SGH Cong Procs Report 2016

The National Congenital Heart Disease Audit

Data Quality Audit for CONGENITAL HEART DISEASE

University Hospital Southampton NHS Foundation Trust

08 September 2016

performed by Lin Denne and Mr A C McLean

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SGH Cong Procs Report 2016IntroductionPrior to this validation visit, the data return to NCHDA from the Congenital Cardiac Department of

University Hospital Southampton, indicates that some 742 procedures (386 surgical operations, 244

therapeutic catheters, 112 others, 15 deaths) have been undertaken during the data collection year of

1 April 2015 to 31 March 2016.

This is the first validation of the extended NCHDA Dataset v5.01 at SGH. It is anticipated that the

data quality indicator score may drop slightly as hospitals adjust to capturing and recording the extra

data that are now required for this registry.

Following the log book audit of cardiac theatres A, B, C and 3 and cath labs 1, 2, 3 and 4, 15 further

procedures were identified that may be suitable for inclusion in NCHDA.

Congenital Audit Data Managers Role As reported in 2013-15, the Congenital Data Managers (DM) role was very fragmented with the

responsibilities being covered by 3 staff with varying degrees of knowledge and understanding of the

audit dataset and congenital cardiology. The senior 0.8WTE Data Manager was also responsible for

the scheduling of both congenital surgery and congenital catheter cases.

At the 2015 visit there were just 2 individuals in post. The 0.8WTE DM had been seconded to another

role. The additional 0.4 WTE role has in turn been seconded.

The 0.8WTE role had been seconded as 1.0WTE that wholly prioritised scheduling with no protected

time to manage the NCHDA data collection. A new post (1.0 WTE) has been created to cover NICOR

data management alongside cross covering scheduling.  This replaces the previous 0.4WTE post.

In 2016 the 0.8WTE role has returned from secondment and maternity leave to be wholly prioritising

the scheduling and waiting lists for the cath lab and operating theatres congenital procedures.

The New Congenital Heart Disease Review (NHSE July 2015) recommendation B32(L1) states that

each Specialist Surgical Centre must have a minimum of 1.0 WTE dedicated paediatric cardiac

surgery/cardiology data collection manager, with at least 1.0 WTE assistant, responsible for audit and

database submissions in accordance with necessary timescales. This is further underpinned by The

Report of the Independent Review of Childrens Cardiac Services in Bristol (June 2016 Grey, Kennedy

1.22(2) and Ch17 )

Many units have recognised the value and importance of these data and have a totally dedicated 2.0

WTEs or greater to provide congenital cardiac data management for the NCHDA and NHS England

requests. NHSE may use NCHDA data to underpin CQUINs (Commissioning for Quality and

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SGH Cong Procs Report 2016Innovation) quarterly dashboards. As previously reported, NHSE require dashboards to be

underpinned by PRAiS (Paediatric Risk Analysis in Surgery) software reports on a quarterly basis. In

busy centres with high numbers of procedures, PRAiS is run on a monthly basis. This does not

appear to have occurred at SGH. The most recent months PRAiS analysis is for April 2016 due to the

lack of staff available to support the NCHDA data collection and data management. This is of

considerable concern and such a fragmented approach may lead to a reduction in the data quality

and the lines of accountability.

It is further noted that at the time of this visit that only a very small number of records (1) have been

submitted for the year 2016-17. This indicates that the Hospital is not meeting the minimum

requirement for quarterly submissions. This appears to be due to the fragmented role of the Data

Managers and lack of personnel support and recognition of the value and importance for the

collection, review and submission of these data.

Actions Undertaken in response to the Recommendation of the 2015 Validation Visit1. There has now been recognition by the Trust that the role of Congenital Cardiac Co-ordinator

should be expanded and reviewed to cover Nicor data management, allowing for banding at

AfC Band.

