Specialty Pharmacy (4.0) 4.0

RM 1-2: Policy Addressing Reporting of Violations

Submited by: Tom Goddard

The Basics

This standard requires that your organization implement a policy that protects whistleblowers from retaliation. A whistleblower is someone who submits a good faith report of suspected violations of ethical, regulatory, or legal requirements. The policy also must address what happens when an individual fails to report such violation, and how your organization will protect the confidentiality of such a report.

Management Tips

This standard requires that you have a very specific policy addressing not only the protection of whistleblowers, but staff members’ obligations to report violations of legal and ethical standards. Do not use general language like “the organization will protect confidentiality of whistleblower reports.” Rather, describe the mechanisms for staff members to use to report violations, the administrative mechanisms for keeping reports confidential, and how staff members will be trained in their rights and responsibilities regarding the reporting of violations.
URAC likely will expect you to maintain documentation of how your staff members are trained in these rights and responsibilities, so add this to the list of staff trainings that your HR department tracks. Merely having a policy will not suffice -- staff needs to know they are not only protected from retaliation, but actually obligated to report legal and ethical violations.

Accreditation Tips

Desktop ReviewSubmit your policy or policies that describe:

  • Whistleblower protections from retaliation;
  • Staff obligations to report legal and ethical violations; and
  • Mechanisms for preserving whistleblower confidentiality.

While not explicitly mentioned in the URAC Accreditation Guide, we also recommend that you submit some sort of documentation of staff training in this policy.
Validation ReviewThe URAC Accreditation Guide says that there is no validation of this standard during the URAC Validation Review. That being said, make sure your staff members have been trained in your policy and can answer questions about it during that review. 

  • 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...