Programme Centre
 | Newborn Blood Spot Screening 'Receipt of Sample' Failsafe PilotCurrent position December 2011Progress update on the Blood Spot Failsafe Procurement · Blood Spot Failsafe Strategy Board have agreed the scope for the Blood Spot Failsafe procurement. · The procurement process has been agreed · Resources have been allocated to the rewrite of the Blood Spot specification · A high level road map for Blood Spot Failsafe is being drafted · Work has commenced on the Project Initiation Document for the Blood Spot failsafe · A communications strategy for the Blood Spot failsafe project will be drafted in the new year · Job Descriptions & Person Specification for the Blood Spot failsafe Implementation Midwife have been worked up Current position July 2011The Fetal, Maternal and Child Health sub-group of the National Screening Committee approved roll-out of the failsafe solution in November 2010. The National Screening Committee is seeking funding for this project. 'Receipt of Sample' Failsafe PilotEvery newborn baby in England is entitled to ‘blood spot' screening for a series of genetic conditions. The test involves a small sample of blood being collected from the baby's heel by a midwife when the baby is aged between 5 and 8 days and submitted on a sample card for testing at a screening laboratory. However, significant proportions of blood spot samples fail to reach the laboratory or are delayed in transit. By the time process failures are detected (if at all), irreversible harm can be caused to babies affected by the screened conditions. Beyond the impact on the lives of affected babies and parents, the cost of additional treatment, care and lost opportunity is significant and avoidable. Further, failures in the blood spot screening process may be indicative of wider failures in the neonatal care process. The UK Newborn Screening Programme and the NHS Sickle Cell and Thalassaemia Screening Programme commissioned a pilot to assist maternity units in monitoring the receipt of valid blood spot samples at a screening laboratory. The pilot ran in three phases from 27 July 2009 to 30 June 2010 (including babies born from 20 June 2009), under the direction of a project board with representation from a range of NHS stakeholders. It focused on the use of a specialised IT system to monitor births within six maternity units, and compare these with blood spot sample cards received in the associated screening laboratories. Pilot sites were selected to test the effectiveness of the system in units with established manual failsafe processes and relatively static populations as well as more challenging inner-city areas. The system also provided oversight of the sample receipt to six Child Health Record Departments. The pilot system was relatively straightforward but differed from existing processes in two main respects. First, because the failsafe software was populated from the NHS birth notification system, the birth unit was assumed to be responsible for the blood spot screening process until either the laboratory confirmed receipt or another unit accepted express responsibility for the baby. Second, because sample receipt was routinely reported by the laboratory to the maternity unit, missing or inadequate samples could be identified at a much earlier stage and a timely repeat sample taken if necessary. Although this is only one component of the wider blood spot screening pathway, no other NHS system addresses the ‘information divide' between the maternity unit and the laboratory. Evaluation of the pilot was challenging: in order to measure improvement, performance driven by the pilot must be compared with previous (pre-intervention) performance, but the latter could not be systematically be measured. As with many IT-based change processes, it is only by introducing new systems that underlying performance can be understood. Within these constraints, the evaluation was based on three complementary measures of change, each assessed against a set of pre-agreed success criteria: 1. Questionnaires completed by participating units before, during and after the pilot; 2. Activity logs completed by participating units before and during the pilot; 3. Performance data derived from the pilot IT system, including data from a ‘run in' period during which the system recorded performance but did not support intervention by units. The evaluation report contains an economic evaluation of whether rolling out a system similar to the pilot system nationally could represent value for money when assessed against the harm and cost resulting from missed or late blood spot screening. Key findings1. Most of the pre-agreed success criteria were satisfied by the pilot. The pilot system clearly identified the maternity unit with responsibility for ensuring that a valid blood spot sample was received at the screening laboratory. Maternity units received clear management reports throughout the pilot which assisted in identifying delays in the blood spot screening process and monitoring of the impact of process improvements. 2. The failsafe solution was well received by all of the maternity units and screening laboratories involved in the pilot, with widespread support for the introduction of a national system. Most pilot units indicated that they would like to continue using the failsafe system despite the additional time overhead, and four of the six units obtained local funding to continue using the system beyond the end of the pilot. 3. Over the three month evaluation period, it is likely that 33 babies (0.54%) would not have been screened but for the pilot system. This equates to around 3,500 babies per year. If these figures are extrapolated, a national failsafe solution would enable early detection of around 4.5 screened conditions each year which would otherwise be missed. The benefits of detecting missed screening would be enhanced if the screening programme was extended to test for additional conditions. 4. In addition to the 33 babies whose screening might have been missed but for the pilot system, analysis of the pilot data identified 142 (2.3%) of babies where blood spot screening appeared not to have been completed. In all of these cases a repeat sample had been requested, but was never received by the laboratory. Although the pilot system was not configured to identify these babies to the responsible maternity unit, a relatively straightforward modification would allow repeat samples to be requested and tracked using the failsafe solution. 5. The two pilot maternity units with least timely sample receipt showed a substantial improvement in achieving receipt of sample by day 12 (after which remedial action is less likely to be effective). However, there was little evidence of improved sample receipt by day 12 in better-performing units, and all units showed a decline in the timeliness of sample receipt shortly after the introduction of the pilot system; this was probably due to factors external to the pilot, such as organisational restructure and the national postal strike. 6. Measuring an improvement in the timeliness of identifying missing blood spot sample cards is challenging, because the point at which a sample should be categorised as ‘missing' is difficult to determine, and because baseline data only included samples received at the laboratory. However, of samples received after day 8, the proportion received between days 9 and 12 showed a significant improvement in every unit with the exception of the unit which performed best against this measure, where no significant change was evident. 7. Two units showed a significant improvement in timeliness against babies moving into the area following the introduction of the pilot, and no unit showed a decline in timeliness amongst this group. 8. The total cost of implementing and operating a national blood spot failsafe solution would be around £4m over 5 years. It is likely that the running cost of the IT system as piloted (included within the overall cost) would around 50p - 60p per baby born, with potential economies if use of the NHS number on blood spot sample cards becomes more widespread. The additional burden of using the system is largely on clerical staff in the maternity unit. 9. It is necessary to make a number of assumptions in assessing the economic feasibility of implementing a national failsafe solution. On the basis of these assumptions however, the economic model developed as part of this evaluation indicates that national rollout of a failsafe solution is likely to be a cost-effective use of NHS funds (Incremental Cost-Effectiveness Ratio approximately £14,200 per QALY, against NICE affordability thresholds of £20,000-£30,000). 10. Additional benefits of a national failsafe solution, such as the ability to track responsibility for newborn screening across all maternity units in England, were identified but not tested during the pilot. On the basis of these findings, the evaluation concluded that the pilot failsafe solution was effective, acceptable to users, and is likely to be affordable if rolled out nationally. National deployment would enable various benefits that could not be delivered if the solution was procured or made available for purchase on a regional or local basis, including comprehensive tracking of responsibility for newborn screening across England, comparative national reporting and a development platform for other strategic information and IT projects. The evaluation report recommends that a failsafe solution for newborn blood spot screening be specified, centrally procured and rolled out across England.
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