PERMANENT RULES
LABOR AND INDUSTRIES
Effective Date of Rule: January 1, 2014, for all sections except for WAC 296-62-50050 is July 1, 2014, and WAC 296-62-50025(2) is January 1, 2015.
Purpose: The 2011 legislature passed ESSB 5594 which requires the department to adopt rules implementing the 2004 National Institute for Occupational Safety and Health (NIOSH) alert on safe handling of hazardous drugs. The legislation requires the rules be consistent with the recommendations set forth in NIOSH's alert and states that the rules may not exceed these recommendations. The department may incorporate Centers for Disease Control and Prevention (CDC) updates and changes to the alert.
NEW SECTIONS:
WAC 296-62-500 Hazardous drugs.
| There are no requirements in this section. |
| Statement that hazardous drugs are also covered under WAC 296-800-170 and the most protective requirement will take precedent. |
| Requirements relating to occupational exposure are located in this section. These requirements are state-initiated and derived from the 2004 NIOSH alert on safe handling of hazardous drugs. |
| There are no requirements in this section. |
| Requirements relating to hazardous drugs control program are located in this section. These requirements are state-initiated and derived from the 2004 NIOSH alert on safe handling of hazardous drugs. |
| Requirements relating to hazard assessment are located in this section. These requirements are state-initiated and derived from the 2004 NIOSH alert on safe handling of hazardous drugs. |
| Requirements relating to engineering controls are located in this section. These requirements are state-initiated and derived from the 2004 NIOSH alert on safe handling of hazardous drugs. |
| Requirements relating to PPE are located in this section. These requirements are state-initiated and derived from the 2004 NIOSH alert on safe handling of hazardous drugs. |
| Requirements relating to safe handling practices are located in this section. These requirements are state-initiated and derived from the 2004 NIOSH alert on safe handling of hazardous drugs. |
| Requirements relating to cleaning and housekeeping procedures are located in this section. These requirements are state-initiated and derived from the 2004 NIOSH alert on safe handling of hazardous drugs. |
| Requirements relating to spill control are located in this section. These requirements are state-initiated and derived from the 2004 NIOSH alert on safe handling of hazardous drugs. |
| Requirements relating to training are located in this section. These requirements are state-initiated and derived from the 2004 NIOSH alert on safe handling of hazardous drugs. |
| Requirements relating to the effective dates of various subsections of the rule are located in this section. These requirements are state-initiated and derived from the 2004 NIOSH alert on safe handling of hazardous drugs. |
Statutory Authority for Adoption: RCW 49.17.010, 49.17.040, 49.17.050, 49.17.060, and chapter 39, Laws of 2011.
Other Authority: Chapter 39, Laws of 2011.
Adopted under notice filed as WSR 11-21-080 on October 18, 2011.
Changes Other than Editing from Proposed to Adopted Version:
CR-102 DOSH Rule Language | CR-103 DOSH Rule Language |
WAC 296-62-500 Hazardous drugs. | WAC 296-62-500 Hazardous drugs. |
This rule provides minimum requirements for developing a hazardous drugs control program; enabling employers to provide effective, assessment-based precautions designed to minimize or eliminate occupational exposure. | This |
Important: Hazardous drugs are covered under WAC 296-800-170, Employer chemical hazard communication -- Introduction. In addition the employer must follow the requirements in WAC 296-800-160 and chapter 296-842 WAC as related to the provision of personal protective equipment and respiratory protection. Whenever there is a conflict between rule requirements the most protective requirement will take precedent. | Important: |
WAC 296-62-50005 Scope. | WAC 296-62-50005 Scope. |
(1) This chapter applies to all health care settings that have employees with occupational exposure to hazardous drugs. | (1) This chapter applies to
all employers in health care
|
(2) Chapter application. | |
(2)(a) The requirements in this rule only apply to the hazardous drugs being used in the workplace. | |
(2)(b) If hazardous drugs are being used in the workplace the requirements in this rule only apply if there is reasonably anticipated exposure as defined in WAC 296-62-50010. | |
(2)(c) If there is reasonably anticipated occupational exposure to one or more hazardous drugs the employer must develop a hazardous drugs control program as required in WAC 296-62-50015. | |
(2)(d) For purposes of making the determinations in this section about scope and application, occupational exposure is that exposure which would be reasonably anticipated in the absence of engineering controls or PPE. | |
(2) The following lists jobs
that may involve
occupational exposure to
hazardous drugs. This is
not an exhaustive list and
there may be other jobs
that fall within the scope of
this chapter:
Nurses (ARNPs, RNs, LPNs, nurses aids); Patient care assistive personnel (nurses aides or technicians); Operating room personnel; Employees in research laboratories; Home health care workers; Veterinarians and veterinary technicians; Pharmacists and pharmacy technicians; Environmental services employees (e.g., housekeeping, laundry, and waste disposal) in health care settings; Employees who ship, or receive hazardous drugs from the manufacturer or distributor. |
Physicians and
physician assistants Nurses (ARNPs,
RNs, LPNs Patient care
assistive personnel (e.g.
