Voluntary Resolution Agreement Between the United States Department of Health and Human Services, Office for Civil Rights and Cedars-Sinai Medical Center

OCR # 22-479470

TABLE OF CONTENTS

I. Introduction...........................................................................................................................................................3

II. Background...........................................................................................................................................................3

III. Jurisdiction..........................................................................................................................................................3

IV. Definitions............................................................................................................................................................4

V. General Provisions................................................................................................................................................5

VI. Specific Obligations.............................................................................................................................................8

VII. Recommended Actions.....................................................................................................................................13

VIII. Signatures.........................................................................................................................................................14

I. Introduction

This Voluntary Resolution Agreement (Agreement) is entered into by the United States Department of Health and Human Services (HHS), Office for Civil Rights (OCR) and Cedars-Sinai Medical Center (Cedars-Sinai) to resolve OCR’s investigation into Cedars-Sinai's compliance with Title VI of the Civil Rights Act of 1964 (Title VI) and Section 1557 of the Patient Protection and Affordable Care Act (Section 1557).

OCR is the HHS law enforcement agency that investigates complaints, conducts compliance, and requires that covered entities take corrective and remedial action to address potential violations of federal civil rights laws, conscience and religious freedom laws, the Health Insurance Portability and Accountability Act (HIPAA) Privacy, Security, and Breach Notification Rules, and the Patient Safety Act and Rule.

Cedars-Sinai is a nonprofit academic healthcare organization serving more than 1 million people each year in over 40 locations, including Los Angeles, California. As a nationally ranked hospital, Cedars-Sinai has over 4,500 physicians and nurses and trains medical professionals through 15 accredited residency programs and 89 fellowship programs. Cedars-Sinai also provides technology and facilities to physicians and scientists conducting research projects and clinical trials and is a grantee of the HHS National Institutes of Health.

To resolve this matter without further burden or the expense of additional investigation, or litigation, Cedars-Sinai agrees to the terms stipulated in this Agreement and affirms that it will comply with all applicable provisions of Title VI and Section 1557. Cedars-Sinai’s willingness to enter into this Agreement with OCR in no way constitutes an admission of liability and demonstrates Cedars-Sinai’s ongoing efforts to ensure that it will comply with all provisions of Title VI and Section 1557. The promises, obligations, or other terms and conditions set forth in this Agreement constitute the exchange of valuable consideration between Cedars-Sinai and OCR.

II. Background

OCR initiated a compliance review of Cedars-Sinai in response to public reports indicating that racial bias in healthcare decision making and treatment contributed to the death of Kira Johnson, a Black maternity patient who died approximately 10 hours after delivering her son at Cedars-Sinai Medical Center. OCR also reviewed general allegations that Black patients and other patients of color receiving pregnancy and maternity care at Cedars-Sinai regularly experience discrimination and are at greater risk for adverse maternal health outcomes due to patterns of racial bias and discrimination at the medical center.

III. Jurisdiction

OCR is authorized to investigate allegations of race discrimination pursuant to its authority under Title VI of the Civil Rights Act of 1964, 42 U.S.C. § 2000d et seq., and its implementing regulation at 45 C.F.R. Part 80 (Title VI) and Section 1557 of the Affordable Care Act, 42 U.S.C. § 18116, and its implementing regulation, 45 C.F.R. Part 92 (Section 1557). Title VI prohibits race, color, and national origin discrimination in any program or activity receiving federal financial assistance, and the Title VI implementing regulations prohibit recipients from using criteria or methods of administering their programs that have the effect of subjecting individuals to discrimination or of substantially impairing accomplishment of the objectives of the program with respect to individuals of a particular race, color, or national origin.

Section 1557 prohibits discrimination on the basis of race, color, national origin, age, disability, or sex in covered health programs and activities. 42 U.S.C. § 18116; 45 C.F.R. § 92.

As a recipient of HHS funding, Cedars-Sinai is obligated to comply with federal civil rights laws and is subject to the requirements of Title VI. As a covered health program or activity receiving financial assistance from HHS, Cedars-Sinai is also subject to Section 1557.

