Pearson Edexcel International
A+ Graded Paper
IAHCSMM CRCST– CRCST Final Exam – JCSPD
Newest Update 2025!! – A+ Graded Submission–
100% Verified Q&A for Success
Questions and Mark scheme
Version: Final
,regulation - ✔✔mandatory law or rule that is issued by a governing body.
standard - ✔✔method of defining basic parameters for processes, products, services, and measurements.
regulatory standard - ✔✔benchmark that is mandated by a governing agency and, if not complied with, may
cause a facility to be in violation a d liable for legal penalty.
voluntary standard - ✔✔benchmark that is strongly recommended.
statute - ✔✔written and enforceable law enacted by a governing body.
FDA - ✔✔Food and Drug administration. Regulates Medical devices, Medical device recalls, device
classification. Etc
Class 1 device - ✔✔low risk devices. Most hand-held surgical instruments, and ultrasonic cleaners. Subject to
general controls which include registration and device listing, device reporting, and quality regulation and
labeling. exempt from PMA and 510k
Class 2 device - ✔✔pose potential risks great enough to warrant higher level of regulation. Sterilization
equipment, packaging materials, biological and chemical indicators. Requires 510k before they can sell these
products, subject to performance standards.
Class 3 device - ✔✔most stringently regulated, pose greatest risk, heart valves, pacemakers, life sustaining
devices. Most obtain a PMA, to demonstrate safety and effectiveness.
510k - ✔✔required for class 1 and class 2 devices, comprehensive package of information designed to
demonstrate that the new product is substantially equivalent to one or more devices already being marketed.
PMA - ✔✔required for most class 3 devices which are new to the market, a PMA is more complicated to
complete because it must prove the device has a reasonable assurance of safety and effectiveness for its
intended use based on valid scientific evidence.
FDA Recall Class 1 - ✔✔High Risk.
Reasonable chance product will cause serious problems or death.
FDA Recall Class 2 - ✔✔Serious Risk.
possibility product will cause a temporary or reversible health problem or remote chance that device will cause
serious health problem.
FDA Recall Class 3 - ✔✔Low Risk.
little chance that using or being exposed to the product will cause health problems.
CDC - ✔✔Centers for Disease Control.
promote the health and quality of life by preventing and controlling disease, injury, and disability, and by
,responding to health emergencies.
DOT - ✔✔Department of Transportation.
EPA - ✔✔Environmental protection agency.
create and enforce laws relating to cleaner water, air, and land. Regulate products such as disinfectants, and
sanitizers.
OSHA - ✔✔Occupational Safety and Health Administration.
protect workers from occupational-caused illnesses and injuries. Exposure to bloodborne Pathogens standard
and guidelines for the use of Ethylene Oxide sterilization.
AAMI - ✔✔Association for the advancement of Medical Instrumentation.
Develop new or revise existing recommended practices and standards that address the use, care and processing
of devices and systems.
ANSI - ✔✔American National standards Institute.
promote and facilitate voluntary consensus standards and ensuring their integrity.
AORN - ✔✔Association of operating room nurses.
Dedicated to providing optimal care to the surgical patient.
APIC - ✔✔Association for professionals in infection control and Epidemiology.
Dedicated to the prevention and control of infections and related outcomes.
Joint Commission - ✔✔Develops standards for health care facilities. on site surveys at least every three years,
loss of accreditation can result in forfeiture of medicare and medicaid payments.
USP-NF - ✔✔United states pharmacopoeia - national formulary.
creates and revises standards for medicines, dosages, forms, drug substances, and dietary supplements. Also set
standards for packaging, labeling, bacteriological purity, pH, and mineral content.
SGNA - ✔✔Society of Gastroenterology Nurses and associates.
collects information and establishes standards and guidelines relating to the processing of flexible endoscopes.
Central Service Umbrella. - ✔✔U-N-S-A-A-A-F-E-J-O.
USP-NF.
NFPA.
State Law.
APIC.
AORN.
AAMI.
FDA.
EPA.
Joint Commission.
OSHA.
, goals of the central service Deparment - ✔✔Eliminate and/or destroy all potentially infectious contaminants
present on reusable instruments and equipment.
safely distribute instruments and equipment.
Establish and enforce standards for decontamination, disinfection and sterilization.
infection - ✔✔invasion of human body tissue by microorganisms which multiply and produce a reaction.
the primary purpose of the central service department is to stop the spread of disease producing microorganisms
in the healthcare facility. - ✔✔each year approximately 2 million patients, about 10% of those hospitalized in
U.S. hospitals develop healthcare facility-associated infection. Resulting in an estimated 90,000 deaths.
fingernails of personnel working in high-risk areas should be maintained at a length of. - ✔✔1/4 inch or less
because they may harbor microorganisms.
Putting on PPE - ✔✔Shoe covers.
Gown.
Mask/respirator.
googles.
face shield.
Gloves.
Removing PPE - ✔✔Shoe covers.
gloves.
face shield.
googles.
gown.
mask/respirator.
PPE - ✔✔specialized clothing or equipment worn by an employee for protection against a hazard.
Standard Precautions - ✔✔appropriate barriers to prevent transmission of infectious organisms from contact
with blood and all other body fluids, non-intact skin, mucous membranes. It applies to all patients, regardless of
diagnosis or presumed infectious status.
OSHA bloodborne pathogens standard, published in 1991. Places responsibility for providing safe work
environment on the employer, and contains several key elements. - ✔✔Written exposure control Plan - THE
PLAN.
Employee Training.
Provide Free hep B vaccine.
Observe standard precautions.
physically remove hazards.
provide PPE.
Clean/sanitary work environment.
biohazard signs.
disposal of all sharps in rigid containers.
proper transport of contaminated items.
