INFECTION CONTROL

SUMMARY
All dentists must ensure that their clinical and office procedures conform to
infection control regulations adopted by the Board of Dental Examiners. These
regulations call for the use of universal precautions rdating to the care of patients.
All dental office personnel must wear gloves whenever there is the potential for
contact with blood or mucous membranes, and must wear other protective attire,
including surgical face masks and protective eyewear, when treating patients.
Instruments, surfaces, intraoral items, handpieces and other dental unit attach-
ments must all be disinfected and/or sterilized after each patient is treated. Items
and surfaces that cannot be cleaned and disinfected must be covered with an
impervious barrier that can be removed and replaced between patients. Air and
water lines must be purged regularly. Water lines must be equipped with one-way
flow valves. Disposal equipment and instruments may not be reused and must be
disposed of as contaminated waste. Each dental office must follow a written
protocol for meeting these requirements and must post a copy of the regulations
in the dental office where it is accessible by all staff.
Dentists who employ one or more employees must also ensure that procedures in
their offices comply with the Bloodbome Pathogen Standard adopted as regula-
tion by the California Occupational Safety and Health Administration (Cal-
OSHA). Under this standard, an employer must devdop a plan for controlling
occupational exposure to bloodbome pathogens. The plan must account for job
classihcations and tasks that involve occupational exposure to infectious hazards,
specify the schedule and method for implementing the various requirements of
the Bloodbome Pathogen Standard, and the procedure for evaluating the circum-
stances surrounding an exposure incident.
An employer must ensure compliance with the standard by implementing specific
requirements relating to handwashing, the handling of sharps, personal conduct
and behavior, the handling of blood and other potentially infectious materials, the
use of personal protective equipment such as gloves, gowns and face shidds, and
housekeeping practices such the decontamination of work areas and the disposal
of contaminated waste.
An employer must provide for hepatitis B vaccination of any employees with
occupational exposure who want the vaccination and must also document an
employee's refusal of vaccination. In the event of an exposure incident such as an
accidental needle stick, an employer must provide for the employee a medical
evaluation and follow-up treatment by a qualified health care provider. The
standard specifies the information an employer must provide to the health care
provider and the documentation the health care provider must provide for the
employer.
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9.2
An employer must inform employees about occupational hazards through the use
of labels on containers of potentially infectious materials and signs identifying
areas of the office or facility where potentially infectious materials are located, and
through an extensive training program presented to all employees at least annu-
ally.
An employer must maintain medical records on all employees with occupational
exposure to potentially infectious materials, as well as records of all training
presented to employees. These records must remain available for examination and
copying by employees, federal inspectors and others.
KEY TERMS
universal precautions
An approach to infection control that regards all human blood and bodily fluids
as infected with bloodborne pathogens including human immunodeficiency virus
(HIV) and hepatitis B virus (HBV).
occupational exposure
Any skin, eye, mucous membrane or parenteral contact with blood or other
potentially infectious materials that can be reasonably anticipated to result from
the performance of an employee's duties.
bloodborne pathogens
Pathogenic microorganisms that are present in human blood and can cause
disease in humans. These pathogens include, but are not limited to, hepatitis B
virus {HBV) and human immunodeficiency virus {HIV).
DISCUSSION
Infection control standards for dental practices and other health care facilities
serve two basic purposes: to protect patients from cross-contamination by
infectious hazards that may originate within the dental office, and to ensure the
safety of employees in the workplace.
Two sections of state law require dental offices to operate and be equipped in
such a way that minimizes the exposure to infectious disease. The Board of
Dental Examiners's minimum standards for infection control are contained in
Section 1077 of the California Code of Regulations. Cal-OSHA's Bloodbome
Pathogen Standard, part of the state's workplace-safety guidelines, are contained
in Code ofRegulations Section 5193.
The latter is specifically designed to protect employees in dental offices and other
health care settings, while the former applies to every dental office, regardless of
size, and is meant to protect dentists, employees and patients. Neither regulation
is intended to direct the specific treatment of a patient who is infected with a
bloodbome pathogen such as HBV or HIY.
CALIFORNIA DENTIST'S LEGAL HANDBOOK/1.98
A. Minimum standards for infection control
In 1991 the California Legislature passed the Patient Protection Act of 1991,
which called upon health care licensing boards such as the Board of Dental
Examiners to adopt regulations to protect patients from the transmission of
bloodborne pathogens when undergoing dental and medical procedures. The
Board of Dental Examiners' regulations, contained in Section 1077 of the
California Code of Regulations, are largely based on informal guidelines estab-
lished by the U.S. Centers for Disease Control and Prevention. Given the very
broad, general language of the regulations, dentists are left to exercise a significant
degree of professional judgment in determining how they will implement the
requirements of these standards. For this reason, the regulations have generated
considerable controversy among dentists since their adoption.
The Patient Protection Act also required licensing boards to adopt license renewal
requirements to ensure that licensed health care professionals receive training in
infection controls. In 1994, the Board of Dental Examiners revised its continuing
education requirements, contained in Section 1017 of the California Code of
Regulations, to require dentists and registered auxiliaries to receive at least four
hours of continuing education instruction in infection control procedures as a
condition of licensure renewal.
Universal precautions
The term universal precautions describes an approach to infection control in
which all human blood and certain human body fluids are treated as if they are
known to be infectious for hepatitis B virus (HBV), human immunodeficiency
virus (HIV) and certain other bloodbome pathogens. Such precautions relate the
use of protective attire, methods for handling instruments and equipment that
present a route for exposure, and methods for handling potentially infectious
materials and waste that is contaminated by such materials. Section 1077 of the
California Code of Regulations specifies minimum standards for each of these
aspects of universal precautions.