health care assistants,
nursing assistants Operating room
personnel Home health care
workers Veterinarians and
veterinary technicians Environmental
services employees (e.g.,
housekeeping, laundry,
and waste disposal) in
health care Employees in health care facilities who ship, or receive hazardous drugs from the manufacturer or distributor. |
Exemption: This chapter does not apply to the drug manufacturing sector. | |
WAC 296-62-50010 Definitions. | WAC 296-62-50010 Definitions. |
Biological safety cabinet means a ventilated cabinet for compounding pharmaceutical ingredients, personnel, product, and environmental protection having an open front with inward airflow for personnel protection, downward high-efficiency air (HEPA)-filtered laminar airflow for product protection, and HEPA-filtered exhausted air for environmental protection. For a complete description of the different types of biologic safety cabinets see the Centers for Disease Control and Prevention (CDC)/National Institutes of Health (NIH) document Primary Containment for Biohazards: Selection, Installation and Use of Biological Safety Cabinets. | Biological safety cabinet means a ventilated cabinet for compounding pharmaceutical ingredients, personnel, product, and environmental protection having an open front with inward airflow for personnel protection, downward high-efficiency air (HEPA)-filtered laminar airflow for product protection, and HEPA-filtered exhausted air for environmental protection. For a complete description of the different types of biologic safety cabinets see the Centers for Disease Control and Prevention (CDC)/National Institutes of Health (NIH) document Primary Containment for Biohazards: Selection, Installation and Use of Biological Safety Cabinets. |
Chemotherapy glove means a medical glove that has been approved by the Food and Drug Administration (FDA) and that meets the permeability standards of the American Society for Testing Materials (ASTM) Standard D6978 - 05. | Chemotherapy glove means a medical glove that has been approved by the Food and Drug Administration (FDA) and that meets the permeability standards of the American Society for Testing Materials (ASTM) Standard D6978 - 05. |
Closed system drug-transfer device means a drug-transfer device that mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drug or vapor concentrations outside of the system. | Closed system drug-transfer device means a drug-transfer device that mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drug or vapor concentrations outside of the system. |
Compounding aseptic containment isolator means a compounding aseptic isolator designed to provide worker protection from exposure to undesirable levels of airborne drug throughout the compounding and material transfer processes and to provide an aseptic environment for compounding sterile preparations. Air exchange with the surrounding environment should not occur unless the air is first passed through a microbial retentive filter (HEPA at a minimum) system capable of containing airborne concentrations of the physical size and state of the drug being compounded. Where volatile hazardous drugs are prepared, the exhaust air from the isolator should be appropriately removed by properly designed building ventilation. | |
Compounding aseptic isolator means a form of isolator specifically designed for compounding pharmaceutical ingredients or preparations. It is designed to maintain an aseptic compounding environment within the isolator throughout the compounding and material transfer processes. Air exchange into the isolator from the surrounding environment should not occur unless the air has first passed through a microbial retentive filter (HEPA minimum). | |
Contaminated means materials or surfaces that have been in direct contact with a hazardous drug. Urine, fecal matter, vomit, blood, or bodily fluids from patients receiving certain hazardous drugs are considered contaminated for a minimum of forty-eight hours after administration. Containers that have held contaminated urine, fecal matter, vomit, blood, or other bodily fluids are considered contaminated until cleaned and decontaminated. | |
Deactivation means treating a chemical agent (such as a hazardous drug) with another chemical, heat, ultraviolet light, or other agent to create a less hazardous agent. | |
Decontamination means inactivation, neutralization, or removal of toxic agents, usually by chemical means. | Decontamination means inactivation, neutralization, or removal of toxic agents, usually by chemical means. |
Engineering controls means devices designed to eliminate or reduce worker exposure to hazards. Examples include biological safety cabinets, containment isolators, safer sharps devices, and safety interlocks. | Engineering controls means devices designed to eliminate or reduce worker exposure to hazards. Examples include biological safety cabinets, laboratory fume hoods, containment isolators, safer sharps devices, and safety interlocks. |
Hazardous drugs means
any drug identified as
hazardous by the National
Institute for Occupational
Safety and Health (NIOSH)
at the Centers for Disease
Control or any drug that
meets at least one of the
following six criteria:
Teratogenicity or developmental toxicity; Reproductive toxicity in humans; Organ toxicity at low doses in humans or animals; Genotoxicity; New drugs that mimic existing hazardous drugs in structure and toxicity. |
Hazardous drugs means
any drug identified as
hazardous by the National
Institute for Occupational
Safety and Health (NIOSH)
at the Centers for Disease
Control (CDC) or any drug
that meets at least one of
the following six criteria:
Teratogenicity or
developmental toxicity Reproductive
toxicity in humans Organ toxicity at
low doses in humans or
animals Genotoxicity New drugs that mimic existing hazardous drugs in structure and toxicity. |
Health care settings means all hospitals, medical clinics, outpatient facilities, physicians' offices, retail pharmacies, home health care, veterinary clinics, and similar settings dedicated to the care of patients. | Health care |
HEPA filter means a high-efficiency particulate air filter rated ninety-nine and ninety-seven percent efficient in capturing 0.3-micron-diameter particles. | HEPA filter means a
high-efficiency particulate
air filter rated |
Isolator means a device that is sealed or is supplied with air through a microbially retentive filtration system (HEPA minimum) and may be reproducibly decontaminated. When closed, an isolator uses only decontaminated interfaces (when necessary) or rapid transfer ports (RTPs) for materials transfer. When open, it allows for the ingress and/or egress of materials through defined openings that have been designed and validated to preclude the transfer of contaminants or unfiltered air to adjacent environments. An isolator can be used for aseptic processing, for containment of potent compounds, or for simultaneous asepsis and containment. Some isolator designs allow operations within the isolator to be conducted through attached rubber gloves without compromising asepsis and/or containment. | |
Aseptic isolator: A
ventilated isolator
designed to exclude
external contamination
from entering the critical
zone inside the isolator. Aseptic containment isolator: A ventilated isolator designed to meet the requirements of both an aseptic isolator and a containment isolator. Containment isolator: A ventilated isolator designed to prevent the toxic materials processed inside it from escaping to the surrounding environment. |
|
Material safety data sheet (MSDS) means a summary provided by the manufacturer to describe the chemical properties and hazards of specific chemicals and ways in which workers can protect themselves from exposure to these chemicals. | Material safety data sheet (MSDS) means a summary provided by the manufacturer to describe the chemical properties and hazards of specific chemicals and ways in which workers can protect themselves from exposure to these chemicals. |
Occupational exposure
means reasonably
anticipated inhalation,
skin, ingestion, or injection
contact with hazardous
drugs as a result of the
performance of an
employee's duties. Factors that affect worker exposure include:
Amount of drug prepared; Frequency and duration of drug handling; Potential for absorption; Use of ventilated cabinets; Personal protective equipment; Work practices.
|
Occupational exposure
means reasonably
anticipated inhalation,
skin, ingestion, or injection
contact with hazardous
drugs as a result of the
performance of an
employee's duties.
Amount of drug prepared; Frequency and duration of drug handling; Potential for absorption; Use of ventilated cabinets; Personal protective equipment; Work practices.
Some drugs defined as hazardous may not pose a significant risk of occupational exposure because of their dosage formulation (for example, coated tablets or capsules that are administered to patients without modifying the formulation). However, they may pose a risk if altered (for example, if tablets are crushed or dissolved, or if capsules are pierced or opened). |
Ventilated cabinet means a
type of engineering control
designed for purposes of
worker protection. These
devices are designed to
minimize worker exposures
by controlling emissions of
airborne contaminants
through the following:
The use of airflow capture velocities to capture and remove airborne contaminants near their point of generation; The use of air pressure relationships that define the direction of airflow into the cabinet.
|
Ventilated cabinet means a
type of engineering control
designed for purposes of
worker protection. These
devices are designed to
minimize worker exposures
by controlling emissions of
airborne contaminants
through the following:
The use of airflow capture velocities to capture and remove airborne contaminants near their point of generation;. The use of air pressure relationships that define the direction of airflow into the cabinet.
