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NIH-CC-18-000080 cGMP Cleaning Supplies National Institutes of Health

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

STATEMENT OF WORK

Good Manufacturing Practice (cGMP) Cleaning Supplies and Pharmacy Cleaning Supplies

Project Title: cGMP Cleaning/Consumable Supplies and Pharmacy Cleaning Supplies

Department: NIH Clinical Center/MMESD

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 and consumables are subject to change and include but are not limited to those listed Technical Exhibits 1 and 2. These supplies will be delivered as needed over the period of the contract. Due to the unpredictability of the amounts and specific chemicals and 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.

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 case of cleaning supplies contains a Certificate of Analysis (COA) for cleaning supplies containing chemicals, Certificate of Certification (COC) for cleaning supplies with no chemicals, and Packing Inserts, specific to the supplies in the case.

· If the COA, COC or Packing Inserts specific to the delivered supplies is/are missing, the Contractor must reply to COR and End Users via email within one hour with instructions for how to obtain the missing documents from the contractor website.

· A web-site log-in must be provided for each user’s Department Section. The COR will provide the contractor with an email list of End Users in each user Section at the beginning of the contract for access to the Contractor’s website. Updates to this list will be sent to the contractor if changes are made to the list.

· The contractor will not substitute cleaning supplies without COR approval.

· The contractor will keep sufficient quantities of cleaning supplies on-hand 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

Contractor must provide contamination control cleaning supplies for NIH biologics manufacturing sites and aseptic processing areas at the NIH CC (Bldg. 10) on the Bethesda, MD campus. It is vital that the Contractor provides Certificates for Analysis (COA), Certificates of Certifications and Packing Inserts in each packaged case of supplies. Contractor must provide the certificates and packing inserts as searchable documents on their website.

SPECIFIC REQUIREMENT

See Technical Exhibit 1 and 2 for a list of currently needed supplies. The exhibit is not all inclusive, and the list may be changed as needed. The Contractor must be able to provide, at least, the currently listed supplies and chemicals upon Contract Award.

For Manufacturer Catalog Numbers, Monthly and Annual Delivery Requirements (See Technical Exhibit 1 and 2). These list of GMP Cleaning/Consumable Supplies and Pharmacy Cleaning Supplies are subject to change, based on additions and deletions of products. The COR will notify the contractor 14 calendar days, if there are any changes

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 January, 2018, with four (4) twelve month Option Periods as follows.

PLACE OF PERFORMANCE

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

National Institutes of Health 9000 Rockville Pike Building 10, Room B2C-123 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 Catalog Numbers, Monthly, and Annual Delivery Requirements See Technical Exhibit 1 and 2

DELIVERY HOURS:

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

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

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.

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

Late delivery

4) Website must be available for ordering purposes 24 hours a day.

5) Contractor’s Certifications:

a. COA,

b. COC and

c. Packing Inserts

Unavailable in boxes, Unavailable on website Citation

Technical Exhibit 1: cGMP Cleaning Supplies

Technical Exhibit 2: cGMP Consumable Supplies

Technical Exhibit 3 Pharmacy Cleaning Supplies