20130618 rwebster clinical governance

8/12/2019 20130618 RWebster Clinical Governance

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Clinical Governance

Rachel Webster

Birmingham Childrens Hospital

This presentation

Definition

Elements

Role of laboratory

Role of clinical governance unit at BCH

IR1 examples specific to Biochemistry


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Definition

A framework through which NHS

organisations are accountable for

continuously improving the quality of

their services and safeguarding high

standards of care by creating an

environment in which excellence in

clinical care will flourish.NHS Executive 1999

Clinical Governance

A systematic approach to maintaining

and improving the quality of patient care

within a health system

Became import after the Bristol heartscandal in 1995


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Clinical Governance

Three key attributes

Recognisably high standards of care

Transparent responsibility and

accountability for those standards

Constant dynamic of improvement

FRCPath questions

Describe the application of Clinical

Governance to Clinical Biochemistry.

Discuss the role of risk management in

laboratory quality procedures. What practicalsteps can be taken in the laboratory to

minimise risk?

Explain the principal elements of continuing

professional development (CPD). Discuss how

you would enable professional staff in the

laboratory to maintain CPD


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Elements of clinical governance

Education & Training

All registered professional mustdemonstrate CPD

Responsibility of the individual and the trust

to ensure that time is available for CPD


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Clinical audit

Already discussed

Pivotal to clinical governance

Clinical effectiveness

How well does something work?

Is it appropriate?

Does is represent value for money?

Is it efficient?

Is it safe?


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R&D

EBM

Critical appraisal of literature

Development of guidelines

Openess

We shouldnt work behind closed doors

We should be open about poorperformance and poor practice

We should learn from mistakes thatothers have made

Stafford!


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Risk management Risk to patients

M&M meetings

Complaints

Environment

Risk to staff

Immunisations

Environment

Risk to the organisation

Employment practice

Role of laboratory

Important role in improving patient care

Services should be

Patient-centered

Timely

Efficient and equitable

Ensure optimal outcome

Barth J Ann Clin Biochem 2012


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Quality in laboratory medicine

Right test

Right time

Right person

Quality in laboratory medicine

Often focussed on performance andefficiency of operational processes

Extra-laboratory factors often overlooked

Pre- and post- analytical where

predominance of errors occur


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Quality indicators

Operational benchmarking

EQA

TAT

Complaints

Cost

Accreditation

User survey

CPA

Quality indicators

Must be measurable so you can reportthem

Available in a timely fashion so theyre

not out-dated before you report them

Choose them carefully as they reflect

your laboratory

Must be provided as and whenrequested


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CGU BCH

Clinical audit

Incident reporting system

Risk register

Risk management (advice/support)

Serious incident investigation

H&S (advice/support)

Formal complaints management

CGU BCH

PALs

Litigation management

Legal advice & support

Coroners inquest management

Information governance advice & support

Compliance management & support(external stds, alerts & guidance)


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CGU BCH

Freedom of information

Policy support (advice/management)

Interpreting services

Incident reporting system

IPIs

Local records

Batch failure

Procedural errors

Ordering

IRIs

Trust records

More serious incidents


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Risk register

Laboratory should make use of the riskregister

All equipment should be registered

Staffing issues

Environmental issues

Entries move up the register as the riskgets bigger

Trust has to address appropriately

Risk management

COSHH

Every chemical/reagent

Risk assessments

Every procedure


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PALs

Dedicated to listening to patients, theirfamilies and other service users

Deal with concerns and suggestions

Provides on the spot advice and support

Takes action and helps make necessary

changes to further improve the service If resolution is not achieved Trust

formal complaints procedure

PALs

Staff induction

Posters and literature

Ward visits


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Litigation

Trust has its own panel of solicitors todeal with litigation

Ensure prevention where possible

Deal with situations as they occur

Legal advice & support

Patients

Staff

Trust


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Coroners inquest

Coroner is involved when:

No doctor has treated the deceased during

the last illness

Deceased not seen within 14 days before or

after death

Death occurred during an operation or

recovery from an anaesthetic Death was sudden and unexplained or due

to suspicious circumstances

Coroners inquest

Help is given to members of the trustwho have to attend

Report writing and providing statements


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Information governance

Ensures all information relating to

patients, staff and corporate business is

dealt with legally, securely, efficientlyand effectively

Trust is responsible for the safe

confidential management of all

information relating to patients, staff andthe corporate business

Information governance

Emails

Fax

Prevention of accidental disclosure

Telephone conversations

Conversations in public areas

Computer screens

White boards


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Information governanve

Secure storage of information

Physical storage

Confidential waste

Taking records outside the hospital

Identification badges

FOI

Freedom of Information Act 2000 came

fully into force in January 2005 and

afforded the public a general right of

access to all types of information The right to be told if the information exists

The right to receive the information


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FOI

Two ways the public can gain access toinformation

Publication scheme

Routinely published information on trust website

Individual right of access

Individual right of access

Unless the information is exempt, mustbe made available within 20 days

Request must be in writing

Must include name and address forcorrespondence

Must include description of information

required

Does not have to say why the information is

being requested


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6 Caldicott Principles Justify the purpose of the information

disclosure

Dont use personal, identifiable

information

Use the minimum amount of identifiableinformation necessary

Access to personal, identifiable

information should be on a strict need to

know basis

6 Caldicott Principles

All staff should be aware of theirresponsibilities

All staff should understand and comply

with the law


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Caldicott guardian

Trusts are obliged to have a CaldicottGuardian

Responsible for ensuring the appropriate

use, protection and disclosure of patient

information within the organisation

FOI requests

Does your NHS Trust have pathology departments or labs within yourorganisation?

