How ASCs can comply with USP standards — 3 Qs with an expert
USP 800 standards for handling dangerous medications safely are scheduled to go into effect Dec. 1.
The USP 800 requires ASCs and other healthcare organizations to be compliant with a number of medication handling standards regarding receiving, transporting, storing, dispensing and disposing of them and standards for patient care.
Brian Williams, director of compliance and regulatory affairs at regulatory training company MedTrainer, shared tips with Becker’s ASC Review about how to prepare for the standards.
Note: Responses have been lightly edited for style and clarity.
Question: When it comes to the USP 800, what should ASCs look for in a compliance leader?
Brian Williams: ASCs should seek an individual who is knowledgeable in regulatory compliance, including the Occupational Safety and Health Administration’s hazardous communication standard and the the National Institute for Occupational Safety and Health list of antineoplastic and other hazardous drugs in healthcare settings (an update is anticipated on Dec. 1), USP 800 standards and applicable state board of pharmacy requirements. They should also have clinical knowledge of how hazardous drugs are received, stored, administered and disposed. This person should have the skill set needed to collaborate with others, including pharmaceutical suppliers, to maintain open lines of communication and leadership commitment.
Appointing a leader is not only a best practice, but requirement of USP 800. It states explicitly that ASCs that compound hazardous drugs, “must designate a person that thoroughly understands the rationale for risk prevention policies, risks to themselves and others, risks of noncompliance that may compromise the safety of patients and others and the responsibility to report potentially hazardous situations to the management team. The designated person must also be responsible for the oversight of monitoring the facility and maintaining reports of testing/sampling performed in facilities and acting on the results.”
USP 800 does not outline specific qualifications of the designated person, but does suggest additional training if needed.
Q: Once the new standards go into effect, what can ASCs do to remain compliant?
BW: ASCs should not wait until the new standards go into effect to become compliant with certain aspects of USP 800 that are already enforceable standards under OSHA’s general duty statutes. Compliance requires that ASCs know which hazardous drugs are applicable to their facility and the associated risks. A good starting point is to complete an inventory of all drugs that are present or could be present (due to physician orders), and then conduct an assessment of risk (AOR) for each hazardous drug and dosage form.
Q: What are the key aspects of a risk assessment ASCs should focus on?
BW: USP 800 and OSHA have very similar requirements regarding the AOR for hazardous drugs. The USP 800 standard requires, at a minimum, an AOR that includes: the type of hazardous drug, specific dosage (for each one), risk of exposure, packaging in which the drug is received, type of manipulation to render the final dosage form, and specific alternative containment strategies to protect employees from ingesting, inhaling or touching hazardous particulates or vapors. ASCs should focus their AOR to ensure compliance can be met with workers’ rights under OSHA, which include working conditions that do not pose a risk of serious harm and to receive information and training.
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