Reagents-Lab Supplies SOW - 20260930 draft.docx

SOLICITATION NO. SPM2DE-11-R-002 Page 81 of 112

Attachment I – ECAT Unit of Sale Codes

Statement of Work Table of Contents

1. General Information

2. Contract Scope

3. Customers

4. Ordering Confirmation/Delivery

5. Customer Service Requirements

6. Special Terms and Conditions

7. Catalog Additions, Deletions, and Changes

8. Contract Pricing

9. Invoicing

10. Electronic Commerce Requirements

11. Preservation, Packaging, Labeling and Marking (PPL&M)

Attachment I: Schedule of Items Attachment II: ECAT Catalog Schema Attachment III: ECAT Registration Guide Attachment IV: Supplier ECAT Order Management User Guide Attachment V: Exchange Rate Revision Attachment VI: Acronym Definitions Attachment VII: Blank ECAT Catalog Loader

STATEMENT OF WORK

1. GENERAL INFORMATION

The Department of Defense (DoD), Defense Logistics Agency Troop Support (DLA TS), the Medical Supplier Operations Directorate is the inventory control point responsible for the acquisition and management of Medical/Surgical, Laboratory, Dental, Optical, Manufacturer Direct, and Medical Equipment supplies for customers located in the Contiguous United States (CONUS) and Outside Contiguous United States (OCONUS).

The intended results of this solicitation is one or more long-term Simplified Indefinite-Delivery Contracts (SIDC) with a base term of five years to provide general purpose laboratory reagents and supplies in support of Defense Logistics Agency Troop Support Europe & Africa (DLA TS E&A) OCONUS customers.

2. CONTRACT SCOPE

Items that may be purchased under this program encompass commercial items required for use in a laboratory; including but not limited to, controls, test kits, and reagents. A laboratory is defined as a building, part of a building, or other place equipped and/or designated to conduct scientific experiments, observation, analysis, tests, studies, investigations, etc., or to manufacture chemicals, medicines, or similar function. A non-traditional setting may also be considered as a laboratory if related to human health and performing any function traditionally done by a laboratory (e.g. testing conducted by individuals in the field).

3. CUSTOMERS

This contract will be used to support DoD OCONUS customers to include the United States Army Medical Materiel Center-Europe (USAMMCE) as well as DLA Troop Support Europe & Africa (DLA TS E&A), acting as the customer. The catalog items available under the resultant contracts will be accessed by only by authorized OCONUS ordering locations. The Government reserves the right to add or delete ordering facilities anytime during the contract period.

OCONUS customers are defined as those located outside the contiguous United States.

Ordering offices that will be supported by any resultant contracts may include, but are not limited to, Department of Defense (DoD) customers, including research centers, hospitals, and laboratory clinics. During the term of the contract, and for any subsequent option periods thereof, DLA TS E&A reserves the right to add or delete ordering activities. Any such additions or deletions made by DLA Troop Support Europe and Africa will not change the maximum contract dollar value.

Each ordering activity shall designate personnel authorized to place orders against this contract. There shall be no limit on the number of authorized personnel per activity who may place orders. The ordering activity will maintain and provide the list of designated of personnel to DLA TS E&A.

4. ORDERING/CONFIRMATION/ DELIVERY

The contractor shall accept individual delivery orders as needed from the ordering facility through DLA’s Electronic Catalog (ECAT) System and manual orders issued by DLA TS E&A.

The contractor shall provide the ordering activity electronic confirmation of order receipt and item availability at the line-item level within one (1) business day of order transmission. Order acknowledgments may be transmitted 24 hours a day, 7 days a week. Any order received on Friday after 4:00 p.m. contractor’s local time, or on a Saturday, Sunday, or American Federal Holiday (see the following for a list of Federal Holidays: http://www.opm.gov/Operating_Status_Schedules/fedhol ) shall be treated as orders received the next business day.

If a contractor cannot provide the ordered quantities by the required delivery date (RDD), they shall coordinate directly with the ordering facility for partial delivery or order cancellation instructions. The ordering activity shall notify DLA TS E&A of all partial deliveries and order cancellations.

Important Note: If the ordering activity requests full or partial cancellation of a line and the contractor proceeds to ship the line(s), the contractor shall not submit an invoice and items will be returned to the contractor at their expense.

