the joint commission national patient safety goals focus on 3 and 8 keith w. trettin r. ph. program manager

1. The Joint Commission National Patient Safety Goals Focus on #3 and #8Keith W. Trettin R. Ph. Program Manager

2. 2

3. 3 Test Your Knowledge

4. 4 Test Your Heparin Knowledge Heparin was discovered in 1916 at Johns Hopkins University? Dr. Charles Best purified and crystallized heparin between 1933-1936? Dr. Best worked at the Connaught’s Dufferin Farm in North Toronto? Connaught Laboratories was owned by the University of Toronto until 1972? 1 Unit of heparin is the quantity of heparin required to keep 1ml of dog’s blood fluid for 24 hours at 0o ?

5. 5 Test Your Heparin Knowledge Heparin was discovered in 1916 at Johns Hopkins University? Dr. Charles Best purified and crystallized heparin between 1933-1936? Dr. Best worked at the Connaught’s Dufferin Farm in North Toronto? Connaught Laboratories was owned by the University of Toronto until 1972? 1 Unit of heparin is the quantity of heparin required to keep 1ml of CAT’s blood fluid for 24 hours at 0o ?

6. 6 Connaught History 1914-1972-U. of Toronto 1972-1989- Connaught laboratories Limited owned by Canadian Development Corp. 1989- Institut Merieux -Pastuer Merieux Connaught -Rhone Poulenc merged with -Hoechest to become -Aventis -Aventis Pasteur

7. 7 Dr. Charles H. Best (1899-1978)

8. 8 Connaught’s Dufferin Farm

9. 9 Extra Credit What other product did Dr. Best along with Dr. Frederick Grant Banting purify which led Dr. Banting and John Rickard Macleod to win the 1923 Nobel Peace Prize?

10. 10 INSULIN

11. 11 Anticoagulation Workgroup

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13. 13 VA Anticoagulation Workgroup Objectives are to Develop Initiatives to Meet 1) The 5 Million Lives Campaign This campaign challenges American hospitals to adopt 12 changes in care that save lives and reduce patient injuries including: Prevent Harm from High-Alert Medications... starting with a focus on anticoagulants, sedatives, narcotics, and insulin 2) JC National Patient Goal #3

14. 14 What is NPSG Goal 3? Goal 3 – Improve the safety of using medications. 3c identify and at a minimum, annually review a list of look-alike/sound-alike drugs used by the organization and take action to prevent errors involving the interchange of these drugs. 3d Label all medications, medication containers or other solutions on and off the sterile field. 3e (03.05.01)Reduce the likelihood of patient harm associated with the use of anticoagulation therapy. Phased in over 2008 and fully implemented by Jan 1, 2009.

15. 15 JC IMPLEMENTATION SCHEDULE April 1, 2008- the organization leadership has assigned responsibility for oversight and coordination of the development, testing, and implementation of requirement 3e. July 1, 2008- an implementation work plan is in place that identifies adequate resources, assigned accountabilities, and a time line for full implementation of requirement 3e by January 1, 2009 October 1, 2008- pilot testing in a least one clinical unit is under way. January 1, 2009- the process is fully implemented across the organization.

16. 16 Rationale for NPSG 3 Anticoagulation is a high-risk treatment, which commonly leads to adverse drug events. Dosing of these medications is complex. Monitoring is required. Patient compliance directly effects outcomes. The use of standardized practices that include patient involvement can reduce the risk of adverse drug events associated with the use of heparin, low-molecular heparin, warfarin, and other anticoagulants. JC Perspectives on Patient Safety Aug 2007

17. 17 Rationale Cont: Coumadin® (warfarin) is Commonly Prescribed Eleventh most prescribed drug overall 4th most prescribed cardiovascular agent Annual sales of $500 million Agency for Healthcare Policy and Research (AHCPR) reports it’s underused for stroke patients because of fears of drug safety. Drug prevents 20 strokes for every bleeding episodes

18. 18 Rationale Cont: MEDMARX Data Anticoagulants Involved in Medication Errors All Errors (Category A to I) Heparin 2% Warfarin 1.5% Enoxaparin 1.2% Errors Causing Harm (Category E-D) Heparin 3.9% Warfarin 2.6% Enoxaparin 1.3%

19. 19 Anticoagulant Events Bates et al. –anticoagulants accounted for 4% of preventable ADEs and 10% of potential ADEs Butnitz et al.-warfarin and Insulin cause 1 in 7 ADE treated in ERs and more than 25% of all hospitalizations

20. 20 Business Case Eckman estimated the cost of an inpatient major anticoagulation-related bleed as ranging from $3,000 to $12,000.

