Informed Consent:
Confidentiality and HIPPA:
Chain of Custody:
Standard of Care:
CLIA Requirements:
- Clinical Laboratory Improvement Amendments of 1988
- Was created to make sure that the quality of lab work performed and results are reliable
- Regulatory mandates issued externally
- Govern most of the activities of the lab
- Regulations are divided into:
- Waived tests (point-of-care)
- Cleared by the FDA for home use
- Simple and easy
- Can be performed by the patient's bedside (hospitalized patients)
- Other healthcare personnel can perform it
- Likelihood of erroneous test results poses no reasonable risk or harm to the patient
- Dipstick or tablet reagent urinalysis (UA)
- Fecal occult blood
- Ovulation tests
- Urine pregnancy tests
- Erythrocyte sedimentation rate
- Hemoglobin
- Blood glucose
- Cholesterol
- Ionized calcium
- Moderately complex tests
- Highly complex tests
- Waived tests (point-of-care)
OSHA:
- Occupational Safety and Health Administration
- Environmental standards that ensure a safe atmosphere and that all precautions have been taken to maintain a safe atmosphere
ASCP, AMT and NCCLS:
- ASCP: American Society for Clinical Pathology
- AMT: American Medical Technologists
- NCCLS:
COLA, CAP and JCAHO:
- COLA: Commission on Office Laboratory Accreditation
- Accredits nearly half of all laboratories
- CAP: College of American Pathologists
- Accredits about a third of all laboratories
- Proficiency Testing
- Certify the lab
- JCAHO: Joint Commission on Accreditation of Healthcare Organizations
- Accredits about a fourth of all laboratories
- Certify the lab
FDA:
- FDA: Food and Drug Administration
CDC and WHO:
- CDC: Centers for Disease Control and Prevention
- Public health laws
- Reporting requirements
- WHO: World Health Organization