Patient Safety- What You Should Know

1. Patient Safety- What You Should Know

2. Course Objectives Importance of Patient Safety System Approach to Errors Quality Care- Regulatory & Consumer Response Implementing a Patient Safety Program Creating a Culture of Safety Tools and Resources Simulations- Case Illustration System Approach to Errors- how do errors actually take place in healthcare? Quality Care- How have Regulatory Agencies and Consumers responded to the IOM report? Implementing a patient Safety Program- You hear about robotics, CPOE etc is it all high tech or are there simple things that all hospitals can implement? Creating a Culture of Safety � what exactly is this?System Approach to Errors- how do errors actually take place in healthcare? Quality Care- How have Regulatory Agencies and Consumers responded to the IOM report? Implementing a patient Safety Program- You hear about robotics, CPOE etc is it all high tech or are there simple things that all hospitals can implement? Creating a Culture of Safety � what exactly is this?

3. Adverse Drug Event- What exactly are we talking about? Error �� An error is defined as the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim. Errors can include problems in practice, products, procedures and systems� Examples � medication, surgical errors, diagnostic errors (misdiagnoses, incorrect therapy or treatment, failure to use indicated diagnostic test), equipment failures (defibrillator without working batteries or a free-flowing IV solution.) nosocomial infections, blood transfusion related injuries, deaths due to restraint use Adverse Drug Event- injuries that result from the use of drugs. They can include prescribing, dispensing and administration errors. Adverse Drug events that are associated with a medication error are considered preventable, while those not associated with a medication error (e.g. known medication side effect) is considered non-preventable. Iatrogenic Injury �injuries due to medical care Sentinel Event- A sentinel event is defined as an unexpected occurrence, involving death or serious physical or psychological injury or risk thereof

4. Medication Error Definition

5. �Harvard Medical Practice Study� 1984 New York Study - up to 98,000 deaths1992 Colorado/ Utah Study - 44,000 deaths The IOM�s Quality of Healthcare in America Project started it�s work in June of 1998. It used the information from two key studies and published it�s result in November of 1999. Lucian Leape and colleagues published a two part series in 1991 in the New England Journal of Medicine called the The �Harvard Medical Practice Study. This was a retrospective study of adverse events in 30,000 medical records from 51 hospitals in New York state from 1984. 3.7% of the patients suffered an Adverse Event (defined as a extended hospital stay, permanent disability at the time of discharge or death). Of this group of 3.7%, 58% were preventable, negligent care accounted for 28% of these patients, 13.6% died as a result of these errors and 2.6% suffered permanent disability. A similar study by Eric Thomas in Colorado and Utah of some 15,000 patient records found a similar adverse event rate of 2.9% from data collected in 1992. This report was only pubished in early 1999 and it found that 53% of the adverse events were preventable with negligence accounting for 27% of these patient injuries. Adverse events leading to death were 6.6%. If you use the lower number of deaths, it is the eighth most frequent cause of death. More people die from errors in healthcare than die each year from Breast Cancer (43,458), Automobile accidents (42,297) and AIDS (16,516) . Bates has found that 6.5% of admissions experience an Adverse Event Medication errors were the most common adverse event, accounting for 19% of all adverse events and were responsible for a disabling injury in 0.7% of hospitalized patients. The Institute of Medicine report noted that healthcare system flaws were responsible for medical errors. Some of the system flaws noted in the report included illegible handwriting, look-alike and sound alike medication names and unsafe medication floor stocking practices. .The IOM�s Quality of Healthcare in America Project started it�s work in June of 1998. It used the information from two key studies and published it�s result in November of 1999. Lucian Leape and colleagues published a two part series in 1991 in the New England Journal of Medicine called the The �Harvard Medical Practice Study. This was a retrospective study of adverse events in 30,000 medical records from 51 hospitals in New York state from 1984. 3.7% of the patients suffered an Adverse Event (defined as a extended hospital stay, permanent disability at the time of discharge or death). Of this group of 3.7%, 58% were preventable, negligent care accounted for 28% of these patients, 13.6% died as a result of these errors and 2.6% suffered permanent disability. A similar study by Eric Thomas in Colorado and Utah of some 15,000 patient records found a similar adverse event rate of 2.9% from data collected in 1992. This report was only pubished in early 1999 and it found that 53% of the adverse events were preventable with negligence accounting for 27% of these patient injuries. Adverse events leading to death were 6.6%. If you use the lower number of deaths, it is the eighth most frequent cause of death. More people die from errors in healthcare than die each year from Breast Cancer (43,458), Automobile accidents (42,297) and AIDS (16,516) . Bates has found that 6.5% of admissions experience an Adverse Event Medication errors were the most common adverse event, accounting for 19% of all adverse events and were responsible for a disabling injury in 0.7% of hospitalized patients. The Institute of Medicine report noted that healthcare system flaws were responsible for medical errors. Some of the system flaws noted in the report included illegible handwriting, look-alike and sound alike medication names and unsafe medication floor stocking practices. .

