Mod2

Mod 2 Steps:

INSTRUCTIONS:

1.

Read:

 

Chapter 6 Introduction to Law (p.154-159) and Chapter 8 Organizational Ethics and the Law (p. 206-242) and Chapter 10 Physician Ethical and Legal Issues (p. 292 – 302) in our textbook, Legal and Ethical Issues for Health Professionals by George D. Pozgar (5th Edition).

 

2. 

Look up the Tennessee Health Services and Development Agency website at the following link: (
https://www.tn.gov/hsda.html).  Read the information under the tabs: Certificate of Need Information; Certificate of Need History; Certificate of Need Basics; and Criteria for Review.

 

3. 

Read the cases:

·

1.
Darling v. Charleston Community Memorial summary in the textbook on page 210. 

2.
NHC . SC DOH 1989 CON case (see link below)

 

4.

Read the three articles posted on D2L (see links below)

· The Toughest Triage – Allocating Ventilators; 

· Ethical Decision-Making About Scarce Resources: A Guide for Managers and Governors; 

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

 

5. 

Experience the Simulation: Go to the publisher’s site (Jones & Bartlett) using the access code that you purchased with your bundle and l
og into the Navigate Scenario for Health Care Ethics First Edition Jones & Bartlett Learning.  Watch the episode
: Stockpiling. 

 

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. 

6.

Complete and upload your answers to Mod 2 Class Preparation and Participation (see link below). 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!

 

This module is dedicated to an overview of the vast array of legal duties of hospitals, as well as liability for negligence by hospitals and physicians. 

 

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

 

· Describe the four basic elements of a negligence lawsuit, the meaning of corporate negligence and the doctrine of 
respondeat superior, and the importance of the landmark case, Darling v. Charleston Community Memorial Hospital.

· Identify the key facts, legal issues, legal rule, court reasoning and decision in both the Darling v. Charleston Community Memorial case and the NHC v. South Carolina Department of Health case.

· Describe what a certificate-of-need is in Tennessee and the four criteria that an applicant must prove to be awarded a CON. 

· Experience a simulation related to a cancer drug shortage in one hospital and a stockpile in your own. Formulate your own recommendation to resolve the scarce resource dilemma synthesizing multiple stakeholder perspectives, legal concerns, guiding values and fair process principles.

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

 

These outcomes correspond to the following course objectives:

 

· 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.

The 
Darling case is a “landmark” case. After reading the case and the textbook, see if you can figure out why this is such an important case.  In the
 NHC case and on Tennessee’s website, we will explore how pre-approval from a state agency may be necessary before a new healthcare facility or service is initiated in some states through certificate-of-need laws.

We will also consider the scarcity of resources in healthcare.  COVID-19 has certainly brought to light how a pandemic can suddenly create a shortage of resources. However, a variety of healthcare resources are in short supply even without a pandemic.  Consider how to ethically allocate these resources as you read the articles for this module. You will also get to experience a simulation and make a recommendation when there is a shortage of a needed cancer drug.

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 #2 WRITTEN ASSIGNMENT FOR Class Preparation and Participation

Healthcare Responsibilities and Liabilities: Allocating Scarce Resources, Negligence, and More

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. Save your answers in a Word document using 12-point Times New Roman font, 1-inch margins, double-spaced, minimum 3 pages. Upload your written assignment by the due date and times posted in D2L.

Part I:
Darling v. Charleston Community Memorial Hospital – Benchmark case

1.
Summarize the Facts:

0. Briefly summarize the key facts of the Darling v. Charleston Community Memorial Hospital case.

1.
Identify the Legal Issue:

1. What is the legal issue (the reason the case is on appeal)?

1.
Plaintiff’s (Darling’s) Arguments:

2. What did the plaintiff argue to support his claim of negligence?

1.
Defendant’s (Charleston Community Hospital) Arguments:

3. What did the hospital argue in its defense? (You may need to infer this from the case)

1.
Court’s Decision and Reasoning:

4. In whose favor did the court decide? Why did the court rule this way?

1.
Evaluate Your Position: Take a position for the side that you favor in this case from both an ethical standpoint and from a legal standpoint. Is there a difference in your legal opinion and your ethical opinion? Briefly explain.

Part II:
NHC v. South Carolina Dept of Health case

1.
Summarize the Facts:

· Briefly summarize the key facts of the NHC v. South Carolina Dept. of Health case.

2.
Identify the Legal Issue:

· What is the legal issue (the reason the case is on appeal)?

3.
Plaintiff’s (NHC) Arguments:

· What did the plaintiff argue to support its claim?

4.
Defendant’s (South Carolina DOH) Arguments:

· What did the Department of Health argue?

5.
Court’s Decision and Reasoning:

· In whose favor did the court decide? Why did the court rule this way?

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

Part III: Construct Your Own Recommendation to the Health Care Ethics Stockpiling Dilemma

FORMULATE a Recommendation to deliver to the CEO of Bright Roads Health Care System 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 episode. Instead, type your answers to the sections below as Part III of this Assignment 2.

YOUR RECOMMENDATION TO THE HEALTH CARE ETHICS SIMULATION:

1.
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.

