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Capgemini

Medication error and patient safety emerged as critical issues in health care in 1999 when the Institute of Medicine (IOM) released their report, To Err is Human: Building A Safer Health System. The report estimated that as many as 98,000 patients die in hospitals each year due to medical errors.

The topic of medication errors is not new. For almost 40 years, medication errors and adverse drug events have been discussed in various publications, but until relatively recently, most were observational studies and anecdotal reports. Organizations such as the Anesthesia Patient Safety Foundation worked actively on patient safety issues, but few others were fully engaged in this effort. Overall, until certain landmark events occurred during the mid-1990s, there was relatively little attention on a national level.

The first inkling of how large a role error plays in health care was revealed in 1991, when the Harvard Medical Practice study was published. This work suggested that 3.7 percent of approximately 30,195 admissions in New York state had accidental injuries, of which 28 percent were due to negligent care.^1,2The single most common form of adverse event was caused by medications (19 percent). This was a landmark work that set the stage for more definitive studies, as well as for the estimates used by the Institute of Medicine.³

In early 1995, national attention was focused on the error-related death of Betsy Lehman, a patient at the Dana-Farber Cancer Institute in Boston. A routine audit of Ms. Lehman's medical record reportedly showed that she had been administered four times the intended dose of chemotherapy, which resulted in her death from congestive heart failure. The fact that this error, which had also reportedly occurred in one other patient, had happened at a leading institution left the public uncertain of the quality of care being offered by all health care institutions.

In July of that year, the first adverse-drug-event prevention studies, or "Harvard ADE Studies," were published. These studies provided a greater understanding of medication errors and adverse drug events in hospitals, and new insight to systems failures in health care.^4,5 The initial studies by this group were later followed by additional insight as to how errors can be detected and potentially prevented through the use of computerized systems,^6,7 how ICU errors can be reduced by the presence of a pharmacist,⁸ and an estimation of the cost of adverse drug events.⁹

It is important to note that studies such as these publish snapshots of observations garnered from relatively few patient care areas. Therefore, using the actual data from these studies, such as percent errors that occur at any stage of the medication-use process, may be hazardous to the health of any quality improvement effort.

In July 1999, the Office of the Inspector General published a report that suggested that the collegial approach of the Joint Commission on the Accreditation of Healthcare Organizations was insufficient to guarantee patient safety. The report also suggested that institutional reporting rates should be published and compared.

The media campaign that followed the OIG report largely suggested that health care organizations were hiding their mistakes and that the best means for ensuring safety was public disclosure and punishment.

In March 1997, the President's Advisory Commission on Consumer Protection and Quality in the Health Care Industry, also known as the Quality Commission, was charged by the President to evaluate the health care system for opportunities for increasing quality, value, and consumer protection. In 1998, the commission published a report, "Quality First: Better Health Care for All Americans," that provided over 50 recommendations to address preventable medical errors, underutilization of health care services, overuse of certain services, and the wide variation in practice patterns evident in our health care system. The commission also included the Consumer Bill of Rights and Responsibilities, also known as the Patient Bill of Rights, which was endorsed by the President in November 1999.¹⁰

The report recommended the formation of two entities, one public and one private, to provide input on health care quality improvement on a national level. President Clinton directed the creation of the Quality Interagency Coordination Task Force. This group, convened in 1998, consists of the Departments of Defense; Veterans Affairs; Labor; Commerce (including the Coast Guard); Health and Human Services; the Offices of Personnel Management and Management and Budget; the Bureau of Prisons; the Federal Trade Commission; and the National Highway Traffic Safety Administration.

In December 1999, the task force was asked to respond to a report issued by the Institute of Medicine (IOM) of the National Academy of Sciences, which is a congressionally chartered adviser to the federal government. This report suggested that 45,000 to 98,000 people die each year because of treatment errors in U.S. hospitals.¹¹

While the estimates of patient injuries due to medical error are highly controversial, the IOM report resulted in a clear, industry-wide call to action by federal and state regulatory agencies.

This report, which was created by the IOM on the Quality of Health Care in America, made several recommendations, including:

• Congressional creation of a National Center for Patient Safety in the Agency for Healthcare Research and Quality (formerly the Agency for Health Care Policy and Research)
• A nationwide mandatory reporting system
• Encouragement of voluntary reporting
• Congressional action to consider data related to patient safety under peer review protection
• Increased attention to safety through changes in performance standards and expectations for health care organizations and health professionals
• Increased FDA attention to pre- and post-marketing drug safety
• Creation of patient safety programs by health care organizations and those professionals affiliated with them
• Implementation of proven medication safety practices by health care organizations

In February 2000, the task force delivered its report to the president.¹² The report recommended that the intent of the IOM recommendation to establish a Center for Patient Safety within the Agency for Healthcare Research and Quality (AHRQ) could be realized by establishing the Center for Quality Improvement and Patient Safety within AHRQ.

While the degree and magnitude of attention on medical errors on a national level is unprecedented, it has provided an environment of conflict and debate.

The attention given to medication errors by the literature, media, government, and private and public groups has been dramatic. Just as notable has been the confusion generated by so many groups providing guidance and opinion to their constituents about error prevention and reporting.

Because error in health care has reached the level of political debate, there are some public and private groups that are attempting to seize the day and secure some central, visible, and permanent role in error prevention.

While much is being debated, our patients and practitioners expect action. A path toward creating a "safety system" is necessary to ensure the safety of patients.

A "safety system" has been defined as a "set of managed, independent, organizational activities that reliably make potential errors visible, reduce risks, and mitigate the effects of errors."¹³ Features of a safety system include:

• Executive/board activities that are specific to safety (goal setting, quantitative progress reviews)
• Ongoing graphic and sound measurement and monitoring of safety, hazard, and conformance to safe practices
• Ongoing processes for learning from safety sciences and human factors research (both in and out of health care)
• Processes for maintaining and encouraging a participative culture, "beyond blame"
• Alignments of internal organizational incentives and recognition systems with safety improvement aims
• Knowledge of effective and efficient prevention methods and safe designs, and regular audits of conformance to those methods and designs

Key Terms and Definitions

Before the journey to assessment and improvement can begin, definitions for some common terms and standards against which medication-related issues will be identified and assessed must be established. These terms include:

Medications (or Drug)

Medications, or drugs, are defined in the Federal Food, Drug, and Cosmetic Act as "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals" and "articles (other than food) intended to affect the structure or any function of the body of man or other animals" (for example, articles intended for weight reduction).¹⁴

Alternative Medications (or Alternative Drug)

Alternative medications, otherwise known as "homeopathic remedies," are those that are available to the public without prescription, used to ameliorate some symptom or otherwise modify disease. Usually classified as "nutritional supplements," traditional Western medicine has generally regarded these products as ineffective, since the U.S. Food and Drug Administration does not regulate them. However, most substances found in these products are pharmacologically active and have the potential to interact with other medications and disease states, as well as have toxicities. Therefore, a patient's use of alternative medications is an essential part of their medication use history and is important to consider when evaluating a patient's overall medication profile.