6. To Err is HumanBuilding A Safer Health System Recommendations Congress to create a Center for Patient Safety Establish a national mandatory reporting system � std info state govt. ADE death or serious patient harm The Center for Patient Safety should improve efforts for voluntary reporting systems Congress to pass legislation peer review protection Performance stds. & expectations- Health care organizations & professionals must focus greater attention to patient safety FDA to increase attention safe use of drugs Healthcare- to establish patient safety programs with defined executive responsibility The Center for Patient Safety should be created within the Agency for Healthcare Research and Quality (AHRQ). The center would be a clearinghouse for states to share this mandatory information and expertise on reporting programs and to identify persistent safety issues. Performance Std- obviously JCAHO has raised the bar with regards to patient safety by tying accreditation to the National Patient safety Goals. In addition, some states such as NY now require a certain number of ce credits for re-licensure of healthcare professionals Within days of the IOM report, then President Clinton asked the Quality Interagency Coordination Task Force (QuIC) to study the report and make recommendations. Their recommendations were to : Keep reporting within state systems Research, evaluation and advisory components within federal agencies Senator�s Kerry, Lieberman sponsored the �Stop All Frequent Errors (SAFE) Act of 2000 that largely mirrored the IOM and QuIC reports calling for non-punitive error reduction system with adequate legal protection 15 states require mandatory reporting from hospitals of adverse events including NY, NJ, PennThe Center for Patient Safety should be created within the Agency for Healthcare Research and Quality (AHRQ). The center would be a clearinghouse for states to share this mandatory information and expertise on reporting programs and to identify persistent safety issues. Performance Std- obviously JCAHO has raised the bar with regards to patient safety by tying accreditation to the National Patient safety Goals. In addition, some states such as NY now require a certain number of ce credits for re-licensure of healthcare professionals Within days of the IOM report, then President Clinton asked the Quality Interagency Coordination Task Force (QuIC) to study the report and make recommendations. Their recommendations were to : Keep reporting within state systems Research, evaluation and advisory components within federal agencies Senator�s Kerry, Lieberman sponsored the �Stop All Frequent Errors (SAFE) Act of 2000 that largely mirrored the IOM and QuIC reports calling for non-punitive error reduction system with adequate legal protection 15 states require mandatory reporting from hospitals of adverse events including NY, NJ, Penn

7. Crossing the Quality Chasm Six Aims for the 21st Century Pt are not injured by the care intended to help them Effective- evidence based Patient Centered Timely Efficient Equitable Pt are not injured by the care intended-Patient�s should receive the same standard of care 24 X 7. Communication between healthcare providers must be improved and patients should be well informed. Effective Evidenced based care � where evidence exists guidelines and protocols should be initiated. Patient Centered � one size does not fit all and there must be a respect for patient preferences, needs and values Timely- excessive waiting time can cause possible harm Efficient- healthcare organizations should work hard on decrease the waste and re-work Equitable- everyone receives the same quality of care.Pt are not injured by the care intended-Patient�s should receive the same standard of care 24 X 7. Communication between healthcare providers must be improved and patients should be well informed. Effective Evidenced based care � where evidence exists guidelines and protocols should be initiated. Patient Centered � one size does not fit all and there must be a respect for patient preferences, needs and values Timely- excessive waiting time can cause possible harm Efficient- healthcare organizations should work hard on decrease the waste and re-work Equitable- everyone receives the same quality of care.

8. Crossing the Quality Chasm Ten Rules for care for 15 Priority Conditions Accessible Flexible Informed pt decision making Free access to info Evidence based Safe Transparent Anticipate Needs Decreased waste Collaboration Free access to information � Why shouldn�t I as a patient be able to see my own medical record? Transparent- all providers should give patient information about their safety record Anticipate Needs � standard of care, but be able to customize when necessary. The fifteen priority conditions include: cancer, diabetes, emphysema, high cholesterol, HIV/AIDS, hypertension, Ischemic heart disease, stroke, arthritis, asthma, gallbladder disease, stomach ulcers, back problems, alzheimers disease and depression/anxietyFree access to information � Why shouldn�t I as a patient be able to see my own medical record? Transparent- all providers should give patient information about their safety record Anticipate Needs � standard of care, but be able to customize when necessary. The fifteen priority conditions include: cancer, diabetes, emphysema, high cholesterol, HIV/AIDS, hypertension, Ischemic heart disease, stroke, arthritis, asthma, gallbladder disease, stomach ulcers, back problems, alzheimers disease and depression/anxiety

9. Keeping Patients Safe: Transforming the Work Environment of Nurses The latest report from the IOM addresses the following: Work environment critical patient safety- specifically staffing & fatigue Creating cultures of safety Framework to construct safe work environments The latest report from the IOM (publication should be out later this spring) looks at human factor information and something called a culture of safety. We will review this information later. The latest report from the IOM (publication should be out later this spring) looks at human factor information and something called a culture of safety. We will review this information later.

10. Additional Statistics US Death Certificates 1983 vs. 1993 2.57-fold increase from medication errors Phillips et al. 1998 Outpatient Deaths - during the same time period 8.48 fold increase 6.5% ADE per 100 non-obstetrical admission Bates et al. Children Hospitals 4.5- 4.9 errors per 1,000 medication orders Pediatric ICU�s even higher at one error per 6.8 admissions Massachusetts State Board of Pharmacy estimated that 2.4 million Rx are filled improperly (wrong drug/ wrong strength) ADE associated with increase length of stay 1.9-4.6 days and up to $4,700 in cost US Deaths � 1983 2,876 people vs 1993 7,391 people died from medication errors. A 2.57 fold increase. The likelihood of experiencing an adverse event increases 6 percent for each day of your hospital stay.US Deaths � 1983 2,876 people vs 1993 7,391 people died from medication errors. A 2.57 fold increase. The likelihood of experiencing an adverse event increases 6 percent for each day of your hospital stay.

