36C77024Q0325.docx
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- Solicitation number
- 36C77024Q0325
About this file
This document is a Sources Sought Notice issued by the Department of Veterans Affairs, VISN 15 Network Contracting Office, seeking providers of Pharmaceutical Reverse Distribution Services for all VA Consolidated Mail Outpatient Pharmacy (CMOP) facilities. The notice is an RFI, not a solicitation, to gain knowledge of potential qualified sources and their size classification relative to NAICS code 561499 - All Other Business Support Services. Responses will be used to make appropriate acquisition decisions, and a solicitation may be published later.
The government is seeking a single Indefinite Delivery, Indefinite Quantity, Firm-Fixed Price contract for a potential 5-year period to provide on-site and off-site reverse distribution services, including processing returns for credit and disposing of non-returnable pharmaceuticals. Pricing will be a percentage of estimated return value for returns and a firm fixed price per pound for disposal. The government estimates annual pharmaceutical returns of $7 million, with a guaranteed minimum order of $2,500. Responses are due by July 12, 2024.
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Sources Sought Notice Sources Sought Notice
| SUBJECT* |
| Pharmaceutical Reverse Distribution (VA-23-00000847) |
GENERAL INFORMATION
| CONTRACTING OFFICE’S ZIP CODE* |
| 66048-5012 |
| SOLICITATION NUMBER* |
| 36C77024Q0325 |
| RESPONSE DATE/TIME/ZONE |
| 07-12-2024 5PM CENTRAL TIME, CHICAGO, USA |
| ARCHIVE |
| 60 DAYS AFTER THE RESPONSE DATE |
| RECOVERY ACT FUNDS |
| N |
SET-ASIDE
| PRODUCT SERVICE CODE* |
| Q517 |
| NAICS CODE* |
| 561499 |
| CONTRACTING OFFICE ADDRESS |
| Department of Veterans Affairs |
NCO 15 Contracting Ofc - CMOP 3450 S. 4th St. Trafficway
Leavenworth KS 66048-5012
POINT OF CONTACT*
Contract Specialist Renee Kreutzer renee.kreutzer@va.gov 913-684-0142
PLACE OF PERFORMANCE
ADDRESS
POSTAL CODE
COUNTRY
ADDITIONAL INFORMATION
AGENCY’S URL
URL DESCRIPTION
AGENCY CONTACT’S EMAIL ADDRESS
EMAIL DESCRIPTION
DESCRIPTION
THIS IS A REQUEST FOR INFORMATION (RFI)
DISCLAIMER:
This RFI is issued solely for information and planning purposes and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI.
The submission of pricing, capabilities for planning purposes, and other market information is highly encouraged and allowed under this RFI In Accordance With (IAW) FAR Part 15.201(e).
SOURCES SOUGHT DESCRIPTION:
This is NOT a solicitation announcement. This is an RFI only. The purpose of this RFI is to gain knowledge of potential qualified sources and their size classification relative to NAICS 561499 –All Other Business Support Services. Responses to this RFI will be used by the Government to make appropriate acquisition decisions. After review of the responses to this RFI, a solicitation announcement may be published. Responses to this RFI are not considered adequate responses for a solicitation announcement.
The following VAAR policies and clauses will be applicable to this requirement if an SDVOSB/VOSB entity is interested and qualified in this requirement:
Limitations on Subcontracting requirements set forth in 15 U.S.C. § 657s and in VAAR 852.219-10 and 852.219-11;
852.219-77, VA Notice of Limitations on Subcontracting—Certificate of Compliance for Services and Construction The Department of Veterans Affairs (VA), VISN 15 Network Contracting Office, is seeking sources that can provide the following:
Pharmaceutical Reverse Distribution Services For All CMOP Facilities It is the responsibility of the interested source to demonstrate to the government that the interested parties can provide the services above. Please see attached Statement of Work for more details regarding the services requested.
If you are interested and capable of providing the sought out services, please provide the requested information below.
1. Please provide the following:
a. Company Name
b. Address
c. Point of Contact Name, Phone Number, and Email Address
d. SAM UEI No.
2. Please indicate the size status and representations of your business, such as, but not limited to: Service-Disabled, Veteran-Owned Small Business (SDVOSB), Veteran-Owned Small Business (VOSB), HUBZone, Woman-Owned Small Business (WOSB), Large Business, etc.).
