Patient Safety Chapter 5

Page 368 Medical Errors Unintentional preventable mistakes in provision of care which may or may not harm the patient Act of commission (doing something wrong) or omission (failing to do the right thing)

Patient Safety Management Page 370-372 Patient Safety Management To Err is Human – IOM Report – 1999 - 2000 Patient Safety = freedom from accidental injury caused by medical care Need a written Patient Safety Program Need a Patient Safety Culture

IOM Recommendations -Medical Errors Page 370-372 IOM Recommendations -Medical Errors National focus Mandatory & voluntary reporting systems Raise standards and expectations for improvements Implement safe practices at the delivery level

Patient Safety Goals and Safe Practices Page 376-378 Patient Safety Goals and Safe Practices Must integrate patient safety goals and safety practices through out the organization World Alliance for Patient Safety (WHO) Identify, evaluate, adopt, coordinate, disseminate, & accelerate improvements in patient safety 19 item Surgical Safety Checklist National Quality Forum Endorsed set of eight measures of safe practices Phase II now being conducted with other measures

Patient Safety Goals and Safe Practices Page 376-378 Patient Safety Goals and Safe Practices Institution for Healthcare Improvement (IHI) Work with others to develop to build patient safety practices Global Trigger Tool Website with patient safety resources AHRQ Patient Safety Indicators Set of risk adjusted indicators that screen for adverse events National Patient Safety Goals (TJC) Developed for all TJC accreditation programs

Poka-Yoke (“poh-kay yoh-kay”) Japanese - Avoid (yokeru) inadvertent errors (poka) Mistake proofing or error proofing A number of small items that are used to detect or prevent errors from occurring Checklist Warnings in software that does not allow you to continue until you complete/correct something Example: marking of operative site and Time Out

Quality Professional Roles Develop Patient Safety Program Facilitate on going evaluation of safety activities Assure that a Safety (culture) Survey is completed & Utilize the findings to develop and implement improvement: i.e.: Fear of reporting due to fear of retribution i.e.: Not reporting because reporting process is too complicated Facilitate improvement activities Integrate safety concepts throughout the organization

Patient Safety Program Pages 379-380 Patient Safety Program IHI recommendations -starting point for a patient safety program Establish patient safety as a strategic priority Culture Infrastructure Learn Engage key stakeholders Governing Body Leadership – including medical staff leadership

Patient Safety Program Pages 379-380 Patient Safety Program Communicate & build awareness Leadership rounds Literature Establish, oversee, and communicate system-level aims Objectives related to strategic plan Measure harm over time Balanced scorecard RCA, FMEA

Patient Safety Program Pages 379-380 Patient Safety Program Support staff and patients/families impacted by medical errors and harm Appropriate disclosure Align system strategy, measures, and improvement projects Redesign care processes to increase reliability Reliability (variation) is key concept

Patient Safety Management Page 389 Patient Safety Management Most organizations have different organizational cultures, including different healthcare organizations Healthcare must change into a Quality and Patient Safety culture if we are to survive There must be a Patient Centered culture Care must be Evidence-Based Teamwork is essential

Patient Safety Culture Pages 380-381 Patient Safety Culture Patient Safety assessments Raise awareness Identify safety issues Help build a patient safety culture Must be an objective by leadership who are willing to utilize resources to reduce potential adverse events resulting from exposure to the healthcare system

Patient Safety Culture Pages 390 Patient Safety Culture Safety Culture Assessment AHRQ –Free Survey on Patient Safety Culture Hospital, Ambulatory Surgery, Medical Office, Nursing Home & Pharmacy Every 2 years on a rotating basis Compared with other similar organizations Helps to identify & measure conditions in healthcare organizations that lead to adverse events & patient harm Need to make improvements based on results from survey!

Just Culture We all make mistakes, no matter who we are Pages 391-392 Just Culture We all make mistakes, no matter who we are Does not mean we meant to make that mistake Just Culture Everyone knows the organization’s values & how to make choices to respect those values Most errors are a result of the process not the individual Human factors do play a part, of course

Pages 391-392 Just Culture When errors are made, must consider the type of error, but also what kind of drift may have occurred For example, nurse utilized a workaround to speed up the medication administration process One patient gets the wrong medication For example, unfortunately there are healthcare individuals who “help” people to pass more comfortably

Role of Technology in Patient Safety Pages 396-401 Role of Technology in Patient Safety Electronic Medical Record Abduction – Elopement Security Systems Smart Pumps Alerts Computerized Physician Order Entry (CPOE) Bar-code Medication Administration Systems

Human Factors 3 types of errors Human error At-Risk behavior Pages 401-403 Human Factors 3 types of errors Human error inadvertent error At-Risk behavior action chosen may lead to an error but don’t expect it to (text while driving) Reckless behavior consciously choses to put self or others in harm’s way

Make minor changes with some risk How humans can cause problems and errors Major risks occur Make minor changes with some risk Way it should be done Drift

Human Factors Engineering Pages 401-403 Human Factors Engineering We are our own worst enemy While we establish policy & processes, they are not always followed Workarounds are commonly used in healthcare However this leads to increased chance of error

Human Factors Engineering Pages 323 - 325 Human Factors Engineering How people interact with tasks, devices, machines, environment, other individuals, groups & teams and the organization Always able to find the gas tank open button in a rent car? When you buy a new version of a kitchen appliance and keep pressing the wrong button to get it to work? Mindlessness -being present and not missing the current moment by spending too much time in our heads Ever put your keys in a place you will always remember only to forget where they are? Ever leave a gas station with the gas pump hose still in your car? Ever place items on top of your car and for get to put them into the care before you drive off?

