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Gail M. Horvath MSN, RN, CNOR, CRCSTPatient Safety Analyst/Consultant IVECRI Institute PSO

Safe Ambulatory Care Strategies for Patient Care and Risk Reduction – In Between the Lines

©2020 ECRI Patient Safety Organization | 2ECRI Patient Safety Organization Confidential

Learning ObjectivesParticipants will be able to:

— Become familiar with the most common and pervasive risks in the ambulatory care setting, as identified in the 2019 ECRI Institute PSO Deep Dive.

— Identify the major risks associated with diagnostic testing, particularly Health IT-related issues, and learn strategies for mitigation.

— Identify situations that can lead to medication-safety-related events, particularly as related to vaccines, and recognize strategies for mitigation.

— Identify fall risk reduction strategies in the outpatient setting, including the implementation of fall risk assessments.

— Identify strategies to address security and safety issues in ambulatory care, particularly with reference to implementing safeguards for the prevention of harm.

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©2020 ECRI Patient Safety Organization | 3ECRI Patient Safety Organization Confidential

Why This Topic for the 2019 Deep Dive?

— The ambulatory care setting represents the largest and most widely used segment of the healthcare system.

— Despite this, most studies around patient safety have focused on the inpatient setting, making it harder to identify risks and mitigation strategies specific to outpatient settings.

— Many of the recommendations for the hospital setting may not carry over to ambulatory care for various reasons, including:• Fewer or still developing utilization of system resources dedicated to safety, quality, and risk

compared to hospitals

• Divergent processes, procedures, and workflows across settings

• Less formal training and experience in safety and quality improvement methods among clinical staff

• Need for a cultural shift toward improving safety reporting and monitoring

©2020 ECRI Patient Safety Organization | 4ECRI Patient Safety Organization Confidential

2019 ECRI Institute PSO Deep Dive Findings

4,300 EVENTS

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2019 ECRI Institute PSO Deep Dive Findings

SECURITY/SAFETY

Safeguards for the preventionof harm

in diverse settings

FALLSAssessments

for prevention

DIAGNOSTICTESTING

Health IT issues and strategies

MEDICATIONVaccines

Diagnostic Testing – Health IT

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Diagnostic Testing Errors

Diagnostic errors are a major source of liability claims: An analysis of more than 10.5k closed medical professional liability claims found that diagnosis-related errors

accounted for approximately 33% of claims and 47% of indemnity payments.

Data suggest that diagnostic testing errors are especially

prevalent in ambulatory care. 40% of primary care patient visits require a medical test

(AHRQ estimate).

40% 33%

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Diagnostic Testing Errors

Of events reported in the 2019 ECRI Institute PSO Deep Dive, most (66%) occurred during the preanalytic stage.

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Diagnostic Testing

A patient was seen for a urinary tract infection, and an antibiotic was prescribed while culture results were awaited. The culture showed Escherichia coli, which is resistant to the antibiotic the patient was taking; the prescribing physician ordered the current antibiotic to be discontinued, and an order for a new antibiotic was sent to the pharmacy. Because the patient had an account on the practice’s portal, the office sent her a message through the portal informing her of the result and providing new instructions. However, the patient did not know how to access her portal and therefore did not receive the message, and continued taking the first antibiotic. The office later received a message from the emergency department stating that the patient had been admitted for sepsis resulting from pyelonephritis.

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Diagnostic Testing – 3 Recommendation for Using Health ITto Close the Loop on Diagnostic Tests

Ensure that health information technologies (IT) support patients and healthcare professionals in the diagnostic process.

— Develop and apply IT solutions to communicate the right information (including data needed for interpretation), to the right people, at the right time, in the right format.

— Implement health IT solutions to track key areas.

— Use health IT to link and acknowledge the review of information and documentation of the action taken.

Adopt the strategies for using health IT safe practices for communicating, tracking, and linking diagnostic results as outlined by the Partnership for Health IT Patient Safety's Closing the Loopguidance.

http://hitsafety.org

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Diagnostic Testing – Health IT Safe Practices for ImprovingCommunication of Diagnostic Results— Provide decision support tools to help providers order the proper tests

— Improve the transmission of information using universally recognizable display icons in the EHR for alerts and notifications

— Use available guidance, such as the Office of the National Coordinator for Health Information Technology's (ONC) SAFER guides (Safety Assurance Factors for EHR Resilience) for Test Results Reporting and Follow-Up and Clinician Communication to help identify best practices associated with EHRs and to incorporate those best practices into the organization's policies

