Assessment of Risk Tools

Below are sample tools to demonstrate methods of how an organization or entity can create an Assessment of Risk.  There is no required format for the AoR as long as it meets the required elements as noted above.  Performing AoRs is a large and time consuming task and there are many ways to create or organize these AoRs.  Please find sample templates for AoRs below.

AoR Format 1
This Assessment of Risk AoR Format 1 document for hazardous medication is an example of a conservative approach to USP Chapter <800> Standards. The USP Chapter <800> standards were applied in an equal manner across the three table categories of hazardous medications (Antineoplastic, Non-Antineoplastic, and Reproductive Risk). With this method, Table 5 from the NIOSH list of antineoplastic and other hazardous drugs in healthcare settings 2016 were applied to each hazardous drug’s dosage form on formulary to meet USP Chapter <800> standards with all medication tables. References in the footnotes are straight from the NIOSH Table 5. Special comments such as medications with a long excretion half-life or that are volatile are in the right hand column. Nurses are directed to the proper PPE based on colored icons on the electronic medication record (matching the dosage form) and signage in medication storage rooms on the patient care units (see attached signage examples).


AoR Format 2
This excel AoR Format 2 spreadsheet contains three tabs- the hazardous drug (HD) list (“HD list”), the master assessment of risk (AoR) tracking tab (“Master AoR List”), and a standardized key for containment strategies (“AoR Containment Strategy Table”). It is intended for use in a large system to help standardize the practice changes put in place for minimizing exposure to hazards.  The entire NIOSH 2016 drug list and all of the drugs’ formulations are listed in the Master AoR tab.  Each drug’s individual dosage form had a formal AoR document written up and tracked on this spreadsheet.  The sample AoR document provided in a Perform an Assessment of Risk to Comply with USP <800> by Kienle and Douglass was used as the template for the formal write up. 


AoR Format 3
This AoR Format 3 document’s intent is to contain all hazardous drugs from NIOSH and determine what safety strategies are need to be implemented for them. The column titled “*HAZ* Labeling” contains drugs identified as hazardous that will be identified in the drug name listing in the EHR, ADC, and other technology used in the facility (ex. Anastrazole *HAZ* 1 mg tablet). The column titled “Chemo/Bio therapy certified nurse required (CHEMO skill type)” identifies which medications per facility policy require a chemotherapy certified nurse to administer the medication. The column titled “eMAR prompt (CDS) for dose double check” identifies which medications have a documented nurse-to-nurse double check in the EHR during medication administration. The column titled “Label Comment Category” identifies the standard label comments that apply to that drug (see the “label comments” tab for examples).

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