2.
Recommendation: Clearly state your recommendation in a few sentences.

3.
Reasons for Your Recommendation: Fully explain your recommendation in 2-4 paragraphs. Your explanation should meet the following criteria:

· Demonstrates that you paid close attention to the simulation.

· Considers both the legal and ethical issues.

· Is supported with evidence and facts stated in the simulation video.

· Carefully considers and analyzes all facts and perspectives.

· Is well-organized and logical.

· Is clear in what why you are making your recommendation.

4.
Fair Process:

a) 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?

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

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

National Health Corp. v. South Carolina Dept. of Health and  

2

98 S.C. 373, 380 S.E.2d 841
S.C.App.,1989.
April 24, 1989 (Approx. 9 pages)

298 S.C. 373, 380 S.E.2d 841, 26 Soc.Sec.Rep.Serv. 474

Court of Appeals of South Carolina.

NATIONAL HEALTH CORPORATION, d/b/a National Health Care Center of Georgetown, Appellant,
v.
SOUTH CAROLINA DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL and Waccamaw River Health Care Center, Inc., Respondents.

No. 1326.

Heard Jan. 19, 1989.
Decided April 24, 1989.

Department of Health and Environmental Control denied health corporation’s application for a certificate of need to build a long-term care nursing facility and granted a certificate of need to another corporation. The health corporation brought an action seeking judicial review of final administrative decision of the Department. The Court of Common Pleas, Richland County, Tom J. Ervin, J., affirmed the Department’s decision, and health corporation appealed. The Court of Appeals held that: (1) the Board of Health and Environmental Control followed the proper standard of review in weighing the evidence and making a decision on the merits based on the preponderance of the evidence; (2) the Board’s findings of inconsistency of health organization’s plan with funding plans of agency responsible for funding of Medicaid beds, and of health organization’s failure to demonstrate financial feasibility were supported by the record; and (3) Board did not violate federal statutory and regularatory provisions governing Medicaid program.

Affirmed.

…*375 David M. Rogers, Greer, for appellant.
General Counsel Walton J. McLeod, III, Sally M. Rentiers and Susan A. Lake, of South Carolina Dept. of Health & Environmental Control, Columbia; and Charles B. Baxley, of Baxley, Pratt & Wells, Lugoff, for respondents.

*376 PER CURIAM:

National Health Corporation (“NHC”) brings this action seeking judicial review of a final administrative decision of the South Carolina Department of Health and Environmental Control (“DHEC”). DHEC denied NHC’s application for a certificate of need (“CON”) to build a long-term care nursing facility and granted a CON to Waccamaw Health Care Center, Inc.

NHC appealed DHEC’s decision to the circuit court. In this appeal NHC made the following arguments; (1) DHEC denied NHC’s CON application because of an insufficiency of Medicaid [sic] funds to support the number of Medicaid beds NHC proposed in its application, and a denial on this basis alone, violates federal Medicaid statutes; (2) DHEC’s finding that NHC’s proposed project was not financially feasible is **843 not supported by the record; (3) the DHEC hearing officer and Board applied the wrong standard of review at the administrative hearing; (4) the trial court should consider the effect of the new Medicaid Nursing Home Permits law in its decision; and (5) DHEC’s denial of NHC’s CON application was inappropriate under the circumstances existing at the time of the administrative hearing. The circuit court addressed each of NHC’s arguments and issued an order affirming DHEC’s decision.

NHC’s appeal to this court raises the identical issues as raised in the trial court. After thoroughly and carefully reviewing the record and the applicable law we find that the circuit court’s order correctly sets forth and properly disposes of all the issues which are before the court. We therefore adopt the order of the circuit court (with minor changes) which we quote as follows:

… This matter is an appellate review of the administrative decision of SC DHEC denying the application of NHC for a Certificate of Need and granting a Certificate of Need for the construction of a forty-four (44) bed nursing care facility to Waccamaw.

NHC and Waccamaw were competing applicants for a Certificate of Need (hereinafter, CON) to construct a nursing home facility in the Georgetown County area. Pursuant to the 1985 State Health Plan, only one of these projects, either Waccamaw’s or NHC’s could be approved. Waccamaw applied for a CON for forty-four (44) dually licensed private-pay beds which would not participate in the Medicaid program, and NHC applied for a CON for eighty-eight (88) long term care beds which would be partially funded through participation in the Medicaid program. On July 16, 1986, after comparatively reviewing the applications of both competitors, Waccamaw and NHC, on July 16, 1986, SC DHEC notified the parties of its decision to grant a CON to Waccamaw and to deny NHC’s application. NHC appealed the Department’s decision to deny its application and to grant a Certificate of Need to Waccamaw. Waccamaw thereafter moved to intervene in the appeal in order to protect its interests, and that motion was properly granted.

On August 12 and August 22, 1986, an administrative adjudicatory hearing was held before an independent Hearing Officer. In his Report and Recommendations, the Hearing Officer determined that the decision of the SC DHEC staff should be upheld. Pursuant to NHC’s request, the Board of Health and Environmental Control (hereinafter, Board) reviewed the Hearing Officer’s Report and Recommendations. On July 29, 1987, the Board issued its Order adopting the Hearing Officer’s Report and Recommendation upholding the SC DHEC staff decision. NHC now seeks judicial review of the SC DHEC decision.

