5.1 California's Minimum Standards for Infection Control (16 CCR § 1005)
Key Takeaways
California's 16 CCR § 1005 requires critical and semi-critical dental items to be sterilized after each use, with high-level disinfection only for heat-sensitive items.
Dental handpieces, rotary components, and reusable air-water syringe and ultrasonic tips must be heat-sterilized after each use under 16 CCR § 1005(b)(15).
Biological spore testing of every sterilizer must be done at least weekly, with results kept for 12 months (16 CCR § 1005(b)(17)).
Dental unit lines must be flushed for at least two minutes at the start of each workday and at least 20 seconds between patients (16 CCR § 1005(b)(21)).
Sterile coolants or irrigants delivered through a sterile system are required for surgical procedures involving soft tissue or bone (16 CCR § 1005(b)(18)).
Why § 1005 is central
B&P § 1680(ad) makes it unprofessional conduct to knowingly fail to follow the Board's infection control guidelines, and § 1680(t) covers unsanitary or unsafe office conditions. The guideline is 16 CCR § 1005, which applies to all dental healthcare personnel (DHCP): dentists, hygienists, assistants, lab technicians, students, contractors, and even clerical and housekeeping staff who might be exposed. Every licensee must complete two units of Board-approved infection control CE each renewal cycle (16 CCR § 1017(a)(1)), and a copy of § 1005 must be posted in every office (§ 1005(b)(3)).
Definitions that drive the rules
| Term | Meaning in § 1005(a) | Required processing |
|---|---|---|
| Critical item | Penetrates soft tissue or bone (scalers, surgical burs, forceps, scalpels) | Discard, or pre-clean, package, and sterilize after each use; heat-sensitive items get at least high-level disinfection and are then packaged |
| Semi-critical item | Contacts mucous membranes or non-intact skin but does not penetrate (mirrors, impression trays, handpieces) | Pre-clean, package, and sterilize; high-level disinfection only if heat-sensitive |
| Non-critical item | Contacts intact skin only (blood pressure cuff, light handle) | Clean and disinfect with a Cal/EPA-registered low-level hospital disinfectant labeled effective against HBV and HIV; intermediate-level (tuberculocidal) if visibly contaminated with blood or OPIM |
| Standard precautions | Hand hygiene, gloves, gown, mask, eye protection or face shield, and safe sharps handling for every patient | Used regardless of diagnosis |
Disinfection levels: low-level kills some bacteria, viruses, and fungi but not TB or spores; intermediate-level kills Mycobacterium tuberculosis var. bovis; high-level kills TB and some spores; sterilization kills all viable microorganisms.
Protective equipment and hand hygiene
- Masks with eyewear or chin-length face shields whenever spray, splash, or spatter is possible. Change masks after each patient; clean, disinfect, or discard eyewear and shields after each patient (§ 1005(b)(4)).
- Protective attire for procedures with spatter and for disinfection work. Change it daily, or between patients if it becomes moist or visibly soiled, and remove it before leaving patient-care areas. Scrubs and uniforms are not PPE (§ 1005(a)(11), (b)(5)).
- Hand hygiene: wash with soap and water at the start and end of each day and whenever hands are visibly soiled. Otherwise alcohol-based rub is acceptable. Dry hands before gloving and wash again after removing gloves. Anyone with weeping dermatitis or exudative lesions on the hands stays out of direct patient care until it heals (§ 1005(b)(6)–(7)).
- Gloves: medical exam gloves for contact with mucosa, blood, or OPIM; heavy-duty utility gloves for handling contaminated sharps; never wash gloves (§ 1005(b)(8)).
Sharps
Recap needles only with the one-handed scoop technique or a device. Never bend or break needles to dispose of them. Place sharps in a sharps container as close as possible to the point of use (§ 1005(b)(9)).
Instrument reprocessing and monitoring
- Clean first. Cleaning must precede disinfection or sterilization (§ 1005(b)(11)).
- Sterilize by steam autoclave, chemical vapor, or dry heat.
- Package and label each pack with the date and, if the office has more than one sterilizer, which one was used. Packages stay sealed until use.
- Handpieces and attachments. High-speed and low-speed handpieces, rotary components, and reusable air-water syringe and ultrasonic scaler tips must be heat-sterilized like semi-critical items (§ 1005(b)(15)). Wiping a handpiece with disinfectant is never enough.
- Single-use items such as prophy angles, cups, brushes, evacuator tips, saliva ejectors, disposable air-water tips, and gloves are used for one patient only (§ 1005(b)(16)).
- Spore tests. Verify each sterilizer at least weekly with a biological indicator, and document and keep results for 12 months (§ 1005(b)(17)).
Operatory surfaces, water, and irrigation
- Barrier-protect surfaces that are hard to clean, and change barriers between patients. Clean and disinfect unprotected clinical contact surfaces after each patient (§ 1005(b)(19)–(20)).
- Dental unit waterlines must be anti-retractive. Flush them with water or purge with air for at least two minutes at the start of each workday before attaching devices, and for at least 20 seconds between patients (§ 1005(b)(21)).
- Surgical procedures involving soft tissue or bone require sterile coolant or irrigant delivered through a sterile delivery system (§ 1005(b)(18)). Separately, irrigating exposed dental pulp with water that is not sterile, or that lacks recognized disinfecting or antibacterial properties, is unprofessional conduct (B&P § 1680(ag)).
Laboratory asepsis
Use splash shields on lathes and fresh pumice with a sterilized or new rag wheel for each patient. Clean and disinfect impressions, bite registrations, and prosthetic or orthodontic appliances with an intermediate-level disinfectant before they go to the lab and again before they go back in the mouth, then rinse (§ 1005(b)(23)–(24)).
The written protocol and Cal/OSHA
Section 1005(b)(2) requires a written protocol for instrument processing, operatory cleanliness, and injury management, available to all staff. The Cal/OSHA Bloodborne Pathogens Standard (8 CCR § 5193) adds an employer duty to keep an Exposure Control Plan that is reviewed at least annually, keep a Sharps Injury Log, train exposed employees, and offer hepatitis B vaccination at no cost within 10 working days of initial assignment. Post-exposure evaluation and follow-up must be made available to exposed employees.
An office's autoclave passed its last biological indicator test 12 days ago, and no test has been run since. What does 16 CCR § 1005 require?
Spore tests are required only monthly, so the office is compliant
Chemical indicator strips on each pack replace spore testing
Spore testing is required only after the sterilizer is repaired
Sterilizer function must be verified at least weekly with a biological indicator, so a spore test is overdue
How must a high-speed handpiece be processed between patients under California's infection control regulation?
It must be cleaned, packaged, labeled, and heat-sterilized like a semi-critical item
It may be wiped with an intermediate-level disinfectant if it is covered with a barrier
It may be processed with high-level disinfection because it does not penetrate bone
It may be flushed for 20 seconds and reused
What water must be used as a coolant during the surgical removal of an impacted third molar that requires a flap and bone removal?
Dental unit water that has been flushed for two minutes that morning
Sterile coolant or irrigant delivered through a sterile delivery system
Tap water treated with a waterline cleaner
Distilled water from the office's bottled-water reservoir
Sections you finish are checked off in the contents.