The importance of PoCTSusan Badman

What, How, Why, When and Where is PoCT?

Benefits of PoCT

Challenges of PoCT

The importance of PoCT

Protecting patients | 2

ISO 22870 Point-of-care testing –

Requirements for quality and competence

defines point-of-care testing as:

“...testing that is performed near or at the

site of a patient with the result leading to

possible change in the care of the

patient...”

What, How, Why, When and

Where is Point-of-Care Testing?

Protecting patients | 3

Protecting patients | 4

http://www.sheknows.com/parenting/articles/961033/history-of-the-pregnancy-test

http://blood-glucose-meters.findthebest.com/guide

http://www.medicacorp.com/applications/blood-gas-analysis/

PatientHealthcare

Setting

Potential Benefits of POCT

Protecting patients | 5

POCT

Benefits

Greater patient convenience and satisfaction

No specimen transport

guided surgical intervention

healthcare cost savingsGreater patient compliance

Patient cost savings

Better health outcomes

smaller specimen volume

Improved patient/doctor relationship

Physician satisfaction

Increasing test menu

Improved doctor/patient relationship

easy incorporation into clinical workflow

Decreased hospital stay

Enhanced clinical management

Increased throughput in ER

PatientHealthcare

Setting

Potential Disadvantages of POCT

Protecting patients | 6

POCT

disadvantages

No specimen available for repeat testing

Increased workload

Additional cost

Increased wait time

Poor health outcomes

inappropriate testing

additional treatment

Increased cost

Potential lack of ability to download

and store results

more expensive cost/test

potential incompatibility with

traditional laboratory methods

Increased consult time

Point-of-care testing has the potential to improvepatient treatment if undertaken within acomprehensive quality management system.

One such example is the use of rapid tests forInfluenza testing in paediatric emergencydepartments.

According to Noyola et al the effect of earlydetection of influenza was a reduction of antibioticusage from 53% to 25% while antiviral use increasedfrom 1.8% to 25%.

Noyola DE, Demmler GJ. Effect of rapid diagnosis on management of influenza A infections. Pediat Infect Dis J. 2000;19(4):303-307

Protecting patients | 7

The most common definition of Evidence-based medicine is

taken from Dr. David Sackett.

Evidence-based medicine is

“…the conscientious, explicit and judicious use of current

best evidence in making decisions about the care of the

individual patient. It means integrating individual clinical

expertise with the best available external clinical evidence

from systematic research.”

(Sackett D, 1996)

http://www.usd.edu/library/evidence-based-medicine-model.cfm

Protecting patients | 8

If applying existing laboratory evidence to point-of-care testing

procedures, it is important to confirm that:

• such evidence matches the patient or group being considered;

• the accuracy and precision of the point-of-care test system is

appropriate for the proposed purpose;

• conclusions derived from high quality data are not transferred to

situations in which the analytical results are provided at an inferior

level of testing;

• there is good concordance between the proposed point-of-care

test results and established laboratory test procedures, such that

reference intervals and action limits in current use are applicable;

and

• clinical practice guidelines are still applicable.

Protecting patients | 9

“The four main challenges are,

(a) producing the evidence to demonstrate that POCTimproves outcomes,

(b) changing clinical practice to deliver the benefit,

(c) maintaining clinical governance for a more distributedlaboratory medicine service, and

(d) adjusting the resource allocation to reflect the likelyincrease in investment in the POCT technology, whilerecouping the resources from the point in the pathway atwhich the benefits are made.”

Point-of-Care Testing: Needs, Opportunity, and Innovation, 3rd Edition.Christopher P. Price, Andrew St John, Larry J. Kricka, eds. Washington, DC,AACC Press, 2010, ISBN: 9871594251030.

Protecting patients | 10

According to the International

Organisation for Standardisation (ISO)

quality is defined as the

“..totality of characteristics of an entity

that bear on its ability to satisfy stated and

implied needs..”

Protecting patients | 11

The desired approach is for

appropriate standards which

support quality testing, not

minimum standards that provide

the chance for quality failures.

Protecting patients | 12

Is the testing fit for purpose?

Is the testing of sufficient quality? Is the quality being maintained?

Are the operators performing the testing trained, skilled and

competent?

Are the equipment and facilities appropriately maintained?

Do the POCT devices comply with defined technical specifications?

Is the testing provided in a safe environment?

Is there a consistent base for all testing and some consistency

amongst service providers?

Are patient records managed appropriately and consistently?