2. There is now increased adult liaison with ACHD team to capture data in a more timely manner

3. There is now increased PICU liaison to capture post intervention events

Consent for External Validation of Hospital NotesThis has been required by NCHDA since 1 April 2007. This is a once only requirement until the

patient reaches 16 years of age. Patients aged over 16 are expected to give their own consent rather

than a guardian or parent on their behalf. At Southampton there was initially a separate consent form,

consisting of one sheet of paper that has been in use since the summer of 2007. This was available

on the paediatric and adult congenital wards. There is a mechanism in place to capture consent from

patients who require procedures as emergencies or out of hours. The paper form has now been

replaced with a sticky label that is appended to the inside cover of the patients hospital notes.

It is reported at this visit that however, that 12 of the selected case notes for review did not have

consent for external validation. These consents were obtained by telephone from the

parent/patient/guardian on all but 1 patient who did not respond. It is reported by SGH that recent

staff education and regular monitoring has increased consent being obtained from parents/patients

and guardians.

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SGH Cong Procs Report 201618/20 Sample patients’ notes that were randomly selected for validation had either a signed consent

form, label in or telephone consent for examination of their hospital notes. 1 set of notes were taken

from the Reserve list to make the 20 casenote sample. There was not another set of case notes

available to make the number up to 20. Therefore 19 patients had a total of 22 procedures, (9

catheters and 13 operations).

Also, as in the 2009-15 reviews, there also appears to be a problem with more than 1 diagnosis and

more than 1 procedure performed being entered in some of the primary diagnosis and primary

procedure fields of some of the submitted records. We caution the team to ensure that any issues of

this nature occurring with the primary diagnosis and procedure performed coding may have knock on

effects for classification and risk adjustment. We would encourage the team to continue to be vigilant

and to reverse validate their data to look for this issue and correct it.

The Data Quality Indicator Score (DQI)The DQI for the Trust is calculated to be (with previous years in parentheses) 95.75% (97.5, 98,

96.5,) with domain scores Demographics 1.0 (.99 1.0 .99,) Pre Procedure .92 (.95 .96 .93)

Procedure .93 (.97 .97 .97) and Outcome .98 (.99 .99 .96).

Separate DQI for Surgery and for CathetersOn further review of the overall DQI for 2015/16, when the cases were split into their surgery and

catheter groups the scores are:

Year of Visit Data Reviewed Surgery Catheters

2009 2007-08 96.5% 93.7%

2010 2008-09 97.25% 98.25%

2011 2009-10 97.75% 96.25%

2012 2010-11 93.5% 95.75%

2013 2011-12 98.75% 99.75%

2013(Nov) 2012-13 95.6% 95.4%

2014 2013-14 98.25% 98.25%

2015 2014-15 98% 97.5%

2016 2015-16 98% 93%

The body of this report is drawn from answers given on the NCHDA Pre Visit Questionnaire (PVQ)

and from discussions on the day of the visit.

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SGH Cong Procs Report 2016IntroductionThe NCHDA data return indicates that the congenital cardiac department of Southampton University

Hospital Trust has undertaken 742 procedures (386 surgical operations, 244 therapeutic catheters,

112 others, 15 deaths) in the data collection year 2015/2016 of which 20 sets of case notes were

randomly selected for review.

The NCHDA Clinical Auditor and one external Consultant Congenital Cardiac Surgeon undertook the

site audit. 1 senior trainee in congenital cardiology, 1 congenital data manager from another hospital

and a project manager from NICOR attended the visit as observers.

Review of notesAs stated above, 18 Sample sets of patient notes were requested for review, a further 10 sets were

selected as Reserves in case any of the first 20 were unavailable. On the day 18 Sample sets were

made available, and 1 set of notes were used from the reserve list. The case notes had been

meticulously prepared for the validation, with each relevant document carefully identified with a sticky

note. The accuracy of the NCHDA data return was then checked against each set of notes. The

accuracy was then recorded to enable the Data Quality Indicator (DQI) to be scored.

1. As previously, the notes on the whole were tidy, but on occasions were not in chronological

order.

2. As at the previous visits, the PICU and medical notes were colour edged green and blue

respectively making them easy to locate.

