LCS Healthcare Newsletter

As the summer comes to an end and we all return from our well earned summer holidays, it is again time to turn our minds to the nagging worries we have about that unexpected “drop in” from the Care Quality Commission (CQC) inspector.

Remember that the latest weapon in the armoury of the CQC is the Provider Compliance Assessment (PCA). These are a set of forms which providers are expected to have in place and regularly review and update in order to demonstrate compliance with Essential Standards of Quality and Safety.

Providers are expected to use the PCAs as “living documents” which they maintain, preferably electronically and which constantly develop as the registered service changes.

For the latest updates and information regarding PCAs and other regulatory compliance issues contact LCS Healthcare on 0845 003 8191 or email us on admin@lcshealthcare.co.uk

The European Standard for Aesthetic Surgery Services (CEN TC403) is now in its second draft and due to be considered further by the committee following receipt of comments made by stake holding parties throughout the EU.

There is considerable confusion and consternation about this document and the possible consequences of it eventual implementation as a standard for the medical and surgical cosmetic sector in the UK.

The EU encourages and supports the development of standards by consensus and agreement between member states using national standards agencies. The adoption of the standards is voluntary by all parties. The confusion seems to arise with this document as to its eventual status in law. This is not a EU Treaty Article, nor a Regulation or Directive ; further this is not even a harmonised standard (which are produced in response to a Commission request to evidence compliance with a Directive).  The eventual outcome will be a standard which carries no force of law whatsoever.

There are some areas of significant conflict between accepted medical practice and UK law when compared to the proposals within the draft standard. Areas of particular concern are detailed below:

1. Many treatments using local anaesthetic are classified under category 2 procedures which should only be undertaken by doctors on the GMC specialist register – this would include ablative lasers and minor surgical procedures.

2. The document refers to categories of EU Medical Specialities – there is no such category for cosmetic doctors so no opportunity to develop skills in any other areas.

3. Nurses would be unable to provide any cosmetic treatments except under direct supervision of a doctor.

4. States that practitioners should charge for all – including initial consultations

5. Many of the procedures listed as category 2 (minor surgical) are not regulated in the UK and can legally be performed by non medically qualified staff. This would in effect mean that medical practitioners would not be able to provide these treatments even though they would be available in the local beauty clinic.

6. The provision of virtually all cosmetic procedures other than botulinum toxin, resorbable dermal fillers and Intense pulsed light treatments would be restricted to plastic surgeons and dermatologists to the exclusion of virtually all other medical professionals.

So, should the cosmetic community be concerned if they do not like the content? Even with the above said it is wise to take these documents seriously. While this standard will not force any significant changes or introduce any restrictions  in the short or medium term, it is just possible that in years to come it will be adopted and incorporated by the Department of Health into proposals for new legislation when this area of law is to be reviewed.

The standard continues on its journey through drafting with proposed amendments from interested stakeholders.

For more information contact LCS Healthcare on 0845 003 8191 of visit www.lcshealthcare.co.uk

The Medical Profession (Responsible Officer) Regulations 2010 came into force on the 1st January this year.

The regulations require that all Designated Bodies – NHS trusts and other bodies, together with other organisations who employ or contract medical practitioners and who carryout activities, by or under the supervision of a registered medical practitioner, regulated under the Health and Social Care Act 2008 by the Care Quality Commission appoint a “Responsible Offcer” – RO

The RO must be a registered medical practitioner of 5 years standing.

The duties of the RO will be to ensure that the designated body carries out regular appraisal on all medical practitioners, implements procedures to investigate concerns raised by patients or staff and where appropriate refers such comcerns to the General Medical Council (GMC). The RO will also be responsible for monitoring compliance with GMC imposed conditions,  making recommendations about a medical pracitioner’s fitness to practice and maintaining records of evaluations and appraisals.

CQC Registered establishments are now being contacted by the Strategic Health Authorities to provide the name of the doctor who will be carrying out the function for their establishment.

