We are USP 800 compliant

We meet all regulatory compliance standards.

USP 800 and The National Institute for Occupational Safety and Health (NIOSH) recommends that employers develop a medical surveillance program to monitor the safety of the employees working with hazardous drugs, including wipe sampling every 6 months.

This recommendation includes using baseline data and ongoing monitoring of environmental hazards as a way to assess the potential risk of employee exposure to hazardous drugs.

Additionally, USP 800 recommends using pre-saturated wipes to decontaminate surface areas.

USP 800 states the following:

Environmental wipe sampling for HD surface residue should be performed routinely (e.g., initially as a benchmark and at least every 6 months, or more often as needed, to verify containment). 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-PECs (e.g., floors directly under C-PEC, staging, and dispensing area)
  • Areas immediately outside the HD buffer room or the C-SCA
  • Patient administration areas

If any measurable contamination is found, the designated person must identify, document, and contain the cause of contamination. Such action may include reevaluating work practices, re-training personnel, performing thorough deactivation, decontamination, cleaning, and improving engineering controls. Repeat the wipe sampling to validate that the deactivation/decontamination and cleaning steps have been effective.

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