3. Reports of echocardiograms were not always present in the hospital notes

4. The operation notes were also easy to locate as these are coloured pink.

5. Perfusion records were seen in all of the surgical patients notes at this visit.

6. Documentation such as sticky labels for implanted devices did not always appear to be

routinely appended to operation or cath lab procedure documentation seen in the hospital

notes.

7. Explicit documentation of date and time of extubation was also difficult to find in some of the

hospital notes where the ITU chart did not appear to be present.

8. Discharge information was variably found within ICP or within other areas of the patient notes.

Review of the Log BooksAs in the previous visits, the Reviewers make the observation that the both the theatre and cath lab

log books are bespoke volumes with ruled lines and columns for certain items of information. The

entries are made in hand writing and at times it was difficult to identify exactly what procedure had

taken place and whether or not it is for congenital heart disease. As in 2015. it is reported at this visit

that there are no plans to move to electronic operating or cath lab log books.

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SGH Cong Procs Report 2016

Operating Theatre There are 4 cardiac theatres at SGH, A, B C and 3. Congenital cardiac surgery is mainly performed

in Theatre 3 and Theatre B. All of the log books were made available with the exception of the log

book for Theatre 3 for the time period April 2015 – November 2015. This book was reported to the

Reviewers as being missing, its location unknown.. Sticky labels are used to identify patient episodes

followed by hand written completion of the procedures performed and operators etc.

1. 1 submitted  surgical record appears to have a coding error

2. 2 further surgery records had been submitted in an incorrect category (Thoracic instead of

Non-Bypass)

3. 2 surgery procedures were identified that may have been missed from the data submission

Cath Lab There are 4 catheter laboratories at SGH; 1,2, 3 and 4. Cath labs 1 and 2 are biplane. The reviewers

are pleased to note that there is now a self inking stamp with the word Congenital in use to help

identify relevant procedures. The log books for all cath labs were made available to the Reviewers.

All fields in the books seen are completed in hand written entries.

As noted in other mixed practice centres identifying adult congenital cases undergoing ablations and

pacemakers is a problem.

1. 6 submitted catheter records appear to have errors in them

2. 13 catheter procedures were identified in the cath lab log books which may have been missed

from the data submission

3. 13 catheter records had been submitted in an incorrect category (Other, instead of Catheter

Intervention).  These were mostly electrophysiological procedures such as pacemaker

implant/explant and RFAs.

4. Reveal device implants and explants are noted to be absent and should be included

5. Electrophysiological studies were also noted to be absent and should be included

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SGH Cong Procs Report 2016

Validation of Deceased Patients Diagnostic and Procedure Coding

Commencing with the validation of the 2013/14 data, the National Congenital Heart Disease Audit

wish to verify any dates of death of deceased patients in the year under review.  The diagnosis and

procedure coding will also be validated.  The requirement for patient/parent/guardian consent to

review the case notes is the same as for the congenital procedures.  In cases where it is unclear if this

consent has been obtained during life, the Medical Director is asked for permission to undertake this

process.  The Validation Team are grateful to the MD of Southampton General Hospital for giving this

permission on the day of the validation visit.  

15 patients who had had procedures during the 2015/16 data collection year were noted to have

died.    Immediately prior to the visit 1 record was discarded as the patient was found not to be

deceased by the SGH congenital data team. 

1. 1 record appears to have an incorrect post code

2. 5 records appear to have errors in the listed previous procedures

3. 4 records appear to have errors in the preoperative weights recorded

4. 1 record appears to have an incorrect procedure code that is precluding it from the NCHDA

Specific Procedures Algorithm

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SGH Cong Procs Report 2016Security and ConfidentialityThe NCHDA system has been registered with the Trusts Data Protection Officer and there are tested

procedures to ensure data backup and disaster recovery. It also appears that the NCHDA system is

fully compliant with the Trusts policies on security and confidentiality.

As previously reported, there are written procedures available to staff in all the areas where staff

collect and manage data. There are processes in place to audit data collection activities such as

weekly reviews of all interventions and inpatient data and monthly presentations of department

activity. There are also monthly reviews of morbidity and mortality data including case summaries.

