I. Patient Safety and Medical Errors
A. Institute of Medicine (IOM) Effort—The IOM launched a concerted, ongoing effort focused on assessing and improving the nation's quality of care in 1996.
1. First phase (1996-1998)—Documented the serious and pervasive nature of the nation's overall quality problem, concluding that "the burden of harm conveyed by the collective impact of all of our health care quality problems is staggering."
2. Second phase (1999-2001)—The Committee on Quality of Health Care in America released two reports, establishing a vision for how the health care system and related policy environment must be radically transformed.
a. To Err Is Human: Building a Safer Health System (1999) reported that tens of thousands of Americans die each year from medical errors. It highlighted the importance of patient safety and quality issues for public and private policymakers.
b. Crossing the Quality Chasm: A New Health System for the 21st Century (2001) stressed broader quality issues and described six aims of care: safe, effective, patient-centered, timely, efficient, and equitable.
3. Third phase (2002-present)—Operationalized the vision of a future health system described in the Quality Chasm report.
a. Identifies stakeholders in creating a more patient-responsive health system: clinicians/health care organizations, employers/consumers, research foundations, government agencies, quality organizations.
b. Focuses reform at three levels: environmental, the health care organization, the interface between clinicians and patients.
B. Collaborative efforts
1. Agency for Healthcare Research and Quality (AHRQ)
a. Research arm of the US Department of Health and Human Services (HHS) and sister agency to the National Institutes of Health (NIH).
b. Home to specialized research centers in major areas of health care research. These centers focus on:
i. Quality improvement in patient safety—Identifying factors that put patients at risk; using computer and other information technology to reduce and prevent errors; developing innovative approaches that reduce errors and produce safety in various health care settings and geographically diverse locations; disseminating research results; and improving patient safety education and training for clinicians and other providers.
ii. Outcomes and effectiveness of care.
iii. Clinical practice and technology assessment.
iv. Health care organization and delivery systems.
v. Primary care.
vi. Health care costs and sources of payment.
c. The AHRQ supports research on health disparities, drugs and other therapeutics, primary care practice, and integrated health care delivery systems.
d. It focuses on evidence-based practice and the translation of research into clinical practice to improve patient care in diverse health care settings.
e. It identifies strategies to improve health care access, foster appropriate use, and reduce unnecessary expenditures.
2. Joint Commission on Accreditation of Healthcare Organizations (JCAHO)
a. The JCAHO is the major accrediting agency for hospitals.
b. It developed a sentinel reporting policy in 1996 that encourages accredited health care organizations to voluntarily report "sentinel" events within 5 days and submit a root cause analysis within 45 days of discovery. A sentinel event is an unexpected occurrence involving death or serious physical or psychological injury, the risk for which a recurrence would carry a significant chance of a serious adverse outcome.
c. Based on root cause analyses, the JCAHO identified the need to establish national patient safety goals. The first National Patient Safety Goals were established in 2002. The JCAHO reevaluates goals annually and identifies steps annually to accomplish goals. It allows alternatives to specific recommendations as long as the alternative is as effective as the original recommendation in achieving the specific patient safety goal.
d. The JCAHO identified 15 National Patient Safety Goals; each year specific steps are identified to accomplish the overarching goals. Examples of goals or steps specific to orthopaedics:
i. JCAHO 2006 National Patient Safety Goal #1: improve the accuracy of patient identification with the elimination of wrong site surgery. Uses the American Academy of Orthopaedic Surgeons' (AAOS) Sign Your Site program. Requires a pre-procedure "timeout" to confirm the correct patient, procedure, and site using active communication techniques.
ii. JCAHO 2006 National Patient Safety Goal #7: reduce the risk of health care-associated infections. Requires that health care organizations establish systems to ensure that the use of prophylactic antibiotic for total hip arthroplasty, total knee arthroplasty, and hip fracture management adhere to the best available evidence, including appropriate antibiotic selection, administration of the antibiotic within 60 minutes of the surgical incision, and discontinuation of prophylactic antibiotic therapy within 24 hours of the time of wound closure.
3. National Patient Safety Foundation (NPSF)
a. Stakeholders include health care practitioners and institutions, manufacturers, educators, insurers, researchers, legal advisers, policymakers, and patients.
i. Identify a core body of knowledge.
ii. Identify pathways to apply the knowledge.
iii. Develop and enhance the culture of receptivity about patient safety.
iv. Raise public awareness and foster communications about patient safety.
Table 1. Chronology of Stark Laws]
A. Stark laws (see Table 1)
1. Rationale for prohibitions
a. In some cases, excessive medical services were ordered for which the patient received unnecessary care, resulting in higher health care costs.
b. Costs for patients covered by government programs were ultimately passed on to taxpayers.
