1. Patient Safety 101 for Neurologists

2. Overview The history of patient safety
Situations that lead to medical errors
Case studies
How do we avoid medical errors

3. Patient Safety: The History
Hippocrates – “Primum Non Nocere”
Beneficence
Non-malfeasance
Florence Nightingale
“It may seem a strange principle to enunciate as the very first requirement in a Hospital that it should do the sick no harm.”
“Primum non nocere”—First do no harm. While this phrase is often attributed to Hippocrates in the Hippocratic oath, the literal translation is not there in the Greek text. However, it is the foundation of our medical ethics and medical morality.
Beneficence – to do good
Non-malfeasance – to do no unjust or harmful act; counterpart to primum non nocere
Florence Nightingale wrote this statement in “Notes on Hospitals” in 1859, recognizing that infections acquired while being treated for illness in hospital often resulted in worse illness or even death. She demonstrated that many deaths occurring in hospitals were preventable—even in the late 1800s–by recognizing that in-hospital death rates were much higher than would be predicted by actual death rates occurring out of hospital in patients treated for similar illness.

4. The History of Patient Safety
Post-World War II
Modern advances in the ability of medicine to help were accompanied by a corresponding increase in the ability to do harm
Studies of the impact of medical errors began to appear in late 1980s to early 1990s
Harvard Medical Practice Study
Reviewed >30,000 charts from randomly selected patients in acute and non-acute hospitals in New York
3.6% of hospitalized patients experienced adverse events resulting in harm
70% of these events resulted in disability lasting less than 6 months, 13.6% resulted in death, 2.7% permanent disability
The Harvard Medical Practice Study (HMPS) set the standard by which adverse events are measured and laid the groundwork for policy discussions both nationally and internationally. Based on medical liability and negligence.
The HMPS used a two-stage method for reviewing charts–first screen by nurses of patients likely to experience an adverse event, then second more detailed physician review of selected charts.
One critique of this is the substantial amount of independent judgment that goes into this type of review.

5. The History of Patient Safety
Quality of Australian Health Care Study in 1995
Placed greater emphasis on quality of care than negligence, i.e., could the adverse event be prevented?
Reviewed >14,000 charts from 28 hospitals
16.6% of hospitalized patients experienced adverse events
77.1% of those had disability lasting less 12 months
13.7% with permanent disability
4.9% ended in death
51% of the adverse events were considered preventable
Australian study prompted by the HMPS, altered the question and methods slightly. Reviewed more than 14,000 charts over 3 years from 28 hospitals. They searched records for adverse events, defined as complication, unintended consequence of surgery or treatment, that prolonged hospital stay or resulted in death or discharge with a disability.
Question–was the finding in this study really due to disparate care in the Australian vs. US health system or due to different methodologies in the research?

6. The History of Patient Safety
In early 1995 an epidemic of errors erupted
Michigan --a surgeon performing a mastectomy on a 69-year-old patient removed the wrong breast
New York--a woman died when a doctor mistook her dialysis catheter for a feeding tube and ordered food to be pumped into her abdomen
Tampa --a 51-year-old diabetic had the wrong foot amputated and a 73-year-old retired electrician died when a therapist mistakenly disconnected his ventilator

7. The History of Patient Safety
Institute of Medicine Report “To Err is Human”
Landmark paper published in 1999
Estimated incidence of patients who die in hospital due to preventable medical error
Was the springboard for emphasis on patient safety, quality improvement initiatives, and ultimately pay for performance

8. What is Medical Error? Definition according to IOM
Failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim
Examples:
adverse drug events
surgical injuries and wrong-site surgery
restraint-related injuries or death
falls
pressure ulcers

9. The History of Patient Safety: IOM report “To Err is Human”
Medical error is the 8th leading cause of death in the US.
Medical errors cause 98,000 deaths per year.
More people die from medical error than from breast cancer, HIV, or MVAs.

