mod3

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Mod 3 Steps:

INSTRUCTIONS:

1.

Read Chapter 7 Government Ethics and the Law (p. 189-197), Chapter 10 Physician Ethical and Legal Issues (p. 292-302); Chapter 12 Patient Consent (p. 330-344).

 

2.

Read 

· The case, 
Nolen v. Boca Raton Community Hospital (see link below)

· The case, 
Ashe v. Radiation Oncology Assoc. (see link below)

 

3. 

Experience the Simulation and Complete Your Role by Answering the Questions in a Word Document: Watch the Jones & Bartlett LearnScapes for Health Care Ethics episode: “
Labor and Delivery

 

You do not need to answer the questions asked at the end of the simulation or submit your recommendation in an email. You will need to answer the questions I give you in Step 6 instructions below.

 

4.

Complete Written Assignment #3 to upload in the Dropbox: This written assignment will not be separately graded but is your ticket to participate in class and receive a grade for Class Preparation and Participation so complete all steps and provide thoughtful written answers to the questions! 

 

 For this assignment you will have both a Word document and an Excel spreadsheet to upload. Click on the link below for the instructions.

This module is dedicated to patients’ rights – HIPAA, EMTALA, and informed consent. 

 

At the conclusion of this module, you should be able to:

 

· Describe the basic purposes and patient rights under EMTALA, HIPPA and the doctrine of Informed consent.

· Drawing on current responses, predict how patient rights will be altered during and after the COVID-19 pandemic.

· Experience the simulation and formulate your own recommendation to resolve a confidentiality dilemma synthesizing multiple stakeholder perspectives, legal concerns, guiding values and fair process principles.

· Advocacy cause/capstone project: research and examine data related to your Advocacy Cause. Generate short-term, intermediate and long-term goals in your LOGIC MODEL Spreadsheet.

· Persuasively articulate your position. Critique a peer’s argument and provide constructive feedback.

 

These outcomes correspond to the following course objectives as stated in your syllabus:

 

· Identify a variety of key legal responsibilities, civil and criminal liability, perspectives and rights of major stakeholders, including selected healthcare organizations, providers, and patients, in the U.S. healthcare system.

· Evaluate and debate resolutions to current healthcare legal issues and ethical dilemmas by applying ethical and legal frameworks and reasoning.

· Creatively formulate and persuasively communicate your strategic recommendations to solve pressing health care problems with ethical and legal solutions.

Book: https://books.google.com/books?hl=en&lr=&id=j7J5DwAAQBAJ&oi=fnd&pg=PP1&dq=Legal+and+Ethical+Issues+for+Health+Professionals&ots=vMqsTnjhzu&sig=v_eGtmtjpSj1LUQwkxVISxwC79U#v=onepage&q=Legal%20and%20Ethical%20Issues%20for%20Health%20Professionals&f=false

MODULE #3 ASSIGNMENT for HIPAA, EMTALA, INFORMED CONSENT & ADVOCACY CAUSE

INSTRUCTIONS: This written assignment will not be separately graded but is your ticket to participate in class and receive a grade for Class Preparation and Participation.
For this assignment you will have both a Word document and an Excel spreadsheet to upload. Copy the questions for Parts I – III below into a Word document. Type and save the questions and your answers in the Word document, using Times New Roman 12 point font, 1 inch margins.

Upload your Word file to the Dropbox by the due date and times posted in D2L.

There is no partial credit for preparing but not attending class or vice versa. 

Part I:
Nolen v. Boca Raton Community Hospital case:

(1) Summarize the Facts: Briefly summarize the key facts of the case.

(2) Identify the Legal Issue: What is the legal issue (the reason the case is on appeal)?

(3) Plaintiff’s Arguments: What did Nolen argue as to why the hospital should be liable? (You may need to infer this from the case.)

(4) Defendant’s Arguments: What did the hospital argue in its defense? (You may need to infer this from the case)?

(5) Court’s Decision and Reasoning: In whose favor did the court rule? Why did the court rule this way?

(6) Your Evaluation: Take a position for the side that you favor in this case from both an ethical standpoint and a legal standpoint. Is there a difference in your legal opinion and your ethical opinion? Briefly
explain.

Part II:
Ashe v. Radiation Oncology Assoc case:

(1) Summarize the Facts: Briefly summarize the key facts of the case.

(2) Identify the Legal Issue: What is the legal issue (the reason the case is on appeal)?

(3) Plaintiff’s Arguments: What did Ashe argue as to why the hospital should be liable? (You may need to infer this from the case.)

(4) Defendant’s Arguments: What did the doctor argue in his defense? (You may need to infer this from the case)?

(5) Court’s Decision and Reasoning: What standard of informed consent did the court adopt? Why? In whose favor did the court rule and why?

(6) Your Evaluation: Take a position for the side that you favor in this case from both an ethical standpoint and a legal standpoint. Is there a difference in your legal opinion and your ethical opinion? Briefly
explain.

Part III: Construct a Recommendation to the Health Care Ethics Labor & Delivery Dilemma

FORMULATE a Recommendation by completing the four sections below.

NOTE: You do not have to answer the multiple choice questions at the end of the episode. Also, do not email your recommendation to me (the instructor) as indicated in the LearnScapes episode. Instead, type your answers to the sections below as part of this assignment.


RECOMMENDATION:

a
Section One – Guiding Values: Consider the most appropriate ethical values to resolve this dilemma. These values can be from our textbook, the article “Ethical Framework for the Allocation of Personal Protective Equipment” or from other sources. List the top three (3) Guiding Values that you consider highest priority to apply to this dilemma.

b
Section Two – Recommendation: Clearly state your recommendation in a few sentences.

c
Section Three – Reasons for Your Recommendation: Fully explain your recommendation in 2-4 paragraphs. Your explanation should meet the following criteria

Indicate that you carefully considered and analyzed all facts and perspectives.

(1) Demonstrates that you paid close attention to the simulation.

(2) Considers both the legal and ethical issues.

(3) Is supported with evidence and facts stated in the simulation video.

(4) Is well-organized with a logical flow.

(5) Is clear in what why you are making your recommendation.

d
Section Four- Fair Process:

(1) Did your decision-making process meet the first principle in the article, “Ethical Decision-Making About Scarce Resources: A Guide for Managers and Governors”? Why or why not?

(2) Should Bright Roads publicize your recommendation (second principle)? Why or why not?

(3) Was there effective stakeholder participation in this decision-making process? Why or why not?

Mod 3 Assignment 5/11/21 Page 1

Page 1 of 6
Framework Authors: Sally Bean, Kevin Reel, Maxwell J. Smith, Blair Henry, and Maria McDonald
[email protected]
Version: March 9, 2020

Ethical Framework for the Allocation of Personal Protective Equipment (during COVID-19)

Background

This ethical framework is intended to guide institutional resource allocation decisions for Personal

Protective Equipment (PPE) during the COVID-19 public health emergency. In a guidance document

issued Feb. 27, 2020, the WHO recommends rational use of PPE for treating patients with confirmed or

suspected COVID-19. Relevant PPE includes gloves, medical masks, goggles or face shields, gowns, and

respirators. The WHO has indicated that the current global stockpile of masks and respirators is

insufficient and shortages in gowns and goggles is also anticipated.

The WHO has issued three overarching recommendations for use of PPE:

1) minimize the need for PPE; and

2) ensure PPE use is rationalized and appropriate; and

3) coordinate PPE supply chain mechanisms.

The WHO recommendations have been integrated into this framework. This ethical framework is a living

document and will require review and updating as the COVID-19 situation evolves and new evidence

emerges. This framework is advisory and was developed to support key decision-makers at the

institutional level regarding the distribution of available PPE supply and potential modification to health

services to conserve PPE. Although this framework is tailored for the acute care setting, ideally there

should be consistency between and among healthcare institutions across the continuum of care to foster a

consistent approach, and as a result, promote the ethical principles of justice and fairness. This framework

may be adapted to address a broader health system perspective.

This ethical framework is adapted from the Ethical Framework for Resource Allocation during the

Drug Supply Shortage, which was drafted by an Ethics Working Group convened by the University of

Toronto Joint Centre for Bioethics in 2012 and endorsed by the Ontario Ministry of Health. The

Allocation of PPE Ethical Framework is comprised of:

a. Allocation principles that are articulated in three stages;

b. Fair process principles; and

c. Guiding values.

Balancing allocation principles and making decisions about PPE allocation should occur according to fair

process principles and generally aim to promote seven guiding values. The guiding value of reciprocity

has been added to the six principles included in the 2012 Drug Supply Shortage framework. The guiding

values are beneficence, equity, reciprocity, solidarity, stewardship, trust, and utility. In addition to the

allocation principles and guiding values, fair process principles, such as the Accountability for

Reasonableness (A4R) Ethical Framework should help inform how decisions are made. The five fair

process principles comprising A4R include relevance, publicity, revision, enforcement, and

empowerment.