2. Stark I (1989)
a. Prohibits referral of Medicare patients who need clinical laboratory service to entities in which the physician has an ownership interest.
b. Prohibits referral of Medicare and certain Medicaid patients for "designated health services" to entities in which the physician or an immediate family member has a financial interest, unless an exemption applies.
c. Proscribes entities to which referrals are made from submitting payment claims to the government for specified services.
3. Stark II (1993)
a. Expands the list of referral services that are prohibited from physician ownership.
b. Expands the referral band to include patients covered by certain Medicaid managed care programs.
c. Identifies circumstances under which referrals are permitted activities, known as exceptions.
4. Final regulations for enactment of Stark II (1998)
a. Issued in 1995, but rolled out in two phases.
b. Supersede the 1995 Stark I regulations.
c. Consist of actual rules physicians must follow.
5. Penalties for violating Stark II phase (Phase I and II) regulations
a. Denial of payment
b. Mandatory refunding of payments that were made in error
c. Civil monetary penalties of $15,000 per claim
d. Prohibition from participation in Medicare and Medicaid programs
6. Phase II exceptions—Five are most important to orthopaedic surgeons.
a. In-office ancillary service in a group practice or by a sole practitioner
b. Bona fide employment
c. Personal service arrangements
d. Fair market value compensation
e. Academic medical centers
B. Health Insurance Portability and Accountability Act (HIPAA; 1996)
1. Title I protects health insurance coverage for workers and their families when the workers change or lose their jobs.
2. Title II addresses "administrative simplification," as well as fraud, abuse, and medical liability reform.
3. Title III establishes medical savings accounts and health insurance deductions for the self-employed.
4. Title IV covers the enforcement of group health plan provisions.
5. Title V focuses on revenue offset provisions.
6. Privacy rules
a. Create national standards to protect patient's medical records and other personal health information.
b. Give patients more control over their health data.
c. Limit the way health care providers may use the information and release it to third parties.
d. Establish guidelines that must be followed to protect the privacy of patient's "protected health information."
e. Hold health plans, health care clearinghouses, and health care providers accountable for violations.
1. Centers for Medicare & Medicaid Services (CMS) definition (verbatim)
a. Intentional deception or misrepresentation that an individual knows to be false (or does not believe to be true) and he or she makes, knowing that the deception could result in some unauthorized benefit to himself or herself or some other person.
b. Most commonly arises from a false statement or misrepresentation made, or caused to be made, that is material to entitlement or payment under the Medicare program.
2. Most common types of fraud in Medicare
a. Billing for services not rendered
b. Misrepresenting a diagnosis to justify payment
c. Soliciting, offering, or receiving a kickback
e. Falsifying treatment plans and medical records to justify payment
III. Medical Malpractice Claims
A. Elements that the patient must prove
1. Duty—Physician's obligation to care for the patient in a manner that is consistent with the quality of care provided by other physicians in treating a patient's particular condition.
2. Breach of duty
a. Facts show that the physician failed to meet the standard of care in treating the patient.
b. Poor outcome, whether permanent or not, or a predictable complication does not necessarily mean that the physician has deviated from the standard of care.
3. Causation—Proof that the violation caused the patient's injury.
4. Damage—Proof that the physician's deviation from the standard of care resulted in physical, emotional, or financial injury to the patient.
B. Informed consent
1. Requires that a physician obtain consent before any treatment is rendered or operation is performed, and before many diagnostic procedures can be performed.
2. Requires a patient to give permission before being "touched" by another; without permission, contact may be considered an "assault," a "battery," or a "trespass" upon the patient.
3. Without an informed consent, the orthopaedic physician may be held liable for violation of the patient's rights, regardless of whether the treatment was appropriate and rendered with due care.
4. Medical care cannot be provided without either expressed or implied permission for the physician to act.
IV. Patient Complaints
A. Factors that contribute to both the likelihood a patient will bring suit as well as the successful prosecution of medical malpractice claims
2. Delay in response to patient/family concerns
3. Failure to diagnose
4. Failure to treat
5. Improper treatment
B. Factors that contribute to patient complaints
1. Inconsistency in communication
2. Promises that are not kept
3. Lack of sufficient details regarding the diagnosis and treatment plan
4. Perceived rudeness
5. Lack of understanding regarding known procedural/surgical complications
6. Perception that the physician and staff are too busy to be concerned with the patient's problem
7. Long wait times
8. Frustration with the inability to "fix" a painful condition
C. Patient-physician communication
1. Effective patient-physician communication will avert many patient complaints.
2. Tools to ensure high-quality patient-physician communication
a. Adequate time
b. Acknowledgment of emotional distress
c. Physician-obtained informed consent
d. Phone calls returned in a timely fashion
D. Skills to assist with addressing complaints when first expressed
1. Take all complaints seriously.
2. Acknowledge the patient's concern/complaint.
3. Provide accurate information to help clarify the situation.
4. Be frank and honest.
5. Avoid negative comments about other health care providers.
E. CMS requirements for complaints
1. All complaints must be addressed with a written response to the patient in a timely manner.
2. Situations requiring a written response to the patient
a. When a patient specifically asks for a written report
b. When there is a dispute about charges based on the patient's perception of quality of care
c. Components of written response
i. Acknowledgment of the complaint
ii. Addressing the issue to the extent possible
iii. Reassurance that the patient's feedback will be used to avoid a similar problem for another patient in the future
V. Standard of Disclosure
A. Varies by state
B. Two standards for assessing adequacy of disclosure
1. Professional or reasonable physicians' standard—Based on what is customary practice in the medical community for physicians to divulge to patients (most common).