The contractor shall be capable of receiving and timely processing of the following types of orders:

Routine/Regular Orders: these orders are placed on an as-needed basis. The contractor shall deliver to the ordering facility within 72 hours of order placement, excluding holidays and weekends. Deliveries will be made between the hours of 8:00 A.M. and 4:00 P.M. local time, Monday through Friday, excluding American and German holidays.

Expedited Orders: these high-priority orders are placed on an as-needed basis. The contractor shall deliver within 24 hours of receipt of an expedited order. Deliveries will be made between the hours of 8:00 A.M. and 4:00 P.M. local time, Monday through Friday, excluding American and German holidays.

Contractors shall provide the ordering activity with the telephone number and email address of the contactor’s representative responsible for expediting these orders.

Expedited order procedures involve the ordering activity utilizing the ECAT application to initially generate delivery order number, then coordinating and confirming stock availability, delivery, and fees with contractor telephonically. The ordering activity will finalize ECAT submission to ensure accuracy of invoice payment.

Scheduled Orders: the ordering activity will schedule these orders in advance based on projected need and the manufacturer’s production schedule of the required items. Order fulfillment shall coincide with the manufacturer’s production schedule.

Scheduled order procedures involve the ordering activity utilizing the ECAT application to initially generate a delivery order number, then coordinating with the contractor to deliver on the date specified in written follow-on instructions. Scheduled order deliveries shall be made between the hours of 8:00 A.M. and 4:00 P.M., local time of the receiving facility, Monday through Friday, excluding American holidays.

The ordering activity will not combine routine/regular, expedited, or scheduled orders on a single order processed through ECAT or by DLA TS E&A.

The contractor may combine routine/regular and scheduled orders on a single shipment. Expedited orders shall be shipped separately.

All confirmed orders shall be delivered to receiving facility at the following address using commercial, traceable, door-to-door shipping methods. Use of the Medical Air Bridge or other military transportation channels are not authorized. Orders shall be shipped to:

USAMMCE

BLDG 2369

Ludwigshafenerstr. 31 67657 Kaiserslautern Germany

Vendors shall contact the following office at USAMMCE to obtain base access for deliveries. Contact USAMMCE S2 Security office/Security Manager Commercial phone number (49)611-143-547-9200/9201. If vendor does not have base access once arriving at the Kaiserslautern Army Depot (KAD) gate they may have the KAD gate security call Distribution & Transportation receiving office (+49)611-143-547-9241 to request an escort to the USAMMCE warehouse for delivery. As noted above (Para. C.1 – C.3) vendors shall make deliveries between 0800 and 1600, Monday through Friday excluding American and German holidays. The vendor shall coordinate any known deliveries to USAMMCE outside these hours by contacting the receiving office between 0800 and 1600.

Commercial Bill of Lading (CBL): The contractor shall prepare a CBL for each shipment. The document can be the same or similar to one that the contractor uses for commercial shipments; however, the CBL/manifest must identify the critical shipment information and the contents of the shipment. Critical information includes the purchase order number, item number, nomenclature/item description, unit of issue, and quantity.

5. CUSTOMER SERVICE REQUIREMENTS

Inspection and acceptance of all supplies will be performed at the receiving facility by an authorized receiving facility representative. The disposition of any discrepancies shall be as agreed upon by the receiving facility and the contractor.

Order Discrepancies: The contractor shall accept returns of goods under any of the following conditions. All costs associated with the return are at the contractor’s expense (including transportation costs).

The contractor shall provide Shelf-Life Code (SLC) “A” through “F” items with no less than 95% remaining shelf at time of delivery. All other SLCs shall have no less than 75% of remaining shelf-life as listed below:

To facilitate the timing of scheduled orders, contractors shall provide the ordering activity with the manufacturer’s production schedule for items on their SIDC with SLCs “A” and “B” within ten (10) business days of contract award, annually thereafter, and as requested by the ordering activity or DLA TS E&A.

The contractor shall have the ability to provide product recall notification to the ordering facility that has received affected product and to DLA TS E&A. Product recall notification must be made within 48 hours, in all cases, of notification by the manufacturer or its supplier/distributor.

