Administrative (22%)
Environmental wipe sampling for HD surface residue
(Course 2; Pg 40) Performed routinely
Universal Waste
- A category of hazardous materials including batteries, and mercury-containing equipment - Electrical equipment
Chapter <800> Requirements
- An entity must maintain a list of hazardous drugs (HDs) used in its facility. - This list must include any HDs found on the 2016 NIOSH list that are handled by the entity. - When an entity uses a new agent or dosage, it should be reviewed against the NIOSH list. - Entities must review their list of HDs at least every 12 months. - If you are unsure if a drug is hazardous, consider it hazardous.
Sharps and infectious waste container
- Any object contaminated with a pathogen or that may become contaminated with a pathogen through handling or during transportation. - Capable of cutting or penetrating skin or a packaging material. - Needles - Syringes (in some cases empty syringes without a needle attached are considered trash-safe waste - Glass slides - Triptic Soy Agar (TSA), malt extract agar (MEA), and other media.
Generator
- Any person or facility whose act or process produces a medical, pharmaceutical, or hazardous waste. - They possess the waste until transported by a licensed waste hauler. - Each site must have an ID number from the EPA.
Non-hazardous pharmaceutical waste (non-RCRA hazardous) white or white/blue container
- Any waste resulting from non-hazardous drug disposal. - Expired drugs (not able to be sent through a reverse distributor). - Antibiotics with pourable amounts (not empty containers). - Full I.V.s or other devices containing non-hazardous medications.
Standard for acceptable limits of HD Surface Contamination
- Currently there are no certifying agencies for vendors of wipe sample kits - No standard - If any measure contamination is found, the designated person must: - - Identify - - Document - - Contain the cause of contamination - - Repeat the wipe sampling to validate that the deactivation/decontamination and cleaning steps have been effective.
Responsibilities of the designated person
- Developing and implementing appropriate procedures. - Compliance with Chapter <800> and applicable laws, regulations, and standards. - Ensuring the competency of compounding personnel. - Overseeing environmental control of storage and compounding areas.
HD Waste disposal in the home
- EPA and FDA have recently made changes to their guidance for pharmaceutical waste in the home. - Refer to the FDA Flush List and follow proper directions for disposal. These include: - - Mix medication with dirt, kitty litter, or coffee grounds - - Place mixture in sealed plastic bag - - Throw into trash - The preferred method from FDA is to dispose of medications at a drug take-back location. - EPA has recently ruled hazardous medications in the home can not be poured down a drain or flushed; these hazardous medications must be disposed properly.
Exceptions to sewerable and trash-safe waste
- Empty items with trace amounts of chemotherapy must be placed into the trace chemotherapy waste container - Empty items with trace amounts of P-listed RCRA hazardous waste are placed in the P-List RCRA hazardous waste container. - State regulations may vary on empty containers with trace amounts of non-hazardous waste.
Trace (residual) chemotherapy/cytotoxic waste yellow container
- Empty vials, empty syringes, empty I.V. solution containers used in the preparation and administration of chemotherapy/cytotoxic drugs. - Other trace-contaminated PPE and supplies used in the preparation and administration of chemotherapy/cytotoxic drugs. - Supplies used to deactivate, decontaminate, clean, and disinfect devices, containers, and areas used in preparation of chemotherapy/cytotoxic drugs.
Trash-safe Waste
- Empty vials, syringes, and other containers where the contents have been removed and only trace amounts remain can be placed in the trash receptacle. - All liquid that can be removed with a syringe has been removed.
HD waste manifest and pickup
- Follow a cradle to grave management of waste - When waste picked up, the waste disposal company generates a manifest from the logs/ - The manifest is to be returned to the waste generator within 45 days. - The shipper is required to retain a copy or electronic image of the manifest for 375 days. - The shipper must retain both copies of the HW manifest for three years; this includes their initial copy and the copy from the disposal facility. - The generator is required to retain a copy or electronic image of this shipping paper for a minimum of three years; the copies must be accessible at, or through the principal place of business, and must be made available if requested.
Expired medications and use of a reverse distributor
- Full intact/unused vials are not considered waste by most state EPA regulations. - If permitted by state regulations, facilities shall utilize a reverse distributor for their outdated pharmaceutical management. - Reverse distributors will provide a DEA 222 form for controlled substances. - Most reverse distributors will not accept hazardous medications, either compounded or in intact/unused vials. - You will need to speak with your reverse distributor to determine what they will accept.
Surface wipe sampling should include
- Interior of the C-PEC and equipment contained in it. - Pass-through chambers - Surfaces in staging or work areas near the C-PEC - Areas adjacent to C-PEC - Areas immediately outside the HD buffer room or the C-SCA - Patient administration areas - Verifying wipe sampling kits before use
Resource Conservation and Recovery Act (RCRA)
- Is a law that created the framework for the proper management of hazardous and non-hazardous solid waste. - Law enacted in 1976 - The law gave the Environmental Protection Agency (EPA) the authority and guideline to develop the program. - It is a joint federal and state endeavor, with the EPA providing basic requirements for each state to adopt, adapt, and enforce. - The EPA has published waste management regulations, which are codified in Title 40 of the Code of Federal Regulations, 239 through 282; regulations regarding management of hazardous waste begin in part 260. - In 1984, Congress expanded the scope of the program, with the enactment of the Hazardous and Solid Waste Amendments (HSWA), which expanded coverage of the law to small quantity generators of hazardous waste.
