P09 - FINAL STATEMENT OF WORK- Rev Mar 2024.docx

.3 STATEMENT OF WORK

A. BACKGROUND

1. The Department of Veterans Affairs (VA) Consolidated Mail Outpatient Pharmacy (CMOP) program serves over 7 million enrolled Veterans, dispensing more than 120 million prescriptions per year for Department of Veterans Affairs Medical Centers (VAMC’s) and Community Based Outpatient Clinics (CBOC’s) throughout the United States. Currently the seven (7) COMP facilities with nine (9) Delivery locations total located (Listed Below in Section T) CMOP facilities that use Repackaged pharmaceuticals in their automated and semi-automated pharmacy systems in order to fulfill the prescription orders. The Government has the right to add/subtract locations as future need to the gov change. CMOP has identified the continued need to receive Repackaged pharmaceuticals from a Food and Drug Administration (FDA) licensed repacker/distributor (contractor) of oral, solid pharmaceuticals.

B. SCOPE

1. Repackaged pharmaceuticals play a vital role in the fulfillment process by improving the efficiency of CMOP operations creating faster delivery times to our veteran patients. Fluctuations in the need for pharmaceuticals make it is difficult to determine the exact quantities that will be required during the contract term(s) however based off on historic data from the previous contract the Government anticipates a need for approximately 14 million repackaged bottles per year.

2. The contractor shall serve as a unit-of-use repacker for pharmaceuticals. Under this program, CMOP will purchase the pharmaceuticals separately from this contract, and arrange delivery of such products to the contractor for processing. The Contracting Officer (CO), Contracting Officers Rep. (COR) or a delegated Ordering Officer (OO) within the CMOP will provide instructions to the contractor for repacking of the product into various bottle sizes. The product list may vary through the life of the contract as the CO or OO adds product and package sizes to the program. The vendor shall receive, validate product, repack, and ship orders submitted by the CO, COR, or OO. If supply chain issues or emergent need require short-term holding of Pharmaceuticals, then the short-term warehousing fees will be negotiated between the vendor and the government prior to receiving Pharmaceuticals Government-Owned pharmaceuticals must be physically segregated from non-Government product. CMOP orders shall not be co-mingled with other government or non-government orders. The contractor shall ship product FOB Destination to the ordering CMOP(s). All actions by the contractor under the awarded contract shall be in accordance with applicable FDA, DEA, EPA, Federal, State, and local codes and laws or regulations.

3. Only a warranted CO or a delegated OO within the CMOP are authorized to order repacking services under this contract. There seven (7) COMP facilities with nine (9) Delivery locations facilities and a CMOP National Office that may have delegated Ordering Officers.

The contractor will be required to deliver all articles that are properly ordered during the contract performance period, in accordance with the terms and conditions of the contract. The contractor will also account for retention samples. Comment by Barrett, Peter: Maybe - The contractor will deliver all repacked orders per the OO or the designated rep. The contractor will also account for retention samples.

C. CONTRACT PERIOD

1. The contract performance period is for a one-year base period plus four one-year option periods. Each period will be exercised at the VA’s discretion.

2. Implementation/Transition Period is defined as the amount of time after contract award and before the contract effective date to ensure sufficient administrative time has been allowed for continuity of service in support of the CMOP program, and the change of contractors from the incumbent contractor to the newly awarded contractor. The implementation/transition period shall be no more than sixty (60) calendar days from date of contract award.

1. The contractor shall provide a written transition plan to minimize any decreases in productivity and to prevent possible negative impact on service. This plan shall include but is not limited to the identification and establishment of new processing facilities and locations, the hiring, and training of staff prior to the start date, and obtaining data. The Transition Plan should be included in proposal and will be incorporated in the contract award.

D. GENERAL REQUIREMENTS

1. The contractor will receive a bulk shipment of medications to be repackaged into various count sizes. The government will procure the pharmaceutical product and have it shipped to the repackaging contractor.

