Standards

Definition

Formal designations of levels of quality defined by industry, occupational groups, or governmental bodies.  

Rationale

Application of standards as they relate to clinical and translational science ranges from laboratory testing procedures to facility operations, with the goal of improving patient and public health outcomes. 

Guidance

Advice from authors on searching for information:

The terms “standards” and “guidelines” often co-occur and can be difficult to separate. According to the U.S. National Library of Medicine, the phrase “Standards and Guidelines” is defined as follows: “Standards are authoritative statements that articulate minimal, acceptable, or excellent levels of performance or that describe expected outcomes in health care delivery, biomedical research and development, health care technology, or professional health care. Guidelines are statements of principles or procedures that assist professionals in ensuring quality in such areas as clinical practice, biomedical research, and health services. Practice guidelines assist the health care practitioner with patient care decisions about appropriate diagnostic, therapeutic, or other clinical procedures for specific clinical circumstances.” 

Resources & Data

Organizations, repositories, websites, and other sources where you can find more information:

Local

Missouri Department of Health & Senior Services 
The Licensing & Regulations section of the Missouri DHSS links to regulations in areas such as nursing homes, hospitals, child care, emergency medical services, and food safety. Resources for each area vary widely depending on applicability. 

General

American National Standards Institute 
ANSI provides searchable Standards & Publications section that includes standards publications for purchase. Clinical-relevant publishers include Association for the Advancement of Medical Instrumentation, American Dental Association, and Clinical and Laboratory Standards Institute. 

Centers for Disease Control and Prevention 
CDC’s Laboratory Quality Assurance and Standardization Programs offer reference materials, proficiency testing, training, guidelines, and consultations for laboratory testing including cardiovascular disease biomarkers, newborn screening, arsenic specification, urinary iodine, hormone, lead/multielement, Vitamin A, and Vitamin D. 

Centers for Medicare & Medicaid Services 
The CMS Center for Clinical Standards and Quality sets best practices and supports performance measurement systems. Additionally, the Regulations & Guidance section links to several regulatory resources. 

Clinical and Laboratory Standards Institute 
CLSI provides health care based laboratory standards developed by volunteers who are professionals in their fields. Specialty areas include clinical chemistry and toxicology, hematology, microbiology, newborn screening, and quality management systems. 

Regulations.gov 
Regulations.gov is an online resource designed to enhance public access to Federal regulations. The Food Safety, Health, and Pharmaceutical section is most relevant to clinical and translational science, and contains rules proposed by the FDA and other health-related agencies. 

Data Limitations

Challenges you may encounter while searching for information:

Data sources provided here serve as examples of repositories where researchers can find commonly adopted standards and the science (reports, papers, projects, etc.) on which the standards are based.

Publications

Articles, books, and other publications in translational science using the indicator:

American Diabetes Association. Standards of Medical Care in Diabetes-2018 Abridged for Primary Care Providers. Clin Diabetes. 2018 Jan;36(1):14-37. doi: 10.2337/cd17-0119.

BoguszCzerniewicz M, Kazmierczak D. Organizational, technical, physical and clinical quality standards for radiotherapy. Rep PractOncolRadiother. 2012 Jul; 17(4): 190-199. doi: 10.1016/j.rpor.2012.05.001.

Cantrill SV. Clinical standards. Emerg Med Clin North Am. 1992; 10(3): 507-522.  

Case Studies

Content coming soon!

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