Mail Service Pharmacy (4.0) 4.0

RM 2-1: Business Continuity Plan

Submited by: Tom Goddard

The Basics

Your organization must implement a business continuity plan ("BCP") for its program operations. The BCP must:

  • Clearly identify the systems and processes that are essential to your organization;
  • Outline the effect that the disruption of these systems and processes would have on your organization;
  • Describe your organization's strategy for dealing with such disruptions in various circumstances, such as various lengths of time of outage.

Management Tips

URAC sees this as a sequential process:

  • In order to prepare a BCP, you first need to figure out what business operations need to be in continuous operation.
  • Once you've done that, you need to envision what would happen if something happened to each of these operations, and document those possible consequences of an outage.
  • Only then are you ready to say what you'll do to respond to an outage in order to maintain operational continuity.
In the midst of your BCP document, we recommend that you build a spreadsheet or grid that outlines all of these possible outage scenarios and your response to each such scenario. Reviewers like grids for this standard.

Accreditation Tips

Desktop Review
Provide the BCP and any other documents that would be useful in conveying to the reviewer that you've thought through and planned for the full array of outage scenarios.
Validation Review
URAC’s Accreditation Guide for this standard claims that this compliance with this standard will not be assessed during the validation review. Nevertheless, we recommend that your IT staff be prepared to show the reviewer any documentation that shows activity related to the BCP since you submitted documents to URAC for desktop review. Such documents might include committee meeting minutes or testing results.

  • Specialty Pharmacy (4.0) 4.0 / 05.19.2020


    Focus area

  • Specialty Pharmacy (4.0) 4.0 / 05.19.2020

    PROD 7-1: Compounding Requirements

    If the pharmacy engages in compounding, it must implement policies and procedures that ensure that the compounding activities meet both USP guidelines and applicable laws and regulations, whether state or federal. Those policies need to identify who is responsible for ensuring such compliance and how he/she/they are to do that. 

  • Specialty Pharmacy (4.0) 4.0 / 05.19.2020

    PROD 6-1: Machine and Equipment Maintenance

    The pharmacy must implement written policies and procedures that:ensure that all machines and equipment in the pharmacy are maintained according to both the guidelines provided by the manufacturers and any applicable regulations, andprovide for the documentation of the implementation of the processes dealing with cleaning, calibrating, and auditing of the machinery and equipment.The machinery and...