Quality Specifications for POCT

Transcription

1 Quality Specifications for POCT the patient journey perspective Christopher P Price Department of Clinical Biochemistry, University of Oxford, Oxford, UK

2 Quality Specifications fit-for-purpose QUALITY refers to the attributes of a product that satisfy the expectations that users have for it. SPECIFICATIONS are explicit statements of requirements to be satisfied by a material, product, or service. QUALITY SPECIFICATIONS are explicit statements on the level of performance required to facilitate clinical decision-making.

3 Quality Specifications point-of-care testing and the patient journey Explicit statements on the level of performance which ensures that the patient undertakes or receives the right.test sample time result decision action..which offers the best outcome.

4 Point-of-Care Testing can be performed by. patients family members and friends pharmacists nursing assistants nurses doctors medical technologists laboratory technologists

5 Point-of-Care Testing has also been called. bed-side near patient extra-laboratory decentralised physicians office ancillary alternate site..testing

6 Point-of-Care Testing what is it? the provision of a test (result) at the point in time at which the result will be used to make a decision and take appropriate action which will result in an improved health outcome

7 Perspectives of Customers Q outcomes U A PATIENT L I T Y CARERS ORGANISATION ENVIRONMENT payor, regulator affordability

8 Health Outcomes care of individual patients maximisation of benefit minimisation of risk reasonable cost Clinical Operational Economic

9 Quality Specifications the need for a care pathway perspective Link between doctor and patient Link between result and patient Utilisation of test results Link between result and action Decision support systems Patient empowerment Devolution of care to community and home Value for money

10 The Patient Journey care pathways and clinical guidelines CARE PATHWAYS are care plans that detail the essential steps in the care of specific problems and describe the expected progress of the patients. CLINICAL GUIDELINES are recommendations on the appropriate treatment and care of people with specific diseases and conditions, based on the best available evidence

11 The Patient Journey Presentation Initial assessment order analyse report review

12 The Patient Journey Triage nurse Doctor Patient Nurse Discharge Diagnostics

13 Chronic Disease Management opportunities and challenges for POCT Complex patients High risk patients 70-80% of chronic care management population Health Promotion

14 I Consultation and sample collection analysis Further consultation or letter II analysis Sample collection Consultation with results III Sampling, analysis and consultation

15 The Patient Journey LEAN thinking Minimising waste Value and the patient journey Identify the value stream Making value steps flow Pulling the patient along the journey Continuous improvement National Primary Care and Trust Development Programme

16 To Err is Human some key headlines Medical errors ~ 100,000 deaths pa Medication errors ~ $2 billion pa Costs of poor quality ~ 30-40% Fragmented, dangerous and wasteful Institute of Medicine 2000

17 Bridging the Quality Chasm underlying reasons for inadequate quality Growing complexity of science and technology Increase in chronic conditions Poorly organised delivery system Constraints in exploiting information technology Institute of Medicine 2001

18 Bridging the Quality Chasm six aims for improvement Safe Effective Patient centred Timely Efficient Equitable Institute of Medicine 2001

19 Improving Health Care Accessibility the role of point-of-care testing Understanding need Producing robust technology Ensuring quality of operation Resourcing (staffing and reimbursement) Changing practice to gain benefits Price and Kricka 2007

20 Key Elements of a Quality Specification CLIA 88 complexity criteria Knowledge Training and experience Reagents and materials preparation Characteristics of operational steps Calibration, quality control and proficiency testing materials Testing system trouble shooting and equipment maintenance Interpretation and judgement

21 Regulation under JCAHO CLIA 88 plus Purpose of test, screening, diagnosis treatment and whether follow-up required Identification of operator and supervisor Documentation and training and continuing competency Current written procedures Defining QC requirements Documenting QC and test records

22 The Patient Journey potential uses of point-of-care testing GP OP IP OP GP Symptoms Diagnosis Treatment (optimisation) Monitoring

23 Laboratory Testing potential sources of errors patient Transmit result Record result Prepare request form Phlebotomy doctor Report result Transport sample Validate result Quality control Analyse sample Prepare sample Register sample

24 Point-of-Care Testing reducing potential errors patient Transmit result Record result Prepare request form Phlebotomy doctor Report result Transport sample Validate result Quality control Analyse sample Prepare sample Register sample

25 Point-of-Care Testing an integrated approach to quality PATIENT question test decision action OUTCOME

26 The Patient Journey potential uses of point-of-care testing GP OP IP OP GP Symptoms Diagnosis Treatment (optimisation) Monitoring request>>test>>decide>>act

27 Sources of Error Diagnostic failure to employ indicated test failure to act on results error or delay in diagnosis Treatment error in performance of procedure or test delay in treatment or response to test error in administering treatment Preventive inadequate monitoring or follow-up Other failure of communication Leape et al 1993

28 Medication Use Processes parallels in diagnostic testing? Prescribing Dispensing Administering Monitoring Systems and management control Nadzam et al 1991

29 Quality and System Redesign evaluation in health care: relevance to POCT structure - health system capacities process assesses interaction between clinicians and patients outcomes evidence about change in patients health status Donabedian 1980 Process Outcomes

30 Outpatient Clinic TATs Q-Probe study Quality Indicator 90% collection to verification (hours) biochemical profile TSH Your laboratory Outpatient clinic Physician s office Remote phlebotomy centre Patient s home Other clinic Steindel et al 2002

31 Hospital Nursing Satisfaction Q-Probe study Quality Indicator Very satisfied (%) Accuracy of results Abnormal test notification Accessibility of lab management Lab POCT support Lab responsiveness Routine test TAT Phlebotomy responsiveness Stat TAT Jones et al 2006