U-listed Waste
- Many chemotherapy drugs - Selenium dioxide - Discarded commercial chemical products
Sewerable Waste
- May be discarded down the sink. - I.V. solutions containing only dextrose, saline, electrolytes, multivitamins, or other nutraceutical products.
Data Elements (of Medical Surveillance)
- Medical (including reproductive) history to assess exposure to HDs. - Work history - Physical examination - Laboratory testing
P-listed waste / Black P-listed Container
- Medications that contain chemicals which are considered acutely toxic under ++RCRA - Arsenic, warfarin, and epinephrine - Nicotine: check local regulations after the recent rulings from EPA - Requires separation from all other waste - Requires special labeling and disposal.
Proper storage of full HD waste
- Once waste containers are full, they can be placed in a segregated area while they await pickup from a licensed waste disposal company for a limited time. - Consider storing HW containers in the negative pressure room (NPR) until pickup - Seal the container and note the date it was sealed on the bin label. - When placing containers in the storage area document on a log the type of waste and date placed into storage. - Ensure the storage area is of adequate size to safely contain the amount of waste generated over a span of time. - Do not stack containers on top of each other to prevent spills. - The holding area must be marked off with tape and warning signs. - Depending on the generator category and type of waste, containers may only be stored on site for a specified timeframe.
That SOPs must address
- Prevention of accidental exposures or spills - Personnel training on response to exposure - Use of a spill kit
Very Small Quantity Generator
- Quantity of acute HW generated in a calendar month: - - < or = 1 kg - Quantity of non-acute HW gen. in a cal. month: - - < or = 100 kg - Qty of residues from a clean up of acute HW gen....: - - < or = 100 kg
Small Quantity Generator
- Quantity of acute HW generated in a calendar month: - - < or = 1 kg - Quantity of non-acute HW gen. in a cal. month: - - > 100 kg and < 1,000 kg - Qty of residues from a clean up of acute HW gen....: - - < or = 100 kg
Large Quantity Generator
- Quantity of acute HW generated in a calendar month: - - > 1 kg - Quantity of non-acute HW gen. in a cal. month: - - > or = 1,000 kg - Qty of residues from a clean up of acute HW gen....: - - > 100 kg
Methods to assess exposure
- Records of HDs handles, with quantities and dosage forms - Number of HDs handles per week - Number of hours spend handling HDs - Physical assessment and laboratory studies
Elements of the Medical Surveillance Program
- Reproductive and general health questionnaire - Laboratory studies - Physical examination
HD Waste Container Information
- Type of waste - Accumulation start date - Waste generators' name and address - Appropriate hazard warning
Pourable is not empty
- Visible amount of solution that can be swirled in a vial or capable of pouring. If the droplets can be swirled into a pourable amount.
Comprehensive Exposure Control Program
A Medical surveillance is part of a ___________ complementing engineering controls, safe work processes, and use of PPE. - Healthcare workers who handle HDs should be enrolled in a medical surveillance program. - The purpose is to minimize adverse health effects in personnel.
Recommended but not required
A medical surveillance program is _____________, under USP <800>.
Designated Person (Also responsible)
Also responsible for: - Reporting potentially hazardous situations to the entity's management team. - Oversight and monitoring of the facility. - Maintaining reports and all testing and sampling conducted in the facility. - Acting on the results of testing and sampling and taking appropriate action.
Hauler or Disposal Company
Collects and transports waste for the purpose of disposal.
The EPA does not
Does the EPA require documentation of training for states that adopt new the regulations?
Hazard Communication Program Plan (cont)
Elements must also include: - Ensuring SDSs are readily accessible to personnel during each work shift and in their work areas. - Providing information and training before initially working with HDs. - Having personnel of reproductive capability confirm in writing that they understand the risks of handling HDs.
Hazard Communication Program Plan
Elements must include: - Providing a written plan on standard implementation - Ensuring all hazardous chemicals are labeled, tagged, or marked with identity of the material and appropriate hazard warnings. - Providing SDS for each hazardous chemical used.
Hazardous and Solid Waste Amendments (HSWA)
Established in 1984, Congress expanded the scope of the RCRA with the enactment of the? - This expanded the coverage of the law to small quantity generators of HD waste.
Personnel Training
Everyone who handles HDs must: - Train based on their job functions - Train before they independently handle HDs - Demonstrate competency in handling HDs - Reassess their competency at least every 12 months. - Train prior to the introduction of new HD or new equipment.
Medical Surveillance Program
Healthcare organizations are expected to have in place a comprehensive approach to worker safety and health, including: - Engineering controls - Good work practices - PPE - Follow-up for workers who had health changes or had a significant exposure
375 days
How log is the shipper required to retain a copy or electronic image of the manifest?