2. The contractor shall be registered with the FDA, Drug Enforcement Agency (DEA), and licensed in order to repack oral, solid pharmaceuticals. In addition, the contractor shall hold a valid, current certificate from DEA for Class III, Class IV, and Class V controlled substances. The contractor shall have a minimum of two years proven past experience, as a repacker, with a repacking volume of at least 14 million bottles of oral solid pharmaceuticals per year. The contractor shall accept shipments of Government-owned pharmaceutical drugs from an authorized CMOP, the prime pharmaceutical vendor, or alternative open market source, to repack into individual bottles per the Statement of Work (SOW). and all Repackaged products shall be shipped to the CMOP or designated location on the order. All repacking work shall be accomplished based on information provided within the delivery orders issued from each CMOP. Comment by Barrett, Peter: Revised gramatically

3. Pharmaceuticals are typically Repackaged into various sizes that may include, but not limited to 15 count, 30 count, 45 count, 60 count, 90 count, 120 count, 135 count, 180 count, 270 count, and 360 count. Repackaged bulk sizes may include, but are not limited to 1 liter, 2-liter, 3-liter and 4-liter bottles.

4. The Government may place one or more employees in the contractor’s facility to observe contractor’s accountability and repacking practices on behalf of the CMOP. The contractor shall provide office space for the employee(s), along with desks and chairs. Other office needs for this employee(s), e.g., IT equipment, file cabinets, telephone, office supplies, etc.), will be the responsibility of the Government.

E. FEDERAL GOVERNMENT HOLIDAYS

F. DEFINITIONS AND ACRONYMS

1. Batch – The production of a product that has the same drug name, strength, expiration date and lot number.

2. Barcode 128 – One-dimensional ("1D") barcode symbol used throughout the ID, inventory, shipping, and distribution chain. Code 128 barcodes are alphanumeric machine-readable symbols. They can be printed with or without human-readable characters.

3. Business day - Monday through Friday of each week, not including Federal Holidays.

4. Consolidated Mail Outpatient Pharmacy (CMOP) – Division of the United States Department of Veterans Affairs; provides mail order prescriptions to veterans. (Current CMOP locations are REF Section T

5. Contracting Officer (CO) – Government employee with the authority to enter into, administer, and/or terminate contracts and make related determinations and findings.

6. Contracting Officer’s Representative (COR) – Representative from the requiring activity assigned by the contracting officer to perform surveillance and to act as liaison to the contractor. This individual has no authority to change the terms or conditions of the contract. The contracting officer reserves the right to designate representatives to act for him/her in furnishing technical guidance and advice or generally monitor the work to be performed under this contract.

7. Contractor – Vendor/Company authorized to provide services awarded under this contract.

8. Disasters – As declared by the Federal/State/Local government for a specific situation. Also, when contractor facilities are unable to provide the requirements of this contract resulting from perils of nature, mechanical or electrical failure, medical epidemic, etc.

9. Drug Supply Chain Security Act (DSCSA) - Enacted by Congress on November 27, 2013. Title II of DQSA outlines steps to build an electronic, interoperable system to identify and trace prescription drugs as they are distributed in the United States.

10. Emergency - An unforeseen combination of circumstances or the resulting state that calls for immediate action.

11. Freight on Board Destination (FOB). - The repacker takes delivery of goods being shipped to it by a supplier once the goods arrive at the repacker's receiving dock.

12. First Databank (FDB) - Part of the Hearst Health network, is the leading provider of drug knowledge that helps healthcare professionals to make precise medication-related decisions worldwide.

13. Immediately – when used in conjunction with a notification requirement, is defined as written notification to the COR or contracting officer within one business day of occurrence.

14. Medi-Span - Master Drug Data Base provides pricing and descriptive drug information on name brand, generic, prescription and OTC medications, and herbal products. It includes industry standard identifiers for all brand and generic drugs on the market including National Drug Code (NDC), Universal Product Code (UPC) and Health Related Item (HRI) numbers.

15. Normal Business Hours – For the purposes of this contract normal business hours will be defined as 8:00AM to 5:00PM CST Monday through Friday excluding Federal holidays.

16. Ordering Officer (OO) - Government employee with the authority to place and administer funded orders against the contract.

17. Promptly – when used in conjunction with a notification requirement, is defined as written notification to the COR or Contracting Officer within two business days of occurrence.

18. Quality Control – Actions taken by a contractor to control the performance of services so that they meet the requirements of the PWS.

19. United States Pharmacopeia (USP) - A scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed, and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than one-hundred forty (140) countries.

G. APPLICABLE CREDENTIALS, CERTIFICATIONS, REGULATIONS AND STANDARDS

1. Contractor shall be FDA registered to repack oral, solid pharmaceuticals and certified with the Drug Enforcement Agency (DEA) for Class III (narcotic and non-narcotic), Class IV, and Class V controlled substances.

