Wednesday, April 24, 2013

Technology and the Keogh report - An informed and empowered public


How can iConsultAesthetic support the recommendations for an informed and empowered public?

Recommendation 31 

Evidence-based standardised patient information should be developed by the RCS Interspecialty Committee on Cosmetic Surgery. This should be done with input from patient organisations. This information should be available on NHS Choices and the Parliamentary Health Service Ombudsman (PHSO) website. 

Recommendation 32 

Patient Decision Aids (PDAs) should be developed for cosmetic procedures and these should be piloted by the RCS Interspecialty Committee on Cosmetic Surgery. 

Using Tablet Computing (iPads) Patient images are captured before treatment, and these can be used to provide a full treatment consultation. Patient can sign on screen to accept 

Recommendation 33 

The RCS Interspecialty Committee on Cosmetic Surgery should develop and describe a multi-stage is consent process for operations. This consent process should be undertaken by the operating surgeon and its use should be mandated as part of the Code of Practice. 

Using Tablet Computing (iPads) iConsultAesthetic has a full digital consent process that is stored with the patient record. 

Recommendation 34 

For non-surgical procedures, a record of consent must be held by the provider. 

Using Tablet Computing (iPads) iConsultAesthetic has a full digital consent process that is stored with the patient record. 

Recommendation 35 

The RCS Interspecialty committee should develop a code of ethical practice developed for all practitioners of cosmetic interventions, and this should include standards to ensure that any advertising is conducted in a socially responsible manner 

Recommendation 36 

CAP should extend its guidance note on cosmetic surgery advertising to cover non-surgical cosmetic procedures, and the sponsoring of TV and other programmes 

Recommendation 37 

The Review Committee considers that the following advertising practices are socially irresponsible and should be prohibited by the professional registers’ codes of practice: Time-limited deals Financial inducements Package deals, such as ‘buy one get one free’ or reduced prices for two people such mother and daughter deals, or refer a friend Offering cosmetic procedures as competition prizes. 

Recommendation 38 

Providers and practitioners should provide continuity of care. Patients should be offered appropriate follow-up and after-care, rather than stand-alone procedures. iConsultAesthetic encourages treatment planning, rather than one off treatments. 

Recommendation 39 

All organisations providing cosmetic surgery should have a doctor on the Board as Medical Director who is professionally accountable for all work carried out by the provider organisation and for its procedures, practices and wider activity. 

Recommendation 40 

The remit of the Parliamentary and Health Service Ombudsman (PHSO) should be extended to cover the whole private healthcare sector, including cosmetic procedures and ophthalmology. Providers should offer advice on their complaints procedures to their patients, and where appropriate this advice should be available on their websites.

Recommendation 41 

Complaints against providers that are investigated and upheld by the Ombudsman should be publicly available. 

Recommendation 42 

All individuals performing cosmetic procedures must possess adequate professional indemnity cover that is commensurate with the type of the operations being performed.

Recommendation 43 

Device manufacturer risk pools should be established. The Department of Health should work with the EU and industry to help support this. This risk pool would meet the costs of complications or corrective surgery in the event of wholesale problems with a device. 

Recommendation 44 

Patient’s rights should be protected even when a provider goes out of business. Providers of cosmetic surgery must either enter a risk pool or have appropriate insurance/financial arrangements to provide treatment following certain complications. The NHS should be able to recoup costs for management of certain complications following cosmetic procedures if the provider has been found to have failed the patient following surgery. A similar arrangement already exists following motor vehicle accidents. 

Recommendation 45 

The insurance status of all practitioners should be displayed on the practitioner register. 

Recommendation 46 

In order to ensure that all patients are adequately protected, overseas surgeons operating in this country should have the same level of professional indemnity as UK-based surgeons.

Technology and the Keogh Report - Ensuring safe products

How can iConsultAesthetic support the recommendations for ensuring safe products?

Recommendation 18 

Those training to be non surgical practitioners should have a clear understanding of the requirement to operate from a safe premises, and the responsibilities involved. The training curriculum should include topics such as infection control, treatment room safety and adverse incident reporting. The code of conduct for those on the register should include an obligation to abide by certain clearly defined minimum standards for premises.

iConsultAesthetic has sections where HCP can sign to demonstrate their acceptance of their responsibilities for each patient and every patient consultation. This information is added to the patient record and made available to the patient. 

Recommendation 19 

The scope of the EU Medical Devices Directive should be extended to cover all cosmetic implants, including all dermal fillers. UK legislation should be introduced to make fillers a prescription only medical device. 

iConsultAesthetic has the functionality to restrict products listed on the system that have achieved certain criteria. 

