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UTMB HANDBOOK OF OPERATING PROCEDURES
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Section 9 Clinical Policies
Subject 9.7 Visitor Information
Policy 9.7.2 Vendor Visitation: UTMB Clinical Enterprise
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10/01/00 -Originated
04/30/08 -Reviewed w/ changes
-Reviewed w/o changes
Logistics -Author
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Industry Vendor Visitation: UTMB Clinical Enterprise
Definitions
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Industry Vendor: Means any sales representative or account executive and includes, but is not limited to, any sales representative, pharmaceutical representative, or equipment or device manufacturer representative.
Clinicians and Staff: Means faculty members and trainees at all levels (students, interns, residents, fellows, post-doctoral trainees) in any patient care discipline, including specialties of medicine, dentistry, nursing, and health professions, also includes volunteers and persons hired by the UTMB to perform work at or on UTMB’s behalf.
Continuum of Care: Means the provision of comprehensive care from the hospital to the home, which advocates the pooling together of medical and social services within the community and the creation of linkages between community care initiatives at all levels of the health care system.
Contractor: Means, any representative of a company contracted to perform long term service related work requiring frequent and routine visits to UTMB Campus.
Hospital and Clinical Enterprise Sites and/or Clinical Enterprise: Means, the buildings used by UTMB for inpatient or outpatient care including physician and administrative offices.
Shadowing: Means, following physicians or other clinical personnel.
Tailgating (Piggybacking): Means that, without officially having an appointment, an individual is accompanying a industry vendor who has a verifiable appointment with a specific department/area.
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Policy
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This policy establishes regulations for Industry Vendors doing business within the Clinical Enterprise at UTMB and ensures appropriate identification of all vendors and consistency with UTMB’s patient care, academic and research missions. It also contains a mechanism for enforcement. To the extent this policy conflicts with IHOP 6.1.1, Clinical Conflict of
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Policy, continued
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UTMB Clinicians and Staff found not to be in compliance with this policy shall be subject to disciplinary action, including dismissal.
Interest, IHOP 6.1.1 shall prevail.
UTMB Clinicians and Staff shall interact with vendors in a manner that meets ethical standards, protects patient confidentiality, does not interfere with the process of patient care, and encourages the appropriate, efficient and cost effective use of equipment, supplies, and pharmaceuticals within UTMB.
Industry Vendors who conduct business at or with UTMB must do so in accordance with policy and procedure guidelines. All UTMB personnel must monitor industry vendors to ensure that they comply with these guidelines. UTMB personnel must immediately report non-compliant vendors to Clinical Purchasing.
Any pricing or contract terms discussed before review/approval by the Clinical Purchasing Department are considered “preliminary”. Final pricing and contract terms will be negotiated only by Clinical Purchasing with input from the requesting department. Under IHOP Policy 4.5.6, only staff members may sign contracts or enter into agreements on behalf of UTMB only when expressly authorized to do so in writing by the President of UTMB.
Therefore, all UTMB employees must route all procurement related contracts and other signature documents to Clinical Purchasing for review, proper execution or further routing to the appropriate UTMB authority.
UTMB Clinicians and staff found not to be in compliance with this policy shall be subject to disciplinary action, including dismissal.
All personnel of the company which employs a industry vendor who violates any of the aforementioned policies may be denied access to the
UTMB campus for a period of time determined by the Executive Vice President and Chief Executive Officer of the UTMB Health System, with notice provided to the appropriate officials.
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Vendor Access
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Industry vendors may not be on campus without prior permission from authorized personnel. In addition, industry vendors must:
• attended vendor orientation
• completed a vendor profile
• have an appointment with authorized personnel before they arrive on campus
• obtained approval from the authorizing department
• obtained and wearing a UTMB vendor/visitor ID badge
• be accompaniment by authorized UTMB staff when in clinical secured areas
Industry vendors representing continuum of care services or facilities (e.g., nursing homes, rehab facilities) are restricted to information about the patient they are scheduled to visit.
Industry vendors may not have access to Protected Health Information (PHI) unless a business associate contract specifically delineates such access or patient authorization has been obtained.
UTMB reserves the right to limit the number of industry vendors that any single company has visiting UTMB facilities.
“Shadowing” and “Tailgating” is prohibited. Each Industry Vendor is responsible for following this policy.
Industry vendors are prohibited from entering patient care areas within
the medical center for promotional purposes.
Industry vendors are not permitted to touch or treat patients or undertake any activity that could be construed as patient care unless the industry vendor has been credentialed by the Medical Staff Office. Clinicians involved in such evaluations or testing are advised to seek clarification from the UTMB Institutional Review Board regarding whether the activity qualifies as human subject research.
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Product/Device Equipment Approval Process
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Only products/equipment approved utilizing the Value Analysis/Cost Management Team process may be purchased with Clinical Enterprise Funds.
Before any patient-related or laboratory equipment is purchased, leased, loaned or accepted as a donation for use or trial involving patients, it must be evaluated by Clinical Equipment Services (CES) or other authorized service departments to determine if it meets the institution’s guidelines outlined in the equipment management plan.
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Criteria for Product/Device Equipment Trial/Evaluation
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• Products/Devices or Equipment that have related consumables must go through the Value Analysis Process prior to evaluation and be presented to the appropriate cost management team
• Products/Devices or Equipment brought in for loan or assessment must have approval from respective approval agency (i.e. Food and Drug Administration, Underwriters Laboratory, etc). If approval has not been obtained, the Institutional Review Board (IRB) must be contacted
• Product samples may not be left by industry vendors in any inpatient or outpatient clinical area and may not be evaluated for patient use without going through the Value Analysis Process and being presented to the appropriate cost management team
• Vendor must complete and sign Vendor Release Form prior to delivery of any loaned equipment or product to UTMB
• All medical electronic devices/equipment brought in by industry vendors for loan or evaluation must be tested for electrical safety and approved by CES or other hospital-authorized service providers before evaluation
• Appropriate training must be provided to personnel in the area where the evaluation takes place as well as personnel in any other impacted areas before using the equipment brought in by industry vendors for loan or evaluation. Training must be documented according to individual departmental policy.
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Criteria for Product/Device Equipment Trial/Evaluation, continued
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• Department-specific guidelines regarding interacting with Industry Vendors must be followed. If publishing is planned, the IRB must be contacted for possible review (research means “a systematic evaluation including development testing and evaluation designed to develop or contribute to generalizable knowledge”)
• Products or equipment may not be evaluated for an “off-label” use. If deemed absolutely necessary, requests for off label use must follow specific guidelines.
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Industry Support for Educational Programs at UTMB
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Industry Vendors must adhere to IHOP 6.1.1 for all industry supported/sponsored educational programs at UTMB.
Industry Vendors shall not attend programs in which specific patients are identified or quality assurance or risk management issues are presented.
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