3 Stages of Validation – Stage 1
Partner models consist of a healthcare institution operating a specialty pharmacy in partnership or in contract with another entity to offer the full range of services required for an accredited specialty pharmacy. Accreditation standards are a valuable resource to healthcare pharmacy leaders to ensure that all internal and partner specific regulatory components are in place. Below are a list of requirements and suggestions for consideration:
Requirements:
- The onus of ensuring all accreditation standards are met is on the institution, not the partner.
- The health system must confirm each partner is providing all services contractually agreed upon.
- Create detailed Business Associated Agreements and Policy and Procedures documents outlining the legal and practical relationship between the institute and the partner services.
- Documents must consider any services provided across state lines requiring the third party to carry licenses from multiple states.
- The health-institution specialty pharmacy or any entity providing services on behalf of it must meet the regulatory statutes laid out in the accreditation standards.
- Health institutions choosing not to have a formal specialty pharmacy model must involve legal and risk management departments in the decision-making process because the implications in these areas may be significant.
Suggestions:
- Careful selection of partner services and validation that such services meet the accreditation standard initially and in an ongoing manner is essential.
- When establishing relationships with partners, it is important to work closely with internal legal and compliance departments to ensure that all necessary contracts are completed and patient health information (PHI) is protected.
- In any partner relationship, it is critical to maintain data elements that may be needed for future reporting.
- Health-system specialty pharmacies need to be prepared for managing third party audits, including those conducted by governmental payers. Such audits ensure proper utilization and often seek remuneration for inappropriate use.
The extent of the partnership will determine the degree to which legal considerations need to be met. For example, there will be unique requirements for partners that need access to PHI or health system dispensing system or EMRs, those that provide proprietary electronic systems for case management, et al. Figure 2 explains this in detail.
Figure 2 Source: ASHP SPECIALTY PHARMACY RESOURCE GUIDE
Specialty Pharmacy Solutions from Mesa Labs
As specialty pharmacy regulations continue to evolve, organizations involved in the delivery of treatments and specialty pharmacy services must keep abreast of current legislation. Specialty Pharmacy Solutions from Mesa Labs can help support health system specialty pharmacy needs and regulations with logistics and transport services, packaging, and monitoring. Mesa’s temperature monitoring systems monitor environmental conditions related to storage and shipment using refrigeration equipment, vehicles, and warehouses.
In addition, our team can support yours on an ongoing basis, providing training, quality standards, drug management processes, provide support for developing Risk Evaluation and Mitigation Strategies (REMS). and pharmacy operational SOPs to support accreditation.
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