The centre is confident that all data are collected with very rare exceptions. This is unchanged in

2016.

Validation and Quality AssuranceAs previously reported the HeartSuite information system is used and there are formal validation

routines built in to the process. Checking for invalid entries and completeness of data items and

duplicates are undertaken by HeartSuite as data are input and error messages generated as

appropriate. NHS Numbers are collected directly from the Trust’s PAS system by HeartSuite. The

DMs validate all data with primary consultant; against log books and radiology data bases. It is

reported in 2015-16 validation visits that the monthly running of PRAiS risk software analysis is not

always occurring.

TrainingResponsibility for training lies with the care group rather than the Trust. Audit training, mandatory

audit training, educational half-days in audit and audit presentation, monthly workshops in data

collection and analysis are all provided via Trust clinical effectiveness team.

It was reported in 2013/14 that tutorial-style training covering all aspects of recording clinical activity

on the NCHDA was provided by consultants and one-on-one sessions provided by the data manager.

Training was provided for all permanent and temporary clinical staff appropriate to their role.

However, in 2016, with the decrease in staff available to support the NCHDA data collection, this has

been compromised. Training is currently part of medical staff induction, with ongoing support from

clinicians and Data Manager.

CommunicationsThere are established procedures for reissuing amended information following changes to the data

and there are procedures to ensure timely collection and dissemination of activity data with the

organisation and to NCHDA. As reported at both the 2013 - 15 validation visits, with the increase in

procedural numbers over recent years and with a decrease in personnel support for this role, the

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SGH Cong Procs Report 2016submission of data to NCHDA has become less timely and is not meeting the agreed schedule of

quarterly uploads. As noted above, it is reported that monthly PRAiS (Partial Risk Analysis in

Surgery) analysis in not occurring due to lack of personnel to support NCHDA and there has been just

1 record submitted to NCHDA for the period April 2016 – March 2017 at the time of this validation

visit.

This unit does not appear at present to be meeting The New Congenital Heart Disease Review

(NHSE July 2015) recommendation B32(L1) that states that each Specialist Surgical Centre must

have a minimum of 1.0 WTE dedicated paediatric cardiac surgery/cardiology data collection manager,

with at least 1.0 WTE assistant, responsible for audit and database submissions in accordance with

necessary timescales. Additional resources may be required for the ACHD data for the various

audits and NHS England quarterly CQINs dashboard requests.

AccountabilityAs reported previously, there is a line of accountability established for the NCHDA system, namely the

Clinical Lead, Clinical Service Manager and the Operations Manager; and there is a designated

person responsible for data quality and standards conformance. However as previously reported, it

appears that there are not always arrangements in place to give those staff responsible for data

quality adequate influence over other staff, whose actions affect the quality of that data.

Health Records ManagementOn the whole all the information required by NCHDA can be found in the notes, but the hospital notes

are not used routinely for data collection or validation. This is unchanged in 2016.

TimelinessDeadlines for data returns to NCHDA were not being met since prior to 2013. There is almost no data

for the 2016-17. Internal targets for data completeness are not being met. As noted earlier staff

issues have resulted in a delay in submitting cases to NCHDA

Completeness and ValidityTransfer tables are available in HeartSuite to ensure patient care events are defined correctly

according to NCHDA classifications or include a list of the acronyms, synonyms and abbreviations.

This is unchanged from previous NCHDA reports.

There are internal targets for completeness of data but these are not being met due to lack of

personnel.

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SGH Cong Procs Report 2016AccuracyAs previously reported, there is a data quality and audit programme in place. Clinical staff input data

at point of treatment and where possible, procedure codes are validated and there are regular audits

of these as mentioned elsewhere in this report.