Gloves and handwashing
Medical exam gloves must be worn whenever there is potential for contact with
blood, blood-contaminated saliva or mucous membranes. Sterile gloves must be
worn during surgical procedures involving soft tissue or bone. Gloves may not be
washed before or after use.
All personnel must wash their hands and put on new gloves before treating each
patient. They must also wash their hands after removing and discarding gloves
after treatment of each patient or before leaving the operatory. Antimicrobial soap
must be used to wash hands for surgical procedures.
Any personnel with open {exudative} lesions or weeping dermatitis must refrain
from all direct contact with patients and from handling patient care equipment
until the condition resolves. Since the regulations assume that every dentist or
auxiliary is already wearing gloves when caring for patients, the wearing of gloves
while lesions heal would not be considered a means for complying with this
particular prohibition.
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9.4
Protective attire
All personnel must wear surgical face masks and either chin-length plastic face
shields or surgical masks and protective eyewear when treating patients. A moist
or contaminated mask must be changed after each patient and during treatment,
if necessary. After each patient, face shields and protective eyewear must be
cleaned and disinfected if contaminated.
All personnel must wear reusable or disposable gowns when their clothing is
likely to be contaminated with blood or other bodily fluids. This attire must be
removed when personnel leaves laboratories or other work areas.
Sterile coolants and lrrlgants
Sterile coolants and irrigants must be used in connection with surgical procedures
involving soft tissue or bone, and must be delivered in accordance with the
manufacturer's directions. Coolants or irrigants are deemed to be sterile when
delivered using a device or process that has a U.S. Food and Drug Administration
marketing clearance for delivery of sterile coolants/irrigants to the patient.
It is worth noting that this particular requirement has generated considerable
controversy among dentists in California, particularly periodontists. This require-
ment could be viewed as adding an additional element to the standard of care for
surgical procedures, despite the fact that coolants and irrigants are not regularly
used in every such surgery. Generally speaking, this requirement is interpreted by
the Board of Dental Examiners to mean that any coolants and irrigants that are
used in surgery involving soft tissue or bone must be sterile.
Impervious barriers
Any items or surfaces that are impossible to clean and disinfect {e.g., light
handles) must be covered with an impervious barrier. These coverings must be
removed and replaced with clean coverings between patients. Splash shields must
be used in dental labs as well.
Needles and sharps
Needles must be recapped only by using the scoop technique, a mechanical devise
designed for holding the needle sheath or a mechanical device that eliminates the
need for two-handed capping.
Needles may not be bent or broken prior to disposal. All sharp items and instru-
ments, such as needles, syringes and scalpel blades, must be placed into a punc-
ture-resistant container for disposal.
Sterilization and disinfection
The regulations specify methods for sterilization and disinfection in the dental
office. High-level disinfection kills some, but not necessarily all bacterial spores. It
is sufficient to kill mycobacterium tuberculosis var bovis, a laboratory test
organism used to classify the strength of disinfectant chemicals, and therefore, less
resistant organisms such as HBV and HIY, as well as other bacteria, fungi and
viruses. Intermediate-level disinfection kills mycobacterium tuberculosis var
bovis. Low-level disinfection, the least effective disinfection process, does not kill
bacterial spores or mycobacterium tuberculosis var bovis.
CALIFORNIA DENTIST'S LEGAL HANDBOOK/1.98
INSTRUMENTS
Before use, heat-stable instruments used to penetrate soft tissue or bone {also
called critical instruments} or contact oral tissue (also called semi-critical instru-
ments) must be cleaned and sterilized using steam under pressure {autoclaving),
dry heat or chemical vapor. Sterilants and disinfectants registered with the EPA
must be used for sterilizing critical instruments and for high-levd disinfection of
heat-sensitive semi-critical instruments.
The proper functioning of the sterilization cycle of sterilizing equipment must be
tested at least weekly using a biological indicator, such as a spore test.
Heavy-duty utility gloves must be used to process instruments before sterilization
or high-level disinfection.
SURFACES
Countertops and the surface of dental units must be cleaned with disposable
towels and an intermediate-level disinfectant between patients. Low-level disin-
fectants must be used to clean visibly soiled areas such as floors, walls and other
housekeeping surfaces.
INTRAORAL ITEMS
Intraoral items such as impressions, bite registrations, and prosthetic and orth-
odontic appliances must be cleaned and disinfected with an intermediate-level
disinfectant before manipulation in the laboratory and before placement in the
patient's mouth.
HANDPIECES AND OTHER DENTAL UNIT ATTACHMENTS
High-speed handpieces, low-speed handpiece components used intraorally, and
other dental unit attachments such as reusable air and water syringe tips and
ultrasonic scaler tips must be heat-sterilized between uses.
Air and water lines
One-way flow valves must be installed in dental unit water lines and maintained
properly. At the beginning of each workday, dental unit lines must be purged
with air or flushed with water for at least two minutes prior to attaching
handpieces, scalers and other devices. The dental unit lines must also be flushed
between patients.
Disposal of single-use Items and solid waste
Single-use disposable instruments such as prophy angles, cups and brushes, tips
for high-speed evacuators, saliva ejectors, and air/water syringe tips, must not be
used on more than one patient. After use, they must be discarded appropriately.
Contaminated solid waste must be disposed of according to applicable federal,
state and local laws. {See Chapter 12- Disposal for state medical
waste disposal guidelines.)
