Guidelines for Healthcare Industry Representatives (HCIR)
UHS has designated facility Supply Chain Operations Directors with the responsibility to properly manage the activities of third party Industry Representatives in their dealings with units/departments, physicians and nurses within UHS facilities. Industry Representatives will be seen by departments only by appointment or during hours designated by the department, must have obtained a hospital approved ID badge, and be registered with the Supply Chain Operations department prior to visiting any department. For those facilities equipped with vendor management kiosks that dispense visitor name badges with proper identification, the industry representative will not have to report to supply chain operations upon entering the facility each time with the exception of drug and medical device sales representatives as outlined below. Each facility reserves the right to bar any industry representative from entering the facility for any reason deemed appropriate.
This policy is limited to the activity of sales representatives (defined herein as Level 2) and is not intended to control the activities of maintenance, repair, delivery and other nonclinical support personnel by external sources (defined as Level 1). Such monitoring controls should be outlined in local facility policies. Sales representatives will be monitored in order to preserve the patients' interests, safety, and right to privacy. UHS is committed to the practices of product standardization, volume purchasing, and quality control over the materials; supplies and services used to support our patient care activities. It is therefore necessary to manage and control the activities of third party Industry Representatives through the procedures associated with this policy.
Supplier Relationship Management
At UHS, we realize that the relationships we forge with our supplier partners are key factors to our team's agility, integrity and ability to meet our patients' needs. We hope the policies and information contained herein will lay the foundation for strong business relationships to develop and prosper between UHS and our Supplier partners:
Vendor Access Practices to UHS Facilities
Status Blue Compliance is a technology and services company which provides the health care industry and vendors serving the industry, with simple, cost-effective, and reliable technology solutions for managing vendor-client relationships, including the credentialing and certification process, compliance standards, facility security, scheduling, tracking and reporting. For more details contact Status Blue Compliance Customer Service at 1-678-324-4487 or log on to www.Status-Blue.com. Depending on the market preference, UHS facilities may use other vendor management technologies, but Status-Blue is the preferred vendor of choice.
Conflicts of Interest and Interactions Between Representatives
It is the policy of UHS that clinical decision-making, education, and research activities be free from influence created by improper financial relationships with, or gifts provided by, Industry. For purposes of this policy, "Industry" is defined as all pharmaceutical manufacturers, and biotechnology, medical device, and hospital equipment supply industry entities and their representatives.
Vendor Responsibilities Under the Deficit Reduction and False Claims Acts
In accordance with the federal Deficit Reduction Act, UHS is required to inform vendors about the Federal False Claims Act. UHS encourages its vendors to read and be familiar with the federal guidelines as they pertain to this important issue. The Deficit Reduction Act also requires UHS to provide vendors with information about whistle blowing and non-retaliation. As part of its Reporting and Non-Retaliation policy, UHS prohibits retaliation for reporting instances of wrongdoing, made in good faith.
No Purchase Order No Payment Policy
UHS Supply Chain Operations has implemented a NO PO NO PAY policy. Under this policy, invoices must contain a valid UHS purchase order number or they will not be processed for payment.
A reference guide for a valid UHS Purchase Order number is as follows:
The PO Number is numeric with 9 Digits
The PO Number has 3 leading numbers identifying the originating facility Example: 158-620723
Items not requiring a purchase order are limited to products such as: books and periodicals, organ acquisition, postage and freight charges, registry, professional fees, long-term purchased services, utilities, long-term leases and rentals, education expenses, travel expenses, and tax/government payments.
New medical devices will not be authorized for use by any UHS facility without prior submission of a price quotation including expected volume for the item's use. UHS will validate the competitiveness of pricing through the UHS Supply Chain Information System and third-party sources prior to approval. Supplier will not be compensated for any new item utilized by a participating UHS facility that has not been approved prior to use.
Definitions
Health Care Industry Representative (HCIR)
A Health Care Industry Representative (HCIR) is a generic term used to refer to a sales professional or other individual that represents a company or companies to healthcare clients, including physicians, nurses, buyers, purchasing agents, and general users of the company's product. HCIRs represent manufacturers, distributors, service companies, and other organizations. HCIRs perform marketing activities, manage contract sales, generate other sales, provide quotes, demonstrate products, solve problems, advise clients on matters, or perform many other duties generally associated with representing their company. For purposes of this guideline, two levels of HCIR are defined:
Classification Level 1 - Non-Clinical Health Care Industry Representatives HCIRs that do not primarily serve in clinical support roles. These HCIRs do not typically provide technical assistance, do not operate equipment, do not generally enter patient care areas, and do not provide assistance or consult with patient care staff.
