fmt001 prevention of medical errors

8/11/2019 FMT001 Prevention of Medical Errors

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Prevention of Medical Errors

INSTRUCTIONSThanks for downloading this Somatic Arts and Sciences continuingeducation course. You are looking at the plain textversion of the course,which can be printed out if you like, or you can click the link below and readthe course entirely online.

http://sasionline.com/fmt001_fmt450.html

TAKING THE QUIZTo take the quiz you can click the link at the end of this document, or youcan take it on the webpage. The advantage to taking it on the webpage isthat the book is embedded in the page right above the quiz, making iteasy to look up the answers (and it has more pictures).

TARGET AUDIENCEThis continuing education course has been designed to meet theeducational needs of massage therapists.

COURSE OVERVIEWThis course is designedto assist massage therapists in developing habitsand awareness that will lead to a reduced number of medical errors.

EDUCATIONAL OBJECTIVESUpon completion of this home study continuing education course, themassage practitioner should be able to:

Describe the magnitude of medical errors.

Define the types of medical errors.

Discuss factors that increase the risk of medical errors.

2013 The Somatic Arts and Sciences Institute

All Rights Reserved

Purchased by Gail Klingseisen, [email protected] #4062870


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Identify populations of special vulnerability.

Discuss responsibilities for reporting medical errors.

Identify processes to improve patient outcomes.

Describe public education measures related to patient safety.



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INTRODUCTIONThis course is presented for educational purposes only. It was developedand marketed specifically for massage therapists that are required to obtaincontinuing education hours for licensing purposes. The author is not givingmedical, legal or other professional advice.

This course is classified as Cognitive learning, meaning that there is nohands on portion.

The Somatic Arts and Sciences Institute strives to provide the most up todate and accurate material possible, however research and newdiscoveries continue daily and we assume no responsibility for errors oromissions due to the rapid advancement of science.

IntroductionIn November 1999, the Institute of Medicine (IOM) revealed a hiddenepidemic in the United States: medical errors, which result in injury to 1 inevery 25 hospital patients and an estimated 44,000 to 98,000 deaths eachyear. Even the lower estimate makes medical errors more deadly thanbreast cancer (42,297), motor vehicle accidents (43,458) or AIDS (16,516).According to the IOM report, To Err is Human: Building a Safer HealthSystem, medical errors cost the economy from $17 to $29 billion each year.

Research funded by the Agency for Healthcare Research and Quality(AHRQ) has shown that medical errors result most frequently from systemserrors-organization of health care delivery and how resources are providedin the delivery system. Only rarely are medical errors the result ofcarelessness or misconduct of a single individual.

As John M. Eisenberg, MD, Director of AHRQ pointed out:

"Mistakes happen in hospitals, they happen in outpatient clinics, theyhappen in nursing homes and home care, and they happen in self-care. We

as clinicians need to acknowledge that they happen. The challenge is toavoid them, and when mistakes do occur, to prevent them from causingharm to our patients." (2000)



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Errors can occur at any point in the health care delivery system.Acknowledging that errors happen, learning from those errors, and workingto prevent future errors represents a major change in the culture of healthcare, a shift from blame and punishment to analysis of the root causes oferrors and strategies to improve systems and processes. Every person onthe healthcare team has a role in making health care safer for patients andworkers.

In response to the IOM report, the Florida State legislature mandated thatall licensees must complete a two-hour course on prevention of medicalerrors, which meets the criteria of Florida Statute 456.013, for initiallicensure and biennial renewal.

Types of Medical Errors

The IOM report defines an error as "the failure of a planned action to becompleted as intended (i.e., error of execution) or the use of a wrong planto achieve an aim (i.e., error of planning)."

An adverse event is an injury caused by medical management rather thanthe underlying condition of the patient. An adverse event attributable toerror is a preventable adverse event, also called a sentinel event, becauseit signals the need to ask why the error occurred and make changes in thesystem.

Research on why humans make errors (Reason, 1990) has identified twotypes of errors: active errors and latent errors.

Active errors tend to occur at the level of the individual and their effects arefelt almost immediately. Latent errors are more likely to be beyond thecontrol of the individual, that is, errors in system design, faulty installationor maintenance of equipment, or ineffective organizational infrastructure.The effects of latent errors may not appear for months or even years butthey can lead to a cascade of active errors, ending in catastrophe. For

example, an undetected design flaw in an airplane (a latent error) maycause the pilot to lose control of the plane (an active error) years after theaircraft was built, and cause the plane to crash.

Close calls or near misses are potential adverse events, errors that couldhave caused harm but did not, either by chance, or because something orsomeone in the system intervened. For example, a nurse who recognizes a



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potential drug overdose in a physician's prescription and does notadminister the drug but instead calls the error to the physician's attentionhas prevented an adverse drug event (ADE). Close calls provideopportunities for developing preventive strategies and actions, and shouldreceive the same level of scrutiny as adverse events.

Surgical ErrorsSurgical errors, or surgical adverse events, may account for a highpercentage of adverse events. A study of hospitals in Colorado and Utah(Gawande, et al, 1999) found that surgical adverse events accounted fortwo-thirds of all adverse events and 1 of 8 hospital deaths.

A review by the Joint Commission on Accreditation of HealthcareOrganizations (JCAHO, 1998) found that wrong-site surgery was most

common in orthopedic procedures. Risk factors contributing to the errorincluded more than one surgeon involved in the case, multiple proceduresperformed during a single operating room visit, and unusual timepressures, particularly pressure to speed up preoperative procedures.

Surgical errors such as wrong-site surgery are not the sole responsibility ofthe operating surgeon, however. All operating room personnel have a rolein ensuring patient safety by verifying the surgical site and pointing out apossible error. Admittedly, this can be difficult in the presence of an attitudethat the surgeon should never be questioned.

To reduce the risk of wrong-site surgeries, JCAHO recommends thefollowing strategies:

Clearly mark the operative site, involving the patient (or the familywhen appropriate) in the marking process

Require oral verification of the correct site in the operating room byeach member of the surgical team

Develop a verification checklist that lists all documents referencing

the intended surgical procedure and site

Diagnostic InaccuraciesAn accurate diagnosis is the first requirement for correct and effectivetreatment. Inaccurate diagnosis may delay treatment or result in incorrect,ineffective treatment or unnecessary tests, which can prove costly andinvasive. Inexperience with a difficult diagnostic procedure can affect the



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accuracy of the results. For example, a study of colposcopy, a test used tofollow up on abnormal Pap smear results, showed that physicians whoperformed 100 or more colposcopies annually had more accurate findingsthan those who performed the procedure less often (Gordon, 1996).

Misdiagnosis is a major factor contributing to delays in treatment, accordingto JCAHO (2002). Hospital emergency departments accounted for just overone-half of all sentinel event cases of patient death or permanent injury dueto delays in treatment. However, these serious events also happen in otherhealthcare settings, including intensive care units, medical-surgical units,inpatient psychiatric hospitals, the operating room, and in the home caresetting. Of the 55 reported cases of delays in treatment, 52 resulted inpatient death.

Medication ErrorsMedication-related error is one of the most common types of error, and ofprimary concern to nurses who administer medications, as well as to thepractitioner who prescribes medications, and the pharmacist whodispenses medications. Medication errors are called preventable adversedrug events (ADEs).

According to the U.S. Pharmacopeia (USP) (2000), the three mostfrequently reported types of medication errors were:

1. Omission errors (failure to administer an ordered medication dose).2. Improper dose/quantity errors (any medication dose, strength or

quantity that differs from that prescribed).3. Unauthorized drug errors (the medication dispensed and/or

administered was not authorized by the prescriber); this categoryincludes dispensing or administering the wrong drug.

Other findings of the USP report included:Of the five phases of the medication process, errors reported originated

primarily in administering and documenting. (The other phases includeordering, dispensing, and monitoring.)

The primary contributing factors to medication errors were distractions andworkload increases, many of which may result from efforts at costcontainment.



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Insulin, heparin and warfarin were the medications most often associatedwith errors.

In 32% of the records where documented action was taken due to amedication error, the personnel involved with initiating or perpetuating theerror were reportedly not informed of their involvement in the medicationerror event.

One study funded by AHRQ in two tertiary care hospitals (Bates, et al,1995) found that errors in ordering medications accounted for 56 percent ofpreventable ADEs, while errors in administering medication accounted for34 percent of preventable ADEs. A second study (Leape, 1995) showedthat dosage errors, in particular, were primarily due to the physician's lackof knowledge about the drug or about the patient for whom it was

prescribed.

A later study attempting to identify risk factors for preventable ADEs amongpatients admitted to medical and surgical units at two large hospitals(Bates, et al, 1999), found few such factors, suggesting that focusing onimproving medication systems would prove more effective.

Even though nurses do not write the prescription or dispense the drug fromthe pharmacy, they are in a position to identify potential errors inprescribing and dispensing and thereby protect the patient. Nursesadministering medication should observe the following six "rights:"

1. Right patient2. Right drug3. Right dose4. Right dosage form5. Right route6. Right time

In 1999, The National Patient Safety Partnership, a coalition of healthcareorganizations, released a list of 16 best practices in medication safety. (seebelow) If hospitals implemented all of these practices, it could markedlyreduce medication errors.



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Best Practices for Medication Safety

To reduce the occurrence of adverse drug events (events that can cause,or lead to, inappropriate medication use and patient harm),

Patients can:

Tell physicians about all medications they are taking andresponses/reactions to them

Ask for information in terms they understand before acceptingmedications

Providing Organizations and Practitioners can: Educate patients Put allergies and medications on patient records Stress dose adjustment in children and older persons Limit access to high hazard drugs Use protocols for high hazard drugs Computerize drug order entry Use pharmacy-based IV and drug mixing programs Avoid abbreviations Use "unit dose" drug systems (packaged and labeled in standard

patient doses) Use "unit dose" drug systems (packaged and labeled in standard

patient doses)

Purchasers can:

Require machine-readable labeling (barcoding) Buy drugs with prominent display on name, strength, warnings Buy "unit of use" packaging ("unit dose") Buy IV solutions with two sided labeling To reduce the potential for taking a medication that was not

prescribed for them or cannot be safely taken by them, patientsshould ask the following five sets of questions before accepting

prescription drugs. Is this the drug my doctor (or other health care provider) ordered?

What is the trade and generic name of the medication? What is the drug for? What is it supposed to do? How and when am I supposed to take it and for how long? What are the likely side effects? What do I do if they occur?



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Is this medication safe to take with other over-the-counter orprescription medications, or dietary supplements, that I am alreadytaking? What food, drink, activities, dietary supplements or othermedication should be avoided while taking this medication?

National Patient Safety Partnership, May 12, 1999

System FailuresAnalysis of medical errors continues to show that human fallibility is onlypart of the picture; system failures are also guilty. A major study (Leape etal, 1995) showed that failures at the system level - in disseminatingpharmaceutical information, in checking drug dosages and patientidentities, and in making patient information available - were the realculprits in more than 75 percent of adverse drug events.

Cost containment is a system-level factor that can affect medical errors.For example, inadequate staffing levels of nurses increased the incidenceof postoperative adverse events, such as urinary tract infections,pneumonia, thrombosis, and pulmonary compromise (Kovner and Gergen,1998).

Research on system failures that have led to major industrial disasters(Peterson, 1996) found that the systems had nine characteristics incommon:

Diffuse responsibilities Underestimation of the severity of risks Belief that compliance with the rules was sufficient to achieve safety Lack of ability for team members to speak up Failure to share and implement lessons learned in other facilities Subordination of safety to other performance goals Persistence of flawed design features Failure to use risk management techniques Poorly defined responsibility for safety within the organization

Healthcare systems with these characteristics create an unsafeenvironment for both patients and staff.



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Factors and Situations that Increase the Risk of ErrorsAs the IOM acknowledges, "to err is human." However, research hasshown that certain factors can increase the error rate (Reason, 1990), suchas:

Fatigue -Working a double shift, for example, can increase the likelihoodof errors. Medical residents on call for 36 hours or more are also at highrisk for errors.

Alcohol and/or other drugs -Use of alcohol and/or drugs is incompatiblewith competent, professional safe patient care. Unfortunately, thecombination of high stress and easy access to medications has led to

substance abuse by physicians, nurses, and other health professionals.

Illness -Coming to work when you aren't well jeopardizes your health andthe health and safety of patients.

Inattention/Distraction -A noisy, busy emergency department can make itdifficult to concentrate on one patient's care, especially if you know thatother patients are waiting to see you.

Emotional states -Anger, anxiety, fear and boredom can all impair jobperformance and lead to errors. A heavy workload, conflict with other staffor with patients, and other sources of stress increase the likelihood oferrors.

Unfamiliar situations or problems -Nurses who "float" from one hospitaldepartment to another may not have the expertise needed for all situations.

Equipment design flaws -Here again, training and experience withequipment are key to avoiding errors.

Inadequate labeling or instructions on medication or equipment -Look-alike or sound-alike drugs can lead to errors. Incomplete or confusinginstructions on equipment can result in inappropriate use.



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Communication problems -Lack of clear communication among staff orbetween providers and patients is one of the most common reasons forerror.

Hard-to-read handwriting -Doctors' handwriting has long been criticizedfor its illegibility, particularly on prescriptions. Fortunately, computerizedmedication ordering has eliminated this problem in many healthcareorganizations.

Unsafe working conditions - Poor lighting and/or slippery floors can lead toerrors, especially falls, a costly hazard in every hospital.

Focusing on the multi-causal nature of errors does not alter the role ofindividual accountability for safe practice. In fact, the National Council of

State Boards of Nursing has testified as follows:

"Both systems liability for mistakes and individual accountability areimportant to protect the public. Absent individual accountability standards,practitioners who leave organizations after serious errors occur and areemployed elsewhere will never receive necessary remediation or educationto address human factors, thus compromising the safety of the patient."(Ridenour, 2000)

Populations of Special VulnerabilityThe safety of all patients is of paramount concern for all care providers.However, some patients - for example, the very young and the very old -are particularly vulnerable to the effects of medical errors, often due to theirinability to participate actively as a member of the health care team, mostcommonly related to communication issues. Nurses and other careproviders need to recognize the special needs of these patients and actaccordingly.

Older PatientsThe normal aging process commonly includes some degree of impairmentin vision and hearing. Older people may also suffer varying degrees ofcognitive impairment. Alone or in combination, these problems contribute todifficulties in communication between patients and care providers. Seriousillness, accidents or trauma, such as surgery, that require hospitalization,add another layer of anxiety and possible confusion that can further



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interfere with communication between patients and care providers,potentially leading to errors.

Older patients are at special risk for medication errors, which can have life-threatening or even fatal effects, due to the declining ability of the agingbody to metabolize drugs. Visual, hearing or cognitive problems may leadto misunderstanding of instructions or failure to question an incorrect orunfamiliar drug. When caring for older patients, communication with aresponsible family member or other patient advocate is essential.

Older patients are also at high risk of falling. Reasons include medicationeffects, existing health problems such as arthritis, confusion or othercognitive deficit, or postural hypotension. Many older people need to usethe bathroom during the night and need assistance to avoid falls.

Infants and ChildrenThe younger the patient, the greater the risk of serious medication errorswith devastating effects. Weight-based dosing is required for almost allpediatric drugs, and pharmacists often must dilute stock solutions.

One research study in two urban teaching hospitals found that errorsoccurred in 5.7 percent of medication orders during the care of 1,120pediatric patients admitted during 1999 (Kaushal, et al, 2001). In addition,the rate of potential adverse drug events - close calls/near misses - wasthree times the rate of potential ADEs found in a similar study ofhospitalized adults.

