DRAFT PPV28 SOW 6-11-2026.pdf

DRAFT PPV 2028 STATEMENT OF WORK

Table of Contents

I-1 Scope I-2 Transition Period (Phase-Out/ Phase-In Period) I-3 Customer Service

BOP and IHSC Specific Customer Service Requirements:

I-4 Electronic Ordering System

CMOP Specific Ordering System Requirements:

Department of Veterans Affairs:

Federal Bureau of Prisons (BOP):

Department of Health and Human Services: Indian Health Service Immigration and Customs Enforcement (ICE) Health Service Corps (IHSC)

I-5 Maintenance and Repair I-6 Training

BOP Specific Training Requirements:

IHS/NSSC/ Oklahoma City Oklahoma Specific Training Requirements:

I-7 Ordering Specific Ordering Requirements: Satellite Facility Proxy Ordering:

CMOP Specific Ordering Requirements:

IHS Specific Ordering Requirements: NSSC, Oklahoma City, Oklahoma:

Other IHS Facilities Specific Ordering Requirements:

Facilities Located Outside the Continental United States- Specific Ordering Requirements:

I-8 Expiration Dating I-9 Substitution I-10 Lock Out Procedures I-11 Manufacturer Back Orders (MBO) I-12 Stock Outages/ Cancellations/ Back Orders, (other than MBO) I-13 Confirmation Printback Report I-14 Fill Rate I-15 Recalls I-16 Delivery

CMOP and National Acquisition Center (NAC) Account(s) Specific Delivery Requirements: .. 35 Facilities Located Outside the Continental United States- Specific Delivery Requirements:

I-17 Emergency Delivery I-18 Invoice System I-19 Returns Goods Policy I-20 Federal Government Holidays I-21 Price Loading I-22 Price Administration I-23 Product Additions I-24 Rebills, Reclaims or Ad bills I-25 Credit Accounts:

Additional Requirements for CMOP Only I-26 Reports Product Allocations

I-26 (A) Reports for Ordering Facilities I-26 (B) Reports for VA National Acquisition Center (Contracting Officer) and Program Management Offices I-26 (C) Online Reports for Pharmacy Directors and Acquisition Offices at the Ordering sites:

I-26 (D) IHS NSSC Specific Report Requirements:

I-27 Distribution Fee:

I-28 Licenses, Permits, and Registration Requirements I-29 – TAA requirement I-30 - Drug Supply Chain Security Act (DSCSA)

STATEMENT OF WORK:

I-1 Scope The Pharmaceutical Prime Vendor (PPV) contract is meant for pharmacy ordering only.

a. The Pharmaceutical Prime Vendor (PPV) shall maintain an adequate supply and distribute all drug/pharmaceutical (Federal Supply Class 65) items and other contracted items dispensed under Government supply contracts. These items are sold under various Federal Supply Schedules (FSS), Blanket Purchase Agreements (BPAs), Basic Ordering Agreements (BOA) and VA/DLA National Contracts established under the Pharmaceutical Standardization Program (NCS). Prospective prime vendors shall have a minimum of 5 years’ experience as a pharmaceutical prime vendor.

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 monthly basis. The Government will negotiate a bilateral modification to add a facility. Facility deletions will also be processed by modification.

c. The Government anticipates that payment under any resultant contract(s) will be made to the PPV contractor(s) within the terms and conditions of the Prompt Payment Act, (clause included).

Fast Pay, a VA administered alternate payment program for the PPV, is mandatory for all VA facilities participating in this contract. The use of the Fast Pay Program is OPTIONAL for Other Government Agencies (OGAs) participating under this contract. Currently there are approximately 800 VA and OGA accounts making payments using the existing Fast Pay Program (See Attachment A). The Government anticipates offers of a larger negative Distribution Fee for those customer accounts using the Fast Pay Program (See Section I-28 Distribution Fee). At any time during the performance period of this contract, when a NET 30 day (calculated from the bulk weekly invoice date) paying customer commits to making payments under the Fast Pay program in order to receive the awarded larger negative distribution fee, the Government will notify the contractor to include the FAST Pay Customer at the awarded Fast Pay distribution fee.

d. The PPV shall provide and have in effect an emergency contingency plan for disaster recovery to protect the Government from disruption of the requirements outlined in this solicitation to include but not limited to government data, virtual inventory, physical inventory and deliveries.

