Name : Suzanna Immanuel

Place, date of birth : Jakarta, 11th March 1953

Education : MD–FMUI 1978

Profession : Clinical Pathologist (SpPK) – FMUI 1984

Consultant [SpPK(K)] – ISCP (PDSPatKlin) 1996

Office : Department of Clinical Pathology

Faculty of Medicine, Universitas Indonesia &

Perjan Dr. Cipto Mangunkusumo General Hospital,

Jakarta

Position : Senior lecturer

Head of Metabolic Endocrine Division Department CP

FMUI

Professor at Faculty of Medicine Universitas Indonesia

(POCT vs NON POCT)

Suzanna Immanuel

Department of Clinical Pathology FMUI /CMGH

Jakarta

Central Laboratory : Electrochemical

Detector: Ion selective electrode

POCT:Measure by dry chemistry OR single use

disposable cartridge sensor system

The Benefit of Blood Gas Analysis

Management for emergency patient

Monitoring therapy for cardiopulmonary and

metabolic disturbance patient

Has been achieve if the result quick and accurate

Ion Selective Electrode

Blood Artery and Vein

PO2 : 90 mmHg PO2 : 35 mmHgPCO2 : 40 mmHg PCO2 : 45 mmHgpH : 7.40 pH : 7.36

Artery

Tissue

Vein

Acid Production

pH blood Vein > acid

blood artery

pH Normal

Intracell pH 7.0

Artery pH 7.40

Vein pH 7.36

Acid Production

Metabolism

O2Acid respiratory

& metabolic

Acid excreted from the body through pulmonary & kidney

Defined as :

Laboratory benchtop analyzer(traditionally)

Placed in a central location Located on or close to critical

care / surgical unit Retains functional requirements

of lab. based system (e.g.maintenance, QC)

Nurse must leave bed to performtest

Near Patient Testing

Defined as :

Portable hand held analyzers Testing performed at patient

bedside Care giver performs rest &

integrated into care process Results within 5” of sample draw Functional requirements

(compared to lab. analyzers)minimized

Point Of Care Testing

Definition of Terms

Useful enough?

• Analyticalperformance

• TAT• Clinical significance

Saving or expense?

• Analytical costs• Number of tests• TQM requirement

• QC• External QA• Workforce

requirement• Training &

competency

How to implement them in our institutions?

• Organization• Defining what we

need• Selecting the

instrument/vendor • Implementation

• Training• Communication

• Evaluation

Considerations

Are They Useful Enough?

Analytical performance

Turn Around Time

Clinical significance

Analytical Performance

Do the current POC diagnostics provide

the required sensitivity and accuracy ?

Requirements differ depending on circumstances;

quality of results dependent also on competent use

TAT: Progression to POC testing

Central/STAT Lab

• TAT: 30 minhours

Near patient testing

• TAT: 5 – 15 min

Point-of-care• TAT: <5 min

Key Drivers : Reduced turn around times

Medical necessity in critical care

POCTBlood Gas Analysis

Harvey M : Point of care laboratory testing in critical care, American Journal of Critical Care, 3/99

Surgery Cancellations

Reduced

Monitoring of Therapy Response

Rapid Intervention

Improved Patient

Management

ICU Stay Reduced

DrugsSurgeryAppropriate TherapyVentilation

FOCUS : Patient Care

Does Reduced TAT Lead to Improved Outcomes?

Research project in A&E Department, Bristol

Reduced time to result

Allowed faster decision making

Reduced time to treatment

Timing critical in 7% of patients

Patients spent no less time in A&E

Did not improve clinical outcomeKendall: BMJ 1998

Faster is not always better

Changes in patient management and

workflow are more efficient than simple

implementation of POCT Nichols et al. Clin Chem 2000;46:543-550

Heyningen et al. Clin Chem 1999;45:437-438

Kendall et al. Br Med J 1998;316:1052-7

Parvin et al. Clin Chem 1996;42:711-717

Faster is not always better !

The most important quality of a laboratory result, regardless of

where it is performed is its…

…accuracy and precision because ultimately they have

the greatest impact on patient outcome!

REDUCED TAT

REDUCED TTAT

Better clinical

decision

IMPROVED CLINICAL OUTCOME

Clinical Significance

Evidence based medicine:NACB recommendation

ICUGuideline 37.

There is fair evidence that more rapid TTAT of ABG results inseveral types of ICU patients leads to IMPROVED CLINICALOUTCOMES Strength/consensus of recommendation: B Level of evidence: I

Guideline 38.There is fair evidence that POCT of ABG results in the ICU leads toimproved clinical outcomes when POCT is found to lead toREDUCED TTAT Strength/consensus of recommendation: B Level of evidence: II

(More prospective randomized controlled studies need to be performed)

NACB: Laboratory medicine practice guidelines:Evidence-based practice for point-of-care testing. AACCPress 2006.

