Title

Make a procedure for selection and regular monitoring of the functioning of referral laboratories

Why

The ISO 15189 states that the laboratory remains responsible for the quality of testing when the it refers samples for testing to other laboratories (referral laboratories). This means that the performance of the referral laboratories must be monitored to assure the quality of performance.

What

Make a procedure for selection and regular monitoring of the functioning of referral laboratories.


Before selecting a referral laboratory make a list of requirements with which this laboratory must comply. The most obvious one is that the referral laboratory must be able to perform the desired test. A second important requirement is that the laboratory must be able to show quality performance of the test. E.g. the laboratory must be able to give you the results of proficiency testing. Also formulate requirements regarding service hours, turnaround time and method of reporting.


When a laboratory is found that complies with all the requirements make appointments and document these.


After agreement has been reached and the laboratory is used for referral testing, start regular monitoring of performance of the referral laboratory. Document this. Make a database starting with an overview of the referral laboratories and then per laboratory the documented appointments and monitoring data. Make a folder entitled “Results of Referral Laboratories” in which the result reports of tests referred to referral laboratories are stored.


Important: Some laboratories do not refer samples to other laboratories. In this case it is important that these laboratories include a statement in the quality manual explaining that no samples are referred and therefore no procedure on selecting and monitoring referral laboratories is present. This is done to release the laboratory from the obligation to have this procedure in place.

How & who

Laboratory Manager:

  1. Draft the procedure for selecting and monitoring referral laboratories in a Procedure SOP according to the protocol for writing a Procedure SOP in the Master SOP and using the template for a Procedure SOP attached to the Master SOP.
  2. Review and authorize the SOP in accordance with the procedures of the SOP for Document Control.
  3. When the SOP is finalized, define the staff members who must familiarize themselves with the SOP and indicate in the Read and Understand List that they must read this SOP. Inform these staff members.
  4. Determine where copies of the SOP are stored and indicate these locations on the first page of the SOP according to the procedure described in the Master SOP.
  5. Once the SOP is authorized, distribute copies of the SOP and start implementing it. Make a folder entitled “Referral Laboratory Database” for storing all the important documents and monitoring data of referral laboratories.

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This activity belongs to the QSE Purchasing & Inventory

 

ISO15189:2007: 4.5.1 4.5.2 4.5.3 4.5.4
ISO15189:2012: 4.1.1.4 4.5.1 4.5.2
ISO15190:2003: