CHI National Vendor Access Policy

LEARN Class

LEARN Class Objective• Understand the changes to the policy.

• Understand staff responsibilities for the policy success.

• Understand vendor responsibility.

• Understand types of vendors.

• Understand process and rules for vendor items brought into the facility.

Change from Facility to National Policy

• Two policies streamlined into one

• Simplified language, process and attachments

• Attachments all located at one site for access and tracking

• Consistency across all entities for vendor credentialing. Once a vendor rep’s credentials are cleared for one, can gain access at a different CHI entity.

• New policy provides entities:– More authority to require vendors to comply with CHI

requirements and documents with clear non-compliance application– no negotiated modifications at the local level

– Safety, Expense Management, Corporate Compliance, Infection Control, etc.

One National Policy - Benefits• Consistency and standardization for all entities (National employee locations,

direct affiliates, subsidiaries where direct affiliate holds power to appoint a majority of the voting members of the governing body of such organization)

• Guarantee of policy implementation at entity level – entity responsibilities outlined– National email address for entities’ use for communicating non-

compliant vendors to policy (corporate compliance)

• Access management consistent across system - RepTrax• RepTrax Vendor Management application improvements for

National tracking and document management at both entity and national (i.e. background screenings available to selected national staff for review and compliance)– Desktop RepTrax vendor management version available for clinics and offices – no kiosk– CHI National Manager of CHI RepTrax System and all facility registration compliance–

Cheryl Clark

• New product introduction, management, training and patient contact issues addressed

• National implementation, training (LEARN) and follow-up support

What is a CHI Entity or Facility?• CHI National Office, any Direct Affiliates and

any Subsidiaries is to manage the access of vendors, healthcare industry representatives, service personnel, consultants and others, who wish to enter a CHI Entity or Facility for the purpose of conducting business.

• Examples include but are not limited to: Hospitals, National Offices, Clinics, Emergency Care, Urgent Care, Long Term Care, Skilled Nursing Facilities, etc.

What system is used for vendor access?

• RepTrax is the designated vendor management system.

• Administrative discretion, regarding the applicability of the System, should be used for small sites with minimal Vendor visits

Where in the facility does this policy apply?

• Nursing floors

• Intensive care units

• Traditional procedure areas

• All areas of the facility

Who is considered a vendor?• Non-employed third party healthcare industry representatives

• Basic Vendor – Areas where no clinical care or treatment is provided to patients.

• Premium Vendor – Access to non-clinical and patient care or surgical and invasive procedure areas once additional credentialing and specific policies and procedures are met.

• NOT a VENDOR: Contracted Staff and Contracted Companies (Ambulance, etc.) Their contract should cover the requirements for immunizations, background check, etc. They should be issued a “contractor” badge and it should have a time limit , ex: 3 months, 6 months, etc. which can be renewed if the contract requires them to be on-site for additional time.

Entity Vendor Access Management• Who in the entity is managing the vendor access

program?

– CHI Entity (hospital) Supply Chain Leadership; Corporate Compliance

– CHI Entity (clinics, ambulatory, national offices) Office Manager or Facility Manager or selected individual

(To find out the management of this at your location contact Materials Management or your Facility Manager)

Entity Vendor Access Management

What are the duties of the entity vendor access program manager?

• Ensure that all Vendors, CHI Entity department leaders and other appropriate individuals are aware and educated on the Vendor Access Policy and their respective responsibilities

• RepTrax System implementation

• Communications, education and awareness

• Enforcement and assistance

Facility Staff Responsibilities• All CHI Entity Department Leaders and other appropriate individuals are to

understand the access policy and enforce it.

• Vendor Requirements:– Must have an appointment or the consent of the CHI Entity designated

department– All vendors are required to register and print an ID badge for each visit– All vendors are required to log out of the RepTrax system by using the kiosk

or texting capabilities at the completion of the appointment and stated purpose of the visit.

