Principles of pre-analytic and post-analytic test management Dr Varsha Shahane
Objectives• To familiarize with selection , assessment and incorporation of diagnostic tests• To review principles of test evaluation and utilisation and their effect on patient outcomes• To describe major elements of requisition and test menu formats• To review principles of formatting of reports of test results• To review needs for record storage
Introduction• Quality Assurance : refers to the systematic activities implemented in a quality system so that quality requirements for a product or service will be fulfilled• ‘PATH OF WORKFLOW’ - 3 phases of QA cycle : Pre analytical Analytical Post analytical
• Level of Quality →minimize errors, minimize resources waste, maximise efficacy ↓ Quality standard guidelines and regulatory accreditation (NCCLS & CLIA guidelines)
(i) Pre analytical• Requisition by physician• Patient preparation• Collection of specimen• Handling of specimen• Transportation• Specimen receipt• Storage of specimen• Referral of specimens
Purposes of lab tests• Screening• Provisional diagnosis• Differential diagnosis• Final diagnosis• Prognosis• Treatment• Monitor response to treatment• Specific events (rape, antenatal, post mortem)
CATEGORIZATION OF TESTS• Waived tests : are those that have few steps and have been shown to be accurate and easy to perform eg –BSL, pregnancy tests, urine dipstick tests, haemoglobin etc• Non waived tests: are the moderately and highly complex tests• Screening tests : good sensitivity and specificity, low cost and risk, confirmatory test available and practical, presymptomatic period detectable and treatable, high prevalence of disease, increased morbidity and mortality of disease
• Diagnostic tests : method well described and easily reproducible, accurate, established reference range, sensitivity and specificity established after a wide study.
FACTORS TO BE CONSIDERED BEFORE PERFORMING TESTS(i) Direct access testing [DAT]- patients are health conscious• No markups or kick backs• Ethical or social issues attached to reports• Usually waived• Doctor X patient relationship
(ii) Cost benefit analysis : benefit/cost ˃ 1 is cost effective(iii) To implement or discontinue the test – adequacy and trained staff ?, kits available or not ?, test volume too low, advanced technology, in vogue or obsolete, reimbursed or not(iv) Pareto principle : 80/20 rule 80% of total revenues generated by 20% of its products –list all tests performed in the lab and rank them according to the total annual revenues produced by each test
Verification / validation of tests• CLIA 1988 guidelines – verify the test and periodically validate it• Periodic evaluation of test utilisation and appropriateness of test• JCI – medical director of clinical and pathological lab services should ensure an active policy for monitoring and evaluation of quality and appropriateness of services is provided• Legal and ethical issues• Professional and moral responsibility of doctor and director
• Overutilisation of tests x• Underutilisation of tests x• Misutilisation of tests x• Laboratory information and consulting center : interpret, counsel, consult online or by mail/fax• Feedback to family doctors – improves test order quality ( provide patient data to lab- rationalise the test order)
REQUISITION• Person ordering the test• Referral from ( lab and person details)• Name/ age / sex• sample with source/ time• date of collection, of reception• LMP/any previous testing,treatment or biopsy• Any additional relevant information for testing
SOPM –standard operating procedure manual• List of tests available• Purpose of examination• Principle of procedure• Detailed instructions about preparation of patient and collection of sample, also type and volume of sample, timing of collection, precautions, labelling, type of container, additives, safe disposal of sample• Clinical information
Pre analytical loopholes• Test requests• Order entry errors• Identification of patient• Identification of specimen• Evaluation of specimen adequacy• Type of medium and/ preservative• Transport delay• Improper patient preparation
Analytic activities• Specific reagents• Test kits• Proper patient information• Proper interpretation- include disclaimers
Factors influencing analytic activities• Proficiency of personnel• Stability, integrity and reliability of reagents• Equipment reliability• Specificity and sensitivity of tests• Use of appropriate controls• Documentation• Assessment
3 components of Analytic phase• Monitor, evaluate and maintain this phase for ensuring reliability of results. This can be done by : Equipment – reliability and maintainence Examination procedures Quality of examination procedure
a) Equipment• Proper installation• Calibration• Validation• Regular maintainence• Train the operator Reputed manufacturers - good manufacturing practices (GMP), annual maintainence contract (AMC), simple to use, safe, moderate running cost, operation manual with trouble shooters
b) Examination procedure• Standard procedures• In house – to be validated – references, interlab comparisons, other references in literature• Review of all procedures periodically
c) Quality of examination procedures• Quality Control : Operational techniques and activities used to fulfill requirements of quality is called Quality Control (QC)• Quality assuranCe : Planned and systematic actions to provide quality in services is called Quality Asssurance (QA)
3 main aspects of QC• ACCURACY• ASSURANCE• REPRODUCTIBILITY Nowadays, there is large dependance on the laboratories (labs) and hence increasing load on technicians – errors ; On a global scale, increasing demand for accreditation of labs has further necessitated QC in labs.
• AIM : To assure the patient, doctor and the laboratory personnel of the validity and preciseness of ALL the tests performed in the lab.
2 types of QC• Internal – the lab itself conducts these processes, maybe once a week , to ensure its credibility• External – an outside agency or reference lab monitors/ supervises the working of the lab to test its quality. Once in 3-4 months.
QC program- DMPOIV• Design : proper facilities, expertise, prepare and maintain SOPM- standard operating manual, daily performed tests signed by director/ head of the lab• Material : reagents, chemicals, media, kits, sera, stains, all certified• Process : Maintainence and calibration of all equipment, SOPM.
• Output: check exceptionally high/low values. Reference ranges are determined. There should be baseline values of all records• Inspection and verification : is done by government or professional groups, medical director, lab consultant, chief lab technician or scientist
(iii) Post Analytical• Results and data review• Reports• Interpretation• Communicate reports to physician• Storage of specimen
Post analytic activities Review and evaluate the following:• Effectiveness of the corrective actions• Procedures and policies to prevent recurrences• Accuracy and completeness of results and reports• Disposition of unacceptable specimens• Turnaround times• Referral specimens and their reports• Corrected reports
Contd.....• Procedures for notification of test results with statistics• Assurance of confidentiality of patient information
(a) Reporting of results• Release of reports only to the authorized person• Timely release of provisional and final report• Any value which exceeds the normal limit must be clearly published, understood and conveyed verbally, electronically or printed form - when, where, what and to whom was reported - document it
• Result format – Name and address of lab Name of patient with gender Lab ID number Date and time of receipt of sample Type of sample Name of test requested with a brief clinical background Result with the units The normal or reference range of the test
Interpretation and explanation of the value of result Any disclaimer/s Value added textual comments Name of the person authorising the release of the report Signature of the person releasing the report
• Expected turnaround time – if delay, notify the doctor• Types of reports – standard paper, electronic and web based• Quality assessment and corrected reports- monitor and evaluate its results• If sample was unacceptable – prompt communication
(b) Storage and retention of samples• Standard procedures• Regulations for process and duration• Records – duration
(c) Assessment of test results on patient outcomes• Patient’ s health – quality of life• Financial outcomes• Publications• Discoveries• Case studies – interventions• Educational programs• Formulate empirical line of treatment
Sequelae to the path of workflow• Interact with teams of : Infectious disease clinicians Hospitalists Infection control epidemiologist Pharmacist Clinical case managers Nursing staff House keeping Cafeteria