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Credentialing FAQ
Q:
Do we need to review the credentials and/or training (human research protection
and Good Clinical Practices) of those individuals whose studies involve chart
reviews (patient medical records) or surveys where the IRB has granted either a
waiver or an exemption from informed consent?
A:
Yes, to both credentialing and education because they are doing human research.
Q:
What do we do if we find someone has lied about a degree they do not have, and
it was 20 years ago?
A:
Applicants for employment generally have to sign a statement that the
information is correct to the best of their knowledge. Potential lying about a
degree is an issue that should be brought to the attention of your facility’s
management and, since falsification may be involved, advice should be sought
from Regional Counsel. Depending on the circumstances, it may be appropriate to
relieve the person of all responsibilities involving human research until the
issue is resolved since falsifying credentials may reflect a tendency to
falsify other information.
Q:
We are having trouble reaching primary sources of education to verify degrees
(e.g., for foreign graduates). What should we do if we’ve tried but are getting
not response?
A:
If your search for documents is unsuccessful, or you don’t get primary source
documents after a minimum of two requests, you can place written documentation
of these efforts in the form of a "Report of Contact" (in the personnel
folder in lieu of the documents sought. It is recommended that you
contact the individual and involve him/her in the attempt to obtain necessary
documentation. In addition, you should consider verification by an individual
who can substantiate the individual's participation in the school/program. You
could obtain this through something comparable to a reference letter verifying
participation. This individual could be a professor, supervisor, or peer
whose own current position can be verified.
Q:
Can we verify education for an applicant/employee over the telephone?
A:
If you cannot obtain written verification of education in the time permitted,
you may verify the employee/applicant’s education and degree over the
telephone. You should use the Verification of Education – Report of Contact,
which is a paper version of the electronic Report of Contact form used by
VetPro. It is very important to provide all the information requested, and to
provide the date of the institutional contact. The person contacting the
institution should sign the Report of Contact form. You should make every
effort to get written verification of education/degrees. You should place the
written confirmation of education/degree in the credentialing file when you
receive it. If you can’t get written confirmation of education/degrees, you
should explain why in the space provided.
Q:
Do summer interns who work on projects that involve human subjects need to be
credentialed?
A:
Yes. All persons involved in VA human research need to be credentialed and
receive training in protection human subjects and GCP training.
Q:
Do IRB and Research & Development Committee members who are not
investigators have to have their credentials checked?
A:
It depends. All members of IRB and R&D Committees (including attorneys and
other professionals), except for lay volunteers (e.g., veterans), should have
their credentials checked.
Q:
Our facility does not use VetPro to credential medical residents, do we have to
credential them for the Stand Down?
A:
If a medical resident is involved in human research, you should verify that the
Resident Credentials Verification Letter (RCVL) and the credentials are on file
at the affiliate. All the credentials are maintained by the affiliate, and the
affiliate should verify the education, training, licensure and any
certification the resident claims. The affiliate generally does not run the
resident’s name against the exclusionary lists maintained by HHS and FDA, so
you will have to do this.
Q:
Where can I get a copy of VA Form 10-2850a, OF 612, SF 85 or OF 306?
A:
All of these forms are now available on the Stand Down Guidance Web site at http://www.va.gov/resdev/programs/pride/policy/stand_down/.
Q:
Does an official college transcript, with the college seal, serve as sufficient
verification of education?
A:
No. According to the VHA Credentialing Office, original transcripts and
diplomas provided by the employee/applicant are not acceptable as
primary source documentation. In this era of Kinko’s and high-resolution color
reproduction, it is too easy to forge these documents.
Q: Does a transcript of
grades serve as sufficient verification of education?
A:
No. It is too easy to forge these documents.
Q:
Must a newly hired person be credentialed prior to starting work?
A:
Yes. It is important that you are sure the person is qualified to perform
his/her job.
Q:
Do clinical personnel (e.g., x-ray, pharmacy, and medical laboratory
technologists in the hospital) have to take the training and be credentialed?
A:
No. If clinical laboratory people are hired by the hospital or clinical lab --
not by researchers, and if their main work centers on regular, non-research
clinical medicine, they do not have to be credentialed or have special
training. If someone works in a research lab, even if they perform the same
tests as clinical laboratory personnel, they are considered to be research
personnel and will need to be credentialed and meet the annual training
requirements in human research protection and Good Clinical Practices.
Q:
Do those who work on the VA research without compensation (WOC) have to take
training and be credentialed?
A:
Yes. WOC’s are considered to be VA employees. If they are actively engaged in
VA research they need to have training and be credentialed.
Q:
If human resources has confirmed someone’s degree with the primary source
(e.g., the school) when he/she was first employed do we have to confirm it
again for the Stand Down?
A:
No. If there is documentation from human resources or another federal facility
that the degree was confirmed by the issuing educational institution (the
primary source), it does not have to be reconfirmed for the Stand Down.
