Policies:

Provisional policy pending completion of review in progress 2/2010

UMHHC Policy 01-04-008

Vendor Visitation and Interaction

Date of Issue: 3/03 Last Reviewed: 2/05 Last Revised: 2/05

I. POLICY STATEMENT

Vendors that conduct business at or with the University of Michigan Hospitals and Health Centers (UMHHC) will do so in accordance with UMHHC policy guidelines. Faculty, house officers, students, and staff of the UMHHC 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 UMHHC. This policy shall be formulated and enforced by the Executive Committee on Clinical Affairs (ECCA). It is the responsibility of all staff to monitor and assure that vendors are compliant with these guidelines. A link to Frequently Asked Questions (FAQ) are included as Exhibit B at the end of the Policy.

II. POLICY PURPOSE

III. DEFINITIONS

IV. POLICY STANDARDS

Faculty and staff are expected to uphold the highest ethical standards in interactions with all vendors. Each member of the faculty and staff is responsible for reporting violations of this policy to the Manager of Contracts and Procurement (734 647-4147) or contact the UMHS Compliance Office by phone (734-615-4400) or email Compliance-Group@med.umich.edu, or to remain anonymous, call the UMHS Compliance Hotline at 1-888-990-0111 or submit an online report.

V. PROCEDURE ACTIONS

Responsible Party/Action

General

1. Each facility at UMHHC will have a designated check-in area for vendors. The check-in function may be performed by a person for whom this is their sole responsibility, or it may be incorporated into the existing responsibilities of an employee. Vendors are only permitted to visit faculty or staff by appointment.

2. All vendors are required to check-in at the designated area and receive an ID badge before proceeding to a department.

3. Vendors who show up at departments without checking in at the designated area and without valid identification, will be asked to leave the facility, or return to the designated area to check-in and receive proper identification.

4. If a vendor does not adhere to this policy, UMHHC Contracts and Procurement will take action as appropriate, such as requesting a replacement vendor or limiting new business with the UMHHC.

5. Notices explaining the vendor policy will be posted at each entrance to UMHHC facilities. The notices will indicate the designated entrance and check-in area for that facility.

6. The University of Michigan reserves the right to limit the number of vendors that any single company has visiting UMHHC facilities.

7. Vendors visiting UMHHC for the sole purpose of initiating and monitoring IRB-approved research studies are exempt from this policy on those occasions only.

8. All vendors who, in the course of providing necessary business services to UMHS, come in contact with patients or have access to identifiable health information must sign a Business Associate Agreement (available from the Health System Attorney's Office) and abide by the UMHS Confidentiality of Patient Information Policy.

Pre-Visit 1. Upon a vendor's first visit to the UMHHC, they shall schedule an appointment with the UMHHC Contracts and Procurement Department (734 647-4147). At that appointment, the vendor will be informed of the organization's solicitation and vendor diversity guidelines.

2. Vendors must schedule an appointment with individuals or departments prior to being allowed to visit.

3. The departments will be responsible for notifying the vendor of the check-in policy and giving them specific directions as to where to check-in.

Pharmacy Specific

  • All new pharmaceutical vendors who call on UMHHC facilities must also report to the Department of Pharmacy Services to register on their initial visit. During registration, the vendor must provide contact information for himself/herself as well as his/her supervisor. The Department of Pharmacy Services will provide the vendor with the pertinent UMHHC policies and guidelines and they will be required to sign a statement confirming that they have received, reviewed, and agree to comply with the policies and guidelines.
Day of Appointment 1. At check in, the vendor must register by signing in on the vendor registry log kept at that check in area. Vendors will register their name, company name, date and time and the individual or department being visited.

2. The vendor will be issued a specific ID identifying them as a vendor. This ID will be temporary, unique in color, valid for one day only, and specify the department they are visiting. Vendors are to wear the ID badge clearly displayed at all times while in UMHHC facilities.

3. At check-in, the designated person will contact the department that the vendor is visiting and get approval to allow the vendor to proceed. Vendors may only visit those departments and personnel when there is a prearranged appointment. Vendors may NOT visit with faculty, staff, or house officers or call on departments without a prearranged appointment.

4. If vendor visits have to occur at times other than during regular business hours, the department must notify the vendor check-in area and obtain in advance a temporary vendor badge for the representative.

Access

1. Vendors are restricted in access to: physicians' offices, Contracts and Procurement, department offices, Pharmacy administrative and Materiel Services offices (all by appointment only), conference rooms (by invitation only), and public areas.