Classification Level 2 - Clinical Health Care Industry Representatives HCIRs that primarily serve in clinical support roles. These HCIRs typically provide technical assistance or operate equipment. Their role requires them to typically work in patient care areas, and/or provide assistance to or consult with patient care staff.
Medical Devices
Medical devices are any supply or equipment item used in the process of providing patient care. Medical devices can be consumable or nonconsumable in nature and may be categorized as operating expense items or capital acquisition items.
Level 2 Compliance Requirements
Providers will require from the HCIR written proof of HCIR's immunization status, i.e. TB, Hepatitis B, measles, mumps, and rubella, Chicken Pox vaccination. The provider must have HIPPA controls in place to protect the information.
Documented evidence of training and competencies in the following topics:
Infection control and aseptic practices
Blood borne pathogens
Patient rights, confidentiality, and HIPPA
Informed patient consent
Product complaints and medical device reporting (MDR) requirements
The medical system, device, product, procedure, or service they will be delivering and/or operating.
A written letter provided by the company is acceptable documentation, as would be electronic database records of a third-party education/training provider.
Medical Device and Drug Sales Representatives
Medical device representatives and drug sales representatives, defined as level 2 representatives, whose products contain drugs will have compounded control and reporting responsibilities. This group of representatives will have to ensure that they meet with both the hospital pharmacist and the supply chain director to advise them that their product may contain a pharmaceutical agent that is not included on the current drug formulary. Medical devices which utilize drugs or drug applications will require approval by both the Value Analysis Committee and the Pharmacy and Therapeutic Committee prior to use in the hospital.
The following guidelines are specific to both medical device and drug sales representatives:
PROCEDURE:
Both the Department of Pharmacy and the Supply Chain Operations Department shall maintain a medical service representative log book and routinely verify that the following current information is on file prior to allowing a sales representative to visit the facility.
Name, address, and telephone number of the current representative
Name, address, and telephone number of the representative's district/regional manager
Each sales representative shall sign a statement acknowledging his/her familiarity with the hospital's policies and procedures governing sales representatives on the hospital's premises and in any ambulatory care areas.
Pharmaceutical sales representatives shall ensure that the Department of Pharmacy is provided with any appropriate, complimentary educational materials as soon as such become available to him/her.
Medical device representatives shall report to the Supply Chain Operations department for sign in and additionally to the Department of Pharmacy if the product they are presenting in any fashion involves the use of a drug or pharmaceutical agent. The Supply Chain Operations department will assure this collaborative notification.
Both pharmaceutical representatives and medical device representatives are allowed into the hospital for the following activities:
For pre-approved assigned displays
For pre-approved scheduled in-services
To make arrangements for the return of goods or expired medications
By the request of the Director of Pharmacy Services or Supply Chain Executive.
Contact with physicians should be limited to those services having offices on hospital premises (e.g., radiology staff, cardiology services staff).
Patient care providers not having service offices at the hospital facility should not be contacted at the facility.
Contact is not permitted with physicians on hospital property unless arrangements have been made beforehand.
Pharmaceutical sales and medical device represenatives shall detail products only according to approved FDA and facility-approved guidelines.
Medications not on the formulary shall not be detailed. If a medical device requires the use of a drug or drug class, the medical device representative will notify the Director of Pharmacy and additionally detail the product and use of the product to the Director of Pharmacy.
All medical devices with drug applications will require guidelines to be written and approved for the medical device by the Pharmacy & Therapeutuc Committee.
Appropriate education of medical, pharmacy, and nursing staff will be required for use of an approved medical device with drug application, prior to utilization.
Pharmaceutical and medical device representatives are prohibited from conducting the following activities:
Any false, undocumented, misleading statements or claims presented to any physician or other healthcare professional associated with the hospital, whether or not made while on hospital or campus grounds, that serve to misrepresent a drug or device usage or therapy product.
Distribution of gifts and promotional products for personal, non-work related activities.
