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Part 3, Chapter 27: Manual Exhibit 3-27-F

EXHIBIT 3-27-F – FACILITY CONSIDERATIONS AND EXCEPTIONS

Facilities that may dispense hazardous drugs infrequently or on a limited basis may follow these exceptions to the guidelines. It is important to note that hazardous drugs, whether dispensed for chemotherapy treatment or for other treatments, are dangerous. All hazardous drugs should always be handled appropriately regardless of dosage or treatment regimen. A risk assessment must be performed prior to utilizing any of the following exceptions.

  1. Policies and Procedures see IHM 3-27 Section 3.

    No exceptions.
  2. Required Training see IHM 3-27 Section 4.

    No exceptions
  3. Engineering Control Planning and Design HDs see IHM 3-27 Section 5.

    No exceptions
  4. Engineering Control Testing and Maintenance see IHM 3-27 Section 6.

    No exceptions
  5. Prevention of Employee Exposure – General Requirements see IHM 3-27 Section 7.

    No exceptions
  6. Personal Protective Equipment see IHM 3-27 Section 8.

    No exceptions
  7. Receiving, Storage, and Transportation see IHM 3-27 Section 9.

    See IHM 3-27 section 9B(2). Ensure there is adequate ventilation in the storage area to prevent the buildup of airborne contaminants. The storage area should maintain the air changes per hour (ACH) for which it was designed, but should not provide less than 4 ACH.
  8. Hazardous Drug Preparation see IHM 3-27 section 10(B)1, Use and Selection.
    1. If an appropriate Containment Primary Engineering Control (C-PEC) is not available, facilities should outsource hazardous drugs preparation by ordering prepared hazardous drugs from other facilities equipped with a C PEC. A C-PEC is not required if manipulations are limited to handling of final dosage forms (e.g., counting or repackaging of tablets and capsules) that do not produce particles, aerosols, or gasses.
    2. Facilities not equipped with an appropriate C-PEC that are considering purchasing a new C-PEC should follow IHS Office of Environmental Health and Engineering Technical Handbook Volume 3, Chapter 21-4.10 - Design Requirements for Compounded Sterile and HD Preparation Areas.
  9. Hazardous Drug Administration see IHM 3-27 Section 11.

    No exceptions.
  10. Hazardous Drugs Waste Handling see IHM 3-27 Section 12.

    No exceptions.
  11. Spill Management and Control see IHM 3-27 Section 13.

    No exceptions.
  12. Emergency Response to Occupational Exposures see IHM 3-27 Section 13(F).

    No exceptions.
  13. Medical Surveillance see IHM 3-27 Section 14.

    The Indian Health Service Staff who are primarily handling hazardous drugs will need to be included in medical surveillance but those who contact them in rare circumstances may not be included. Those who are occupationally exposed through spills, body fluid exposure, etc., should always be medically evaluated.