Activity to be Audited
5.4.3 Request Form Information:
a) Does the request form contain:
I. Forename and surname
II. Gender
III. Date of birth
IV. Address
V. Hospital number
b) Name or other unique identifier of clinician or other person legally authorized to request examinations & Destination of report:
c) Type of primary sample and the anatomic site of origin, where appropriate;
d) Examinations requested;
e) Clinical information relevant to the patient, which should include gender and date of birth, as a minimum, for interpretation purposes;
f) Date and time of primary sample collection;
g) Date and time of receipt of sample by the laboratory.
If this is a test where information for patients is required e.g. for sample collection, is this
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If the method has been recently changed have the relevant change management procedures been followed?
If the method has been recently changed, resulting in a change in results or interpretation have the users been notified?
5.6 Ensuring Quality of examination results:
Are quality control procedures included in the documented procedure available for the examination?
Has this document been acknowledged by all necessary staff?
Are there acceptance criteria for the IQC of this analysis?
Are there instructions of what to do in event of IQC failure?
In the event of an IQC failure were any patient samples run? If so have they been re-examined one IQC passed?
Is EQA satisfactory for this examination?
Is there a documented procedure relating to the EQA participation?
Is EQA processed in the same manner as patient samples?
Was the last EQA report reviewed by relevant staff?
5.8 & 5.9 Reporting & release of Results:
Have all members of this laboratory acknowledged the current revision of the department’s own resrel document?
Does this document include a process for notifying the requester when an examination is delayed & could compromise patient