|
WAC 296-62-50015 Hazardous drugs control program. | WAC 296-62-50015 Hazardous drugs control program. |
(1) By July 1, 2012 each health care setting shall develop and implement a written hazardous drugs control program specific to the workplace. The hazardous drugs control program must, at a minimum, include the following: | (1) |
(1)(a) A current hazard assessment; | (1)(a) |
(1)(b) A written inventory of hazardous drugs in the workplace; | (1)(b) |
(1)(c) A description of the hazardous drugs training program; | |
(1)(d) Hazardous drugs policies and procedures including, but not limited to: | |
(1)(d)(i) Personal protective equipment; | |
(1)(d)(ii) Engineering controls (equipment use and maintenance); | |
(1)(d)(iii) Safe handling practices (receiving and storage, labeling, preparing, administering, and disposing of hazardous drugs); | (1)( |
(1)(d)(iv) Cleaning, housekeeping, and waste handling; | (1)( |
(1)(d)(v) Spill control; | (1)( |
(1)(d)(vi) Medical surveillance; | |
(1)(d)(vii) Personnel issues (such as exposure of pregnant workers); | (1)( |
(1)(d)(viii) Training; | (1)( |
(1)(d)(ix) Recordkeeping. | |
Note: Elements of the hazardous drugs control program may be located in other documents such as the employer's accident prevention program or other policies and procedures as long as they are referenced in the program. | |
Reference: Refer to the most current NIOSH list of antineoplastic and other hazardous drugs in healthcare settings for guidance on developing and maintaining a hazardous drugs list. | |
(2) A standard or universal precautions approach to managing occupational exposure to hazardous drugs is recommended by NIOSH; however, due to a variety of factors that affect occupational exposure some health care facilities may find it more effective to institute precautions based on exposure risk. For example a tiered approach that effectively matches precautions to the nature of exposure may be used including, but not limited to, handling, storing, cleaning, preparing and engineering controls. | |
(2) Review and update the written hazardous drugs control program on at least an annual basis and whenever changes that affect occupational exposure occur, such as introduction of a new hazardous drug, or a change in handling practices. | ( |
(3) Seek input from employees who handle hazardous drugs and from other employees who may be exposed to hazardous drugs as a result of the performance of their duties regarding the quality and effectiveness of the hazardous drugs control program. | ( |
WAC 296-62-50020 Hazard assessment. | WAC 296-62-50020 Hazard assessment. |
(1) Each health care setting must conduct initial and at least annual hazard assessments in order to determine the appropriate protective actions to be taken. | (1) Each health care |
(2) The assessment must include, but is not limited to, the following: | (2) |
(2)(a) Total working environment; | (2)(a) |
(2)(b) Equipment (i.e., ventilated cabinets, closed-system drug transfer devices, glovebags, needleless systems, and personal protective equipment); | (2)(b) |
(2)(c) Physical layout of work areas; | (2)(c) Physical layout of
work areas |
(2)(d) Types of drugs being handled; | (2)(d) Types of hazardous
drugs being handled |
(2)(e) Volume, frequency, and form of drugs handled (tablets, coated versus uncoated, powder versus liquid); | (2)(e) Volume, frequency,
packaging and form of
hazardous drugs handled
(tablets, coated versus
uncoated, powder versus
liquid) |
(2)(f) Equipment maintenance; | (2)(f) Equipment
maintenance |
(2)(g) Decontamination and cleaning; | (2)(g) Decontamination
and cleaning |
(2)(h) Waste handling; | (2)(h) Waste handling |
(2)(i) Potential exposures during work, including hazardous drugs, bloodborne pathogens, and chemicals used to deactivate hazardous drugs or to clean drug-contaminated surfaces; | (2)(i) Potential hazardous
drug exposures during
work operations, |
(2)(j) Routine operations; | |
(2)(k) Spill response; | (2)( |
(2)(l) Waste segregation, containment, and disposal. | |
(3) Conduct a hazard assessment as part of the hazardous drugs control program update and whenever changes that affect occupational exposure occur, such as introduction of a new hazardous drug, or a change in handling practices. | |
Note: The likelihood that a worker will experience adverse effects from exposure to hazardous drugs varies depending upon the relative toxicity and absorptive properties of a drug, the amount, duration and frequency of contact, and the lack of proper work precautions. | |
WAC 296-62-50025 Personal protective equipment (PPE). | WAC 296-62- |
(1) Conduct a PPE hazard assessment and provide appropriate PPE at no cost to employees. | (1) When there is
reasonably anticipated
exposure to hazardous
drugs each health care
facility must conduct
|
(2) Use appropriate PPE whenever handling body fluids and contaminated laundry. | |
(2) Gloves. | ( |
(2)(a) Wear appropriate gloves when handling hazardous drugs or when there is potential contact with hazardous drug contaminated materials or surfaces. | |
(2)(b) Use powder-free chemotherapy gloves when handling chemotherapy drugs or when there is potential contact with chemotherapy contaminated items or surfaces. | |
Note: Consider using chemotherapy gloves for hazardous drugs that are not chemotherapy drugs or for which no information is available. | |
(2)(c) Provide latex-free gloves to employees with latex sensitivities. | |
(2)(d) Wear two pairs of gloves whenever there is a risk of exposure to hazardous drugs, e.g., during compounding, administering, handling contaminated bodily fluids and linens, and cleaning up hazardous drug spills. | |
(2)(e) Make sure that the outer glove extends over the cuff of the gown. | |
(2)(f) Instruct all employees to inspect gloves for physical defects before use. | |
(2)(g) Change gloves every thirty minutes or when torn, punctured, or contaminated. | |
Note: Glove thickness cannot be relied upon as the sole determination of protection. It is important to evaluate test information provided by the glove manufacturer and other research that demonstrates permeation resistance to the specific hazardous drug being handled. | |
(3) Protective clothing. | ( |
(3)(a) Wear gowns whenever there is the possibility of a splash or spill, or contact with contaminated materials or surfaces, including opening drug packages, handling vials or finished products, labeling hazardous drug containers, disposal of waste and all activities associated with drug administration. | ( |
(3)(b) Wear gowns made of polyethylene-coated polypropylene or other protective material as determined by the PPE hazard assessment. Make sure the gown has a closed front, long sleeves, and elastic or knit cuffs. | ( |
(3)(c) Remove and dispose of gowns at the end of drug handling activities, when leaving the drug handling area and as soon as possible when damaged or contaminated. | ( |
(3)(d) If no permeation information is available, change gowns every two to three hours. | ( |
(4) Face protection. Wear a full-face shield when splashes to the eyes, nose, or mouth may occur. Examples include cleaning a spill or performing a procedure such as bladder instillation. | |
(5) Respiratory protection. | ( |
(5)(a) Use N95 or equivalent respiratory protection during spill clean up and whenever there is risk of exposure to hazardous drug particulates. | ( |
(5)(b) Use an appropriate full-facepiece chemical cartridge-type respirator whenever there is a significant risk of exposure to hazardous drug vapors or gases (e.g., for events such as large spills when an intravenous (IV) bag breaks or a line disconnects and leaks). | ( |
(6) Dispose of PPE immediately after use or whenever contaminated. | ( |
WAC 296-62-50030 Engineering controls. | WAC 296-62- |
(1) Use engineering controls to eliminate or minimize employee exposure to hazardous drugs. Examples of engineering controls include, but are not limited to: | (1) Evaluate and implement
appropriate |
(1)(a) Biologic safety cabinets; | |
(1)(b) Containment isolators; | |
(1)(c) Closed system transfer devices; | (1)( |
(1)(d) Safer sharps devices; | (1)( |
(1)(e) Safety interlocks. | (1)( |
(1)(d) Ventilated cabinets. | |
(2) Develop a written safety plan for all routine maintenance activities performed on equipment that could be contaminated with hazardous drugs. | |
(3) General ventilation. Make sure that storage areas have sufficient general exhaust ventilation to dilute and remove airborne contaminants. | |
Note: Depending on the physical nature and quantity of the stored drugs, consider installing a dedicated emergency exhaust fan that is large enough to quickly purge airborne contaminants from the storage room in the event of a spill and prevent contamination in adjacent areas. | |
(4) Ventilated cabinets. | |
(4)(a) Prepare (mix, compound, crush, pour liquid) hazardous drugs inside an appropriate ventilated cabinet designed to prevent release into the work environment. | |
(4)(b) When selecting ventilated cabinets based on the need for aseptic processing make sure to use ventilated cabinets designed for both hazardous drug containment and aseptic processing. When asepsis is not required, a Class I biosafety cabinet or isolator intended for containment applications may be sufficient. | (2)(a)(i) Alternate
precautions may be used
where the hazard
assessment determines a
low occupational exposure
risk while preparing
hazardous drugs other
than chemotherapy agents
(e.g., crushing and
splitting tablets, drawing
medication into a syringe).