2. Contractor control, accounting and repacking of pharmaceuticals shall be done using FDA and DEA guidance, regulations, and approved procedures, and in accordance with current Good Manufacturing Practices (cGMPs). https://www.fda.gov/cosmetics/guidanceregulation/guidancedocuments/ucm2005190.htm

Section 3 amended revisions incorporated below the lined items Rev. July 2023

3. The contractor shall submit to First Databank (FOB), Medi-Span and Multum the product information pertaining to the products Repackaged under this contract, including the contractor's unique National Drug Code(s) (NDC), during the period of contract performance. A New Product Submission Form or submission information can be found by contacting the following:

Email:Editorial_Services@fdbhealth.com;

Email: mfgdata@wolterskluwer.com

d. Oracle Cerner Multrum: Web Address Drug Database solution | Cerner New Form Email: MultumSupport@Cerner.com Send Update Email: mfgproducts@Cerner.com

e. Contract Awardee will not assume any liability or responsibility for accuracy of pricing or other data received from Prime Vendor Contract holders that is required to be submitted to third party databases. The purpose of the reports are only to provide necessary information for claims resolution with insurance providers to ensure the lowest cost to Veterans as practical.

4. The contractor will supply a weekly report to the OO and COR new NDC’s registered with either First Databank or Media-Span.

5. The contractor shall follow all appropriate requirements as implemented in the DSCSA.

H. CONTRACTOR RESPONSIBILITY

1. The contractor shall schedule work based on the delivery orders placed in accordance with the terms and conditions of the contract.

2. The contractor shall be responsible for full control and accounting of all products that are delivered for repacking in accordance with the Government Property clause (FAR 52.245-2).

3. The contractor shall establish processes acceptable to CMOP for performing the receiving inventory function, to include but not be limited to accurate counting of product being received. The contractor shall also be responsible for recording all DSCSA information (such as lot number and quantity of each) and forwarding that information immediately to the ordering office. The CO, OO and the COR shall be immediately notified of any discrepancies. The contractor shall have processes which include, but are not limited to, auditable receiving processes and document trails for all products being received. The contractor will be in compliance with all current and future DSCSA requirements.

4. The contractor shall have adequate resources, to include sufficient space for controlling inventory and segregation of stock. Government-Owned pharmaceuticals must be physically segregated from non-Government product. Government orders shall not be co-mingled with other Government orders.

5. Controlled pharmaceuticals must be received and stored in a secured in a separate location in accordance with FDA, DEA, and EPA regulations.

6. Control, accounting, and repacking shall be accomplished using FDA and DEA approved procedures, and in accordance with current Good Manufacturing Practices (cGMPs).

7. Any excess product in the repacking process shall not be added to the FDA-mandated retention samples. Destruction of these stored amounts shall be in accordance with all FDA, DEA, and EPA regulations. Reports of stored samples and subsequent destruction shall be submitted to the appropriate CMOP. Damaged product received prior to the repacking process shall be returned to the ordering CMOP.

8. Contractor shall have a policy in place for initial hiring drug tests, random drug testing, and for drug testing when there is reasonable suspicion of impairment.

9. Contractor shall have a plan for contingency operations for disasters, which identifies the ability to provide uninterrupted support under unprecedented situations that cannot be reasonably mitigated and/or contingency conditions.

I. GOVERNMENT RESPONSIBILITY

1. A warranted CO or delegated OO within the CMOP Contracting Office, with a warrant or delegation which allows placing delivery orders against existing contracts, will be the delegated authority to place delivery orders to the contractor citing the terms and conditions of the contract resulting from this solicitation.

2. The delivery order shall:

a. Identify the total number of bottles to be Repackaged, to include the “mix” required (i.e., 50mg, 30 per bottle; 100mg, 90 per bottle; etc.).

b. Provide a required delivery date for the delivery order to be completed.

c. Identify a point of contact at CMOP for the contractor. Generally, this will be the OO.

d. Identify the exact delivery information for the CMOP(s) where the Repackaged products are to be delivered.

3. CMOP will make every effort to limit the number of lot numbers to three or less per drug.

4. CMOP will attempt to obtain a single lot number for the stock to be Repackaged for small production repacking runs which can be less than 100 bottles.

J. PRODUCT CHARACTERISTIC REQUIREMENTS

1. The contractor shall provide bottles, caps, and labels to repackage all medications. All bottles will have to be approved for usage with Government Equipment. Any bottles size requirement changes will be approved by both the contractor and the contract officer of the government.