The PPV is required to submit an emergency contingency plan annually or when there is a change in the plan. A plan sufficient to ensure normal operations in the event there are two or more natural disasters in different geographical regions of the country. When nation-wide allocations occur the federal government contract participants will be prioritized. This will be coordinated through the contracting officer and the pharmacy benefits management program office.

e. The PPV shall be required to make available upon request the following product categories at the established government prices. The product categories are listed as Special Item Numbers (SINs) on Federal Supply Schedule (FSS) Group 65, Part I, Section B, Drugs, Pharmaceuticals &

Hematology Related Products. In the event there is a non-availability determination specific authorization for each exception will be provided to the PPV.

Table 1: Special Item Categories l Item Number (SIN) Description SIN 42-2A Single source innovator, multiple source innovator, and biological insulin pharmaceutical products (i.e. covered drugs)

SIN 42-2B Generic & multiple source pharmaceuticals & drugs, human blood products, & over-the-counter drugs

SIN 42-3 Complete IV delivery systems

SIN 42-5 Dietary/Nutritional/Supplements

SIN 622 Antiseptic Skin Cleansers, Detergents, Dispensers only small personal sizes and no industrial dispenser items.

f. In addition to the above product categories, the PPV shall also maintain an adequate supply of, and distribute products under the FSS and NCS contract’s programs listed below.

1. Blood-glucose Monitoring Units and Consumables including Miscellaneous items included on a National Contract or Federal Supply Schedule Group 65, Part VII, In-Vitro Diagnostics, Reagents, Test Kits, and Test Sets.

2. Only Medical/surgical products on VA' s NCS National Standardization Contracts in the categories listed in Table 2 below shall be made available at established contract prices. Availability and delivery of medical/surgical items through the PPV contract shall be in limited quantities strictly for outpatient pharmacy dispensing at the medical facility level. The PPV is prohibited from fulfilling bulk orders (i.e., bulk orders placed by VA's CMOP facilities) for this category of items (with the exceptions noted in number 3 below). The medical/surgical items to be included on VA' s NCS National Standardization Contracts provided on the PPV contract(s) are shown in Table 2. The purchase of medical and surgical products through the PPV contract(s) is optional for ordering facilities. These medical/surgical contracted items are not the same as the MSPV contracts. The PPV must supply vials and caps awarded via national contract. The negative distribution fee applied to med surge items would apply to the vials and caps.

3. Insulin Syringes: Consolidated Mail Outpatient Pharmacies (CMOPs) may purchase Insulin Syringes and pen needles on contract through the Pharmaceutical Prime Vendor (PPV) contract. Orders for Insulin Syringes and pen needles shall be placed routinely through the PPV contract.

4. Antiseptic Liquid Skin Cleansing Detergents and Soaps included on a National Contract or Federal Supply Schedule Special Item Number 622.

5. Ultra Expensive is defined as a WAC price greater than or equal to $30,000.00.

6. GLP-1s are products not ultra expensive that:

a. Injectable and

b. Require refrigeration and

c. Have a mechanism of action, either alone or in combination with, glucagon-like peptide

(GLP-1) receptor agonists or dual agonists (e.g., GIP/GLP-1) or triple agonists (e.g.

GIP/GLP-1/Glucagon Receptor Agonist) or amylin receptor agonists

7. Specialty is defined as medications that are not ultra expensive or GLP-1s which treat chronic, complex or rare diseases, and which have a minimum of four out of five additional characteristics related to the distribution, care delivery and/or cost of the medicines. These five characteristics include: WAC price in excess of $3000 initiated/maintained by a specialist, requiring special handling in the supply chain, distributed through non-traditional channels, or medication has significant side-effects that require additional monitoring of therapy and/or disease requires additional monitoring of therapy.

8. OTC means over the counter medications that can be purchased without a prescription, are safe and effective for consumer self-use when taken as directed and regulated by the FDA.

9. VA FSS, all other and VA/DLA national contracts to include medical surgical items and medical devices that are packaged, labeled, and commercialized like drug product and therefore receive a FDA National Drug Code (NDC) or National Reimbursement Code (NRC).

This category also includes, dietary supplements, Blood-glucose Monitoring Units and Consumables including Miscellaneous items included on a National Contract or Federal Supply Schedule Group 65, Part VII, In-Vitro Diagnostics, Reagents, Test Kits, and Test Sets.

10. WBPG ANDA are defined as generics prices based on their Wholesale Acquisition Cost with an FDA abbreviated new drug application.

