1. Step To Excellence … Getting to Zero Adverse Errors 1

2. Step To Excellence … Getting to Zero Adverse Errors  Lapses in patient safety are a major health care quality problem, and the occurrence of patient harm due to such lapses is remarkably common, causing tens of thousands of deaths each year.  A large majority of these lapses are preventable and are the unintended consequences of a highly complex and imperfect health care delivery system, in which individual minor mishaps sometimes combine to cause harmful—or even disastrous—results. 2

3. Step To Excellence … Getting to Zero Adverse Errors  Although there is no national reporting of such occurrences, a number of standards require reporting at least some types of these adverse events however, it is widely agreed that, even where there is required reporting, such events are grossly underreported.  The starting point in any improvement effort is to collect data.  Identifying where and when in the care process mishaps occur, and changing processes of care to reduce the chance of harm, requires reliable data about the occurrence of preventable adverse events. 3

4. Step To Excellence … Getting to Zero Adverse Errors  Unfortunately, few such data exist, as there is no standardized national reporting system to provide information on the number and type of even the most serious preventable adverse events.  On the other hand, the public expects health care providers to take all appropriate measures to ensure that care is safe, and the public looks to government and other oversight bodies to make sure that such actions are taken. 4

5. Step To Excellence … Getting to Zero Adverse Errors  The occurrence of a serious preventable adverse event in health care—e.g., operating on the wrong patient or wrong body part or transfusing the wrong type of blood into a patient—suggests (but does not prove) that a flaw exists in the health care organization's efforts to safeguard patients.  It is reasonable for the public to expect an oversight body to investigate such occurrences 5

6. Step To Excellence … Getting to Zero Adverse Errors  Accountability entails both an obligation of health care providers to report on their performance and of oversight bodies to investigate specified occurrences, and to enforce compliance with accepted standards of care for ensuring safety.  Having a standardized set of reportable adverse events should facilitate fulfillment of this obligation. 6

7. Step To Excellence … Getting to Zero Adverse Errors  For example, the practice followed in the USA to establish a list of serious adverse events was started by the Institute of Medicine (IOM)-USA.  As part of a comprehensive approach to improving patient safety, IOM recommended that health care errors and adverse events be reported in a systematic manner. 7

8. Step To Excellence … Getting to Zero Adverse Errors  A National Quality Forum (NQF) was established in Feb., 2000 (a voluntary consensus standards- setting organization) with the mission of improving American Health Care through the endorsement of consensus-based national standards for the measurement and public reporting of health care performance data.  This was an initial step on the road to provide meaningful information about whether care is safe, timely, beneficial, patient-centered, equitable, and efficient. 8

9. Step To Excellence … Getting to Zero Adverse Errors  NQF has a formal process by which it achieves consensus and endorses standards.  In addition to endorsing voluntary consensus standards, the NQF also functions as an “honest broker” for health care quality improvement, convening health care's many stakeholders to focus on specific quality-related issues, promoting the use of standards, linking quality measurement to strategies for quality improvement, providing leadership, disseminating information, and exchanging knowledge and ideas 9

10. Step To Excellence … Getting to Zero Adverse Errors  In March 2000, NQF identified “a set of patient safety measurements that should be a basic component of any medical errors reporting system”.  NQF established a standardized core list of serious reportable preventable events, that would facilitate reporting of such occurrences.  To qualify for this list an event must be: Unambiguous, usually preventable, and serious.  It should also be one of the following: Adverse. Indicative of a problem in a health care facility's safety systems. Important for public credibility or public accountability. 10

11. Step To Excellence … Getting to Zero Adverse Errors  The list of serious and preventable events developed by NQF contains 27 serious reportable events that should be reported and investigated by all health care facilities if they occur (see appendix).  The events are organized in six categories, five that relate to the provision of care: Surgical, product or device, patient protection, care management, and environmental.  One category includes four criminal events, which includes illegal acts, or acts of misconduct, and are included because they could be indicative of an environment that is unsafe for patients 11

12. Step To Excellence … Getting to Zero Adverse Errors  The data collected using the list of adverse events should be used in every way possible to actually improve patient safety.  There are various approaches for performance improvements: PDPC Juran improvement methodology:  Define problem  Diagnose Causes  Develop remedies  Replicate results 12

13. Step To Excellence … Getting to Zero Adverse Errors  Six Sigma methodology (DMAIC): Define: define the problem Measure: define the various factors affecting the problem and measure the problem under different values of such factors. Analyze: analyze the impact of the different factors on the problem and identify the root causes Improve: propose a solution to the problem and implement it. Control: put the new solution under control Replicate: Repeat with other adverse events  There is a misconception about Six Sigma, that it requires using sophisticated statistical tools. However, many problems can be solved with simple tools (and statistical knowledge could be acquired). 13

14. Step To Excellence … Getting to Zero Adverse Errors  Assume we collected some data on medication errors in a healthcare facility. Data in table 2 is hypothetical data.  Define the problem: We have an average medication errors of 895 per 1000 patient days. Establish process baseline:  Draw an ImR chart to understand how the process performs. 14

15. Step To Excellence … Getting to Zero Adverse Errors 15 Out of control situation  Out of control points should be investigated. If its causes can be prevented, it is removed from the data set

16. Step To Excellence … Getting to Zero Adverse Errors  We need to investigate the factors affect the problem. We can look at medication errors by drug type. To do so we need data.  If the medication errors are already documented by drug type, then we will extract the required data from our records. If not, we will need to monitor the process over a reasonable time period and record data on medication errors by drug type. 16

17. Step To Excellence … Getting to Zero Adverse Errors  Factor 1: Drug type  The Pareto tells us that errors associated with Insulin alone accounted for 45% of the total. The first three errors accounted for 89%. 17

18. Step To Excellence … Getting to Zero Adverse Errors  We need to dig more into details of medication errors associated with Insulin.  The previous Pareto was on the number of errors. We might be more interested about which of these errors caused harm to patients.  knowing which of these errors caused harm to the patient requires more data. We need to collect data about for harm by drug type and draw another Pareto chart. 18

19. Step To Excellence … Getting to Zero Adverse Errors  Factor 2: Harm to patient  Again, Insulin alone accounted for 39.5% of the harm due to medication. The three first drugs together accounted for 89% of the total. 19

20. Step To Excellence … Getting to Zero Adverse Errors  The Pareto shows that again, harm due to heparin and Warfarin is large, which suggests we probably need to start new improvement projects to look into each of them individually.  The two Pareto charts confirms that Insulin is a major contributor (vital few) to the problem of medication errors, whether we were concerned about the number of errors, or the number of harmful events.  We now need to dig more into Insulin errors, and collect data on types of errors occurring in Insulin medication process. 20

21. Step To Excellence … Getting to Zero Adverse Errors  The improvement team decided to brainstorm the types of medication errors occurring in their facility. 21 SerialError TypeSerialError Type 1Omission7Prescribing error 2Improper dosage8Wrong administration- technique 3Unauthorized drug9Deteriorated drug 4Wrong time10Monitoring error 5Wrong dosage-form11Compliance error 6Wrong drug- preparation 12Other medication error

22. Step To Excellence … Getting to Zero Adverse Errors  After colleting data, the following Pareto was constructed 22

23. Step To Excellence … Getting to Zero Adverse Errors  The Pareto shows that omissions and improper dosage together account for 49% of the total. The first three categories account for 64% of the total.  At this point, we may choose to form three different teams; each team handles one of the three major contributors to the problem.  We can also construct a similar Pareto chart for both Heparin and Warfarin and see what major types of medication errors we will see in both cases. 23

24. Step To Excellence … Getting to Zero Adverse Errors  Assume we decided to take omissions and brain storm for possible causes of omission.  A cause and effect diagram is constructed 24

25. Step To Excellence … Getting to Zero Adverse Errors  Identify Root Causes From the list of possible causes on the C-E diagram, the team selected possible root causes to test. The solution to the problem will address the root cause. Data proved that the root causes for “Omission” were: 1.Drug unavailable 2.Nurse to patient ratio. The solution would be:  Revisit drug ordering system and identify what drugs need to be available and in what quantities.  Adjust nurse to Patient ratio. 25

26. Step To Excellence … Getting to Zero Adverse Errors  An action plan must be developed for both solutions.  After implementing the solutions, a new performance baseline is developed for the medication process, using an ImR control chart.  It will be possible to reduce medication errors even more, if we investigate the errors associated with Heparin and Warfarin.  By repeating the whole cycle again, it is possible to keep reducing the medication until we reach the zero level. 26