On September 10, 1987, this Court heard arguments in this matter and determined that more than substantial evidence exists in the record to uphold the SC DHEC decision. The SC DHEC decision is neither arbitrary, capricious, nor contrary to applicable laws. Rather, the SC DHEC decision is reasonable and in full compliance with regulatory and statutory requirements.

*378 [1]
It is well-established that the “substantial evidence” rule set forth in the Administrative Procedures Act provides for judicial intervention “only in those cases where a manifest or gross error of law has been committed by the administrative agency.”

Lark v. Bi-Lo, Inc., 276 S.C. 130, 276 S.E.2d 304, 307 (1981)

. The Court must not substitute its judgment for that of the agency, and a judgment upon which reasonable men might differ will not be set aside. **844 Lark v. Bi-Lo, Inc., 276 S.C. 130, 276 S.E.2d 304, 307 (1981);

Bilton v. Best Western Royal Motor Lodge, 282 S.C. 634, 321 S.E.2d 63 (App., 1984)

. In this case, the judgment of the agency was reasonable and proper. The record contains more than sufficient evidence to support the conclusions of the Board.

[2]
NHC complains that the Board’s decision was in error because the Board applied the “arbitrary and capricious” standard of review, rather than a “de novo” standard of review. While the Plaintiff couches its argument in terms of whether NHC was entitled to a “de novo” review, the real issue raised in argument addresses the appropriate burden of proof. Plaintiff acknowledges that he was generally given the benefits associated with “de novo” review, such as the full opportunity to present evidence and cross-examine witnesses. FN1 The Plaintiff argues, however, on the basis of some general, introductory language in the Order under review, that the Board did not base its decision on the “merits.” The Report of the Hearing Officer, which was adopted as the Board’s Order, states at page 2 “that the issues presented in this administrative appellate review are whether this Department’s decision to deny NHC’s application*379 and grant Waccamaw a Certificate of Need was arbitrary, capricious, or contrary to appellate law, and whether the applicable state law is unconstitutional or in conflict with Federal law.” Plaintiff contends that this statement of the issue indicates that the Board was applying the “substantial evidence” standard of review or burden of proof. However, the Hearing Officer’s Report goes on to state:

FN1. Black’s Law Dictionary defines “trial de novo” as “a new trial or retrial had in which the whole case is tried as if no trial whatsoever had been had in the first instance.” Black’s Law Dictionary, (Fifth Ed., 1979). The proceeding before the Board had the “trappings” generally associated with a “trial de novo,” i.e., the right to be heard, to present documents, to cross examine witnesses and have a decision of the merits. This is in accord with the requirements of the APA. However, it is recognized that the Board proceeding is still essentially an administrative “review” of a preliminary agency decision.

Section 44-7-375 of S.C.Code Ann

., (1976, as amended) (repealed eff. June 21, 1988) provides:

Upon a written request of any affected person within thirty days of the department’s decision to approve, disapprove, or withdraw a Certificate of Need, the decision must be administratively reviewed by the Board of Health and Environmental Control under the State Administrative Procedures Act.

With this in mind, it is understood that the Board proceeding, while encompassing many elements of a “trial de novo,” is in some aspects “essentially appellate.” See,

Milliken and Co. v. S.C. Dept. of Labor, 275 S.C. 264, 269 S.E.2d 763, 764 (1980)

. The question then is not whether the proceeding is “de novo” or “appellate.” In order to accord with the APA and the Supreme Court ruling in

Milliken,

the hearing must be handled as a quasi-de novo, quasi-appellant proceeding. The real issue which the Court must address in the present case revolves around the proper standard of review, or burden of proof.

“the evidence presented at the hearing before the hearing officer amply showed that the application of Waccamaw was superior to that of NHC both in terms of documentation and in terms of the finances and efficiency of the proposed facility.”

(Hearing Officer’s Report and Recommendations, p. 10.)

[3]
[4]
It is clear from the Board’s Order read as a whole that the Board fully exercised its authority to weigh the evidence, and make a decision on the merits based upon the preponderance of evidence. This is in accord with the review process provided for in DHEC

Regulation

61-15

Section 402, S.C.Code Ann., Vol 24A (1976, as amended). The agency regulation requires that the decision on review be made by the Board on the basis of the evidence presented in the hearing before it or its designee. Since the State Administrative Procedures Act is silent on the standard of review or burden of proof at the agency level contested case hearing, the Department regulations are controlling. I find that there has been compliance with DHEC R. 61-15 and that the proper standard of review was applied. Plaintiff’s argument has no merit whatsoever.

*380 [5]
[6]
NHC complains that SC DHEC did not consider all of the grounds or reasons for which NHC challenged the SC DHEC decision. This argument is without **845 merit. The Hearing Officer in his Report and Recommendations, which the Board adopted, clearly considered all of the issues raised by NHC. Review of the Hearing Officer’s Report and Recommendations and the Transcript of Record in this case leaves no doubt that all of the issues raised by NHC were thoroughly addressed throughout the administrative process.

