Human Resources

Pharmacy Core, Version 3.0 PHARM Core 41 - Employment Background Screening


The Basics

Standard requires that your organization conducts an employment background check for employees who handle pharmaceuticals and patient data.  In a response to a request for interpretation, URAC has stated that criminal background checks are required for every employee who handles patient data and drug testing/screening is required for every employee who handles pharmaceuticals.

The criminal background check must include a minimum identification check, criminal history, a record as a sex offender, and other relevant information.  The drug testing and screening that is contemplated by the standard should not be limited to illegal drugs.  This is a consumer safety issue, so any substance abuse issue that could affect consumer safety, including alcohol abuse, is within the scope of the standard.

Management Tips

Your policies and procedures should not only address the two elements of this standard, i.e., background check and drug check, which also include mechanisms for taking corrective action in case the organization's substance abuse policy is violated.  The policies and procedures also should include a discussion as to how your employees will be trained regarding your screening programs.  Finally, your program should have a mechanism of recording consumer complaints regarding violations of access to personal information of the consumer.

One question has been whether this is required of all employees who come in contact with drugs and/or patient records or only new hires. While the standard is not clear on this subject, none of the interpretive information we have seen would suggest that you can limit this to new hires. The frequency with which you do this, once you've done it, is certainly up to you, however. 

URAC Accreditation Tips

Both of the elements of the standard are mandatory.

For the desktop review, submit your conference of policies and procedures regarding background checks, substance abuse, and training.

During on-site review, the reviewer will examine a log of consumer complaints in search of evidence that you handle complaints about personal information violations appropriately.  Be prepared to produce evidence that, where such a complaint has been lodged, your organization has taken appropriate corrective action.

 

CORE, Version 3.0 -- Personnel File Contents


Management Tips

What will the URAC reviewers find when they pull a random sample of your employees' personnel files? What should they find?

The URAC standards are rife with requirements that are likely to be evidenced in your personnel files. Because these standards are scattered throughout the Core module, it may not be immediately apparent what a URAC applicant should have in its personnel files.

Here's a short list, taken from an actual URAC onsite review agenda one of our clients just received from URAC, rearranged for clarity's sake:

Evidence of Training

  • Conflict of Interest Training
  • Education on URAC Standards
  • Continuing Education
  • Orientation to job
  • Staff Confidentiality Statements
  • Regulatory Training
  • Fraud & Abuse Training

Other documentary requirements

  • Annual Performance Review Process
  • Job description/qualification evaluation

Special requirements for clinical staff

  • Scope of Practice Attestations
  • License verification
  • Certification verification

Particularly if your organization is a first-time applicant, you may be realizing that your personnel files don't have all these documents. What do you do now?

We recommend this four-step approach:

  • Conduct a thorough initial assessment. How bad is it? Take a random sample of your employee files and run down the above list for each one. Using this list to perform a gap analysis that will let you know the difference between what you have and what you need to have by the time the reviewers arrive.
  • Look for alternative sources of information. Now that you know what you need, find out whether you have that information, but not in the personnel files. For example, if your company has a centralized training tracking function, you may be able to take care of demonstrating compliance with all or most of the training documentation requirements through that tracking function.
  • Make a plan. With those items that are neither in the personnel files nor in a centralized function, you need to make a written plan, with specific time lines (that end before the reviewers arrive!), for pulling your files into compliance with the URAC standards. The discipline of going through such an exercise will be necessary, as may be the assistance of temporary help if your staff doesn't have the capacity to handle this task.
  • Look to the future. Once you have your personnel files in order and compliant with the URAC standards, make sure your policies and procedures are written in such a way to keep those files up-to-date. It will do no good to get the files into compliance this year if, for example, you are not doing annual performance reviews for all your employees and getting the results of those reviews into your personnel files.

Well-kept personnel files will help you meet the requirements of a significant number of important Core standards. Getting them into compliance may take some time, so start now.

CORE, Version 3.0 CORE 30 - Clinical Staff Credentialing


The Basics

This standard requires the implementation of a P&P policy to conduct primary-source verification the licenses and credentials of personnel (including consultants) who are required to be licensed and certified.  This verification must occur upon hire, and no less frequently than 3 years after hire.  Furthermore, the verification must be "primary source verification."

In addition, the standard places an obligation on such staff members to notify the organization of any adverse change in licensure or certification status.  Finally, the organization's P&P on the topic needs to empower and require the organization to take corrective action when it learns of such adverse changes in the licensure or certification status.

URAC has added a new, experimental requirement that has no point value -- a requirement that your organization conduct primary source verification of licensure and certification upon hire and thereafter no later than the scheduled expiration date.  Naturally, this will require organizations to track employee licensure and certification expiration dates, something not historically required by this standard.

Management Tips

It is important to note that the scope of the standard is broad: "licensed or certified personnel/consultants". While these are not defined terms, it is fairly clear that the URAC standard would sweep up a pretty broad array of licensed and certified people, not just employees.

Another thing to note is that the standard applies not only to licensure, but also to certification. This is particularly important with respect to accreditation standards such as case management, where certification might be a requirement. Be sure, therefore, that your process of verification, both as described in your policy and procedure and in practice, includes all certifications that might be required by the particular accreditation standards under which you are applying or by your own policies and procedures.

Additionally, make sure not only that your policy and procedure on the subject imposes an affirmative obligation on the licensed personnel and consultants to notify the organization of adverse changes in licensure or certification status, but that everybody has been trained on this obligation. It would not be a good thing in an interview with a member of your staff if it became apparent that this requirement was unknown to licensed or certified staff members.

Finally, a new interpretation, one we encountered for the first time in April 2012, requires that your policy specifies what would happen to the employee during the period of time during which a minor violation is being resolved. Typically, this might involve reassignment to duties that are non-clinical until the issue is resolved.

URAC Accreditation Tips

The first three elements of this standard are mandatory; the last one is a Leading Indicator. 

The documentation required for the standard in the application is straightforward: job descriptions and a policy and procedure that addresses all three elements of the standard.

The documentation for the on-site review, on the other hand, is usually where the problems arise, if there are any. During the on-site review, the URAC reviewer will request a listing of all the members of the staff (at least those that are the subject of the review), randomly select several of the staff members, and ask to see their personnel files. The reviewer will be checking the job description and resume of each of the selected employees to see if the employees meet the requirements of the job as described in the job description. In addition, the reviewer will be looking for evidence that the employee's required licenses and certifications have been verified. Therefore, a best practice is for the organization to conduct periodic audits of all of its clinical staff members' personnel files to make sure that this is happening on ongoing basis, and particularly before the reviewer arrives.  

CORE, Version 3.0 CORE 29 - Staff Assessment Program


The Basics

This standard requires that the organization operate a formal employee assessment program that contains two essential features: (1) an annual review, and (2) the review of documentation produced by the employee.

Management Tips

Some organizations have tried to meet the intent of this standard, and particularly the requirement that the appraisal include a review of documentation produced by the employee, by including in the template appraisal form a section allowing the employee to comment on his/her performance or on the supervisor's appraisal.  It is increasingly clear that this will not suffice.  Rather, your P&P and your template appraisal should be written to require and document that the supervisor looked a actual documentation produced by the employee in the course of performing his/her job.

 

URAC Accreditation Tips

The elements of this standard is weighted 2 and 3.

You need not submit an actual review in the initial, AccreditNet phase.  A template will suffice.  As usual, however, you also must submit a P&P that requires both the annual appraisal and a review of the documents produced by the employee.

The onsite review will involve an actual examination of the last one or two performance appraisals from the selected employees' personnel files.

