM 12.01.03), and uses only approved standardized
terminology, abbreviations, acronyms, symbols, and dose
designations (IM 13.01.01).
5.
6.
7.
Employees in this position have access to protected health
information (includes demographics, date of service,
insurance/billing, medical record summary information, and all
other information that may be contained in patient records).
Maintains auditable 340B records and working files sufficient to
demonstrate compliance to HRSA, manufacturers, and the
hospital’s compliance function throughout the applicable audit look-
back period.
Reports suspected noncompliance promptly through the Pharmacy
340B Program Coordinator or the hospital’s compliance reporting
2000 Mowry Avenue
Fremont, CA 94538
510.797.1111
