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Point-of-Care testing in home and hospital






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Point-of-Care testing in home and hospital. 22 nd Biomedical Instrumentation conference. Asst. Prof. Somchat Taertulakarn Allied Health Sciences Faculty Thammasat University. Introduction. Point - of –Care- Testing ( POCT ) P rovides an alternative to laboratory testing
Point-of-Care testing in home and hospital

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Slide 1

Point-of-Care testingin home and hospital

22nd Biomedical Instrumentation conference

Asst. Prof. Somchat Taertulakarn

Allied Health Sciences Faculty

Thammasat University

Slide 3

Introduction

Point-of–Care-Testing (POCT)

  • Providesanalternative

    tolaboratorytesting

  • Thatiseasy, portable,

    andaccurate

  • Allowsfortestingeither

    byphysicianorpatient

Slide 4

Point-of–Care-Testing

  • Cost-effective for many disease ,such as diabetes, acute coronary syndrome

  • Results can be shared instantaneously with all members of the medical team through software interface enhancing communication by decreasing turn around time

Slide 5

bedside analysis, near-patient analysis

decentralized analysis, andoff-sit analysis

http://alphainternationalmall.com/Glucose_Monitors.html

Slide 7

Where it all began 20 years ago?

Slide 8

Advantages of POCT

  • Reduce TAT

  • Reduce errors

  • Reduce paper

  • Smaller sample size(microliters vs. milliliters)

Slide 9

POCT: Advantages

  • Faster stabilisation of life-threatening crises (drug overdose, electrolyte disturbance)

  • Closer therapeutic management (eg. diabetes)

  • Better patient compliance with therapy (diabetes, anticoagulation, hyperlipidaemia)

  • Reduce:

    • repeat clinic/practice visits

    • length of stay in hospital

    • complications (intra- & postoperative)

    • use of blood products (surgery)

Slide 10

POCT: Advantages

  • Reduces the risk of preanalytical errors

    • the handling

    • the labeling

    • the transportation of samples

  • No need laboratorian staff. ???

Slide 11

POCT: DISADVANTAGES

  • Analytical performance can be inferior to lab (eg. glucose meters), so need lab backup

  • Risk of poor operator competence

  • Risk of poor quality patient information

  • Risk of poor equipment maintenance

Slide 12

POCT: DISADVANTAGES

  • Cost per test (>>lab), so look at clinical & economic OUTCOMES of patient episode

  • All depend on the way equipment is selected and used

  • Lack of adequate documentation

    • results may get mishandled or misplaced

    • have an affect on potential reimbursement issues.

Slide 13

What were some of

the most important ‘tools’

that you used when you

first got involved

with POCT?

Slide 14

POCT Informatic Tools

Early to mid 1990’s

  • Bench-top analyzers

  • Touch screen PCs

  • Results sent to centrallaboratory for analysis

University of Virginia Health Science Center – Original Home of RALS Technology

Slide 15

What’s Driving POC Informatics?

  • Hospital POC growth rate

  • Decentralized patient testing

  • Reducing overall healthcare costs

Slide 16

The Information Revolution…

As POCT evolves, needs will include:

  • Instant information

  • Getting more data to the EMR

  • Continuous glucose testing and monitoring

  • Open IT standards

  • RF and web-based communication and connectivity

  • Optimum security

Slide 17

Emerging Trends inPoint-of-Care and theirImpact on Data Management…

Slide 18

Trends…

1. It’s not just glucose anymore…

Slide 19

POCT is Not Just for Glucose!

% of Hospitals with POC Devices by Discipline

98%

Glucose

99%

51%

Coagulation

62%

34%

Blood Gas

50%

14%

Chemistry

36%

18%

Hematology

28%

5%

Urinalysis

1999 (510 Hospitals)

15%

2001 (584 Hospitals)

1%

Cardiac

Source: Enterprise Analysis Corp. Stamford, CT

3%

Slide 20

Trends…

  • It’s not just glucose anymore…

  • Goodbye Paper…Hello e-Patient

Slide 21

Goodbye Paper…Hello e-Patient!

It’s a “Paperless” World!

  • EMRs reduce overhead andimprove efficiency

  • EMRs increase patient care

Slide 22

Goodbye Paper…Hello e-Patient!

  • Download stations must always down load

  • Servers must always be on the network

  • Connections to host systems (LIS/ HIS) never lost

Slide 24

Trends…

  • It’s not just glucose anymore…

  • Goodbye Paper… Hello e-Patient

  • Zero Tolerance for Errors!

Slide 25

Zero Tolerance of Medical Errors

The Need for Data Management

  • Total control of POCT Programfrom device to operator topatient to test order

  • Federal initiative launched to reducemedical errors and improve patient safety

Slide 26

In the Future….

Look for more patient outcome data

  • Statistics to validate quality

  • New reports to allow users to sort data on various criteria such as nursing unit, patient, result, etc.

  • POCT as a separate laboratory department

Slide 27

Trends…

  • It’s not just glucose anymore…

  • Goodbye Paper… Hello e-Patient

  • Zero Tolerance for Errors!

  • Where have all the Med Techs gone??

Slide 28

  • Who does POCT?

    Doctors Nurses Ambulance paramedics

    Pharmacists

    Patients Careers Retail & Leisure centre staff

  • Where?

    ICUs Operating theatres

    A&E Delivery Suites

    General wards Ambulances

    GP surgeries Pharmacies

    Field hospitals Retail & leisure centers

Slide 29

  • Purpose?

