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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 testingin home and hospital 22nd Biomedical Instrumentation conference Asst. Prof. Somchat Taertulakarn Allied Health Sciences Faculty Thammasat University
Introduction Point-of–Care-Testing (POCT) • Providesanalternative tolaboratorytesting • Thatiseasy, portable, andaccurate • Allowsfortestingeither byphysicianorpatient
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, andoff-sit analysis http://alphainternationalmall.com/Glucose_Monitors.html
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 centrallaboratory 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 inPoint-of-Care and theirImpact on Data Management…
Trends… 1. It’s not just glucose anymore…
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%
Trends… • It’s not just glucose anymore… • 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-Patient! • Download stations must always down load • Servers must always be on the network • Connections to host systems (LIS/ HIS) never lost
Trends… • 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 Programfrom device to operator topatient to test order • Federal initiative launched to reducemedical 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… • 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 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
Purpose? • Monitoring chronic disease (or acute disease in ICUs) • Diagnosis, risk stratification • Screening
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
Presicion Plus Medisense Accu-chek Roche Diagnostics EuroFlash Lifescan
Amperometric method Glucoseoxidase
HemoCue HemoCue AB OneTouch Lifescan
Photometric Glucoseoxidase,Peroxidase
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… 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 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 • Laboratory professional (Chair) • POCT Co-ordinator(s) • Nurse • Clinicians • Information Technology Manager • Medical Equipment Manager • Accountant • Pharmacist • Risk / Safety Officer
Documentation Statement of intent POLICY Instructions PROCEDURES Evidence RECORDS
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 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