HSPA CRCST exam questions and
answers pass guaranteed 100%.
Microbiology - Correct Answers The study of microorganisms
Contamination - Correct Answers The state of being soiled by contact with infectious organisms or other
materials.
Cross-contamination - Correct Answers The process by which microorganisms are unintentionally
transferred from one substance or object to another, with harmful effect.
U.S. Food and Drug Administration (FDA) - Correct Answers responsible for ensuring that medical
devices are safe and effective for patient care. It regulates the manufacturing of all medical devices. It
regulates sterilant, high-level disinfectants, packaging materials, sterilizers, and quality monitoring (e.g.,
biological monitoring).
Medical Device Classification - Correct Answers Class 1: Electric Toothbrushes
Class 2: Infusion Pumps
Class 3: Pacemakers
Class I Devices - Correct AnswersLow risk - hand-held instruments, hospital beds, ultrasonic cleaners
Class II Devices - Correct AnswersPotential risk - sterilization equipment, biological indicators, chemical
indicators
MedWatch - Correct AnswersThis is the FDA reporting service for adverse effects that occur from use of
approved drugs.
Medical Device Recalls - Correct AnswersClass I: high risk
Class II: Less serious risk
, Class III:Low risk
FDA Enforcement Requirements for Healthcare Facilities Reprocessing Single-Use Devices (SUD) -
Correct AnswersRequires compliance with FDA 510(k) directives when reprocessing SUDs.
Emergency Use Authorization (EUA) - Correct AnswersAllows the FDA to help strengthen the nation's
public health protections against chemical and biological threats, including infectious diseases, and
other threats.
Center for Disease Control and Prevention (CDC) - Correct AnswersThe CDC promotes health and quality
of life by preventing and controlling disease, injury, and disability and by responding to health
emergencies.
U.S. Environmental Protection Agency (EPA) - Correct AnswersThe EPA is responsible for minimizing
greenhouse gases and toxic emission, regulating the reuse of solid wastes, controlling indoor air
pollution, and developing and enforcing chemical regulations. requires an EPA registration number for
every covered disinfectant and sanitizer and requires data relating to labeling claims, efficacy, and safety
U.S. Department of Transportation - Correct Answersensures a fast, safe, and efficient transportation
system. It regulates the transportation of minimally processed instrumentation for repair or
reprocessing and the transportation of hazardous and radioactive wastes.
The Occupational Exposure to Bloodborne Pathogens Standards - Correct AnswersOSHA guidelines
outline employee safety in all areas of the facility as they relate to potential exposure from bloodborne
pathogens.
General Duty Clause of the Occupational Safety and Health Act - Correct AnswersRequires employers to
provide each employee with a place of employment that is free from recognized hazards that are
causing or are likely to cause death or serious physical harm to employees.
Health Insurance Portability and Accountability Act (HIPAA) - Correct Answersestablished national
standards to protect patients' medical records and other personal health information
answers pass guaranteed 100%.
Microbiology - Correct Answers The study of microorganisms
Contamination - Correct Answers The state of being soiled by contact with infectious organisms or other
materials.
Cross-contamination - Correct Answers The process by which microorganisms are unintentionally
transferred from one substance or object to another, with harmful effect.
U.S. Food and Drug Administration (FDA) - Correct Answers responsible for ensuring that medical
devices are safe and effective for patient care. It regulates the manufacturing of all medical devices. It
regulates sterilant, high-level disinfectants, packaging materials, sterilizers, and quality monitoring (e.g.,
biological monitoring).
Medical Device Classification - Correct Answers Class 1: Electric Toothbrushes
Class 2: Infusion Pumps
Class 3: Pacemakers
Class I Devices - Correct AnswersLow risk - hand-held instruments, hospital beds, ultrasonic cleaners
Class II Devices - Correct AnswersPotential risk - sterilization equipment, biological indicators, chemical
indicators
MedWatch - Correct AnswersThis is the FDA reporting service for adverse effects that occur from use of
approved drugs.
Medical Device Recalls - Correct AnswersClass I: high risk
Class II: Less serious risk
, Class III:Low risk
FDA Enforcement Requirements for Healthcare Facilities Reprocessing Single-Use Devices (SUD) -
Correct AnswersRequires compliance with FDA 510(k) directives when reprocessing SUDs.
Emergency Use Authorization (EUA) - Correct AnswersAllows the FDA to help strengthen the nation's
public health protections against chemical and biological threats, including infectious diseases, and
other threats.
Center for Disease Control and Prevention (CDC) - Correct AnswersThe CDC promotes health and quality
of life by preventing and controlling disease, injury, and disability and by responding to health
emergencies.
U.S. Environmental Protection Agency (EPA) - Correct AnswersThe EPA is responsible for minimizing
greenhouse gases and toxic emission, regulating the reuse of solid wastes, controlling indoor air
pollution, and developing and enforcing chemical regulations. requires an EPA registration number for
every covered disinfectant and sanitizer and requires data relating to labeling claims, efficacy, and safety
U.S. Department of Transportation - Correct Answersensures a fast, safe, and efficient transportation
system. It regulates the transportation of minimally processed instrumentation for repair or
reprocessing and the transportation of hazardous and radioactive wastes.
The Occupational Exposure to Bloodborne Pathogens Standards - Correct AnswersOSHA guidelines
outline employee safety in all areas of the facility as they relate to potential exposure from bloodborne
pathogens.
General Duty Clause of the Occupational Safety and Health Act - Correct AnswersRequires employers to
provide each employee with a place of employment that is free from recognized hazards that are
causing or are likely to cause death or serious physical harm to employees.
Health Insurance Portability and Accountability Act (HIPAA) - Correct Answersestablished national
standards to protect patients' medical records and other personal health information