CORE, Version 3.0 CORE 28 - Staff Operational Tools and Support


The Basics

This standard requires that the organization provide the staff with both appropriate P&Ps and necessary clinical decision support tools.  This means that each employee needs to know where to find the P&Ps and tools that help them understand the proper way to perform his/her job.  Having a general notion that the applicable P&Ps are "somewhere on the shared drive" or "somewhere in the supervisor's office" is not enough.  Each employee needs to have ready access to the applicable P&Ps and clinical tools.

Management Tips

The keys here are employee access and training.  We strongly recommend against reliance on paper P&Ps and tools.  Keeping a single copy of the current P&Ps and tools on a shared drive to which all employees have access is the best practice, and about the only way an organization can be sure that the correct version of P&Ps and tools are in the hands of the people who need them -- the employees.

URAC Accreditation Tips

All elements of this standard carry a weight of 2.

Documentation for the standard is straightforward.  The Master List of P&Ps should be submitted here, as it was for Core 3.  In addition, the P&P or program description that describes the clinical decision support tools that the organization uses should be uploaded to AccreditNet.  You also should submit any documentation you have of providing regulatory requirements to appropriate staff members.

The onsite review will test access as much as anything.  Employees are likely to be asked something like, "if you have a question about how to do a certain aspect of your job, where would you find the proper procedure described?"  The best answer will be if they can go directly to the P&P or clinical tool in question on their computer.  The reviewer will need to see that the P&Ps are a useful tool for employees, not simply a document occupying space on a hard drive or a shelf.

CORE, Version 3.0 CORE 27 - Staff Training Program


Management Tips

As you know, URAC has specific requirements for staff training that relate both to the content of staff training and its administration:

Content

Most of the explicit training requirements in the URAC standards are found in these standards: 

  • Initial orientation and/or training for all staff before assuming assigned roles and responsibilities; 
  • Ongoing training, at a minimum annually, to maintain professional competency; 
  • Training in current URAC Standards as appropriate to job functions; 
  • Training in state and regulatory requirements as related to job functions; 
  • Conflict of interest; and
  • Confidentiality.

Administration

There must be documentation of all training provided for staff.

There must be a signed document acknowledging training on confidentiality issues.

Some of this is company-wide training (e.g., confidentiality); some is department-specific (e.g., P&Ps on how to follow DM P&Ps.)  Company-wide training is typically handled either through:

  • company-wide meetings
  • computer-based training modules required of all employees, or
  • smaller, face-to-face trainings required of all employees. 

Department-specific training is typically handled through

  • modular computer-based training programs or
  • departmental staff meetings

URAC Accreditation Tips

The element requiring training and confidentiality standards is mandatory.  The rest are either weighted 2 or 4.

The best preparation for the URAC review is the substantive training described in the previous section.  A staff member who knows his/her job as described by the applicable P&Ps, knows the URAC standards that apply to the job, and can retrieve the documents to be sought by the URAC reviewer is unlikely to get tripped up in a URAC review, even if they have no specific preparation for the onsite review process.

Additionally, the mock onsite review we conduct for our clients is valuable for staff members likely to be either interviewed or pulling documents during the onsite review.  We spend a good portion of our time onsite not only conducting document-pulls and interviews as realistically as possible, but also counseling staff members on how to improve their performance for the actual review.

Documentation for the desktop review should include training and education program outlines and agendas across the organization, as well as any tools you use in training.

For the onsite review, be prepared to produce comprehensive orientation and training materials for selected staff members.  In addition, at any point during the on-site review, the reviewer is likely to ask the staff member about his or her training across the full scope of the standard's requirements.

CORE, Version 3.0 CORE 26 - Staff Qualifications


The Basics

This standard very simply requires that your staff members meet the requirements of the jobs they occupy, as described in the job descriptions required by the previous standard.

Management Tips

The personnel file audit we recommend in our lengthier blog on the topic later in this unit should include a check for a concurrence between job descriptions and résumés.

URAC Accreditation Tips

The standard is mandatory, and, like Core 25, has a straightforward documentation requirement at the AccreditNet phase of the process: submit job descriptions.  You may (and should) submit the same documents you submitted for Core 25.

The difference here with Core 4 is in the onsite review: for the staff members selected from the employee directory, the reviewer will compare the job descriptions' requirements to the résumés of the respective employees to make sure that they meet the requirements as outlined in the job descriptions.  

CORE, Version 3.0 CORE 25 - Job Descriptions


The Basics

This standard requires URAC accredited companies to have job descriptions for all staff members.  Those job descriptions must describe required background (education and experience), required competencies, licenses, and/or certificates, and describe the jobs' scope of role and responsibilities.

Management Tips

This standard typically is missed onsite by organizations that have not set minimum requirements for non-clinical staff members.  Therefore, we recommend a complete internal audit, particularly by the HR departments of first-time applicants, of all the job descriptions to assure that they all (clinicaland non-clinical) have minimum requirements.  

One other tip -- eliminate the words "or equivalent experience."  They are, in URAC's view (and mine), meaningless.  Describe what that equivalent experience might be, and you'll be fine. 

URAC Accreditation Tips

Each of the elements of this standard carries a weight of only 2, indicating how distant job descriptions are from consumer protection, at least in URAC's mind.  

The documentary requirements for this standard are straightforward -- submit up to 9 job descriptions of the staff members who do the bulk of the work in the areas that are the subject of the accreditation module(s).  The onsite review is, as you might expect, a random selection of actual job descriptions, chosen from the staff directory. 

PHARM Core 25 - Job Descriptions


The Basics

This standard requires URAC accredited companies to have job descriptions for all staff members.  Those job descriptions must describe required background (education and experience), required competencies, licenses, and/or certificates, and describe the jobs' scope of role and responsibilities.

Management Tips

This standard typically is missed onsite by organizations that have not set minimum requirements for non-clinical staff members.  Therefore, we recommend a complete internal audit, particularly by the HR departments of first-time applicants, of all the job descriptions to assure that they all (clinicaland non-clinical) have minimum requirements.  

One other tip -- eliminate the words "or equivalent experience."  They are, in URAC's view (and mine), meaningless.  Describe what that equivalent experience might be, and you'll be fine. 

URAC Accreditation Tips

Each of the elements of this standard carries a weight of only 2, indicating how distant job descriptions are from consumer protection, at least in URAC's mind.  

The documentary requirements for this standard are straightforward -- submit up to 9 job descriptions of the staff members who do the bulk of the work in the areas that are the subject of the accreditation module(s).  The onsite review is, as you might expect, a random selection of actual job descriptions, chosen from the staff directory. 

CORE, Version 3.0 CORE 31 - Senior Clinical Staff Requirements


The Basics

This standard requires that the organization designated at least one senior clinical staff person to perform the functions described in Core 32.  This standard sets forth at the required qualifications of that person.  Those qualifications are:

  • a current unrestricted clinical license,
  • sufficient qualifications (e.g., experience, credentials, certifications) to conduct clinical oversight for the services provided by the organization,
  • post-graduate patient care experience, and
  • if the person is an M.D. or D.O., board certification.

This person typically is the medical or clinical director of your organization.  

Management Tips

People in management positions should keep in mind that it is not sufficient that your senior clinician meet these minimum requirements.  Rather, it is also required that the job description for that person, or some other document describing the person's role, require all of these qualifications.

The person occupying this position can be part time or full time.

URAC Accreditation Tips

All of the elements of this standard exit the requirement for board certification are mandatory.  The board certification requirement carries the weight of three.

Documentation for the initial submission should include the designated senior clinician's job description and resume.  In addition, you should submit either a program description or policies and procedures that described the senior clinician's role and accountabilities.

The on-site review will hinge on an interview of the designated senior clinician.  In addition, the reviewer will examine the clinician's personnel file to assure that licensure, board certification, and work history are all documented appropriately.