32 Errors in Laboratory Medicine Digoxin Timing Wrong Improper Hepatitis C Order Incorrect ID Patient Incomplete IP Venipuncture Duplicate TSH Order Specimen Rejection Proficiency Test Failure Ca ++ QC Out Of Control Erroneous Phone Message Test Not Resulted Phlebotomy Dissatisfaction Hypercalcemia Not Noted Frequency of Errors (%) Howanitz et al 2005

33 Laboratory Performance Six Sigma Scale Quality Indicator Parts per million Six Sigma Quality 3.4 Order accuracy: tests ordered/not ordered Wristband errors: patients not banded 6500 Therapeutic drug monitoring timing Chemistry specimen acceptability 3000 Laboratory proficiency testing 9000 Pap smear rescreening false-negative rate Reporting error 477 Nevalainen et al 2000

34 Disease Management in Diabetes a systematic review HbA1c monitoring 15.6% (IQC 4% to 39%) n=15 Urine protein screening 9.6% (IQC 0% to - 44%) n=7 HbA1c 0.5% (IQR %) n=19 Health utilization 31% (IQR 82.3% %) n=5 Norris et al 2002

35 Diabetes and Disease Management audit of performance Primary diabetes care: 64-70% of recommended HbA1c results: 44% recorded Glasgow et al 2000 Peters et al 1996 Urine protein testing: 48% performed Peters et al 1996

36 Setting Quality Specifications a hierarchical approach Impact of analytical performance on specific clinical decision making Impact of analytical performance on general clinical decision making Professional recommendations Set by regulation or EQAS organisers Published data on state of the art Fraser 2001

37 Quality Specifications for POCT a patient journey perspective Clinical problem and setting Request Sample Analysis Interpretation Decision Action

38 Quality Specifications for POCT a patient journey perspective Clinical problem and setting Request Sample Analysis Interpretation Decision Action Primary care Secondary care Urgent/elective Previous history Screening Diagnosis Prognosis Monitoring Is there evidence of effectiveness for the use of the test in this decision pathway?

39 Quality Specifications for POCT a patient journey perspective Clinical problem and setting Request Sample Analysis Interpretation Decision Action Diet Fasting/Starvation Posture Exercise Type Time Stability Identity Phlebotomy Transport Centrifugation Storage Is there evidence of impact of these factors on the use of the test in this decision pathway?

40 Quality Specifications for POCT a patient journey perspective Clinical problem and setting Request Sample Analysis Interpretation Decision Action Biological variation Decision limits Reference values Screening Diagnosis Prognosis Monitoring Analytical system Precision Bias Is there evidence of impact of analytical performance on the use of the test in this decision pathway? Reference change values

41 Impact of Analytical Performance on Outcomes glucose HbA1c troponin thyrotroponin prostate specific antigen screening for Down syndrome

42 Effect of Glucose Imprecision on Insulin Dose simulation modelling Boyd and Bruns 2001

43 Effect of Glucose Bias on Insulin Dose simulation modelling Boyd and Bruns 2001

44 Imprecision in Glucose Measurement comparison of patient and technician data Imprecision based on duplicate measurement (CV%)* Technician Patient Glucometer Elite Medisense Accutrend One touch Gluco Touch * Outliers excluded Skeie et al 2002

45 Impact of Bias in Glucose Results calibration coding error Incidence of use of wrong calibration code with glucose meters 16% Raine 2003 Kristensen et al 2004

46 Impact of Bias in Glucose Results calibration coding error Error at blood glucose mmol/l Therasense - up to 4.4 mmol/l Glucomen 1.5 mmol/l Medisense 1.0 mmol/l One Touch Ultra 2.0 mmol/l Accu-Check NSD Medical Devices Agency reports

47 Impact of Calibration Coding Error System A (m m ol/l) Percent Difference (m g/dl) L o t B (R1) Re su lt Baum et al 2006

48 Impact of Calibration Coding Error system C (m m ol/l) Percent Difference (m g/dl) Code 17 (R1) Result Baum et al 2006

49 Quality Specifications for HbA1c intra individual variation Intra individual variation (CV i %) non-diabetic diabetic stable control variable control monitoring period 0-1 yr

50 Quality Specifications for HbA1c intra individual variation Normal (women) - 30d <0.7%* - 365d 2.6% Normal (men) - 84d 1.7%** Stable control diabetic - 150d 4.1%*** Stable control diabetic - 25d 4.2%**** - 85d 7.1% Variable control diabetics - 25d 5.1% - 85d 9.8% * Garde et al 2000 ** Rohlfing et al 2002 ***Larsen et al 1991 **** Phillipou and Phillips 1993

51 Seasonal variation Garde et al. 2000

52 Quality Specifications for HbA1c performance requirements CV i CV g Desirable performance (%) Imprecision Bias Total Error RCV at HbA1c ~ 7.5% = 7.92% (CV a = 2.3%)* RCV at HbA1c ~ 7.5% = 24.4% (CV a = 7.1%)** *Rohlfing et al 2002 **Trape et al 2000

53 Quality Specifications for POCT a patient journey perspective Clinical problem and setting Request Sample Analysis Interpretation Decision Action Screening Diagnosis Prognosis Monitoring Patient concerns and values EBM Primary care Secondary care Urgent/elective Previous history Best research evidence Clinical experience

54 Quality Specifications for POCT a patient journey perspective Clinical problem and setting Request Sample Analysis Interpretation Decision Action Primary care Secondary care Urgent/elective Previous history Screening Diagnosis Prognosis Monitoring Are the doctor - and patient - aware of the results, any confounding factors and the appropriate treatment?

55 Quality Specifications for POCT a patient journey challenges Clinical problem and setting Request Sample Analysis Interpretation Decision Action XXXX