One to One (North West) Limited is a private community based maternity service that provides antenatal, intrapartum and postnatal care to expectant mothers. The service is based in the Bidston and St James Children’s centre. The service was set up in 2011. The company aims to provide a single midwife to support expectant mothers aged 14 years and older through antenatal care, birth and postnatal care. Midwives working for the company were allowed to go into NHS hospitals to act as advocates or support if the woman chose a hospital birth. One to one midwives were not allowed to deliver babies in NHS hospitals but they could stay with women on their case load if the woman made this request. The midwives employed by the trust were responsible for all maternity care once a woman was admitted to hospital.

This service was previously inspected on 13 April 2015 as part of an unannounced focused inspection and we found that there were concerns related to medicines management, the use of Cardiotocography (CTGs) in a community setting and the management of risk and governance. At that inspection we were not given the assurance that risk was being managed effectively across the organisation to provide a safe environment for high risk pregnancies. At that inspection we also found no evidence of joint pathways in place with local providers and agreed processes for flagging up or considering additional needs of the mother were not in place. We asked the provider to make improvements in these areas.

We carried out a further comprehensive inspection on the 30 November and 1 December 2015. We have not published a rating for this service. CQC does not currently have a legal duty to award ratings for those services that provide solely or mainly community maternity services.

We found that incidents were not being reported to CQC under the statutory notifications’ regulation.  The incidents the staff were required to report to CQC was limited to “serious incidents which has potential to threaten registration status”. The clinical incident policy did not require staff to report clinical incidents to CQC. Regulation 18 of the CQC (Registration) Regulations 2009 requires providers to notify CQC of certain defined incidents. This would include incidents of patients experiencing prolonged pain or prolonged psychological harm or certain types of injury to a service user.

The North West service reported 788 births during this period and reported one intrauterine death, one intrapartum death and one neonatal death which involved joint care with an NHS trust. Two serious incidents were reported to the Care Quality Commission between April 2015 and December 2015. Our records indicated that the CCG informed the Care Quality Commission about two of these occurrences. We had to seek additional information from the One to One services. This meant the service was fulfilling their obligation to provide CQC with notifications of incidents required under the Act.

Staff we spoke to was confident in the use of the incident reporting systems; however, they were unclear about the breadth of events that should be reported. Staff said they were given feedback from their manager about the incidents they reported.

Managers responsible for running the service undertook the root cause analysis (RCA) of incidents and feedback from incidents was provided. Staff directly involved in incidents received individual feedback and any lessons learned were disseminated throughout the organisation in order to improve the care delivered to women and babies.

Action had been taken to provide the appropriate skill mix of midwifery staff for low risk pregnancies throughout pregnancy. This included changing the notice period for permanent midwives who wanted to leave the service. This was to ensure a handover period during which new recruits could become confident in carrying out their roles.

The provider did not present evidence of specific training about underlying conditions which made a pregnancy high risk. As midwives did not encounter these conditions very often they accessed best practice guidance available at the time the information was needed.

Birth records indicated that midwives took the correct actions during labour and used their skills to deal with complications during childbirth such as shoulder dystocia. This is when women need extra help to allow the shoulders of the baby to be born.

Concerns remained about how well high risk pregnancies were monitored during pregnancy because staff stated they had not received specialist training to support women with underlying conditions such as epilepsy and diabetes. Concerns were also raised about action taken for women who may develop unforeseen complications who then refused to seek medical intervention and/or hospital support when midwives identified that this was needed.

Schedule 2 Controlled Drugs were no longer used by the service and women were well informed about the pain relief the service could provide.

Processes were established to ensure medication was appropriately stored and accounted for.

There were plentiful stocks of personal protective equipment, such as disposable gloves and aprons.

Midwives carried hand gel for use when hand washing facilities were not available.

Midwives held a maximum caseload of 32 women.

Risks within the organisation were identified and included safeguarding training rates for midwives, potential gaps in the handover process between midwives when the lead midwife was unavailable and; women who chose to deviate from NICE guidance who also had complex needs with a risk of overall poor outcomes. A gap in integrated working with other providers was also identified as a risk.

The service continued to work with partner agencies to develop single care pathways for women who would opt for joint care with One to One North West Ltd and the acute trust obstetrician-led service.