    • Monitoring chronic disease (or acute disease in ICUs)

    • Diagnosis, risk stratification

    • Screening

Slide 30

EXAMPLES OF POC TESTS

• Bilirubin

• PTH

• Paracetamol, salicylate

• Drugs of abuse

• Occult blood (faecal or

gastric)

• Urinalysis: blood, albumin,

hCG, ketones, glucose,

leucocytes, pH, nitrite,

• CRP, Infections

• Coagulation, TEG

• Haemoglobin/Haematocrit

• Blood gases: pH,

pCO2 pO2

• Na, K, Ca, Cl-

• Lactate

• Glucose

• HbA1c

• Urea, Creatinine

• Cholesterol, TGs

• BNP

• Troponin, CK-MB,

Myoglobin

Slide 31

Glucose meter

Slide 32

Presicion Plus

Medisense

Accu-chek

Roche Diagnostics

EuroFlash

Lifescan

Slide 33

Amperometric method

Glucoseoxidase

Slide 34

HemoCue

HemoCue AB

OneTouch

Lifescan

Slide 35

Photometric

Glucoseoxidase,Peroxidase

Slide 39

POCT Closer to Home…

  • 2 million+ on Anti-Coagulation therapy

  • Warfarin - 22nd most common drug

  • 1,100 Clinics growing at 20% a year

  • Indications

    • Atrial fibrillation

    • Heart Valve replacement

    • Stroke

Slide 40

The Use of Portable Coag Devices…

Bedside testing enables:

  • Home health providers to make immediate changes in coagulation therapy if necessary

  • Frequent testing = Fewer complications

  • Home testing with data communication= improved patient management

Slide 41

Management of POCT

Director of Pathology

Healthcare

Professionals

Group

POCT Group

Primary care

ICUs

Wards

A/E

Dip sticks

HbA1c

Cholesterol

Blood gases

Glucose

Dip sticks

Glucose

MI markers

Drug

Preg tests

Slide 42

The multidisciplinary POCT group

  • Laboratory professional (Chair)

  • POCT Co-ordinator(s)

  • Nurse

  • Clinicians

  • Information Technology Manager

  • Medical Equipment Manager

  • Accountant

  • Pharmacist

  • Risk / Safety Officer

Slide 43

Documentation

Statement of intent

POLICY

Instructions

PROCEDURES

Evidence

RECORDS

Slide 44

POCT Policy

  • Needs and requirements of users

  • Laboratory Support

  • Selection and siting of Equipment

  • Validation (technical & diagnostic)

  • Health, safety and risk management

  • Training

  • Procedures

  • Quality Control

  • Post analytical

  • Patient records

  • Other records

  • Cost

  • Audit

POLICY

Slide 45

POCT Management Procedure

PROCEDURES

Slide 46

Procedures and instructions

  • Sample collection

  • Use of equipment

  • Recording results

  • Document control

PROCEDURES

Slide 47

Providing the evidence

  • Application for POCT device

  • Certificate of competence

  • Maintenance log form

  • Electronic logs

  • QC records

RECORDS

Slide 48

Training

  • Who is trained?

    • Nurses/Doctors

    • Medical assistants

  • Who does the training?

    • Laboratory staff

  • What is the content?

    • Knowledge

    • Practical skills

    • National/International Occupational Standards

Slide 49

Certification

  • Assessment of competence

    • Written test

    • Multiple choice questionnaire

    • Direct observation

  • Update training

    • EQA

    • Updates

    • Self assessment

  • Training records

    • Certificates

    • Central record

Slide 50

POCT accreditation standards

Hospital controlled POCT

ISO 15189:2003

Medical laboratories - Particular

requirements for quality and competence

Non Hospital POCT – Primary care

ISO 22870:2006

Point-of-care testing` (POCT) -- Requirements for quality and competence

Pharmacists

UKAS Individual Licence

Slide 51

Data Management at Home

  • Provides direct oversight by the care provider

  • Eliminates patient transcription errors

  • Allows for timely medication adjustment

  • Improves patient satisfaction

Slide 52

1. Where are POCT diagnostics currently being used?

2. What are their benefits over lab based clinical

diagnostics?

Depends on clinical context, circumstances & quality of

local POCT management

3. What are their current limitations?

Cost, IT networking capability, ?wireless, ease of use,

insufficiently “idiot-proof” and robust, range of tests

available. Need more non-invasive systems (eg bilirubin)

Little currently on the market for continuous minimally

invasive monitoring (eg for diabetes).

Slide 53

4.What features could be improved?

Simplicity of use, miniaturisation, robustness (device &

consumables), costs, IT connectivity, remote lockout for

unaccredited users, decision support software, inclusion of

quality materials within costs, training support. Suppliers to

encourage “whole system” approach to implementation as

part of local diagnostic support.

5. Do they provide clinically useful information? Are they what clinicians want?

Very dependent on appropriate implementation and

consideration of outcomes. Clinicians want ease of use,

reliability, low cost. Managers want improved capacity &

throughput, reduction of beds and staff costs.

Slide 54

6. Do the current POCT diagnostics provide the

required sensitivity and accuracy?

Requirements differ depending on circumstances; quality of

results dependent also on competent use

7. Will POCT diagnostics replace lab based

diagnostics or will it be the other way round?

NEITHER: both are an essential & integral part of

diagnostic provision and will continue to be in the

foreseeable future.

Major changes in profiles of healthcare provision, IT

developments, analytical technology, requirements of

Clinical Governance and risk management --> blending of

deliveries and need for increasing flexibility of systems.

Slide 55

PATIENT-CENTRED CARE

Slide 56

Thank you for your attention


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