• ALL Entity employees, medical staff, contracted staff and the CHI Entity Security Department shall enforce this policy by:– Not allowing vendor to access to any areas or conduct business in in area of

the facility if the vendor does not display ID badge– CHI Entity staff may remove access privileges for any vendor not complying

with these log-in and log-out procedures and shall document such restriction in the RepTrax system.

– Vendor with denied access or appearing at an appointment without an appropriate ID badge must be directed to the CHI Entity designated department (i.e. MM, Security, Risk Management, etc.)

Facility Staff ResponsibilitiesBids• All bids, quotations and special offers must be submitted to

Supply Chain/MM regardless of who originally requested the bids

• All bids must comply with Supply Chain Policy 1

Vendor Equipment and New Product Evaluations and Approval Process• Supply Chain/MM must ensure review, confirm FDA approval

(or in the case of an investigational drug or investigational device, confirm the FDA, IND or IDE number) and authorize the use of a non-CHI Entity owned equipment/products/drugs/devices brought into the CHI Entity by a vendor prior to use.

• Product evaluation process conducted with approvals and authorization documentation maintained as well as appropriate training and education conducted

Facility Staff ResponsibilitiesVendor Equipment and New Product Evaluations and Approval Process continued…• Products with no prior approval by the CHI Entity will be considered a

DONATION by the Vendor and will NOT BE COMPENSATED.

• CHI Entity IS NOT RESPONSIBLE NOR WILL THE CHI ENTITY PAY for any item left on CHI Entity property without a purchase order or written agreement between the CHI Entity and Vendor.

• Operation and maintenance of the Product will be according to the CHI Entity department, Primary Provider and manufacturers’ specifications and instructions.

• All non-sterile equipment requested to be brought into a perioperative or operating area must be disinfected prior to entering a Patient Care or Surgical and Invasive Procedure Area. In the event that an unanticipated outcome or adverse event occurs, the CHI Entity will sequester or seize any device, equipment or instrumentation brought into the facility by the vendor.

Vendor Responsibilities

Prohibition on Marketing

• Unless previously authorized by the department manager:– Vendors may not market any product to other

physicians and/or CHI Entity staff while present in a department• No marketing of products beyond the scope of currently

agreed upon use

• Negative comments regarding other vendors or products will not be tolerated and will posted in the RepTrax system by the CHI Entity

Vendor Responsibilities• Vendors are not allowed or permitted in a CHI Entity without an appointment or the

consent of the CHI Entity designated department– All vendors are required to log in and register with the RepTrax system– All vendors are required to print an ID badge for each visit– All vendors are required to log out of the RepTrax system by using the kiosk or texting

capabilities at the completion of the appointment and stated purpose of the visit.

• Vendor shall:– Prominently display the ID badge at all times while on the CHI Entity premises– Confine activities to the authorized destination, business and time of departure stated

on ID badge

• CHI Entity staff may remove access privileges for any vendor not complying with these log-in and log-out procedures and shall document such restriction in the RepTrax system.– Privileges may be revoked for individual or company if repeated non-compliance– Violations of any CHI Entity policies or procedures, Standards of Conduct as outlined in the

Vendor Business Standards Agreement, Attachment 1 repeated violations, or any other requirements may result in suspension or termination of a Vendor’s ability to conduct business at the CHI Entity or a Vendor’s visiting privileges at a CHI Entity and documented in the System.

– Termination of Visits. Nothing in this Policy shall limit the ability of any department staff or administrator of the Hospital to immediately terminate any Vendor’s access to any area of the Hospital, including the Patient Care or Surgical and Invasive Procedure Areas, in the interest of business reasons and/or the quality, safety and well-being of the patient, research subjects, employees, or other third parties.

Vendor ResponsibilitiesVendor Business Standards Agreement

– All vendors receive copy of policy and are required to adhere to its contents

– Premium and Basic vendors visiting the facility two or more times in a year must also agree to, abide by and record such agreement of the Vendor Business Standards Agreement located in the RepTrax system as Attachment #1

Vendor Business Associates Agreement

– HIPAA compliance requires the vendor to complete and execute this agreement and post in the system as Attachment #2

Vendor Conflict of Interest Disclosures

– Vendor is required to complete, supplement as needed and document in the RepTrax system Attachment #3

Vendor Responsibilities

Good Health

– Vendor must be in good health to access the facility. No signs of fever, runny nose or taking medications for transmissible illness.

• Premium vendors must maintain proof of compliance with all requirements in the RepTrax system

Attire

– Premium vendor must abide by the CHI Entity Hospital’s Patient Care or Surgical and Invasive Procedure area’s attire policy

Other Restrictions

– Vendors must follow any CHI Entity restrictions

Premium Vendor and Entity Clinical Responsibilities

Prohibition on Patient Contact• Basic vendors are prohibited access to, participation in or observation of any

patient care activities

Premium Vendor Access to Patient Care or Surgical and Invasive Procedure Areas Requirements:• Premium vendors must be specifically approved 24 hours prior to access by the

patient’s physician, the Chief of Service or Administrative Director of the service/department involved or the Director of MM/Supply Chain or the Research Manager and must meet all other requirements of the Premium vendor access to Patient Care or Surgical and Invasive Procedure Areas.– If the primary care physician does not initiate the request for the premium vendor, the

physician will be notified and must approve the request prior to premium vendor access to the area requested.

– The primary care physician is responsible for obtaining patient consent for the premium vendor to observe the procedure

– Written requests and approvals shall be kept in a CHI designated department– All premium vendors in the patient care or surgical and invasive procedure areas must be

documented in the intraoperative nurses’ notes.

• The manager or designee of the clinical area where the premium vendor desires access is responsible for requiring all Premium vendors to execute the Vendor Health Statement and Release (Attachment #4) and maintain it in the RepTrax system. The research manager is responsible for all vendors involved in clinical research.

Premium Vendor and Entity Clinical Responsibilities

• Vendors must comply with all requirements before requesting access and submit all documents in the RepTrax system. Trainings, experience providing technical support, aseptic technique, biohazard safety, HIPAA training and knowledge, fire and disaster safety, electrical and/or radiation safety– If CHI entity is serving as training site, a separate agreement may be in play

– Letters of reference for technical trainings

• CHI Entity shall establish and maintain the required orientation procedures for education and verification of training compliance; documentation must be maintained in the RepTrax system.

• Liability Insurance (see policy)

• Background screening check verification as required by CHI entity policy in accordance with CHI National Policy requirements and recommendations. This should be documented in the RepTrax system.

Premium Vendor and Entity Clinical Responsibilities

• Execute and document in the RepTrax system the Vendor Health Statement and Release Attachment #4– Premium vendors are not considered surgical

assistants and cannot:• Participate in any procedure performed on the patient

• Touch the patient

• Scrub in on a procedure

• Perform duties of the OR/Perioperative staff

• Operate or inspect another vendor’s equipment

• Operate equipment or devices attached to a patient

Vendor Responsibilities

• Confidentiality – Premium Vendors must execute a Confidentiality

Agreement, Attachment 5 located on the System before they will be granted access to any Patient Care or Surgical and Invasive Procedure Area.

– Patient’s right to confidentiality and safety must be maintained according to all applicable local, state and federal regulations, CHI Entity Hospital rules, regulations, policies, and procedures.• If the Premium Vendor requests to photograph, record or

videotape the patient or procedure, the Authorization of Patient to be Photographed, Recorded and/or Videotaped, Attachment 7 located on the System must be signed by the patient and placed in the patient’s chart.

Questions

• Please contact your local Materials Manager, Facility Manager or Office Manager.

• Regional Supply Chain Directors

• Regional Supply Chain Contracting Leadership

• National Contacts:– Cheryl Clark, Manager Integrated Supply Chain

Programs cherylclark@catholichealth.net

– John Gould, Vice President Supply Chain Operations johngould@catholichealth.net

– Susan Schrupp, Vice President Supply Chain Contracting susanschrupp@catholichealth.net