365 days
How long can healthcare facilities accumulate non-creditable hazardous waste, if they meet certain qualifications?
At least every 12 months
How often must entities review their list of HDs?
At least monthly
How often should the areas under the work tray in the C-PECs be cleaned to reduce the contamination level?
Within 45 days
How soon is the manifest to be returned to the waste generator?
Medical Records Surveillance
Maintained according to OSHA regulations, should include: - Monitoring workers' health prospectively - Monitoring of the data - Follow-up plan for workers who have shown health changes - Exit Examination
Black Hazardous Waste Container (Medical RCRA)
Medications and containers placed in the container include hazardous waste: - Cytotoxic drugs in vials, bags, syringes, or other containers. - Toxic - Ignitable - Hormones - Contents of a used Chemo Spill Kit. - Selenium or chromium remaining in a vial - Trace element combinations containing selenium remaining in a vial
Powered Air-Purifying Respirator (PAPR)
Motorized respirator that uses a filter to clean surrounding air, then delivers it to the wearer to breathe; typically includes a headpiece, breathing tube, and a blower/battery box that is worn on the belt.
SOPs for Spill Control
Must address: - Size and scope of the spill - Who is responsible for spill management - Type of PPE required - Location of spill kits - Clean-up materials - Capacity of the spill kit - Appropriate full-facepiece chemical cartridge-type respirators
Minimum Personnel Training
Must include at least: - Entity's list of HDs and their risks. - Entity's SOPs related to handling of HDs. - Proper use of PPE - Proper use of equipment and devices - Response to known or suspected HD exposure - Spill management - Proper disposal of HDs and trace-contaminated materials
Hazardous Drug Training
Must include at least: - Overview of entity's list of HDs and their risks - Review of the entity's SOPs related to handling of HDs - Proper use of PPE - Proper use of equipment and devices (e.g., engineering controls) - Response to known or suspected HD exposure - Spill management - Proper disposal of HDs and trace-contaminated materials
Chemical product for P and U list
Per the RCRA and EPA, these commercial products are either 100 per pure, technical grade, or the sole active ingredient in a chemical formulation.
Training Documentation
Personnel who transport, compound, or administer hazardous drugs must document what, according to OSHA standards and all other applicable laws and standards?
Recommended Standard Operating Procedures
Recommended under Chapter <800>: - Hand hygiene and use of PPE based on activity - Deactivation, decontamination, cleaning, and disinfection - Dispensing - Transport - Administering - Environmental monitoring - Disposal - Spill control - Medical surveillance
Standard Operating Procedures (Programs)
Recommended under Chapter <800>: - Hazard Communication Program - Occupational Safety Program - Designation of HD areas - Receipt - Storage - Compounding - Use and maintenance of proper engineering controls
Standard Operating Procedures (SOP)
Recommended under Chapter <800>: - They must be reviewed at least every 12 months. - The review must be documented. - Changes must be communicated to personnel who handle HDs.
Environmental Wipe Sampling
Should be: - Performed routinely Should include: - Interior of the C-PEC and equipment in it - Pass-through chambers - Surfaces in staging or work areas near the C-PEC - Areas adjacent to C-PECs - Areas immediately outside the HD buffer room or the C-SCA - Patient administration areas - Verifying kits before use
All personnel who handle HDs
Who's responsibility is it to understand the fundamental practices and precautions that ensure the safe handling of HDs?
EPA's Website
Where are the list of P listed and U chemicals published?
Title 40 of the Code of Federal Regulations (239-282; HD in part 260+)
Where has the EPA published waste management regulations?
Negative pressure room (NPR)
Where should waste containers storing hazardous medications, or PPE used during hazardous drug compounding be located?
California and Florida
Which states include onsite annual inspections of hazardous waste?
You and entire communities
Who can be at risk if a medication or chemical is disposed of unsafely?
Currently no certifying agencies
Who is in charge or certifying vendors of wipe sample kits?
The entity
Who must maintain Standard Operating Procedures (SOPs) for the safe handling of HDs in all situations in which they are used throughout the facility?
Designated Personnel
Under Chapter <800>, the entity must have someone who has the responsibility of overseeing the handling of HDs.
P and U listed waste characteristics
Waste defined by the chemical combinations or ingredients that exhibit hazardous characteristics: - Ignitability - Toxicity - Corrosivity - Reactivity
Large, Small, and Very Small Quantity Generator
What are the Generator Categories based on quality of waste generated in a calendar month?
No standard
What is the acceptable limits for HD surface contamination?
Standard Operating Procedures (Development)
What must entities develop to ensure effective training regarding proper: - Labeling - Storage and disposal of HDs - Transport - Use of Safety Data Sheets (SDS)
USP Chapter <800>
What requires training regarding regulations?
Fit tested and trained
What should personnel do to use respiratory protection?
1976
What year was the RCRA law enacted?
Any measurable contamination
When should the designated person: - Identify - Document - Contain the cause of contamination - Repeat the wipe sampling to validate that the deactivation/decontamination and cleaning steps have been effective?