Product Correction, Removal, or Recall: If any product awarded under this solicitation is recalled by the FDA, is removed or recalled by the contractor or manufacturer due to defects in the product or potential dangers, or if any required correction, removal, or recall is suggested or mandated by a regulatory or official agency, the following steps will immediately be taken by the contractor or manufacturer:

All the following offices and points of contact should be emailed a notification:

Each individual Customer POC on any referenced orders for the product, regardless of whether or not delivery and/or acceptance has already been made.

DLA Contracting Officer cited in any delivery orders for the product, regardless of whether delivery/and or acceptance has been made.

The following information must be provided in each individual notification that is forwarded to all above offices and points of contact:

Complete item description and/or identification, the contract number and delivery order numbers.

Reasons for modifications, removal, or recall.

Proposed offers for return for credit, replacement or corrective action shall be forwarded to the customer POC and Contracting Officer, for consideration by the Government.

The vendor will be responsible for all costs associated with a recall or other action described in this paragraph. Product recall notification and other notifications described in this paragraph, must be made immediately after initiation of the recall or other action by the manufacturer and/or the contractor. In no cases may notification be made in more than 48 hours.

Shipping Label: shall contain the purchase order number as well the entire address including the “Ship To” Address and the “Mark For” text.

The contractor shall enclose a packing list/slip with each order shipped to indicate contractor, purchase order number, itemized list of supplies with item number and description, quantity ordered, quantity shipped, ship to address, and “mark for” information.

To assure that all receiving activities can properly identify items requiring special handling and storage, the contractor shall annotate its packing list with the following notation: “Requires Special Handling and/or Storage.” Examples of the special handling and storage statements include the following: “STORE BETWEEN 2o – 8o C (36o - 46o F),” “Keep Frozen,” or “Flammable”.

Refrigerated material that is allowed to be temporarily unrefrigerated (Limited Unrefrigerated Medical Shipment) shall indicate the maximum remaining allowable time that the material can remain unrefrigerated at the time of delivery to the receiving activity without impacting shelf life. If storage information for the product requires 2-8C and not shipped cold or received with maximum allowable excursion time, product will be rejected. If payment was already rendered, it will be refunded to the receiving activity in full. The shipping organization will be responsible for any return costs if return of the product is requested. Failure to correctly ship materials and loss of revenue may not be factored into future cost increases.

Fill Rate: The contractor shall maintain a 95% fill rate for the contract. Companies unable to comply with the requirements of the fill rate may be suspended from ECAT until such time as they can demonstrate that they will meet the fill rate requirements of the contracts. The fill rate is reviewed twice a year for the entire contract. The Fill Rate calculation is:

Total Lines Filled/Total Lines Ordered

Contract Delivery Rate: The vendor is meeting the delivery timeframe specified in the contract. The contractor shall maintain a 95% on-time delivery rate for the contract. Companies unable to comply with the requirements of the fill rate may be suspended from ECAT until such time as they can demonstrate that they will meet the fill rate requirements of the contracts. The fill rate is reviewed twice a year for the entire contract. The Fill Rate calculation is:

Total On-time Deliveries/Total Deliveries

6. SPECIAL TERMS AND CONDITIONS

Due to the nature of the contract, deliveries or performance shall be made only as authorized by orders issued in accordance with the clause FAR 52.216-18, Ordering. Except for any limitation on quantities or dollar amount in the Order Limitations Clause, there is no limit on the number of orders issued.

Electronic Catalog System (ECAT): DLA TS Medical operates and manages the DLA Electronic Catalog System (ECAT). All catalog updates, changes, or deletions will be processed by a DLA TS E&A Contracting Officer.

Basic Requirements:

ECAT will be the means by which orders will be placed, confirmed, and invoiced under this contract. Each contractor agrees to use the ECAT system to display its catalog and awarded price(s) for the items offered.

All items will be identified by the manufacturer’s name and part number and conform to the manufacturer’s specifications. At a minimum the contractor will provide the following, Product Name, Product Description, Contract Price, Unit of Issue, Items per Unit of Issue, Manufacturer Name and Part Number, and Quoted Lead Time as described in the Statement of Work herein.

The contractor agrees to let all authorized ECAT users view any information displayed in the system. “Authorized Users” are defined as customers of DLA Troop Support Europe & Africa (DLA TS E&A.) The contractor agrees to permit authorized users (customers) to order from its catalog using the system. While the bulk of orders placed against this contract will flow through the ECAT system, DLA TS E&A reserves the right to place manual orders on behalf of the customer outside ECAT.