11. Items the PV considers in the Ultra Expensive, GLP-1 and Specialty categories will be reported to the contracting officer and PBM on a monthly basis and determined by mutual agreement.

12. Limited distribution/Closed distribution drugs that require specialty pharmacy distribution are excluded from this contract.

Table 2: Medical/Surgical Item Categories Description Needles, Syringes & Jet Injectors Needles, Hypodermic Syringes Syringes & Needle Combination Syringes & Needle Combination (anti stick) Implants, Surgical – Joints, Hip, Knee, and Accessories- hyaluronic acid injection products (e.g., Synvisc, Orthovisc, Monovisc and similar items).

Medication and supply packaging and dispensing equipment-vials, caps and similar items.

Additional contracted medical/surgical items may be added by mutual agreement.

g. All items ordered shall be provided to the ordering facilities in accordance with the terms and conditions of the PPV contract and on a "Fill or Kill" basis. Individual delivery orders will be issued by participating facilities against the PPV contract for the items required.

h. CMOP Specific Requirements -The PPV shall, at VA's request, furnish the VA CMOP facilities with bulk orders and bulk delivery of pharmaceuticals and products listed in I-1 (e). The PPV shall designate a VA CMOP Distribution Coordinator that will be responsible for coordinating all business activities at the National CMOP Office level and the PPV.

i. National Acquisition Center (NAC) Accounts Specific Requirements - Upon request by the NAC accounts, the PPV shall coordinate large and bulk orders from a standard list of pharmaceutical items (such list will be furnished to the PPV during the implementation period). Drop shipments shall be made through product contractors only when approved by the customers. The awarded PPV distribution fee for such drop shipments shall be applied to the orders. A NAC Account Distribution Coordinator designated by the PPV shall be responsible for coordinating all business activities between the Directors and the PPV operations officials.

Consolidated Mail Outpatient Pharmacy (CMOP) National Office Account Specific Requirements - Upon request by the National CMOP Office, the PPV shall coordinate large bulk pharmaceutical orders directly from the manufacturer/supplier with shipment made to the designated CMOP (product list and CMOP POC's shall be provided prior to the end of the fiscal year). A NAC Account Distribution Coordinator designated by the PPV shall be responsible for organizing communication between the PPV, the manufacturer and the National CMOP Office.

j. Emergency Pharmacy Service (EPS) Account Specific Requirements - Upon request by the EPS accounts, the PPV shall coordinate large and bulk orders from a standard list of pharmaceutical items (a list will be furnished to the PPV during the implementation period). EPS orders shall be filled with one lot number when possible. Written approval by the EPS is required prior to delivery of product with more than three lot numbers. The expiration date/shelf life of products shall be a minimum of 20 months. The EPS may authorize the delivery of products with a shorter shelf life on a case-by-case basis. Drop shipments and pass-through orders shall be authorized when mutually agreed upon between the PPV, the EPS and the product supplier. The awarded PPV distribution fee for drop shipments and pass-through orders shall be applied to the order. An EPS Coordinator designated by the PPV shall be responsible for coordinating all business activities between EPS and the PPV operations officials.

Emergency Pharmacy Service (EPS) Account Specific Requirements for virtual inventory. Upon request by the EPS accounts, the PPV shall coordinate a virtual inventory of a list of pharmaceutical items. The PPV shall ensure the physical inventory of stock never falls below the virtual inventory levels as agreed upon by the NAC Contracting Officer and EPS. The PPV shall obtain confirmation from the NAC CO prior to changing the status, deleting, or removing any drug listed on the virtual inventory drug list. (EPS shall provide a list of pharmaceuticals to the PPV during the implementation period).

k. IHS Tribal Account Specific Requirements – pharmacy accounts must have separate PPV login credentials and pharmacies must maintain separate physical inventory for different government pricing programs (e.g. 340B).

l. Facilities appearing in the ordering system shall have the 2-4 alphanumeric Agency Class, 3-5 station number (if exists), facility type (hosp/clin/cmop), facility city and account type as part of the name.

m. The PPV shall be required to provide FDA approved pharmaceuticals and those that comply with the Trade Agreements Act (TAA) WAC Based Priced Generics (WBPG). Only WBPG with FDA approved National Drug Codes (NDC) and published WAC are included in this requirement. For OTC WBPG, products that comply with a final monograph or tentative final monograph promulgated by FDA under its TC Drug review Procedures in 21 CFR Part 330 would be included, as these products do not go through a traditional process for FDA approval. The PPV is required to carry the lowest WAC priced generic pharmaceuticals when provided with description of the item and usage rate by the PPV customer. Order placement of WBPG through the PPV contract is optional and subject to periodic review by the Government. The Government may unilaterally cancel in part or in whole the requirement for the PPV to provide WBPG (cancellation can be by individual agency or for all PPV participants).

n. Covered (branded) and national contract drugs missing from Government electronic price file(s):

Once included in the Government electronic price file(s), covered and national contract drugs are not expected to disappear from the Government price files. The PPV shall obtain confirmation from the NAC Contracting Officer prior to changing the status, deleting or removing any covered drugs from the PPV's electronic catalog. The PPV shall continue to make available all covered and national contract drugs for purchase by all eligible PPV customers (Big 4) at the price on the last day the item (s) appeared in the Government electronic price file(s). Once the appropriateness of the removal or deletion is determined by the NAC Contracting Officer, the PPV will be authorized to process any credit/rebill or charge/invoice as appropriate.

o. PPV shall not accept drop shipment orders for non-contracted items, including items under NCS or FSS contracts that are designated as Prime Vendor False.

p. Other prices that are not included in the price file will be provided by the CO (i.e. Defense Logistics

Agency awarded joint national contracts).

p. Whenever products with no expiration date assigned by the manufacturer, PPV shall enter in the invoice for those items, an expiration date of five years from the Purchase Order date.

I-2 Transition Period (Phase-Out/ Phase-In Period)

To ensure sufficient administrative time has been allowed for continuity of services at required quality levels as well as anticipated inventory levels, contract(s) shall begin after a 120-calendar day implementation period or by mutual agreement. All contract costs associated with the transition period shall be borne by the PPV contract awardee.

For VA customers only - The VA PBM will provide the most recent year of PPV historical data for each ordering facility to the PPV 30 calendar days after date of award through an electronic means of transfer. For OGAs, each ordering facility shall provide usage data to the PPV within 30 calendar days after date of award. The PPV shall download all FSS and National contract products and prices for current contracts from the website at https://www.va.gov/nac/, no later than the 15th day prior to the start of the period of performance, with the most current update to be downloaded the day prior to the start of the period of performance of the contract. A copy of all DLA or other government agency awards that are not contained within the NAC pricing database will be provided to the PPV contractor by the CO within 30 calendar days of date of award and must be entered into the PPV listing of potential contract items available.

I-3 Customer Service

a. VA or OGAs may request either in-person (not to exceed 4 per year) and/or virtual meetings monthly by a facility level PPV representative. PPV shall reach out to all sites each year to determine their preferred visit schedule. Additional calls may be required to answer questions, solve billing and inventory problems, and review reports. A designated CMOP level PPV representative shall make a weekly scheduled physical visit to all CMOP sites to discuss customer satisfaction unless an alternate plan is agreed upon by the CMOP POC.

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 VA NAC, PBM representatives, and the contract designated PPV Contract Administrator. Quarterly business reviews will also be conducted with the VA VISN Pharmacy Executive, IHS NSSC Pharmacy Branch, and BOP Chief, Pharmacy Logistics Officer. The Government will give the participants 15 calendar days’ notice prior to the conference call or meeting.

c. Conference calls pertaining to paragraph b. above will be organized and initiated by VA NAC or OGA 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 visits as outlined in I-3(a), the PPV representative shall review at a minimum the following with each facility POC or designee(s):

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

2. Review shelf labels/inventory management systems 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) http://www.pbm.va.gov/

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

f. In addition to any scheduled conference calls, any and all problems and critical issues will be addressed immediately by the PPV upon notification by the using facility, COTRs or NAC Contracting Officers.

BOP and IHSC Specific Customer Service Requirements:

a. Prospective PPVs are advised that due to certain restrictions within the Federal Bureau of

Prisons, PPV employees that enter the secure confines of BOP and IHSC facilities/institutions will be subject to the following investigative procedures. (Note: These investigative procedures will not be required in situations where routine/emergency deliveries do not require entry into the secured BOP or IHSC facility.)

1. National Crime Information Center (NCIC) Check

2. Completion of the Contractor Pre-Employment Form

3. Daily possession of a valid picture identification and daily entry into secured facility via metal detector

4. May be subject to ion spectrometry

b. Employees, such as the Customer Service representatives, that need ongoing entry into secured

BOP or IHSC institutions will also need to provide a fingerprint check and a name check at the discretion of the BOP or IHSC institution.