The following seven guiding values appear in alphabetical order and are not rank-ordered.

Page 2 of 6
Framework Authors: Sally Bean, Kevin Reel, Maxwell J. Smith, Blair Henry, and Maria McDonald
[email protected]
Version: March 9, 2020

Table 1.Guiding Values

Value Definition

Beneficence Promoting highest quality of safe and effective care within resource constraints by:

a. Ensuring standard of care and best Infection Prevention & Control (IP&C) practices whenever possible

b. Training healthcare providers (construed broadly to include anyone with direct contact with patients including both regulated and unregulated

providers, administrative staff, environmental services, porters, etc.) to select the proper PPE, how to safely doff, don, and dispose of PPE after

use

c. Committing to use best available data/evidence to inform PPE allocation decision-making

d. Using alternative PPE where evidence suggests similar or similarly adequate efficacy

e. Informing and educating healthcare providers about risks and benefits of alternate PPE including risk mitigation strategies

f. Enabling delivery of care in the most appropriate setting, e.g. negative pressure rooms or decontamination areas to help mitigate risk of exposure

Equity Promote just/fair access to PPE by:

a. Using allocation processes for distribution of PPE that do not arbitrarily disadvantage any healthcare provider

b. Not discriminating between healthcare providers based on factors not relevant to provision of healthcare (e.g., social status)

c. Treating similar cases similarly and treating dissimilar cases in a manner that reflects the differences.

Reciprocity To support healthcare providers that may be or are exposed to COVID-19 in the course of their employment, mitigate potential harms/burdens this may

cause to the individual by:

a. Describing the steps healthcare providers should take to reduce exposure or spread to others, including family members

b. Working with Occupational Health & Safety to clarify requirements and implications for fitness to work

c. Ensure that healthcare providers exposed to COVID-19 are aware of all known ways to reduce symptoms and complications associated with

COVID-19

d. Prioritizing healthcare providers most at risk of COVID-19 exposure in the course of their employment for future vaccines or treatments that

may be developed or become available

e. If hospital visitation is suspended, support use of technology for patients and staff that are isolated from families to safely communicate

Solidarity To build, preserve and strengthen interprofessional and intra-institutional collaboration is the responsibility of all leaders and decision-makers through:

a. Embracing a shared commitment to the well-being of patients and healthcare providers regardless of care setting (i.e. all sites and more broadly

across the continuum of care)

b. Establishing, encouraging, and enabling open lines of communication and coordination

c. Sharing and redistributing PPE within the healthcare institution

d. Supporting allocation decisions that are consistent with ethical framework

Page 3 of 6
Framework Authors: Sally Bean, Kevin Reel, Maxwell J. Smith, Blair Henry, and Maria McDonald
[email protected]
Version: March 9, 2020

e. Recognizing importance of collaboration with health system partners beyond the acute care setting

f. Recognizing some healthcare providers may feel a strong duty to care for patients despite inadequate PPE but this individual decision may have

overriding negative consequences, e.g. resources required if the healthcare provider becomes ill

g. Acknowledging that due to individual circumstances, some healthcare providers may have competing interests (e.g. ill family members),

underlying health issues that put them at an elevated risk if infected, etc. such that they may be unavailable to provide care or might need to be

redeployed to other low risk areas

h. Providing psychosocial support to healthcare providers delivering care to COVID-19 patients to ensure they feel supported and not marginalized

Stewardship Upholding principles use of available PPE carefully and responsibly by:

a. Ensuring PPE utilization is consistent with best available evidence

b. Avoiding stockpiling for personal use

c. Postponing elective procedures/treatments that require use of PPE that are in limited supply

d. Prioritizing access to scarce PPE based on risk of exposure and pathogen transmission dynamics

e. Monitoring PPE utilization and distribution to facilitate course corrections as needed

f. If deemed acceptable for IP&C practices, extend life of PPE through extended PPE use (e.g. use same respirator while caring for multiple

patients with the same diagnosis without removing PPE)

Trust Foster and maintain public, patient, and health care provider confidence in PPE distribution system by:

a. Communicating in a clear and timely fashion, including expectations around accepting or refusing work assignments

b. Making decisions in an open, inclusive and transparent way with clearly defined decision-making authority and accountability

c. Being transparent and providing a rationale about what criteria are informing PPE allocation and staff assignment decisions

d. Collating short and long-term lessons learned

Utility While balancing the other principles, maximize the greatest possible good for the greatest possible number of individuals by:

a. Promote administrative control measures that minimize direct patient care to essential encounters

b. Distributing PPE in short supply to healthcare providers administering direct patient care

c. Distributing PPE in short supply to healthcare providers with the highest risk of exposure (e.g. providing direct care and aerosol-generating

procedures) and pathogen transmission dynamics

d. Sharing PPE within the healthcare institution

e. Where feasible, sourcing additional PPE supply

f. Identifying healthcare providers that may be at increased risk for the more serious (health-related) impacts of COVID-19 if they were to become

infected and potentially redeploy to lower risk areas.

Page 4 of 6
Framework Authors: Sally Bean, Kevin Reel, Maxwell J. Smith, Blair Henry, and Maria McDonald
[email protected]
Version: March 9, 2020

Allocation Principles:

The following allocation principles apply generally across all types of PPE. They provide a foundation to

inform discussion and decision-making at the relevant governance level during.

Stage 1. Implement strategies to preserve or approximate standard of care and best IP&C practices to

the extent possible within available PPE supply

When there is risk of PPE shortage,

1a. Conserve existing supply of PPE using strategies such as:

 Developing an inventory of available PPE and review at frequent intervals

 Reviewing PPE usage practices in light of best available evidence

 Reducing wastage of PPE (e.g., where evidence does not support use or is weak)

 Minimize need for PPE by using alternatives to face-to-face care such as telemedicine or

consultation across physical barriers for appropriate interactions

 Using alternative PPE where evidence suggests adequately similar efficacy to the PPE in short

supply

 Limit or prohibit hospital visitation (to reduce or eliminate visitors use of PPE)

 Limit access to PPE to only those providing direct patient care to COVID-19 (or other diseases

that require PPE)

 Cancelling non-urgent or elective procedures that require use of PPE

 Co-horting COVID-19 patients (i.e. create a care ecology so that healthcare providers can

optimally use PPE for treating a group of similarly situated patients)

 Utilize expired PPE for training purposes and consider if safe to use for direct care

 Delaying new enrollment in research studies using PPE in short supply

1b. Access new supply of PPE by:

 Collaborating with partners and governments to identify and procure alternative sources

And if these strategies are insufficient…

1c. Postpone or reduce procedures/treatments that require the use of PPE in short supply that are not

related to COVID-19.

Stage 2. Apply Primary Allocation Principles based on risk of exposure and risk of harm (to self and

others, e.g. if work with a patient population that might be more negatively impacted) if infected:

When Stage 1 strategies are insufficient to meet the need for PPE in short supply, give priority access in

rank order to:

Page 5 of 6
Framework Authors: Sally Bean, Kevin Reel, Maxwell J. Smith, Blair Henry, and Maria McDonald
[email protected]
Version: March 9, 2020

2a. Healthcare providers who are at highest risk for exposure to (or risk of harm from) COVID-19 (or

other diseases that require PPE) that are providing direct care to patients.

2b. Healthcare providers who are at moderate risk for exposure to (or risk of harm from) COVID-19

(or other diseases that require PPE) that are providing direct care to patients.

2c. Healthcare providers who are at lowest risk for exposure to (or risk of harm from) COVID-19 (or

other diseases that require PPE) that are providing direct care to patients.

Meanwhile…

 Continue with Stage 1 strategies, and

 Reassess healthcare provider’s risk of exposure on an ongoing basis to identify any changes in

level of priority.

Stage 3. Apply Secondary Allocation Principles to Ensure Fair Access to PPE

When decisions must be made between healthcare providers within a level of priority as described in

Stage 2, prioritize healthcare providers using a fair and unbiased procedure that does discriminate

between healthcare providers based on factors not relevant to their risk of exposure (e.g., race, social

value, sex, age) or risk of harm if infected such as:

 First come, first served (where queuing is feasible with regular clinical practice), or

 Other procedure that is developed and sanctioned by affected stakeholders (e.g., random

selection). A lottery system would mean that only some healthcare providers get PPE and only

those healthcare providers would be able to provide care.

Meanwhile…

 Continue with Stage 1 strategies, and

 Reassess healthcare providers’ risk of exposure on an ongoing basis to identify any changes in

level of priority.

A4R Ethical Framework (Process Conditions) for Resource Allocation Decision-Making:

The A4R framework has been adopted by Sunnybrook as a tool to help shape ethically defensible
processes for resource allocation decision-making. It outlines 5 fair process principles that help ensure
the process fair and perceived as such:

 Relevance; Publicity; Revision; Enforcement; and Empowerment

When considering implementing this framework, every effort should be made to promote fairness in
decision-making. Fairness can be promoted by ensuring that this process aligns with Sunnybrook’s

Page 6 of 6
Framework Authors: Sally Bean, Kevin Reel, Maxwell J. Smith, Blair Henry, and Maria McDonald
[email protected]
Version: March 9, 2020

framework for organizational decision-making, A4R. Further details of the A4R framework and its use
are available on Sunnynet. External individuals can read more about implementing A4R here.

Appendix I:

Areas Requiring Further Consideration:

 Redistributing PPE among health system partners

 IP&C guidelines/direction on PPE minimum standards, PPE substitutions, or alternations to

standard usage such as PPE extended use or reuse

 Expectations around reporting to work or self-quarantine if a family member living in the same

residence is positive for COVID-19

 Legal context if emergency measures are invoked

 Staff assignments to care for COVID-19 patients

 Healthcare providers ability to refuse “unsafe” work or assignments

 Access to PPE in community and unique challenges of allocation in community setting

 If healthcare providers have contracted COVID-19 and since recovered, what is the risk of re-

infection?

 If PPE supply gets to zero, can healthcare providers independently decide to provide care without

PPE (i.e. assume risk)?

 End-of-life decision-making issues (withholding or withdrawing treatment)

 Allocation of potentially life sustaining treatments, e.g. ventilators, ECMO, etc.

Page 1

373 F.3d 1151, 17 Fla. L. Weekly Fed. C 677
(Cite as: 373 F.3d 1151)

© 2009 Thomson Reuters. No Claim to Orig. US Gov. Works.

United States Court of Appeals,

Eleventh Circuit.
Anne Marie NOLEN, individually, and as natural

heir of the Estate of Baby B, and Baby C, Plaintiff-

Appellant,
v.

BOCA RATON COMMUNITY HOSPITAL, INC., a

Florida corporation, Geoffrey Zann, M.D., Joan

Reinsvold, RN, Susan Slavicek, Defendants-

Appellees.
No. 04-10228

Non-Argument Calendar.

June 18, 2004.

Background: The United States District Court for

the Southern District of Florida, No. 02-80410-CV-

KLR, Kenneth L. Ryskamp, J., granted summary

judgment in favor of hospital on outpatient’s Emer-

gency Medical Treatment and Active Labor Act

(EMTALA) claims, and outpatient appealed.

Holdings: The Court of Appeals held that:
(1) hospital was not required under EMTALA to

have a written emergency screening procedure, and
(2) there was no violation of the EMTALA where

hospital gave to pregnant outpatient the same quality

screening that it would have given a similarly situat-

ed outpatient.

Affirmed.

Appeal from the United States District Court for the

Southern District of Florida.

Before CARNES, HULL and PRYOR, Circuit Judg-

es.

PER CURIAM:

Anne Marie Nolen appeals from a summary judg-

ment entered against her. The district court held that

Nolen’s complaint, brought under both the Emergen-

cy Medical Treatment and Active Labor Act (EM-

TALA), 42 U.S.C. section 1395dd, and Florida law,

failed as a matter of law. We affirm; the district court

properly granted summary judgment in favor of the

Boca Raton Community Hospital, Inc. (Hospital).

I. FACTS AND PROCEDURAL HISTORY

Nolen was a pediatric nurse at the Hospital. She was

about twenty-two weeks pregnant with triplets and

had insurance coverage. At approximately 5:00 p.m.

on May 4, 2000, Nolen arrived at the Hospital for a

labor check at the direction of her physician, Dr.

Zann. The Hospital admitted Nolen as an outpatient

about twenty minutes later. She complained of

cramping and a mucous discharge that she feared

signaled the onset of labor.

Nolen was first treated by a Hospital nurse,

Reinsvold, in the labor and delivery unit of the Hos-

pital, One Family Place. Reinsvold undertook prelim-

inary care processes, including the following

measures: taking Nolen’s vital signs, taking Nolen’s

medical history, listening to the unborn babies’ hearts,

conducting a fetal monitor, and giving an initial ex-

amination of Nolen’s abdomen. Nolen was attached

to a fetal monitor, which detects uterine contractions

and uterine irritability, for more than an hour.

Reinsvold also paged Dr. Zann to see Nolen shortly

after Nolen’s admission to One Family Place.

After the initial assessment performed by Reinsvold,

Dr. Zann arrived to examine Nolen, who was still on

outpatient status, about an hour and ten minutes after

she was first registered by the Hospital. Dr. Zann

performed a visual exam of Nolen’s cervix, took a

culture of her vagina, and *1153 fully evaluated No-

len’s cervix. Nolen’s cervix was found to be neither

dilated nor thinned. The laboratory results from the

culture were negative. Dr. Zann concluded that No-

len’s lower uterine segment was consistent with what

he expected from a normal pregnancy in this circum-

stance. Dr. Zann performed an ultrasound to evaluate

each of the three fetal heart rates. He did not order

further testing.

Dr. Zann concluded that Nolen was not dilated and

Page 2

373 F.3d 1151, 17 Fla. L. Weekly Fed. C 677
(Cite as: 373 F.3d 1151)

© 2009 Thomson Reuters. No Claim to Orig. US Gov. Works.

that she had only one conclusive episodic contrac-

tion, which occurred at 5:32 p.m. Another potential

episodic contraction occurred at 6:04 p.m., but it was

inconclusive because Nolen was being repositioned

when the fetal monitor registered that movement.

Satisfied that Nolen had been adequately diagnosed

and stabilized, Dr. Zann discharged her from the

Hospital at 6:48 p.m. He ordered Nolen to keep her

scheduled appointment with her perinatologist, Dr.

Scott, the next morning.

After leaving the Hospital, Nolen’s condition changed

for the worse. She testified at deposition that she be-

gan cramping after leaving the Hospital. She made no

effort to contact Dr. Zann or the Hospital after this

change in condition.

When she reached Dr. Scott’s office the next morn-

ing, Nolen fully described the events of the previous

day. Nolen also told Dr. Scott of the change in condi-

tion she experienced after leaving the Hospital. Dr.

Scott examined Nolen and concluded that she may

have been entering pre-term labor on that day be-

cause the partial effacement and dilation of her cer-

vix. Dr. Scott determined that Nolen could not have

been entering pre-term labor on the previous day

when she was at the Hospital in the care of Dr. Zann.

Dr. Scott sent Nolen back to the Hospital to suppress

her pre-term labor. Nolen stayed there until May 7,

2000, when she was transferred to Broward General

Hospital because it had a superior neonatal care unit.

Nolen went into pre-term labor. Her first baby was

stillborn, and her other two babies were born alive.

Neither of her two live births survived past May 24,

2000, however.

Nolen filed a complaint under 42 U.S.C. section

1395dd on May 3, 2002, and alleged that the Hospital

(1) did not provide her with an adequate screening

examination, (2) did not stabilize her labor condition

adequately, and (3) discharged her in violation of the

EMTALA. Nolen received leave from the district

court to amend her complaint to include six counts of

medical malpractice under Florida law. Dr. Zann,

Reinsvold, and Slavicek, another nurse from the

Hospital, were added as defendants on those claims.

The district court declined to exercise jurisdiction

over all but one of the state law claims.

Both parties filed cross-motions for summary judg-

ment after the close of discovery. The district court

granted the motions made by the Hospital and the

other defendants on all three counts under the EM-

TALA and the remaining state law claim. Nolen does

not address the grant of summary judgment by the

district court on her state law claim in her brief be-

fore this Court, so any arguments on that claim are

waived. Farrow v. West, 320 F.3d 1235, 1242 (11th

Cir.2003); Kelliher v. Veneman, 313 F.3d 1270, 1274

n. 3 (11th Cir.2002); Greenbriar, Ltd. v. City of Ala-

baster, 881 F.2d 1570, 1573 n. 6 (11th Cir.1989).

II. STANDARD OF REVIEW

Summary judgment is only appropriate if “the plead-

ings, depositions, answers to interrogatories, and ad-

missions on file, together with the affidavits, if any,

show that there is no genuine issue as to any materi-

al*1154 fact and that the moving party is entitled to a

judgment as a matter of law.” Fed.R.Civ.P. 56(c);

Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247,

106 S.Ct. 2505, 2510, 91 L.Ed.2d 202 (1986) (quot-

ing Fed.R.Civ.P. 56(c)). Summary judgment should

be granted when, after an adequate time for discov-

ery, a party fails to make a showing sufficient to es-

tablish the existence of an essential element of that

party’s case. Celotex Corp. v. Catrett, 477 U.S. 317,

322, 106 S.Ct. 2548, 2552, 91 L.Ed.2d 265 (1986).

