Quality Patient Safety Checklist: Keys to Successful ... · Patient Safety Checklist: Keys to Successful Implementation ... Effectively use RCA and FMEA processes ... the medication

46 JULY • AUGUST 2006 THE PHYSICIANEXECUTIVE

• Identifying quality improvement

• Calculating the resources required

• Generating a business case with an adequate ROI

Two components central to the implementation ofpatient safety programs are communication and culture.Key implementation techniques recommended by experi-enced change management leaders include:

Initial culture and communication assessment survey

It is important for each organization to complete aself-assessment of its patient safety culture and communi-cation strengths and weaknesses prior to implementationof programmatic changes. This self-assessment serves as abaseline measure and a mechanism to raise awareness.

Some organizations attempt to generalize dataobtained from others as a shortcut. As physicians we areaware of the risks attendant with “treating the most likelycauses” rather than establishing an accurate diagnosis andinitiating effective therapy.

Most organizations discover that identification ofissues specific to their situation is well worth the effort ofadministering a survey tool. The U.S. Dept. of Health andHuman Services Agency for Healthcare Research andQuality (AHRQ) provides a standardized hospital surveyon patient safety culture on it’s website(http://www.ahrq.gov/qual/hospculture/).

Areas of query include: assessment of whetherreporting incidents/errors results in punitive actions orpositive changes, whether workload and staffing levels

No doubt exists regarding the importance ofdeveloping patient safety programs in all clinicalcare settings. The size, complexity, and multipleinteractions among the components of health caredelivery systems cause implementation of these programs to be a difficult and daunting task.

When thinking about a safety program, there are 11key concepts to keep in mind:

• Key implementation components

• Communication

• Culture

• Key tips for medication safety

• Medication system steps

• Methods to create favorable conditions for change

• Key techniques to measure the medication process

• Medical errors and prevention

• Process

• Knowledge

• Electronic medical records

When implementing a patient safety program it ishelpful to remember that all of the rules around changemanagement must be deployed. These include dividingthe process into incremental steps, seeking buy-in fromthe staff, marketing the improvements the change willproduce, speaking to existing best practices and toutingthe competitive advantages in the marketplace.

Specific successful approaches to implementing apatient safety program include:

• Demonstrating error reductions

• Forecasting risk reduction

Patient Safety Checklist: Keys to SuccessfulImplementationBy Philip Fracica, MD, Mohamed Lafeer, MD, FAAP, CPE,Marie Minnich, MD, MMM, MBA, CPE, and Raymond Fabius, MD, CPE, FACPE During the 2005 ACPE Fall Institute, a group of

physician executives gathered to discuss key lessonslearned while implementing patient safety programsand agreed to record, summarize and expand on thistopic so that others could benefit from this meeting.

Quality

IN THIS ARTICLE…

THE PHYSICIANEXECUTIVE JULY • AUGUST 2006 47

are appropriately matched, perception of managerialemphasis on safety or working faster, and assessment ofchannels of communication.

Conduct periodic culture and communication reassessment surveys

These measurements serve as information gatheringmechanisms, as well as reinforcement of necessary cul-ture and communications techniques. It is important towork early and often on building a culture focused onpatient safety, emphasizing everyone’s role in patientsafety efforts. These cultural changes should be support-ed by both top down and bottom up approaches.

Build buy-in

These efforts need to be inclusive of all health careproviders and support personnel. Early efforts should beaimed at influencing opinion leaders to facilitate develop-ment of a patient safety culture. Using external driverssuch as the Institute for Healthcare Improvement, theNational Quality Forum, and the Joint Commission onAccreditation of Healthcare Organizations, among others,can help develop buy-in.

Develop robust reporting tools

Encourage reporting of near misses and use these aslearning tools to improve patient care processes. Whetherreporting tools are paper-based or Web-based, ease ofcompletion and clarity are important. In many cases, reli-able and easy-to-use systems can be acquired “off theshelf” rather than investing in self-developed tools.

Reports should be equally easy to produce so thatpersonnel close to the work unit can easily access thedata. The easier to use, the more likely the system is tobe successful.

Develop educational tools

These may include live training exercises, videotapedor CD lectures, case discussions, etc.

Effectively use RCA and FMEA processes

A root cause analysis (RCA) is performed followingthe occurrence of a significant incident or near miss. TheRCA should be performed by a multidisciplinary teamwith membership appropriate to the incident. This teamfocuses on the various causes or potential causes of theincident with emphasis on a systems approach ratherthan people approach.

The failure mode and effects analysis (FMEA) utilizesan analogous process by selecting a process that couldresult in an incident, i.e., a proactive approach. Theseprocesses help direct attention to the importance ofpotential errors and prioritization of change efforts.

Develop robust feedback mechanisms

This allows for continual culture development andassessment. These mechanisms include alternatives rang-ing from written and graphic reports, newsletters, person-al stories, frequent senior leader safety walk-arounds, andother types of communication.

Foster the development of a system focused, non-puni-tive safety culture

In most cases health care professionals involved inerrors are sincerely making their best efforts to provideexcellent care. Rather than identifying the individual asthe fault, we should make a concerted effort to identifyin what ways the system allowed the error to occur.

To focus on people as the problem does a disserviceto dedicated staff who can be set up to fail by a poorlydesigned system and to our patients who remain exposedto an unsafe system that is never addressed when wejump to blame staff for problems.

A non-punitive environment encourages staff toreport errors and near misses. The system focus allowsan organization to use the reports to redesign processesfor higher reliability. This is a marked contrast to a cul-ture of blame and shame where staff live in fear of punishment for mistakes that they must hide.


Reinforce safe behaviors, refuse to tolerate unsafebehaviors

Reinforcing the importance of safety policies by rec-ognizing people and teams that consistently demonstratesafe care supports the transition to a safety culture.Likewise, clear and consistent non-tolerance for behaviorsthat breach patient safety policies is critical.

This non-tolerant approach can coexist with a non-punitive safety environment. Some organizations haveimplemented self-reporting “safe-harbor” polices that pro-vide staff with protection from disciplinary action whenthey self report an error.

Develop effective communication techniques

Emphasis on the interactions between various mem-bers of the care team enhances patient safety efforts.

Once culture and the communication of the need forchange has been addressed, the next step is to look atspecific areas where safety programs can be deployed.

Medication safety

The medication system is one of the main areas offocus for any comprehensive patient safety program.Functional integration of the inpatient medication systemand the outpatient medication system is increasinglybeing recognized as a critical requirement for effectiveimprovements in patient safety.

The less structurally integrated ambulatory and inpa-tient care processes are, the more important it is to takesteps to provide some measure of functional integration.While ambulatory medication system safety is clearlyimportant, much of the existing literature on medicationsystem safety focuses on the inpatient process.

The medication system can be considered to consistof several steps:

Ordering—Was the right drug and dose prescribed? Thisprocess can be improved by:

• Obtaining a reliable drug therapy history that can bereconciled with current medications

• Checking that there is not a conflict between prescribed drugs and recorded allergies

• Using decision support tools at the clinical unit levelto assist the physician in selecting the appropriatedrug and dosage.

Transcribing—Was the order correctly transmitted to thepharmacy? Transcribing can be improved by:

• Avoiding the use of high-risk abbreviations. Institutionscan educate staff about unsafe abbreviations. Some facil-ities place stickers on the charts or post signs in physi-cian work areas reminding staff of the unsafe abbrevia-tions. One effective strategy is to place a laminated cardlisting unsafe abbreviations as a chart divider at the frontof the physician order section of the chart.

• Establishing standards for order legibility. It is appropriate for the pharmacy to refuse to dispensemedication for orders with significant unaddressedsafety concerns such as illegibility.

• Avoiding verbal orders whenever possible and use ofread-back verification processes if verbal orders cannotbe avoided.

• Using high resolution scanning technology to transmitphysician orders to the pharmacy.

• Installing computerized physician order entry. CPOE isa very promising innovation that is capable of provid-ing real-time decision support input to the physicianabout drug selection and dosing, as the order is beingwritten. CPOE promises to eliminate problems of legi-bility and miscommunication. A major challenge ofCPOE system implementation is fine tuning the deci-sion support component to provide useful physicianprompts and suggestions without becoming intrusiveand disrupting the workflow.

Dispensing—Did the pharmacy provide the right medica-tion to the right clinical unit?

The reliability of the dispensing step can beimproved by the use of automated drug dispensing tech-nology. This is an exciting development and is likely tobe much more successful than interventions that rely onincreased human vigilance such as double-checking med-ication carts.

Other useful safeguard strategies include routinepharmacy review of certain drugs, access control withspecial labeling and dispensing precautions, use of stan-dardized protocols for ordering, dosing and administra-tion which include standardized solution concentrationsand preprinted protocol order sheets.

For drugs with narrow therapeutic windows, stan-dardized mandatory drug level (or therapeutic endpoint)testing with pharmacy review of the results is an effectivesafety measure.


Another focus should be on medication reconcilia-tion. Transitions of care and patient hand-offs from onecare environment to another can be a source of preventa-ble adverse medication events. Important medicationsmay be inadvertently discontinued, or patients mayreceive dangerous duplicate doses of medications.

For inpatients, the medication reconciliation processshould include a process to obtain a “reasonable besteffort” documentation of outpatient drug therapy that isprovided to the physician and the pharmacy compareswith the patient’s admission orders. Potential discrepan-cies are identified and resolved by communication withthe physician.

Upon transfer from one level of care to another,there should be a process to reduce the chances for drugomissions or duplication. And finally, pharmacy profes-sionals should be involved in a review of discharge med-ications, which includes pre-admission outpatient therapyand inpatient medication.

Administration—Did the nursing staff correctly adminis-ter and document the medication?

This is typically one of the most problematic areas.For all of the other steps, there are opportunities forother professionals to provide a safety net for errors.

For example, the pharmacist can identify a dosingerror in a physician’s order or clarify an illegible orderand a nurse can identify that the wrong drug was dis-pensed, but there are limited safeguards for administra-tion errors. Strategies that can help improve the reliabilityof the administration step include:

• Better monitoring of the accuracy of the processthrough correlation of automated dispensing unit activ-ity logs with medication administration records andintermittent direct observation of medication adminis-tration by trained observers.

• Involving patients and families in the process. Patientsshould be told what medications they are beingadministered and encouraged to ask questions if theyare being given an unfamiliar medication.

• Double-checking processes for the administration ofhigh-risk medications. This can be effective if usedvery selectively but is a poor substitute for automatedmethods.

• Using bedside scanning technology to allow real-timeverification of proper administration and automateddocumentation. This technology is not widely availablebut holds great promise to revolutionize the reliabilityand safety of drug administration.

It will be hard to achieve meaningful change if themedical staff is not convinced that change regardingmedication safety is necessary or desirable. Experiencedhealth care leaders believe that these are effective methods to create favorable conditions for change:

• Use examples of system failures. Examples of situa-tions in which the medication system failed should dis-turb all health care professionals and motivate them toprevent future similar harm to patients. This can beachieved by use of confidentiality protected real-lifeexamples. Video dramatization of how failures occurcan be particularly effective. The Partnership forPatient Safety® (p4ps.org) produces the “First Do NoHarm” videos. The Institute for Health SystemImprovement (IHI.org) provides a video of the pro-duction “Charlie Victor Romeo” which is a dramatiza-tion of a series of aircraft disasters. These dramatiza-tions are effective because they engage the audiencein a story that shows exactly how systems fail.

• Use examples of poor medication order writing.Examples of near misses can also be effective. Illegibleorder writing by physicians can be a frequent con-tributing factor to medication error. While the use ofCPOE systems may resolve this problem, until suchsystems are in use, presenting examples of illegibleorders can help raise staff awareness of this problem.

• Make the malpractice case. Malpractice premiums area ubiquitous concern for physicians. Input from mal-practice insurance carriers that effective medicationsystem safety initiatives can help curb malpractice ratesand protect physicians can be a very effective mes-sage. Establishing system-focused programs to improvesystems and prevent future liability has been called“proactive risk management.” Colorado PhysiciansInsurance Company (COPIC) is a physician-sponsoredmalpractice insurer that provides coverage for 75 per-cent of Colorado physicians. COPIC’s proactive riskmanagement approach includes near-miss reporting,

Pharmacy professionals should be involvedin a review of discharge medications


risk assessment surveys of practice patterns and a mal-practice price structure tied to safety survey scores,corrective action and participation in risk reductionprograms. While the COPIC initiative is the best exam-ple of a direct linkage between adoption of patientsafety practices and reductions of malpractice premi-ums, other malpractice insurance carriers such asMedical Mutual have begun to emphasize proactiverisk management.

• Make the business case. Improved patient safety hasbeen shown to reduce health care costs by decreasingcostly adverse events. According to the AmericanJournal of Health-System Pharmacists, over 3 percentof hospital admissions result from a need to treat amedication error. Over 4 percent of hospitalizationsare complicated by an adverse drug event and theaverage additional cost of an admission attributable toan ADE is over $2,000. Educating staff about the finan-cial benefits can be effective as long as it is madeclear that patient welfare, not finances, is the primarydriver of the change initiative.

• Educate staff about external drivers of change. It isimpossible to get full buy-in from everyone. There arealways some staff members who will argue and resistany change. The need to comply with national stan-dards, particularly those mandated by regulatory oraccrediting agencies such as CMS and JCAHO can becited as an effective reason for change for those staffwho don’t get it.

Medication process

It is difficult to change a process that cannot bemeasured. Effective change requires effective measure-ment so that improvement goals can be set and progresscan be monitored. Patient safety advocates recommendthese techniques to measure the effectiveness of medica-tion system safety initiatives:

Establish and measure indicators for medication system safety.

Institutions can measure process indicators (such asthe percentage of illegible orders received or the numberof orders written which fail to adjust dosage for renalfunction) and outcome indicators (such as the frequencyof adverse events such as hypoglycemia or anticoagulantrelated hemorrhage). These indicators can help an institu-tion prioritize areas that need improvement and are criti-cal to assessing whether system changes are having thedesired beneficial effects.

Use external benchmarks.

While it is important for every institution to have itsown goals for improving patient safety, it can be instruc-tive to compare performance with similar organizations.This benchmarking can help identify areas that may needparticular attention for improvement.

Track and trend events.

When adverse events occur, it is important to try andidentify and trend common contributing factors such as lostorders or poor legibility. This tracking can help the institu-tion identify priorities for systematic improvement.

Institute near miss reporting.

Organizations with an effective safety culture will notjust focus on adverse events but will actively measure nearmiss events. These are situations where some aspect of thesystem failed, but a vigilant staff member intervened to pre-vent or significantly reduce the actual patient harm.Institutions should view near miss reports as patient safety“treasures” since they can teach us valuable lessons aboutpotential deficiencies in our systems, without having to paythe price of an adverse patient outcome. Institutions with ahealthy patient safety culture do not ignore multiple nearmiss events and wait for a serious adverse patient outcometo take effective corrective action.

Assess risk.

While effective measurement of adverse events andnear misses are important, there are some medicationsafety practices that should be instituted as a routine mat-ter. These are issues that have been demonstrated to beimportant safety concerns at other institutions. JCAHOSentinel Event Alerts and Institute for Safe MedicationPractices Quarterly Action Agendas (formerly SafetyAlerts) are notable examples.

While it is important to measure patient safety per-formance, measurement alone is not enough. The goal ofthe measurement process is to provide the necessaryenvironment to support effective change. The use of aneffective strategy such as rapid cycle testing in a series ofPDSA (Plan Do Study Act) cycles is essential in order toimprove the safety and reliability of the medication sys-tem. It is critical to act upon the information provided bymeasurement systems and then re-measure the process toassure that the desired outcome has indeed beenachieved.

In addition to investigating root causes of adverseevents and learning from other institutions, organizationscan engage in proactive risk assessment activities such asfailure mode effect analyses.


FMEA involves mapping out a process from start tofinish into component steps. A team of staff members whoare familiar with the process will then consider how theprocess might hypothetically fail, step-by-step. Each possiblefailure is scored based on the anticipated frequency, severityand likelihood of detection of the failure. This gives anoverall risk score for each step and for the entire process.Steps with the highest risk scores generally contribute thehighest risk and should be redesigned.

These different risk assessment methods are comple-mentary and will often identify the same high risk areasof the medication system such as administration ofinsulin, opiates and narcotics, benzodiazepines, anticoag-ulant therapy, injectable KCl, hypertonic saline and cancer chemotherapy agents.

Medical error prevention

Another major area to focus on regarding patientsafety is medical errors because they result in highly sig-nificant morbidity, mortality and excess costs.

Medical errors can be classified into two categories:

1. Process errors— those related to administrative tasks,initial investigation, treatment delivery, communicationand payment

2. Knowledge errors— those related to a lack of accessto clinical knowledge or skills

Administrative errors and knowledge errors related toinformation access and delivery are among the most pre-ventable of all medical errors. What all of these errorsshare is a direct relationship to health care documents,including patient records, physician orders, prescriptions,test results, insurance forms and many others.

Typically, administrative errors can be traced back toan inaccurate source document as a result of poor docu-ment management.

Electronic medical records

Paper records are subject to errors from poor or mis-interpreted handwriting. Many medical errors can beattributed to the slow, tortuous and unreliable process of

paper record retrieval and review prior to providing care. So how can an EMR help to address medical errors?

How is an EMR better than a paper system if they containthe same materials? There are many facets of an EMRthat can prevent medical errors:

Health maintenance prompts and proactive care

An EMR will prompt a physician to order a healthmaintenance test such as a mammogram. The EMRprompt can prevent a patient safety issue from develop-ing if the test is ordered. Most patient care is reactive andepisodic. When an EMR is used reactive visits can includemore proactive care and all visits can include optimiza-tion of disease management. An EMR can also use a dis-ease registry for population management and this can beintegrated with a secure patient portal for eVisits.

Medication management

Using an EMR with a medication manager, a cliniciancan reduce a variety of medication prescription errors.These errors include mistakes related to illegible hand-writing, selection of the wrong dose of medicine, andprescribing two or more different medications that endup causing an adverse drug interaction, etc.

Complete patient history

In a properly executed EMR all information is avail-able at the clinician’s finger tips without having to sortthrough a voluminous paper chart that may be incom-plete. Organization of the records is much easier in theelectronic format and data can be mined very efficientlyfor the management of the patient.

Interoffice communication

With an EMR, clinicians can send intra-office mes-sages to one another that are time-sensitive and high-pri-ority which leads to timely care of the patient and reduc-tion of medical errors.

Complete documentation

In an ideal EMR, all of the relevant clinical reportsincluding those from lab, imaging, physical therapy, etc.,


and those from consultants are loaded into a preformat-ted matrix and cross-linked for continuity of care. Evenpatient inputs are included in some EMR systems. Thereis less chance of an error when care is being provided bymany sources and all the information from those sourcesis placed in a medical record.

Electronic decision support systems

Information systems that provide evidence-basedmedical knowledge at the time of care can standardizeclinical decision-making and reduce the clinical decisionerror rate. This enables practitioners to benefit fromexpert advice at the point of care. Decision support sys-tem designers can never anticipate every possible set ofcircumstances. Optimal decision support system designand management allow the system to evolve and improvethrough feedback from users.

Having information that is standardized, usable, andshareable is the very essence of error reduction An EMRallows a health system to easily audit the quality of careand develop patient safety programs with the knowledgethat the audits obtain. A comprehensive information systemwill provide an extension to the future National QualityForum’s patient safety event taxonomy, which is intendedto facilitate a common approach for patient safety.

While increasing sophistication is slowly reducingmedical errors, all efforts must start with awareness. Asstaff members understand their own limitations and thatof the system, improvements can be made.

We hope that some of these key tips will prove help-ful to your efforts to improve the safety and reliability ofexisting systems while we work together to build the sys-tems of the future. Preventing even one misadventure canbe a compelling justification for these efforts.

First, do no harm.

Brush Up On Ways to Creatively Manage Your Organization

Philip Fracica, MD, is medical director of qualityimprovement and critical care services at St.Joseph’s Hospital and Medical Center in

Phoenix, Ariz. He can be reached at [email protected].

Mohamed Lafeer, MD, FAAP, CPE, is the med-ical director of quality improvement and com-pliance for Shah Associates, MD, LLC, in

Hollywood, Md., and the medical director for health primeinternational in Rockville, Md. He can be reached [email protected].

Marie E. Minnich, MD, MMM, MBA, CPE, ischairperson of the Performance ImprovementAdvisory Group for the Division of

Anesthesiology of Geisinger Health System in Danville, Pa.She may be reached at [email protected].

Raymond J. Fabius, MD, CPE, FACPE, is presi-dent and chief medical officer of I-trax(AMEX:DMX) and a member of the ACPE Board

of Directors. He can be reached at [email protected].

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