System Connecting Care
Action Planned
System Connecting Care plan to implement NEWTT2 in the Neonatal and Maternity application for delivery to the customer estate once NHS England has finalised the release of NEWTT2 and ensure that the NEWS functionality is clearly distinguishable from UK national guidance by defining its full title of Newborn Early Warning Score. (AI summary)
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R e g. offi c e: S y st e m C H e alt h c ar e Lt d, Ar d e n C o urt , Ar d e n Str e et, Str atf or d u p o n A v o n, W ar wi c k s hir e, C V 3 7 6 N T
A ut h or:
V er si o n:
1. 5 Cr e at e d: 21 /11 / 2 0 2 3 U p d at e d: 0 3 / 01 / 2 0 2 4 Cl a s sifi c ati o n: C O M M E R CI A L I N C O N FI D E N C E
S C H -1 6 9 – I n v e sti g ati o n R e p o rt
© S y st e m C H e alt h c ar e Lt d 2 0 2 3 P a g e 2 of 1 0 C O M M E R CI A L I N C O N FI D E N C E
C o nfi d e nti alit y / D o c u m e nt c o ntr ol T hi s d o c u m e nt c o nt ai n s i nf or m ati o n t h at i s c o nfi d e nti al t o S y st e m C H e alt h c ar e Lt d ( S y st e m C) a n d i s s u b mitt e d b y S y st e m C i n or d er f or t h e p ot e nti al c u st o m er t o u s e it s ol el y f or t h e p ur p o s e s of e v al u ati n g S y st e m C’ s pr o p o s al a n d it m u st n ot b e u s e d f or a n y ot h er p ur p o s e n or di s cl o s e d t o a n y ot h er p art y, eit h er w h ol e or i n p art, wit h o ut t h e pri or writt e n c o n s e nt of S y st e m C e x c e pt a s f oll o w s. T h e p ot e nti al c u st o m er m a y p er mit t h o s e of it s e m pl o y e e s, a d vi s or s a n d a g e nt s h a vi n g a n e e d t o k n o w t h e c o nt e nt s of t hi s pr o p o s al, t o h a v e a c c e s s t o s u c h of t h e c o nt e nt s a s ar e stri ctl y n e c e s s ar y, b ut t h e p ot e nti al c u st o m er s h all e n s ur e t h at s u c h e m pl o y e e s, a d vi s or s, a n d a g e nt s ar e b o u n d t o it b y a n o bli g ati o n, i n si mil ar t er m, t o k e e p it c o nfi d e nti al. T h e p ot e nti al c u st o m er’ s a c c e pt a n c e of t h e s e o bli g ati o n s s h all b e i n di c at e d b y t h e c u st o m er’ s u s e of a n y of t h e i nf or m ati o n c o nt ai n e d i n t hi s d o c u m e nt. S y st e m C a c k n o wl e d g e s t h at t h e p ot e nti al c u st o m er m a y b e b o u n d b y t h e Fr e e d o m of I nf or m ati o n A ct 2 0 0 0 ( F OI A). I n s u c h a c a s e S y st e m C c o n si d er s t h at t h e c o nt e nt s of t hi s d o c u m e nt ar e c o nfi d e nti al a n d e x e m pt fr o m di s cl o s ur e p ur s u a nt t o s e cti o n 41 of t h e F OI A. T h e p ot e nti al c u st o m er s h o ul d c o n s ult S y st e m C b ef or e m a ki n g a n y di s cl o s ur e of i nf or m ati o n r el ati n g t o S y st e m C u n d er t h e F OI A. S y st e m C’ s pri ci n g i nf or m ati o n, m et h o d ol o gi e s, s ol uti o n s, a s w ell a s r ef er e n c e t o S y st e m C cli e nt s a n d t h eir pr oj e ct s ar e al w a y s c o n si d er e d b y S y st e m C t o b e e x e m pt fr o m di s cl o s ur e b y virt u e of s e cti o n 41 a n d 4 3 of t h e F OI A, w h et h er i n di c at e d or n ot. Pr o d u ct I nf or m ati o n: A n y d e s cri pti o n s of f ut ur e f u n cti o n alit y r efl e ct c urr e nt pr o d u ct dir e cti o n, ar e f or i nf or m ati o n al p ur p o s e s o nl y a n d d o n ot c o n stit ut e a c o m mit m e nt t o pr o vi d e s p e cifi c f u n cti o n alit y. Ti mi n g a n d a v ail a bilit y r e m ai n at S y st e m C’ s di s cr eti o n a n d ar e s u bj e ct t o c h a n g e a n d a p pli c a bl e r e g ul at or y a p pr o v al s. © C o p yri g ht 2 0 2 3, S y st e m C H e alt h c ar e Lt d
D o c u m e nt c o ntr ol N a m e R ol e D at e C o m m e nt
A ut h or 21 /11 / 2 0 2 3
C o ntri b ut or 2 9 /11 / 2 0 2 3
A m e n d m e nt r e c or d I s s u e st at u s V er si o n D at e A cti o n e d b y D e s cri pti o n Dr aft V 0.1 21 /11 / 2 0 2 3
I nt er n al c o pi e s f or r e vi e w & a ut h ori s ati o n Fi n al V1. 0 2 9 /11 / 2 0 2 3
I s s u e d t o cli e nt Fi n al V1.1 0 7 /1 2 / 2 0 2 3
U p d at e d Fi n al V1. 2 1 5 /1 2 / 2 0 2 3
U p d at e d Fi n al V1. 3 2 9 /1 2 / 2 0 2 3
U p d at e d Fi n al V1. 4 0 3 / 01 / 2 0 2 4
U p d at e d Fi n al V1. 5 0 4 / 01 / 2 0 2 4
U p d at e d
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Table of contents 1 Executive Summary .............................................................................................................................................................. 4 2 Investigation Methodology ............................................................................................................................................. 6
2.1 Stakeholders ....................................................................................................................................................................... 6
2.2 Roles & Responsibilities .............................................................................................................................................. 6
2.2.1 Primary Investigator ................................................................................................................................ 6
2.2.2 Investigator .................................................................................................................................................... 6
2.2.3 Legal Counsel .............................................................................................................................................. 6
2.2.4 Executive Sponsor .................................................................................................................................... 6
