Statement of Requirements V4.2 Final.docx

Statement of Requirements – Coolers and Gel Packs

Any information submitted by an offeror for consideration will not be returned and will remain the property of the VA. All costs associated with submitting the above are the responsibility of the Contractor.

Background Information

The Department of Veteran Affairs (VA), Consolidated Mail Outpatient Pharmacy (CMOP) is a fulfillment program for outpatient pharmaceutical and Med/Surg supplies. As such, CMOP uses shipping containers daily for shipping necessary medical supplies and pharmaceuticals directly to the patient’s place of residence. The shipping containers requested in this procurement are for the uninterrupted source of supply to support all CMOP locations/ operations mailing of “Temperature Sensitive Pharmaceuticals” and phase change materials (PCM).

Guidance is available in the United States Pharmacopeia (USP) Chapter 1079 Risks and Mitigation Strategies for the Storage and Transportation of Finished Drug Products on maintaining pharmaceutical integrity throughout the supply chain to the patient. The Parenteral Drug Association (PDA) Technical Report 39 (TR 39) Guidance for Temperature-Controlled Medicinal Products: Maintaining the Quality of Temperature-Sensitive Medicinal Products through the Transportation Environment also addresses temperature-controlled distribution of pharmaceuticals. Cold chain distribution within CMOP requires storage conditions to maintain temperature inside the box at a mean kinetic temperature at or below 45 degrees Fahrenheit ((45°F − 32) × 5/9 = 7.222°C) for a minimum of 48 hours. Passive thermal containers using phase change materials (PCM) such as frozen gel packs for refrigerants are used to ensure medications are dispensed under proper storage conditions.

The current cold chain shipping process at all seven Consolidated Mail Outpatient Pharmacies (CMOPs) varies, however most include seasonal packing changes with adjustment of the number of frozen gel packs to maintain a mean kinetic temperature at or below 45 degrees Fahrenheit (45°F − 32) × 5/9 = 7.222°C) for a minimum of 48 hours.

Multiple Delivery Locations:

760, CMOP Leavenworth, 5000 S. 13th Street Leavenworth, KS 66048 (Current Location)

760 CMOP Leavenworth, 23501 W 84th Street Shawnee, Ks. 66227 (Future Location)

761, CMOP Chelmsford, 10 Industrial Ave Chelmsford, MA 01824

762, CMOP Tucson, 3675 E Britannia Dr.

Tucson AZ 85706

763, CMOP Dallas, 2962 S. Longhorn Dr.

Lancaster, TX 75134

764, CMOP Mid South, 3209 Elam Farms Parkway Murfreesboro, TN 37127

764, CMOP Mid South, 5171 Sam Jared Drive Murfreesboro, TN 37130

765, CMOP Great Lakes, 5th Ave & Roosevelt Rd BLD 37 NW DOCK 19, Hines, IL 60141

766, CMOP Charleston, 4136 Carolina Commerce Parkway Ladson SC 29456 Salient Characteristics All items need to meet statutory mandates as applicable for federal purchasing to meet or exceed the minimum biobased content requirements USDA Bio-Preferred Program Categories of Biobased Products for Mandatory Federal Purchasing: By Functional Area>Shipping.

(A) The USDA Bio-Preferred® Program designates categories for federal purchasing as well as identifies certification categories for the voluntary labeling initiative. Unique biobased content minimums have been established as part of the process of designating categories for federal purchasing preference. Categories that only fall under the voluntary labeling initiative have a minimum biobased content of 25%.

(B) USDA Bio-Preferred Program Categories of Biobased Products for Mandatory Federal Purchasing: By Functional Area>Shipping.

· Expanded Polystyrene Foam Recycling Products (90%)

· Packing and Insulating Materials (74%)

· Durable Thermal Shipping Containers (21%)

· Non-Durable Thermal Shipping Materials (82%)

· Non-Durable Films (85%)

· Semi-Durable Films (45%).

Purchasing environmentally preferable products or services that:

· Meet or exceed specifications, standards, or labels required by mandatory federal purchasing guidelines under USDA BioPreferred © Program that have been determined to assist agencies in meeting their needs and further advance sustainable procurement goals of this order. Vendor shall provide data for their biobased products.

