Independent Healthcare Inspection (Announced) Lee Voltz Laser Removal at Frontier Tattoo Parlour, Cardiff

Transcription

1 Independent Healthcare Inspection (Announced) Lee Voltz Laser Removal at Frontier Tattoo Parlour, Cardiff Inspection Date: 13 February 2017 Publication Date: 15 May 2017

2 This publication and other HIW information can be provided in alternative formats or languages on request. There will be a short delay as alternative languages and formats are produced when requested to meet individual needs. Please contact us for assistance. Copies of all reports, when published, will be available on our website or by contacting us: In writing: Or via Communications Manager Healthcare Inspectorate Wales Welsh Government Rhydycar Business Park Merthyr Tydfil CF48 1UZ Phone: hiw@wales.gsi.gov.uk Fax: Website: Digital ISBN Crown copyright 2017

3 Contents 1. Introduction Methodology Context Summary Findings... 6 Quality of patient experience... 6 Delivery of safe and effective care... 8 Quality of management and leadership Next Steps Appendix A... 14

4 1. Introduction Healthcare Inspectorate Wales (HIW) is the independent inspectorate and regulator of all health care in Wales. HIW s primary focus is on: Making a contribution to improving the safety and quality of healthcare services in Wales Improving citizens experience of healthcare in Wales whether as a patient, service user, carer, relative or employee Strengthening the voice of patients and the public in the way health services are reviewed Ensuring that timely, useful, accessible and relevant information about the safety and quality of healthcare in Wales is made available to all. HIW inspections of independent healthcare services seek to ensure services comply with the Care Standards Act 2000 and requirements of the Independent Health Care (Wales) s 2011 and establish how services meet the National Minimum Standards (NMS) for Independent Health Care Services in Wales 1. This report details our findings following the inspection of an independent health care service. HIW is responsible for the registration and inspection of independent healthcare services in Wales. This includes independent hospitals, independent clinics and independent medical agencies. We publish our findings within our inspection reports under three themes: Quality of patient experience Delivery of safe and effective care Quality of management and leadership. 1 The National Minimum Standards (NMS) for Independent Health Care Services in Wales were published in April The intention of the NMS is to ensure patients and people who choose private healthcare are assured of safe, quality services. 2

5 2. Methodology During the inspection we gather information from a number of sources including: Information held by HIW Interviews with staff (where appropriate) and registered manager of the service Conversations with patients and relatives (where appropriate) Examination of a sample of patient records Examination of policies and procedures Examination of equipment and the environment Information within the service s statement of purpose, patient s guide and website (where applicable) HIW patient questionnaires completed prior to inspection. At the end of each inspection, we provide an overview of our main findings to representatives of the service to ensure that they receive appropriate feedback. Any urgent concerns that may arise from an inspection will be notified to the registered provider of the service via a non-compliance notice 2. Any such findings will be detailed, along with any other improvements needed, within Appendix A of the inspection report. Inspections capture a snapshot on the day of the inspection of the extent to which services are meeting essential safety and quality standards and regulations. 2 As part of HIW s non-compliance and enforcement process for independent healthcare, a non compliance notice will be issued where regulatory non-compliance is more serious and relates to poor outcomes and systemic failing. This is where there are poor outcomes for people (adults or children) using the service, and where failures lead to people s rights being compromised. A copy of HIW s compliance process is available upon request. 3

6 3. Context Lee Voltz Laser Removal is registered as an independent hospital because it provides Class 3B/4 laser and Intense Pulsed Light Technology (IPL) 3 treatments at Frontier Tattoo Parlour, 2 St Mary Street, Cardiff, CF10 1AT. The service was first registered in February At the time of inspection, the staff team included the Registered Manager as the sole laser operator. The service is registered to provide the following treatments to patients over the age of 18 years: Eclipse Compact Q-Switched Nd:YAG Laser for the following treatments: Tattoo removal 3 IPL is a broad spectrum light source technology and is used by cosmetic and medical practitioners to perform various skin treatments for aesthetic and therapeutic uses. 4

