Chapter , Part R Hazardous Drugs

Transcription

1 Chapter , Part R Hazardous Drugs WAC WAC WAC WAC WAC WAC WAC WAC WAC WAC WAC WAC WAC WAC Hazardous Drugs Scope Definitions Hazard Assessment Hazardous Drugs Control Plan Engineering Controls Personal Protective Equipment Safe Handling Practices Spill Control Housekeeping Labeling and Signage Medical Surveillance Training Recordkeeping WAC Hazardous drugs Important: Hazardous drugs are also covered under Chapter WAC, Employer Chemical Hazard Communication. The employer must ensure that the requirements related to hazardous drugs in both this chapter and chapter WAC are met. Whenever there is a conflict between the requirements of these two rules the most protective requirement will take precedent. WAC Scope. (1) This chapter applies to all health care settings that have employees with occupational exposure to hazardous drugs. (2) Occupational exposure includes potential and actual exposure to hazardous drugs in the air, on work surfaces, clothing, and medical equipment or through contact with patients and their excrement. 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: Physicians and physician assistants Nurses (ARNPs, RNs, LPNs, nurses aids) Operating room personnel Employees in research laboratories Home health care workers Veterinarians and veterinary technicians 1

2 Pharmacists and pharmacy technicians (in both clinical and retail pharmacy settings) Environmental services employees (e.g., housekeeping, laundry, and waste disposal) in health care settings Emloyees who ship, or receive hazardous drugs from the manufacturer or distributor Employees in laundries that provide services to health care settings (3) Exemption. This chapter does not apply to the drug manufacturing sector. WAC Definitions. Biological safety cabinet means a ventilated cabinet for compounding pharmaceutical ingredients, personnel, product, and environmental protection having an open front with in-ward airflow for personnel protection, down-ward high-efficiency air (HEPA)-filtered laminar airflow for product protection, and HEPA-filtered exhausted air for environmental protection. 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 D 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 passes through a microbial retentive filter (HEPA minimum). Dangerous waste means any waste that designates under WAC (3). Dangerous waste includes both Resource and Conservation Recovery Act (RCRA) hazardous waste and state-only dangerous waste. 2

3 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. 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. Exposure incident means unprotected exposure to a hazardous drug through skin, mucous membrane, or inhalation contact. Hazardous drugs means any drug identified as hazardous by the National Institute for Occupational Safety and Health at the Centers for Disease Control 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 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. HEPA filter means a high-efficiency particulate air filter rated 99.97% efficient in capturing 0.3-micron-diameter particles. 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. 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. 3

4 WAC Hazard assessment. (1) Each health care setting shall conduct initial and at least annual hazard assessments. At a minimum, evaluate the following: (a) All work areas, including physical layout, in which hazardous drugs may be present. (b) Types of hazardous drugs being handled. (c) Volume, frequency, form of drugs handled (tablets, coated versus uncoated, powder versus liquid, aerosol), and handling practices (compounding or manipulating the original form as in crushing tablets, making suspensions, etc.). (d) Potential exposures including hazardous drugs, bloodborne pathogens, and chemicals used to deactivate hazardous drugs or decontaminate drug-contaminated surfaces. (e) Engineering controls and personal protective equipment. (f) Decontamination and cleaning. (g) Waste segregation, containment, and disposal. (h) Spill response. (2) Document the hazard assessment including: (a) All elements evaluated and findings. (b) Names of persons conducting the assessment. (c) Assessment dates. 4

5 WAC 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: (a) Designation of personnel responsible for implementation of the Hazardous Drugs Control Program. (b) Process used to evaluate drugs for hazards. (c) A list of hazardous drugs in the workplace. (d) An exposure determination listing job classes or positions of employees with occupational exposure to hazardous drugs. (e) Personnel policies addressing management of of employees who are preganat, breastfeeding, or trying to conceive. (f) Policies and procedures addressing all elements of this rule. Note: Elements of the Hazardous Drugs Control Program may be located in other documents such as 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) Review and update the written Hazardous Drugs Control Program at least annually and whenever changes in the workplace occur, such as introduction of a new hazardous drug, or a change in handling practices. (3) Solicit input from non-managerial employees on all aspects of the Hazardous Drugs Control Program. (4) Make the Hazardous Drugs Control Program readily available to employees and their representatives. 5

