Dear Colleagues,

While the vast majority of activities at Johns Hopkins Medicine operate smoothly and bring extraordinarily positive attention, the increasing complexity of those activities sometimes presents challenges that must be addressed in a rigorous, and coordinated fashion. The Crisis Notification Policy and Guidelines attached below were developed to assist faculty and staff in meeting those occasional challenges. Your attention to them, and cooperation, are appreciated.

Sincerely,

CRISIS NOTIFICATION POLICY AND GUIDELINES

Policy and Rationale: Research, clinical, educational and administrative operations of The Johns Hopkins Hospital and Health System, and The Johns Hopkins University School of Medicine (collectively, JHM) are the focus of intense and sometimes overlapping scrutiny and formal investigatory and legal activity by governmental, regulatory, accrediting, law enforcement, media and public interest offices and organizations. The targeted issues and operations are frequently complex and may have the potential to result in highly visible investigations, penalties, expenses and damage to institutional reputation. Providing appropriate attention and resources to all such activities, and reducing our vulnerabilities, require a high level of coordinated risk assessment, risk management, corrective actions, and communications to internal and external audiences and stakeholders. To meet this requirement, JHM leadership and relevant experts must be made aware as soon as possible of such activities and potential vulnerabilities. Therefore, it is the policy of JHM to require all employees, including faculty, directors, managers, house officers, and nurses to immediately notify appropriate leadership if they receive or have information related to such activities by outside organizations. The following guidelines are intended to facilitate notification.

--Notification should be made immediately about actual or probable activities including, but not limited to inquiries, investigations, audits or formal reviews by legal, law enforcement, regulatory, accrediting, and similar institutions and organizations.* (See examples below.)

--Notification can be oral or written, but should include all pertinent documents and details. For example, if an employee receives a notice from the U.S. Food and Drug Administration regarding a recall, the name of the drug or device, along with its manufacturer, and any other relevant dates or identifying information, should be provided.

--Notification should be directed to JHM Vice President and General Counsel Joanne Pollak, BRB 102, 733 North Broadway, Baltimore, MD 21205 (410 614 3322, jpollak@jhmi.edu ), with a copy to JHU Vice President and General Counsel Kumiki Gibson, Garland Hall #113, 3400 North Charles Street, Baltimore, MD 21218 ( 410 516 8128, kgibson@jhu.edu), as well as to your supervisors (e.g., department chairman, dean, division head). It is the responsibility of the JHM General Counsel's office to evaluate each notification, confidentially relay pertinent information to a Core Crisis Management Group (CCMG) and, when necessary, to convene members of the CCMG or other relevant experts to develop and implement appropriate responses.

--The Core Crisis Management Group will be comprised of Edward D. Miller, M.D., Dean/CEO, JHM; Ronald R. Peterson, President, The Johns Hopkins Hospital and Health System; Richard Grossi, Chief Financial Officer, JHM; Judy A. Reitz, Sc.D., Vice President for Quality Improvement, JHM and Executive Vice President, The Johns Hopkins Hospital; Joanne E. Pollak, Vice President and General Counsel, JHM; Kumiki Gibson, Vice President and General Counsel, Johns Hopkins University; G. Daniel Shealer, Vice President for Corporate Compliance, The Johns Hopkins Hospital and Health System; Frederick Savage, JHU Deputy General Counsel; Joseph Coppola, Vice President, Corporate Security, JHM; Elaine Freeman, Vice President, Corporate Communications, JHM; Joann Rodgers, Deputy Director, Corporate Communications and Director of Media Relations, JHM; and Christine White, Assistant Dean, School of Medicine.

*Examples:
1. A department chair receives word from the Accreditation Council for General Medical Education (ACGME) that a resident has threatened to file a complaint charging a violation of rules governing residency hours.

2. A public information officer learns from a reporter that a Hopkins patient claims he has been misdiagnosed and mistreated, and that the patient's family is planning a press conference to announce a lawsuit against Hopkins physicians and the Hospital.

3. A pulmonologist notices an unusual cluster of treatment-related infections and deaths among patients in his clinic shortly after initiating a new protocol and must consider reporting the cluster to health departments and/or the U.S. Centers for Disease Control.

4. A clinic administrator receives a letter from a patient complaining that her privacy has been invaded and that information about her medical condition has been inappropriately divulged to a member of her family.
5. An administrator and a principal investigator receive a letter notifying them that the federal Inspector General's office intends to audit financial information related to a clinical trial.

6. A financial officer learns from an employee that a renewal application for an NIH grant by a faculty member may contain fraudulent or incorrect billing information.
7. A nurse learns that a regulatory agency has, without notice, sent a team of inspectors to her clinical unit and is asking for certain medical records.

8. An administrator receives a notice from a state agency stating that a regulation has been violated and asking for a response within fifteen (15) days.

9. A physician learns of a recall notice from a medical device manufacturer to a purchasing agent that potentially raises questions about harm to patients from prior use of the device.

10. A resident in the ER sees a healthy research volunteer who has recently participated in a study and has completely unexpected and potentially life threatening symptoms.