Audit and Us Gill White Regional Cytogenetics Centre Bristol

About Us 58 members of staff 7,000 + samples a year Postnatal, prenatal, FISH, malignancy Last accredited (under old standards) in April 2002 Due for inspection under new standards in Spring 2002.

Where are we now? Most (85%+) SOPs updated and in place Document control system in place (Q Pulse) System in place for recording and monitoring non-conformances (Q Pulse) Quality manual completed and submitted to CPA with application for inspection.

Quality Manager in post

What CPA says about Audit Planned and scheduled Conducted against agreed criteria Carried out by personnel trained in audit (preferably independent of the work being audited) Any non-conformities should be recorded along with recommendations and timescales for CA.

Designing the Paperwork We have three different Audit Forms: One for horizontal Audit One for Vertical Audit One for Examination Audit.

Horizontal Audit Form FM122 Date of Audit: Audit carried out by : Other staff involved in Audit: Area or standard to be examined: Observations Actions required: By Whom: Target date for completion: Select one element of a process, e.g: Are all reagents clearly labelled? Do all staff have a current job description? Is there a system of document control for SOP’s? Horizontal Audit

Examination Audit We use a slightly adapted version of the CPA form. Audit takes the form of witnessing a member of staff carrying out a procedure and comparing to the written SOP.

Vertical Audit Again we use a slightly adapted version of the CPA Vertical audit form. We take the laboratory number of a case picked at random (e.g. from the day book) and follow all elements of processing through from start to finish.

Putting it into Practice or What have we done so far? Produced the paperwork! Set up Q Pulse to schedule an audit calendar and to record non-conformances. Carried out some examination audits and vertical audits.

Who carries them out? CPA says “personnel trained in Internal Audit” Our audits have been carried out by a group of interested staff members at all levels including Clerical staff, Trainee scientists, Support staff etc. “Training” consists of explaining the examination audit process and what we need to achieve from the audit.

What have we learnt? Keen, enthusiastic staff of all levels make the best auditors. A member of staff can efficiently audit an area completely independent of their normal area of work, e.g. Office manager auditing pre-natal slide making.

Good things about Audit. Are a good tool for detecting if staff are following the SOP correctly. Will spot errors and omissions in the SOP Occasionally detect improvements to the procedure!

BUT…… Staff attitude can be a problem. Staff can easily understand the need to get a result out to a patient, but it some staff do not understand the need for what is seen as a needless paper shuffling exercise.

Staff may “perform” to an audit and carry out a task in the way they know it should be done. In the case of a discrepancy between SOP and staff member, it is not necessarily the staff member who is wrong. It is easy to think of “obvious” tasks to audit, e.g.setting up an amnio, but need to consider in particular less frequently carried out tasks

Time! Not only to carry out the audits but to implement the corrective actions needed! There are always cases that need screening. Can be dispiriting to carry out audits which then reveal necessary corrective actions. How large must an error be before it needs correcting?

In Summary A feeling of “we’re getting there”. Staff attitude is changing, but more education is needed to help them see audit as A Good Thing. New staff are now always trained from an SOP – a new generation of perfect staff???