OM Pharmaceutical Solicitation FINAL.pdf

Solicitation Number: IHS-22-03B Release Date: April 27, 2022 Closing Date: May 18, 2022

TITLE: Open Market Pharmaceuticals Blanket Purchase Agreement

BACKGROUND:

The Indian Health Service (IHS), an agency within the Department of Health and Human Services, is responsible for providing federal health services to American Indians and Alaska Natives. The mission of IHS is to raise the physical, mental, social, and spiritual health of Alaska Natives to the highest level and assure that comprehensive, culturally acceptable personal and public health services are available and accessible to members of the 574 Federally recognized Tribes across the United States.

PART I - THE SCHEDULE

SECTION A - SOLICITATION/CONTRACT FORM

The combined synopsis/solicitation for commercial products or commercial services prepared in accordance with the format in subpart 12.6, as supplemented with additional information in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The solicitation is used as a Request For Proposal. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC 2022-04 (Effective Date: 01/30/2022)

NAICS: 424210 SIZE STANDARD: 500 Employees SET-ASIDE: No Set-Aside

A.1 ISSUING OFFICE:

Indian Health Service National Supply Service Center 501 NE 122nd Suite F Oklahoma City, OK 73114

A.2 SOLICITATION NUMBER: IHS-22-03B

A.3 DATE OF ISSUANCE: 04/27/2022

A.4 CLOSING DATE: 05/18/2022 NLT 4:00 pm CST

A.5 NUMBER OF PAGES: 82 Pages with attachments

A.6 REQUISITION OR OTHER PURCHASE AUTHORITY: IHS-22-0005

A.7 DESCRIPTION OF ITEM OR SERVICE:

This requirement is to purchase pharmaceutical supplies not available through the VA Pharmacy Prime Vendor contract. These pharmaceutical products are a continuous requirement for IHS nationwide to enable us to provide for and treat IHS patients.

A.8 OFFEROR REQUIREMENT:

Offeror shall provide information including offeror name, contact name, contact information, and GSA contract information if applicable. The attached Proposal Form shall be filled out and returned with quote.

Offeror shall address all elements of the statement of work.

A.9 OFFER EXPIRATION DATE:

Proposal shall be valid for 60 calendar days after the close of the solicitation.

SECTION B - PRODUCTS OR SERVICES AND PRICES/COSTS

B.1 PRODUCT OR SERVICES:

IHS has identified a continual need to purchase pharmaceutical supplies not provided through the VA Pharmacy Prime Vendor. This will be done through a Supplemental Prime Vendor (SPV) Blanket Purchase Agreement (BPA). Contractor will be required to provide experienced and capable customer service, an online ordering system, and “just-in-time” delivery.

B.2 PRICING:

Pricing information shall be filled out on the Proposal Form - Attachment #1 and turned in with proposal.

SECTION C - DESCRIPTIONS / SPECIFICATIONS / STATEMENT OF WORK

C.1 Scope:

The statement of work is as follows:

C.2 Transition period C.3 Customer Service C.4 Electronic Ordering System C.5 Maintenance and Repair C.6 Training C.7 Ordering C.8 Expiration Dating C.9 Manufacturer Back Orders (MBO) C.10 Stock Outages/Cancelations/Back Orders (other than MBO) C.11 Confirmation Printback Report

C.12 Fill Rate C.13 Recalls C.14 Pass Through and Drop Shipment Delivery C.15 Emergency Deliveries / Orders / Plans C.16 Invoice System C.17 Return Goods C.18 Rebills, Reclaims, or Ad Bills C.19 Credit Accounts C.20 Reports C.21 Licenses, Permits, and Registration Requirements C.22 Drug Supply Chain Security Act (DSCSA)

a. The SPV shall maintain an adequate supply and distribute all drug/pharmaceutical items not available on the VA Pharmaceutical Prime Vendor (PPV) contract. Prospective vendors shall have a minimum of 5-years’ experience as a pharmaceutical prime vendor and a minimum of $1 million of annual pharmaceutical sales.

b. Products and any incidental services under any resultant contract(s) are for direct use by the facilities covered under this contract. Resale of products by participating facilities is prohibited. The Government anticipates that after award additional facilities/agencies may be added to the contract(s) on a quarterly basis. The Government will negotiate a bilateral modification to add a facility. Facility deletions will also be processed by modification.

c. SPV contractor shall provide services to all the participating facilities covered by the region(s) on which an award is made. Individual delivery orders will be issued by participating facilities against the SPV contract for the items required.

C.2 Transition Period (Phase-out/Phase-In period)

a. Requirements under this contract are vital to the Government and shall be continued without interruption and that, upon contract expiration, a successor shall continue them.

b. The awardee agrees to furnish phase-in, phase-out services for up to 60 days after contract implementation and expiration at no additional cost to the government.

c. Phase-In Services Include:

1. Acquire and maintain all required quantity levels as well as anticipated inventory levels as to allow for continuity of services.

2. Following all implementation requirements throughout this statement of work.

A. C.6 Training B. C.7.q Ordering C. C.15.d Emergency Deliveries

d. Phase-Out Services Include:

1. Negotiate in good faith a plan with a successor to determine the nature and extent of phase-in, phase-out services required. The plan shall specify a training program and a date for transferring responsibilities for each division of work described in the plan, and shall be subject to the Contracting Officer’s approval.

The awardee shall provide sufficient experienced personnel during the phase-in, phase-out period to ensure that the services called for by this contract are maintained at the required level of proficiency.

2. The awardee shall allow as many personnel as practicable to remain on the job to help the successor maintain the continuity and consistency of the services required by this contract.

3. Awardee shall ensure that all outstanding invoices through this phase-out period are submitted within 30 days of contract expiration.

C.3 Customer Service

a. A designated facility level SPV representative shall make a monthly scheduled physical visit to all sites to discuss customer satisfaction unless an alternate plan is agreed upon by the POC. Additional calls may be required to answer questions, solve billing and inventory problems, and review reports.

b. Quarterly meetings or conference calls at the discretion of the government will be held with the participating Agency Program Managers, Contracting Officials at the IHS NSSC and the contract designated SPV Contract Administrator. Quarterly business reviews will also be conducted with the IHS Area Pharmacy Consultants (APC) and the IHS NSSC Director. The Government will give the participants 15 calendar days’ notice prior to the conference call or meeting.

c. Conference calls or meetings pertaining to paragraph II above will be organized and initiated by IHS NSSC and will serve to encourage communication between all parties and serve as a forum to resolve any common issues within a region or activity.

d. During each monthly or weekly site visit as outlined in this section, the SPV representative shall review at a minimum the following with each facility point of contact or designee(s):

1. Assess the utility of hand-held/mobile ordering devices and web-based ordering system.

2. Review shelf labels and modify as necessary and requested by facilities.

3. Review inventory support software for proper calculation of order turns and ordering quantities (for those government agencies utilizing inventory support software)

4. Review pertinent updates/improvements with ordering and reporting system.

5. Provide account overview (i.e. contract compliance, product utilization, etc.) and advise of improvement strategies.

6. Provide education/field questions as requested or as deemed necessary.

7. Assists with any issues or concerns with regard to: ordering, deliveries, returns and account billing.

e. In addition to any scheduled conference calls, any and all problems and critical issues will be addressed immediately by the SPV upon notification by the using facility, CORs, or IHS NSSC Contracting Officials.

f. Technical support shall be available to customers daily. Hours are based of standard business hours for the location but shall not end before 6:00 pm local time. Support is not required during Federal Holidays.

C.4 Electronic Ordering System

a. The SPV shall provide, at no additional cost to the Government, each participating ordering facility the newest software necessary for electronic ordering entry and bar code scanning.

b. The SPV shall provide at no cost to the Government, individual access for each user via the internet (ordering facility’s ordering point(s)) of the SPV program.

c. As part of its negative distribution fee, the SPV shall provide each SPV ordering account two of the newest, most advanced hand-held order entry devices and any accessories associated with such devices for on-line real-time ordering. The pharmaceutical vendor shall replace at no cost the ordering facilities any nonfunctioning hand-held devices due to normal use and handling. Additional hand-held order entry devices above the two required to be provided to each account may be provided at no cost based on availability as determined by the SPV.

d. Technology, corresponding education, and software upgrades shall be refreshed by the SPV at the release of new hand-held devices within 30 days of introduction to the commercial market at no cost to the Government.

e. SPV furnished hand-held devices to be provided at a minimum, unless required elsewhere throughout this solicitation:

1. Accepting information from customer’s bar coded shelves

2. Accepting product information from barcodes

3. Accepting hand keyed in product information

4. Providing item description

5. Updating labels

6. Providing Current Economic Ordering Quantity

7. Providing Current Safety Stock Level

8. Processing product receipt

9. Transmitting SPV order through SPV furnished Automated Order System.

10. Two-way communication with at least daily updates of the item catalog

11. Capability for assignment of a unique username/password for technical receiving product and for signing the receipt of an invoice.

The device shall meet IHS wireless security requirements for 802.11 wireless standards.

The SPV shall meet Internet Security Act requirements for the agency if it breaks through the firewall.

f. SPV shall also provide, at no cost to the Government, the software necessary to order products. SPV provided software shall be capable of providing:

1. A web-based ordering system

2. A communication page containing, but not limited to: links to recalls, manufacturer backorders, updates, training opportunities, and specific government messaging.

3. Access to the SPV’s complete product database (electronic catalog) in addition to access to the SPV’s national level customer real-time database. Any item on contract should be displaced in a single catalog.

4. Access for all SPV customers to view the databases for pricing and product source selection prior to creating and transmitting an order to the SPV. Upon selection, the ordering screen will show lower cost alternatives as defined by generic sequence code, packed size, and unit dose as defined in First DataBank® or other comparable pharmaceutical database.

