King sdaughtershealths ystem VendorCredentialingR equirem ents

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1 King sdaughtershealths ystem VendorCredentialingR equirem ents 1 R equirem ents Com pleteddatas heet(application) Com pletedem ployerverifications heet(tobecom pletedby supervisor)orproofofeachrequirem ent. Copy ofcertificateofl iability Insurance(m ustbeacurrentpolicy) P roofofcurrentp P D /T B skintest(only validfor1 year) P roofofhepb Vacc.(forL eveliii O peratingr oom & P rocedureareas) P roofofflu S hot(r equiredonly DuringFlu S eason N ov1 st thru M arch31 st eachyearorr epm U S T w earface m askataltim esw hileinthefacility) S ignedr eleasefrom L iability form S ignedkdm C P harm acy GuidelinesAcknow ledgem ent& CodeofConduct(O nly forp harm aceuticalreps) Com pletedgeneralcom pliancet rainingands ignedattestationform M eetw ithkd P harm acy S upervisor(o N L Y forp harm aceuticalr eps;only forinitialcredentialing;notrequiredfor renew al) P aym entofcredentialingfee(s eestep4 below ) KD VendorR epid Badge(M U S T bew ornataltim esw hileinfacility) 2. Com pletecorporatecom pliancet raining: w w.kingsdaughtershealth.com /About-U s/com pliance-integrity-r eporting.aspx ordirectlinkforvideo Video- w w.youtube.com /w atch?v=etn8x6d6lm Q & feature=youtu.be&autoplay=1 R eview P olicy - w w.kdm c.com /P ortals/0/kdm C/Docum ents/l egal/com pliancehandbookjune% % 20R evision.pdf Com plete& returngeneralcom pliancet rainingattestationform (canbefoundinthispacket) 3. R eturnalrequired docum ents& attached form sviaem ail,fax,orinperson. Em ail Vendors@ kdm c.kdhs.us O ffice 2301 L exingtonave,s uite320 Ashland,KY P F P ay yearly vendorcredentialingfeeof$ p aym entcanbem adeviacreditcard online(t opay online,goto linkinstep5 below )orinperson.w ealsoacceptcom pany Check.(T hisisrequired foreachrepresentative needingaccess/credentialing) 5. S cheduleanappointm entathttps://kdvc.acuityscheduling.com tocom pleteyourvendorcredentialingandp ick upid Badge.T oexpeditethisprocess,pleaseinsurealrequirem entshavebeensenttopriortoyour appointm ent.you canattachaphotoofyourselffortheid badge. 6. Ifyou areap harm aceuticalr ep-you M U S T w ithourp harm acy M GT inperson(only onceduringinitial credentialing);.you m ay pickupyourid badgeafteryourinitialm eeting. U pdated6/22/2017

2 KING S DAUGHTERS MEDICAL CENTER ADMINISTRATIVE POLICY POLICY AND PROCEDURE EFFECTIVE DATE: 3/4/16 SUPERSEDES Reviewed Date: 6/20/12; 08/02/04; 11/1/2003 FILE: SECTION F (5) SUBJECT: SALES REPRESENTATIVES IN THE MEDICAL CENTER POLICY: I. Medical service representatives (sales representatives) may visit the facility in conjunction with their duties. Representatives are guests of the Medical Center and as such may provide services in accordance with accepted rules of conduct within the facility. Representatives are required to fulfill requirements as set forth below. II. Representatives shall limit their visits to providing information and servicing the account. PROCEDURE: 1. To continue to provide quality patient care while enabling our staff to evaluate new products with up to date information. This will enable us to maintain our innovative technology for the benefit of our patients. 2. Responsibilities 2.1 Documentation * All sales representatives must complete the Acknowledgment and Release from Liability form (Attachment A) and comply with all requirements within the vendor management program: Required Documentation LEVEL I LEVEL II LEVEL III Completed KDMC Sales Rep Data Sheet Completed Employer-Level Verification Sheet Proof of a current TB skin test / PPD record Proof of a current influenza immunization, or elect to wear mask Proof of a Hepatitis B vaccination Signed Code of Conduct and Compliance Training Attestation Signed KDMC Acknowledgement and Release from Liability Form Signed KDMC Pharmacy Guidelines Acknowledgement (required only of pharmaceutical reps) Payment of Annual Fee Vendor Badge* All sales representatives must present a competency statement from their company outlining their expertise about the applicable product.

3 2.1.3 All sales representatives must present current documentation of an annual TB skin test for clinical areas All sales representatives must sign the Medical Service Representatives Pharmacy Addendum (Attachment B) All sales representatives must complete the Sales Representative Data Sheet (Attachment C). 2.2 KDMC s Policies and Procedures All sales representatives must review and be knowledgeable about KDMC s policies and procedures related to fire and electrical safety as well as patient confidentiality * As a prerequisite, all vendors must follow the medical centers policy regarding vendor credentialing, requirements, behavior and expectations All sales representatives will be given informational material for which they will be responsible to follow while a visitor at KDMC Any sales representative who fails to comply with the requirements of this policy and/or fails to familiarize her/ himself with the applicable policies and procedures will not be permitted in the Medical Center. 2.3 *Other Breaks may be taken in staff lounge. Sales representatives are not permitted in physician s lounge All sales representatives should have an appointment. 3. Clinical Department Responsibilities: 3.1 * Arrival of Sales Representative As stated above, after receiving a badge, supply sales representatives must sign in and out at the vendor liaison office when using the Ashland campus and KDOH security desk when calling on Kings Daughters Ohio. Pharmaceutical representatives Must report to the pharmacy prior to visiting any other areas of the medical center (see attachment B) Verify that the sales representative is wearing the applicable name badge. 2

4 3.1.4 Assure that the sales representative follows KDMC procedures regarding proper attire, aseptic technique and standard precautions If a sales representative arrives at the medical center to present new equipment, prior to use of the new equipment, the approval of the Director of Materials Management as well as an ad hoc committee must be obtained KDHS Biomedical department before used on patients must inspect equipment. 3.2 * Consignment All items to be consigned must have a completed, signed agreement on file in the Materials Management office. Any additions or deletions to the consigned items must be presented to and approved by Surgical Services and Materials Management prior to implementation Prior to removing consignment products from the facility, the vendor and a KDMC team member will inventory the outgoing products Vendors are responsible for shipment of replacements into inventory. Refilling and rotation of the stock will be the sole responsibility of the vendor Vendor/Representative is responsible for maintaining and validating consignment on a weekly basis All vendors are required to submit Bill-Only invoices within 7 days of case date or be subjected to a potential 10% decrease in total invoice per week. 3.3 * During Procedure As a general rule, sales representatives have no hands on contact with patients; however, if it is necessary that a sales representative have hands-on contact with a patient or piece of equipment being utilized in connection with a patient s treatment and care, the patient must be informed and the team member notifying the patient shall document, in the medical record, that the patient was informed Sales representatives cannot operate equipment. All participation must be limited to verbal guidance only, the only exception being the required programming for pacemakers Sales representatives are to leave immediately after the procedure Sales representatives do not open sterile supplies onto the sterile field. All products must be given to the Circulator to open Sales representatives in the procedure area are to wear lead aprons and thyroid shields whenever x-ray or fluoro is being used, or leave the exposure area. It is the responsibility of the sales representatives and his or her company to provide and maintain x-ray badges. KDMC is not responsible for any exposure. 3

5 3.4 * Other Sales representatives are to conduct themselves in accordance with KDMC policies and procedures. Failure to follow policies and instructions will result in a request to leave the Medical Center Consent: The patient will be informed of the proposed presence of a sales representative in their procedure at the discretion of the physician KDMC does not reimburse vendors for trialed product. President/CEO Attachments: A Acknowledgment and Release from Liability B Medical Service Representatives Pharmacy Addendum C Sales Representative Data Sheet 4