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9.8
Written protocol
A dentist must develop a written protocol for proper instrument processing,
operatory cleanliness and management of injuries. The regulations do not state
the specific content of this protocol, although clearly it should reflect the require-
ments of the regulations. Generally speaking, a comprehensive plan for imple-
menting infection controls in the dental office would be sufficiently broad to
satisfy this requirement.
A copy of the regulations contained in Section 1077 must also be conspicuously
posted in an area of the dental office where staff can readily see it.
See Appendix C- Forms: Business and Employment for a copy of the Section
1077 regulations concerning minimum infection control standards.
B. Bloodborne Pathogen Standard
In 1991 the federal Occupational Safety and Health Administration (OSHA)
issued a standard that requires employers to protect employees from occupational
exposure to bloodborne pathogens such as HBV and HIY. States, in turn, were
required to adopt the same standard or one that is stricter. In 1992, Cal-OSHA
adopted the federal Bloodborne Pathogen Standard as Section 5193 of the
California Code of Regulations. The standard is part of the state's worker safety
law sometimes known as SB 198, after the number of the state Senate bill that
created the law. The law requires employers to develop a program to prevent
illness and injury among workers.
The standard applies to instances of potential and actual exposure to blood or
other potentially infectious materials. The standard specifies methods for control-
ling exposure to bloodborne pathogens; complying with the standard that
includes engineering and work practice controls and personal protective equip-
ment; housekeeping practices, including decontamination of equipment and
work surfaces and handling of regulated waste; providing HBV vaccinations and
post-exposure evaluation and follow-up for employees; communicating with
employees about hazards; and record-keeping.
Who is covered
As a worker safety law, the Bloodbome Pathogen Standard specifically applies to
any dental office with one or more employees. An employee is defined as anyone
under the direction or control of an employer, which includes full-time, part-time
and temporary employees. The definition of employees also includes dentists who
are incorporated and therefore employees of the corporation (in which case the
corporation is the employer}. Independent contractors are .not em-
ployees under federal law ... of the
standard. However, if an independent contractor, such as an associate dentist,
creates a hazard to which regular employees were exposed, the practice owner
could be held responsible. Dentists who are not subject to the requirements for
employees in the Bloodbome Pathogen Standard nevertheless have a legal and
ethical duty to refrain from any actions that would endanger the health of others.
CALIFORNIA DENTIST'S LEGAL HANDBOOK/1.98
Exposure control
An employer having one or more employees with an occupational exposure must
establish a written Exposure Control Plan that is designed to eliminate or mini-
mize an employee's exposure. This plan must be consistent with the employer's
Illness and Injury Prevention Plan. The plan must contain the following de-
ments:
The exposure determination, as described below;
The schedule and method of implementation for each of the requirements in
the standard relating to methods of compliance (engineering and work
practice controls and personal protective equipment), HBV vaccination and
post-exposure evaluation and follow-up, communication of hazards to em-
ployees and record-keeping; and
The procedure for evaluating the circumstances surrounding an exposure
incident.
An employer must ensure that a copy of the plan is accessible to employees in
accordance with the requirements of the illness and Injury Prevention Program.
The plan must be reviewed and updated at least once a year and whenever
necessary to reflect new or modified tasks and procedures that affect occupational
exposure, new or revised employee positions with occupational exposure, and the
exposure incidents that occurred since the previous update. The plan must also be
made available for examination and copying by the chief of the National Institute
for Occupational Safety and Health (NIOSH) or his or her designee upon
request.
An employer who has one or more employees with occupational exposure must
prepare an exposure determination that contains of the following:
A list of all job classifications in which all employees have occupational
exposure, for example, an associate dentist or registered dental hygienist.
A list of job classifications in which some employees have occupational
exposure, for example, an office manager who also fUnctions as a dental
assistant. For these employees, the exposure determination must list all tasks
and procedures or groups of closely related tasks and procedures in which
occupational exposure occurs.
The exposure determination must be made without regard to the use of personal
protective equipment. In other words, it must reflect a job or task that has
occupational exposure that might otherwise be eliminated or minimized through
the use of gloves, a gown and a face shield.
Engineering and work practice controls
Engineering and work practice controls are the methods and procedures, such as
those relating to handwashing and the handling of sharps and blood, by which an
employer eliminates or minimizes occupational exposure. An employer must
examine, maintain, and where necessary, replace these methods and procedures to
ensure their effectiveness.
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9.8
Engineering and work practice controls
continued
Where the occupational exposure remains after these methods and procedures are
instituted, the employer must also implement the use of personal protective
equipment, such as gloves, gowns and eye protection. Generally speaking, both
engineering and work practice controls and personal protective equipment are
necessary in most dental practices.
HANDWASHING
An employer must ensure that handwashing facilities, such as a sink, faucet and
soap, are readily accessible to employees. Where this is not feasible, the employer
must provide an appropriate antiseptic hand cleanser and clean cloth or paper
towels, or antiseptic towelettes. When any of these are used, an employee must
wash his or her hands with soap and running water as soon as feasible. Generally
speaking, such alternatives are only acceptable where soap and running water are
not feasible, which is seldom the case in dental offices.
An employer must ensure that all employees wash their hands immediately or as
soon as feasible after removing gloves or other personal protective equipment,
such as masks, gowns or face shields. Employees who have direct contact with
blood or other potentially infectious materials must immediately wash their
hands and any other skin with soap and water, or flush mucous membranes with
water, or as soon as feasible after such contact.