5. Upon request, an inventory management program for all IHS NSSC customers. The inventory management program provided by the SPC shall have the following reporting capabilities:

A. Demand Forecasting: Weighting factors are applied to past purchases to predict future needs by NDC.

B. Economic order quantity: The quantity of stock to order that minimizes costs.

C. Safety stock levels: Safety Stock is used to compensate for delays in delivery or greater than anticipated demand.

D. Calculations of reorder point and minimum and maximum inventory stock levels. Generation of barcoded shelf labels containing this information.

E. Ability to override normal demand forecasting.

F. Ability to designate lead-time, which affects required inventory stock levels.

G. Calculation of theoretical inventory turns by product, Generic Sequence Code, facility and per customer account.

H. Shall use A, B, C stratified inventory analysis for tracking of high dollar cost products so these products can be managed more aggressively.

I. Ability to determine the confidence level of calculated results (using a method such as Mean Absolute Deviation Percentage

(MADP).

J. Report capability to support the available tools, including the ability to run national, and facility level reports.

6. The capability for all customers to update and print labels and barcodes.

Customers should be provided with choice of liner and/or 2D barcode.

During the implementation period, the SPV shall provide all bar code shelf labels and affix the labels to the ordering facilities’ pharmacy shelves. The SPV shall print and delivery shelf labels for all items as requested by facility. Labels shall be color coded according to the stratified inventory analysis method (i.e. Orange for A items, Blue for B items, and Yellow for C items).

7. An online accessible account that can accommodate up to ten user-defined fields.

8. A Confirmation Printback. Minimum requirements for this Printback can be found in Section C.11 of this solicitation.

9. A paperless invoice system in addition to a physical invoice provided upon each delivery.

g. SPV’s automated ordering system shall contain and not be limited to, the following fields with the option to customize the display for products:

1. SPV to assign account number (ordering agency to identify read-only or ordering account)

2. Product Name

3. Generic Name

4. Product Description: Strength, Package Size, Manufacturer

5. National Drug Code (NDC) for applicable pharmaceutical products

6. Universal Product Number (UPN) (when available) - applies to healthcare products

7. Universal Product Code (UPC) (when available)

8. SPV’s Product Number - standardized across vendor’s ordering system

9. Class/Drug Classification System (i.e. AHRS, First DataBank®)

10. Product Number as assigned by ordering facility (when available)

11. Product denoted with its specific Control Schedule (CII, CIII, CIV, where applicable)

12. Reference of established DEA number (where applicable)

13. Reference of established HIN number (where applicable)

14. Product price including unit price (specific to the pricing of each customer)

15. WAC Price

16. Drug Efficacy Study Implementation (DESI) Indicator Standards

17. Product Lot number (on Invoice and Reports Only)

18. Product Expiration Date (on Invoice and Reports Only)

19. Product Bio-equivalency Rating

20. Product denoted as available as a Drop Shipment

21. Product denoted as available as a Pass-Through Shipment

22. Product denoted as unavailable due to MBO, SPV out of stock, Lockout procedures or Allocation situations

23. Automatic Substitution options

24. Product Inquiry search option

25. Generic equivalent search option (when applicable)

26. Allocation Level

27. Allocation remaining

28. SPV Distribution Center releasing requested product

29. SPV assigned invoice number

30. SPV payment information

31. Option to query product availability at alternate Distribution Centers and all Distribution Centers (limited to NSSC)

32. Hazardous Waste Classification as defined by EPA regulations (where applicable)

33. Listed as “Hazardous Drug” as defined by most current “NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings” (where applicable)

h. The SPV shall provide real time pricing updates and actual product quantity available. All updates are to be accomplished by 6:00am (ET) of the effective date of the update. For order placement, all pricing updates shall be available and viewable by 6:00am (ET) daily on the facility's ordering screen. In the event that the pricing the day of the order is different than the pricing of the product the day that it is received (i.e. product ordered on last day of contract but received the next day), then the pricing in effect the day of the order is the price that the customer should be charged for the product.

i. The SPV automated ordering system shall provide on-screen, real time, generic cost referencing. The generic cost referencing look-up screen shall contain all of the trade names and generic names for a product when either the trade or generic name is entered by the customer for referencing.

j. For the purpose of this solicitation and any resultant contract(s), the Government has the right to use, disclose, reproduce, prepare derivative works, and display publicly in its facilities in any manner and for any purpose, data generated from the resultant contract. Data means recorded information, regardless of form or the media on which it may be recorded. The term includes technical data and computer software.

k. The SPV shall also provide, at no cost to the Government, the latest software necessary to support physical inventories. The software provided by the SPV shall have the capability of accepting data from the hand-held devices or from manual data entries. The software capability shall also support acceptance of inventories from independent companies if properly formatted. Inventories shall be editable and exportable after submission.

