1. POCT: Building and Managing a Top-Notch Program a Top-Notch Program SHARON S. EHRMEYER, Ph.D. MEDICAL SCHOOL Department of Pathology and Laboratory Medicine UNIVERSITY OF WISCONSIN MADISON, WI

2. POCT -- Where are we now? v Two US hospital surveys, one in 1999 (510) and one in 2001 (584)* –Tracked POCT in hospitals –Provided information to manufacturers, healthcare providers, and testing sites * - US Hospitals POCT Survey, Enterprise Analysis Corp (EAC), Stamford, Connecticut

3. POCT -- Where are we now? v Instrument category % (584) hospitals using POCT –Blood glucose meters 100% –Coagulation62% –Blood gas/electrolytes50% –Chemistry (other)36% –Hematology28% –Urine chemistry15% –Cardiacmarkers4% * - US Hospitals POCT Survey, Enterprise Analysis Corp (EAC), Stamford, Connecticut

4. POCT Growth v Predicted - growth rate will double in next 5 years –Now 1 in 4 tests performed at POC –May represent 40% of laboratory tests in future v Current POCT market is estimated at $4.9 billion –Expected to double within next 5 – 10 years –414 of 584 hospitals anticipate purchasing POCT instruments before June 2002 * - US Hospitals POCT Survey, Enterprise

5. POCT – Benefits v Improved turn around times (TAT) –Quicker intervention –Better treatment –Improved patient outcomes v Convenience –Patient –Physician v Potential for decreased costs –Reduced cost for episode of care

6. POCT -- What about cost? Be careful with any POCT comparisons

7. POCT Concerns Oversight and Quality Each addressed through: Structure, Leadership and Managing the Process

8. POCT: Structure Provides: Authority, responsibility, and accountability for POCT

9. Administrative Structure v Situational-specific –Design for local needs v Should be reality driven, not perception driven v Includes players/parties involved in POCT –Hospital and laboratory administration –Medical staff –Nursing –Pharmacy –Purchasing –Information Services –Risk management –etc., etc.

10. Administrative Oversight v Determines appropriateness of POCT –For a given site, test, and patient u cost vs benefits u influence on length of stay (LOS) v Assures appropriate selection of testing procedure / instrument –Assists in evaluation of technology v Assures training of testing personnel –Makes recommendations on who will test –Advises senior management of status/changes –Builds bridges with all involved

11. Administrative Oversight v Assures regulations are met –Determines needed policies and procedures –Documentation –QC/QA v Provides oversight for getting the job done right –Advise senior management of status/changes –Build bridges with all involved

12. Administrative Oversight Authority –Make and enforce policy –Assign responsibility –Make decisions –Problem solve –Provide administrative support

13. POCT Oversight Authority assures a team effort v Clinicians define the medical situations where POCT is appropriate v Laboratory focuses on good POCT results v Nursing and other health professionals strive for good patient care

14. Oversight - Leadership Leadership Pick the right coordinator

15. POCT Oversight Final Outcome Right test Right result Right patient Right time Right record

16. POCT Concerns Quality

17. Quality of Health Care in U.S. v Institute of Medicine* –Medical errors cause 44,000 to 98,000 deaths each year u Equivalent to 200 deaths each day in airline crashes u Fifth leading cause of death in U.S. –Ahead of diabetes, breast cancer, HIV u Lab testing certainly contributes to deaths –Lab is looking for built-in safeguards to prevent errors *To Err is Human: Building a Safer Health System. Washington, DC, National Academy Press; 2000

18. Errors in perspective (per 10 6 ) Airline passenger fatalities0.2 Deaths due to general anesthesia 2-5 Viral transmissions from blood transfusions29 Deaths/accidents due to defective Firestone tires300 Lost bags of airplane passengers 5000 Lab errors 10000-30000 Arch Pathol Lab Med 123:761, 1999

19. Quality POCT Results - a major concern! Must focus on reducing medical errors v Patients deserve quality v POC needs to generate quality results –Yet, non-laboratorians often do the testing

20. IOM - Why Testing Fails v Human error v Lack of documentation v Lack of test management

21. Error Reduction v Prevention of human error will fuel the next wave of significant change in medical care –Data management and QC processes are key to error prevention –Error prevention will result in both better patient safety and decreased costs –Goals of regulations are to reduce/eliminate errors –Error prevention cannot be achieved without participation from industry (manufacturers)

22. In U.S.: CLIA sets minimum testing standards Intent of Regulations is reduce/eliminate errors v Quality Control v Personnel v Proficiency testing (external assessment) v Quality Assurance v Inspection

23. POCT Concerns v Regulatory compliance –Will POCT meet regulatory requirement? –Will POCT be acceptable to the central laboratory?

24. POCT – Users Major Compliance Concerns v QC –Performance; remedial actions;documentation v Operator certification –Authorized operators; recertification when required v Lack of identification –Operator; patient v Appropriate documentation in patient records –Patient results in a timely manner –Audit trail to link patient result with analyst, instrument, QC, time, date v Documentation –Method verification, reagent validation, proficiency testing, etc. –http://www.advanceforal.com/asp/spotanswer.asp

25. Top POCT Deficiencies – 5 Cincinnati Hospitals v Following manufacturers instructions v Documentation of patient results in patient record v Patient identification v Operator identification v Failure to do QC v Failure to respond to out-of-control situations v Unauthorized tester v Using outdated/expired reagents v Failure to observe safety requirements u Barbara Goldsmith, 2001

26. POCT: Oversight v Centralize decisions allows for: –Appropriate POCT instrument selection u Built-in safeguards u Quality assured results u Documentation

27. POCT 2003 & Beyond l Consider the environment l Select the appropriate instruments/methods l Proactively manage the process

28. POCT versus Central Lab Testing Central Lab POCT Testing personnel Pathologists,, PhDs, Med. Lab Technologists Nurses, other care givers Primary duties Laboratory testing Patient care Knows laboratory testing ExtensiveMinimal Understands instruments quality checks ExtensiveMinimal Can interpret QC data Yes Probably not Skills to resolve problems, troubleshooting YesNo Recognizes quality testing Yes Not necessarily

29. POCT Environment v Nurses are patient caregivers v Nurses are very competent v Nurses are very busy v Nurses perspective must be considered when selecting POCT instruments: –Quality POCT to better treat patients –Easy and trouble free POCT

30. POCT instrument selection criteria v Testing needs (menu) –Many instruments or just one –Space limitations / portability needs –Reagents and storage requirements –Test volume; Sample volume v Accuracy and precision v Measurement range v Costs v Reliability v Manufacturer support

31. POCT instrument selection criteria To prevent human errors, need: v Embed operating rules –Impossible not to follow manufacturers testing instructions v Patient ID v No sample preparation –Easy sample application Kost, GJ, Arch Pathol Lab Med. (2001) 125:1307–1315

32. POCT instrument selection criteria To prevent human errors, need: v Operator ID required –Trained and competent operators only u Operator lockout v Preventative maintenance done automatically v No expired/deteriorated reagents allowed v Automatic assured calibration Kost, GJ, Arch Pathol Lab Med. (2001) 125:1307–1315

33. POCT instrument selection criteria To prevent human errors, need: v Assured quality of test results –Automatic QC and data evaluation u Result withheld when QC fails –Automatic monitoring of instrument functions –Automatic error detection and correction u Instrument shutdown when correction is not possible –Tracking of errors Kost, GJ, Arch Pathol Lab Med. (2001) 125:1307–1315

34. POCT instrument selection criteria To prevent human errors, need: v Automatic data capture (documentation) –Patient results in patient record –Instrument checks –Regulatory / legal information Kost, GJ, Arch Pathol Lab Med. (2001) 125:1307–1315

35. Instrumentation 2003 l 2003 instrument philosophy l Coca Cola anyone? l Put sample in; get quality result l Quality control/quality assurance l Not my problem; dont bother me; just do it l Documentation/Connectivity l Automatic; dont bother me; just do it

36. Instrumentation 2003 v Accurate and precise v Easy to operate – foolproof –Built-in safeguards v Minimum (no) maintenance v 24/7 availability; instant results v Readily accessible to all care providers v Quality control – dont bother me; just do it v Quality assurance – not my problem v Data capture – automatic v Result in patient record -- automatic

37. Instrumentation 2003 & Beyond v Automatic self-calibration –On-board calibrator materials v Automatic QC –On-board QC materials –Automatic QC interpretation v Guaranteed quality results –Withhold bad results v Connectivity –Paperless system –From order to report to billing v Regulations are no problem –Requirements met; data assessed; documentation inspector- ready

38. Connectivity – Solves many POCT problems

39. Benefits of connectivity v Increased surveillance –Patient results, QC, QA, analyst –Alerts supervisor to problems v Reduced data handling –Less chance for transcription errors v Full data record for traceability –Links patient result, instrument, analyst, QC –Patient results in patient record v Cost savings –Fewer repeats –Only authorized testing

40. Where are we now? v Documentation* –Estimated that only 15% of POCT results get into patient record (US) * - US Hospitals POCT Survey, Enterprise Analysis Corp (EAC)