6 WAC Engineering controls. (1) Use engineering controls to eliminate or minimize employee exposure to hazardous drugs. Examples of engineering controls include, but are not limited to: Biologic safety cabinets Containment isolators Robotic compounding devices Closed system transfer devices Safer sharps devices Safety interlocks (2) Examine and maintain or replace engineering controls on a regular schedule to make sure they remain effective. (3) General ventilation. Make sure that storage areas have at least four air changes per hour to dilute and remove any 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 (a) Prepare (i.e., mix, compound, crush, pour) hazardous drugs inside a ventilated cabinet designed to prevent hazardous drugs from being released into the work environment. (b) Use supplemental engineering controls (such as needleless systems, glove bags, and closed-system drug transfer devices) as an adjunct to ventilated cabinets and not as a substitution for them. (c) Use a HEPA filtered Class II Type B2 biological cabinet when preparing hazardous drugs. (i) The use of Class II A2 or B1 biological cabinet, class I biological cabinet or containment isolator may be appropriate when preparing nonvolatile drugs, e.g., when handling drugs in a manner that would not create aerosols. (ii) For containment isolators 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. 6

7 (d) Exhaust one hundred percent of the air to the outside of the building wherever feasible. (e) Install the outside exhaust so that it is at least twenty-five feet from air intakes, points of building entry such as windows and doors, and areas that may be populated. (f) Place fans downstream of the HEPA filter so that contaminated ducts are maintained under negative pressure. (g) Ventilated cabinets must be equipped with a continuous monitoring device to confirm adequate airflow. (h) Develop and implement maintenance and cleaning procedures that ensure the effectiveness and safety of the ventilated cabinet. (i) Field-certify ventilated 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. (ii) Prominently display a current field-certification label on the ventilated cabinet. (iii) Make sure employees, including contract workers, performing maintenance are informed of the hazardous drugs compounded and have access to material safety data Sheets. (iv) Remove all hazardous drugs and chemicals, and decontaminate the ventilated cabinet before beginning maintenance activities. (v) Notify occupants in the affected areas immediately before the maintenance activity begins, and place warning signs on all affected equipment. (vi) De-energize the ventilated cabinet in accordance with chapter WAC, Lockout/Tagout (control of hazardous energy). (vii) Decontaminate and bag equipment parts removed for replacement or repair before they are taken outside the facility. (viii) Seal used filtration media in plastic immediately upon removal, and tag it for disposal as dangerous waste. (5) Instituation of effective ventilation controls must be accomplished by December 1,

8 WAC Personal protective equipment. (1) Conduct a personal protective equipment hazard assessment as required by chapter WAC, Personal Protective Equipment. (2) Provide, at no cost to the employee, and ensure the use of appropriate personal protective equipment when working with hazardous drugs such as handling vials, compounding and administering hazardous drugs, and performing housekeeping activities. (3) Disposable personal protective equipment must be disposed of as dangerous waste. (4) Gloves. (a) Use powder-free chemotherapy gloves for all hazardous drug handling activities such as opening shipping containers, transporting drugs within the facility, and handling waste containers. (b) Provide latex-free gloves to employees with latex sensitivities. (c) Wear two pairs of gloves when compounding, administering, disposing, and cleaning up hazardous drug spills. The outer glove must extend over the cuff of the gown. (d) Instruct all employees to inspect gloves for physical defects before use. (e) Remove and dispose of gloves between patients, at least every thirty minutes, and whenever as soon as possible whendamaged 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. (5) Protective clothing. (a) Use disposable gowns made of polyethylene-coated polypropylene or other material of equivalent protection whenever there is a risk of skin or clothing contamination. Gowns must be solid in front (back closure), long sleeved, and have tight fitting cuffs. (b) Remove and dispose of gowns at the end of drug handling activites, when leaving the drug handling area, at least every three hours, and as soon as possible when damaged or contaminated. 8