HANDLING OF SHARPS
Contaminated needles and other sharps must not be bent, recapped or removed,
unless the employer can demonstrate that it is required by the specific dental
procedure or that there is no feasible alternative. Any bending, recapping or
needle removal must be accomplished through the use of a mechanical device or a
one-handed technique.
Immediately or as soon as possible after use, contaminated removable sharps must
be placed in appropriate containers until properly reprocessed. The container
must be:
Puncture resistant.
Labeled as required by law (see ''Labels, "page 9.17).
Leakproof on the sides and bottom.
Designed to conform to the housekeeping requirements relating to reusable
sharps {see "Housekeeping, "page 9.11).
PERSONAL CONDUCT AND GROOMING
Because they could provide a means of exposure to an occupational hazard,
eating, drinking, smoking and applying cosmetics or lip balm, and handling
contact lenses are prohibited in work areas where there is a reasonable likelihood
of occupational exposure.
CALIFORNIA DENTIST'S LEGAL HANDBOOK/1.98
PERSONAL CONDUCT AND GROOMING
continued
Additionally, food and drink must be kept physically separate from potentially
infectious materials. Food and drink may not be kept in refrigerators, freezers,
shelves and cabinets, or on countertops or benchtops where blood or other
potentially infectious materials are placed or stored.
HANDLING OF BLOOD AND OTHER POTENTIALLY INFECTIOUS MATERIALS
All procedures involving blood or other potentially infectious materials must be
performed in such a manner as to minimize splashing, spraying, spattering, and
the generation of droplets of these substances. Mouth pi petting or suctioning of
blood or other potentially infectious materials is prohibited.
Specimens of blood or other potentially infectious materials must be placed in a
container which prevents leaks during collection, handling, processing, storage,
transport or shipping. The container for storage, transport or shipping must be
labeled or color-coded {e.g., red) as required by law {see "Labels, page 9.17).
If the exterior of the container becomes contaminated, the entire container can be
placed in a second container that prevents leakage during collection, handling,
processing, storage, transport or shipping and is labeled accordingly. Similarly, if
the specimen could punctUre in the primary container, the primary container can
be placed within a second container that is puncture-resistant and labeled accord-
ingly.
Equipment that becomes contaminated with blood or other potentially infectious
materials must be examined prior to servicing or shipping and must be decon-
taminated as necessary, unless the employer can demonstrate that decontamina-
tion is not feasible.
Personal protective equipment
Where there is an occupational exposure, the employer must provide, at no cost
to the employee, such appropriate personal protective equipment as:
Gloves.
Gowns.
Laboratory coats.
Face shields or marks and eye protection.
Mouthpieces, resuscitation bags, pocket masks or other ventilation devices.
Any other protective equipment that might be necessary given the nature of
the occupational exposure.
Such equipment is considered appropriate only if it does not permit blood or
other potentially infectious materials to pass through to or reach the employee's
work clothes, street clothes, underclothes, skin, eyes, mouth or other mucous
membranes under normal conditions of use and for the period during which the
equipment is used. If any garment is penetrated by blood or potentially infectious
materials, it must be removed immediately or as soon as feasible.
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9.2. 0
Personal protective equipment
continued
The employee must ensure that the employee uses the personal protective
equipment, although the law makes an exception where the employer shows that
the employee temporarily and brieHy declined to use the equipment when, under
rare and extraordinary circumstances, it was the employee's professional judgment
that using the equipment would have prevented the delivery of health care or
public safety services, or would have posed an increased hazard to the safety of the
worker or co-worker. When the employee makes this judgment, the circum-
stances must be investigated and documented in order to determine whether
changes can be instituted to prevent such occurrences in the future. The employer
must encourage employees to report all such instances without fear of reprisal.
The employer must ensure that the personal protective equipment in proper sizes
is readily accessible at the worksite or is issued to employees. The employer must
clean, launder and dispose of the equipment, and repair or replace it as needed to
maintain its effectiveness, at no cost to the employee.
GLOVES
An employee must wear gloves when it can be reasonably anticipated that he or
she may have direct contact with blood, other potentially infectious materials,
mucous membranes and broken skin, or when handling or touching contami-
nated items or surfaces.
Disposable (single use} surgical or examination gloves must be replaced as soon as
practical when contaminated or as soon as feasible if they become tom, punc-
tured or when their ability to function as a barrier is otherwise compromised.
Such gloves may not be be washed or decontaminated for reuse.
Utility gloves may be decontaminated for reuse if the integrity of the glove is not
compromised. However, they must be discarded if they are cracked, peeling, torn,
punctured or when their ability to function as a barrier is otherwise compro-
mised.
The employer must also make hypoallergenic gloves, glove liners, powderless
gloves or other similar alternatives readily accessible to those employees who are
allergic to the gloves normally provided.
MASKS, EYE PROTECTION AND FACE SHIELDS
An employee must wear a mask in combination with eye protection devices, such
as goggles or glasses with solid side shields, or chin-length face shield, whenever
splashes, spray, spatter or droplets of blood or other potentially infectious materi-
als may be generated and that contamination of the employee's eyes, nose or
mouth can be reasonably anticipated. {Masks and face shields must also meet
state safety requirements concerning eye and respiratory protection contained in
California Code of Regulations Sections 3304 and 5144.)