2.2.5 Clinical Safety Officer ............................................................................................................................. 7
2.2.6 Technical Authority .................................................................................................................................. 7
2.3 Investigation Plan ............................................................................................................................................................ 8 3 Investigation Findings ......................................................................................................................................................... 9 4 Improvements & Lessons Learnt ................................................................................................................................ 9
4.1 Implement NEWTT2 ..................................................................................................................................................... 9 5 References ................................................................................................................................................................................ 10
© S y st e m C H e alt h c ar e Lt d 2 0 2 3 P a g e 4 of 1 0 C O M M E R CI A L I N C O N FI D E N C E
1 E x e c uti v e S u m m ar y A c or o n er’ s r e p ort w a s r e c ei v e d o n t h e 21 st of N o v e m b er 2 0 2 3 t h at r e q uir e d a n i n v e sti g ati o n t o b e c o n d u ct e d, th e L e g al I n v e sti g ati o n pr o c e s s w a s i niti at e d. T w o f a ct or s w er e i d e ntifi e d i n t h e c or o n er’ s r e p ort t h at r e q uir e d i n v e sti g ati o n:
• I n t h e B a d g er n et el e ctr o ni c s y st e m u s e d at t h e R o y al Vi ct ori a I nfir m ar y b y t h e N e w c a stl e U p o n T y n e H o s pit al s N H S F o u n d ati o n Tr u st, t h e c urr e nt ri s k a s s e s s m e nt ( N E W S) d o e s n ot m a p t h e n ati o n al g ui d a n c e f ull y a n d if w o ul d b e m or e u s er- fri e n dl y, a n d t h er e b y a s si st t o w ar d s m or e eff e cti v e, a n d t h er ef or e s af er, ri s k a s s e s s m e nt f or it t o m a p t h e n ati o n al g ui d a n c e c o m pl et el y.
• T h e c urr e nt N E W T T 2 c h art i s n ot y et a v ail a bl e, a n d it w o ul d a s si st i n t h e m or e eff e cti v e m a n a g e m e nt of ri s k f or it t o b e i n B a d g er n et. T hi s w a s s u p p o s e d t o b e i m pl e m e nt e d i n J ul y 2 0 2 3 b ut a s, y et it h a s n ot. T h e S y st e m C i n v e sti g ati o n (“t h e i n v e sti g ati o n”) c o m m e n c e d o n T u e s d a y 21 st of N o v e m b er 2 0 2 3. T h er e ar e t hr e e m ai n ‘B a d g er n et ’ pr o d u ct s a s f oll o w s:
1. M at er nit y
2. N e o n at al E P R
3. Cli ni c al S u m m ar y F or t h e a v oi d a n c e of d o u bt, t h e o nl y pr o d u ct i n Li v e u s e at t h e Tr u st at t h e ti m e of t h e i n ci d e nt w a s Cli ni c al S u m m ar y i n n e o n at al. T h e i n v e sti g ati o n f o u n d th at on t h e 1 3 t h of J u n e 2 0 2 2, t h e c u st o m er sit e r ef er e n c e d i n t h e r e p ort w a s utili si n g t h e Cli ni c al S u m m ar y a p pli c ati o n f or n e o n at al d e p art m e nt o nl y. T h e p ati e nt w a s n ot a d mitt e d i nt o N e o n at al a n d t h er ef or e w a s n e v er a d d e d t o t h e Cli ni c al S u m m ar y. T h e Cli ni c al S u m m ar y a p pli c ati o n pr o d u ct d o e s n ot c o nt ai n t h e N ati o n al E arl y W ar ni n g S c or e ( N E W S) 1, N e w b or n E arl y W ar ni n g S c or e ( N E W S – N e w Z e al a n d N ati o n al G ui d a n c e) 4, P a e di atri c E arl y W ar ni n g S c or e ( P E W S) or t h e N e w b or n E arl y W ar ni n g Tri g g er & Tr a c k ( N E W T T)2 f u n cti o n alit y a n d t h er ef or e a n y r e c or di n g of i nf or m ati o n o n t h e N E W T T c h art w a s n ot g e n er at e d fr o m t h e ‘ B a d g er n et’ Cli ni c al S u m m ar y a p pli c ati o n. T h e c u st o m er a gr e e d a d e pl o y m e nt pl a n of M at er nit y f or G o Li v e i n J a n u ar y 2 0 2 3 a n d N e o n at al E P R f or t h e 1 4t h of N o v e m b er 2 0 2 3. T h e M at er nit y pr o d u ct i m pl e m e nt e d i n J a n u ar y 2 0 2 3 c o nt ai n s N e w b or n E arl y W ar ni n g S c or e ( N E W S – N e w Z e al a n d N ati o n al G ui d a n c e) 4 f u n cti o n alit y r e q u e st e d f or N e w Z e al a n d c u st o m er s t h at m a p t o N e w Z e al a n d n ati o n al g ui d a n c e . T hi s f u n cti o n alit y i s a v ail a bl e t o U nit e d Ki n g d o m c u st o m er s o n a n el e cti v e b a si s a n d i s n ot i nt e n d e d t o m a p t o N e w b or n E arl y W ar ni n g Tri g g er & Tr a c k ( N E W T T) 2 S y st e m C a d o pt b e st pr a cti c e a n d n ati o n al g ui d a n c e fr o m m ulti pl e c o u ntri e s, c u st o m er s c a n el e ct t o u s e t h e f u n cti o n alit y t o m e et t h eir s p e cifi c n e e d s. N e w b or n E arl y W ar ni n g Tri g g er & Tr a c k ( N E W T T) 2 f u n cti o n alit y i s a v ail a bl e i n t h e N e o n at al E P R pr o d u ct, w hi c h w a s d e pl o y e d i n N o v e m b er 2 0 2 3, t hi s d o e s m a p t o N H S E n gl a n d n ati o n al g ui d eli n e s a s i nt e n d e d. N E W T T 2 3 i s pl a n n e d t o b e i ntr o d u c e d i nt o N e o n at al E P R a n d M at er nit y o n c e t h e f a ct or s aff e cti n g d e pl o y m e nt h a v e b e e n a d dr e s s e d. It s h o ul d b e n ot e d t h at N E W T T 2 w a s n ot f ull y a gr e e d b y N H S E n gl a n d u ntil J u n e 2 0 2 3 a n d a di git al s p e cifi c ati o n will b e m a d e a v ail a bl e b y N H S E n gl a n d b y A ut u m n 2 0 2 4. Fr o m t h e i n v e sti g ati o n it h a s b e e n d et er mi n e d t h at t h e f oll o wi n g l e s s o n s l e ar nt n e e d t o b e c o m pl et e d .
• T o pl a n t o i m pl e m e nt N E W T T 2 i n t h e N e o n at al a n d M at er nit y a p pli c ati o n f or d eli v er y t o t h e c u st o m er e st at e o n c e N H S E n gl a n d h a s fi n ali s e d t h e r el e a s e of N E W T T 2.
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x Ensure the NEWS functionality is clearly distinguishable from UK national guidance by defining its full title of Newborn Early Warning Score.
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2 Investigation Methodology
2.1 Stakeholders The following stakeholders have been identified to complete the investigation. Name Role
Primary Investigator Investigator Legal Counsel
Executive Sponsor
Executive Sponsor
Executive Sponsor
Clinical Safety Officer
Technical Authority
Technical Authority
Technical Authority
Technical Authority
2.2 Roles & Responsibilities
2.2.1 Primary Investigator Accountable for directing the investigation, to act impartial and independent to ensure a thorough investigation is conducted. Accountable for the creation of an investigation methodology plan that is followed that defines the actions to be completed, expected deliverables, targets and measurements as required. Accountable for the identification of stakeholders with specific competency to assist in the investigation, to ensure stakeholders are clearly defined and what remit they have within the constraints of the investigation.
2.2.2 Investigator Responsible for performing specific activities during the investigation as directed by the Primary investigator. Responsible for ensuring investigations progress to agreed deliverables and evaluate the outputs.
2.2.3 Legal Counsel Accountable for providing legal guidance during the investigation and support any actions that are required that have legal implications and therefore require special attention.
2.2.4 Executive Sponsor Accountable for providing sponsorship to the investigation allowing autonomy for the investigation to be conducted without impedance, delegating authority for resource allocation to the Primary investigator. Responsible for providing support to the investigation for appropriate escalations when required from the Primary Investigator.
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2.2.5 Clinical Safety Officer Accountable for providing clinical safety authority within the investigation.
2.2.6 Technical Authority Accountable for providing technical investigation, defining the technical actions required to investigate and retrieve information relevant to the investigation. To perform analysis of technical information to support the outcome of the investigation.
© S y st e m C H e alt h c ar e Lt d 2 0 2 3 P a g e 8 of 1 0 C O M M E R CI A L I N C O N FI D E N C E
2. 3 I n v e sti g ati o n Pl a n T h e i n v e sti g ati o n c o m m e n c e d o n T u e s d a y 21 st of N o v e m b er 2 0 2 3 aft er e s c al ati o n of a c or o n er’ s r e p ort fr o m l e g al c o u n s el r e q uiri n g a n i n v e sti g ati o n t o b e c o n d u ct e d t o pr o vi d e a r e p ort t o t h e c or o n er. T w o f a ct or s w er e i d e ntifi e d i n t h e c or o n er’ s r e p ort t h at r e q uir e d i n v e sti g ati o n:
• I n t h e B a d g er n et el e ctr o ni c s y st e m u s e d at t h e R o y al Vi ct ori a I nfir m ar y b y t h e N e w c a stl e U p o n T y n e H o s pit al s N H S F o u n d ati o n Tr u st, t h e c urr e nt ri s k a s s e s s m e nt ( N E W S) d o e s n ot m a p t h e n ati o n al g ui d a n c e f ull y a n d if w o ul d b e m or e u s er- fri e n dl y, a n d t h er e b y a s si st t o w ar d s m or e eff e cti v e, a n d t h er ef or e s af er, ri s k a s s e s s m e nt f or it t o m a p t h e n ati o n al g ui d a n c e c o m pl et el y.
• T h e c urr e nt N E W T T 2 c h art i s n ot y et a v ail a bl e, a n d it w o ul d a s si st i n t h e m or e eff e cti v e m a n a g e m e nt of ri s k f or it t o b e i n B a d g er n et. T hi s w a s s u p p o s e d t o b e i m pl e m e nt e d i n J ul y 2 0 2 3 b ut a s y et it h a s n ot. T o g at h er i nf or m ati o n a b o ut t h e a d mi s si o n of t h e p ati e nt a n d u n d er st a n d w h at s y st e m s w er e i n u s e, a c c e s s e d t h e Cli ni c al S u m m ar y pr o d u ct f or t h e sit e a n d filt er e d t h e d at e s b et w e e n t h e 1 2t h of J u n e 2 0 2 2 a n d t h e 1 4 t h of J u n e 2 0 2 2. T h e i n v e sti g at or c o nfir m e d t h e p ati e nt r e c or d di d n ot e xi st i n t h e s y st e m b et w e e n t h e s e d at e s. T o d et er mi n e if t h e Cli ni c al S u m m ar y pr o d u ct m a p s t o t h e N H S E n gl a n d n ati o n al g ui d a n c e, t h e i n v e sti g ati o n r e q uir e d t h e d et er mi n ati o n of t h e pr o d u ct a n d f u n cti o n alit y i n u s e at t h e ti m e of o c c urr e n c e o n t h e 1 3t h of J u n e 2 0 2 2 . T o d et er mi n e w h at pr o d u ct s w er e d e pl o y e d at t h e ti m e of t h e i n ci d e nt t h e i n v e sti g ati o n e n g a g e d a s t h e t e c h ni c al a ut h orit y f or d e v el o p m e nt. H e r e vi e w e d r el e a s e n ot e s t o u n d er st a n d w h at v er si o n s a n d f u n cti o n alit y h a d b e e n d e pl o y e d t o t h e sit e a n d w h e n. C o ntr a ct s w er e r e vi e w e d f or t h e d eli v er y of M at er nit y a n d N e o n at al E P R pr o d u ct s wit h t h e pr oj e ct d eli v er a bl e s a gr e e d wit h t h e c u st o m er f or G o Li v e s of M at er nit y a n d N e o n at al i n 2 0 2 3. T o d et er mi n e w h at f u n cti o n alit y w a s wit hi n t h e d e pl o y e d pr o d u ct s at t h e ti m e of t h e i n ci d e nt, t h e i n v e sti g ati o n e n g a g e d a s t h e pr o d u ct cli ni c al s p e ci ali st t e c h ni c al a ut h orit y. T h e f u n cti o n alit y of t h e pr o d u ct w a s d e m o n str at e d t o d et er mi n e w h et h er N E W S a n d / or N E W T T w a s i n cl u d e d i n t h e pr o d u ct t o t h e i n v e sti g at or s. T o d et er mi n e if t h e N e o n at al E P R a n d M at er nit y pr o d u ct m a p s t o n ati o n al g ui d a n c e,
a s s e s s e d t h e N e o n at al E P R a n d d et er mi n e d N E W T T f u n cti o n alit y i s i n cl u d e d a n d d o e s m a p t o n ati o n al g ui d a n c e a n d N e w b or n E arl y W ar ni n g S c or e ( N E W S – N e w Z e al a n d) f u n cti o n alit y i s i n cl u d e d a n d m a p s t o N e w Z e al a n d n ati o n al g ui d a n c e. C u st o m er s c a n el e ct t o u s e eit h er or b ot h f u n cti o n s. T h e c u st o m er d o e s n ot h a v e eit h er e n a bl e d, t h er ef or e c a n n ot u s e t h e s e wit hi n t h e N e o n at al E P R pr o d u ct c urr e ntl y. T o d et er mi n e if t h e M at er nit y pr o d u ct m a p s t o N ati o n al G ui d a n c e, v erifi e d N E W T T f u n cti o n alit y i s n ot i n cl u d e d i n t h e pr o d u ct a n d N e w b or n E arl y W ar ni n g S c or e ( N E W S – N e w Z e al a n d ) f u n cti o n alit y d o e s m a p t o n ati o n al g ui d a n c e f or N e w Z e al a n d. C u st o m er s c a n el e ct t o u s e t hi s f u n cti o n alit y . ( Pr o d u ct Cli ni c al S p e ci ali st – M at er nit y L e a d) i d e ntifi e d N E W T T 2 w a s p o st p o n e d i n t h e n e o n at al a p pli c ati o n d u e t o:
• N E W T T 2 3 i s pl a n n e d t o b e i ntr o d u c e d i nt o N e o n at al E P R a n d M at er nit y o n c e t h e f a ct or s aff e cti n g d e pl o y m e nt h a v e b e e n a d dr e s s e d. It s h o ul d b e n ot e d t h at N E W T T 2 w a s n ot f ull y a gr e e d b y N H S E n gl a n d u ntil J u n e 2 0 2 3 a n d a di git al s p e cifi c ati o n t o b e m a d e a v ail a bl e b y N H S E n gl a n d b y A ut u m n 2 0 2 4.
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3 Investigation Findings On the 13th of June 2022, the site was utilising the Clinical Summary application within the neonatal unit, the patient was not admitted to the neonatal unit and therefore was not recorded into the Clinical Summary application. In addition, the Clinical Summary application product did not contain the National Early Warning Score (NEWS)1, Newborn Early Warning Score (NEWS – New Zealand National Guidance)4, Paediatric Early Warning Score (PEWS) or the Newborn Early Warning Trigger & Track (NEWTT)2 functionality and therefore any recording of information on the NEWTT chart was not generated from the ‘Badgernet’ Clinical Summary application. The customer would not have been able to record National Early Warning Score (NEWS) or Newborn Early Warning Trigger & Track (NEWTT)2 records within the Clinical Summary application as this was not part of the application, and therefore had to use another system or forms provided directly from the NHS as advised under the Newborn Early Warning Trigger & Track (NEWTT) – a Framework for practice (2015)2. Further investigation by the trust would be required to determine what solution was used to generate the NEWTT chart referenced. The customer agreed a deployment plan of Maternity for Go Live in January 2023 and Neonatal EPR for the 14th of November 2023. The Maternity product implemented in January 2023 contains Newborn Early Warning Score (NEWS – New Zealand National Guidance)4 functionality requested for New Zealand customers that map to New Zealand national guidance. This functionality is available to United Kingdom customers on an elective basis and is not intended to map to Newborn Early Warning Trigger & Track (NEWTT)2 System C adopt best practice and national guidance from multiple countries, customers can elect to use the functionality to meet their specific needs. Newborn Early Warning Trigger & Track (NEWTT)2 functionality is available in the Neonatal EPR product, which was deployed in November 2023, this does map to NHS England national guidelines as intended. NEWTT23 is planned to be introduced into Neonatal EPR and Maternity once the factors affecting deployment have been addressed. It should be noted that NEWTT2 was not fully agreed by NHS England until June 2023 and a digital specification made available by NHS England by Autumn 2024.
4 Improvements & Lessons Learnt
4.1 Implement NEWTT2 x To plan to implement NEWTT2 in the Neonatal and Maternity application for delivery to the customer estate once NHS England has finalised the release of NEWTT2. x Ensure that the NEWS functionality is clearly distinguishable from UK national guidance by defining its full title of Newborn Early Warning Score.
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5 References
1. National Early Warning Score (NEWS) -
news-2 Royal College of Physicians, July 2012.
2. Newborn Early Warning Trigger & Track (NEWTT) – a Framework for practice (2015) (https://www.bapm.org/resources/38-newborn-early-warning-trigger-track- newtt-a-framework-for-practice-2015). British Association of Perinatal Medicine. 31st of May 2015.
3. Framework: NEWTT2 – Deterioration of the Newborn, A Framework for Practice. (https://www.bapm.org/resources/deterioration-of-the-newborn-newtt-2-a- framework-for-practice). British Association of Perinatal Medicine. 19th of January
2023.
4. Newborn Early Warning Score (NEWS) -
health/Documents/Policies-and-guidelines/Newborn-Assessment-Observation- Chart-Early-Warning-Score.pdf Te Whatu Ora, Health New Zealand. 23rd February 2021
A ut h or:
V er si o n:
1. 5 Cr e at e d: 21 /11 / 2 0 2 3 U p d at e d: 0 3 / 01 / 2 0 2 4 Cl a s sifi c ati o n: C O M M E R CI A L I N C O N FI D E N C E
S C H -1 6 9 – I n v e sti g ati o n R e p o rt
© S y st e m C H e alt h c ar e Lt d 2 0 2 3 P a g e 2 of 1 0 C O M M E R CI A L I N C O N FI D E N C E
C o nfi d e nti alit y / D o c u m e nt c o ntr ol T hi s d o c u m e nt c o nt ai n s i nf or m ati o n t h at i s c o nfi d e nti al t o S y st e m C H e alt h c ar e Lt d ( S y st e m C) a n d i s s u b mitt e d b y S y st e m C i n or d er f or t h e p ot e nti al c u st o m er t o u s e it s ol el y f or t h e p ur p o s e s of e v al u ati n g S y st e m C’ s pr o p o s al a n d it m u st n ot b e u s e d f or a n y ot h er p ur p o s e n or di s cl o s e d t o a n y ot h er p art y, eit h er w h ol e or i n p art, wit h o ut t h e pri or writt e n c o n s e nt of S y st e m C e x c e pt a s f oll o w s. T h e p ot e nti al c u st o m er m a y p er mit t h o s e of it s e m pl o y e e s, a d vi s or s a n d a g e nt s h a vi n g a n e e d t o k n o w t h e c o nt e nt s of t hi s pr o p o s al, t o h a v e a c c e s s t o s u c h of t h e c o nt e nt s a s ar e stri ctl y n e c e s s ar y, b ut t h e p ot e nti al c u st o m er s h all e n s ur e t h at s u c h e m pl o y e e s, a d vi s or s, a n d a g e nt s ar e b o u n d t o it b y a n o bli g ati o n, i n si mil ar t er m, t o k e e p it c o nfi d e nti al. T h e p ot e nti al c u st o m er’ s a c c e pt a n c e of t h e s e o bli g ati o n s s h all b e i n di c at e d b y t h e c u st o m er’ s u s e of a n y of t h e i nf or m ati o n c o nt ai n e d i n t hi s d o c u m e nt. S y st e m C a c k n o wl e d g e s t h at t h e p ot e nti al c u st o m er m a y b e b o u n d b y t h e Fr e e d o m of I nf or m ati o n A ct 2 0 0 0 ( F OI A). I n s u c h a c a s e S y st e m C c o n si d er s t h at t h e c o nt e nt s of t hi s d o c u m e nt ar e c o nfi d e nti al a n d e x e m pt fr o m di s cl o s ur e p ur s u a nt t o s e cti o n 41 of t h e F OI A. T h e p ot e nti al c u st o m er s h o ul d c o n s ult S y st e m C b ef or e m a ki n g a n y di s cl o s ur e of i nf or m ati o n r el ati n g t o S y st e m C u n d er t h e F OI A. S y st e m C’ s pri ci n g i nf or m ati o n, m et h o d ol o gi e s, s ol uti o n s, a s w ell a s r ef er e n c e t o S y st e m C cli e nt s a n d t h eir pr oj e ct s ar e al w a y s c o n si d er e d b y S y st e m C t o b e e x e m pt fr o m di s cl o s ur e b y virt u e of s e cti o n 41 a n d 4 3 of t h e F OI A, w h et h er i n di c at e d or n ot. Pr o d u ct I nf or m ati o n: A n y d e s cri pti o n s of f ut ur e f u n cti o n alit y r efl e ct c urr e nt pr o d u ct dir e cti o n, ar e f or i nf or m ati o n al p ur p o s e s o nl y a n d d o n ot c o n stit ut e a c o m mit m e nt t o pr o vi d e s p e cifi c f u n cti o n alit y. Ti mi n g a n d a v ail a bilit y r e m ai n at S y st e m C’ s di s cr eti o n a n d ar e s u bj e ct t o c h a n g e a n d a p pli c a bl e r e g ul at or y a p pr o v al s. © C o p yri g ht 2 0 2 3, S y st e m C H e alt h c ar e Lt d
D o c u m e nt c o ntr ol N a m e R ol e D at e C o m m e nt
A ut h or 21 /11 / 2 0 2 3
C o ntri b ut or 2 9 /11 / 2 0 2 3
A m e n d m e nt r e c or d I s s u e st at u s V er si o n D at e A cti o n e d b y D e s cri pti o n Dr aft V 0.1 21 /11 / 2 0 2 3
I nt er n al c o pi e s f or r e vi e w & a ut h ori s ati o n Fi n al V1. 0 2 9 /11 / 2 0 2 3
I s s u e d t o cli e nt Fi n al V1.1 0 7 /1 2 / 2 0 2 3
U p d at e d Fi n al V1. 2 1 5 /1 2 / 2 0 2 3
U p d at e d Fi n al V1. 3 2 9 /1 2 / 2 0 2 3
U p d at e d Fi n al V1. 4 0 3 / 01 / 2 0 2 4
U p d at e d Fi n al V1. 5 0 4 / 01 / 2 0 2 4
U p d at e d
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Table of contents 1 Executive Summary .............................................................................................................................................................. 4 2 Investigation Methodology ............................................................................................................................................. 6
2.1 Stakeholders ....................................................................................................................................................................... 6
2.2 Roles & Responsibilities .............................................................................................................................................. 6
2.2.1 Primary Investigator ................................................................................................................................ 6
2.2.2 Investigator .................................................................................................................................................... 6
2.2.3 Legal Counsel .............................................................................................................................................. 6
2.2.4 Executive Sponsor .................................................................................................................................... 6
2.2.5 Clinical Safety Officer ............................................................................................................................. 7
2.2.6 Technical Authority .................................................................................................................................. 7
2.3 Investigation Plan ............................................................................................................................................................ 8 3 Investigation Findings ......................................................................................................................................................... 9 4 Improvements & Lessons Learnt ................................................................................................................................ 9
4.1 Implement NEWTT2 ..................................................................................................................................................... 9 5 References ................................................................................................................................................................................ 10
© S y st e m C H e alt h c ar e Lt d 2 0 2 3 P a g e 4 of 1 0 C O M M E R CI A L I N C O N FI D E N C E
1 E x e c uti v e S u m m ar y A c or o n er’ s r e p ort w a s r e c ei v e d o n t h e 21 st of N o v e m b er 2 0 2 3 t h at r e q uir e d a n i n v e sti g ati o n t o b e c o n d u ct e d, th e L e g al I n v e sti g ati o n pr o c e s s w a s i niti at e d. T w o f a ct or s w er e i d e ntifi e d i n t h e c or o n er’ s r e p ort t h at r e q uir e d i n v e sti g ati o n:
• I n t h e B a d g er n et el e ctr o ni c s y st e m u s e d at t h e R o y al Vi ct ori a I nfir m ar y b y t h e N e w c a stl e U p o n T y n e H o s pit al s N H S F o u n d ati o n Tr u st, t h e c urr e nt ri s k a s s e s s m e nt ( N E W S) d o e s n ot m a p t h e n ati o n al g ui d a n c e f ull y a n d if w o ul d b e m or e u s er- fri e n dl y, a n d t h er e b y a s si st t o w ar d s m or e eff e cti v e, a n d t h er ef or e s af er, ri s k a s s e s s m e nt f or it t o m a p t h e n ati o n al g ui d a n c e c o m pl et el y.
• T h e c urr e nt N E W T T 2 c h art i s n ot y et a v ail a bl e, a n d it w o ul d a s si st i n t h e m or e eff e cti v e m a n a g e m e nt of ri s k f or it t o b e i n B a d g er n et. T hi s w a s s u p p o s e d t o b e i m pl e m e nt e d i n J ul y 2 0 2 3 b ut a s, y et it h a s n ot. T h e S y st e m C i n v e sti g ati o n (“t h e i n v e sti g ati o n”) c o m m e n c e d o n T u e s d a y 21 st of N o v e m b er 2 0 2 3. T h er e ar e t hr e e m ai n ‘B a d g er n et ’ pr o d u ct s a s f oll o w s:
1. M at er nit y
2. N e o n at al E P R
3. Cli ni c al S u m m ar y F or t h e a v oi d a n c e of d o u bt, t h e o nl y pr o d u ct i n Li v e u s e at t h e Tr u st at t h e ti m e of t h e i n ci d e nt w a s Cli ni c al S u m m ar y i n n e o n at al. T h e i n v e sti g ati o n f o u n d th at on t h e 1 3 t h of J u n e 2 0 2 2, t h e c u st o m er sit e r ef er e n c e d i n t h e r e p ort w a s utili si n g t h e Cli ni c al S u m m ar y a p pli c ati o n f or n e o n at al d e p art m e nt o nl y. T h e p ati e nt w a s n ot a d mitt e d i nt o N e o n at al a n d t h er ef or e w a s n e v er a d d e d t o t h e Cli ni c al S u m m ar y. T h e Cli ni c al S u m m ar y a p pli c ati o n pr o d u ct d o e s n ot c o nt ai n t h e N ati o n al E arl y W ar ni n g S c or e ( N E W S) 1, N e w b or n E arl y W ar ni n g S c or e ( N E W S – N e w Z e al a n d N ati o n al G ui d a n c e) 4, P a e di atri c E arl y W ar ni n g S c or e ( P E W S) or t h e N e w b or n E arl y W ar ni n g Tri g g er & Tr a c k ( N E W T T)2 f u n cti o n alit y a n d t h er ef or e a n y r e c or di n g of i nf or m ati o n o n t h e N E W T T c h art w a s n ot g e n er at e d fr o m t h e ‘ B a d g er n et’ Cli ni c al S u m m ar y a p pli c ati o n. T h e c u st o m er a gr e e d a d e pl o y m e nt pl a n of M at er nit y f or G o Li v e i n J a n u ar y 2 0 2 3 a n d N e o n at al E P R f or t h e 1 4t h of N o v e m b er 2 0 2 3. T h e M at er nit y pr o d u ct i m pl e m e nt e d i n J a n u ar y 2 0 2 3 c o nt ai n s N e w b or n E arl y W ar ni n g S c or e ( N E W S – N e w Z e al a n d N ati o n al G ui d a n c e) 4 f u n cti o n alit y r e q u e st e d f or N e w Z e al a n d c u st o m er s t h at m a p t o N e w Z e al a n d n ati o n al g ui d a n c e . T hi s f u n cti o n alit y i s a v ail a bl e t o U nit e d Ki n g d o m c u st o m er s o n a n el e cti v e b a si s a n d i s n ot i nt e n d e d t o m a p t o N e w b or n E arl y W ar ni n g Tri g g er & Tr a c k ( N E W T T) 2 S y st e m C a d o pt b e st pr a cti c e a n d n ati o n al g ui d a n c e fr o m m ulti pl e c o u ntri e s, c u st o m er s c a n el e ct t o u s e t h e f u n cti o n alit y t o m e et t h eir s p e cifi c n e e d s. N e w b or n E arl y W ar ni n g Tri g g er & Tr a c k ( N E W T T) 2 f u n cti o n alit y i s a v ail a bl e i n t h e N e o n at al E P R pr o d u ct, w hi c h w a s d e pl o y e d i n N o v e m b er 2 0 2 3, t hi s d o e s m a p t o N H S E n gl a n d n ati o n al g ui d eli n e s a s i nt e n d e d. N E W T T 2 3 i s pl a n n e d t o b e i ntr o d u c e d i nt o N e o n at al E P R a n d M at er nit y o n c e t h e f a ct or s aff e cti n g d e pl o y m e nt h a v e b e e n a d dr e s s e d. It s h o ul d b e n ot e d t h at N E W T T 2 w a s n ot f ull y a gr e e d b y N H S E n gl a n d u ntil J u n e 2 0 2 3 a n d a di git al s p e cifi c ati o n will b e m a d e a v ail a bl e b y N H S E n gl a n d b y A ut u m n 2 0 2 4. Fr o m t h e i n v e sti g ati o n it h a s b e e n d et er mi n e d t h at t h e f oll o wi n g l e s s o n s l e ar nt n e e d t o b e c o m pl et e d .
• T o pl a n t o i m pl e m e nt N E W T T 2 i n t h e N e o n at al a n d M at er nit y a p pli c ati o n f or d eli v er y t o t h e c u st o m er e st at e o n c e N H S E n gl a n d h a s fi n ali s e d t h e r el e a s e of N E W T T 2.
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x Ensure the NEWS functionality is clearly distinguishable from UK national guidance by defining its full title of Newborn Early Warning Score.
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2 Investigation Methodology
2.1 Stakeholders The following stakeholders have been identified to complete the investigation. Name Role
Primary Investigator Investigator Legal Counsel
Executive Sponsor
Executive Sponsor
Executive Sponsor
Clinical Safety Officer
Technical Authority
Technical Authority
Technical Authority
Technical Authority
2.2 Roles & Responsibilities
2.2.1 Primary Investigator Accountable for directing the investigation, to act impartial and independent to ensure a thorough investigation is conducted. Accountable for the creation of an investigation methodology plan that is followed that defines the actions to be completed, expected deliverables, targets and measurements as required. Accountable for the identification of stakeholders with specific competency to assist in the investigation, to ensure stakeholders are clearly defined and what remit they have within the constraints of the investigation.
2.2.2 Investigator Responsible for performing specific activities during the investigation as directed by the Primary investigator. Responsible for ensuring investigations progress to agreed deliverables and evaluate the outputs.
2.2.3 Legal Counsel Accountable for providing legal guidance during the investigation and support any actions that are required that have legal implications and therefore require special attention.
2.2.4 Executive Sponsor Accountable for providing sponsorship to the investigation allowing autonomy for the investigation to be conducted without impedance, delegating authority for resource allocation to the Primary investigator. Responsible for providing support to the investigation for appropriate escalations when required from the Primary Investigator.
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2.2.5 Clinical Safety Officer Accountable for providing clinical safety authority within the investigation.
2.2.6 Technical Authority Accountable for providing technical investigation, defining the technical actions required to investigate and retrieve information relevant to the investigation. To perform analysis of technical information to support the outcome of the investigation.
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2. 3 I n v e sti g ati o n Pl a n T h e i n v e sti g ati o n c o m m e n c e d o n T u e s d a y 21 st of N o v e m b er 2 0 2 3 aft er e s c al ati o n of a c or o n er’ s r e p ort fr o m l e g al c o u n s el r e q uiri n g a n i n v e sti g ati o n t o b e c o n d u ct e d t o pr o vi d e a r e p ort t o t h e c or o n er. T w o f a ct or s w er e i d e ntifi e d i n t h e c or o n er’ s r e p ort t h at r e q uir e d i n v e sti g ati o n:
• I n t h e B a d g er n et el e ctr o ni c s y st e m u s e d at t h e R o y al Vi ct ori a I nfir m ar y b y t h e N e w c a stl e U p o n T y n e H o s pit al s N H S F o u n d ati o n Tr u st, t h e c urr e nt ri s k a s s e s s m e nt ( N E W S) d o e s n ot m a p t h e n ati o n al g ui d a n c e f ull y a n d if w o ul d b e m or e u s er- fri e n dl y, a n d t h er e b y a s si st t o w ar d s m or e eff e cti v e, a n d t h er ef or e s af er, ri s k a s s e s s m e nt f or it t o m a p t h e n ati o n al g ui d a n c e c o m pl et el y.
• T h e c urr e nt N E W T T 2 c h art i s n ot y et a v ail a bl e, a n d it w o ul d a s si st i n t h e m or e eff e cti v e m a n a g e m e nt of ri s k f or it t o b e i n B a d g er n et. T hi s w a s s u p p o s e d t o b e i m pl e m e nt e d i n J ul y 2 0 2 3 b ut a s y et it h a s n ot. T o g at h er i nf or m ati o n a b o ut t h e a d mi s si o n of t h e p ati e nt a n d u n d er st a n d w h at s y st e m s w er e i n u s e, a c c e s s e d t h e Cli ni c al S u m m ar y pr o d u ct f or t h e sit e a n d filt er e d t h e d at e s b et w e e n t h e 1 2t h of J u n e 2 0 2 2 a n d t h e 1 4 t h of J u n e 2 0 2 2. T h e i n v e sti g at or c o nfir m e d t h e p ati e nt r e c or d di d n ot e xi st i n t h e s y st e m b et w e e n t h e s e d at e s. T o d et er mi n e if t h e Cli ni c al S u m m ar y pr o d u ct m a p s t o t h e N H S E n gl a n d n ati o n al g ui d a n c e, t h e i n v e sti g ati o n r e q uir e d t h e d et er mi n ati o n of t h e pr o d u ct a n d f u n cti o n alit y i n u s e at t h e ti m e of o c c urr e n c e o n t h e 1 3t h of J u n e 2 0 2 2 . T o d et er mi n e w h at pr o d u ct s w er e d e pl o y e d at t h e ti m e of t h e i n ci d e nt t h e i n v e sti g ati o n e n g a g e d a s t h e t e c h ni c al a ut h orit y f or d e v el o p m e nt. H e r e vi e w e d r el e a s e n ot e s t o u n d er st a n d w h at v er si o n s a n d f u n cti o n alit y h a d b e e n d e pl o y e d t o t h e sit e a n d w h e n. C o ntr a ct s w er e r e vi e w e d f or t h e d eli v er y of M at er nit y a n d N e o n at al E P R pr o d u ct s wit h t h e pr oj e ct d eli v er a bl e s a gr e e d wit h t h e c u st o m er f or G o Li v e s of M at er nit y a n d N e o n at al i n 2 0 2 3. T o d et er mi n e w h at f u n cti o n alit y w a s wit hi n t h e d e pl o y e d pr o d u ct s at t h e ti m e of t h e i n ci d e nt, t h e i n v e sti g ati o n e n g a g e d a s t h e pr o d u ct cli ni c al s p e ci ali st t e c h ni c al a ut h orit y. T h e f u n cti o n alit y of t h e pr o d u ct w a s d e m o n str at e d t o d et er mi n e w h et h er N E W S a n d / or N E W T T w a s i n cl u d e d i n t h e pr o d u ct t o t h e i n v e sti g at or s. T o d et er mi n e if t h e N e o n at al E P R a n d M at er nit y pr o d u ct m a p s t o n ati o n al g ui d a n c e,
a s s e s s e d t h e N e o n at al E P R a n d d et er mi n e d N E W T T f u n cti o n alit y i s i n cl u d e d a n d d o e s m a p t o n ati o n al g ui d a n c e a n d N e w b or n E arl y W ar ni n g S c or e ( N E W S – N e w Z e al a n d) f u n cti o n alit y i s i n cl u d e d a n d m a p s t o N e w Z e al a n d n ati o n al g ui d a n c e. C u st o m er s c a n el e ct t o u s e eit h er or b ot h f u n cti o n s. T h e c u st o m er d o e s n ot h a v e eit h er e n a bl e d, t h er ef or e c a n n ot u s e t h e s e wit hi n t h e N e o n at al E P R pr o d u ct c urr e ntl y. T o d et er mi n e if t h e M at er nit y pr o d u ct m a p s t o N ati o n al G ui d a n c e, v erifi e d N E W T T f u n cti o n alit y i s n ot i n cl u d e d i n t h e pr o d u ct a n d N e w b or n E arl y W ar ni n g S c or e ( N E W S – N e w Z e al a n d ) f u n cti o n alit y d o e s m a p t o n ati o n al g ui d a n c e f or N e w Z e al a n d. C u st o m er s c a n el e ct t o u s e t hi s f u n cti o n alit y . ( Pr o d u ct Cli ni c al S p e ci ali st – M at er nit y L e a d) i d e ntifi e d N E W T T 2 w a s p o st p o n e d i n t h e n e o n at al a p pli c ati o n d u e t o:
• N E W T T 2 3 i s pl a n n e d t o b e i ntr o d u c e d i nt o N e o n at al E P R a n d M at er nit y o n c e t h e f a ct or s aff e cti n g d e pl o y m e nt h a v e b e e n a d dr e s s e d. It s h o ul d b e n ot e d t h at N E W T T 2 w a s n ot f ull y a gr e e d b y N H S E n gl a n d u ntil J u n e 2 0 2 3 a n d a di git al s p e cifi c ati o n t o b e m a d e a v ail a bl e b y N H S E n gl a n d b y A ut u m n 2 0 2 4.
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3 Investigation Findings On the 13th of June 2022, the site was utilising the Clinical Summary application within the neonatal unit, the patient was not admitted to the neonatal unit and therefore was not recorded into the Clinical Summary application. In addition, the Clinical Summary application product did not contain the National Early Warning Score (NEWS)1, Newborn Early Warning Score (NEWS – New Zealand National Guidance)4, Paediatric Early Warning Score (PEWS) or the Newborn Early Warning Trigger & Track (NEWTT)2 functionality and therefore any recording of information on the NEWTT chart was not generated from the ‘Badgernet’ Clinical Summary application. The customer would not have been able to record National Early Warning Score (NEWS) or Newborn Early Warning Trigger & Track (NEWTT)2 records within the Clinical Summary application as this was not part of the application, and therefore had to use another system or forms provided directly from the NHS as advised under the Newborn Early Warning Trigger & Track (NEWTT) – a Framework for practice (2015)2. Further investigation by the trust would be required to determine what solution was used to generate the NEWTT chart referenced. The customer agreed a deployment plan of Maternity for Go Live in January 2023 and Neonatal EPR for the 14th of November 2023. The Maternity product implemented in January 2023 contains Newborn Early Warning Score (NEWS – New Zealand National Guidance)4 functionality requested for New Zealand customers that map to New Zealand national guidance. This functionality is available to United Kingdom customers on an elective basis and is not intended to map to Newborn Early Warning Trigger & Track (NEWTT)2 System C adopt best practice and national guidance from multiple countries, customers can elect to use the functionality to meet their specific needs. Newborn Early Warning Trigger & Track (NEWTT)2 functionality is available in the Neonatal EPR product, which was deployed in November 2023, this does map to NHS England national guidelines as intended. NEWTT23 is planned to be introduced into Neonatal EPR and Maternity once the factors affecting deployment have been addressed. It should be noted that NEWTT2 was not fully agreed by NHS England until June 2023 and a digital specification made available by NHS England by Autumn 2024.
4 Improvements & Lessons Learnt
4.1 Implement NEWTT2 x To plan to implement NEWTT2 in the Neonatal and Maternity application for delivery to the customer estate once NHS England has finalised the release of NEWTT2. x Ensure that the NEWS functionality is clearly distinguishable from UK national guidance by defining its full title of Newborn Early Warning Score.
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5 References
1. National Early Warning Score (NEWS) -
news-2 Royal College of Physicians, July 2012.
2. Newborn Early Warning Trigger & Track (NEWTT) – a Framework for practice (2015) (https://www.bapm.org/resources/38-newborn-early-warning-trigger-track- newtt-a-framework-for-practice-2015). British Association of Perinatal Medicine. 31st of May 2015.
3. Framework: NEWTT2 – Deterioration of the Newborn, A Framework for Practice. (https://www.bapm.org/resources/deterioration-of-the-newborn-newtt-2-a- framework-for-practice). British Association of Perinatal Medicine. 19th of January
2023.
4. Newborn Early Warning Score (NEWS) -
health/Documents/Policies-and-guidelines/Newborn-Assessment-Observation- Chart-Early-Warning-Score.pdf Te Whatu Ora, Health New Zealand. 23rd February 2021