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SGH Cong Procs Report 2016Casenote Audit

Parameter Total Score

Total No

Comments Scores for Cardiology & Surgery

C S

1 Hospital Number 19 19 8 11

2 NHS Number 19 19 8 11

3 Surname 19 19 8 11

4 First Name 19 19 8 11

5 Sex 19 19 8 11

6 DOB 19 19 8 11

7 Ethnicity 19 19 8 11

8 Patient Status 19 19 8 11

9 Postcode 19 19 8 11

10 Pre Procedure

Diagnosis

22 22 2 incomplete 9 13

11 Previous Procedures 35 36 1 absent 25 10/11

12 Patients Weight at

Operation

22 22 9 13

13 Height 20 20 9 11

14 Ante Natal Diagnosis 2 2 - 2

15 Pre Proc Seizures 22 22 9 13

16 Pre Proc NYHA 2 5 3 absent 1/4 1

17 Pre Proc Smoker 2 5 3 absent 1/4 1

18 Pre Proc Diabetes 2 5 3 absent 1/4 1

19 Hx Pulmonary Dis 2 5 3 absent 1/4 1

20 Pre Proc IHD 2 5 3 absent 1/4 1

21 Comorbidity Present 10 11 1 absent 5 5/6

22 Comorbid Conditions 20 21 1 absent 6 14/15

23 Pre Proc Systemic

Ventricular EF

18 19 1 unable to validate 8 10/11

24 Pre Proc Sub Pul

Ventricular EF

17 18 1 unable to validate 8 9/10

25 Pre-proc valve/septal

defect/ vessel size

1 1 1 -

26 Consultant 22 22 9 13

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SGH Cong Procs Report 2016

Parameter Total Score

Total No

Comments Scores for Cardiology & Surgery

C S

27 Date of Procedure 22 22 9 13

28 Time Start 22 22 9 13

29 Proc Urgency 22 22 - -

30 Unplanned Proc - - 2 -

31 Single Operator 2 2 2 -

32 Operator 1 22 22 9 13

33 Operator 1 Grade 18 22 4 incorrect 5/9 13

34 Operator 2 18 20 2 incorrect 5/7 13

35 Operator 2 Grade 16 20 4 incorrect 3/7 13

36 Procedure Type 22 22 9 13

37 Sternotomy

Sequence

11 11 - 11

38 Operation

Performed

22 22 9 13

39 Sizing balloon used

for septal defect

0 1 1 absent 0/1 -

40 No of stents or coils 0 1 1 absent 0/1 -

41 Device

Manufacturer

6 8 2 absent 6/7 0/1

42 Device Model 13 15 2 absent 13/14 0/1

43 Device Ser No 12 15 1 absent, 2 unable to validate 12/14 0/1

44 Device Size 11 11 11 11

45 Total Bypass Time 10 10 - 10

46 XClamp Time, 8 8 - 8

47 Total Arrest 1 1 - 1

48 Cath Proc Time, 9 9 9 -

49 Cath Fluro Time, 7 7 7 -

50 Cath Fluro Dose, 7 7 7 -

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SGH Cong Procs Report 2016Parameter Total

ScoreTotal No

Comments Scores for Cardiology & Surgery

C S

51 Duration of Post Op

Intubation

13 13 - 13/13

52 Post Procedure

Seizures

22 22 9 13

54 Post Proc

Complications

55 Date of Discharge 21 22 1 incorrect 8/9 13

56 Date of Death 1 1

57 Status at Discharge 22 22 9 13

58 Discharge

Destination

21 22 1 incorrect 9 12/13

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SGH Cong Procs Report 2016Data Quality Indicator Assessment:

The Overall Trust DQI = 95.75% Cardiology DQI = 93% Surgery DQI = 98%

This DQI is based upon the domain scoring below. The methodology for this DQI is provided in the paper The CCAD Audit –

An Introduction to the Process.

