Informed Consent and Documentation Guidelines PDF

# Informed Consent - Required elements - Consent is freely given - Patient is capable of comprehending and understanding the treatment or procedure being proposed - Comprehensive education - Includes: risks, benefits, and alternatives - Consent is represented by the patient's si...

# Informed Consent - Required elements - Consent is freely given - Patient is capable of comprehending and understanding the treatment or procedure being proposed - Comprehensive education - Includes: risks, benefits, and alternatives - Consent is represented by the patient's signature and documented in accordance with institution policy and procedures, and is compliant with individual state regulations for informed consent. - The exact process of obtaining consent, including who is responsible for obtaining and witnessing the consent, varies by county/state/organization but the clinician performing the procedure is responsible for ensuring that consent has been appropriately obtained) - Implied/Emergent Consent: Many jurisdictions/institutions have policies in place for types of emergent consent when a patient is unable to consent, and a delay of care constitutes an emergent or life-threatening situation - Patient must be informed of specific medical conditions and asked about personal or social concerns that make some risks relevant to the discussion. Examples: - Presence of pacemaker - Chronic Kidney Disease - Axillary Lymph node dissection - Anticoagulant use - Active lifestyle (i.e., daily swimming) - Alternatives to a procedure or the option of "no treatment" or not having a procedure performed are included in the discussion with the patient ## Considerations with Vulnerable Patient Populations - Always assess for the existence of a medical power of attorney, advanced directives, or a living will prior to making any medical decisions on behalf of a mentally incompetent or vulnerable patient. - Children: parents or legal guardians provide the informed consent with the assent of the child whenever appropriate - Assent is the process of helping pediatric patients achieve a developmentally appropriate awareness of the nature of their condition - Pediatric patients should be informed of what they can expect when undergoing procedures and treatment. Teaching is developmentally appropriate and uses age-appropriate teaching aids (dolls, stuffed animals) # Documentation - Purposes of medical record documentation - Required by federal law - Provides enduring record of patient care - Facilitates communication among healthcare providers - Supports billing and reimbursement - Supplies data for internal or external analyses (i.e., disease incidence, outcome indicators, adverse events) - General documentation guidelines - Occurs in "real time" as care is provided (never in advance of or after providing care) - Accurate - Objective - Legible signature on all entries (written and electronic) - Do not document care provided by others (do not chart for someone else) - Ensure correct items are "clicked" or selected on electronic systems and flow sheets - Adhere to organizational approved abbreviations - Document the implementation of a "time-out" verification process prior to invasive procedures - Patient and device monitoring - Frequency determined by organizational policy, type of infusate (i.e., blood products, vesicant chemotherapy), and patient's clinical and cognitive status (i.e., ability to follow instructions) - Site assessment using standardized grading scales - Actual or suspected complications of infusion therapy - Date and time when signs and symptoms were noted - Patient clinical status and device condition - All communication (i.e., physician notification) - Interventions and patient response - Patient and caregiver education and response to education # Unusual Occurrence/Incident Reporting - Institutions/Organizations - Unusual occurrence or variance form/document is unique to each facility/organization or entity - Internal reporting mechanism notifies individuals in the organization that an unusual or unexpected event has occurred - Form/document provides facts concerning the event - Follow-up by Risk Management usually includes an investigative component # Regulatory Agencies | Agency | Contributions | Effect | | :---------------------------------------- | :----------------------------------------- | :--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | | Occupational Safety and Health Administration (OSHA) | Needlestick Safety and Prevention Act (2001) | Recognized that despite blood-borne pathogen (BBP) precautions, needlestick injuries and BBP exposure continued to be a problem. Requires built-in safety mechanisms to needles and other sharps, use of needleless access devices and connectors, and improving record keeping regarding needlestick injuries. | | | OSHA Bloodborne Pathogens Rule (2001) | Establishes more engineering controls, exposure control plans, solicitation of employee input, and detailed recordkeeping. | | Food and Drug Administration (FDA) | Safe Medical Device Act (1990) | Requires device users to notify the FDA and device manufacturer (if known) of incidents in which a medical device may have contributed to serious injury, serious illness, or death of a patient. | | | Med Watch Reporting | National reporting mechanism for problems with medical devices, including VADs, solution containers, electronic infusion pumps, and devices. | | Occupational Safety and Health Administration (OSHA) | MAUDE: Manufacturer and User Facility Device Experience Database | Repository for data on adverse events involving medical devices, includes all voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996. Online search function allows database search for information on medical devices that may have malfunctioned or caused death or serious injury. | # Vascular Access Products - General Considerations - FDA requires Instructions for Use (IFU), for all devices - Device information is intended to promote safe use, maintenance, and performance of devices - Failure to follow manufacturer's IFU may lead to unsafe use and patient injury - IFU must include manufacture name, place of business and contact information - Product Development - Products typically enter development to address a new or unmet clinical need - All equipment used to deliver infusion therapy is regulated by the Center for Devices and Radiological Health (CDRH) and the Food and Drug Administration (FDA) - Before devices can be sold in the U.S., they must complete designated CDRH and FDA processes - **Class I devices:** Devices with the lowest risk of patient harm (i.e., catheter stabilization devices, IV poles) - **Class II devices:** Devices with a moderate risk of harm (i.e., catheters, introducers, guide wires) - **Class III devices:** Devices with the greatest risk of harm (i.e., cardiac pacemakers, mechanical heart valves) - The device class determines the CDRH review process - Pre-market notification process: Process of documenting that a new device is substantially equivalent to similar products sold in the US. This usually does not require clinical studies, and is a commonly used process for approving class II devices