The service needed to develop clear pathways for women with high risk pregnancies who refused to accept care based on best practice guidance.

We visited the One to One North West office and clinic at the Bidston and St James children centre and the Warrington Pregnancy Advice Centre in the Golden Square shopping centre.

We carried out 10 telephone interviews with midwives chosen at random and a number midwives attended a focus group. We interviewed two locality co-ordinators and met three midwives working at the pregnancy advice centre. Three women who used the service were interviewed face to face and seven were interviewed over the telephone.

One to One (North West) Limited is a private community based maternity service that provides antenatal, intrapartum and postnatal care to women. The service is based in the Bidston and St James Children’s centre.

The service was set up in 2011.The company provides a single midwife to see women through antenatal care, birth and postnatal care. Midwives working for the company are allowed to go into NHS hospitals to act as advocates or support if the woman chooses a hospital birth.

We carried out an unannounced focussed inspection on 13 April 2015.This was due to a number of concerns raised about the care of women at the service and to follow up the compliance actions issued at our previous inspection in September 2014.

The main areas of concern found were the way medicines were managed and operating outside of the widest accepted view of normal midwifery scope of practice re Cardiotography (CTGs). Cardiotography is a method of monitoring and recording fetal heart rate and uterine contractions during pregnancy and labour, allowing for assessment of fetal response and well-being. It is usually used in hospital where medical staff are available to review the recording. CTG is not recommended for low risk labour (NICE Intrapartum Guidelines, 2014).

Overall the provider showed some improvement in governance since our last inspection. However there was a continued issue re the management of governance in the organisation. We were not given the assurance that risk was being managed effectively across the organisation to provide a safe environment for mothers and unborn babies.

Our key findings were as follows:

Incidents

• There had been six maternity incidents reported through the local NHS Commissioning reporting system for 2013/2014 averaging over 1500 births.
• Staff were confident in the use of the incident reporting systems for the reporting of adverse clinical incidents, but told us they were less likely to report non- clinical incidents such as access to staff. Staff were reporting incidents and feedback.
• Managers responsible for the running of the service undertook the root cause analysis (RCA) of incidents.
• Feedback from incidents was found to be good. Staff directly involved in incidents received individual feedback and any lessons learned were disseminated throughout the organisation in order to improve the care delivered to women and babies. The Local Supervising Authority (LSA) expressed concerns that the number of junior staff grades would require a lot of support to carry out their job role particularly as they all worked predominantly in isolation. This was of particular concern for women who may develop unforeseen complications who then refuse when advised by the midwife to seek medical intervention and/or hospital support.

Medicines

• Schedule 2 Controlled Drugs were being supplied to midwives from Bidston and St James’s Children’s Centre without the appropriate Home Office licence. We brought this to the attention of the provider following our inspection and this practice has now ceased.
• Midwives stored some medicines, including medical gases, in their homes when not on duty. With the exception of Controlled Drugs, the standard operating procedures for the management of medicines did not contain any information on how any risks associated with the storage of these medicines were to be managed.
• The standard operating procedures for the management of medicines did not contain satisfactory information regarding how the risks associated with the transport of medicines by midwives, including Controlled Drugs, were to be managed.

Cleanliness, infection control and hygiene

• There were plentiful stocks of personal protective equipment, such as disposable gloves and aprons. Midwives carried hand gel for use when hand washing facilities were not available.

Midwifery staffing

• There were approximately 50 midwives employed at One to One at the time of our inspection. Due to nature of the way the service was provided there was a lack of comparable data with which to determine whether the midwifery establishment was sufficient for the numbers of women booked under their care.
• Midwives without additional duties held a maximum caseload of 40 women. None of the midwives we spoke with held the maximum number of women on their caseloads at the time of our inspection.
• We found examples of staff reporting that they did not always have a second midwife. One example given was that they would not always contact their buddy in the middle of the night. This did not assure us that access to support for women was available in a timely manner.