21. 21 VA Anticoagulation Vulnerabilities Identified from RCAs Calculation and set up of heparin doses Multiple methods to order anticoagulants (CPRS, protocols, text orders, etc) Failure to appreciate half lives and peak effect times of various drugs (e.g. today's dose effects day after tomorrow's lab) Absolute and relative contraindications to anticoagulation (up to date risk: benefit ratios) Selection of intensity of anticoagulation to meet the risk benefit ratio Timing and reporting and evaluation of PTT results (often drawn before steady state) Specimen collection (adequate volume, appropriate site of phlebotomy) Transition therapy for outpatients needing reversal of warfarin for outpatient procedures or surgery Transition therapy for inpatients from heparin therapy to warfarin Reversal of anticoagulant effect with protamine, Vitamin K, or FFP (to reverse or to wait and see) Vitamin K dosing and administration (too high a dose leads to prolonged warfarin resistance) Therapy with new drugs that interact with anticoagulants (inadequate information about drug interactions) Patient compliance with anticoagulant regimen (drug therapy, diet, monitoring) Alternative medicines and risk of drug interactions and bleeding Enteral supplements and protein binding effects with warfarin Monitoring for side effects (CBC, HBG, PLT, thrombocytopenia, etc and frank bleeding) Medication use systems - floor stock and infusion devices Lack of double check systems (infusion device, calculations, loading dose, etc) IV compatibility and infusion related interruption issues Flow of information (need paper or electronic flow sheet similar to diabetes or ICU care)

22. 22 2009 Elements of Performance for NPSG 03.05.01 The hospital implements a defined anticoagulation management program to individualize the care provided to each patient receiving anticoagulation therapy. To reduce compounding and labeling errors, the hospital uses only oral unit dose products, prefilled syringes or pre-mixed infusion bags when available. The hospital used approved protocols for the intiation and maintenance of anticoagulation therapy appropriate to the medication used, to the condition being treated, and to the potential for medication interactions. For patients starting on warfarin, a baseline INR is available, and for all patients receiving warfarin therapy, a current INR is available and is used to monitor and adjust therapy. When dietary services are provided by the hospital, the service is notified of all patients receiving warfarin and responds according to its established food/medication interaction program.

23. 23 2009 Elements of Performance for NPSG 03.05.01 Cont. When heparin is administered intravenously and continuously, the hospital uses programmable infusion pumps in order to provide consistent and accurate dosing. The hospital provides education regarding anticoagulation therapy to prescribers, staff, patients and families. Including monitoring, compliance issues, dietary restrictions, and potential for adverse drug reactions and interactions. The hospital has a written policy that addresses baseline and ongoing laboratory tests that are required for heparin and low molecular weight heparin therapies. 9. The hospital evaluates its anticoagulation safety practices, takes appropriate action to improve its practices, and measures the effectiveness of those actions on a regular basis.

24. 24 1. VAMC to Develop a Process in Which Stat INRs in CBOCS are Processed and Reported within 60 minutes of the Blood Draw Recommendation: Report OP INRs within a time frame that allows adjustment of doses while the patient is still in clinic Rationale: Contacting patient and communicating changes in warfarin regiments over the phone increases risk of miscommunication. Establishing warfarin monitoring procedures are a req. of NPSG#3 Fix: Use a portable INR test in CBOCs Example Roche Coagucheck

25. 25 2. VAMC to Develop a Process in Which Stat INRs in Community Based Outpatient Clinics are Processed and Reported within 60 minutes of the Blood Draw

26. 26 3. INR Considered Critical Value Recommendation: INR must be drawn at a minimum of every 45 days. INRs should not be calculated sooner than 36 hrs after a dosage adjustment. If VAMC accepts lab values from outside the VA the INR should be added to the VA lab reporting system Rationale: INR values must be accurate and readily available to the practitioner to make informed clinical decisions. Reporting should be the same as other critical values as determined by the VAMC. JC requires determination of critical values and associated procedures. IHI Recommendation to report to someone that can take action. Fix: Develop order set that links Pro Time/INR order to warfarin order. CPRS to prompt a requirement for INR report