Refurbished or used products will not be accepted.

The contractor shall provide its own computer hardware and software necessary to transmit and receive transaction sets, such as orders, order confirmations, invoices, etc.

7. CATALOG ADDITIONS, DELETIONS, AND CHANGES

The ordering activity may request additions as needed. Requests for catalog additions shall be submitted to the Contracting Officer. Catalog additions may take up to 10 business days. DLA TS E&A may expedite the catalog addition(s) if an email is received directly from the ordering activity detailing the urgency.

Prior to adding a new item, the Contracting Officer must determine the contractor’s price fair and reasonable by; 1) Verifying the list price for the item(s) being added; 2) Comparing the proposed ECAT price to Veteran Affairs FSS, or other Government or commercial pricing or; 3) requiring the contractor to provide other than cost and pricing data such as invoices. The Contracting Officer has discretion to request and rely on additional or alternative information to determine if an offered price is fair and reasonable. Items determined by the Contracting Officer to not be fair and reasonable will not be added to the ECAT catalog.

When requesting the addition of a new item, the contractor shall submit Attachment I: ECAT Catalog Loader to the Contracting Officer. The contractor must submit required documentation to the Contracting Officer that contains the same information provided during the proposal process.

Vendors may request item deletions at any time by sending the Contracting Officer a copy of Attachment 1 containing the Manufacturer’s Name, Manufacturer’s Part Number, Supplier Name, Supplier Part Number, Line-Item Number, and Line-Item Action (D). Only the item master sheet tab shall be filled out for this action.

Changes to a field in Attachment I must also be submitted as an update. This action will be completed on the item master and/or price offer sheet located in the loader. This applies for any updates to a part number such as product description, product name, unit of issue etc. When the part number for an item is changing, the vendor must submit a request to delete the item and then submit a separate request to add the item containing the new information only. Vendors may submit changes monthly NLT the fifth working day of the every month. Other than certified cost and pricing data may be necessary for these submissions.

8. CONTRACT PRICING

All prices shall be FOB Destination and fixed at time of contract award for the five-year ordering period.

Price Decrease: It is the responsibility of the contractor to pass all price decreases in accordance with the Economic Price Adjustment terms contained in the contract.

Price Increase: The Contracting Officer will entertain price increases in accordance with the Economic Price Adjustment terms contained in the contract which allow for one price increase every 12 months.

Orders received at such time the pricing is being evaluated for an increase must be filled at the price at time of order. The vendor will be required to honor orders at the lower price until price increases have been processed and loaded into the vendor’s ECAT catalog.

Special or Discounts – Contractors may offer “specials” or “discounts” at any time during the term of the contract. Once the “special” or “discount” period expires, MediPrice, the ECAT contracting management system, will revert the pricing back to its original contract price.

Additionally, it is the responsibility of the contractor to ensure that the unit price of the item matches the contractor’s current contract price prior to acknowledgement of an order.

UNIT PRICE EXCHANGE RATE FLUCTUATION

Vendors shall submit a quarterly revision to Attachment I – ECAT Catalog Loader to adjust only the exchange rate used to convert unit prices from Euros to US Dollars. The revision will adjust the unit prices in ECAT for upward and downward exchange rate fluctuation only, not for other changes to supply cost.

At the beginning of the fourth full calendar month after award of the contracts, and every three months thereafter, Vendors shall submit an exchange rate adjustment to reconcile upward or downward currency fluctuation.

No later than 14:00 on the first Friday of the quarter, Vendors shall submit a revised version of the ECAT Loader that revises the exchange rate to the average rate over the preceding three months. No later than the second Friday of the quarter, DLA will upload the adjusted unit prices into ECAT. The prices will become effective approximately three business days after the ECAT upload. Pending approval of any proposed exchange rate changes and update of the USD unit prices in the ECAT System, payment shall be made at the unit prices in effect at the time of order.

Upon receipt of the quarterly revision, the Contracting Officer (KO)will review the exchange rate adjustment for fair and reasonableness. Upon acceptance of the rate, the revised ECAT Loader will be uploaded to without a contract modification as the Euro unit prices are unchanged. Failure to provide a reasonable rate, or required supporting documentation, will delay processing of the revision. If the vendor fails to submit a timely revision, the KO reserves the right to apply the average rate for the preceding three months retrieved from any open-source or subscription website for that quarter’s revision and proceed with the currency adjustment.