The researchers noted that physicians at both hospitals handwrotemedication orders, copies of which were sent to the pharmacy. Accordingto the researchers, computerized medication order entry and decisionsupport (with automatic checks on patient drug allergies, drug dosage, anddrug-drug interaction) could have prevented 93 percent of potential ADEs,as could the participation of ward-based clinical pharmacists in ward

rounds. Nearly 80 percent of potential ADEs occurred in drug ordering, and34 percent involved incorrect dosing.

Infants and young children do not have the communication abilities neededto alert clinicians about potential drug errors or adverse effects that theyexperience. Infants, particularly newborns, are physiologically ill equippedto deal with drug errors. Parents of infants and children need to be fully



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informed and involved in their child's care during hospitalization and mustbe educated to question caregivers about medications and procedures.

Persons with Limited English Language Skills and/or Limited Literacy

Meeting the healthcare needs of Florida's culturally and ethnically diversepopulation may require bilingual care providers, translators or interpreters,or other communication experts. Without these experts available,communication of vital information between patient and provider can leadto misunderstanding and errors.

Many hospitals have translators or interpreters available for non-Englishspeaking patients. If translation assistance is not available, communicatingwith a family member or other support person is essential. It is important to

keep your words simple and concrete, and to use pictures or diagrams toexplain procedures.

General guidelines to assist nurses caring for patients from 23 differentcultural groups can be found in Culture and Nursing Care: A Pocket Guide(Lipson, Dibble, and Minarik, 1996). Each chapter outlines issues related tohealth and illness, symptom expression, self-care, birth, death, religion,family participation in care, and other topics.

When caring for patients whose verbal abilities are limited either byeducation, development, or neurological impairment, assistive devices suchas an alphabet board, a picture board or magic slate may prove helpful.Patients who are unable to speak because of a tracheostomy or othersurgical procedure should also have these devices available along withpencil and paper (Adkins, 1991).

Fall RiskFalls are a commonly reported sentinel event and can be fatal. Olderpatients are not the only population at risk. Any patient who has had

excessive blood loss may experience postural hypotension, increasing therisk of falling. Maternity patients or other patients who have epiduralanesthesia are at risk for falls due to decreased lower body sensation.Factors that increase the risk of falls are summarized on the followingpage.



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Risk Factors for Falls Age 65 or over History of falling Impaired mobility or difficulty walking Need for assistance in getting out of bed or transferring to and from a

chair History of dizziness or seizures Impaired vision, hearing, or speech Need for mobility assistive devices (cane, walker, wheelchair,

crutches or braces) Weakness or fatigue

Confusion, disorientation, impaired cognitive function Use of medications such as diuretics, laxatives, or consciousness-

altering drugs, including sedatives, analgesics, hypnotics, anti-depressants, tranquilizers.

Reporting ErrorsImproving patient safety begins with prompt reporting of errors followed byanalysis of the root causes and contributing factors and developing a planof action to prevent similar errors in the future. Only in this way can a healthcare organization assess the safety of care delivered and whether safety isimproving.

The mistaken attitude in healthcare that errors are solely the fault ofindividual practitioners has proved a major barrier to reporting. Instead ofanalyzing the multiple factors that contribute to errors, efforts have focusedalmost entirely on making providers more careful, reinforced by fear ofpunishment when they fail. Until the mid-1990s, this punitive attitudeseverely limited the reporting of errors. In fact, research shows that whenthe fear of punishment is removed, reporting of errors increases by as

much as 10 to 20 fold (Leape, 2000).

Joint Commission on Accreditation of Healthcare Organizations

Each accredited healthcare organization must have two systems in placefor reporting errors: an internal system and an external system. The Joint



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Joint Commission on Accreditation of Healthcare Organizations, whosemission is "to continuously improve the safety and quality of care providedto the public," requires that healthcare organizations:Have a process in place to recognize sentinel events;

Conduct thorough and credible root cause analyses that focus on processand system factors, not on individual blame;

Document a risk-reduction strategy and internal corrective action planwithin 45 days of the organization becoming aware of the sentinel event.JCAHO defines a sentinel event as any unexpected occurrence involvingdeath or serious physical or psychological injury, or the risk thereof.Including the words "or the risk thereof" broadens the definition to includepotential sentinel events (close calls/near misses). In other words, if similar

circumstances recurred, a serious adverse outcome would be likely.

Reportable JCAHO sentinel events are summarized below.

Unanticipated death or major permanent loss of function, unrelated to thenatural course of the patient's illness or underlying condition, or one of thefollowing:

JCAHO Reportable Sentinel Events Suicides Infant abduction or discharge to the wrong family Rape Transfusion reaction Surgery on the wrong body part

Accredited facilities are to report not only actual sentinel events butpotential sentinel events, the close calls/near misses that afford valuablelearning opportunities for prevention of future errors. JCAHO alsoencourages facilities to submit the findings of their root cause analyses and

corrective action plans. This information can be included in JCAHO'sreview of sentinel events, helping track national trends and developstrategies for improving patient safety.

Since 1995, JCAHO has reviewed 1,609 sentinel events. Of these, themost common are patient suicide (16.7percent), operative/postoperative



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complications (12.2 percent), medication errors (11.4 percent), and wrong-site surgery (11.3 percent).

JCAHO published an online newsletter, Sentinel Event Alert, whichidentifies specific sentinel events, describes their common underlyingcauses and suggests actions to prevent these occurrences. Accreditedorganizations are expected to:

Review and consider relevant information, if appropriate to theorganization's services, from each Sentinel Event Alert.

Consider information in an alert when designing or redesigningrelevant processes.

Evaluate systems in light of information in an alert.

Consider standard-specific concerns.

Implement relevant suggestions or reasonable alternatives or providea reasonable explanation for not implementing relevant changes .

Florida LawReporting sentinel events to JCAHO is voluntary. However, Florida lawmakes such reporting mandatory. Florida's Comprehensive MedicalMalpractice Reform Act of 1985 (F.S.395.0197) mandates that eachlicensed hospital implement a risk-management program with stateoversight and an internal incident-reporting system. State oversight isprovided by the Florida Agency for Health Care Administration (AHCA).Each licensed facility is required to hire a risk manager, licensed under F.S.395-10974, who is responsible for implementation and oversight of the riskmanagement program.

Statute 395.0197 mandates internal reporting of any adverse incident

(event) "over which health care personnel could exercise control, and whichis associated in whole or in part with medical intervention, rather than thecondition for which such intervention occurred, and which:

(a) Results in one of the following injuries:

Death;



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Brain or spinal damage; Permanent disfigurement; Fracture or dislocation of bones or joints; A resulting limitation of neurological, physical, or sensory function

which continues after discharge from the facility; Any condition that required specialized medical attention or surgical

intervention resulting from non-emergency medical intervention, otherthan an emergency medical condition, to which the patient has notgiven his or her informed consent; or

Any condition that required the transfer of the patient, within oroutside the facility, to a unit providing a more acute level of care dueto the adverse incident, rather than the patient's condition prior to theadverse incident;

(b) Was the performance of a surgical procedure on the wrong patient, awrong surgical procedure, a wrong-side surgical procedure, or a surgicalprocedure otherwise unrelated to the patient's diagnosis or medicalcondition;

(c) Required the surgical repair of damage resulting to a patient from aplanned surgical procedure, where the damage was not a recognizedspecific risk, as disclosed to the patient and documented through theinformed-consent process; or

(d) Was a procedure to remove unplanned foreign objects remaining from asurgical procedure."

The risk-management reporting system must:

Investigate and analyze the frequency and causes of adverseincidents to patients

Educate facility staff and agents

Analyze patient grievances related to patient care

All incident reports must be filed with the risk manager of the healthcareorganization or his or her designee within 3 days after the event occurred.Following receipt of the report, the risk manager in turn must report theevent to the Florida Agency for Health Care Administration (AHCA). Certain



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adverse incidents (sentinel events), referred to as Code 24 events, must bereported to AHCA within 24 hours of the occurrence.

Code 24 Sentinel EventsReport to AHCA within 24 hours of occurrence:

Death of a patient Brain or spinal damage to a patient Performance of a surgical procedure on the wrong patient Performance of a wrong-site surgical procedure Performance of a wrong surgical procedure

In addition to their internal reporting system, Florida hospitals and

ambulatory surgical centers also must submit to the Florida Agency forHealth Care Administration (ACHA) an annual report of all adverseincidents and malpractice actions (new, pending, and closed). They arealso required to report any injuries of which they are aware that occurthrough any health care service, including nursing homes, home healthorganizations, doctors' offices, dentists' offices, or any other purveyor ofhealth care service. Florida Statute 641.55 requires similar reporting ofpatient injury incidents by HMOs.

Three types of reports are required by ACHA:

1. The Annual Report, which includes all adverse incidents that occur inthe facility in the course of a calendar year. These reports are dueafter the first of each year for the previous year.

2. 24-Hour Urgent Issue Report, a preliminary report of serious patientinjuries of a more complicated nature, within 24 hours of theoccurrence of the injury. (See Box 4)

3. Code 15 Reports, which report in detail on each serious patient injury,the facility's investigation of the injury, and whether the factorscausing or resulting in the adverse incident represent a potential riskto other patients.



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The findings of that investigation must be reported to AHCA within 15 daysof an adverse incident. Failure to comply with this mandate may result infines of as much as $25,000.

Moving Beyond Blame: Improving Patient Outcomes

"The medical imperative is clear: to make health care safe we need toredesign our systems to make errors difficult to commit, and create aculture in which the existence of risk is acknowledged and injury preventionis recognized as everyone's responsibility." (Leape et al, 1998)

Root Cause Analysis (RCA)JCAHO requires that a thorough, credible root cause analysis (RCA) be

performed for each reported sentinel event. The goal of a Root CauseAnalysis is to find out:

Whathappened?Why did it happen?What do you do to preventit from happening again?

VA National Center for Patient SafetyRoot Cause Analysis (RCA) is a tool for identifying error preventionstrategies. It is a process for discovering basic and contributing causes oferror with the continuing goal of preventing recurrence.

RCA is an interdisciplinary process involving:

Experts from all services involved Those who are the most familiar with the situation Asking why at each level of cause and effect Identification of changes needed As great a degree of impartiality as possibility

According to the VA National Center for Patient Safety (2002), a thoroughRCA must include:

Determination of human and other factors Determination of related processes and systems



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Analysis of underlying cause and effect systems through a series ofWHY questions

Identification of risks and their potential contributions* Determination of potential improvement in processes or systems

One step in the RCA of both actual adverse events and close calls isdetermining the Safety Assessment Code (SAC) score of the event.The Severity and Probability Categories and the SAC Matrix areshown in Figure 3. (VHA Handbook 1050.1, Appendix D-1 and D-2).

A credible RCA must:

Include participation by the leadership of the organization and thosemost closely involved in the processes and systems.

Be internally consistent.

Include consideration of relevant literature.

In July 2001, the Agency for Healthcare Research and Quality released areport outlining evidenced-based clinical recommendations for improvingpatient safety. Titled "Making Health Care Safer: A Critical Analysis ofPatient Safety Practices," the report reviews 79 practices to preventadverse events and improve patient safety, based on current research.

The 11 most highly rated practices are listed below. The authors of thisreport emphasized that this list should not be considered complete, andthat it was weighted toward care of the very ill, rather than the mildly orchronically ill.

Clinical Opportunities for Safety Improvement

Appropriate use of prophylaxis to prevent venous thromboembolismin patients at risk.

Use of perioperative beta-blockers in appropriate patients to preventperioperative morbidity and mortality.

Use of maximum sterile barriers while placing central intravenouscatheters to prevent infections.



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Appropriate use of antibiotic prophylaxis in surgical patients toprevent perioperative infections.

Asking that patients recall and restate what they have been told

during the informed consent process.

Continuous aspiration of subglottic secretions (CASS) to preventventilator-associated pneumonia.

Use of pressure relieving bedding materials to prevent pressureulcers.

Use of real-time ultrasound guidance during central line insertion toprevent complications.

Patient self-management for warfarin (Coumadin) to achieveappropriate outpatient anticoagulation and prevent complications.

Appropriate provision of nutrition, with a particular emphasis on earlyenteral nutrition in critically ill and surgical patients.

Use of antibiotic-impregnated central venous catheters to preventcatheter-related infections.

In July 2002, The Joint Commission on the Accreditation of HealthcareOrganizations (JCAHO) issued new mandatory goals andrecommendations to improve patient safety, to take effect in January 2003.Hospitals and other organizations will be evaluated by accreditationrepresentatives to see whether these recommendations or acceptablealternative measures are being implemented. Failure to implement therecommendations could result in loss of accreditation and federal funding.The 2003 National Patient Safety Goals and Recommendations aresummarized below.

2003 National Patient Safety Goals and Recommendations

Goal 1.Improve the accuracy of patient identification.Recommendations:



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Use at least two patient identifiers (neither of which is the patient's roomnumber) whenever taking blood samples or administering medications orblood products.

Prior to the start of any surgical or invasive procedure, conduct a finalverification process, such as a "time out," to confirm the correct patient,procedure, and site, using active - not passive - communication techniquesGoal 2.Improve the effectiveness of communication among caregivers.

Recommendations:Implement a process for taking verbal or telephone orders that requires averification "read-back" of the complete order by the person receiving theorder.

Standardize the abbreviations, acronyms and symbols used throughout theorganization, including a list of abbreviations, acronyms and symbols not touse.

Goal 3.Improve the safety of using high-alert medications.

Recommendations:Remove concentrated electrolytes (including, but not limited to, potassiumchloride, potassium phosphate, sodium chloride >.9%) from patient careunits.

Standardize and limit the number of drug concentrations available in theorganization.

Goal 4.Eliminate wrong-site, wrong-patient and wrong-procedure surgery.

Recommendations:Create and use a preoperative verification process, such as a checklist, toconfirm that appropriate documents (e.g., medical records, imaging

studies) are available.

Implement a process to mark the surgical site and involve the patient in themarking process.

Goal 5. Improve the safety of using infusion pumps.Recommendations:



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Ensure-free-flow protection on all general-use and PCA intravenousinfusion pumps used in the organization.

Goal 6.Improve the effectiveness of clinical alarm systems.

Recommendations:Implement regular preventive maintenance and testing of alarm systems.Assure that alarms are activated with appropriate settings and aresufficiently audible with respect to distances and competing noise within theunit.

A National Problem of Epidemic Proportion

It is clear that, although the United States provides some of the best healthcare in the world, the numbers of errors in health care are at unacceptablyhigh levels. The Institute of Medicines report estimates that more than halfof the adverse medical events occurring each year are due to preventablemedical errors, causing the death of tens of thousands. The costassociated with these errors in lost income, disability, and health care costsis as much as $29 billion annually. The consequences of medical mistakesare often more severe than the consequences of mistakes in otherindustriesleading to death or disability rather than inconvenience on thepart of consumersunderscoring the need for aggressive action in thisarea.

A wide body of research, including many studies funded by AHRQ,supports the IOM conclusions. The two seminal studies on medical error)have shown that adverse events occur to approximately 34 percent ofpatients. In another study the average intensive care unit (ICU) patientexperienced almost two errors per day. This translates to a level ofproficiency of approximately 99 percent. One out of five of these errorswere potentially serious or fatal. If performance levels of 99.9 percent

substantially better than those found in the ICUapplied to the airline andbanking industries, it would equate to two dangerous landings per day atO'Hare International Airport and 32,000 checks deducted from the wrongaccount per hour .

Many of these adverse events are associated with the use ofpharmaceuticals, and are potentially preventable. The IOM estimates the



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number of lives lost to preventable medication errors alone represents over7,000 deaths annuallymore than the number of Americans injured in theworkplace each year. In addition, preventable medication errors areestimated to increase hospital costs by about $2 billion nationwide. A 1995study estimated that problems related to the use of pharmaceutical drugsaccount for nearly 10 percent of all hospital admissions, and significantlycontribute to increased morbidity and mortality in the United States. A 1991study of hospitals in New York State indicated that drug complicationsrepresent 19 percent of all adverse events, and that 45 percent of theseadverse events were caused by medical errors. In this study, 30 percent ofthe individuals with drug-related injuries died

In early 1997, the President established the Advisory Commission onConsumer Protection and Quality in the Health Care Industry (Quality

Commission) and appointed Health and Human Services Secretary Shalalaand Labor Secretary Herman as co-chairs. The Quality Commissionreleased two seminal reports focusing on patient protections and qualityimprovement. Subsequent to the Commissions second report on patientsafety and quality improvement and consistent with its recommendations,the President established the Quality Interagency Coordination Task Force(QuIC), a umbrella organization also co-chaired by Secretary Shalala andSecretary Herman, to coordinate Administration efforts to improve quality.As he established the QuIC, the President stated that "For all of itsstrengths, our health care system still is plagued by avoidable errors."

Also consistent with the Quality Commissions recommendations, VicePresident Gore launched the National Forum for Health Care QualityMeasurement and Reporting. Known as the Quality Forum, it is a broad-based, widely representative private body that establishes standard qualitymeasurement tools to help all purchasers, providers, and consumers ofhealth care better evaluate and ensure the delivery of quality services. Inaddition to the work and significant potential of the QuIC and QualityForum, other Federal agencies have made significant efforts to reduce

medical errors and increase attention on patient safety.

In accordance with its recent reauthorization, the AHRQ is the lead agencyfor the Federal government on quality in health care. It sponsors researchexamining the frequency and cause of medical errors and tests techniquesdesigned to reduce these mistakes. It also examines issues generallyrelated to health care quality, including overuse and underuse of services.



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The Department of Defense (DoD) and the Department of Veterans Affairs(VA), serving over 11 million patients nationwide, have begun to implementcomputerized physician order entry systems, proven effective in reducingmedical errors. In addition, Veterans Affairs has implemented acomputerized medical record in all their 172 hospitals, making it possible toreduce errors by providing complete information about patients at the pointof care. Over the past 3 years, the VA created an error reporting system,established four Centers of Inquiry for Patient Safety, and began to usebarcode technology to reduce medication errors.

The Health Care Financing Administration (HCFA), through its Peer ReviewOrganizations (PROs), is working to reduce errors of omission for the 39million Medicare beneficiaries. Under their current performance-based

contracts, the PROs are working to prevent failures and delays in deliveringservices for breast cancer, diabetes, heart attack, heart failure, pneumonia,and stroke. These efforts have already decreased mortality for heart attackvictims.

The Centers for Disease Control and Prevention (CDC) and the Food andDrug Administration (FDA) collect data on adverse events that are theresult of treatment, such as hospital-acquired infections and the unintendedeffects of drugs and medical devices. CDC's National NosocomialInfections Surveillance (NNIS) system is a hospital-based reporting systemthat monitors hospital-acquired infections that afflict more than two millionpatients every year. Among participating hospitals, bloodstream infectionrates have decreased by more than 30 percent since 1990, and woundinfections following surgery have decreased by 60 percent among high-riskpatients. FDA receives approximately 100,000 reports per year of adverseevents associated with medical devices and over 250,000 reportsassociated with pharmaceuticals. FDA estimates that over one-third of theadverse events associated with medical devices and pharmaceuticals arepreventable.

In all of these efforts, the Administration has worked closely with the privatesector and the States. Many States and members of the private sector aremoving ahead with actions to reduce the number of medical errors.Currently, almost 20 States have implemented mandatory reportingsystems to improve patient safety and hold health care organizationsresponsible for the quality of care they provide. The private sector has also



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taken large strides to address the issue of patient safety, most recently withthe creation of the Leapfrog Group by executives of some of the Nationsbiggest companies, including General Motors and General Electric. Thisgroup encourages all employers to make safe medicine a top priority of thehealth insurance they provide and to steer workers to the hospitals thatmake the fewest mistakes.

While both the public and private sectors have made notable contributionsto reducing preventable medical errors, additional and aggressive effortsare needed in and outside of the Federal government to further reducethese mistakes.

Institute of Medicine RecommendationsThe IOM report recommends the establishment of a national goal of

reducing the number of medical errors by 50 percent over 5 years. To thatend, it outlined a four-tiered approach to reduce medical mistakesnationwide, including actions to:

Establish a national focus to create leadership, research, tools, andprotocols to enhance the knowledge base about safety.Identify and learn from medical errors through both mandatory andvoluntary reporting systems.

Raise standards and expectations for improvements in safety through theactions of oversight organizations, group purchasers, and professionalgroups.

Implement safe practices at the delivery level.

A Road Map for Action: The Federal ResponseThe QuIC agencies join the IOMs call for action to reduce errors,implement a system of public accountability, develop a robust knowledgebase about medical errors, and change the culture in health care

organizations to promote the recognition of errors and improvement inpatient safety. This report describes the actions that the QuIC agencies willtake to build on current programs and develop new initiatives to reduceerrors.

The QuIC fully endorses the IOMs goal of reducing the number of medicalmistakes by 50 percent over 5 years and has developed a strategy that



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builds on the IOM recommendations and, in some cases, goes beyondthem. This strategy is detailed below.

Creating a National Focus to Enhance the Knowledge Base on PatientSafety

IOM Recommendation: Creating a Center for Patient Safety. The IOMrecommends that Congress fund a Center for Patient Safety within theAgency for Healthcare Research and Quality (AHRQ) that will set nationalgoals for patient safety, track progress in meeting these goals, and issuean annual report to the President and Congress on patient safety. TheCenter should also enhance the current knowledge base on patient safetyby developing a research agenda, disseminating grants for research onpatient safety, funding Centers of Excellence, evaluating methods for

identifying and preventing errors, and funding dissemination andcommunication activities to improve patient safety.

QuIC Response. The Administration endorses the IOM recommendationand the President has included $20 million in the Fiscal Year (FY) 2001budget to support a Center for Quality Improvement and Patient Safety atthe AHRQ, as part of the Agencys broader quality agenda. The Center willfund research on medical errors, principally through extramural grants andcontracts. It will work with private-sector entities and public sector partners,including the Quality Forum, to develop national goals for patient safety;issue an annual report on the state of patient safety nationally; promote thetranslation of research findings into improved practices and policies; andeducate patients, consumers, and health care providers about patientsafety.

IOM Recommendation: Establishing reporting systems nationwide. TheIOM recommends that the Administration and the Congress move toestablish a nationwide system of error reporting that includes bothmandatory and voluntary components.

Mandatory Reporting Systems. The IOM recommends the development ofa nationwide mandatory reporting system to provide for the collection ofstandardized information by state governments about adverse events thatresult in death or serious harm. The report states that adverse eventreporting should initially be required of hospitals and eventually be requiredof other institutional and ambulatory care delivery systems. It recommends



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that this system should be implemented nationwide, linked to systems ofaccountability, and made available to the public. The IOM concludes that ifStates choose not to implement the mandatory reporting system, theDepartment of Health and Human Services (DHHS) should serve as theresponsible entity.

Voluntary Reporting Systems. The IOM report does not propose theestablishment of a national voluntary reporting system; rather, it offers avariety of options for more limited voluntary reporting systems that functionin all 50 States and build on currently existing options, including thedevelopment of systems focused on selected areas, such as medications,surgery, and pediatrics or using a sampling technique to collect the full

range of information from a limited subset of health care providers. TheIOM recommends that more research be conducted to determine the bestway to develop voluntary reporting systems that complement proposedmandatory reporting systems and can identify potential precursors toerrors, thus preventing patient harm. It also recommends that the Congressextend peer review protections to data related to patient safety and qualityimprovement collected through voluntary reporting systems.

QuIC response. The Administration agrees with the IOM that error reportingsystems should be established in all 50 States, and that these systemsshould have both mandatory and voluntary components. Such an effortshould establish important complementary approaches to both learning andaccountability on errors. Well-designed patient safety programs includereporting systems that both hold health systems accountable for deliveringhigh quality health care and provide important information to health caredecision-makers that improves patient safety.

The QuIC agrees with the IOM that individuals should have access toinformation leading up to and including the occurrence of a preventable

error that caused their serious injury or the death of a family member.However, we believe that subsequent "root-cause" analyses undertaken todetermine the internal shortcomings of the hospitals delivery systemshould not be subject to discovery in litigation and that appropriatelegislation should be enacted in conjunction with or prior to theimplementation of mandatory or voluntary reporting systems.



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It is important to note that the QuIC believes that any legislation oradministrative intervention in this area should not undermine individualsrights to redress for criminal activity, malpractice, or negligence. The QuICdoes not support legislation that would allow safety reporting systems toserve as a shield for providers engaging in illegal or negligent behavior.

Mandatory Reporting Systems. The QuIC supports the development ofState-based systems to require the collection of standardized informationon preventable, adverse events that result in death or serious harm, andbelieves that the development of these systems are ultimately in the bestinterests of patients. We agree with the IOM that the scope of eventstargeted by mandatory reporting systems that contain public disclosurecomponents should be limited to serious, preventable, and identifiableadverse events. By limiting required reporting systems to the most serious

of errorsthose causing life-long disability or deaththis approach willmost effectively target egregious problems and minimize the cost ofoperating such a system. The QuIC believes that, once mandatory systemsare fully implemented, such information for each health system should beconsolidated and made public, but that there should be no identification ofpatients or individual health care professionals. The QuIC believes thatmandatory reporting systems that contain public disclosure componentsshould not be used as a tool for punitive action by State and localauthorities, but should be used as a mechanism to provide the public withinformation about the safety of its health systems and to highlight errorsthat can and should be prevented.

The IOM has a set of specific recommendations for the structure of anationwide mandatory reporting system. The QuIC believes that there are anumber of issues that need to be addressed prior to determining the bestmechanism to ensure the establishment of State-based mandatoryreporting systems. The Administration will work with the Congress tooutline the appropriate Federal role in such a system. However, while theseissues are being resolved, the Administration will take the following actions

to demonstrate the importance of implementing mandatory reportingsystems and to create an environment in which there is more widespreadsupport for their use.

Implement a mandatory reporting system in the over 500 hospitals andclinics operated by the Department of Defense. Beginning this spring, theDepartment of Defense will implement a new reporting system in its 500



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hospitals and clinics serving approximately 8 million patients. Thisconfidential reporting system will be modeled on the system in operation atthe Department of Veterans Affairs and will be used to provide health careprofessionals and facilities with the information necessary to protect patientsafety. This system will begin to be pilot tested in August of 2000, willcollect information on adverse events, medication errors, close calls, andother patient safety issues. DoD providers will inform affected patients ortheir families when serious medical errors occur.

Expand mandatory reporting requirements for blood banks andestablishments that deal with blood products nationwide. By the end of theyear, the Food and Drug Administration (FDA) will release regulations toimprove the safety of blood transfusions by requiring the over 3,000 bloodbanks and establishments dealing with blood products to report errors and

accidents, such as mistyping blood products and adverse events affectingdonors, that affect patient safety. Currently, only 400 blood banks arerequired to report such errors.

In addition to Federal action to integrate mandatory reporting systems intoFederal agencies delivering care and strengthen the mandatory systemsthat currently exist, there is a critical need for Federal leadership in thedevelopment of patient safety standards. To that end, the Federalgovernment will:

Identify a set of patient safety measurements critical to the identification ofmedical errors. The QuIC will ask the Quality Forum to identify a set ofpatient safety measurements that should be a basic component of anymedical errors reporting system. Developing standardized measures laysthe foundation for a uniform system of data collection and facilitates thedevelopment of these systems.

Identify a set of patient safety practices critical to prevention of medicalerrors. The QuIC will ask the Quality Forum to identify, within 12 months,

patient safety practices that should be adopted by all hospitals and healthsystems, and will undertake activities to encourage their widespread use.The QuIC suggests that mandatory reporting systems include informationon whether hospitals and health systems' adopt these patient safetypractices.



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Identify issues related to the implementation of mandatory reporting forerror reduction. Using the Quality Forums recommendations for medicalerror reporting, HCFA will develop a pilot project, through the PROprogram, for up to 100 hospitals that volunteer to implement penalty-free,confidential, mandatory reporting systems. These pilot projects will assisthospitals in changing their medical delivery systems to reduce or eliminateerrors. This pilot project will include a rigorous evaluation component andidentify issues related to the implementation of medical error reportingsystems.

Determine the most effective way to present information on the incidence ofmedical errors to the public. HCFA, OPM, and AHRQ will lead a QuIC effortto work with the Quality Forum and States that have mandatory reportingsystems to determine how data on medical errors can be collected,

validated, and presented to the general public and local policy officialsand to determine the impact of providing such information. Since informingthe public about the safety of their health care systems is a criticalcomponent of mandatory reporting systems, this pilot project will provideinsights on presenting this information to the public.

Examine existing mandatory reporting systems. The Center for QualityImprovement and Patient Safety, in collaboration with other QuIC agencies,will evaluate the effectiveness of currently existing mandatory reportingsystems at the Federal and State levels and develop recommendations toimprove them. This information will be presented to States and otherorganizations considering developing such systems or that currently haveexisting systems, to help them design effective reporting systems likely toimprove patient safety.

The QuIC believes that these actions will encourage States to beginimplementing their own mandatory reporting systems for preventableadverse events, with the goal that all 50 States have mandatory reportingsystems for preventable adverse events within 3 years. This time frame will

enable the Federal government, working with the Congress and otherprivate-sector stakeholders, to conclusively resolve outstandingimplementation issues. If all states have not implemented mandatoryreporting systems within three years, the QuIC will deliverrecommendations to the President that assure all health care institutionsare reporting serious, preventable adverse events.



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Although currently the QuIC believes that moving towards a mandatoryreporting system is the appropriate course of action, if research conductedby AHRQ and other agencies indicates that the implementation of thesesystems does not enhance (or detracts from) patient safety, these resultswill be reported to the QuIC. Special emphasis will be placed on efforts todetermine whether making information public serves to hold health systemsaccountable and reduce preventable errors, or whether it only stiflesreporting.

Voluntary Reporting Systems. The QuIC agrees with the IOM that voluntaryreporting systems are a critical component of a national strategy to reduceerrors. Information from voluntary reporting systems is usually gathered byan independent entity and is used to identify patterns of errors. The QuICproposes to integrate existing Federal voluntary reporting systems with

data collection efforts by States and private organizations. The QuICagrees with the IOM that these programs should be confidential to protectthe privacy of patients, institutions, and providers reporting errors and closecalls. Experience in other industries demonstrates that confidentialityencourages reporting. In order to encourage the development of voluntaryreporting systems, the Administration will:

Implement a voluntary reporting system nationwide for veterans hospitals.The VA currently operates a mandatory reporting system. By the end of theyear, the VA will implement a voluntary reporting system for both adverseevents and close calls nationwide. Information will be collected by anindependent external entity, analyzed, and disseminated to all VA healthcare networks to help prevent medical errors. Implementing this system islikely to lead to a richer database of information, as incidents are reportedon a de-identified basis, and will allow researchers to compare theeffectiveness of identified systems to de-identified ones.

Examine existing voluntary systems. The Center for Quality Improvementand Patient Safety, with its QuIC partners, will evaluate the effectiveness of

existing voluntary reporting systems at the Federal and State levels anddevelop recommendations to improve them. This study will demonstratewhich entity or entities would be best to collect, analyze, and disseminateinformation on frequently occurring errors and the best interventions toprevent them.



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Setting Performance Standards and Expectations for SafetyIOM Recommendation: Include patient safety in performance standardsand expectation for health care organizations. The IOM recommends thatregulators and accreditors should require health care organizations toimplement meaningful patient safety programs with defined executiveresponsibility. Public and private purchasers should provide incentives tohealth care organizations to demonstrate continuous improvement inpatient safety.

QuIC response. The QuIC reviewed current Federal activities andproposed several ways to improve safety through current oversightactivities. These include:

Assuring that all hospitals participating in the Medicare program implement

patient safety programs. The Health Care Financing Administration intendsto publish regulations this year requiring the over 6000 hospitalsparticipating in the Medicare program to have ongoing medical errorreduction programs that would include, among other interventions,mechanisms to reduce medication errors. To comply with this newregulation, most hospitals are likely to implement systems such asautomated pharmacy order-entry systems and automatic safeguardsagainst harmful drug interactions and other adverse events.

Requiring the almost 300 health plans in the Federal Employees HealthBenefits Program to implement patient safety programs. In its annual callletter, to be issued this April, the Office of Personnel Management willannounce that, beginning in 2001, all health plans participating in theprogram will be required to implement patient safety initiatives. OPM willencourage health plans to collaborate with their providers to reduce errorsand improve the quality of care.

Working with private-sector employers and employees to incorporatepatient safety into purchasing decisions. This year, the Department of

Labor will include information on medical errors in the Health BenefitsEducation Campaign. This national effort educates employees about issuesof quality and safety under their employer-provided health benefits so thatthey can make informed health benefits decisions and educates employersin order to facilitate the provision of high-quality, affordable health benefitsto their employees.



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IOM Recommendation: Performance standards and expectations for healthprofessionals should focus greater attention on patient safety. Periodic re-examination and re-licensing of doctors, nurses, and other key providersshould be conducted based on both competence and knowledge of safetypractices. Professional societies should make a visible commitment topatient safety by establishing a permanent committee dedicated to safetyimprovement.

QuIC response. The QuIC is supportive of these goals, but recognizes andagrees with the IOM that they appropriately fall under State jurisdiction andoversight. However, the QuIC agencies will provide technical assistance toState or professional agencies seeking to ensure a basic level ofknowledge for health care providers on patient safety issues, promotemodel patient safety programs that include evidence-based best patient

safety practices to provider organizations, or help agencies encourage thecultural change necessary to make reporting systems a success.

IOM Recommendation: FDA should increase attention to the safe use ofdrugs. Both pre- and postmarketing processes should be improved tomaximize safe drug use. FDA should develop and enforce standards forthe design of drug packaging and labeling that will maximize safety in useand require pharmaceutical companies to test proposed drug names toidentify potential sources of confusion with existing drug names. In addition,the Agency should work with physicians, pharmacists, consumers, andothers to establish appropriate responses to problems identified throughpost-marketing surveillance activities.

QuIC response. The QuIC endorses the IOM recommendation. FDAcurrently has a strong program of pre- and post-market surveillance, and ispleased that the President is committing $33 million, an increase of 65percent over last years funding level, in his FY 2001 budget to preventmedical errors associated with drugs and medical devices. Among otherthings, it would:

Initiate new efforts to ensure that pharmaceuticals are packaged andmarketed in a manner that promotes patient safety. Within one year, FDAwill develop new standards to help prevent medical errors caused byproprietary drug names that sound similar or packaging that looks similar,making it easy for health care providers to confuse medications. TheAgency will also develop new label standards by the end of the year that



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highlight common drug-drug interactions and dosage errors related tomedications.

The QuIC will ask the Quality Forum to define unambiguously, within 12months, a set of egregious errors that are preventable and should neveroccur. These measures will serve as criteria for a HCFA-sponsoredmandatory reporting demonstration project with a State that already has anexisting mandatory reporting requirement. HCFA will publish the hospitalrates for these events without patient identifiers.

HCFA and its QuIC partners will evaluate whether consumers found thisinformation valuable and what they understood about it. Based on theseresults, HCFA will move towards a national mandatory reporting system,with publication of findings, for all hospitals participating in Medicare.

Federal agencies, in partnership with other organizations, will developoptions for mandatory reporting systems that provide the public andpurchasers with publicly available information about programs andprocedures in place to reduce errors. This work will require thedevelopment of evidence-based, systems-level measures in collaborationwith the Quality Forum.

OPM will require that health plans have error reduction plans and will reporton its web site whether the health plans have reliable patient safetyinitiatives in place.

QuIC will ask the Quality Forum to identify, within 12 months, patient safetypractices that institutions should undertake and urges that informationabout whether the measures are in place be made available to the public.FDA will report to the public on the safety of drugs, devices, and biologicproducts.

QuIC proposes that State and Federal mandatory reporting systems, aswell as those of private accrediting and other oversight groups, be

evaluated to determine the ways in which they are helpful in assuring publicaccountability for patient safety, and that these results be used to developfuture reporting systems.

AHRQ will include information on patient safety in the National QualityReport it is developing in collaboration with other agencies, in particular,the National Center for Health Statistics.



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OPM will require that health plans describe their patient safety initiatives,will make patient safety information available in both print and electronicformats for the open enrollment period in Fall, 2000, and will expand itsWeb site to include information about programs designed to reduce errorsand enhance patient safety.

OPM will encourage health plans to annotate Preferred ProviderOrganization (PPO) directories to indicate which hospitals and physiciansoffices use automated information systems.

FDA will improve the safety of transfusions by expanding mandatoryreporting requirements for blood bank errors and accidents, so that theyapply to all registered blood establishments.

Learning from ErrorsThe new Center for Quality Improvement and Patient Safety (CQuIPS) atAHRQ will identify existing State and Federal reporting systems (bothmandatory and voluntary), evaluate their suitability in helping to build anational system of errors reporting, and evaluate how their data collectionor enforcement efforts can be enhanced to improve the value of thosesystems.

QuIC will work with the Quality Forum to develop reporting criteria thatassure that information can be pooled and shared as needed acrossorganizations.

CQuIPS, working with the QuIC, will describe and disseminate informationon characteristics of existing voluntary reporting programs associated withsuccessful error reduction and patient safety improvement efforts. FDA,CDC, and NASA will provide expertise in the development of thesenonpunitive systems.

Within six months, HCFA, working with a Peer Review Organization (PRO)program, will develop a pilot of a confidential, penalty-free learning systemwith several hospitals on a voluntary basis.

Federal agencies, including the FDA, VA, DoD, CDC, HCFA, and AHRQ,will integrate data from different sources and conduct and support analysisto identify error prone procedures, products, and systems.



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By August 2000, the DoD will complete development of a patient safetyimprovement program based on a reporting system modeled on that of theVA.VA will establish a voluntary reporting system to supplement its existingmandatory system.

AHRQ, in collaboration with other Federal agencies, will investigate,develop and test strategies to provide effective feedback to clinicians andinstitutions on methods for improving patient safety.

Federal agencies will assist health care providers to develop the skillsnecessary for analyzing adverse events and near misses (e.g., root causeanalysis, trending, search tools). Federal agencies providing health care

will develop internal systems to 1) identify and report errors to cliniciansand other decision makers, and 2) learn from those errors and near missesto prevent future events.

Outreach to Stakeholders: QuIC will develop programs to foster thedissemination of research findings to end users through activities such asAHRQs User Liaison Program; provide support to the Quality Forum toincrease the national discussion on errors, their reduction, andstandardized measures of errors; and fund collaborative agreements withhealth care professional organizations that foster education, track patientsafety initiatives, provide input to the new patient safety research centers,and translate, disseminate, and promote adoption of research findings.Patient Safety Clearinghouse: AHRQ will develop a clearinghouse inpartnership with other Federal agencies and private-sector organizations toprovide an objective source of state-of-the art information on patient safety.AHRQ will initiate a "National Morbidity & Mortality Conference" postingselected cases (stripped of identifying information) in a public forum viaInternet technology, and establish a Web site where patients can reportincidents that will be analyzed to identify emerging problems.

Peer Review ProtectionsThe QuIC supports the extension of peer review protections to facilitatereporting of errors in a blame-free environment, and will proposeconsiderations of confidentiality that will not undermine currentmechanisms to address criminal activity or negligence.



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As part the development of the national reporting system, appropriateelectronic protections (i.e., firewalls and encryption) will be constructed toensure that the confidentiality of the patients involved and the clinician orinstitution providing the information is maintained, and that the informationgathered will not be used for punitive purposes. Experience with reportingsystems in other industries demonstrates that this approach encouragesreporting of errors.

Setting Performance Standards and Expectations for Safety

Raising the Standards for Health Care OrganizationsHCFA will use its power as a purchaser and regulator to promote the use ofeffective error-reduction initiatives in the health care institutions with whichit deals.

HCFA will publish regulations this year requiring hospitals participating inthe Medicare Program to ongoing medical error reduction programs.OPM will follow the lead of selected private purchasers to raise thestandard for participation by requiring that all health plans with which itcontracts seek accreditation from an independent, national accreditingorganization that includes evaluation of patient safety and programs toreduce errors in health care.

Raising the Standards for Health Care ProfessionalsThe QuIC will:

Develop and evaluate programs introducing health professionals to errorsanalysis and the challenges of practicing in a technically complexenvironment, explore the use and testing of simulators and automation aseducation tools, support training in errors research and evaluation, anddevelop patient safety expertise at the State level using the CDCsEpidemic Intelligence Service as a model.

Convene a meeting of the accrediting, licensing, and certifying bodies ofthe health professions to review information on medical errors in thecontext of current practice requirements and propose methods ofstrengthening health professions education in the areas of medical errorprevention and medical error evaluation as a means of improving patientsafety.



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Collaborate with the Federation of State Medical Boards and other entitiesto encourage that error reduction and prevention education be a provisionfor relicensing of health professionals.

Collaborate in the planning, implementation, and evaluation of a nationalsummit addressing patient safety and medical error reduction programs,and in producing directives for the future.

Provide training within the QuIC agencies that provide care to encourageuse of patient safety information and encourage enhanced reporting inpartnership with private-sector accreditors, purchasers, and providers.Provide technical assistance to State or professional agencies seeking toensure a basic level of knowledge for health care providers on patientsafety issues.

Safe Use of Drugs and Devices

Within 1 year, the FDA will initiate programs to:

Develop additional standards for proprietary drug names to avoid nameconfusion.

Develop standards for packaging to prevent dosing and drug mix-ups.Develop new label standards for drugs, highlight drugdrug interactions,potential dosing errors, and address other common errors related tomedications.

Implement the Phase II pilot study of the Congressionally mandatedMedical Product Surveillance Network (MedSUN).

Intensify efforts to ensure manufacturers compliance with FDA programs,specifically naming, labeling, and packaging.

Provide access to databases linked to health care systems and othersources of adverse-event and marketing data, and link these to existingregistries of product users.

Complete the on-line Adverse Event Reporting Systems (AERS) for drugsand biologics.



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Strengthen FDA's analytical and investigative capacities.

Strengthen FDA outreach activities and collaboration with otherGovernment agencies and stakeholders

Under the leadership of the CQuIPS, the QuIC will promote, at theexecutive level, the development and dissemination of evidence-based,best patient-safety practices to provider organizations.

QuIC participants, including HCFA, VA, DoD, AHRQ, CDC, and FDA, willexplore opportunities with private-sector accreditation, purchaser, andprovider organizations to develop organization-based, patient-safetymodels that could be evaluated, and if found effective, disseminated widely.In addition, these stakeholders will be engaged in a regular dialogue with

QuIC participants to ensure that the stakeholders organizational needs arebeing met through Federal research and reporting initiatives.

Building Public Awareness of Medical ErrorsThrough the QuICs Enhancing Patient and Consumer Information WorkingGroup, led by OPM and HCFA, Federal agencies will develop andcoordinate an information campaign for their constituencies andbeneficiaries to increase their awareness of the problem of medical errorsand patient safety.

AHRQ will develop generic material for the public on preventing medicalerrors that Federal agencies can disseminate, reprint, or adapt. Thismaterial will enable patients to become more involved in their care and tobe more active participants in the decisionmaking surrounding their care.The CQuIPS will develop and test patient safety questions for inclusion inthe patient survey now being developed for provider-level assessment ofhealth care.

HCFA will conduct research aimed at shaping programs to educate

beneficiaries about medical errors.

Within 1 year, FDA will increase collaborative programs with patient andconsumer groups regarding patient safety.

FDA will enhance its interactions with the public through meetings withconsumer and patient organizations, and through grass-roots informational



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meetings. The meetings will focus on patient needs and the safe use ofmedical products, particularly for home use. The meetings will also discusshow to reach patients with important information on safe use of medicalproductsincluding through the use of local networks, the Internet, andelectronic and print media. This will occur within 1 year.

Building Purchasers Awareness of the ProblemBuilding on existing relationships with purchasers and business coalitions,such as the National Business Coalition on Health, and the Washington(DC) and Midwest Business Coalitions on Health, DOL, HCFA, OPM, andAHRQ will spearhead the QuICs efforts to promote collaborative programswith other public- and private-sector partners to increase purchasers andproviders awareness of medical errors as a health care problem and ofsteps that each can take to address this problem, such as addressing

patients health literacy skills.

At the Federal Benefits Conference (June 2000), OPM will shareinformation about patient safety with representatives from Federal agenciesthroughout the Nation.

Working with Providers to Improve Patient SafetyThrough the QuIC, Federal agencies will take advantage of existingresources to promote collaborative patient safety programs involvingagency constituents, the health professions community, the public,academia, and other stakeholders, such as the American MedicalAssociation, the American Nurses Association, NPSF, NPSP, and theQuality Forum.

VA will develop and run pilot patient safety education programs for medicalresidents and students.

Using Decision-support Systems and Information Technologies

AHRQ and CDC will expand research efforts in the area of informatics toinclude initiatives aimed at developing and evaluating electronic systems toidentify, track, and address patient safety concerns.

CQuIPS at AHRQ, along with VA, DoD, FDA and other QuIC memberagencies, will evaluate the effectiveness of automated physician orderentry systems in hospitals.



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DoD, VA, and IHS will introduce electronic patient records to offerstructured documentation and a common clinical lexicon for practitionersworking throughout those systems. The QuIC will encourage other potentialFederal participants to do likewise.

Using Standardized Procedures, Checklists, and the Results of HumanFactors Research

CDC and FDA will work with the DHHS Advisory Committee on BloodSafety and Availability to help ensure that the highest quality standards aremet in blood collection and transfusion.

Within 1 year, FDA will begin working with manufacturers of medical

products to explore incorporating standards, including human factorsstandards, into guidance to ensure that medical products are designed tominimize the chance of errors.

NASA will be invited to become a participant in QuIC activities and bring itsunderstanding and experience in redesigning processes and procedures toenhance safety. Linkages between NASA and the CQuIPS will beestablished through the NASA Medical Policy Board.

The QuIC will sponsor an educational program, noted in the section onresearch above, to increase the awareness of Federal regulators andpolicymakers regarding patient safety, human factors, and systems-basedimprovement.

VA will continue to work with private-sector organizations (e. g., theAmerican Hospital Association and JCAHO) to explore the utility of itscomprehensive error analysis and corrective action system.Author: Center for Disease Control and Prevention and U.S. Department ofHealth and Human Services

TAKE THE QUIZ: http://quizegg.com/q/73729



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References

Making Health Care Safer: A Critical Analysis of Patient Safety PracticesJuly 2001. Agency for Healthcare Research and QualitySource: Preventionof Medical Errors Continuing Education Ceus, Florida

Joint Commission on the Accreditation of Healthcare Organizations.

U.S. Department of Health and Human Services; Agency for Health CareResearch and Quality

fmt001 prevention of medical errors

Documents