— Optimize alerts by limiting automated alerts to those that are clinically relevant, in order to avoid alert fatigue

— Enhance the usability of communication of diagnostic results

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Diagnostic Testing – Health IT Safe Practices for Tracking DiaResults

—Automate the notification process using existing EHR functionality

—Set up electronic tracking and monitoring systems that clearly identify the ordering provider; include hard stops to ensure the provider takes appropriate action; and assign responsibility for oversight and monitoring the system

—Anticipate and address potential gaps in electronic tracking systems, including the following: • Determine how information from external labs or testing centers will be transferred or

entered into the system • Establish written back-up procedures to implement during technical malfunctions or

disruptions

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Diagnostic Testing – Health IT Safe Practices For Linking and Acknowledging Diagnostic Results

—Ensure that the actions taken related to test ordering, tracking, and follow-up are documented

—Optimize technology to link and store an acknowledgement and to record the actions taken

—Develop policies for patient notification and the use of patient portals

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Medication Safety Events -Vaccines

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Medication Safety Events

— Medication safety events are some of the most common adverse events in healthcare and are a leading cause of malpractice claims in ambulatory care.

— Such events can occur during any stage of the medication process, and are rarely the fault of one person; rather, as with most adverse events, they result from a series of failures within a system.

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The Medication Management Process

— The medication management process is complex, encompassing several nodes:

In its 2019 Deep Dive, ECRI Institute PSO found that most of the reported adverse events occurred during the administration node (40%),

followed by the dispensing node (25%) and the prescribing node (23%).

Administration node40%

Dispensing node25%

Prescribing node23%

• Storage• Transcribing

• Prescribing• Dispensing

• Administration• Monitoring

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Medication Safety EventsMEDICATION SAFETY EVENTS SUBMITTED 12/1/2017 - 11/30/2018

Percentages may not add up to 100 due to rounding

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Special Areas of Concern

In the ambulatory care setting, two categories of medication are of particular concern:

— Vaccines

— High-alert medications

• Antiretroviral agents • Chemotherapeutic agents, oral• Hypoglycemic agents, oral• Immunosuppressant agents • Insulin

• Opioids• Pediatric liquid medications

that require measurement• Pregnancy category X drugs

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©2020 ECRI Patient Safety Organization | 19ECRI Patient Safety Organization Confidential

Medication Safety Events - VaccinesAccording to ISMP, contributing factors in vaccine events include the following:

— Confusion about age-dependent formulations of a vaccine

— Unfamiliarity with a vaccine (e.g., dose, dosing schedule, age-specific indications, preparation/reconstitution, route or site of administration)

— Failure to check a patient's age or immunization history

— Similar vaccine names and packaging leading to mix-ups

— Unsafe storage conditions (e.g., vaccines with similar names or packaging stored near each other, fluctuations in refrigerator temperatures during vaccine storage)

— Failure to check expiration dates

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Medication Safety EventsVaccines - Recommendations— Establish a process for vaccinations that covers everything from storage to

administration and that incorporates best practices, standards, and guidelines, such as those included in the Centers for Disease Control and Prevention's (CDC) Vaccine Storage and Handling Toolkit and its Immunization Schedules.

— Consider designating a primary vaccine coordinator and at least one alternate coordinator to be in charge of vaccine storage and handling at the organization.

— Provide standard order sets in electronic and paper formats listing pertinent information for vaccines (e.g., vaccine name, age-specific formulations, dose, frequency, route of administration, indications, and contraindications).

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Medication Safety Events Vaccines – RecommendationsThe Rights of Vaccine Administration:

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Medication Safety Events Vaccines - Recommendations

—Provide education to staff on how to hold open discussions with patients and parents of pediatric patients who may have concerns about a vaccine's side effects and possible serious adverse effects, vaccine ingredients, and vaccination schedules.

— If a patient or the parent of a patient still refuses to vaccinate after an open discussion, instruct staff to request that they sign a refusal-to-vaccinate form and to keep the form in the patient's medical record.

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©2020 ECRI Patient Safety Organization | 23ECRI Patient Safety Organization Confidential

Medication Safety EventsVaccines – RecommendationsThe 5S project—standing for "Sort, Set in order, Shine, Standardize, and Sustain"— All refrigerators were reorganized to contain bins with clear labels, and all vaccines must be

stored in their proper bins.

— Icons are placed on look-alike/sound-alike vaccines, and such vaccines are stored on different shelves.

— Pediatric vaccines are stored on the lower shelves, while adult vaccines are stored on the upper shelves.

— Vaccines with two vials that must be mixed prior to administration are banded together to make it clear that they are a set.