No retroactive adjustments will be approved. Prices will remain effective for three months until the following quarter’s revision. See the sample schedule in Attachment V - Exchange Rate Adjustment Schedule.

Vendors may use any open-source or subscription website, such as oanda.com, to determine the average exchange rate for the previous quarter. Vendors shall provide a copy of the date range, daily rates, and any other information used to determine the previous quarter’s average exchange rate. The exchange rate data shall be retrieved and provided directly from the source, not summarized in a document authored by the vendor. The first exchange rate calculation shall be based on the first full three months of the contract after award. Each subsequent calculation shall begin from the first day of following month through the last day of third month. See Attachment V for details.

9. INVOICING

The vendor is not prohibited from filling an order from more than one warehouse or multiple source locations.

Only detailed invoices are acceptable. Each line item must be listed separately on the invoice. Invoices shall include the contract number, delivery order number and the purchase order number.

10. ELECTRONIC COMMERCE REQUIREMENTS

The offeror will use The ECAT Order Management Interface (OMI) to facilitate order communication.

ECAT Order Management (OM) Requirements: is a browser-based supplier interface allows offerors to respond to orders and submit invoices. The Supplier ECAT Order Management User Guide is located at https://www.medical.dla.mil/Portal/ECAT/EcatHome.aspx under the ECAT tab and at Attachment IV of this SOW. Note that offerors may not be able to view this tab until after they have registered an ECAT login account and are able to log in. To use the Order Management Interface, contractors need an Internet connection and Web Browser.

To Register in ECAT; offerors should use the ECAT Registration Guide located at https://www.medical.dla.mil/Portal/ECAT/EcatHome.aspx . and Attachment III - ECAT Registration Guide of this SOW. Click “Registration Guide” as shown below:

Through the OM interface, the contractor will receive an e-mail notification of any new orders. The contractor shall then log into ECAT with a user ID supplied by DLA TS E&A. There the contractor can view the order(s), acknowledge the order(s), provide an estimated shipping date, shipping company, and tracking number. ECAT will then update the order status for the customer to view.

Invoicing: The contractor shall submit invoices through the OM link. The contractor may submit one or multiple invoices per delivery order. The contractor is required to verify that the invoice amount displayed is correct, input an invoice number and click the submit button. ECAT will ensure the detailed invoice is generated and sent to DFAS. Payment will be made after receipt of a valid invoice. Payment will be made via Electronic Funds Transfer (EFT) to the contractor’s financial institution. Refer to Attachment IV – Supplier ECAT Order Management User Guide for additional instructions.

Note: Access to submit an invoice will not be made available unless tracking information on the delivery order has been completed.

To take advantage of invoicing through ECAT, the contractor must register with Wide Area Workflow (WAWF). After registering with WAWF, the contractor must inform the DLA TS E&A Contracting Officer to have invoicing capability enabled for your ECAT account. Prior to obtaining WAWF account you must verify that your company is registered in the System for Award Management (SAM), and that your company’s CAGE Code is active in WAWF. All WAWF users must complete the WAWF Self-Registration Form online at https://wawf.eb.mil.

11. PRESERVATION, PACKAGING, LABELING, AND MARKING (PPL&M)

Unless otherwise specified, all PPL&M requirements specified herein shall apply to all shipments of medical items including hazardous and non-hazardous items.

Preservation, packaging and packing: shall be in accordance with manufacturer shipping instructions and the European Good Distribution Practices sufficient to preclude damage to containers and/or contents thereof under normal shipping and handling conditions. Exterior (shipping) containers shall conform to the applicable carrier's regulations and shall be substantial commercial containers (export when necessary) of the type, size and kind commonly used for the purpose, so constructed as to ensure acceptance and safe delivery by common or other carriers, at the lowest rate, to point of delivery called for in the order. As required, shipments shall be properly packaged and packed for international movement. This includes customs clearance acceptable packaging and labeling.

European Good Distribution Practices can be found at (https://www.ema.europa.eu/en/human-regulatory/post-authorisation/compliance/good-distribution-practice) .

