PHAR 464 Final Exam

(11/7) Bursua/Larson: Introducing Patient Safety Leading Causes of Death in the US: Preventable medical errors are 3rd. Swish Cheese Model: Imagined as successive layers of defenses, some holes develop due to active failures, while others arise from latent conditions. Accidents happen when these successive holes align.

- Active Failures: “Sharp end” of error. Defined as unsafe acts committed by the person with direct contact with the pt or system. Slips and lapses

- Latent Failures: “Blunt end” of error. Vulnerabilities or conditions that contribute to active failures – error-provoking conditions. May be dormant

- Often times active failures are the result of a multitude of latent failures Human Factors and Error Prevention “To reduce error, it is important to make the right thing to do the easy thing to do”

- Human Error: Due to the design of the system and behavioral choices o Solution: Better design, training, procedures, new processes

- At-Risk Behavior: The result of a choice – a risk believed to be insignificant or justified o Solution: Remove incentives for these behaviors, create new incentives for healthy ones.

- Reckless Behavior: A conscious disregard of substantial and unjustifiable risk o Solution: Remedial action, punitive action

(11/7) Duhig Lecture: Human Factors and Patient Safety Safety Decision Analytics (SDA): Enabling the best possible decision in the earliest and most efficient manner

- Purpose: Integrate quantitative and qualitative analyses into every aspect of safety science. This involves the Process, Platform, and People.

Self-Efficacy: aka personal efficacy – this is the extend or strength of ones belief in ones own ability to complete tasks and reach goals. Self-efficacy affects every area of human endeavor, and thus requires cognitive behavioral research

- Issue: The demands placed on patients to administer/monitor their own care outweighs their capabilities User-Centered Design: Meant to optimize human well-being and overall system performance. Ex: Google Use vs. User Errors

- Use Error: This occurs repetitively to the extent it can be predicted. It can be identified through usability testing and hazard analysis to prospectively minimize through design.

- User Error: Results from fundamental errors by humans that has no reasonable possibility of prediction. It cannot be prevented and cannot be addressed by the device designer. This implies blame on the user.

- Abnormal Use: Beyond the control of the manufacturer – sabotage. Defining Hazards and Harms

- Hazard: A potential source of harm - Hazardous Situation: Exposure to the hazard occurs, but no harm - Harm: When physical injury or damage to people, property, environment

Use-Related Risk Analysis (URRA): A systemic assessment of a product’s use, location of use, users, and potential hazardous situations. There’s many other terms similar to URRA, such as FMEA (Failure modes and effects analysis) Risk Control Hierarchy:

- Design Out the Error (make a bridge, eliminate the chance) - Prevent the Error (barriers at train crossings) - Warn about Error (alarms, stop signs) - Inform about the Error (labeling, instructions, training)

Medication Error - Definition: Any preventable event that may cause or lead to inappropriate medication use or patient harm while

the medication is in the control of the health care professional, patient, or consumer Health Literacy: A multidimensional challenging involving system demands and complexities as well as the skills and abilities of individuals @Abbvie VENCLEXTA Summative Study

- Critical Tasks: The decisions and simulated use of patient’s using Venclexta. - Essential Tasks: Assessed the knowledge of patients following Venclexta product review. The “what ifs”

Design Prevent Warn Inform

(11/10) Larson Lecture: Root Cause Analysis and Failure Modes and Effect Analysis Safety/Adverse Event: An undesirable occurrence directly associated with the care or services provided within the jurisdiction of the medical facility Sentinel Event: A patient safety event that results in death, permanent harm, or severe temporary harm. –The JC Root Cause: Any identified reason in the sequence of events that, if prevented, will stop a recurrence of the particular event. There must be a clear cause and effect such that if you eliminate the cause, future events will be prevented. Root Cause Analysis (RCA): A systematic process utilized to determine the primary cause of system failures

- Goal: Identify the root cause(s) and develop an action plan to prevent recurrence or mitigate a future event

