Archived: Polmedics Limited - West Bromwich

We carried out an announced inspection on 10 February 2017 of Polmedics Ltd (the provider) at their administrative head office located at 36 Regent Place, Rugby CV21 2PN. (We were informed by the provider that all governance and management systems in place were located at this address in Rugby and not the provider address registered with the Commission which is located in Wellingborough. We obtained verbal and written consent from the provider to carry out this inspection at their administrative head office in Rugby).

At the same time, we also carried out unannounced focused inspections of Polmedics Limited – Bristol and Polmedics Limited - Wellingborough on 10 February 2017.

These inspections were carried out due to concerns raised following a series of inspections carried out at Polmedics Limited - Allison Street, Birmingham on 9 & 30 November 2016, Polmedics Limited - West Bromwich on 16 December 2016 and Polmedics Limited - Rugby on 17 December 2016 identifying serious concerns linked to the provider’s lack of governance and infrastructure arrangements.

We inspected the provider to assess their governance and leadership arrangements in respect of these concerns, therefore it was not necessary to use all key lines of enquiry.

Our findings were:

Are services safe?

We found that the provider was not providing safe care in accordance with the relevant regulations. We have told the provider to take action (see full details of this action in the Enforcement section at the end of this report).

Are services effective?

We found that the provider was not providing effective care in accordance with the relevant regulations. We have told the provider to take action (see full details of this action in the Enforcement section at the end of this report).

Are services well-led?

We found that the provider was not providing well-led care in accordance with the relevant regulations. We have told the provider to take action (see full details of this action in the Enforcement section at the end of this report).

Background

We carried out this inspection under Section 60 of the Health and Social Care Act 2008 as part of our regulatory functions. This inspection was planned to check whether the provider was meeting the legal requirements and regulations associated with the Health and Social Care Act 2008.

Polmedics Ltd was established in 2013 and is an independent provider of dental and medical services including gynaecology, sexual health screening and other services such as consultation services which includes the diagnosis and treatment of disease and prescribing of medicines. Consultation services are provided by doctors who are referred to as internists and treats both adults and children. (At the time of our inspection, the provider confirmed that all medical services had been suspended voluntarily based on concerns found during the Commission’s inspections of three other locations during November and December 2016. It was the intention of the provider to recommence the provision of medical services in the near future).

Services are provided across seven locations in Birmingham, Bristol, Ealing, Redditch, Rugby, West Bromwich and Wellingborough primarily but not restricted to Polish patients who reside in the United Kingdom (UK). Services are available to people on a pre-bookable appointment basis and we were informed during our inspection that patients book appointments by contacting a call centre located in Poland. The provider advertise a variety of other additional services on their website such as cardiology, dermatology, midwifery, psychiatry, paediatric and orthopaedic services however, we were advised prior to our inspection that these additional services are no longer provided. The range of services advertised on the providers website differs at each location. We were informed by the provider that there are approximately 33,000 registered patients across all Polmedics Ltd locations.

Polmedics Ltd (the provider) is registered with the Care Quality Commission to provide the regulated activities of diagnostic and screening procedures, family planning, maternity and midwifery services, surgical procedures and treatment of disease, disorder or injury.

The provider had not ensured that a registered manager was in place at each location. (A registered manager is a person who is registered with the Care Quality Commission to manage the service. Like registered providers, they are ‘registered persons’. Registered persons have legal responsibility for meeting the requirements in the Health and Social Care Act 2008 and associated Regulations about how the service is run). At the time of our inspection, one of seven locations had a registered manager in place, registered manager applications were in progress for five locations.