DOMAIN DOMAINScore

Demographics

Hospital Number, NHS Number, Surname, First Name, DOB, Sex, Ethnicity, Postcode, Patient

Status,

Overall 1.0

Card1.0

Surg1.0

Pre Procedure

Pre procedure Diagnosis, Selected Previous Procedures, Patient Weight at Operation,

Consultant, Antenatal Diagnosis, Pre Procedure Seizures, Comorbid Conditions,

Height, Pre Procedure NYHA, Pre Procedure Smoker, Pre Procedure Diabetes, Previous Pulmonary Disease, Pre Procedure Ischaemic Heart Disease, Comorbidity Present, Pre Procedure Systemic Ventricular Ejection Fraction, Pre Procedure Sub Pulmonary Ejection Fraction, Pre Procedure valve/septal defect/vessel size,

Note, the scores for his domain are affected by the selected previous procedure and pre procedure

diagnosis

Overall .92

Card

.87

Surg

.96

Procedure

Date of procedure, Operator 1, Operator 2 Cardiopulmonary Bypass used, Operator 1 grade,

Operator 2 grade, Operation performed, Sternotomy sequence, Bypass Time, CircArrest,

XClamp Time, Cath Proc Time, Cath Fluro Time, Cath Fluro Dose,

Time Start, Procedure Urgency, Unplanned Procedure, Single Operator, Sizing Balloon

Used, No of Stents/Coils, Device Mfr, Device Model, Device Ser No, Device Size,

Overall .93

Card

.88

Surg

.98

Outcome

Duration of Post Op Intubation, Post Procedure Seizures, Date of Discharge, Date of Death,

Status at Discharge, Discharge Destination.

Post Procedure Complications.

Overall .98

Card.97

Surg.98

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SGH Cong Procs Report 2016

Data Quality Indicator AssessmentThe Overall Trust DQI = 95.75% (97.5, 98, 96.5)

This DQI is based upon the domain scoring below. The methodology for this DQI is provided in the

paper The NCHDA Audit – An Introduction to the Process.

DOMAIN 2016 2015 2014 2013(Nov)

2013

Demographic 1.0 .99 1.0 .99 1.0

Pre Procedure .92 .95 .96 .93 1.0

Procedure .93 .97 .97 .97 .99

Outcome .98 .99 .99 .96 .97

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SGH Cong Procs Report 2016ConclusionsOn the whole the NCHDA data were accurate, well documented, and were appropriately recorded in

the Theatre and Cath Lab log books that were seen. This is the first validation of the NCHDA v5.01

dataset which is considerably enlarged (30%) on the previous one and as such it is fully anticipated

that the DQI for all congenital cardiac centres may drop in the initial 1-2 years of review.

The Data Quality Indicator (DQI) is 95.75%. This is a drop of 1.75%. The less than adequate staff in

post to support this data collection and submission have done a good job on the 2015-16 NCHDA

given the constraints they were under. The Reviewers would also like to particularly thank the DMs

for their very high standard of document preparation for this visit. This greatly assisted the process.

Comparable congenital cardiac centres   now have or are moving towards 2.0WTEs at AfC Band 7 (or

one Band 7 and one Band 6) due to the demands for timely and accurate data submission and the

requirements for data reports. Added to this the expansion of the NCHDA dataset that includes

specific data points for ACHD patients, all diagnostic cardiac catheter procedures in patients with

congenital heart disease and extra details on all implanted devices and materials such as serial

numbers make and model names, will need identified individuals to manage this. It is of extreme

concern that the 0.8WTE titled role Congenital Coordinator is actually prioritised for scheduling all

congenital operating and cath lab procedures and the relevant waiting lists. However, SGH wish to

state that since August 2016,  increased staffing resources should facilitate improved NCHDA

management.

The Reviewers conclude that the previously high DQI score, data collection and internal audit

practices for the NCHDA may be significantly compromised if further resources are not allocated to

support the timely submission of data. The data submission for 2015/16 was extremely late and

therefore overdue. The Reviewers are mindful that almost no data for the year 2016-17 has been

submitted and that the monthly PRAiS analysis has only just been undertaken for the month of April

2016. This may not meet the NHSE Dashboard standards. It is also clear from the validation of the

data that there is no routine reverse validation of the data once it has been submitted to the NCHDA

database. Such a practice helps to quickly identify Specific Procedure counts and whether or not

procedure coding in particular is correct or items have been missed.

