Hot Topics: Leased Space, Unlicensed Physicians,

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Hot Topics Leased Space, Unlicensed
Physicians, Auditing

• SRA
• October 2007

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Topics

• Leased space
• Credentialing of unlicensed physicians
• Audits

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Leased Space
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Leased Space Issues

• More gray areas then black and white areas
• More questions then answers
• More work to do -- ORD and ORO working together
  on this issue

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Leased Space Questions to be Asked

• Do the benefits of the lease outweigh the risks
  and liability for VA?
  
• Who is conducting the research?
• What are the responsibilities of the RD
  Committee?
  
• What are the responsibilities of the research
  program and research office staff?
  
• What should be included in a lease or agreement?
• Should you lease the space out?

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Do the Benefits Outweigh the Risks?

• Potential benefits
• Increased funds
• Expertise
• Collaborations strengthened
• Potential risks
• Not correctly defining what is VA research
• Liability for any untoward events
• Financial, political, environmental, physical
• Difficult to maintain security of labs
• Time resources needed to initiate and monitor
  lease

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Who Is Conducting the Research?

• VA?
• VA research if
• VA investigator conducting research while on VA
  time
  
• Utilizing VA resources not covered in the lease
  (funding, equipment, computers, staff)
  
• Using VA space not covered under the lease
• Lessee?
• VA and lessee research?
• Gray area VA staff collaborate

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What are possible responsibilities of the RD
Committee?

• Review of the research
• If VA research, must review it and approve or
  disapprove the protocol
  
• If not VA research possible role
• Review to ascertain if it should be done at VA in
  leased space
  
• Concur it can be done but does not approve it
• Oversight of VAs research program
• Oversight of the research only if it is
  determined to be VA research
  
• Possible Review the reports on the lessees
  compliance with lease requirements if
  requirements affect the VAs research program
  

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What Are Possible Responsibilities for the
Research Program/Office

• Monitoring compliance with lease
• Security (physical, IT, personnel)
• Safety of lessees staff, environment, VA
  personnel, patients, or visitors
  
• Use of common areas and equipment
• Liability
• If animal research
• OLAW assurance held by lessee
• IACUC approval
• Accreditation

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Special Areas of Concern

• Select Agents and Toxins
• Compliance with those regulations
• Added difficulties for VA
• Probably not appropriate
• Consult ORD
• BSL-3
• Existing or new BSL-3
• Expensive to build and maintain
• Additional requirements for safety security
• Long term utilization issues

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What should be included in a lease or written
agreement?

• Type of research
• Assurance from OLAW
• IACUC approved research
• Security of the space
• Personnel security what type of background
  checks especially if lessee must enter VA space
  
• Incorporation into the facility's' emergency
  response plan (fire, natural disaster, spills,
  etc.)
  
• IT security any connections with VA servers
  etc.
  
• Other items?

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Complexities the Animal Program

• Sharing a veterinarian with affiliate
• VA staff used for care for animals
• How is this funded?
• Who is responsible supervision?
• HR considerations?
• Unable to separate out portion of animal facility
  for lessee
  
• Joint IACUC

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Political Complications

• Affiliate relationships
• Congressional inquires
• Funding challenges

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• Think carefully before making a decision on
  leasing space!

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Credentialing of Unlicensed Physicians
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The Issue

• Unlicensed physicians serving as research
  assistants functioning outside their scope of
  practice, engaging in activities that may
  constitute the practice of medicine

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Other Related Issues

• Lack of policies related to the scope of practice
  for unlicensed physicians
  
• Scopes of Practice including procedures that may
  constitute the practice of medicine or for which
  the person is not qualified
  
• Inadequate documentation of research procedures
  in the medical record

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Applicability

• All unlicensed physicians regardless of the
  position held within the research program must be
  credentialed
  
• Clinical as research assistant/coordinator
• Research assistants or other positions within VA
  research laboratories

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Degrees Held by Physicians

• MBBS Bachelor of Medicine and Bachelor of
  Surgery
  
• MBChB Bachelor of Medicine, Bachelor of
  Surgery
  
• MB Bachelor of Medicine
• Ch.D. Doctor of Surgery
• Ch.B. Bachelor of Surgery
• DrMed Doctor of Medicine
• ChM or CM Master of Surgery
• D.O. Doctor of Osteopathic Medicine

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Credentialing

• The formal systematic process of verifying,
  screening, and evaluating qualifications and
  other credentials that include education,
  licensure, relevant training and experience,
  current competence, and health status.

