SELECTION OF A CLINICAL CHEMISTRY INSTRUMENT

1. SELECTION OF A CLINICAL CHEMISTRY INSTRUMENT Prof. AbdusSattar MBBS, MCPS,M.Phil, FCPS Dept of Pathology CMH Lahore Medical College Lahore

2. Introduction In the past most lab tests performed manually by endogenous reagent preparation for most of lab procedures Now ready made reagents kits are available Manual work replaced by automated lab instruments

3. Clinical Chemistry Analyzers

4. Immunoassay Systems

5. Introduction • Instrument Selection • Instrument Evaluation • Guidelines and scheme of selection and evaluation: • Barnett and Youden 1960s • IFCC • Westgard – concepts and principles of evaluation • CLIA ‘1988

6. Instrument Selection Because instrument purchases are some of the largest laboratory expenditures, the selection process should allow time for extensive research and evaluation.

7. Instrument Selection Steps in selection of lab instrument • Performing a Comprehensive Needs Assessment • Review Literature • Researching the availability of instrument in market • Extensive study of instrument literature in the light of defined need • Evaluating all the data gathered to determine which instrument will be acquired

8. Selecting an Equipment • Define/ evaluate need: The key question why a new equipment is required? • Need may be related to clinicians request or input. • Requirement to replace an older, labor intensive equip with a more efficient system. • Need also encompasses the work load, Type of work load, running cost/test and capital money available • The need helps to define the characteristics required of a potential equip. • Pertinent properties relate to medical usefulness and include diagnostic sensitivity and specificity as well as the precision and accuracy required for effective performance.

9. Needs Assessment • Features & Characteristics • Should satisfy the need /requirements of lab • Should attempt to define both present & future needs • Team approach (assessment team includes reps. of personnel on all shifts, management, lab information specialist, QA officer, safety officer & others with special expertise)

10. Practicality characteristics Type of specimen Sample size including pediatric specimens Turnaround time & the hours of test availability Interrupt feature for stat application Test throughput Test repertoire Specimen handling Run size Personnel skill requirements & training requirement Cost per test* Method of calibration Frequency of Calibration

11. Practicality characteristics • Capability of random access / batch analysis • Quality control approach • Open versus closed system • Robotic arms for specimen/reagents • Labor consideration • Minimal sample loading time • Walk-away features • Automatic sample dilution • Instrument QC features • Ease of troubleshooting • Maintenance downtime • Space needs (including reagent storage) • Waste disposal requirements • Chemical hazards / safety requirements

12. Practicality characteristics • Cost per test: • It has been defined as application characteristic due to compelling economic pressure. • The cost include; • Depreciation capital cost • Reagent cost (including water and accessories) • Cost of consumables( including daily, weekly, monthly and yearly maintenance cost) • Bar code reading facility expenses • Service and repair cost • Computer interface cost • Labor cost • Future increment in prices Open vs Closed System

13. Needs Assessment • Quality of performance (setting minimum standards for acceptable instrument performance) • Linearity • Sensitivity • Specificity • Accuracy • Precision

14. Research • Determine what is available in the market • Meeting with sales personnel • Review the literature supplied by the supplier • Research of product from manufacturer web sites • Contact colleague having experience of using the under consideration equip. • Some professional organizations maintain information related to locating sources for instruments, reagents and other products (e.g. AABB Buyer’s Guide at www.aabb.org)

15. Research • Compare the collected information • Short list the acceptable instruments • Final selection • Net-working with other facilities • Satisfaction of other consumers regarding • Manufacturer support services • Timeliness of repairs • Reagent problems • Actual instrument downtime • Compare the actual user findings to company claims

16. Research • Develop a Request For Proposal (RFP) • Team to develop RFP • List of questions each vender replies • Venders may assist team by providing sample RFP questions and formats • Compare the instruments from venders answers

17. Evaluation & Decision Making • Based on the developed need list and comparison data developed through the research process. • Eliminate unacceptable instruments. • Develop consensus decision between management and users. • Worker’s input makes it “our” instrument rather than management’s new instrument.

19. Needs Assessment • Characteristics of the individual Lab. • Lab test menu needed in future • Current and future lab workload • Work flow situation (need of STAT capability) • Labor consideration • Minimal sample loading time • Walk-away features • Automatic sample dilution • Instrument QC features • Data generation features • Ease of troubleshooting • Maintenance downtime

20. Selecting An Analytical Method The principle of the assay. The composition of reagents and reference materials including their storage requirements (e.g., space, temperature, light and humidity restrictions) applicable both before and after the opening of the original containers. The stability of reagents and reference materials. Possible hazards, appropriate safety precautions. The type, quantity, and disposal of waste generated. Specimen requirements – that is, conditions for collection, specimen volume requirements, the need for anticoagulants and preservatives, and necessary storage conditions.

21. Selecting An Analytical Method Anticipated analytical performance – that is, accuracy, precision, reportable range, and specificity using biological samples. The reference interval, including information on how it was derived; typical values obtained in health and disease. The detailed protocol for performing the test. Instrumental requirements and limitations. The availability of technical support, supplies, and service.

22. Selecting An Analytical Method Is the requisite measure equipment available? If not, is sufficient space available for new equipment? How much of a technologist’s time is required, and what skill level should he or she have? If training the entire in a new technique is required, is such training worth the possible benefit? What is the estimated cost of performing an assay using the proposed method, including the cost of calibrators, quality control specimens, and a technologist’s time? Are the data generated compatible with the data processing equipment already available?

24. Research • Meeting with sales personnel • Contacts to determine what is available in market • Review the literature supplied by the supplier • Research of product from manufacturer web sites • Some professional organizations maintain information related to locating sources for instruments, reagents and other products (e.g. AABB Buyer’s Guide at www.aabb.org)

25. Research Automated Features of some Sample Processing & Archiving Systems

26. Research

27. Needs Assessment • Additional instrument features • Instrument throughput • Sample processing method • Sequential vs simultaneous • Random vs fixed ordering • Batching capabilities • Bar coding • Sample identification system • Safety features (primary tube sampling) • Methodologies (photometric vs electrochemical) • Compatibility with LIS • Data storage capabilities

28. Research • Cost • Instrument • Reagents • Consumables • Service contracts • Spares • Labor • Cost is the limiting factor in determining, how many desired features are realistic. • Cost may determine what is really “needed” versus what is “wanted”. • Thorough research into all the details of cost will avoid surprises in the future.

29. CAP Participant Summary (Glucose)

30. CAP Participant Summary (TSH)

31. Hematology Analyzer

32. Needs Assessment • Lab Environment • Size • Special electrical & plumbing needs • Heat generation during operation