2. The pharmaceutical bottles shall have the following characteristics:

a) White pharmacy grade high-density polyethylene. Are we sure this could always be white?

b) Round with no ridges, bowing or protrusions that would prevent them from being horizontally or vertically stacked. (Convex shaped bottles are unacceptable).

c) Must have a flat surface with minimum dimensions of 2.5’’ W x 5.5’’ L sufficient for applying a label without overlap.

d) Bottle sizes Repackaged into are 120cc, 200cc, 300cc, 400cc, 625cc, 1Liter, 2Liter, 3Liter and 4Liter.

e. Bottles shall be identified with a number 1, 2, or 3 designations for recycling.

f. A tamper evident seal shall be applied to each bottle. This seal must not be above/over the cap.

g. Must be capable of being dispensed from the automated labeling and automated dispensing systems installed at each CMOP facility, including but not limited to: A-Frames, Flex-Pick systems, Automated Dispensing Unit (ADU) systems, Checking and Labeling Systems (CLS), and Package Dispensing and Labeling Automation (PDLA).

h. The prospective contractor must supply testing data / certification showing that the cap bottle assembly / unit is in compliance with the Consumer Product Safety Commissions (CPSC) current protocol and standards for child resistant effectiveness as per Code of Federal Regulations (C.F.R.) Title 16, Part 1700. (This paragraph does not apply to the bulk up sized bottles, i.e., liter size bottles).

2. The bottle caps shall have the follow characteristics:

a) Shall not exceed the diameter of the bottle.

b) Shall be of convertible design to allow user to convert it from child-resistant to non-child resistant with hand applied pressure to outer ring of the cap when cap is on the bottle. Five-hundred forty (540) count bottles or less will be required to have a child-resistant cap.

c) Shall be imprinted with the MyHealtheVet logo or other logos that will be alternated at the discretion of the CO in accordance with the attached logo specifications. See Section D Attachment 4. No more than four logos will be required.

d. The imprint must be high quality resolution, visible under the cap surface, and be approved for use by the CO.

e) All bottle and cap combinations shall meet or exceed the USP standards for moisture permeability and light resistance.

3). The product labels shall have the following characteristics:

a) Shall not exceed 3.5 mils thickness (for affixed labels).

b) Directly printed labels may be used, but shall be machine readable and non-smudging.

c) Labels must not peel off or be damaged in automated machinery.

d) Centered in bottle label area to ensure barcode readability.

4). The product labels shall include the following:

a. The product label must be of a material that will allow a patient label to adhere to it.

b. Fill size and strength for quick recognition. The generic name shall be bold font and larger font than other printed label information.

c. Drug name positioned such that after applying the patient label the product can still identified. The product name, strength and package size shall be printed twice on the label: once in the middle of the label and once on the extreme left-hand side vertically. Font size for both label locations is to be the same.

The government requires the 2D BAR Code (Q/R) type automated information data carrier required by the DSCSA along with the Barcode 128 (1D) on the Label.

d. Bar codes shall be clear and defined with no break in the bar code graphics. A sufficient amount of clear white space needs to be around the bar code so numbers and/or letters do not interfere with the bar code.

e. The Government requires one vertical linear 1D Bar Code on the left side of the label and one 2D Bar Code on the right side of the label. The Manufacturer Lot Number, Repackaged Batch Number, Expiration Date, and NDC number shall appear as human readable language adjacent to the bar code.

f. State storage conditions.

g. Indicate the “Manufactured By” name and “Packaged By” name and address.

h. The statement "Warning: May be habit forming" where applicable, the controlled drug substances symbol required by DEA, and the name and quantity or proportion of any substance as required.

i. Boxes or cases shall be clearly marked with a product label as described in 2.D, above. Case quantity shall be stamped on the outside of each case if it contains less than the standard container capacity (e.g.: 40 bottles in a box or case that holds 100) than would be expected. Inside the case, each 10 pack should be shrink wrapped for easy handling and filling of automated equipment. This is essential for control substance audits that are required daily.

10. Upcoming DSCSA requirements such as, but not limited to, serialization must be incorporated by the contractor on the dates required by the DSCSA. The contractor will comply and be in inspectable compliance with all current and future DSCSA requirements.

K. PLACEMENT OF DELIVERY ORDERS

1. The CMOP’s are supported by the contracting office located in Leavenworth KS. A warranted CO or a delegated OO within the CMOP will allow them to place delivery orders against existing contracts citing the terms and conditions of the contract resulting from this solicitation. No oral orders may be placed; all orders shall be written. (See FAR Clause 52.216-18)

2. Individual CMOPs shall be responsible for providing repacking instructions to the contractor and are responsible for administration of their repacking orders.