Can you provide me with a Pathology departmental breakdown of

structure within your Trust?

The amount spent on Locum Biomedical Scientist in the financial year

2011 and the year 2012? Within your pathology departments the total number of specimens

booked in for the year 2011, 2012 and the last specimen number

generated on the 30 April 2013. For ease of convenience please use the

excel template attached to this email. As an example Clinical Chemistry10,000, Mortuary 8000, Histology 5700 etc.

Within these Pathology Disciplines can you provide a) A list of all Pathological diagnostic test performed including Antibodies used for

Immunohistochemistry or Immunology?

b) If these tests are performed in-house or sent to an external NHS Trust or a Privateprovider?


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FOI requests c) The average turnaround times for the tests for the year 2011,2012 and your

envisaged average turnaround time for 2013 ?

d) The number of tests performed including controls for the year 2011, 2012 and thenumber of tests performed up to 30 April 2013?

e) The cost per test (this is usually the cost including fixed, variable and labour cost) forthe year 2011, 2012 and 2013?

f) The cost per test taking into account only your cost of consumables and no other costfor the year 2011,2012 and 2013?

Is the ordering for your pathology disciplines under a managed service contract,or is the ordering ad-hoc (as and when the need arises) or both?

For your procurement/ordering needs do you use an in house built or third party

consumable ordering software? Is this the same software used in the Pathology

department and the Procurement department. If third party software please state. Do you use any software that monitors your inventory for consumables and

reagents usage and provides analytics on purchasing, usage, wastage etc? If yes

please state.

Do you use any Electronic Quality Management Software (eQMS) within your

laboratories? If yes please state.

FOI requests

Does your eQMS have an incident reporting functionality if so is this thesame software used throughout your trust for incident reporting?

Do you use any form of data analytical software within your

laboratories? If so please state.

Do you use any cloud based software within your laboratories? If yes

please state. When you receive and use a consumable or reagent what information is

stored about the product e.g. date when the reagent was first used, date

when reagent finished use, expiry date, batch number, lot number, data

sheets and COSHH etc?

Do you have any software that records the disposal of laboratory

consumables due to human error, mechanical error, over ordering of

laboratory supplies where the reagent has been disposed due to being

out of date? If no what software is used what is in place to minimise thewastage of laboratory supplies?


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Interpreting service

Very important!

Clinical explanations, consent,

information must be available to all

IR1s specific to Biochemistry

Major incident identified and reportedusing IR1 forms

Trust carries out RCA

Changes put into place


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Incident summary - NBS One patient cared for on ward 11 (cardiac) and PICU and a

second patient cared for on the Neonatal Surgical Ward were

both found to have congenital hypothyroidism when their

neonatal blood spot samples were analysed. These samples

were however taken late (day 16 of age) which resulted in

delayed diagnosis and start of treatment. Neither patient has

come to on going harm as a consequence of these care

management failures.

This has highlighted that we frequently struggle taking these

samples on day 5 (and failing that between days 5-8 of life)and that we also frequently struggle taking pre-transfusion

blood spot samples to test for sickle cell disease when a

transfusion is required before day 5 of life.

RCA outcome

Five whys

Why was the blood spot sample not taken

on admission?

Why was the blood spot sample not takenafter admission but before day 8 of life?

Why was it challenging for staff to track

whether the sample had been taken.

Why did laboratory staff not prompt ward

staff for a sample at an earlier stage?


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New BCH Process

BCH neonatal admissions pack

Guides staff through required actions

Parent information leaflet

Blood spot card

Incident summary - IMD

The Patient involved in this case is a 10 year old girl who is tall and has some learningdifficulties. Before the incident she was able to attend main stream education with some

additional support, however, she has suffered from a stroke and this may impact on herfunctionality.

The Patient was being managed as an outpatient by Community Paediatricians running a

clinic at City Hospital. A plasma amino acid test was requested in May 2012. This test is notcarried out at City Hospital, and so the sample was sent to the laboratory at Birmingham

Childrens Hospital (BCH) for analysis. A qualitative plasma amino acid test was performed which did not identify the patients

metabolic condition resulting in a delay in diagnosis

This was followed by clinical deterioration, caused by a stroke, which resulted in the Patient

presenting to the BCH Emergency Department on the 12th January 2013. She was admitted toone of the BCH medical wards and investigations revealed that she was suffering from ametabolic condition.

The Patients condition is called Homocystinuria . This is a recessive condition in which the

enzyme (cystathione synthetase) is missing. This enzyme converts homocysteine and serine

into cystathione, a precursor of cysteine. Deficiency of this enzyme has widespreadconsequences in the connective tissue, circulation and nervous system.

Patients with this condition are usually particularly tall.


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RCA outcome

Resource issue

Operational procedure issue

New BCH Process

All plasma samples have quantitativeamino acids

Forms are not separated at booking in

Reviewing workload and TAT

Will report back to Trust

? New instrument

Patient doing remarkably well

Sibling also diagnosed


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Clinical governance

Responsibility of everyone

20130618 rwebster clinical governance

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