3. Is your company considered small under the NAICS code identified under this RFI?
4. Does your company have an FSS contract with GSA, VA NAC, NASA SEWP, or any other Federal contract that can be utilized to procure the requirement listed above? If so, please provide the contract number.
5. Please submit your capabilities that show clear, compelling and convincing evidence that you can meet the requirement described in the attached Statement of Work.
Responses to this notice shall be submitted via email to Renee Kreutzer at renee.kreutzer@va.gov. Telephone responses shall not be accepted. Responses must be received no later than Friday, July 12th, 2024, at 5:00PM CDT. If a solicitation is issued, it shall be announced later and all interested parties must respond to that solicitation announcement separately from their response to this RFI. Responses to this notice are not a request to be added to a prospective bidders list or to receive a copy of the solicitation.
STATEMENT OF WORK
Pharmaceutical Reverse Distribution Department of Veterans Affairs Consolidated Mail Outpatient Pharmacy
GENERAL
The purpose of this solicitation is to establish one contract with a reverse distributor with destruction capability, hereafter referred to as the Contractor, capable of assisting the Department of Veterans Affairs (VA) Consolidated Mail Outpatient Pharmacy (CMOP), in achieving maximum credit return and in processing any related pharmaceutical waste that may arise out of non-returnable pharmaceuticals. The Government's need for on-site and off-site processing function is imperative to assure optimum inventory control and to minimize the violation of laws and regulations, especially in the area of pharmaceutical waste disposal. The contractor shall be compliant with all applicable regulations related to hazardous waste handling. Comment by Lamb, Tammie L.: Shouldn't pharmaceutical waste generated by non-returnable be disposed of with our existing hazardous waste existing contract? This was specifically brought up in the OIG report.
It is the intent that an efficient returns processing method where expired pharmaceuticals shipped to a
| centralized reverse distributor will reduce total costs in the health care system Returns to be processed will cover expired pharmaceuticals and pharmaceuticals due to be expire within 120 days from authorized agencies approved to participate in the VA’s Pharmaceutical Prime Vendor (PPV) program. Contractor | Comment by Lamb, Tammie L.: Wasn't it also discussed in report the maintaining 120 days locally until ready for return/disposition? |
| shall only accept OTCs and pharmaceutical products including unit dose and partial bottles any other products will be returned to the facility by the Contractor at the expense of the facility. | Comment by Lamb, Tammie L.: The OIG report wanted the decision made prior to sending to vendor/pickup from vendor. |
AWARD
The Government intends to award one (1) Indefinite Delivery, Indefinite Quantity, Firm-Fixed Price Comment by Lamb, Tammie L.: How is it a firm fixed price when the value given can be unknown at submission?
contract, resulting from this solicitation for a potential five-year period of performance. The Government will make this award based on Technical Capability, Past Performance and Price. Service fees shall consist of a percentage of the estimated return value for expired or near expired pharmaceuticals and the costs associated with destruction of non-returnable pharmaceuticals. Estimated return value is the amount that is expected to be credited based on the pricing file on the date the material arrives at the Contractor’s processing facility. The proposed reverse distribution processing fee shall be a firm fixed fee of the percentage of estimated return value and should cover all the contractor’s costs including, but not limited to, packaging, shipping, processing and any other applicable costs or fees incurred in performance of reverse distribution services. Payments shall be based on the actual credits, not estimated or anticipated credits, thereby increasing the contractor’s incentive to obtain maximum credit amounts. The proposed waste disposal fee shall be a firm fixed fee based on the number of pounds of product destroyed. Award will be made in the aggregate for all line items for the base year and option years. To be considered for award, offerors are required to submit a proposal for all line items. Proposals that fail to include fees for the base year and each of the four option years for all line items will be rejected and will receive no further consideration. Comment by Lamb, Tammie L.: How is estimated return value calculated? Comment by Lamb, Tammie L.: Where does the price field come from? What about open market items and Aphena? Comment by Lamb, Tammie L.: What it they don't process timely upon receipt?
