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Total Testing Process, begins and ends with patients care, Pre-analytical
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Total Testing Process
11 Steps
4 components
Analytical
- Sample prepared
- Analysis performed
- Result verified
Post-analytical
- Result reported
- Clinical answer
- Action taken
- Effect on patient care
Pre-analytical
- Clinical questions
- Test selected
- Test ordered
- Specimen collected
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Outcome assessment
To assess the outcome of TDM, consider the 3 components that influence care:
Structure
Patient & Provider variables:
- patient's variables - age, gender, comorbidity
- providers' variables - hospital, clinic, physician office, home
- characteristics & training of practitioners - generalist, technologist, technicians
- method of payment
Outcome
- Non-economic results - cure, failure, change in physiological variables, quality of life
- Economic result - cost of care
Process
- procedures for delivering the intervention
- methods of communication & counselling
- types of tests
- quality of test performance
- TTP: the performance of TDM test should incorporated assessment of:
- Clinical indication of testing
- Timing & collection of the analysis
- Proper interpretation of result
- Initiation of indication action
- Impact of indication in patient care
- TDM service guides in TTP to ensure serum drug conc. will give maximal positive impact on patient care.
- TDM service - include impact on patient care + economic efficient
- TTP provides coherent & effective template for economic analysis of TDM
- Appropriate steps in TTP to calculate cost-effectiveness // cost-benefit analyses of TDM
Outcome component care
- Provide feedback for modifying the structure & process components of care
- Eg. Evaluation outcome in Steps 9-11 :arrow_right: Modify structure & variables in Steps 2-8; to improve care.
- Drawback: analyses of TDM focus more on process//system-related than outcome//patient-related
- Considerations: Process, Outcomes, System-related, Patient-centered
- Process measure - fraction of patients who hv serum drug conc measured at correct time. [step 3&4]
- Outcome measure - fraction of patients whose serum drug conc. in appropriate therapeutic ranges. [step 8,9,10]
- System-related measure - how well the procedure work
- fraction of patient whose serum drug conc. in appropriate therapeutic range [step 8,9,10]
- Patient-centered measure - effect of the intervention on the status of patient
- fraction of patient in TDM who treated effectively & without drug adverse effects [step 10,11]
- Examine distinction between system-related & patient-centered:
- Determine effectiveness of TDM system achieves drug conc. to appropriate therapeutic.targeted conc.
- Determine effectiveness of TDM to avoid drug-induced toxicity/adverse reaction
Definition
The 11 steps of laboratory testing that begin with clinical question prompted by a patient-clinician encounter and conclude with the impact of test result on patient care.
TDM process
- TTP requires consideration TDM as a full system
- improve the interpretation of TDM
- identify all steps of TDM testing procedure
- interpret TDM results in these factors
- direct application to the field of TDM
- a practice applied to drug with direct relationship between serum conc. & pharmacological response
- drug with narrow range of concentration that are effective & safe
- drug concentration measurements used in measures of other clinical observation to assess patient's status
- Describe the full sequence of laboratory testing activities
- apply to analysis & interpretation of serum drug conc.
- leads to decision that influence drug therapy outcome in patient
- begins and ends with patients care
- Pre-analytical
- clinical-patient encounter tht raies a clinical question capable of being answered by a test
- clinicians considers what tests migh be appropriate to answer the questions
selection s translated into test order
- specimens collection & transport specimens to lab
- Anaytical
- intralaboratory processing
- testing of specimen
- verificaqtion of test results
- Post-analytical
- reporting the test results
- interprete test results in light of the original clinica questions
- action taken in esponse to the results
- results of these action on patients' care