- Criteria: To be effective, the RCA should clearly: o Define the problem and its Significance o Delineate/describe the causes of the problem o Establish causal relationships between the cause & problem o Present evidence to support the existence of the identified causes o Explain how the proposed solutions will prevent recurrence of the problem o Document all of the above criteria in a final RCA report so others can follow the logic of the analysis

- Indication: Leadership groups, such as Risk Managers, decide which events to conduct a formal RCA. They may decide which safety events warrant a RCA. However, Sentinel events must have a RCA – The JC

o Sentinel Events o Trends of near miss events (recurring process gap)

- RCA Team Members: Subject matter experts on the event, an individual not familiar with the event, a leader who is well-verse in the RCA process, front-line staff working in the area/process, and a patient representative.

o Interviews occur with individuals outside and within the RCA team. Review identified deviations and obtain information from peers on the affected process.

- Methods: Use the ‘5 Whys’ and draw Flow Diagrams such as the Ishikawa/Cause and Effect/fishbone diagrams o 5 whys: The root cause has been identified when asking “why” no longer provides useful information o Flow diagrams: Maps out the decision and event tree, explaining processes and rationale for methods

§ May require sub-processes to better define the procedure, as there may be hidden causes - Action plan: Developed with the intent of preventing the recurrence with certainty.

Failure Mode and Effects Analysis (FMEA): Ongoing quality improvement process using a multidisciplinary team - Purpose: This proactive problem-solving tool is used to analyze a process or system to identify possible modes of

failure, and possible consequences of those failures. Most often used to examine new products and the design of new services prevent potential failures before errors occur.

- Opinion: Honest accidents and mistakes cannot be eliminated – errors may occur. That being said, the FMEA seeks to prevent an error from becoming an accident by using safety systems or error traps

- Method: o Assemble multidisciplinary team (often involving major stakeholders – MD, Pharmacist, etc) o Define the Specific Focus of the FMEA topic o Draw a Process Flow Diagram (highlight all sub-processes) o Hazard Analysis: List the possible/potential failure modes. Calculate the

risk priority number (RPN) or criticality index (CI) o Actions – Decide on actions to reduce the RPN o Follow-up: Create a process or outcome indicators that can be measured

for the improved process - Risk Priority Number (RPN): The higher the number, the more risk associated with that part of the process.

o Action items should be investigated and prioritized for higher RPNs

Safety Assessment Code (SAC): Using a probability/severity matrix - Severity

o Catastrophic: Death or permanent loss of function o Major: Lessening of bodily function/disfigured o Moderate: Increased length of stay or increased level of care

for one or two patients o Minor: No injury or increased length of stay.

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- Probability o Frequent: Likely to occur immediately or within a short period of time (several times in a year) o Occasional: 1-2x per year. Uncommon: once in 2-5 years Remote: once in 5-30 years. Unlikely.

- Ranked Matrix Score: Paired categories for an actual event OR a close call provide the score o Highest risk: 3, Intermediate 2, low 1.

(11/14) Bursua Lecture: Process Improvements for Patient Safety Types of Change

- Technical: Experts clearly define a problem and change the product/process so it doesn’t happen again. This type of change faces little resistance, and many may not even notice that the change has occurred (No ‘loss’ experience)

o This change improves a current practice o Example: Take a blood pressure medication Repair a broken bone via surgery

- Adaptive : The stakeholders together address a problem that is difficult to define and requires changing the hearts and minds of others. Resistance is high, as stakeholders choose between contradictory values (experience loss).

o This change requires a new practice o Example: Adapt your lifestyle to increase exercise and eat healthier. Avoid high-risk activities