2. Under most circumstances, vendors are prohibited from entering patient care areas within the hospitals and health centers including the: Emergency Department, the Operating Rooms, Medical Procedures Unit, Cardiac Study Unit, patient care units, outpatient clinics, clinic staff rooms, waiting rooms, and hallways, Pharmacy dispensing areas and the Materiel Services warehouse. An exception to this is a situation in which a vendor is required for training on new equipment or devices already purchased by UM, setting up such equipment, or similar activities associated with a contractually agreed to business purpose associated with new technology or devices. These cases must be approved by the appropriate director/chair/division or service chief and are subject to the confidentiality protections in the contract language and the Business Associate Agreement.

3. Vendors are not permitted in the House Officer Lounge. Vendors may leave a message with the appropriate department in order to arrange an appointment with a House Officer. Vendors may meet with House Officers in public areas such as the cafeteria.

4. Vendors are prohibited from attending any conference where patient specific information or quality assurance activities are being discussed (see confidentiality).

5. Vendors shall only use elevators designed for visitor use.

6. Vendors may not use the UMHHC e-mail or paging systems to contact faculty or staff unless specifically requested by the faculty or staff member.

7. Vendors are not to place (or ask staff to place) information in mailboxes of any UMHHC faculty or staff unless specifically requested by the individual faculty or staff.

Food and Beverages 1. Food or drink may not be provided directly by vendors.
Displays 1. Vendors are not permitted to display products or product information within UMHHC.

2. Displays may be allowed in the Towsley Center and other Medical School Areas in conjunction with formal externally directed CME courses sponsored in conjunction with the UM Office of Continuing Medical Education, approved research symposia or other Medical School activities if: 1) the course director or faculty member in charge of the activity approves having commercial displays, 2) procedures and displays are consistent with national policies endorsed by the Medical School concerning conflict of interest (e.g., Accreditation Council for CME Standards for Commercial Support)

Promotional Activities 1. Cash or other incentive programs are strictly prohibited at the UMHHC.

2. No personal gifts of any kind from vendors to faculty or staff are permitted.

3. Vendors are not permitted to distribute, post or leave any type of printed or handwritten material, advertisements, signs or other such promotional materials anywhere on the UMHHC premises. Unsolicited materials may not be provided to clinicians; any promotional or informational material provided by a vendor must be explicitly requested by faculty or staff.

4. Distribution of vendor patient educational material that may be useful to our patients should be left at the appropriate department. Either the department or the Patient Education Oversight Committee must review all educational information before it is distributed to patients or families. Vendors are strictly prohibited from providing educational material of any type directly to patients or from leaving them in areas accessible to patients.

5. Only pricing/cost information which has been approved by UMHHC Contracts and Procurement may be discussed with clinicians. Absolutely, no contracts may be presented to clinical staff; all contracts must be routed through Contracts and Procurement.

6. Raffles, lotteries, or contests which provide the winner with gifts of any value are not permitted

7. Promotion of drugs against UMHHC restrictions, drug utilization guidelines, or clinical guidelines/initiatives is prohibited. Non-formulary drugs or drugs not on the UMHS/FGP Preferred Drug List may only be discussed if the pharmaceutical vendor fully discloses this status to the UMHS faculty physician or staff member. Pharmaceutical vendors who do discuss such agents without an appropriate disclosure will be immediately suspended from visiting UMHHC sites pending review of the event.

8. Pre-printed prescription pads may not be distributed by pharmaceutical sales representatives.

Samples 1. Samples are controlled by UMHHC Policy 05-03-024.
Educational Programs 1. Vendors shall not sponsor any educational programs without approval by the Department Director, Department Chair, Division Director, Section Chief, Service Chief or Residency Program Director. In all cases, the selection of speakers and assurance of the educational integrity of the program is the responsibility of the responsible UM faculty member or program chair. While the support of vendors for educational programs may be acknowledged, vendors must not speak or present information in conjunction with education program time. Further, there can be no activities to promote or market specific products in conjunction with educational time.

2. Vendors shall not attend programs intended specifically for medical students, house staff and faculty or staff without prior permission of the responsible faculty member or program chair. Even if permission to attend is granted, Vendors are not permitted to speak, nor to promote or market products at these programs.

3. Vendors shall not attend programs in which specific patients are identified or when quality assurance or risk management issues are presented.

Grants/Gifts 1. No personal gifts of any kind from vendors to faculty or staff are permitted.