These may include, but are
not limited to, temporarily
designating a preparation
area, use of appropriate
personal protective
equipment, and instituting
cleaning procedures. |
(4)(c) Do not use supplemental engineering or process controls (such as needleless systems, glovebags, and closed system drug transfer devices) as a substitution for ventilated cabinets. | (2)(a)(ii) Chemotherapy
drugs must be prepared in
an appropriate ventilated
cabinet with the exception
of circumstances where the
employer can document
evidence of a clinical need
(e.g., there is a nonroutine
need to provide
chemotherapy treatment,
compounding services are
not readily available, and it
is in the best interest of the
patient to provide local
care). In such
circumstances alternate
precautions must be
instituted as described
above. |
(4)(d) Equip ventilated cabinets with a continuous monitoring device to confirm adequate airflow before each use. | |
(4)(e) Use a high-efficiency particulate air filter (HEPA filter) for exhaust, and where feasible, exhaust one hundred percent of the filtered air to the outside. | |
(4)(f) Install the outside exhaust so that the exhausted air is not pulled back into the building by the heating, ventilating, and air conditioning systems or by the windows, doors, or other points of entry. | |
(4)(g) Place fans downstream of the HEPA filter so that contaminated ducts are maintained under negative pressure. | |
(4)(h) Do not use a ventilated cabinet that recirculates air inside the cabinet or exhausts air back into the room environment unless the hazardous drug(s) in use will not volatilize while they are being handled or after they are captured by the HEPA filter. | |
(4)(i) Develop and implement maintenance and cleaning procedures that ensure the effectiveness and safety of the ventilated cabinet. | |
(4)(i)(i) Field-certify biosafety cabinet performance, in accordance with National Sanitation Foundation/American National Standards Institute Standard 49, after installation, relocation, maintenance, repairs to internal components, HEPA filter replacement, and every six months thereafter. | |
(4)(i)(ii) Select appropriate performance and test methods for containment isolators, at a minimum, conduct leak and containment integrity tests in accordance with current American Glovebox Society guidelines. In addition perform a HEPA filter leak test for those containment isolators that utilize HEPA filtration. | |
(4)(i)(iii) Prominently display a current field-certification label on the ventilated cabinet. | |
(4)(i)(iv) Make sure that workers performing maintenance are familiar with applicable safety procedures, warned about hazards, and trained in appropriate work techniques and PPE needed to minimize exposure. | |
(4)(i)(v) Remove all hazardous drugs and chemicals, and decontaminate the ventilated cabinet before beginning maintenance activities. | |
(4)(i)(vi) Notify occupants in the affected areas immediately before the maintenance activity begins, and place warning signs on all affected equipment. | |
(4)(i)(vii) Deenergize the ventilated cabinet in accordance with chapter 296-803 WAC, Lockout/Tagout (control of hazardous energy). | |
(4)(i)(viii) Decontaminate and bag equipment parts removed for replacement or repair before they are taken outside the facility. | |
(4)(i)(ix) Seal used filtration media in plastic immediately upon removal, and dispose as contaminated waste. | |
(5) Institution of effective ventilation controls must be accomplished by December 1, 2012. | |
Note: Consult the
following documents for
performance test methods
and selection criteria for
ventilated cabinets: (a) Primary Containment for Biohazards: Selection, Installation and Use of Biological Safety Cabinets (CDC/NIH). (b) NSF/ANSI 49, Class II (laminar flow) Biosafety Cabinetry. |
Note: Consult the
following documents for
performance test methods
and selection criteria for
ventilated cabinets: ( ( |
WAC 296-62-50035 Safe handling practices. | WAC 296-62-50035 Safe handling practices. |
(1) Receiving and storage. | (1) Receiving and storage. |
(1)(a) Make sure that all hazardous drug containers received from the manufacturer, distributor, another pharmacy, or medical clinic are labeled. | |
(1)(b) At a minimum wear appropriate gloves when opening and unpacking shipping containers, and transporting hazardous drugs. | |
(1)(c) Store hazardous drugs separately from other drugs, and in a manner that minimizes the potential for spills. | |
(1)(d) Prohibit the use of unventilated areas for drug storage. | |
(1)(e) Transport hazardous drugs in closed containers that minimize the risk of breakage. | |
(2) Labeling. | |
(2)(a) Label hazardous drug containers in accordance with WAC 296-800-170, Employer chemical hazard communication. | ( |
(2)(b) Label pharmaceutical waste containers in accordance with WAC 173-303-200, Accumulating dangerous waste on-site. See the Washington state department of ecology pharmaceutical waste web site for more information. | ( |
(3) Preparing. | ( |
(3)(a) Provide work areas that are devoted solely to preparing hazardous drugs and limited to authorized personnel. | ( |
(3)(b) Coordinate tasks associated with preparing and administering hazardous drugs to minimize exposure risks. | ( |
(3)(c) Use engineering controls such as closed-system transfer devices, glovebags, and needleless systems when transferring hazardous drugs from primary packaging (such as vials) to dosing equipment (such as infusion bags, bottles, or pumps). | |
(3)(d) Spike and prime the IV tubing and syringes inside an appropriate ventilated cabinet, never in the patient's room. | ( |
(2)(d) Do not remove tubing from an IV bag containing a hazardous drug. | |
(3)(e) When drug preparation is complete, seal the final product in a clear plastic bag or other sealable container for transport before removing it from the ventilated cabinet. | ( |
(3)(f) Seal and decontaminate all waste containers inside the ventilated cabinet before removing them from the ventilated cabinet. | |
(2)(e)(ii) Seal and wipe all waste containers inside the ventilated cabinet before removing them from the cabinet. | |
(3)(g) Remove outer gloves and sleeve covers (if used) and bag them for disposal while inside the ventilated cabinet. | |
(4) Administering. | |
(4)(a) Ensure that staff has been trained and follow policies and procedures regarding the safe administration of hazardous drugs and related patient care. Examples include, but are not limited to; oral, intravenous, intramuscular or subcutaneous injections, topical, intracavitary, and aerosol administration. | |
(4)(b) Use engineering controls to transfer and administer hazardous drugs. | |
(4)(c) Wear appropriate personal protective equipment when administering hazardous drugs. | |
(4)(d) Spike and prime administration sets prior to adding the drug to the bag. | |
(4)(e) Do not remove tubing from an IV bag containing a hazardous drug. | |
(4)(f) Do not disconnect tubing at other points in the system until the tubing has been thoroughly flushed. | |
(3) Waste handling. | |
(3)(a) Dispose of pharmaceutical waste in accordance with applicable state and federal regulations. | |