6 Vendor Representative Credentialing Application Date First Name Phone (Cell) Last Name Phone (Home) Address Home Address City State Zip Code Company Position / Title Products Covered Area's Covered Phone # of Company Address of Company City State Zip Code Name of Immediate Supervisor Address of Immediate Supervisor Access Level Requesting Please Check approite Box. LEVEL I Vendor Guests and Vendor Representative Managers Access to facility, but NO access to clinical or patient care areas Does NOT consult with patient care staff or clinicians Does NOT operate equipment or provide technical assistance Visits less than 3 times per year (more frequent visitors classified as LEVEL II) LEVEL II Tech Support and Sales Vendor Reps Access to patient care environments EXCLUDING sterile or restricted areas Includes vendor and supplier sales representatives that interact with providers Includes DME providers, medical device sales, pharmacy sales, and lab/radiology/diagnostic reps or frequent LEVEL I vendors LEVEL III Clinical Support and Sales Vendors Access to patient care environments INCLUDING sterile or restricted areas Attends and/or observes patient procedures Resource for physicians and medical professionals concerning equipment operation, calibration, etc.

7 EMPLOYER VERIFICATION SHEET (To be completed by Supervising Manager of Representative servicing account of King s Daughters Medical Center and affiliates) Supervising Manager Name Supervising Manager Phone Supervising Manager Company Name Representative Name Liability Insurance Carrier Policy Number Policy Expiration Date Is representative a current employee?. Upon hire, was a background check performed for the vendor representative, specific to criminal background check and sex offender registry?. Has the representative received training concerning the product(s) or service(s) provided to King s Daughters Medical Center?. Has the representative received training concerning blood-borne pathogens?. Has the representative received training concerning Operating Room protocol and sterile procedures?. Supervising Manager Name. Supervising Manager Signature. Date.

8 KING'S DAUGHTERS HEALTH SYSTEM ACKNOWLEDGMENT AND RELEASE FROM LIABILITY I (First & Last Name) hereby confirm that I am a sales representative with (company name) and that I am on the premises to promote the purchase, sale and use of (product name). I acknowledge and understand that while King's Daughters Medical Center will strive to provide a safe and secure environment and that my presence at the facility will be that of an invitee. As such, I will have any and all rights and remedies associated with such status. In accordance with my status as an invitee, I hereby release King's Daughters Medical Center, its agents, employees and physicians from any and all liability for injuries that may occur as a result of open and obvious hazards on the premises. Additional, I hereby release King's Daughters Medical Center, its agents, employees and physicians from any and all liability for injuries that may occur in connection with activities that exceed the duty of care owed to me as an invitee. I understand and agree that my presence on the premises and in the facility is for my own business benefit as well as that of the Medical Center, and as such, I may be permitted to enter areas that are not open to the general public. I understand and agree that in areas such as these, my status is not that of an invitee, and I assume any and all risks associated with my presence in these areas. Specifically, I hereby release King's Daughters Medical Center, its agents, employees and physicians from any and all injuries that may occur as a result of my involvement or participation in medical, radiological and surgical procedures. Further, I specifically release King's Daughters Medical Center, its agents, employees and physicians from any and all liability associated with any type of exposure that may occur in connection with a procedure and acknowledge that King's Daughters Medical Center is not responsible for any injury that might occur as a result. Notwithstanding the foregoing, King's Daughters Medical Center will make every effort to provide a safe environment, as provided for its own employees. I acknowledge and understand that King's Daughters Medical Center shall have the right to remove, limit or completely prohibit my presence in the facility or my participation or involvement in a procedure if, in its sole discretion, it finds my presence, health, actions or performance is detrimental to patient well-being or safety or the therapeutic or other business function of the department. I further acknowledge receipt and understanding of King's Daughters Medical Center's policies and procedures related to fire and electrical safety as well as the Medical Center's Privacy Policy and I agree to adhere to the terms thereof. I further agree that King's Daughters Medical Center has a right to rely on my representations with respect to my understanding of the above-referenced policies and procedures. Signature of Sales Representative Date Company

