o Acknowledgement of emergency protocols.
o Protocols on the appropriate time for a vendor to enter the surgical suite (the vendor is not to enter until the patient is draped).
o Protocols and procedures regarding the prohibition of vendor representatives from opening or handling any sterile items within the sterile field.
o Policies prohibiting vendors from providing any patient care (the vendor will act as support agent for products only).
o Observational Experience Agreement Forms (to be completed for each representative present in a procedure. Forms can be kept on file in the department and updated on an annual basis).
o Patient consent form (which can include check box for vendor representatives).
• Hospital expectations on the delivery and removal of supplies, products, and instruments.
• Policy on interactions with surgical practitioners, staff, clinicians, fellows, residents’ requirements. This includes designated meeting areas for discussions, appointments and a listing of key contacts for specific areas or departments within the hospital.
• Protocols surrounding compliance, accountability, and conflict resolution processes.
• Hospital health and safety rules and regulations.
Additionally hospitals and their leadership teams should consider how vendor conduct and vendor management policies impact on or may be affected by regulations that govern the operation of a hospital. They should also consider safety, patient confidentiality and environmental issues.
Vendor Credentialing:
A vendor credentialing program can help ensure the hospital meets its obligation to provide a safe, secure, and infection-free environment. Credentialing can provide confidence that vendors and their representatives are indeed who they claim to be. These programs are often carried out in partnership with a third party or private company that can be very effective assisting the hospital in establishing, and/or maintaining the credentialing program.
These programs may be attractive as hospitals become more operationally complex entities with multiple entry points that are largely unsecured. Purchasing departments are sometimes located off site, so it can be difficult for hospital staff and surgeons to know all of their vendors.Vendors should be
classified according to the level of access they have within a hospital. This is particularly important in the perioperative area.
General vendor credentialing can include the following:
• Background checks such as criminal record checks on individual representatives, proof of
insurance, professional credentials, national / international lists of excluded persons or companies, etc.
• General financial and business information on the vendor company, including Workplace Safety and Insurance Board compliance, tax compliance, etc.
• Immunization record checks for TB, Influenza, Hepatitis B, Mumps, Measles, Rubella, Chicken pox, etc.
• Behaviour guidelines and compliance: these are general expectations and hospital safety rules, regulations (and may include training for vendors through various educational media).
Importantly, this can include OR / perioperative environment protocol and aseptic technique (conduct within sterile conditions) and training on the elements of the Personal Health Information Protection Act.
Some vendors may be required in ORs to assist surgeons in developing competency with certain equipment. For these vendors, consider additional requirements such as:
• Product training attestation letter with reasonable expiry timelines
• OR protocol expectations course
• Blood borne pathogens training
• Sharps training.
Credentialing may also include rules and regulations concerning business performance metrics such as delivery terms and order fill requirements, but most often these issues are dealt with in contractual terms. (For more information, see Example D at the end of this section.)
CONDUCTING YOUR VENDOR MANAGEMENT RESEARCH
Hospitals have many resources available to them to assist in the development of vendor management strategies, policies, and formalized contracts and agreements. To start, hospitals can work with their procurement professionals, shared services organizations and peer hospitals. They can also leverage many of the resources made available by various organizations, including the Government of Ontario’s
publications such as the Ministry of Finance’s Broader Public Sector Procurement Directive (www.fin.gov.on.ca/en/bpssupplychain/documents/bps_procurement_directive.html ) and advice to vendors in, Doing Business With the Broader Public Sector: A guide for small and medium enterprises (www.fin.gov.on.ca/en/bpssupplychain/documents/bps_doing_business_handbook.html ).
Information on vendor credentialing programs and standards can be found through the U.S.-based Association of Perioperative Registered Nurses (www.aorn.org) and also through The Joint Commission (www.jointcommission.org ).
Additionally, Accreditation Canada (www.accreditation.ca) , the Canadian Standards Association (www.csa.ca) , and the Operating Room Nurses Association of Canada (www.ornac.ca) all provide valuable information on standards of practice (for conduct and products) that can be applicable to vendors within the hospital environment.
Many resources are available to Ontario’s hospital professionals (and shared services organizations) to assist in the development of addressing vendor management issues. These include:
• Accreditation Canada www.accreditation.ca
• Advanced Medical Equipment Technology Association (Advamed) – www.advamed.org (code of ethics)
• Association for Healthcare and Resource Materials Management www.ahrmm.org (part of the American Hospital Association)
• America College of Surgeons www.facs.org – Statement on Health Care Industry Representative
• Association of Canada’s Medical Technology Companies - MEDEC (code of conduct) –
www.medec.org
Appendix C: A Guide to vendor Management based on the OR Supply Chain Program
• Association for Perioperative Practice (AFPP) www.afpp.org.uk/home - formerly National Association of Theatre Nurses
• Association of Operating Room Nurses (AORN) – www.aorn.org position statements and guidance documents including “The Role of the Health Care Industry Representative in the Perioperative/Invasive Procedure Setting”
• Canadian Medical Association – www.cma.ca CMA Policy – Guidelines for Physicians in Interactions with Industry
• The Joint Commission (responsible for accreditation of hospitals in USA)
www.jointcommission.org – FAQ on Health Care Industry/Vendor Representatives
• Ontario College of Physicians and Surgeons www.cpso.on.ca (who have adopted CMA Guidelines)
• Operating Room Nurses Association of Canada www.ornac.ca (advice within Guidelines and Position Statements on ‘visitors to the surgical suite’)
VENDOR MANAGEMENT TOOLS AND TEMPLATES
Source: Southwest General Health Center, Middleburg Heights, Ohio.
http://www.ormanager.com/PDF/reps.PDF
GUIDELINES FOR HEALTH CARE INDUSTRY REPRESENTATIVES IN THE OPERATING ROOM
POLICY
Only knowledgeable health care industry representatives will be permitted access to the operating room at Southwest General Health Center (SWGHC) for the purpose of providing technical support during a surgical intervention.
The presence of any health care industry representative in the OR must be justified by his or her contribution to positive patient outcome and is subject to approval by the resource coordinator, associate administrator, or administrator of the Surgical Care Center.
REQUISITES
1. All health care industry representatives must present written verification of their successful completion of an approved course inclusive of OR protocol, blood borne pathogens, and HIPAA requirements. (Note: SWGHC has approved the on-line course: OR Protocol TM, Blood borne
Pathogens Vol I: “Exposure to Blood borne Pathogens in the Surgical Environment,” and Blood borne Pathogens Vol II: “Infectious Diseases.” These courses can be accessed at
www.healthstream.com/training)
2. All health care industry representatives must present written proof of current TB testing and Hepatitis vaccination.
3. All approved health care industry representatives must obtain a Southwest General Health Center photo ID
a. Photo ID will be kept at SWGHC and will be given to the health care industry representative at time of sign-in.
b. Photo ID will be visible at all times.
c. Photo ID will be returned to the control desk associate when leaving.
d. Failure to return ID will require health care industry representative to apply for a duplicate photo ID.
PRACTICE
1. An approved list of vendors for each respective OR schedule will be located in our health care industry representative log.
2. Upon arrival, the health care industry representative will check in at the control desk and sign in the vendor log book.
3. The health care industry representative will respect all SWGHC protocols created to protect patient confidentiality. The health care industry representative:
EXAMPLE A:Guidelines for health care industry representatives in the operating room