“We review the district court’s rulings on motion for

summary judgment de novo, applying the same legal

standards that bound the district court.” Carter v.

Galloway, 352 F.3d 1346, 1348 (11th Cir.2003).

III. ANALYSIS

Nolen asserts two grounds on which the district court

erred in holding that the Hospital gave her an appro-

priate screening when she entered as an outpatient on

May 4, 2000. First, she contends that the Hospital did

not have a standard written screening procedure or,

alternatively, that the Hospital did not follow its

screening procedure, either of which, she contends,

violated the EMTALA. Second, Nolen argues that the

district court should not have considered the evidence

submitted by the Hospital that proved Nolen was not,

in fact, in pre-term labor when she was examined at

the Hospital on May 4, 2000, by her personal physi-

cian, Dr. Zann. Each of these arguments is addressed

and rejected below.

[1][2][3] As we have previously stated,

Page 3

373 F.3d 1151, 17 Fla. L. Weekly Fed. C 677
(Cite as: 373 F.3d 1151)

© 2009 Thomson Reuters. No Claim to Orig. US Gov. Works.

In 1986, Congress enacted EMTALA in response

to widely publicized reports of emergency care

providers transferring indigent patients from one

hospital to the next while the patients’ emergency

medical conditions worsened. EMTALA was de-

signed specifically to address this important socie-

tal concern; it was not intended to be a federal

malpractice statute. Under EMTALA, hospital

emergency rooms are subject to two principal obli-

gations, commonly referred to as the appropriate

medical screening requirement and the stabilization

requirement…. The appropriate medical screening

requirement obligates hospital emergency rooms to

provide an appropriate medical screening to any

individual seeking treatment in order to determine

whether the individual has an emergency medical

condition…. If an emergency medical condition ex-

ists, the hospital is required to provide stabilization

treatment before transferring the individual.

Harry v. Marchant, 291 F.3d 767, 770 (11th

Cir.2002) (en banc).

[4] First, we address Nolen’s contention that the Hos-

pital was required to have a written screening proce-

dure. A similar argument was rejected by the Eighth

Circuit. Summers v. Baptist Med. Ctr. Arkadelphia,

91 F.3d 1132, 1140 (8th Cir.1996) (en banc). The

Eighth Circuit held that a hospital with emergency

screening procedures that were unwritten, in whole or

in part, did not violate the EMTALA. Id. (stating that

“the hospital did have a screening procedure, even if

unwritten in part, and the statute makes no additional

requirement”). Nolen’s argument that the Hospital

was required to have a written screening procedure

also fails because a written procedure is not required

by the terms of section 1395dd(a).

[5] Nolen alternatively contends that the Hospital did

not follow its policies for screening patients in pre-

term labor situations. Nolen relies on several policies

propagated by the Hospital to create doubt about the

quality of screening she received. As long as the

Hospital screened *1155 Nolen in a manner con-

sistent with the screening that any other patient in the

care of a private physician would have received, there

can be no liability under the EMTALA. The Hospital

presented undisputed evidence that Reinsvold per-

formed exactly the type of screening that would have

been given to any other outpatient in Nolen’s position

according to the only policy that applied to Nolen’s

case. Because the Hospital met its initial burden of

disproving the applicability of the EMTALA, the

burden shifts back to Nolen to show the existence of

a genuine issue of material fact. Hammer v. Slater, 20

F.3d 1137, 1141 (11th Cir.1994). Nolen did not meet

that burden.

[6] The undisputed record shows that Nolen, if any-

thing, received superior care from the Hospital.

Reinsvold promptly summoned Dr. Zann to perform

an in-person exam of Nolen, which only 6 percent of

similarly situated patients receive. The uncontrovert-

ed evidence showed that 94 percent of other patients

who came to the Hospital for a labor check did not

receive as extensive a screening as the one Nolen

received. As the Fourth Circuit has explained, a hos-

pital has every right to tailor its screening procedures

to a patient to account for her condition, stated symp-

toms, and the determinations made by her personal

physician. Baber v. Hosp. Corp. of Am., 977 F.2d

872, 879 n. 6 (4th Cir.1992); see also Baker v. Ad-

ventist Health, Inc., 260 F.3d 987, 995 (9th Cir.2001)

(“Hospitals are not required to provide patients pre-

senting different symptoms with identical screen-

ings.”). Nolen’s treatment was provided primarily by

her private physician, who was in a better position to

provide care beyond the screening mandated by the

EMTALA. So long as the Hospital gave to Nolen the

same quality screening that it would have given a

similarly situated outpatient, there is no violation of

the EMTALA. Harry, 291 F.3d at 770.

Second, we turn to Nolen’s argument that the district

court impermissibly weighed evidence and usurped

the function of a jury. We disagree. The Hospital

proffered evidence from experts and the principals

that confirmed that Nolen received an adequate

screening. It was Nolen’s responsibility then to pre-

sent evidence of a genuine issue of material fact,

which would have precluded summary judgment.

Celotex, 477 U.S. at 322-24, 106 S.Ct. at 2552-54.

Nolen did not satisfy that burden, and the district

court properly granted summary judgment.

Baber is also instructive on this point. The Fourth

Circuit held in Baber that one cursory affidavit from

a physician was insufficient to create a genuine issue

of material fact as to the adequacy of the screening

that the patient received. 977 F.2d at 881-82. Nolen

has failed to present even a single affidavit of a phy-

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373 F.3d 1151, 17 Fla. L. Weekly Fed. C 677
(Cite as: 373 F.3d 1151)

© 2009 Thomson Reuters. No Claim to Orig. US Gov. Works.

sician to dispute the adequacy of the screening pro-

vided by the Hospital.

Accordingly, the summary judgment entered by the

district court is

AFFIRMED.

C.A.11 (Fla.),2004.
Nolen v. Boca Raton Community Hosp., Inc.
373 F.3d 1151, 17 Fla. L. Weekly Fed. C 677

END OF DOCUMENT

Page 1

9 S.W.3d 119
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Supreme Court of Tennessee,

at Nashville.
Patricia P. ASHE, Plaintiff/Appellant,

v.
RADIATION ONCOLOGY ASSOCIATES and

Steven L. Stroup, M.D., Defendants/Appellees.
Dec. 27, 1999.

Rehearing Denied Jan. 7, 2000.

Patient brought informed consent claim against doctor

after she underwent radiation treatment for lung tu-

mor, sustained radiation myelitis, and was rendered

paraplegic. The Circuit Court, Davidson County,

Hamilton V. Gayden Jr., J., entered directed verdict

for doctor. Patient appealed and the Court of Appeals,

Cain, J., reversed and remanded. On doctor’s appeal,

the Supreme Court, Holder, J., held that: (1) objective

standard was adopted for informed consent cases, and

(2) whether reasonable person in patient’s position

would have chosen different course of treatment was

issue for jury.

Judgment of Court of Appeals affirmed and case re-

manded.

West Headnotes
*120 O P I N I O N

HOLDER, J.

We granted this appeal to address the appropriate

standard to be employed when assessing the issue of

causation in a medical malpractice informed consent

case. We find that the objective standard as set forth in

this opinion best balances a patient’s right to

self-determination with the need for a realistic

framework for rational resolution of the issue of cau-

sation. We hold that the standard to be applied in

informed consent cases is whether a reasonable person

in the patient’s position would have consented to the

procedure or treatment in question if adequately in-

formed of all significant perils. The decision of the

Court of Appeals is affirmed, and the case is remanded

to the trial court for a new trial.

BACKGROUND

The plaintiff, Patricia P. Ashe, was diagnosed with

breast cancer in 1988. She ultimately underwent a

double mastectomy and chemotherapy as treatment

for her breast cancer. In 1993, she began experiencing

problems with a cough and a fever. She returned to her

oncologist, Dr. Michael Kuzu, where she presented

symptoms of fever, cough, pain in the abdomen,

weight loss, decreased appetite, and irritability. A

chest x-ray and a CT scan revealed the presence of a

mass in the medial left apex of her left lung.

The record indicates that the lung tumor could possi-

bly have been metastatic cancer from the breast. Ms.

Ashe underwent surgery, and the upper portion of her

left lung was removed. She underwent chemotherapy

and was referred to the defendant, Dr. Steven L.

Stroup, for consideration of radiation therapy. Dr.

Stroup testified that chemotherapy alone would be

indicated if the lung tumor were metastasized breast

cancer. He, however, opined that radiation therapy

would be indicated if the lung cancer were primary as

opposed to secondary cancer.

Dr. Stroup prescribed radiation treatment for Ms.

Ashe. She received a daily dose of 200 centigray for

twenty-five days. He described the dose as a “mid-

plane dose.” Ms. Ashe sustained “radiation myelitis”

caused by a permanent radiation injury to her spinal

cord. She is now a paraplegic.

