charlie houston point of care past,present & future

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POCT Past ,Present & Future Charlie Houston Senior Specialist Biomedical Scientist [email protected]

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Overview of Point of Care testing

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Page 1: Charlie Houston point of care past,present & future

POCTPast ,Present & Future

Charlie Houston Senior Specialist Biomedical Scientist

[email protected]

Page 2: Charlie Houston point of care past,present & future

What Is POCT

Definition (s)

“Diagnostic testing at or near the site of patient care.”

“POCT is the testing of patient samples outside the hospital laboratory, in clinical areas near to the patient, usually by staff who are not trained and registered healthcare scientists.

Page 3: Charlie Houston point of care past,present & future

Goals of POCT

Goals

• improve medical outcomes

• Improve economic outcomes

• decrease therapeutic turnaround time (TTAT)

(TTAT = time from test request to patient treatment)

Page 4: Charlie Houston point of care past,present & future

POCT settings –some examples• Critical Care Unit

• Emergency Department

• Respiratory Medicine Outpatient Department

• Community Respiratory Service in managing COPD

• Air Ambulance Retrieval Unit

• Remote Rural Hospitals

• Intra–operatively in cardiac bypass surgery

• General Practice

• Home Use

• Military Medicine

– Army Field Surgical Teams

– Naval Sick bay facilities

– Air Force casualty evacuation units

• This list is not exhaustive

Page 5: Charlie Houston point of care past,present & future

Ancient POCT

1500 B.C. Egypt

The pharaoh’s doctor noticed accumulation of ants around the urine of some people rather than others

Page 6: Charlie Houston point of care past,present & future

Ancient POCT

Thomas Willis 1621- 1675

“..but in our age, given to good fellowship and guzzling down chiefly of unallayed wine, we meet with examples of this disease wherefore the urine of the sick is so wonderfully sweet, or hath a honey taste…”

Page 7: Charlie Houston point of care past,present & future

Diagnostic testing in the pre -1900s

Chemical analysis have been carried out close to the patient, i.e., at the bedside, or more commonly, in specially designated ward side-rooms since they were first introduced for diagnostic purposes during the early 19th century at Guy’s Hospital

Lancet i:956, 1883

Page 8: Charlie Houston point of care past,present & future

The move from point of care to labs • Need for better analytical sensitivity• Need for improved specificity• Better turn around times• Need for operator independent testing• Increase in workload• Technological advances with introduction of better

analytical methods

Page 9: Charlie Houston point of care past,present & future

The move from labs to point of care

• 1950s - Urine test strips in the sense used today were first made on industrial scale and offered commercially.

• 1964 - The company Boehringer Mannheim, today a top leader on the world market under the name of Roche, launched its first Combur test strips (urine).

• 1965 Ames developed and introduced in a product called Dextrostix®

Page 10: Charlie Houston point of care past,present & future

The move from point of care to labs

• 1970 - The first blood glucose meter.. The same Dextrostix were used and the concept was that you play a beam of light on that blue color and the darker the blue the less light would be reflected.

Ames Reflectance Meter

Page 11: Charlie Houston point of care past,present & future

The move from labs to point of care

• 1990 -- MediSense, now owned by Abbott Laboratories, introduced electro-chemical readings or biosensors, which were supposed to make glucometers more accurate. This is done by turning biochemical reactions into electrical signals.

Page 12: Charlie Houston point of care past,present & future

So -back to Point of Care Testing

Page 13: Charlie Houston point of care past,present & future

POCT the present

Page 14: Charlie Houston point of care past,present & future

• Rothesay Victoria Hospital• Cowal Community Hospital• Larkfield Unit • Ravenscraig Hospital

Geographical areas covered by POCT service

Page 15: Charlie Houston point of care past,present & future

Analytes performed by POCT analysers that we manage

• Glucose• Blood Gases• Lactate• Co-oximetery• Haemoglobin A1c

 

Page 16: Charlie Houston point of care past,present & future

POCT analysers managed

• Abbott Precision Xceed Pro Glucose Meters connected via Precision WEB

• Abbott Precision Optimum Xceed Glucose Meters• IL Gem Blood Gas analyser connected via

GemWeb• Siemens DCA 2000 Haemoglobin A1c Analyser • Menarini HA-8160 Haemoglobin A1c Analyser

Page 17: Charlie Houston point of care past,present & future

Glucose Meters in use

• Abbott Precision Xceed Pro - connected • Precision Optimum Xceed - non -connected

• As with most glucose POCT meters both meters have limitations and should not be used in the following;– Severe dehydration– Severe hypotensive or in shock– In a hyperglycaemic-hyperosmolar state e.g. DKA

 

Page 18: Charlie Houston point of care past,present & future

Blood Gases, pH, Lactate & Co-oximetery

• Arterial blood gases (ABGs) provide the following information:– Oxygenation– Adequacy of ventilation– Acid-base levels

• Blood pH• Lactate • Co-oximetery • Blood Gases, Lactate & Co-oximetery are analysed on

ILGem 4000 blood gas analysers. 4 ILGEM blood gas analysers replaced 3 Roche AVL and 1 Roche OMNIS blood gas analysers in March 2009

Page 19: Charlie Houston point of care past,present & future

IL gems

• The Il Gems have been a popular replacement with both users and laboratory staff due to:

• Self-contained• Maintenance-free• iQM, IL's Intelligent Quality Management system,

automates quality control.• GEMweb® Plus, IL's remote management

software, enables access to any networked analyzer to see results, monitor performance and assure standard configurations

Page 20: Charlie Houston point of care past,present & future

DCA 2000 Haemoglobin A1c

The Siemens DCA 2000 is a good point of care analyser• Easily used non-laboratory operators• Light weight small footprint portable• Requires no operator interpretation of chromatogram• No pre dilution if using finger prick• Monoclonal antibody method for HbA1c –no

interference from abnormal haemoglobins• Correlation study shows 99% agreement with the

HPLC method.• No connectivity –results have to be manually entered

on LIMS

Page 21: Charlie Houston point of care past,present & future

Menarini HA-8160

 • The Menarini HA-8160 in contrast  • Not easily used by non –laboratory operators • Heavy bulky analyser requires to be transported

on a large trolley• Requires operator interpretation of chromatogram• Requires pre dilution of eluate if using finger prick• HPLC method for HbA1c –possible interference

from abnormal haemoglobins.• Connectivity –results transmitted to LIMS .

Page 22: Charlie Houston point of care past,present & future

Discussion

• Are the above POCT appropriate –• The above POCT are appropriate as they meet the TTAT

required for the sites where they are located. If the above testing was performed by laboratory based analysers the TTAT may not be met due to geographical locations of some wards and departments (and lack of pneumatic transport system).

• Finance – • Currently only the Siemens DCA 2000 is funded outwith the

Diagnostic’s budget (funded by Woman’s and Children’s directorate), with consumables, IQC and EQA managed by Biochemistry. POCT tend to be more expensive per test in comparison to laboratory based analysers therefore there is a reluctance to provide POCT where the laboratory can meet the TTAT examples of this are the recent decisions to withdraw Troponin testing as a POCT and also to assay B-type natriuretic peptide (BNP) in the laboratory rather than as a POCT.

Page 23: Charlie Houston point of care past,present & future

Future developments

• Abbott Diabetes Care have launched a blood Ketones strip for the Glucose meters that are currently used ,there is the possibility of replacing Urine Ketone testing with Blood Ketone testing as a POCT (4)

• Precision web is not interfaced with the laboratory information management software LIMS (iSOFT APEX). It is proposed that Precision web will be interfaced to LIMS (5)

• GEMweb® Plus is not interfaced with LIMS .It is proposed that GEMweb® Plus will interfaced to LIMS.

• Review the use of the Menarini HA-8160 for adult diabetic clinic.

• An audit of all POCT within the IRH catchment area is required in order to assess if regulatory matters are being complied with (for example MHRA, CPA ).

