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

Policy Number: 001-01 Revision Date: 04/12/2018

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.

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 for the purpose of 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 for the purpose
of 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.
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 at all times 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. Visitors are never allowed to directly walk into any clinic/pod without first
checking in at the front desk in Suite 110.

Urology San Antonio, P.A. Facility

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

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.

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. A list of USA sites and contact personnel is
attached. Questions should be directed to Lucero (Lucy) Garcia at the front desk
or to 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.
A. 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 provided to each site. 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.
A. Representatives are encouraged to schedule appointments in Urology San
Antonio, P.A. facilities between 12:15 PM and 1:00 PM, Monday through Friday.
However, if necessary for the convenience of Urology San Antonio, P.A. staff,
appointments at other times may be permissible; however, they should never
interfere with or delay patient care. The requesting physician or allied health
professional must request this exception and receive approval through the
Director of Operations (Gloria Clark). This process may require up to a 3-day lead
time to make the arrangements/receive approval.
B. 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 the course of their business. 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 Director of Operations 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.

B. In-services for use of a specific product that has been approved by the Board of
Directors and/or Medical Director are allowed.
C. 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.
D. 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.
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.