(4)(g) Place contaminated waste and other disposable items directly into a designated waste container. | |
(4) Personal hygiene. | |
(4)(h) Personal hygiene. Prohibit eating, drinking, smoking, applying cosmetics or lip balm, and handling contact lenses in work areas where hazardous drugs may be found. | (4)( |
(5) Handwashing. Wash hands with soap and water before donning gloves, immediately after removal, and whenever hands become contaminated. | ( |
(6) Laundry. Place contaminated laundry in leakproof, labeled or color-coded containers. | |
WAC 296-62-50040 Cleaning, housekeeping, and waste handling. | WAC 296-62-50040
Cleaning |
(1) Establish procedures for cleaning and decontamination of areas and equipment where hazardous drugs are present. | (1) Establish procedures for cleaning and decontamination of areas and equipment where hazardous drugs are present. |
(2) Perform cleaning and decontamination work in areas that are sufficiently ventilated to prevent buildup of hazardous airborne concentrations. | (2) |
(3) Clean work surfaces with an appropriate deactivation agent and cleaning agent before and after each continuous activity and at the end of the work shift. | (3) Clean work surfaces
|
(4) Wear appropriate gloves for cleaning and decontamination work. | |
(5) Wear a gown and face protection whenever splashing or contact with contaminated materials or surfaces is possible. | |
(6) Wear appropriate gloves and gown when handling linens, feces, or urine from patients who have received hazardous drugs within the last forty-eight hours that may be excreted in the urine or feces. In some cases handling precautions may need to be extended beyond forty-eight hours; e.g., Cisplatin may be excreted in urine for up to seven days. | |
(7) Place hazardous drug contaminated waste in designated pharmaceutical waste containers and dispose of in accordance with Washington state department of ecology dangerous waste requirements, chapter 173-303 WAC. | |
(8) Waste containers must be: | |
(8)(a) Leakproof and appropriate for intended use, e.g., containers holding sharps must be puncture resistant; | |
(8)(b) Color-coded or labeled; | |
(8)(c) Located as close as feasible to the immediate area where contaminated waste is generated or can be anticipated to be found; | |
(8)(d) Maintained upright throughout use; | |
(8)(e) Not allowed to overfill; | |
(8)(f) Closed except when in use, and prior to removal or replacement. | |
WAC 296-62-50045 Spill control. | WAC 296-62-50045 Spill control. |
(1) Develop written spill response procedures based on the hazardous drugs present and potential spill or release conditions. | (1) Develop written spill response procedures based on the hazardous drugs present and potential spill or release conditions. |
(2) Spill procedures must include, at a minimum: | (2) Spill procedures must include, at a minimum: |
(2)(a) Description of who is authorized to respond and under what circumstances; | (2)(a) Description of who is
authorized to respond and
under what
circumstances |
(2)(b) PPE (including respiratory protection) for various drugs and spill sizes; | (2)(b) PPE |
(2)(c) Location and use of spill kits or clean-up materials, and personal protective equipment; | (2)(c) Location and use of
spill kits or clean-up
materials. |
(2)(d) Possible spreading of material, and area containment and signage; | (2)(d) Possible spreading
of contamination, |
(2)(e) Reporting and evaluating the circumstances surrounding spills and releases; | (2)(e) Reporting and
evaluating the
circumstances surrounding
spills and releases |
(2)(f) Restricted access to hazardous drug spills. | (2)(f) Restricted access to hazardous drug spills. |
(2)(g) Waste disposal. | |
(3) Provide spill kits or clean-up materials near all potential spill sources. | (3) |
(4) Dispose of all clean-up materials in an appropriate pharmaceutical waste container. | |
Note: See chapter 296-824 WAC, Emergency response for requirements regarding response to spills that create significant safety and health risks. See the scope of chapter 296-824 WAC for further guidance. See WAC 296-800-150, first aid for emergency washing requirements. | Note: See chapter 296-824 WAC, Emergency
response for requirements
regarding response to
spills that create
significant safety and
health risks |
WAC 296-62-50050 Medical surveillance. | |
(1) Make confidential medical evaluations available to employees who directly handle hazardous drugs, and others who may come directly into contact with patient wastes within forty-eight hours after receiving a hazardous drug (e.g., nurses aides, laundry workers) under the following schedule: | |
(1)(a) Upon hire and on a scheduled basis thereafter; | |
(1)(b) Following acute exposures; | |
(1)(c) At the time of job termination or transfer (exit evaluation). | |
(2) Ensure that all medical evaluations are performed by or under the supervision of a licensed health care provider (LHCP), and are provided at no cost to the employee and at a reasonable time and place. | |
(3) The medical evaluations must include: | |
(3)(a) A health questionnaire that includes reproductive and occupational information. | |
(3)(b) Baseline and periodic laboratory work as indicated based on the health hazards of the hazardous drugs the employee is exposed to or reasonably likely to be exposed to. | |
(3)(c) A physical examination at the time of hire and as indicated based on the health questionnaire, changes in health status or laboratory work findings. | |
(3)(d) Additional testing and examinations as recommended by the LHCP. | |
Note: Many hazardous drugs may affect the production of blood cells and may cause bladder damage. Because of this many authoritative bodies (e.g., NIOSH, the Occupational Health and Safety Administration, and the Oncology Nursing Society) recommend a complete blood count with differential, and examination for blood in the urine. Additional laboratory work, such as liver function testing, may be indicated. | |
(4) Provide the LHCP the following information: | |
(4)(a) A description of the employee's duties as they relate to the employee's exposure; | |
(4)(b) The employee's exposure levels or anticipated exposure levels; | |
(4)(c) A description of the personal protective equipment and respiratory protection used or to be used; | |
(4)(d) Information available from previous medical examinations of the employee, which is not readily available to the LHCP. | |
WAC 296-62-50055 Training. | WAC 296-62- |
(1) Provide hazardous drugs training to all employees with occupational exposure at the time of their initial job assignment, on a regular basis, and whenever changes in the workplace occur that may affect occupational exposure. | (1) Provide hazardous
drugs training to all
employees with
occupational exposure at
the time of their initial job
assignment |
(2) Employee training includes, but is not limited to, the following elements: | |
(2)(a) A review of the hazardous drugs control program and how to access a copy of the program; | |
(2)(b) An explanation of and how to access material safety data sheets (MSDSs); | |
(2)(c) Sources of exposure to hazardous drugs; | |