Dr. Stroup did not inform Ms. Ashe that the radiation

treatment might result in a permanent injury to her

spinal cord. According to Dr. Stroup, the risk that she

would sustain a spinal cord injury was less than one

percent. Mrs. Ashe proffered the testimony of her

expert, Dr. Carlos Perez. Dr. Perez opined that the risk

of spinal cord injury was one to two percent. Dr. Perez

testified that the applicable standard of care required

physicians to warn patients about the risk of radiation

injury to the spinal cord.

Ms. Ashe filed the present action alleging claims for

medical malpractice and lack of informed consent. At

trial, she testified that she would not have consented to

the radiation therapy had she been informed of the risk

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of paralysis. Defense counsel on cross-examination

pointed out that the plaintiff did equivocate in her

deposition on the issue of consent. Her deposition

testimony indicated that she did not know what she

would have done had she been warned about the risk

of spinal cord injury. She then testified on redirect

examination as follows:

True, but the risk of being paralyzed and put in a

wheelchair for the rest of your life was not one of

the items, if there was any discussed, because had he

said that within a six-month period-which they said

that would be the time frame for it to happen-had he

said, ‘Patty, if you do this there is a risk that you will

be in a wheelchair six months from now,’ I would

have told him, ‘I will take my chances.’ I would not

have it done.

The trial court found that the plaintiff’s trial testimony

conflicted with her deposition testimony regarding

whether she *121 would have consented to the pro-

cedure had she been warned of the risk of spinal cord

injury. The trial court, therefore, struck the trial tes-

timony and granted the defendant a directed verdict on

the informed consent claim. The plaintiff’s malprac-

tice claim went to the jury. The jury was unable to

reach a verdict, and a mistrial was declared.

The plaintiff appealed to the Court of Appeals. The

Court of Appeals held that as part of the plaintiff’s

informed consent claim she was required to prove that

a reasonable person knowing of the risk for spinal cord

injury would have decided not to have had the pro-

cedure performed. The Court held that the discrepancy

between the trial testimony and deposition testimony

went to the issue of credibility and that the trial tes-

timony should not have been stricken. The Court of

Appeals reversed the trial court’s grant of a directed

verdict on the informed consent claim and remanded

the case for a new trial.

ANALYSIS

[1] The burden of proof on the standard of care ele-

ment in medical malpractice informed consent cases is

controlled by Tenn.Code Ann. § 29-26-118. Pursuant

to § 29-26-118, a plaintiff must prove by expert tes-

timony that

the defendant did not supply appropriate infor-

mation to the patient in obtaining his informed

consent to the procedure out of which plaintiff’s

claim allegedly arose in accordance with the rec-

ognized standard of acceptable professional practice

in the profession and in the specialty, if any, that the

defendant practices in the community in which he

practices or in similar communities.

Id. In addition, Tenn.Code Ann. § 29-26-115 requires

that the plaintiff prove the recognized standard of

acceptable professional practice, that the defendant

acted with less than ordinary and reasonable care in

accordance with that standard, and that the plaintiff

sustained injuries as a result of the defendant’s negli-

gent act or omission. Accordingly, the plaintiff in an

informed consent medical malpractice case has the

burden of proving: (1) what a reasonable medical

practitioner in the same or similar community would

have disclosed to the patient about the risk posed by

the proposed procedure or treatment; and (2) that the

defendant departed from the norm. German v. Ni-

chopoulos, 577 S.W.2d 197, 204 (Tenn. Ct.

App.1978).

This Court recently enunciated a distinction between a

lack of informed consent case and a pure medical

battery case. In Blanchard v. Kellum, 975 S.W.2d 522

(Tenn.1998), this Court defined a medical battery as a

case in which a doctor performs an unauthorized

procedure. Id. at 524. A medical battery may typically

occur when: (1) a professional performs a procedure

that the patient was unaware the doctor was going to

perform; or (2) the procedure was performed on a part

of the body other than that part explained to the patient

(i.e., amputation of the wrong leg). Id. A lack of in-

formed consent claim typically occurs when the pa-

tient was aware that the procedure was going to be

performed but the patient was unaware of the risk

associated with the procedure. Id.

The case now before us is not a medical battery case.

Ms. Ashe had authorized the radiation treatment. Ms.

Ashe, however, contends that she was not apprised of

certain risks inherent in the treatment. Her claim,

therefore, is premised on the lack of informed consent.

The issue with which we are now confronted is

whether an objective, subjective, or a hybrid subjec-

tive/objective test shall be employed when assessing

causation in medical malpractice informed consent

cases. The issue is one of first impression in Tennes-

see. The majority of jurisdictions having addressed

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9 S.W.3d 119
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© 2010 Thomson Reuters. No Claim to Orig. US Gov. Works.

this issue follow an objective standard. A minority of

jurisdictions having addressed the issue follow the

subjective approach. One jurisdiction, Hawaii, em-

ployed a “modified objective standard”*122 for in-

formed consent cases for approximately ten years.

Hawaii has now abandoned the modified approach in

favor of the objective standard. We shall now examine

the various approaches and the rationales behind these

approaches.

Subjective Standard

The plaintiff urges this Court to follow the minority

rule or adopt a subjective standard when evaluating

causation in an informed consent case. Causation

under the subjective standard is established solely by

patient testimony. Patients must testify and prove that

they would not have consented to the procedures had

they been advised of the particular risk in question.

See e.g., Scott v. Bradford, 606 P.2d 554 (Okla.1979);

Wilkinson v. Vesey, 110 R.I. 606, 295 A.2d 676

(1972). Accordingly, resolution of causation under a

subjective standard is premised elusively on the

credibility of a patient’s testimony.

The subjective standard engages in an abstract analy-

sis. The abstract analysis not only poses a purely hy-

pothetical question but seeks to answer the hypothet-

ical question. One commentator has framed this hy-

pothetical question as follows: “Viewed from the

point at which [the patient] had to decide, would the

patient have decided differently had he known some-

thing he did not know?” Canterbury v. Spence, 464

F.2d 772, 790 (D.C.Cir.1972) quoting Waltz &

Scheuneman, Informed Consent to Therapy, 64

Nw.U.L.Rev. 628, 647 (1970).

Proponents of the subjective test argue that a patient

should have the right to make medical determinations

regardless of whether the determination is rational or

reasonable. Gouse v. Cassel, 532 Pa. 197, 615 A.2d

331, 335 (1992). Opponents, however, focus on the

unfairness of allowing the issue of causation to turn on

the credibility of the hindsight of a person seeking

recovery after experiencing a most undesirable result.

Sard v. Hardy, 281 Md. 432, 379 A.2d 1014, 1025

(1977). “Patients cannot divorce their re-created de-

cision process from hindsight.” F. Rozovsky, Consent

to Treatment, § 1.13.4, 62-63 (1984). Accordingly, the

subjective test potentially places the physician in

jeopardy of the patient’s hindsight and bitterness.

Sard, 379 A.2d at 1025. Moreover, the adoption of a

subjective standard could preclude recovery in an

informed consent case in which the patient died as a

result of an unforewarned collateral consequence. Id.

Objective Standard

The majority

FN1
approach or the so-called objective

standard emanates from the seminal decision in Can-

terbury v. Spence, 464 F.2d 772 (D.C.Cir.1972). In

Canterbury, the court held that causation in informed

consent cases is better resolved on an objective basis

“in terms of what a prudent person in the patient’s

position would have decided if suitably informed of all

perils bearing significance.” Id. at 791. The objective

view recognizes that neither the plaintiff nor the

fact-finder can provide a definitive answer as to what

the patient would have done had the patient known of

the particular risk prior to consenting to the procedure

or treatment. Id. at 790. Accordingly, the patient’s

testimony is relevant under an objective approach, but

the testimony is not controlling. Id. at 791.

FN1. Jurisdictions applying the objective

standard include: Fain v. Smith, 479 So.2d

1150 (Ala.1985); Aronson v. Harriman, 321

Ark. 359, 901 S.W.2d 832 (1995); Hamilton

v. Hardy, 37 Colo.App. 375, 549 P.2d 1099

(1976); Hammer v. Mount Sinai Hosp., 25

Conn.App. 702, 596 A.2d 1318 (1991);

Bernard v. Char, 79 Hawai‘i 362, 903 P.2d

667 (1995); Sherwood v. Carter, 119 Idaho

246, 805 P.2d 452 (1990); Funke v. Field-

man, 212 Kan. 524, 512 P.2d 539 (1973);

Sard v. Hardy, 281 Md. 432, 379 A.2d 1014

(1977); Woolley v. Henderson, 418 A.2d

1123 (Me.1980); Phillips v. Hull, 516 So.2d

488 (Miss.1987); Backlund v. University of

Washington, 137 Wash.2d 651, 975 P.2d 950

(1999); Scaria v. St. Paul Fire & Marine Ins.