I-4 Electronic Ordering System

a. The PPV shall provide, at no additional cost to the Government, each participating ordering facility the newest software necessary for electronic order entry and bar code scanning capability that are compatible and compliant with the VA Technical Reference Model available at https://www.oit.va.gov/Services/TRM/TRMHomePage.aspx and are operational behind the agency internet firewall.

b. The PPV shall provide at no cost to the Government, individual access protected by multi-factor authentication (MFA) for each user via the internet (ordering facility's ordering points(s)) of the PPV Program.

c. As part of its distribution fee, the PPV shall provide each PPV ordering account two of the newest, most advanced model hand-held order entry devices and any accessories associated with such devices. The hand-held order entry devices will enable on-line real-time ordering. The prime vendor shall replace at no cost to 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 PPV. This requirement may be removed from all or some of the PPV https://www.oit.va.gov/Services/TRM/TRMHomePage.aspx participants over the life of the contract.

d. Additional hand-held order entry devices shall be temporarily loaned by the PPV at no additional cost to the Government for periodic inventory purposes. The temporary loan of the devices shall not exceed two weeks.

e. Technology and corresponding education shall be refreshed by the PPV at the release of new handheld devices within 30 days of introduction to the commercial market at no cost to the Government.

f. Software upgrades shall be provided and installed by the PPV as they become available at no cost to the Government.

g. PPV furnished hand-held devices to be provided for each Parent and Satellite ordering account shall include, at a minimum, unless required elsewhere throughout this solicitation:

Two hand-held/mobile order entry devices per ordering account capable of

Accepting information from customers bar coded shelves Accepting product information from bar codes Accepting hand keyed in product information Providing item description Updating labels Providing Current Economic Order

Quantity Providing Current Safety Stock Level Processing product receipt Transmitting PPV order through PPV furnished Automated Order

System.

Two-way communication with at least daily updates of the item catalog Capability for assignment of a unique username/password for technician receiving product and for signing the receipt of an invoice.

Scanning serialization information to support transactions under

DSCSA.

The devices must meet VA's and OGA's wireless security requirements for 802.11 wireless standards. The PPV must meet Internet Security Act for the agency if it breaks through the firewall.

a. All software and associated programmable devices shall be compliant with current VA OI&T security and group policies.

b. Compliant with the processes and procedures for all pharmaceutical products covered under the Drug Supply Chain Security Act (DSCSA)

c. The PPV system shall interface with other third-party platforms for auto-order generation and inventory management structures in a real-time.

d. Integrate with all CMOP WMS software for data transfer.

e. Manage incoming shipments concurrently through multiple receiving stations

f. Ability to grant and restrict access for inventory transactions

g. Record all inventory transactions to include but not limited to, receive, returns/damages, and manual quantity changes.

h. Prevents a need to enter data more than once

i. Ability for multiple users to receive the same purchase order (PO) without duplication of receiving events/line items

j. Prevents duplicate/double entry of data

k. Ability to insert line-item comments at receiving

l. Handheld functionality shall be available on desktop.

m. Allow adjustable parameters for managing stock expiration date, prevent receiving of short-dated stock

n. Receive at a minimum of 3 levels of containers: pallet, case, and stock unit

o. Ability to access a detailed log of all transactions by user is required.

p. Physical wall-to-wall inventory functionality by zone and location

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

1. A web-based ordering system

2. The vendor shall provide a communication page containing, but not limited to: links to recalls, manufacturer back orders, updates, training opportunities, and specific government messaging.

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

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

5. An inventory management program for all VA facilities and those OGA customers requesting the program. The inventory management program provided by the PPV shall have the following reporting capabilities:

a. Demand Forecasting- Weighting factors are applied to past purchases to predict future needs by NDC, CMOP ID for CMOP reports (data will be provided to the PV)

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

e. Generation of bar-coded shelf labels containing this information

f. Ability to override normal demand forecasting

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

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

i. Must use A, B, C stratified inventory analysis per VHA directive 1108.08. The tracking of high dollar cost products so these products can be managed more aggressively.

