YOUR Important Role in Patient Safety

1. YOUR Important Role in Patient Safety Lucia M. Berte Laboratories Made Better! www.LaboratoriesMadeBetter.com

2. What does quality mean to YOU?

3. What is Quality? Quality is doing the right things and doing those things right. Philip Crosby

4. What are the RIGHT quality “things” to do?

5. Clinical Pathways Decision Algorithms Do the Right Things Practice Guidelines

6. Decision Algorithms • Guide decisions as to which tests to order given previous test results • Require collaboration of medical staff and pathologists • Common applications • identifying microbiological organisms • transfusion service problem-solving • coagulation testing investigations

7. Clinical Pathways • Follows the sequence of activities for the patient throughout hospital stay • Based on diagnostic category • Includes ancillary testing services • Needs input from the medical laboratory

8. Practice Guidelines • Includes physician’s office and home care • Objective is to keep patient out of the hospital • Important role for laboratory testing in outpatient care

9. Doing the Right Things= Appropriateness • Physicians order laboratory tests • Order the right test • For the right reason • On the right patient • At the correct time

10. Laboratory’s Role in Appropriateness • Pathologists as the “doctors’ doctor” • Collaboration of the laboratory and medical staff on • test algorithms • laboratory tests in clinical pathways • role of lab testing in chronic diseases

11. What is Quality? Quality is doing the right things and doing thosethings right. Philip Crosby

12. How do you know how to “do things right” in the laboratory?

13. Quality Assurance Quality Control Do Things Right Quality System

14. Quality Control = Method Control • Control of test method performance only • Not related to correctness of patient identification or sample collection • Does not prevent medical errors • Required by law and accreditation • ISO 15189, CLIA ’88, CSA • CAP, AABB

15. Quality Assurance • Measures how well the work is being done • Represented by indicators • number of specific events divided by number of opportunities • Examples • rate of unacceptable samples • turnaround time for test results • rate of laboratory reporting error 6 = DPMO

16. PoW QSEs Quality System= all laboratory operations • Technical operations (the work you do), supported by • Managerial infrastructure (the work done by supervisors, administrative director, quality manager)

17. Organization Facilities and Safety Personnel Equipment Purchasing/Inventory Process Control Documents/Records Information Management Occurrence Management Assessments: Int/Ext Customer Service Process Improvement Quality System Model:Laboratory Services Laboratory’s Path of Workflow Preanalytic Analytic Postanalytic Quality System Essentials

18. Quality System Do Right Do ThingsThings Right Practice Guidelines Quality Assurance Clinical Pathways Decision Algorithms Quality Control Medicine Process Management Data: Process indicators Data: Patient Outcomes Total System Quality ASCP Lab Med 29(2):116

19. The Quality Hierarchy TQM Quality cost management Quality system Quality assurance Quality control

20. WHY do we need quality in health care?

21. WHY Quality? • It prevents medical errors that harm patients !! • It saves money • It’s the laboratory’s best advantage in competitive challenges

22. “Medical error is a failure of process.” IOM To Err is Human… 1999

23. Therefore…Patient Safety=Process Management

24. Understand your laboratory’s processes

25. “Quality is the fabric of the organization. It is everyone’s responsibility.” Dr. Dennis O’Leary, JCAHO

26. Organization Facilities and Safety Personnel Equipment Purchasing/Inventory Process Control Documents/Records Information Management Occurrence Management Assessments: Int/Ext Customer Service Process Improvement Service's Path of Workflow Quality System Model Quality System Essentials

27. PoW QSEs Quality System Model • Path of Workflow • each service has a path of workflow • objective is to understand and document • Staff are to be trained and competent • Quality Systems Essentials • building blocks of quality • management’s “procedure manual”

28. The Path of Workflow 1. • Sequence of activities that turns a physician’s order into laboratory test results • PoW is the same for all laboratory disciplines • anatomic and cyto-pathology • automated testing (chem, heme, coag) • micro, transfusion, immuno PoW

