Legal Considerations in Orthopaedic Practice

                               Dr. KS Dhillon

Informed Consent

Components 

When obtaining an informed consent the patient must be provided with all the information needed to make an informed decision. The patient must be told of the diagnosis or medical problem for which treatment is recommended. The patient also has to be told who will be performing the surgery. 

If the surgeon has tested positive for HIV/HBV/HCV the information has to be disclosed to the patient at the time of scheduling an "exposure-prone" procedure. The patient has to be told of the proposed treatment or procedure. This would include its purpose, duration, methods, and implements used, and the probability of success.

The origin of surgical implants should be discussed with the patient. This may have implications for their use based on a patient's religious background. 

In Hinduism, the use of bovine-derived implants should be discussed and in Judaism and Islam, the use of porcine-derived implants should be discussed.

The patient has to be told of all material risks of the procedure or treatment. The patient has to be told about any reasonable alternatives to the proposed procedure and of the risks of not being treated.

Special situations

Patient consent is not needed when communicating Health Information Portability and Accountability Act (HIPAA) protected information to other treating providers.

Institutional Review Board (IRB) approval for obtaining informed consent from patients enrolled in clinical trials is required. IRB approval is not required for quality improvement studies used for internal purposes only. 

The IRB aims to ensure the rights and welfare of human subjects participating in research.  

Informed consent for elective surgical procedures is best obtained in the office/clinic setting a few days before the scheduled procedure. 

In life-threatening injuries requiring surgical intervention but without available legal consent, the surgeon should confirm and document the necessity of care with a fellow orthopaedic surgeon or colleague. In non-life threatening injuries, consent must be obtained prior to surgical intervention. 

 When patients are non-consentable the legal guardians have the highest precedence. The "next of kin" precedence has been established to assist in determining the order of consent.  

Patient-physician relationship

Termination of care can be initiated by the physician with due process. The patient must be notified in writing the relationship will be terminated. A grace period of 30-45 days of continued care should be given to allow the patient to arrange for further treatment. Termination without a grace period is considered abandonment.

Physician Errors

Communication errors are the leading cause of wrong-side surgeries, medication errors, diagnostic delays, or loss to follow-up. These errors result in increased treatment costs, treatment delays, and complications. 

Crew resource management has been shown to improve communication and team dynamics. It has led to an improvement in patient safety and team morale. 

Wrong site surgery has to be prevented. The patient should be involved in identifying the correct side in the pre-operative area prior to induction. 

Pertinent imaging must be displayed in the operating room. The correct site with the surgeon's initials should be marked visibly in the surgical field. A time-out should be performed with the operating room team prior to the incision.

When wrong site surgery has been performed the error must be  

acknowledged with immediate discussions with the family. There is a need to apologize and accept responsibility. Blame must not be placed on others. 

Surgical errors can be prevented by having a surgical "time-out".

According to the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), time out should include the following: 

 

• identify the correct patient, site, and side

• verify the correct procedure

All members of the team should be present for the time out.

WHO implementation of the surgical safety checklists began in 2009. It resulted in measurable improvements in surgical mortality, in-hospital complications, and adherence to surgical plan in OR crisis situations (e.g., massive hemorrhage, cardiac arrest). The surgeon is the most effective OR team member at reducing complications when using the surgical checklist and "time-out".

Medication prescribing errors are reduced when physicians use computerized order entry. 

Medical documentation errors are sometimes seen. Altering the medical record for any reason is illegal. No one has the authority to authorize a physician to alter the medical record. The errors can be noted and addendums can be added.

The second-opinion surgeon is ethically required to disclose the effect of medical errors on patient outcome. Only the patient can unilaterally decide to transfer care to a second surgeon. The surgeon is not ethically allowed to seek out transfer of care of a patient.

Litigation

In the USA medical liability lawsuits involving orthopaedic surgeons increased by 13% from 2003 to 2008. It is thought to be related to the aging population. Compared to other specialties, orthopaedic surgery has the 7th highest number of lawsuits. About 33% of all orthopaedic surgery claims result in payment to plaintiffs. The average cost of defending orthopaedic surgery claims is about USD 47,000. 

"Improper performance" makes up 45% of lawsuits. The most commonly associated procedures include:

• open reduction of dislocation

• closed reduction of fractures

• operative procedures of joint structures (not including spinal fusion)

• operative procedures on bones

• operative procedures on cranial and peripheral nerves

The most commonly associated clinical diagnoses include:

• osteoarthritis (21%)

• disorder of joints, not including arthritis

• fracture of femur

Legislation

In the USA there are several legislation that protect the patient.

1. Stark Law (1993)

A federal regulation that prohibits the self-referral of physicians to organizations with which they have a financial relationship. 

2. Patient Protection and Affordable Care Act (2010)

It provides numerous rights and protections that make health coverage fairer, easier to understand, and more affordable.

3. Physician Payments Sunshine Act (2010)

It requires the collection and reporting of financial relationships between physicians/teaching hospitals and businesses (manufacturers of drugs, devices, medical supplies). All payments of more than $10 must be reported to Centers for Medicare and Medicaid Services.

Physician Impairment

Physician impairment is defined as the inability or impending inability to practice according to accepted standards due to substance use, abuse, or dependency/addiction.

Surgeons who discover chemical impairment, dependence, or incompetence of a colleague or supervisor have a responsibility to ensure that the problem is identified and treated.

Medical Negligence

Medical negligence is the failure to provide the standard of health care resulting in medical injuries. A second-opinion physician has an ethical obligation, but not a legal obligation, to disclose if the standard of care has been breached by a treating physician. 

 Successful patient-plaintiff lawsuits for medical negligence require that all of the following 4 elements be alleged and proven in a court of law. 

Duty - Obligation to provide care that meets the professional standard of care, i.e. the same standard of care ordinarily executed by surgeons in the same medical specialty. 

Breach of duty - occurs when action or failure to act deviates from the standard of care.

Causation - established if it is demonstrated that failure to meet the standard of care was the direct cause of the patient’s injuries.

Damages - monies awarded as compensation for injuries sustained as the result of medical negligence.

Workers Compensation

Maximum medical improvement is reached when further restoration of function is no longer anticipated, allowing patients to settle their claim. 

Impairment occurs when there is a loss of function resulting from an anatomic or physiologic derangement. 

There is disability when there is limitation of an individual’s capacity to meet certain personal social or occupational demands.

Physician Employment

When the physician is employed as an independent contractor the employer influences the outcome. The contractor determines the methods and means of achieving the result of the work. The employer does not pay taxes, provide insurance, or offer retirement benefits. 

When the physician is employed the employer determines the result of the work and provides the means and methods for the result. The employer also provides resources and training. The employer pays taxes, provides insurance, and retirement benefits