Is testing controlled and appropriate?

Is there a mechanism to assess the distribution of funding?

Protecting patients | 13

Protecting patients | 14

http://www.qaams.org.au

Protecting patients | 15

http://www.starobserver.com.au/news/local-doctors-offer-rapid-hiv-testing-early/100200

Protecting patients | 16

http://www.aleretoxicology.co.uk

“Although POCT appears to be deceptively simple, if

incorrectly performed it may present a risk to patient

care and, if used inappropriately or overused can lead to

significant increases in the cost of patient care. To

ensure results obtained are comparable to the traditional

pathology laboratory, POCT should be implemented

within a framework of quality standards.” … “This

quality framework should include: operator education,

training and competency, quality control, proficiency

testing and accreditation.”

Tirimacco R. Design, implementation and outcomes for POCT: cost

implications. POC 2008; 7 (3): 128.

Protecting patients | 17

According to Sharp et al there were reductions in point-

of-care testing error via periodic inspection and

accreditation processes. The authors “...found that

inspection correlated directly with laboratory error.” That

is, fewer errors were produced as the number of

inspections by the point-of-care manager increased.

Their results emphasised “..that the challenges to

management of POCT are the same as those for clinical

laboratory testing, and indicate that need for measures

for continual and methodical surveillance of all

laboratory testing.”

Sharp GH, etal. Physician office testing – The importance of ongoing

monitoring. POC 2003; 2(3): 179.

Protecting patients | 18

Point-of-care quality assurance includes all the measures

taken to ensure that investigations are reliable such as:

• correct patient ID;

• appropriate test selection;

• collecting an adequate specimen;

• analysing the specimen in a timely manner;

• recording the results promptly and correctly;

• interpreting the result accurately;

• taking all appropriate actions;

• documenting all procedures;

• ensuring all internal QC requirements are met;

• participate in an EQA scheme to an acceptable standard;

• correct any nonconformities.

Protecting patients | 19

In a study conducted by the CDC Good laboratory practices for

waived testing sites, the principle deficiencies were found to be that

sites did not:

• perform the minimum QC as specified by the manufacturer (21%);

• routinely check new product inserts for changes (21%);

• report test results with appropriate terminology or units (18%);

• have current manufacturer’s instructions (12%);

• comply with expiration dates (6%);

• perform the required function or calibration checks (5%);

• perform instrument maintenance (3%);

• adhere to storage and handling instructions (3%);

• use an appropriate specimen for the test (2%).

Protecting patients | 20

RCPAQAP HIV POCT 2011 - 2014

Protecting patients | 21

0%

5%

10%

15%

20%

25%

30%

35%

40%

45%

RCPAQAP HIV POCT expired kits

0%

5%

10%

15%

20%

RCPAQAP HIV POCT out of consensus results

Protecting patients | 22

...point-of-care testing errors are

relatively common, and it must be

identified that the likelihood of

affecting patient care is amplified

by rapid availability of results and

immediate therapeutic

implications...

Protecting patients | 23

Connectivity can:

• increase productivity and safety:

• improve reporting;

• be integrated with eHealth records;

• streamline billing;

• be used to streamline QC and QA practices;

• reduce error, ultimately increasing patient safety.

Protecting patients | 24

For point-of-care testing to provide valuein the general practice situation “...Aneffective quality management system isessential. Clinicians need reassurancethat their decisions are based on reliable,accurate and precise results to ensure thatpatient safety is not compromised.”

Australian Government, Department of Health and Ageing. Point of care testing in general practice trial. http://www.health.gov.au/internet/main/publishing.nsf/Content/health-

pathology-poctt-index.htm Accessed September 2014.

Conclusion

Protecting patients | 25

“Inherent with POCT growth

come challenges in performing

high quality accurate testing.

Decreasing laboratory errors

and improving patient safety

must also be considered…”

Sautter RL and Lipford EH. Point-of-care-testing: Guidelines and

challenges. North Carolina Medical Journal 2007;68: 132.

Protecting patients | 26

Review Policies, Procedures and Guidelines for Point-of-Care Testing. Prepared on behalf of the RCPA QualityAssurance Programs Pty Limited by Ian Farrance BSc MCB FAACB FRCPath April 2012.