We were told that the provider had made recent changes to staffing levels and confirmed that 50 members of staff were employed across all locations. The staffing structure included three directors (one director acted as company secretary and one director who is a dentist acted as medical director). We were told that recent changes had taken place within the board of directors, there were previously four directors in post however, we were verbally informed that one director was dismissed by the provider due to a referral being carried out to the General Dental Council (GDC) we were unable to see any documented evidence of the dismissal process followed during our inspection. Each director has a specific area of responsibility such as premises and maintenance management, appointments system and scheduling, IT and recruitment. The provider employed one nominated individual who carried out the role of operational manager to oversee the management of all seven locations. There is a finance and human resources department which we were informed is located on the ground floor of Polmedics - Allison Street, Birmingham consisting of four members of staff. We were informed of seven managers being in post, one at each location (some managers were still awaiting commencement of their post dependent upon either a DBS check being received or confirmation as a CQC registered manager being received). The provider also employed a number of dentists, trainee dental nurses and receptionists across all locations. Some clinicians including dentists working in the locations live in Poland and travel to England on a regular basis to carry out shifts at each location.

Our key findings were:

• There was an ineffective, governance framework in place to support the delivery of the strategy and good quality care. There was a lack of effective systems and processes in place for identifying, assessing and monitoring risks and the quality of the service provision across all locations.
• There was an ineffective leadership structure in place, there was a lack of suitably trained and experienced management support in place on a daily basis at each location and there was a lack of clinical leadership and oversight at both location and provider level.
• There was no process for ensuring that the board of directors were fit and proper persons to manage the service. This is a duty required by the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014. Key documentation on the recruitment of individuals was missing from personnel files.
• The provider had not ensured that a registered manager was in place at each location. It is a requirement of registration with the Care Quality Commission where regulated activities are provided to have a registered manager in place.
• There was a lack of identification of risks and ineffective risk management processes in place at location and provider level to mitigate these through effective risk registers or appropriate discussion and acknowledgement of risk where highlighted by internal staff.

• The professional registration of clinical staff working at all locations were not all routinely checked at employment. The provider did not ensure that a system was in place within the organisation to ensure professional registration was routinely checked on an ongoing basis.
• The provider did not have an effective system or process within the organisation to ensure appropriate checks of current medical indemnity insurance had been carried out on all clinicians upon commencement of employment.
• There was not effective governance or monitoring processes in place to ensure that children and young people were safeguarded from abuse and improper treatment. The provider had not ensured a safeguarding lead was in place for each location. There was no policy in place in relation to female genital mutilation (FGM) and child sexual exploitation.
• There was poor quality monitoring of services in areas such as consent with clinicians having limited knowledge and understanding and not adhering to national guidance.
• The provider did not hold formal, structured, minuted meetings at either provider or location level. Meetings were either held informally or were ad-hoc. Staff we spoke with told us meetings at location level were not recorded.
• There was not an effective system in place for the reporting and investigation of incidents or lessons learned as a result. The provider did not have a process in place to ensure oversight of the reporting, recording and investigation of any incidents or significant events which may have either occurred or been reported across all locations.
• The provider had not ensured adequate arrangements were in place across all locations to respond to emergencies and major incidents as the provider had not acted upon all previous concerns raised in a timely manner during location inspections carried out during November and December 2016.

We identified regulations that were not being met and the provider must:

• Ensure an effective governance and leadership framework is in place to monitor the services provided and reduce the risk of harm.
• Ensure effective systems and processes are in place for identifying, assessing and monitoring risks and the quality of the service provision across all locations such as implementing a system of clinical audits and a system of clinical supervision/mentorship and clinical oversight for all clinical staff including trainee dental nurses. Ensure all clinical staff are competent to ensure the safety of patients using the service.
• Ensure appropriate systems are in place to properly assess and mitigate against risks including risks associated with infection prevention and control, legionella, managing emergency situations and premises and equipment.
• Ensure a review is undertaken of chaperone arrangements and that chaperone training is undertaken by staff who perform chaperone duties.

• Ensure arrangements to safeguard children and vulnerable adults from abuse reflect relevant legislation and local requirements.

• Ensure effective processes for timely reporting, recording, acting on and monitoring of significant events, incidents and near misses are in place across all locations.
• Ensure an effective process is in place to monitor patient care records so that patient information is recorded in line with the ‘Records Management Code of Practice for Health and Social Care 2016.
• Ensure the practice's recruitment policy and procedures are suitable and the recruitment arrangements are in line with Schedule 3 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, with necessary employment checks are in place for all staff and the required specified information in respect of persons employed by the provider is held.
• Ensure a registered manager is in place at each location. (It is a requirement of registration with the Care Quality Commission where regulated activities are provided to have a registered manager in place).
• Review processes in place in relation to clinicians medical indemnity insurance to show that appropriate checks of clinicians own insurance is carried out prior to commencement of employment.
• Ensure that staff taking consent have the appropriate knowledge, skills and competence. Ensure consent is sought from adults and children including those that are vulnerable in line with legislation and guidance.

There were areas where the provider could make improvements and should:

• Ensure a system of appraisals is in place so all members of staff across the organisation receive an appraisal at least annually.

• Ensure appropriate policies and procedures are implemented, relevant to the organisation so all staff are aware of and understand them.

Enforcement action was taken against the provider on the 15 February 2017, when we issued an urgent notice of decision to immediately suspend their registration as a service provider (in respect of all regulated activities for which they are registered) for a period of six months. We took this action because we believed that a person would or might be exposed to the risk of harm if we did not take this action.

We carried out an unannounced focussed inspection on 16 December 2016 of Polmedics Limited - West Bromwich. This inspection was carried out because we had concerns in relation to the safety and overall governance of services provided at Polmedics Limited – West Bromwich following an inspection carried out at Polmedics Limited – Allison Street in Birmingham on 9 and 30 November 2016 where serious concerns were found.

Our findings were:

Are services safe?

We found that this service was not providing safe care in accordance with the relevant regulations. We have told the provider to take action (see full details of this action in the Enforcement section at the end of this report).

Are services effective?

We found that this service was not providing effective care in accordance with the relevant regulations. We have told the provider to take action (see full details of this action in the Enforcement section at the end of this report).

Are services responsive?

We found that this service was not providing responsive care in accordance with the relevant regulations. We have told the provider to take action (see full details of this action in the Enforcement section at the end of this report).

Are services well-led?

We found that this service was not providing well-led care in accordance with the relevant regulations. We have told the provider to take action (see full details of this action in the Enforcement section at the end of this report).

Background

We carried out this inspection under Section 60 of the Health and Social Care Act 2008 as part of our regulatory functions. This inspection was planned to check whether the practice was meeting the legal requirements and regulations associated with the Health and Social Care Act 2008.

Polmedics Limited - West Bromwich is an independent provider of dental and gynaecology services and also provides consultation services by a doctor who is referred to as an internist and treats both adults and children. This doctor provides consultation services including the prescribing of medicines and antibiotics to both adults and children. Services are provided primarily to polish patients who reside in the United Kingdom (UK). Services are available to people on a pre-bookable appointment basis. Although we were informed by the provider that only dental and internist services were provided, we also found evidence that a psychotherapist provided consultations at this location.

The practice is located in a busy commercial area of West Bromwich in the West Midlands and is located on the first floor of a converted, commercial property. The property is leased by the provider and consists of a large patient waiting room which includes a reception desk, a decontamination room used for cleaning, sterilising and packing dental instruments, two dental treatment rooms and one medical consulting room used by a doctor. The practice is not accessible to wheelchair users, prams and patients with limited mobility. Car parking was available in the vicinity of the practice.

The provider which is Polmedics Ltd is registered with the Care Quality Commission to provide the regulated activities of diagnostic and screening procedures, maternity and midwifery services, surgical procedures and treatment of disease, disorder or injury from seven locations including Polmedics Limited - West Bromwich.

The practice holds a list of registered patients and offers services to patients who reside in West Bromwich and surrounding areas but also to patients who live in other areas of the UK who require their services. The provider provides regulated activities from seven different locations. We were informed by the provider that there are approximately 33,000 registered patients across all Polmedics Ltd locations.

The provider had not ensured that a registered manager was in place. (A registered manager is a person who is registered with the Care Quality Commission to manage the service. Like registered providers, they are ‘registered persons’. Registered persons have legal responsibility for meeting the requirements in the Health and Social Care Act 2008 and associated Regulations about how the service is run).

We were told that the practice employed five dentists, two gynaecologists, two receptionist/trainee dental nurses, one receptionist and one doctor who they referred to as an internist. A psychotherapist also provided services to patients at this practice. During our inspection, we were introduced to a trainee practice manager whom the provider had informed us was already in post however, during our inspection we were informed that this person had not yet ceased employment with their current employer and was not in fact in post. It was the intention of the provider that this manager would also apply to become the registered manager with the Commission. Staff were supported by an operational manager who was located at a different location. Some clinicians including dentists working in the practice live in Poland and travel to England on a regular basis to carry out shifts at Polmedics Limited – West Bromwich.

The practice provides appointment from 9am until 9pm Monday to Sunday. We were informed that the practice may close at short notice if there is no demand for appointments.

The provider is not required to offer an out of hours service. Patients who need emergency medical assistance out of corporate operating hours are requested to seek assistance from alternative services such as the NHS 111 telephone service or accident and emergency. This is detailed on the practice website.

Our key findings were:

• The practice had limited formal governance arrangements in place. The practice did not have an effective, documented business plan in place. Patient outcomes were hard to identify as little or no reference was made to audits or quality improvement.
• The provider had not ensured that adequate medical indemnity insurance was in place or that appropriate checks of current insurance had been carried out on all clinicians upon commencement of employment.
• Paper based, hand written, patient care records were written mainly in Polish, some records written by individual dentists and doctors were either illegible, not appropriately signed and did not always contain full and detailed information in relation to the consultation.
• Blank private prescriptions and medical statements (Med3 forms) were left unsecure, on a desk in an unlocked room, these prescriptions and forms had been pre-stamped with the name and GMC number of a doctor. Confidential clinical patient information was found unsecure on a desk in an unlocked room.
• The practice held medicines and life-saving equipment for dealing with medical emergencies in a primary care setting, although there were some gaps with respect to the recommended emergency medicines and equipment. The practice did not have emergency medicines or equipment in line with the British National Formulary (BNF) and Resuscitation Council UK guidance or all that were recommended for medical emergencies in dental practice. Not all staff we spoke with were aware of the location of emergency medicines and equipment.
• Arrangements to safeguard children and vulnerable adults from abuse did not reflect relevant legislation and local requirements. There was no assurance that all members of staff had completed up to date safeguarding training.
• There was not an effective system in place for the reporting and investigation of incidents or lessons learned as a result.
• The practice did not hold regular, formal multi-disciplinary or team meetings, meetings that did take place were ad-hoc and were not minuted.
• There was no formal process in place to ensure all members of staff received an appraisal. A doctor did not have a responsible officer in place.
• We were not assured that staff were supported by the provider in their continued professional development (CPD). A doctor had not completed any CPD for approximately ten years.
• There was no evidence of formal clinical supervision, mentorship and support in place for all members of staff including trainee dental nurses.
• Information about services and how to complain was available and easy to understand. Complaints were fully investigated and patients responded to with an apology and full explanation.
• Not all risks to patients were assessed and well managed. The practice did not always maintain appropriate standards of cleanliness and hygiene. Infection control procedures did not follow guidance issued by the Department of Health - Health Technical Memorandum 01-05: Decontamination in primary care dental practices.
• The dental treatment room was visibly clean and well maintained.
• There was very limited evidence that staff had received training appropriate to their roles, including update training in infection control and safeguarding.
• There was no evidence that the practice had implemented actions recommended from the critical examination test carried out in October 2013 for x-ray equipment.
• The practice did not have an effective process in place to ensure patients were informed of their pathology results including those that were urgent or positive in a timely way.

• The practice had a number of policies and procedures in place to govern activity, but some of these required updating.
• The provider had not ensured that a registered manager was in place. It is a requirement of registration with the Care Quality Commission where regulated activities are provided to have a registered manager in place.