IV. Definitions

For purposes of this Agreement, the terms listed below shall have the following meaning:

Companion means a family member, friend or associate of a Patient, who along with the Patient, is an appropriate person with whom Cedars-Sinai should communicate.
Doula means a trained non-medical professional who provides continuous physical, emotional, and informational support to birthing people through pregnancy, labor, and childbirth.
Duration of this Agreement means the period of time this Agreement remains in effect.
Effective Date of this Agreement means the date the Agreement is signed by all Parties.
Family Member, Partner, and Support Person means a person whom the Patient designates to communicate with Cedars-Sinai on their behalf regarding the Patient’s condition or care, or to help the Patient act on the information, advice, or instructions provided by Cedars-Sinai.
Medical Staff Member with Privileges means physicians, dentists, and podiatrists holding a license with approved privileges to provide patient care at Cedars-Sinai.
Patient means any individual who is seeking access to, or participating in, the healthcare related goods, services, facilities, privileges, advantages, or accommodations of Cedars-Sinai, whether as an inpatient or an outpatient.
Workforce Member means employees, full-time faculty, residents, fellows, volunteers, and other persons whose conduct, in the performance of work for Cedars-Sinai, is under the direct control of Cedars-Sinai, whether or not they are paid.

V. General Provisions

Programs Covered by Agreement. This Agreement covers all healthcare programs, services, and activities, which Cedars-Sinai administers or provides directly or through sub-recipients or contractors, throughout the term of this Agreement.
Suspension of Administrative Actions: Subject to Cedars-Sinai’s continued performance of the stated obligations and required actions contained in this Agreement and in conformity with Section V. E., Failure to Comply with the Agreement, OCR shall suspend administrative action on OCR Transaction Number: 22-479470, 23-537104, 23-539207, and 24-555000.
Effective Date and Term of the Agreement: This Agreement shall become effective on the date it is signed by all parties (the “Effective Date”) and will remain in effect for three (3) years after the Effective Date, at which point if OCR determines that Cedars-Sinai substantially complied with this Agreement, then OCR’s review and monitoring of this Agreement shall terminate. Notwithstanding the Term of this Agreement, Cedars-Sinai acknowledges that it will comply with Title VI, Section 1557, and other applicable federal civil rights laws and their implementing regulations, for so long as it continues to receive federal financial assistance from HHS.
Timely Written Requests for Extensions: If Cedars-Sinai, despite good faith efforts, anticipates that it will be unable to meet any deadline set forth in this Agreement, it will timely notify OCR of the delay and the reason for it. The Parties will negotiate in good faith to agree to a reasonable adjusted timeline.
Failure to Comply with the Agreement: If OCR determines that Cedars-Sinai has failed to substantially comply with any provision of this Agreement, the parties will confer and attempt to reach agreement as to what steps may be necessary to resolve the compliance issues to both parties’ satisfaction. If an agreement is not reached, OCR may terminate this Agreement with one (1) months’ notice and take appropriate measures to effectuate Cedars-Sinai’s compliance with Title VI and Section 1557. Such measures may include OCR reopening its investigation of Cedars-Sinai’s compliance with Title VI and Section 1557. OCR may incorporate into its reopened investigation any relevant evidence of noncompliance with the Agreement and any relevant evidence obtained by OCR prior to signing of the Agreement. OCR may also exercise all rights available under Title VI and Section 1557, including, but not limited to issuing noncompliance findings and the initiation of enforcement proceedings to terminate federal financial assistance to Cedars-Sinai.