ISO 22870:2006. Point-of-care testing (POCT) – Requirements for quality and competence.

http://www.sheknows.com/parenting/articles/961033/history-of-the-pregnancy-test

http://blood-glucose-meters.findthebest.com/guide

http://www.medicacorp.com/applications/blood-gas-analysis/

Noyola DE, Demmler GJ. Effect of rapid diagnosis on management of influenza A infections. Pediat Infect Dis J.2000;19(4):303-307

http://www.usd.edu/library/evidence-based-medicine-model.cfm

Evidence-based Laboratory Medicine: Supporting Decision-Making. Christopher P. Price, Clin Chem 2000; 46:1041.

Point-of-Care Testing: Needs, Opportunity, and Innovation, 3rd Edition. Christopher P. Price, Andrew St John,Larry J. Kricka, eds. Washington, DC, AACC Press, 2010, ISBN: 9871594251030.

References

Protecting patients | 27

National Academy of Clinical Biochemistry (NACB). Laboratory medicine practice guidelines: Evidence-based

practice for point-of-care testing. 2006.

http://www.aacc.org/SiteCollectionDocuments/NACB/LMPG/POCTLMPG.pdf#page=1 Accessed September 2014.

Bubner TK, etal. Effectiveness of point-of-care testing for therapeutic control of chronic conditions: results from

the POCT in general practice trial. MJA 2009; 190: 624.

St John A. The evidence to support point-of-care testing. Clin Biochem Rev 2010; 31: 111.

http://www.qaams.org.au

http://www.starobserver.com.au/news/local-doctors-offer-rapid-hiv-testing-early/100200 Accessed September 2014

Shephard M, Leobie A, Dimech W, Condie D and Nolan M. Guidelines and recommendations for the quality-

assured conduct of Point-of-Care testing for infectious diseases and drugs of abuse in Australia. Aust J Med Sci

2012 33:143-154.

http://www.aleretoxicology.co.uk

References

Protecting patients | 28

World Health Organisation. Guidelines for Assuring the Accuracy and Reliability of HIV Rapid Testing: Applying aQuality System Approach. Geneva. WHO; 2005.

World Health Organisation. The use of Malaria Rapid Diagnostic Tests. Second edition. Geneva. WHO; 2006.

World Health Organisation. How to use rapid diagnostic tests (RDT): A guide for training at a village and cliniclevel. Geneva. WHO; 2009.

National HIV Testing Policy 2011 version 1.3 http://testingportal.ashm.org.au/hiv Accessed September 2014.

National Hepatitis B Testing Policy 2012 v1.1 http://testingportal.ashm.org.au/hbv Accessed September 2014.

National Hepatitis C Testing Policy 2012 v1.1 http://testingportal.ashm.org.au/hcv Accessed September 2014.

AS/NZS 4308:2008 Procedures for specimen collection and the detection and quantitation of drugs of abuse inurine.

Tirimacco R. Design, implementation and outcomes for POCT: cost implications. POC 2008; 7 (3): 128.

Plebani M. Does POCT reduce the risk of error in laboratory testing? Clin Chim Acta 2009; 404: 59.

Nichols JH. Medical errors – Can we achieve an error-free system? POCT 2005; 4(4): 139.

References

Protecting patients | 29

Thompson ND and Perz JF. Eliminating the blood: ongoing outbreaks of hepatitis B virus infection and the need

for innovative glucose monitoring technologies. J Diab Sci and Technol 2009; 3(2): 283.

Sharp GH, etal. Physician office testing – The importance of ongoing monitoring. POC 2003; 2(3): 179.

Bonini P, etal. Errors in laboratory medicine. Clin Chem 2002; 48: 691

Centers for Disease Control and Prevention (CDC). Good laboratory practices for waived testing sites.

http://www.cdc.gov/mmwr/PDF/rr/rr5413.pdf Accessed September 2014.

http://www.tga.gov.au/consumers/information-devices-hiv-rapid-tests-alere-determine.htm#.VAfD601Zp9M

Accessed September 2014.

http://www.health.gov.au/internet/main/publishing.nsf/Content/35C1FC4407C2FAC4CA257BF0001F9EC5/$File/PCE

HR_Pathology_Consultation_Paper.PDF Accessed September 2014.

Australian Government, Department of Health and Ageing. Point of care testing in general practice trial.

http://www.health.gov.au/internet/main/publishing.nsf/Content/health-pathology-poctt-index.htm Accessed

September 2014.

Sautter RL and Lipford EH. Point-of-care-testing: Guidelines and challenges. North Carolina Medical Journal

2007;68: 132.

References

Protecting patients | 30