9 CODE OF CONDUCT CERTIFICATION AND INITIAL GENERAL TRAINING ATTESTATION Instructions: Complete the information below, sign the form, date the form, check the boxes, and return to your King s Daughters Medical Center contact. Printed Name: Specialty/Company: Supervisor: Date, 20 I have received, read and understand the Code of Conduct. I certify that on the date below I completed the mandatory two (2) hour Initial General Compliance Training session which included education on KDMC s Corporate Integrity Agreement, KDMC s compliance policies and procedures, Code of Conduct, reporting requirements for suspected violations of any Federal healthcare program and KDMC s own Policies and Procedures. Based upon this education I agree: To abide by the Code of Conduct, the compliance program policies and procedures and the Medical Center policies and procedures. I agree to comply with all Federal health care program requirements. I understand it is my obligation to promptly report any suspected violations of any Federal health care program requirements, the Code of Conduct, or of the Medical Center s own policies and procedures. I understand that failure to comply with the Code of Conduct and compliance program policies and procedures may lead to disciplinary actions. I understand and agree to abide by the obligations set forth in the Corporate Integrity Agreement. Signature

10 Pharmaceutical Rep Process For credentialing please see Jeff Jones (materials management). He can be reached at or Once you have completed the application and all of its requirements, submit everything to Jeff Jones. Then go to the web link on the first page of this application,(step 4) and schedule an appointment for NEW Pharm Rep. You will be meeting with Tonya Pope to discuss KDMC Sales Rep Policy and product line. Please make sure you bring all your education material detailing the products that you cover. Tonya will be going over the process of formulary and nonformulary products during this meeting. Directions: Use the Heart and Vascular Center entrance>go straight ahead to the Pre-admission testing registration desk> use the elevator 36 or 37 which is located to the left of Pre-admission testing desk (around the corner) > You will go to the 6 th floor > Upon arrival to the Pharmacy Department, you will ring the doorbell and inform the person who answers that you are here to see Tonya Pope. You will be asked to take a seat by the elevators. When the initial meeting concludes, go to Supply Chain MGMT / Vendor Credentialing > Jeff Jones to pick up your KDHS Vendor ID Badge, which is to be worn at all times while on KDMC campus and/or at all KD facilities. Once you are fully credentialed & have a current ID Badge: You will then be able to make appointments with contacts within the hospital. These appointments should be made as early as possible so the following people can be contacted about your visit. Lori-Belle Slone, Tonya Pope, and Becky Yates Becky.Yates@kdmc.kdhs.us Upon arrival for your appointment with your KDMC contact, you MUST come to the pharmacy to be checked in. You will ring the doorbell, show your ID to the camera, inform the person who answers that you are here to sign-in for a meeting and wait for someone to bring the sign-in book out to you for your signature. After your appointment is complete, you MUST come back to the pharmacy to sign out.

11 Policy No DEPARTMENT: Pharmacy Page 1 of 2 FUNCTION: SUBJECT: Management of the Environment of Care (Security) Medical Service Representatives: Guidelines EFFECTIVE/REVIEW DATE: January 1, 2005 POLICY Medical service representatives (sales representatives) may visit the facility in conjunction with their duties. Representatives are visitors of the facility and as such may provide services in accordance with accepted rules of conduct within the facility. LIMITS ON VISITS Representatives shall limit their visits to providing information and servicing the account. VISITING THE PHARMACY The Director of Pharmacy or Clinical Director shall see medical service representatives by appointment only. To make an appointment, representatives shall contact the pharmacy in advance indicating the reason for their visit. Representatives must check in with the information desk in the lobby immediately upon entering the facility. The front desk will contact the pharmacy to authorize entry into the facility. The representative must report directly to the pharmacy prior to visiting other areas of the facility to obtain a yellow vendor badge. YELLOW VENDOR BADGES Upon reporting to the pharmacy, the representative will indicate the reason for their visit and whom they intend to visit while in the facility. After receiving approval from the Director of Pharmacy or Clinical Director, the representative will be issued a yellow, numbered badge. The badge must be signed out and signed back in with the pharmacy department upon leaving the facility. Under no circumstances may a representative leave the facility with the badge. Leaving the facility without returning the badge will result in suspension from the facility for a minimum of 6 months. Any representative found in the hospital without a badge will be removed from the facility immediately and will not be permitted to return to the facility for a minimum period of 6 months. The representative s supervisors will be contacted. Hospital staff observing a representative without a yellow, numbered vendor badge should immediately contact security. VISITING OTHER DEPARTMENTS Medical service representatives shall contact the Director of Pharmacy or Clinical Director to arrange interviews or meetings with other facility departments. The representative shall explain the purpose for the visit. At that time it will be determined whether or not the visit is appropriate. Visits may not be conducted in patient care areas.

12 SOLICITATION, DISPLAYS, PROMOTIONS, AND EDUCATIONAL PROGRAMS Medical service representatives shall contact the Continuing Medical Education coordinator to schedule displays, and physician educational programs. Displays are limited to the Paul G. Blazer Health Education Center and may not occur in the main hospital. Distribution of promotional materials is prohibited without prior approval of the Director of Pharmacy or Clinical Director. Medications that are not on the formulary cannot be displayed or promoted within the facility. No sample medications may be provided and distribution of educational materials is limited to the display area. This policy does not apply to samples or materials mailed to practitioners at their homes or offices. SCHEDULING EDUCATIONAL PROGRAMS FOR FACILITY EMPLOYEES Medical service representatives shall contact the Clinical Director to schedule educational programs. The Clinical Director shall contact the appropriate department to coordinate communication and arrangements between the medical service representative and the department. Educational programs cannot be conducted in patient care areas. SIGNED AGREEMENTS All medical representatives must have a current, signed agreement on file with the Materials Management Department. Agreements will be provided to representatives on their first appointment. Only agreements signed after June 1, 2005 will be considered current. A list of approved representatives will be kept on file with the pharmacy. Any representative not on the list will not be seen and is not allowed within the facility. I acknowledge that I have received a copy of the Pharmacy guidelines for Medical Sales Representatives. I have read and understand the above and agree to cooperate. Signature Company Date

13 CODE OF CONDUCT MEDICAL SERVICE REPRESENTATIVES Pharmacy personnel and medical service representatives should work together to encourage the best use of medications in the facility. Teamwork will ensure outcomesoriented, cost-effective therapy and will improve the quality of patient care. Commitment by pharmacy personnel and medical service representatives to the following Code of Conduct will ensure mutual success: - The pharmacy will provide a policy outlining specific guidelines for medical service representative visits to the pharmacy and other departments in the facility. The medical service representative will review and sign the policy at their initial visit to the facility. Only agreements signed after January 1, 2005 will be considered current. - The pharmacy will provide a general outline of the Econotherapeutic philosophy to each medical service representative. - Appointments are necessary to prevent an interruption in workflow that may negatively affect patient care. Requests for an appointment should include an agenda for the meeting. - Discussions should include new product information and updates on new indications for products currently marketed. Agreement on acceptable product use protocols within the facility is necessary prior to distributing literature and detailing physicians. - The Director of Pharmacy, Clinical Director or designee will review, in advance, all medical service representative requests for distribution of promotional materials or other activities within the facility. If approved, medical service representatives will visit only designated non-patient care areas. - Medical service representatives will honor formulary decisions of the pharmacy and therapeutics committee. - Medical service representatives are encouraged to provide educational programs. The Director of Pharmacy, Clinical Director or designee will review and authorize pharmacy and medical staff educational programs in advance. - Pharmacy policies and procedures will state the restrictions on distribution of medication samples. I have read and understand the KDMC Medical Service Representative Policy and Procedure and agree to cooperate. Signature Date Company Represented

14 KINGS DAUGHTERS HEALTH SYSTEM MEDICAL SERVICE REPRESENTATIVES (PHARMECUTICAL) PHARMACY ADDENDUM Medical service representatives (Pharmaceutical representatives) may visit the facility in conjunction with their duties. Representatives are guests of the facility and as such may provide services in accordance with the accepted code of conduct within the facility. Representatives MUST report to the Pharmacy Department prior to visiting other areas each time they enter the facility. They shall limit their visits to providing information and servicing their account. The Director of Pharmacy and the Clinical Manager shall see representatives by appointment only. Representatives must contact the pharmacy to arrange appointments with other departments within the Medical Center. Solicitations, displays, and distribution of samples or other promotional materials in the medical center are prohibited without prior approval from the pharmacy. Medications that are not on formulary cannot be displayed or promoted within the facility. I acknowledge that I have received a copy of the Pharmacy guidelines for Medical Sales Representatives. I have read and understand the above and agree to cooperate. Signature Company Represented Date