Effect on Other Compliance Matters: The terms of this Agreement do not apply to any other issues, reviews, investigations, or complaints of discrimination that are unrelated to the subject matter of this Agreement and that may be pending before OCR or any other federal agency. Any unrelated compliance matter arising from subsequent reviews or investigations shall be addressed and resolved separately. Nothing in this Agreement shall be construed to limit or restrict OCR’s statutory and regulatory authority to conduct future complaint investigations and compliance reviews related to Cedars-Sinai and the subject matter of this Agreement. This Agreement does not address or resolve issues involved in any other complaint investigation, compliance review, or administrative action under federal laws by other federal agencies or with any issues or complaints that relate to any other division of Cedars-Sinai, including any action or investigation under Section 504 and/or Title II of the ADA.
Prohibition Against Retaliation and Intimidation: Cedars-Sinai, whether directly or through its sub-recipients or contractors, shall not retaliate, intimidate, threaten, coerce or discriminate against any person who has filed a complaint or who has assisted or participated in the investigation of any matter addressed in this Agreement.
Non-Waiver Provision: OCR’s failure to enforce this entire Agreement or any provision thereof with respect to any deadline or any other provision shall not be construed as a waiver of OCR’s right to enforce other deadlines or any provisions of this Agreement.
Entire Agreement: This Agreement constitutes the entire understanding between Cedars-Sinai and OCR in resolution of OCR Transaction Number: 22-479470, 23-537104, 23-539207, and 24-555000. Any statement, promise, or agreement not contained herein shall not be enforceable through this Agreement.
Modification of Agreement: This Agreement may be modified by mutual agreement of the parties in writing.
Confidentiality of Agreement: OCR makes available to the public, final agreed-upon voluntary resolution agreements. Accordingly, the parties agree that the contents of this Agreement may be made available by OCR. Cedars-Sinai’s performance of the terms set forth herein, however, shall remain confidential, except for any public communications mutually agreed upon with respect to the contents hereof. The parties acknowledge that OCR may be required to release any related materials to this Agreement to any person upon request, consistent with the requirements of the Freedom of Information Act, 5 U.S.C. § 522, and its implementing regulation, 45 C.F.R. Part 5, but shall use best efforts to maintain such confidentiality during the Term of this Agreement.
Third Party Rights: This Agreement can be enforced only by the parties specified in this Agreement, their legal representatives and assigns. This Agreement shall be unenforceable by third parties and shall not be construed to create third party beneficiary rights.
Technical Assistance: OCR will provide appropriate technical assistance to Cedars-Sinai regarding compliance with this Agreement, as requested and as reasonably necessary.
Miscellaneous: When OCR verifies that Cedars-Sinai has completed all actions contained in this Agreement, OCR shall consider all matters related to this investigation resolved and so notify Cedars-Sinai in writing.
Authority of Signer: The individual who signs this Agreement on behalf of Cedars-Sinai represents that he or she is authorized to bind Cedars-Sinai to the Agreement.
Severability: In the event that a court of competent jurisdiction determines that any provision of this Agreement is unenforceable, such provision shall be severed from the Agreement and all other provisions shall remain valid and enforceable; provided, however, that if the severance of any such provision materially alters the rights or obligation of the Parties, they shall, through reasonable, good faith negotiations, agree upon such other amendments hereto as may be necessary to restore the Parties as closely as possible to the relative rights and obligation initially intended to them hereunder.
Successor in Interest: This Agreement is binding on the Parties, and their successors in interest, and Cedars-Sinai shall have a duty to so notify all such successors in interest of the existence and terms of this Agreement.
Contact Persons: The parties hereby designate the following persons as contacts for any notice, report or document required by this Agreement, except as otherwise may be required.
1. For the Office for Civil Rights:
  
