Source of Standards for Diagnostic Service
Standards for Diagnostic Testing
Examples of Applied Standards for Diagnostic Testing
Professional practice parameters of American Nurses Association (ANA), American Medical Association (AMA), American Society for Clinical Pathology (ASCP), American College of Radiology, Centers for Disease Control and Prevention (CDC), and The Joint Commission healthcare practice requirements
Use a model as a framework for choosing the proper test or procedure and to interpret test results. Use laboratory and diagnostic procedures for screening, differential diagnoses, follow-up, and case management.
Test strategies include single tests or combinations or panels of tests. Panels can be performed in parallel, as a series, or both. Patient education and proper patient preparation are involved.
The guidelines of the major agencies, such as American Heart Association (e.g., stress tests after abnormal electrocardiogram [ECG]), American Cancer Society (e.g., colonoscopy for colon cancer), and American Diabetes Association (e.g., hemoglobin A1c <7% for diabetes)
Order the correct test; appropriately collect and transport specimens. Properly perform tests in an accredited laboratory or diagnostic facility. Accurately report test results. Communicate and interpret test findings. Treat or monitor the disease and the course of therapy. Provide diagnosis as well as prognosis.
Patients receive diagnostic services based on a documented assessment of need for diagnostic evaluation. Patients have the right to receive information about the benefits and risks of testing so they can make informed decisions that reflect their needs and desires for diagnostic care.
Individual agency and institution standards:
Policies, procedures, and quality control criteria for specimen collection
Procedure statement for monitoring the patient after an invasive procedure
Policy for universal witnessed consent situations
Statements on quality improvement standards
Standards of professional practice and standards of patient care
Policy for obtaining informed consent or witnessed consent
Policies for unusual situations
Observe standard precautions (formerly known as universal precautions). Use latex allergy protocols and required methodology of specimen collection. Use standards and statements for monitoring patients who receive sedation and analgesia. Vital signs are monitored and recorded at specific times before and after the procedure. Patients are monitored for bleeding and respiratory or neurovascular changes. Record data regarding outcomes when defined care criteria are implemented and practiced. Protocols to obtain appropriate consents are employed, and deviations from basic consent policies are documented and reported to the proper individual.
The healthcare provider wears protective eyewear and gloves when handling all body fluids and employs proper handwashing before and after handling specimens and between patient contacts. Labeled biohazard bags are used for specimen transport. Vital signs are monitored and recorded at specific times before and after the procedure. Patients are monitored for bleeding and respiratory or neurovascular changes. Record data regarding outcomes when defined care criteria are implemented and practiced. Protocols to obtain appropriate consents are employed, and deviations from basic consent policies are documented and reported to the proper individual.
State and federal government communicable disease reporting regulations: Centers for Disease Control and Prevention (CDC), U.S. Department of Health & Human Services, Agency for Healthcare Research and Quality (AHRQ), and Clinical Laboratory Improvement Act (CLIA)
Clinical laboratory personnel and other healthcare providers follow regulations to control the spread of communicable diseases by reporting certain disease conditions, outbreaks, and unusual manifestations, morbidity, and mortality data. Findings from research studies provide healthcare policy makers with evidence-based guidelines for appropriate selection of tests and procedures.
The healthcare provider reports laboratory evidence of certain disease classes (e.g., sexually transmitted diseases, diphtheria, Lyme disease, symptomatic HIV infection; see list of reportable diseases). Personnel with hepatitis A may not handle food or care for patients, young children, or elderly people for a specific period of time. Federal government regulates shipment of diagnostic specimens. Magnetic resonance imaging and computed tomography are used to evaluate persistent low back pain according to AHRQ guidelines.
U.S. Department of Transportation
Alcohol testing is done in emergency departments in special situations (e.g., following a motor vehicle crash, homicide, or suicide or in an unconscious individual).
Properly trained personnel perform blood, saliva, and breath alcohol testing and use required kits as referenced by federal law.
Occupational Safety and Health Administration (OSHA)
The healthcare provider is properly trained, under mandated guidelines, to administer employee medical surveillance.
Properly trained personnel perform respirator qualification, fit testing, and monitoring for toxic exposure.
Clinical and Laboratory Standards Institute (CLSI)
Develops standards and guidelines for laboratory testing. Standards define specific materials, methods, and practices as they relate to laboratory specimen tests. Guidelines describe essential criteria for a procedure that can be modified by the user to fit his or her needs.
Provides healthcare professionals with practical guidelines for consistency in procedural methods in laboratory testing.