Policy Area: Providers Effective Date: 04/09/2013

Policy Number: 001-01 Revision Date: 03/27/19

Approved by: Board

Pharmaceutical and Medical Device Industry

Representative Visitation
PURPOSE:
This policy will delineate guidelines for Pharmaceutical and Medical Device Industry
Representative visitation at all Urology San Antonio, P.A. (USA) facilities and applies specifically to
those activities conducted on the physical premises of a USA facility. The policy will address
appropriate activities and interactions between Urology San Antonio, P.A. personnel
(including physicians, physician's assistants, nurse practitioners, medical assistants, and
administrative staff.) Clinic-specific exceptions are listed at the end of the policy.

The policy does not apply to hospital representatives or to personnel from other medical clinics
in the service area.

POLICY STATEMENT:
The goal of the Urology San Antonio, P.A. is to foster an environment in which
Pharmaceutical and Medical Device Industry Representatives provide information to medical,
pharmacy, nursing staff and other allied health professionals that will promote safe and cost-
effective use of medications and/or medical devices without disruption to normal clinic
operations.

DEFINITIONS:

(1) Pharmaceutical or Medical Device Industry Representative

The term "Representative” refers to anyone acting on behalf of a pharmaceutical
or medical device manufacturer or its business partners promoting the use of items by
patients of Urology San Antonio, P.A. These items primarily include drugs, but also include
any medical supplies, nutritional supplements, and similar commodities. “Representative”
also refers to anyone acting on behalf of a pharmaceutical or medical device
manufacturer or its business partners promoting drugs, equipment, or supplies that
are used in conjunction with its products (for example, catheters and related
supplies) belonging to that company or one of its partners.

(2) Visit
Refers to any contact with Urology San Antonio, P.A. staff, including but not limited to,
clinical or clerical/administrative staff working in a Urology San Antonio, P.A.
facility/clinic. Any visit may only be through controlled access at each site. This policy
was established to promote patient safety, security and privacy and requires that
 vendors wear Urology San Antonio, P.A. provided name tags when they are at a Urology
San Antonio, P.A. facility. It further requires that vendors check in and check out at
the facility. All representatives should review the entire policy to assure compliance.
Visitors to the 7909 Fredericksburg Road location must check in only in Suite 110 and
host events only in the large conference room. Visitors are never allowed to directly
walk into any clinic/pod without first checking in at the front desk in Suite 110.

(3) Urology San Antonio, P.A. Facility

This is defined as any facility owned and/or operated by the Urology San Antonio, P.A.

(4) Meal
A "meal" is the food served and eaten at one of the customary times for eating, as in
breakfast, lunch, dinner, or "on call" dinners. Representatives hosting a lunch for a
particular pod / clinic are restricted to detailing in that clinic only. Lunches for any
pod at the 7909 Fredericksburg Road location are held only in the Large Conference
Room in Suite 110. No food/drink of any kind is allowed in any pod.

(5) Presentation
The process of presenting the content of an educational topic appropriate to the
specialty of Urology to an audience.

GUIDELINES FOR VISITATION:

I. REGISTRATION

A. Visits are by appointment only. All visits are coordinated exclusively through
RxVantage. Specific questions should be submitted through RxVantage and not
directly to the receptionist at any location. Representatives should never ask a
staff member to schedule any visit. If you have specific issues which have not
been addressed through RxVantage, you may contact Director of Operations
Elizabeth (Liz) Rodriguez-Balch, at 210.731.2050.

B. Any visit may only be through controlled access at each site. It further requires that
vendors check in and check out at the respective facility. Prior to visiting a
physician/health care provider within Urology San Antonio, P.A. facilities, the
representative must register at the appropriate office to receive a vendor badge which
must be returned at the conclusion of the visit. This registration is for a ONE-TIME VISIT
ONLY. It does not provide authorization to visit other areas or other individuals
encountered within the area. Individuals in the designated registration area will
verify an appointment before the vendor is given a badge to proceed to the visit.
Access to Urology San Antonio, P.A. facilities by sales representatives who have not
made a previously scheduled appointment is not permitted and may result in that
representative being permanently banned from all USA locations.
 C. Urology San Antonio, P.A. staff/clinic personnel may develop a list of individuals
or departments that do not wish to be called upon by sales representatives.
These lists will be entered into RxVantage by the Executive Director or Director of
Operations. The initial list of site-specific requirements appears in Section VII
below. Representatives must not attempt to make appointments with
individuals or departments on the list.
D. Representatives are encouraged to schedule appointments in Urology San Antonio,
P.A. facilities between 11:30 PM and 1:00 PM, Monday through Friday. A lunch may
not be set up prior to 11:15 a.m. Exceptions must be approved by the Executive
Director with no less than a three day response period.
E. To respect patient privacy, representatives are not permitted unescorted in patient
care areas. Examples of patient care areas include, but are not limited to, the
following:
1. Nurses’ Stations (unless the purpose of the visit is to restock the samples and
the samples are stored near / behind the nurse’s station)
2. Clinic examination rooms;