We identified regulations that were not being met and the provider must:

• Ensure the practice's recruitment policy and procedures are suitable and the recruitment arrangements are in line with Schedule 3 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, to ensure necessary employment checks are in place for all staff and the required specified information in respect of persons employed by the practice is held.
• Ensure that a system is in place to ensure all clinicians have adequate medical indemnity insurance in place and that appropriate checks of clinicians own insurance is carried out upon commencement of employment.
• Ensure all staff complete all essential training requirements and that a system for collating the records of training, learning and development needs of staff members is established.
• Ensure there is effective clinical leadership in place and a system of clinical supervision/mentorship for all clinical staff.
• Ensure the safe storage and security of patient information, private prescriptions and medical statements.
• Ensure effective governance arrangements are in place in relation to information governance including systems to monitor patient care records to ensure that patient information is recorded in line with the ‘Records Management Code of Practice for Health and Social Care 2016. Ensure that an accurate, complete and contemporaneous record is maintained for every patient.
• Ensure dental care records are maintained appropriately giving due regard to guidance provided by the Faculty of General Dental Practice and the General Dental Council regarding clinical examinations and record keeping.
• Ensure audits of radiography are undertaken at regular intervals to help improve the quality of service.
• Ensure that the practice is in compliance with its legal obligations under Ionising Radiation Regulations (IRR) 99 and Ionising Radiation (Medical Exposure) Regulation (IRMER) 2000.
• Ensure that patient safety alerts (including MHRA) are received by the practice, and then actioned if relevant. Put systems in place to ensure all doctors are kept up to date with national guidance and guidelines.
• Ensure that there are appropriate systems in place to properly assess and mitigate against risks including risks associated with infection prevention and control and emergency situations and legionella. Review the availability of a mercury spillage and bodily fluids spillage kit. Review procedures to ensure compliance with the practice annual statement in relation to infection prevention control required under The Health and Social Care Act 2008: ‘Code of Practice about the prevention and control of infections and related guidance.
• Ensure a record is held of Hepatitis B status for clinical members of staff who have direct contact with patients’ blood for example through contact with sharps.
• Ensure a review is undertaken of the availability of medicines, staff training and equipment to manage medical emergencies giving due regard to guidelines issued by the Resuscitation Council (UK), and the General Dental Council (GDC) standards for the dental team. Specifically ensuring the availability of buccal Midazolam for dealing with epileptic seizures, availability of glucagon, a volumetric spacer for use with the recommended inhaler and child chest pads for the automated external defibrillator.
• Ensure a review is undertaken of chaperone arrangements and the policy for ensuring chaperones are available and that chaperone training is undertaken by staff who perform chaperone duties.
• Ensure a review is undertaken for the process of informing patients of pathology results including those that are urgent or positive, ensuring results are given to patients in a timely way.

There were areas where the provider could make improvements and should:

• Review processes for ensuring fees are explained to patients prior to the procedure to enable patients to make informed decisions about their care.
• Review the availability of hearing loops for patients who are hard of hearing.
• Review the practice’s infection control procedures and protocols giving due regard to guidelines issued by the Department of Health - Health Technical Memorandum 01-05: Decontamination in primary care dental practices and The Health and Social Care Act 2008: ‘Code of Practice about the prevention and control of infections and related guidance. The practice should also review the frequency of protein testing associated with the ultrasonic cleaning bath in line with HTM 01 05 guidelines so that these are carried out weekly rather than monthly.
• Ensure a system of appraisals is in place to ensure all members of staff receive an appraisal at least annually.
• Ensure appropriate policies and procedures are implemented, relevant to the practice ensuring all staff are aware of and understand them.
• Review the provision of translation services for service users and members of staff.
• Review processes for collecting and acting upon patient and staff feedback.

On the 19 December 2016, the provider took actions to temporarily close all Polmedics Ltd locations which included Polmedics Limited – West Bromwich until 31 January 2017.