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Novation, the Contracting Services Company of VHA, UHC and Provista
ABOUT NOVATION
 
 
 
 
 
 
 
 

BUSINESS CONDUCT, COMPLIANCE AND ETHICS PROGRAM

Quality Assurance/Regulatory Affairs

Novation does not manufacture, label, package, repackage, maintain, inventory, sell, distribute or control specifications for any products; all such activities are the sole responsibility of the product’s manufacturer, distributor or other seller. To ensure unmatched quality and value to members, Novation has implemented a quality program to effectively select and monitor suppliers and, as appropriate, to ensure proactive and timely communication to members.

Novation’s Quality Policy is as follows:

“Novation strives to provide members with a unique competitive advantage in the marketplace by providing members with access to anesthesia, medical, pharmaceutical, radiology, respiratory, surgical and other health care and non-health care products with unmatched quality, value and efficiency.”

Because selection of products by members is totally voluntary, one of Novation’s highest priorities is to select suppliers whom we believe will provide safe, efficacious, readily available and cost-effective products for use by the members of VHA, UHC and Provista. Further, Novation is committed to monitoring suppliers’ quality and regulatory performance, monitoring overall industry standards and, as appropriate, proactively notifying members of any material quality or regulatory issues or trends.

Quality Program

To help ensure that all products meet the high expectations of VHA, UHC and Provista members, Novation has implemented the following quality program:

Supplier Selection and Approval

Novation carefully selects and approves suppliers based on member direction and other predetermined criteria, and strives to select only products that meet the highest quality and safety standards. On members’ behalf, Novation conducts a targeted review prior to the selection of any supplier.

Monitoring of Suppliers

Novation quality assurance/regulatory affairs personnel monitor suppliers’ quality and regulatory performance to facilitate any necessary actions or communications with members.

Notification and Communication to Members

As a result of monitoring suppliers and the quality and regulatory environment associated with products, Novation works to provide material information regarding the safety or efficacy of products to members in a timely manner. Events resulting in member notification may include product recalls, product shortages, consent decrees, customer complaint trends or other regulatory issues.

Liaison Between Members and Suppliers for Product Complaints and Safety-Related Concerns

When requested by members or contracted suppliers (manufacturers), Novation will reasonably assist in the resolution of situations involving member complaints and safety concerns. In such cases, Novation QA/RA personnel will endeavor to address any concerns to the members’ satisfaction.

NOVAPLUS® Label Differentiation

NOVAPLUS, the private label of VHA, UHC and Provista, is part of Novation’s comprehensive supply chain management strategy that focuses on standardization and delivering quality medical products at the best prices. NOVAPLUS products are identical to the manufacturer-branded equivalents.

NOVAPLUS products are held to the manufacturer and U.S. Food and Drug Administration standards for good manufacturing practices, and also they are held to Novation’s high standards. The Novation quality assurance/regulatory affairs team tracks all NOVAPLUS products to ensure that they meet or exceed stringent quality standards and regularly inspects the plants that manufacture NOVAPLUS products.

Novation is committed to coordinating with NOVAPLUS suppliers to minimize, whenever possible, medication errors, product mix-ups or mis-administrations due to similar appearing labels.

Machine-Readable Bar Coding

Working closely with the U.S. Food and Drug Administration, other hospital groups and suppliers, Novation only selects NOVAPLUS suppliers that apply machine-readable bar codes on product labels at the unit of use, or smallest package size. Non-NOVAPLUS suppliers are encouraged to apply similar bar codes on product labels at the unit of use or smallest package size.

Applicable Supporting Documentation and Procedures

  • Novation’s Standards of Business Conduct
  • 21 CFR Part 211
  • 21 CFR Part 820