10. Types of Error Diagnostic Treatment Preventative Other
Failure to order appropriate test
Delay in diagnosis
Failure to act on results or monitoring
Treatment
Error in the performance of an operation, procedure, or test
Error in administering the treatment
Error in the dose or method of using a drug
Preventative
Failure to provide appropriate monitoring or follow-up
Failure to provide prophylactic treatment
Other
Failure of communication
Equipment failure
Other system failure
Failure to provide prophylactic treatment could include failure to provide vaccinations, failure to provide peri-operative antibiotics or beta-blockers in cardiac patients

11. USA TODAY Thursday, June 28, 2001
Hospital mistakes must be disclosed
Accreditation at risk if patients aren’t told
By Robert Davis
Hospitals must now tell patients and their families when they have been hurt by a medical error, according to nationwide standards that take effect Sunday.
The standards by the nation’s leading health care accrediting agency are the first to hold hospitals accountable for a higher level of patient safety. …
In 2001, the Joint Commission began making patient safety a priority. Required hospital disclosure of medical error as a standard for maintenance of accreditation. The goal was to promote open discussion when errors occurred so that system problems could be identified and solutions found.

12. How Unsafe is Healthcare??
Deaths per 100 million hours
Being pregnant 1
Traveling by train 5
Working at home 8
Working in agriculture 10
Driving
Working in construction 67
Being hospitalized 2000
But you may find yourself asking–“Really, how unsafe is healthcare? What are the chances of dying due to being treated in a hospital?” This statistic puts things into perspective. Proportionately, people spend many more hours working at home, driving, and for many women even more hours being pregnant than they will ever spend in a hospital, yet the risk of dying is astoundingly higher. Some might say–well people in the hospital are sick or have suffered trauma. But this does not apply to the hundreds of thousands of healthy women giving birth or the millions undergoing elective procedures annually.

13. Cost of Medical Error
Estimated direct cost of medical error in US $17 billion
Preventable adverse events to Medicare patients estimated to cost in excess of $880 million annually
A study from 2008 revealed overall cost of medical error in the US to be >$19.5 billion
Total cost per error approx. $13,000
>2500 avoidable deaths
>10 million days of lost productivity at work, costing $1.1 billion in short-term disability claims
From: The Economic Measurement of Medical Errors, John Shreve et al, sponsored by the Society of Actuaries Health Section; published June 2010
Evaluated medical claims data – determined whether likely due to medical error than just effect of treatment

14. Cost of Most Common Medical Errors
Event
Number of injuries 2008
% considered due to error
Medical cost per event
Total cost per event
Pressure ulcers
394,699
>90
$8730
$10,288
Post-operative infections
265,995
$13,312
$14,458
Mechanical complication of device, implant or graft
268,353
10-35
$17,709
$18,771
Hemorrhage complicating procedure
156,433
35-65
$8,665
$12,272

15. Why is Healthcare Prone to Error?
Multiple and varied interactions with technology
Many individuals involved in care
Multiple hand-offs
High acuity of illness
Distracting work environment
Rapid, time-pressured decisions
High volume, unpredictable patient flow
Multiple step processes

16. Why is Patient Safety Important to Me?
It can save lives
It can make YOU a better physician
It is part of every hospital plan – no matter where you work
Focused programs are required by the Joint Commission
It is a required part of resident education curriculum by the ACGME and RRC

17. How Does This Affect Neurology?
Many patient groups at risk
Stroke patients with many comorbid illnesses
Potential for drug interactions
High risk for falls
Seizure patients with poor compliance or complex regimens
Parkinson’s patients and dementia patients
Significant cognitive impairment may result in medication error
Physical disabilities may increase risk of falls and injury
The above are just a few examples. As neurologists, we care for patients with many complex and debilitating diseases. Medical treatment regimens are often complicated and may be associated with significant side effects or potential for adverse events. Cognitive impairment may contribute to poor communication. We are often the consulting physician, but not responsible for the overarching care of the patient, and poor communication between referring providers and consulting providers may result in error.

18. Of the 300 neurologic lawsuits requiring a pay out in 2004, most common diagnoses:
Disc disorder
Stroke
Headaches/migraine
Seizure
Cancer
Meningitis
Paralysis
Aneurysm

19. National Academy of Science’s Institute of Medicine (IOM)
In 2001, the IOM laid out six dimensions of quality for health care.
According to the IOM, health care should be
Safe
Effective
Patient-centered
Timely
Efficient
Equitable

20. Patient Safety and Quality Improvement Act of 2005
Signed into Law 7/29/05
Nationwide Goals
“To encourage the voluntary reporting of medical errors”
Report to “Certified Patient Safety Organizations”
Many providers fear repercussions
Act provides federal legal privilege and confidentiality protection
When this presentation was first created in , there were no certified PSOs. There are now approximately 75 organizations in 30 states and the District of Columbia. These PSOs can operate nationwide, however, regardless of their home state.