2. Patient viewpoint standard—Based on what a reasonable person in the patient's position would want to know in similar circumstances.
3. More information generally is revealed with patient viewpoint standard than in jurisdictions that adhere to the professional or reasonable physicians' standard.
C. Elements of informed consent
1. Stated diagnosis
2. Nature of the condition or illness requiring medical or surgical intervention
3. Nature and purpose of the treatment or procedure recommended
4. Risks and potential complications associated with the recommended treatment or procedure
5. All feasible alternative treatments or procedures noted, including the option of taking no action
6. Relative probability of success for treatment or procedure in terms the patient will understand
Top 10 Medicolegal Terms
1. Abandonment: Termination of the physician-patient relationship by the physician without reasonable notice to the patient at a time when the patient requires medical attention and without the opportunity to make arrangements for appropriate continuation and follow-up care.
2. Burden of proof: Typically, a plaintiff's responsibility to affirmatively prove a fact or facts in dispute on an issue raised between parties in a case.
3. Causation: The causal connection between the act or omission of the defendant and the injury suffered by the plaintiff. The plaintiff must show causation of an injury by the defendant to prove negligence.
4. Damages: Money receivable through judicial order by a plaintiff sustaining harm, impairment, or loss to his or her person or property as the result of the accidental, intentional, or negligent act of another. Damages can be grouped into two primary types: compensatory and punitive.
• Compensatory damages are to compensate the injured party for the injury sustained and nothing more. Compensatory damages can be divided into economic, noneconomic, and special damages.
• Economic damages include an estimate of lost wages, both past and future, of the plaintiff and affected family members, and all costs associated with residual disability of the patient.
• Noneconomic damages include intangible damage resulting from the negligent act such as pain and suffering, disfigurement, and interference with the ordinary enjoyment of life.
• Special damages are the actual out-of-pocket losses incurred by the plaintiff, such as medical expenses, rehabilitation expenses, and earnings lost during treatment and recovery.
• Punitive damages are awarded to punish a defendant who has acted maliciously or in reckless disregard of the plaintiff's rights.
5. Duty is the obligation of the physician to care for the patient in a manner that is consistent with the quality of care provided by other physicians in treating a patient's particular condition.
6. Fraud is the intentional deception or misrepresentation that an individual knows to be false (or does not believe to be true) and he or she makes, knowing that the deception could result in some unauthorized benefit to himself or herself or some other person.
7. Informed consent: Consent is "fully informed" only when the patient knows and understands the information necessary to make an informed decision about the treatment or procedure. There is no informed consent when the treatment or procedure extends beyond the scope of consent. For example, if the risk associated with the changed treatment or procedure is substantially different from that contemplated by the patient, the courts may find the original informed consent was not sufficient. There are certain circumstances for which special informed consent rules apply. These are medical emergencies, situations involving a minor, and those rare circumstances where authorization for treatment or procedure is obtained from a court.
8. Malpractice: In the case of a physician, failure to exercise the degree of care and skill that a physician or surgeon of the same specialty would use under similar circumstances (professional negligence).
9. Negligence: In medical malpractice cases, a legal cause of action involving the failure of a defendant physician to exercise that degree of diligence and care that an average qualified physician practicing in the same specialty as that of the defendant physician would have exercised in a similar situation, and which has resulted in the breach of a legal duty owed by the physician to the patient which proximately caused an injury which the law recognizes as deserving of compensation (damages).
10. Res ipsa loquitur ("The thing speaks for itself"): A doctrine that may be invoked in a negligence action when the plaintiff has no direct evidence of negligence, but the injury itself leads to the inference that it would not have occurred in the absence of a negligent act. It raises an inference of the defendant's negligence, thereby altering the burden of proof so that the defendant must produce evidence that he or she did not commit a negligent act.
AAOS Government Relations website: www.aaos.org/govern/govern.asp.
AAOS Risk Management CME website: www5.aaos.org/OKO/RiskManagement.cfm.
Agency for Healthcare Quality and Research website: www.ahrq.gov.
Institute of Medicine website: www.iom.edu.
Joint Commission on Accreditation of Healthcare Organizations website: www.jointcommission.org.
National Patient Safety Foundation website: www.npsf.org.