Home » PCRS: What to expect when they’re inspecting
Through Clause 7 of the Pharmacy Contract (hereafter referred to as ‘the Contract’), the pharmacy contractor agrees to allow PCRS inspections. Clause 14 requires the contractor to co-operate with the PCRS in establishing the accuracy of claims.
Unlike PSI authorised officers, PCRS inspectors are not exercising statutory functions and so their powers are much more limited.
Key points:A PCRS inspection can take place “at any reasonable time” in two circumstances:
PSI inspections are of course different and can be much more wide-ranging. The PCRS and PSI have been known to conduct joint inspections. However, given the difference in the respective powers of PSI authorised officers and PCRS inspectors, there are a range of potential legal and data protection issues with information obtained by the PSI potentially being given to the PCRS, and to a certain extent vice-versa.
The Contract requires the contractor to allow such inspections to take place. Accordingly, contractors should pay close attention to Clause 15 which deals with a suspected failure to comply with any term of the Contract followed by investigations by a complaints committee under Clause 16. Complaints that are upheld can result in a number of sanctions ranging from admonishment, to deduction of monies due to the contractor under the scheme, and, ultimately, the termination of the Contract.
The provisions relating to inspections under the Contract lack detail, but there are some points to consider:
As any member of staff may be the first point of contact in the event of an inspection, it is important that they all have access to a document providing key information and that they receive relevant training. ”
There are steps you can take in anticipation of an inspection, or if you receive notice of an inspection, beyond of course being compliant with your clinical and contractual obligations, and ensuring that your PCRS-related documentation, systems and records are up-to-date. Here are some additional steps you can take which might include:
Put a response plan in place: Pharmacies are run on the basis of SOPs so having an operating policy in place to deal with inspections is advised. This will help ensure a calm and consistent response on behalf of your business to an inspection. As any member of staff may be the first point of contact in the event of an inspection, it is important that they all have access to a document providing key information and that they receive relevant training. This policy might include such matters as:
Appoint your response team: A response team would ideally be made up of those individuals with sufficient seniority to make key decisions and command the assistance of their relevant teams:
Once the inspectors have been greeted, allocated to a designated room/area, and have presented their credentials, there are a number of steps to be considered.
Immediate steps:
Cooperation: As set out above, the terms of the contract require a contracting pharmacist to allow an inspection to take place, so inspectors should be treated in an open and co-operative manner, which includes facilitating reasonable requests for access, documents and information.
Shadowing inspectors: If an inspector seeks to undertake a physical search of the premises, it is prudent to arrange for him/her to be accompanied at all times by someone who is sufficiently senior and familiar with the rules in this area, and the scope of the PCRS’s powers. A carefully written, factual record should be made of where they go, what they look at and who they speak to.
Questioning:
Documents:
Before the inspectors leave
An inspection is a delicate balancing act between the duty of a contracting pharmacist under the PCRS Contract to facilitate the HSE inspectors, while respecting the right to enjoy fair procedures in the conduct of that inspection. Preparing for an inspection is key to ensure everyone involved is aware of the extent, and limits, of their obligations. In the event of an inspection, you should contact the Contract Unit within the IPU or your own legal advisors.
About the authors: Aidan Healy is Legal Director in DAC Beachcroft Dublin Regulatory, Professional & Public Law team, which is lead by Gary Rice, Partner. DAC Beachcroft has advised the IPU and its members for many years and specialises in the legal aspects of pharmacy practice. For more information, please contact Aidan Healy. For more information on any legal aspect of pharmacy practice, please contact Gary Rice.
DAC Beachcroft
Global, Commercial Litigation,
Professional and Regulatory Practice Team
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