SARAH BUCKLEY guides us through the process of opening an independent travel clinic.

Getting your independent travel clinic through the Healthcare Commission process

Are you considering opening a travel clinic? If so, and you are based in England or Wales, you will need to register with the Healthcare Commission (HC). This body oversees all independent health care providers, including private hospitals and residential homes, private doctors, hyperbaric oxygen chambers and beauticians using laser treatments.

When registering a travel clinic, applications by either a doctor or nurse will be dealt with under the sub-section of "Private Doctors" and you will have to prove compliance with National Minimum Standards and Regulations for Independent Health Care, a statement published by the Secretary of State under section 23(1) of the Care Standards Act 2000.

If you propose setting up an independent clinic, you cannot open or operate until registration is completed. Allow three-to-four months from application submission to an inspection of premises, bearing in mind that the HC will not complete your registration until they have seen a copy of the signed lease for the premises.

The concept of a travel clinic may be new to town or county planners. If  the current lease for your proposed premises doesn't include use as a clinic and they have no "case history", they may request an application for change of use. Your solicitor will not complete your lease until this is approved.

What if I don't get the planning application? What if the HC refuses my application?

If you are ultra-cautious, these issues are a real worry. Unfortunately, unless you have premises set up and ready to go, your HC application will not be passed.

On a personal note, I submitted my application to the HC in mid-March and moved into my premises at the beginning of May. My application was provisionally passed at the end of June, but registration could not be completed until the lease was signed. This was held up by the planning application, and delayed opening until mid-August, causing six weeks of utter frustration.

In my defence I had been given erroneous advice by a government business advice organisation. Instead of relying on third-party advice, I should have checked with the council earlier.

All the required information can be accessed from the quick links on the HC website home page through "Independent Healthcare".

Application forms and the National Minimum Standards can be downloaded, but as this publication is going to be your "bible" you may find it useful to have a hard copy, available from the Stationery Office (TSO). There are links to the various government acts which you should know about.

First things first

First you need to submit application Form R1, together with the registration fee (£990 for 2007-2008). The checklist states very clearly that the HC will not process incomplete applications, although in practice they recognise that you may not be in your premises or have the completed lease.

Documentation regarding the premises is the only thing you can postpone at this stage (although you must have the clinic address) and this includes insurance arrangements, lease and site plans. The HC must possess details of everything relating to those who will provide the services, and the services themselves, or they will not proceed.

They also require a financial reference from your business bank manager. By this stage you should have:

  • opened a business account, even if no deposit has been made
  • produced a business plan
  • organised a business loan if required.

As the applicant, you are deemed to be the "Responsible Individual", but you also need a "Registered Manager" (that is, a business manager). If you are setting up as a sole trader, you can apply to be both. The HC will also want information on the person who will stand in as manager if you are absent. You will need to provide a current CV, photo, evidence of professional qualifications and a completed medical declaration for each person.

You need to provide a "statement of purpose" for the establishment, a draft of your proposed patient guide and a copy of your business plan (including a cash flow forecast).

Now what exactly do you plan to do?

The application form will ask what services you are applying to register. Do include all services you will provide on opening and are planning for later. Will you cater for children? If so, you must state this. If you intend offering non travel-related vaccines such as the rotavirus vaccine, for example, which can be given from the age of six months, then you will need to state that you aim to treat children from the age of six months onwards.

The "statement of purpose" expands on the services you will provide and can appear overwhelming. It includes:

  • aims and objectives
  • staff and their qualifications
  • organisational structure
  • treatments and services
  • meeting client needs
  • facilities for the benefit of clients
  • client consultation
  • privacy and dignity of clients
  • complaints.

Don't be daunted by the jargon - advice and guidance are on the website and HC staff are there to help you through the process, not to trip you up. Remember, they have a vested interest in helping your application to succeed.

Think of the "patient guide" as your business "brochure"

It should include a précis of the statement of purpose, plus information that patients will need, including:

  • what services you offer
  • how to find your premises
  • what to expect at a consultation
  • your prices
  • how to complain.

A first draft is sufficient for the HC at this stage, but this patient guide will eventually need to become a printed brochure or available via your website.

At the application stage you need to state how you will comply with the Disability Discrimination Act - for example, this may include wheelchair access and a loop induction system for the hard of hearing. Also, how will you handle and store patient records? You must state how you will provide staff training and development, and what arrangements you have made for personal clinical supervision.

Further, you must provide a list of policies and procedures that will be in place by the time of your inspection. Guidance on policy requirements is on the HC website as well as in the National Minimum Standards document.