27. 27 4. Patient Education Brochures Recommendation: Anticoagulation patient education materials should be provided at discharge from MC or Clinic Rationale: NPSG #13 Encourage the active involvement of patients and their families in the patient’s own care as a patient safety strategy. JC PC6.10 “The patient receives education and training specific to the patient’s needs and as appropriate.” IHI Recommendation to “Engage patients and families in self-management” Fix: Purchase or use provided warfarin patient education brochures. Samples available on NCPS web site http://vaww.ncps.med.va.gov/Guidelines/NPSG/index.html Patient Education Materials available on the MyHealtheVet Web site. http://preview.myhealth.va.gov/mhv-portal-web/anonymous.portal?_nfpb=true&_nfto=false&_pageLabel=medicalLibraryHome

28. 28 5. Education Provided at Least Once a Year. Recommendation: Provide education to medical providers, nurses, pharmacists and laboratory staff Rationale: Staff will remain up to date on prescribing, dispensing and monitoring. Requirement of NPSG #3 implementation standard (M) C 9 Fix: VAMCs will place on annual education schedule

29. 29 6. Standardized Weight Based Heparin Protocol are Available in CPRS. Recommendation: Each VAMC adopts and places into CPRS a weight based heparin protocol Rationale: Reduces variation in practice. Requirement of NPSG#3 implementation standards, IHI 5M Lives recommendation Fix: Create Heparin CPRS Quick Orders based on Patients Weight. Sample protocols and setup found on the NCPS web site. http://vaww.ncps.med.va.gov/Guidelines/NPSG/index.html

30. 30 7. Anticoagulants (IV and Oral) Designated “High Risk” Recommendation: Anticoagulants should be designated as high risk and all specific VAMC high risk policy’s and procedures should apply Rationale: Increased awareness of the safety requirements of these products. JC and IHI have designated these High Risk. National Quality Forum recommendation Fix: Pharmacy and Therapeutics (P & T) Committees to adopt

31. 31 8. IV Heparin Administered Through a Programmable Pump Recommendation: Use IV pumps rather than gravity feed for anticoagulants. Smart pumps with guardrails should be used when possible Rationale: Allows better control of rates and free flow protection - JCAHO requirement for NPSG #3. - Programmable was clarified by Peter Angood (3/08) from JC to mean pumps rather than smart pumps - Smart pumps recommended by ISMP, IHI Fix: VAMC should have pumps available. Purchase smart pumps when budget and infrastructure (wireless connect ability) allows

32. 32 9. Concentrations of Injectable Heparin Standardized/Minimized. Recommendation: Decrease number of concentrations of heparin Rationale: Decreases risk of injecting incorrect concentration. Requirement of the JC NPSG 3B and MM 2.20, IHI Recommendation Fix: VAMCs P&T to review

33. 33 HEPARIN IS HIGH RISK

34. 34 10. IV Heparin is Purchased in Manufacturers’ Prefilled Bags. Recommendation: VAMCs to purchase heparin in prefilled bags Rationale: Decreases risk of bacterial contamination, dispensing errors, and/or IV pump setup errors. Requirement of NPSG#3 Implementation Standards Fix: VA Pharmacy Departments to purchase

35. 35 11. Coumadin Tablet Strengths have been Minimized. Recommendation: Restrict number of tablet strengths of warfarin Rationale: CPRS blinds physician to the tablet strength of warfarin actually dispensed by Pharmacy Department for a prescribed dose. Decrease patient confusion by reducing the number of different tablet strengths. Minimize waste caused by frequent dosage changes. IHI 5M Lives recommendation Fix: P&T to determine strengths available and Pharmacy Dept to restrict formulary availability of strengths

36. 36 Warfarin accounts for 1.5% of all Reported Errors and 2.6% of Errors Resulting in Harm/Fatalities

37. 37 12. Coumadin Dispensed in Automated Storage Devices (Pyxis and Omnicel) are Placed in Cubies or Different Strengths in Separate Drawers. Recommendation: Separate anticoagulants when using automatic dispensing devices Rationale: Minimize the risk of selecting the incorrect strength Fix: Pharmacy Dept. to separate anticoagulants in automatic dispenser devices

38. 38 Specialized Drawers in Automated Medication Dispensing Devices increase Safety.