The SC DHEC decision was based on the state law and regulations applicable to the SC DHEC Certificate of Need program. One of the legal requirements to obtain a CON is SC DHEC R. 61-15, Section 503 which provides:

In the case of any proposed new institutional health service for the provision of health services to inpatients, the Department shall not grant a Certificate of Need under its Certificate of Need program, or otherwise make a finding that such proposed new institutional health service is needed, unless:

* * * * * *

(b) the Department makes each of the following findings in writing:

* * * * * *

(4) That in the case of a proposal for the addition of beds for the provision of skilled nursing or intermediate care services, the addition will be consistent with the plans of other agencies of the State responsible for provision and financing of long-term care (including home health) services.

The SHHSFC is the agency responsible for the funding of the Medicaid beds in South Carolina. The record in this case is replete with evidence that NHC’s CON application was not consistent with the funding plans of SHHSFC. (Transcript of Adjudicatory Hearing, p. 51, line 15-p. 52, line 17; p. 66, lines 1-7; p. 171, lines 9-20; p. 178, lines 24-p. 179, line 9; p. 183, line 25-p. 184, line 4) In its application, NHC *381 proposed to fill its facility with 65% Medicaid patients. The balance of beds would serve private pay patients. NHC submitted budgets based on this patient mix. Yet, evidence and testimony was presented at the hearing that the budget plan of SHHSFC was not consistent with the NHC proposal which would require the funding of new Medicaid beds.

Additionally, SC DHEC regulations require that an applicant for a Certificate of Need document the financial feasibility of a proposed project. SC DHEC R. 61-15, Section 202, B(14) states:

Demonstration by the applicant that the proposed project is economically feasible, both immediately and long-term, and can be accommodated in the patient charge structure without unreasonable increases. If the project is not economically feasible, justify the request for the project.

SC DHEC cannot approve a project which is not financially feasible. The record supports a finding that NHC’s proposed project does not meet this requirement while the Waccamaw project has more than adequately demonstrated financial feasibility. The Waccamaw project was designed for only private pay beds where the source of funding would not be Medicaid. The evidence indicates that Waccamaw would obtain sufficient funding from non-Medicaid sources so as to make the project financially feasible. The NHC project, on the other hand, was designed to include 65% of its beds as Medicaid beds. The record contains clear evidence that Medicaid funds would not be available for the NHC beds. The Board also found that inconsistencies in four budgets submitted by NHC and the discrepancies between those budgets and the cost reports submitted by NHC to the State Health and Human Services Finance Commission raised serious questions regarding the financial feasibility of the NHC project.

The Board’s findings with regard to inconsistency with the funding plans of SHHSFC and failure to demonstrate financial feasibility are supported by the record. Where there is substantial evidence in the record to support the agency’s findings, the Court will not substitute its judgment for that of the agency.

Lark v. Bi-Lo, Inc., 276 S.C. 130, 276 S.E.2d 304 (1981)

.

*382 [7]
However, NHC argues that DHEC erred in considering Medicaid budgetary **846 constraints in the denial of its application. NHC has cited a number of federal codes and regulatory provisions which it charges DHEC has violated. The provisions it has cited governing the Medicaid program are applicable to the State Medicaid agency, which is SHHSFC, and do not address the Certificate of Need program.

42 U.S.C. § 1396a(a)(8) (1982 & Supp.1986)

,

42 U.S.C. § 1396a(a)(1) (1982 & Supp.1986)

, and 42 C.F.R. § 205.5(a),

431.50

,

447.250(b)(c)

, and

447.255 (1987)

set forth requirements for the State Plan for medical assistance developed by the State Medicaid agency-HHSFC. Likewise,

42 C.F.R. § 440.230 (1987)

,

42 U.S.C. § 1396a(a)(2)(23)

(1982 & Sup.1986) and

42 C.F.R. § 447.204 (1987)

govern acts of the State Medicaid agency. The denial of a Certificate of Need to NHC is not in violation of the provisions cited.FN2

FN2. 42 C.F.R. §§ 123.412(a)(5)(i) and (6), and 123.413 (1987) have been effectively repealed.

The cases cited by NHC generally relate to Medicaid reimbursement and do not discuss or suggest any requirement regarding the approval of Medicaid beds under the Certificate of Need program.

Alabama Nursing Home Assn. v. Harris, 617 F.2d 388 (5th Cir.1980)

, and

Thomas v. Johnston, 557 F.Supp. 879 (W.D.Tex.1983)

, speak only to reimbursement under the Medicaid program. The U.S. Supreme Court in

Alexander v. Choate, 469 U.S. 287, 105 S.Ct. 712, 83 L.Ed.2d 661 (1985)

, addresses issues of amount and scope of services and nondiscriminatory availability of services. In that case, the Supreme Court upheld a 14 day limit on Medicaid reimbursement for inpatient hospital services put into effect by the State of Tennessee solely because of a budgetary shortfall. Plaintiff’s reliance on Kentucky Association of Health Care Facilities v. Dept. for Human Resources, [1981-1 Transfer Binder] Medicare and Medicaid Guide (CCH) Par. 30,995 at 10,108 (E.D. Kentucky 1981) is also misplaced. This case relates to a Medicaid Plan developed pursuant to the federal Medicaid program. The State Plan introduced at the hearing in this case is the State Medicaid Facilities Plan developed pursuant to the State Certificate of Need Program. Additionally NHC has submitted*383 a letter ruling from the Healthcare Financing Administration, (Plaintiff’s Exhibit B). Without ruling on the authority of that document, the court notes that the Board action in this case is not contrary to the position set forth in the letter. In this case, the denial of the NHC application was not based solely on Medicaid funding, the Certificate of Need requirements are totally separate from the State Medicaid Plan, and there is no provision for limiting Medicaid coverage to a certain number or percentage of beds. The Board correctly found that none of the federal statutory and regulatory provisions advanced by Plaintiff were violated by the denial of the NHC application.

