Statement of the American Academy of Orthopaedic Surgeons

The American Academy of Orthopaedic Surgeons (AAOS), representing 18,000 board-certified orthopaedic surgeons, appreciates Chairman Johnson’s efforts to hold a hearing to address health quality and patient safety.  AAOS has long supported initiatives to reduce medical errors and improve the quality of health care not only for Medicare patients, but for all health care recipients. 

AAOS shares the concerns of the Subcommittee on Health that medical adverse events must be decreased, especially in light of the recent report by the Institute of Medicine: To Err is Human: Building a Safer Health System. We agree that there is a need to create a culture of safety in reporting, and that we must embrace efforts that continuously strive to improve the quality of patient care. 

AAOS has designated the elimination of medical errors as a high priority in our policies and practices, and, as a result, has committed significant financial and clinical resources to educate our members in the practice of safe care.  We are pleased to share highlights of our work over the past several years to reduce or eliminate specific types of surgical errors. 

In 1997, we launched the “Sign Your Site” initiative, an education program that urges surgeons of all surgical specialties to mark the operative site, in consultation with the patient, as part of their pre-surgery routine.  This protocol has the overwhelming support of our members, who believe this program will prevent wrong-site surgery.  Numerous hospitals throughout the country have responded positively to this campaign, and mandatory “Sign Your Site” programs have been initiated at an increasing number of hospitals.  AAOS supports the “Sign Your Site” initiative as a required protocol for every hospital seeking certification by the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO).  We also believe that a unified effort among surgeons, hospitals and other health care providers to initiate pre-operative and other procedures will help to prevent surgical error. 

Since 1990, the AAOS Committee on Professional Liability has conducted a series of closed-claim professional liability insurance studies, through on-site retrospective review of the records of insurance companies across the country, in order to assist orthopaedic surgeons in providing optimum patient care.  Several orthopaedic diagnoses and procedures have been reviewed, including foot and ankle surgery, spine surgery and spine fusion, total hip and knee replacement, knee arthroscopy, fractures of the hip, femur and tibia, and pediatric problems, and have resulted in the publication of two books and numerous articles that have identified trends in unexpected outcomes and medical errors and provided risk management.  From these studies, we have been able to establish or clarify appropriate treatment protocols and methods of operation, enabling us to promote safe and appropriate surgical practice.  This guidance emphasizes thorough patient consent discussions about treatment options and alternatives, risks of treatment, non-treatment, and patient expectations regarding eventual functional ability after treatment. 

The AAOS Board of Directors recently created a “Patient Safety Committee” within the organization to promote safe practices and to reduce and prevent adverse events that could occur in orthopaedic practice.  This permanent committee will undertake several initiatives over the next few years to enhance member and patient knowledge about safe medical practices.  A few of the Committee’s goals include the development of educational programs and communication publications that will alert our members to potential medical product and drug interaction complications; development of a curriculum on patient safety for adoption into residency and fellowship programs; and development of working relationships with other professional societies and federal agencies that will focus on community based and national collaborative initiatives for implementation of patient safety improvements.  A major charge to the Committee will be the continued education of AAOS members to achieve a culture of safety within their practice and to incorporate patient safety considerations into practice guidelines. 

AAOS also remains a recognized leader in the process of Continuous Quality Improvement (CQI), an important cornerstone of our strategic plan that helps us provide “Best Care” to our patients.  We have developed a comprehensive patient education program that will empower patients by encouraging them to take control of managing their own health care and increased communications to the public about the AAOS’ own commitment to this effort.  The AAOS Committee on Evidence Based Medicine remains focused on developing clinical practice guidelines and performance measures to improve quality and efficiency of care, which can be used to assist physicians in diagnosis and treatment decisions.

In addition to our internal education efforts, we continue to look beyond our own organization to work with Federal agencies and other health care organizations that support efforts to reduce medical errors.  The Department of Health and Human Services’ Agency for Healthcare Research and Quality (AHRQ) dedicated itself under the leadership of Director John Eisenberg, MD, to conduct and disseminate research in order to improve the outcomes, quality, access, cost and utilization of health care services.  We have maintained a dialogue with key AHRQ staff to continue to provide input into their research efforts and medical error projects, and AAOS Fellows have participated in discussions surrounding the formation of a key AHRQ initiative, the Patient Safety Task Force.  This Task Force has begun to evaluate and explore ways to minimize the burden of reporting adverse events and errors and to explore the development of a single, coordinated system for collecting data that would be easy to use and would provide reliable, valid information. 

We are active participants in the National Quality Forum (NQF), a not-for-profit public-private membership organization established to develop and implement a national strategy for health care quality measurement and reporting.  AAOS remains committed to participating in the Ambulatory Surgical Care Consensus Project of the National Patient Safety Foundation, a broad-based partnership of health care clinicians, consumer advocates, health product manufacturers, public and private employers and payers, researchers, regulators, and policymakers. 

