FDA-SOL-21-1237487.pdf

FDA- SOL-21-1237487

Notice of Intent to Issue a Sole Source Purchase Order for 13 cold storage units under repository services with four (4) (one (1) year optional services)

The Food and Drug Administration intends to issue a sole-source purchase order to KamTek Inc., located at 4851 International Boulevard, Frederick, MD 21703. The anticipated purchase order is for 13 cold storage units. An Award will be made in accordance with Federal Acquisition Regulation (FAR) Part 6.302-1, only one responsible source and no other supplies or services will satisfy the agency requirements using Simplified Acquisition Procedures per FAR Part 13.5. This notice of intent is not a request for competitive quotes. However, all responsible sources may submit a capability statement within seven (7) days after the publication of this synopsis, which will be considered by the agency. Responses received after seven (7) days or without the required information may not be considered. A determination by the Government not to compete as a result, of information received is solely within the discretion of the Government. Information received will be considered solely for determining whether to conduct a competitive procurement. For information concerning this acquisition, contact Linda Troutman, Contract Specialist at Linda.Troutman@fda.hhs.gov.

mailto:Linda.Troutman@fda.hhs.gov mailto:Linda.Troutman@fda.hhs.gov

Scope

The contractor shall perform the services described in the Technical Requirements and Deliverables and Deliverables Schedule sections for the following 13 FDA (CBER) cold storage units:

Unit Type Make Model Serial Dimensions

-80C, Upright HARRIS HLT- 21V-

85E-UA

OA-28480-15-E L 39" x W 39" x H 80"

Inside Dimensions

L 24" x W 34" x H 50"

-80C, Upright PANASONIC MDF-

U76VC-

PA

15027J0355 L 39" x W 39" x H 80"

-80C, Upright HARRIS HLT- 21V-

85E-UA

OA-28480-17-E L 39" x W 39" x H 80"

-80C, Upright FORMA 906 825034-4230 L 39" x W 39" x H 80"

-80C, Upright PANASONIC MDF-

U76VC-

PA

15027J0355 L 39" x W 39" x H 80"

-80C, Upright FORMA 8693 811194-248 L 39" x W 39" x H 80"

85E-UA

OA-28480-4-E L 39" x W 39" x H 80"

85E-UA

OA-284802-E L 39" x W 39" x H 80"

-20C, Walk-in HARFORD DL3678866

IM5E

XWF9221 7'9" x 9'8" x 7'6-1/4" (add 20-1/2" compressor height)

4C, Walk-in HARFORD DL3678866

IM5S

WXT4301 7'9" x 9'8" x 7'6-1/4" (add 20-1/2" compressor height)

LN2 MVE MVE1841F CEFN03H101 39-1/4" d x 37-1/2" deep

LN2 MVE MVE511-

GEN2F

CDDF05K102 39-1/4" d x 37-1/2" deep

LN2 TAYLOR

WHARTON

LABS40K 772-002-W08 39-1/4" d x 37-1/2" deep

The Contractor shall provide a suitable storage facility within a 50-mile radius of Silver Spring, MD. This is a requirement for maintaining International Organization for Standardization (ISO) accreditation of FDA (CBER) laboratories in the Division of Biological Standards and Quality Control.

I. Technical Requirements All technical requirements apply to the following 13 cold storage units. These cold storage units listed in (Scope Section III) and their contents are the property of FDA (CBER).

A. Facility for housing the 13 cold storage units

1. The Contractor shall provide a suitable storage facility within a 50-mile radius of

Silver Spring, MD. This is a requirement for maintaining International Organization for Standardization (ISO) accreditation of FDA (CBER) laboratories in the Division of Biological Standards and Quality Control.

2. The Contractor shall provide a relocation plan in the event that the 13 cold storage units and contents currently stored at 4851 International Boulevard Frederick, MD 21703 need to be transported to the new location.

3. The storage facility shall have adequate floor space to accommodate the 13 cold storage units and for 5 additional cold storage units if required by FDA (CBER).

Dimensions for each cold storage unit are included in the list above. The storage space will be used to store containers of bulk biological material (see attached list) for short- and long-term storage and should have capacity of at least 100 square feet each.

4. The storage facility shall be completely air-conditioned. The air conditioning system must be capable of providing an ambient temperature of 72 degree to 73 degree Fahrenheit when all the cold storage units housed in this facility are operating.

5. The Contractor shall provide an adequate utility electrical power supply for the storage facility to safely operate all low temperature storage equipment, alarms, https://www.iso.org/home.html https://www.iso.org/home.html https://www.iso.org/home.html https://www.iso.org/home.html https://www.iso.org/home.html lights, HVAC systems and the immediate transfer of low temperature storage equipment for short- or long-term storage.

6. The Contractor shall provide, as a safety measure, an emergency electrical generator system that is capable of providing electrical power to all systems in the event of a utility power failure.

7. The contractor shall have a liquid nitrogen tank large enough to operate the liquid nitrogen freezers.

8. The Contractor shall equip the storage facility with a remote and central alarm security system. The system must have audible alarms that can be heard inside the facility by the Contractor’s personnel. The system will contact a secondary facility personnel if primary personnel contact is not confirmed, this will also be documented, and notification attempts will continue until either personnel is contacted by telephone. These central alarm systems will be operational and monitored 24 hours a day, 365 days a year and have the capability to operate in the event of failure to traditional landline telephone system. The central alarms shall monitor all the cold storage units, communications systems, emergency generator service, fire and perimeter security systems.

9. The Contractor shall adhere to the requirement that designated FDA (CBER) storage space shall be used for storing only FDA (CBER) material at all times.

