Procedure

[bevydawn]

This is my first year for CAP inspection as a supervisor at the facility that I am currently working. Upon going through my checklist, I noticed that for this question, I don't have a solid answer. I can find documentation for when reagents have been switched, comparisons have been done between the old and new reagent prior to putting the new in to use. However, there is no written procedure as to how many specimens must be compared or what to do if some comparisons don't work. Can anyone tell me what guidelines they follow that pertain to this CAP question?!?! Any help would be greatly appreciated.

**NEW** 12/29/2004

TRM.30882 Phase II N/A YES NO

Does the transfusion service laboratory have an effective mechanism for evaluating and selecting suppliers of critical materials and monitoring suppliers’ ability to meet the laboratory’s needs?

[Lcsmrz]

The item is a response to the CAP's move to a Quality Management System; the AABB has been using quality systems for over 15 years. QMS is an approach to build quality into a final product or service by undestanding the processes used to build or deliver it and by controlling those processes for consistency.

The CAP item has several implications. First, you have to understand what your customers' need from you. While that may sound intuitive, just try to record your customers' requirements and expectations for a product or service on a piece of paper!

Next, you have to decide what material is critical. Test tubes used to perform bench work may be a commodity, but the reagents used definitely are critical material. Each facility has to decide for themselves what is a critical material, but generally things with a lot number, temperature requirements, and an expiration date are a critical material and need to be controlled to produce a quality product or service. How you control them is always facility-specific, but should track the storage, testing and usage of the material from receipt to final disposition/use.

Third, you have to understand what you need from your supplier. Licensure, transportation, contracts, notifications, and the like play a part in determining whether a supplier can meet your needs. On-going evaluation should be part of your program.

Finally, there should be a defined process for selecting and evaluating suppliers of critical material. Price should never be the only criteria!

The inspector will look for your process for critical material, then check for documentation that you're following it. The days of only dating a vial when opened are gone !!

Larry Smrz, MBA, MT(ASCP)SBB, CQA(ASQ)

Indianapolis, IN

AABB and CAP Assessor