Co., 68 Wis.2d 1, 227 N.W.2d 647 (1975);

Dixon v. Peters, 63 N.C.App. 592, 306

S.E.2d 477 (1983).

*123 Modified Objective Standard

The modified objective standard was first recognized

in Leyson v. Steuermann, 5 Haw.App. 504, 705 P.2d

37 (1985). In Leyson, the Hawaii Court of Appeals

attempted to balance patient’s right to

self-determination with the concerns espoused in

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Canterbury of subjecting a physician to a patient’s

bitterness or hindsight following an undesirable result.

The resulting test determined causation “from the

viewpoint of the actual patient acting rationally and

reasonably.” Id. at 47, n. 10.

Approximately ten years after the inception of the

modified approach, the approach was declared to be

onerous in application. In Bernard v. Char, 79 Ha-

wai‘i 362, 903 P.2d 667 (1995), the Hawaii Supreme

Court elaborated that:

In its effort to achieve the desired result of com-

bining the objective and subjective standards, the

modified objective standard injects at least one extra

level of complexity into the causation analysis.

Under the objective standard, the factfinder must

suspend his or her own viewpoint and step into the

viewpoint of a reasonable person to objectively as-

sess the plaintiff-patient’s decision to undergo

treatment. Under the subjective standard, the fact-

finder must simply assess the credibility of the

plaintiff-patient when he or she invariably asserts

that he or she would have declined treatment with

proper disclosure. Under the “modified objective

standard,” however, the factfinder must first sus-

pend his or her viewpoint, then place himself or

herself in the mind of the actual patient, and, then,

while maintaining the viewpoint of the actual pa-

tient, try to determine what the actual patient would

have decided about the proposed medical treatment

or procedure, if the actual patient were acting ra-

tionally and reasonably.

Id. at 673. Accordingly, the modified approach was

abandoned in favor of the objective standard.
[D]espite being well-intentioned, [it] exacts too

much of a cost in the form of added complexity in

seeking to solve problems associated with the

preexisting objective and subjective standards while

at the same time remaining faithful to the laudable

purposes behind such standards.

Id. The Court held: (1) that the objective standard

provided “a better, simpler, and more equitable ana-

lytical process;” and (2) that the objective standard

ultimately addressed the concerns which prompted the

creation of the modified test.

CONCLUSION

[2] We agree with the majority of jurisdictions having

addressed this issue and hold that the objective ap-

proach is the better approach. The objective approach

circumvents the need to place the fact-finder in a po-

sition of deciding whether a speculative and perhaps

emotional answer to a purely hypothetical question

shall dictate the outcome of the litigation. The objec-

tive standard is consistent with the prevailing standard

in negligence cases which measures the conduct of the

person in question with that of a reasonable person in

like circumstances. Restatement (Second) of Torts §

283, p. 12 (1965); see also 1 S. Pegalis & H.

Wachsman, American Law of Medical Malpractice, §

2.15, 103-104 (1980) (criticizing subjective test as

being out of step with general negligence concepts).

The objective test provides a realistic framework for

rational resolution of the issue of causation. We,

therefore, believe that causation may best be assessed

in informed consent cases by the finder of fact deter-

mining how nondisclosure would affect a reasonable

person in the plaintiff’s position.

[3] We also are of the opinion that the objective test

appropriately respects a patient’s right to

self-determination. The finder of fact may consider

and give weight to the patient’s testimony as to

whether the patient would have consented to the pro-

cedure upon full disclosure of the *124 risks. When

applying the objective standard, the finder of fact may

also take into account the characteristics of the plain-

tiff including the plaintiff’s idiosyncrasies, fears, age,

medical condition, and religious beliefs. Bernard v.

Char, 79 Hawai‘i 362, 903 P.2d 667, 674 (1995); Fain

v. Smith, 479 So.2d 1150, 1155 (Ala.1985); Backlund

v. University of Washington, 137 Wash.2d 651, 975

P.2d 950 (1999). Accordingly, the objective standard

affords the ease of applying a uniform standard and

yet maintains the flexibility of allowing the finder of

fact to make appropriate adjustments to accommodate

the individual characteristics and idiosyncrasies of an

individual patient. We, therefore, hold that the stand-

ard to be applied in informed consent cases is whether

a reasonable person in the patient’s position would

have consented to the procedure or treatment in ques-

tion if adequately informed of all significant perils.

[4] In applying the objective standard to the facts of

this case, we agree with the Court of Appeals that the

jury should not have been precluded from deciding the

issue of informed consent. Under the objective analy-

sis, the plaintiff’s testimony is only a factor when

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9 S.W.3d 119
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© 2010 Thomson Reuters. No Claim to Orig. US Gov. Works.

determining the issue of informed consent. The dis-

positive issue is not whether Ms. Ashe would herself

have chosen a different course of treatment. The issue

is whether a reasonable patient in Ms. Ashe’s position

would have chosen a different course of treatment.

The jury, therefore, should have been allowed to de-

cide whether a reasonable person in Ms. Ashe’s posi-

tion would have consented to the radiation therapy had

the risk of paralysis been disclosed.

The judgment of the Court of Appeals reversing the

trial court is affirmed. The case is remanded for a new

trial consistent with this opinion. Costs of the appeal

to the Court of Appeals shall be as previously taxed;

costs of the appeal to this Court shall be taxed against

the plaintiff for which execution may issue if neces-

sary.

ANDERSON, C.J., DROWOTA, BIRCH, and

BARKER, J.J., concur.
Tenn.,1999.
Ashe v. Radiation Oncology Associates
9 S.W.3d 119

END OF DOCUMENT

Page 1 of 6
Framework Authors: Sally Bean, Kevin Reel, Maxwell J. Smith, Blair Henry, and Maria McDonald
[email protected]
Version: March 9, 2020

Ethical Framework for the Allocation of Personal Protective Equipment (during COVID-19)

Background

This ethical framework is intended to guide institutional resource allocation decisions for Personal

Protective Equipment (PPE) during the COVID-19 public health emergency. In a guidance document

issued Feb. 27, 2020, the WHO recommends rational use of PPE for treating patients with confirmed or

suspected COVID-19. Relevant PPE includes gloves, medical masks, goggles or face shields, gowns, and

respirators. The WHO has indicated that the current global stockpile of masks and respirators is

insufficient and shortages in gowns and goggles is also anticipated.

The WHO has issued three overarching recommendations for use of PPE:

1) minimize the need for PPE; and

2) ensure PPE use is rationalized and appropriate; and

3) coordinate PPE supply chain mechanisms.

The WHO recommendations have been integrated into this framework. This ethical framework is a living

document and will require review and updating as the COVID-19 situation evolves and new evidence

emerges. This framework is advisory and was developed to support key decision-makers at the

institutional level regarding the distribution of available PPE supply and potential modification to health

services to conserve PPE. Although this framework is tailored for the acute care setting, ideally there

should be consistency between and among healthcare institutions across the continuum of care to foster a

consistent approach, and as a result, promote the ethical principles of justice and fairness. This framework

may be adapted to address a broader health system perspective.

This ethical framework is adapted from the Ethical Framework for Resource Allocation during the

Drug Supply Shortage, which was drafted by an Ethics Working Group convened by the University of

Toronto Joint Centre for Bioethics in 2012 and endorsed by the Ontario Ministry of Health. The

Allocation of PPE Ethical Framework is comprised of:

a. Allocation principles that are articulated in three stages;

b. Fair process principles; and

c. Guiding values.

Balancing allocation principles and making decisions about PPE allocation should occur according to fair

process principles and generally aim to promote seven guiding values. The guiding value of reciprocity

has been added to the six principles included in the 2012 Drug Supply Shortage framework. The guiding

values are beneficence, equity, reciprocity, solidarity, stewardship, trust, and utility. In addition to the

allocation principles and guiding values, fair process principles, such as the Accountability for

Reasonableness (A4R) Ethical Framework should help inform how decisions are made. The five fair

process principles comprising A4R include relevance, publicity, revision, enforcement, and

empowerment.

The following seven guiding values appear in alphabetical order and are not rank-ordered.

Page 2 of 6
Framework Authors: Sally Bean, Kevin Reel, Maxwell J. Smith, Blair Henry, and Maria McDonald
[email protected]
Version: March 9, 2020

Table 1.Guiding Values

Value Definition

Beneficence Promoting highest quality of safe and effective care within resource constraints by:

a. Ensuring standard of care and best Infection Prevention & Control (IP&C) practices whenever possible

b. Training healthcare providers (construed broadly to include anyone with direct contact with patients including both regulated and unregulated

providers, administrative staff, environmental services, porters, etc.) to select the proper PPE, how to safely doff, don, and dispose of PPE after

use

c. Committing to use best available data/evidence to inform PPE allocation decision-making

d. Using alternative PPE where evidence suggests similar or similarly adequate efficacy

e. Informing and educating healthcare providers about risks and benefits of alternate PPE including risk mitigation strategies

f. Enabling delivery of care in the most appropriate setting, e.g. negative pressure rooms or decontamination areas to help mitigate risk of exposure

Equity Promote just/fair access to PPE by:

a. Using allocation processes for distribution of PPE that do not arbitrarily disadvantage any healthcare provider

b. Not discriminating between healthcare providers based on factors not relevant to provision of healthcare (e.g., social status)

c. Treating similar cases similarly and treating dissimilar cases in a manner that reflects the differences.

