clinical and institutional disclosure of adverse events to patients may 21, 2012 – call 1 of 2

Clinical and Institutional Disclosure of Adverse Events to Patients

May 21, 2012 – Call 1 of 2Sponsoring Offices:National Center for Ethics in Health Care Office of Quality, Safety and Value, Risk Management Program

VETERANS HEALTH ADMINISTRATION 2

Welcome• Materials from this call as well as the call from

August 6, 2012 (Critical Thinking About Institutional Disclosure of Adverse Events to Patients) are available on these websites:– National Center for Ethics in Health Care (slides only)

http://vaww.ethics.va.gov/index.asp

– Office of Quality, Safety, and Value, Risk Management Program (slides and audio) http://vaww.oqsv.med.va.gov/functions/mindfulness/rm/rmLearning.aspx

http://vaww.ethics.va.gov/index.asp

http://vaww.oqsv.med.va.gov/functions/mindfulness/rm/rmLearning.aspx

VETERANS HEALTH ADMINISTRATION

Learning Objectives:After participating in this conference, the participant will be able

to:• Identify the ethical basis for disclosure of adverse events to patients.• Identify the features of an adverse event that may require clinical and/or

institutional disclosure.• Describe the difference between clinical and institutional disclosure.• Evaluate scenarios to determine whether the adverse events described

warrant clinical or institutional disclosure or both.• Describe the responsibilities of VHA facility staff in clinical and institutional

disclosure of adverse events to patients.


Disclosure of Adverse Events to Patients: Ethical Basis

• Patient’s right to know• Professional duty of truth-telling

– Respecting patient autonomy– Establishing and maintaining patient trust

• Utilitarian ethics: Disclosure produces the greatest balance of benefit over harm– Good for patients– Good for providers– Good for health care organizations


Disclosure vs. Reporting of Adverse Events• DISCLOSURE

– VHA Handbook 1004,08*: Disclosure of Adverse Events to Patients.– Trigger is unanticipated harm or potential future harm (or event that is

perceptible)– Obligation of honesty and respect to specific patients– Disclosure is to patients (or their personal representatives)

• REPORTING– VHA Handbook 1050.01: VHA National Patient Safety Improvement– Trigger is an adverse event (that may or may not have caused harm)– Obligation to ensure patient safety and continuously improve the delivery of

care in general based on information about the occurrence of an adverse event or close call

– Reporting is to oversight bodies, e.g., VHA’s National Center for Patient Safety, regulatory agencies , Joint Commission


Adverse Event (as defined in VHA Handbook 1004.08 and VHA Handbook 1050.01)

• An adverse event is an untoward incident, diagnostic or therapeutic misadventure, iatrogenic injury, or other occurrence of harm or potential harm directly associated with care or services provided within the jurisdiction of the Veterans Healthcare System.

• In other words, an adverse event is an adverse occurrence in the patient’s care that was unexpected or unanticipated.


Disclosure of Adverse Event (VHA Handbook 1004.08)

• For the purpose of this Handbook, the phrase “disclosure of adverse events” refers to the forthright and empathetic discussion of clinically significant facts between providers or other VHA personnel and patients or their personal representatives about the occurrence of a harmful adverse event, or an adverse event that could result in harm in the foreseeable future.


Disclosure vs. Reporting of Adverse Events• DISCLOSURE

– VHA Handbook 1004.08 : Disclosure of Adverse Events to Patients.– Trigger is unanticipated harm or potential future harm (or event that is

perceptible)– Obligation of honesty and respect to specific patients– Disclosure is to patients (or their personal representatives)

• REPORTING– VHA Handbook 1050.01: VHA National Patient Safety Improvement– Trigger is an adverse event (that may or may not have caused harm)– Obligation to ensure patient safety and continuously improve the delivery of

care in general based on information about the occurrence of an adverse event or close call

– Reporting is to oversight bodies, e.g., VHA’s National Center for Patient Safety, regulatory agencies , Joint Commission


Types of Disclosure (VHA Handbook 1004.08)

• Clinical disclosure of adverse events. An informal process for informing patients (or their personal representatives) of harmful adverse events related to the patient’s care. This type of disclosure is considered a routine part of clinical practice. (In general, clinical disclosure should be immediate, and should be carried out by the person involved in the event, such as a nurse, physician, physical therapist, or the like. Clinical disclosure should be documented in CPRS as a normal note, not a templated note).

• Institutional disclosure of adverse events. A formal process required in cases resulting in serious injury or death, or those involving reasonably expected serious injury. (During an institutional disclosure, the patient or representative will receive a copy of the SF95, which tells them how to file a claim if they choose. A decision that an institutional disclosure is appropriate involves a decision at the facility leadership level and the disclosure is made by facility leadership and others. Documentation of institutional disclosures in CPRS is made on a templated note).

• Large-scale disclosure of adverse events . For adverse events involving multiple patients, collaboration

with Department of Veterans Affairs (VA) Central Office is required for evaluation and planning. Decisions regarding large scale disclosure of adverse events are made by the Principal Deputy Under Secretary for Health.


Case 1 – Mr. A

Mr. A has been in the CLC for over a year. He is not a high-risk for falls but lacks decision-making capacity and is sometimes confused and disoriented. The nurses heard the bed alarm and came in the room and found that the patient had fallen out of bed. He had minor cuts and scrapes, but no serious injury from his fall. Mr. A’s son arrived at Mr. A’s room for a planned visit and found the nurse there with his father.


Case 1 – Mr. AIs this an adverse event?

Yes (see Notes section below for answer explanation)

b. Noc. I don’t know

a.


Case 1 – Mr. ADoes this adverse event need to be reported?



a.


Case 1 – Mr. AIf I report the adverse event, have I satisfied the disclosure requirement?

a. YesNo (see Notes section below for answer explanation)

c. I don’t knowb.


Case 1 – Mr. AIs a disclosure required?



a.


Case 1 – Mr. AWhat type/s of disclosure is/are

required? Clinical (see Notes section below for answer

explanation)

b. Institutionalc. Both clinical and institutional

a.


Case 1 – Mr. ATo whom should the disclosure be made?

a. Only the patient, Mr. Ab. Only Mr. A’s sonBoth Mr. A and his son (see Notes section below

for answer explanation)

d. Mr. A’s surrogate

c.


Case 1 – Mr. AIs a clinical disclosure required if the patient has no cuts or scrapes from this fall, that is, the patient didn’t suffer even a minor injury?



a.


Question from the AudienceWhy was the bed alarm on if the patient was not a fall

risk?

Most newer beds come with a bed alarm, and some cannot be disabled. In addition, the local facility policy may mandate that patients with diminished capacity of any degree must have the alarm activated. These local policies may govern the setting of the alarm


Case 1 – Mr. A Summary Of Teaching Points

SUMMARY OF TEACHING POINTS: (1) Reporting and disclosure are separate requirements that are fulfilled separately

and that are governed by separate policies(2) The trigger for disclosure is an adverse event that results in harm (or risk of future

harm) to the patient or that has a clinical effect that is perceptible to the patient or others

(3) Clinical disclosure is appropriate for minor harms(4) If an adverse event results in a minor harm to a patient who lacks decision making

capacity, the clinical disclosure should be made to the patient (if the patient is able), a family member(s) involved in the patient’s care, or the patient’s personal representative/surrogate and others desired by the personal representative/surrogate


Case 2 – Mr. BWhile getting out of bed with the nurse’s assistance following a hernia repair, Mr. B fell to the floor. Other than the hernia, he has been in good health and was not at risk for falls. The nurse called for assistance and she and another nurse placed the patient back on his bed. As the nurses were readying Mr. B for transport to X-ray, Mr. B’s daughter arrived at Mr. B’s room for a planned visit. She found the nurses there with her father, who was now showing signs of pain and disorientation. Later, the X-ray showed a hip fracture.


Case 2 – Mr. BIs this an adverse event?



a.


Case 2 – Mr. BDoes this adverse event need to be reported?



a.


Case 2 – Mr. BIf I report the adverse event, have I satisfied the disclosure requirement?

a. YesNo (see Notes section below for answer explanation)

c. I don’t knowb.


Case 2 – Mr. BIs a disclosure required?



a.


Case 2 – Mr. BWhat type/s of disclosure is/are required?

a. Clinicalb. InstitutionalBoth clinical and institutionalc.


Case 2 – Mr. BTo whom should the clinical disclosure be made?

a. Only the patient, Mr. Bb. Only Mr. B’s daughterBoth Mr. B and his daughterd. Mr. B’s surrogate

c.


Case 2 – Mr. BTo whom should the institutional disclosure be made?

a. Only the patient, Mr. Bb. Only Mr. B’s daughterc. Both Mr. B and his daughterMr. B (if able) and Mr. B’s surrogate/personal

representatived.