Recommendation 20 

The EU General Product Safety Directive (GPSD) should be revised so that products used as part of a professional service are no longer exempt from product safety legislation. 

Recommendation 21 

All European Notified Bodies should be regularly and rigorously assessed and audited, to ensure they all work to the same high international standards; and reports of these assessments should be made public. 

Recommendation 22 

There needs to be unannounced inspections of manufacturers of class III and IIb medical devices to ensure production is compliant with the regulations. Reports of such inspections should be made public where possible. 

Recommendation 23 

Manufacturers should inform the MHRA when bringing a new product to the UK market and the MHRA should publish a list of the cosmetic devices available in the UK.

Recommendation 24 

A system should be set up to link the Unique Device Identifier for all implants to the patient’s electronic record, enabling routine collection through Hospital Episode Statistic (HES) data. This information would enable assessment of implant performance, and the tracking and tracing of patients in case of a safety alert. HES should be a CQC registration requirement.

Recommendation 25 

Until such a system is developed, a National Breast and Cosmetic Implant Registry needs to be established and this should be operational within 12 months. All cosmetic surgery providers need to keep a minimum data set that should be defined by the RCS Interspecialty Group. This would be expected to include details of the implant, the surgeon, the hospital and outcomes, and these data need to be held in electronic format until the registry is operational. These data should be easily accessible in the case of a product recall. 

Recommendation 26 

People who have undergone implant surgery should be able to compare their own personal data, and aggregated data from the registry for the implant, surgeon and provider.

Recommendation 27 

Full participation of providers in national registries and databases should be an essential component of the Care Quality Commission (CQC) registration and assessment, and full participation by surgeons should be an essential component of their annual appraisal and revalidation. 

24 - iConsultAesthetic automatically links all product data to the patient record, enabling HES collection and facilitating product tracking/tracing and patient follow up. The system can link to a National Breast and Cosmetic Implant Registry providing realtime data electronically and enabling easy access online for all stakeholders. 

25 -Using Tablet Computing (iPads) Patient images are captured in theatre before surgery, and the product numbers are recorded at the moment of implantation, minimising risk of mistakes. Patient images are captured post surgery, which would be a valuable record in the event of a claim. 


26 - Patients are given an access level, and provided with their notes in PDF format but can login to the system to be able to compare personal and aggregated data. 


27 - Adapting this system to this task would be a fraction of the cost of developing a bespoke solution, and could be operational within 6 months. Data would be stored on dedicated servers and password protected. 


Recommendation 28 

The Director of Patient Safety for the England should develop a framework to encourage and support the reporting of suspected device failures to the MHRA. 

Recommendation 29 

Formal relationships need to be developed between the MHRA, and professional organisations such as the Academy of Medical Royal Colleges and the Specialist Associations whose members implant medical and cosmetic devices and deal with the consequences of failure. 

Recommendation 30 

Assessment of systems for reporting adverse events should be part of CQC’s registration and assessment of providers. Adverse incident reporting should be a standard component of professional appraisals and revalidation. 

Technology and the Keogh Report - High Quality Care

How can iConsultAesthetic support the recommendations for providing High Quality Care?

Recommendation 1 

The Royal College of Surgeons (RCS) should establish a Cosmetic Surgery Interspecialty Committee. This should consist of representatives from all the relevant specialty associations and professional associations and societies, including plastic surgery, ENT surgery, maxillofacial surgery, ophthalmology, breast surgery and gynaecology. Its task should be to: 

Set standards for the training and practice of cosmetic surgery. 
Make arrangements for the formal certification of all surgeons regarded as competent to undertake cosmetic procedures, taking account of training and experience. 

Establish and oversee a clinical audit database for cosmetic surgery, working with the Healthcare Quality Improvement Partnership (HQIP). 

Work with the Parliamentary and Health Service Ombudsman (PHSO) on dispute resolution (see recommendations regarding accessible resolution and redress). 

Meet the General Medical Council (GMC), Care Quality Commission (CQC), and the Medicines and Healthcare products Regulatory Agency (MHRA) regularly and, when appropriate, with provider representatives, to discuss current issues and share information and intelligence on the quality of care being provided. 

Develop a specific code of ethical practice for cosmetic surgery, in collaboration with the GMC, to include guidance on advertising, insurance requirements and the psychological assessment for patients.