ESTIMATED ANNUAL REQUIREMENTS
VA estimated pharmaceutical returns for 2023 were $7,000,000.00. The estimated volume for each facility listed in Attachment “A “represents the Government’s best estimate of annual returns in dollars and pounds of disposal that will be made through resultant contracts. The Government guarantees that it will order a minimum of $2,500 from the contract awardee for the performance of reverse distribution services under any contract resulting from this solicitation. The total ceiling for all CMOP generated sales from the performance of reverse distribution service shall not exceed $10,000,000 for the entire performance period, inclusive of the base year all four option years and the 6-month option to extend. Comment by Lamb, Tammie L.: What is the minimum for and is it on a credit card? Comment by Lamb, Tammie L.: Will the total ceiling be sufficient?
REGULATORY COMPLIANCE
The Contractor shall be required to provide all plant, equipment, materials, and labor needed to process credit return and/or arrange for proper disposal of designated pharmaceuticals. Contractor shall be responsible for complying with all applicable federal regulations such as the Code of Federal Regulation (CFR) Title 21 Food & Drugs, Title 29 Hazardous Materials, Title 40 Protection of the Environment, Title 49 Department of Transportation: U.S. Environmental Protection Agency (EPA), Occupational Safety and Health Administration (OSHA), Food and Drug Administration (FDA), Drug Enforcement Comment by Lamb, Tammie L.: Define designated?
Administration (DEA), 41 U.S.C. chapter 67, Service Contract Labor Standards and VA regulations. The Contractor shall also comply with applicable state/local regulations, and consult with regional offices of the federal regulatory agencies that have jurisdiction over their operations to ensure compliance with laws and regulations of host countries. Accordingly, the Contractor shall arrange for, recommend, and/or advise the returning drug distribution point of the proper means of transporting the returned products to Comment by Lamb, Tammie L.: OIG report wanted the decision made prior to leaving facility.
the Contractor's central processing facility.
LICENSES, PERMITS, REGISTRATION, INSURANCE
All necessary permits and licenses required by Federal, state, and local authorities shall be acquired and maintained by the Contractor for the life of the contract. This includes required licenses, certifications, etc. for individual contractor staff as well as any required permits and licenses for interstate transport, and storage/disposal of hazardous and non-hazardous unserviceable and non-returnable items or returns. This includes but is not limited to DEA, DOT, EPA, FDA, OSHA and individual State regulations.
The Contractor shall be a licensed DEA registrant to handle Schedule II - V controlled substances. A copy of all renewals shall be forwarded to the NCO 15 contracting officer for retention in the contract file.
The Contractor shall have proper insurance coverage, including environmental remediation and be prepared to list the CMOP as additional insured if awarded a contract. A copy of such insurance coverage shall be provided to the Contracting Officer, upon request.
CONTRACTOR AND SUBCONTRACTOR LICENSE QUALIFICATIONS REQUIREMENTS
The Contractor and any respective subcontractors shall maintain all necessary licenses, permits and certifications required by the Resource Conservation and Recovery Act, Clean Air Act, Clean Water Act, Occupational Safety and Health Administration, and all licenses and permits required by local agencies for reverse distribution operations. All vehicles shall have proper State and Federal Department of Transportation (DOT) licenses required for the transportation of hazardous wastes for each jurisdiction in which they will be operating under this contract.
SHIPPING/PROCESSING ARRANGEMENTS
The CMOP will contact the Contractor directly to arrange for a return shipping date. The Contractor shall provide all instructions, forms, labels and DEA approved tamper-proof pouches needed to ship the designated items to a Contractor's central processing facility. Facilities will make the determination whether to have a contractor work on-site to list all pharmaceuticals and prepare their outdated products for shipment to the reverse distribution facility for processing or have the Contractor provide off-site service. Whether the returns are processed using the Contractor’s on-site representative or via off-site processing, the Contractor is responsible for the shipment and associated costs from the facility to the Contractor’s reverse distribution facility.
If on-site service is desired, the Contractor shall provide on-site servicing within ten (15) business days from the date of the facility request. When proposing fees in response to this solicitation, the Contractor shall anticipate, at a minimum, 12 on-site visits within a calendar year per facility. Facilities requiring Comment by Lamb, Tammie L.: A minimum might be hard for new systems coming up.
