The actual certification examination for sterile processing and distribution technicians is composed of 125 questions plus 25 pre-test questions for a total of 150 multiple-choice questions. You have 3 hours to complete
Domain 1: Roles and Responsibilities – 13% of exam (24 questions)
1.K.1 Potential workplace hazards (e.g., wet floors, Fires, electrical outlets, EtO, fumes, body fluids, microorganisms, sharps, latex allergy, medical waste).
1.K.2 Ergonomic considerations and body mechanics.
1.K.3 Policies and procedures related to sterile processing functions (e.g., Safety, Infection Control, Disaster, incident reports, QA).
1.K.4 Federal, state and local guidelines, standards and regulations (e.g., OSHA, FDA, CDC, EPA). Includes quarantine of implants, SDS, medical and biohazardous waste
1.K.5 Professional standards related to personal hygiene and dress codes.
1.K.6 Function and workflow/traffic flow of the sterile processing department.
1.K.7 Processes for loaner instrumentation.
1.K.8 Compliance with manufacturer’s instructions for use (includes chemicals, instrument cleaning, assembly and sterilization equipment)
1.K.9 Procedures for handling CJD contaminated instruments, supplies and equipment.
1.K.10 Signs and symbols in IFUs and packaging.
Domain 2: Life Science – 9% of exam (14 questions)
2.K.1 Microbiology related to cleaning, disinfecting and sterilizing, including biofilm
2.K.2 Factors in disease transmission and modes of cross transmission (e.g., blood, skin, air). Body’s defenses against infection, handwashing
2.K.3 Types of microorganisms (e.g., bacteria, virus, fungus, prions).
2.K.4 Microbial growth conditions (e.g., temperature, humidity).
2.K.5 Basic anatomy and physiology.
2.K.6 Basic medical terminology
Domain 3: Decontamination and Disinfection – 19% of exam (23 questions)
3.K.1 Types of chemicals and their uses (e.g., detergents, environmental disinfectants, enzymatics, germicides, pH). Knowledge of water quality and its impact on detergents and rinsing.
3.K.2 Safe Use of high-level disinfectants (e.g. Trophon, ortho-phthalaldehyde) and sterilant chemicals (e.g., peracetic acid). (PPE, rinsing, disposal of
chemicals, concentration, expiration date, level of disinfection, temperature, contact time).
3.K.3 Documentation for HLD including items processed, MEC testing, QA testing of test strips, temperature of solution, etc.
3.K.4 Standard Precautions and Personal Protective Equipment used in the Decontamination Area; donning and doffing PPE
3.K.5 Operation, maintenance, and testing of decontamination equipment (e.g., washer/decontaminator, sonic lumen cleaners, cart washers, ultrasonic
cleaners, etc.) Loading and unloading procedures for washers and sonics, positioning of devices; degassing of sonics, checking spray arms in washers, etc.
Water quality testing and documentation of test results.
3.K.6 Methods of sorting, cleaning, disinfecting, and decontaminating instruments, lumens, rigid container systems and equipment.
Use, maintenance and inspection of cleaning implements. Manual cleaning protocols. Processing of instruments used on chemotherapy agents.
3.K.7 Factors affecting decontamination (e.g., procedures, water quality, water impurities, opening and disassembling instruments and devices).
Frequency of changing of enzyme soak and sonic solutions. Dilution of detergents and cleaning agents.
3.K.8 Protection of devices from re-contamination after high level disinfection.
3.K.9 Basic care and handling of instruments and equipment during cleaning. Includes using gloves when instruments only sonic cleaned, TASS precautions.
Domain 4: Preparation and Handling – 16% of exam (25 questions)
4.K.1 Instrument terminology and anatomy (e.g., jaws, shanks, box locks, rings).
4.K.2 Types and functions of instruments (e.g., General, GYN, ENT, endoscopic, power, GU, Neuro, Orthopedics, Dental, Plastic, Cardiovascular,
Thoracic, microsurgical, robotic). Identification of surgical instruments by proper name. How instruments are used (instrument use in specific types of surgery).