For more information contact LCS Healthcare on 0845 003 8191 or visit www.lcshealthcare.co.uk

Nurses and Midwives who prescribe or administer Botox and other cosmetic injectable products have been issued with new advice from their regulator – the Nursing & Midwifery Council.

The advice makes clear the NMC’s position that remote prescription or directions to administer should not be used to administer injectable cosmetic medicinal products such as botulinum toxin (eg Botox, Dysport, Xeomin etc).

The advice supports the NMC’s Standards for Medicines Management and was developed in patnership with the Royal College of Nursing (RCN). It is said to reflect a growing industry where nurses and midwives work more independently and often run their own clinics.

Roger Thompson (NMC Director of Policy and Standards) is quoted as saying:
“As the regulator for the UK’s 660000 nurses and midwives we are committed to safeguarding the public. This advice will support the registered nurses and midwives working in the field of aesthetic practice to make (sure) their local policies are fully compliant with the standards”

The full advice is available from the link below:

Remote prescribing and injectable cosmetic medicinal products

For more information on regulatory compliance issues contact LCS Healthcare on 0845 003 8191 or visit www.lcshealthcare.co.uk

If you are a GP or Practice Manager faced with the task of bring your practice into the CQC registration process next year, you may now be wondering how and when to begin the process. So what should you be doing at this stage in order to get ahead before the whole process becomes a mad rush with sleepless nights and headaches? The advice is true whether you are a GP practice, dental practice or any other healthcare provider who is required to register with the Care Quality Commission (CQC) under the Health and Social Care Act 2008.

The best advice is plan ahead.

1. You should begin to look at how you organisation if structured – Are you a limited company, partnership, sole trader, LLP or limited company?
This can be important from both the accounting point of view and also has relevance to how you application with be framed when the time arrives to submit. If you operate more than one company in providing services you should be aware that you will be asked to register all of them increasing workload and the headaches of paperwork and compliance.

2. Who will be responsible for holding the CQC registration for your practice?
You are required to name one person who will hold the registration on behalf of the the practice/company, the Nominated Individual. This person will be ultimately responsible at law to the CQC for the way in which the organisation operates – usually the owner, a senior partner or director. If your organisation is of a significant size you may well need to appoint a Registered Manager. The Registered Manager is the other legally responsible person who holds the registration, he or she will be responsible for ensuring that the regulations and Essential Standards for Quality and Safety are enforced with the practice. If you operate from more than one location you will probably need a Registered Manager for each site.

3. What services do you currently provide and do you intend to provide any additional services in the near future?
The Health and Social Care Act 2008 and associated regulations create a number of “regulated activities” – these are activities which are controlled by law and in order to provide these services to the public a provider must be registered with the CQC. Regulated activities include: Treatment of Disease, Disorder or Injury, Diagnostic and Screening Services, Surgical Procedures, Slimming, Termination of Pregnancy amongst others. Which specific services you provide will dictate which regulated activities you will apply for and ultimately be registered to provide.

4. How do you become compliant with the Essential Standards of Quality and Safety?
The ESQS have been published by the CQC and are a guide as to how you can fulfill your obligations under the Health and Social Care Act 2008 and the HSCA 2008 (Regulated Activity) Regulations 2010. You will need to adopt and integrate these into the day to day operation of your practice and be able to demonstrate by the production of evidence that you are actually complying (Don’t be fooled by the simple form which just allows you to tick the boxes saying that you declare compliance, the CQC will be following up and asking for you evidence in due course!).

If you require any advice or assistance with the process of CQC Registration contact LCS Healthcare on 0845 003 8191 or visit www.lcshealthcare.co.uk

The CQC today announced that from 1st April it is to abolish it initial application fees for all new registrations.

It has also announced changes to the annual fee structure which will affect all registered establishments.

Number of locations           Fee payable
1                                               £1,500
2 to 3                                       £3,000
4 to 6                                       £6,000
7 to 10                                     £12,000
11 to 15                                   £24,000
More than 15                           £48,000

Other changes are also announced including new application forms and information requirements for new applicants.