(2)(d) Health hazards of the hazardous drugs in the work area, including the possible physical symptoms or effects of exposure; | |
(2)(e) Steps employees can take to protect themselves from exposure to hazardous drugs in the workplace, including specific procedures to protect employees from exposure to hazardous chemicals. Specific procedures may include: | |
(2)(e)(i) Personal protective equipment; | |
(2)(e)(ii) Engineering controls; | |
(2)(e)(iii) Safe handling practices; | |
(2)(e)(iv) Cleaning, housekeeping, and waste disposal; | |
(2)(e)(v) Spill control; | |
(2)(e)(vi) System for reporting exposure incidents and hazardous conditions. | |
(2)(f) Medical surveillance. | |
(3) Initial and periodic assessments of preparation and administration technique. | |
(4) The training must be conducted in a manner which the employees are able to understand. | |
Note: This training will suffice for the training on hazardous drugs required under WAC 296-800-170, Employer chemical hazard communication -- Introduction. | |
WAC 296-62-50060 Recordkeeping. | |
(1) Training records. | |
(1)(a) Maintain current training records for each employee. | |
(1)(b) Training records must include the following: | |
(1)(b)(i) Dates of training sessions; | |
(1)(b)(ii) Contents or a summary of the training sessions; | |
(1)(b)(iii) Names and job titles of employees taking the training. | |
(2) Medical and exposure records. Establish and maintain employee medical and exposure records in accordance with chapter 296-802 WAC, Employee medical and exposure records. | |
(3) Spill records. Maintain spill records and evaluation findings for at least one year from the date of the spill or release. | |
WAC 296-62-50055 Implementation plan. | |
(1) Effective dates. | |
(1)(a) The written hazardous drugs control program must be completed and implemented by January 1, 2014, with the exception of (b) and (c) of this subsection. | |
(1)(b) Employee training must be implemented by July 1, 2014. | |
(1)(c) Installation of appropriate ventilated cabinets must be completed by January 1, 2015. | |
(2) The department will work with stakeholders to implement this chapter by doing the following: | |
(2)(a) Establish a hazardous drugs advisory committee to discuss new NIOSH recommendations, scientific and technological developments and other unanticipated issues related to rule implementation. This committee will include employer and employee representatives of the health care industry and representatives of affected state agencies. It may provide recommendations to the department regarding appropriate actions. | |
(2)(b) Work with trade associations, labor unions and other representatives from the health care industry to develop model programs for implementation of these rules in a variety of health care facilities and settings. The department will provide education, training and consultation services to ensure that these model programs are widely distributed and can be effectively utilized. | |
(2)(c) Establish a hazardous drugs web page, and post relevant resources, sample programs and forms. |
Number of Sections Adopted in Order to Comply with Federal Statute: New 0, Amended 0, Repealed 0; Federal Rules or Standards: New 12, Amended 0, Repealed 0; or Recently Enacted State Statutes: New 0, Amended 0, Repealed 0.
Number of Sections Adopted at Request of a Nongovernmental Entity: New 0, Amended 0, Repealed 0.
Number of Sections Adopted on the Agency's Own Initiative: New 12, Amended 0, Repealed 0.
Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 12, Amended 0, Repealed 0.
Number of Sections Adopted Using Negotiated Rule Making: New 0, Amended 0, Repealed 0; Pilot Rule Making: New 0, Amended 0, Repealed 0; or Other Alternative Rule Making: New 12, Amended 0, Repealed 0.
Date Adopted: January 3, 2012.
Judy Schurke
Director
OTS-4325.4
PART R -- HAZARDOUS DRUGS
NEW SECTION
WAC 296-62-500
Hazardous drugs.
This chapter provides
minimum requirements for developing a hazardous drugs control
program when occupational exposure to hazardous drugs is
reasonably anticipated. It is designed to provide effective,
assessment-based precautions to minimize or eliminate
occupational exposure to hazardous drugs.
IMPORTANT:
Occupational exposure to hazardous drugs is also covered under WAC 296-800-170, Employer chemical hazard communication -- Introduction. In addition the employer must follow the requirements in WAC 296-800-160, personal protective equipment (PPE) and chapter 296-842 WAC, Respirators. Whenever there is a conflict between rule requirements the most protective requirement will take precedent.
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(2) Chapter application.
(a) The requirements in this rule only apply to the hazardous drugs being used in the workplace.
(b) If hazardous drugs are being used in the workplace the requirements in this rule only apply if there is reasonably anticipated occupational exposure as defined in WAC 296-62-50010.
(c) If there is reasonably anticipated occupational exposure to one or more hazardous drugs, the employer must develop a hazardous drugs control program as required in section WAC 296-62-50015.
(d) For purposes of making the determinations in this section about scope and application, occupational exposure is that exposure which would be reasonably anticipated in the absence of engineering controls or PPE.
(3) The following lists jobs that may involve occupational exposure to hazardous drugs. This is not an exhaustive list and there may be other jobs that fall within the scope of this chapter:
Pharmacists and pharmacy technicians.
Physicians and physician assistants.
Nurses (ARNPs, RNs, LPNs).
Patient care assistive personnel (e.g., health care assistants, nursing assistants).
Operating room personnel.
Home health care workers.
Veterinarians and veterinary technicians.
Environmental services employees (e.g., housekeeping, laundry, and waste disposal) in health care facilities.
Employees in health care facilities who ship, or receive hazardous drugs from the manufacturer or distributor.
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Chemotherapy glove means a medical glove that has been approved by the Food and Drug Administration (FDA) and that meets the permeability standards of the American Society for Testing Materials (ASTM) Standard D6978 - 05.
Closed system drug-transfer device means a drug-transfer device that mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drug or vapor concentrations outside of the system.
Decontamination means inactivation, neutralization, or removal of toxic agents, usually by chemical means.
Engineering controls means devices designed to eliminate or reduce worker exposure to hazards. Examples include biological safety cabinets, laboratory fume hoods, containment isolators, safer sharps devices, and safety interlocks.
Hazardous drugs means any drug identified as hazardous by the National Institute for Occupational Safety and Health (NIOSH) at the Centers for Disease Control (CDC) or any drug that meets at least one of the following six criteria:
Carcinogenicity.
Teratogenicity or developmental toxicity.