  Steven Chen
  Investigator, Pacific Region
  U.S. Department of Health & Human Services
  Office for Civil Rights
  90 7th Street, Suite 4-100
  San Francisco, CA 94103
  Steven.Chen@hhs.gov
2. For Cedars-Sinai:
  
  Pamela S. Hamilton, R.N., Esq.
  Vice President, Risk Management
  Cedars-Sinai Medical Center
  6500 Wilshire Blvd., 10th Floor
  Los Angeles, CA 90048
  Pamela.Hamilton@cshs.org
  
  Brett Moodie, Esq.
  Corporate Counsel, Legal Affairs
  Cedars-Sinai Medical Center
  6500 Wilshire Blvd., Suite 2250
  Los Angeles, CA 90048
  Brett.Moodie@cshs.org

VI. Specific Obligations

Recognition
Cedars-Sinai recognizes that as a recipient of HHS funding, and Cedars-Sinai must comply with the nondiscrimination requirements of Title VI and Section 1557 which prohibits discrimination on the basis of, among other things, race, color, or national origin.

As acknowledged by Cedars-Sinai’s Public Civil Rights Compliance Program Policy, “(I)t is the policy of Cedars-Sinai to comply with Title VI of the Civil Rights Act of 1964, Section 504 of the Rehabilitation Act of 1973, the Americans with Disabilities Act of 1990, the Age Discrimination Act of 1975, Section 1557 of the Patient Protection and Affordable Care Act of 2010, and other related statutes, regulations, executive orders, and directives, in order to ensure that Cedars-Sinai does not exclude, deny benefits to, or otherwise discriminate against any person on the basis of race, color, national origin, disability, age, sex, or other personal characteristic in admission to, participation in, or receipt of the services and benefits under any of its programs and activities, whether carried out by Cedars-Sinai directly or through a contractor or any other entity with which Cedars-Sinai arranges to carry out its programs and activities.”
Early Maternal Warning Systems
1. Within one (1) month of the effective date of this Agreement, Cedars-Sinai will provide a written summary and updated overview of any Department of Obstetrics and Gynecology (“Department”) early maternal warning systems implemented or current programs to facilitate timely recognition, diagnosis, and treatment for pregnant women developing critical illness and any other measures designed to prevent maternal morbidity and mortality. Cedars-Sinai will also provide copies of any written Department policies, procedures, or treatment protocols currently in effect for OCR’s review.
Training on Federal Nondiscrimination Requirements including Title VI and Section 1557
1. Cedars-Sinai acknowledges that its Title VI/Section 1557 Coordinator shall collaborate directly with OCR in its implementation of all training required pursuant to this Agreement, including, but not limited to, a review of Cedars-Sinai’s current civil rights compliance policies and procedures to ensure that said policies are current and up-to-date.
2. Within one (1) year of the Effective Date of this Agreement, the Title VI/ Section 1557 Coordinator, after collaborating with OCR, shall provide the updated training to all Workforce Members on Cedars-Sinai’s obligations under Title VI and Section 1557 and this Agreement, including such topics as preventing discrimination and harassment and promoting diversity and equity as applicable to both Workforce staff and patient populations. Cedars-Sinai shall incorporate such training into its standard onboarding process for Workforce Members at the next available training. Cedars-Sinai shall additionally make such training available to all Medical Staff Members with Privileges, and shall recommend to the Medical Executive Committee of the Medical Staff of Cedars-Sinai (“Executive Committee”) that such training be mandatorily incorporated into the standard re-credentialing process for Medical Staff Members.
3. In addition, Cedars-Sinai shall provide Workforce Members refresher training on the above referenced obligations within one (1) year of the initial training required pursuant to this Agreement, or shall incorporate such training into its annual training program, and retain attendance logs for all attendees for the duration of this Agreement. The attendance logs shall be forwarded to OCR upon request.
Review of Cedar-Sinai’s Guidelines for Trial of Labor After Cesarean Delivery (TOLAC) and Vaginal Birth After Cesarean Section (VBAC) Success Rate Reporting
1. Within six (6) months of the Effective Date of this Agreement, Cedars-Sinai shall submit to OCR for approval Department Guidelines for Trial of Labor After Cesarean Delivery (TOLAC), and shall continue to track success rates of vaginal births after cesarean section (VBAC).
2. Cedars-Sinai shall require that all Department Workforce Members in patient care settings receive the TOLAC guidelines, and shall incorporate such guidelines into its standard onboarding process for Department Workforce Members in patient care settings. Cedars-Sinai shall additionally make the Department Guidelines available to all Medical Staff Members with Privileges, and shall recommend to the Executive Committee that such Department Guidelines and tracking requirements be mandatorily incorporated into the standard re-credentialing process for Medical Staff Members.
3. Cedars-Sinai shall maintain its records to document its VBAC success rates. Within twelve (12) months of the effective date of this Agreement, Cedars-Sinai shall report to OCR with its VBAC success rates for the preceding year. Thereafter, for each subsequent twelve (12) month period during the Term, Cedars-Sinai shall continue to report to OCR with its VBAC success rates for the calendar year for the duration of this Agreement.
Training on Cedar-Sinai’s Obstetric Hemorrhage Management Policy
1. Within six (6) months of the Effective Date of this Agreement, Cedars-Sinai shall require that all Department Workforce Members complete training on Cedars-Sinai’s Obstetric Hemorrhage Management policy. Cedars-Sinai shall incorporate such training into its standard onboarding process for Department Workforce Members in patient care settings. Cedars-Sinai shall additionally make such training available to all Medical Staff Members with Privileges, and shall recommend to the Executive Committee that such training be mandatorily incorporated into the standard re-credentialing process for Medical Staff Members treating patients in the Department.
2. In addition, Cedars-Sinai shall provide Department Workforce Members refresher training on the above referenced obligations within one (1) year of the initial training required pursuant to this Agreement, or shall incorporate such training into its annual training program, and retain attendance logs for all attendees for the duration of this Agreement. The attendance logs shall be forwarded to OCR upon request.