more than 12 on-site visits within a calendar year may be subject to additional fees per additional visits,
| such fees shall be negotiated at the order level by the cognizant Contracting Officer. The Contractor shall | Comment by Lamb, Tammie L.: Isn't this against the OIG report? |
| not separate returnable from non-returnable pharmaceuticals on-site, instead the Contractor shall package the designated returns and transport them to the Contractor’s facility where the determination will be made concerning product that is returnable and product that is waste. The Contractor shall prepare a list of pharmaceuticals removed from the pharmacy and the facility must validate the contents of the list for | Comment by Lamb, Tammie L.: How will the site validate when already removed from facility? |
| accuracy. Any discrepancies shall be resolved prior to the removal of the pharmaceuticals from the | Comment by Lamb, Tammie L.: Discrepancies have been very difficult to reconcile because of the way the vendor accounts for half tabs or pieces. |
| facility by the Contractor. The Contractor shall remove or pick up controlled substance returns from the | Comment by Lamb, Tammie L.: Because of the discrepancies were such an issue, both controlled CMOP locations are doing in house. |
facility by close of business the same day as service is completed and boxed for return. Large or special pickups requiring separate removal shall be scheduled within 48 hours of service, and daily updates will be provided to the facility until pickup is complete. Chain of custody paperwork shall be prepared for controlled substances and given to the returning facility by the Contractor at the time the package(s) are prepared for shipment. Within thirty (30) days of receiving the returned goods, the Contractor shall process all designated items by sorting, listing, and processing items through either a manufacturer's credit program or through the disposal process in accordance with all applicable federal, state and local regulations. The Contractor shall comply with any participating customers’ additional security requirements and procedures for access to facilities. All costs associated with gaining access to any customer facility shall be the responsibility of the Contractor. Comment by Lamb, Tammie L.: Isn't this against what the OIG report identified?
PHARMACEUTICALS QUALIFYING FOR MANUFACTURER'S RETURN
Products qualifying for manufacturer’s return are pharmaceuticals, including partials pharmaceuticals, in the original manufacturer containers. Everything else is considered waste and facilities must follow applicable federal, state, and local laws and ordinance for waste disposal. For pharmaceuticals that qualify for manufacturer’s return, the Contractor shall provide the returning facility a report stating the Estimated Return Value (ERV) of those items. The ERV will be used by the customer and the Contractor as an estimate for the amount that is expected to be credited. To obtain the manufacturer's ERV the Comment by Lamb, Tammie L.: How is ERV determined?
Contractor shall use the file at http://www.pbm.va.gov/DrugPharmaceuticalPrices.aspx. Because there are daily price changes, the date to be used for the pricing file is the date the material arrives at the reverse distributor’s processing facility. The file is a dBase III compatible database (.DBF) file.
To determine the appropriate price to establish the ERV, the contractor shall use the following order of precedence, and as eligibility for these prices dictates:
1. National Contract Price (NC Price)
2. VA Federal Supply Schedule Price Restricted (VA_FSS)
3. BIG 4 Price (Big4_Price)
4. Federal Supply Schedule Price (FSS Price) Comment by Lamb, Tammie L.: What about open market and consolidated purchases?
If an item does not appear in the database, then the contractor shall use the Wholesale Acquisition Cost (WAC) as the basis for establishing the ERV for that item. The contractor shall use the prices published by First Data Bank as the source for obtaining the WAC prices. Single Order Processing: Single order processing is required for each visit/pickup/package sent. No batch processing. Comment by Lamb, Tammie L.: Define Single order processing.
PHARMACEUTICALS INELIGIBLE FOR CREDIT FROM MANUFACTURER
The Contractor shall list all items (including non-controlled and controlled substances and non-hazardous and hazardous substances) designated for disposal on a disposal manifest. This list will include at a minimum product name, National Drug Code (NDC) or catalog number, quantity, total estimated return value, and reason for non-eligibility for credit. Separate manifests shall be provided for the disposal of Comment by Lamb, Tammie L.: OIG report referenced a database where they could tell immediately if something was non-eligible.
Schedule II – V controlled substances and when disposing of hazardous waste products as defined by the EPA Resource Conservation and Recovery Act (RCRA) regulations. A Certificate of Destruction including the disposal date, destruction method, destruction location, weight, disposal company name and proof of destruction affidavit shall be provided to the returning facility and maintained on the reporting website upon completion of destruction. All Manifests shall be provided to the returning facility within 30 calendar days of Contractor's item receipt, with the exception of the Certificate of Destruction/Affidavit which shall be provided within 30 days of the completion of destruction.
