CSA Practice Exam
unless otherwise specified by the manufacturer, what is the max percentage of the inner surface area of the porous side of the sterilization pouch that can be filled?
0.75%
Which statement does NOT describe the materials or systems used for packaging of medical devices for chemical sterilization? 1. Prevent the aseptic removal of the sterilized medical devices 2. Be a barrier to microorganisms, dust and vermin 3. Be strong enough to withstand normal handling 4. Allow for adequate sterilant penetration, exposure and removal
1. Prevent the aseptic removal of the sterilized medical devices
Which statement is correct involving the manual steps for cleaning ultrasound transducer probes? 1. While the probe is immersed, wipe the entire surface with a soft lint free cloth to remove blood, body fluids, and any reside debris 2. Immerse the ultrasound probe in a utility sink filled with sufficient water to partially immerse the operative end of the probe 3. Ensure that the detergent is not diluted for the volume of water contained in the sink in accordance with the detergents manufacturer's instructions for use 4. While the probe is partially immersed, wipe the entire surface with a soft lint free cloth to removed blood, body fluids, and any residue debris
1. While the probe is immersed, wipe the entire surface with a soft lint free cloth to remove blood, body fluids, and any reside debris
If shipping pallets are used for storage of unopened containers, what may the clearance from the floor be reduced to?
10 cm (4 in)
What are the time and temperature range for Peracetic Acid (PAA) (0.2%) to achieve HLD?
12 mins at 5- = 56 degrees C
When loading a sterilizer chamber, how much space shall there be between packages away from the contact point
2 cm ( 1 inch)
According to CSA standards, which is not a requirement to placing packages in the sterilizer chamber? 1. Between packages, there shall be adequate space, a minimum of 2-3 cm 2. Between packages, there shall be adequate space, a minimum of 1-2 cm 3. Packages, shall not be compressed
2. Between packages, there shall be adequate space, a minimum of 1-2 cm
Which statement, in relation to safety and security provisions within the MDRD is incorrect? 1. Restrict access to the MDRD within the health care setting 2. Enable indirect observation of all persons entering the MDRD 3. Provide access control systems 4. Provide alarm systems and/or staff emergency assistance alarms for staff security
2. Enable indirect observation of all persons entering the MDRD
If relative humidity exceeds 70% in a sterile storage area, which action is NOT appropriate? 1. Notify the facility's management department to undertake remedial action 2. No action required unless relative humidity exceeds 75% 3. Visual inspection of packages for damage and/or wetness 4. Convening a meeting with stakeholders to determine the transfer of packages to an alternate site.
2. No action required unless humidity exceeds 75%
Medical device reprocessing areas shall be designed with the intent to reduce the potential for adverse health effects by providing all the following expect what? 1. Storing, donning, and removing protective apparel 2. Non automated loading and unloading equipment whenever possible 3. Chemical or Biological monitoring equipment when required 4. Space for improvement of carts between work areas
2. Non automated loading and unloading equipment whenever possible
Parameters of each sterilization cycle shall be recorded in printed or electronic form. Which action shall not be part of this record? 1. identify the sterilizer whose data is recorded 2. Record manager/supervisor initals 3. Record the cycle parameters of exposure time, temp, pressure 4. identify the load number in that sterilizer
2. Record Manger/supervisor initals
What criteria is not part of manufacturer's time instructions that shall be included in endoscope procedures? 1. Contact time in cleaning solution 2. standing time in an AER prior to cycle completion 3. Standing time in an AER after cycle cycle completion 4. Waiting time between cleaning, rinsing and disinfection steps
2. Standing time in an AER prior to cycle completion
What does the acronym ABHR stand for?
Alcohol-based hand rub
In preparation of instrument sets to be sterilized, what statement is important for MDRD personnel to know?
All instruments shall be open, unlocked and/or diassembled to allow sterilant contact with all surfaces
What conditions and procedures are used to exclude the introduction of microbial contamination
Aseptic
To ensure that the entire floor surfaces can be cleaned in storage areas, what is the frequency that cartons, carts, and pallets should be moved?
At least annually
In addition to testing products and loads, performance qualifications of both products and loads shall be performed how often?
At least every 5 years
Unless otherwise specified by the HLD manufacturer, how many separate rinse(s) shall be included for manual rinsing of flexible endoscopes?