11. Healthcare currently is borderline hazardous. If the studies are correct, they are the equivalent of 1 jumbo jet crashing every three days. Note in the early 1980�s mortality rates from anesthesiology were 2 deaths per 10,000 cases vs currently 1 death per 300,000 cases. The likelihood of your being in a fatal crash is 1 in 8 million vs. 1 in 2 million during 1967-1976. You would have to fly for 438 years 24 hours a day 7 days a week before you would be involved in a fatal crash. Healthcare currently is borderline hazardous. If the studies are correct, they are the equivalent of 1 jumbo jet crashing every three days. Note in the early 1980�s mortality rates from anesthesiology were 2 deaths per 10,000 cases vs currently 1 death per 300,000 cases. The likelihood of your being in a fatal crash is 1 in 8 million vs. 1 in 2 million during 1967-1976. You would have to fly for 438 years 24 hours a day 7 days a week before you would be involved in a fatal crash.

12. Being the best, is no guarantee that you will be safe from harm. You will recall this summer the tragic situation at Duke University Medical Center (#6 on this listing of best hospitals) in which a patient during a kidney transplant received the wrong blood transfusion. This past December our #1 Hospital John�s Hopkins also had a death attributed to the care that a small child received.Being the best, is no guarantee that you will be safe from harm. You will recall this summer the tragic situation at Duke University Medical Center (#6 on this listing of best hospitals) in which a patient during a kidney transplant received the wrong blood transfusion. This past December our #1 Hospital John�s Hopkins also had a death attributed to the care that a small child received.

13. Being the Best Doesn�t Mean Mistakes Can�t Happen

14. The Importance of Patient Safety The Consequences of a Mistake Injury to the patient Goes against everything we stand for Professional, Legal & Regulatory consequences For every error three other people are hurt- the patient�s family, the healthcare professional who was effected and���.. the next patient if the system is not improved! Video - Beyond Blame � 9 minutes

15. Objective IISystem Approach to Errors Accidents � almost never have a single cause Latent Failures � dormant factors and are properties of the system that call forth errors & failures on the part of human workers Process of design management Resource allocation

16. Challenger Disaster Latent Failures- design flaw happened before the launch Production Pressures � leads to tragic decision to launch Vaughan, D. Challenger Launch Decision: Risky Technology, Culture and Deviance at NASA If we were to review the challenger disaster we would find that design flaws created the latent failure that would show up eleven years later on the launch pad. Production pressures led work groups and individuals to make decisions that they were uncomfortable with and ultimately resulted in tradegy.If we were to review the challenger disaster we would find that design flaws created the latent failure that would show up eleven years later on the launch pad. Production pressures led work groups and individuals to make decisions that they were uncomfortable with and ultimately resulted in tradegy.

17. James Reason�s Swiss Cheese Model James Reason is a professor of psychology from the University of Manchester, Manchester England reason@psy.man.ac.uk He has done extensive research into Human Errors and ReliabilityJames Reason�s Swiss Cheese Model James Reason is a professor of psychology from the University of Manchester, Manchester England reason@psy.man.ac.uk He has done extensive research into Human Errors and Reliability

18. Healthcare- A Complex System Key Elements in a Medication System Patient Information Drug Information Communication of Drug Information Labeling, Packaging & Drug Nomenclature Drug Storage, Stocking & Standardization Drug Device Acquisition, Use & Monitoring Environmental Stressors Competency & Staff Education Patient Education Quality Processes & Risk Management

19. Element #1 Communication of Patient Information Legibility of Physician Orders including name of patient Strategies include: CPOE Computer Generated patient labels Pre-printed order sets Order scanning capabilities-

22. Missing dose of Trazodone called for- You make the call

23. Element #4 Nomenclature � Look-Alike/ Sound-AlikeLantus or Lente?

25. Objective IIIRegulatory & Consumer Response Safety Movements Regulatory JCAHO- National Patient Safety Goals CMS- Quality Indicators NJ Patient Safety Bill- reporting stds Overtime mandates FDA � bar coding Consumers Leapfrog Group NJ Patient Safety Bill � which would require hospitals and healthcare practitioners to report all serious medical errors and to encourage them to report near misses and mistakes that don�t cause patient harm. Hospitals would be required to report all serious adverse events as defined by the law to an internal hospital committee and the state department of health. Information generated by a hospital�s internal committee would be shielded from legal discovery except those that kill or seriously harm patients. There would be on line reporting capabilities. CMS (Center for Medicare & Medicaid Services) has required quality performance data as part of the Medicare Prescription Drug Law. 10 Quality Measures are being monitored and hospitals not reporting will receive 0.4 percent less in Medicare re-imbursement.NJ Patient Safety Bill � which would require hospitals and healthcare practitioners to report all serious medical errors and to encourage them to report near misses and mistakes that don�t cause patient harm. Hospitals would be required to report all serious adverse events as defined by the law to an internal hospital committee and the state department of health. Information generated by a hospital�s internal committee would be shielded from legal discovery except those that kill or seriously harm patients. There would be on line reporting capabilities. CMS (Center for Medicare & Medicaid Services) has required quality performance data as part of the Medicare Prescription Drug Law. 10 Quality Measures are being monitored and hospitals not reporting will receive 0.4 percent less in Medicare re-imbursement.