3. Currently CMOP is using both a consolidated ordering function and an individual site level ordering function. The consolidated order is a high-volume repacking order being placed from the CMOP National Office with delivery to multiple CMOP facilities. Orders may be placed by one CMOP with delivery directly to that CMOP.

L. ORDERING SYSTEM - WEB BASED Comment by Barrett, Peter: I am not sure this is a current option for other than NAC repacking requests. It would be nice to see an ordering system for other than NAC orders. However, in the past, the contractor had issue with a web based ordering system that was not specifice to a specific drug and drug size. There was no warehousing, so it would be ordere based on future delivery of bulk items to the contractors site. So, In short, it would be nice for a contractor to work outside the box for order entry, but CMOP and the governement present some limitations to vendors meeting that expectation.

1. The contractor must have the ability to provide CMOP with a secure web-based ordering system. Only CO’s or OO’s may be granted logins, unique for each individual. Passwords must adhere to the standards established by CMOP. Comment by Lamb, Tammie L.: I currently have access to review filling data and validating the NAC purchase order amounts in relation to inventory reconciliation.

2. The ordering system shall be able to provide real-time confirmation within the system when an order is placed. The system shall cancel items that cannot be filled. The confirmation should indicate the cancelled items.

M. ORDERING SYSTEM – MANUAL

1. When the order has shipped from the repacker, an email shall be sent to the individual placing the order unless otherwise indicated identifying the complete shipment, projected delivery date, and tracking number. The Vendor Shall include in the subject line the individual ordering CMOPs PO number. This email shall also include a comma separated variable (CSV) file as an attachment, which will include the following minimum data fields: Comment by Lamb, Tammie L.: I would like to see this information sent to a distribution group created for each site to ensure data rec'd just in case OO is out of office. Comment by Reuwer, Phillip K.: Could just say that the information will be sent to the issuing station and tell the CMOP's that they should crate a group mailbox f their OO and Facility manager to get this info.

Provide a reconciliation that details the destination of each tablet/capsule that was received (the contents of each bulk bottle). Such as, how many were kept as samples, how many were manufacturer overage/shortage, if any were unusable due to breakage, if any were contaminated and if the contamination was caused by the manufacturer or the contractor.

Provide a packing list for all items in the shipment.

Provide a detailed contractor invoice for all items in the shipment.

Manual ordering methods may include facsimile (fax), email, or in writing delivered by standard delivery methods (e.g.: USPS, UPS, etc.). Every delivery order shall be in writing and electronically signed by the OO. ORAL ORDERS ARE NOT AUTHORIZED.

2. The repacking contractor will not procure the drugs to be Repackaged. Each CMOP shall provide the contractor with the drug to be Repackaged. The shipment of the product to be Repackaged by the contractor shall be arranged and underwritten by the CMOP and shall be by a conveyance deemed appropriate by the CMOP that meets all FDA and/or USP requirements for safe and secure transit of the material. (See 2H., Product Handling, below for information on the responsibilities toward return shipment to the CMOP.)

3. The products will be purchased in the most economical count size. CMOP will not necessarily purchase the stock to be Repackaged in the largest count package available if a smaller count package is more economical. When the Pharmaceutical Prime Vendor (PPV) contract is used by the CMOP for ordering, the PPV contractor may ship the product to the repacking contractor and will bill the CMOP for the product.

N. PRODUCT HANDLING

1. Pharmaceuticals shall be received by the contractor directly from a CMOP, a prime Vendor contractor, or alternative source pharmaceutical supplier. These pharmaceuticals are Government-Owned property. Immediately upon receipt of Government-Owned property, the contractor shall log and reconcile the invoice for all products received and report any damages or discrepancies to ordering facility as well as verifying DSCSA transaction information. Within 24 hours of receipt. the contractor shall email the ordering CMOP the signed and dated invoice/packing slip that accompanied the shipment, verifying all items listed were received and detailing any discrepancies.

2. The contractor shall be responsible for reporting to the ordering CMOP when an excess of three lot numbers for a single drug are received. Comment by Barrett, Peter: this requirement? This is a nice thing to know, but it really hangs on the bulk provider or McKesson. Once the repacker contacts us that there are more than three lots…. What is next? Does the CO on this contract have pull with the CO on the McKesson contract? 99.9% of the time we just tell them to repack. Is there a better way to try to eliminate/change this so we can coordinate between vendors to lower lit numbers and increase quantity and lot discounts?

3. The contractor is responsible for product damaged while the product is in the contractor’s care. These pharmaceuticals will be Repackaged into unit of use sizes by direction of the CO, OO or as defined by the delivery order.

4. Pharmaceutical product retention shall be handled as defined in CFR Title 21, Section 211.

5. Any excess product in the repacking process shall not be added to the FDA-mandated retention samples.

6. Product shall be processed and Repackaged and delivered into unit of use sizes in accordance with the instructions provided by the CO or OO no later than ten (10) calendar days after receipt of pharmaceuticals, or, as agreed upon between the repacker and the CO or OO. Shipments to the requesting CMOP are to be sent FOB Destination.

7. Finished product that is shipped on pallets shall be shrink-wrapped. All pallets shall be wrapped using black shrink wrap to encapsulate the pallet and containers.

8. Pallets shall contain a packing slip identifying contents as well as an itemized invoice alphabetized line by line.

9. Controlled substances shall be wrapped separately from other portions of a shipment.

10. No more than 100 bottles per box or case.

11. A maximum weight of 25 pounds per box or case.

12. No “mix” of fill sizes, strengths, or drugs in any one box or case.

13. All partially filled boxes, as well as partial deliveries, must be clearly marked ad placed at the top of each shipping pallet used.

14. Destruction of retained samples, controls, and excess and/or damaged product shall be done in accordance with applicable regulations, including but not limited to any required by the DEA, FDA, and EPA. Within fourteen (14) calendar days after destruction the contractor shall provide the Government with a Certificate of Destruction to the CO, COR, and OO. Comment by Barrett, Peter: Who gets this information? Who gets certificate of destruction?

15. The repacking contractor will be accountable for, and will reimburse the ordering CMOP for, any government property spilled or damage occurring while in their possession or as a result of the repackaging process. CMOP will be reimbursed for the price paid for the unusable product.

16. Finished products that are received at the CMOP that are damaged, including missing or damaged caps, damaged bottles, missing or damaged labels that cannot be barcode scanned or are otherwise illegible, shall be returned to the repacking contractor for identification of the drug content and proper disposal. The damaged product will be credited back to CMOP for the cost of the product plus repacking fee. If 10% or more of a batch is received damaged, the contractor must also pay for expedited shipment of replacement product.

O. REPORTS

1. Quarterly Sales Report: The contractor shall provide a sales report made to Government agencies under this contract for the proceeding calendar quarter. The overall dollar value shall be rounded to the nearest whole dollar, of all sales. For the purpose of this requirement, the calendar quarters are Jan – Mar, Apr – Jun, Jul – Sep, and Oct - Dec. This report shall segment these sales by Department of Veterans Affairs (CMOP) and Other Government Agencies (OGA) (when applicable). The initial report will be due 30 days after contract award and subsequent reports shall be due within 10 days from the end of the next Government fiscal quarter following contract award and every quarter there after until contract completion. The report may be prepared and submitted in a format of the contractor’s choosing as long as it contains the minimum required data and clearly identifies the period of time reported. The report may be prepared and submitted in a format of the contractor’s choosing as long as it contains the minimum of dollars by bottle size by CMOP facility based on facility orders, and dollars by bottle size by CMOP facility based on centralized orders.

2. Monthly Sales Reports: The contractor shall provide an: overall dollar value, rounded to the nearest whole dollar, of all sales made to Government agencies via this contract during the preceding month. The initial report will be due 30 days after contract award and subsequent reports shall be due within 10 days from the end of the next Government fiscal quarter following contract award and every quarter there after until contract completion. The report may be prepared and submitted in a format of the contractor’s choosing as long as it contains the minimum of dollars by bottle size by CMOP facility based on facility orders, and dollars by bottle size by CMOP facility based on centralized orders.

3. Monthly Retention Reports: The contractor shall provide a report identifying: retention samples and their consequent destruction. This report will reflect total count and associated identifying data for all products held as retention samples and will reflect if and when any consequent destruction has occurred. The initial report will be due 30 days after contract award and subsequent reports shall be due within 10 days from the end of the next Government fiscal quarter following contract award and every quarter there after until contract completion. The report may be prepared and submitted in a format of the contractor’s choosing as long as it contains the minimum required data and clearly identifies the period of time reported.

4. Weekly Yield Report – The contractor shall provide a weekly actual yield report in Microsoft Excel format. This report shall be provided by product and lot number reflecting at a minimum: the date received, quantity received, lot numbers, repacking start and completion date, total yield (including samples and partials), quantity turned in for sale, samples not turned in, and process status (if in process, finished, etc.) Standard acceptance criteria for total unit doses packaged shall be + 1% variation; however reasonable variations may be permitted based on historic data by individual drug product. This report shall include distribution-only product as well to reflect shipment receipt. The CO shall be consulted to establish any variation other than the 1% stated. For purposes of reporting, the week will begin on Thursday and end at close of business Wednesday with reports due by close of business the following day.

P. ESTIMATED QUANTITIES

NOTE: It is not always possible for CMOP to obtain a single lot number for the stock to be Repackaged, and small production repacking runs which can be less than 100 bottles

1. The Government anticipates a total of approximately 14 million Repackaged bottles per year, consisting of oral, solid pharmaceutical tablets and/or capsules. This estimate is based on historic data from the previous repacking contract. The anticipated use will include, but not be limited to, bottle counts previously stated. Estimated quantities are anticipated to remain stable for the base year.

2. During option years there is likelihood that the volume may change, upward or downward, although total change cannot be estimated due to the size of the served patient population being in constant flux and other variable factors, including but not limited to fluctuations in need for repacking certain oral solid pharmaceuticals which could be based on alternative availability. Therefore, it is impossible to determine the exact quantities that will be required during the contract term, nor the quantities that may be required by each CMOP.

3. The following is an estimated volume, based on historic data, for each bottle size been used in prior repacking activity. Past use does not guarantee future volume, although it will show an approximate relative pattern of the usage per size. The volume below is based on usage averages and will not total 100%.

120cc Bottles: > 70%, estimated at > approximately 11,250,000 – 13,500,000 bottles.

200cc Bottles: < 15%, estimated at < approximately 2,250,000 – 2,700,000 bottles.

300cc Bottles: < 7%, estimated at < approximately 1,050,000 – 1,260,000 bottles.

400cc Bottles: < 5%, estimated at < approximately 750,000 – 900,000 bottles.

625cc Bottles: < 2%, estimated at < approximately 450,000 – 540,000 bottles.

1,000cc Bottles: <1%, estimated at < approximately 150,000 – 180,000 bottles.

2,000cc Bottles: <1%, estimated at < approximately 150,000 – 180,000 bottles.

3,000cc Bottles: <1%, estimated at < approximately 150,000 – 180,000 bottles.

4,000cc Bottles: <2%, estimated at < approximately 450,000 – 540,000 bottles.

4. The contractor will be required to deliver all articles that are properly ordered during the contract term, in accordance with the terms and conditions of the contract.

Q. SCHEDULE OF SUPPLIES/SERVICES AND PRICE/COSTS.

1. Offeror’s prices are a repacking fee that is quoted per bottle, and as such must include all the offeror’s costs. These costs include, but are not limited to labor, G&A costs, supplies (e.g. bottles, labels, shipping cartons, etc.), and shipping costs to the CMOP.

2. Offeror shall specify any additional charges (if applicable) per delivery trip, for emergency orders which exceed the two per month shipment limitation.

3. The minimum value of services that the Government agrees to order during the period of this contract is $2,500. If, at the conclusion of the contract period the contractor has received orders for less than $2,500, the Government will pay (upon request) the difference between the amount ordered and the $2,500. The maximum is the estimated 14,000,000 bottles per year. Comment by Lamb, Tammie L.: Do we need to include a range instead of just one value to allow for growth? Comment by Reuwer, Phillip K.: Yes, it is a requirement of the IDIQ contract type unless we wanted to discuss other contract types but and IDIQ will always have a min-max for accountability of the size and scope of the contract. Comment by Reuwer, Phillip K.: I would be curious if we have been close to reaching this max, I don't have access to that kind of data but if we have we should revise to account for much more as I would suspect the PACT act recipients is going to increase the volume of work the VA is going to be receiving. Comment by Barrett, Peter: I would think we have an overlying issue here. First, the value of repacking… With prices at $1 per bottle, is it still cost effective/economical? Second, CMOP's are getting better eq. I see both Leavenworth and Charleston staging a mutiny over repacks versus their machines. Third, the dynamics are changing to a point of almost a paradigm shift.

4. Request for payment of any amount due under this contract shall be submitted in writing to the CO within 30 days after the end of the contract period.

