Combining Quality Plan with the General Lab?

The Transfusion Service QA person at a large hospital has been asked to combine the transfusion service quality plan with the overall laboratory quality plan. She writes "We are rewriting our laboratory's Quality Management plan and our Laboratory Administrator wants Blood Bank incorporated in this plan, not mentioning Blood Bank specifically. I am wondering if this is what other facilities are doing now with the lean and core lab mentality. I am finding it hard to incorporate, as the Transfusion Service has so many specifics just for that area. I would appreciate responses from other laboratories, as to how they handle the Quality Management Plan for the Laboratory in general and their Transfusion Service. Separate Documents or one?"

The following comments have been submitted in response.

ADDENDA July 31, 2010

1. According to Lucia Berte, an experienced facilitator of quality principles in both blood banks and clinical laboratories and current president of Laboratories Made Better! (attribution used with permission), for transfusion services within the main hospital laboratory department, it is desirable to use the 10 AABB Quality System Essentials (QSEs) or the 12 Clinical and Laboratory Standard Institute (CLSI) QSEs on which to base a quality plan or quality manual. The QSEs provide an excellent generic framework on which laboratory-wide policies, processes, and procedures can be developed in a quality manual. In facilities that have consolidated into a single laboratory quality manual, Ms. Berte has found that policies and processes are usually generic across laboratory clinical disciplines. For example, the policy and process for participation in external proficiency testing is the same for the entire laboratory, as would be the policy and process for external accreditation inspections. It is also often found that even at the procedure level, instructions can be the same for the whole laboratory. Examples include: how to report a nonconforming event; how to correct an erroneous record in the LIS; how to make a change to an approved document, etc. There may be legitimate section-specific differences, such as those for record retention, with most of the laboratory at 2 years' retention and the blood bank at 5 or more years. However, a single record retention schedule can be created for the entire laboratory with different retention times for the different types of records. Using tables is another way to have the same laboratory-wide process or procedure document and display discipline-specific differences. Laboratories that are accredited by the Joint Commission, CAP, or COLA have benefitted from having a consolidated laboratory quality manual because in a hospital laboratory the transfusion service or blood bank does not usually function in an administratively isolated environment from the rest of the laboratory. The quality manual is really nothing more than a sorting of the laboratory's existing administrative manual into the 10 or 12 QSEs and consolidating and cleaning up the policy, process, and procedure documents to cover all the administrative regulatory and accreditation requirements.

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