A+ Graded Paper
IAHCSMM CRCST– CRCST Final Exam – JCSPD
Newest Update 2025!! – A+ Graded Submission–
100% Verified Q&A for Success
Questions and Mark scheme
Version: Final
,regulation - ✔✔mandatory law or rule that is issued by a governing body.
standard - ✔✔method of defining basic parameters for processes, products, services, and measurements.
regulatory standard - ✔✔benchmark that is mandated by a governing agency and, if not complied with, may
cause a facility to be in violation a d liable for legal penalty.
voluntary standard - ✔✔benchmark that is strongly recommended.
statute - ✔✔written and enforceable law enacted by a governing body.
FDA - ✔✔Food and Drug administration. Regulates Medical devices, Medical device recalls, device
classification. Etc
Class 1 device - ✔✔low risk devices. Most hand-held surgical instruments, and ultrasonic cleaners. Subject to
general controls which include registration and device listing, device reporting, and quality regulation and
labeling. exempt from PMA and 510k
Class 2 device - ✔✔pose potential risks great enough to warrant higher level of regulation. Sterilization
equipment, packaging materials, biological and chemical indicators. Requires 510k before they can sell these
products, subject to performance standards.
Class 3 device - ✔✔most stringently regulated, pose greatest risk, heart valves, pacemakers, life sustaining
devices. Most obtain a PMA, to demonstrate safety and effectiveness.
510k - ✔✔required for class 1 and class 2 devices, comprehensive package of information designed to
demonstrate that the new product is substantially equivalent to one or more devices already being marketed.
PMA - ✔✔required for most class 3 devices which are new to the market, a PMA is more complicated to
complete because it must prove the device has a reasonable assurance of safety and effectiveness for its
intended use based on valid scientific evidence.
FDA Recall Class 1 - ✔✔High Risk.
Reasonable chance product will cause serious problems or death.
FDA Recall Class 2 - ✔✔Serious Risk.
possibility product will cause a temporary or reversible health problem or remote chance that device will cause
serious health problem.
FDA Recall Class 3 - ✔✔Low Risk.
little chance that using or being exposed to the product will cause health problems.
CDC - ✔✔Centers for Disease Control.
promote the health and quality of life by preventing and controlling disease, injury, and disability, and by
,responding to health emergencies.
DOT - ✔✔Department of Transportation.
EPA - ✔✔Environmental protection agency.
create and enforce laws relating to cleaner water, air, and land. Regulate products such as disinfectants, and
sanitizers.
OSHA - ✔✔Occupational Safety and Health Administration.
protect workers from occupational-caused illnesses and injuries. Exposure to bloodborne Pathogens standard
and guidelines for the use of Ethylene Oxide sterilization.
AAMI - ✔✔Association for the advancement of Medical Instrumentation.
Develop new or revise existing recommended practices and standards that address the use, care and processing
of devices and systems.
ANSI - ✔✔American National standards Institute.
promote and facilitate voluntary consensus standards and ensuring their integrity.
AORN - ✔✔Association of operating room nurses.
Dedicated to providing optimal care to the surgical patient.
APIC - ✔✔Association for professionals in infection control and Epidemiology.
Dedicated to the prevention and control of infections and related outcomes.
Joint Commission - ✔✔Develops standards for health care facilities. on site surveys at least every three years,
loss of accreditation can result in forfeiture of medicare and medicaid payments.
USP-NF - ✔✔United states pharmacopoeia - national formulary.
creates and revises standards for medicines, dosages, forms, drug substances, and dietary supplements. Also set
standards for packaging, labeling, bacteriological purity, pH, and mineral content.
SGNA - ✔✔Society of Gastroenterology Nurses and associates.
collects information and establishes standards and guidelines relating to the processing of flexible endoscopes.
Central Service Umbrella. - ✔✔U-N-S-A-A-A-F-E-J-O.
USP-NF.
NFPA.
State Law.
APIC.
AORN.
AAMI.
FDA.
EPA.
Joint Commission.
OSHA.
, goals of the central service Deparment - ✔✔Eliminate and/or destroy all potentially infectious contaminants
present on reusable instruments and equipment.
safely distribute instruments and equipment.
Establish and enforce standards for decontamination, disinfection and sterilization.
infection - ✔✔invasion of human body tissue by microorganisms which multiply and produce a reaction.
the primary purpose of the central service department is to stop the spread of disease producing microorganisms
in the healthcare facility. - ✔✔each year approximately 2 million patients, about 10% of those hospitalized in
U.S. hospitals develop healthcare facility-associated infection. Resulting in an estimated 90,000 deaths.
fingernails of personnel working in high-risk areas should be maintained at a length of. - ✔✔1/4 inch or less
because they may harbor microorganisms.
Putting on PPE - ✔✔Shoe covers.
Gown.
Mask/respirator.
googles.
face shield.
Gloves.
Removing PPE - ✔✔Shoe covers.
gloves.
face shield.
googles.
gown.
mask/respirator.
PPE - ✔✔specialized clothing or equipment worn by an employee for protection against a hazard.
Standard Precautions - ✔✔appropriate barriers to prevent transmission of infectious organisms from contact
with blood and all other body fluids, non-intact skin, mucous membranes. It applies to all patients, regardless of
diagnosis or presumed infectious status.
OSHA bloodborne pathogens standard, published in 1991. Places responsibility for providing safe work
environment on the employer, and contains several key elements. - ✔✔Written exposure control Plan - THE
PLAN.
Employee Training.
Provide Free hep B vaccine.
Observe standard precautions.
physically remove hazards.
provide PPE.
Clean/sanitary work environment.
biohazard signs.
disposal of all sharps in rigid containers.
proper transport of contaminated items.