5. The guaranteed minimum does not apply if the contract is terminated for convenience or cause.

R. DELIVERY

1. Delivery is required within ten (10) calendar days of receipt of a delivery order and the product to be Repackaged, although voluntary earlier deliveries are generally acceptable. If the seventh calendar day falls on a weekend or Federal Holiday, then delivery may be made on the next normal business day for the CMOP. Comment by Barrett, Peter: OK… when does the 10 days start?? With one drug, it is when the COMPLETE bulk order is delivered. If the order has multiple bulk items coming from either one or multiple sources arriving at the repacker facility at separate times, I believe the 10 days starts when the last of the bulk arrives. THEN THE REPACKERT CAN SHIP the entire order at once. This is a point of contention between CMOP, National management, and the repacker.

2. Emergency deliveries are F.O.B. Destination and apply to Repackaged drugs requiring expedited delivery to ensure facilities have enough stock until the next scheduled delivery day. The contractor shall provide a minimum of two monthly emergency deliveries for each delivery account at no additional charge. Emergency deliveries shall be made within 48 hours after receipt of order. Contractor shall indicate the number of emergency deliveries offered at no additional charge beyond the two required by this contract, and the Offeror shall specify any additional charges (if applicable) per delivery trip, for emergency orders which exceed the two per month shipment limitation. Additional emergency order delivery charges in excess of the two no charge deliveries shall be charged at a flat rate per delivery trip.

3. Each CMOP is entitled to two emergency deliveries per month. Any emergency order in excess of two per month are subject to an expedited fee paid by the CMOP.

4. Partial Deliveries, delivery of shipment by the scheduled date shown on each delivery order will be complete except as authorized by the OO.

S. INVOICES

1. Contractor shall submit invoices for payment to the office shown on each individual delivery or order. Any partial deliveries, when approved by the OO, shall be separately invoiced to each delivery made from the over-arching order, not invoiced as a single delivery.

a) A detailed version of the invoice containing the following information shall be submitted to a designated CMOP contact on the same date the electronic version is submitted to the FSC.

· Vendor name, address, DEA number, phone number, invoice number, and date. Sold to information. Contract number, Order date/ship/invoice date.

· Complete purchase order number assigned by CMOP for goods or services. To ensure prompt payment, please contact the VA facility to ensure that the assigned purchase order number is current and correct.

· Itemized description of goods or services to include:

· Batch number

· Drug Name

· Contractor NDC

· Bottle type (120cc, 250cc, etc.)

· Lot Number

· Expiration date

· Pill Count (number per bottle)

· Containers Shipped (per batch)

· Number of tablets in the batch

· Standard price (repackaging’s fee)

· Volume Price (repackaging’s discounted price based on pre-determined volume)

· Lot Price (repackaging’s discounted price if there’s only one lot per drug strength)

· Extended Price (total for each Batch)

· Total of all containers shipped.

· Total of all tablets shipped.

· Total price for all batches

· Discount or net terms

3. Each invoice must be able to be reconciled to the line-item level. Invoices shall be separated into three areas as follows:

a. Total product price

b. Total handling fee

c. Invoice grand total

d. Aggregated price by individual drug repack total.

T. SUPPORTED FACILITIES

1. The following facilities are eligible to order from the resultant contract.

760 - Leavenworth, KS CMOP

761 - Chelmsford, MA

VA CMOP Chelmsford - 761

Hours of Ops

10 Industrial Avenue

5:30AM-3:00PM

Chelmsford, MA 01824-3610

762 - Tucson, AZ

VA CMOP Tucson - 762

Hours of Ops

3675 Britannia Drive

3:00AM-12:00AM

Tucson, AZ 85706-5041

763 - Lancaster, TX

VA CMOP Lancaster - 763

Hours of Ops

2962 S. Longhorn Drive

6:00AM-4:30PM

Lancaster, TX 75134-2118

764 - Murfreesboro, TN – SJ & EF

765 - Hines, IL (Great Lakes CMOP)

VA CMOP Hines - 765

Hours of Ops

5th and Roosevelt, Building 37 NW Dock 18

5:00AM-12:00AM

Hines, IL 60141-3030

766 - Charleston, SC

VA CMOP Charleston - 766

Hours of Ops

4136 Carolina Commerce Parkway

5:30AM-11:30PM

Ladson, SC 29456

Mon - Fri

770 - VA CMOP National Office

VA CMOP National Office - 700

23501 W 84th Street

Shawnee, KS

2. This list may be changed by modification, after award, to include new facilities or delete existing facilities.