At least three times
What does AER stand for?
Automated Endoscope Reprocessing
What does the washer-disinfector combine to effectively remove potentially infectious micro-organisms
Automated and chemical cleaning and rinsing phases
when manually disinfecting all parts of the medical devices shall
Be in complete contact with the solution
What is important to consider regarding the transportation of contaminated medical devices?
Clean medical devices and soiled medical devices shall not be transported together
What is the term for an area within a facility where access is limited to those whose work responsibilities require them to enter the area and where environmental conditions are maintain within a range of specified values
Controlled area
What is a Medical Device Reprocessing Department required to do to eliminate the cause of non-conformity to prevent recurrence?
Corrective action
Which statement is correct in relation to decontaminated medical devices?
Decontaminated medical devices shall be visually examined for cleanliness prior to terminal sterilization, disinfection or subsequent use
What process is described as cleaning to remove, inactivate, or destroy, that is followed by the inactivation of pathogenic micro-organisms?
Decontamination
All manufacturer's instructions and related information shall be device-specific and reference what information
Device name and model number
According to the Spaulding's classification, what is the definition of a semi-critical equipment/device
Equipment/device that comes in contact with non-intact skin or mucous membranes bu does not penetrate them
Which criteria is NOT applicable if an implantable device must be released before the biological indicator test results are available?
Evaluation of a chemical indicator in the Bi PCD
Why is it important to use low-sudsing detergents or enzymatic detergents when cleaning flexible endoscopes?
Flexible endoscopes can be clearly seen during the cleaning process
What is the required cleaning sequence for surfaces and equipment within the medical device reprocessing department
From higher to lower and from least contaminated to most contaminated
What is the term for a process capable of killing vegetative bacteria, mycobacteria including mycobacterium tuberculosis, fungi, and lipid and non-lipid viruses, as well as some, but not necessarily high numbers of bacterial spores?
HLD
What term defines the personnel performing work that affects product quality and who shall be competent on the basis of appropriate education, training, skills and experience?
HR
When using lubricants on medical devices, the device manufacturer's instructions shall be followed with regard to all of the following except for what?
Lubricants shall be of silicon-based due to its compatibility with medical devices
Gloves, gowns, and other PPE help to break what link in the chain of infection?
Means of entry
Who is responsible to take corrective action to eliminate the cause of non-conformities to prevent recurrences?
Medical Device Reprocessing Department
Ozone can be used to sterilize cleaned, rinsed and dried reusable medical devices sensitive to which parameters?
Moisture and heat
What is one of several contributing factors that determine when micro-organisms can become harmful
Pathogenicity
What term is defined as the vessel in which the sterilization process occurs, and is surrounded by a steel case
chamber
What term defines a synthetic cleansing agent that can emulsify and suspend soil
detergent
Where should chemical indicators be placed in relation to double pouched items?
geometric centre of the inner pouch, and between plastic of the inner and outer pouches
Why is it important not to write on the paper side of the sterilization pouch?
ink penetration or puncturing of the pouch
Health care facilities shall have documented procedures, including WHMIS requirements, for the management of a hazardous substance spill. Where should these procedures be stored?
outside potential spill areas
What personnel group should be assessed by the health care setting's occupational and health personnel prior to working with cleaning agents, chemical disinfectants, or chemical sterilants?
personnel who have chronic respiratory conditions
According to CSA standards, for what type of items may paper-plastic sterilization pouches be used?
small, light-weight, low profile items
Which statement is correct in relation to the handling of soiled linen by MDRD personnel?
soiled linen shall be contained at the point of use until it is received in the laundry
Why should cleaning methods of semi-critical devices be consistent with the medical device manufacturer's instructions and be appropriate for the type of medical device and amount of soil to be removed?
to ensure that any inorganic and organic matter is removed since they can inhibit the disinfection and sterilization process
Health care settings performing any reprocessing function(s) shall implement a Quality Management System that includes what?
Policies and procedures reviewed at specific intervals
What is the definition of bioburden?
Population of visible micro-organisms on or in the product and/ or sterile barrier system
The steps taken to remove the causes of potential non conformities or situations what are undesirable are referred to as what?
Preventive actions
Before removing sterilized items from the sterilizer cart or rack, MDRD personnel shall inspect the packs for integrity and evidence of contaminants. If a package does not meet the inspection criteria, how shall contents be handled?
