NJR Accountability and Transparency Model

NJR Accountability and Transparency Model

Background to the NJR model

The monitoring of surgeon, hospital and implant performance outcomes is a key function of our work. The NJR Accountability and Transparency model was developed in 2017 following a root and branch review of the patient safety processes that were already in place.

As part of the review, we consulted closely with regulatory and orthopaedic professional bodies and specialty societies. Engagement with the Medicines and Healthcare products Regulatory Agency (MHRA), Care Quality Commission (CQC) and the British Orthopaedic Association (BOA) forms a key part of the model, thus enabling greater patient safety and improved quality of care.

Five key monitoring processes were agreed:

1. Alert and Alarm Surgeon Process
2. Alert and Alarm Hospital (Unit) Process
3. Surgeon Appraisal Enhancement Process
4. Implant Outlier Process
5. Implant Mismatch Notification Process

You can find FAQs on the Accountability and Transparency model here

For information on how to access NJR Support click here

Alert and Alarm Surgeon Processes

The NJR surgeon performance monitoring process identifies those surgeons with a revision ratio (an indication of implant failure or surgical performance outcomes) that are higher in volume than expected. The process has a defined mechanism to contact these surgeons so that an appropriate review of practice can be taken to identify possible causes and actions. Analyses in the NJR are risk-adjusted in order to make a fair comparison between different surgeons.

More information on the surgeon alert and alarm process can be found here and more detailed information on the analysis is contained as part of our FAQs.

Alert and Alarm Hospital (Unit) Process

Monitoring hospital (unit) performance is one of our key functions as part of the NJR Accountability and Transparency Model which was developed and introduced in 2017.

The NJR surgeon monitoring process identifies hospitals with revision ratio (an indication of implant failure or surgical performance) that are higher than expected and has a defined mechanism to contact these hospitals so that an appropriate review of practice can be taken to identify possible causes and actions. Data analyses in the registry are risk adjusted in order to make a fair comparison between different hospitals.

The two outcomes the NJR uses in outlier analyses are revision surgery of a primary hip or knee replacement, and mortality in the first 90 days following surgery of a primary hip or knee replacement. These events are used in the calculation of risk-adjusted standardised mortality ratio (SMR) and risk adjusted standardised revision ratio (SRR).

We notify hospitals when they are either at alert (borderline) or alarm (outlier) status.

For alert level hospitals, their SRR or SMR falls between the 95% and 99.8% control limits. At this time, we ask surgeons to review and discuss their data locally to identify any possible causes.

An alarm level hospitals is contacted when their SRR or SMR crosses the 99.8% control limit (3 standard deviations from the expected number of deaths or revisions for that hospital). As part of this process, we contact the hospital’s medical director or clinical lead to discuss the data outcome levels with them. Hospitals are then asked to review their data and write an action plan to address any causation issue identified.

We also work closely with the Care Quality Commission and British Orthopaedic Association to collaboratively provide support to hospitals to address any issues or potential concerns.

More information on the hospital alert and alarm process can be found here.
Specific FAQs on hospital outlier status for revision can be found here

Surgeon Appraisal Enhancement Process

We encourage all surgeons who carry out joint replacement surgery to use and reflect upon their NJR performance outcome data in a structured and accountable way.

The NJR’s Surgeon Appraisal Enhancement Process has given surgeons formal mechanism to demonstrate that they have downloaded their Consultant Level Report. The NJR monitors surgeon engagement and encourages reflection of their own practice and performance data. This process is reported back via each individual hospital’s NJR Annual Clinical Report to ensure patient safety and assurance. Alongside use as part of their appraisals, all hospitals are encouraged to hold regular meetings for surgeons to discuss their outcome data.

‘Practitioner reflection’ is also supported by NHS England, the British Orthopaedic Association, and NHS Improvement.

More information on the surgeon appraisal enhancement process can be found here.

Implant Outlier Process

We support medical implant suppliers in the routine post-market surveillance of their implants. Information on implant performance outcomes is also made available to clinicians, patients, hospital management and the MHRA through a range of analyses outputs. Data on implant performance is also published as part of the NJR Annual Report (hyperlink to site) each year.

Implant Outlier Process

As part of the NJR Accountability and Transparency model, the NJR identifies hip and knee implants which fall outside the designated patient time incidence rate (PTIR) confidence intervals. The aim of this process it so act as an early warning of any issues relating to patient safety to allow appropriate action to be taken. Analysis of data is undertaken twice a year in March and September and is reviewed by the NJR Implant Scrutiny Committee.

There are two levels of implant notification to manufacturers:

Level 1 implant outlier notification process – triggered when an implant has a patient time incidence rate (PTIR) of at least twice the overall PTIR, for implants that have been used in at least 100 primary operations in the NJR.

Level 2 implant outlier notification process – triggered when an implant has a PTIR of at least twice the overall PTIR, for implants that have been used in less than 100 primary operations in the NJR. It can also be triggered when an implant has a PTIR of at least one and a half times the overall PTIR, for implants that have been used in at least 100 primary operations in the NJR. 

As part of this process, we write to manufacturers and ask them to review the relevant data. In the case of level 1 outliers, we also work with the MHRA to ensure that any appropriate action is taken.

Implant Mismatch Notification Process

The purpose of the NJR Implant Mismatch Notification Process is to provide immediate warning notification of potential implant mismatches.

The NJR records and reports on a range of potential mismatches of components:

• For hips – a mismatch in size, for example; between a hip cup or liner and head.
• For knees – a mismatch in side, for example; a right-sided component recorded as being implanted for a left knee surgery/procedure.
• Mix and match of components from different manufacturers

As part of the NJR Implant Mismatch Process, an automated pop-up notification is generated, warning the data entry user that the selected choice represents a potential mismatch and that the component selection should be confirmed with the surgeon. 

The majority of mismatches that are alerted are subsequently found to be data entry errors. The NJR data entry system enables hospitals to immediately recognise and correct wrongly entered mismatch data entry errors.

Never Events

Genuine potential implant mismatches are called ‘Never Events’. The Department of Health and Social Care defines ‘Never Events’ as ‘very serious patient safety incidents, which are largely preventable and should not have occurred if the relevant preventative measures had been put in place.’ Where a genuine mismatch has occurred the notification process will assist early implant revision, if this is deemed appropriate.

The NJR has also developed an implant scanning tool which hospitals can use to check components in theatre at the time of surgery to further minimise the risk of genuine never events.

The chair of the NJR’s Surgeon Performance and Implant Scrutiny Committees, Mr Peter Howard, commented: “Now with around 3.7 million records in the registry, our role in monitoring the performance of implants remains of vital importance. Through the robust monitoring processes that are in place, which were enhanced as part of the implementation of the new model, we can quickly identify if there are potential discrepancies in data relating to hip and knee replacement procedures with the wrong size or side respectively. Identifying potential implant mismatches demonstrates how the NJR is ensuring even greater patient safety.”

More information on the implant mismatch notification process can be found here.