Q:
If a staff person has already been credentialed when he/she was hired does
he/she have to be re-credentialed for the Stand Down?
A:
No. If the initial credentialing obtained primary verification of education,
training, certification and licenses, it does not have to be repeated. However,
each license or renewable certificate must have been confirmed within the past
year, and then annually.
Q:
Are there electronic means available for verifying education?
A:
Yes. You can access a number of the schools electronically through the http://www.studentclearinghouse.com.
Other Schools have their own web sites for verifying education (please check
directly with the school). For a fee (generally $5/verification), you can
verify degrees from participating institutions. Clearinghouse records are
considered a "Primary Source" and are approved for credential verification
by Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and
the National Committee for Quality Assurance (NCQA). Your institution must pay
any fees involved in verifying credentials.
Q:
If a person’s license, like a medical license, is awarded for a period of 2 to
3 years, do we still have to confirm it annually?
A:
Yes. It could have been revoked for some reason during the past year. License
verification is required at the time of initial appointment and re-appointment,
and at the time of expiration. However, if physicians are credentialed through
VetPro, and if there is documentation of a query to the Federation of State
Medical Boards, then their licenses are monitored regularly for adverse
actions, so you only need to re-verify their licenses at the time of expiration
and re-appointment.
Q:
What people can be exempted from ORD training and credentialing requirements?
A:
After a lot of discussion with many people, including many people in the field,
the following people will not be required to go through the ORD training
or credentialing process:
Administrative support staff don’t have to go through the ORD required credentialing or training.
People who are based at
an affiliate or other outside institution, and who do not come to the VA or
directly interact with VA research participants. (NOTE: people who are based at
an affiliate or other outside institution, but who do come to the VA to
conduct human research, do have to have training and credentialing). People who
are not affected include the following:
- Co-investigators who do
not do work at the VA (e.g., a VA researcher may collaborate with
researchers from outside the VA, but the VA portion of the study is conducted
at the VA with VA personnel. The outside people may be co-investigators on a VA
study, and have their names listed on consent forms given to VA enrollees, but
if the outside researchers do not come to the VA to perform the research or
enroll VA patients, they are not affected - only the VA researcher and his/her
VA research team are affected).
- Biostatisticians (e.g.,
VA researchers may send their data to an affiliate- or other outside-based
statistician for processing. The outside biostatistician does not have to be
trained nor have credentials checked).
- Lab technicians (e.g.,
a VA researcher may send VA specimens to be processed at an affiliate or other
outside lab. ORD training and credentialing requirements do not apply to the
outside technicians).
Volunteers from the
community who serve on an IRB or Research & Development Committee do not
have to take the ORD required training or have the credentialing. HOWEVER, the
Common Rule mandates that ALL IRB MEMBERS must be trained sufficiently to
perform their duties in order to be voting members. We will be happy to discuss
the exact nature of this training with you or your IRB chair.
Members of groups like
data safety monitoring boards (DSMB) who are recruited from non-VA institutions
don't have to go through the ORD required credentialing or training.
Clinical personnel who
periodically perform tests on research patients as part of their routine jobs
(e.g., x-ray, nuclear medicine, or medical laboratory technologists who
occasionally perform a test on a research patient as part of their routine
clinical duties). However, if someone like a nurse or an x-ray tech was hired
primarily to do clinical work but becomes part of a research team, he or she is
affected and does have to take training and be credentialed.
Q:
If a physician or nurse is part of the research team, but is not functioning in
their professional capacity as a physician or nurse, respectively, do we have
to check their professional credentials?
A:
Yes. The reason is that in many instances these people are asked to perform
duties based on their training and experience, even if the duties are outside
the defined scope of practice.
Q:
Do all members of our oncology team need to be credentialed if they have
patients on research protocols?
A:
It depends. If most of the patients on an oncology service are on protocols,
and if all of the oncology team members are involved in carrying out the
protocols, then the Stand Down training and credentialing requirements apply.
If only an occasional patient is on a protocol and most members of the team are
not involved in performing the study, then only those members who are directly
involved in the research are affected by the Stand Down.
Q:
If some of our co-investigators are based at another VA facility, is it our
responsibility to see that they are credentialed and trained for the Stand
Down?
A:
No. It is the responsibility of their home VA facility.
Q:
Are background checks and fingerprinting required as part of the credentialing
process for the Stand Down?
A:
If a person's background check and fingerprinting have been performed already,
they do not have to be repeated for the purpose of the Stand Down. If, in the
course of verifying credentials for the Stand Down you find that someone has
not had a background check you should know that irrespective of the type of
appointment (paid or WOC), VA employees are to have a National Agency check
which requires fingerprinting. Most of the time these are done at the time of
processing through Human Resources Management Service (HRMS). VHA recognizes
that processing time will be dependent on OPM. We recommend documenting that
fingerprints were submitted, and follow-up in 90 days, and 180 days until a
response is received.
Q:
What if a member of our research team has only graduated from high school and
has no degrees or licenses to verify? What should we do to document their
suitability for their duties in human research?
A:
You should confirm that the person has the training or experience necessary to
perform the duties listed in his/her scope of practice. Confirmation can take
the form of a verification letter from a previous employer detailing experience
and skill. If the employee has worked for the current VA supervisor for a
prolonged period of time, or if the VA experience is this person's only
relevant job experience, the current supervisor can provide the verification
letter documenting that this person has the appropriate training and skills
needed to perform his/her duties in human research.
Q:
Do we need to do background checks on high school students who work on research
projects?
A:
No.
Q:
Do ex-officio members of the R&D Committee (such as the COS, MCD,
representative from fiscal) have to be credentialed?
A:
No, these individuals should have already had their backgrounds checked as part
of their original employment.
Q:
Do Deans’ Committee representatives on the R&D Committee have to be
credentialed?
A:
No, Deans’ Committee representatives do not need to be credentialed. However,
to protect them from liability claims they should have a Without Compensation
(WOC) appointment. WOC appointments generally require a background check (SF
85).
Q:
We've had a number of investigators with credentialing requests from several
VAs - all-asking for the same info. What should we have on file at our facility
if the verification is performed at another VA facility?
A:
Credentials should only be verified by the employee’s home VA site. Copies of
materials collected and verified by the home VA site should be shared with
other VA sites requiring this information. The other VA sites do not have to do
primary verification of credentials.
Q:
We have identified another site from which we can obtain degree verification
for some schools that are no on the Clearinghouse list. The site is http://www.degreechk.com.
Can we use this list?
A:
Yes. Facilities may wish to check this site to see if the schools they need to
contact share information with this organization.
Q:
Some investigators work with more than one VA. Does credentialing have to be
verified at each facility, or just the "home" VA? If it does not have
to be verified at all facilities, what should be on file at the non-home VA
facilities?
A:
Credentials should only be verified by the employee's home VA site. Copies of
materials collected and verified by the home VA site should be shared with the
other VA sites where the employee works. The other VA sites do not have to do
primary verification of credentials, but should keep the copies of the
verification on file.
Q:
We have a number of long-time research employees who have only a high school
diploma that we are unable to verify (school closed, cannot find, etc.). What
should we do?
A:
Document your good faith effort to find the high school and verify the
graduation. Since the employee's position is most likely tied to his/her on the
job training (OJT) and not the high school degree, have his/her supervisor(s)
document their OJT.
Q:
What do we mean by "good faith effort for credentialing?" How do we
document it?
A:
Good Faith Effort refers to the process of attempting to obtain documents.
"Good Faith Effort" is invoked when a search is unsuccessful, or
primary source documents are not received after a minimum of two requests. Full
written documentation of these efforts, in the form of a report of contact,
should be placed in the credentialing folder while awaiting the documents
requested. Documentation for Good Faith Effort should include, but is not
limited to, the dates of the written requests (e.g. dates of letters to primary
sources), reasons for the inability to obtain information (e.g. program closed,
records destroyed, etc.) and what secondary sources have been sought and found
(e.g. references from authoritative sources, copies of certificates, etc.).
For your
convenience here are the FAQs on Good Faith Effort that we distributed on
4/29/03:
Q:
We are having trouble reaching primary sources of education to verify degrees
(e.g., for foreign graduates). What should we do if we've tried but are getting
not response?
A:
If your search for documents is unsuccessful, or you don't get primary source
documents after a minimum of two requests, you can place written documentation
of these efforts in the form of a "Report of Contact" (in the
personnel folder in lieu of the documents sought. It is recommended that you
contact the individual and involve him/her in the attempt to obtain necessary
documentation. In addition, you should consider verification by an individual
who can substantiate the individual's participation in the school/program. You
could obtain this through something comparable to a reference letter verifying
participation. This individual could be a professor, supervisor, or peer whose
own current position can be verified. Q: Can we verify education for an
applicant/employee over the telephone?
A:
If you cannot obtain written verification of education in the time permitted,
you may verify the employee/applicant's education and degree over the
telephone. You should use the Verification of Education - Report of Contact,
which is a paper version of the electronic Report of Contact form used by
VetPro. It is very important to provide all the information requested, and to
provide the date of the institutional contact. The person contacting the
institution should sign the Report of Contact form. You should make every
effort to get written verification of education/degrees. You should place the
written confirmation of education/degree in the credentialing file when you
receive it. If you can't get written confirmation of education/degrees, you
should explain why in the space provided.
Q:
For purposes of professional liability, will the Department of Justice
recognize a Without Compensation (WOC) employee and defend them in court?>
A:
We will make inquires and get back to you if we can provide more guidance on
this issue.
Q:
Can you get us an example of what a Resident/Trainee Credentials Verification
Letter (RCVL) looks like?
A: After searching long and
hard we found a copy in VA Directive 5005 Staffing. The form is described in
Part II Chapter 3 page II-79.
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