Pharmacy Core, Version 3.0 PHARM Core 35 - Consumer Complaint Process


The Basics

This standard spells out requirements for your organization's formal process to handle consumer complaints and appeals.  That process must include:

  • a system that provides for a prompt response to complaints
  • notice of final resolution with an explanation
  • a means to let consumers know how to appeal those decisions
  • documentation that the organization is meeting its time frames for resolution of complaints
  • a mechanism to report to the organization's QM committee on complaints and appeals.

This standard is comprehensive in the sense that it addresses all expressions of dissatisfaction with the organization's performance.  So, what employees need to know is that, if your organization is compliant with this standard, every employee who receives a complaint has a corresponding P&P that describes what should be done with that.  If you are an employee and don't know what to do with a complaint, look at your P&Ps to make sure you've got the procedure down pat.  If you look and find that your organization doesn't have a P&P that fits you or your situation, bring that to someone's attention so that an appropriate P&P can be developed to handle it.  Remember -- URAC requires that you have some sort of process for every expression of dissatisfaction.

Management Tips

The question I get most often from my clients about these standards is this: "Does this create appeal rights for all complaints?"

The answer is, "no". The standards are careful to use the phrases "if available" and "when appropriate" when referring to appeal rights. Other URAC standards do grant very specific appeal rights, but not these.

No, these standards simply explain that you must have a system for responding promptly to all complaints, and where you do offer appeal rights, that it be formal, including written notice of final determination, notification of the process for appeal, and reasonable time for resolution. And, don't forget to report periodically to the quality committee!

If you say you have no complaints, URAC's view, articulated at a recent education seminar, is that your employees probably don't know what a complaint is.  URAC's definition is broad: "An expression of dissatisfaction regarding the organization’s products or services."  With a definition that broad, URAC's thinking goes, you should have some complaints in your tracking system.

URAC Accreditation Tips

One of the elements is mandatory; the other four are weighted 4 or 3.

For the desktop review, submit all P&Ps and program descriptions that describe your mechanism(s) for handling complaints and appeals.  Also, make sure you submit a report from your complaint tracking system(s).  URAC will need to see that you have a way of not only capturing and handling all complaints, but for tracking and trending those complaints so that, when you report them to the QM committee, that committee will be empowered to take action to address systemic concerns identified by those complaints.  Also, any mechanisms for notifying consumers of appeal rights (template letters, telephone scripts) also should be part of your AccreditNet submission.

The onsite review will require that you provide reviewers with the complaint log.  The reviewer will select complaints from that log to examine how your organization handled the complaint, to make sure that you did so in compliance with your own P&Ps.  Also, everybody involved with the complaint and appeals system(s) will need to be conversant in your P&Ps on the topic.  Remember -- compliance with your own P&Ps is the most important component of this set of standards.