Future_of Healthcare_Regulation

The Future of Healthcare Regulation

in England 2010

Text Box: The Future of Healthcare Regulation in England 2010 The Health & Social Care Act 2008 (HSCA 2008) comes to effect on 1st October 2010. This Act repeals in its entirety the Care Standards Act 2000 and all associated regulations. The HSCA 2008 also enables The Health and Social Care Act 2008 (Regulated Activities) Regulations 20091 and the Care Quality Commission (Registration) Regulations 2009. The effect of this new raft of regulation, which applies only to England, is to oblige Healthcare Professionals2 to register with the Care Quality Commission (CQC) if they carry out any “Regulated Activities”. Because the 2000 Act is being repealed in full this will also have the effect of cancelling all existing registrations with the CQC and mean that all healthcare providers will need to re-register. The process of re-registration will begin in April and carry on until 1st October 2010 when new registrations will be granted to successful applicants3. The introduction of the Regulations is staggered for providers - all standard dental treatments, including dental implants (1st April 2011) and NHS General Practices (1st April 2012). The new regulations are technical and complex however in broad outline the new requirements are as follows: There is a fundamental change of direction in the regulatory process in that the new outcomes are focused on what the patient should expect from the service provider rather than simply meeting a “standard”. The provider will be expected to demonstrate and evidence compliance with the new Essential Standards of Quality and Safety and also provide independent verification that the evidence provided is correct. Establishment of sound principles of clinical governance is central to the operation of establishments (including appraisal for Healthcare Professionals) There is an emphasis on compliance with hygiene and infection control and specifically the Code of Practice for Health & Social Care on the Prevention and Control of Infection. The existing requirements for providers such as complaints, consent, confidentiality, human resources, management of information and records etc. are retained and strengthened in the new Regulations. Regulation 3 prescribes certain activities which are to be regulated under the HSCA 2008 and these are detailed in Schedule 1(5) of the Regulations: Where Regulated Activities are carried out by or under the supervision of a Healthcare Professional (HCP) or where the team includes a Healthcare Professional registration is required. The provision of all treatments for disease, disorder or injury are Regulated Activities (with some narrow and specific exemptions) c. Specifically detailed Regulated Activities include: All surgical procedures, including pre-op and post op care for the treatment of disease, disorder or injury and ALL cosmetic surgical procedures “where the procedure involves the use of instruments or equipment which are inserted into the body”. Diagnostic or Screening Services Slimming Clinics d. Exemptions (this is not the definitive or exhaustive list) are given for: Cryo-surgery, curettage of skin lesions, warts etc under local anaesthetic and “the subcutaneous injection of a substance or substances for the purpose of enhancing a person’s appearance” (i.e. Botox and Dermal Fillers) Medical practitioners in their private practice, who also provide NHS services, however this does not apply if any regulated activities are carried using any form of anaesthesia and or iv sedation. Sch2 4(a) and 5(a) What does this mean? The new Regulations will apply to all HCPs (with the notable exception of physiotherapists(?)). Any HCP providing any treatment (directly or indirectly within an organisation), irrespective of the modality of that treatment (and including lasers and intense light sources), for the treatment of disease, disorder or injury will be registerable under the new Regulations with the CQC, subject to the exemptions provided (eg (d) above). The inclusion in the Regulations of the term “disorder” is very significant. This has been further defined in the guidance document (not legally binding) as an “illness or condition”. The scope of a “disorder” can be taken to include many conditions treated by HCPs using lasers and intense light sources for example pigmented and vascular lesions and could even include hair removal in patients with polycystic ovarian syndrome. The terms will most certainly include the treatment of such conditions as acne and rosacea by either traditional methods or using lasers and intense light sources. The failure to include non surgical lasers and intense light sources in the new Regulations at first glance seemed to mean that the whole “non-surgical“ industry would be deregulated from October 2010. The way in which the new Regulations have been framed means that HCPs who perform treatments for Regulated Activities (including using lasers and intense light sources) will continue to be regulated This document is a summary and is intended for initial guidance only and without liability. Reference to original Statutes and Regulations is required for full details. For more information and advice on future regulatory requirements contact LCS Ltd on 0845 003 8191 Notes: These regulations are subject to imminent Parliamentary approval and we understand that the instrument will be laid prior to purdah pending the 2010 general election. Healthcare Professional is defined as “ (i) a medical practitioner, (ii) a dental practitioner, (iii) a dental hygienist, (iv) a dental therapist, (v) a dental nurse, (vi) a dental technician, (vii) an orthodontic therapist, (viii) a nurse, (ix) a midwife, (x) a biomedical scientist, (xi) a clinical scientist, (xii) an operating department practitioner, (xiii) a paramedic, or (xiv) a radiographer.” Application does not automatically guarantee that a new registration will be granted because each provider will be required to meet the new standards and requirements.

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