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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

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point of care testing in home and hospital

Point-of-Care testingin home and hospital

22nd Biomedical Instrumentation conference

Asst. Prof. Somchat Taertulakarn

Allied Health Sciences Faculty

Thammasat University

introduction
Introduction

Point-of–Care-Testing (POCT)

  • Providesanalternative

tolaboratorytesting

  • Thatiseasy, portable,

andaccurate

  • Allowsfortestingeither

byphysicianorpatient

slide4

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
slide5
bedside analysis, near-patient analysis

decentralized analysis, andoff-sit analysis

http://alphainternationalmall.com/Glucose_Monitors.html

advantages of poct
Advantages of POCT
  • Reduce TAT
  • Reduce errors
  • Reduce paper
  • Smaller sample size(microliters vs. milliliters)
poct advantages
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)
poct advantages1
POCT: Advantages
  • Reduces the risk of preanalytical errors
    • the handling
    • the labeling
    • the transportation of samples
  • No need laboratorian staff. ???
poct disadvantages
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
poct disadvantages1
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.
slide13
What were some of

the most important ‘tools’

that you used when you

first got involved

with POCT?

poct informatic tools
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

what s driving poc informatics
What’s Driving POC Informatics?
  • Hospital POC growth rate
  • Decentralized patient testing
  • Reducing overall healthcare costs
the information revolution
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
trends
Trends…

1. It’s not just glucose anymore…

poct is not just for glucose
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%

trends1
Trends…
  • It’s not just glucose anymore…
  • Goodbye Paper…Hello e-Patient
goodbye paper hello e patient
Goodbye Paper…Hello e-Patient!

It’s a “Paperless” World!

  • EMRs reduce overhead andimprove efficiency
  • EMRs increase patient care
goodbye paper hello e patient1
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
trends2
Trends…
  • It’s not just glucose anymore…
  • Goodbye Paper… Hello e-Patient
  • Zero Tolerance for Errors!
zero tolerance of medical errors
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
in the future
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
trends3
Trends…
  • It’s not just glucose anymore…
  • Goodbye Paper… Hello e-Patient
  • Zero Tolerance for Errors!
  • Where have all the Med Techs gone??
slide28
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

slide29
Purpose?
    • Monitoring chronic disease (or acute disease in ICUs)
    • Diagnosis, risk stratification
    • Screening
examples of poc tests
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

slide32

Presicion Plus

Medisense

Accu-chek

Roche Diagnostics

EuroFlash

Lifescan

amperometric method
Amperometric method

Glucoseoxidase

slide34

HemoCue

HemoCue AB

OneTouch

Lifescan

photometric
Photometric

Glucoseoxidase,Peroxidase

poct closer to home
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
the use of portable coag devices
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
management of poct
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

the multidisciplinary poct group
The multidisciplinary POCT group
  • Laboratory professional (Chair)
  • POCT Co-ordinator(s)
  • Nurse
  • Clinicians
  • Information Technology Manager
  • Medical Equipment Manager
  • Accountant
  • Pharmacist
  • Risk / Safety Officer
documentation
Documentation

Statement of intent

POLICY

Instructions

PROCEDURES

Evidence

RECORDS

poct policy
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

procedures and instructions
Procedures and instructions
  • Sample collection
  • Use of equipment
  • Recording results
  • Document control

PROCEDURES

providing the evidence
Providing the evidence
  • Application for POCT device
  • Certificate of competence
  • Maintenance log form
  • Electronic logs
  • QC records

RECORDS

training
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
certification
Certification
  • Assessment of competence
    • Written test
    • Multiple choice questionnaire
    • Direct observation
  • Update training
    • EQA
    • Updates
    • Self assessment
  • Training records
    • Certificates
    • Central record
poct accreditation standards
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

data management at home
Data Management at Home
  • Provides direct oversight by the care provider
  • Eliminates patient transcription errors
  • Allows for timely medication adjustment
  • Improves patient satisfaction
slide52
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).

slide53
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.

slide54
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.

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