4.K.3 Types of instrument construction (e.g., finish, composition).
4.K.4 Basic principles of packaging and set configuration. Includes labeling of sets. Avoiding damage to sets. Labeling of packages, Use of instrument air, use of tip protectors
4.K.5 Use and characteristics of packaging materials in relationship to sterilization methods. Includes paper-plastic pouches, Tyvek pouches, woven
and non-woven wraps, rigid containers, dust covers; inspection of packaging/containers
4.K.6 Inspection and testing procedures for surgical instruments and equipment (including lap instruments). Documentation of insulation testing, frequency of testing.
4.K.7 Tray construction (e.g., size, shape, density, weight) and configuration of instruments on sets.
4.K.8 Methods and products used to monitor sterilization (e.g., integrators, chemical indicators) for trays, packs, and rigid containers.
4.K.9 Care, handling of instruments to include use of instrument lubricant, handling of implants, receipt of new instruments; storage of non-sterile instruments, etc.
4.K.10 Tamper evident seals and package closures (e.g., sterilization tape, its application and use).
Domain 5: Sterilization – 18% of exam (20 questions)
5.K.1 Types of sterilizers and methods of sterilization (e.g., steam, gas plasma, EtO, dry heat, hydrogen peroxide-ozone, vapor phase hydrogen peroxide, etc.)
5.K.2 Sterilization cycles and parameters for each sterilization methodology (e.g., time, temperature, concentration, steam under pressure, humidity).
Sterility assurance levels.
5.K.3 Quality assurance testing of sterilizers; includes Bowie-Dick tests, biological tests, leak tests, etc. Purpose, types, interpretation and
documentation of sterilization printouts, charts, biological indicators, chemical indicators and chemical integrators. Includes temp of incubators,
documentation of biological and chemical indicators/integrators; signing and interpretation of sterilizer printouts, keeping records neat; saving records.
Documentation of load contents and load information (e.g., time, temperature, cycle, etc.).
5.K.4 Operation of sterilizers including loading and unloading criteria and procedures for all types of sterilization methods. Includes cooling of packs
5.K.5 Lot control and record keeping for all methods of sterilization including documentation of load contents, date and lot number, etc. on sterilization
log. Including types of lot control labels for all sterilization methods and time related versus event related labels.
5.K.6 Procedures for wet packs (e.g., causes, resolution).
5.K.7 Cleaning procedures for various sterilization equipment.
5.K.8 Recall procedures for items sterilized within the facility or purchased from an outside manufacturer.
Domain 6: Sterile Storage, Inventory Management and Distribution 11% of exam (11questions)
6.K.1 Factors that affect shelf life (e.g., packaging materials, moisture, damage, excessive handling).
6.K.2 Storage requirements and shelving design (e.g., environmental conditions – humidity, air exchange, placement).
6.K.3 Stock rotation (e.g., FIFO).
6.K.4 Inventory management in sterile storage.
6.K.5 Distribution systems (e.g., case carts, code carts, specialty carts).
6.K.6 Receiving systems (e.g., corrugated boxes, breakout, containers).
6.K.7 Procedures for tracking usage and location of specialty carts.
Domain 7: Patient Care Equipment – 6% of exam (6 questions)
7.K.1 Collection, processing and reassembly of patient care equipment. Tracking usage and location of patient care equipment.
7.K.2 Disinfection, storage and distribution of patient care equipment
7.K.3 Types of patient care equipment and their use.
Domain 8: Ethics 8% of exam ( 2 questions)
8.K.1 Compliance with regulatory standards, best practices, procedures and/or guidelines that impact on patient, employee or environmental safety;
reporting instances of non-compliance.
8.K.2 Professional behavior (e.g., non-compliance with dress code; disruptive behavior; theft; willful damage to equipment/property)
