I.          INTRODUCTION/PRINCIPLE:    

            Quality Improvement standards require that each process/procedure operates in a state of
            control.  This proof of operation is verified by a process validation.  Each new process/
            procedure in the clinical laboratory must be validated prior to implementation.  The
            existing processes may be validated with the system audits already in existence.

II.        SPECIMEN/REAGENTS/EQUIPMENT:

               1.         New Process
            2.         Process Validation Form
            3.         Manufacture’s instructions if required

III.       PROCEDURE:

             I.          Process Validation

                        A.  Identifying new processes that require validation.

1.  Each time the Laboratory switches from one method to another,
    or a new process is introduced, the new process has to be validated.        

                        B.  Process validation for a new method of processing.

      1.    If the Laboratory is changing methods, then the new method must be
       validated, and the end result compared to the end result of the old method.  

                              2.  The new method’s end result must compare favorably with the old
                                    method’s end result.  The new method must show some form of
                                    improvement such as saving time, space, money, or providing a
                                    superior product that will benefit the patient or the institution.

                               3.  This comparison will be documented and reviewed by the Supervisor,
                                    Medical and Administrative Director, Manager and Quality Assurance
                                    Officer as necessary.  All of the parties must agree on the use of the product. 
                                    The Medical Director has the final ruling on the use of a new product or method.

                         C.  Process validation for a new process.

                              1.  The new process must be validated prior to use.

                              2.  Most manufacturers should provide us with a model of a validation process 
                                    or  recommendations.

      3.      Follow the manufacturer’s recommendations for validation process.

                              4.    If the manufacturer does not have any recommendations for validation, then
                                     the Supervisor, Manager, Quality Assurance Officer and Medical and
                                     Administrative Director will decide on a method of validation.

                              5.   The validation will be documented and reviewed by the Supervisor, Medical
                                    and Administrative Director, Quality Assurance Officer, and Manager.

                              6.  The end results will be set by the Supervisor, Medical and Administrative
                                   Director, Quality Assurance Officer, and Manager.  If the end results are not
                                   the results expected, then the process will not be accepted.

IV.      RESULTS:

            The new method or new process must benefit the laboratory and/or patient prior to its
            use.  The review staff will review the validation with the laboratory staff and UAMS
            patient in mind.
 

V.        NOTES:

            The laboratory section involved will perform the validation and the management must
            review the results and agree on the use of the new method or process.  The Medical
            Director always has the right to override the ruling of the review staff if the process is
            deemed a medical necessity.
 

VI.     RECORD RETENTION:

            Records of the new validation process as well as the previously used process must
be maintained according to federal and regulatory requirements. 
 

VII.     REFERENCES:

            American Association of Blood Banks, TECHNICAL MANUAL, 14^th Edition, Bethesda,
            MD., 2002.

            American Association of Blood Banks, “STANDARDS for BLOOD BANKS and
            TRANSFUSION SERVICES”, 20^th Edition, Bethesda, MD 2002.

            Office of the Federal Register, Code of Federal Regulations, Title 21, Washington:  2000.

 
 VIII.    SIGNATURES:

 Policy review date and signatures are available and on file in the Laboratory.