Medication Misadventure, Adverse Drug Reaction/Event, and Medication Error

According to the American Society of Health-System Pharmacists (ASHP), a "medication misadventure" is an iatrogenic hazard or incident:

• That is an inherent risk when medication therapy is indicated.
• That is created through either omission or commission by the administration of a medicine with which a patient may be harmed; effects range from mild discomfort to fatality.
• Whose outcome may or may not be independent of the pre-existing pathology or disease.
• That may be attributable to error (human, system, or both), immunologic response.
• That is always unexpected or undesirable to the patient and health professional.¹⁵

There are many similarities between this definition and the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) definition for "medication error" (below), which is the one we recommend for standardization.

The World Health Organization (WHO) definition for adverse drug reactions (ADRs), adopted by many health care facilities nationwide, is no longer relevant for internal detection, reporting, and analysis purposes.

The WHO definition for ADR that was adopted by many health care institutions to meet the standards of the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) is ill-suited for error-prevention programs.

WHO defines an adverse drug reaction to be "any response to a drug which is noxious and unintended, and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease or for the modification of physiological function."¹⁶ Unfortunately, this definition does not include injuries caused by medication errors, which are considered to be the majority of patient injuries associated with medication use.¹⁷

Also, obsolete for error assessments are the nomograms used for assigning probable cause for ADRs. The most popular method, using the "Naranjo Nomogram,"¹⁸ has been in use for almost two decades. While such systems are usually easy to use and provide quick insight to the link between a drug and a reaction, they are not designed nor intended to provide insight into underlying or "root" causes, such as system or operator error, for the reaction. The FDA definition for ADRs is necessary for external, voluntary reporting to the FDA, but not for internal medication error reporting.

It is important to note that the FDA definition for ADR should still be maintained for external voluntary reporting by facilities, even though it is not directly related to error. The FDA defines an ADR as:

Any adverse event associated with the use of a drug in humans, whether or not considered drug-related, including adverse events occurring:

• In the course of the use of a drug product in professional practice
  
• From drug overdose (accidental or not)
  
• From drug abuse
  
• From drug withdrawal
  
• From any significant failure of pharmacologic action

All health care facilities must maintain this definition for external, voluntary reports to the FDA.

Since preventable adverse drug events (PADEs) are mostly caused by error, the NCC MERP definition for "medication error" is ideal for standardizing a definition for internal reporting purposes.

The NCC MERP has proposed that its definition become the national standard, which has been supported by groups closely related to the NCC MERP, such as the United States Pharmacopoeia (USP), Institute for Safe Medication Practices (ISMP), and others.

An "adverse drug event" has been defined as any injury resulting from medical intervention related to a drug.¹⁹ This broader definition encompasses both error and ADEs, as well as all injuries related to medications, whether or not as a result of error. But since preventable ADEs are mostly caused by error, facilities should standardize on "medication error" as the primary definition for process improvement.

The following definition for medication error was put forth by the NCC MERP:²⁰

A medication error is any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer.

Such events may be related to professional practice; health care products; procedures and systems, including prescribing; order communication; product labeling; packaging; and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use.

This definition spans the entire scope of medication use. With this definition, an error does not have to reach a patient to be reportable: near misses are opportunities for improvement.

As shown in Figure 1, ADEs and ADRs are treated similarly: both involve a reaction or injury to the patient. What is important is the relationship between error (preventability) and the event.

Figure 1: Relationship of Adverse Drug Event, Adverse Drug Reaction, and Error (Adapted from Bates DW et al. J Gen Intern Med. 1995;10: 199-205)

Sentinel Event

A sentinel event is defined by the JCAHO as an "unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof. Serious injury specifically includes loss of limb or function. The phrase, 'or the risk thereof' includes any process variation for which a recurrence would carry a significant chance of a serious adverse outcome. Such events are termed "sentinel" because they signal the need for immediate investigation and response." ²¹

Near Miss

The term "near miss" describes errors that occur but result in no harm. The value of monitoring near misses cannot be understated. The miss that is caught today may get through tomorrow or the day after that. Near misses are golden opportunities to improve quality without having been a result of patient injury or death.

Root Cause Analysis (RCA)

A "root cause" can be defined as the fundamental failure that initiated an error to occur. Numerous tools, techniques, and even software are targeted toward supporting root cause analyses. However, the easiest way to perform an RCA is through repetitive inquiry: a team keeps asking the simple question "why?" until no further answers can be given.

RCA is an invaluable tool and is a necessary component of any reporting system. It is also important to note that it is far more powerful when performed by an interdisciplinary team. While the answers to the why questions may seem obvious to some, the real underlying causes of errors are best found through the eyes of multiple disciplines.

Peer Review

Peer review is an internal process that enables performance improvement to occur in a manner usually considered to be protected from disclosure. This process has been the cornerstone for internal groups who review confidential materials related to incident/error reporting.

The peer-review process is generally maintained through internal review. If any element of a report is sent to a party considered to be outside of peer review, those data are now at risk for discovery or "redisclosure."

Redisclosure, when confidential information is shared with another party after initial reporting, is a risk for any error data that are shared with a party outside of the peer-review process, including external agencies and vendors.

While the integrity of the reporting process may be tightly maintained and defended by health care facilities, there are numerous opportunities for reports of medication errors and other incidents to be "redisclosed" after submission. For example, if an incident report is forwarded to a state agency, it is possible that the report is now considered in the public domain and accessible by any party outside of the performance-improvement environment.

In most situations, if reports are submitted to a third-party agency or database, they may be considered to be outside of the peer review process, and therefore treated as discoverable by parties wishing to include such reports in litigation.

What's the ideal culture? "One that's never satisfied. It's a dangerous feeling to believe you're the best." — Bob Lutz, former vice chairman, Chrysler

Detecting Medication Errors

There are two major components that lead to the analysis of medication errors: detection and reporting. This section will address detection mechanisms. The next section will address reporting methods and processes.