Question from the AudienceQ: Why does this need to be disclosed if the nurses did nothing wrong? (Is a disclosure required if the patient’s fall and fracture were not the result of an error?) A: The trigger for disclosure of an adverse event is harm or potential harm to the patient, that is, its effect on the patient. Mr. B sustained a hip fracture, which means that disclosure is required. Although the cause of the adverse event is important for purposes of quality improvement, peer review, liability etc. What is important about the adverse event from the perspective of disclosure is not its cause, but its effect. So, it is not necessary for the patient’s harm to be the result of an error in order for a disclosure to be required.


Question from the AudienceQ: How would you handle a disclosure if Mr. B (whose decision-making capacity is not in doubt) does not want his daughter notified of the event?

A: If you are aware that this patient -- who has decision-making capacity -- does not want his health information to be shared with a his daughter, then you have an ethical obligation to respect the wishes of the patient.


Question from the AudienceQ: I heard during the presentation today that we need to do an institutional disclosure when someone has a fracture. Currently we only do Root Cause Analyses (RCA)s on patients who fall, fracture and require surgery. Are we to understand that we need to do an institutional disclosure for all falls with fracture? A: Remember that the triggers and rationales for disclosure and reporting (and RCAs) are different. The trigger for a disclosure is harm to the patient. In most instances, a patient who sustains a fracture related to a fall would, therefore, require an institutional disclosure. A RCA is conducted to ensure patient safety and continuously improve the delivery of care in general . An institutional disclosure may be required regardless of whether an RCA is required and vice versa. One does not always preclude or necessitate the other.


Case 2 – Mr. B Summary Of Teaching Points(1) Reporting and disclosure are separate requirements that are fulfilled separately and

that are governed by separate policies(2) The trigger for disclosure is an adverse event that results in harm (or risk of future

harm) to the patient or that has a clinical effect that is perceptible to the patient or others

(3) Not all adverse event s are the result of an error. It is not necessary for the patient’s harm to be the result of an error in order for disclosure/s to be required.

(3) Disclosure may be a process involving a series of conversations, beginning with a clinical disclosure and, after more facts are known, requiring an institutional disclosure.

(4) Institutional disclosure is required for a serious harm.(5) If an adverse event affects a patient whose decision-making capacity is uncertain, the initial

clinical disclosure should be made to the patient (if the patient is able) and either a family member(s) involved in the patient’s care or the patient’s personal representative/surrogate and others desired by the personal representative/surrogate

(6) If the patient has decision making capacity, the institutional disclosure should be provided to the patient and anyone the patient desires.


Question from the AudienceIf the harm that the patient experienced was a known

complication of surgery, is it still an adverse event?There may be times when a complication/side effect that was anticipated and discussed in the informed consent process will occur. When such complications/side effects occur, they need to be discussed with the patient (or patient’s representative) as part of ongoing clinical care. In general, an adverse event is an event that was unexpected or unanticipated. Since “disclosure” suggests revealing or exposing information that is otherwise not known, complications/side effects that were discussed in the informed consent process are not considered adverse events that require disclosure under policy, UNLESS the event is deemed to be untoward or preventable.

We will discuss this in more detail on our second August 6, 2012.

VETERANS HEALTH ADMINISTRATION 33

For more information:• Please access VHA Handbook 1004.08:

DISCLOSURE OF ADVERSE EVENTS TO PATIENTS at: http://vaww1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2800

http://vaww1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2800

http://vaww1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2800


Course Faculty & Planning Committee

National Center for Ethics in Health Care Karen M. Rasmussen, M.D., Chief, Ethics PolicyVirginia Ashby Sharpe, Ph.D., Medical Ethicist Samantha Johnson, LSW, MBE, Ethics Policy Specialist

Office of Quality, Safety and ValueYuri N. Walker, RN, JD, MPH, Director, Risk Management ProgramKaren Maudlin BSN, MS, LHRM, VHA-CM, Health Systems SpecialistBarbara Rose, PhD, RN, Clinical Program Specialist, Risk ManagementLisa Stiles, RN, MA, CPHRM, Clinical Program Specialist, Risk Management

Employee Education SystemConstance Singleton, Project ManagerDerek Pringle, Program Support Assistant Shannon Trammell, Program Support Assistant

clinical and institutional disclosure of adverse events to patients may 21, 2012 – call 1 of 2

Documents

adverse occurrence

health care slides

ethical basis patients

health care office of

occurrence of harm

publication of vha handbook

potential harm

unanticipated harm