Page 24: Charlie Houston point of care past,present & future

Near Future

The possibilities of POCT replacing on site laboratory testing in certain circumstance are considered in the following scenario -

Page 25: Charlie Houston point of care past,present & future

Introduction of the iSTAT analyser at the Vale of Leven

Hospital

A proposal to save money by the introduction of further point of care testing

Page 26: Charlie Houston point of care past,present & future

Reasons

• NHSGG&C policy paper “Vision for the Vale “

• A&E closed –replaced my MAU

• Forecast reduction of OOH requests to 1320 requests per annum

• EWTD compliance

Page 27: Charlie Houston point of care past,present & future

POCT already available within MAU

• Hemochron INR system

• IL Gem ABG analyser

• Clearview pregnancy testing kits

• Abbott Xceed blood glucose analyser.

• NO POCT solution for U&E

Page 28: Charlie Houston point of care past,present & future

Options -1

• Stay with current OOH laboratory system– Strengths

• Easy!• Known costs• Low risk

– Weakness• Fails to meet current or future expectations from "Vision for

the Vale”• Expensive• Not EWTD complaint -Unlawful

Page 29: Charlie Houston point of care past,present & future

Options -2

• Perform U&E on i-STAT– Strengths

• Proven pathway • True point of care technology• Highly Portable• Secure, robust results• Enables service flexibility

– Weaknesses • Investment and revenue costs - iSTAT instrument , Staff

Training• Lack of support/opposition from staff-more work for nursing staff

Page 30: Charlie Houston point of care past,present & future

Options -3

• Await Urea/Creatinine assay for Il Gem ABG – Strength

• Users already experienced with this• When cartridges introduced only increase will be in Revenue

costs

– Weakness• Don’t know when available - untried

Page 31: Charlie Houston point of care past,present & future

Benefits & Risks

• Benefits: – Significant cost benefits– Laboratory staff will work EWTD compliant hours– Rapid therapeutic turnaround out of hours

• Risks: Possible risks – Lower income for laboratory staff leading to job dissatisfaction

(possible pay protection or performing OOH work at Royal Alexander Hospital)

– Slow implementation due to training issues (availability of staff)

– New service availability inevitably simulates its own increase demand

Page 32: Charlie Houston point of care past,present & future

Costs

Capital • i-Stat Analyzer x1 package ( includes printer,

rechargeable battery, downloader/recharger, electronic simulator and training) £8,356.00

Revenue• ISTAT Chem8 Cartridges (Box of 25) @ £150.00

approx pr box 25 Total pr year approx £7950.00• Level 1 and 3 Control @ £13.00 each £130.00Training• Training for the use of iSTAT analyser will be

provided by the medical instrument company .

Page 33: Charlie Houston point of care past,present & future

Will we save money?Investment Appraisal / Costs: Benefits Analysis: 

Currently out of hours call out @ £25.00 on possible

1760 U&E =

£44,000 per annum

First year costs Capital £8,356.00 + revenue

£7950.00 on possible 1760 U&E =

£16,306 in 1st year

NET saving in first year £27,694

Page 34: Charlie Houston point of care past,present & future

Please note that this part of my presentation was intended for course work on the Biomed Online POCT course and is not NHSGG& C Policy

Page 35: Charlie Houston point of care past,present & future

Near Future

Web-based solutions• Allows fewer people to do more• Viewing and maintaining operator lists• Viewing and correcting results records• Conducting and certifying initial training on specific

information • Monitoring and re-certifying competencies

Page 36: Charlie Houston point of care past,present & future

Near Future

• Point-of-care technology and wireless networks fit hand-in-glovein health care and use of thenetworks is poised for growth

• Wireless networks topped technology “wish list” -- 76% in 2004

Page 37: Charlie Houston point of care past,present & future

The Distant Future ???

Medical Tri-corder

a medical tri - corder from the original Star Trek which "Bones" would use to diagnose everything

Page 38: Charlie Houston point of care past,present & future

Thanks very much listening Any questions?