Dear Mr Bricknell

Re: Jake Perry; Regulation 28 Report to Prevent Future Deaths

I write in response to your Regulation 28 Report issued to Birmingham Women’s and Children’s NHS Foundation Trust on 1 April 2020, following the inquest into the tragic death of Jake Perry. We would like to reiterate our sincere condolences to Jake’s family, who sadly have lost a very special young person. The matters of concern you raised in your Report refer to the variation of Parenteral Nutrition and communication of such. Specifically, you are concerned that secure procedures are required in connection with changes to Parenteral Nutrition and that consideration should be given to the production of a standard Parenteral Nutrition which is varied on specific instructions of the prescribing consultant. I will respond to each of your concerns in turn. You are aware that immediately following this incident, the Trust commissioned an investigation into the care and treatment we provided to Jake. Following the investigation of this incident a significant amount of work has been undertaken by the Trust to improve our own internal processes. We have ensured that national guidance such as that the best practice guidance on Homecare medicines, issued in 2011 and known as ‘the Hackett Report’1, has been put into practice. For ease of reference, the relevant sections within the report are reproduced below:

1 http://media.dh.gov.uk/network/121/files/2011/12/111201-Homecare-Medicines-Towards-a-Vision-for-the-Future2.pdf

Chief Medical Officer Executive Team Birmingham Women’s and Children’s NHSFT Steelhouse Lane Birmingham B4 6NH

5.15 Ensure governance arrangements in relation to patient safety state aspects of care for which the following are responsible
• Hospital
• Homecare Company
• GP
• Health professionals
• Patient
• Availability of backup advice and support

5.16 It should explain:
• How will the treatment plan be communicated to the patient, homecare company, GP other healthcare providers.
• How will the initial prescription and repeat prescriptions be produced, and who will check this prescription in the Trust before communicating to the home healthcare company.
• What level of clinical checking of the prescription and patient will the home healthcare company undertake.
• How will the clinical and laboratory monitoring be undertaken.
• What are the arrangements for patient safety incident reporting, performance monitoring and outcome monitoring? All these reports should be shared with the Trust and then the NRLS. The Trust should have a formal way of reviewing these reports and taking necessary action.

5.17 The home healthcare company should also provide to the Trust electronic copies of medicines policies, control of infection policies, and other policies impacting on patient safety and clinical effectiveness.

The Hackett Report was written generally, for all medicines delivered by homecare companies and not specifically for home Parenteral Nutrition. It has therefore taken some time to agree the details of such arrangements for this specialised area. There have been improvements at a national level, such as an agreed national template for the initial prescription and improved working with homecare suppliers to identify errors and learn from them. Improvements have also been made to the National framework. There is a national review being undertaken on the safety and resilience of aseptic services, including the production of home Parenteral Nutrition2. Birmingham Women’s and Children’s NHS Foundation Trust has submitted evidence to this review on various aspects of paediatric services including the lessons learnt directly from Jake’s case. As you are aware, we have reflected upon Jake’s sad and untimely death in detail and we have put measures in place in an attempt to prevent any recurrence of such an incident. In order to strengthen the measures we have put in place locally, the Trust considers that computerised prescription should be used throughout the ordering process of PN. However, unfortunately, the Trust is not in a position to effect such a change in the market; the requirement for a single format electronic prescription for PN would require a mandate by NHS England. PN is an intravenous medication, with more than 50 ingredients and additives, and as such is liable to medication errors, especially in paediatric patients where all the calculations are weight-based. Computerised prescription, whether standardised or bespoke to the individual patient, ought to be used in the ordering process of PN. We therefore consider that computer assisted prescribing software for PN should become readily available, as a standard for all units set out in the national Home PN Framework as these programs can save time, decrease prescription and compounding errors, and improve the quality of nutritional care. We have recommended a national standardised electronic prescribing system for Parenteral Nutrition as we noted that there needed to be improved communication between Trusts and suppliers, specifically with clarity on responsibilities. This issue was also highlighted within our RCA.

2 https://improvement.nhs.uk/resources/call-evidence-pharmacy-aseptic-services-review/

Furthermore, the Trust’s Chief Pharmacist has been asked by the Chief Pharmaceutical Officer of England to provide a synopsis of the lessons learnt in Jake’s case for pharmacy professionals nationally. There are mechanisms for sharing such learning through a number of networks including the All England Chief Pharmacists’ Network, Medication Safety Officer Network and through presentations at local and national professional meetings. The findings will also be shared with the National Homecare Medicines Committee who have input into the national framework for the procurement of homecare products. The national lead for outsourced medicines has advised the Trust on improvements following the incident involving Jake’s Parenteral Nutrition and will also receive a copy of the lessons learnt. In response to your concern regarding the production of a standard Parenteral Nutrition which is varied on specific instructions of the prescribing consultant, I have discussed this matter with Dr Protheroe and can respond as follows; There are two Parenteral Nutrition (PN) solutions available for use. Those are a) standard feeding regimens known as All-in-One (AIO) or multi-chamber bags (MCB) which contain all the required nutritional components, or b) individually compounded mixtures which are manufactured in a suitable pharmacy manufacturing unit and contain bespoke nutritional requirements for an individual patient. Commercially prepared mixtures of vitamins and minerals are available and will provide well-balanced amounts of all essential vitamins and trace elements. These mixtures must be added to individually compounded bags of PN or AIO bags under controlled aseptic pharmaceutical conditions. Standard PN bags are used for children and young people in hospital on a short term basis only. This is in order to reduce the risk of ordering errors, as well as the risk of compounding errors in the hospital pharmacy, which deals with many different PN prescriptions on a daily basis. These commercially batch-produced standardised PN bags require an addition of parenteral multi-vitamins shortly before infusion. This is a limitation that requires proper handling to assure aseptic conditions and to avoid errors and as a consequence is not an option available for home use. Moreover, the inclusion of various trace elements may shorten the shelf life of the standard bag. Regular use of standard formulations in infants and children requiring PN for prolonged periods (such as those on home PN particularly over longer periods of time), may be less than optimal for growth and development and as a result, these patients require bespoke formulations of PN, as was the case with Jake.i There are a number of reasons why a patient will require individualised PN; A] patients with chronic intestinal failure requiring long term home PN (HPN) B] particularly where parenteral nutrition is a supplement to oral intake and B] children and rapidly growing adolescents on HPN in order to meet their specific nutritional requirements. Jake fulfilled all of these three criteria and consequently was prescribed individualised PN.3 As you heard in evidence provided at Inquest, an adequate supply of micronutrients is essential for patients on PN to prevent clinical deterioration. Specific patient related requirements for parenteral vitamins, trace elements and minerals vary among patients depending on their clinical and metabolic status and the need to replace any losses or prevent toxicity. It is for this reason that long-term PN patients, who have their PN administered at home, require a bespoke formulation rather than a standard preparation.

3 https://www.bapen.org.uk/85-nutrition-support/parenteral-nutrition

I hope that this information serves to adequately address your concerns. Jake’s death has had a significant impact on staff caring for Jake and we are truly sorry for the errors in processes that led to Jake’s death. Once again, I would like to offer my sincere condolences to Jake’s family.

Dear Mr Bicknell Re: Jake Thomas Perry Thank you for granting me a 14-day extension to allow me to respond to your regulation 28 report to prevent future deaths with regard to Jake Perry. I am sorry that the current situation with regard to Coronavirus has delayed this important communication. From the outset, I would like to extend my deepest sympathies to Jake’s parents and family. Jake suffered from a rare gastrointestinal disease, which rendered it necessary for him to receive nutrition through an artificial feeding line. He was under the care of the gastroenterology team at Birmingham Children’s Hospital and the children’s community nursing team in Hereford. He had direct access to the children’s ward in Hereford. On Saturday 15 July, he attended the children’s ward at Wye Valley Trust because he had been unwell with vomiting and constipation. Jake suffered these type of episodes quite often but usually managed to cope with them at home. In addition, he complained of increasing weakness of his legs. After examination, an initial diagnosis of Guillain Barre Syndrome was made and the paediatric neurologist at Birmingham Children’s Hospital contacted. Following the review by second paediatric consultant later in the day Jake’s low folate result was noted and the team planned to discuss this with Jake’s gastroenterology team at Birmingham Children’s Hospital. The next day Sunday 16 July, Jake continued to deteriorate with increased weakness. The neurologist at Birmingham Children’s Hospital was contacted again and both teams were still of the opinion Jake was suffering from Guillain Barre Syndrome. Tel: 01432 364000

Glen Burley, Chief Executive

Russell Hardy, Chairman Jake was reviewed again on 17 July in Hereford when it was felt that some of his signs and symptoms could represent a nephrological problem and the plan was made to discuss with the renal team at Birmingham Children’s Hospital. Jake underwent a lumbar puncture on 18 July following which the consultant team at Hereford contacted the neurological team at Birmingham Children’s Hospital for a further opinion. Later that day Jake became increasingly unwell. He required intensive resuscitation in our intensive care unit and theatre and because of a concern that he may have suffered damage to bowel underwent a laparotomy that evening. Jake continued to deteriorate following a laparotomy and sadly died at 2030 that evening. Subsequent investigation has revealed that the parenteral nutrition Jake was receiving had been deficient in B vitamins and had been for several months. Jake’s inquest reached the conclusion that this deficiency of B group vitamins led directly to his death. We conducted our own internal investigation into Jake’s death to establish how our care could be improved. The four main findings were:
1. It would have been best practice to have contacted Jake’s gastroenterology team at Birmingham Children’s Hospital on admission.
2. Although we established that Jake suffered a low folate we did not discuss this with our own dieticians or the parenteral nutrition team at Birmingham Children’s Hospital.
3. We did not consider alternative diagnoses as a cause for Jake’s presentation. We became focused on the diagnosis of Guillain Barre Syndrome.
4. Our resuscitation and treatment of Jake’s metabolic acidosis and impending shock was not timely.

We immediately instigated an action plan to improve our practice. This included the following:
1. To improve the information held on patients with open access to the children’s ward.
2. To develop a proforma to include details of all health professionals involved in the care of the patient and the management plan for admission
3. These information proforma’s will be updated and reviewed annually by the consultant paediatrician team.
4. An open access standard operating procedure would be developed.
5. The “situational awareness for everyone programme”, designed by the Royal College of paediatrics and Child health would be implemented on the ward.

In addition, your regulation 28 report stipulates two actions I need to take:
1. Patients with a medical condition overseen by another hospital should have a named consultant at their local hospital.
2. Where a patient is admitted and has a medical condition overseen by another hospital the specialist Department (generally involved in the patient’s care) of the overseen hospital (in addition to any other specialist hospital or Department) should be consulted.

Glen Burley, Chief Executive

Russell Hardy, Chairman I can confirm that we have developed a standard operating procedure for both the medical division and the surgical division (the paediatric department is contained within the surgical division) which address both of these issues. In addition, I have confirmed with the associate medical directors of the respective divisions, and that the standard operating procedures have been through the relevant governance processes in the respective divisions and are in operation. I trust the above reassures you and Jake’s family that we have reviewed the circumstances around Jakes tragic death, and learned important lessons from it.