Process Improvement Strategies - Donald Norman User-Centered Design (6 strategies)

o (1) Make important information Visible § Ex: Writing on leg that you will amputate

o (2) Simplify the structure of tasks § Ex: Expedite workflow to avoid unnecessary tasks

o (3) Affordances and Natural Mapping (Utility) § Affordance: Characterizing how equipment should be used (door handle) § Natural Mapping: Make relationships intuitive – control & function diagram

o (4) Use Constraints (forcing functions) to Guide the user § System oriented solutions/interventions = most effective

o (5) Make it easy to Reverse error prone operations and hard to carry out non-reversible ones

o (6) Standardize and Simplify Actions Leading Change through the Healthcare System Six Sigma and DMAIC

- Define Define the problem, identify the customer - Measure Establish the basis for improvement - Analyze Prioritize problems (latent) and consider the risks associated with the proposed solutions - Improve Perhaps try a pilot first. Prepare the stakeholders for the change. Collect data along the way. Do it - Control Lock the gains, manage the resistance, celebrate the wins. Hip hip, hooray….. ffs

The PDSA Cycle (Plan-Do-Study-Act) - Plan: Plan your strategy, identify your goal, formulate - Do: Develop and implement your plan, identify barriers - Study: Monitor your outcomes, identify problem areas - Act: Reassess and respond, adjust, change, integrate.

Things to thing about: Yes, leading process improvements is challenging work, so start with the easy options – technical changes are easier to implement. But user-centered design is the key to solving problems. Make it so that the safe thing to do is the easy thing to do. These system oriented interventions are usually more effective than human oriented ones. We can use six sigma as a framework for our success. Doesn’t this sound terrific! I hope you’re as excited as I!

Donald Normal Visible

Simplify Utilization

Guide Reversibility Standardize

(11/17) Kumor Lecture: Patient Safety in Community Pharmacy Practice FYI: 1 in 1000 errors in the retail setting are clinically significant every week. The RISK POINTS in community-based practice

- Speed versus safety - Staffing restrictions - Burn out

- Incomplete medication profile - Communication issues/assumptions

Institute of Safe Medication Practice (ISMP): Devoted to medical error prevention and medical use error - Gold Standard: Essential patient information must be obtained when dispensing medication - Safety Element: Patient Info: Acquire basic demographic information – this is the gold standard.

o Risk Reduction: Ask for allergy info at every visit, use 2 patient identifiers, pediatric weight for Rx - Safety Element: Drug Information: Know the common dosage forms, contraindications, and new meds

o Risk Reduction: Educate the team, have dedicated online resources (ISMP), review updates. Some references include: Micromedex, LexiComp, UptoDate, Package Insert

- Safety Element: Drug Labeling: Even now, errors with Look-Alike/Sound-Alike still occur. o Risk Reduction: OPEN THE BAG at the point of sale!

- Safety Element Counseling: This is a chance to address patient questions, identify errors, validate dx. o Address this: 5 most common drug classes with ADE: Insulins, Opioids, Hypoglycemic agents,

Amoxicillin products, antihistamines/cold meds o Risk Reduction: Mandatory Counseling. New pt, New med, Ddose/RoA/Sig Implemented 9/1/17

Adverse Medication Event Reporting: Every report makes a difference, even if uncertain of the cause, the ADR should be reported. Unfortunately, not all serious ADR are documented by the time the drug is released to the market

- Purpose: Satisfy the need for heightened post-marketing surveillance, it is crucial for organization-wide system changes. Where to report it? MedWatch

Risk Evaluation and Mitigation Strategy (REMS): The Food and Drug Administration Amendments Act (FDAAA) of 2007 gives the FDA the right to impose a REMS on any drug to ensure that the:

benefits outweigh the risks The manufacturer is responsible for developing the REMS, and are approved by the FDA as part of the drug approval process. They may also be submitted post-approval if new safety information becomes available. Furthermore, once approved, the drug manufacturer is responsible for the implementation and monitoring of the REMS program. Elements of REMS (FDA website lists all the meds with REMS)

- Medication Guide: Informs patients about the serious risks associated with the medication (Ex. Bupropion)