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

k. Report capabilities to support the available tools, including the ability to run national, VISN and facility level reports

6. The capability for all customers to update and print labels and bar codes. During the implementation period, the PPV shall provide all bar code shelf labels and affix the labels to the ordering facilities' pharmacy shelves. The PPV shall print and deliver shelf labels for all items as requested by facilities. Labels must be color coded according to the stratified inventory analysis method (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

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

i. PPV's automated ordering system shall contain and not be limited to, the following fields with the option to customize the display for products:

1. PV 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. PPV' s Product Number- standardized across vendor's ordering system

9. CMOP Product Identification

10. VA Class/Drug Classification System (i.e. AHFS, First Databank)

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

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

13. Reference of established DEA number (where applicable)

14. Reference of established HIN number (where applicable)

15. Government Product Contract Number (FSS. National, BPA, BOA, or Miscellaneous) At a minimum, the last five digits of the Government Contract # will be included

16. Type of contract - contract identification or code that identifies as FSS (F), National (N), Miscellaneous or other government (M) contracts (See Reports I-26(B)3, CNTLD)

17. Product Government Contract start date

18. Product Government Contract expiration date

19. Product Contract price including unit price (specific to the pricing and contract eligibility of each customer)

20. Drug Efficacy Study Implementation (DESI) Indicator Standards

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

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

23. Product Bio-equivalency Rating

24. Customer Delivery Zone (CMOP applicable)

25. Product denoted as available as a Drop Shipment

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

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

28. PV Distribution Center releasing requested product

29. PV assigned invoice number

30. PV payment information

31. Option to query product availability at alternate Distribution Centers and all Distribution

Centers with access limited to VISN/regional, national level accounts and CMOP or VA appointed designees.

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)

34. User notes field per account

35. User notes field per Agency

j. The PPV 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 or next day if the price change is provided the morning of the effective date. For order placement, all pricing updates must 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.

k. The PPV 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.

l. 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. The PPV shall not sell or share Government purchasing data.

m. The PPV shall also provide, at no cost to the Government, the latest VA TRM approved software necessary to support physical inventories. The software provided by the PPV shall have the capability of accepting data from the hand-held devices or from manual data entries.

The software capabilities shall also support acceptance of inventories from independent inventory companies if properly formatted. Inventories shall be editable and exportable after submission.

This system must 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 (DSCSA) data, including lot number and expiration date.

n. 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 VISNs and facilities using multiple search parameters and display the results based on the search parameter(s) used. This capability shall be available to program offices (VA NAC, PBM, NSSC for IHS facilities, BOP for BOP facilities, IHSC for IHSC facilities). Only PBM and NAC will have access to all PPV accounts.

Example, search by State should yield result that displays all the PPV facilities in a particular state, or search by VISN should display all facilities located within a particular VISN:

Table 3: Inquiry Search

DEA

Number

ID or Account Number

Facility Name

VISN City State

The search result display shall include at a minimum the following heading: Agency/Class of Trade (COT), DEA Number, ID or Account Number, Facility Name and Complete Address, VISN, Distribution Center, Fast pay indicator (Y or N), Distribution Fee and 12 Month Sales.

Table 4: Sample Search Result to Display

DEA

Number

ID or Account Number

VISN Facility Name Distribution Center

Fast Pay (Y or N)

Dist. Fee 12 Month Sales

PD1222331 825200 16 VA outpatient Clinic, Mobile, AL 36604

Birmingham Y -5% 12,000,000

AB2233445 111111 16 FCI Forrest City, Forrest City, AR 72335

Little Rock N -4.75% 50,000

AC5566778 234566 16 Coushatta Tribe, Elton, LA 70532

Birmingham N -4.75% 150,000

AD7788991 123456 16 Oklahoma SVH, Ardmore, OK

Oklahoma City

N -4.75% 100,000

CMOP Specific Ordering System Requirements:

a. The PPV shall provide all VA CMOP facilities with software meeting the requirements as outlined in Section I-4, a. through n. above.

b. The PPV shall also provide all VA CMOP facilities, at no cost to the Government, appropriate software interfaces to operate Automatic Replenishment communications used with automated warehouse materiel management systems. Appropriate interfaces shall be made available to CMOP operating systems. The CMOPs' inventory control systems track the NDC number, lot number, and expiration date. The system must be able to support serialization (which is required now) and 2D barcodes, when the 2D barcode standard is deployed as required in the Drug Supply Chain Security Act (DSCSA).

c. To meet the specific ordering requirements of the CMOP (see Section I-7), interface with the CMOP inventory system shall at a minimum provide the following:

1. Automatic ordering based on usage and/or minimal par levels by VA Product identifier.

2. Paperless invoice system

3. Automatic replenishment, stocking of the products into the inventory system

4. Unique electronic signature for receiving each line item on an invoice

5. Barcode technology to facilitate tote management by zone (i.e., each CMOP has as many as

20 zones for products to be stored, each zone has specific product package size requirements defined by the NDC code. A product may be required in multiple zones).