The South Carolina Certificate of Need Program, administered by SCHEC, as adopted by the General Assembly of the State of South Carolina, is a valid, legislatively mandated control on the construction and provision of health care facilities and services. The requirements of South Carolina Certificate of Need Program regarding funding are similar to Certificate of Need requirements of other states. See 19 Indiana Law Review No. 4, p. 1025 (1987), citing:

Me.Rev.State.Ann. tit. 22 § 307(6-A) (comparative review of new nursing home bed addition projects based on availability of legislative appropriations);

Mich.Comp.Laws Ann. § 333.2213(2)(f) (Supp.1985)

(certificate of need criterion, for nursing home bed addition, of consideration of Medicaid agency plans); Mont.Code Ann. § 50-5-430(2) (1985) (authority to condition nursing home bed additions on availability of Medicaid funding); 1985 N.H. Laws Ch. 378, § 378:6 (to be codified at

N.H.Rev.Stat.Ann. § 151-C:5 (II)(b)

) (coverage of all health facility transfers of ownership except those subject to federal restrictions on asset revaluation for Medicare/Medicaid reimbursement purposes); Pa.Cons.Stat.Ann. § 4448.707(c)(7) (Purdon Supp.1985) (nursing home bed addition criterion of consistency with Medicaid agency plans); **847 Vt.Stat.Ann. tit. 18 § 2406(a)(4) (Supp.1985) (certificate of need criterion for nursing home bed addition of consideration of Medicaid agency plans);

Wis.Stat.Ann. § 150.39 (West Supp.1985)

(nursing home project criteria of sufficient Medicaid funds appropriated to reimburse for care to be provided, and *384 statutory ceiling on approvable nursing home beds to enable the state to accurately establish Medicaid budget); 1985 Wisc.Legis.Serv. Act 29 § 1975 (West) (to be codified at

Wis.Stat.Ann. § 150.31

.)

[8]
The Board, in rejecting NHC’s argument that consideration of State budgetary considerations is in violation of federal law, cited the case of

Wilmac

Corporation v. Heckler, 633 F.Supp. 1000 (E.D.Pa.1986)

, rev’d on other grounds,

811 F.2d 809 (3rd Cir.1987)

. NHC argues that reliance on this case was improper inasmuch as the case has been reversed upon appeal. This case was vacated on procedural grounds and not because of any substantive error. Moreover, it is noted that the Board’s discussion of this case was dicta.
Wilmac was not relied upon as part of the Board’s holding. While this case may have no binding precedential status, I find, as did the Board, that the analysis in the case is correct. The Board’s reliance on this case in no way affects the appropriateness of the Board’s outcome.

NHC also complains that SC DHEC erred in considering a moratorium on Medicaid funding which existed in South Carolina when SC DHEC considered these applications. In his Report and Recommendations, adopted by the Board, the Hearing Officer properly noted:

NHC’s reliance on this position is misplaced, since the basis for the Department’s decision was Section 503(b)(4) of Regulation
61-15, quoted above rather than on the “Medicaid proviso”, which makes reference to the Health Care Planning Oversight Committee.

* * * * * *

NHC’s arguments that the Medicaid proviso is void as a violation of federal law and is also in violation of the Constitutional doctrine of separation of powers should not be addressed in this administrative review, since these questions are now moot in that the proviso has been withdrawn. The only reason for these arguments to be addressed herein would be if the department’s decision was based on the Medicaid proviso alone, and if this was the only criteria used in determining that *385 NHC’s application would have been denied. However, the Department’s decision was not based upon budgetary considerations alone (Tr. p. 202, 1.23), and in the comparative analysis of NHC’s application and Waccamaw’s application, the Department determined that the application submitted by Waccamaw was superior.

[9]
NHC additionally argues that the recently enacted “Medicaid Nursing Home Permit” legislation (to be codified at

S.C.Code Ann., Section 44-7-80

et seq., (1976, as amended)) will give NHC an opportunity to participate in the Medicaid Program and so NHC should receive a CON. SC DHEC points out that funding for additional Medicaid beds is speculative. The new law provides that preference in the allocation of Medicaid patient days must be given to facilities already participating in the Medicaid program and that patient days allocated to a nursing home cannot be decreased in subsequent years. See,

Section 44-7-84(B)

. Moreover, if funding for additional Medicaid beds is appropriate, nursing homes other than NHC would be in a position to use those funds to make beds available to Medicaid patients. Indeed, Waccamaw has stated a desire to participate in the Medicaid program if funding becomes available. Waccamaw has agreed not to participate in the Medicaid program, and has budgeted accordingly, to maintain compliance with CON requirements. The existence of additional Medicaid funding, if it does become available, does not entitle NHC to approval of such CON application. As determined by the agency, NHC had the weaker CON proposal.