Shipments to the Contractor that require transport to the disposal location shall be done via approved and licensed vehicles in accordance with federal, state, and local laws and regulations where the processing will be completed. Contractor spills or releases of toxic/hazardous substances into the environment shall be reported to the returning facility immediately.
PAYMENTS
This contract is issued under Exchange/Sale Authority, allowing the government to retain reverse distributed pharmaceutical proceeds for the sole purpose of procuring additional pharmaceuticals. Such Comment by Lamb, Tammie L.: I need to review Exchange/Sale Authority.
proceeds are referred to as “credits” throughout this contract to align with commercial practice. The payment of return fees and disposal services to the Contractor based on the Estimated Return Value (ERV) obtained from the pricing file in paragraph 9 of the Statement of Work will be paid by the Government and NOT out of facilities’ credits after actual credits are obtained from the manufacturer through the VA Pharmaceutical Prime Vendor (PPV). When actual credits are received, the Contractor shall update its database reflecting the actual credits received from the manufacturer and reconcile the difference between the estimated return value and the actual credits received based on the manufacturers’ credit memos. Credit memos must be requested by the Contractor from the manufacturers for all credits issued. Credit memos will be provided by the Contractor to each facility receiving credits and used by each facility for comparison of records/transactions of credits pending, credits received. On a quarterly basis, the Contractor and each agency/facility will work together to reconcile any discrepancies between the facility records and the Contractor records. The exact payment amount to be made to the Contractor shall include only the awarded contracted fee for return and disposal services as defined under paragraph 2, Awards and shall be paid directly from the Government not through credits. Comment by Lamb, Tammie L.: Is this amount paid for using a credit card or by OOD with money estimated for each pickup for the year?
To ensure adequate tracking of credits from inception to disposition, the Contractor shall provide the PPV confirmation of itemized credit statements received from the manufacturers at least on a monthly basis.
The contractor shall instruct manufacturers to issue all credits directly to the PPV since the PPV has credit accounts established for each authorized user of the PPV Program for purposes including reverse distribution. Any credits received by the Contractor from the manufacturer shall be forwarded to the PPV within ten (10) business days from date of receipt. In addition, each agency/facility that receives credits directly from the manufacturers as a result of reverse distribution processing will be instructed to notify the Contractor of receipt of such credits so that the Contractor can update their electronic reporting system. Credits will be deposited into the individual facility accounts by the PPV upon receipt of itemized credit statements for each individual facility provided by the Contractor. The credit statements provided by the Contractor to the PPV shall include the customer account number and appropriate invoice number to facilitate this process and for tracking purposes. Based on the above, any arrangements to facilitate the processing of credits through the PPV must be made solely between the Reverse Distributor and the PPV. Any fees associated with this arrangement shall not be removed from the facility credits due. Credits may NOT be used by VA PPV customers for additional value-added services from the Contractor, such as report customization or additional site visits, for VA facilities. Comment by Lamb, Tammie L.: Will we need a special PPV account for RD? Are they going to use the TPC account?
Within 15 days from receipt of award, the CMOP Contracting Officer shall be notified by the contractor awarded a contract under this solicitation if any business-to-business agreements cannot be reached with the VA PPV. Failure or refusal to reach agreement with the VA PPV shall constitute sufficient cause for terminating the contract under Federal Acquisition Regulation Part 52.212-4(m), Contract Terms and Conditions-Commercial Items, Termination for Cause unless such failure is unintentional and for valid and justifiable reasons despite good faith discussions. The Contractor is encouraged to establish a working relationship with each manufacturer and comply with each manufacturer’s return goods policy to ensure maximum credit receipt and reduce the cost of returning non-returnable items. The Contractor is responsible for contacting the manufacturer to ensure that credits are received in accordance with the negotiated timeframe stated in each return goods policy and to assist in resolving issues of inadequate or non-payment of outstanding credits. If manufacturers have an established reverse distributor that handles their credit and return process, the awarded Contractor shall make every effort to work with these reverse distributors that have current agreements directly with the manufacturers.
NOTE: There may be instances where more favorable return good policies have been negotiated on Federal Government contracts. In order to take advantage of more favorable return policies, Comment by Lamb, Tammie L.: It has been my experience that other reverse distribution centers doing the work for manufacturers historically are very difficult and slow to get supporting documentation.
the Government Contracting Officer will assist in providing a copy of the negotiated agreement(s) to the Contractor. There may be manufacturers that will only accept returns directly from the facility and will only provide credits through their own reverse distributor. If known, the Contractor shall identify in its proposal, those manufacturers that will not accept products through this Reverse Distribution Program.
