- The link between patient safety and legal and regulatorycompliance
- The role of accreditation and standard-setting organizations inpatient safety
- Failure modes and effect analysis
- Voluntary and regulatory oversight of medical error
- Evidence-based outcomes and standards of care
- Creation and preservation of reports, data, and device evidencein medical error situations
- Claims management when dealing with patient safety events
- Full disclosure
- Patient safety in human research
- Managing confidentiality in the face of litigation
- Managing patient safety compliance through accountability-basedcredentialing for health care professionals
- Planning for the future
|Product dimensions:||9.25(w) x 7.50(h) x 0.60(d)|
About the Author
James R. Woods, Jr., MD is the Henry A. Thiede Professorand Chair of the Department of Obstetrics and Gynecology at theUniversity of Rochester School of Medicine, Rochester, NY. Dr.Woods has authored and co-authored over one hundred forty articleson maternal-fetal medicine, maternal drug addiction, complicationsof pregnancy and clinical research. His book publications includePregnancy Loss, Medical Therapeutics and PracticalConsiderations, and Loss in Pregnancy or in the NewbornPeriod. Dr. Woods has lectured extensively on loss and grief inthe medical setting. He has pioneered strategies for transformingsome of the most challenging clinical interactions with patientsafter adverse outcomes into extraordinary opportunities forcompassionate connection between clinicians and their patients andfamily members.
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The Handbook of Patient Safety Compliance
By Fay A. Rozovsky
John Wiley & SonsISBN: 0-7879-6510-3
Chapter OnePATIENT SAFETY
Crossing the Chasm from Legal and Regulatory Compliance
Fay A. Rozovsky
The concept of patient safety caught mainstream attention with the publication of To Err Is Human: Building a Safer Health System (Kohn, Corrigan, and Donaldson, 2000). This Institute of Medicine (IOM) report captured worldwide attention with the suggestion that every year, 44,000 to 98,000 Americans lose their lives to medical error, a startling statistic. The data suggested that health care took more lives than those lost to motor vehicle accidents, breast cancer, AIDS, and workplace accidents. The report suggested that these deaths were due largely to bad systems in American health care. Regulatory and market-based strategies were offered in the IOM report, along with a goal of at least a 50 percent reduction in medical errors over a five-year period.
Two major themes emerged in To Err Is Human: that medical error is a systemic problem and that concerns about liability make health care systems hesitant to report errors. Yet without such information the health care field cannot learn effectively about mistakes and make positive changes.
Federal agencies responded with a report that delineated a number of recommendations for implementing the strategies discussed in To Err Is Human. The Quality Interagency Coordination Task Force report (QuIC, 2000) outlined a number of measures intended to effect positive change. At the state level, a number of jurisdictions have enacted legislation with the goal of improving patient safety. This legislation has taken many forms, from laws about voluntary and mandatory reporting of medical errors and adverse events (for example, in Florida, New York, and Pennsylvania) (Flowers and Riley, 2001) to laws designed to encourage disclosure (for example, in Colorado) to laws that set nurse-patient ratios (for example, in California).
Systemic change has also been provoked by private organizations, associations, and accreditation bodies. Medical residency programs must now comply with well-defined parameters for the number of hours of work that program participants may perform. Patient safety indicators called never events have been promoted by the National Quality Forum (NQF). Additionally, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) has put in place a host of standards designed to enhance patient safety along the continuum of care (see, for example, JCAHO, 2004).
Notwithstanding this mosaic of federal and state laws and private initiatives, patient safety seems an elusive goal. That this is the case is reflected in subsequent reports from the IOM, data from other groups that collect information on medication errors, and case law reports. Frustration with persistent patient safety concerns has resulted in some rethinking about what can be done to reduce medical error. Moving from an approach premised on systemic change to more individual-based accountability is one step in this regard. Redesigning laws that address evidentiary protection is another area of serious consideration.
Clearly, patient safety is an evolving concept in contemporary health care. The terms that define patient safety continue to undergo change. Care providers, lawyers, and public policy professionals grapple with what can be done to bridge the chasm between the goal of patient safety on the one hand and on the other the legal and regulatory environment that must be put in place to promote significant reduction in medical error.
Terms That Define Patient Safety
In its recent report titled Patient Safety: Achieving a New Standard for Care, the Institute of Medicine pointed out that the patient safety field needs a standardized terminology to facilitate data aggregation (IOM, 2004). Absent a common taxonomy with terms that all can use, and absent a standardized format for obtaining and reporting data, the field will be hard pressed to learn and to improve systems. The lack of a coherent taxonomy means that health care organizations spend too much effort comparing apples to oranges rather than apples to apples and oranges to oranges. The lack of standardized information sets is ironic in a field driven by data. The reality is that an error barely averted might be a near miss at one health care organization and a good catch at another facility.