Reciprocity To support healthcare providers that may be or are exposed to COVID-19 in the course of their employment, mitigate potential harms/burdens this may

cause to the individual by:

a. Describing the steps healthcare providers should take to reduce exposure or spread to others, including family members

b. Working with Occupational Health & Safety to clarify requirements and implications for fitness to work

c. Ensure that healthcare providers exposed to COVID-19 are aware of all known ways to reduce symptoms and complications associated with

COVID-19

d. Prioritizing healthcare providers most at risk of COVID-19 exposure in the course of their employment for future vaccines or treatments that

may be developed or become available

e. If hospital visitation is suspended, support use of technology for patients and staff that are isolated from families to safely communicate

Solidarity To build, preserve and strengthen interprofessional and intra-institutional collaboration is the responsibility of all leaders and decision-makers through:

a. Embracing a shared commitment to the well-being of patients and healthcare providers regardless of care setting (i.e. all sites and more broadly

across the continuum of care)

b. Establishing, encouraging, and enabling open lines of communication and coordination

c. Sharing and redistributing PPE within the healthcare institution

d. Supporting allocation decisions that are consistent with ethical framework

Page 3 of 6
Framework Authors: Sally Bean, Kevin Reel, Maxwell J. Smith, Blair Henry, and Maria McDonald
[email protected]
Version: March 9, 2020

e. Recognizing importance of collaboration with health system partners beyond the acute care setting

f. Recognizing some healthcare providers may feel a strong duty to care for patients despite inadequate PPE but this individual decision may have

overriding negative consequences, e.g. resources required if the healthcare provider becomes ill

g. Acknowledging that due to individual circumstances, some healthcare providers may have competing interests (e.g. ill family members),

underlying health issues that put them at an elevated risk if infected, etc. such that they may be unavailable to provide care or might need to be

redeployed to other low risk areas

h. Providing psychosocial support to healthcare providers delivering care to COVID-19 patients to ensure they feel supported and not marginalized

Stewardship Upholding principles use of available PPE carefully and responsibly by:

a. Ensuring PPE utilization is consistent with best available evidence

b. Avoiding stockpiling for personal use

c. Postponing elective procedures/treatments that require use of PPE that are in limited supply

d. Prioritizing access to scarce PPE based on risk of exposure and pathogen transmission dynamics

e. Monitoring PPE utilization and distribution to facilitate course corrections as needed

f. If deemed acceptable for IP&C practices, extend life of PPE through extended PPE use (e.g. use same respirator while caring for multiple

patients with the same diagnosis without removing PPE)

Trust Foster and maintain public, patient, and health care provider confidence in PPE distribution system by:

a. Communicating in a clear and timely fashion, including expectations around accepting or refusing work assignments

b. Making decisions in an open, inclusive and transparent way with clearly defined decision-making authority and accountability

c. Being transparent and providing a rationale about what criteria are informing PPE allocation and staff assignment decisions

d. Collating short and long-term lessons learned

Utility While balancing the other principles, maximize the greatest possible good for the greatest possible number of individuals by:

a. Promote administrative control measures that minimize direct patient care to essential encounters

b. Distributing PPE in short supply to healthcare providers administering direct patient care

c. Distributing PPE in short supply to healthcare providers with the highest risk of exposure (e.g. providing direct care and aerosol-generating

procedures) and pathogen transmission dynamics

d. Sharing PPE within the healthcare institution

e. Where feasible, sourcing additional PPE supply

f. Identifying healthcare providers that may be at increased risk for the more serious (health-related) impacts of COVID-19 if they were to become

infected and potentially redeploy to lower risk areas.

Page 4 of 6
Framework Authors: Sally Bean, Kevin Reel, Maxwell J. Smith, Blair Henry, and Maria McDonald
[email protected]
Version: March 9, 2020

Allocation Principles:

The following allocation principles apply generally across all types of PPE. They provide a foundation to

inform discussion and decision-making at the relevant governance level during.

Stage 1. Implement strategies to preserve or approximate standard of care and best IP&C practices to

the extent possible within available PPE supply

When there is risk of PPE shortage,

1a. Conserve existing supply of PPE using strategies such as:

 Developing an inventory of available PPE and review at frequent intervals

 Reviewing PPE usage practices in light of best available evidence

 Reducing wastage of PPE (e.g., where evidence does not support use or is weak)

 Minimize need for PPE by using alternatives to face-to-face care such as telemedicine or

consultation across physical barriers for appropriate interactions

 Using alternative PPE where evidence suggests adequately similar efficacy to the PPE in short

supply

 Limit or prohibit hospital visitation (to reduce or eliminate visitors use of PPE)

 Limit access to PPE to only those providing direct patient care to COVID-19 (or other diseases

that require PPE)

 Cancelling non-urgent or elective procedures that require use of PPE

 Co-horting COVID-19 patients (i.e. create a care ecology so that healthcare providers can

optimally use PPE for treating a group of similarly situated patients)

 Utilize expired PPE for training purposes and consider if safe to use for direct care

 Delaying new enrollment in research studies using PPE in short supply

1b. Access new supply of PPE by:

 Collaborating with partners and governments to identify and procure alternative sources

And if these strategies are insufficient…

1c. Postpone or reduce procedures/treatments that require the use of PPE in short supply that are not

related to COVID-19.

Stage 2. Apply Primary Allocation Principles based on risk of exposure and risk of harm (to self and

others, e.g. if work with a patient population that might be more negatively impacted) if infected:

When Stage 1 strategies are insufficient to meet the need for PPE in short supply, give priority access in

rank order to:

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Framework Authors: Sally Bean, Kevin Reel, Maxwell J. Smith, Blair Henry, and Maria McDonald
[email protected]
Version: March 9, 2020

2a. Healthcare providers who are at highest risk for exposure to (or risk of harm from) COVID-19 (or

other diseases that require PPE) that are providing direct care to patients.

2b. Healthcare providers who are at moderate risk for exposure to (or risk of harm from) COVID-19

(or other diseases that require PPE) that are providing direct care to patients.

2c. Healthcare providers who are at lowest risk for exposure to (or risk of harm from) COVID-19 (or

other diseases that require PPE) that are providing direct care to patients.

Meanwhile…

 Continue with Stage 1 strategies, and

 Reassess healthcare provider’s risk of exposure on an ongoing basis to identify any changes in

level of priority.

Stage 3. Apply Secondary Allocation Principles to Ensure Fair Access to PPE

When decisions must be made between healthcare providers within a level of priority as described in

Stage 2, prioritize healthcare providers using a fair and unbiased procedure that does discriminate

between healthcare providers based on factors not relevant to their risk of exposure (e.g., race, social

value, sex, age) or risk of harm if infected such as:

 First come, first served (where queuing is feasible with regular clinical practice), or

 Other procedure that is developed and sanctioned by affected stakeholders (e.g., random

selection). A lottery system would mean that only some healthcare providers get PPE and only

those healthcare providers would be able to provide care.

Meanwhile…

 Continue with Stage 1 strategies, and

 Reassess healthcare providers’ risk of exposure on an ongoing basis to identify any changes in

level of priority.

A4R Ethical Framework (Process Conditions) for Resource Allocation Decision-Making:

The A4R framework has been adopted by Sunnybrook as a tool to help shape ethically defensible
processes for resource allocation decision-making. It outlines 5 fair process principles that help ensure
the process fair and perceived as such:

 Relevance; Publicity; Revision; Enforcement; and Empowerment

When considering implementing this framework, every effort should be made to promote fairness in
decision-making. Fairness can be promoted by ensuring that this process aligns with Sunnybrook’s

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Framework Authors: Sally Bean, Kevin Reel, Maxwell J. Smith, Blair Henry, and Maria McDonald
[email protected]
Version: March 9, 2020

framework for organizational decision-making, A4R. Further details of the A4R framework and its use
are available on Sunnynet. External individuals can read more about implementing A4R here.

Appendix I:

Areas Requiring Further Consideration:

 Redistributing PPE among health system partners

 IP&C guidelines/direction on PPE minimum standards, PPE substitutions, or alternations to

standard usage such as PPE extended use or reuse

 Expectations around reporting to work or self-quarantine if a family member living in the same

residence is positive for COVID-19

 Legal context if emergency measures are invoked

 Staff assignments to care for COVID-19 patients

 Healthcare providers ability to refuse “unsafe” work or assignments

 Access to PPE in community and unique challenges of allocation in community setting

 If healthcare providers have contracted COVID-19 and since recovered, what is the risk of re-

infection?