7 4. Summary We looked at how the service complied with the requirements of the Independent Health Care (Wales) s 2011 and met the National Minimum Standards. This is what we found the service did well: Patients were provided with enough information to make an informed decision about their treatment The service is committed to providing a positive experience for patients We saw evidence that patients were completing and signed up-dated medical histories at each appointment. This is what we found the service needed to improve: A system to capture feedback from patients is required so the quality of the service provision can be monitored Certificates need to be obtained to evidence Core of Knowledge training and the servicing of the laser machine by the manufacturer A risk assessment is required Policies and procedures need to be up-dated and/or implemented and need to be kept and available at the premises An updated laser protection adviser report, medical protocols and fire extinguisher servicing needs to be implemented. Further details of these improvements are provided in Appendix A. Given the findings from this inspection, improvements are needed in the quality assurance and governance arrangements of this service to ensure compliance with the relevant regulations and standards. This is important to ensure the safety and effectiveness of the service provided. Whilst this has not resulted in the issue of a non compliance notice, there is an expectation that the registered manager take meaningful action to address these matters, as a failure to do so could result in HIW taking action for non-compliance with the regulations. 5

8 5. Findings Quality of patient experience Patient information and consent (Standard 9) We found evidence to indicate that patients were provided with enough information to make an informed decision about their treatment. We were told that patients were provided with a verbal consultation prior to treatment, which included discussion of the risks and benefits. Patients were asked to provide written consent to treatment and we saw examples of information and aftercare guidance given to patients. We saw that patients were asked to complete medical history forms. Any updates or changes were documented at each appointment and saved on the patient s record. Lee Voltz laser removal service used an individual patient treatment register to record treatment information, including the area treated, comments regarding the treatment which may include any adverse effects, date, patient name, the laser s shot count and the signature of the operator. We saw examples of some records and noted the appropriate information recorded. In addition, each patient treated had their own file which contained consent and treatment information. However, at the time of the visit, we discussed the need for an overarching treatment register to be implemented. The register would need to capture when the laser is used and the nature of the procedure. This would then provide the registered manager with a system and audit trail that would lead to the easy identification of any patient treatment issues or equipment malfunction when undertaking laser procedures. The registered manager agreed to implement the treatment register. Communicating effectively (Standard 18) A patients guide was available and included the required information in accordance with the regulations. A statement of purpose was available and this included the relevant information about the service being offered. Citizen engagement and feedback (Standard 5) 6

9 Before the inspection, the clinic was asked to give out HIW questionnaires to obtain patient views of the services provided. Unfortunately, no questionnaires were completed prior to the date of inspection. We were told the service did not have a formal system for regularly gaining patient feedback, as a way of monitoring the quality of the service provided. We were told that patients had provided the registered manager with verbal comments/feedback, but there was no system to record or evidence this. We were also told that patients used social media to provide feedback about the service, but again this could only be viewed by those with access to the specific websites. The statement of purpose did state that patient satisfaction surveys were provided to patients, however, none had been returned, therefore no analysis was available. We recommended that a formal system of capturing feedback and comments from patients was used so that such information could be analysed to identify areas for improvement and monitor the quality of the service. A system needs to be put in place to capture all feedback and comments from patients so that the quality of the service provided can be monitored. 7

10 Delivery of safe and effective care Safe and clinically effective care (Standard 7) and medical devices, equipment and diagnostic systems (Standard 16) The laser operator told us they had received training by the manufacturer on how to use the laser machine and that Core of Knowledge training had been completed, however there were no certificates available at the time of our visit to evidence this. Evidence needs to be provided to confirm that the registered manager has completed the Core of Knowledge training and completed training on how to use the laser machine (by the manufacturer). We saw that there was a contract in place with a Laser Protection Adviser (LPA) and there were local rules detailing the safe operation of the machine. These rules had been recently reviewed by the LPA and we saw that they had been signed by the registered manager which indicated their awareness and agreement to follow them. Discussions with the registered manager confirmed that the LPA had not visited the premises; instead photographic images had been sent to the LPA of the treatment room layout and machine. A LPA report was provided, but was dated An updated report is therefore required to ensure the facilities and equipment are safe. An updated Laser Protection Adviser report is required to ensure the facilities and equipment are safe. There was no risk assessment in place, conducted by either the Laser Protection Adviser or registered manager. We recommended that a risk assessment is developed and kept up to date and include aspects listed under Standard 22 of the National Minimum Standards for Independent Health Care Services in Wales. A risk assessment needs to be developed and kept up to date to ensure the safety of patients, staff and the premises. We saw that eye protection was available for patients and the laser operator. The eye protection appeared to be in suitable condition and we were told that it was checked and cleaned each time, prior to them being used. 8

