POLICY STATEMENT. The Guthrie Clinic POLICY & PROCEDURE. SECTION: ADMINISTRATIVE SUBJECT: Vendor Policy DEPT. SUPPLY CHAIN, REGULATORY COMPLIANCE

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POLICY & PROCEDURE

SECTION: ADMINISTRATIVE SUBJECT: Vendor Policy DEPT. SUPPLY CHAIN,

REGULATORY COMPLIANCE

EFFECTIVE: July 1, 2016 POLICY # TGC–955--59

SUPERCEDES: New PAGE # 1 of 12

DISTRIBUTION: All Departments

I. OBJECTIVE

To establish and promote adherence to corporate policy, credentialing and badging requirements while maintaining customer satisfaction and promoting the safety of patients and healthcare

workers. This policy shall supersede all previous policies and is the established policy for all areas and facilities within The Guthrie Clinic Should any existing or future policy of any underlying area or facility within The Guthrie Clinic be, in any way, a stricter interpretation of definitions, policies, procedures, etc. the more stringent and restrictive policy shall supersede.

II. POLICY STATEMENT

To assist The Guthrie Clinic in fulfilling its mission, vision and values, The Guthrie Clinic has

established regulations and standards to promote the purchase of equipment, supplies, products, service and maintenance in a manner that is consistent with the systems operating principles. Equipment, supplies and products used in the diagnosis and treatment of patients have significant impact on safety, quality and fiscal responsibility. The advent of new and expensive technology calls for careful

evaluation of each product to assure its rational, safe, and cost-efficient use. III. DEFINITIONS

TGC: The Guthrie Clinic includes all Business Units (Hospitals, Clinics, Business Offices, etc...) Vendors: Sales representatives who market products and services to the various entities

comprising The Guthrie Clinic.

TGC Central Purchasing: The Central Purchasing office located at 115 Hospital Place, Sayre PA 18840 is the department responsible for all purchasing and contracting related issues, contracts, and sourcing decisions at The Guthrie Clinic

Service Representatives: Those who provide warranty or repair service for equipment or systems. Procedural Patient Care Category: Participation in providing resources (devices, implants, etc.)

or equipment during a procedure or intervention. Vendors in this category who are provided access to sterile procedural areas will wear a Red Surgical Cap, provided by Guthrie, at all times when at a The Guthrie Clinic facility as designation of vendor status.

Pharmacy/Nutritional Category: Pharmaceutical Company Representatives (PCR) / Nutritional vendors interacting with the Pharmacy department.

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If you are viewing a printed copy of this policy, please note that the most current version is located on the intranet site.

Transitional Care Category: Vendors meeting with clinical staff and patients related to the transition of care. i.e., Skilled Nursing Facility vendors

Visitor Category: Vendors who are acting, as a “visitor” i.e., conducting business meetings, conducting education, etc., that doesn’t involve patient contact or is not doing business within a procedural setting.

Facility: Any inpatient, outpatient or administrative location or office within The Guthrie Clinic facilities, including but not limited to The Guthrie Clinic-Robert Packer Hospital, Corning Hospital, Corning Surgery Center, Troy Community Hospital, Towanda Memorial Hospital, The Guthrie Clinic Medical Group Physician Offices, The Guthrie Clinic Corporate, etc.

IV. POLICY

A. All vendors and representatives must report to TGC Central Purchasing office on their first visit to receive the Guidelines for Vendors and complete other appropriate paperwork based on their level of activity for the visit. The vendor will meet with the appropriate Contract Manager to provide the purpose of the visit, names of staff members to be seen (Purchasing will verify there is an appointment) and share product or service information to be discussed at the appointment. Vendors and representatives will provide complete and factual information on their products/services while respecting the needs and policies of our facilities. Vendors and representatives visiting The Guthrie Clinic outpatient facilities must follow site specific processes and policies in addition to those outlined by TGC Central Purchasing.

B. Vendors must comply with the established procedures related to implants, products, medical devices, supplies, or equipment not currently being purchased by The Guthrie Clinic, as detailed in the Guidelines for Vendors. Failure to comply with this will result in the vendor being barred from doing business in all The Guthrie Clinic facilities, and may result in, and up to, termination of contracts and/or contracting privileges.

C. Consistent with our values, The Guthrie Clinic requires vendors to observe the same standards of conduct and professional behavior that apply to our associates. The Guthrie Clinic will not allow vendor representatives who violate these principles or whose behavior conflict with our standards to work at our facilities, and reserves the right at its discretion to request and receive an appropriate vendor representative replacement or to bar vendor representative from any or all The Guthrie Clinic facilities.

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D. Vendor must make arrangements/appointments with the appropriate department, personnel, or medical staff prior to arriving at a facility. No representative will be allowed at any or all The Guthrie Clinic facility without the request of a surgeon for the OR, Cath Lab, or other surgical procedure area for which the vendor is providing intra-operative assistance. Guthrie Medical Group policy specifically forbids

physicians from scheduling appointments with sales reps during patient care hours. E. Vendors will wear their company designated identification badge, in addition to the TGC

printed badge. Prior to visiting any Guthrie Clinic facilities, vendors must check in with Central Purchasing or Materials Management at an inpatient facility (The Guthrie Clinic – Robert Packer, Corning, Troy Community, or Towanda Memorial) and obtain a printed pass. The printed pass is acceptable for that calendar day and that calendar day only. Only those vendors designated as approved on TGC Central Purchasing website will be allowed to print a pass. If a vendor is not designated as “Approved” and unable to print a pass, the vendor will need to report to TGC Central Purchasing for resolution.

F. Vendors may engage in activities related to the business at hand during normal business hours. Any vendor requiring activity after hours must have the approval of the department director/manager and TGC Central Purchasing. Additionally the Safety & Security

Department must be notified of vendors requiring after-hours access.

G. Service Representatives installing, servicing, or demonstrating medical equipment/devices, or providing loaner equipment/devices, must have these devices inspected by the

Clinical/BioMedical Engineering Department prior to use in any The Guthrie Clinic facility. These inspections shall be coordinated and scheduled with the

Clinical/BioMedical Engineering Department during normal business hours with a minimum of 24 hours prior to the equipment inspection requirement.

H. All medical equipment/devices/instrument trays that may be used during a patient

procedure will need to be processed in one of TGC’s Sterile Processing Departments (SPD) prior to use. SPD will need specific instructions on the handling and sterilization of the equipment/devices/instrument trays in advance and will require a minimum of 48 hours to process prior to the scheduled procedure.

I. Credentialing Criteria:

1) To complete the credentialing process all vendors will be required to complete or attest to the following:

(a) Credentialing application (b) HIPAA training

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2) In addition the following are required for vendor access in Patient Care areas: (a) Proof of MMR - dates of vaccines or titers showing immunity;

(b) History of Varicella disease, proof of vaccines or titer showing immunity;

(c) Annual flu vaccine is required for ALL (not just in Service and Procedural patient category) - starting Dec. 1 until May 1 each year - annual requirement;

(d) Proof of PPD within last year, or T-spot / Quantiferon Gold test within last year; PPD's are no longer an annual requirement - but initially, we would need proof they are negative;

(e) For any vendors going into areas that bronchoscopy procedures are being done, a respirator Fit test is required.

(f) Infection Control

(g) Aseptic Principles and Techniques

(h) Attendance at a blood borne pathogens in-service (required by OSHA)

V. PROCEDURE

A. Vendor Parking- Vendors will park in the vendor and service personnel designated parking lot located by the receiving dock on Hospital Place. Temporary parking passes can be obtained at the reception desk of the Facilities/Strategic Planning & Marketing office located at the entrance to the vendor and service personnel parking lot.

B. Registration

1) Prior to receiving clearance to enter a The Guthrie Clinic facility, prospective vendors must appear at TGC Central Purchasing, state the purpose of their interactions with The Guthrie Clinic and complete any/all appropriate paperwork.

2) Each Vendor should receive a copy of the Guidelines for Vendors. 3) Vendors will be directed to Reptrax System and must meet the

requirements/documentation necessary to achieve “Green” status and secure access to a The Guthrie Clinic facility. Vendor profiles are considered current for 1-12 month period. However, the vendor profile in the Reptrax system must be updated on as needed basis as well as re-certified prior to expiration of application anniversary date. Once “Green” access is granted vendors must secure a Reptrax printed pass prior to being cleared to enter a The Guthrie Clinic facility. Printed passes are required on a daily basis as all passes expire date of issuance.

C. For vendors in the Procedural Patient Care (PPC) category, health care testing, interpretation of the tests and attestation for proof of health care screening criteria compliance is the sole responsibility of the vendor applicant as defined in this vendor credentialing process. Without satisfactory completion of all elements of the health screen, the application will be considered incomplete and access denied.

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D. An "Emergent Situation" can be declared by the OR/procedural Director and or Manager in consultation with the physician doing the procedure or patient care intervention. In

instances where a device, implant, or supply is necessary for timely patient care, and it is approved for use at The Guthrie Clinic either by the appropriate Value Analysis Team or the OR Director in consultation with the attending physician, but is only available from a vendor who has not completed their vendor packet, then the vendor must complete the paperwork post case as soon as possible.

E. The Guthrie Clinic ID Badging

1) Daily vendor passes are required through Reptrax and can be printed at Vendor check-in stations or via mobile application.

2) Guthrie hard badges/ID’s will no longer be issued unless by exception as determined by the Safety and Security Department and the Purchasing Manager.

3) All vendors in possession of a hard badge/ID must return to TGC Central Purchasing, the hard badge/ID previously issued within 30 days of receipt of this policy update. TGC Central Purchasing will cross reference, with the assistance of security, to review and ensure all hard badge/ID’s that were previously issued are returned within the above referenced timeframe. Any vendor who does not meet this requirement will have all visitor privileges revoked at the sole discretion of TGC Central Purchasing.

F. Re-certification

1) Vendor profile and certification is valid for 12 months from original issuance date, with a 30 day grace period if deemed appropriate.

2) Prior to the 12 month application anniversary date vendor will be required to re-certify with Reptrax.

G. Pharmaceutical Company Representatives (PCR)/Nutritional Vendors 1) See Addendum -1 for Pharmacy Specific Guidelines

H. Transitional Care:

1) Representatives providing transitional care services such as; home health, skilled nursing, rehabilitation and hospice may access The Guthrie Clinic facilities for purposes of evaluation, collaboration and assessment.

2) Representatives will be required to obtain and wear their company designated identification badge, in addition to the TGC printed badge and abide by any/all applicable policies and procedures contained herein.

a) For more information on registration with Reptrax, please contact Central Purchasing or the safety & security office.

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I. Procedural Patient Care (PPC) and Service Vendors: 1) Routine Business

a) Procedural Patient Care vendor’s access to The Guthrie Clinic facilities is strictly limited to the OR, Cath Lab or Special Procedure Suite areas where participation in providing resources (devices, implants, etc.) or equipment during a procedure or intervention is required. Vendor representatives will be allowed access during a procedure by the specific and explicit invitation of the attending physician or surgeon. If the vendor arrives without prior notification, the physician/surgeon will be asked if he/she does in fact require the vendor to be present during a specific procedure. If the physician/surgeon has not requested the vendor to be present, this will be considered a violation of the Vendor Representative Guidelines.

b) At no time is vendor permitted to enter, physician lounge, employee lounge physician dining room. Nor are vendors to enter, uninvited and/or unaccompanied by the Guthrie staff member extending the invitation to classrooms, conference rooms or other areas within the facility that are not related to the provision of services, with the exception of the OR Locker Room(s) to change into provided Scrubs. Any PPC identified as having violated this area restriction will be barred from the facility at the sole discretion of TGC Central Purchasing.

c) Vendors will not use their cell phone and/or camera in Operating Rooms or Procedural Areas.

d) Vendors are not allowed to bring outside duffle bags or backpacks into the OR. e) Vendors in PPC category who are provided access to sterile procedural areas will

wear Red Surgical Caps, provided by Guthrie, at all times when at a The Guthrie Clinic facility as designation of vendor status.

f) Service vendor’s access to The Guthrie Clinic facilities is strictly limited to those areas in which equipment, technology or instrumentation requires repair or delivery at any one given time. All service vendors must notify TGC Central Purchasing, department director/manager and Safety and Security Department of both arrival and departure. A log of the arrival times, departures and repairs will be maintained by TGC CENTRAL PURCHASING.

2) Educational Programs (In-services) at The Guthrie Clinic facilities a) In-service/educational programs are strictly prohibited unless:

(1) Coordinated in conjunction with the Continuing Medical Education Offices and associated with the issuance of CEU’s or CME’s associated with a skills or cadaver lab.

(2) OR and Cath Lab, provided the in-service/education program relates to a specific; TGC Central Purchasing or facility based product purchase of new products or equipment, continuing education associated with existing product purchases, products or equipment.

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(3) Transition of Care education must be coordinated with the Director, Care Coordination, and is deemed necessary for changes in services offered and to update operating processes.

3) Clinical Trials and Evaluations must have prior approval, and no-charge purchase order issued by TGC Central Purchasing. Any products and/or equipment that have not obtained this approval will be considered gratis and non-reimbursable to the vendor. Approved trials and evaluations will be facilitated and monitored by TGC Central Purchasing and the Value Analysis Team (VAT) in conjunction with the corresponding clinical council.

J. Compliance with TGC Vendor Policies:

1) TGC’s Central Purchasing and Pharmacy Administration have primary responsibility for administrating and enforcing the vendor policies and relationships with our trading partners. Vendors are expected to work through Central Purchasing or Pharmacy Administration on all new product, contract, pricing, terms and transactional issues. 2) Disciplinary action against a vendor may result if the vendor violates any part of this

policy.

a) First Violation- Verbal warning to the representative.

b) Second Violation- Written warning to the representative and the representative’s manager or supervisor.

c) Third Violation- Suspension of representative AND all of the representatives from the offending company from visiting The Guthrie Clinic facilities and staff, for a period not to exceed six (6) months, along with written notification to the representatives National Accounts Manager or VP of Sales.

d) Fourth Violation- Suspension of representative AND all of the representatives from the offending company from visiting The Guthrie Clinic facilities and staff for a period in excess of six (6) months, along with written notification to the representatives National Accounts Manager or VP of Sales.

e) If the severity of a violation warrants, Guthrie reserves the right to bypass the progressive process to take the appropriate immediate action (determined solely by Guthrie and administered by Central Purchasing) up to and including

suspension. 3) Reinstatement:

a) Suspended representatives must petition for reinstatement to the appropriate Contract Manager in Central Purchasing or Pharmacy Administration, following the term of suspension.

NOTE: Suspended representatives will not be automatically reinstated.

b) Violations are cumulative with no time limit. The Guthrie Clinic will not provide an opportunity to have status repaired by removing violations over time or through other reparation actions.

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Providing gifts, food and catered meals:

The Guthrie Clinic strictly prohibits vendors from providing gifts of a personal nature. Non-Cash gifts such as flowers, candy, baked goods or decorative crafts that are of a nominal value may be accepted on behalf of the entire work unit.

Appropriate entrances for vendors to register

Robert Packer Hospital/Sayre Campus: One Guthrie Square, Sayre PA, 18840

 Main Entrance-Hallway to RPH-Alcove on Right.

 Sumner Building Lobby.

 Purchasing Office, School of Nursing building.

 Emergency Entrance- After Hours Emergency Access ONLY (for equipment breakdown repair or Emergency Surgery trunk stock)

Corning Hospital/Campus: One Guthrie Drive, Corning NY, 14830-2899

 Main Entrance.

Corning Surgery Center: 31 Arnot Drive, Horesheads NY 14845-8533

 Main Entrance.

Troy Community Hospital: 275 Guthrie Drive, Troy PA 16947

 Main Entrance.

Towanda Memorial Hospital: 91 Hospital Drive, Towanda PA, 18848

 Main Entrance.

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Developed: 12/16/15 Reviewed/Approved 5/10/16:

Revised: 05/11/2016 Owner: TGC Supply Chain

Addendum 1- Pharmacy Vendors

1. Routine Business

a) Pharmaceutical/Nutritional Vendors are strictly prohibited from accessing all The Guthrie Clinic facilities except for:

(1) TGC Central Purchasing (2) Pharmacy Directors office

b) Vouchers or coupons will be accepted via any direct shipment method (ex: FedEx, UPS, etc.) to the pharmacy manager/director or site administrator for the facility.

c) Exceptions are exclusively provided by the Director of Pharmacy, TGC. 2. Authorized Drug Purchases

a) Only the Pharmacy Department of the Robert Packer Hospital is authorized to make drug purchases on behalf of The Guthrie Clinic. Other departments such as Purchasing and Radiology may purchase drugs for The Guthrie Clinic System with approval of the Pharmacy Department.

b) Pharmaceutical representatives may not accept any order (verbal, phone, electronic, fax or written) for pharmaceuticals unless an official purchase order has been completed by the Pharmacy Department.

3. Directory

a) A file of current supplier contact information is maintained in both the Pharmacy and Purchasing Departments.

b) Upon request, the pharmacy department may provide the supplier’s contact information to the facility’s professional staff.

c) The Pharmacy Department has the right to deny planned activities by the pharmaceutical representatives.

d) The pharmaceutical representative will be provided with a dated name tag to be prominently worn along with the representative’s current company nametag.

4. Locations Permitted

a) Pharmaceutical representatives are restricted from pharmacy storage and work areas without supervision and any other area as defined in specific departmental policies and procedures.

b) Meetings with professional staff are conducted in areas convenient to staff and generally in non-patient care areas.

c) Pharmaceutical representatives must maintain confidentiality of patient information.

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a) Pharmaceutical representatives are required to schedule in advance appointments with appropriate pharmacy department staff to: (1) provide information useful for product evaluation

(2) provide timely information on the supplier’s products and services (3) facilitate procurement and crediting transactions

(4) obtain and provide information necessary to support the organization’s formulary system

(5) facilitate informational activities for the pharmacy staff with respect to the supplier’s products

b) Representatives are encouraged to schedule, in advance, appointments with other Guthrie Departments outside of Patient Care hours. These

appointments may be used to facilitate informational activities for health care professionals with respect to the supplier’s products that are currently on the hospital formulary

c) Pharmaceutical representatives may not make appointments with other The Guthrie Clinic Departments to discuss non-formulary medications without prior approval from the Pharmacy Director well in advance of the

appointment.

6. Dissemination of Promotional Materials

a) The pharmaceutical representative may not disseminate information regarding non-formulary products to anyone other than the Pharmacy Department unless approval is granted from the Department of Pharmacy b) Pharmaceutical representatives may be asked to provide the pharmacy

department with copies of all informational and promotional materials disseminated in the organization.

c) The U.S. Food and Drug Administration (FDA) prohibits advertising and promoting drug products for uses not reflected in FDA approved product labeling. Pharmacists and other health care professionals should be aware of these laws and regulations when evaluating the content of promotional materials.

d) The Guthrie Clinic Pharmacy Administration may limit the type of materials disseminated by pharmaceutical representatives to include only company-approved, labeled material and reprints from peer-reviewed journals.

e) Promotional techniques that violate FDA guidelines are subject to reporting. f) Pharmaceutical representatives are expected to communicate warnings and

contraindications as well as indications and endorsements by medical experts.

g) Pharmaceutical representatives may not solicit providers to complete a formulary request form for their product. Providers are required to contact a

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member of the Pharmacy Department to request a review of a medication for formulary addition.

7. Dissemination of Hospital/Pharmacy Policy

a) No pharmaceutical representative shall interpret or communicate policies of the hospital, Pharmacy Department or Pharmacy and Therapeutics

committee to any member of the hospital or medical staff.

b) All such communication must be referred to the appropriate member of the Pharmacy Department.

8. Dissemination of Drug Price Information

a) Pharmaceutical representatives may not provide comparative cost data to physicians as they do not have access to the actual acquisition prices of the hospital and therefore cannot provide accurate price comparisons of their drug and a competitive drug.

9. New Information on Products

a) The pharmaceutical representative is responsible for communicating all changes in the legal or therapeutic status, new labeling or product formulation to the pharmacy department for all drug products currently stocked.

10. Gratuities

a) The pharmaceutical representative will abide by Guthrie’s Corporate Compliance policy regarding gifts and gratuities.

b) The pharmaceutical representative may not supply trademark/logo materials including but not limited to pens, paper pads, tote bags, clip boards and other paraphernalia.

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Addendum-2 Loaner Instruments

1) When surgery is completed, loaner instruments are soaked in an enzyme solution, returned to SPD in a case cart, and processed in the washer-sterilizer for decontamination. If necessary, the ultrasonic cleaner is used to remove debris. Instrument sets are held in SPD for the vendor to reassemble and package for shipping out. If the vendor is unable to do so, prior arrangements must be made with the Team Leader. Removal of

instruments and implants must be completed within 24 hours of the surgery date.

2) If an instrument set is required for an impending surgery. The vendor will be responsible for reassembling the set for sterilization.

3) Prior to instruments and implants leaving a Guthrie facility, the vendor will sign them out on the loaner instrument board in SPD. The vendor is also responsible for reconciling all billable items used and their cost with the OR Inventory Coordinator. This information is used to ensure accurate patient charging and communication of billing information to Purchasing against the purchase order.