Medical Formulary SOW.pdf

UNITED STATES DEPARTMENT OF COMMERCE

National Oceanic and Atmospheric Administration

Office of Marine and Aviation Operations Marine Operations Center, Atlantic

Statement of Work for NOAA Health Services NFFMI

1) Introduction

a) NOAA Health Services (NHS) is tasked to maintain the NOAA Fleet Formulary and Medical

Inventory (NFFMI) aboard 15 research, fishery, and hydrographic vessels operated by NOAA’s Office of Marine and Aviation Operations (OMAO). NHS must supply eight Medical Class A inventories and seven Medical Class B inventories as defined on the NFFMI to the OMAO fleet annually. NHS must also resupply items consumed aboard these ships on a periodic basis throughout the year.

2) Scope

a) "Provide NHS with various types and brands of medical supplies in accordance with the

NFFMI for delivery, including direct shipping to operations units and ships. Additionally, manage a shared document to track and update the inventory of supplies currently on each vessel."

3) General Requirements

a) The Contractor shall deliver a wide variety of medical supplies which fall under two main categories:

i) Medical Class A:

(1) Medical Class A items, denoted yellow/orange highlight on the NFFMI, shall be stocked on Medical Class A ships (which is in addition to the Medical Class B items). There are, however, some items highlighted yellow/orange that are on both Medical Class A and B ships but in higher quantities for Medical Class A ships. Medical Class A ships have a U. S. Public Health Service (USPHS) Medical Officer and at least one Medical Person-in Charge (MPIC) assigned to the ship. For further clarification, items with an asterisk (*) exist only on Medical Class A ships.

ii) Medical Class B:

(1) Medical Class B ships have at least two MPICs assigned to the ship. Medical Class B items, non-highlighted, on the NFFMI shall be stocked on Medical Class B ships.

Again, noting that there are few yellow/orange highlighted items that exist on both Medical Class A ships but in lower quantities for Medical Class B ships.

b) Quality Control

(1) The contractor shall have a quality control and warranty program in place to ensure that only quality products are provided. Quality control is the capability to maintain materials that are of high quality, not damaged or appearing worn and current (not expiring for a minimum of at least 12 months), through the application of shelf-life best practices. This includes quality; processes, policies, third-party quality standards or certifications achieved, and warranty policy. Discrepancies to this quality control warranty will be returned to the vendor at their expense.

c) Ordering/Shipping/Communication

(1) The contractor will initiate contact with individual units and ships every six months to coordinate the replacement of all scheduled expired and used medical supplies. This communication will be led by the contractor.

(2) The contractor will maintain a shared spreadsheet accessible to the units, the contracted company, and OMAO. This spreadsheet will include all current medical supplies on each ship, along with their expiration dates. This proactive approach will enable the contracted company to anticipate and prepare for necessary shipments prior to each communication. During these interactions, unit medical supply managers will confirm existing supplies and expiration dates, while also notifying the contractor of any unforeseen usage of medical supplies.

(3) Delivery orders will be placed by individual unit medical supply managers acting within their scope of delegated procurement authority. Individual orders will detail the respective supplies and quantities. The contractor will ship (see “Partial Orders” below) the order within the time period specified by the contractor but no later than sixty days after issue of each individual order. Exceptions can be made on the delivery schedule based on manufacturer availability/shortages.

(3) Tracking information is to be forwarded to the CMHS or designee upon shipping purchase orders.

(4) Manufacturer backorders/shortages will be brought to the attention of CMM or designee within 48 hours of receiving the purchase order request. All medications and equipment/supplies must have at least one year remaining on the expiration date when received by the CMM.

4) Ordering Period

a) Supplies furnished under this contract shall be ordered by issuance of delivery orders by the individuals or activities designated in the supply schedule identified at the time of award. Such orders may be issued from the date of award through one-hundred-twenty (120) months thereafter.

5) Customer Service and Returns/Replacements/Exchanges

a) General

i) The contractor shall provide a current order status at any time as requested by CMMDMHS or designee within 12 hours of receipt of request.

ii) All customer phone calls and questions shall be responded to on the same day or by the following day.

iii) The Contractor shall only provide dated/shelf life products at least 12 months prior to their expiration date. For those medications/supply which routinely have an initial expiration/shelf life of 12 months or less, the Contractor shall provide at least 75% of the dating, i.e. at least nine months remaining on a 12 month shelf life.

iv) For those products/equipment with a manufacturer warranty, contractor/vendors shall transfer the applicable manufacturer’s warranty in full for the products upon delivery to the government i.e. a product that is commercially available with a one year warranty from the manufacturer shall be received by the government customer with that original entire one year manufacturer’s warranty in place. Differing warranties offered by the reseller on these products or refurbished products will not be accepted.

b) Returns

i) The contractor shall accept returns of goods at their expense under any of the following conditions:

(a) products shipped in error (wrong item or type/dosing supplied)

(b) products with concealed shipping damages

(c) products which had incorrect product descriptions and did not meet the CMM’s published specifications on the NFFMI and/or was without written prior authorization for substitution

ii) The contractor shall, in general, accept returns of goods under the following circumstances

(a) products which are recalled

(i) The contractor shall adhere to all FDA regulations for product recall notifications. In addition to notifying the customers, the contractor shall provide the Contracting Officer with a copy of any product recall alerts and/or notifications.

