Surviving an inspection
In Analysis
Follow this topic
Bookmark
Record learning outcomes
Over 90 per cent of the pharmacies inspected by the General Pharmaceutical Council in its new regulatory regime have been described only as satisfactory €“ so what can you do to get your pharmacy rated as good or excellent?
When the new-style premises inspection process was launched last year, the General Pharmaceutical Council (GPhC) said that it expected very few pharmacies to achieve an excellent rating. Coming up to a year and over 1,600 inspected pharmacies later (at the time of writing this article), not one pharmacy has been rated as excellent.
The GPhC's expectation of excellence is partly based on the fact that the new standards cover a much wider range of issues than previous standards, and that the contrast presents pharmacists and their teams with a €steep learning curve€ that will take time to achieve, according to GPhC head of inspections, Mark Voce.
There is also, perhaps, some acknowledgement by the GPhC that the current 'prototype' premises inspection phase is, in itself, also on a learning curve €“ although, as Voce says, the general feeling is that the approach is right. €Overall, feedback has been remarkably positive. People have welcomed the professional approach, feedback from the inspectors, explanation of the standards and the involvement of the whole pharmacy team.€
There is still no fixed date to end the prototype phase, after which a pharmacy's inspection report will be published for everyone to see.
Before, during and after: your checklist for inspection success
Before the inspection
Pharmacies due for an inspection are notified that one will take place in the next four to six weeks. This is the time to act.
Get your team on board
Ensure staff know what to expect: show them the regulator's information on standards and discuss this with them. Make sure they realise that the inspector will be talking to the whole team €“ if not they may be shocked to be asked questions.
Stress that they need to be open and honest and that they should be able to 'show and tell' €“ show how things are done and tell the reasons why. It is no longer sufficient to show that SOPs have been signed. The inspector will want to ask staff what they would do in a certain situation (e.g. child protection concerns) to ensure that SOPs are being followed.
Know what will be inspected
Look at the standards for registered pharmacies in detail €“ talk to a pharmacist who has been inspected so you know what to expect. Use the GPhC's own decision-making framework to understand the different standards and what the inspector is looking for. These can be accessed via the regulator's pharmacy standards guide.
Understand the difference between the labels
- A 'poor' pharmacy is one that has not met the satisfactory standard overall. It is likely to have a range of concerns and/or standards not met, either within one principle, or more often than not, across a number of principles.
- A 'satisfactory' pharmacy will meet the vast majority of individual standards. Any standards not met will be minor in nature.
- To be considered as 'good' a pharmacy will need to be consistently good across the standards and demonstrate some positive outcomes for patients. A pharmacy cannot be good if it fails any of the individual standards.
- To be considered as 'excellent' a pharmacy will need to not only meet all the standards consistently well but also demonstrate innovation in the delivery of pharmacy services with clear positive health outcomes for its patients.
Get your evidence together
Use the GPhC's evidence bank to understand the types of evidence that you can present during an inspection. Collect evidence of the excellent things you do on a day-to-day basis and make sure these are all up-to-date. This will include staff training (e.g. certificates of attendance), as well as patient feedback and outcomes research, and governance (SOP files, CD registers, healthy living pharmacy evidence, 'near miss' logs and complaints records).
Take the advice of others
Attend any meetings on the new inspection process and take advantage of any mock inspection services on offer.
Rotas and staff changes
Don't re-arrange rotas or make any other staff-related changes for the notified period. You might give a false impression that will not be backed up by staff's comments.
Processes
Don't change any processes. The best process will be one that is tried and tested and is familiar to staff.
Premises
There's no need to start rearranging the pharmacy, but do make sure that it is as clean, tidy and professional-looking as possible.
During the inspection
Give time
Be ready to spend time with the inspector; you may be looking at a four-hour visit.
Promote yourself
Promote what you do well and don't wait to be asked. Show the inspector your patient survey results, the letters from grateful customers and (e.g.) your high smoking cessation quit rates.
After the inspection
The draft report should be read carefully. Pharmacies have 48 hours in which to check for factual accuracy. If any action points are raised, an indication of how these will be addressed should be provided. Note: action points do not have to be resolved within the 48-hour period.