APPROPRIATE CLOTHING
Appropriate clothing such as gowns, aprons, lab coats, clinic jackets or similar
outer garments must be worn in situations where there is the potential for
occupational exposure. The type and characteristics of such clothing must depend
CALIFORNIA DENTIST'S LEGAL HANDBOOK/1.98
APPROPRIATE CLOTHING
continued
on the task and degree of exposure anticipated (such clothing mwt also conform
to the state's safety requirements concerning body protection contained in
California Code of Regulations Section 3383). Surgical caps or hoods and/or
shoe covers or boots must be worn in instances where gross contamination can be
reasonably anticipated, for example, in certain orthognathic surgeries.
Housekeeping
An employer must ensure that the workplace is maintained in a clean and
sanitary condition, using methods and cleaning schedules based on the location
within the facility, type of surface to be cleaned, type of soil present, and tasks or
procedures being performed in the area.
EQUIPMENT AND ENVIRONMENTAL AND WORK SURFACES
Contaminated work surfaces must be decontaminated with an appropriate
disinfectant after completion of procedlires; immediately or as soon as feasible
when surfaces are overtly contaminated or after any spill of blood or other
potentially infectious materials; and at the end of the work shift if the surface
may have become contaminated since the last cleaning. An EPA-registered
tuberculocidal disinfectant is considered appropriate for cleaning blood or other
potentially infectious materials. A solution of 5.25% sodium hypochlorite
(household bleach), diluted between 1: 10 and 1:1 00 with water, is also acceptable
for cleaning contaminated surfaces.
Protective coverings, such as plastic wrap, aluminum foil or imperviowly backed
absorbent paper wed to cover equipment and environmental surfaces must be
removed and replaced as soon as feasible when they become overtly contaminated
or at the end of the work shift if they may have become contaminated during the
shift.
Bins, pails and other receptacles intended for reuse which have a reasonable
likelihood for becoming contaminated with blood or other potentially infectious
materials must be inspected and decontaminated on a regularly scheduled basis
and cleaned and decontaminated immediately or ass soon as feasible upon visible
contamination.
Broken glassware that may be contaminated must not be picked up directly with
the hands. It must be cleaned up using mechanical means, such as a brush and
dust pan, tongs or forceps.
Reusable sharps that are contaminated with blood or other potentially infectious
materials shall not be stored or processed in a manner that requires employees to
reach by hand into the containers where these sharps have been placed.
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9.12
REGULATED WASTE
Regulated waste is defined as all waste that has may be contaminated by blood or
other potentially infectious materials. Regulated waste requires special handling.
Such waste includes:
Liquid or semi-liquid blood or other potentially infections materials.
Contaminated items, such as blood-soaked gauze or paper towels, that would
release blood or other potentially infectious materials in a liquid or semi-liquid
state if compressed.
Items that are caked with dried blood or other potentially infectious materials
and capable or rdeasing these materials during handling.
Contaminated sharps, such as needles, broken pipettes and root canal files.
Pathological and microbiological wastes containing blood or other potentially
infectious materials.
The definition of regulated waste contained in the Bloodborne Pathogen Stan-
dard includes medical waste as defined in the Medical Waste Management Act.
The handling, storage, treatment and disposal of all regulated waste must be in
accordance to the act. (See Chapter 12- Medical Waste Disposal for
more information.)
Contaminated sharps must be discarded immediatdy or as soon as feasible in
containers that are:
Closable.
Puncture resistant.
Leakproof on sides and bottom.
Labded according to standards for communicating with employees about
hazards (see "Communication of Hazards to page 9 .17).
During use, sharps containers must be:
Easily accessible to personnd and located as close as is feasible to the immedi-
ate area where sharps are used or can be reasonable anticipated to be found.
Maintained upright throughout.
Replaced routinely and not be allowed to overBow.
When moved from the area of use, sharps containers must be:
Closed immediately prior to removal or replacement to prevent the contents
from spilling or protruding during handling, storage, transport or shipping.
Placed in a second container if leakage is possible. The second container must
also be closable, constructed to contain all the contents and prevent leakage
during handling, storage, transport or shipping, and labded accordingly.
Reusable sharps containers must not be opened, emptied or cleaned manually or
any other manner that would expose employees to the risk of percutaneous
injury.
CALIFORNIA DENTIST'S LEGAL HANDBOOK/1.98
REGULATED WASTE
continued
Other regulated waste, such as gauze caked with dried blood or soaked with
liquid or semi-liquid blood, or disposable gloves or other protective equipment
that has been contaminated with a potentially infectious material, must be placed
in containers that are:
Closable.
Constructed to contain all contents and prevent leakage of fluids during
handling, storage, transpon or shipping.
Labeled accordingly.
Closed prior to removal to prevent the contents from spilling or protruding
during handling, storage, transpon or shipping.
If the exterior of the container is contaminated, it must be placed in a second
container that also meets the above requirements.
LAUNDRY
While waiting to be washed, contaminated laundry must be handled as little as
possible with a minimum of agitation. It must be bagged or placed in a container
at the location where it was used and may not be sorted or rinsed at that location.
Contaminated laundry must be placed and transponed in bags or containers that
are labeled or color-coded so as to notify employees that it must be handled in
accordance with universal precautions {see "page 9.17).
Whenever contaminated laundry is wet and presents a reasonable likelihood of
soaking through or leaking from the bag or container, it must be placed and
transported in soak-proof or leak-resistant bags or containers.
An employer must ensure that employees who have contact with contaminated
laundry wear protective gloves and other appropriate personal protective equip-
ment.
While the washing of contaminated laundry is the employer's responsibility,
California law does not require an employer to purchase laundry equipment in
order to meet the above requirement. An employer may choose to contact out
laundry services or to use disposal personal protective equipment. Employees are
not allowed to take their protective equipment {e.g., lab coats) home for launder-
ing.