Recommendation 2 

The RCS Interspecialty Committee should work with the CQC and the new Chief Inspector of Hospitals to ensure that providers follow the standards developed. In the meantime, the Review Committee recommend that only doctors on a GMC Specialist Register should perform cosmetic surgery, and that those doctors should work within the scope of their Specialty specific training. 

Recommendation 3 

The RCS Interspecialty Committee should be responsible for developing clear, credible outcome measures for cosmetic surgery that are published at individual surgeon and provider level on the NHS Choices website. 

iConsultAesthetic records patient notes and outcomes at the moment of treatment, it could easily incorporate the RCS outcome measures which could then be shared with the NHS Choices website.

Recommendation 4 

All non-surgical procedures must be performed under the responsibility of a clinical professional who has gained the accredited qualification to prescribe, administer and supervise aesthetic procedures. 

iConsultAesthetic requires professional body and the registration number of the Prescribing Healthcare Professional, who would have also performed the physical examination. This information is then recorded on the patient documentation and clearly identifies to the patient the accrediting body and qualification.

Recommendation 5 

Non-healthcare practitioners who have achieved the required accredited qualification may perform these procedures under the supervision of an appropriate qualified clinical professional. 

iConsultAesthetic requires professional body and the registration number of the Healthcare Professional. This information is then recorded on the patient documentation and clearly identifies to the patient the accrediting body and qualification. 

Recommendation 6 

The Government’s mandate for Health Education England (HEE) should include the development of appropriate accredited qualifications for providers of non-surgical interventions and it should determine accreditation requirements for the various professional groups. This work should be completed in 2013. 

iConsultAesthetic requires professional body and the registration number of the Healthcare Professional. This information is then recorded on the patient documentation and clearly identifies to the patient the accrediting body and qualification. The system could also reference a database of accredited HCP’s. 

Recommendation 7 

All practitioners must be registered centrally. The register should be independent of particular professional groups or commercial bodies, and should be funded through registration fees. 

Recommendation 8 

Entry to the register should be subject to: achievement of accredited qualification premises meeting certain requirements adherence to a code of practice that covers handling complaints and redress, insurance requirements, responsible advertising practice and consent practices continued demonstration of competence through an annual appraisal.

iConsultAesthetic requires professional body and the registration number of the Healthcare Professional. This information could reference the central register preventing individuals not registered from performing consultations using the system. iConsultAesthetic could also capture the qualification, approved premises, date of last appraisal, and record these on the patient documentation. 

Recommendation 9 

The CQC should recruit inspectors with appropriate expertise and experience in this sector.

Recommendation 10

The CQC should work with professional organisations to produce inspection guidelines for cosmetic surgery providers. 

Recommendation 11 

Risk-based and unannounced CQC inspections should be performed. 

Recommendation 12 

The CQC should use this data and clinical audit findings to analyse outcomes and assess risk, and this data should be used to guide inspection teams. 

Recommendation 13 

Full participation in all clinical audit and data collection programmes that have been recommended by the RCS Interspecialty Committee should be part of CQC registration requirements. 

This information could be made available to patients on the iConsultAesthetic System, and any changes to the CQC status could be sent to patients registered with that clinic through “Push Notifications” 

Recommendation 14 

Data on performance should be made publicly available at surgeon and provider level. 

This information could be made available to patients on the iConsultAesthetic System, and any changes to the Performance Data could be sent to patients registered with that clinic through “Push Notifications” 

Recommendation 15 

Providers should be required to notify the public on their websites of any CQC inspection concerns or notices. 

This information could be made available to patients on the iConsultAesthetic System, and any changes to the CQC status could be sent to patients registered with that clinic through “Push Notifications” 

Recommendation 16 

All providers must keep full patient records, including clear operative records and precise details of any implant or device used. Providers should also be able to access data of implant cohorts readily and this should be available to regulatory authorities. Details of the surgery and implant used must be sent to the patient and to the patient’s GP. 

iConsultAesthetic keeps detailed pre and post treatment notes, along with before and after images, batch numbers of product and expiry dates. This information is added to the patient record and made available to both the patient and the patients GP. 

Furthermore, the Review Committee accepts the recommendation made by the NCEPOD in its report On the face of it9, that: 

Recommendation 17 

‘Independent healthcare providers should only allow practising privileges to those cosmetic surgeons who can demonstrate that they have achieved and are able to maintain competence in the procedures which they offer’. 

How can technology make the Keogh report a reality?


Morning has broken, Sir Bruce has spoken, all of the Blackbirds are having a nice day. 

A year in the making and we finally have our 44 recommendations on what we can do to drag our industry out of the gutter and ensure that it grows with the patient at its centre. 


The Executive Summary of the report begins with; “The cosmetic interventions sector is growing rapidly. The existing regulatory framework has not kept pace with changes and it does not provide enough protection against many of the potential risks from cosmetic procedures”. 


I couldn’t agree more. 


We have unconsciously, not consciously designed the patient experience in Medical Aesthetics, and allowed complacency and poor practice to become the norm. 


The purpose of this blog and summary, is to highlight the ways that iConsult Software and our product iConsultAesthetic can utilise technology to bring the Keogh Reports recommendations to fruition to in an expedient and cost effective manner. During the development of iConsultAesthetic, it became clear that we needed to adopt a set of principles to shape the product. 


 We needed to; 

  • Improve Accountability 
  • Improve Integrity 
  • Improve Transparency 
  • Improve Compliance 
  • Improve Patient Safety
 As predicted by RCS in his development of iConsultAesthetic, the Keogh report identifies  “Overarching Objectives” 

 “There are three key areas in which changes are needed: high quality care with safe products, skilled practitioners and responsible providers; an informed and empowered public to ensure people get accurate advice and that the vulnerable are protected; and, accessible redress and resolution in case things go wrong”. 

  • High quality care 
  • An informed and empowered public 
  • Accessible resolution and redress 

Clearly Sir Bruce and his team are fans of the rule of three and these are the right battles to fight. 


However, as with all things there is a significant difference between knowing the issue, fixing the issue and making sure it stays fixed. 


This is where technological Interventions can help, so lets look at the recommendations in some detail and identify the key technological “fixes” that can provide a solid framework to enable and enforce compliance. 


I have reviewed each recommendation individually, and highlighted how the current iConsultAesthetic system, or planned system will be able to support it.


Integrity


Integrity comes in two forms; personal and professional and iConsultAesthetic supports both.
With our data management processes we help you to demonstrate high levels of professional compliance by recording all of the pertinent data about a treatment performed, such as product used, areas treated and storing it digitally allowing it to be measured and audited.

The value of this can be measured not only in reducing your working hours, but also being able to show a very personal client experience, and by choosing iConsultAesthetic, not only are you providing a clear statement to your patients that you are committed to them, you are also making a very clear statement to your competition. Clearly differentiate yourself with your commitment to best practice, high levels of client engagement and increased retention.
We practice what we preach, and use state of the art encryption and security to maintain our integrity and keep your data safe.

Transparency


We believe strongly believe that a transparent process enhances the trust between you and your client. This is why iConsultAesthetic has been designed to actively record the qualification of the practitioner, providing the client with additional safeguards against being treated by the unqualified and unscrupulous.

Transparency is at the heart of iConsultAesthetic, and underlines our pioneering approach, as iConsultAesthetic is not just a system, but an ecosystem. A new online community built on Accountability, Integrity, Transparency, Compliance and Safety. We have created a Client Portal, where the “iConsulted” can view their patient notes, medical history, before and after images and products used. 

This level of patient access is rare in healthcare, as the ecosystems do not exist, and is truly unrivalled anywhere in this industry, and marks the practitioners who use iConsultAesthetic as true pioneers.

How many times have you seen a client who has had poor treatment elsewhere, and doesn’t know what product was used where? 

We thought this was odd too, so we have a built in Patient Passport, where your patients can vote with their feet, go to another practitioner using iConsultAesthetic and take their patient notes with them.

Compliance


Compliance, in our view is simply placing Safety, Integrity and transparency above all else, and then making the various regulatory bodies and groups aware of what you are doing. The aftermath of the PIP scandal in the UK is that the medical aesthetics industry will be forced to become far more particular in the products that are used. iConsultAesthetic supports this by encouraging and demanding that all clients treated have the product used recorded

This drive to help set the gold standard and provide a consistent approach to process will result in happier patients, reduced claims, higher quality paperwork, Improved visibility of treatments provided and the creation of a live record of product safety data.

Without anyone doing anything different. Thats the power of Digital Ecosystems!

Safety

The overarching goal of iConsultAesthetic is to contribute, and provide a robust mechanism for the best practitioners to flourish and be supported. The unqualified and unscrupulous will fear iConsultAesthetic as there is nowhere to hide! As a wise old man said “The good will be found, the bad will be found out”.

By enabling high levels of record keeping Integrity, clinical best practice, transparency, accountability and compliance, we can show your patients your commitment to best practice, and create and maximise the emotional attachment that will keep them coming back again and again.


So there we have it. Check the blog series for specific information on how iConsultAesthetic supports compliance with 20 out of the 44 recommendations