This system shall record at a minimum:

1. Date

2. Account Number

3. Account Name

4. NDC or UPC

5. Vendor stock number

6. Product description

7. Quantity of inventory

8. Unit Price

9. Total Inventory Cost

10. Manufacturer package size

11. Ability to capture available Drug Supply Chain Security Act (DSCA) data, including lot number and expiration date.

l. The electronic ordering system shall also have the capability to auto-sort (for example, A to Z or smallest number to largest number) and search for facilities using multiple search parameters and display the results based on the search parameter(s) used. This capability shall be available to program offices (NSSC for IHS facilities). Only IHS NSSC Director and designees will have access to all SPV accounts.

Example: search by State should yield results that display all the SPV facilities in a particular state:

Table 3: Inquiry Search

DEA Number ID or Account Number

Facility Name City State

The search result display shall include at a minimum the following heading: DEA Number, ID or Account Number, Facility Name and Complete Address, Distribution Center, Cost of Goods or Negative Distribution Fee and 12 Month Sales.

Table 4: Sample Search Results to Display

DEA

Number

ID or Account Number

Facility Name Distribution Center

Cost of Goods or Dist. Fee

12 Month Sales

AC5566778 234566 Coushatta Tribe, Elton, LA 70532

Birmingham -4.75% 150,000

C.5 Maintenance and Repair

Emergency service and repair calls shall be made available on an unlimited basis at no cost to the Government. The SPV shall restore the ordering system and malfunctioning SPV-furnished hand-held order entry devices to normal operating condition within 24 hours after notification by the Government. If repair is not feasible, SPV shall replace the devices with the same or updated devices. Government ordering facilities shall not be without order entry devices (whether repaired or replaced) for more than 48 hours from the time notice was given to the SPV. The SPV shall not be responsible for any repairs or replacement parts needed because Government employees, as determined by the Government, neglected the devices, made improper application, maintenance or alteration, or because external factors (i.e. deficiencies in air conditioning, humidity control or electrical power) contributed to the malfunction or damage. Risk of loss remains with the contractor with the exception of repairs necessitated by abuse, neglect, vandalism, or Acts of God. Upon completion of the contract term, the SPV shall arrange to pick-up all SPV furnished devices at no expense to the Government.

C.6 Training

a. The SPV shall provide, at no cost to the Government, orientation and training in the operation of its automated ordering system and process, to personnel at each customer's ordering facilities, or national agency. Facilities may request training for new employees. Training should be provided on- site at each participating customers' facility. However, in the rare instances where the SPV requests that the training be offered somewhere other than the customers' facility, then the location of the off-site training site shall be within a 100-mile radius from the customers' facility.

b. The SPV shall coordinate with all sites 14 calendar days before the date of their scheduled training. The training shall include actual demonstration and operation of the software and hand-held order entry devices. Qualified SPV personnel shall provide the training no later than ten calendar days prior to the end of the 60-calendar day transition period. Along with the Implementation Plan, the SPV shall also furnish training schedules for all sites.

c. Prior to site training, the SPV shall make available webinar training sessions providing an overview of the SPV's ordering system.

d. Training at a minimum shall cover the following and shall include an electronic version of the training information (e.g. power point):

1. Proper use of order entry devices

2. How to access SPV’s inventory status

3. Order placement process (product inquiry, placement, order edit, printback confirmation, drop-shipment process, pass-throughs, new item requests for stock additions, identifying drop-shipments, controlled substances, how to request new items, etc.)

4. How to maintain ordering system.

5. Downloading price changes

6. Performing file maintenance

7. Requesting bar code labels

8. Download contractually required reports

9. Operation of Inventory Management program

10. Any other commercially available training in use of the order entry devices and ancillary items

11. How to use the reporting system.

e. SPV shall also provide updates or systems changes and training if applicable or requested on these changes within 30 days as they occur throughout the term of the contract. The designated point of contact at each facility will be responsible for assurance that the appropriate personnel to be trained are available.

f. A SPV contact person and telephone number shall be provided to each facility in the event additional instruction is necessary. The training shall be at no cost to the government. The SPV shall be responsible for training when there is a change in ordering personnel and on demand throughout the contract period.

g. The SPV shall be required to provide, at no cost to the government, a complete set of electronic Training Guides and Operating Manuals for the ordering system, hand-held order entry device and software furnished by the SPV to each individual ordering facility and national program (NSSC) and maintain them online. The Training Guides and Operating Manuals shall be provided prior to but no later than the actual time of training.

h. In addition to the initial training requirements, the SPV shall provide quarterly web-based training on SPV related topics to be identified by the facility POV. The SPV shall notify the contracting officer of the availability of these training sessions.

i. During implementation, participating management offices and individual facilities will work with NSSC to coordinate initial training. A designated point of contact at each facility will be provided. The schedule shall reflect a listing containing all the customers with scheduled times, locations, points of contact, and facility phone numbers.

C.7 Ordering

a. The SPV will supply an auto-generated order # as follows: 6-digit date (YYMMDD), account number, and 2 -digit order number. For example, the first generated order of the day would be “01” for each account. The auto-generated order # would not be generated until the order is submitted by the originating account. The order # will not be a field that can be altered by the originating account.

b. A secondary order # or memo field will be available for the originating account to use.

c. Facilities appearing in the ordering system shall have the city and alphanumeric number provided by the IHS NSSC.

d. For split screen ordering, the user that created the original order and the user that submitted the order at the parent facility, will be a field available in the reporting system.