Hepatitis B vaccination and post-exposure evaluation and follow-up
An employer must provide employees who have an occupational exposure to
HBV with a vaccination to prevent infection. In the event of an exposure inci-
dent, such as an accidental needle stick, the employer must also see that the
employee receives an evaluation and follow-up by a qualified health care profes-
sional (physician or nurse practitioner).
.... -.:
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9.14
Hepatitis B vaccination and post-exposure evaluation and follow-up
continued
An employer may act as the evaluating health care professional, if he or she is
qualified to do so, for example, by holding a medical license. Otherwise, the
employer must send the employee to a physician or nurse practitioner. When an
employer is also acting as the evaluating health care professional, he or she must
advises an employee following an exposure incident that the employee has the
right to refuse to consent to the post-exposure evaluation and follow-up from the
employer. If the employee refuses, the employer must immediatdy provide for a
confidential medical evaluation and follow-up by another health care profes-
sional.
HEPATITIS B VACCINATION
An employer must make HBV vaccination available within I 0 working days of
initial assignment {e.g., hiring or assignment to a position that involves occupa-
tional exposure}, after an employee has received training as described below {see
"Communication ofhazards to employees, "page 9.17). The employer need not
provide the vaccination where the employee has previously received the HBV
vaccination series, where antibody testing has revealed that the employee is
immune, or where the vaccine is contraindicated for medical reasons. If the U.S.
Public Health Service recommends routine boosters of the HBV vaccine at some
future date, an employer must also provide it to employees.
An employee has the right to decline hepatitis B vaccination, as well as any post-
exposure evaluation and follow up; California law does not make HBV vaccina-
tion a condition of employment. If an employer who initially declines the vaccine
but later, while still covered by the standard, decides to accept it, the employer
must make the vaccination available. An employer must ensure that an employee
who declines to accept the HBV vaccination offered by the employer signs a
statement that documents the employee's decision.
See Appendix C- Forms: Business and Employmmt for a ready-to-use
statement to be signed by an employee who refuses an HBV vaccination provided
by an employer.
An employer may not require prescreening for HBV antibodies as a prerequisite
for receiving HBV vaccination.
POST-EXPOSURE EVALUATION AND FOLLOW-UP
In the event that an employee is involved in an incident involving exposure to a
potentially infectious material, an employer must immediately make available to
the employee a confidential medical evaluation and follow-up to determine
whether the employee has been exposed to or infected by HBV or HIY. The
evaluation may be provided by the employer, if her or she is a qualified health
care professional (e.g., an oral surgeon who is also a licensed physician). Other-
wise, the employer must refer the employee to a physician or other health care
professional qualified to evaluate and treat the patient's condition.
CALIFORNIA DENTIST'S LEGAL HANDBOOK/1.98
POST-EXPOSURE EVALUATION AND FOLLOW-UP
continued
The evaluation and follow-up must at least include the following six dements:
Documentation of the route(s) of exposure and the circumstances under
which the exposure incident occurred.
Identification and documentation of the source individual (e.g., patient),
unless the employer can establish that identification is infeasible or prohibited
by state or local law. As soon as possible after the source individual's consent
has been obtained, his or her blood must be tested to determine whether
infection with HBV or HN has occurred. If the individual refuses to consent.
The employer must document the reason why consent could not be obtained.
Where the individual's consent is not required by law, his or her blood must
be tested and the results documented. (As a general rule, the source
individual's consent is almost always required prior to testing.) Test results
must be made available to the employee, who must be informed of applicable
laws governing disclosure of the individual's identity and infectious status.
The employee's blood must be collected for testing as soon as feasible after he
or she consents to the blood test. If the employee consents to basdine blood
collection for future testing, but does not give consent at that time for HN
serologic testing at that time, the sample must be preserved for at least 90
days. If, within 90 days following the exposure incident, the employee dects to
have the basdine sample tested, such testing must be done as soon as feasible.
Any additional collection and testing recommended by the U.S. Public Health
Service must also be made available.
The employee must receive post-exposure prophylaxis, when medically
indicated, as recommended by the U.S. Public Health Service. For example,
an employee exposed to HN may qualify to receive a prophylactic dose of
AZT.
Counseling that includes the U.S. Public Health Service recommendations for
prevention and transmission of HN infection. These recommendations
concern re&aining from the donation of blood, semen or organs; abstaining
from sexual intercourse or using measures to prevent HIV transmission during
sexual intercourse; and refraining from breast-feeding infants during the
follow-up period. Counseling must be made available regardless of the
employee's decision to accept or decline serologic testing.
Evaluation of reponed illnesses.
INFORMATION PROVIDED TO THE HEALTH CARE PROFESSIONAL
An employer must ensure that the health care professional responsible for the
employee's HBV vaccination receives a copy of the Bloodborne Pathogen
Standard.
-
......
C A L I F 0 R N I A D E N T I S T ' S L E G A L H A N D B 0 0 K / 1 9 8 9.15
9.16
INFORMATION PROVIDED TO THE HEALTH CARE PROFESSIONAL
continued
An employer must also ensure that the health care professional evaluating an
employee after an exposure incident receives the following information:
A copy of this regulation.
A description of the exposure employee's duties as they relate to the exposure
incident.
Documentation of the route{s) of exposure and circumstances under which
the exposure incident occurred.
Results of the source individual's blood test, if available.
All medical records relevant to the appropriate treatment of the employee
including vaccination status. The employer is responsible for maintaining
these records {see "Record-keeping, "'page 9.19).
