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04. Statement of Work (SOW).pdf

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July 12, 2021, 1:26 a.m.
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STATEMENT OF WORK (SOW)

Pharmacy Outpatient Robotic Dispensing System

PROJECT TITLE:

DEPARTMENT:

National Institutes of Health (NIH), Clinical Center (CC), Pharmacy Department

TABLE OF CONTENTS
PART 1 – GENERAL INFORMATION 3

PART 2 – MINIMUM REQUIREMENTS 7

PART 3 - GOVERNMENT FURNISHED PROPERTY, EQUIPMENT, AND SERVICES 8

PART 4 - CONTRACTOR FURNISHED ITEMS AND SERVICES 9

PART 5 – OTHER SYSTEM AND TECHNICAL SPECIFICATIONS 10

PART 6 – PROJECT MANAGEMENT, IMPLEMENTATION, SERVICE 18

PART 7 - APPLICABLE PUBLICATIONS 22

PART 8 - DEFINITIONS & ACRONYMS 23

Technical Exhibit 1 – Deliverables Schedule (Upon Request by COR) 24

Technical Exhibit 2 – Estimated Workload Data (Upon Request by COR) 26

Technical Exhibit 3 – CC Data Center 27

Technical Exhibit 4 – NIH CC EHR Clinical Research Informatics Information System (CRIS) 28

Technical Exhibit 5 – NIH CC EHR CRIS ADT Interface 29

Technical Exhibit 6 – CC Remote Access Options 30

Technical Exhibit 7 – ATO Documentation 31

PART 1 – GENERAL INFORMATION

The purpose of this acquisition is to procure an outpatient robotics system for the NIH Clinical Center
Pharmacy to support the proper storage, inventory control, and customizable reporting of the medications
managed by the Outpatient unit.

This Statement of Work (SOW) issued by National Institute of Health, Clinical Center describes the goals
expected to be achieved with regard to planning, delivery, installation and support of the Outpatient
Pharmacy Robotics System

1.1 Introduction:

The National Institutes of Health (NIH), a part of the U.S. Department of Health and Human Services, is
the primary federal agency for conducting and supporting medical research. Helping to lead the way
toward important medical discoveries that improve people’s health and save lives, NIH scientists
investigate ways to prevent disease as well as the causes, treatments, and even cures for common and
rare diseases. Composed of 27 institute and centers, the NIH provides leadership and financial support to
researches in all fifty states and throughout the world.

The Clinical Center (CC) at the NIH in Bethesda, Maryland, is the nation’s largest hospital devoted to
clinical research. It is a national resource that makes it possible to rapidly translate scientific observations
and laboratory discoveries into new approaches for diagnosing, treating, and preventing disease.
Approximately 1,500 studies are in progress at the NIH Clinical Center. About half the studies are the first
tests of new medications or medical treatments in patients

1.2 Current Environment:

The primary operating objective of the Department of Pharmacy is to support and conduct research by
providing safe, high quality care. The secondary operating objective is to standardize, improve
effectiveness (service, outcomes), and reduce waste.

The NIH Clinical Center Pharmacy, Outpatient unit processes approximately 500 prescriptions per day,
including both commercial and investigational drug products. The pharmacists review prescriptions that
crossed over from Allscripts and submit them to be filled. The pharmacy technicians fill the prescriptions
which then get verified by the pharmacists and batched to different designations (i.e. pick-up, FedEx,
International delivery, or USPS mail)

In the 4th quarter of 2021, the NIH CC Pharmacy will be relocating to a newly designed facility. The
Outpatient section is looking to have a fully integrated automated dispensing system that maximizes
speed and minimizes the amount of physical space required for onsite prescription review, filling,
verification, and drug storage.

The Clinical Center currently utilizes Allscripts Sunrise v118.4 as the primary Electronic Health Record
(EHR) for Prescriber Order Entry. The EHR is primarily managed by the Department of Clinical Research
Informatics (DCRI). The NIH CC Pharmacy has initiated the efforts to create a fully automated facility for
the dispensing and inventory management phase of the Medication Use Process. This robotics system is
to further strengthen the structure of the final design.

1.3 Objectives:

1.4 Scope of Work:

To purchase and install a pharmacy outpatient robotic dispensing system.

The Contractor shall provide the applicable services in support of the requirements identified in the SOW.
1.4.1 The Contractor shall provide the Contractor shall provide hardware, software, services for the

lifecycle of the system.

1.4.2 The Contractor shall provide a solution that will Interface with other COTS outpatient

pharmacy systems to exchange medication and patient data.

1.4.3 The Contractor shall be responsible for planning, installing, testing and providing continuous

maintenance support of the systems.

1.4.4 The Contractor shall be responsible for providing initial in-person and/or virtual training of all

User Roles.

1.4.5 The Contractor shall be responsible for providing initial in-person and/or virtual training of the

identified set of Initial Users identified by the Project Team.

1.4.6 The Contractor must submit the required Memorandum of Understanding (MOU) with NIH CC
Security Team and Maintenance Contract for any REMOTE SUPPORT Agreement.

1.5 Contract Type and Period of Performance:

The Period of Performance for this requirement shall consist of a Base Period of twelve (12) months
commencing at the time of Contract Award and four (4) one (1) year Option Periods. Options to increase
quantities may be exercised by formal modification to the contract should there be a need to provide
additional services or support.

The equipment/software pertaining to the this requirement must be in place No-Later-Than (NLT)
December of 2021 to keep pace with the Construction Schedule associated with the new Pharmacy
Construction Build-Out Process.

1.6 Recognized Holidays: Work may occur on Federal Holidays. Maintenance Support may occur all
hours and across all days. The Federal Government recognizes the Federal Holidays listed below:

New Year’s Day

Martin Luther King, Jr.’s Birthday
President’s Day
Memorial Day
Juneteenth
Independence Day
Labor Day
Columbus Day
Veterans Day
Thanksgiving Day
Christmas Day

January 1st
Third Monday in January
Third Monday in February
Last Monday in May
June 19th
July 4th
First Monday in September
Second Monday in October
November 11th
Fourth Thursday in November
December 25th

Also, any other day declared by the President of the United States to be a National or Federal
holiday.

1.7 Hours of Operation: The NIH CC operates 365 days per year, 24 hours per day including all
holidays. Maintenance Support must be provided across all days and hours (365x24x7).

1.8 Installation Timing: The Contractor will work with the robotics system implementation team to

schedule and perform the installation. Installation will be performed at the convenience of the location
receiving the system. Installation may occur between the hours of 9:00 AM EST and 7:00 PM EST.,
Monday through Sunday, including holidays and any day declared an official Federal Holiday.

1.9 Place of Performance: The work to be performed under this contract will be performed at the NIH

Clinical Center Pharmacy, 10 Center Drive, Building 10, Bethesda, MD 20892.

1.10

Security Requirements: Contractor personnel performing work under this contract must have a

NIH CC Contractor badge/PIV Card which will require fingerprinting and a background check.

a. Physical Security: The Contractor shall be responsible for safeguarding all government
equipment, information, and property. At the close of each work period, government
facilities, equipment, and materials shall be secured.

b. Key Control: The Contractor shall establish and- implement methods of making sure all

keys/key cards issued to the Contractor by the Government are not lost or misplaced and
are not used by unauthorized persons. NOTE: All references to keys include key cards.
No keys issued to the Contractor by the Government shall be duplicated. The Contractor
shall develop procedures covering key control that shall be included in the Quality Control
Plan. Such procedures shall include turn-in of any issued keys by personnel who no

longer require access to locked areas. The Contractor shall immediately report any
occurrences of lost or duplicate keys/key cards to the NIH CC Contracting Officer.
In the event keys, other than master keys, are lost or duplicated, the Contractor shall,
upon direction of the NIH CC Contracting Officer, re-key or replace the affected lock
or locks; however, the Government, at its option, may replace the affected lock or
locks or perform re-keying. When the replacement of locks or re-keying is performed
by the Government, the total cost of re-keying or the replacement of the lock or locks
shall be deducted from the monthly payment due the Contractor. In the event a
master key is lost or duplicated, all locks and keys for that System shall be replaced
by the Government and the total cost deducted from the monthly payment due the
Contractor.

2. The Contractor shall prohibit the use of Government issued keys/key cards by any

persons other than the Contractor’s employees.… Show All