You Cannot Analyze What You Do Not Detect

The event detection system has both people and process, and sometimes machine components. Computer or laboratory detection cannot detect some events. For example, over-sedation with haloperidol (Haldol®) would most likely escape detection in most contemporary systems and might be found only on manual chart review. In situations like these, the human component is vital to event detection for reporting; while this type of event may be "accepted" as normal, the personnel involved with the care of the patient are best situated to capture this type of event as it happens.

You Cannot Detect What You Cannot See

Ways that errors can be made more visible include:

Active Detection

• Information systems interfaces, rules, and alerts. For example: synchronous computerized alerts that prevent an error from getting into the system in the first place (alert the prescriber to a four-fold overdose, for example)
  
• "Hot reporting," where a pharmacist or other health professional immediately investigates "target drug" orders or when out-of-range laboratories are reported
  
• Chart review/audit
  
• Review of ICD-9 error codes

Passive Detection

• Spontaneous reporting
  
• Quality management reports
  
• Medicolegal claims data

Active Detection Processes Incorporate Diligent Methods That Identify Potential Errors Without Relying on Human Reporting

A quality- or performance-improvement team that sets forth to discover errors can be like a submarine crew seeking another underwater craft. Active detection processes act like active sonar, where the medication-use system has to be actively "pinged," or diligently examined, for error. Passive detection processes are like passive sonar; a team would wait for a report to be filed just as a submarine crew waits for the other craft to make noise.

Use of "target drug" and "target lab" lists can assist in designing manual and/or computerized active detection processes for identifying potential medication errors. Facilities can use either manual or, preferably, computerized methods to discover events through the use of target drugs. These agents are usually antidotes or drugs used to correct or prevent adverse drug events.

Unexpected order changes also can be indicative of an adverse drug event or adverse drug reaction and can lead to identification of potential error. Order changes can also be flagged to discover potential adverse drug events. "Discontinue" orders given before a course of therapy is expected to end, "hold orders," or a reduction in dosage can also be indicators that an adverse drug event has occurred.

The literature has shown that even active detection systems that use computerization will not make all errors visible. Jha et al. ²² found that many errors may remain undetected, even though computerized methods for actively detecting medication errors increases efficiency and can reliably uncover an array of errors. Therefore, information systems alone cannot be relied upon to "deliver the program."

Manual chart review and staff interviews may uncover the greatest number of errors, but require substantial manpower.

The Adverse Drug Event Prevention Studies detected medication errors primarily through chart review and interviews with staff. While this method was highly effective in uncovering errors, it required an intensive use of resources. Regardless of whether error is detected through active or passive systems, time to report is critical for capturing important data elements.

As with any type of safety system, time is a critical element: the sooner the follow-up or intervention, the better. Otherwise, as time progresses, the trail gets colder, and the amount of information useful to design preventive strategies diminishes.

The best combination for detecting errors with efficiency is to combine active detection through the use of computers and passive detection through the use of non-punitive reporting processes.

Increasing manpower for chart audits to detect error is financially not feasible for most health care organizations. While the computer is efficient and cost-effective, it cannot detect all error. Therefore, spontaneous error reporting by personnel is critical to capture many types of errors, as well as to gain greater insight as to their prevention.

Non-Punitive Error Reporting

James Reason defines error to include all occasions where a planned sequence of events fails to achieve its intended outcome. ²³

Reason suggests that good performance and system error are opposite sides of the same coin. He proposes that before defining or classifying human error you must first understand what kind of intention was involved with the event. The three main categories of human error are:

• Non-intentional behavior.
  
• Unintentional behavior: slips (actions that happen but are not planned) and lapses (failure of memory).
  
• Intentional, but mistaken, behavior.

American health care has been embedded with zero tolerance for error, which is appropriate when given what is at stake when an error occurs. What has been inappropriate has been the punitive culture that has arisen from this environment, where punishment is practiced as the first and only remedial method for error.

As such, the reward usually awaiting the spontaneous reporter is disciplinary action, often regardless of whether the root cause of the error was the result of the reporter's action or inaction. In order to stimulate reporting and gain traction with improving performance, there needs to be a better way to encourage reporting other than penalization.

Non-punitive reporting policies are the only way to encourage spontaneous reporting of error.

The aviation industry has learned that non-punitive reporting policies and procedures greatly increase trust. Immunity policies for reporters have been shown to be associated with a 56 percent increase in reports to the Aviation Safety Reporting System.

The shift from "who's gonna get it?" to "what happened?" is a necessary change of focus for performance improvement.

Non-punitive policies and procedures do not remove or reduce the high expectations for personal responsibility and duty to the patient. The trust that health care personnel place in the reporting system must not overshadow the trust that our patients have in our care. So when should administrative action be taken in a situation involving error?

The FAA Aviation Safety Action Program (ASAP) provides some guidance in this area for personnel involved with commercial aviation. ²⁴ The elements of this program are set forth in a Memorandum of Understanding (MOU) between the FAA, certificate holders, management, and employee groups or their representatives. An adaptation of their recommendation is as follows:

Administrative action is a means for disposing of violations or alleged violations that do not warrant the use of legal enforcement sanctions. The two types of administrative action are:

• A warning notice
  
• A letter of correction

Administrative action may be taken in lieu of legal enforcement action when all of the following elements are present:

• Applicable law does not require legal enforcement action
  
• Lack of qualification or competency was not involved
  
• The violation was inadvertent and not deliberate
  
• The violation was not the result of a substantial disregard* for safety or security and the circumstances of the violation are not aggravated
  
• The alleged violator has a constructive attitude toward complying with the regulations
  
• The alleged violator has not been involved previously in similar violations
  
• After consideration of the above, a determination is made that administrative action will serve as an adequate deterrent

*In this system, "substantial disregard" means the act or failure to act was a substantial deviation from the degree of care, judgement, and responsibility normally expected of a person holding a license with that type, level of experience, and proficiency.

Leadership commitment to identification of solutions to medication errors and non-punitive reporting is critical to our combined success in creating the ideal culture for safety and reporting.