(b) products damaged in shipment

(c) returns consistent with the contractor’s normal return policy

c) Replacements and Exchanges

i) Replacements and/or exchanges for items within situations outlined in section e.i and e.ii above shall be resent within 5 business days of notification.

d) Backorders/Shortages

i) If an item is not currently available this information will be brought to the CMMattention DMHS or designee within 48 hours of receiving the purchase order request. If the contractor has a firm date of when the item will be made available, the contractor is to communicate this to the government customer prior to accepting the order. If the customer accepts the revised delivery date, the order shall be filled. If an item is not presently available, the contractor will notify the government customer within 24 hours of receipt of order.

6) Delivery

a) General

i) Location of delivery shall be set forth in individual orders. Delivery will be necessary to various NOAA/OMAO/NHS locations throughout CONUS and OCONUS.

*CONUS is comprised of the 48 contiguous states including the District of Columbia. OCONUS is comprised of U.S. states and territories outside the contiguous United States and includes Alaska, Hawaii, Puerto Rico, Guam and any other location a NOAA ship is located.

b) Delivery Specifications/Requirements

i) Partial Orders

(a) Unless otherwise specified, the contractor shall only make complete and not partial deliveries. The government customer must be notified within 48 hours when partial shipments are necessary due to widely varying lead times.

(b) Products shall be delivered to the needed location stated in the order within seven business days or less after confirmation of the order. The contractor shall deliver to an OCONUS ordering facility within ten business days after confirmation of the order.

(2) Extended lead time products (items not backordered or on shortage)

(a) The contractor shall notify CMM or designee within 24 hours with an estimated time frame for delivery of items that are not readily available in the contractor’s warehouse and not available for delivery within the time specified time frame of 60 days so that alternative arrangements can be made with other vendors if the need shall arise.

(b) If the estimate for delivery of non-available supplies is to exceed 60 days the Director Marine Medicine (CMM) can seek another supplier to fill the purchase request.

7) Packaging

a) All shipments under this agreement shall be accompanied by a packing slip containing the following minimum information:

(1) Name of Vendor

(2) Purchase Order Number

(3) Date of Order

(4) List of included items with a brief item Description, Quantity, How Supplied

(5) Date of Shipment

(6) Name of Designee Placing Order

(7) Verified contents signature or initial block

b) Preservation, packaging, packing, labeling and marking shall be specified with the order.

HAZMAT shall be packaged and labeled accordingly.

c) Material Safety Data Sheets (MSDS’s) and Hazard warning labels (HWLs) shall be supplied as needed.

d) Unless otherwise specified, all items to be delivered under this contract shall be preserved, packaged, and packed in accordance with normal commercial practices to meet the packing requirements of the carrier and ensure safe delivery at destination. Preservation, packaging and packing shall provide adequate protection against physical damage during shipment for all ordered items

8) Inspection and Acceptance

a) Legal title to the goods (ownership) transfers from the contractor to the government at the time of acceptance of quality, quantity, and the condition of tendered supplies. Acceptance is the act of an authorized Government agent which formally determines that the supplies submitted by a contractor satisfactorily fulfill the contractor’s duty of performance under the delivered order to the fullest extent possible. Once the last item is received to the fullest extent possible the contractor is required to send a final invoice for that order within 30 days. Within 7 days of receipt of the final invoice, CMM or designee validates that all the supplies received satisfactorily fulfills the order to the fullest extent possible and that the original order coincides with the final invoice. Actual payment to the contractor is processed within 30 days. Invoice submissions are completed through the method in which the Contract Officer Identifies as method for submitting invoices.

9) Historical performance and contractor requirements

a) The contractor must be able to provide historical performance and experience of the following.

(1) Managing ship and nautical based medical supply inventories.

(2) Shipping medical supplies to worldwide locations.

(3) An established quality assurance program.

(4) Legal acquisition, shipping, management of controlled substances to ships within the United States including Guam, and Puerto Rico.

b) The contractor must have a license pharmacist within the company.

c) The contractor must be able to legally accept and manage expired medications.