- Communication Plan: Education and information to raise awareness of the medication risks for Healthcare providers. Tools.

o (Ex: Drugs that cause CML or ALL – Inclusig) - Elements to Assure Safe Use (ETASU): Most comprehensive

REMS program that can be implemented, associated with the highest risks. Involves required medical interventions that need to be executed prior to prescribing, dispensing, and even continuing on a medication. (Ex: Clozapine – Neutropenia)

- Implementation Plan: Drug mfg may be required to take steps to monitor and evaluate ETASU strategies and data processing. (Ex: iPledge)

ETASU-REMS Criteria - (1) Prescriber is trained or has experience or special certification - (2) Pharmacies, practitioners, or health care settings are specially certified. - (3) Drug is dispensed only in health care settings - (4) Drug is dispensed to patients with evidence or documentation of safe use conditions (like lab values) - (5) Each patient using the drug is subject to certain monitoring - (6) Each patient using the drug is enrolled in a registry

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(11/21) Bursua Lecture: Just Culture and Patient Safety Just Culture: A system of justice providing Just balance between human and system accountability

- Definition: A culture in which front-line operators and others are not punished for actions, omissions, or decisions taken by them which are commensurate with their experience and training, but where gross negligence, willful violations and destructive acts are not tolerated.

o à Do not punish someone if they mess up in a way anyone could o à Only punish if they exhibit gross negligence, willful violations, and destructive acts

- Goal(s): Maximize safety of the health system and promote fairness to individual healthcare providers - Methods:

o Recognition of human fallibility o Recognizing human tendency to engage in risky behaviors o Focus on the system, not the individual o Just Culture provides a framework for error investigation and a fair disciplinary system

Just Culture Model (JC) - Recall: Active and Latent failures (11/14) Lecture

o Active Failure: Unsafe act by the individual Slips and lapses o Latent Failure: Fundamental vulnerabilities or conditions of the system Dormant danger

- The Just Culture model recognizes that humans will always make these types of errors. Every health system has humans that are going to make mistakes. The safest health systems Work to identify and remove latent failures

- RCA + Voluntary Reporting: Punishing individuals for making mistakes does not improve the system or make it safer. In fact, it can make the system less self-aware, allowing latent failures to continue. Thus voluntary error reporting is critical. To have an effective RCA, we must identify latent conditions to improve.

o Focusing on active failures creates tunnel vision - Shame &Blame vs JC: Rather than shame and blame the

individual with punishment, JC promotes an investigation into the Root Cause, focusing on faculty systems, processes, and conditions, reservation of judgement and blame

o Shame and Blame: Employee feels reduced satisfaction and stigmatization, root cause never identified, latent conditions for the error remain. Next time, there is reluctance to report the error

o JC: Staff are more likely to recover after a mistake, and more likely to self-report. Faulty processes and latent conditions are discovered and corrective action can be implemented

JC & Accountability: JC does not mean that individuals are not held accountable for their actions. If reckless or malicious in nature, they should be disciplined. Repeated high risk behavior required discipline It is important recognize that:

- Errors are a combination of active and latent failures - Focus should be on the individual and system accountability - Punishing human error compromises error reporting and

discovery of unsafe conditions Differentiating Errors

- Basic Human Error: Slips, lapses, mistakes. Active failures o Clicking wrong button = Slip. Using wrong method = mistake. Failing to catch an error = lapse

- At-Risk Behavior: A behavioural choice that increases the risk where risk is not recognized o Human behavior bends towards risk-taking. Incentives often drive the tendency to take risky shortcuts. o Positive reinforcement: Immediate and predictable. “I saved 2 minutes by throwing the bottle of Xanax” o Negative reinforcement: Removed, distant, unlikely. The bottle was not closed, Xanax all over the floor o Hand washing behavior, why is it not improving: Much positive, but little negative reinforcement