Evidence based medicine:NACB recommendation

EMERGENCY DEPARTMENT (ED) Guideline 40

There is fair evidence that more rapid TTAT of ABG results inseveral types of ED patients leads to IMPROVED CLINICALOUTCOMESStrength/consensus of recommendation: BLevel of evidence: II

Guideline 41There is fair evidence that POCT of ABG results in the ED leadsto improved clinical outcomes when POCT is found to lead toREDUCED TTATStrength/consensus of recommendation: BLevel of evidence: II

(More prospective randomized controlled studies need to be performed)

NACB: Laboratory medicine practice guidelines:Evidence-based practice for point-of-care testing. AACCPress 2006.

Evidences showed that ABG POCT has been

useful but ….it depends on many factors

The people

The system

The equipments

COSTS of POCT

Is POCT more expensive than laboratory testing?

Baer 1998:

About half the literature demonstrated that it was,

BUT most studies did not consider the costs of the

whole patient episode

Therefore true costs depend on the clinical situation,

the test and the treatment system of which POCT is

part – and the value assigned to outcomes

Influences on True Costs of POCT

Excessive or inappropriate testing: the Mallory

approach: “because it’s there”

Continuing requests to main lab: “just to make sure”

Poor quality and increased risk: no analytical quality

procedures, poor compliance with training errors harm

to patients, wasted consumables

Time out of clinical work perform test

Hidden costs of supervision of POCT, user training,

managing QC and EQA

Equipment & Personnel Expenses

Staffing, training & responsibility consideration More people to be trained and observed

QC , EQA and TQM

• 1 or 2 ABG devices for many tests, servingmany/all locations

• 3 – 6 personnel

Central Lab

• 1 or 2 devices for each location• More than 3 locations e.g. ICU, NICU, ED (>2), OR

(>2)• More than 6 devices for one hospital?• 6 – 12 personnel must be competent in each location,

for just a few tests

POCT locations

Evidence based medicine:NACB recommendation – ABOUT COST

ICUGuideline 39

There is some evidence that POCT of ABG results in the ICU may

lead to reduced costs… but the balance of benefit to no benefit is

too close to justify.

No recommendation for POCT of ABG results being considered as

a way to reduce costs..

Strength/consensus of recommendation: I

(Insufficient evidence)

Level of evidence: II

(More prospective randomized controlled studies need to be performed)

NACB: Laboratory medicine practice guidelines:Evidence-based practice for point-of-care testing. AACCPress 2006.

The Process

Planning: costs, equipments, supporting network

and staffing

Defining what we need

Detailed specification

Assess the performance of equipment

Procurement and installation

Training

IQC, EQA, audit, continuous quality monitoring

and improvement

Changing Laboratory Role :One Solution – The POC Coordinator

LaboratoryPoint Of Care Coordinator

In context of a team

Active team participant, not a policeman

Quality Assurance QC procedures User certification / registration Record documentation

Training Nurses Train the trainer Certified course

Device Evaluations Accuracy Ease of use Maintenance requirements

Inventory Management Manage reagents / consumables Maximize uptime Prevent depletion Maintain storage requirements

Monitoring QC (liquid & electronic) Test usage Analyzer failure logs Compliance with

accreditation standards

Equipments Selection

ABG devices:

Analytical performance, features, ease of use,

training & after sales support

Recommended: Bar-coding system

IT support

Hardware

Software

Blood gas identification errors: manual vs. bar-coded

Nichols JH, Bartholomew C, Brunton M. Reducing medical errors through barcoding at the point of care. ClinLeadership Manag Rev 2004; 18: 328-334.

Features of Critical care analyzers that minimize risk of errors and contribute to ease of use

Long-life, maintenance freeelectrodes or disposable sensorpacks

Touch screens as the userinterface

Software that can demand userand patient identification

Built-in barcode scanners

Reduced sample sizes

Clot detection within thedetection chamber

Sample detection to preventshort samples

Liquid calibration systemsinstead of gas bottles

Automated calibrations

Automated QC sampling

Sophisticated QC programsincluding interpretation ofdata

Connectivity to informationsystems allowing remotemonitoring and control

St. John A. Benchtop instruments for point-of-care testing. In: Price CP, St John A, Hicks JM. Point-of-care testing. 2nd

ed. AACC Press. 2004. p.33.