Provision of information or distribution of promotional material regarding non-formulary, newly-approved, restricted or non-contracted drugs or devices within the facility, without first obtaining approval in writing from the Director of Pharmacy Services and Supply Chain Director. This also includes P&T and MEC members.
Drug displays are strictly prohibited at the hospital unless requested by the Director of Pharmacy Services and approved by administration prior to display.
Medical Device displays are prohibited except with the expressed permission of the Supply Chain Operations department.
Distribution of pharmaceutical samples or device samples (and acceptance by hospital staff) is strictly prohibited.
Acts deemed inappropriate by the Department of Pharmacy, the Supply Chain Operations department, or any other department of the hospital will require that the representative involved be censured or barred from visiting the facility. This ban will be in effect until lifted by written permission from an administrative officer of the hospital.
Representatives must wear his/her company's badge.
Representatives are not allowed in any patient care areas.
Any representative discovered not wearing a badge will be asked to leave the premises. In such cases, hospital security and the Department of Pharmacy and/or the Supply Chain Operations department will be notified.
Sales representatives shall conduct business within established facility normal working hours determined by the Department of Pharmacy or the Supply Chain Operations department.
For appointments that are not within the specified time frames, representatives should obtain permission from the Departmennt of Pharmacy or the Supply Chain Operations department, at least 48 hours prior to their visit.
HCIRs in the Surgical and Cardiac Catherization/Interventional Radiology Departments
If the facility is not equipped with a vendor management kiosk, Supply Chain personnel, or their designee, will call respective departments to notify them that their vendor appointment is in the facility and will be at the department after receiving their visitor's badge.
All vendors must have made prior arrangements with the appropriate department manager, clinical nurse supervisor, or designee to gain admittance to the peri-operative / invasive areas. All appointments must be scheduled by the clinician (or their designee). Drop-in visits will not be permitted.
Unscheduled or unauthorized persons will not be permitted to enter the interior of the hospital and will be asked to return with an authorized appointment.
If a visit is scheduled and verified, the representative will then be asked to check-in at the facility designated area (Supply Chain Department or Rep Tracking System kiosk). If vendors are coming in to support Surgical Services before or after department hours they will sign in at the pre-arranged designated location.
All vendors will wear and display their vendor badge valid for the designated date only.
Vendors are only to go to the department for which they have an appointment for and only for the time allocated.
Vendors without a pass or found to be in an unauthorized department will be asked to report to the Supply Chain Department immediately.
After checking in on the scheduled date, vendors will proceed to the front desk of the department they are visiting. The designated individual at the front desk will verify that the vendor has completed the check-in procedure.
Vendors visiting an invasive area will be properly attired in accordance with the facility policy. (See Peri-operative Policy & Procedure: "Attire-Operating Room")
The appropriate manager, Surgery Department supervisor, or designee will be informed of the sales representative's presence at the front desk and will inform the area of the vendor's presence in the department, and the vendor will then be directed or escorted to the appropriate room.
In the event that a vendor will be present during a surgical or invasive procedure, the facility policy regarding informing patient and obtaining consent will be followed.
During a surgical or invasive procedure, the attending physician and circulating nurse will oversee all activities/movements of the vendor.
The vendor is not permitted to:
Touch the patient and/or administer hands on care to a patient.
Operate or control any equipment in the procedure suite.
Scrub on any case.
Open sterile supplies.
Solicit comparative cost information from staff
Initiate unsolicited contact by telephone, beeper or liaison with medical students, house staff, attending physicians, pharmacists, nurses, and other clinical staff during working hours in the hospital.
Offer or provide for use of any medical device not on contract for UHS unless it is for trial test and evaluation; that being the case, the provisions of UHS policy PURCH 1.02J (part 10 in this Manual) for such evaluations must be followed.
The vendor's role is that of a resource, providing technical support to include set-up and calibration of equipment as well as advice and trouble-shooting support if the product or equipment malfunctions. At any time, any member of the hospital team can request that the vendor depart if necessary for patient safety. Such action will be reported to the unit's manager.
If the vendor is acting as an independent contractor operating patient care equipment, adjusting devices, or otherwise providing direct patient care services he/she must have an independent contractor agreement executed and on file with the Supply Chain department.
At the end of the case or visit, the vendor must leave the department, return to the Rep Tracking System kiosk to sign out, and depart from the facility. They may be required to obtain a purchase order prior to departure. However, absolutely no loitering in the hospital will be allowed.