Additional and detailed Split Screen Ordering requirements are listed below on page 14.

e. All orders for items authorized for distribution through the SPV shall be processed through use of the SPV furnished electronic order entry system as specified in section C-

4. The SPV shall also accept phone and or facsimile orders when use of the electronic order entry system is temporarily unavailable or inoperable, or in the case of an emergency delivery requirement.

f. Facilities that require a parent facility for order approval shall also be responsible for their own order placement, however, they shall be required to process all electronic orders through the Split-Screen Ordering System specified under the Satellite Facility Split Screen Ordering Requirements of this section.

g. SPV customers shall have access to order only their unique database for pricing and product source selection.

h. The SPV shall process delivery orders on a “fill or kill” basis. The SPV shall cancel from the order items that cannot be filled. The SPV shall indicate the canceled items on the customer order confirmation. No backorders are allowed. Once canceled, the SPV is precluded from placing the canceled items on backorder.

i. The SPV’s ordering system shall have an item-description link for the customer to notify the SPV of expected item usage. The SPV shall respond to the usage request within two business days with the expected date of availability, amount of stock, or the reason for the inability to stock.

j. In some instances, the SPV shall be required to first fill government orders before filling its commercial-based customers’ orders. In such situations, the Government will present the SPV with a written agreement from the product supplier to release the product to the SPV customers first.

k. NSSC reserves the right to direct the SPV allocation to IHS facilities.

l. Reservation Orders: In order to give the participating SPV customers the same procurement opportunity as the prime vendor's commercial customers, the participating customers shall have the opportunity to place a reservation order for a product that is determined to be on a manufacturer's back order (MBO). In the ordering process, when an item is "killed" off the customer's order due to a MBO, the customer may inform the SPV to reserve and then release the product back to the requesting customer upon its availability. The customer will be responsible for a separate and distinct reservation order through the SPV's electronic order system for the MBO product. Reservation orders shall not be included in the contract fill-rate calculation. Reservation orders may remain unfilled for a period not longer than 30 days from the customer's initiation before the customer is notified of its cancellation by the SPV, or by an earlier cancellation at the customer's request. A reservation order may not remain open for longer than 30 days. If the order is filled before the 30-day time-frame, then the order is closed by the SPV. For cancellations of reservation orders due to the 30-day timeframe, the customer shall have the opportunity to re-issue a new, separate and distinct reservation order for the same product and quantity, without losing their original position on the SPV's availability wait list. The product price charged to the customer for a reservation order shall be the contract price in effect at the time the initial reservation order is placed.

m. The SPV shall make every effort to ship orders complete with single lot numbers. When quantity equaling a case is ordered, then a full complete case is expected versus a case quantity of loose items.

n. For special orders such as those for Control Drugs (CII’s) and Closed Distribution shipments, the orders shall be identified as such on the customers’ SPV ordering screen. The confirmation printback shall reflect the total line item cost of the customer’s special order.

The customer’s electronic automated order request for Schedule II Control Drugs, in accordance with Controlled Substances Ordering System (CSOS), shall be followed up by the ordering facility by providing the SPV with an electronic or hard copy of their DEA Form 222. It is the responsibility of the SPV to release and deliver the customers Control Drug order under the terms and conditions outlined in this solicitation, and commences upon the receipt of the required form. Printback for electronic orders shall resemble DEA Form 222 in compliance with all DEA regulations.

o. Drug Bio-Equivalency Rating: The SPV shall show the Food & Drug Administration

(FDA) Orange Book therapeutic drug equivalency rating for each drug on each customer’s order screen which will allow customers to view the equivalency rating when making drug product selections. If the SPV plans to use another rating system, such as the Z-Rated system, the SPV shall identify and explain the system that will be used and what it means.

This information shall be provided to all ordering officials at the time of the program installation and training. Information regarding the drug bio-equivalency rating shall also be posted on the SPV website for instructions and guidance throughout the term of the contract.

p. The SPV shall provide within the Implementation period, at no cost to the government an

HL-7 interface that allows for the Agency’s internal inventory system associated with its operating system (RPMS, etc) to generate and automatically upload product reorder quantities into the SPV’s online ordering system for order review and submission.

Specific Ordering Requirements: Satellite Facility Split-Screen Ordering

a. The SPV shall provide an automated ordering system capable of establishing a “Split- Screen Ordering” process for IHS NSSC facilities. This process does not apply to emergency orders.

b. Satellite facilities will be responsible for ordering their own products through the SPV web-based ordering system. However, a satellite facility being serviced by a parent facility shall have its orders transmitted simultaneously to the designated Parent Facility and the SPV through the split-screen system. The satellite facility’s order is required to be approved by the parent facility prior to the SPV delivering the order to the satellite facility. Full function users are excluded from this process.

c. Whenever the SPV order requests are initiated by the satellite facilities and transmitted through the SPV’s “split order” concept, the following functions shall take place:

1. The satellite facility’s order shall be sent electronically to the SPV for acknowledgment of receipt of order and stock allocation but held in abeyance until approval has been received from the parent ordering facility before the order is filled.