11 Discussions with the registered manager confirmed that the laser machine had been serviced and calibrated in 2015, however there was no certificate/evidence to confirm this. Discussions with the registered manager confirmed that servicing was to be undertaken once the machine had reached a fixed number of shots. We asked the registered manager to clarify the frequency of servicing for the laser machine and ensure this is kept and documented. Evidence of servicing and calibration of the laser machine is required. There was a sign on the outside of the treatment room to indicate when the laser machine was in use. We were also told that the treatment room door was locked at such times, in order to prevent unauthorised access. We were told that the laser machine was switched off and the key removed after treatment and that the room was closed to prevent any unauthorised access. There were medical protocols in place for use of the laser machine, which were signed by an expert medical practitioner. The document had a review date of August 2014.so we asked the registered manager to obtain an up-to-date medical protocol front sheet. Medical protocols need to be up dated in-line with the review date recorded on the front sheet of the document. Safeguarding children and vulnerable adults (Standard 11) The service is registered to treat patients over the age of 18 years only. The registered manager confirmed that this was complied with. The safeguarding policy was not available to us on the day of our visit. It is essential that the policy is kept on site so staff can follow the correct procedure should a safeguarding incident occur. In addition we recommended that training in safeguarding was undertaken. The safeguarding policy needs to be available at the setting. Training in safeguarding is required and certificates retained to evidence competence. 9

12 Infection prevention and control and decontamination (Standard 13) We saw the service was visibly clean and tidy. We were informed of the arrangements in place to ensure the service was cleaned appropriately and were provided with a checklist which was used to evidence that all cleaning duties had been carried out. An infection control policy is required to clearly state what the infection control arrangements are at the service. The policy should include hand hygiene and cleaning arrangements for treatment areas and equipment, between patients. An infection control policy must be put in place to clearly state what the arrangements are at the service. Managing risk and health and safety (Standard 22) We saw evidence that Portable Appliance Testing (PAT) had been conducted, to help ensure that small electrical appliances were safe to use. We also saw evidence that there had been a building wiring check within the last five years. We looked at the arrangements for fire safety. A fire safety checklist was being used to check fire alarms and extinguishers. Servicing labels on the fire extinguishers showed they required to be serviced in January Fire exits were signposted. There was an emergency first aid kit available and trained first aid staff were available to support in an emergency. Arrangements need to be made for all fire extinguishers to be serviced in-line with the dates stated on the servicing labels. 10

13 Quality of management and leadership Governance and accountability framework (Standard 1) Lee Voltz Laser Removal was run by a registered manager, who was the sole operator of the laser machine. We found that the service needed to develop a number of policies/procedures-, including infection control. The documents would need to include a version/review date to ensure they were regularly reviewed and appropriate for the service provision. All policies and procedures specific to this service need to be kept at the premises. All policies and procedures specific to the laser service must be kept on the premises and available to all applicable staff. Dealing with concerns and managing incidents (Standard 23) A complaints procedure was available and details of the complaints procedure had been included within the statement of purpose/patient guide. No complaints had been received, however, we recommended a system be put in place to record and monitor complaints and informal comments so that any emerging themes could be identified (see page 6 for the recommendation). Records management (Standard 20) We found that patient information was kept in a filing cabinet, but at the time of our visit the lock was broken. We advised that records needed to be stored securely. All patient records must be stored securely. Workforce recruitment and employment practices (Standard 24) The registered manager had an enhanced Disclosure Barring Service (DBS) check in place. The laser operator had completed some training, but some training certificates were not seen on the day of the inspection, including the Core of Knowledge. We recommended that these are obtained to evidence competence in the trained areas. 11

14 We also made recommendations for safeguarding training to be undertaken. (see pages 8 and 9 for the specific recommendations) Given the findings from this inspection, improvements were needed in respect of the quality assurance and governance arrangements of this service. This was to ensure ongoing compliance with the relevant regulations and standards. The operation of sound quality assurance and governance arrangements and a registered provider s timely response to remedy issues of concern are important indicators of a provider s ability to run their service with sufficient care, competence and skill. There is an expectation, therefore, that the registered manager and responsible individual take meaningful action to address these matters, as a failure to do so could result in HIW taking action for non-compliance with regulations. 12