AAOS, as part of a large group of national health care organizations, developed a set of key principles and safeguards that we believe should be incorporated into voluntary patient safety reporting systems. 

These principles call for: the creation of a non-punitive environment for safety reporting that focuses on preventing and correcting systems as opposed to laying blame on individuals or organizations, a comprehensive analysis of data to identify where improvements can be made and new protocols should be developed, assurance of confidentiality protections for patients, healthcare professionals and organizations, the ability to disseminate and share patient safety information to facilitate positive improvements, and federal protection for reporting system information.  We believe it is critical that data collected and shared for the purposes of improving patient safety be privileged, or use of patient safety reporting systems may ultimately be discouraged.  (Please see attached listing of principles.)    

As the Subcommittee evaluates appropriate responses to prevent patient harm and minimize health systems errors, policies should encourage a constructive partnership between the federal government, hospitals, physicians, and other medical providers and personnel.  These public and private initiatives should be encouraged through a non-punitive, cooperative environment, and should take a system-wide approach that ensures patient confidentiality and appropriate legal protection of all information involved in patient safety reporting systems.  Before instituting new reporting systems, AAOS encourages federal and state governments to determine through initial, scientifically sound research whether and how existing reporting programs have led to a reduction in medical errors. 

AAOS thanks Chairman Johnson, and the members of the Subcommittee for holding this important hearing.  We stand ready to work with the Subcommittee and other Members of Congress to ensure safe practices in our health care system.

General Principles for Patient Safety Reporting Systems

1.  Creating an Environment for Safety.  There should be a nonpunitive culture for reporting healthcare errors that focuses on preventing and correcting systems failures and not on individual or organization culpability. 

• Healthcare professionals and organizations should foster a positive atmosphere that encourages the submission of healthcare error reports to public or private oversight organizations, accrediting bodies, an official compendial body, or other generally recognized patient safety reporting systems.  The existence of a reporting system does not relieve healthcare professionals and organizations of their responsibility to maintain professionally recognized standards of care.

2.  Data Analysis.  Information submitted to reporting systems must be comprehensively analyzed to identify actions that would minimize the risk that reported events recur. 

• Systems within organizations should be scrutinized to identify weaknesses and processes that make healthcare errors possible or likely to occur, and to identify actions to prevent future errors.  Effective procedures and/or protocols developed through reporting systems should be compiled and widely disseminated to all healthcare professionals and organizations.

3.  Confidentiality.  Confidentiality protections for patients, healthcare professionals, and healthcare organizations are essential to the ability of any reporting system to learn about errors and effect their reduction. 

• Reporting systems should protect the identity of individual patients and abide by all relevant confidentiality laws and regulations.  The identities of healthcare professionals and organizations involved in errors should not be disclosed outside a reporting system without consent.

4.  Information Sharing.  Reporting systems should facilitate the sharing of patient safety information among healthcare organizations and foster confidential collaboration with other healthcare reporting systems.

• Sharing information is fundamental to a reporting system’s ability to achieve widespread improvements in patient safety and to instill a confidence in the public that safety issues are being addressed.  Sharing of error-related information is subject to the confidentiality principle.
• The causes of errors and their solutions must be widely shared so that all healthcare organizations can learn from the experiences of others.
• In some circumstances, it will be desirable to share reports of errors among reporting systems, and with other appropriate quality improvement entities, in order to accomplish root cause analyses, to construct action plans, and to engage in other efforts to enhance patient safety.

5.  Legal Status of Reporting System Information.  The absence of federal protection for information submitted to patient safety reporting systems discourages the use of such systems, which reduces the opportunity to identify trends and implement corrective measures.  Informationdeveloped in connection with reporting systems should be privileged for purposes of federal and state judicial proceedings in civil matters, and for purposes of federal and state administrative proceedings, including with respect to discovery, subpoenas, testimony, or any other form of disclosure.

(a) Scope.  The privilege for the information prepared for a reporting system should extend to any data, report, memorandum, analysis, statement, or other communication developed for the purposes of the system. This privilege should not interfere with the disclosure of information that is otherwise available, including the right of individuals to access their own medical records.

(b) No Waiver.  The submission of healthcare error information to a reporting system, or the sharing of information by healthcare organizations or reporting systems with third parties in accordance with these principles, should not be construed as waiving this privilege or any other privilege under federal or state law that exists with respect to the information. 

(c) Freedom of Information Act.  Healthcare error information received by and from reporting systems should be exempt from the Freedom of Information Act and other similar state laws.  Such an exemption is necessary to preserve the privilege discussed in this principle.   

(d) Impact on State Law.  A federal law is necessary to assure protection of information submitted to national reporting systems, but the federal protection should not preempt state evidentiary laws that provide greater protection than federal law.  Providing such information to reporting systems should not constitute a waiver of any state law privilege.