As the Responsible Individual, your Criminal Records Bureau (CRB) check must be done by the HC. You may wait until your site visit to get this countersigned, but you cannot be registered until the CRB check is completed, which takes at least four weeks. Alternatively, you can travel to London and get authorisation early on.

Yet another form!

Hidden near the bottom of the application form checklist is a small line reminding you to complete and enclose the relevant sections of Form R2. This is service specific so you need to complete only those parts related to independent clinics. Some sections are a repetition (just state "As detailed in Form R1"), but some are new and will include details of:

  • your supervising physician
  • referral pathways
  • diagnostic tests
  • resuscitation procedures
  • disposal of clinical waste
  • prescribing arrangements (including patient group directions)
  • clinical governance.

Again, don't be daunted. Just state your provisional arrangements. If, for example, you have not yet made arrangements for your clinical waste, state that it will be disposed of by an accredited local company and forward details once this is done.

Given all this, you will have realised by now that completing the HC forms will be time consuming and cannot be completed in an evening. Work steadily on them when time is available and you should complete in one or two weeks. It will pay dividends to complete them in a measured and considered manner. Copy everything you send to the HC and send it by registered post.

Provided you have sent all the required documentation, you will shortly receive a confirmatory letter and be assigned an inspector who will contact you to arrange a site visit. Once you have selected a date, your mind will become focused on writing policies and preparing the premises.

The visit may be weeks or months away

But in the meantime you have to move into your premises and undertake all the practical work required there as well as carry on with your normal job. The premises must be as ready as if you were expecting to open that day - that means your vaccine fridge installed and working, towels in the dispenser, files in the cabinet, pillow on the couch.

If you haven't already forwarded site plans and copies of insurance arrangements, then do it now. Keep an eye on how the planning application and the lease are progressing too. Business leases can involve more solicitor time than buying a house, another good reason to get started well ahead of time.

Writing policies can be challenging if you haven't tackled it before, but you should know how many are required and have an idea of the subjects. You may find that some policies can be neatly dovetailed together into one rather than two or three separate ones.

Don't worry if your final policy list is not exactly the one previously supplied to the HC. As long as everything is covered, that's not a problem.

Now you will need to focus clearly

Start on the longest and most important policies:

  • arrangements for assessing patients
  • child protection
  • medicines management
  • consent to treatment
  • health and safety
  • infection control.

Arm yourself with plenty of information - the NSPCC and HSE websites are excellent. Don't try to write them from scratch. Search the Internet for policies and adapt them to your needs. Then, as you complete each policy, email it to your inspector and you should receive useful feedback.

I found this stage the most stressful, with so much to do and what appeared to be little time in which to do it. Make sure you eat properly at least once each day and factor in some time off every week.

Coming down to the wire

Although you may be proposing a small establishment with few staff. the HC will want to see that you comply fully with health and safety legislation. Your site visit will be shorter if you have carried out a full premises and fire risk assessment before the inspection. Formal fire inspections are not a statutory requirement, but you will need to have had a visit from a reputable supplier of fire-fighting equipment who will issue a visit record.

Before the inspection, you will be asked to complete a "Fit person assessment interview pro-forma" and return this to your inspector. During the inspection you will be questioned further on the contents. The pro-forma uses jargon like "How will patients be engaged in the process of creating an appropriate environment?" In other words, how will you get the views of patients so you can continue to improve your facilities?

This questionnaire takes a few hours to complete properly so don't rush it - if you have done a good job on the paper pro-forma, the site visit will not be as nerve-wracking.

Then finally it's D-Day!

The site visit may take up to five hours. Look smart - if you are going to be in uniform, then wear it for the inspection. During the first part, the two inspectors will go over your premises thoroughly and may make suggestions for improvement, but this doesn't mean you'll fail the inspection.

They will look at your policies and PGDs so if they have already seen your policies, you have an advantage as it won't take as long. Have your completed premises and fire risk assessments to hand so the inspectors do not have to carry these out themselves.

The second part of the inspection comprises the fit person interview when you will be questioned on the contents of the pro-forma.

Following the inspection, you will receive a letter informing you if there are any outstanding tasks to be completed before you can be registered. This does not normally involve a second site visit, but you may need to email your inspector stating you have completed anything which was outstanding.

A few days later you will receive your certificate ...

Should you want to use the HC logo on your letterhead and stationery, you need to request permission and your inspector will tell you who to contact.

Above all, talk to others who have been through the process. They will have tales to tell about their experience of the registration process and some of the stories will help you. Generally people are happy to help.

The whole process is one huge learning curve, but you will gain from it - all the knowledge you require to take on the responsibility of premises, staff and patients. And, of course, a huge sense of achievement.

It is worth it - just try to enjoy the journey!

You can also contact Sarah at: sarahbuckley1@btconnect.com

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