The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
The Risk Manager is a member of the Mount Auburn Hospital (MAH) Department of Quality and Safety. The Risk Manager is responsible for managing all aspects of the MAH risk management program, including the identification, evaluation and treatment of risk at Mount Auburn Hospital and the Mount Auburn Professional Services ambulatory practices. The Risk Manager provides leadership in risk management, by promoting the highest level of quality care to the patients, ensuring regulatory compliance and mitigating malpractice risk through loss prevention. The Risk Manager plays an integral role in regulatory and accreditation readiness by assisting with the implementation of the Patient Care Assessment Plan and the Quality Improvement Plan consistent with Board of Trustee approved goals and regulatory and standard setting agencies. The Risk Manager performs as an internal compliance consultant by maintaining current knowledge of hospital regulations including DPH, BRM, The Joint Commission, CMS, and FDA. The Risk Manager will develop external and internal relationships to ensure compliance with applicable regulations.
PRIMARY DUTIES AND RESPONSIBILITIES:
1. Responsible for the reviews and evaluation of safety events, incidents and claims for ambulatory and inpatient care, including the identification and prioritization of serious events for further evaluation.
2. Patient Care Assessment Coordinator (PCAC).
3. Collaborate with the Director of Patient Safety, Performance Measurement, and Performance Improvement/Regulatory Affairs as needed in implementing, facilitating, coordinating, or otherwise, the MAH Patient Care Assessment Program and with ensuring compliance with the Board of Registration in Medicine requirements. (243 CMR 3.00).
a. Collaborates with the Director of Patient Safety in the review of cases involving patient harm or significant deviation of standard procedures which could cause patient harm.
b. Collaborates preparation and submission of required semi-annual and annual reports; files serious quality reviews (SQRs), responds to inquiries from BRM; interprets regulations, educates staff regarding current or new BRM regulations; interprets with medical staff, and the Office of General Counsel appropriate cases to be filed as an SQR.
4. Facilitates the root cause analysis process in the event of a sentinel or near miss event. Coordinates review of medical information, interviews staff, debriefs all individuals as indicated, and ensures appropriate and timely follow up for identified action items.
5. Provides timely information to CRICO when an untoward event occurs, whether by accident or not, that causes serious harm to a patient.
6. Participates on various committees as requested including the Collaborative Case Review Committee, the Board Quality and Safety Committee, and Performance Excellence Committee.
7. With colleagues in the Q&S Department, and other MAH departments, assess compliance with standards via audits, case reviews and chart reviews; educate, as appropriate, regarding regulatory changes; act as a resource to Institute leadership to provide overviews of status of clinical regulatory compliance; investigate clinical compliance issues or suspected deficiencies.
8. Provides support to clinical departments, administration and committees regarding Risk Management issues including evaluation of clinical incidents for severity and potential reporting to regulatory agencies.
9. Collaborates in ongoing regulatory readiness activities and functions as a member of the onsite survey management team during regulatory and licensure surveys by the Department of Public Health, Department of Mental Health, Board of Registration in Medicine, Centers for Medicare and Medicaid Services and The Joint Commission.
10. Collaborates with Q&S leadership, the Chief Quality Officer, Directors of Performance Measurement, Performance Improvement/Regulatory Affairs, and the Director of Patient Safety to support the Quality and Patient Safety Program by being a resource for areas such as error detection and prevention, and facilitating Failure Mode and Effects Analysis projects.
11. Participates in the process of disclosure and apology of medical errors when called upon.
12. Co-leads the MAH Peer Support Program including co-Chair of the Peer Support Steering Committee.
13. Collaborates with the Office of General Counsel attorneys on legal matters when requested.
14. Other duties as assigned.
KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:
1. Bachelor’s degree in health or legal-related field required. Previous clinical practice experience required.
2. 5 years’ risk management experience preferred.
3. Ability to learn and use rL safety reporting system in order to review and manage safety events.
4. Knowledge of hospital administrative and medication policies.
5. Knowledge of The Joint Commission standards, OSHA, CDC, DPH, BRM and CLIA regulations.
6. Clinical judgment to evaluate findings in medical record review.
7. Interpersonal skills and maturity to work with multiple levels of hospital staff and administration.
8. Ability to work with confidential patient information.
9. Ability to identify resources to obtain needed information.
10. Writing skills to complete committee meeting minutes, summary and analysis reports, and inter-departmental memos.
11. Organizational skills to facilitate small task forces for problem investigation and solving.
12. Knowledge of PC computer programs - Word processing (e.g. Microsoft Word) and spreadsheet programs for creating tables and charts (e.g. Excel).
1. Normal office environment.
2. Upper extremity demands include ability to perform data entry with repetitive hand movement, and visual concentration at video display terminal, to review and enter data.
Internal Number: 10708
About Mount Auburn Hospital
Founded in 1886 as the first hospital in Cambridge, Massachusetts, Mount Auburn Hospital is dedicated to delivering healthcare services to you in a personable, convenient and compassionate manner. Our mission is to improve the health of the residents of Cambridge and its surrounding communities. We respect the dignity of you, our patients, as well as that of your families.
Mount Auburn Hospital is a top notch teaching healthcare system affiliated with Harvard Medical School . This allows us to make significant contributions to educating the caregivers of tomorrow, thereby maximizing your quality of care.
The hospital is fully accredited by the Joint Commission on Accreditation of Healthcare Organizations and is a member of the American Hospital Association, the Council on Teaching Hospitals, and the Association of American Medical Colleges. We have received numerous awards in recognition of our high standard of quality care.
With 217 licensed beds in all private rooms, and comprehensive inpatient services in all medical specialties, we aim to provide you with the highest level of care and comfort. You can rely on top-level care in all treatment areas, including our Cardiac... Care and Cancer Care departments, both known as centers of excellence. The hospital also offers specialized and streamlined services for men, women and seniors.
Mount Auburn Hospital is part of Beth Israel Lahey Health, a new health care system that brings together academic medical centers and teaching hospitals, community and specialty hospitals, more than 4,000 physicians and 35,000 employees in a shared mission to expand access to great care and advance the science and practice of medicine through groundbreaking research and education.