- Recklessness: A behavioural choice to consciously disregard a substantial and unjustifiable risk o The risk is substantial but the individual does not believe the risk is justified, so takes it on anyways. The

goals of this behavior are self-centered rather than patient-centered or organization-centered

What can we control? To err is human, we can’t fix basic human error. Neither can we fix people and their recklessness - We can control At-Risk Behavior

o (1) Remove the rewards/incentives for the risky behavior (often efficiency incentives) o (2) Create incentives for safe behavior, track performance on drug interactions and reward the wins o (3) Increase mindfulness, share examples of good catches and encourage a culture of safety

Patient Safety Organizations (PSO) - Patient Safety and Quality Improvement Act (2005): Authorized the creation of PSOs to provide a legally secure

environment to collect and analyze data on errors. Prior to this, clinicians/organizations were reluctant to report errors. PSOs incentivize error reporting by conferring guaranteed federal protection of error related-data

o Privilege and confidentiality, a “safe space” - Services provided by PSO: Collection and analyze data, provide data codes, develop error-prevention methods,

run pilot projects, lead awareness campaigns, fundraising, advocacy. Two big examples: ISMP, Leapfrog (11/28) Ferraro Lecture: Safety & the Role of Health Information Technology

The 5 ‘rights’ Right dose, drug, patient, time, route

To Err is Human: Medical errors 98,000 deaths/year, 3rd largest cause of death. The Institute of Medicine (IOM) suggests preventing death and injury from medical errors requires dramatic, system-wide changes

- Human Factors: How humans interact with products, devices, procedures, work spaces, and the environments we work and live in.

- Systems Engineering: Set of interdependent components interacting to achieve a common specific goal. “does not come naturally”

To promote a reduction of medical errors in hospitals, there are 3 general mechanisms - Professionalism: System of self-governance, members set standards shared

through: Norms, Values, Educational Activities o Tools: Standards of Practice, required education, knowing ‘err is human’

- Regulation: Gov’t establishes a set of standards by which all parties must adhere. o Tools: Accreditation Bodies (The JC), Incentive programs, meaningful use o This has been the primary driver for the Hospitals’ patient safety

initiatives, driven by the Joint Commission on Accreditation of Healthcare organizations o Regulatory review by the Centers for Medicare and Medicaid Services (CMS)

- Market: It must be a patient driven market, with a goal of patient safety. The purchasers can reward/punish hospitals by their patient-safety performance or progress

o Tools: Leapfrog, consumer engagement Common Safety Issues:

- Medication Administration: This is the most common, often due to incorrect patient, dose, overdose, omitted drug, wrong drug.

o CAUSES: Failure to follow checking procedures, written miscommunication, transcription errors, misfiled, calculation errors.

- Adverse drug events, Healthcare-association infections, Care coordination, Transition of care Safety in healthcare organizations depends on the successful execution of individual tasks, categorized into 5 stages:

(1) Order and Prescribing: Clinical Decision Support, CPOE, Medication Reconciliation (2) Administration: Bar Code Medication administration (BCMA), Smart Pumps (3) Dispensing: Automated dispensing cabinets (4) Monitoring: (5) Documentation: Falls

Tools/Updates - Clinical Decision Support Systems (CDSS): Works to enhance decision-making in the clinical workflow

o At the right time, does the alert come up for the right patient and the right provider? o Functions: alerts/reminders, documentation forms, CPOE, clinical guidelines. o ‘almost half of all medical errors are associated with incomplete knowledge about the pt or drugs’

- STEADI: Tools screen used to assess fall risk by analyzing gait, strength, balance. This fall-risk evaluation can be used to identify patient goals, intervene, and monitor outcomes

- CPOE: The biggest change within the CPOE system were order sets. Order entry+Order sets: Errors ß 83%. o Functions: Warnings and alerts about ADR, ALL, or toxic dosing. Maintains accurate current information

o Benefits: Ordered sets promotes adherence to standards of care by making the right thing the easy thing. CPOE intercepts errors at the time of ordering