21. Location of Patient Safety Organizations by State
Accessed from

22. Joint Commission Goals
Improve the accuracy of patient identification
“NEVER” events
Improve the effectiveness of communication among caregivers
Improve the safety of using medications
Reduce the likelihood of patient harm associated with the use of anticoagulation therapy
Reduce the risk of health care-associated infections
NEVER events include death or serious disability resulting from falls within a health care institution, acquisition of state 3 or 4 pressure ulcers while in a health care facility, central line associated blood infections, wrong site surgery, etc.

23. Joint Commission Goals
Accurately and completely reconcile medications across the continuum of care
Reduce the risk of patient harm resulting from falls
Encourage patients’ active involvement in their own care as a patient safety strategy
Recognize and respond to changes in a patient’s condition

24. Crossing the Quality Chasm– IOM report
IOM was supposed to be balanced
“…to strike a balance between regulatory and market-based initiatives, and between the roles of professionals and organizations”
But it was compliance-heavy
“…to create sufficient pressure to make errors so costly in terms of ability to conduct business in the marketplace, market share and reputation that the organization must take action”
CMS – government driven; third party insurers; HMOs – may penalize health care providers or organizations

25. IOM Stakeholders Providers JCAHO Payors Government Employers
Implement tools that support
clinical decision making and prepare for new reporting requirements.
JCAHO
Establish disease -specific
care performance indicators and mandatory reporting for accreditation
High quality SAFE patient care
Payors
Provide incentives to providers that use tools to increase safety and can demonstrate performance
Government
Monitor provider
organizations through
mandatory and voluntary
reporting
Employers
Provide incentives
to providers that use tools to increase safety.

26. “Traditional” Patient Safety
Honored traditional teaching Blame… Shame… Denial… Errors are caused by… Time-honored solutions to error? Anger… Shoot the messenger… Work harder…Try harder… Blame the system…

27. “Culture”
The system of shared beliefs, values, customs, behaviors, and artifacts that the members of that society use to cope with their world and one another, AND … that are transmitted from generation to generation through learning.

28. “Culture of Safety”
Acknowledges high-risk, error-prone nature of modern health care
Shared acceptance of responsibility for risk reduction
Encourages open communication about safety concerns in non-punitive environment

29. “Culture of Safety”
Facilitates reporting of errors and safety concerns
Learns from errors and redesigns safer systems
Ensures that organizational processes, goals, and rewards are aligned with improving patient safety

30. Most Common things that can result in harm to patients

31. #1 MEDICATION ERRORS

32. 1. Medication Errors Occur frequently in hospitals
Approximately 2% of admissions experienced preventable Adverse Drug Event (ADE)
Estimated increased cost $5000 per patient
ADEs cost about $5.6 million per hospital annually
Average cost per ADE in tertiary hospital $3244 with increased length of stay (LOS) of 2.2 days
Average cost per ADE in community hospital $3420 and increased LOS of 3.1 days

33. Medication Errors Most common medications associated with harm
Anticoagulants
Antidepressants
Antipsychotic medications
Cardiovascular drugs
Analgesics
All commonly prescribed drugs in the neurology clinic and neurology wards or Neuro ICU

34. Predictors of ADEs
Cannot solely be predicted based on patient factors or drug types
Some associated risks:
Older age
Polypharmacy
Severity of illness

35. Medication Errors: What can you do to reduce error or potential harm?
Check your orders for accuracy of dosing
Check medication interactions
Ask specifically about herbals and OTC products
Check medication side effects and ask the patient about these on subsequent visits
Check to see that the patient is receiving the medication as prescribed
Encourage patients to bring in written lists
Use EHR
Herbals and OTC products are often not consider to be “medications” by patients, especially herbals or vitamins which may be viewed as “natural” and thus not potentially harmful. However common interactions exist, example – vitamin E and warfarin, or gingko and warfarin – increased bleeding risks

36. #2 POOR COMMUNICATION

37. 2. Poor Communication
In an average 4-day hospital stay, a single patient may encounter up to 50 different hospital employees
More than 1/5 of patients reported hospital system problems
Staff providing conflicting information
Not clear who the physician responsible for their care is
Hospital care today involves many handovers, potentially with many individuals at different levels of training (nursing and medical students, medical assistants, CNAs, RNs, pharmacists, therapists, residents, faculty physicians, etc., multiple consulting teams)
Patients often do not know who the responsible doctor is or cannot identify or distinguish resident from faculty physician

38. Poor Communication
With ineffective communication, great potential for harm
Lack of critical information
Misinterpretation of information
Overlooked change in status
Unclear orders over the phone
Communication errors identified as the root cause of sentinel (“Never”) events reported to the Joint Commission from 1995 to 2004
Poor communication can stem from many things: Assuming someone else will or has told the patient or family the critical information; assuming they understood the information. We in the medical profession have a tendency to use jargon which the average person does not understand.
Hand-overs can be a very dangerous time in the care of a patient due to poor or inadequate communication between care teams.

39. Barriers to Effective Communication
Hierarchical differences
Inter-professional and intra-professional rivalries
The health literacy of the patient
Differences in language and jargon
Cultural differences
Generational differences
Hierarchical differences may contribute to patients’ trust in the information or the quality of information provided. Young trainees may not be viewed by the patient as experienced, and thus information from them may be dismissed.
Health literacy is a huge issue. The average patient in the US has a health literacy level approximate to that of a fourth grader. English as second language patients may potentially have even lower health literacy.

40. Barriers to Effective Communication
Despite your best efforts to communicate and your belief that your have communicated effectively, more patients than you may realize don’t understand what you think they understand.
Rarely will patients reveal limitations in their understanding because they are embarrassed to do so.

41. Barriers to Effective Communication
Health Literacy - Factors affecting patients’ ability to understand
Ability to read
Ability to understand English
Ability to understand medical “lingo”
Cultural / ethnic views of cause and treatment of disease
Complexities of health care system
We often assume the patient or family can read, or at least fail to ask the question.
Use of handouts or visual information may help to enhance understanding in those patients with low levels of health literacy.

42. What can we do to improve communication within the health care team?
Ensure that the information is conveyed between staff members at shift changes.
Written sign out including diagnosis, clinical status of patient, pending results, key test results, allergies, CODE status, and “what to do if…”
If possible, bring the nurse into the room to demonstrate the current findings and specific things that you want to be notified about.
Document the teaching and follow-up.
ASSUME NOTHING!
If you don’t document it, it didn’t happen.
Use teach-back methods – have patient or family teach you what you’ve communicated to them (i.e., med instructions).
Repetition is your friend – and the patient’s.

43. What can we do to promote effective communication with our patients?
Speak in plain everyday terms– avoid medical jargon
Use teach-back methods
When possible utilize pictures or diagrams
Provide written information or handouts
Make every attempt to use a medical translator for those patients who are non-English speakers

44. 3. Infection Resulting from Lines and Tubes
Don’t use a Foley catheter unless it is absolutely necessary.
Lines should be dated and checked daily
Lines should be removed as early as possible, and if there is ANY sign of infection
As of 2009, CMS and some insurance companies will not pay for infections that develop once a patient is in the hospital
CAUTI (catheter associated UTI) is a major National Patient Safety Goal for 2012 from the Joint Commission.

45. 4. The Patient is Not Sufficiently Monitored
Patients may need frequent vitals monitoring, telemetry, serial lab testing depending on their condition
No one will fault you for being “overly cautious”

46. 5. Handwriting
Errors in misinterpretation of written orders account for a large percentage of inpatient mistakes.
Avoid use of trailing zeros
Use 5mg not 5.0mg
Use leading zeros
0.5mg
Standardized order sets are used to help decrease orders of OMISSION.
However may increase orders of COMMISSION due to duplication of tests or inappropriate medications/tests
Use of electronic health record systems can reduce errors caused by handwriting

47. 6. The Diagnosis is Not Clear
A wrong diagnosis is made because of failure to order the appropriate test
Always evaluate for life-threatening processes that require immediate attention (stroke, myocardial ischemia, pulmonary embolism, intracranial hemorrhage) as appropriate
Review all test results in a timely fashion to ensure that patients are treated appropriately
Who will notify the patient about their test results? How will they be notified?

