We have a service agreement with our blood component supplier.  As for reagents, we've always purchased from Ortho and Immucor.  We don't have a "process", we just always have!  Can anyone give me an example of how you handle this?

 

Thanks!!

 

Beverly

Edited May 28, 201510 yr by blee

This might be managed by a hospital Materials department that governs contracts and vets suppliers.  I would suggest checking if there is an hospital process already in place that would cover this for you.

I have a vague sort of general policy that I use to cover this standard. I have copied and pasted most of it here. I haven't been dinged on it.

 

PRINCIPLE AND CLINICAL SIGNIFICANCE:

Materials and supplies used as inputs to a process are considered “critical” if they affect the quality of products and services being produced. A critical material is a good, supply or service used in the collection, preservation, storage, preparation or testing of blood components that directly affects quality or patient safety. Suppliers must meet certain specifications in order to be considered as providers of critical materials.

 

POLICY:

1. Supplier Specifications:

Any new suppliers of critical materials or services will be evaluated according to the following criteria:

1. Traceability of materials.
2. Availability of QC procedures and QC data for review.
3. Quality management system in place.
4. If applicable, evidence that current good manufacturing practices are in place.

 

Current suppliers will be reevaluated if error, incident, and variance documents indicate that the products or services are not satisfactory.

 

1. Supplier Qualification

Detailed information about the nature or function of the product/service is important.  If there are questions regarding licensure/registration, a statement from the supplier may be requested.  This can include documentation that quality systems are in place in the manufacturing of the product/service. Contracts should include detailed information on shipping, storage requirements, and availability of services, cost, and technical assistance as applicable for the product/service.  These contracts should be approved by the Laboratory Director, and if applicable, by the Hospital Administrator. Any changes of products/service require approval of the Laboratory Director and Blood Bank Medical Director.

 

1. Inventory Management

As supplies, reagents and labels are received, they are inspected by the Inventory Coordinator.  Blood components are inspected and placed into inventory through the laboratory computer system.  SOPs are in place to document receipt of blood products.  Records of returns will be recorded on the appropriate blood center form and in the Laboratory information System.  Records of recalls will be maintained by the Blood Bank Lead Technologist.

We have something similar to Debbie. We also have a document that describes our high flying needs for our blood product supplier in the event someone tries shopping around for a cheaper contract.

Thank you so much, that is very helpful

We have a policy/procedure somewhat similar to DebbieL's.  (Nice job, DebbieL!)

 

Then we also have a sheet where we record any problems we have encountered with our current suppliers.  We also document (at least once a year) that we have looked at various suppliers, evaluated if they could meet our needs, list their pros and cons, and state what our decision is for who will be our supplier for the coming year.  (It usually takes only a few minutes to fill our the form.)

 

Donna

Donna,

 

Would you mind sharing your form with us?