- Bar Code Medication Administration: Identifies medication errors at the point of administration. Provides a valuable double check, ensuring that the 5 rights are upheld (dose, drug, patient, time, route)

- Reconciliation: Comparing the patient’s medication orders to all of prescribed meds, helps avoids errors and is of great use in transition of care [5 Steps to Know]

o Steps: (1) Develop a list of current meds, (2) Develop of list of meds to be rx, (3) Compare meds on the 2 lists, (4) make clinical decisions upon comparison, (5) Communicate that new list to caregivers/pt

- Equipment: o Smart pumps: These are drug libraries with standardized concentrations, offering point of care feedback

for suggestive high or low doses, also include medication order integration. Compare to EHR o Automated dispensing cabinets: Involves secure med storage, integration with HER, tracking

mechanisms, and proactive monitoring of drug usage patterns o Device integration: Reduction of transcription errors, focus on patient care.

Common Workaround Issues - Alert Fatigue: This is the #1 cause of errors in the EHR, it describes how busy workers become desensitized to

safety alerts. Distracting, disruptive, false-positive, interrupt workflow, low-value, poor acceptance - Non-Compliance: #1 reason for not scanning. Fuck it - Workflow, Overrides, Contributing errors (confusing screens)

(11/28) Ohler Lecture: Communicating Safely in the Healthcare Environment “Information is the currency of safe care, and communication is the vehicle by which that currency moves”

- If we cannot communicate our patient information safely and effectively, we are compromising patient care - $236 billion/year unnecessary health care expenses due to patient misunderstanding

Measuring incidence of communication-related errors by setting: ~Equally distributed among inpatient and outpatient Why do communication failures occur?

- Lack of people skills, language or comprehension barriers, information is unrecorded/incomplete, information is misdirected, information is not received/retrieved, information is ignored/misinterpreted, distractions/interruptions

Verbal Orders: When the prescriber verbally gives an order to another healthcare professional who then transcribes it - Sources of Error: (1) Miscommunication of order, (2) Misunderstanding of order, (3) Incorrect transcription - Factors for Error Risk: Interruptions, Multiple verbal orders at once, Multiple physicians at once, variations in

physician’s practices, familiarity with patient for whom verbal orders are given, multiple transcriptions o Solution? à Read back and verify

Common communication errors [Provider-to-Patient] - Instructions written higher than a 5th grade

level. (Use size 12 font btw) - Unnecessary use of medical jargon - Referring patients to the internet for more info - Using abstract examples to explain concepts

- Taking understanding for granted - Being culturally unaware and insensitivity

(Speak in patients 1st language) - Not allowing time for questions - Not explaining the meaning of Rx labels

Processes to Prevent Miscommunication Errors - Closed-Loop Communication: Seen to the right - SBAR: Tool for communicating changes in a patient’s status

o S: Situation What’s happening now, CC? o B: Background What led up to this event? Factors hx o A: Assessment What do you think happened, severity? o R: Recommendation What action do you propose

- I-PASS: Communication for patient transitions o I: Illness severity o P: Patient Summary o A: Action List o S: Situation awareness & contingency planning o S: Synthesis by receiver

- ISHAPED: Communication tool for patient transfers – The ‘handoff’ tool o Introduction, Story, History, Assessment, Plan, Error Prevention, Dialogue

- Teach-Back: This method has shown to improve patient-comprehension & information retention. The best example is the inhaler technique, showing a patient, and having them show you back.