The evaluating health care professional must provide the employer with a repon
of his or her evaluation of the employee.
HEALTH CARE PROFESSIONAL'S WRinEN OPINION
An employer must obtain and provide the employee with a copy of the evaluating
health care professionals written opinion within 15 days of its completion. The
opinion for HBV vaccination must be limited to whether HBV vaccination is
indicated for the employee and whether the employee has received it.
The opinion for post-exposure evaluation and follow-up must be limited to the
following information:
That the employee has been informed of the results of the evaluation.
That the employee has been told about any medical conditions resulting from
the exposure incident that require further evaluation or treatment.
All findings and diagnoses must remain confidential and must not be pan of the
written repon.
MEDICAL RECORD-KEEPING
Medical records required for this provision must be kept in accordance to the
record-keeping requirements specified below {see "Record-keeping, "'page 9.19).
DOCUMENTING AN EXPOSURE INCIDENT
The exposure incident itself may also have to be documented, pursuant to federal
requirements that are not reflected in Cal-OSHA's Bloodbome Pathogen Stan-
darcl. Federal OSHA requires employers with 11 or more employees to document
all occupational injuries and illnesses, and specifies the content of such documen-
tation. For employers with ten or fewer employees, which would include most
dental offices, there is no specific requirement to document an exposure incident.
However, since Cal-OSHA's bloodborne pathogen standard requires an employer
to revise his or her exposure control plan based on past exposure incidents,
keeping a log of such incidents can help in determining what kinds of revisions
are indicated. Such documentation should enable an employer to determine
CALIFORNIA DENTIST'S LEGAL HANDBOOK/1.98
DOCUMENTING AN EXPOSURE INCIDENT
continued
repeated exposure incidents share common characteristics that might indicate a
chance in office procedures. At minimum, the employer should document the
employee's name and job tide, the nature of the incident, the circumstances
surrounding the incident, and whether the employee required medical attention
as a result of the incident.
Communication of hazards to employees
An employer must inform employees about occupational exposures through the
use of labels on containers or potentially infectious materials and through
training programs provided during work hours.
LABELS
An employer must affix warning labels to:
Containers of regulated waste.
Refrigerators and freezers containing blood or other potentially infectious
materials.
Other containers used to store, transport ship blood or other potentially
infectious materials.
The following items are exempt from the labeling requirement:
Containers of blood, blood components or blood products that are labded as
to their contents and have been released for transfusion or other clinical use.
Individual containers of blood or other potentially infectious materials when
they are placed in a labeled container during storage, transport, shipping or
disposal. For example, individual containers of blood stored in a properly
labded refrigerator need not be labeled.
Regulated waste that has been decontaminated. (See Chapter 12-Medical
Waste Disposal for more information on decontaminating waste.)
Required labels must include either the word "BIOHAZARD" and the interna-
tional biohazard symbol or, in the case of regulated waste, the words
"BIOHAZARDOUS WASTE." These labels must be at least predominantly
fluorescent orange or orange-red, with lettering and symbols in a contrasting
color. Such labds can generally be purchased from commercial vendors of
medical and dental office supplies.
These labels must be printed directly on the container or affixed as close as
feasible to the container by string, wire, adhesive or other method that prevents
their loss or unintentional removal.
Red bags or red containers may be substituted for labels, except for sharps
containers or regulated waste red bags, which must be labeled. Bags used to
contain regulated waste must be color-coded red and must be labeled as described
above, however, labels on red bags or red containers do not need to be color-
coded.
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C A L I F 0 R N I A D E N T I S T ' S L E G A L H A N D B 0 0 K / 1 . 9 8 9.17
9.18
LABELS
continued
Equipment that becomes contaminated must be labeled in accordance with the
above requirements and must also state which portions of the equipment remain
contaminated. (See "Handling of blood and other potentially infectious materials, "
page 9.9.)
INFORMATION AND TRAINING
An employer must ensure that all employees with occupational exposure partici-
pate in a training program provided during work hours and at no cost to the
employee. The training must take place at the time of the initial assignment to
tasks where occupational exposure may take place and at least annually thereafter.
The content and language of such training must be appropriate to the educa-
tional level, literacy and language of the employees. In some cases, this may
require training in a language other than English.
An employer must provide additional training when an employee's occupational
exposure changes due to the modification of tasks or procedures or the introduc-
tion of new tasks or procedures. The additional training may be limited to
addressing the new exposures created by the change. For example, where a dental
practices introduces a new type of surgical procedure for patients that creates new
occupational exposures, the additional training need only address the new
exposure.
At minimum, the training program must cover the following:
An accessible copy of the regulatory text of this standard and an explanation of
its contents.
A general explanation of the epidemiology and symptoms of bloodborne
diseases.
An explanation of the modes of transmission of bloodbome pathogens.
An explanation of the employer's exposure control plan and the means by
which an employee can obtain a copy.
An explanation of the methods to be used to prevent or reduce exposure,
including engineering controls, work practices and personal protective equip-
ment, as well as the limitations of these methods.
Informacion on the types, proper use, location, removal, handling, decontami-
nation and disposal of personal protective equipment.
An explanation of the basis for selection of personal protective equipment.
Information on the HBV vaccine, including information on its efficacy, safety,
method of administration, the benefits of being vaccinated, and that the
vaccine and vaccination will be offered to employees free of charge.
Information on the appropriate actions to take and persons to contact in an
emergency involving blood or other potentially infectious materials.
An explanation of the procedure to follow if an exposure incident occurs,
including the method of reporting the incident and the medical follow-up that
will be made available.