39. 39 13. Dietary Consults are Available. Recommendation: Dietary consults focusing on the interactions with anticoagulants should be readily available Rationale: Foods high in Vitamin K substantially effect the risk of sub or supra therapeutic levels of warfarin. Requirement of NPSG #3 implementation standard Fix: VAMC administration to assure access to staff responsible for dietary education

40. 40 14. Specialized Anticoagulation Service Available to All Inpatients and Outpatients Recommendation: Anticoagulation clinics should be available to all veterans taking anticoagulants Rationale: Patients seen in clinics have increased monitoring and therapeutic levels, IHI Recommendation Fix: Recent PBM study indicates there are 128 clinics already in operation

41. Current VA Anticoagulation Management

42. 42 Measure Denominator Within past rolling 15 months, patients with diagnosis of Atrial Fibrillation (ICD-9 427.31), but not valve replacement Who have been seen in a clinic in the past rolling 12 months Who have an active warfarin script (using drug name, not drug class) (dispensed in prior four months) Established patients: At least two 30 day scripts in past rolling 4 months New patients: only 1 script, none in prior 8 mos, used as support indicator Numerator INR test performed in last 60 days INR test performed in last 60 days; most current (if multiple) in therapeutic range for Atrial Fibrillation (2.0-3.0) Available KLF menu https://vssc.med.va.gov/dss_ssl/inr.asp SSN and SSSN available for drilldown Reports by age, gender, new vs. established, Coumadin clinic vs. not

43. 43 National results, trends

44. 44 Better performance within Coumadin clinics

45. 45 Absolute Advantages of Coumadin Clinics, within Facilities

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48. 48 Pharmacist’s Role 100% of VA Anticoagulation Services have Pharmacists involvement IHI -“Consider pharmacist-or nurse run anticoagulation service” A recent study indicate Pharmacists involvement increase INR control and patient satisfaction Target INR reached in 76% vs. 48% Sub therapeutic levels decreased from 12% to 1% Supratherapeutic levels decreased from 5% to 1%

49. 49 Medication Reconciliation

50. 50 The Joint Commission 2007National Patient Safety Goals Improve the accuracy of patient identification. Improve the effectiveness of communication among caregivers. Improve the safety of using medications. (Retired) - Eliminate wrong site, wrong patient, and wrong procedure surgery. (Retired) - Improve the safety of using infusion pumps. (Retired) - Improve the effectiveness of clinical alarm systems. Reduce the risk of healthcare-associated infections. Accurately and completely reconcile medications across the continuum of care. Reduce the risk of patient harm resulting from falls. Reduce the risk of influenza and pneumococcal disease in institutionalized older adults. Reduce the risk of surgical fires. Encourage the active involvement of patients and their families in the patient’s own care as a patient safety strategy. Prevent healthcare-associated pressure ulcers (decubitus ulcers). The organization identifies safety risks inherent in its patient population. 15A: The organization identifies patients at risk for suicide. 15B: The organization identifies risks associated with long-term oxygen therapy, such as home fires.

51. 51 What is NPSG Goal 8? 2009 Changes Goal 8 - Accurately and completely reconcile medications across the continuum of care. 8a (08.01.01) A process exists for comparing the patient’s current medications with those ordered for the patient while under the care of the organization 8b (08.02.01) When a patient is referred to or transferred from one organization to another, the complete and reconciled list of medications is communicated to the next provider of service and communication is documented. Alternatively, when a patient leaves the organization care directly to his or her home, the complete and reconciled list of medications is provided to the patient’s known primacy care provider, or the originial referring provider, or a know next provider of service. Note: When the next provider of service is unknown or when no known formal relationship is planned with the next provider, giving the patient/family as needed, the list of reconciled medications is sufficient.

52. 52 What is NPSG Goal 8? Goal 8 - Accurately and completely reconcile medications across the continuum of care. 8b (08.03.01) When a patient leaves the organization’s care, a complete and reconciled list of the patient’s medications is provided directly to the patient, and the patient’s family as needed, and the list is explained to the patient and or family. (08.04.01) In settings where medications are used minimally, or prescribed for a short duration, modified med rec processes are performed.