II. SPECIFIC PROHIBITED OR REGULATED ACTIVITIES

A. Representatives related to any Urology San Antonio, P.A. employee and/or

physician should not call on that person. In this situation, the drug or device
company must provide another representative to call on that physician or
Urology San Antonio, P.A. employee.
B. Urology San Antonio, P.A. employees, including physicians practicing in Urology San
Antonio, P.A. facilities, may not accept any form of personal gift, regardless of
value, from industry or its representatives without the prior consent of the
Board of Directors.
C. Representatives are not allowed to attend medical care treatment facility
conferences where patient-specific material is discussed or presented without
explicit permission from the Executive Director and verification of a signed
Confidentiality/HIPAA Business Associate Agreement.
D. Representatives are prohibited from marketing to medical, pharmacy, nursing
and other health profession students without the presence of a faculty or
licensed professional.
E. Representatives are prohibited from sponsoring any activities related to the
employees’ personal events such as birthdays, baby showers, etc. If an
employee approaches the pharmaceutical or medical device representative
about doing so, it should be reported to the Director of Operations.

III. ACCEPTABLE PROMOTIONAL ACTIVITIES

A. Presentation of programs through donation of unrestricted educational grants is

allowed. These programs may be planned and carried out by Urology San Antonio,
 P.A. or by a speaker sponsored by the company. In these instances, a reasonable
portion of the grant may be used for food to the extent that this is required by the
timing or nature of the educational program.
B. Presentations may be made by speakers brought in from outside the facility. In these
cases, the representative must submit a statement of non-bias and the syllabus.
This should be done two (2) weeks prior to the presentation.
C. In-services for use of a specific product that has been approved by the Board of
Directors and/or Medical Director are allowed but must be scheduled.
D. Presentations sponsored by drug industry (not including in-services for new products
or for patient safety training, etc.), must be prior reviewed by the Medical Director
to assure there is no commercialism or bias.
E. Industry-sponsored talks and the ability of physicians employed by or
shareholders in Urology San Antonio, P.A. are governed by the terms of the
respective physician’s employment / member agreement. For questions related
to specific presentations, please contact the group’s Executive Director.

IV. DRUG SAMPLES

Drug samples are allowed. However, detailing that specific drug or another drug from
the same pharmaceutical company will be allowed only during appointed times. If
pharmaceutical representatives must re-stock the samples at a time other than during
a scheduled appointment, the rep should restock the drug(s), acquire the required
signature, and leave the clinic. Reps who choose to detail the Providers or staff
during non-appointed times will have their next appointment time canceled.
Repeated violations will result in their company being contacted and asked to assign a
different representative. A Rep may represent more than one drug but cannot
register for visits for each drug. One rep; one visit regardless of the number of drugs
being detailed.

V. INFRACTIONS AND DISCIPLINARY ACTION

A. All vendors must ensure that their representatives who provide services to the
Urology San Antonio, P.A. meet and adhere to all requirements, rules, policies,
procedures, regulations and vendor protocol of Urology San Antonio, P.A.
B. Vendor representatives who violate any of these rules, policies, procedures and
regulations will be subject to removal and/or refusal of entry.
C. Vendors who are not properly identified and have not completed the vendor
check-in process must be referred to the Vendor Registration area at each site.
Reps are not allowed to enter initially by any door other than the main patient
door. Once the rep has secured the required identification badge, he/she may use
another clinic access point to deliver food, samples, etc. Any rep entering by a
door without an ID badge will be prohibited from making an appointment at the
site for a minimum of four weeks for any purpose.
 D. The Director of Operations will follow up on complaints regarding
representatives and may take action up to and including banning the individual
and/or company for a specified period of time.

VI. DEPARTMENTAL/EMPLOYEE RESPONSIBILITIES

A. Directors, managers, and supervisors of departments must ensure that all Vendors
follow all policies, procedures, rules, and regulations while on the premises.
B. Employees must be vigilant regarding the presence of unauthorized personnel in the
workplace. Persons not displaying appropriate identification shall be referred to
Director of Operations.

VII. CLINIC SPECIFIC EXCEPTIONS

Northeast – Detailing is limited to no more than two representatives between 7:30

a.m. – 8:00 a.m. Monday – Friday, with an appointment. No lunches are allowed.

Stone Oak – Detailing permitted only between 12:15 p.m. – 1:00 p.m. The
physicians have a strong preference that restocking of samples occur during this
same time period. No detailing is allowed under any circumstances outside of the
designated time.

Medical Center – Pod A (Effective 03-26-19) has removed all appointments from
RxVantage. Replacement of samples is permitted, but no detailing of any kind at
any time.