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Ready for <800> Checklist: Hazardous Drugs (HDs) Handling in Healthcare Setting

  1. Scope
    Rationale: Applies to all entities & healthcare personnel where HDs (Hazardous Drugs) are handled.
    1. HD handling activities occur in settings:
      • Receipt and Storage
      • Compounding
      • Dispensing
      • Administration
      • Disposal of Products and Preparations
      • Transport
    2. Occupational Safety Plan
  1. List of Hazardous Drugs (HDs)
    Rationale: All requirements of <800> must be followed for drugs on NIOSH list if they are APIs or antineoplastic HDs requiring manipulation. Exceptions are final dosage forms if only counted or repackaged, or for specific dosage forms based on an assessment of risk.
    1. Entity maintains a list of HDs
    2. List includes all items on the current NIOSH list that the entity handles
    3. Entity reviews list at least every 12 months (Date reviewed: ________________)
    4. Assessment of risk for specific dosage forms reviewed every 12 months (date performed: ______________)
    5. Documentation of alternative containment strategies for specific dosage forms
      Assessment Risk Considers:
      • Drug
      • Dosage form
      • Risk of exposure
      • Packaging
      • Manipulation
  2. Responsibilities of Personnel Handling HDs
    Rationale: All personnel who handle HDs are responsible for practices and precautions to prevent patient harm, minimize worker exposure, and minimize environmental contamination
    1. Entity designates a person to oversee compliance
    2. Designated person is qualified and trained
    3. Designated person monitors compliance, maintains reports of testing/ sampling
  3. Facilities and Engineering Controls
    Rationale: HDs are handled under conditions that promote patient safety, worker safety and environmental protection.
    1. HD receiving area(s)
      • Signs Designating the hazard are displayed at entrance
      • Neutral or negative pressure relative to surrounding areas
      • No unpacking from shipping containers in sterile compounding area
    2. HD storage area(s)
      • Signs designating the hazard are displayed at entrance
      • No HD drugs stored on the floor
      • Manner of storage prevents spills and breakage
      • HD stored separately from non-HDs
      • Refrigerated HDs stored in dedicated refrigerator
      • HDs stored in externally vented, negative pressure room w/ 12 ACPH
    3. Compounding – Sterile products
      • Containment primary engineering control (C-PEC) (type:____________)
      • C-PEC externally vented
      • C-PEC operates continuously
      • Containment secondary engineering control (C-SEC)(room where C-PEC placed)
      • C-SEC externally vented through HEPA filtration
      • Physically separated from other preparation areas
      • Appropriate air exchange
      • Negative pressure relative to surrounding areas (0.01-0.03 in. water)
      • Sink for handwashing
      • Eyewash station
    4. Compounding – Nonsterile products
      • Dedicated C-PEC (Type:_______________________)
      • C-PEC externally vented or redundant-HEPA filters in series
      • Located in C-SPEC
        • C-SEC externally vented
      • Minimum 12 air changers per hour
      • Supplemental Engineering Controls used:
        • Compounding
        • Administration
  4. Environmental Quality and Control
    Rationale: Environmental Sampling for contamination is used to verify containment of HDs
    1. Environmental wipe sampling is performed at baseline and every 6 months
    2. The designated person takes action and identify, document and contain the cause when measurable contamination is found
    3. Assesses facility & Personnel compliance with USP <797> (sterile compounding)
      • Total particle counts
      • Viable air sampling
      • Surface sampling
      • Gloved fingertip sampling
      • Appropriate growth media used
    4. Documents facility and personnel compliance with USP <797>
      • When sampling occurs
      • Where sampling occurs
      • Number of samples
      • Conditions under which sampling occurs
      • Materials required
      • Action levels
  5. Personal Protective Equipment
    Rationale: Appropriate PPE provides worker protection when handling HDs
    1. SOP describes PPE to be worn for HD handling activities
    2. Chemotherapy gloves provided
      • Chemotherapy gloves meet ASTM standard D6978
      • Sterile gloves provided for sterile compounding
      • Double gloves worn for HD administration
    3. Chemotherapy gowns provided
      • Gowns shown to resist HD permeation
      • Disposable gowns provided
    4. Head, hair, shoe, and sleeve covers provided for HD preparation
    5. Eye and face protection provided
    6. Respiratory protection provided
    7. Used PPE is discarded according to local, state, and federal regulations
  6. Hazard Communication Program
    Rationale: Workers who handle HDs are informed of the risks and method of reducing exposure
    1. Written hazard communication program in place
    2. All HD containers are labeled with a hazard warning
    3. SDS onsite for each Hazardous chemical
    4. SDSs accessible to personnel in all locations and at all times
    5. Personnel receive initial and updated information and training
    6. Personnel of reproductive capability confirm understanding of risks in writing
  7. Personnel Training
    Rationale: All personnel who handle HDs are trained based on their job functions
    1. Initial training for HD handling is provided and documented
    2. Initial HD handling competency is evaluated
    3. HD handling competency is validated at leave every 12 months
    4. Other potential competencies:
      • Environmental sampling
      • Material handling
      • Use of SEC
  8. Receiving
    Rationale: HDs are handled safely in receiving and internal transfer process
    1. SOPs are in place for receiving HDs
    2. HDs are segregated from other drugs
      • Supplier clearly marks outer container
      • Single container should contain only HDs
      • HDs in marker container should be enclosed in impervious plastic
    3. PPE is provided and worn by workers unpacking HDs
    4. HDs are delivered to HD storage area immediately after unpacking
    5. Policies address handling damaged or broken HD containers
    6. Spill kit available in receiving
  9. Labeling, Packaging, Transport, and Disposal
    Rationale: Policies specify that HDs are labeled, packaged and transported in a manner to minimizes worker exposure
    1. HDs are clearly labeled at all times during transport
    2. HDs are packaged to maintain integrity, stability, and sterility during transport
    3. HDs are transported in a manner to minimize breakage, leakage
      • Consideration given to who transports
      • Pneumatic tubes are not used to transport HDs
    4. Policies address HD waste handling based on local, state, and federal regulations
  10. Dispensing Final Dosage Forms
    Rationale: Dosage forms that are not manipulated may not need all containment requirements
    1. Dedicated equipment is used for counting and repackaging HDs
    2. Automated counting or packaging machine are not used for solid HD forms
    3. IV tubing attached and primed prior to adding HDs to infusion containers
    4. Designated decontamination agent used to wipe final CSP surface prior to transfer out of C-PEC
    5. Final containers have luer lock or CSTD systems in place
    6. Final CSP placed in zip-locked bag clearly marked
  11. Compounding
    Rationale: Compounding is performed in accordance with USP standards including 795 and 797
    1. Compounding is performed in proper engineering controls
    2. Plastic-backed preparation mats are used on work surface of C-PEC
    3. Equipment used for compounding HDs is dedicated for us with HDs
  12. Administering
    Rationale: HDs are administered safely
    1. Needleless system used
    2. Closed System Transfer Devices (CSTDs) used when dosage form allows
    3. Spiking and priming IV tubing NOT performed at administration site
    4. Manipulation of dosage forms limited
    5. All appropriate PPE available and used
    6. Designated waste containers available
    7. Spill kit available at sites of administration
  13. Deactivating, Decontamination, Cleaning, and Disinfecting
    Rationale: Deactivating, decontamination, cleaning, and disinfecting reduce environmental contamination with HDs
    1. Written procedures exist for decontamination, deactivation, cleaning and for sterile compounding areas, disinfection
    2. Policies specify agents, dilutions, frequency, and documentation requirements
      • Decontamination agent is EPA registered oxidizing agent
      • Cleaning agent contains a surfactant
      • Sporicidal agent is used weekly
      • Sterile IPA 70% used as disinfectant
      • Contact time documented for all agents used
      • Manufacturer instructions followed for use of all agents
      • MSDS available for all cleaning agents
      • Documentation of non RTU solutions available
      • Cleaning performed from cleanest to dirtiest
      • Monitoring program exists for compliance with PnP
      • Appropriate cleaning supplies used (mops, bucket, ect.)
      • Cleaning equipment stored appropriately
    3. Personnel performing activities are trained and wear appropriate PPE
      • Only authorized pharmacy personnel clean PEC
      • Eye/face protection worn when cleaning and disinfection performed
      • Respiratory protection utilized
      • Gown & double gloves worn
  14. Spill Control
    Rationale: Qualified personnel available to manage HD spills; SOPs describe spill management procedures
    1. SOP for spill management in place
    2. Spill training provided
      • Spill drills performed
    3. Spill kits available in all areas where HDs are handled
    4. Spill reporting process in place
  15. Documentation and Standard Operating Procedures
    Rationale: Standard operating procedures describe the safe handling of HDs throughout the facility
    1. SOPs address entire HD safety program
    2. SOPs are reviewed every 12 months and the review is documented
    3. Updates to SOPs and communicated to all personnel handling HDs
      • SOPs are:
        • Clear and concise
        • Complete with all necessary information
        • Are objective not opinion
        • Coherent sequential steps
        • Consistent and used to train new staff
        • Accessible for reference
      • SOP format
        • Header that clearly identifies information
        • Sections
          • Definitions and purpose
          • Policy statement
          • Reference other documents (internal and/or external)
          • Procedures
          • Documentation (sample forms)
        • Footers
          • Pages number
          • Confidentiality statement
  16. Medical Surveillance
    Rationale: Medical surveillance is used to minimize adverse health effects in personnel potentially exposed to HDs
    1. Entity has process to identify workers who are potentially exposed to HDs
    2. Medical surveillance service is available onsite or by contract
    3. Entity provides pre-placement assessment of workers who handle HDs (health history, HD exposure history, physical examination, laboratory testing)
    4. Entity provides periodic surveillance (health history, exposure history, physical assessment, and laboratory testing if appropriate
    5. Entity monitors surveillance data
    6. Entity provides exit health assessment for workers who handle HDs
    7. Entity has plan for post-exposure follow up
    8. Entity uses medical surveillance data to evaluate effectiveness of HD program

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