6. Automatic authorized price updating

7. Payment system based upon receiving an item under a given order

8. PPV product number linked to NDC, UPC or UPN number

9. PPV Software program shall recognize that inventory is available (on the shelf) once the inventory level has been updated in the CMOP inventory system

10. Ordering system shall be compatible with the VA network

11. Capability for assignment of a unique user name/password for the technician receiving product and for signing the receipt of an invoice

12. Lot number and lot expiration date shall be passed back to the CMOP automated system

Offerors are encouraged to make site visits to multiple CMOP facilities prior to the submission of offer. CMOP addresses are shown in Attachment A. Please contact the VA NAC contracting officer at 708-786-5231 to coordinate the visit.

The PPV shall provide to the following Government program management offices, at no cost to the Government; appropriate software applications listed above in this section, and shall ensure read-only access to appropriate management offices of the Agency ordering sites below.

Only VA NAC and PBM will have access to all participating agencies' records. The Director of the IHS NSSC and designees in Oklahoma City, Oklahoma shall have access to all the IHS and Tribal participating facilities records. The BOP Chief Pharmacist, Chief, Pharmacy Logistics Support and designees shall have access to all participating BOP institutions’ records. Other agency Program Management offices will be given access to their respective facilities records.

Department of Veterans Affairs:

a. Contracting Officer, or designees, PPV Team, National Contract Service, VA National Acquisition

Center, P.O. Box 76, Hines, IL 60141 (viewing capability for all ordering sites)

b. Deputy Chief Consultant PBM, or designees, Pharmacy Benefits Management (119), Veterans Health Administration, building 37, Room 139, 1st Ave. 1 Block North of 22nd Street, Hines, IL 60141 (viewing capability for all ordering sites)

c. Associate Deputy Chief Consultant PBM/CMOP, or designees, Veterans Health Administration, 23501 W 84th St, Lenexa, KS, 66227-3296 (viewing capability for all ordering sites)

Federal Bureau of Prisons (BOP):

a. Chief, Pharmacist, Health Services Division, Federal Bureau of Prisons, 320 1st Street, NW, Washington, DC 20534 (All participating BOP sites).

b. Access shall also be provided to Chief, Pharmacy Logistics Support; Chief, Clinical Pharmacy Programs; Chief, Central Pharmacy Services; BOP Regional Chief Pharmacists; Bureau's Electronic Health Record Pharmacists; pharmacist designees and relevant contracting and business office personnel.

Department of Health and Human Services: Indian Health Service

Director, NSSC, or designees, 501 N.E. 122nd St, Suite F, Oklahoma City Oklahoma 73114 (IHS and Tribal facilities Nationwide)

Immigration and Customs Enforcement (ICE) Health Service Corps (IHSC)

a. Chief of IHSC Resource Management, Department of Homeland Security, Immigration & Customs Enforcement, Enforcement Removal Operations, ICE Health Service Corps, 500 12th St. SW, 2nd Floor, Washington, DC 20536-5202 (All participating IHSC sites).

b. Access shall also be provided to IHSC Regional Consultant Pharmacists, and future IHSC Headquarters/regional office positions as delegated/designated by IHSC Chief Pharmacist/Pharmacy Consultant.

I-5 Maintenance and Repair

Emergency service and repair calls shall be made available on an unlimited basis at no cost to the Government. The PPV shall restore the ordering system to normal operating condition within 24 hours after notification by the Government. The PPV shall also restore to normal operating condition within 24 hours after notification by the Government malfunctioning PPV-furnished hand-held order entry devices. If repair is not feasible, PPV 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 PPV. The PPV 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 (e.g. 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 PPV shall arrange to pick up all PPV furnished devices at no expense to the Government.

I-6 Training

a. The PPV 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, VISN and national agency or virtually at the discretion of the facility. Facilities may request training for new employees at any time throughout the contract. Training should be provided on- site at each participating customers' facility.

b. The PPV 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 PPV personnel shall provide the training no later than ten calendar days prior to the end of the 120-calendar day transition period. Along with the Implementation Plan, the PPV shall also furnish training schedules for all sites (Instructions to Offerors, FAR Clause 52.212-1).

c. PPV shall make available webinar training sessions providing an overview of the PPV's ordering system readily available, on demand and live after award.