Pain Management Protocol
1. Within six (6) months of the Effective Date of this Agreement, Cedars-Sinai will submit to OCR for approval, a Department pain management protocol for the assessment and management of acute pain for birthing patients. The protocol should, at minimum, include screening and pain management procedures and treatment strategies and planning for pain management during deliver and after discharge.
2. Within one (1) year of approval by OCR, Cedars-Sinai shall require that all Department Workforce Members complete training on the pain management protocol. Cedars-Sinai shall incorporate such training into its standard onboarding process for Department Workforce Members in patient care settings. Cedars-Sinai shall additionally make the Department protocol available to all Medical Staff Members with Privileges and shall recommend to the Executive Committee that such training be mandatorily incorporated into the standard re-credentialing process for Medical Staff Members.
3. In addition, Cedars-Sinai shall provide Department Workforce Members annual training on the above within one (1) year of the initial training required pursuant to this Agreement, or shall incorporate such training into its annual training program. Cedars-Sinai will retain attendance logs for all attendees for the duration of this Agreement. The attendance logs shall be forwarded to OCR upon request.
Medical Staff Oversight and Communication
1. Within twelve (12) months of the effective date of this Agreement, Cedars-Sinai leadership shall meet with the Executive Committee to review current oversight, supervision, and peer review practices and make recommendations related to the following:
  1. Internal monitoring and auditing;
  2. Implementation of compliance and practice standards through the development of written standards and procedures;
  3. Additional training and education on practice standards and procedures;
  4. Mechanisms to respond promptly and appropriately to violations through the investigation of allegations and the disclosure of incidents to appropriate Cedars-Sinai officials and/or government entities;
  5. Development of open lines of communication between Patients, Medical Staff Members, and Workforce Members;
  6. Enforcement of disciplinary standards.
2. To the extent that such meetings result in new policies or procedures, within one (1) year of the implementation of such changes, Cedars-Sinai will provide relevant training to its Workforce Staff Members, and shall incorporate such training into its standard onboarding process at the next available training, including but not limited to annual trainings for Workforce Members in patient care settings. Cedars-Sinai shall additionally make such training available to all Medical Staff Members with Privileges, and shall recommend to the Executive Committee that such training be mandatorily incorporated into the standard re-credentialing process for Medical Staff Members treating patients in the Department.
Bias Reporting Tool
1. Cedars-Sinai shall implement an online reporting tool, or shall review with OCR existing reporting tools, to document incidents of bias or suspected bias experienced by Department patients and the public during interactions with Workforce Members and Medical Staff Members with Privileges.
2. The tool should allow incidents of bias to be reported anonymously. The tool should, at a minimum, include:
  1. The affected individual;
  2. The identity targeted by biased behavior (e.g., race, disability, sex, etc.);
  3. The individual(s) reported to have engaged in biased behavior; and
  4. The location where incident occurred (e.g., Emergency Department, outpatient clinic, etc.)
3. Within six (6) months of approval by OCR, Cedars-Sinai shall develop plain language materials, or shall update existing materials to inform Department Workforce Members, Medical Staff Members with Privileges, Patients, Family Members, Partners, Companions, Support Persons, the public, and other interested persons about the online Bias Reporting Tool. This information shall be communicated in a manner agreed upon by the parties.
4. Any proposed revisions to the online Bias Reporting Tool during the Term may be timely reviewed and commented upon by OCR before being implemented by Cedars-Sinai. Once any revisions to the Tool are implemented, Cedars-Sinai will update its training materials to reflect updates to the Tool and highlight substantive changes in any subsequent trainings.
5. Cedars-Sinai shall develop an annual report summarizing key findings from the Bias Reporting Tool, which may include information such as the number of bias reports received, nature of bias reported, examples of bias incidents, trends of bias incidents, and corrective actions, if any, taken by Cedars-Sinai to respond such reports.
6. Cedars-Sinai shall make the annual report available to its Workforce Members, Medical Staff Members with Privileges, the public, and other interested persons. Cedars-Sinai shall publish the annual report on its website and take appropriate steps to ensure that the report is available in accessible formats.
The American College of Obstetricians and Gynecologists (ACOG) Respectful Care eModules
1. Within one (1) year of the Effective Date of this Agreement, Cedars-Sinai shall require that all Department Workforce Members complete ACOG’s Respectful Care eModules (or training covering equivalent material). The online courses raise awareness about racial disparities in maternal mortality and morbidity rates in the United States, history of medicalization and unethical experimentation on enslaved women and other populations, and efforts to reduce inequities in birth outcomes.
2. Cedars-Sinai shall incorporate such training into its standard onboarding process for Department Workforce Members in patient care settings. Cedars-Sinai shall additionally make such training available to all Medical Staff Members with Privileges, and shall recommend to the Executive Committee that such training be incorporated into the standard re-credentialing process for Medical Staff Members treating patients in the Department.
Doula Program
1. Within one (1) year of the Effective Date of this Agreement, Cedars-Sinai shall develop a program to facilitate patient access to doula resources and utilization of doulas in the Department during labor and delivery. Cedars-Sinai shall promote such program among Department patients, and shall provide OCR copies of such promotional and/or educational materials upon request.

