Consumer Safety

CORE, Version 3.0 CORE 38 - Consumer Safety Mechanism


The Basics

One of the most important of the URAC standards is this one, which requires that the organization have processes to respond quickly to urgent situations that threaten consumers' well-being.

Even though the standard speaks of "a mechanism", the reality is that it requires a system of mechanisms dealing with the full array of urgent situations that are likely to confront the applicant. You can see this intent reflected in the Program Guide under the "Evidence for Desktop Review" section:

Policies and procedures regarding responses to consumer safety address suicide, domestic violence, accessing emergency services for members, addressing significant reportable events, quality of care concerns.

What this means for the average employee is that you need to know what to do in the event you come into possession of information that consumers' health or welfare are threatened.  Your organization's P&Ps should provide you with that information -- if not, talk to a supervisor about this issue.

Examples of such urgent situations include:

  • Suicide threats
  • Child abuse
  • Spousal abuse
  • Elder abuse
  • Drug and/or medical device recalls

A particularly important issue -- one that is likely to be raised by a URAC reviewer if he/she should happen to talk to you about this standard -- is what happens when a consumer threatens suicide.  Your organization likely has a policy on this topic, so be sure you're familiar with it.

Management Tips

Your P&Ps should address the full array of likely issues.  Brainstorm with your colleagues about all the possible emergencies that could arise for consumers, and how your staff members might come into possession of that information.

URAC has a very specific notion of what is required of protocols for handling potentially suicidal callers.

Of course, as I’ve noted above, URAC expects a comprehensive system of mechanisms to respond to a wide variety of urgent situations that threaten consumers. However, it appears that, to the extent a URAC applicant has a specific mechanism regarding suicide, URAC requires that the applicant use national standards regarding handling suicide calls when it develops that policy.

Our source for this is a recent URAC desktop review summary that one of our readers sent us for review. Citing the American Foundation for Suicide Prevention’s publication, Facts About Suicide, as well as publications from Suicide Awareness Voices of Education and the National Quality Forum, the URAC reviewer commented that, “ At a minimum, this policy and process must include the process where any staff member, who has the potential to receive a consumer telephone call, can obtain a real-time assistance from another staff member while NOT hanging up, transferring, or putting on hold the caller.”

However, the tricky part of passing this standard is not so much knowing what to submit with the application, but making sure your staff members know what the basic standards of care for each of these urgent situations is.

The upshot of this is that your staff training should include appropriate responses to urgent situations. The URAC reviewers will pose a series of hypotheticals to your staff members, and will listen carefully to their answers to detect the quality of your training.

URAC Accreditation Tips

The standard is a mandatory standard. In other words, you mess up this standard and you cannot achieve full accreditation.

In the application, make sure to submit P&Ps that address the full array of likely issues.

To prepare for the onsite review, make sure everybody on your staff (and we mean everybody) can answer the question, "what kinds of situations might arise in your position in which you learn that consumers are in danger, and what would you do in such circumstances?"

 

N-NM 18-Participating Provider Suspension Mechanism for Consumer Safety


The Basics

The standard is for the special situation of a provider whose conduct is so egregious as to give rise to a well-founded concern by your medical director that the provider is posing a threat to the well-being of your consumers.  This is a very important consumer safety standard.  Not only must you are medical director be freed from the requirement of taking such a dispute through the normal, often slow, dispute resolution process, it places an affirmative requirement on him or her to handle such a situation in an expeditious manner.

The proper procedure, once the medical director concludes that the provider poses such a danger, is to suspend immediately the provider.  Then, after the suspension, your organization should conduct an expedited investigation to make sure that the medical Director's concerns were well-founded.  Finally, the dispute resolution mechanism described in the previous standards must be made available to the suspended provider.

Management Tips

The requirements of this standard must be embodied in your credentialing plan or a policy and procedure that explicitly contemplates this circumstance.  In addition, your medical director must be absolutely clear that he or she not only has this authority, but also an affirmative obligation to exercise this authority.

URAC Accreditation Tips

This is a mandatory standard, and all of the elements are primary.

For the desktop review phase, you may submit the same documentation that you submit for the previous dispute resolution standards.  

During the on-site review, this issue will come up in the reviewer's interview with the medical director.  He or she must be prepared to answer this question, as it is almost a certainty to come up.  This kind of emergency suspension procedure is fairly uncommon, so it would not be surprising if you had no documented examples.  However, if you do, we recommend that you be prepared to produce one or more examples of such an emergency suspension for the reviewer's examination.

Pharm Core 23 - Consumer Safety Mechanism


 

The Basics

One of the most important of the URAC standards is this one, which requires that the organization have processes to respond quickly to urgent situations that threaten consumers' well-being.

Even though the standard speaks of "a mechanism", the reality is that it requires a system of mechanisms dealing with the full array of urgent situations that are likely to confront the applicant. You can see this intent reflected in the Program Guide under the "Evidence for Desktop Review" section:

Policies and procedures regarding responses to consumer safety address suicide, domestic violence, accessing emergency services for members, addressing significant reportable events, quality of care concerns.

What this means for the average employee is that you need to know what to do in the event you come into possession of information that consumers' health or welfare are threatened.  Your organization's P&Ps should provide you with that information -- if not, talk to a supervisor about this issue.

