The SICP shall provide guidelines to ensure the identification and control of vendor and service representatives within an institution, specifically the invasive cardiovascular laboratories. These guidelines are established to ensure that business relations operate in a manner that fall within JCAHO and HIPAA requirements. All vendor and service representatives must obtain authorization for access to the facility and shall follow the established institutions purchasing/materials managements existing policies.

OBJECTIVES
1. To support staff education pertaining to the use of products currently and/or scheduled to be utilized within the institution.
2. To avoid interference with patient care activities and create an environment that maintains patient confidentiality.
3. To facilitate centralized contracting, purchasing, and distribution for each individual institution.
4. To promote patient safety by assuring adequate information is provided to appropriate institution employees.
5. To support an institution™s cost containment activities.
6. To assure that the materials management information system contains accurate supplier and product information.

IMPLEMENTATION:
A. Vendor/Service Representatives Registration
1. All vendor representatives shall indicate that they have reviewed and are in agreement with hospital policy as determined by each institution. This review must be completed on an annual basis or as determined by the institution.
2. All vendor representatives shall register in the designated area as set by each institution™s policy.
3. Vendor representatives shall provide accurate information as determined by the hospital policy.
a. Up-to-date info about themselves and their company.
b. MSDS sheets for products they represent.
c. Current contract price files.
4. Before a non-employee is brought into the hospital by a Licensed Independent Practitioner to provide direct patient care, treatment or services, the hospital shall determine the non-employee™s qualifications and competence as if the individual were to be employed by the organization to perform the same or similar services.
a. Qualifications and evidence of competencies shall be provided by the non-employee™s organization, including but not limited to:
1) Hiring qualifications, including background check
2) Licensure and/or certification requirements
3) Training and references
4) Current TB test results (must be performed annually)
5) Job description
6) Written validation of competency by an appropriate professional showing validation methods that correspond to the skills being assessed
5. Upon completion of stated requirements, the vendor shall receive admission into the hospital and specifically the invasive cardiovascular laboratories.
6. Vendors must at all times wear a visible photo ID per individual institution policy. Ideally, the ID must contain the company name, individual name, and job title.

B. VENDOR REPRESENTATIVE PRESENTATIONS
1. Vendor representatives may present topic- or product-related programs to the staff, students, and physicians.
2. Presentations must have an educational basis (new product, new research), not just for product promotion.
3. Presentations may be given as product training as required by each institution™s departmental preceptoring/training program.
4. Catering of food and provision of gifts by vendor representatives within the hospital is determined by hospital policy.

C. PRODUCT EVALUATIONS AND STANDARDIZATIONS
1. Physicians, hospital personnel, patient care committees, and vendor representatives may request that new products or equipment may be considered by the department.
a. Requests for such usage must adhere to guidelines as set forth by each institution.
b. New products should be evaluated per the institution™s guidelines.
2. Staff and medical staff will be inserviced on all new products prior to their use on patients. Failure to comply may jeopardize the vendor™s ability to conduct further business with said institutions.
3. All in-servicing and product demonstration will occur with the prior knowledge and authorization of each institution™s individualized guidelines and policies.

D. EQUIPMENT
1. All equipment/instrumentation which has contact with a patient, must be reviewed and approved prior to use by an institution™s appropriate biomedical engineering department.
2. No equipment or instrumentation will be removed unless accompanied by authorized paperwork as set forth by each institution.

E. LEGAL LIABILITIES
1. There are circumstances where direct or in-direct treatment of a patient by a vendor representative may take place (i.e., pacemaker/implantable defibrillator testing). A legal understanding by both the vendor representative and the institution must be in place, regarding responsibility prior to any such treatment and/or procedures.
2. Vendor representatives are prohibited by the FDA from proactively discussing off-label use of products, and/or directly distributing promotional material or reprints of publications that mention off-label use of products.