Internal Report Processing and Analysis

Looking for errors means looking for trouble, but not asking for it. The Pharmacy and Therapeutics Committee is ideally positioned to give the medication safety effort the greatest leverage and potential for success. Specific P&T-related activities can include:

• Looking at trends for dosages to see if drug companies can evaluate/produce unit doses or a different dosage vial to eliminate waste or margin for error in distribution.
• Scheduling the standardization of solutions/mixture and preparation in general dosages as a standard agenda item.
• Standardizing the monitoring and evaluation tools throughout the organization.
  • Number of times drug administered when there is an allergy documented
  • Measure monitor outcomes to determine future recommendations
  • Audit facilities for recommended policies
  • Number of inpatients and outpatients who receive armbands
  • Medication errors versus length of stay
  • Daily medications that are not time-dependent and should not be counted as an error if not given within 30 minutes before or after scheduled time
  • Track medication errors system-wide and isolate meaningful differences and best practices (such as processes related to staffing ratios, hours worked, or environmental variables) in facilities that have a low level of errors

Commissioning a Drug Safety Team

To support these activities, commissioning a Drug Safety Team as a subcommittee of the P&T committee can help maintain quality focus on the medication use process. The Drug Safety Team would ideally be an interdisciplinary subcommittee of the P&T committee. Representatives from the medical staff, nursing, pharmacy, quality, risk management, administration, and biomedical engineering should be standing members of the team.

It must be stressed that medication error reduction is not the responsibility of any one profession. It is interdisciplinary by definition and therefore should not be delegated as solely a "pharmacy" or "nursing" issue.

Harmonization of reporting paths for incident reports and adverse drug event reports must occur to ensure that the team and all stakeholders see the same data. This team would review all reports of patient injury involving a drug. The Drug Safety Team can perform two major roles:

• Ongoing performance improvement.
• As "crash team" for medication error root cause analysis and sentinel event review and reporting.

Upon commissioning, Drug Safety Teams will initially have two major tasks:

• "SWAT" team approach to bringing organization to compliance with short-term recommendations from design session. Particular attention will be paid to high-risk agents.
• Implementation of process redesign for event prevention, detection, and reporting

Interdisciplinary Root Cause Analysis: The Cornerstone of the Reporting Process

Traditional reporting processes have not provided sufficient detail for examiners to both understand the underlying cause of the error and categorize the error for trending. Root cause analysis provides the necessary detail to learn true system flaws as well as design system fixes to prevent recurrence.

For health care delivery networks, creating a Patient Safety Board at the corporate level can also support performance improvement across the entire network. The roles and responsibilities of the Patient Safety Board could be defined as:

• Establish short and long-term goals and implementation plan.
  
• Develop reporting mechanism/process for medical errors.
  
• Identify best demonstrated practice (BDP) trends, opportunities, and barriers to patient safety.
  
• Advocate voluntary reporting to select organization.
  
• Provide information and education to organization.
  
• Develop guidelines from BDP for facility use and/or implementation.
  
• Monitor compliance and approve timeline.

At a corporate level, depersonalized reports from individual facilities and practitioners could be analyzed for trends and enterprise-wide process improvement. This permits the Patient Safety Board to create toolkits for system fixes and assistance in sentinel event analysis and reporting.

Whether local, regional, or corporate, rapid dissemination of information across disciplines is key to providing both a pathway toward faster system improvement as well as the feedback those reporters desire.

Information from medication error reports has the power to affect not only local system performance, but also to improve the performance of the entire network. Further, rapid dissemination of knowledge gained from these reports is one of the best rewards for a reporter — otherwise, the only incentive for reporting would be the more traditional risk-avoidance approach.

Automated Methods for Reporting

Automated methods for reporting should be developed to encourage reporting as well as make the dissemination of reports "real time." Experience with automated reporting systems has shown that such systems can increase the number of reports simply by making reporting features easier and more accessible. The faster a report enters the system and can be disseminated, the quicker the follow-up and improvement opportunity.

Manual reporting methods are still the mainstay for most organizations and should be streamlined to improve the collection and dissemination of key data elements.

Besides the traditional reporting forms used in health care, one possible addition that comes from other industries is the institution of an "opportunity for improvement" process. Using an anonymous suggestion-box style for reporting, system weaknesses can be identified and reported with total impunity, allowing those individuals who still remain fearful of reporting errors or proposing solutions the opportunity to identify and improve the medication use system.

Certain Key Data Elements Are Important to Capture for Performance Improvement

Historically, incident reports and ADR reports have not included important information for either concurrent or retrospective error analysis. Along with harmonizing the pathway for this information to flow, new data elements that can help capture root causes of error are required in order to make any gains toward error prevention.

While traditional quality improvement tools lend themselves well to this effort, there is opportunity for out-of-the-box thinking to change "data" to "information" to "knowledge."

Traditional tools include process-flow diagrams, "fish bone" (Ishikawa) diagrams, and flow/control charts. All these are useful for error analysis for retrospective analysis.

For prospective analysis, which translates into active prevention, one of the more useful tools is "failure mode and effects analysis." This tool should be applied whenever a team wants to ask, "where will it happen" as opposed to, "where did it happen."

One example of a process flow that can depict errors in the medication use process is shown in Figure 2.

FIgure 2: TJe ise pf "dashboards" to depict system data can help P & T Committees take a "systemjs view" to process improvement. (Used with permission.)

The NCC MERP Taxonomy Is Useful for Structuring Event Reports into Discrete Categories for Analysis.

The NCC MERP taxonomy for categorizing medication errors has been available for several months ²⁵ but has not yet had widespread usage. It does provide one of the best structures to consider for internal reporting purposes and can be formed as the basis for internal report analysis.

For all patients to benefit from a system-wide performance improvement program, reporting will flow from the local facility to the corporate level.

The function of a network Patient Safety Board will necessitate the institution of a new process for sharing "depersonalized" reports with the group for enterprise-wide quality improvement. Information needed at this level has more to do with "what happened, and what can be done to prevent it from happening anywhere else at any other time," than "who did it." This information flow can then permit system-wide improvement to flow from the network level back to network members.

"Best practice" sharing can only be accomplished when best practices are known. Therefore, one of the objectives of analyzing reports at a corporate level is the ability to provide opportunities for sharing what works and what doesn't.

Benchmarking can be problematic. The lack of standardized definitions and reporting processes prevents meaningful comparisons of facility performance. For example, a facility that implements non-punitive reporting policies and procedures and subsequently improves reporting dramatically could be misinterpreted as having more errors than peers.

Focus should instead be on implementation of key interventions, process changes, and policies.

The risk that early, inappropriate benchmarking will deaden any improvement initiative should be well understood and acknowledged. The approach to improvement should focus on achievable, measurable interventions.

External Reporting

Recent media attention to the issue of error in health care has spawned a new debate. One of the central questions posed by both private and public parties alike is: should the reporting of errors to outside agencies become mandatory?

To achieve true performance improvement, there needs to be an environment that permits open sharing of information with internal as well as external parties whose sole interest is making the system safer for patients.

While this appears to be the current trend in patient safety, there is still controversy, and risk, in external sharing of information. The external environment is not yet supportive of non-punitive systems. Until that day arrives, facilities should promote the creation of an environment that best nurtures and supports safety and accountability.

"Mandatory Reporting" Should Mean "Doing the Right Thing"

Mandatory reporting means all stakeholders who should learn of error get the information they need to assist in preventing other systems from failing the patient in the same way.

Informing the patient and the family as soon as an error is discovered is not just good practice, it is also aligned with the high ethical and moral standards expected of health care facilities and patient caregivers.

This also extends to compliance with federal, state, and local regulations, as well as expectations set forth by the JCAHO, the Centers for Medicare and Medicaid Services (CMS), and other health care quality organizations. In this instance, compliance is not just about what is written in the rules, but that the underlying definition of error is adhered to when determining whether or not an error actually happened.

The CMS, state regulators, and the JCAHO require local reporting. While the current environment is still focused on punitive actions for organizations that report, there are still many benefits, including:

• By feeding into local process-improvement activities, knowledge about system failures can lead to prevention in other local organizations
• Compliance with local reporting reduces overall risk by openly sharing information and not providing any basis for appearing to "cover up" data
• While we believe in non-punitive systems, accountability must still be maintained, and local reporting provides the oversight that helps assure integrity by holding organizations and caregivers accountable for their actions
• Over time, local reporting will allow a measure of individual performance and in the future could lead to more meaningful comparisons and improvement opportunities for individual facilities
• Local efforts can effect changes at the individual practitioner level that might otherwise be difficult to accomplish
• Organizations can use "name suppression" for those performance improvement activities where the sole focus is on system, not individual performance

There is an expectation that all organizations should be in full compliance with their state and local regulations regarding reporting.

The "mandatory reporting" debate should instead focus on how we can make these reports beneficial for patients to the greatest extent possible. Each report of an error is an opportunity to improve the system. Currently, no local or national reporting systems have been established to gain the greatest degree of learning from errors.

One direction we recommend is compatible with those of major stakeholders such as AHA and the AMA/National Patient Safety Foundation.

The American Hospital Association (AHA) has taken the position that mandatory reporting may not be the best way to reduce these errors, but that a system of voluntary reporting and process improvement may, in fact, best minimize medical mistakes.

NPSF supports the federal plan to reduce medical errors and supports mandatory reporting under the following provisions: ²⁶

• The reporting system assigns accountability, but not blame
• Reporting system information should be independently reviewed and analyzed
• There needs to be "safe harbor" provisions to report mistakes without fear of reprisal or release of their names to the public or to licensing bodies
• Definitions for the types of errors that would be reported need to be clearly identified

This direction is also consistent with that of other groups, such as the American Society of Health-System Pharmacists.

The membership of ASHP largely comprises hospital pharmacists. (Of note, the ASHP Foundation, along with Harvard Risk Management Foundation, supported the second Harvard ADE prevention study, and not the Agency for Health Care Policy and Research, which supported the first.) ASHP believes that a national system for reporting should include: ²⁷

• Mandatory reporting of adverse events that cause death or serious harm using a standardized, uniform system.
• Continued development of voluntary reporting systems.
• Improved implementation of process changes that reduce risk of error and improve patient care.

ASHP characterizes the mandatory reporting system as follows:

• Overall focus on improving processes and analyzing/learning from reports
• Legal protection of confidentiality for patients and health care professionals
• Submission of a report does not result in punitive action, per se, against the individual or institution
• Defining "serious harm" as long-term or irreversible patient harm
• National efforts to ensure compliance with standardized methods of reporting, emphasizing process improvement while avoiding a culture of blame
• Adequate resources for timely dissemination of information from analyses, and development of appropriate quality improvement efforts

Periodic System Assessment to Ensure Mandatory Reporting Is Meeting its Intent

Consistent with the IOM, we believe that there needs to be a national, non-regulatory, interdisciplinary authority that oversees patient safety improvement with which facilities can form a mutually beneficial partnership.

The IOM report recommended the formation of a National Center for Patient Safety. This center would align all stakeholders, provided that it:

• Is non-regulatory
  
• Is interdisciplinary
  
• Has representation from human factors areas

In March 2000, a group of aerospace and health policy representatives were convened at a roundtable sponsored by the Kaiser Permanente Institute for Health Policy, the National Quality Forum, and the Peter F. Drucker Archive and Institute. This group, which included representatives from the JCAHO, NASA Ames Research Center, the Department of Veterans Affairs, the American Hospital Association, and others, suggested that the primary goals for a reporting system would be to improve safety and enhance public trust. ²⁸ The following elements for a reporting system were recommended:

• All patients should be informed when they have been injured receiving care
• Implementation of safety practices should be made public, so that there is external communication regarding the adoption of safety practices
• Adverse events and "near misses" reports should be made confidentially to a non-regulatory body (except for intentional unsafe or grossly negligent acts) for compilation, analysis, and dissemination. The group also suggested that a similar type of system be used to establish a National Center for Patient Safety.
• Existing state mandatory reporting systems should focus on errors related to violations of licensing regulations

We recommend the use of the USP Medication Error Reporting Program and the FDA MedWatch Program. The United States Pharmacopoeia (USP) is a private, not-for-profit organization that was established in 1820 for setting standards for medications. The United States Pharmacopoeia/ National Formulary (USP/NF) is recognized as the legal standard for various medication-related characteristics, including pharmaceutical purity, stability, and strength.

During the mid-1990s, the USP began to dramatically increase its activity in the area of medication error prevention. The USP Medication Errors Reporting Program (USP MERP) was established as a spontaneous reporting system for medication errors. It was established by and operates in relationship with the Institute for Safe Medication Practices.

The standard USP paper reporting system or Web-based reporting method provides opportunities for anonymous reporting without concern for redisclosure. Either can be easily accessible at the point of care and are easy to use.

In 1962, Congress passed the Kefauver-Harris Amendments to the Food, Drug, and Cosmetic Act of 1938, which required the FDA to have a spontaneous ADR reporting system and for manufacturers to report ADRs to the FDA. MedWatch was initiated in June 1993 to improve reporting documentation and processes for practitioners. The Medical Products Reporting Program of the Office of Epidemiology and Biostatistics administers it.

Historically, the FDA has expected practitioners to file serious adverse events (life-threatening, disabling, requiring hospitalization or intervention, resulting in death or congenital anomaly) and unexpected adverse events (not listed in product labeling or of greater severity or specificity than labeled).

The greater onus for reporting ADRs to MedWatch still remains largely with the pharmaceutical industry, where companies face regulatory actions for not reporting ADRs to the FDA. Further, serious or unexpected reactions require full reports within 15 days from the time the company first learns of an ADR. The clock begins as soon as any employee of the company, from pharmaceutical representative to drug safety specialist, learns about the reaction.

Hospitals and other health care providers do not have such requirements or expectations set forth under federal regulations. For health providers and health care institutions, MedWatch is a voluntary system. For adverse events or problems with products regulated by the FDA, the MedWatch form is used.

The ideal external reporting process would enhance learning from errors and would maximize patient trust without putting practitioners or facilities at risk for penalties or redisclosure. As described above, ideal external processes do not exist. That will not preclude facilities from creating internal processes.

Be Careful When Selecting Software for Reporting and Analysis of Events

Over the past several months, vendors that promote software and services aimed at medication error reporting and analysis have begun to proliferate. Some involve the use of Web-based systems.

Some Web-based systems have advantages over the paper methods. They generally structure reports, provide an easy/intuitive interface, and have graphic reporting capabilities. The primary disadvantage to these is, if the data are transmitted over the Internet to an external organization or server, the potential for redisclosure is unknown and untested, even with the use of confidential codes. Successful attempts at discovery of these data would lead to disclosure of potentially large amounts of organizational error data.

Patients' Rights

While the debate over patient disclosure is waged, it must be remembered that not only is there an ethical/moral basis to informing patients about errors that may occur in their care, but it also can be interpreted to be a patients' rights issue.

For example, the CMS and AHA have defined a patient's rights to include information regarding their treatment, including full access to their medical record. Further, patients have a right to be informed of their health status, be involved with their care planning and treatment, and to file a grievance when their care does not meet their expectations.

Clearly, a patient then has a right to be informed when an error has occurred, since untoward episodes of care impact a patient's health status and are documented in the medical record. This must be seriously considered when creating the organizational culture necessary to support processes and skills of how and when patients will be informed when an error has occurred in their care.

Regulatory Issues

The groundwork for the federal patient safety focus was laid by the CMS, the Medicare Payment Advisory Commission (MedPAC), and the Office of the Inspector General (OIG).

The Role of the Centers for Medicare and Medicaid Services

The CMS is a part of the U.S. Department of Health and Human Services. Its published mission is to provide consumer information that assists beneficiaries in making choices in health care, setting provider accountability for process and outcome criteria, and facilitating quality improvement activities at the program level by focusing on national Medicare/Medicaid key clinical priorities at the plan and provider level.

In December 1997, the CMS (at that time called the Health Care Financing Administration) published proposed rule changes for Medicare and Medicaid programs, including conditions of participation for hospitals. ²⁹ These changes included proposed medication errors assessments to be required for an organization to participate with Medicare and Medicaid. The proposal set a limit for overall medication error rates of no more than 2 percent, which was considered to be a "reasonable medication error rate to achieve" based on the opinions expressed in a single published paper, ³⁰ with "zero tolerance" for significant medication errors. However, these proposals were set aside during a legislative push to quickly respond to other proposals that would address rising public concerns about use of restraints and seclusion.

The Role of MedPAC

In June 1999, MedPAC published recommendations to Congress regarding how health care errors should be addressed under the Medicare program. ³¹ Among the most progressive of federal reports, this report made several recommendations for the Secretary of Health and Human Services:

• Establish patient safety as a quality improvement priority for Medicare and take steps to minimize the incidence of preventable errors in the delivery of care to Medicare beneficiaries
• Support and make use of ongoing public and private error-reduction initiatives, including those that promote incident reporting by providers, analysis of root causes and patterns in occurrence, and dissemination of information designed to prevent recurrence through Medicare's policies and quality improvement activities
• Consider opportunities for minimizing avoidable errors in delivery through coverage and payment policies, quality measurement initiatives, and quality improvement programs.
• Work with providers and other stakeholders to identify and promote effective and efficient processes, structures, and activities for reducing preventable errors and to set progressive targets of improvement in patient safety through Medicare quality improvement programs
• Do not establish requirements that specify "maximum tolerance rates" of errors in health care delivery under Medicare's conditions of participation for health care providers
• Fund research to study appropriate use of autopsies and to evaluate approaches for using information derived from autopsies in health care quality improvement and error-reduction initiatives

The report also recommended that Congress enact legislation to protect the confidentiality of individually identifiable information relating to errors in health care delivery when that information is reported for quality improvement activities.

The Role of the Office of Inspector General

The OIG is a federal office that is charged with overseeing the integrity of programs that fall under the Federal Department of Health and Human Services and performs audits and other investigations, including sanctions, for the Department.

The debate about the "collegial" versus "regulatory" approaches to patient safety surfaced in July 1999, when the OIG published a four-part report, "The External Review of Hospital Quality." ^32-35

While the report did acknowledge that the current system of JCAHO and state agencies had its strengths, there was concern that the "collegial" approach, where the emphasis is placed on education and individual accountability, was winning over the "regulatory" approach, which is punitive in nature. The report further suggested that the JCAHO continue to tilt toward the collegial approach, while state agencies maintain the regulatory approach. This report provided several recommendations for the CMS:

• Hold JCAHO and state agencies more accountable for their performance in reviewing hospitals (This included recommendations that the CMS make performance data public, including publishing facility-specific and incident-specific information on the Internet.)

• Determine the minimum cycle for reviewing non-accredited organizations in order to reduce the backlog for surveying provider organizations

The OIG report fueled further debates about mandatory versus voluntary reporting, public disclosure of error information, as well as benchmarking facilities against each other using safety data. The basis for this debate was public access to information.

Further, the concept of a system where the JCAHO would be largely permitted to be the "good guy," and the state agencies be permitted to continue their regulatory approach to find guilt and assign blame was suggested. In such a system, a hospital that reports a sentinel event could possibly be held up by the JCAHO as an example of an organization that performed an excellent root cause analysis and improvement plan, while the state agency makes an example of the hospital through findings of regulatory violations. This type of "good cop, bad cop" approach, by itself, does not encourage active and open participation in error reporting, since the punitive nature of the environment still exists.

Errors Associated With Packaging, Labeling, and Branding

Subsequent changes at the FDA may directly impact many common types of errors associated with packaging, labeling, and branding.The FDA Office of Post-Marketing Drug Risk Assessment is currently taking steps to address "look-alike, sound-alike" products, with a particular focus on reducing the opportunity for error before a product reaches the market.

New Legislation Proposed to Make Patient Safety a Priority

The IOM recommendations spawned several new legislative initiatives at both federal and state levels. The resulting debate, as well as the current priorities of Congress, may stall many or all of them.

Health Care Groups

The Leapfrog Group

This group, which includes the Pacific Business Group on Health, the Buyers Health Care Action Group, and General Motors, announced in 1999 that it would have two major areas of initial focus in health care quality improvement:

• Incorporating the relationships between service volumes and outcomes in determining appropriate sites of service
• Promoting the installation of physician order entry systems into hospitals to reduce medical error

National Committee for Quality Assurance (NCQA)

The NCQA, which accredits health plans, has determined that all participating organizations must have documented development of patient safety plans by 2001, and have implemented activities by 2002. ³⁶

Massachusetts Coalition for the Prevention of Medical Errors

This group has published recommendations for hospitals as well as patient teaching materials.

The Pharmaceutical Research and Manufacturers Association (PhRMA)

PhRMA was notably tacit after the release of the IOM report as well as during subsequent months when demands for standardizing bar codes for medications came from provider organizations.

As of this writing, the FDA has released proposed rule changes that address the bar coding of medications. While less than a handful of companies have publicly embraced the bar coding effort, a national standard should be in place some time over the next three to five years.

Consumer Advocacy Groups

A number of consumer advocacy groups, such as Public Citizen, have also weighed in on the issue of medical error. Most groups urge that all data concerning all errors be released to the public, and that those involved be punished and/or terminated.

The major themes of many of these groups are accountability and justice. While any theme can be taken into extremes, they are, in essence, consistent with the vision that we must be ever-vigilant to protect patients against injury, and potential injury, that can arise in their care.

The Future State "Living Safety System"

Establishing a Non-Punitive Reporting Process Is the Only Means to Ensure Adequate Reporting of Errors

Much has been published about changing the culture of the health care environment from one that primarily seeks to assess blame and punishment for error, to one that first looks for where the system failed to allow the error to occur.

James Reason, Professor of Psychology at the University of Manchester and world-renowned thought-leader in human error, wrote, "Rather than being the main instigators of an accident, operators tend to be the inheritors of system defects. … Their part is that of adding the final garnish to a lethal brew whose ingredients have already been long in the cooking."

This is a drastic change for health care, which has for generations perpetuated a culture where losing your job may be the first and only punishment you receive for being implicated in an error. Therefore, what has been outlined above regarding non-punitive systems is a cornerstone of the future state system.

The "living safety system," as shown in Figure 3, is one that can respond instantly to error or potential patient harm and prevent the error or injury from happening to a patient.

Figure 3: A "living system" integrates all data into a system that can react when necessary to protect the patient from error or harm.

An example of the "living safety system" is as follows:

A patient who is being treated for hypokalemia with potassium chloride has had the underlying cause for potassium loss corrected, yet the order for the potassium chloride is still active on the patient record. A routine check of the patient's electrolytes shows that the serum potassium has risen to toxic levels.

The laboratory system, which is interfaced with the practitioner order entry system, the pharmacy system, the medication administration record, the hospital paging system, the automated dispensing device, and the medication administration bar code system, fires an alert.

The prescriber becomes alerted to the fact that a patient is in danger due to hyperkalemia through his beeper as well as an alert as he logs on to the practitioner order entry system. The pharmacist is alerted through a warning sent to the pharmacy system, and the nurse is alerted via the electronic MAR.

The pharmacy system will not permit the pharmacist to dispense potassium chloride for the patient, the automated dispensing device will not permit potassium to be removed from the cabinet, and the bar code checking software will immediately warn the nurse that administering potassium chloride to the patient could be harmful or fatal.

This living safety system, therefore, integrates all knowledge about a patient and the process together so that intervention can be immediate, effective, and involve all possible use of automation to provide necessary forcing functions as a backup to human systems.

Conclusion

We believe the key to success is taking a proactive, evidence-based approach to addressing safety in our health care systems. Health care leaders should be committed to:

• Providing leadership that will drive enhancements into systems that will enhance safety for all patients and will serve as a role model for others to follow
• Creating approaches to error detection, reporting, analysis, and prevention that is interdisciplinary and evidence-based, and that is committed to a systems approach
• Providing patient-focused care that is inclusive of the patient and family as participants in their care
• Establishing mechanisms for sharing information across the networks for health care quality improvement

It is our belief that this is more than just good practice; it is all about taking even better care of patients.

Endnotes

1 Leape, L.L., Brennan, T.A., Laird, N., et al. "The Nature of Adverse Events in Hospitalized Patients: Results of the Harvard Medical Practice Study II." New England Journal of Medicine. 324 (1991): 377-84.

2 Brennan, T.A., Leape, L.L., Laird, N.M., et al. "Incidence of Adverse Events and Negligence in Hospitalized Patients: Results of the Harvard Medical Practice Study I." New England Journal of Medicine 324 (1991): 370-6.

3 Kohn, L.T., Corrigan, Jim, Donaldson, M.S., Eds. To Err is Human: Building a Safer Health System. Washington: National Academy Press, 1999.

4 Leape, L.L., Bates, D.W., Cullen, D.J., Cooper, J., DeMonaco, H., Gallivan, T., Hallisey, R., Ives, J., Laird, N., Laffell, G., Nemeskal, R., Peterson, L.A., Porter, K., Servi, D., Shea, B.F., Small, S., Sweitzer, B., Thompson, T., VanderVliet, M. "Systems Analysis of Adverse Drug Events." JAMA 274 (1995): 35-43.

5 Bates, D.W., Cullen, D.J., Laird, N., Peterson, L.A., Small, S.D., Servi, D., Laffel, G., Sweitzer, B.J., Shea, B.F., Hallisey, R., VanderVliet, M., Nemeskal, R., Leape, L.L., and the ADE Prevention Study Group. "Incidence of Adverse Drug Events and Potential Adverse Drug Events: Implications for Prevention." JAMA 274 (1995): 29-34.

6 Jha, A.K., Kuperman, G.J., Teich, J.M., Leape, L., Shea, B., Rittenberg, E., et al. "Identifying Adverse Drug Events: Development of a Computer-Based Monitor and Comparison with Chart Review and Stimulated Voluntary Report." Journal of the American Medical Informatics Association May-Jun 5 (1998): 305-14.

7 Bates, D.W., Leape, L.L., Cullen, D.J., Laird, N., Petersen, L.A., Teich, J.M., Burdick, E., Hickey, M., Kleefield, S., Shea, B., VanderVliet, M., Seger, D.L. "Effect of Computerized Physician Order Entry and a Team Intervention on Prevention of Serious Medication Errors." JAMA 280 (1998): 1311-6.

8 Leape, L.L., Cullen, D.J., Clapp, M.D., et al. "Pharmacist Participation on Physician Rounds and Adverse Drug Events in the Intensive Care Unit." JAMA 282 (1997): 267-70.

9 Bates, D.W., Spell, N., Cullen, D.J., et al. "The Costs of Adverse Drug Events in Hospitalized Patients." JAMA 277 (1997): 307-11.

10 Consumer Bill of Rights and Responsibilities. Healthcare Quality Commission Web site: www.hcqualitycommission.gov

11 Institute of Medicine (US). To Err is Human: Building a Safer Health System. Washington: The Institute. 1999.

12 The Quality Interagency Coordination Task Force. Doing What Counts: Federal Actions to Reduce Medical Errors and Their Impact. February 2000.

13 Phillips, D.F. 'New Look' Reflects Changing Style of Patient Safety Enhancement." JAMA 281 (1999): 217-9.

14 Federal Food Drug and Cosmetic Act of 1938. 21 U.S.C. 321- 201 (g)(1)(B) and (g)(1)(C)

15 Manasse, H.R. Jr. "Medication Use in an Imperfect World: Drug Misadventuring as an Issue." American Journal of Hospital Pharmacy 46 (1989): 929-44.

16 Consultant, Council for International Organizations of Medical Sciences (CIOMS). Establishing Requirements for the Use of Terms for Adverse Drug Reactions (ADR). Mater. Med. Pol. 25 (1993): 45-6.

17 Classen, D.C., Pestotnik, S.L., Evans, R.S., Burke, J.P. "Computerized Surveillance of Adverse Drug Events in Hospital Patients." JAMA 324:266 (1991): 2847-51.

18 Naranjo, C.A., Busto, U., Sellers, E.M., Sandor, P., Ruiz, I., Roberts, E.A., Janecek, E., Domecq, C., Greenblatt, D.J. "A Method for Estimating the Probability of Adverse Drug Reactions." Journal of Clinical Pharmacy and Therapeutics Aug. (2)30 (1981): 239-45.

19 See reference 4.

20 National Coordinating Council on Medication Error Reporting and Prevention. NCC MERP Taxonomy of Medication Errors. Rockville, MD. 1997.

21 Joint Commission on the Accreditation of Healthcare Organizations Standards.

22 Jha, A.K., Kuperman, G., Teich, J.M., Leape, L.L., Shea, B., et al. "Identifying Adverse Drug Events: Development of a Computer-Based Monitor and Comparison with Chart Review and Stimulated Voluntary Report." Journal of the American Medical Informatics Association 5 (1998): 305-14.

23 Reason, J. Human Error. Cambridge, England: Cambridge University Press. 1990.

24 National Aeronautics and Space Administration. Aviation Safety Reporting System: Program Overview. 1998.

25 See reference 18.

26 National Patient Safety Foundation. NPSF supports mandatory reporting with specific provisions to improve patient safety. NPSF Press Release Feb 25, 2000.

27 ASHP statement on reporting medical errors. American Journal of Health-System Pharmacy 57 (2000): 1531-2.

28 Kaiser Permanente Institute for Health Policy, the National Quality Forum, and the Peter F. Drucker Archive and Institute. Roundtable Discussion: Reporting as a Means to Improve Patient Safety. Claremont, California: March 16-17, 2000.

29 Health Care Financing Administration, Department of Health and Human Services. 42 CFR Parts 416, 482, 485, and 489: Medicare and Medicaid Programs: Hospital Conditions of Participation, Provider Agreements and Supplier Approvals: Proposed Rule. Federal Register Dec 19, 1997.

30 Barker, K.N., Harris, J.A., Webster, D.B., Stringer, J.F., Pearson, R.E., Mikeal, R.L., Glotzhober, G.R., Miller, G.J. "Consultant Evaluation of a Hospital Medication System: Analysis of the Existing System." American Journal of Hospital Pharmacy 41 (1984): 2009-16.

31 The Medicare Payment Advisory Committee Report to Congress. June 1999.

32 Department of Health and Human Services Office of the Inspector General. The External Review of Hospital Quality: A Call for Greater Accountability. July 1999: OEI-01-97-00050;

33 Department of Health and Human Services Office of the Inspector General. The External Review of Hospital Quality OIG Report: Holding the Reviewers Accountable. July 1999: OEI-01-97-00053;

34 Department of Health and Human Services Office of the Inspector General. The External Review of Hospital Quality OIG Report: Role of Accreditation. July 1999: OEI-01-97-00051.

35 Department of Health and Human Services Office of the Inspector General. The External Review of Hospital Quality OIG Report: Role of Medicare Certification. July 1999: OEI-01-97-00052.

36 National Committee for Quality Assurance (NCQA). Proposed Patient Safety Modifications to the MCHO and MBHO 2001 Standards. Washington DC: NCQA. April 2000.

37 Phillips, D.F. "'New Look' Reflects Changing Style of Patient Safety Enhancement." JAMA 281 (1999): 217-9.

About the Author

Title: 

Senior Manager

Capgemini

Brian F. Shea, Pharm.D. is a senior manager with CGE&Y and a former member of the Harvard ADE Prevention Study Group. He has dedicated his career to improving the materials and standards applied by the pharmacy and physician communities to improve a patient''s safety. Dr. Shea has served as the Secretary of the Pharmacy and Therapeutics Committee at Brigham and Women''s Hospital and was elected a fellow of the American College of Clinical Pharmacy in 1997.