[10]
NHC’s argument that its proposed project was superior to Waccamaw’s simply because NHC proposed to serve Medicaid patients is not supported by the record. The record contains abundant evidence that **848 the Waccamaw project was superior to that of NHC. (Tr. of Adjudicatory Hearing, p. 185, lines 17-24). The Board found that the NHC application was an extremely poor one. (Tr. of Adjudicatory Hearing, p. 204, line 22-p. 205, line 9). There is also ample evidence in the record to support SC DHEC’s finding that NHC’s budget costs were understated.

The decision of the Board of the South Carolina Department of Health and Environmental Control granting the *386 CON application of Waccamaw and denying the CON application of NHC to construct a nursing facility in Georgetown County was proper, reasonable, consistent with applicable laws and regulations, and supported by more than substantial evidence in the record. None of the grounds set forth in the Administrative Procedures Act at

S.C.Code Ann., Section 1-23-380(g)(1) through (6)

(1976, as amended) for reversal or modification of an agency decision exist in this case. The Board’s determination is supported by substantial evidence in the record and will not be disturbed. NHC has failed to show that the administrative decision under review is in violation of constitutional or statutory law, in excess of agency authority, made upon unlawful procedure, affected by error of law, contrary to substantial evidence in the record or otherwise erroneous, arbitrary or capricious. The decision is hereby affirmed.

IT IS ORDERED that SC DHEC issue the Certificate of Need to Waccamaw River Healthcare Center, Inc., for the construction of its forty-four (44) bed nursing care facility.

AND IT IS SO ORDERED.

AFFIRMED.

S.C.App.,1989.
National Health Corp. v. South Carolina Dept. of Health and Environmental Control
298 S.C. 373, 380 S.E.2d 841, 26 Soc.Sec.Rep.Serv. 474
END OF DOCUMENT
(c) 2010 Thomson Reuters. No Claim to Orig. US Gov. Works.

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EETTHHIICCAALL DDEECCIISSIIOONN–MMAAKKIINNGG AABBOOUUTT
SSCCAARRCCEE RREESSOOUURRCCEESS::

A GUIDE FOR
MANAGERS AND GOVERNORS

© 2002 (Updated 2012)

Guide for Managers and Governors 2
2019

A. Introduction

Resource allocation is one of the most challenging ethical issues faced in healthcare organizations. Priorities must be set because demand for

health care exceeds available resources. For decision-makers, this is at once a practical challenge of determining how best to make these

choices. It is also an ethical challenge about how to allocate resources fairly when not all needs can be met. From experience, we know how

difficult it is to reach agreement on what constitutes a fair outcome (i.e., distributive fairness). This means that decision-makers must rely on a

fair process (i.e., procedural fairness) to establish the ethical legitimacy of resource allocation decisions (Daniels and Sabin 2002; Holm 2000).

The purpose of this guide is to help health sector managers and board members make resource allocation decisions through an ethical lens. The

guide introduces an ethical decision-making framework, provides practical suggestions about how to apply it, and addresses some frequently

asked questions. The Appendix includes an implementation checklist and an evaluation checklist.1

B. Accountability for reasonableness: an ethical decision-making framework

Accountability for reasonableness (A4R) outlines five principles of fair priority setting process that contributes to establishing the ethical

legitimacy of priority setting decisions, particularly in the eyes of affected stakeholders – patients/clients, providers, and funders (Daniels &

Sabin 2002; Gibson et al 2005a). Together, these conditions describe an open and transparent priority-setting process which is flexible enough to

incorporate a range of relevant decision factors, facilitates constructive stakeholder engagement around the decisions, and supports decision-

makers’ public accountability for managing limited resources (Gibson et al 2005b).

RELEVANCE Decisions should be based on reasons (i.e., evidence, principles, values) that fair-minded people can agree are relevant
under the circumstances.

PUBLICITY Decisions and their rationales should be made publicly accessible.

REVISION There should be opportunities to revisit and revise decisions and a mechanism to resolve disputes.

EMPOWERMENT Efforts should be made to minimize power differences and to ensure effective stakeholder participation.

ENFORCEMENT There should be voluntary or public regulation to ensure the other four conditions are met.

1 Acknowledgments: An earlier version of this guide was developed with support from a Canadian Health Services Research Foundation post-doctoral fellowship
in partnership with the University of Toronto Joint Centre for Bioethics and Sunnybrook & Women’s College Health Sciences Centre.

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C. A4R in action: How can I approach ethical decision-making in practice?

This section offers some practical suggestions about how to operationalize each A4R condition. These suggestions can be used as a guide for

designing ethical decision-making processes in your local health care setting. (For case examples and additional practical advice on how to put

A4R into action, see: Gibson, Martin & Singer, 2005b.)

RELEVANCE:

➢ Clarify the aim and scope of the priority setting process (including what is out-of-scope)

➢ Identify clear and explicit decision criteria.
❑ Align criteria explicitly with the institution’s mission, vision, and values, operational goals, and other relevant factors.
❑ Engage stakeholders in identifying and defining relevant decision criteria.
❑ Ensure each criterion describes a distinct concept.
❑ Build criteria into decision tools (e.g., decision trees, business case templates).