VII. Recommended Actions

Cedars-Sinai is encouraged to participate in and/or provide additional training to its Physicians, Physician Assistants, Nurse Practitioners, and other appropriate direct service Workforce Members and Medical Staff Members with Privileges through the following HHS programs, which will support its compliance efforts under Title VI and Section 1557. Cedars-Sinai agrees to share any information with OCR regarding its participation and/or supplemental training obtained from the below HHS agencies within one (1) month of implementation.
1. Centers for Disease Control and Prevention’s Hear Her© campaign: https://www.cdc.gov/hearher/about/index.html.
2. HHS Office of Minority Health’s e-learning programs:
  1. Culturally and Linguistically Appropriate Services in Maternal Health Care: https://thinkculturalhealth.hhs.gov/education/maternal-health-care.
  2. A Physician’s Practical Guide to Culturally Competent Care: https://thinkculturalhealth.hhs.gov/education/physicians.
  3. Culturally and Linguistically Appropriate Services in Nursing: https://thinkculturalhealth.hhs.gov/education/nurses.
3. Agency for Healthcare Research and Quality (AHRQ):
  1. TeamSTEPPS 3.0: https://www.ahrq.gov/teamstepps-program/index.html
  2. Safety Program for Perinatal Care I: https://www.ahrq.gov/patient-safety/settings/labor-delivery/perinatal-care/index.html.
  3. Safety Program for Perinatal Care II: https://www.ahrq.gov/patient-safety/settings/labor-delivery/perinatal-care-2/index.html.
  4. Engaging Patients and Families in Their Health Care, For Hospital Staff: https://www.ahrq.gov/patient-safety/patients-families/index.html#hospital-staff.
  5. Engaging Patients and Families in Their Health Care, For Patients and Families in the Hospital: https://www.ahrq.gov/patient-safety/patients-families/index.html#hospital-patients.

AGREED AND CONSENTED TO:

For Cedars-Sinai Medical Center:
/s/
Christina Harris, M.D.
Vice President, Chief Health Equity Officer
Cedars-Sinai Medical Center
8700 Beverly Blvd.
Los Angeles, CA 90048

Dated: 01/16/2025

For the U.S. Department of Health and Human Services, Office for Civil Rights
/s/
Melanie Fontes Rainer
Director
Office for Civil Rights

U.S. Department of Health and Human Services
200 Independence Avenue SW
Suite 509F
Washington, DC 20201

Dated: 01/16/2025

Voluntary Resolution Agreement Between the United States Department of Health and Human Services, Office for Civil Rights and Cedars-Sinai Medical Center

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