: Suzanna Immanuel Place, date of birth : Jakarta, 11 th March 1953 Education : MD FMUI 1978 Profession : Clinical Pathologist (SpPK) FMUI 1984

Transcription

1 Name : Suzanna Immanuel Place, date of birth : Jakarta, 11 th 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

2 (POCT vs NON POCT) Suzanna Immanuel Department of Clinical Pathology FMUI /CMGH Jakarta

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4 Central Laboratory : Electrochemical Detector: Ion selective electrode POCT: Measure by dry chemistry OR single use disposable cartridge sensor system

5 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

6 Ion Selective Electrode

7 Blood Artery and Vein PO 2 : 90 mmhg PO 2 : 35 mmhg PCO 2 : 40 mmhg PCO 2 : 45 mmhg ph : 7.40 ph : 7.36 Artery Tissue Vein

8 Acid Production ph Normal Intracell ph 7.0 Acid Production Metabolism Artery ph 7.40 Vein ph 7.36 O 2 Acid respiratory & metabolic ph blood Vein > acid blood artery Acid excreted from the body through pulmonary & kidney

9 Definition of Terms Near Patient Testing Point Of Care Testing 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 perform test 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

10 Considerations Useful enough? Analytical performance 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

11 Are They Useful Enough? Analytical performance Turn Around Time Clinical significance

12 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

13 TAT: Progression to POC testing Point-of-care TAT: <5 min Near patient testing TAT: 5 15 min Central/STAT Lab TAT: 30 min hours

14 POCT Blood Gas Analysis Key Drivers : Reduced turn around times Medical necessity in critical care FOCUS : Patient Care Improved Patient Management Rapid Intervention Monitoring of Therapy Response Surgery Cancellations Reduced ICU Stay Reduced Drugs Surgery Appropriate Therapy Ventilation Harvey M : Point of care laboratory testing in critical care, American Journal of Critical Care, 3/99

15 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 outcome Kendall: BMJ 1998

16 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: Heyningen et al. Clin Chem 1999;45: Kendall et al. Br Med J 1998;316: Parvin et al. Clin Chem 1996;42:

17 Faster is not always better!

18 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!

19 Clinical Significance REDUCED TAT REDUCED TTAT Better clinical decision IMPROVED CLINICAL OUTCOME

20 Evidence based medicine: NACB recommendation ICU Guideline 37. There is fair evidence that more rapid TTAT of ABG results in several types of ICU patients leads to IMPROVED CLINICAL OUTCOMES Strength/consensus of recommendation: B Level of evidence: I Guideline 38. There is fair evidence that POCT of ABG results in the ICU leads to improved clinical outcomes when POCT is found to lead to REDUCED 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.

21 Evidence based medicine: NACB recommendation EMERGENCY DEPARTMENT (ED) Guideline 40 There is fair evidence that more rapid TTAT of ABG results in several types of ED patients leads to IMPROVED CLINICAL OUTCOMES Strength/consensus of recommendation: B Level of evidence: II Guideline 41 There is fair evidence that POCT of ABG results in the ED leads to improved clinical outcomes when POCT is found to lead to REDUCED 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.

22 Evidences showed that ABG POCT has been useful but.it depends on many factors The people The system The equipments

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24 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

25 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

26 Equipment & Personnel Expenses Central Lab 1 or 2 ABG devices for many tests, serving many/all locations 3 6 personnel POCT locations 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 Staffing, training & responsibility consideration More people to be trained and observed QC, EQA and TQM

27 Evidence based medicine: NACB recommendation ABOUT COST ICU Guideline 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.

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29 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

30 Changing Laboratory Role : One Solution The POC Coordinator Laboratory Point Of Care Coordinator In context of a team 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 Active team participant, not a policeman

31 Equipments Selection ABG devices: Analytical performance, features, ease of use, training & after sales support Recommended: Bar-coding system IT support Hardware Software

32 Blood gas identification errors: manual vs. bar-coded Nichols JH, Bartholomew C, Brunton M. Reducing medical errors through barcoding at the point of care. Clin Leadership Manag Rev 2004; 18:

33 Features of Critical care analyzers that minimize risk of errors and contribute to ease of use Long-life, maintenance free electrodes or disposable sensor packs Touch screens as the user interface Software that can demand user and patient identification Built-in barcode scanners Reduced sample sizes Clot detection within the detection chamber Sample detection to prevent short samples Liquid calibration systems instead of gas bottles Automated calibrations Automated QC sampling Sophisticated QC programs including interpretation of data Connectivity to information systems allowing remote monitoring and control St. John A. Benchtop instruments for point-of-care testing. In: Price CP, St John A, Hicks JM. Point-of-care testing. 2 nd ed. AACC Press p.33.

34 POCT Needs connectivity & Interfaces to LIS Because: Large amount of time & labor Required manually download results Patients & QC results Not properly managed Result : Processing exceptions Handling compliance issues Meeting regulatory Delayed / Avoided

35 Summary of Compliance Impact Pre & Post-Connectivity Pre-connectivity Post-connectivity Operator Errors QC application errors Exception Type QC comment errors Total exceptions

36 Benefit POCT Program with Connectivity Time & labor requirements Improves workflow : Down load results Print reports Evaluate QC Patient test report

37 Recommended: POCT ABG to LIS/HIS interface for a better flow & documentation of results Satellite laboratory POCT POCT STAT POCT Satellite laboratory POCT LIS HIS POCT STAT POCT Satellite laboratory 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. 2 nd ed. AACC Press p.86

38 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. 2 nd ed. AACC Press p.122.

39 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. 2 nd ed. AACC Press p.122.

40 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-ofcare testing. 2 nd ed. AACC Press p.122.

41 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. Pointof-care testing. 2 nd ed. AACC Press p.122.

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

43 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

44 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.

45 Will POC diagnostics replace lab base diagnostics or Will it be the other way around? NEITHER! Both are an essential & integral part of diagnostic provision and will continue to be in the foreseeable future Blending of deliveries is needed

46 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

47 Patient centered care

48 Definition of Terms Near Patient Testing Point Of Care Testing 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 perform test 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

49 Choosing the right analyzers for the right test volumes Benchtop Cartridge-based Single-use / handheld Not portable Semiportable Truly portable Amount of maintenance is progressively reducing Maybe the most costeffective system for medium to large test volume Little maintenance May be cost-effective for medium to large test volumes Least maintenance May be only be cost effective for small to medium test volumes St. John A. Benchtop instruments for point-of-care testing. In: Price CP, St John A, Hicks JM. Point-of-care testing. 2 nd ed. AACC Press p.33.