POCT Needs connectivity & Interfaces to LIS

Because: Large amountof time & labor

Result : – Processing exceptions

– Handling compliance issues

– Meeting regulatory

Required manually download results

Patients & QC results Not properly managed

Delayed / Avoided

Summary of Compliance Impact Pre & Post-Connectivity

Pre-connectivityPost-connectivity

OperatorErrors

QC applicationerrors

QC commenterrors

Totalexceptions

Exception Type

450

400

250

300

350

200

150

0

100

50

231.7

37.3

433.3

20.7

66.7

31.7

135.0

89.7

Benefit POCT Program with Connectivity

Time & labor requirements

Improves workflow : Down load results

Print reports

Evaluate QC

Patient test report

POCT

POCT

POCT

POCT

POCT

STAT

STAT

POCT

Satellite laboratory

Satellite laboratory

Satellite laboratory LIS HIS

LIS : Laboratory information system ; HIS: Hospital information system

Pearson & Barnes. Approaches to delivering a laboratory medicine service: distributed laboratory services. In: Price CP, St John A, Hicks JM. Point-of-care testing. 2nd ed. AACC Press. 2004. p.86

Recommended: POCT ABG to LIS/HIS interface for a better flow & documentation of results

Training: for correct performance of testing

Awareness of pre-analytical factors

Obtaining the correct specimen

The importance of clinical contraindications

Sample handling

Stability of sample

Stability of reagents, test devices

Modified from: Wood JF & Burnett D. Training and certification for point-of-care testing. In: Price CP, St John A, Hicks JM. Point-of-care testing. 2nd ed. AACC Press. 2004. p.122.

Training: for correct performance of testing

Analytical skills:

Operation, calibration, and routine maintenance

Understanding of any analytical limitation of the

instrument or test system

Recognize instrument malfunction and able to do

simple trouble shooting techniques

Principles, procedures and documentation of

internal QC & External QA and patient results

Cleaning, decontamination, and disposal procedures

Modified from: Wood JF & Burnett D. Training and certification for point-of-care testing. In: Price CP, St John A, Hicks JM. Point-of-care testing. 2nd ed. AACC Press. 2004. p.122.

Training to ensure correct action is taken when the test result is obtained

Action to be taken if result is outside the limits of

the test system

Action to be taken if the result is within or outside

preprescribed action, critical or alert limits

Basic knowledge of the importance of abnormal results

Accurate documentation of patient data

Wood JF & Burnett D. Training and certification for point-of-care testing. In: Price CP, St John A, Hicks JM. Point-of-care testing. 2nd ed. AACC Press. 2004. p.122.

Certification of training / competence and post-training surveillance

Use multiple assessment techniques

Techniques for assessing competence Self assessment

Multiple-choice questionnaire

Peer comparison

Written examination

Observation

Certificate: unique identifying number, expiry date,

name of the trainee, areas of competence (tests and

equipments), signed by the trainer and supervisor.

Post-training surveillance: continuous review process

Wood JF & Burnett D. Training and certification for point-of-care testing. In: Price CP, St John A, Hicks JM. Point-of-care testing. 2nd ed. AACC Press. 2004. p.122.

Pearson J. Point-of-Care Testing: the future? Leeds Teaching Hospitals (UK).

“HORROR STORIES”

A locum junior doctor used the blood gas analyser

without training, found a v low pH, at variance with

the patient’s clinical condition, but intended to treat

with bicarbonate. The sister insisted on checking.

Correct pH was in the normal range. The doctor

had used the analyser incorrectly and the

unnecessary treatment could have seriously

harmed the patient (LTH)

The Advantage of POCT

Reduced TAT

Rapid data availability

pre-analytical & post-analytical testing errors

Self contained & user friendly instruments

Small sample volume requirements

Frequent serial whole – blood testing

The Disadvantage of POCT

Major concerns are regarding analyzer in accuracy,

imprecision & performance (interfering substances)

Poorly trained non-laboratories

High cost of tests

No quality assurance program

No documentation

Difficult to manage on regulatory un-supervision

Precision is not good at the very low and very high

concentration.

Will POC diagnostics replace lab base diagnostics or

Will it be the other way around?

Both are an essential & integral part of diagnostic

provision and will continue to be in the

foreseeable future

Blending of deliveries is needed

NEITHER !

SUMMARY

POCT has been remarkable development in

laboratory medicine

POCT has advantage and disadvantage vs non POCT

POCT & non POCT BOTH are AN ESSESNTIAL

& INTEGRAL PART of DIAGNOSTIC provision

Patient centered care …

Defined as :

Laboratory benchtop analyzer(traditionally)

Placed in a central location Located on or close to critical

care / surgical unit Retains functional requirements

of lab. based system (e.g.maintenance, QC)

Nurse must leave bed to performtest

Near Patient Testing

Defined as :

Portable hand held analyzers Testing performed at patient

bedside Care giver performs rest &

integrated into care process Results within 5” of sample draw Functional requirements

(compared to lab. analyzers)minimized

Point Of Care Testing

Definition of Terms

Choosing the right analyzers for the right test volumes

Benchtop Cartridge-based Single-use / handheld

Not portable Semiportable Truly portable

Amount of maintenanceis progressively reducing

Little maintenance Least maintenance

Maybe the most cost-effective system formedium to large testvolume

May be cost-effectivefor medium to largetest volumes

May be only be cost effectivefor small to medium testvolumes

St. John A. Benchtop instruments for point-of-care testing. In: Price CP, St John A, Hicks JM. Point-of-care testing. 2nd ed. AACC Press. 2004. p.33.