➢ Collect data/information related to the criteria.

❑ Validate accuracy and completeness of data/information with stakeholders.

➢ Develop a rationale for each decision based on the criteria and data/information.

❑ Ensure sufficient time for deliberation and discussion to build agreement on the rationale.
❑ Provide an explanation for any departures from the established decision criteria, data/information, or procedures.

➢ Engage a broad range of stakeholder perspectives and relevant experience/expertise in the priority setting process.

PUBLICITY:

➢ Develop a formal communications plan to support decision-making.
❑ Identify appropriate mechanisms to communicate effectively with affected stakeholders.
❑ Communicate why decisions must be made (i.e., what the decision-making process is/is not about), how decisions will be made,

who will make decisions, which criteria will be used to make decisions, how stakeholders can participate, and what stakeholders
can expect once the decision has been made.

➢ Publicize the decision and its rationale.
❑ Communicate the rationale for each decision related back to the decision criteria and available data/information.

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REVISION:

➢ Incorporate opportunities for iterative decision review.
❑ Revise decisions as new data/information or errors in data/information emerge.
❑ Share draft decisions with stakeholders for feedback and comment.

➢ Develop a formal decision review.

❑ Define explicit decision-review criteria (e.g., new information, correction of errors, failure of due process).
❑ Be explicit about which decisions may be subject to review.
❑ Develop a communication strategy to support the decision review process.
❑ Communicate the final decision and rationale to affected stakeholders.

EMPOWERMENT:

➢ Facilitate the effective participation of all affected stakeholders.
❑ Include critical mass of affected stakeholders in consultation and decision-making, where significant disparities in influence exist

among stakeholder groups.
❑ Develop communications materials in accessible language and use multiple communications media to optimize reach.
❑ Consider decision procedures that optimize decision-making autonomy (e.g., closed voting)

➢ Provide training and support for staff.

❑ Train and provide ongoing assistance to program managers and staff in the use of decision tools, workbooks, etc.
❑ Provide communication materials for managers to use locally with their staff.

➢ Support the process with appropriate change management strategies.

ENFORCEMENT:

➢ Lead by example.
❑ Commit to ethical decision-making and encourage and support colleagues to do the same.
❑ Maintain a low tolerance for political end-runs and ‘gaming’ behaviour.

➢ Evaluate and improve the decision-making process.

❑ Monitor process to ensure fairness and make mid-course corrections as needed.
❑ Develop a formal evaluation strategy to identify good practices and opportunities for improvement.
❑ Identify improvement strategies to use in future decision-making.

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D. Frequently asked questions

1. How do I know we’ve made the ‘right’ decision?
The ethical framework provides guidance on how to reach decisions rightly – that is, it creates a fair process for deliberation and reflection
among affected stakeholders (including decision-makers) about what the decision should be. It is because these decisions are value-based
that an open, transparent, and inclusive decision-making process is so important.

2. How transparent should the process be?
In general, stakeholders should have access to as much information about the decision and the decision-making process as is available and
as they desire. This is because stakeholders deserve to know and understand how and why a decision that affects them was made. Decision-
makers sometimes express reticence about being too public about their decisions. It is important to remember that transparency is not just
about the transmission of information; it is also about keeping people engaged constructively in the process. In the rare cases where
confidentiality is ethically necessary, the process should still be made as transparent as possible by identifying explicitly what the
confidentiality constraints are and why, and by maintaining transparency about other aspects of the decision-making process.

3. Won’t a formal decision review process escalate conflict between stakeholders and decision-makers?
Our experience so far is that this is not likely to be the case if the decision-review process is open and transparent and if it uses decision-
review criteria that focus on bringing forward new data/information, correcting material errors in the original decision and addressing the
material impact of any procedural inconsistencies. The purpose of decision review is not to prove wrong doing or assign blame, but instead
to improve the quality of decisions. A formal decision review process creates conditions for constructive stakeholder feedback around the
decisions.

4. Affected stakeholders have an interest in the decision, so how can they be expected to be ‘fair-minded’?
Being “fair-minded” doesn’t require being disinterested. Decision-makers are stakeholders as well and also have an interest in the decision-
making outcome. Instead, being “fair-minded” means being willing to play fair with each other in deciding how resources will be allocated,
whether or not one’s interests are ultimately served. Stakeholder involvement can have three benefits: 1) it can often be a good way to
encourage buy-in and to mitigate feelings of alienation and vulnerability that many stakeholders experience when subject to decisions
they’ve had no part in making; 2) it can increase the chances that the decision will be based on relevant reasons, including stakeholder
interests; and 3) it can contribute to cultivating collaboration among stakeholder groups toward finding collective solutions.

5. Isn’t this just ethical window-dressing?
Politics can always hide behind the veil of “ethical legitimacy”. However, because the ethical decision-making framework focuses on making
the reasons for decisions transparent and creating conditions of fair play among participants, attempts to exert political influence or to game
the process can be minimized.

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E. References

Daniels N, Sabin JE. Setting limits fairly: Can we learn to share medical resources? Oxford: Oxford University Press, 2002

Gibson JL, Martin DK, Singer PA. Priority setting in hospitals: fairness, inclusiveness, and the problem of institutional power differences. Social
Science & Medicine 2005a; 61: 2355-2362.

