Delivering QIPP through NICE

To increase productivity and improve service quality by introducing an innovation in female sterilisation, supported by NICE interventional procedure guidance. 1. Reduced anaesthetic risk for the patient. 2. Reduced peri-operative risk of complications and adverse events resulting from peritoneal access. 3. Faster recovery for the patient. 4. No external scarring. 5. Reduce overall costs per case. 6. Create additional theatre capacity. 7. Compliance with NICE guidance.

Hysteroscopic female sterilisation is supported by NICE Interventional Procedure Guidance 315, issued on 23 September 2009. This procedure is a surgical and minimally invasive alternative to the current standard for permanent female sterilisation in England, which is a laparoscopic sterilisation by clipping of the fallopian tubes. This standard procedure is carried out under general anaesthetic in an operating theatre and incision(s) must be made through the abdominal wall to gain access into the abdominal cavity. The Collaborative Research group for tubal sterilisation elucidated that the 10 year failure probability is 18.5 pregnancies per 1000 procedures. In addition, the risk of complications from laparoscopic tubal sterilisation is 1.6% with an unintended laparotomy (i.e. conversion to open surgery) rate of 0.9% (Peterson et al, 1996). On the other hand hysteroscopic female sterilisation can be carried out in an outpatient treatment room under local anaesthetic, eliminating the risks and limitations to patient selection associated with general anaesthetic. No incision into the abdominal wall is required, avoiding scarring and permitting faster recovery. In 2009, all of the Trust's female surgical sterilisations (n=125) were carried out laparoscopically. 2% of these patients had an overnight stay and the procedures were carried out in the main general theatres because of limited day case capacity. At that time, some of the local gynaecology surgery was being carried out off site at Bodmin Hospital, part of the Cornwall Partnership NHS Trust and plans were agreed to bring this activity back to the Trust with no planned expansion. It was therefore critical for the gynaecology service to increase productivity within existing capacity. The gynaecology team were therefore keen to add hysteroscopic female sterilisation to their range of interventional hyteroscopy procedures already carried out in the Lancaster Suite and release some theatre time.

Building onto the existing expertise of the team in interventional hysteroscopy in outpatients, specialised procedure training was provided with support from other centres of expertise, such as Birmingham Women's NHS Foundation Trust. The hysteroscopic sterilisation procedure requires a disposable device kit containing implants and cannulators. All other equipment and disposable requirements are standard for an outpatient hysteroscopy suite. In our experience the procedure is well tolerated by the majority of patients without any local anaesthetic. It was necessary to adjust job plans and timetables in order to transfer activity between settings without increasing overall staff ratios. This was achieved using effective stakeholder engagement and consensus building. The device costs associated with the new procedure are much higher than for the lap. steri. but these are more than offset by the reduction in resource costs associated with shorter procedure time, reduced anaesthetic costs and the use of a less intensive setting. A financial impact model was used to predict a reduction in procedure cost in the order of £150 per case. It was proposed to use the theatre and bed capacity generated to accommodate the activity transferred from Bodmin Hospital. One major concern was the PbR tariff. The procedure was coded as OPCS Q35.8 (other specified endoscopic bilateral occlusion of fallopian tubes) which maps to HRG code MA10Z. In 2009 the day surgery tariff was £850 for both a lap. and a hysteroscopic sterilisation, regardless of setting of care. In April 2010, a mandatory outpatient procedure tariff was introduced at £274, whilst the day case rate remained much higher. It became clear that the Trust would lose income by treating and coding these patients in outpatients. This problem was overcome by transferring patients from theatres to a dedicated day suite, designed to be less intensive and run at lower cost.

In 2010/11 23 patients have had hysteroscopic sterilisations under local anaesthetic on the Lancaster Suite. An audit confirmed that there has been a corresponding reduction in laparoscopic sterilisations carried out in main theatres. In 2011/12, we plan to carry out around 50 of the new procedures, with further corresponding reductions in main theatres. However, this increase will need to be supported by additional nursing time, since staff are currently utilised to full capacity. Patients are tolerating the procedure well. At the three month check, tubal patency has been confirmed although a few patients have been referred on for an HSG as the plain abdominal film has not been conclusive. We are hoping to provide this confirmation with an ultrasound scan in the future. No major complications have occurred. We have had no repeat procedures or failed insertions. Although the guidance was implemented only part way through the 2010/11 financial year, there is clear evidence that objectives have been achieved and that implementing the guidance has contributed to the delivery of the NHS QUIPP agenda and to enabling the extra activity from Bodmin Hospital to be absorbed.

Although the technology to support outpatient hysteroscopic sterilisation has been around for some time and is supported by NICE guidance, many Trusts have been slow to adopt the procedure. In 2009/10 more than 11,600 NHS laparoscopic sterilisation procedures were carried out in England, compared to less than 700 hysteroscopic sterilisations . Significant progress can be achieved in improving women's services across the NHS, by sharing and basing continuous improvement on the successes and lessons learned from recent pilot and the early trailblazing centres. The risks and disincentives created by current PbR rules in relation to outpatient hysteroscopy procedures have been raised with the PbR development team by the British Association of Gynaecology Endoscopists, Chaired by one of this Trust's Consultants. From April 2011 a new code has been designated for hysteroscopic sterilisation: OPCS 4.6 Q35.4 (endoscopic bilateral placement of intrafallopian implants). Discussions are already underway to create a best practice tariff for hysteroscopic sterilisation in 2012/13. Based on our own cost estimates, a fair tariff would need to be around £500 higher than the proposed 2011/12 outpatient procedure tariff. This would reinstate the incentive for Trusts to support their gynaecologists to innovate practice; increase productivity; and improve quality and compliance with NICE guidance. In the interim, it is in the interests of patients and the NHS for PCTs to engage with local hospital Trusts in agreements on top up tariffs for those procedures supported by NICE, in situations where financial disincentives are currently stifling innovation.