— Vaccine labels and vaccine information sheets are color-coded to match.

— A Kanban card system—a Lean tool designed to streamline the production process—can be implemented to cue workers to notify the pharmacy when vaccine stocks are running low.

®2019 ECRI Institute | www.ecri.org | 24ECRI Institute Confidential

Fall Events

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Fall Events

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Falls

— Each year in the United States, more than one in four older adults experiences a fall, and one in five of those who fall will suffer a serious injury. Approximately 800,000 patients will be hospitalized each year with a fall-related injury, usually a head injury or a fractured hip.

— The cost of falls in 2015 was estimated at more than $50 billion.

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©2020 ECRI Patient Safety Organization | 27ECRI Patient Safety Organization Confidential

Falls

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Falls

— The patient was in a seated position during a discussion about a procedure. He felt lightheaded and asked for a minute before lying down. Within seconds the patient fainted, falling forward onto the floor and hitting his head. He was unconscious for approximately 20 seconds.

— A new patient left the exam room to use the bathroom. The staff heard a loud noise when the patient fell. Upon examination, the physician diagnosed the patient as dehydrated and as suffering from syncope resulting from the medical reason for his visit.

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Falls in the Ambulatory Care Setting— Activities that may increase the risk of falls include:

• Ambulating

• Assistance (or lack of assistance) in the restroom

• Moving or transferring a patient:◦ On or off a scale

◦ On or off an exam table

◦ In or out of an exam chair

◦ To or from standing to seated

◦ In or out of a vehicle

• Positioning on an exam table

• Assistance (or lack of assistance) with dressing

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Falls – Assessment for Prevention - Recommendations

Identify Fall Risk— Unlike acute or long-term care settings, the ambulatory care setting has not

emphasized falls risk assessment for all patients because patients may not be seen frequently (e.g., only during their annual exam).

— Visits are often short, and the patient may present at each visit with differing complaints (e.g., cold or flu symptoms).

— However, identifying and reducing fall risk is an important component of every patient visit.

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Falls – Assessment for Prevention - Recommendations

Identify Fall Risk— Fall reduction strategies include:

• patient screening and assessment

• staff attention to potential side effects of treatments

• environmental hazard surveillance

— Develop, implement, and routinely update all policies and protocols related to the fall prevention program, including screening questions (e.g., CDC's STEADI initiative[Stopping Elderly Accidents, Deaths & Injuries]) and high-risk fall assessment (e.g., CDC's Algorithm for Fall Risk Screening, Assessment, and Intervention).

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Falls – Assessment for Prevention - Recommendations

— Screen all patients for fall risk at each contact

— Conduct fall risk assessment for high-risk patients

— Ensure that a "flag" appears in the EHR to alert staff of high fall risk

— Educate patient about fall risks and provide written materials for later review, if appropriate (have materials available in different languages)

— Ensure the patient understands his or her role in preventing falls

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Falls – Assessment for Prevention - Recommendations

— Ask patients if they need assistance with ambulation

— Provide wheelchair or staff assistance for ambulation as needed

— Offer assistance to patient getting on and off a scale—encourage use of handrails

— Offer assistance with toileting and changing clothes

— Encourage patient to notify staff if feeling weak or unsteady

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Falls – Assessment for Prevention - Recommendations

— Develop a fall prevention plan of care for high-fall-risk patients:• Recommend vitamin D and calcium

• Recommend nonskid footwear

• Evaluate use of medication that carries inherent fall risk—ensure EHR flags medication as fall risk

• Order rehabilitation therapy

• Order assistive devices (e.g., walker, wheelchair)

• Arrange podiatry consultations to address foot-related issues

• Arrange ophthalmology consultation to address vision issues

• Monitor for effectiveness of fall prevention strategies

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©2020 ECRI Patient Safety Organization | 35ECRI Patient Safety Organization Confidential

Falls – Assessment for Prevention - Recommendations

— Develop, implement, and routinely update all policies and protocols related to the fall prevention program, including screening questions (e.g., CDC's STEADI initiative[Stopping Elderly Accidents, Deaths & Injuries]) and high-risk fall assessment (e.g., CDC's Algorithm for Fall Risk Screening, Assessment, and Intervention).

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Security & Safety Events –Safeguards for the Prevention of Harm

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©2020 ECRI Patient Safety Organization | 37ECRI Patient Safety Organization Confidential

Security and Safety Issues

—The vast majority of security and safety events reported to ECRI Institute PSO involved verbal threats or disruptive behavior by patients or visitors, including family members.

