Draft_SOW_-_Benchmark_GMP_Cleaning_Supplies_as_of_17_JAN_2017.pdf

NIH Clinical Center Materials Management & Environmental Services Department (MMESD)

STATEMENT OF WORK

Good Manufacturing Practice (cGMP) Cleaning Supplies

Project Title: cGMP Cleaning-Benchmark Supplies Department: NIH Clinical Center/MMESD

Contracting Officer Representative (COR): Nathaniel Johnson Alternate COR: Kathy Krisko Performance Period: January 15, 2017 – January 14, 2018 With four (4) 12 month options

INTRODUCTION

The mission of the NIH CC is to provide clinical research servicing the needs of the NIH Intramural Research Program by providing a safe and effective environment for the care and treatment of patients participating in structured biomedical research protocols.

BACKGROUND

The NIH CC is a 200-bed research hospital located on the main campus of the National Institutes of Health in Bethesda, MD. The NIH CC provides state-of-the-art clinical care for patients that are enrolled in NIH research study protocols. The Clinical Research Center (CRC) serves as a center of excellence in medical research, training, and the clinical care for patients with unique and rare conditions. The CRC plays a critical role in the discovery and application of novel therapeutic agents to assist in the treatment or cure of acute and chronic diseases. To achieve this, the CRC carries out specialized research and is involved in the discovery and development of pharmaceutical grade reagents, cell therapy products, Positron Emission Tomography (PET)/radioactive drugs, and vaccine products. Optimal sterility testing practices of these human administered products manufactured by NIH facilities is of upmost importance to ensure best clinical care and patient safety outcomes.

The Food and Drug Administration and international certified Good Manufacturing Practice (cGMP) regulations, especially those on sterile manufacturing, require stringent cleaning and hygiene programs in pharmaceutical manufacturing areas. Regulations require that aseptically produced biologics be produced in a cleanroom environment. A critical component to contamination control is the cleaning program for the controlled areas, which must be well-defined, contain detailed cleaning processes that must be stringently followed by highly trained and competent cleaning staff, and use appropriate, in some cases sterile, and dedicated cleaning supplies and equipment.

OBJECTIVE

The NIH Clinical Center, MMESD must obtain cGMP cleaning supplies. The needed supplies are subject to change and include but are not limited to those listed Exhibits 1. These supplies will be delivered as needed over the period of the contract. Due to the unpredictability of the amounts and specific supplies, an Indefinite Delivery, Indefinite Quantity fixed price contract is planned.

SCOPE OF WORK

The Contractor must provide cGMP cleaning supplies as specified in each Delivery/task Order, F.O.B. Destination, to the National Institutes of Health (NIH) Clinical Center (CC) in Bethesda, MD. Deliveries are intended for use in NIH biologics manufacturing sites and aseptic processing areas The government will not furnish any equipment or materials for the delivery of these supplies.

SPECIFIC TASKS

Deliver cleaning supplies in the quantities and at the schedule requested, FOB

Destination.

Ensure each delivery of sterile cleaning supplies contains, or makes available within 24 hours of delivery, a manufacturer’s Certificate of Conformance (COC) specific to the delivered cleaning supplies with no chemicals.

The contractor will not substitute cleaning supplies without COR approval.

The contractor will keep sufficient quantities of cleaning supplies on-hand at all times for the ability to deliver within four days of receipt of Delivery/Task Order.

The contractor shall provide a plan, via email to the COR, to replace the unusable supplies within 30 minutes of the determination. The COR will report all cleaning supplies that are damaged or the sterility is compromised to the contractor.

Delivery of ordered supplies must be within four business days after receipt of called in order.

PACKAGING AND DELIVERY

The Contractor must provide inside delivery.

The Contractor shall ensure contamination control cleaning supplies are properly sealed and packaged with no visual damage to the packaging.

The Contractor shall provide Certificates of Conformance with each delivery of sterile products.

SPECIFIC REQUIREMENT

See Technical Exhibits 1 for a list of currently needed supplies. The exhibit is not all inclusive, and the list and quantities may be changed as needed. The Contractor must be able to provide, at least, the currently listed supplies upon Contract Award.

For Manufacturer Catalog Numbers, Monthly and Annual Delivery Requirements (See Exhibit 1)

Supplies required in the Statement of Work of the Contract and in each Task Order must not be substituted without the approval of the Contract Officer Representative (COR). If the Contractor substitutes a cleaning supply without the COR approval, it will be rejected and the Contractor shall be responsible for all costs associated with the return of the supply.

CONTRACT ORDER/TYPE

This solicitation will result in the award of a firm fixed price Indefinite Delivery/Indefinite Quantity Contract. Funding will be obligated by issued Delivery/Task Orders.

PERIOD OF PERFORMANCE / PLACE OF PERFORMANCE

The period of performance is anticipated to include a Base Period of 12 months, starting around February, 2018, with four (4) twelve month Option Periods estimated as follows.

Base Period 2/15/2018–2/14/2019

Option Period 1 2/15/2019–2/14/2020 Option Period 2 2/15/2020–2/14/2021 Option Period 3 2/15/2021–2/14/2022 Option Period 4 2/15/2022–2/14/2023

PLACE OF PERFORMANCE

The contractor shall transport and deliver cleaning supplies to the following address:

National Institutes of Health 9000 Rockville Pike

Building and Room To Be Announced Storage and Distribution, Receiving Section

Attention: Contracting Officer’s Representative Bethesda, MD 20892

Please note that the loading dock is equipped to handle all types of delivery trucks.

For Manufacturer, Manufacturer Catalog Numbers, Unit of Measure, Monthly, and Annual Delivery Requirements

See Technical Exhibits 1

DELIVERY HOURS:

The contractor shall deliver the cleaning supplies Monday through Friday between the hours of 7:30 AM and 3:00 PM; except Federal Government Holidays.

Contractor will be required to deliver cleaning supplies during inclement weather.

Government holidays include the following:

New Year's Day Martin Luther King JR’s Birthday Presidents Day Memorial Day Independence Day Labor Day Columbus Day Veterans Day Thanksgiving Day Christmas Day Inauguration Day (when applicable)

IDENTIFICATION:

Employees hired to work under this agreement will be citizens of the United States, or, if Alien, have the appropriate permits to work. Employees must be fluent in the English language. It is the contractor’s responsibility to perform past performance reference checks on their provided drivers and staff in order to ensure a secure and safe work environment for the NIH patients and staff.

INTERNAL INFORMATION

Smoking Policies within NIH Campus: The Contractor shall ensure that all employees comply with NIH’s Tobacco Free Campus smoking policies while performing services under this contract. The use of all tobacco products (including cigarettes, cigars, pipes, smokeless tobacco, or other tobacco products) is prohibited at all times in all buildings and on all outside property or grounds, including parking areas on the NIH Bethesda Campus.

Safety: The Contractor employees shall be responsible for knowing and complying with all installation safety prevention regulations. Such regulations include, but are not limited to, general safety, fire prevention, and waste disposal.

Media Inquiries: The Contractor employee shall not respond to any media inquiries. Any inquiries from the media shall be immediately relayed to the COR and/or CO. There shall be no interviews, comments, or any other response without the knowledge and approval of the Office of Communication and Media Relations.

APPLICABLE DOCUMENTS/REFERENCES

Quality Assurance Surveillance Plan At a minimum, the Contractor must perform to the standards in the Statement of Work. The following specific areas will be evaluated for each delivered supply.

Contractor Performance Requirement Non- Compliance (example)

Notification Consequence

1) Provide identified government cleaning supplies within four business days of receiving the Task Order

Late delivery

Citation (Three) citations will be cause for termination of the contract

2) Do not substitute cleaning supplies Wrong or un-approved delivery

Citation Replacement delivery required

3) Replace wrong, unapproved, or damaged cleaning supplies within one business day.

Late or non-compliant remedy

Citation (Three) citations will be cause for termination of the contract

4) Contractor’s Certifications:

a. Certificate of Conformance

Unavailable in boxes, Citation

Attachment: Technical Exhibit 1: cGMP Cleaning Supplies

Line Item Number

Product Manufacturer / Catalog #

Unit of Measure

Monthly Usage

Annual Usage

Mop, Gamma IRR Touchless, Floor, 18 inch Wipe

BENCHMARK

PRODUCTS /

Y-TL-FM-25IR

CASE (25

per case) 15 180

PAD, TOOL, 16 inch Strips, Non-Sterile

BENCHMARK

PRODUCTS /

Y-10516-10

CASE (10

packs per case) 1 12

COVER, SUITE TOOL Sterile

BENCHMARK

PRODUCTS /

Y-TCC-IBDI-20S

CASE (20

per case) 4 48