A particularly important issue -- one that is likely to be raised by a URAC reviewer if he/she should happen to talk to you about this standard -- is what happens when a consumer threatens suicide.  Your organization likely has a policy on this topic, so be sure you're familiar with it.

Management Tips

Your P&Ps should address the full array of likely issues.  Brainstorm with your colleagues about all the possible emergencies that could arise for consumers, and how your staff members might come into possession of that information.

URAC has a very specific notion of what is required of protocols for handling potentially suicidal callers.

Of course, as I’ve noted above, URAC expects a comprehensive system of mechanisms to respond to a wide variety of urgent situations that threaten consumers. However, it appears that, to the extent a URAC applicant has a specific mechanism regarding suicide, URAC requires that the applicant use national standards regarding handling suicide calls when it develops that policy.

Our source for this is a recent URAC desktop review summary that one of our readers sent us for review. Citing the American Foundation for Suicide Prevention’s publication, Facts About Suicide, as well as publications from Suicide Awareness Voices of Education and the National Quality Forum, the URAC reviewer commented that, “ At a minimum, this policy and process must include the process where any staff member, who has the potential to receive a consumer telephone call, can obtain a real-time assistance from another staff number while NOT hanging up, transferring, or putting on hold the caller.”

However, the tricky part of passing this standard is not so much knowing what to submit with the application, but making sure your staff members know what the basic standards of care for each of these urgent situations is.

The upshot of this is that your staff training should include appropriate responses to urgent situations. The URAC reviewers will pose a series of hypotheticals to your staff members, and will listen carefully to their answers to detect the quality of your training.

URAC Accreditation Tips

The standard is a mandatory standard. In other words, you mess up this standard and you cannot achieve full accreditation.

In the application, make sure to submit P&Ps that address the full array of likely issues.

To prepare for the onsite review, make sure everybody on your staff (and we mean everybody) can answer the question, "what kinds of situations might arise in your position in which you learn that consumers are in danger, and what would you do in such circumstances?"

 

DrUM 5 - Consumer Safety


The Basics

This standard reflects URAC's all-pervasive interest in consumer safety.  It requires that the organizations drug utilization management program implement systems to address consumer safety issues. 

  • The first of the two required components of the consumer safety system is a method to identify drug-drug consumer safety issues through some form of communication to the requesting pharmacy and the prescriber. 
  • The second required component of the consumer safety program involves the capacity to identify other situations that may compromise the safety of the consumer and escalate those safety issues as appropriate.

Management Tips

The approach you must take in developing the policy and procedures for this standard is much like that required by Pharm Core 23.  Even though the standard speaks of "a mechanism,” the reality is that it requires a system of mechanisms dealing with the full array of urgent situations that are likely to confront the applicant.  Your P&Ps should address the full array of likely issues.  Brainstorm with your colleagues about all the possible emergencies that could arise for consumers, and how your staff members might come into possession of that information.

However, the tricky part of passing this standard is not so much knowing what to submit with the application, but making sure your staff members know what the basic standards of care for each of these urgent situations is.

The upshot of this is that your staff training should include appropriate responses to urgent situations.  The URAC reviewers will pose a series of hypotheticals to your staff members, and will listen carefully to their answers to detect the quality of your training.

URAC Accreditation Tips

Both elements of this standard are mandatory.

At the desktop review level, documentation submitted should include both your confidence of policy and procedure on consumer safety and any documentation of the alert system at point-of-service.  This likely will be found in a pharmacy provider manual or other documentation describing the relationship with pharmacies.

Much of the on-site review process for this standard involves interviews with both management and staff-level personnel.  In fact, it is likely that, in connection both with the standard and Pharm Core 23, the reviewer will ask virtually everybody a variety of questions around consumer safety issues, from drug recalls to suicide prevention.  In addition, your organization likely will be called upon to demonstrate the clinical information management software regarding consumer safety issues.  Finally, the reviewer will examine case files for evidence that the organization's consumer safety mechanisms are functioning properly.

URAC Core 23 -- Consumer Safety Mechanism -- Suicide Prevention Policy


Management Tips

URAC has a very specific notion of what is required of protocols for handling potentially suicidal callers. This notion is not expressed in a standard, but falls under the broad requirements of Core 23. That standard provides:

The organization has a mechanism to respond on an urgent basis to situations that pose an immediate threat to the health and safety of consumers.

Of course, as I’ve noted elsewhere in an earlier blog about this standard, URAC expects a comprehensive system of mechanisms to respond to a wide variety of urgent situations that threaten consumers. However, it appears that, to the extent a URAC applicant has a specific mechanism regarding suicide, URAC requires that the applicant use national standards regarding handling suicide calls when it develops that policy.

Our source for this is a recent URAC desktop review summary that one of our readers sent us for review. Citing the American Foundation for Suicide Prevention’s publication, Facts About Suicide, as well as publications from Suicide Awareness Voices of Education and the National Quality Forum, the URAC reviewer commented that, “ At a minimum, this policy and process must include the process where any staff member, who has the potential to receive a consumer telephone call, can obtain a real-time assistance from another staff number while NOT hanging up, transferring, or putting on hold the caller.”