— If a behavior escalated from threatening (e.g., yelling, harassing) to committing physical violence (e.g., hitting, kicking, pushing, throwing objects), then it was categorized as violent behavior. Only 5 events (3%) escalated to physical violence by patients.

“Based my experience in the emergency room and in law enforcement and EMS, I believe this number is grossly under reported.”

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Security and Safety Events

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Human and Environmental Factors That May Foster Disruptive Behavior

— Stressful conditions for patients or family members (e.g., long wait times, crowding, receiving bad news)

— Lack of training and policies to help staff to recognize and de-escalate hostile behaviors

— Staff working in isolation or in stand-alone settings, including opening and closing the office

— Unrestricted public access— Inadequate or no security staffThe 2018 edition of The Facility Guidelines Institute (FGI) which many states have adopted now require a security risk assessment for all new construction. TJC requires access control between the waiting room and the PACU.

― Perception that disruptive behavior or violence is tolerated (“part of the job”)

― Poor environmental designs that may block vision or escape routes

― Open floor plans that include no barriers (e.g., glass, locked door) between waiting room and treatment areas

― Poor lighting in corridors, rooms, parking lots, and other areas

― Lack of a means of emergency communication

― Access to firearms in open-carry or concealed-carry jurisdictions

― Staff leaving late at night and parking furthest away from the building.

©2020 ECRI Patient Safety Organization | 40ECRI Patient Safety Organization Confidential

Disruptive Behavior/Workplace Violence

— The agitated spouse of a patient ignored staff instructions to stay in the waiting room. He instead went searching for his wife, opening several exam room doors where other patients were being treated. Ultimately, he was redirected to the correct exam room.

— A patient was frustrated with information that had been sent to a specialist. The patient demanded to see a copy of paperwork to confirm it had the correct contact information. While staff gathered the requested paperwork, the patient became very anxious, repeatedly berating the staff for not meeting his needs quickly enough. He eventually stormed out of the office.

— A 19 y/o male who had just smoked a moon flower plant arrived at a freestanding emergency room and took off his clothes. He jumped the registration desk and pulled out a knife with an 8- inch blade.

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Security/Safety Events Disruptive Behavior ConsequencesStaff, providers, employees— Fear

— Physical and emotional trauma

— Time away from work

— Burnout

— Job dissatisfaction

— Decreased productivity.

Organizations— Liability risk

— Costs associated with hiring temporary staff and with supporting affected staff

— Potential staff turnover if safety concerns are not directly addressed

— Reputational damage

©2020 ECRI Patient Safety Organization | 42ECRI Patient Safety Organization Confidential

Security/Safety Events – Safeguard Recommendations —Establish a comprehensive workplace violence prevention program.

—Conduct an all-hazards risk assessment to evaluate the potential for violence at least annually, incorporating patient-related risk factors, environmental risks, and operational risks.

—Employ interventions that are designed to minimize stress for patients and visitors.• Evaluate workflow and staffing during peak times to decrease wait times. • Inform patients and their families about estimated wait times; update the information

as needed.• Empathy for the persons situation. • Provide distractions to long waits (internet, TV, music, reading material).

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Security/Safety Events – Safeguard Recommendations

—Ensure that all staff are trained in de-escalation techniques.

—Encourage all employees and other staff to report incidents of violence or perceived threats of violence.

—Ensure appropriate follow-up to workplace-violence-related events, including reporting, post-incident support, and investigation. Develop and communicate codes of conduct for employees and patients.

—Report issues that might spill over into the workplace including threats, family issues, and criminal activity around the outpatient center.

©2020 ECRI Patient Safety Organization | 44ECRI Patient Safety Organization Confidential

Security/Safety Events – Safeguard Recommendations

Outpatient facilities vary in location and design. Some are part of large hospital systems that have their own armed security, while others operate in leased buildings owned by others. Most outpatient facilities are freestanding. Security measures vary widely. Jeff Lehmann describes a recurring theme of minimal actions taken "to harden, fortify and train facilities and the staff within them.“

—Ask local police to drive through the parking lot, stop in for coffee, and maintain a presence at the outpatient facility.

—Hire an armed security company.

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©2020 ECRI Patient Safety Organization | 45ECRI Patient Safety Organization Confidential

Security/Safety Events – Safeguard Recommendations

—Consider structural and door enhancements

—Make parking areas safer

—Establish a process to follow when an event occurs

—Provide staff training

— Install a surveillance system• Monitor the surveillance from workstations and not just in an IT closet

—Practical scenarios

—Establish safe rooms

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Questions?

Thank You

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