26. Who Else Thinks Patient Safety Is Important?

27. The National Patient Safety Goals Improve Accuracy of Patient Identification To use at least two patient identifiers neither can be the patient room number Prior to the start of any surgical or invasive procedure- thou shall conduct a final verification process such as a �time out to confirm the correct patient, procedure and site Improve Effectiveness of Communication among caregivers Implement a �Read Back� process for taking Verbal or Telephone Orders as well as Critical Test Result Process Dangerous abbreviations � JCAHO mandate by Jan 1st �U,IU,QD,QOD,MS,MSO4,MgSO4,trailing zero, lack leading zero

28. THE ENRON CASE Could it be from bad communications?�TELEPHONE ORDER- Importance of Read Back Was the call- �SHIP THE ENRON DOCUMENTS TO THE FEDS� Or was the call- �RIP THE ENRON DOCUMENTS TO SHREDS�

31. A few examples Blood Mix-up- Washington Post- Simulation exercise High Alert Medication Misadventures Video

32. National Patient Safety Goals Continued Improve Safety of High- Alert Medications Removal concentrated electrolytes To standardize and limit the number of drug concentrations Eliminate Wrong-site, Wrong-patient, Wrong Procedure Surgery Preoperative verification process- i.e checklist Surgical site marking & patient involvement Improve the Safety of Infusion Pumps Ensure free-flow protection intravenous pumps NYPORTS Occurrences (NY Patient Occurrence & Tracking System) By the way- New York State is way ahead of most states including NJ in terms of monitoring and reporting patient safety events. During the past year, a total of 88 incidents were reported. Interestingly, only 18 events occurred within the OR with the remaining 70 occurring due to procedures at the patient bedside. NYPORTS Occurrences (NY Patient Occurrence & Tracking System) By the way- New York State is way ahead of most states including NJ in terms of monitoring and reporting patient safety events. During the past year, a total of 88 incidents were reported. Interestingly, only 18 events occurred within the OR with the remaining 70 occurring due to procedures at the patient bedside.

33. National Patient Safety Goals Continued Improve the effectiveness of clinical alarm systems Implement regular preventive maintenance and testing of alarm systems Assure that alarms are activated with appropriate settings and are sufficiently audible with respect to the distances and competing noise within the unit Reduce the risk of health care acquired infections Comply with current CDC hand-hygiene guidelines Manage as sentinel events all ID cases of unanticipated death associated with noscomial infections

34. In response to the IOM Report, the Business Roundtable an association of CEO�s of Fortune 500 companies formed the Leapfrog Group in 2000 in an effort to stimulate healthcare improvements. 3 Patient Safety Initiatives were identified: Lack of incentives and organizational/ technical challenges have hindered hospital buy-in and fulfillment of the Leapfrog Standards. Many hospital disagree with the chosen standards, there are no re-imbursements and there is significant time to fill out the survey and collect data.In response to the IOM Report, the Business Roundtable an association of CEO�s of Fortune 500 companies formed the Leapfrog Group in 2000 in an effort to stimulate healthcare improvements. 3 Patient Safety Initiatives were identified: Lack of incentives and organizational/ technical challenges have hindered hospital buy-in and fulfillment of the Leapfrog Standards. Many hospital disagree with the chosen standards, there are no re-imbursements and there is significant time to fill out the survey and collect data.

35. CEO�s also are concerned that we are pushing MD�s too hard and fast on patient safety. MD�s contend volume thresholds for high risk procedures is not as strong and a recent study has validated this. Also there is a national shortage of intensivists.CEO�s also are concerned that we are pushing MD�s too hard and fast on patient safety. MD�s contend volume thresholds for high risk procedures is not as strong and a recent study has validated this. Also there is a national shortage of intensivists.

36. Leapfrog Market Survey Results Only 63% of hospitals have completed the Leapfrog Survey with a decline in subsequent survey compliance. Overall the state of NJ is even lower than this. Only 63% of hospitals have completed the Leapfrog Survey with a decline in subsequent survey compliance. Overall the state of NJ is even lower than this.

37. Harvard Executive Session on Medical Accident & Patient Safety Governing Board/ Leadership � to declare patient safety a priority Leadership- accepts responsibility, demonstrates accountability Safety System- built on current knowledge (lessons learned) Policies & Practices � disclosure, near misses- to be made clear to staff Building a Culture of Safety

38. How Healthcare is Responding to the Challenge HUMC�s Approach/ Infrastructure Patient Safety Steering Committee Even when hospital view patient safety as a requirement, they lack organizational capacity; including time, money, managerial & clinical leadership and expertise. At HUMC we developed a Patient Safety Steering Committee with the following reporting structure.Even when hospital view patient safety as a requirement, they lack organizational capacity; including time, money, managerial & clinical leadership and expertise. At HUMC we developed a Patient Safety Steering Committee with the following reporting structure.

39. We operate within the PI structure at Hackensack University Medical Center. Here you can see that the Medication Safety Committee reports up through the Performance Improvement Coordinating Committee to the Quality Council. We also report to the P&T Committee up to the Medical Board as well as to Administrative Operations. We operate within the PI structure at Hackensack University Medical Center. Here you can see that the Medication Safety Committee reports up through the Performance Improvement Coordinating Committee to the Quality Council. We also report to the P&T Committee up to the Medical Board as well as to Administrative Operations.

40. Does your Hospital have a Patient Safety Plan? Leadership Driven- Coordinated & Integrated Effort -purpose improve patient safety & reduce risk Objectives Recognize Patient Safety as Everyone�s Job Responsibility Provide Education on Patient Safety- Competency Encourage all staff in the recognition and reporting process Understand the role of Human Factors in Patient Safety Education and Deployment of FMEA � Proactive Process Improvement Efforts- This year�s Topic Is? Enforce a Culture of Safety -Minimize blame- Annual Survey Encourage Organizational Learning about Medical Errors

41. Historical Perspective- Strong Leadership Involvement Med Safety Committee established-1997 First Educational Program on Med Safety Jan 1998 Institute Safe Medication Practices (ISMP)- 3 day audit of our systems/ processes 1998 Collaborative Work � starting in 2000 thru today Institute for Healthcare Improvement � Quantum Leaps in Patient Safety FMEA, Culture of Safety, Reconciliation- Anticoagulation & Oncology Vermont Oxford- Pediatrics/ Neonatology Pursuing Perfection � RWJ Project Organizational Goal � Leadership Recognition Administrative Safety Rounds/ Safety Briefings Newsletter Make Safety a Clinical Organizational Measure- Increase Reporting by 20% in 2002 & Improve Level of Patient Harm in 2003 & 2004 National Patient Safety Goals in 2004 Establish a Medication Safety Officer Medication Safety � ID High Risk Process � FMEA Work The LEADERSHIP of Hackensack University Medical Center has always taken a very proactive approach toward Patient Safety. Since 1997 we have had a very active Medication Safety Committee. A year and one half before the IOM Report (To Err is Human), Hackensack was already reviewing our systems pro-actively with the Institute for Safe Medication Practices (ISMP). They conducted a 3 day audit of our medication systems and made many outstanding recommendations that have been implemented by our Medication Safety Team from that review. We have incorporated patient safety throughout our Mission, Values and Core Strategies. This year we have set as an organization goal to increase the number of voluntary reported medication errors by 20%. Pat Santaniello will review more specific information with you. Medication Safety has been identified as an organizational priority and you will hear more information on our use of FMEA to improve that process. We have been involved in various Collaborative�s (IHI Quantum Leaps in Medication safety, the Vermont Oxford pediatric initiative and the RWJ grant. The LEADERSHIP of Hackensack University Medical Center has always taken a very proactive approach toward Patient Safety. Since 1997 we have had a very active Medication Safety Committee. A year and one half before the IOM Report (To Err is Human), Hackensack was already reviewing our systems pro-actively with the Institute for Safe Medication Practices (ISMP). They conducted a 3 day audit of our medication systems and made many outstanding recommendations that have been implemented by our Medication Safety Team from that review. We have incorporated patient safety throughout our Mission, Values and Core Strategies. This year we have set as an organization goal to increase the number of voluntary reported medication errors by 20%. Pat Santaniello will review more specific information with you. Medication Safety has been identified as an organizational priority and you will hear more information on our use of FMEA to improve that process. We have been involved in various Collaborative�s (IHI Quantum Leaps in Medication safety, the Vermont Oxford pediatric initiative and the RWJ grant.

42. Objective IVWhat exactly is a Safety Culture? Strategic Emphasis on Patient Safety Blame- Free environment Shared accountability Desire to learn and change Systems that defy errors Proactive focus Teamwork Community involvement Safety measurements Strategic Emphasis- leadership driven, middle managers convey culture to front line staff, message supported by organizational behavior that re-enforces safety as a priority and permeates the entire hospital. Strategic plan with long-term goals and change projects to improve safety. Blame free- no fear of retribution or embarrassment for raising cocerns or reporting errors, management style for dealing with error, use of storytelling to teach people about errors, administrative safety rounding Shared accountability �based upon realistic expectations (no one is perfect) everyone is responsible for improving safety systems- it begins at orientation. That safety is job one. Desire to learn and change- error detection and reporting is key to understanding what went wrong and to recommend error reduction strategies. Learning from mistakes are key Systems that defy errors- forcing functions, technology, warnings, constraints, redundancies Proactive focus- FMEA (don�t wait for mistakes to happen) Teamwork � all people are empowered to correct safety hazards as they are identified. Community Involvement � build relationships with your patients and the media � Safety Measurements- you can�t improve anything if you are not measuring it. Strategic Emphasis- leadership driven, middle managers convey culture to front line staff, message supported by organizational behavior that re-enforces safety as a priority and permeates the entire hospital. Strategic plan with long-term goals and change projects to improve safety. Blame free- no fear of retribution or embarrassment for raising cocerns or reporting errors, management style for dealing with error, use of storytelling to teach people about errors, administrative safety rounding Shared accountability �based upon realistic expectations (no one is perfect) everyone is responsible for improving safety systems- it begins at orientation. That safety is job one. Desire to learn and change- error detection and reporting is key to understanding what went wrong and to recommend error reduction strategies. Learning from mistakes are key Systems that defy errors- forcing functions, technology, warnings, constraints, redundancies Proactive focus- FMEA (don�t wait for mistakes to happen) Teamwork � all people are empowered to correct safety hazards as they are identified. Community Involvement � build relationships with your patients and the media � Safety Measurements- you can�t improve anything if you are not measuring it.