27. Step To Excellence … Getting to Zero Adverse Errors 27

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30. Getting to Zero Adverse Errors EventAdditional specifications 1. Surgical events A. Surgery performed on the wrong body part Defined as any surgery performed on a body part that is not consistent with the documented informed consent for that patient. Excludes emergent situations that occur in the course of surgery and/or whose exigency precludes obtaining informed consent. B. Surgery performed on the wrong patient Defined as any surgery on a patient that is not consistent with the documented informed consent for that patient. C. Wrong surgical procedure performed on a patient Defined as any procedure performed on a patient that is not consistent with the documented informed consent for that patient. Excludes emergent situations that occur in the course of surgery and/or whose exigency precludes obtaining informed consent. Surgery includes endoscopies and other invasive procedures. D. Retention of a foreign object in a patient after surgery or other procedure Excludes objects intentionally implanted as part of a planned intervention and objects present prior to surgery that were intentionally retained. E. Intraoperative or immediately post- operative death in an ASA Class I patient Includes all ASA Class I patient deaths in situations where anesthesia was administered; the planned surgical procedure may or may not have been carried out. Immediately post-operative means within 24 hours after induction of anesthesia (if surgery not completed), surgery, or other invasive procedure was completed.

31. Getting to Zero Adverse Errors EventAdditional specifications 2. Product or device events A. Patient death or serious disability associated with the use of contaminated drugs, devices, or biologics provided by the health care facility Includes generally detectable contaminants in drugs, devices, or biologics regardless of the source of contamination and/or product. B. Patient death or serious disability associated with the use or function of a device in patient care, in which the device is used for functions other than as intended Includes, but is not limited to, catheters, drains and other specialized tubes, infusion pumps, and ventilators. C. Patient death or serious disability associated with intravascular air embolism that occurs while being cared for in a health care facility Excludes deaths associated with neurosurgical procedures known to be a high risk of intravascular air embolism. 3. Patient protection events A. Infant discharged to the wrong person B. Patient death or serious disability associated with patient elopement (disappearance) for more than four hours Excludes events involving competent adults. C. Patient suicide, or attempted suicide resulting in serious disability, while being cared for in a health care facility Defined as events that result from patient actions after admission to a health care facility. Excludes deaths resulting from self-inflicted injuries that were the reason for admission to the health care facility.

32. Getting to Zero Adverse Errors EventAdditional specifications 4. Care management events A. Patient death or serious disability associated with a medication error (e.g., errors involving the wrong drug, wrong dose, wrong patient, wrong time, wrong rate, wrong preparation, or wrong route of administration) Excludes reasonable differences in clinical judgment on drug selection and dose. B. Patient death or serious disability associated with a hemolytic reaction due to the administration of ABO- incompatible blood or blood products C. Maternal death or serious disability associated with labor or delivery in a low-risk pregnancy while being cared for in a health care facility Includes events that occur within 42 days post- delivery. Excludes deaths from pulmonary or amniotic fluid embolism, acute fatty liver of pregnancy or cardiomyopathy. D. Patient death or serious disability associated with hypoglycemia, the onset of which occurs while the patient is being cared for in a health care facility E. Death or serious disability (kernicterus) associated with failure to identify and treat hyperbilirubinimia in neonates Hyperbilirubinimia is defined as bilirubin levels >30 mg/dl. Neonates refers to the first 28 days of life. F. Stage 3 or 4 pressure ulcers acquired after admission to a health care facility Excludes progression from Stage 2 to Stage 3 if Stage 2 was recognized upon admission. G. Patient death or serious disability due to spinal manipulative therapy

33. Getting to Zero Adverse Errors EventAdditional specifications 5. Environmental events A. Patient death or serious disability associated with an electric shock while being cared for in a health care facility Excludes events involving planned treatments such as electric counter shock. B. Any incident in which a line designated for oxygen or other gas to be delivered to a patient contains the wrong gas or is contaminated by toxic substances C. Patient death or serious disability associated with a burn incurred from any source while being cared for in a health care facility D. Patient death associated with a fall while being cared for in a health care facility E. Patient death or serious disability associated with the use of restraints or bedrails while being cared for in a health care facility 6. Criminal events A. Any instance of care ordered by or provided by someone impersonating a physician, nurse, pharmacist, or other licensed health care provider B. Abduction of a patient of any age C. Sexual assault on a patient within or on the grounds of the health care facility D. Death or significant injury of a patient or staff member resulting from a physical assault (i.e., battery) that occurs within or on the grounds of the health care facility