- Medication labeling: Such as units and those errors. Teaspoon versus mL - Medication Reconciliation: Should occur at every transition point within the healthcare system

o Components: Obtain a complete medication list, assess compliance, assess side effects, discuss the patient’s understanding of the medication

MyICU: A mini patient portal, made accessible by tablets in patient’s rooms. Used to inform patients of their upcoming schedule, and the patient can post questions to the medical team. (12/1) Larson Lecture: Medication Errors… outside of UI Health External Sources for Medication Errors and Safety Issue Support

- US FDA: Go to their website to report serious adverse effects. Sign up for their listserv, via MedWatch. Stay informed! Report stuff! Get updated. For example, FDA alerts healthcare professionals about ongoing trials or recent discoveries on adverse effects associated with certain medications

- Manufacturers and Wholesalers: Recall. Make sure to follow-up - Institute of Safe Medication Practices (ISMP): Newsletters, they send out like 5 of ‘em

o Safe Practice Recommendations: Quarterly Action Agendas § Identify the problem § Provide a recommendation § Perform an organization assessment § What response do we need? Action required/assignment

- ListServs: An application that distributes messages to subscribers on an electronic mailing list – generally used to determine various practices elsewhere. Asking other hospitals and companies how to do stuff, and identify problems

Questions and Steps involved with evaluating externally reported safety issues - Could the same situation happen here - Where could this drug/process be problematic

Problems with Morphine – Potential Safety Issues - Run outta the 4mg syrings – Drug-shortage. People use 2x 2mg syringes, naaaahhhh bad idea - Communication Issues about the shortage from the Pharmacy

Problems with Vincristine - Intrathecal administration is uniformly fatal. Stop dispensing it as a syringe, give it as a minibag. - Why is it bad? Vincristine is a vesicant, that shit will fuck you. Leakage into the surrounding tissues during

infusion may cause serious harm. Take Home Points:

- Review externally reported problems – this is a treasure trove of information to prevent issues and improve - Critically review systems to identify organizational risk - Review/Consider recommended safety strategies - Learn from other people’s mistakes - Root cause analysis is helpful in evaluating internal errors after they happen - To be proactive – we can use the FMEA: Failure Modes and Effect Analysis

Process Improvement Process - PDSA: Plan Do Study Act:

o P: Address the issues and engage the stakeholders to ensure their concerns are included to:

§ (1) enhance effectiveness § (2) get buy-in to proposed systems solutions.

o D: Implement system solutions where warranted along with providing education

o S: Monitor – THIS IS CRITICAL, otherwise you may introduce more errors, verify shit goes as planned.

o A: Ensure compliance and modify the process when needed.

(12/5) Panel Discussion Notes

- Many patients want to get better on their own and be independent – walking around. But this poses a fall-risk. Maintain safety by communicating using a safety huddle and establishing an understanding with the pt and other practitioners.

- Always question orders, find the validity How can we make alerts more effective?

- Make them hard stops with major clinically relevant drug interactions - Alert from nurses with duplication orders - RN Review of sitting orders, make sure written order are followed through on. - Forced Functionality to eliminate major sources of error

Incorporation of double checks - Patient identifiers x2, Comp scan, blood transfusion with 2 signatures, check patient band (BCMA)

(12/8) Larson Lecture: Patient Safety Regulations Word bank

- Accreditation: Determination that an eligible organization complies with applicable requirements (standards) - Standard: Principle of patient safety and quality of care that a well-run organization meets - Survey: A key component in the accreditation process whereby a surveyor conducts an on-site evaluation of an

organization’s compliance with accreditation requirements - Best Practices: Clinical, scientific, or professional practices that are recognized by a majority of professionals in

a particular field as being exemplary. These practices typically (1) evidence-based and (2) consensus-driven - Deemed Status: Status conferred by the CMS on an organization whose standards and survey process are

determined to be the equivalent to those of the medicare program or other federal laws Illinois Department of Public Health (IDPH)

- Set Requirements o In order to receive medicare/Medicaid payments: Hospitals are required to be in compliance with the

federal requirements set forth in the Medicare Conditions of Participation (CoP) o Certification: Observations, interviews, and document/record reviews determine hospital compliance with

the CoP - Survey Process: focuses on a hospital’s performance of patient-focused and organizational functions and

processes. The survey is a means to assess compliance with standards and to ensure that the beneficiary receives safe quality care and services.