Governance, risk management and quality measurement

• A quality dashboard had been developed and was being used to monitor performance and quality against a range of targets. We were not assured by the data, monitoring and review of the dashboard to maintain an effective monitoring process. For example when looking at the minutes of the monthly quality monitoring meeting we saw no reference that the quality dashboard had been referred to.
• Risks within the organisation were not always identified and those which had been identified were not always managed effectively. This included risks where actions had been completed which should have been closed on the risk register. This had not always been done. We were not assured that the provider was managing risk appropriately and safely in line with their statement of purpose.
• Although we saw comprehensive handover sheets we did not see any evidence of joint pathways in place with local trusts in order to manage the risks associated with the women’s journey. The provider told us they had made representations to other trusts to have pathways in place however this had not been actioned.
• We found that the provider may be operating outside of the widest accepted view of normal midwifery scope of practice re Cardiotography (CTGs).Cardiotography is a method of monitoring and recording fetal heart rate and uterine contractions during pregnancy and labour, allowing for assessment of fetal response and well-being. It is usually used in hospital where medical staff are available to review the recording. CTG monitoring is not recommended for women experiencing low risk labour (NICE Intrapartum Guidelines, 2014).

Culture within the service

• Midwives expressed concern that although they were satisfied with the current model of working, this may not be sustainable in the longer term. Although they had at least one guaranteed day off per week, they told us that the requirement for them to be responsive to the needs of women on their caseload 24 hours per day had an impact on their family lives.

There were some areas of poor practice where the provider needs to make improvements.

Importantly the provider must:

• The provider must ensure that Schedule 2 Controlled Drugs being supplied to midwives from Bidston and St James’s Children’s Centre with the appropriate Home Office licence.
• The provider must have processes and policies are in place to ensure the proper and safe use of medicines in the service.
• The provider must review its practices to ensure that it is working within the widest accepted view of normal midwifery scope of practice such as the use of Cardiotography (CTGs).
• The provider must take steps to ensure a robust system is in place for good governance.
• The provider must ensure that is clearly identifies risks and they are managed effectively and safely.

In addition the provider should:

• The provider should review the access to a second midwife to ensure that support for women is available in a timely manner.
• The provider should work closely with partners such as the LSA Midwifery Officer with regard to the number of practice reviews and supervisory investigations and practice reviews that are being triggered.
• The provider should ensure they follow best practice in regards to independent review of serious incidents.
• Ensure all newly qualified midwives receive support and supervision as per their perceptorship guidance, taking into account the lone working and model of care at one to one.
• The provider should continue to ensure the interface between risk, governance and supervision remains robust and that Managers take the lead on feeding back ‘lessons learned’ to midwives and staff.
• The provider should review its processes for providing appropriate medical support when women choose to remain at home when advised by the midwife to the contrary.

Professor Sir Mike Richards, Chief Inspector of Hospitals

We spoke with five women who used the service. The feedback we received was unreservedly positive about their experience at One to One. One person told us: "I could not praise them enough."

Other comments included:

"The care was excellent I was a high risk pregnancy and they supported me fully with all the options clearly explained."

"They fitted my appointments around my work."

"The midwives were excellent...I was very well informed."

"They were absolutely fantastic."

Women felt that they had been fully involved in the decisions about their care and that the service had been provided around their needs. We found that care was based on best practice and treatment was planned and delivered to take account of individual needs.

We found there were suitable systems in place to safeguard people who used the service. Staff were trained and supported to carry out their roles and responsibilities. We found that systems were in place to ensure cooperation with other providers. Improvements were required to ensure that the systems in place to assess and monitor quality were effectively managed.

Bidston and St James Children’s Centre is operated by One to One (North West) Limited. The North West registered location is situated in the Bidston and St James Children’s Centre, Birkenhead.

There are also three-satellite community Hubs or Patient Advisory Centre’s (PAC), situated in Crewe, Warrington and Ellesmere Port.

The service provides maternity care.

We inspected this service using our comprehensive inspection methodology. We carried out the inspection on 16 and 17 January 2017. We interviewed 25 members of staff and four service users.

To get to the heart of women’s’ experiences of care and treatment, we ask the same five questions of all services: are they safe, effective, caring, responsive to people's needs, and well-led? Where we have a legal duty to do so we rate services’ performance against each key question as outstanding, good, requires improvement or inadequate.

Throughout the inspection, we took account of what people told us and how the provider understood and complied with the Mental Capacity Act 2005.

Strategy for the service was underpinned by the service five core values: excellence, safety, women centred, integrity and professionalism. These also underpinned midwifery practice and organisational systems.