41. POCT oversight Pick the right instrument

42. Selecting right instrument eliminates problems v Following manufacturers instructions v Documentation of patient results in patient record v Patient identification v Operator identification v Failure to do QC v Failure to respond to out-of-control situations v Unauthorized tester v Using outdated/expired reagents v Failure to observe safety requirements u Barbara Goldsmith, 2000

43. Management v It is all about management, only management v Features and benefits exist only in the context of customers situations v Take a quality systems approach

44. Error Source Ross and Boone 1 Plebani et al. 2 Pre-analytical 46%68% Analytical7%13% Post-analytical 47% 19% 1 – Ross and Boone, Inst. of Critical Issues in Health Lab Practices, DuPont Press, 1991 2 - Plebani and Carraro. Clin Chem 43:1348, 1997 Total Analytical Error Distribution

45. Error management Quality system NCCLS Document EP18 Quality Management (System*) for Unit-use Testing

46. Error management Quality system v Quality systems approach to identify potential error sources –pre-analytical, analytical and post analytical –pre-analytical, analytical and post analytical v Identify strategies to eliminate/reduce errors –Differs for different test systems v Design a quality system for all of POCT, not just analytical phase EP18

47. Sources of error POCT v Pre-analytical –patient identification –specimen collection u arterial versus venous u fasting versus non-fasting u wrong anticoagulant u contamination from intravenous fluids, cleansing agents u inadequate amount collected u hemolysis –delay in sample analysis –etc., etc., etc.

48. Sources of error POCT v Analytical –sample inadequately mixed –introduction of air bubbles –adverse reaction conditions u temperature, humidity, power, barometric pressure, altitude –outdated reagents –deterioration of reagents –instrument failure –QC out of acceptable limits –inadequate maintenance –etc., etc., etc.

49. Sources of error POCT v Post-analytical –incorrect reading of results –outlier, nonsense result –result does not correlate with patients condition –result outside of linear limits –non-recognition of interferences –no result recorded –result recorded in wrong patient chart –etc., etc., etc.

50. EP18P Basic premise v Errors impacting results vary with the test device –a single quality regimen cannot cover all devices v Partnership between users and manufacturers –devices design should eliminate/minimize sources of error u manufacturer identifies what device does in terms of detecting / preventing these errors u manufacturer discloses errors NOT detected –POCT incorporates manufacturers approaches and develops additional practices to detect/minimize errors that remain

51. EP18 (quality tool) error matrix Pre-analytical Potential source of error (critical points) Device capabilities (function checks, EQC, etc.) Liquid QC Frequency of checks Training/Policies/Maintenance Patient ID Collection technique Hemolysis Time of collection Interfering substances

52. EP18 (quality tool) error matrix Analytical Potential source of error (critical points) Device capabilities (function checks, EQC, etc.) Liquid QC Frequency of checks Training/Policies/Maintenance Reaction temperature Sample volume Reagent storage Reagent failure Poor precision

53. EP18 (quality tool) error matrix Post-analytical Potential source of error (critical points) Device capabilities (function checks, EQC, etc.) Liquid QC Frequency of checks Training/Policies/Maintenance Nonsense result Result outside of reportable range No result recorded Incorrect information recorded

54. A real-world example for using EP18 The Biosite Triage® Cardiac System

55. Pre-analytical Triage® Cardiac System Pre-analytical Potential source of error (critical points) Device capabilities (function checks, EQC, etc.) Liquid QC Frequency of checks* Training/Policies/Maintenance Patient ID X Each patient X Patient info X Specimen collection X Wrong sample X

56. Analytical Triage® Cardiac System Analytical * M = with each measurement Potential source of error (critical points) Device capabilities (function checks, EQC, etc.) Liquid QC Frequency of checks* Training/Policies/Maintenance Cartridge integrity XMX Authorized operator X Sample application XXMX PrecisionXXM InaccuracyXXM Meter status XMX

57. Post-analytical Triage® Cardiac System Post-analytical Potential source of error (critical points) Device capabilities (function checks, EQC, etc.) Liquid QC Frequency of checks* Training/Policies/Maintenance Interpretation of QC XMX Outlier recognized and marked XMX Critical value recognized XMX Result in patient chart X (connectivity) X Results uploaded to data management system XX * M = with each measurement

58. Error management Quality System EP18 v Users must –identify relevant sources of error –develop strategies to ensure quality test results v Tools –manufacturers approaches –additional protocols (QC and QA practices) u training u protocolspolicies and procedures

59. What Defines Quality for Patient Testing? v Right test v Right time v Right patient v Right specimen v Right (accurate) result v Leading to the right therapeutic action