As previously reported, the handwritten entries in the cath lab and theatre log books while quite neat

and well kept were sometimes very difficult to transcribe and it was impossible without further

research to determine if some patients had congenital or acquired heart disease. The use of the

Congenital stamp in the cath lab log book does help identify cases. The surgical definition of which

cases should be included in NCHDA can be found here:-

https://nicor4.nicor.org.uk/CHD/an_paeds.nsf/vwContent/Technical%20Information?Opendocument

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SGH Cong Procs Report 2016

Deceased Patients Data ValidationCase notes for all deceased patients was made available. As stated above, 1 patient listed as

deceased was found to be alive prior to the validation visit. There were a number of errors identified

and the most important of these was the incorrect format of coding for a operation that precluded it

from the Specific Procedure analysis algorithm and from PRAiS.

Reverse validation of the submitted data to NCHDA would have quickly identified many of these

errors.

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SGH Cong Procs Report 2016Recommendations.

1. It is recommended that in line with the New Congenital Heart Disease Review (NHSE July

2015) recommendation B32(L1) that each Specialist Surgical Centre must have a minimum of

1.0 WTE dedicated paediatric cardiac surgery/cardiology data collection manager, with at

least 1.0 WTE assistant, responsible for audit and database submissions in accordance with

necessary timescales. This is further underpinned by The Report of the Independent Review

of Childrens Cardiac Services in Bristol (June 2016 Grey, Kennedy 1.22(2) and Ch17 ) This

should be a dedicated role to meet the growing demands of the NCHDA data collection and

NHSE with no other ‘add on’ parts such as scheduling.

2. It is recommended (if not already in place) that in liaison with the Lead Clinicians for

cardiology and cardiac surgery, the Congenital Data Manager(s), devise a standard operating

procedure (SOP) to capture all data on congenital patients in a timely manner. The SOP

should clearly set out exactly who is responsible for;

a. Ensuring consent for external validation of hospital notes is obtained

prospectively from all patients with congenital heart disease

b. Input of congenital patients NCHDA required dataset items and at which point of

service delivery

c. Encouraging responsible clinician input of the procedure data for each operation,

diagnostic or catheter intervention at the point of the service delivery

d. Recording the knife to skin time for all surgical procedures where it can be

validated (ie perfusion or anaesthetic record).

e. Validity checking and completeness and the time intervals for feedback to

responsible clinicians on this with a clear time scale and line of responsibility for

rectifying any omissions or errors in both surgery and cardiology disciplines

f. Reverse validation of the data submitted to NCHDA by responsible clinicians in

conjunction with the Data Managers at least monthly.

g. Running the PRAiS (Paediatric Risk Analysis in Surgery) analysis tool monthly.

This will inform the quarterly NHSE Dashboard reports.

h. Ensuring that dates of death are reported for any ACH patient who has previously

had a record submitted to the NCHDA

i. Leading the local review (and how frequently and in which forum for both

disciplines)

j. Making timely submissions (monthly is recommended) and

k. Including details of manufacturer, model and serial numbers of all implantable

devices with each patient record for a procedure.

3. To ensure all staff collecting and submitting data have access to Lotus notes for the purpose

of validation of data, communication from NCHDA of patient identifiable data etc. as

previously recommended

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SGH Cong Procs Report 20164. It is recommended that entries in the theatre log books for procedures for congenital heart

disease should be clearly identified as such (e.g. with a self inking stamp).

5. As previously recommended, to urgently liaise with Systeria and local users to ensure that

only 1 diagnosis and 1 procedure per field can be entered and the placement of comorbid

conditions is correct

6. Documentation of all procedures connected with the clinical audit process should be reviewed

on a regular basis to accommodate changes that may be required by the Trust and/or

NCHDA.

7. It is recommended that all staff who are involved with collecting, reviewing and managing the

NCHDA data should attend at least one external validation visit per year.

8. All senior trainees (ST6 and above) should be actively encouraged to volunteer to assist with

external validation visits to other centres.

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