Human Factors Engineering Pages 401-403 Human Factors Engineering Human Factors Engineering By looking at these factors helps improve or have better design processes to reduce errors Unsafe actions Failure to follow P&P Preconditions for unsafe actions Environment, situations (poor handoffs), behavioral Oversight/supervisory factors Organizational influences

Annie’s Story Annie's Story: How A System's Approach Can Change Safety Culture : https://www.youtube.com/watch?v=zeldVu-3DpM MedStar Health

Just Culture When an error is made, Pages 404-406 Just Culture When an error is made, there needs to be an evaluation of how the error occurred, if drift was part of that situation, and if the process, equipment, etc. would attribute to that error How the organization reacts to the individual(s) who made the mistake should depend on why the mistake was made. The process should be examined to determine if there is a fault with the process or the individual(s) Exception: RED RULES: Absolute Compliance required ! Annie’s Story https://www.youtube.com/watch?v=zeldVu-3DpM&t=36s

Page 403-404 Sentinel Events When an adverse outcome is identified that involves death, or serious physical or psychological injury, or the risk thereof Sentinel events are Special Cause variation & must have an intensive analysis conducted to determine what happened and why

Most Frequently Identified Root Causes Human Factors 614 635 547 999 Leadership 557 Communication 563 517 849 532 489 744 Assessment 482 505 392 545 Information Mgmt 203 155 Physical Environment 115 202 150 138 Care Planning 72 Health Information Technology-related 125 Operative care 95 103 75 Continuum of Care 93 97 59 Operative Care 62 Medication Use 91 77 58 60 81 76 57 Information Management 52 No longer published by TJC 2012 (N = 901) 2013 (N=887) 2014 (N=764) Human Factors 614 635 547 Leadership 557 Communication 563 517 532 489 Assessment 482 505 392 Information Mgmt 203 155 Physical Environment 115 150 138 Care Planning 72 Operative care 95 103 Continuum of Care 93 97 Health Information Technology-related 59 Medication Use 91 77 Operative Care 58 81 76 57 The Joint Commission, 2012-2014

Sentinel Events Requires apology & disclosure to patient Page 403-404 Sentinel Events Requires apology & disclosure to patient Most only want to know what happened & what is going to be done about preventing it again Sentinel event patterns & trends from TJC Sentinel Event Alerts Root Cause Analysis (RCA)

Root Cause Analysis (RCA) Page 406-408 Root Cause Analysis (RCA) A systematic process for identifying the most basic or causal factor(s) underlining variation in performance Usually completed AFTER a bad event or near miss RCA to be conducted – intensive analysis Ask ‘Why’ at least 5 times Problem must be defined as succinctly as possible Interview all involved in the event

RCA Areas to evaluate Flow chart of this incident Human factors The best tool out there is The Joint Commission’s RCA format http://www.jointcommission.org/sentinel_event.aspx PART 1 – Incident itself Areas to evaluate Flow chart of this incident Human factors Equipment factors Controllable environmental factors Uncontrollable external factors Other factors

RCA Part 2: Facility Wide Areas to evaluate Page 327-329 RCA Part 2: Facility Wide Areas to evaluate Other areas in organization where this could happen Human Resource/Staffing issues Information Management/Communication issues Environmental Management issues Leadership issues – Corporate culture – Risk reduction Encouragement of communication Clear communication of priorities Technology issues

RCA Part 3: Action Plan Defines action based on each root cause identified Must specify time frames & who responsible Must be implemented Must follow-up and assure compliance AND sustainment Action Plan developed MUST be implemented and outcomes monitored

Failure Mode Effectiveness Analysis FMEA or HFMEA Pages 408-411 Failure Mode Effectiveness Analysis FMEA or HFMEA Proactive tool to systematically evaluate a process to determine where it could result into an error Proactive – done BEFORE something bad happens Identifies and improves steps in a process to reasonably ensure a safe and clinically desirable outcome

FMEA Terms Failure Modes: Risk Priority Number (RPN) Pages 408-411 FMEA Terms Failure Modes: Different ways that a process can fail to function or provide desired results Risk Priority Number (RPN) What the overall risk of occurrence is

FMEA Steps: 1. Describe and understand the process Pages 408-411 FMEA Steps: 1. Describe and understand the process Flowchart current process (macro) 2. Brainstorm potential failure modes Consecutively number each potential failure point

1 3 2 4

FMEA Steps: 3. Identify the potential causes of each failure mode Pages 408-411 FMEA Steps: 3. Identify the potential causes of each failure mode 4. List potential effects (adverse outcomes) of each failure mode

Forget to Register Product Pages 410 FMEA Worksheet 1 3   Failure Mode Failure Causes Failure Effects Occurrence Detection Severity RPN 1 Buy Wrong Version   xxxx yyyy  2 Credit Card Denied   xxxxx  yyyy 3 Forget to Pay Invoice  4 Forget to Register Product   yyy 1-10 O x D x S 2

FMEA Steps 5. Assign ratings for each effect – Scale of 1-10 Severity Pages 408-411 FMEA Steps 5. Assign ratings for each effect – Scale of 1-10 Severity Frequency/occurrence Detection 6. Calculate the Risk Priority Number for each effect Severity x Frequency/Occurrence x Detection Highest Risk Priority Numbers are tackled first

Forget to Register Product Pages 408-411 FMEA Worksheet 1 3   Failure Mode Failure Causes Failure Effects Occurrence Detection Severity RPN 1 Buy Wrong Version   xxxx yyyy   5 9 45  2 Credit Card Denied   xxxxx  yyyy 1  10  3 Forget to Pay Invoice  4  2   8 64  4 Forget to Register Product   yyy  6 12 1-10 O x D x S 2

FMEA Pages 408-411 STEPS 7. Take action to eliminate or reduce the high risk failure modes 8. Identify performance measures to monitor the effectiveness of the redesigned process