2. Textbooks and items of educational value may be provided to the institution if approved by the department chair/director and if consistent with UMHS and Medical School policies. Vendor representatives may not give to individuals or the institution any promotional gifts (such as pens, pads, etc.) featuring product names. All gifts to the institution must be consistent with UMHS and Medical School policies concerning conflicts of interest which are modeled after the AMA Ethical Opinion on Gifts to Physicians, including the following:

a. "Receiving Small Institutional Gifts from Commercial Companies" (6/3/93) - differentiates between grants/contracts to be processed through UM's research office (DRDA) and gifts to be received directly by individual units, explains acceptable gift purposes, and outline procedures for receiving and handling funds.

b. "Commercial Support for Continuing Medical Education" (6/3/93) - endorses the Standards of Commercial Support of the Accreditation Council for CME, which address institutional responsibility, handling of funds, reasonableness of payments, disclosure, and other issues.

Confidentiality 1. Vendors shall not attend programs in which specific patients are discussed or when quality assurance or risk management issues are presented.

2. Preceptorship programs (programs for the education of pharmaceutical representatives) involving contact with, discussion of, or observation of individual patients, are prohibited unless approved in advance by the Office of Clinical Affairs and the Health System Attorney's Office.

Responsibility Departments and Staff
All UMHHC departments and staff are responsible for assuring that vendors interacting with our organization comply with this policy. Non-compliant vendors are to be immediately reported to the Manager of Contracts and Procurement (734 647-4147) or the Compliance Help Line (1-888-990-0111).

Security
Security may, at any time, request to inspect a vendor's identification badge. Vendors without proper identification badges will be escorted to the appropriate vendor check in area. Uncooperative vendors or those in violation of UMHHC policies may be escorted off the premises.

Compliance

1. The Manager of Contracts and Procurement shall thoroughly investigate any reported violations of this policy.

2. Vendors who fail to comply with UMHHC requirements are subject to losing their business privileges at the UMHHC. The UMHHC reserves the right to restrict the representative and the company they represent from UMHHC property.

3. The Manager of Contract and Procurement will determine the appropriate disciplinary action in conjunction with the appropriate parties such as the departmental directors and/or chairs of the Pharmacy and Therapeutics and the Ambulatory Formulary Committees.

4. UMHHC faculty and staff found not to be in compliance or supportive of this policy will be reported to their supervisor for action. Depending on the severity of the situation, discipline up to and including discharge may be warranted.

5. The Manager of Contracts and Procurement will report all disciplinary action to the Office of Clinical Affairs, the Chief Operating Officer and the Directors of: Security, Pharmacy and Materiel Services.

VI. EXHIBITS

Exhibit A: UMHHC Policy 05-03-024, Drug Samples in UMHHC
Exhibit B: Frequently Asked Questions - Vendor Visitation and Interaction Policy

VII. REFERENCES

1. Council on Ethical and Judicial Affairs of the American Medical Association, Gifts to Physicians from Industry. JAMA 1991; 265:501.

2. Council on Ethical and Judicial Affairs of the American Medical Association, Report on Gifts to Physicians from Industry (Report G, 1-90), Chicago, IL: American Medical Association,1990

3. Council on Ethical and Judicial Affairs of the American Medical Association, Annotated Guidelines on Gifts to Physicians from Industry, Chicago, IL: American Medical Association, 1991

4. Gifts to physicians from industry: Opinion 8.061, Chicago, IL: American Medical Association, 1998

5. Clarification of gifts to physicians from industry, Addendum II, Opinion 8.061, Chicago, IL: American Medical Association, 2000

6. Zarowitz BJ, Muma B, Coggan P, Davis G, Barkley GL. Managing the pharmaceutical industry-health system interface. Ann Pharmacother 2001; 35:1661-8.

7. Coyle Sl, for the Ethics and Human Rights Committee, American College of Physicians-American Society of Internal Medicine. Physician-industry relations. Part 1: Individual physicians. Ann Intern Med 2002; 136:369-402.

8. Coyle Sl, for the Ethics and Human Rights Committee, American College of Physicians-American Society of Internal Medicine. Physician-industry relations. Part 2: Organizational issues. Ann Intern Med 2002; 136:403-406.

9. PhRMA Code on interactions with healthcare professionals. www.PhRMA.org

Authors: John Billi, MD
Frank Krupansky
Mark Pearlman, MD
James Stevenson, PharmD
Jeoffrey Stross, MD

Reviewed with the Hospitals and Health Centers Executive Board, December 18, 2002
Approved By: Executive Committee on Clinical Affairs, February 14, 2003; February 10, 2005
Director and Chief Executive Officer, UMHHC, March 25, 2003; February 23, 2005


Original policies are held by Carolyn Ladd, Policy Coordinator, Executive Directors Office,
telephone 647-2510
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