In Patient Safety, the IOM calls for a streamlined approach. If this approach is accepted, the health care field would use the HL7 Clinical Document Architecture format, which enables a user to incorporate a narrative section within the framework of a standardized taxonomy of terms. As new terminology is identified, it would be incorporated using the Systemized Nomenclature of Human and Veterinary Medicine or SNOMED CT. To facilitate use of this common ground of patient safety terminology, the National Library of Medicine would be funded to maintain and distribute the taxonomy. The World Health Organization would be encouraged to enhance the International Classification of Diseases (ICD) 9/10-CM E-codes to permit collection of information on adverse events. This would enable international comparisons in the patient safety arena.
From a legal and regulatory standpoint the 2004 IOM report portends new legal concerns. It includes suggestions about delineating omissions and commissions in medical error. It suggests employing both primary and secondary event types. The latter could be significant in litigation. Depending on the infrastructure of the taxonomy and the way in which these terms are used in a legal setting, these primary and secondary event types might translate into contributory negligence or comparative negligence if part of the accountability for an adverse event is ascribed to the patient or family caregiver. At a more fundamental legal level the taxonomy might also be used out of context by lawyers representing aggrieved patients. Terms like near miss, risk assessment index, and omission and commission could be portrayed in an electronic display before a jury and make more difficult for the defense the task of presenting factual information about what transpired in the occurrence.
There is a need for a consistent taxonomy of terms in the patient safety arena. There is a concomitant need for standardized data sets and other information with which to develop practical methods for error reduction. Using SNOMED CT and refreshing the content of ICD-9/10-CM E-codes are good starts. However, the developmental phase of the process needs to be schooled by an understanding of the ways the taxonomy and data may be used for other purposes. Medical malpractice litigation is but one example. The taxonomy and data might also be used in terminations of agreements between health care facilities and health plans, professional licensure proceedings, and regulatory inquiries by federal funding sources. If the terminology can be easily taken out of context and used for other purposes, the recoil may be a reluctance to use it. These concerns can be avoided. In developing the taxonomy and the data sets, several steps can be taken to ensure proper use:
The passage of legislation and regulations defining specific and limited uses of the taxonomy for purposes of patient safety and medical error reduction
The involvement of risk management professionals and health care attorneys in the process of developing a coherent, neutral taxonomy of terms
The inclusion of data weighting and stratification to ensure accurate use of the information and apple-to-apple comparisons
Restrictions on using data gathered in the reporting process as evidence in certain circumstances, including litigation
The education of the public and the media on how to interpret the results of data gleaned from the process
Whether or not these strategies are implemented, health care organizations can take positive steps to limit potential harm from embracing a standardized taxonomy of terms and data aggregation for patient safety. Working with legal counsel, risk management, and health information professionals, senior leadership can implement safeguards with respect to
Using and explaining information in reports
Explaining information to the community
By taking such steps, health care facilities can preempt out-of-context reports or other information use. Staff will know what the data and reports mean within the framework of the health care organization. Legal counsel defending the organization will have a solid foundation from which to respond to out-of-context use of the data by plaintiffs' counsel or those representing the government in an adjudicatory proceeding. The following example demonstrates this approach:
A hospital CEO learns that a patient safety report has received notoriety in the local press. The headline reads, "Falls out of control at local hospital." The article describes the findings of a patient safety project focused on medical-surgical falls. It highlights the fact that some 10 patients suffered injuries in postsurgical falls. What the article does not include are some very important data: the 10 falls occurred among a patient population of 5,500 identified as "at risk" for postsurgical falls. All the injuries involved bruises and contusions. There were no fractured limbs or internal injuries. Rather than a project that portrayed a disaster in patient care, the study was the culmination of a patient safety program for those at risk of falling in the twenty-four hours following inpatient surgery. The study had been conducted after the environment of care had been revamped and staff educated on fall avoidance. The number of falls had been reduced from 105 for a similar cohort a year earlier, when 3 patients had suffered pelvic and wrist fractures and 2 had sustained concussions. Instead of a hospital "out of control" on falls, the study revealed a major victory in patient safety.
Although the CEO has the public relations officer do some damage control, the public is irate. When confronted with the truth, the newspaper apologizes and promises to help unwind the false impression it created in its headline and story. The newspaper editor says that a reporter saw a storyboard on the study on a hospital bulletin board and misunderstood the information.
The lesson learned was this: when dealing with a new initiative (such as a patient safety taxonomy and data aggregation tool), make certain that all consumers of the information understand what they are reading and how to use the information.
The Legal and Regulatory Influences Constraining Patient Safety: Evidentiary Protection
A number of initiatives are underway to encourage the sharing of adverse-event information among health care organizations. The goal is to learn from these situations in order to reduce the likelihood of repetitions that could result in catastrophic injury. Few would dispute the importance of this laudable goal. Avoiding needless patient injuries while improving quality outcomes of care is a common theme found in acute care and other health care facilities. Aside from technical issues such as the taxonomy of terms and standardized data sets, some legal and regulatory constraints exist:
Legal requirements for confidentiality of data
Concern that identifying an adverse event will be tantamount to an admission of liability
Fear that sharing data outside the facility will be seen as a voluntary relinquishment of evidentiary protection under applicable state laws
Fear that providing data will mean a physician is blamed for the event and will result in corrective action under medical staff bylaws
Fear that providing data will mean that a nurse or pharmacist is disciplined or fired under the facility's employment requirements
Some may question whether these are substantive legal concerns or merely speculation engendered by a lack of understanding of the law. Addressing each item individually puts these concerns in context.
Legal Requirements for Confidentiality of Data
As is discussed later in this book (Chapter Eleven), there is no uniform legal approach to maintaining confidentiality of adverse-event information. Although some states provide strong legal protections, others do not do so. Further, the application of state-based confidentiality laws varies within each jurisdiction for hospitals, for long-term care facilities, and for other types of health care organizations.
The absence of confidentiality protection at the federal level also reinforces a concern that adverse-event information could be used for purposes that do not promote patient safety. Indeed, even when adverse-event information is generated under the protection of a state law provision, if those data are then properly obtained by a federal agency as part of a focused review involving patient safety, the information will no longer be cloaked by the state-based confidentiality requirements. This potential reinforces concerns about sharing adverse-event information.
Concern That Identifying an Adverse Event Will Be Tantamount to an Admission of Liability
There are some observers who believe that the mere characterization of an outcome as an adverse event will be interpreted as an admission of culpability for a negligent act. The prospect of this risk serves as a deterrent to reporting of adverse events. Although this risk appears to be remote, it can be addressed with a practical strategy. Statements can be included in the policy and procedure that specify the intent of the adverse-event reporting process. The description of the intent should make it clear that identification of adverse events does not constitute an admission of culpability or constitute a negligent act. And a definition should be included that gives precision to the meaning of adverse event. Even if adverse-event data is considered discoverable and admissible as evidence of negligent care, the defense can use the policy and procedure to correct any misunderstandings about the nature and purpose of the information. Implementing this type of strategy can help address the concern that adverse-event data may be seen as evidence of negligence.
Fear That Sharing Data Outside the Facility Will Be Seen as a Voluntary Relinquishment of Evidentiary Protection Under Applicable State Laws
A legitimate concern is that adverse-event data sharing among various health care facilities might abrogate evidentiary protection. This concern is genuine in some states, and the response in those states may be to refrain from sharing adverse-event data.
However, another approach is to explore how certain data elements can be shared with other entities without fear of this type of evidentiary outcome. One strategy may be to include participants from other health care facilities as members of the peer review or quality improvement process under which the data are generated and evaluated. The review of the data is enriched by including others as members of the protected review process, yet the data remain within the organization rather than migrating. Additional steps are needed to make this a practical option. Legal counsel need to examine carefully the specifics of state law to make certain that this approach will work. Additionally, bylaws, policies, and procedures of the facility may need to be amended to provide for others to participate in the review process. The review will have to be done at the data-generating organization.
Ideally, enhanced peer review and quality improvement laws will remove the need for employing such an option. Nonetheless, for those who want to share adverse-event information to improve patient safety, this may be a practical step.
Fear That Providing Data Will Mean a Physician Is Blamed for the Event and Will Result in Corrective Action Under Medical Staff Bylaws
Many physicians are concerned that adverse-event data may be used to affix blame on them, a concern that is incongruent with the underlying systems philosophy of the patient safety movement. Those who share this concern fear that a blaming mentality will have serious repercussions, including corrective action within the health care organization and possible licensure proceedings through the auspices of the state board regulating the practice of medicine.
There is a difference between a punitive approach and an accountability philosophy in patient safety. Assigning responsibility to physicians or blaming physicians for adverse outcomes does not recognize that most untoward events are the culmination of several systemic failures that coalesce in failure. It is easier to point a finger at some physicians than it is to tease out which system components failed and how these problems can be corrected.
Excerpted from The Handbook of Patient Safety Compliance by Fay A. Rozovsky Excerpted by permission.
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Table of ContentsFigures, Tables, and Exhibits.
Foreword (Maree Bellamy).
1. Patient Safety: Crossing the Chasm from Legal and RegulatoryCompliance (Fay A. Rozovsky).
2. Patient Safety Laws and Regulations (Ronni P.Solomon).
3. Medical Error Reduction Initiatives Among Accreditation andStandard-Setting Organizations (Fay A. Rozovsky).
4. Failure Modes and Effects Analysis: The Risks and the Rewardsin Health Care (Robert J. Latino).
5. Medication Error Reduction: Voluntary and RegulatoryOversight (David M. Benjamin, John P. Santell).
6. Benchmarking: Evidence-Based Outcome Information andStandards of Care (Peter J. Pronovost, Fay A. Rozovsky).
7. Creation and Preservation of Reports, Data, and DeviceEvidence in Medical Error Situations (Jane C. McConnell, SusanDurbin Kinter).
8. Claims Management Risks in Patient Safety Events (PamelaL. Popp).
9. Full Disclosure (James R. Woods Jr.).
10. Patient Safety in Human Research (Rodney K.Adams).
11. Medical Error Reporting: Maintaining Confidentiality in theFace of Litigation (Frederick Robinson, Lara E. Parkin).
12. Managing Patient Safety Compliance with Health Professionals(Mark A. Kadzielski, Christina W. Giles).
13. Planning for the Future (Fay A. Rozovsky, James R. WoodsJr.).