In a country of nearly 310,000,000, the burdens placed on hospitals are both enormous and complex as they attempt to provide first rate health care to an ever-increasing population while adhering to strict and sometimes contradictory regulations from several different sources. To understand the scope of issues a hospital may face on any given day, it is important to become familiar with the building blocks that make up today’s health care hierarchy.
Who is responsible for oversight? At the top of the health care pyramid is the nation’s President, Barack Obama. Underneath the President lies a complex organization of individuals and agencies at both the federal and state level, who make up the gargantuan structure commonly referred to as health care. The President directly oversees the Office of the Secretary, U.S. Department of Health and Human Services (HHS). The following is the Organizational Chart for HHS:
Leading the HHS is the Acting Secretary, who is responsible for protecting the health of all Americans and providing essential human services to those in need. The Acting Secretary also serves as the Assistant Secretary for Budget, Technology, and Finance. Next, the Office of Intergovernmental Affairs (IGA) serves the Secretary as the primary link between the HHS and state, local, and tribal governments. After the IGA is the Office of Public Health and Science (OPHS).
The OPHS is comprised of 12 core public health offices and the Commissioned Corps, a uniformed service of more than 6,000 health professionals who serve at HHS and other federal agencies. The Assistant Secretary for Health (ASH) oversees the OPHS and stands as the primary advisor to the Secretary of the HHS on matters involving the nation’s public health. The Surgeon General, head of the Office of the Surgeon General (OSG), is responsible for overseeing all OPHS operations. Thereafter, the agencies below OPHS include:
- Office of the Assistant Secretary for Administration and Management (ASAM);
- Office of the Assistant Secretary for Resources and Technology (ASRT);
- Office of the Assistant Secretary for Planning and Evaluation (ASPE);
- Office of the Assistant Secretary for Preparedness and Response (ASPR);
- Office of the Assistant Secretary for Legislation (ASL);
- Office of the Assistant Secretary for Public Affairs (ASPA);
- Office of the General Counsel (OGC);
- Office of Medicare Hearings and Appeals (OMHA);
- Office for Civil Rights (OCR);
- Office of Inspector General (OIG);
- Office of Global Health Affairs (OGHA);
- Departmental Appeals Board (DAB);
- Office of the National Coordinator for Health Information Technology (ONC); and
- Center for Faith-Based and Community Initiatives (CFBCI).
The key operating divisions under OPHS jurisdiction include:
- Administration for Children and Families (ACF);
- Administration on Aging (AoA);
- Agency for Healthcare Research and Quality (AHRQ);
- Agency for Toxic Substances and Disease Registry (ATSDR);
- Centers for Disease Control and Prevention (CDC);
- Centers for Medicare & Medicaid Services (CMS);
- Food and Drug Administration (FDA);
- Health Resources and Services Administration (HRSA);
- Indian Health Service (IHS);
- National Institutes of Health (NIH); and
- Substance Abuse and Mental Health Services Administration (SAMHSA).
Each of the agencies and divisions under the OPHS serves a critical role in the delivery of health care nationwide, though some have a more prominent place in the public spotlight due to the nature of their jurisdiction. For example, one such division is the Centers for Medicare & Medicaid Services (CMS). Among its many roles, CMS is responsible for overseeing the certification of hospitals so that they can qualify for state and/or federal funding. Hospital clinical laboratories must be approved by a division of CMS, commonly known as CLIA (the Clinical Laboratory Improvement Amendments). Covering approximately 200,000 laboratory programs, CLIA regulates all laboratory testing (except research) performed on humans in the United States.
Another important agency under HHS is the Food and Drug Administration (FDA). Protecting and promoting public health, the FDA consists of nine centers/offices, including:
- Center for Biologics Evaluation and Research (CBER);
- Center for Devices and Radiological Health (CDRH);
- Center for Drug Evaluation and Research (CDER);
- Center for Food Safety and Applied Nutrition (CFSAN);
- Center for Veterinary Medicine (CVM);
- National Center for Toxicological Research (NCTR);
- Office of Chief Counsel;
- Office of the Commissioner (OC); and
- Office of Regulatory Affairs (ORA).
Though itself a regulatory agency, even within the FDA there exist many additional levels of oversight. Inside the OC, for example, at least 18 different entities are tasked with implementing the FDA’s mission efficiently and effectively. These programs and offices include:
- Ethics Program;
- Good Clinical Practice Program;
- History Office;
- Office of Chief Counsel;
- Office of Combination Products;
- Office of Crisis Management;
- Office of Equal Employment Opportunity and Diversity Management;
- Office of Financial Management;
- Office of International Programs;
- Office of the Ombudsman;
- Office of Orphan Products Development;
- Office of Pediatric Therapeutics;
- Office of Planning;
- Office of Policy;
- Office of Public Affairs;
- Office of Special Health Issues;
- Office of Women’s Health; and
- Small Business Program.
Accreditation and Certification
Due to the sensitive nature of their services, hospitals must exist in a heavily regulated industry. Notwithstanding the seemingly endless number of agencies within agencies within HHS, the Federal government is only part of the overall health care regulatory equation. Accreditation, certification and periodic review come from a variety of both public and private sources, though the goal is generally consistent: develop uniform standards to ensure that hospitals in the United States all operate at an acceptable safety level and deliver quality patient care in an appropriate and effective manner.
Any one healthcare institution can be subject to accreditation review at any time from entities such as the Joint Commission, Healthcare Facilities Accreditation Program (HFAP, formerly the American Osteopathic Association), Community Health Accreditation Program, Accreditation Commission for Health Care, The Compliance Team, or Healthcare Quality Association on Accreditation (HQAA).
Each program or department is governed by its own set of rules. For example, Joint Commission surveys hospitals by following more than 276 standards, reviewing 1,612 elements of performance. HFAP does largely the same thing, pursuant to its 1,100 or more individual standards. Focusing on durable medical equipment (DME), HQAA has developed its own review process, and “vows to continuously strive to set standards of the highest quality on behalf of the DME industry and business owners.” Indeed, HQAA “listen[s] . . . act[s] . . . [and] stand[s] together and in unison to bring the whole of DME service and provision to the next level.”
There are numerous other entities participating in the certification/accreditation process, and virtually every facet of the health care system is governed and reviewed by multiple organizations. Take the American Hospital Association, which designs and administers Certification Programs to recognize mastery of well-defined bodies of knowledge within health care management disciplines. The Certification Commission for Healthcare Information Technology is a recognized certification body for electronic health records and their networks. Even educational programs, general education or specialty education (such as podiatric medicine) must receive proper accreditation in a hospital setting.
In addition to the list above, every hospital is subject to special regulations from its own state. Health care facilities in California are licensed, regulated, inspected, and/or certified by a number of public and private agencies at both the state and federal level, including the California Department of Public Health (CDPH, previously called the California Department of Health Services).
State and federal agencies have separate jurisdictions, but there is overlap. For example, CDPH’s License and Certification Division (“L&C”) is responsible for ensuring that hospitals comply with state law, but it also cooperates with CMS to verify that facilities accepting Medicare and Medi-Cal (Medi-Cal is California’s version of Medicaid) payments meet federal requirements. California’s Office of Statewide Health Planning and Development (OSHPD) regulates hospital construction and administers programs which endeavor to implement the vision of “Equitable Healthcare Accessibility for California.”
These two examples serve to emphasize as well as outline the complexities of state regulations that often accompany their federal counterparts. CDPH is divided into eight separate programs, including:
- Office of the Director, or State Public Health Officer;
- External Affairs;
- Policy and Programs;
- Center for Chronic Disease and Health Promotion;
- Center for Environmental Health;
- Center for Family Health;
- Center for Health Care Quality; and
- Center for Infectious Disease.
Like CDPH, OSHPD is part of California’s Health and Human Services Agency.
Made up of six separate boards and commissions, OSHPD’s mission is “to promote healthcare accessibility through leadership in analyzing California’s healthcare infrastructure, promoting a diverse and competent healthcare workforce, providing information about healthcare outcomes, assuring the safety of buildings used in providing healthcare, insuring loans to encourage the development of healthcare facilities, and facilitating development of sustained capacity for communities to address local healthcare issues.”
Under OSHPD’s jurisdiction is the Hospital Building Safety Board (HBSB), which oversees seismic safety standards for hospitals in California. HBSB is made up of sixteen board members appointed by the Director of OSHPD from nominations submitted by professional associations. Six additional members, representing state agencies that interact with the hospital design and construction program, also have seats on the Board. The Director has the authority to appoint three additional members as desired. Appointed Board members serve 4-year terms with a two term limit. This board is particularly important, as California hospitals will spend approximately $120 billion before 2013 in order to meet state seismic safety standards.