Repackaged and Re sterilized
What should be done when a new high level disinfectant is sourced for the MDRD?
Review the MSDS in the WHMIS binder
What action shall processing personnel take before preparation and sterilization of multi part sets or complex medical devices
Review the validation manufacturers written instructions
According to CSA standards, which action does not protect storage conditions for processed items from contamination?
Rotating stock via first in, last out (FILO)
What do the CSA standards state about a specific agent used fro the pre-cleaning of instruments ?
Saline shall not be used as an agent for pre-cleaning
How shall reusable medical devices that are sharp or that incorporate sharp components be handled?
Shall be segregated to prevent injury to personnel
What is a key device in protecting health care works from injuries when handling and transporting waste sharps?
Sharp disposal containers
To remove any residual disinfectant, waterproof devices should be rinsed with copious amounts of what?
Sterile water
What action shall be performed for medical devices used in tests sets
Sterilized before reuse
What is necessary to include if a washer-disinfector provides an integral forced-heated-air drying phase?
The drying air shall be HEPA-filtered
If the device manufacturer's recommended cycle differs from a standard steam sterilization cycle, what should the health care setting do?
The health care setting shall consult with the sterilizer manufacturer to ensure that the equipment can effectively deliver that cycle
What is important for MDRD personnel to identify in relation to the reprocessing areas for endoscopes?
The reprocessing area shall be physically separated from client services areas, patient treatment room and clean storage area
According to CSA standards in relation to the preparation of medical devices in sterilization trays or container systems, care shall be used to ensure what with respect to heavier medical devices?
They do not damage medical devices
According to CSA standards, which feature is NOT part of the endoscope reprocessing area?
Three-way workflow patterns
What is the classification of the sterile storage areas associated with the operating room and medical device reprocessing areas including third party/off site reprocessors?
Tier 1
What is the MDR Technician's responsibility to comply with legislated OH&S regulations?
Use personal protective equipment and clothing as directed by the employer
A documented procedure for obtaining, recording, and interpreting the results required to establish that a process will consistently yield product complying with predetermined specifications is called?
Validation
To minimize damage to sensitive medical devices, what should be considered for vehicles used for transport clean and sterile single use or reprocessed medical devices or supplies?
Vehicle pneumatic suspensions
What equipment provides an automated cleaning process followed by a hot-water thermal pasteurization process and is typically used for anaesthetic and respiratory devices?
Washer-pasteurizer
Within the MDRD work areas, floors shall be constructed of materials able to withstand what?
Wet mopping and the application of cleaning agents
When should single use devices or components be considered?
When they are difficult to reprocess effectively
Single-use and reusable wrappers shall be securely applied. What is important for MDRD personnel to identify in relation to wrappers?
Wrappers shall not be pulled to an extent that package contents are compressed
According to CSA standards, what is not included in a typical PCD for IUSS
a tamper evident device
How often shall device storage locations be cleaned and disinfected
at least weekly
According to CSA standards, which statement is incorrect in relation to water and enzymatic detergent used in the cleaning of flexible endoscopes? 1. Tap water may be used for cleaning of endoscopes 2. When using an enzymatic detergent, care should be taken to ensure that the scope has been properly wiped down with a lint free brush 3.Low sudsing detergents or enzymatic detergents should be used so that the flexible endoscope can be clearly seen during the cleaning process 4. When an enzymatic detergent is used, care should be taken to ensure complete rinsing
2. When using an enzymatic detergent, care should be taken to ensure that the scope has been properly wiped down with a lint free brush
If open shelving units are used for storage of clean and sterile single use or reprocessed medical devices, how high off the follow should the shelves be?
25cm (10 in)
According to CSA standards, which statement is accurate about personal protective equipment? 1.Hands shall be washed before donning gloves 2. Hands shall only have clear nail polish before donning gloves 3. Hands shall be washed following the removal of gloves 4. There is no need to wash hands since gloves provide absolute protection
3. Hands shall be washed following the removal of gloves
What is the range of relative humidity for reprocessed products to be maintained in Tiers 1 and 2 storage area?
30 and 60%
What is the maximum length of time that a fully cleaned and rinsed flexible endoscope should sit prior to proceeding to the HLD stage?