53. 53 Definition of Reconcile Reconcile is to compare and reach agreement. To avoid errors of transcription, omission, duplication of therapy, drug-drug and drug-disease interactions etc.

54. 54 Scope of the Problem In August 2006, the Institute of Medicine of the National Academies released a major study on medication errors in American hospitals that found adverse drug events (ADEs) harm more than 1.5 million people and kill several thousand a year, costing at least $3.5 billion annually. (Committee on Identifying and Preventing Medication Errors, 2006) Variances between medications patients were taking prior to admission and what was written on their admission orders ranged 30-70% in several studies. (Gleason, et al 2004, Cornish & Knowles, 2005, Vira et al, 2006), Luther Midelfort-Mayo found 250 potential or actual medication errors for every 100 charts. (Rozich & Resar, 2001) Most common discrepancy is omission of home medication (left off the list), followed by commissions (inappropriate medications that shouldn’t be ordered due to the patient’s condition, wrong dose, route etc.). (USP Patient Safety CAPSLink, 2005) Estimated >50% of adverse medical events occur at interfaces of care. (Resar,2005, Kripalini et al, 2007)

55. 55 What about the VA? In 2004, of 493 VA patients over 65 yo with 5+ medications, only 5.3% had perfect agreement with what they were taking and what was listed in CPRS. (Kaboli, 2004) Recent survey at the outpatient clinic at WRJ VA, revealed 40% patients bring a list of medications or medications “brown bag”,<40% patients leave with an updated list. (Layden, 2007)

56. 56 Why Medication Reconciliation? Decreased ADEs; 43% at Cambridge Health Alliance after institution of Medication Reconciliation program. (Bartick & Baron, 2006) Decreased overall time spent; On average 20-40 minutes at each interface due to eliminated rework. (Rozich & Resar, 2001) Decreased costs; NW Memorial Chicago Medication Reconciliation cost $11 per patient, but ADEs cost $2000-6000 per patient, at 4% error rate, approx $80 per patient. Costs: Readmission, increased LOS. Extra office, urgent care, ER visits, patient calls. (Gleason, et al, 2004) May increase patient & staff satisfaction. (Cohen,2006)

57. 57 You are Not Alone in this Struggle Institute for Safe Medication Practices in a May 2006 study showed nurses, pharmacists, both outpatient and inpatient, 91% knew of National Patient Safety Goal (NPSG) #8. 89% Felt it added great value to patient safety. Only 25% of their organizations had a Medication Reconciliation process in place at 6 months, 18% for 1 year or more.

58. 58 VA & Non-VA Percent (%) of Frequently Cited JCAHO NPSGsAll Accreditation Programs (Hospital, BHC, HC LTC)

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61. 61 2006 JC Survey of 1,429 Hospitals indicates 72.5% Compliance to 8BVA=88%

62. 62 Compliance to Medication Reconciliation is Dropping

63. 63 Medication Reconciliation Hines Class 3 Software Portland Patient Safety Center of Improvement NCPS “PLAY IT SAFE” Cognitive Aids VISN 1 Collaborative Joint Commission Intervention

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66. 66 JC Interpretation March 2008

67. The Automated Patient History Intake Device(APHID) Leveraging technology to improve clinic efficiency and data reconciliation Blake Lesselroth MD, MBI Robert Felder DDS, MPH, CAC Phillip Cauthers, CAC Shawn Adams Gordon Wong, RPh, CAC Sherrie Schuldheis, PhD, RN David Douglas, MD

68. 68 Demographics

69. 69 Patient Allergies

70. 70 Medication Reconciliation

71. 71 Usability Data Approximately 85% of primary care patients can use kiosk Cycle time for patient throughput was acceptable for primary care Most primary care providers were satisfied with workflow impact and quality of data Some challenges associated with staff allocation and device configuration This model meets current security and privacy standards for a healthcare enterprise

72. 72 Maureen Layden, MD Fellow, VA Quality Scholars Program VAMC (11Q) 215 North Main Street White River Junction, VT 05009-0001 Phone:802 295-9363 Ext.6032 Fax:802 291-6286 Email: Maureen.Layden@va.gov Email: Maureen.Q.Layden@Dartmouth.edu

73. THANK YOU