29. The Path of Workflow 2. • Processes for producing laboratory test results • Personnel who work in PoW include • physicians - lab assistants • nurses - phlebotomists • unit clerks - technicians / technologists • transporters - pathologists PoW

30. What is the laboratory’s path of workflow? PoW

31. Real Life • Work does not happen in alphabetical order! • Work does happen in processes • A process describes a set of procedures

32. Understand your laboratory’s Path of Workflow • Document the actual sequence of activities for “how it happens here” • Identify “who does what and when” • Identify “where am I in this process?” • Learn both the process and the procedures • Maintain your competence • Find ways to improve the process

33. Example: Sample Collection Process Collection board ? Special handling ? Patient is identified Phlebotomy performed Sample Transport Process Collection board updated Start Collection list generated No Yes Special handling performed No Sample is labeled Yes

34. Generating Collection List in LIS Identifying Patients Collecting Whole Blood by Venipuncture Labeling Blood Samples Providing Special Sample Handling Updating Sample Collection Board Procedures Needed

35. Another example

36. Example: Sample Receiving Process Sampleaccessioned Samplesdistributed Sample evaluated Samplesprocessed Packagesopened Sample problem solvingperformed Samples arrive Sampleacceptable? No Yes Intact? No Processingneeded? Safety performed No Yes Yes TestingProcess

37. Procedures Needed • Opening Sample Shipping Packages • Handling Broken Samples • Evaluating Samples • Solving Sample Problems • Accessioning Samples in LIS • Processing Samples • Distributing Samples for Testing

38. Test ordering order entry requisition prep instructions Sample collection lab and non-lab personnel patient identification !! sample labeling !! Sample transport modes used instructions Sample receipt and accessioning central or decentralized sample evaluation acceptance or rejection Preanalytic Activities

39. Important Notes on Preanalytic Activities • Not always performed by lab personnel • Good instructions are essential • Know your lab’s preanalytic activities • Communicate courteously to non-lab personnel for sample problems

40. Test performance automated and manual quantitative and qualitative follow procedures without personal deviations !! Quality Control is here Review and interpretation results reviewed for absurd values alert (critical) values technical problems interpretations of qualitative results transfusion service microbiology Analytic Activities

41. Important Notes on Analytic Activities • This is not the only part of the path of workflow ! • Garbage in - garbage out! • Report problems with documents! • DO NOT do one of these… • * • * • *

42. Result reporting verifying results calling alert values, documenting call printing and distributing reports making changes to reports Sample Archiving post-testing storage sample retention sample retrieval Post-analytic activities 1.

43. [Charge capture] manual charging manual crediting Post-report consultation questions about test results follow-up testing reporting errors Post-analytic activities 2.

44. Important Notes on Postanalytic Activities • Carefully review all results before verifying • Call and document alert values per protocol • Put clean samples away in proper places • Charge and credit testing carefully • Know when you don’t know how to answer the question

45. Completing a requisition Faxing a copy of results Performing daily QC on CBC analyzer “Tubing” samples to the lab Capillary puncture Identifying a parasite Aliquoting a sample Accessioning a sample Issuing a blood component Staining blood smears Putting away today’s samples Which part of the PoW is it in?

46. What do you need to know about the PoW in any job you have?

47. QSEs Quality System Model • Path of Workflow • each service has a path of workflow • objective is to understand and document • Staff are to be trained and competent • Quality Systems Essentials • building blocks of quality • management’s “procedure manual”

48. The Lab The Measurement The Work • Organization • Facilities & Safety • Personnel • Equipment • Purchasing & Inventory • Assessments • Occurrence Management • Customer Satisfaction • Process Improvement • Process Control • Documents & Records • Information Management A Quality Foundation Path of Workflow Pre-service Service Post-service Quality System Essentials: The Building Blocks

49. QSEs QSEs: Infrastructure for quality • Management sets policies and designs processes for each QSE • Both management and staff follow procedures in the QSEs • QSEs are everyone’s responsibility!

50. PATIENT The Patient and the Quality System Assessment Response Path of Workflow QSEs CLSi HS1-A, 2002