2. Within 30 minutes of the SPV’s receipt of the satellite facility’s order, a confirmation printback shall be generated from the SPV and transmitted back to the satellite facility. The printback at a minimum shall meet the requirements set in section C.11. Upon receipt of a printback, the requesting satellite facility shall be capable of requesting a substitute product/item/unit and generating a substitute order, if needed, through the same electronic split screen ordering process.

3. The parent facility shall approve the order and funding by assigning the final purchase order number. For IHS facilities using split screen ordering, the PO# will remain the auto-generated PO#, but the final submission will take place by a user at the parent facility. The parent facility shall also be able to perform maintenance on the order, i.e., view, edit, add or delete items as needed and approve the order before the SPV fills the order. This process shall be completed electronically except when use of the electronic order entry equipment is unavailable or inoperable, a full function user submits the order, or in a case of an emergency delivery requirement.

4. When approved by the parent facility, the order is transmitted electronically to the SPV. The approved order is the final authorization for the SPV to fill and deliver the order to the satellite facility.

5. Within 30 minutes of receipt by the SPV of the approved order from the parent facility, a confirmation printback, shall be generated by the SPV and sent electronically to the parent facility. The printback shall, at a minimum, confirm what items will be "filled or killed" along with the information required in Section C.11.

6. Before payment can be made to the SPV for any satellite facility order placed, the order shall indicate the parent facility's correct purchase order number assigned when the order was originally approved by the parent facility. For IHS facilities using split screen ordering, the auto-generated PO# will remain intact;

however, the final user submitting the order shall be a user located in the parent facility.

7. The designated parent facility is responsible for the payment of their satellite facility orders if:

A. Orders have been properly relayed to the designated parent facility through the SPV’s split-screen ordering system.

B. The user submitted the final order is designated within the parent organization as full function.

C. Orders were assigned a parent purchase order number prior to the delivery of the order by the SPV, and

D. The parent facility has received a proper SPV Invoice.*

*In the event that the parent facility receives a SPV invoice that does not reflect the required information, the invoice will be returned to the SPV unpaid within 7 days of receipt, for correction, proof of authorization to release product, proof of delivery and subsequent resubmittal by SPV of a proper invoice.

In the event that the SPV releases a Satellite facility order without the direction and approval of their designated ordering/approving office, that order shall be considered to have been released without the Government's authority and the Government shall not be obligated for any payments.

In some instances, the IHS may request orders to be approved with prior parent facility approval e.g. emergency situations or office closures. *

Specific Ordering Requirements: NSSC, Oklahoma City, Oklahoma

In addition to the general ordering requirements listed above, the IHS Specific Order Requirements for the National Supply Service Center (NSSC) shall consist of:

a. A SPV-furnished web-based ordering system:

1. That allows a minimum of five individuals to place SPV orders simultaneously.

2. That allows a minimum of three individuals to place split-screen orders simultaneously.

3. That has the capability to receive, send, and release individual customer orders without having any effect on each other.

4. That has the capability to receive, send, release, and print each order individually.

5. That has the capability to delete or add to customer’s orders once received at the

NSSC.

b. A SPV-furnished Split-Screen Ordering System for all customers serviced by the NSSC.

The NSSC, or designee, provides SPV procurement support services to more than 275 IHS and Tribal facilities through the pharmaceutical vendor program.

c. A SPV-furnished Paperless Invoicing System

d. A SPV-furnished electronic ordering system that provides a unique password that shall be assigned to each individual to be identified once the order has been transmitted from the satellite facility to the NSSC. The individual’s name, or code shall be attached to the order, and once printed at the NSSC, the name or code shall be printed at the end of the order transmission.

e. A SPV-furnished electronic ordering program that provides a unique electronic signature for receiving each line item on an invoice.

f. A SPV-furnished electronic ordering program that provides technicians receiving product to have a unique password for the signing receipt of an invoice.

Specific Ordering Requirements: Other IHS Facilities

a. The SPV shall establish a “Split Order” feature for each designated IHS Parent Facility for the automated order entry software installed at the following IHS sites and for the IHS and Tribal customers serviced by the SPV. IHS requires the ability to have multi-level user accounts.

b. The software program provided by the SPV shall have the capability to process all electronic orders placed by the IHS satellite facilities in a manner as specified above in “Special Ordering Requirements: Satellite Facility Split Screen Ordering”. The process that transmits a request for an order to the satellite facility’s designated Parent Facility and simultaneously to the SPV’s distribution center.

Specific Ordering Requirements: Facilities located Outside the Continental United States

The participating facilities that are geographically located outside the Continental United States, orders will be placed Monday through Friday, and the SPV will be required to provide delivery no later than 48 hours from receipt of order.

C.8 Expiration Dating

a. Expiration dating of all pharmaceutical products delivered under this program shall have a minimum shelf life of six (6) months remaining upon delivery to the Government.

b. Prior approval by the facility or NSSC is required before delivery of short-dated products.

C.9 Manufacturer Backorders

a. The SPV shall notify facilities on the SPV’s confirmation printback report (C.11) of any manufacturer back-ordered (MBO) item. The SPV shall also notify the IHS NSSC Contract Specialist (CS) and Contracting Officer Representative (COR) of any MBO’s.

b. The Government retains the right to investigate the backorder situation to determine the cause of the backorder and to provide assistance to the SPV and the participating customers during the MBO period.

C.10 Stock Outages/Cancellations/ Backorders (other than MBO)

a. SPV Stock outages due to cancellations/backorders by the SPV, on products that have met the prerequisites (Fill Rate Section C-12, paragraphs a through d) of the fill rate formula, shall be included in the service level calculator of the fill-rate.

b. SPV Stock outages due to cancellations/backorders by the SPV shall be considered a failure to perform by the SPV and may be considered grounds for Termination for Cause.

c. A failure by the SPV to provide customers with products ordered due to a SPV stock outage or cancellation, or back order on products that have met the prerequisites of the fill rate formula (Fill Rate Section C-12, paragraphs a through d), shall free the requesting ordering facility to acquire the same or similar items from another source without breaching/violating the SPV contract, while holding the SPV responsible for any excess product procurement costs incurred by a participating SPV customer due to the SPV’s stock outage.

d. Credits due to the SPV customers based on excess product procurement costs caused by a SPV stock outage, cancellation/backorder, shall be routed from the SPV back to the participating SPV customer in accordance with the Credits Section of this solicitation.

e. If facility DC or alternate DC is out of stock of item(s) ordered multiple times (i.e. 10 times or more) within the last six (6) months, the SPV shall obtain from other DC at no additional cost beyond the cost of the product.

C.11 Confirmation Printback Report

a. A confirmation shall be printed back to the ordering facility within 30 minutes of order transmission to the SPV from the facility. A confirmation relating to a customer's request for a drop shipment or pass-through order, shall be printed back to the ordering facility within 24 hours of order placement. The confirmation printback shall appear on the customer's ordering screen, be printable and accessible through the report’s module.

The confirmation printback shall reflect the correct product price to be charged the customer at the time the order is placed. The awarded negative distribution fee shall be imbedded in the correct product price. A confirmation printback for a drop shipment or pass-through order, shall also reflect the expected product supplier’s delivery time, along with any other special terms and conditions required by the product supplier.

b. At a minimum, the confirmation printback provided by the SPV shall reflect the following information:

1. SPV name and address and SPV "bill to" address.

2. The Government ordering facility's name and ship to address.

3. The Government ordering facility's SPV assigned account number.

4. The Government ordering facility's Purchase order/Delivery order number. This would be the final, approved Purchase order/Delivery order number assigned by Parent facility if order was initiated by a Satellite Government facility.

5. Confirmation printback report date and time.

6. Product Description for each item ordered.

7. NDC, UPN, UPC, or appropriate product number (non-pharmaceutical items) listed for each item ordered.

8. SPV established product number for each product ordered.

9. Product Number as assigned by ordering facility (where available).

10. Quantity requested and availability confirmed for each product ordered. If the product is unavailable, printback shall indicate if the product is available at any distribution center.

11. Unit price confirmed for each product ordered.

12. Extended price of each line item, reflecting SPV negative distribution fee (imbedded in each contract product price).

13. Identification of, and reason(s) why product is unavailable, such as MBO's, SPV stock outages, product deletions, or manufacturer or SPV allocations (Codes are acceptable).

14. Confirmed grand total of the order.

15. Indication of what requested product are special order or require a drop shipment or pass-through process.

16. Assigned paperless invoice number from the SPV.

17. Invoice.dat: data file information (required for Drug Accountability).

c. The Government reserves the right to amend the drug accountability data file during the contract period at no cost to the Government.

C.12 Fill Rate

a. The SPV shall provide next-day delivery (or scheduled delivery day as specified) with a minimum 97% fil-rate as defined below in the service level calculation. The fill rate shall be calculated on a daily basis for each individual facility account.

Table 5: Service Level Calculation

Fill Rate = Units (Items) Delivered Units (Items) Ordered (Less MBO Units*)

b. All items ordered, but killed by the SPV, shall be included as an item ordered in the gross and adjusted fill calculations. If the fill rate is less than 97%, the SPV shall be able (when requested) to provide documentation to the Government of its attempts to maintain product availability from the manufacturer. The supporting documentation requested by the Government could include, but is not limited to, documentation that supports the existence of an outstanding purchase order between the SPV and the product manufacturer/supplier for the requested units/items. In order for the SPV to include an MBO Unit in the above Service Level Calculation, the outstanding purchase order between the SPV and the product supplier shall have been in existence for no less than three calendar days prior to the customer's request. Failure by the SPV to meet next-day or next scheduled day delivery fill-rates will be officially recorded as part of the SPV contract performance which is available for public review and may also be considered as grounds for Termination for Cause.

*In order for the SPV to include an MBO Unit in the above Service Level Calculation, an MBO Unit shall be equal to or greater than the number of units ordered on the customers' order.

c. The following are prerequisites to the application of the Service Level Calculation/Fill- Rate:

1. Ordering facilities shall provide the SPV usage information as soon as possible after award. The initial 60 calendar days from start-up of each individual institution are exempt from the calculation. If an award is made to the incumbent SPV, the 60 day exception does not apply. After 60 days, the SPV is responsible for tracking usage and for adjusting its inventories to assume the 97% fill rate.

2. Products ordered by a facility whose usage data has not been provided or determined through order history will be excluded from service level calculation, for a period of 60 days from SPV’s notification of such usage.

3. Product quantities of the most recent month in question that exceeds the prior 30-day usage by 150% will be exempt from the calculation (excludes MBOs from the past 90 days)

d. When the adjusted fill rate falls below 97% for the customer’s SPV primary distribution center, the SPV shall establish the use of alternate SPV Distribution Center(s) at the request of the customer. Before an underperforming distribution center is re-established as a customer’s primary distribution center, the SPV shall provide documentation to the NSSC of corrective actions taken to improve the fill rate.

C.13 Recalls

If any product distributed under this contract is recalled or removed by the manufacturer, or if a recall is suggested or mandated by a regulatory or official Agency, the SPV shall be responsible for taking he following actions:

a. Immediately upon receiving notice of the recall, the SPV shall notify all customers electronically receiving distribution of the product under this contract using the most expeditious manner. The subject line shall include the name of the product being recalled.

b. The SPV shall not ship recalled products to the customers.

c. Expeditiously notify IHS NSSC electronically of any and all recalls. NSSC will provide information on the individuals to be notified within the implementation period.

d. At a minimum, the recall notifications shall include the following information:

1. A complete item description, (product number & lot number) and/or identification along with the manufacturer and national drug code.

2. Contract and Order number

3. Reason for recall

4. Disposition Instructions. If a direct recall is issued, the PV shall include the manufacturer disposition instructions.

5. Level of recall

The SPV will provide within their reporting system a report that provides historical data on purchases by account for a specific item or NDC which will include actual lot numbers and expiration dates.

The notification will be sent via e-mail and by the SPV through its electronic ordering system and shall be separate and independent from any other correspondence such as invoices. The product name (generic and trade), and level of recall (if available) shall be included in the subject line.

e. The SPV shall issue credit for any product where specified in accordance with the manufacturer recall.

C.14 Pass through and Drop Shipment Delivery

a. Drop Shipments & Deliveries

1. Bulky items may be drop shipped when mutually agreed upon between the SPV, the participating customer, and the product supplier. Drop Shipments shall be shown on the customer confirmation printback. The awarded SPV negative distribution fee shall be applied to drop-shipment orders and should not incur extra charges upon agreement from all parties.

2. A drop shipment order placed with the SPV shall be identified on the customer’s ordering screen for approval by the customer prior to the order being picked/filled/delivered. The SPV shall confirm in the customer confirmation printback the item as being drop shipped. Unless approved by the customer, drop shipments directly from product manufacturers for recurring products are prohibited.

3. When drop shipment request is initiated by the SPV customer, the SPV shall be responsible for placing the drop shipment order to the product supplier.

The SPV shall, within 24 hours, provide the customer a confirmation printback regarding the expected delivery date from the product supplier, the product pricing, and the following minimum information.

A. SPV name and address and SPV “bill to” address.

B. The Government ordering facility’s name and ship to address.

C. The Government ordering facility’s SPV assigned account number.

D. The Order number from the ordering facility. This would be the final, approved order number assigned by Parent facility if the order was initiated by the Satellite Government facility.

E. Confirmation printback report date and time.

F. NDC, UPN, UPC, or appropriate product number (non-pharmaceutical items) listed for each item ordered.

G. Product number as assigned by ordering facility. (where available)

H. Quantity requested and availability confirmed for each product ordered.

I. Unit price confirmed for each product ordered.

J. Extended price of each line item, reflecting any possible SPV awarded negative distribution fees.

K. Confirmed grand total of the order.

L. Paperless invoice number from the SPV.

M. Invoice.dat; data file information (required for Drug Accountability)

N. Name of individual placing order.

4. When a drop shipment method is required by the SPV to meet a facility’s request for a quantity of products that is excluded from the fill rate calculation and the quantity requested exceeds the SPV’s stock, the SPV remains responsible and shall accept the Government’s order. Next day or next scheduled delivery day requirements do not apply to drop shipment orders as indicated in this paragraph.

b. Pass-Through Orders & Deliveries

1. The SPV shall act as a conduit to pass through orders to expedite and simplify the order and payment process.

2. When the SPV is notified by the customer of a “Pass-Through Delivery” being made by the product supplier to the ordering customer, the SPV shall be responsible for invoicing the customer in accordance with the terms of this contract.