48. 7. New Information is Ignored
Lab results in clinic resulted but not reviewed or patient not notified of result
Additional history from patient or family
A patient admitted for one thing may develop a new problem while hospitalized
(e.g., patient with a stroke develops an MI)

49. 8. The Patient Who Needs Frequent Blood Monitoring: Diabetes and Anticoagulation
Insulin dosing errors in patients who are not eating
Glucose fluctuations in patients who have infections/stress of illness
Increased risk for bleed in anticoagulated patients
Interactions with other medications
Ex. Many drugs interact with warfarin and may cause INR to increase or decrease
Ex. Antibiotics may interact with and alter levels of anti-epileptic drugs

50. And last but not least. . .

51. THE PHYSICIAN WHO ASSUMES THAT ERRORS DO NOT OCCUR!
If we carefully review our work, we are less likely to make errors
We should avoid making the same mistakes over again- system and practice change
“If you don’t have time to do it right the first time, how are you going to have the time to go back and fix it later?”

52. Case Studies

53. Case 1
Patient admitted to stroke service by night float resident (or hospitalist). EKG ordered as part of standard order set.
EKG result not reviewed by the night float (hospitalist); signed out by phone to the day resident (or next shift) who has 4 new admits and forgets to check about the EKG.
Medicine consulted for HTN management 2 days later and notices EKG with evidence of MI on admit.

54. Case 1: Key Learning Points
Review all test results and history at time of admission and also transitions of care
Adequate handoffs and sign-out are critical, optimally are written
Communication between providers is best done face to face

55. Case 2 Neurology consulted for patient with delirium in ER
The patient has history of seizures. Lab tests reveal a phenytoin level of 65, and patient is ataxic on exam
Resident does not communicate situation to nursing staff
Patient is placed in room away from nursing station without bedrails up, and no falls precautions noted.
Patient falls out of bed attempting to go to bathroom and suffers subarachnoid hemorrhage and subdural hematoma.

56. Case 2: Key Learning Points
Recognition of adverse drug event—supratherapeutic drug level. Why?
Failure to follow up on test result
Communication between providers and care team members
Inadequate supervision of falls risk patient
Supratherapeutic drug level could be due to medication interaction or poor understanding of medication regimen by patient

57. Case 3 Neurology patient admitted to the ICU for status epilepticus
Patient seizing for several hours with a low valproic acid level
Valproate level was not being monitored and was dosed incorrectly
ICU team not aware of when to call neurology
Neurology cross-cover had no sign out for “bed check” or lab follow-up

58. Case 4
Patient presented to the ER with mental status change and found to have a pneumonia.
Neurology consulted because of strange eye findings.
Neurology resident recommended head CT in the ER but never looked at the scan.
Patient admitted to medicine for the pneumonia and never had head CT done until 24 hours later, which reveals an acute obstructive hydrocephalus.

59. Case 5
Patient admitted to stroke service with new atrial fibrillation and put on warfarin.
Patient discharged to PCP for follow up.
PCP never received notification of admission and discharge recommendations, was not following INR, and also thought that patient was not a warfarin candidate because of falls.
Patient is readmitted for second stroke 30 days later with INR of 1.1, even though patient reported compliance with medication.
Communication to patient, caregiver and other providers
Potential ADE

60. What is the impact of medical Error on the health care professional?

61. Impact of Error on Caregivers
Surgeons who believed they made medical errors 3 x more likely to consider suicide (Archives of Surgery)
Survey by Amy Waterman of 3100 physicians
92% reported a “near miss” or a minor error
57% reported a serious mistake
Of those who reported serious error
2/3 reported anxiety about future error
50% reported decreased job confidence and satisfaction