9 (6) 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. (7) Respiratory Protection. Select and use respirators as required in chapter WAC, Respirators. WAC Safe Handling practices. (1) Storage and transport (a) Make sure that all hazardous drug packages received from the manufacturer, distributor, another pharmacy, or medical clinic are in separate, labeled containers. (b) Wear chemotherapy gloves, appropriate gown and a face shield when opening shipping containers. (c) Store hazardous drugs separately from other drugs, and in a manner that minimizes the potential for spills. (d) Store and transport hazardous drugs in closed containers that minimize the risk of breakage. (e) Do not transport hazardous drugs via a pneumatic tube or in any other manner that may result in damaged or broken containers. (2) Preparation (a) Provide work areas that are devoted solely to preparing hazardous drugs and limited to authorized personnel. (b) Use engineering controls such as ventilated cabinets and closed-system transfer devices, when compounding, and transferring hazardous drugs from primary packaging (such as vials) to dosing equipment (such as infusion bags, bottles, or pumps). (c) Spike and prime the IV tubing and syringes inside the ventilated cabinet, or prime them in-line with non-drug solutions. (d) 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. 9

10 (e) Seal and decontaminate all waste containers inside the ventilated cabinet before removing them from the ventilated cabinet. (f) Remove outer gloves and sleeve covers and bag them for disposal while inside the ventilated cabinet. Reference: U.S. Pharmacopeial Convention, Pharmaceutical Compounding Sterile Preparations, Chapter 797. (3) Administering (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, and intracavitary administration. (b) Use engineering controls to transfer and administer hazardous drugs. (c) Wear appropriate PPE when administering hazardous drugs. (d) Spike and prime administration sets prior to adding the drug to the bag. (e) Do not remove tubing from an IV bag containing a hazardous drug. (f) Do not disconnect tubing at other points in the system until the tubing has been thoroughly flushed. (g) Place dangerous waste and other disposable items directly into a designated dangerous waste container. (4) Personal hygiene (a) Prohibit eating, drinking, smoking, applying cosmetics or lip balm, and handling contact lenses in work areas where hazardous drugs may be found. (b) Make sure food and drink are not kept in refrigerators, freezers, shelves, cabinets, or on countertops or bench tops where hazardous drugs are present. (5) Hand washing (a) Provide hand washing facilities that are readily accessible to employees. (b) Wash hands with soap and water before donning chemotherapy gloves, immediately after removal, and whenever hands become contaminated. 10

11 WAC Spill control. (1) Develop written spill response procedures based on the hazardous drugs present in the setting and potential spill or release scenarios. (2) Spill procedures must include, at a minimum: (a) Description of who is authorized to respond and under what circumstances. (b) PPE for various drugs and spill sizes. (c) Location and use of spill kits or clean-up materials, and personal protective equipment. (d) Area containment and signage. (e) Reporting and evaluating the circumstances surrounding spills. (3) Provide spill kits or clean-up materials near all potential spill sources. (4) Use surgical N95 level respiratory protection for clean-up of small spills. Clean-up of large spills or volatile drugs (e.g. Carmustine) require the use of higher level protection such as full face-piece elastomeric respirators. (5) Dispose of all disposable clean-up materials as dangerous waste. Note: See chapter WAC, Emergency Response for requirements when employees are assigned to respond to spills that create significant safety and health risks. See the Scope of chapter for further guidance. See chapter WAC, First Aid for emergency washing requirements. WAC Housekeeping. (1) Establish procedures for routine cleaning and decontamination of areas and equipment where hazardous drugs are present. (2) Clean work surfaces with an appropriate deactivation agent and cleaning agent before and after each activity and at the end of the work shift. 11

12 (3) Wear chemotherapy gloves for routine decontamination and cleaning work. (4) Wear a gown and face protection whenever splashing is possible. (5) Wear two pairs of chemotherapy gloves and gown when handling linens, feces, or urine from patients who have received hazardous drugs. (6) Place laundry in leak-proof, labeled or color-coded containers. (a) If laundry is shipped to an off-site to a second facility that does not handle all laundry as potentially contaminated place laundry in containers that a distinctly color-coded or labled. (7) Place potentially contaminated waste in yellow dangerous waste containers. (a) Do not mix dangerous waste and biomedical or other type wastes. (b) Dangerous waste containers must be: (i) Rigid, leak-proof, and puncture-resistant. (ii) Color-coded and labeled. (iii) Located as close as feasible to the immediate area where dangerous waste is generated or can be anticipated to be found. (iv) Maintained upright throughout use. (v) Replaced routinely and not allowed to overfill. (vi) Closed except when in use, and prior to removal or replacement. 12

13 WAC Labeling and signage. (1) Label hazardous drug containers in accordance with chapter WAC, Employer chemical hazard communication. (2) Post warning signs which are clearly visible in all areas where hazardous drugs are stored or prepared. (3) Post signage or otherwise effectively restrict access to spill areas when appropriate. WAC Medical surveillance. (1) Provide confidential medical evaluations to employees under the following schedule: (a) Upon hire and on a scheduled basis thereafter. (b) Immediately following an exposure incident. (c) Whenever an employee develops signs and symptoms associated with occupational exposure. (d) Whenever an employee requests medical advice on reproductive issues. (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: (a) A medical history that includes reproductive and occupational information. (b) A physical examination that includes evaluation of the skin, mucous membrane, cardiopulmonary and lymphatic systems, and liver. (c) A complete blood count and urinalysis. (d) Additional testing and examinations as recommended by the physician. 13

14 (4) Provide the LHCP the following information: (a) A copy of this chapter. (b) A list of hazardous drugs the employee is exposed to. (c) A description of the employee s duties as they relate to hazardous drugs. (d) A description of the personal protective equipment and respiratory protection the employee uses. (e) Information available from previous employment-related examinations when this information isn t available to the physician. (5) Obtain a LHCP written opinion for each employee medical evaluation and make sure the employee receives a copy within five business days after receiving the written opinion. (6) Instruct the LHCP that written opinions be limited to the following information: (a) Whether or not medical conditions were found that would increase the employee s risk for impairment from exposure to hazardous drugs. (b) Any recommended limitations on the employee or upon use of personal protective equipment. (c) A statement that the employee has been informed of medical results and medical conditions linked with exposure to hazardous drugs requiring further examination or treatment. WAC Training. (1) Provide employees with effective training in the safe handling of hazardous drugs at the time of their initial job assignment, at least annually, and whenever changes in the workplace occur that affect occupational exposure. (2) Make sure employee training includes: (a) The requirements of this rule. (b) A review of the Hazardous Drugs Control Program and how to access a copy of the Program. (c) An explanation of and how to access Material Safety Data Sheets (MSDS). 14

15 (d) Any operations in their work areas where hazardous drugs are present. (e) Health hazards of the hazardous drugs in the work area, including the likely physical symptoms or effects of exposure. (f) Methods and observations that may be used to detect the presence or release of hazardous drugs in the work area. (g) 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: Work practices Engineering controls Personal protective equipment selection and use Spill control System for reporting exposure incidents and hazardous conditions. (h) Medical surveillance protocols. (3) 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 chapter WAC, Employer chemical hazard communication. WAC Recordkeeping. (1) Training Records. (a) Maintain training records for three years from the date of training. (b) Training records must include the following: (i) (ii) Dates of training sessions. Contents or a summary of the training sessions. (iii) Names of person conducting the training sessions. 15

16 (2) Medical Records. (iv) Names and job titles of employees. (a) Establish and maintain a medical record for each employee subject to medical surveillance. (b) The medical records shall include at least the following: (i) (ii) The name and personnel identification number of the employee. Copies of medical examination and test results. (iii) LHCP written opinions. (iv) Any medical complaints related to exposure to hazardous drugs. (c) Maintain and provide access to medical records in accordance with chapter WAC, Employee medical and exposure records. (d) Exposure records. Maintain and provide access to MSDS and other exposure records in accordance with chapter WAC, Employee medical and exposure records. (e) Spill Records. Maintain spill records and evaluation findings for three years from the date of the spill or release. 16