15 6. Next Steps This inspection has resulted in the need for the service to complete an improvement plan in respect of improvements identified within this report. The details of this can be seen within Appendix A of this report. The improvement plan should clearly state how the improvement identified at Lee Voltz Laser Removal will be addressed, including timescales. The improvement plan, once agreed, will be published on HIW s website and will be evaluated as part of the ongoing inspection process. 13

16 Appendix A Improvement Plan Service: Lee Voltz Laser Removal Date of Inspection: 13 February 2017 Page Number Improvement Needed / Standard Service Action Responsible Officer Timescale Quality of Patient Experience 7 A system needs to be put in place to capture all feedback and comments from patients so that the quality of the service provided can be monitored 19 (1) (a) & (2) (b) (i) Feedback forms have been created and available from frontier tattoo parlour in store. The feedback questionnaires can be handed back in at the desk or can be posted to the shop. Any feedback that needs to be forwarded to the h.i.w will be sent immediately. Lee Peterson 10 th May 2017 Delivery of Safe & Effective Care 8 Evidence needs to be provided to confirm that the registered manager has completed the Core 20 (1) (a) I am currently undergoing my revision for my Core of knowledge exam, once the service process is Lee Peterson Currently ongoing

17 Page Number Improvement Needed of Knowledge training and completed training on how to use the laser machine (by the manufacturer) / Standard Service Action complete all certificates and documentation will be sent to the H.I.W immediately. Responsible Officer Timescale 8 An updated Laser Protection Adviser report is required to ensure the facilities and equipment are safe. 19 (1) (a) (b) & (2) (a) Updated LPA report and photos forwarded to the H.I.W, showing correct signage and eye ware for treatment and reviewed during the inspection. Lee Peterson Complete 8 A risk assessment needs to be developed and kept up to date to ensure the safety of patients, staff and the premises 15 (1) (b) A patient register and return to treatment forms have been created and kept up to date to ensure safety of patients on the premises. No extra staff so no assessment was created. Lee Peterson Available 9 Evidence of servicing and calibration of the laser machine is required. 23 (3) (a) (b) (c) Payment sent awaiting collection for Machine service. Once complete all certificates and documentation will be sent to the H.I.W immediately. Lee Peterson Currently ongoing 9 Medical protocols need to be up dated in-line with the review date recorded on the front sheet of the document. 15 (10) Medical protocols have been paid for 4 th May 2017, currently awaiting documents. All documents will be sent the H.I.W immediately Lee Peterson Currently ongoing

18 Page Number Improvement Needed / Standard Service Action Responsible Officer Timescale 9 The safeguarding policy needs to be available at the setting. 9 (7) Safeguarding policy will be revised once online training is complete. Lee Peterson July Training in safeguarding is required and certificates retained to evidence competence. 16 (3) (a) & 20 (1) (a) Enrolled on Safeguarding of Vulnerable Adults E Learning course with modules including: 1. Fire Safety 2. Health & Safety 3. Lone Worker 4. Handling of Violence & Aggression 5. Infection Control 6. Information Governance 7. Complaint Training & Conflict Resolution 8. COSHH 9. RIDDOR Lee Peterson July An infection control policy must be put in place to clearly state what the arrangements are at the service. 9 (1) (n) Once certificate is received it will be forwarded to the H.I.W. An infection control policy was created to clearly state what the infection control arrangements before and after the treatment. The policy includes hand hygiene, cleaning treatment areas and equipment between patients. Lee Peterson Available

19 Page Number Improvement Needed / Standard Service Action Responsible Officer Timescale 10 Arrangements need to be made for all fire extinguishers to be serviced in-line with the dates stated on the servicing labels. 26 (2) (a) & (4) (a) Service has been completed and documents have been sent to the H.I.W. Lee Peterson Available 11 All policies and procedures specific to the laser service must be kept on the premises and available to all applicable staff. 9 (1) (d) (e) (f) (k) (n) & (5) (a) (b) & (6) (7) Policies and Procedures will be printed out and available to view in the shop upon request. Lee Peterson Available 11 All patient records must be stored securely. 23 (2) (a) All client s documents are stored in a lockable filing cabinet, access to these files can be seen by the client upon request. Lee Peterson Available Service Representative: Name (print):

20 Title: Date: