3 E NSAYOS PREVIOS
3.3. Determinación de la rigidez del sistema
3.3.1 Justificación de la necesidad de la rigidez
A num ber o f in d ep en d en t regulatory bodies w ork closely w ith th e D e p a rtm e n t o f Health
to regulate, develop and im p lem en t policies and guidelines across th e NHS. The National
Institute fo r Clinical Excellence (NICE) was originally set up in 1999. Its aim was to assess
and approve th e m ost clinically and cost effective drugs and tre a tm e n ts fo r use in NHS
Trusts in England and W ales. In 2005, NICE merged w ith th e Health D evelo p m en t Agency,
form ing th e N ational Institute o f Health and Care Excellence. Its m an d ate expanded to
developing public health guidance to help p reven t ill health and p ro m o te health ier
lifestyles. In 2 0 1 3 , NICE becam e a Non D ep artm en tal Public Body, and its responsibility
extended to developing guidelines and standards in health and social care fo r England as
set o u t in th e Health and Social Care Act 2 0 1 2 . Although sponsored by th e D e p a rtm e n t of
H ealth, NICE is o p erationally independent o f th e govern m en t. In d ep en d en t com m ittees
o f experts m ake NICE guidelines and recom m endations and its Board and Senior
M a n a g e m e n t Team are responsible fo r developing its strategic policies and operational
decision-m aking. Guideline d evelo p m en t com m ittees prim arily use evidence fro m
random ised controlled trials and system atic reviews because these m ethods are d eem ed
to provide th e highest quality of evidence. By August 2 0 1 4 , NICE had developed 8 50
guidelines covering a diverse range of topics such as venous th ro m b o em b o lism , acutely ill
patients in hospitals, prostate cancer and medicines adherence am ong others.
NICE has seven D irectorates covering clinical practice, public health, health technology
evaluation, com m unications, health and social care, evidence resources and business,
planning and resources. The Centre fo r Health Technology Evaluation develops guidance
and technology appraisals on th e use o f n ew and existing tre a tm e n ts and procedures in
th e NHS, such as medicines, medical devices, diagnostic techniques, surgical procedures
and o th e r interventions. Its research and d e v e lo p m e n t te a m is responsible fo r d eveloping
and im proving m ethods used in guideline d evelo p m en t and com m issioning relevant
research. The Health and Social Care D irecto rate is responsible fo r im proving qu ality in
th e NHS through quality standards and th e ir im p lem en tatio n in practice. It is also
responsible fo r NICE Pathways, which are online tools th a t com bine all NICE guidelines,
quality standards and o th e r related m aterials into easily accessible fo rm ats. The Health
Technologies Adoption program m e also falls under th e Health and Social Care D ire c to ra te .
It facilitates th e adoption o f selected m edical and diagnostic technologies in th e NHS. The
Evidence Resources D irectorate manages databases th a t provide a u th o rita tiv e evidence
and best practice relating to new m edicines in develo p m en t. This D ire c to ra te is also
Resources team s. These team s are responsible fo r NICE digital services and identifying,
selecting and appraising new evidence. Although NICE Pathways are supposed to be used
w ithin th e context o f individual NHS Trusts and th e ir existing initiatives, in m ost cases,
th e y are applied as de facto "how to " guides in clinical areas. This m ay have im plications
fo r th e evaluations th a t are carried out by NHS Trusts because th e y m ay prim arily focus
on issues th a t are receiving th e m ost atten tio n at national level, w h ile missing useful
inform ation on relevant contextual issues.
The Health and Social Care In form ation Centre is part o f th e D e p a rtm e n t o f Health
Inform atics D irectorate, which replaced th e NHS Connecting fo r Health in M arch 2013
[HSCIC, 2 0 14]. Its prim ary role is to be th e a u th o ritative source o f data and in form ation
relating to health and social care. It also supports th e delivery o f IT infrastructure,
inform ation systems and standards to im prove p atien t outcom es. Its catalogue o f data
includes official statistics, results from surveys, audits and reports th a t are collected fro m
various sources in health and social systems. The Health and Social Care In fo rm atio n
Centre also produces guidance from hospital based in fo rm atio n including clinical audits
and data quality resources fo r clinicians, Hospital Episode Statistics, P atient R eported
O utcom e M easures, Secondary Uses Service, and th e Sum m ary Hospital M o rta lity
Indicator (The Health and Social Care Inform ation Centre, 2 0 1 5 ).
A n o th er im p o rtan t regulatory body is th e M edicines and H ealthcare Products Regulatory
Agency (M HRA). This is an executive agency o f th e D e p a rtm e n t o f Health responsible fo r
regulating medicines in th e UK. The M HRA also produces guidance on medical devices and
stand-alone medical softw are, as w ell as outlining requirem ents fo r CE m arking fo r stand
alone softw are th a t is used as a medical device. Stand-alone s o ftw are (so ftw are medical
device) is defined as softw are which has a medical purpose at th e tim e o f it being placed
on to th e m arket (M HRA, 2 0 1 4 ). It does not include softw are th a t is incorporated into an
existing medical device, such as softw are th a t controls th e function o f a h eart scanner,
which is deem ed to be part o f th e device. H ow ever, th e regulation o f s o ftw are medical
devices is lim ited by th e intended purpose as defined by th e m anufacturer. The M edical
Device Directive defines a softw are medical device as "softw are... intended by th e
m an u factu rer to be used fo r hum an beings fo r th e purpose of: diagnosis, prevention,
m onitoring, tre a tm e n t or alleviation o f disease, diagnosis, m onitoring, tre a tm e n t,
alleviation o f or com pensation fo r an injury or handicap, investigation, rep lacem e n t or
m odification o f th e a n ato m y or of a physiological process, control o f co n cep tio n ...
(M H R A , 2 0 1 4 ). T2 and T3 (see Chapter 6 and 7 respectively) are both registered w ith th e
M HRA. Before and a fte r registration o f a softw are medical device, developers are required
to carry o u t various evaluations thro u g h o u t th e lifecycle o f th e so ftw are m edical device's
d e v e lo p m e n t and im p lem en tatio n , focusing prim arily on th e technical and clinical
efficacy, as w ell as post im p lem en tatio n longitudinal data collection to show th a t th e
device is safe fo r use in clinical areas. H ow ever, it is up to individual developers to decide
w h e th e r or not th e ir device requires registration, and thus effectively m ay have an effect
on which evaluations are p erform ed, if at all.
Dr Foster Intelligence was launched in 2 0 0 6 as a jo in t ven tu re w ith th e D e p a rtm e n t of
H ealth. Its aim is to im prove th e quality o f health and social care by m o n ito rin g th e
perform ance o f th e NHS and providing healthcare inform ation to th e public. Dr Foster
Intelligence works collaboratively w ith various stakeholders such as NHS organisations,
th e D e p a rtm e n t o f H ealth, local governm ent, academ ia and th e private sector. Its Dr
Foster U nit at Im perial College London is responsible fo r developing m ethodologies th a t
facilitate th e identification o f potential problem s in clinical p erform ance as w ell as
commissioners to benchm ark th e quality and efficiency o f health services, and cost and
clinical effectiveness against key indicators. Examples include th e Dr Foster Care Q uality
Tracker which collates latest data from m ultiple sources and is linked w ith th e Care Q u ality
Commission's Hospital Intelligent M o n ito rin g indicators. The Care Q uality Tracker is an
"early w arning system" th a t enables NHS Trusts to tim eously id en tify and investigate
alerts before notifications are raised by th e regulators. NHS Trusts can also m o n ito r and
m easure th e ir quality outcom es and p atien t safety through Dr Foster's Real Tim e
M o n ito rin g tool and th e hospital standardised m o rtality ratios (HSMR). Dr Foster
Intelligence affects all th re e CDSSs selected fo r this research through HSMR m on ito rin g
and its proxim ity to th e D e p a rtm e n t o f H ealth, and specifically th e VTE risk assessment
tool because Dr Foster undertook audits looking at how individual NHS Trusts w e re
im p lem en tin g g o vern m en t policy (see C hapter 5). Dr Foster's influential position has an
im pact on evaluations th a t are carried out by NHS Trusts because th e y are required to
subm it inform ation on th e ir perform ance m onthly and in some cases, th e y are ranked
according to th e results. H ow ever, some NHS Trusts (including th e study site) have
questioned th e credibility o f DR Foster Intelligence m ethods o f collecting in fo rm atio n and
presenting results. They argued th a t these m ethods failed to take into consideration o th e r
key perform ance criteria and relevant contextual issues.
A n o th er key D e p a rtm e n t o f Health body is th e N ational Patient S afety Agency (NPSA). The
NPSA aims to identify and reduce risks, and im prove th e safety o f care provided to
patients by NHS organisations in England and W ales. C onfidential reports on p a tie n t
safety incidents are reported by NHS organisations through th e N ational R eporting and
Learning System. These reports are then analysed by clinicians and p a tie n t safety experts
to identify risks and opportunities to im prove p a tie n t safety and provide feed b ack and
guidance as necessary. The NPSA works collaboratively w ith th e Royal M edical Colleges, 1 2 3
NHS staff and related organisations, p a tie n t groups, th e D e p a rtm e n t o f H ealth and its
agencies, academ ia and o th e r stakeholders. The NPSA developed a ro o t cause analysis
m ethodology, which seeks to identify systemic and process failures in clinical areas, learn
fro m th e m and im p le m e n t action plans to ensure th a t th e y do not recur. The NPSA root
cause analysis m ethodology is w id ely used across th e study Trust, particularly by th e
Clinical G overnance and Audit and Effectiveness d ep artm en ts in collaboration w ith
d e p a rtm e n ta l Clinical Directors and Nurse M anagers as a de facto evaluation m ethod fo r
investigating serious adverse events. This m ethod was also adopted by th e study Trust's
Thrombosis C o m m ittee to investigate all cases o f venous th rom boem bolism s th a t
occurred w ithin 90 days o f a hospital admission (See C hapter 5). Results fro m these
investigations w e re shared across th e study Trust's clinical specialties to learn fro m
failures and im prove processes w h e re recom m ended.