All recycled coolers are shipped out inside a box to ensure thermal protection for refrigerated pharmaceuticals to keep a mean kinetic temperature at or below 45 degrees Fahrenheit (45°F − 32) × 5/9 = 7.222°C) for a minimum of 48 hours. This temperature is defined as the temperature maintained thermostatically between 2 and 8° C (36 F and 46 F), that allows for excursions in temperature between 0 and 15 ° C (32 and 59 F) that may be experienced during storage, shipping, and distribution such that the allowable calculated MKT is not more than 8 ° (46 F). Transient spikes up to 25 ° (77 F) may be permitted if the manufacturer so instructs and provided that such spikes do not exceed 24 hours for cold storage. Box shall have:

1) Minimal insulation inside a thin plastic acting as insulation inside the box to form a cooler and maintain mean kinetic temperature at or below 45 degrees Fahrenheit (45°F − 32) × 5/9 = 7.222°C) for a minimum of 48 hrs.

a) Cooler (outer box) meets the minimum 65 lbs. Corner Crush Test.

b) Box requires a weather resistance adhesive strip/double sided tape on the inside top flap of box for ease of closure and to maintain seal during humidity and high temperatures during the shipping process.

i. Tape should be similar/equivalent to 3M Stock # 7010374001.

c) “Refrigerate Upon Arrival" shall be stenciled in black ink with a minimum size of "1" letters placed on the top of the outer box.

i. ¾-inch above tear-away zipper or similar.

d) Cooler (outer box) has a perforated tear-away zipper the length of the box at the top of the box with ½” bold lettering that states “Pull Open”.

e) The bottoms of the box taped, sealed, and ready for use.

2) None of the material used should be hazardous or toxic.

3) If the gel packs are using Phased Change Materials(PCMs) needs to be frozen for use, the Contractor will have the ability to supply in a frozen state.

a) PCM = A substance that could be used within the gel packs that absorbs and releases large amounts of thermal energy.

4) The Contractor will provide written instructions on how to pack the container. Consideration will be given to the ease of pack out measured in the number of minutes required and materials required for assembly. Universal pack outs that do not require seasonal adjustments will also be taken into consideration.

5) Recycled coolers shall have outside dimensions that can have a 0.75” plus variance:

a) Small cooler: OD 11” x 9” x 7.25” plus 0.75” like or similar

b) Medium cooler: OD11.25” x 9.25” x 10.25” like or similar

c) Large cooler: OD 13.74” x 11.25” x 12.5” like or similar

d) Extra Large cooler: OD17” x 14.5” x 14.75” like or similar

6) Recycled coolers shall have minimum inside dimensions that can have a 0.75” plus variance:

a) Small cooler: ID 8” x 6” x 4”

b) Medium cooler: ID 8” x 6” x 7.5”

c) Large cooler: ID 10.5” x 8.5” x 6.25”

d) Extra Large cooler: ID 14.5” x 11.5” x 12.25”

Gel Packs

1. Gel Pack Frozen: 8-ounce

2. Gel Pack Non-Frozen: 8-ounce

3. Gel Pack Frozen: 12-ounce

4. Gel Pack Non-Frozen: 12 ounce

5. Gel Pack Frozen: 16-ounce

6. Foam Brick Frozen: 4.5” x 4” x 0.75” like or similar.

Weekly Deliveries:

1. Multiple deliveries per week up to daily due to storage constraints

a. Seasonal Changes to weekly demand increases.

NOTE: 3ea Sample(s) of ALL products being proposed shall be sent for testing to:

Department of Veteran Affairs 764 Mid South, Consolidated Mail Outpatient Pharmacy (CMOP)

RFP 36C77025R0002

ATTN: Tammie Lamb 5171 Sam Jared Drive Murfreesboro, TN 37130

*All product samples will be evaluated on a pass/fail basis to ensure compliance with the minimum requirements in the Statement of requirements (SOR) to include, size, construction material used and the ability to maintain temperature. Proposals from Offerors whose product samples failed to meet the minimum requirements of the SOR will be rejected and will receive no further consideration.

*ALL SAMPLES MUST BE RECEIVED BY SPECIFIED DATE IN THE RFP FOR CONSIDERATIONS*

References to Biopreferred products;

1) BioPreferred|Product Categories Packing and Insulating Materials Description: Pre-formed and molded materials that are used to hold package contents in place during shipping or for insulating and sound proofing applications.

Minimum Biobased Content: 74%

2) BP_ProductCategories_Infographic_FF Expanded Polystyrene Foam Recycling Products (90%) Packing and Insulating Materials (74%) Durable Thermal Shipping Containers (21%) Non-Durable Thermal Shipping Materials (82%) Non-Durable Films (85%) Semi-Durable Films (45%)

3) BioPreferred|Product Categories Thermal Shipping Containers - Non-Durable Description: Insulated containers designed for shipping temperature-sensitive materials. These are thermal shipping containers that are designed to be used once.

Minimum Biobased Content: 82% image2.png image1.png