Accreditation: Method for ensuring an organization achieves and maintains high-quality patient care - PRIMARY CONCERN of all accrediting agencies: Patient Safety - Process: Participation is voluntary. The agency will present current and updated standards/practices that reflect

national concerns. - Benefits: The accreditation process helps raise the levels of safety, quality, and value of care provided by an org

o Provides a competitive edge in the market place o May reduce liability insurance costs o Insurers and other 3rd parties may require it is a prerequisite for reimbursement o Provides deemed status for Medicare certification without undergoing a separate gov’t quality inspection

- Accrediting Agencies o The Joint Commission (TJC): UIC and most area hospitals are accredited by the TJC o Healthcare Facilities Accreditation Program (HFAP) o National Integrated Accreditation for Healthcare Organizations (NIAHO)

The Joint Commission (TJC) - Accreditation process: TJC specifically requires compliance with (1) Standards, (2) National Patient Safety Goals

o Frequency: Unannounced triennial surveys. The length of which depends on the size of the organization - (1) Standards and Elements of Performance (EPs) 18 chapters, 268 total standards and NPSGs

o Standard: Defines the performance expectations, structures, or processes that must be substantially in place in an organization to enhance the quality of care, treatment, or services

§ Ex: Medication orders are clear and accurate o Element of Performance (EPs): How those standards are met

§ Ex: The hospital minimizes the use of verbal and telephone medication orders

- (2) National Patient Safety Goals (NPSG): Developed and updated by the Patient Safety Advisory Group, this group includes: Physicians, Pharmacists, Nurses, Risk Managers, Clinical Engineers, and others.

o Purpose: Help accredited organizations address specific areas of concern in regards to patient safety - 2017 NPSG

o (1) Improve the accuracy of patient identification § Intent: Reliably identify the individual and match the service or tx to that individual § Meant to eliminate administration of incorrect blood

o (2) Improve the effectiveness of communication among caregivers § EP: Report critical results of tests and diagnostic procedures on a timely basis

o (3) Improve the safety of using medications § EP: Label all medications, medication containers, and other solutions on and off the sterile field. § EP: Reduce the likelihood of pt harm on anti-coagulant therapies § EP: Medication reconciliation

o (6) Reduce the harm associated with clinical alarm systems o (7) Reduce the risk of health care-associated infections

§ Implement evidence-based practices to prevent health care-associated infections due to multidrug-resistant organisms in acute care hospitals

§ EP: Implement a laboratory-based alert system that identifies new pt with multidrug-resistant organisms.

§ EP: Comply with either CDC hand hygiene guidelines or WHO hand hygiene guidelines § Other EP: CLABSI, SSI, CAUTI

o (9) Reduce the risk of patient harm resulting from falls § EP: Reduce the risk of falls

o (15) Organization identifies safety risks inherent in its patient population § EP: Identify patients at risk of suicide. § FYI: Suicide of a patient while in a staffed-round-the-clock care setting is a frequently reported

sentinel event. Universal Protocol (UP) for preventing wrong site, wrong procedure, wrong person surgery

- Conduct a preprocedure verification process - Mark the procedure site - Time-out performed before the surgery

Medication Management (MM) Standards: - Recently a NPSG goal, Look-alike/Sound-alike medication requirements was changed to be a MM standard - EP: Hospital develops a list of look-alike/sound-alike medications it stores, dispenses, or administers. If the

organization needs help doing this, they can consult the ISMP

Safety and Compliance is everyone’s responsibility Look, NPSG has their goals, but has also identified the UP and MM UIC Safety Goal Teams

- Evaluate best practices - Advise on policies, procedures, and educational materials that guide staff - Analyze data sources to validate process - Report compliance data to the Safety Committee including any barriers - Make recommendations for improvement