CALIFORNIA DENTIST'S LEGAL HANDBOOK/1.98
INFORMATION AND TRAINING
continued
Information on the post-exposure evaluation and follow-up that the employer
is required to provide for employees following an exposure incident.
An explanation of required signs and labds and/or color-coding as described
above.
An opportunity for employees to ask and discuss questions and answers with
the person conducting the training session.
An employer is not required to lead the training directly but may hire an instruc-
tor who is knowledgeable in the subject. Dentists should contact their local
dental societies for more information on qualified trainers.
Record-keeping
The bloodbome pathogen standard specifies records that must be maintained by
the employer, including medical records and training records, and specifies how
these records must be rdeased and handled.
MEDICAL RECORDS
The employer must establish and maintain an accurate record for each employee
with occupational exposure. The record must include:
Employee's name and Social Security number.
Copy of the employee's HBV vaccination status, including the dates of all such
vaccinations and any medical records rdating to the employee's ability to
receive vaccination as required by the HBV vaccination and post-exposure
evaluation and follow-up procedure.
Copy of all results of examinations, medical testing and follow-up procedures.
Employer's copy of the health care professional's written opinion.
Copy of the information provided to the health care professional.
The employee must keep these records confidential. He or she may not disclose
or report these records to any person within or outside the workplace except as
required by this section without the employee's express written consent
The employer must maintain these records for at least the duration of the
employee's employment plus 30 years.
TRAINING RECORDS
The employer must maintain training records that include the following informa-
tion:
Dates of training sessions.
Contents or a summary of the training sessions.
Names and qualifications of persons conducting the training.
Name and job titles of all persons attending the training sessions.
These records must be maintained for three years from the date on which the
training occurred.
C A L I F 0 R N I A 0 E N T I S T ' S L E G A L H A N D B 0 0 K / 1 9 8 9.19
9.2 0
AVAILABILITY
An employer must ensure that all required records are made available upon
request to the chief ofNIOSH for examination and copying. Employee training
records must be provided upon request for examination and copying to employ-
ees, to employee representatives, to the chief ofNIOSH and to NIOSH staff.
Employee medical records must be provided upon request for examination and
copying to the employee, to anyone having the employee's written consent to
receive the records, to the chief ofNIOSH and to NIOSH in accordance with
the requirements of the Illness and Injury Prevention Program contained in
California Code of Regulations Section 3204.
TRANSFER OF RECORDS
An employer must comply with the requirements for the transfer of records as set
forth in Section 3204. If the employer ceases to do business and there is no
successor employer to receive and retain the records for the prescribed period, the
employer must notify NIOSH at least three months prior to their disposal and
transmit them to NIOSH, if so required by NIOSH, within that three-month
period.
C. Implementing infections controls
Between the regulations adopted by the Board of Dental Examiners and Cal-
OSHA respectively, dentists must comply with a variety of detailed, slightly
differing and seemingly redundant requirements relating to infection control. For
example, both the board and Cal-OSHA call for dentists to maintain detailed
plans for implementation of and adherence to the requirements specified in their
respective regulations. However, California law does not specify a single, consis-
tent approach to infection control that makes compliance a relatively straightfor-
ward task.
It is important to note that these regulations represent minimum standards of
practice; indeed, infection control is a constantly evolving area of study, sup-
potted by a thriving marketplace of state-of-the-an technologies and resources.
Rather than attempting to satisfy the minimum requirements of each state law,
dentists are strongly encouraged to view infection controls &om a broad, compre-
hensive perspective. Approaching infection controls in a comprehensive manner
ensures compliance with the minimum requirements of state law.
PRACTICAL TIPS
Make it a priority to stay informed about the most current thinking on
infection control, through both professional literature and continuing educa-
tion. Consider panicipating in the efforts of organizations such as the Office
and Safety Asepsis Procedures (OSAP) Research Foundation, which suppon
the ongoing study of infection control issues and methods.
The next time the dental unit is serviced, specifically ask the repair technician
to inspect the anti-retraction valves and to indicate this inspection on the
invoice. This provides documentation that you have this particular item
checked and serviced regularly.
CALIFORNIA DENTIST'S LEGAL HANDBOOK/1.98
Test your sterilizer at least weekly to ensure that it is operating properly.
However, testing more frequendy may be necessary if the unit malfunctions or
has been repaired, or if new employees are being trained to use it. For ex-
ample, when the sterilizer is returned from being repaired, test it to be sure it
is actually working. Similarly, testing the unit can indicate whether new staff
are overloading it or taking shoncuts.
When interviewing a prospective employee whose duties may involve exposure
to infectious hazards, make this fact clear in the interview and explain specifi-
cally the types of hazards and the measures you'll take to protect the employee.
This will help ensure that prospective staff members understand the fact that
their duties would involve some degree of risk, thus avoiding the disruptions
that could occur later if an employee refused to perform a task or procedure
that involved an occupational exposure.
When soliciting the services of an infection control consultant, carefully
review his or her credentials. Look for a solid background in the subject,
including specific courses of study and membership in professional organiza-
tions such as OSA.P. Ask to see work samples, if possible, and carefully check
all references.
Be prepared to answer questions from patients who may be concerned about
infectious hazards or infection control procedures in the office. At the same
time, recognize that explicitly promoting your infection control practices as a
marketing strategy directed to all patients may prompt patients without such
concerns to question your past practices {e.g., whether you previously did not
practice infection controls) or those of colleagues who do not promote their
infection control practices.
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CALIFORNIA DENTIST'S LEGAL HANDBOOK/1.98 9.21