Labeling and marking: All materiel including routine items and items requiring special handling, i.e., hazardous, perishable, and sensitive/controlled/pilferable material shall be marked in accordance with commercial practice, manufacturer shipping instructions, and the European Good Distribution Practices

Applicable to all Medical items: The product number is the number assigned to the item by the supplier/manufacturer and may be any number which the supplier/manufacturer uses to identify the product, e.g., National Stock Number (NSN), Universal Product Number (UPN), catalog number, etc.

Packing list: A properly completed packing list shall accompany each order. The packing list shall include, as a minimum, the name of the vendor, purchase order number, itemized list of shipped items by product number, unit of issue, quantity ordered, quantity shipped, delivered unit price, and the total delivered cost for the order. The product number used in both the order and confirmation must be duplicated on the packing list. The delivered unit price will reflect two decimal places (the third decimal place will be rounded down for “4” and below and will be rounded up for “5” and above).

Destination address label: A destination address label shall be supplied on each exterior (shipping) container, affixed in a way that prevents damage or loss, a second copy will be included within the interior shipping container.

Materiel requiring special handling: Materiel requiring special handling must be properly identified in accordance with the manufacturer’s shipping instructions and the European Good Distribution Practices in order to alert the receiving activity that the materiel requires special handling and storage. Examples of special handling and storage statements include the following: “STORE BETWEEN 2o – 8o C (36o – 46oF)”, “KEEP FROZEN”, “FLAMMABLE”, etc. In addition, the exterior (shipping) container shall be marked with the applicable storage statements. For Medical items subject to damage by freezing, marking on each shipping container shall include the statement "DO NOT PERMIT TO FREEZE"; in addition, “ARROW” and “FRAGILE” markings, as appropriate, shall be applied to each shipping container. Similar commercial storage statements are acceptable on the packing list and the exterior (shipping) container. The markings/labels will be affixed to the shipment on at least two sides and protected from weather damage and or loss.

Hazardous material (HAZMAT): HAZMAT includes any materiel defined as hazardous under 49 CFR 171.8 (Code of Federal Regulations (CFR) Title 49) and the latest version of FED-STD-313.

Material Safety Data Sheets (MSDSs): MSDSs shall meet the requirements of 29 CFR 1910-1200 (g) and FED- STD-313. Nothing contained in this contract shall relieve the contractor from complying with applicable Federal, State, and local laws, codes, ordinances and regulations (including the obtaining of licenses and permits) in connection with hazardous material.

Neither the requirements of this contract, nor any act or failure to act by the Government, shall relieve the contractor of any responsibility or liability for the safety of Government, contractor, or Subcontractor personnel or property.

The contractor shall retain all applicable MSDSs as specified herein and furnish a copy to the customer upon request.

If at any time during the contract there is a change in the composition of any item or a revision to FED-STD-313, which renders incomplete or inaccurate the data previously submitted, the contractor shall promptly notify USAMMCE.

Packaging, labeling and marking of HAZMAT:

Packaging, labeling and marking of HAZMAT shall comply with all applicable federal and local regulations including the European Good Distribution Practices.

Special shipping instructions. Orders placed for HAZMAT should normally include special shipping instructions. If the contractor does not receive special shipping instructions in an order, the contractor shall contact the ordering activity. If special shipping instructions apply to the order, the ordering activity shall promptly furnish them to the contractor.

Perishable Medical Materiel:

Packaging, packing, labeling, and marking of perishable medical materiel shall be in accordance with all applicable regulatory requirements including the European Good Distribution Practices, manufacturer shipping instructions, and commercial practice.

Perishable medical materiel requiring chill or freeze temperatures shall be properly packaged and packed to ensure that the manufacturer required temperature is maintained during shipment. Required packaging shall be determined by the type of materiel being shipped, the climatic conditions under which the shipment will be made, and the destination's ambient temperature.

In-Vitro Diagnostic Substances, Reagents, Test Kits and Sets requiring constant refrigeration shall be prepared for shipment in accordance with stringent cold chain management protocols.

Items Requiring Constant Freeze Temperatures:

Items identified as requiring constant freeze temperatures shall be packed in suitable insulated shipping containers to maintain proper preservation of the materiel during shipment. Commercial packaging may be used, provided the proper temperature is maintained during handling and shipment to the ordering facility.

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