Transcript Slide 1
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
That is easy , portable, and accurate
Allows for testing either by physician or patient
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
bedside analysis, near-patient analysis decentralized analysis, and off-sit analysis
http ://alphainternationalmall.com/Glucose_Monitors.html
Where it all began 20 years ago?
Advantages of POCT
Reduce TAT Reduce errors Reduce paper Smaller sample size (microliters vs. milliliters)
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: Advantages
Reduces the risk of preanalytical errors the handling the labeling the transportation of samples No need laboratorian staff. ???
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: 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.
What were some of the most important ‘tools’ that you used when you first got involved with POCT?
POCT Informatic Tools
Early to mid 1990’s Bench-top analyzers Touch screen PCs Results sent to central laboratory for analysis
University of Virginia Health Science Center – Original Home of RALS Technology
What’s Driving POC Informatics?
Hospital POC growth rate Decentralized patient testing Reducing overall healthcare costs
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
Emerging Trends in Point-of-Care and their Impact on Data Management…
Trends…
1. It’s not just glucose anymore…
POCT is Not Just for Glucose!
% of Hospitals with POC Devices by Discipline
Glucose 98% 99% 51% Coagulation 62% 34% Blood Gas Chemistry Hematology Urinalysis Cardiac 14% 18% 5% 15% 1% 3% 28% 36% 50% 1999 (510 Hospitals ) 2001 (584 Hospitals )
Source: Enterprise Analysis Corp. Stamford, CT
Trends…
1.
2.
It’s not just glucose anymore…
Goodbye Paper…Hello e-Patient
Goodbye Paper…Hello e-Patient!
It’s a “Paperless” World!
EMRs reduce overhead and improve efficiency EMRs increase patient care
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
Trends…
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3.
It’s not just glucose anymore… Goodbye Paper… Hello e-Patient
Zero Tolerance for Errors!
Zero Tolerance of Medical Errors
The Need for Data Management Total control of POCT Program from device to operator to patient to test order Federal initiative launched to reduce medical errors and improve patient safety
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
Trends…
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It’s not just glucose anymore… Goodbye Paper… Hello e-Patient Zero Tolerance for Errors!
Where have all the Med Techs gone??
Who does POCT?
Doctors Nurses
Pharmacists Patients Careers
Ambulance paramedics
Retail & Leisure centre staff
Where?
ICUs A&E General wards
GP surgeries Field hospitals
Operating theatres Delivery Suites Ambulances
Pharmacies Retail & leisure centers
Purpose?
Monitoring chronic disease (or acute disease in ICUs) Diagnosis, risk stratification Screening
EXAMPLES OF POC TESTS
• Blood gases: pH, pCO 2 pO 2 • Na, K, Ca, Cl • Lactate • Glucose • HbA 1c • Urea, Creatinine • Cholesterol, TGs • BNP • Troponin, CK-MB, Myoglobin • 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
Glucose meter
Accu-chek
Roche Diagnostics
Presicion Plus
Medisense
EuroFlash
Lifescan
Amperometric method
Glucoseoxidase
HemoCue HemoCue AB OneTouch Lifescan
Photometric
Glucoseoxidase,Peroxidase
POCT Closer to Home…
2 million+ on Anti-Coagulation therapy Warfarin - 22 nd most common drug 1,100 Clinics growing at 20% a year Indications Atrial fibrillation Heart Valve replacement Stroke
The Use of Portable Coag Devices… Bedside testing enables: Home health providers to make immediate changes in coagulation therapy if necessary Frequent testing
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Fewer complications Home testing with data communication
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improved patient management
Management of POCT
Director of Pathology Healthcare Professionals Group POCT Group Primary care Dip sticks HbA 1c Cholesterol ICUs Blood gases Glucose Wards Dip sticks Glucose A/E MI markers Drug Preg tests
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
POLICY
Statement of intent
PROCEDURES RECORDS
Instructions Evidence
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
POCT Management Procedure
INTRODUCTION
Purpose and scope Responsibilities References Definitions Documentation
ORGANISATION AND MANAGEMENT
Working Group on POCT Membership Agendas and minutes Frequency of meetings
IN VITRO DIAGNOSTIC DEVICES (IVD)
IVD inventory IVD maintenance Stock control
HAZARDS AND PRECAUTIONS TRAINING AND CERTIFICATION
Trainers Training courses Register of certified users
DOCUMENTATION
Procedures and working instructions Manufacturer’s information Patient’s records Quality records
ASSURING THE QUALITY OF POCT
Internal quality control External quality assessment Internal quality audit
INTERPRETATION AND COMMUNICATION OF RESULTS PROCEDURES
Procedures and instructions
• Sample collection • Use of equipment • Recording results • Document control
PROCEDURES
Providing the evidence
Application for POCT device Certificate of competence Maintenance log form Electronic logs QC records
RECORDS
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
Assessment of competence Written test Multiple choice questionnaire Direct observation Update training EQA Updates Self assessment Training records Certificates Central record
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
Provides direct oversight by the care provider Eliminates patient transcription errors Allows for timely medication adjustment Improves patient satisfaction
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).
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.
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
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blending of deliveries and need for increasing flexibility of systems.
PATIENT-CENTRED CARE