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Credentialing Process

• Credentialed in VetPro
• Credentialing can be completed per your
  facilitys policies
  
• Research must track the process confirm it has
  been completed
  
• Maintain records that it has been completed in
  the research office

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Required Verifications

• All education
• Leading to a degree
• Certification or training that is relevant to the
  activities allowed in the Scope of Practice
  
• Verification is from primary sources
• All licenses certifications
• Past employment

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Additional Precautionary Checks

• Exclusionary lists
• List of Excluded Individuals and Entities (LEIE)
• Maintained by HHS
• Debarment list
• Disqualified/Restricted/Assurances List for
  Clinical Investigators
  
• Maintained by the FDA
• National Practitioner Databanks
• If ever licensed anywhere in the US

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Scope of Practice

• A Scope of Practice is Mandatory
• Based on
• The occupational category under which the person
  is hired
  
• Consistent with the persons qualifications
  (license, education training)
  
• Consistent with Federal state laws/regs

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Scope of Practice (Cont.)

• Must be specific
• All protocol PIs must be aware of what is in the
  Scope of Practice for all persons working on
  his/her protocols
  
• Scope of Practice must be approved by
• Employees supervisor
• ACOS/RD
• Must be signed by the employee, the employees
  supervisor, ACOS/RD

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Scope of Practice (Cont.)

• It may not allow the employee to conduct any
  procedure or have responsibilities in an area
  that requires a license
  
• Practice of Medicine or Nursing
• Pharmacy
• Etc.
• Scope of Practice must be reviewed yearly
• Working outside the Scope of Practice must be
  reported to the supervisor ACOS/RD

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Scope of Practice (Cont)

• Unlicensed physicians must have the same
  qualification to perform a procedure or task as
  persons in the clinical setting.
  
• Some procedures that cannot be done
• Perform physical examinations
• Interpret test and change care based on his or
  her interpretation
  
• Can not do phlebotomies unless the hold the same
  credentials/training as a person in the clinical
  area
  
• Cannot alter types or doses of medication
• Cannot do minor surgical procedures

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• Unlicensed physicians cannot be treated like
  medical students!

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Auditing
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The IGs Recommendation

• We recommend that the Under Secretary for
  Health require facility IRB compliance program
  audits to assess the privacy and confidentiality
  protections for human subjects in research,
  including whether the use of research data
  complies with information security requirements
  specified in HIPAA waivers or waivers of informed
  consent.

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VAs Response

• Develop a new policy
• Directive to address periodic auditing
• Human subjects research protocols
• HRPP processes

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Required Actions MCD

• Identify the office or entity that is responsible
  for the auditing
  
• At least annually evaluating the effectiveness of
  the program
  

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Required Actions The Auditing Program

• Developing related policies
• Conduct the audits
• Documenting audits
• Reporting results of the audits
• Principal Investigator
• IRB
• RD Committee
• Others
• Evaluating the effectiveness of the program

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The Audits

• Both random and periodic
• Systematic sampling
• Appropriate sample size
• Examples for areas to audit
• Compliance with the protocol
• Informed consent documents processes
• Waiver of HIPAA authorization
• Inclusion/exclusion criteria
• Type of data obtained

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Audits More Than Counts

• Adequacy of the processes in place
• Functioning of the HRPP
• Communication between all parts of the HRPP
• Interactions with research subjects
• Training of staff

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Follow Through

• Documentation of results
• Submit written report
• Develop corrective actions
• Implement the required actions
• Evaluate the success of the actions

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Responsibilities

• Follow through in an appropriate time frame
• Evaluate the risks to determine the time frame
• Submit reports to required persons and committees
  
  
• Document
• Review of the audit reports
• Response to the audits
• Required actions
• Assessment of corrective actions
• Ensure there is closure and it is documented

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Bottom Line

• Develop policies define specific
  responsibilities
  
• Conduct audits
• Specific documents/aspects
• HRPP processes
• Determine what to audit based on risk and
  importance
  
• Determine appropriate time frame
• Ensure appropriate follow through with corrective
  actions and re-audit
  
• Leave a paper trail