Docusign Envelope ID: 7A5B3479-9D4C-88D2-83E5-044BBCB62EF5
5. Participate s in ongoing education and training necessary to maintain
or increase competence, including 340B-specific training (HR
11.03.01).
6. Attends and completes all required health and safety classes,
updates, and health screenings/testing (NPG Goal 12).
7. Seeks out opportunities to learn and apply best practices.
8. Must be able to demonstrate the knowledge and skills necessary to
provide care and/or 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.
9. Maintains current knowledge of HRSA/OPA guidance, Apexus
resources, CMS rulemaking affecting 340B, and state legislative
developments, and briefs pharmacy leadership on changes affecting
the program.
1. Demonstrate s 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 regulat ions.
2. Supports compliance with Joint Commission Medication Management
(MM) requirements as they apply to 340B purchasing, storage, and
inventory, 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, and removal of expired or otherwise unusable medications
from patient use (MM 13.01.01).
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. Ensures 340B accumulation, replenishment, and split-billing practices
do not compromise medication safety expectations under National
Performance Goal 14 (medication management program focused on
safety), including standardized drug concentrations and management
of medication shortages (NPG 14.02.01).
4. Maintains 340B records, reports, and split-billing 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. 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).
6. Maintains 340B policies and procedures within the hospital’s policy
framework (LD 13.01.09), supports leadership in demonstrating
compliance with law and regulation (LD 13.01.01), and supports
oversight of contracted services, including contract pharmacies, split-
billing vendors, and third-party administrators (LD 13.03.03).
7. Maintains continuous survey readiness for all 340B-related
documentation and participates in tracer activity, medication
2000 Mowry Avenue
Fremont, CA 94538
510.797. 1111