Reproductive toxicity in humans.
Organ toxicity at low doses in humans or animals.
Genotoxicity.
New drugs that mimic existing hazardous drugs in structure and toxicity.
Health care facilities means all hospitals, clinics, nursing homes, laboratories, offices or similar places where a health care provider provides health care to patients. For purposes of this chapter this includes veterinary medicine, retail pharmacies, home health care agencies and also those research laboratories in settings where a health care provider provides health care to patients. It does not include the drug manufacturing sector or research laboratories where health care providers do not provide health care to patients.
HEPA filter means a high-efficiency particulate air filter rated 99.97% efficient in capturing 0.3-micron-diameter particles.
Isolator means a device that is sealed or is supplied with air through a microbially retentive filtration system (HEPA minimum) and may be reproducibly decontaminated. When closed, an isolator uses only decontaminated interfaces (when necessary) or rapid transfer ports (RTPs) for materials transfer. When open, it allows for the ingress and/or egress of materials through defined openings that have been designed and validated to preclude the transfer of contaminants or unfiltered air to adjacent environments. An isolator can be used for aseptic processing, for containment of potent compounds, or for simultaneous asepsis and containment. Some isolator designs allow operations within the isolator to be conducted through attached rubber gloves without compromising asepsis and/or containment.
Aseptic isolator: A ventilated isolator designed to exclude external contamination from entering the critical zone inside the isolator.
Aseptic containment isolator: A ventilated isolator designed to meet the requirements of both an aseptic isolator and a containment isolator.
Containment isolator: A ventilated isolator designed to prevent the toxic materials processed inside it from escaping to the surrounding environment.
Material safety data sheet (MSDS) means a summary provided by the manufacturer to describe the chemical properties and hazards of specific chemicals and ways in which workers can protect themselves from exposure to these chemicals.
Occupational exposure means reasonably anticipated inhalation, skin, ingestion, or injection contact with hazardous drugs as a result of the performance of an employee's duties. Some drugs defined as hazardous may not pose a significant risk of occupational exposure because of their dosage formulation (for example, coated tablets or capsules that are administered to patients without modifying the formulation). However, they may pose a risk if altered (for example, if tablets are crushed or dissolved, or if capsules are pierced or opened).
Ventilated cabinet means a type of engineering control designed for purposes of worker protection. These devices are designed to minimize worker exposures by controlling emissions of airborne contaminants through the following:
The full or partial enclosure of a potential contaminant source.
The use of airflow capture velocities to capture and remove airborne contaminants near their point of generation.
The use of air pressure relationships that define the direction of airflow into the cabinet.
Examples of ventilated cabinets include biological safety cabinets and containment isolators.
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(a) A written inventory of hazardous drugs in the workplace.
(b) A current hazard assessment for hazardous drugs for which there is reasonably anticipated occupational exposure.
(c) Hazardous drugs policies and procedures including, but not limited to:
(i) Engineering controls (equipment use and maintenance).
(ii) Personal protective equipment.
(iii) Safe handling practices (receiving and storage, labeling, preparing, administering, and disposing of hazardous drugs).
(iv) Cleaning, housekeeping, and waste handling.
(v) Spill control.
(vi) Personnel issues (such as exposure of pregnant workers).
(vii) Training.
(2) A standard or universal precautions approach to managing occupational exposure to hazardous drugs is recommended by NIOSH; however, due to the variety of factors that affect occupational exposure some health care facilities may find it more effective to institute precautions based on exposure risk. For example a tiered approach that effectively matches precautions to the nature of exposure may be used including, but not limited to, handling, storing, cleaning, preparing and engineering controls.
(3) Review and update the written hazardous drugs control program annually and whenever changes that affect occupational exposure occur, such as introduction of a new hazardous drug, or a change in handling practices.
(4) Seek and consider input from employees who may be exposed to hazardous drugs as a result of the performance of their duties regarding the quality and effectiveness of the hazardous drugs control program.
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(2) Assessments must include the following elements as appropriate:
(a) Personal protective equipment.
(b) Engineering controls (e.g., ventilated cabinets, closed-system drug transfer devices, glovebags, and needleless systems).
(c) Physical layout of work areas.
(d) Types of hazardous drugs being handled.
(e) Volume, frequency, packaging, and form of hazardous drugs handled (tablets, coated versus uncoated, powder versus liquid).
(f) Equipment maintenance.
(g) Decontamination and cleaning.
(h) Waste handling.
(i) Potential hazardous drug exposures during work operations, such as drug preparation and administration.
(j) Spill response.
(3) Conduct a hazard assessment as part of the hazardous drugs control program update and whenever changes that affect occupational exposure occur, such as introduction of a new hazardous drug or a change in handling practices.
Note: | The likelihood that a worker will experience adverse effects from exposure to hazardous drugs varies depending upon the relative toxicity and absorptive properties of a drug, the amount, duration and frequency of contact, and the lack of proper work precautions. |
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(a) Closed system transfer devices.
(b) Safer sharps devices.
(c) Safety interlocks.
(d) Ventilated cabinets.
(2) Ventilated cabinets.
(a) Prepare (e.g., mix, compound, crush) hazardous drugs inside an appropriate ventilated cabinet designed to prevent release into the work environment. When asepsis is not required, a Class I biosafety cabinet or isolator intended for containment applications may be sufficient.
(i) Alternate precautions may be used where the hazard assessment determines a low occupational exposure risk while preparing hazardous drugs other than chemotherapy agents (e.g., crushing and splitting tablets, drawing medication into a syringe). These may include, but are not limited to, temporarily designating a preparation area, use of appropriate personal protective equipment, and instituting cleaning procedures.
(ii) Chemotherapy drugs must be prepared in an appropriate ventilated cabinet with the exception of circumstances where the employer can document evidence of a clinical need (e.g., there is a nonroutine need to provide chemotherapy treatment, compounding services are not readily available, and it is in the best interest of the patient to provide local care). In such circumstances alternate precautions must be instituted as described above.
(b) Equip ventilated cabinets with a continuous monitoring device to confirm adequate airflow before each use.
(c) Use filtering media that is approved by the cabinet manufacturer and is appropriate for the agent being captured, such as a high-efficiency particulate air filter (HEPA filter) for exhaust, and where feasible, exhaust one hundred percent of the filtered air to the outside unless the employer can provide an evidence-based justification to do otherwise.
(d) Install the outside exhaust so that the exhausted air is not pulled back into the building by the heating, ventilating, and air conditioning systems or by the windows, doors, or other points of entry.
(e) Place fans downstream of the filter so that contaminated ducts are maintained under negative pressure.
(f) Do not use a ventilated cabinet that recirculates air inside the cabinet or exhausts air back into the room environment unless the hazardous drug(s) in use will not volatilize while they are being handled or after they are captured by the filter.
(g) Develop and implement maintenance and cleaning procedures that ensure the effectiveness and safety of the ventilated cabinet.