 If PPE supply gets to zero, can healthcare providers independently decide to provide care without

PPE (i.e. assume risk)?

 End-of-life decision-making issues (withholding or withdrawing treatment)

 Allocation of potentially life sustaining treatments, e.g. ventilators, ECMO, etc.

EMTALA Articles and resources 6/3/21

https://www.latimes.com/california/story/2021-03-01/more-nurses-oversight-for-home-accused-of-patient-dumping-during-pandemic



CALIFORNIA

L.A. nursing home ‘dumped’ residents to bring in lucrative COVID patients, authorities say

Los Angeles City Atty. Mike Feuer said the Lakeview Terrace skilled nursing home had agreed to settle a lawsuit alleging that it discharged patients to make room for others suffering from COVID-19, who are generally more lucrative to treat. 

(Francine Orr / Los Angeles Times)

By 

JAMES RAINEY
STAFF WRITER 

MARCH 1, 2021 4:13 PM PT

A nursing home accused of illegally “dumping” patients onto city streets and into ill-equipped homes in order to take in more lucrative COVID-19 patients will nearly double its nursing staff, allow increased oversight and pay $275,000 in penalties and costs to settle a lawsuit brought by the Los Angeles city attorney’s office.

City Atty. Mike Feuer on Monday announced the legal agreement with the Lakeview Terrace skilled nursing facility, which he had accused of “sustained” and “intentional” misconduct in failing to adequately tend to some patients, while pushing others out of the 99-bed home.

The city alleged in its lawsuit that the facility west of downtown had an incentive to discharge long-term residents in order to make room for COVID-19 patients, who brought Lakeview Terrace much higher reimbursement payments from Medicare.

“This victory for these patients is all the more important given COVID-19’s devastating impact on nursing home residents in L.A. and across the nation,” Feuer said in announcing the settlement. He predicted that the agreement would result in “dramatic improvements in patient care, new COVID-related protections [and] improved oversight when patients are discharged.”

The city attorney’s lawsuit said Lakeview Terrace had failed to give prescribed medication to chronically ill patients and falsely reported that the medicine had been given.



CALIFORNIA



Tracking the coronavirus in California

Dec. 19, 2020

The July action, filed in Superior Court, also charged that family members were not consulted when patients were “dumped” at other facilities or onto the street.

In one instance, the lawsuit said, an 88-year-old man with dementia was transferred from the nursing home in the Westlake neighborhood to a boarding house in Van Nuys, only to be found a day later wandering the streets, profoundly confused.

Another Lakeview Terrace patient who is positive for HIV was released and ended up cowering in a friend’s backyard, hoping he would be safe there from the coronavirus, the suit contended.

“Although Lakeview disputes the underlying allegations, the costs associated with litigating against the City are most appropriately put towards resident care,” the facility’s administrator, DJ Weaver, said via email.

Feuer acknowledged that the facility had cooperated with the city attorney’s office throughout the investigation. Weaver’s statement concluded: “Put simply, all Lakeview residents can expect the utmost in care and treatment. Residents have been, and will continue to be, Lakeview’s highest priority.”

Healthcare experts have warned that the money skilled nursing facilities are paid under a plan by the federal government to care for people stricken by the coronavirus would lead to patient-dumping by unscrupulous operators. The reimbursement plan pays more than four times more for COVID-19 patients than homes can charge for long-term residents with relatively mild conditions.

The lawsuit is similar to another filed in 2019 by the city attorney’s office against Lakeview Terrace. That action also accused the home of patient-dumping, inadequate care and failure to maintain adequate patient records.

The new settlement brings back an outside monitor first imposed on Lakeview Terrace following the 2019 lawsuit. This time, the monitor will have broader powers to protect residents, with 24-hour access to patient records and the ability to make unannounced inspections. The outside overseer will remain in place for up to 18 months, at the discretion of Feuer’s office.

According to county health officials tracking care facilities, Lakeview Terrace has reported that 38 staff members and 48 patients have contracted the coronavirus since the start of the pandemic. The facility has recorded three COVID-19 deaths.

Other resources to view:

Physician review sheet:
https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/som107_exhibit_138.pdf

EMTALA for Dummies:
http://sinaiem.org/emtala-for-dummies/#:~:text=EMTALA%20stands%20for%20%E2%80%9CEmergency%20Medical%20Treatment%20%26%20Labor,race%2C%20gender%2C%20national%20origin%2C%20preexisting%20medical%20conditions%2C%20etc.

Washington State Hospital Associate EMTALA Fact Sheet:
http://www.wsha.org/wp-content/uploads/emergencies_EMTALA-fact-sheet.pdf

EMTALA Quick Sheet¨ https://assets.hcca-info.org/Portals/0/PDFs/Resources/Conference_Handouts/Compliance_Institute/2019/410_Handout.3.pdf

Patient Dumping Still a Problem Despite Law 4/1/19:
https://www.usnews.com/news/health-news/articles/2019-04-01/patient-dumping-still-a-problem-despite-federal-law

‘Patient Dumping’ Still a Problem Despite Law

Financial motivations play a strong role in hospitals providing appropriate care, new research suggests.

By Gaby Galvin

|

April 1, 2019, at 11:00 a.m.

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Study: ‘Patient Dumping’ Still a Problem

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New study findings indicate that lower-income patients still face unequal treatment in emergency care settings.
(GETTY IMAGES/BLEND IMAGES)

A sweeping new analysis indicates a federal law designed to prevent hospital “patient dumping” and ensure equal access to emergency medical care is falling short.

Researchers from 
Yale University and elsewhere analyzed 215,028 emergency department visits to 160 hospitals for pneumonia, asthma and chronic obstructive pulmonary disease in 2015.

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Duration 1:11

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After being stabilized, patients who were uninsured or covered by Medicaid were more likely to be transferred to another hospita
than privately insured patients. Uninsured patients also were “markedly” more likely to be discharged from the emergency department, according to the study, published Monday in 
JAMA Internal Medicine.

The results “confirm the belief that financial incentives, or a patient’s ability to pay, may be associated with hospitalization decisions,” researchers wrote. They adjusted for factors such as patient age, sex, income and health conditions in an effort to eliminate bias in the results.

The findings indicate that more than three decades after the Emergency Medical Treatment and Active Labor Act took effect, lower-income patients still face unequal treatment in emergency care settings. The law requires hospitals to 
screen anyone who comes into their emergency department and stabilize anyone with an emergency medical condition, regardless of citizenship status, insurance status or ability to pay.

The law was 
enacted in 1986 amid concern that hospitals were “patient dumping,” or discharging people before they’d been stabilized and denying care to poor patients with medical emergencies. Its requirements have fed into 
the debate over whether government-provided universal health coverage is necessary, since everyone has access to care in a true medical emergency.

But the new research indicates the decision to transfer lower-income patients to other facilities – reducing the chance a hospital will not be paid for providing care – means hospitals can technically meet the law’s requirements without meaningfully helping patients who need inpatient hospital care. Notably, patients severely ill from pneumonia, COPD or asthma “can generally be cared for in hospitals with standard intensive care capabilities,” researchers say, so transfers to other facilities may not meet the law’s threshold for “appropriate” transfers.

“By restricting this analysis to hospitals capable of providing critical care for patients with pulmonary conditions, we were less prone to incorrectly identifying medically necessary transfers as financially motivated,” the study says.

A secondary analysis conducted by researchers showed how the decision to transfer patients to other hospitals from the emergency department unfolds by hospital ownership status. Using a smaller sample of hospitals and patients, researchers found that compared with privately insured patients, uninsured patients were more likely to be transferred from for-profit hospitals and less likely to be transferred from nonprofit hospitals, though researchers said further study is needed to confirm those conclusions.

“Policymakers should broaden the scope of hospital quality, payment, and certification initiatives to reduce these disparities and improve access to hospital-based care,” study authors wrote.

Addressing the gap in insurance coverage and ensuring access to non-emergency care would be the surest way to improve the U.S. health care system, Dr. Mitchell Katz, president and CEO of NYC Health + Hospitals, and Dr. Eric Wei, the health system’s vice president and chief quality officer, wrote in a commentary accompanying the research.

There is no equivalent mandate in the U.S. to provide medically necessary non-emergency care, they note, which may force patients with chronic conditions like diabetes or hypertension to wait until their conditions become an emergency to seek care and contribute to worse health outcomes.

“Providing universal health insurance would improve the health of uninsured persons, reduce unnecessary emergency care, and strengthen the health care system in the United States,” Katz and Wei wrote.

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