An established leadership team, were both visible and accessible in the North West service. Staff, we interviewed as part of the inspection, were positive about the visibility and support from senior team. In addition, there were regular opportunities for midwives to meet with their line managers to discuss cases related to risks and suitable plans of care.

For long-term sustainability of the service, One to One envisaged the ongoing provision of the midwifery caseloading continuity of carer model. Caseload midwifery offers continuity of care by a primary midwife during the antenatal, intrapartum and postpartum periods.

We regulate and inspected this service but we do not currently rate single service providers. We highlighted good practice and issues that service providers need to improve and take regulatory action as necessary.

We found the following areas of good practice:

• There was risk assessment guidance in place and an escalation policy to ensure women received safe care. Risk assessments were reviewed regularly, and when there were any concerns about the health of the woman or her baby, referrals were made to other providers.

• The service had internal and one external supervisor of midwives (SoM) to support staff and women.

• Ninety eight percent of staff had completed safeguarding training in line with best practice guidance. Staff had an awareness of issues relating to domestic violence and female genital mutilation.

• Caseloads were planned based on midwife availability, staff experience and women’s complex care needs. The service monitored the number of women on its caseload to ensure there was sufficient staff to provide the level of care required.

• Care and treatment was provided in line with One to One policies and Practice Points (similar to standard operating procedures), which reflected guidance from the National Institute of Health and Care Excellence (NICE) and Royal Colleges.

• Women received education about choices for feeding their babies and they were supported by staff to feed their baby by their chosen method.

• Some staff had completed the NHS New born and Infant Physical Examination Programme (NIPE).

• Twenty-one of the 47 midwives were trained in hypnobirthing.

• One to One (North West) Limited worked closely with a number of external agencies and third party providers and were working towards improvements in communication to increase shared working pathways with other providers in an effective way.

• Staff were kind, caring and sensitive in the way they communicated. They spent time speaking with women, addressing any worries or concerns. Care was individualised and women valued the close relationships they built with the midwives.

• Staff took time to discuss previous birth experiences, worries, and fears about the current pregnancy. Women spoke very positively about the high level of emotional support provided and told us they felt confident and reassured by the support they were given.

• Staff spoke with women about their mental and physical well-being. They had access to formal assessment tools to use where there were concerns about depression or anxiety.

• Appointments were tailored around the needs of the women. Midwives provided care in the PACs and women’s homes.

• Staff had access to a telephone translation service if required.

• There was access to advice from a midwife 24 hours a day. Appointments could be arranged at mutually convenient times with women. Midwives were able to visit women on the same day if requested and considered necessary.

• Complaints were managed in a timely manner and communication with families were undertaken by telephone or a home visit and followed up with a letter addressing concerns with an action plan. We saw evidence of lessons learnt from complaints displayed.

• Quality of care, incidents, risks and lessons learnt were reviewed and discussed at regular meetings.

• There was a risk management policy in place that set out how risks should be monitored and mitigated and we saw examples of completed risk assessments.

• There was a positive, open and enthusiastic culture within the service. Staff were committed to provide the best service possible to their women.

• There was a vision and strategy for the service that had been developed by the registered manager.

• However, we also found the following issues that the service provider needs to improve:

• The service did not follow best practice guidance in relation to infection prevention and control.

• The environment was not always visibly clean.

• Clinical risk assessments were completed for women. These were documented well on the electronic records system but not always clearly or concisely in women’s handheld maternity notes.

• Electronic records were maintained to a high standard, however, these were not contemporaneous with the women’s handheld notes, which were difficult to follow, information was not clearly or concisely recorded and copies of screening results and hospital discharge letters were not filed in a timely manner.

• Staff supported women to make decisions and choices about their care and treatment. However, this was not always fully and concisely documented in the women’s handheld records.

• Seventy nine per cent of staff had received an annual appraisal. However, specific personal development objectives were set and discussed as part of the “consolidation” passport.

• Following this inspection, we told the provider that it must take some actions to comply with the regulations and that it should make other improvements, even though a regulation had not been breached, to help the service improve. We also issued the provider with five requirement notices that affected maternity and midwifery services. Details are at the end of the report.

Ellen Armistead

Deputy Chief Inspector of Hospitals North Region