(i) Field-certify biosafety cabinet performance, in accordance with National Sanitation Foundation/American National Standards Institute Standard 49, after installation, relocation, maintenance, repairs to internal components, HEPA filter replacement, and every six months thereafter or as recommended by the manufacturer.
(ii) Select appropriate performance and test methods for isolators, depending on the type (containment only or aseptic containment), the operating pressure (positive or negative and designed magnitude), and toxicity of the hazardous drug. At a minimum, conduct leak and containment integrity tests in accordance with current American Glovebox Society guidelines. In addition perform a HEPA filter leak test for those isolators that utilize HEPA filtration.
(iii) Prominently display a current field-certification label on the ventilated cabinet.
(iv) Make sure that workers performing maintenance are familiar with applicable safety procedures, warned about hazards (e.g., through the provision of material safety data sheet or other equivalent information resources), and trained in appropriate work techniques and PPE needed to minimize exposure.
(v) Remove all hazardous drugs and chemicals, and decontaminate the ventilated cabinet before beginning maintenance activities.
(vi) Notify occupants in the affected areas immediately before the maintenance activity begins, and place warning signs on all affected equipment.
(vii) Deenergize the ventilated cabinet in accordance with chapter 296-803 WAC, Lockout/Tagout (control of hazardous energy).
(viii) Decontaminate and bag equipment parts removed for replacement or repair before they are taken outside the facility.
(ix) Seal used filtration media in plastic immediately upon removal, and dispose as contaminated waste.
Note: | Consult the following documents for performance test methods and selection criteria for ventilated cabinets: |
(1) Primary Containment for Biohazards: Selection, Installation and Use of Biological Safety Cabinets (CDC/NIH). | |
(2) NSF/ANSI 49, Class II (laminar flow) Biosafety Cabinetry. |
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(2) Use appropriate PPE whenever handling body fluids and contaminated laundry.
(3) Gloves.
(a) Use powder-free chemotherapy gloves when handling chemotherapy drugs or when there is potential contact with chemotherapy contaminated items or surfaces.
(b) Provide latex-free gloves to employees with latex sensitivities.
(c) Wear two pairs of gloves when there is a significant risk of breakage or contamination or permeation, e.g., during compounding, extended handling periods, and cleaning up large hazardous drug spills.
(d) Change gloves every thirty to sixty minutes or when torn, punctured, or contaminated.
(4) Protective clothing.
(a) Wear gowns whenever there is a reasonable possibility of a hazardous drug splash or spill such as in compounding, preparing and administering hazardous drugs.
(b) Wear gowns made of polyethylene-coated polypropylene or other nonabsorbent, nonlinting protective material as determined by the PPE hazard assessment. Make sure the gown has a closed front, long sleeves, and elastic or knit cuffs.
(c) Remove and dispose of gowns at the end of hazardous drug handling activities, when leaving the hazardous drug handling area and as soon as possible when damaged or contaminated.
(d) If no permeation information is available, change gowns every two to three hours or when contaminated after a splash or spill.
(5) Face protection. Wear a full-face shield or a mask and eye protection as appropriate when splashes to the eyes, nose, or mouth may occur; examples include cleaning a spill, or performing a procedure such as bladder instillation.
(6) Respiratory protection.
(a) Use N95 or equivalent respiratory protection during spill clean up and whenever there is a significant risk of inhalation exposure to hazardous drug particulates.
(b) Use an appropriate chemical cartridge-type respirator for events such as large spills of volatile hazardous drugs, e.g., when an intravenous (IV) bag breaks or a line disconnects.
(7) Disposable PPE must be discarded into appropriate containers immediately after use or as soon as feasible after contamination. Reusable PPE must be properly cleaned and decontaminated after use or contamination.
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(a) Label hazardous drug containers in accordance with WAC 296-800-170, Employer chemical hazard communication -- Introduction.
(b) Store and transport hazardous drugs in a manner that minimizes the risk of breakage.
(2) Preparation and administration.
(a) Provide designated work areas for the preparation of hazardous drugs and limit access during preparation.
(b) Coordinate tasks associated with preparing and administering hazardous drugs for the most effective control of worker exposure.
(c) Spike and prime the IV tubing and prepare syringes in a manner that most effectively limits occupational exposure.
(d) Do not remove tubing from an IV bag containing a hazardous drug.
(e) When drug preparation is completed in a ventilated cabinet:
(i) Seal the final product in a plastic bag or other sealed container for transport before taking it out of the cabinet.
(ii) Seal and wipe all waste containers inside the ventilated cabinet before removing them from the cabinet.
(iii) Remove all outer gloves and sleeve covers and bag them for disposal while inside the cabinet.
(3) Waste handling.
(a) Dispose of pharmaceutical waste in accordance with applicable state and federal regulations.
(b) Place disposable items in designated containers.
(4) Personal hygiene.
(a) Prohibit eating or drinking in areas where hazardous drugs are handled.
(b) Wash hands with soap and water before donning gloves, immediately after removal, and whenever hands become contaminated.
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(2) Do not clean contaminated equipment in unventilated areas.
(3) Clean work surfaces before and after each continuous activity and at the end of the work shift.
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(2) Spill procedures must include, at a minimum:
(a) Description of who is authorized to respond and under what circumstances.
(b) PPE for various hazardous drugs and spill sizes.
(c) Location and use of spill kits or clean-up materials.
(d) Possible spreading of contamination, and area containment and signage.
(e) Reporting and evaluating the circumstances surrounding spills and releases.
(f) Restricted access to hazardous drug spills.
(g) Waste disposal.
(3) Locate spill kits or clean-up materials near all potential spill sources.
Note: | See chapter 296-824 WAC, Emergency response for requirements regarding response to spills that create significant safety and health risks, and WAC 296-800-150, first-aid summary for emergency washing requirements. |
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(2) Include the training elements listed in WAC 296-800-17030, Inform and train your employees about hazardous chemicals in your workplace.
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(a) The written hazardous drugs control program must be completed and implemented by January 1, 2014, with the exception of (b) and (c) of this subsection.
(b) Employee training must be implemented by July 1, 2014.
(c) Installation of appropriate ventilated cabinets must be completed by January 1, 2015.
(2) The department will work with stakeholders to implement this chapter by doing the following:
(a) Establish a hazardous drugs advisory committee to discuss new NIOSH recommendations, scientific and technological developments and other unanticipated issues related to rule implementation. This committee will include employer and employee representatives of the health care industry and representatives of affected state agencies. It may provide recommendations to the department regarding appropriate actions.
(b) Work with trade associations, labor unions and other representatives from the health care industry to develop model programs for implementation of these rules in a variety of health care facilities and settings. The department will provide education, training and consultation services to ensure that these model programs are widely distributed and can be effectively utilized.
(c) Establish a hazardous drugs web page, and post relevant resources, sample programs and forms.
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