62. How Do We Avoid Medical Errors?
Recognize the most common errors and take steps to avoid them
Review records, orders, admission and discharge information
Review orders and medications at times of transfer between units
Review vital signs daily or more frequently as possible as these are early signs of changes in clinical status
Review all test results in a timely fashion
Identify patients at risk for falls
Write clearly

63. How to Avoid Medical Errors?
Review medication lists at EVERY appointment
Have a formal sign-out or hand-off procedure
Provide written communication to referring providers in a timely fashion

64. How to Avoid Medical Errors?
Make sure there is a clear follow up plan
Provide appointment on discharge summary for patients discharged from the hospital
Provide written information about medications or diagnoses
Discuss discharge planning with case managers early so that patients are not waiting extra days in the hospital for rehab therapy or home health services to be arranged

65. How to Avoid Medical Errors?
All of these things take time. . .
BUT
In the end it saves time and resources by reducing complications, length of stay, and cost to patients and systems.

66. When errors occur: What comes next?

67. Disclosing Errors Required by the Joint Commission
Important elements of disclosure that matter most according to patients
Disclosure of all harmful errors
An explanation as to why the error occurred
How the error's effects will be minimized
Steps the physician (and organization) will take to prevent recurrences

68. Disclosing Errors
Doesn’t mean you talk to the patient or family without stopping to think first
You should tell the truth, but tell it wisely
This means:
Not withholding key information
Providing factual information in a timely manner while acknowledging if there is uncertainty about the course of events or the consequences of the error
Speculation ≠ Truth

69. Disclosing Errors Wisely
First and foremost, when an error happens take care of the patient
Once the dust settles, get help
Physician or nurse supervisors (preferably both)
Get the facts--and sometimes that takes time
Was there a departure from a standard of care?
Was the patient harmed?
Was the error avoidable?
Don’t blame, point fingers, or gossip

70. Disclosing Errors Wisely
Get advice if necessary from Risk Management, the hospital attorney, or the ethics committee
Plan the disclosure—DON’T WING IT
The most skilled and responsible person should conduct the discussion
Should not be delegated to an intern or other subordinate

71. Disclosure ≠ Liability
Disclosure is simply a statement that an error happened.
Liability requires:
Negligence—departure from standard of care
Damages—i.e., the patient was harmed
Proximate cause—the harm resulted from the departure from the standard of care

72. Summary
Be aware of the potential for errors across all environments and systems in which patients are cared for
Communication is key!
Remove tubes/lines as early as possible
Practice preventive medicine
e.g., DVT prophylaxis

73. References
Nightingale, Florence. Notes on Hospitals. London: Longman, Green, Longman, Roberts and Green, 1863.
Brennan TA, Leape LL, Laird NM, et al. Incidence of adverse events and negligence in hospitalized patients: results of the Harvard Medical Practice Study I. N Engl J Med 1991;324:370–7.
Wilson RM, Runciman WB, Gibberd RW, et al. The Quality in Australia Health Care Study. Med J Aust 1995;163:458–76.
Kohn LT, Corrigan JM, Donaldson MS, eds. To err is human: building a safer health system. Washington, DC: National Academy Press, 1999.
Leape L, Lawthers AG, Brennan TA, et al. Preventing Medical Injury. Qual Rev Bull. 19(5):144–149, 1993.
Layde, P. M., Meurer, L.N., Guse, C., Meurer, J. R., Yang, H., Laud, P., Kuhn, E.M., Brasel, K.J., & Hargarten, S.W. Medical Injury Identification Using Hospital Discharge Data. Advances in Patient Safety: From Research to Implementation. Rockville, MD: Agency for Healthcare Research and Quality; AHRQ Publication Nos (1–4). Vol. 2;119–132.

74. References
Balthasar LH, Keohane C, Seger DL et al. Cost of adverse drug events in community hospitals. Jt Comm Jour on Qual and Patient Safety 2012; 38:
Kaushal R, Shojania KG, Bates DW. Effects of computerized physician order entry and clinical decision support systems on medication safety: A systematic review. Arch Intern Med 2003 Jun 23;163(12):1409–1416.
Gallagher TH, Garbutt JM, Waterman AD, et al. Choosing your words carefully: how physicians would disclose harmful medical errors to patients. Arch Intern Med 2006;166: