Compliance with Safety Standards

In the Healthcare Delivery Systems module, you were introduced to the terms OSHA and CDC. You may have noticed that many of the learning activities that are incorporated into these learning modules are directly linked to both OSHA and CDC. Both the Occupational Safety and Health Administration (OSHA) and the Centers for Disease Control and Prevention (CDC) are governmental agencies that guide the delivery of healthcare. You will have an opportunity to explore more regarding the agency that is responsible for the safety regulation of food and drug products (FDA) sold to the public in the Biotechnology Research and Development unit. Still, there are other regulatory agencies that contribute to the quality of care delivered to patients.

Clinical Laboratory Safety Amendments

The Clinical Laboratory Improvement Amendments of 1988 (CLIA) establish quality standards for all laboratory testing to ensure the accuracy, reliability, and timeliness of patient test results regardless of where the test was performed. A laboratory is defined as any facility that performs laboratory testing on specimens derived from humans for the purpose of providing information for the diagnosis, prevention, treatment of disease, or impairment of, or assessment of health.

The CLIA program has three-way management through the CDC, FDA, and Centers for Medicare and Medicaid Services.

International Organization for Standardization

The International Organization for Standardization (ISO) is a global organization that consists of 163 member countries, each with an independent office. The ISO is headquartered in Geneva, Switzerland.

The ISO is responsible for providing standardization of products and services as a measure of consistent delivery of environmental, health, and safety policies. Standards developed by the ISO ensure that a product or service is safe. On August 9, 2013, a project committee was approved to oversee the development of an International Standard for occupational health and safety (OH&S). Standardization of OH&S will "provide governmental agencies, industry and other affective stakeholders with effective, usable guidance for improving worker safety in countries around the world".

The International Labour Organization states "6300 people die every day as a result of occupational accidents or work-related diseases – more than 2.3 million deaths per year. 317 million accidents occur on the job annually: many of these resulting in extended absences from work. Many such accidents can be prevented, and the future ISO standard will provide, for the first time, an international framework for OH&S best practice and, in so doing, reduce work-related accidents, injuries, and disease worldwide."

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