Gibson JL, Martin DK, Singer PA. Evidence, economics, and ethics: resource allocation in health services organizations. Healthcare Quarterly
2005b; 8(2): 50-59.

Holm, S. Developments in the Nordic countries— goodbye to the simple solutions. In A. Coulter, & C. Ham (Eds.), The global challenge of health
care rationing. Buckingham: Open University Press, 2000, pp. 29-37.

Martin DK, Singer PA. A strategy to improve priority setting in health care institutions. Health Care Analysis 2003; 11(1):59-68.

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Appendix 1. Implementation Checklist

The following questions can serve as a “double-check” in the design of a priority setting process.

Relevance:

• Are we clear on the criteria we will use in making this decision? Do we anticipate any emerging decision factors that will inform our
decision?

• Have we got the data/information we will need to apply the criteria?

• Which internal and external stakeholders will be most affected by this decision and what are their specific interests?

Publicity:

• Have we clearly articulated the context, goal(s), criteria, processes, and possible outcomes of our decisionmaking process? What
mechanism will we use to communicate our decisions and rationales to affected stakeholders (internal & external)?

• How will we communicate with stakeholders about the implications of these decisions?

Revision

• If stakeholders have concerns about the decision process or the outcomes, what mechanism should they use to address these concerns
to us?

• If new information emerges or errors are identified, what mechanism will be used to revise our decisions?

Empowerment

• Given our stakeholders’ competing interests, how will we ensure that less powerful groups or vulnerable populations have a fair chance
of voicing these interests to inform our decision-making?

• If we are asking managers, staff, and other stakeholders to contribute to the decision-making process, what needs do they have and
what can be done to support these within our timeframe to ensure their effective and constructive participation?

• Given the differential impact of our decisions on stakeholders, what supports do we have in place to facilitate the implementation
process?

Enforcement

• What am I going to do to make sure we stay true to our ethical framework? What are we going to do as a team to ensure we stay true to
our ethical framework?

• What mechanism do we have in place to learn from this experience to improve future iterations?

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Appendix 2. Evaluation Checklist

Each decision-making process should include an evaluation strategy to facilitate on-going quality improvement. Decision-making processes can

be more or less fair. A4R provides a helpful framework for evaluating the fairness of decision-making processes. Good practices are indicated

where there is correspondence with A4R and opportunities for improvement are indicated where there are gaps between A4R (i.e., what should

be done) and practice (i.e., what is done) (Martin & Singer 2003). The following checklist provides a starting point to assist you in evaluating the

fairness of your decision-making process.

RELEVANCE

• Were appropriate criteria used to set priorities? (Do stakeholders agree that the criteria were appropriate?)

• Were available data and information sufficient to make evidence-guided decisions? (What critical gaps in data/information
need to be filled for future priority setting?)

• Was a rationale for each decision clearly identified based on aim and scope of the priority setting process, the decision
criteria, and available data/information?

PUBLICITY

• Were the context, aim and scope, criteria, processes, and possible outcomes of the priority setting process communicated
clearly from the outset and throughout to both hospital staff and external stakeholders?

• Was the decision and its rationale communicated clearly to stakeholders?

• Was the communication plan effective in reaching affected stakeholders, including staff, providers, patient/client
populations, and the community? (How do you know? What do we need to improve for future processes?)

REVISION

• If stakeholders had concerns about the decision process or the outcomes, did we provide an effective mechanism to capture
and respond to these concerns in a timely fashion? (How do you know? What do we need to improve for future processes?)

• Were there opportunities to revisit and revise decisions on the basis of new evidence or argument, and a validation process

Guide for Managers and Governors 9
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to engage stakeholders around draft decisions?

• Did any decisions change as a result of these revision processes?

EMPOWERMENT

• Were any stakeholder views allowed to dominate the decision-making process? (What was the effect? How well did we
manage this?)

• Were there any stakeholders that we realize in retrospect that we ought to have engaged, but did not? (What are we doing
now to engage them?)

• Were we attentive to the impact of our decisions on vulnerable client or patient populations? (How are we monitoring this?)

ENFORCEMENT

• Were we disciplined in our commitment to apply the priority setting framework consistently and if we needed to depart
from it, were we able to articulate good reasons for this to our stakeholders?

• Was a formal evaluation strategy implemented to monitor progress and to identify good practices and opportunities for
improvement?

• Is there a mechanism in place to learn from this experience to improve future iterations?

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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.

mailto:sally.bean@sunnybrook.ca

https://apps.who.int/iris/bitstream/handle/10665/331215/WHO-2019-nCov-IPCPPE_use-2020.1-eng

http://www.health.gov.on.ca/en/pro/programs/drugs/supply/docs/ethical_framework

http://www.health.gov.on.ca/en/pro/programs/drugs/supply/docs/ethical_framework

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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

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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.

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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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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 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.

mailto:sally.bean@sunnybrook.ca

http://sunnynet.ca/data/1/rec_docs/5866_Organizational_Ethics_Decision_Making_Framework

http://www.jcb.utoronto.ca/docs/A4R_Implementation_Guide2011_hospitals