43.  How Healthcare is Responding to the Challenge/ HUMC�s Approach CULTURE OF SAFETY Collaborative Work with Leadership Groups � ISMP/ IHI/ RWJ Culture of Safety Survey �annual Continue to Measure to support increasing/improving system of voluntary reporting- Safety Rounds- senior administrative �interdisciplinary rounds to patient care units � results communicated Communication �Safety newsletters �SAFETY BRIEFINGS� & �ISMP NEWSLETTER� Patient Involvement � Speak Up� for Safety Campaign- JCAHO Publication for patients Dedicate Resources for Patient Safety- Medication Safety Officer �An effective Patient Safety Program cannot exist without optimal reporting of safety related medical events. All personnel are required to report suspected and identified medical/health errors. The reporting of the suspected error will not result in an adverse employment action, although the underlying medical/health error may lead to appropriate disciplinary action. Failure to report such suspected errors shall itself be grounds for disciplinary action up to and including separation of employment. This organization supports the concept that events occur due to a breakdown in systems and processes, and will focus on improving systems and processes and adopt the use of James Reason�s �Unsafe Acts Alogrithm� ( attached) to assist in the determination of Blamelessness Vs Culpability. (LD.3.4.1) � Patient dsafety Plan �An effective Patient Safety Program cannot exist without optimal reporting of safety related medical events. All personnel are required to report suspected and identified medical/health errors. The reporting of the suspected error will not result in an adverse employment action, although the underlying medical/health error may lead to appropriate disciplinary action. Failure to report such suspected errors shall itself be grounds for disciplinary action up to and including separation of employment. This organization supports the concept that events occur due to a breakdown in systems and processes, and will focus on improving systems and processes and adopt the use of James Reason�s �Unsafe Acts Alogrithm� ( attached) to assist in the determination of Blamelessness Vs Culpability. (LD.3.4.1) � Patient dsafety Plan

44. Administrative Safety Rounds Sample Questions Can you think of any events that have resulted in prolonged hospitalization for a pt. Have there been any �near misses� that almost caused pt harm but didn�t? Have we harmed anyone recently What aspects of the environment are likely to lead to the next patient being harmed? Can you think of a way in which the system or environment fails you on a consistent basis. Some sample questions we ask during our weekly rounding.Some sample questions we ask during our weekly rounding.

45. Culture of Safety Survey Results August 2003 QUESTIONS My supervisor listens to me and cares about my concern. My suggestions about safety would be acted upon if I expressed them to management. Management will never compromise safety concerns for productivity. I am encouraged by my supervisors and co-workers to report any unsafe conditions that I observe. I know the proper channels to report my safety concerns. I am satisfied with availability of clinical leadership (MD, RN, RP). Leadership is driving us to be a safety centered institution. I am aware that patient safety has become a major area for improvement in my institution. I believe that most adverse events occur as a result of multiple small failures, and are not attributable to one individual's actions.

46. People �Unsafe acts- aberrant mental processes forgetfulness, inattention, poor motivation, carelessness, negligence and recklessness � NOTE: NJ Star Ledger Advertisement this weekend. Countermeasures � poster campaigns that appeal to their sense of fear, disciplinary measures, threats of litigation, writing another procedure Errors are seen as consequences rather than causes, having their origins not so much in human nature as in �upstream� systemic factors such as error traps in the workplace and organizational processes that give rise to them. Countermeasure- based upon assumption that though we cannot change the human condition, we can change the conditions under which humans work. A central idea is that of system defenses. When an error occurs, the important issue is not who blundered but how and why the defenses failed. People �Unsafe acts- aberrant mental processes forgetfulness, inattention, poor motivation, carelessness, negligence and recklessness � NOTE: NJ Star Ledger Advertisement this weekend. Countermeasures � poster campaigns that appeal to their sense of fear, disciplinary measures, threats of litigation, writing another procedure Errors are seen as consequences rather than causes, having their origins not so much in human nature as in �upstream� systemic factors such as error traps in the workplace and organizational processes that give rise to them. Countermeasure- based upon assumption that though we cannot change the human condition, we can change the conditions under which humans work. A central idea is that of system defenses. When an error occurs, the important issue is not who blundered but how and why the defenses failed.

47. Objective VImplementing a Patient Safety Program Multiple Approaches Safety Planning Measurement ,Reporting & Performance Improvement It�s everyone�s responsibility including the patient System�s Improvement Training/ Education/ Communication � Patient Safety Technology

48. Healthcare is a Complex Process In the next section we will be looking at what things you can do at your institutions that can be used to implement a Patient Safety Program from a medication perspective. For each of these boxes, I have provided you with some suggestions about transforming your organizations. In the next section we will be looking at what things you can do at your institutions that can be used to implement a Patient Safety Program from a medication perspective. For each of these boxes, I have provided you with some suggestions about transforming your organizations.

49. Selection, Procurement & Storage Strategies Drug�s are evaluated for safety considerations even before going to P&T & Medical Board Look-A-Like Medication Storage is constantly being evaluated.

50. Drug Storage, Stocking & Standardization Strategies Include: Centralized IV Admixture Service Automated technology including bar coding for QA process Pharmacy only access to concentrated electrolytes Smart Infusion Pumps

54. Ordering & Transcribing Strategies Prescribing- Computerized Physician Order Entry Medication Administration Record Documentation Pre-Printed Order sets Emergency Drug Administration Charts

55. CPOE- Medication Selection Screen

56. CPOE -Medication Ordering

57. eMAR WorklistAll Scheduled meds to be given 7AM-3:30 PM on 11/19/03

58. Preparing & Dispensing AUTOMATION STRATEGY Pharmacy Robotic Dispensing In support of Bar Coding effort

59. Administration Smart Pumps Early studies of point-of-care systems bar code technology have shown a 65- to 86- percent decrease in medication errors.

60. The Medley� Smart Pump System The MEDLEY� System is much more than just an infusion device. It has been designed to have power and communications capability, as well as the ability to support different medication therapies. The MEDLEY� System along with the Guardrails� Software integrates drug infusion, patient monitoring and information management in one modular, easy to use platform at the patient�s bedside. The modular nature of this system allows you to standardize programming and communications with different types of devices. Even more importantly, this platform will allow you to extend the benefits of the Guardrails� Software to syringe and PCA applications. The MEDLEY� System is much more than just an infusion device. It has been designed to have power and communications capability, as well as the ability to support different medication therapies. The MEDLEY� System along with the Guardrails� Software integrates drug infusion, patient monitoring and information management in one modular, easy to use platform at the patient�s bedside. The modular nature of this system allows you to standardize programming and communications with different types of devices. Even more importantly, this platform will allow you to extend the benefits of the Guardrails� Software to syringe and PCA applications.

61. How Guardrails� Software Can Change Outcomes Guardrails� could have protected against these highly publicized preventable adverse drug events with infusion programming errors Cost to prevent these errors is minimal in comparison to the consequences, evidence that error prevention software will likely become a standard of care for infusion devices Guardrails� could have protected against these highly publicized preventable adverse drug events with infusion programming errors Cost to prevent these errors is minimal in comparison to the consequences, evidence that error prevention software will likely become a standard of care for infusion devices

62. Monitoring of Patient Care Use of Nomograms to guide therapy Clinical Specialists such as PharmD�s & APN�s (pharmacokinetics) Interdisciplinary Care Rounds When Clinical Pharmacists Round Lucian Leape found that in ICU�s preventable ADE significantly lowered by 72% from 12.4 ADE/ 1,000 patient days to 3.5 ADE/1,000 patient days. At the Henry Ford Hospital- on general medical units ADE were lowered by 78% from 26.5 ADE to 5.7 ADE/ 1,000 patient daysWhen Clinical Pharmacists Round Lucian Leape found that in ICU�s preventable ADE significantly lowered by 72% from 12.4 ADE/ 1,000 patient days to 3.5 ADE/1,000 patient days. At the Henry Ford Hospital- on general medical units ADE were lowered by 78% from 26.5 ADE to 5.7 ADE/ 1,000 patient days

63. Objective VISome Tools & Resource Suggestions Members of the Patient Safety Steering Committee Deployment of Patient Safety Training Courses Management Certification National Patient Safety Goals Performance Improvement Monitoring Administrative Safety Rounds Immediately make an impression that Safety is a Leadership Priority Newsletters ISMP Hospital Specific Safety Newsletters

64. Human Factors Definition Human Factors- is a discipline devoted to studying the interaction of people and equipment and other variables that affect the outcome of the contact. James Reason regarding as having been responsible for this new science. There are five dimensions to Human Factors Engineering: Design of equipment and tools Design of the task itself Environmental conditions of work The training and education of the staff The selection of employees. Hospitals typically concentrate on the last two dimensions. James Reasons was an organizational psychologist.James Reason regarding as having been responsible for this new science. There are five dimensions to Human Factors Engineering: Design of equipment and tools Design of the task itself Environmental conditions of work The training and education of the staff The selection of employees. Hospitals typically concentrate on the last two dimensions. James Reasons was an organizational psychologist.

65. Human Factor- System Levels Point of Care Ergonomics Physical design of equipment & immediate environment Point of Care Environment Physical surrounds of the unit Individual Human Factors Personal factors that influence system reliability (fatigue) Team & Group Factors Team performance elements such as communication & hierarchy Organization & Management Factors Policies and practices of the organization

66. Human Factors & Healthcare The FDA�s Center for Devices and Radiological Health (CDRH) recognize the need for human factors knowledge in healthcare. They estimate that 1/3 of incident reports they receive involve equipment use error a term referring to flawed design

67. How Reliably do we make errors? General Human Error of Commission 0.003 misreading a label General Error of Omission 0.01 failure to turn off a switch Simple arithmetic calculation error 0.03 with rechecking but not rewriting the #s Transposition error 0.0006 crossing wires, mixing drug dosages Errors under high stress in danger 0.25 *This assumes no undue time pressure or stress Salvendy �Compendium of Human Factors� Cognitive Psychology � study of human response in complex demanding environments. Errors are NOT simply random events but occur in predictable patients and circumstances (stress and fatigue)Cognitive Psychology � study of human response in complex demanding environments. Errors are NOT simply random events but occur in predictable patients and circumstances (stress and fatigue)