For more information contact LCS Healthcare on 0845 003 8191 or visit www.lcshealthcare.co.uk

To many GP’s the 1st April 2012 will still seem a lifetime away.  Trust us, it is not.

The CQC are already making plans to introduce the registration process for NHS Primary Care GPs and it is not too early to begin to assess how you will meet the requriements of registration in your practice.

The actual registration process will open in October 2011 with an online enrolment form. This will request the basic details of the practice including how it is structured (partnership, LLP, Ltd company etc), together with the details of practice locations and person to contact.

The next phase will require that you validate the details and ensure that they reflect the correct information.

The third phase will be completion of the application including full details of regulated activities provided, practice locations and details of the Registered Managers for each location from which the practice operates. You will also be requried to declare compliance with the Essential Standards of Qaulity and Safety (ESQS).

The whole process will be deceptively simple, however it is important that GPs understand what declaring compliance means. If you make this declaration then you are stating in a legal document that you meet all of the ESQS – you should take care, because if in reality you do not, then when the inspector visits (and they will visit) you can be found to be in breach of the regulations, right from the start.

Be sure that if you do not comply fully then you state this and put in place an action plan as to how you will be able to in a reasonable time frame. This way you are showing that you recognise your limitations and that you know what you need to do to put things right.

The main areas which are likley to be tested initially by the CQC during the first few months of the registration programme are:

• Outcome 4: Care and welfare of the people who use services.
• Outcome 8: Cleanliness and infection control.
• Outcome 9: Management of medicines.
• Outcome 11:Safety, availability and suitability of equipment.
• Outcome 16: Assessing and monitoring the quality of service provision 

If you require any advice or assistance with preparation for CQC application or the registration process contact us on 0845 003 8191 or visit www.lcshealthcare.co.uk

The LCS Healthcare Newsletter now has the facility for you to SUBSCRIBE to updates.

If you add your email address to the box at the top right of the page you will automatically receive an email whenever we add new information or updates.

This will allow you to stay right upto date and in touch with the lates developments in the the regulatory compliance field.

The latest round of CQC provider self assessment under the new regulations has now commenced!

Care Quality Commission inspectors are now making unannounced visits to registered and unregistered healthcare providers in order to determine which services are being provided and to issue requests for establishments to provide appropriate evidence of compliance against the new Essential Standards of Quality and Safety.

Providers who declared compliance last October with the new standards are now being asked to provide the evidence to justify that they are actually meeting them by completing the Provider Compliance Assessment forms and the necessary supporting documentation verifying compliance.

All registered providers should now be checking their compliance to ensure that they can produce this evidence if and when an inspector comes to call!

For further information about CQC registration or regulatory compliance including the PCA please contact LCS Healthcare on 0845 003 8191 or visit our website at www.lcshealthcare.co.uk

By now, if you are a dental practice offering primary dental care services in England, you should have enrolled and provided the validation information for the practice to the Care Quality Commission.

If you have not, the CQC will now not guarantee that you will be registered by the deadline date of 1st April 2011.

There has been extensive resistance by the dental profession to the requirement for registration, however, you should not be mislead by professional and press rhetoric, registration is a legal requirement, it is coming and if you fail to register AND comply with the regulatory framework the CQC will take enforcement action.

The CQC have no choice or discretion in when or whether they introduce the registration process. The requirements and time frame are laid down in the legislation and these will not now change.

Registration does not simply mean filling in the online form and ticking the boxes, nor is it simply producing a set of glossy policies in a manual. The new regulatory framework involves an ongoing process of demonstrating compliance with the Essential Standards of Quality and Safety and ensuring that the procedures and processes are in place within your practice to enable you to collect and present evidence of compliance in terms of patient care.

Time is now short.

It is time for those who have buried their heads in the sand to pull them out and begin the sprint to the finish line!

For information or assistance with CQC regulatory compliance contact LCS on 0845 003 8191 of visit our website www.lcshealthcare.co.uk