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 PPV'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 substance management threshold increase request process, controlled substances, how to request new items, etc.)

4. PPV data dictionary of acronyms including but not limited to contract type

5. How to make returns including DSCSA specific requirements

6. How to maintain ordering system

7. Downloading price changes

8. Performing file maintenance

9. Requesting bar code labels

10. Download contractually required reports

11. Operation of Inventory Management program

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

13. How to use the reporting system

e. After award, participating management offices and individual facilities will provide the PPV a designated point of contact. The PPV shall work with each Agency's managing office to contact each facility to schedule the initial training for each site. PPV 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 PPV point of contact, email 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 PPV shall be responsible for training when there is a change in ordering personnel and on demand throughout the contract period. Training reports at an Agency/regional level will be made available on request.

g. The PPV 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 PPV to each individual ordering facility, VISN, national 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 PPV shall provide quarterly web-based training on PPV related topics, if requested with topics to be identified by the facility POC. The PPV shall notify the contracting officer of the availability of these training sessions.

BOP Specific Training Requirements:

BOP must approve a Federal Bureau of Prisons Security Clearance Application for each individual employed by the PPV who will be assigned by the PPV to provide the required training to BOP personnel. Security Clearance must be approved by BOP prior to PPV personnel obtaining access to a BOP facility. The PPV shall coordinate with the BOP designated Point of Contact to notify individual authorized prison personnel at least 45 calendar days prior to making any site visits for the purpose of training.

IHS/NSSC/ Oklahoma City Oklahoma Specific Training Requirements:

The NSSC shall coordinate with the PPV during the implementation period to provide a training schedule for all its satellite facilities. The schedule shall reflect a listing containing all of the customers with scheduled times, locations, points of contact, and facility phone numbers.

I-7 Ordering

a. Each authorized ordering facility will be responsible for its own order placement. For the Department of Veterans Affairs, order placement will be made by duly designated (in writing) Ordering Officers and/or warranted contracting staff. For OGAs, order placement will be made by persons with authority to place orders and obligate funds for their respective agency.

b. For IHS accounts, the PPV will supply an auto-generated PO# 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). This auto-generated PO# will not be generated until the order is submitted by the originating account. The PO# will not be a field that can be altered by the originating account.

c. For IHS accounts a secondary PO# or memo field will be available for the originating account to use for local recording purposes. This field will be available in the reporting system as well.

d. For proxy ordering, the user that created the original order will be a field available in the reporting system.

e. For proxy ordering, the user that submitted the order (at the parent facility) will be a field available in the reporting system.

f. All orders for items authorized for distribution through the PPV shall be processed through use of the PPV furnished electronic order entry system as specified in Section I-4. The PPV shall also accept phone, email 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.

Customer service personnel will be trained on the direct phone/fax/email order placement process for PPV participants.

g. Facilities such as Option 2 SVHs, NSSC serviced facilities, BOP and other IHS 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 Proxy Ordering System specified under the Satellite Facility Proxy requirements of this solicitation. Each IHS hospital will have one user designated as full function.

h. PPV customers shall have access to order only their unique database for pricing and product source selection. The ordering system will alert and direct the user to use contract compliant items first prior to orders being submitted.

i. The PPV shall process delivery orders on a "fill or kill" basis. The PPV shall cancel from the delivery order items that cannot be filled. The PPV shall indicate the cancelled items on the customer order confirmation. Once cancelled, the PPV is precluded from placing the cancelled items on backorder.

j. The PPV’s ordering system shall include the option for backorders upon request per product should be fulfilled and alerted on a just-in-time basis.

k. Controlled substance management threshold increase requests will not require excessive purchase history/dispensing information from sites not required by law or regulation. Those increase requests will abide by federal regulations.

l. The PPV's ordering system shall have an item-description link for the customer to notify the PPV of expected item usage. The PPV 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.

In some instances, (for example but not limited to a national emergency) the PPV shall be required to fill government orders first before filling its commercial-based customers’ orders. The NAC contracting officer will notify the PPV when the PPV is required to fill the government's orders first. In such situations, the Government will present the PPV with a written agreement from the product supplier to release the product to the PPV customers first.

m. PBM/NSSC reserves the right to direct the PPV allocation to VA and IHS facilities.

J. The PPV 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.

k. At a minimum, the PPV's customer ordering screen must contain the following fields.