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The VAMC at-a-glance
The VAMC is part of a network of government healthcare facilities that service the Upstate New York area.
The VA Medical Center has an active affiliation with the State University of New York Upstate Medical University where over 650 of their students, residents, interns, and fellows receive training at the Medical Center each year.
This network functions out of six medical centers and thirty community based outpatient clinics
The VAMC at-a-glance cont’d
The VA has extensive and comprehensive services that are offered in a 106-bed general medicine and surgical facility for Veterans and their families through ten specialties: Primary care, Mental Health care, Tertiary care, Long-term care, Physical medicine, Rehabilitation, Neurology, Oncology, Dentistry, and Geriatric.
consent is a legal doctrine that provides that a patient has the right to know the potential risks, benefits, and alternatives of a proposed procedure.” (Pozgar, 2007, p. 278)
Informed Consent cont’d
According to the Veteran’s Healthcare Administration (VHA) Handbook 1004.1 (DVA, 2009) the definition of informed consent is further delineated by the differentiation between competency and capacity. The handbook states, “Competency is a legal determination made by a court of law that a patient has the requisite capacities to make a medical decision.” (p. 1). Decision-making capacity, “is a clinical determination made by the practitioner…the patient’s ability to understand and appreciate the nature and expected consequences of each health care decision…and the ability to formulate a judgment and communicate a clear decision concerning health care.” (p. 2).
Informed Consent Development
Nuremberg Code of 1947 Schloendorff 1914 Natanson 1960 Salgo 1957 Canterbury 1972 Candura 1978
Mandate of proper and ethical treatment of patients
Doctrine of Informed Consent
Healthcare Truth and Transparency Act of 2011
Ensure that patients receive accurate health information…in the provision of health care services
Informed Consent Process
In order to obtain signature informed consent, the practitioner must determine whether the patient has decision-making capacity. Patient’s are presumed to have decisionmaking capacity unless an appropriate clinical evaluation determines that the patient lacks decision-making capacity, or the patient is a minor, or the patient has been ruled incompetent by a court of law.
Informed Consent Process
The practitioner must perform (or obtain) and document a clinical assessment of decision-making capacity for any patient suspected of lacking decisionmaking capacity.
Informed Consent Process
Provide information in understandable language Clear, concise Details of the procedure, likelihood of success, expected risks and benefits, reasonable alternatives Name and profession of primary practitioner Advise patient of his/her responsibilities during recuperative period Advise patient if the treatment is novel or unorthodox Ensure that the patient indicates understanding Encourage the patient to ask questions
Practitioner’s assessment of the patient’s decision-making capacity Name of all practitioners Brief description of the procedure
• • •
A statement that all relevant aspects including indications, risks and benefits, alternatives including NO treatment have been discussed in easy to understand language and that the patient understood and had an opportunity to ask questions without coercion Date, time, and signature of practitioner
Treatments that DO NOT require signature consent are:
Treatments and procedures that are low risk and are WITHIN BROADLY ACCEPTED STANDARDS OF MEDICAL PRACTICE (e.g. administration of most drugs or for the performance of minor treatments such as routine x-rays) do not require signature consent. Signature consent is not required for routine injection of contrast media for imaging procedures. However, the informed consent process must be documented in the medical record. In accordance with VHA Policy on documentation of patient records, documentation must be sufficient to serve as a basis to plan patient care, support diagnoses, and warrant treatment.
In medical emergencies, the patient’s consent is implied by law. The practitioner may provide necessary medical care when ALL of the following are met:
Immediate care is needed to preserve life or avert serious impairment Patent is unable to consent No surrogate is available or waiting to obtain would do harm Reasonable attempts to contact surrogate must be made as promptly as possible to explain nature, indications, and expected outcome Advance Directives are to be followed if available Documentation must include-the patient’s inability to provide consent, imminent danger, rationale for decision to undertake procedure, and attempts to contact surrogate with specifics Executive Chief of Staff must sign and date consent
Separate signature informed consent for Anesthesia
Separate Anesthesia progress note
Decision-making capacity Separate consent for Anesthesia
More requirements for documentation
There are many factors that may contribute to a provider’s inability to provide the information necessary to receive a patient’s informed consent. Ethically and legally, it is still the provider’s responsibility to provide the necessary information in a way that ensures understanding, patient safety, and the provision of equitable, patient-centered healthcare.
Additionally, it is the healthcare facility’s of which the provider is working through that is responsible for making sure that all provider’s who participate in the information process of a patient’s treatment and/or procedure is fully, competently, and equally trained as their senior counterparts. This is the process that must be enhanced at the Veteran’s Administration Medical Center.
Consistent training of Residents and Fellows Medical Center Policy that upholds the requirement for standard training among rotating providers Consistent rotation schedule for training that mirrors the rotation schedule of the Residents and Fellows
Quick but, comprehensive and effective training program
Pozgar, G.D. (2007). Legal aspects of health care administration 10th ed. Massachusetts: Jones and Bartlett U.S. Department of Veterans Affairs. (2009). VHA Handbook (1004.01): Informed consent for clinical treatments and procedures. Retrieved from http://www1.va.gov/vhapublications/ViewPublic ation.asp?pub_ID=2055 on February 22, 2011