10. The Contractor shall provide access to the storage facility for authorized FDA (CBER) employees on regular business days during the hours of 8:00 am to 4:30

pm. CBER shall provide the Contractor details of who these CBER employees shall be during the contract kick-off meeting.

11. The Contractor shall also provide all necessary information for emergency access to the facility to a maximum of 2 employees of FDA (CBER). This emergency access shall be in the event of an emergency requiring immediate transfer of non-infectious biological materials from other approved FDA (CBER) facilities.

12. The Contractor shall ensure only authorized FDA (CBER) employees have access to the stored inventory and maintain a log of personnel accessing FDA (CBER) inventory storage. This log shall include the name of the FDA (CBER) employee, date, time, and storage location accessed.

B. Monitoring the 13 cold storage units

1. The Contractor shall monitor the temperature and functioning of each of the 13 cold storage unit and maintain monitoring logs for each cold storage unit. Monitoring of each unit shall be constant, that is, 24 hours a day 365 days a year.

2. The Contractor shall ensure the proper functioning of the alarm system for monitoring each cold storage unit’s set temperature.

3. Upon request, the Contractor shall provide monitoring log records for each cold storage unit.

C. Maintaining the 13 cold storage units

1. The Contractor shall perform routine preventative maintenance services twice a year on each of the 13 cold storage units.

2. As necessary or twice a year the Contractor shall remove, transfer and temporarily hold the entire contents of each freezer for the purpose of defrosting and cleaning the freezers. This procedure shall be accomplished in a manner that causes no detrimental effect to the biologic material or storage equipment.

3. A description of all routine maintenance services shall be included in the Contractor’s monthly report.

4. The Contractor shall maintain and operate standby cold storage equipment in the event of loss of refrigeration capacity for all storage areas.

5. The Contractor shall ensure all emergency and non-emergency repairs approved by FDA (CBER) are performed on each of the cold storage units.

6. Costs for repairs are not included and shall be approved by FDA (CBER) prior to any repairs.

7. A description of all repairs shall be included in the Contractor’s monthly report.

II. Performance Standards

A. Facility for housing the 13 cold storage units

1. The Contractor shall provide a suitable storage facility within a 50-mile radius of

Silver Spring, MD. This is a requirement for maintaining International Organization for Standardization (ISO) accreditation of FDA (CBER) laboratories in the Division of Biological Standards and Quality Control.

2. If the Contractor knows of expected changes to the facility, the Contractor shall as soon as reasonably possible notify and work with the FDA (CBER) POC to minimize impacting the 13 cold storage units.

3. The Contractor shall ensure the cold storage units are positioned according to the space requirements described in the technical requirements section.

4. The Contractor shall ensure that there is no disruption of electrical power to each of the 13 cold storage units.

5. The Contractor shall ensure the proper functioning of the alarm systems for the facility and each of the 13 cold storage units.

6. The Contractor shall ensure there is enough liquid nitrogen available on-site for the liquid nitrogen units.

7. In the event of an emergency, the Contractor shall have immediate access for transferring the contents of the cold storage units to their proper storage temperatures.

8. The Contractor shall ensure only FDA (CBER) authorized personnel have access to the cold storage units for depositing or withdrawing contents.

B. Monitoring the 13 cold storage units

1. In the event of an emergency with one of the cold storage units, the Contractor shall notify the FDA (CBER) POC as soon as reasonably possible.

C. Maintaining the 13 cold storage units

1. Applicable technical requirements for maintaining and repairing the cold storage units shall be performed as per applicable manufacturers’ specifications.

2. If the contents must be moved for routine maintenance or repairs, the Contractor shall transfer the contents in such a manner that causes no detrimental effect to the biologic material or storage equipment.

3. In the event of necessary repairs to one of the cold storage units, the Contractor shall inform FDA (CBER) as timely as possible so that FDA (CBER) has time for a decision to approve the repairs or not.

4. The Contractor shall ensure that repairs approved by FDA (CBER) are properly performed and in a timely manner.

III. Deliverables and Deliverables Schedule

A. The Contractor shall perform the services described in the Technical Requirements and Performance Standards sections for each of the 13 cold storage unit listed in the Scope (Section III).

B. The Contractor shall provide monthly reports on the 7th of each month to the Contract Specialist and COR for the contract. These reports shall include:

1. An outline of the previous month’s activities.

2. A description of all repairs and routine maintenance services for each of the cold storage unit listed in the Scope (Section III).

IV. Period of Performance Period of performance shall be one base year plus four separate option years. Each option year shall be authorized and exercised solely by FDA (CBER). The expected dates are:

• Base year: 09/30/2021 thru 09/29/2022

• Option year 1: 09/30/2022 thru 09/29/2023

• Option year 2: 09/30/2023 thru 09/29/2024

• Option year 3: 09/30/2024 thru 09/29/2025

• Option year 4: 09/30/2025 thru 09/29/2026

V. Security Requirements A. FDA (CBER) personnel accessing the cold storage shall be authorized by FDA (CBER).

B. Any FDA (CBER) items deposited or withdrew from the place of performance shall be authorized by FDA (CBER).

C. The Contractor shall be responsible for its staff or any outside staff performing any of the technical requirements.

VI. Other Considerations (e.g., Section 508 compliance; guidance pertaining to holidays, work hours, overtime, weekends, on-call services; contractor travel and training, GFP, list of materials, etc.)

A. The Contractor shall provide access to the storage facility for authorized FDA (CBER) employees on regular business days (no holiday or weekends) during the hours of 8:00 am to 4:30 pm.

B. Monthly invoices shall be e-mailed for payment and copied to the Contract Specialist and COR for the contract.