30 minutes
Approximately how many mL of bacteria-free water shall be flushed through a lumen after a colonoscope has been manually HLD?
300
According to CSA standards, which statement is correct in relation to automated cleaning? 1. Automated cleaning is achieved using an ultra sonic cleaner 2. Automated cleaning is achieved using a washer-pasteurizer 3. Automated cleaning is achieved using friction with wire brushes 4. Automated cleaning is achieved using a washer disinfector
4. Automated cleaning is achieved using a washer disinfector
If packages are to be sealed with banding, which statement does NOT apply to the bands? 1. Be of a type that is easy to unfasten without tearing 2. Not be reused 3. Not constrict the middle of the package to create an hourglass effect 4. Be of a type that is not easy to unfasten without tearing
4. Be of a type that is not easy to unfasten without tearing
Which statement is applicable if an endoscope will be used immediately for a patient procedure? 1. It is necessary to flush channels with alcohol for drying 2. It is necessary to flush the biopsy ports with enzymatic detergent to remove any bioburden 3. It is not necessary to document the serial number after drying due tot he urgency of patient demand 4. It is not necessary to flush the channels with alcohol for drying
4. It is not necessary to flush the channels with alcohol for drying
Following pasteurization, which action shall NOT be performed by MDR personnel removing medical devices from the washer-pasteurizer? 1. MDR personnel should surface disinfect the exterior of the washer-pasteurizer 2. MDR personnel should remove soiled PPE 3. MDR personnel should perform hand hygiene 4. MDR personnel should surface disinfect the interior of the washer- pasteurizer
4. MDR personnel should surface disinfect the interior fo the washer pasteurizer
According to CSA standards, which statement is not a protective measure to break chain of infection? 1. Receiving appropriate vaccinations 2. Preforming hand hygiene 3. Assuming that all devices received in the decontamination area are contaminated and potentially infectious 4. Performing manual cleaning of devices above the surface of the cleaning solution
4. Performing manual cleaning of devices above the surface of the cleaning solution
Which statement applies to off-site vehicles used for the transportation of single use and reusable medical devices or supplies? 1. Shall be large enough to house clean and soiled medical devices or supplies 2. Shall be approved by the health care facility 3. Shall be inspected daily for cleanliness and maintenance 4. Shall no compromise the condition of the sterile medical device or supplies
4. Shall no compromise the condition of the sterile medical device or supplies
According to CSA standards, which PPE attire is not acceptable within the MDRD? 1. Bouffant hair covering 2. Cover gown 3. Mask 4. Surgical gown
4. Surgical gown
If open shelving units are used for storage of clean and sterile single use or reprocessed medical devices, how far from the ceiling should the shelves be?
45 cm (18in)
Potable water is suitable for use in precleaning and rinsing a device immediately after patient use to remove gross soil. To prevent coagulation of blood and other proteins, the water used for this purpose should not exceed what temperature?
45 degrees C or 113 degrees F
If open shelving units are used for storage of clean and sterile single use or reprocessed medical devices, how far from an outside wall should the shelves be?
5 cm (2 in)
When medical devices are exposed to a thermal disinfection phase, What A-O value in a washer-disinfector process typically achieves thermal disinfecting conditions?
600 or equivalent
After how many days in storage do flexible endoscopes with limens have to be fully reprocessed prior to use?
7 days
In relation to flexible scope cleaning, which feature is NOT offered by AERs?
A drying cycle for flexible endoscope biopsy ports
What is the term for a mass that readily absorbs heat
Heat sink
According to CSA standards, devices that might be adversely affected by a vacuum shall not be sterilized by what type of system that employs a deep vacuum?
Hydrogen peroxide
For which of the following steps shall procedures be established?
Identification, documentation, review and approval
Test set shall be retrieved after sterilization. Which statement does not apply in the event of biological or chemical indictor test failures?
If failed indicator tests occurred in a sert, the set many have divided and placed into one large packaged and retested
What is important for MDRD personnel to remember when wrapping instruments sets?
Instrument sets shall be prepared so that the mass is evenly distributed in a single layer within the container unless the container is designed to have more than one year
What is the term that applies to the collection of information regarding service volumes and patterns of medical devices used and reviewing of standard operating procedures?
Key Performance indicators
What is the term for a measurement used to evaluate an organization's success or the success of a particular activity in which it is engaged?
Key performance indicators