68. The Role of Complexity in Errors Probability of Performing Perfectly: Cognitive Psychology � Study of human response in complex demanding environments Errors are NOT simply random events but occur in predictable patterns & circumstances (stress & fatigue) Cognitive Psychology � Study of human response in complex demanding environments Errors are NOT simply random events but occur in predictable patterns & circumstances (stress & fatigue) Cognitive Psychology � Study of human response in complex demanding environments Errors are NOT simply random events but occur in predictable patterns & circumstances (stress & fatigue) Cognitive Psychology � Study of human response in complex demanding environments Errors are NOT simply random events but occur in predictable patterns & circumstances (stress & fatigue)

69. Healthcare- Not Very Reliable Barriers to Reliability High Premium placed on medical autonomy and perfection. Lack of professional cooperation & effective communications. Mistakes treated as personal & professional failure. Teamwork & Collaboration in problem solving- poor. Accepting the occurrence of error as an opportunity to learn & improve reliability. High Reliability Organizations (US Navy Nuclear aircraft carriers, Nuclear power plants and air traffic control centers) have the following characteristics: They are complex, internally dynamic and intermittently, intensely interactive They performed exacting tasks under considerable time pressure They had carried out these demanding activities with low incident rates and an almost complete absence of catastrophic failures over several years. These organizations share important characteristics with healthcare institutions. High Reliability Organizations (US Navy Nuclear aircraft carriers, Nuclear power plants and air traffic control centers) have the following characteristics: They are complex, internally dynamic and intermittently, intensely interactive They performed exacting tasks under considerable time pressure They had carried out these demanding activities with low incident rates and an almost complete absence of catastrophic failures over several years. These organizations share important characteristics with healthcare institutions.

70. Reliability in Healthcare Key Elements

71. Rank Order of Error Reduction Strategies Forcing Functions & Constraints Automation & Computerization Standardization & Protocols Checklists & Double Check Systems Rules & Policies Education & Information Be more careful, be vigilant

72. What happens to my Incident Report? Multi-Disciplinary Group Review Identification of Process Stage Failure Type of Error (wrong dose, pt, route) Severity Rating NCC MERP system- Level of Harm identified Type of Medication

73. Medication Error Reporting System

74. Medication Errors

75. The average hospital in this group reports about 400 errors each year. Do you know what your hospital number is?The average hospital in this group reports about 400 errors each year. Do you know what your hospital number is?

76. Top 50 Drug Products* Associated with Medication Errors

78. Important Policies & Procedures Administrative Manual Patient Safety Plan Sentinel Event Policy & Procedure Unanticipated Outcome Disclosure Clinical Alarms Reporting Critical Test Values Verbal/ Telephone Orders � Safety Manual Safety Management Plan

79. Unanticipated Outcome Definition- a result that differs significantly from what was anticipated to be the result of a treatment or procedure.

80. Sentinel Event Policy/ Procedure Definition � an unexpected occurrence, involving death or serious physical or psychological injury or risk thereof. Examples Suicide of a patient in a hospital setting Infant abduction Rate Hemolytic transfusion reaction Wrong site surgery Medication Error- causing death or permanent inj.

81. What should we do if there is a mistake? Disclosure CON Does the patient really want to know Undermines trust in MD/ Hospital Aren�t we all human? Unanticipated outcome How severe was the error? Ability to conceal PRO The Golden Rule- do onto others etc. �Watergate syndrome� Right to Know Its your body Bear the burden of consequences Reality vs. The Truth

82. Principles of Communication Caregivers have a duty to accurately and completely inform pt timely Provide info � pt/ next of kin that will produce an understanding of the nature and significance of the event Caregiver- to provide as accurate info as available at the time Attending MD- primary responsibility to fully & accurately explain nature/ consequences

83. Parts of a FMEA format & what they mean � Section I Process- This is identified as a major step of each workflow. (Example Prescribing of Medications) Failure Mode- This would be the next level of the major process step. (Example within prescribing the physician would need the proper information about the patient). Cause of Failure- Here is where you come up with experience about what could go wrong (Example � patient information incorrect information is collected about a patient allergy).

84. Parts of a FMEA format & what they mean � Section II Scoring Likelihood of Occurrence- Identify how often a process breaks (4 daily, 3 monthly, 2 weekly, 1 once a year) Effect & Severity (Criticality) if Failure Occurs- Identify the consequences if that error were to occur Probability of Detection- Identify the ability for someone to easily find an error should it occur. Here scoring is 1-3 with the following definitions: 1 The process cannot continue without this info, 2 the process could continue but info would need to be obtained, 3 there is a low probability of detection such that no information is available for other depts to enable discoverability

85. FMEA Methodology We use the Institute for Healthcare Improvement�s Methodology for Failure Mode and Effects Analysis. I have included an example of how this is done for your review. Talk through slide info.We use the Institute for Healthcare Improvement�s Methodology for Failure Mode and Effects Analysis. I have included an example of how this is done for your review. Talk through slide info.

86. Root Cause Analysis

87. Medical Error Simulation Case Presentation

88. Thank You I hope that you found the presentation to have met your expectations!!!!!!