WEB-BASED SERVICE REQUEST ORDERING SYSTEM
The contractor shall provide an 800 number and a web-based service request ordering system for work order placement by customers. At a minimum, the system shall include entry fields for Facility Name, Address, City, State, Zip Code, Contact Name, Phone Number, E-mail, DEA Number, Desired Pickup Date, Description of Returns and Estimated Quantity. In addition, the web-based service request ordering system shall allow for electronic order confirmation, inventory status of credits, credit reconciliation, and reporting capabilities to allow facilities to track from inception of product to credit disbursement and/or disposal.
REVERSE DISTRIBUTION PROGRAM ELIGIBLE FACILITIES
Government Participants. The contractor shall provide reverse distribution services at the fees awarded herein for the facilities below as well as other government agencies approved to participate in the VA’s Pharmaceutical Prime Vendor (PPV) program.
Consolidated Mail Outpatient Pharmacies (CMOPs)
VA CMOP
Leavenworth – 760 5000 South 13th St Leavenworth KS 66048
**VA CMOP
Leavenworth – 760 5000 South 13th St Shawnee KS 66048 **Future Location
VA CMOP
Chelmsford – 761 10 Industrial Ave.
Chelmsford, MA 01824-3610
VA CMOP
Tucson – 762 3675 Britannia Dr Tucson, AZ 85706
VA CMOP
Lancaster – 763 2962 S. Longhorn Dr Lancaster, TX 75134
VA CMOP
Murfreesboro – 764 5171 Sam Jared Drive Murfreesboro, TN. 37130
VA CMOP
Murfreesboro II – 764 3209 Elam Farms Pkwy Murfreesboro, TN 37127
VA CMOP
Hines – 765 5th and Roosevelt Bldg. 37 NW Dock 18 Hines, IL 60141
VA CMOP
Charleston – 766 4136 Carolina Commerce Parkway Ladson SC 29456
Offerors are advised that a limited number of additional participants may be added or deleted by modification throughout the life of the contract. Comment by Lamb, Tammie L.: Need to add EPS & possibly MbM.
IMPLEMENTATION PLAN
Offerors shall submit a written proposed plan detailing implementation of the Reverse Distribution Program including details on how billing will be completed (credit card, PO, etc.). Recognizing that some facilities may prepare their returns on a monthly basis, the Government anticipates no more than sixty (60) days from the date of award to transition facilities over to the new prospective contracts.
Billing requires the ability to accept both credit card (Visa and MasterCard) and invoice options depending on the value of the transaction. Individual orders will specify the local options. Additional information regarding invoicing procedures is included in the clauses.
CONTINGENCY PLAN
The contractor shall submit and maintain a plan for contingency operations, which identifies the ability to provide uninterrupted support of the requirements outlined in this solicitation under emergency and/or contingency conditions. Comment by Lamb, Tammie L.: Would need to add the functionality to ship every thing in to facility in times similar to pandemic.
REPORTS
The Contractor shall provide a return detail report by manufacturer to each returning facility within (30) calendar days after processing for all credit returns. This report should include at a minimum, the customer account number, applicable order or invoice number, product name, NDC or catalog number, lot or batch number, quantity returned, date returned, unit of measure, estimated return value, and a list of non-returnable pharmaceuticals with the weight and cost for disposal. An additional credit report shall be provided showing both the estimated credits and actual credits received, including total actual credit received and credit received by unit of measure for each NDC, as well as the date that the credit was issued, and identify contractor fees taken for each pharmaceutical return. The contractor shall provide copies of the manufacturer credit memos with this report to ensure adequate tracking of credits from inception to disposition. Separate reports shall be provided for Schedule II – V controlled substances and for hazardous waste to include weight of disposal. The Contractor shall provide a web-based reporting tool that will generate the following reports: Comment by Lamb, Tammie L.: Will this vendor handle DSCSA or will manufacturer be notified to handle?
1. Monthly status reports of credit receipts listing the contract/order or invoice number, manufacturer, estimated return value, actual return value, and pending credits from the contractor to the facility.
2.Monthly reconciliation reports for each individual account. Reconciliation data shall include but not be limited to NDCs, quantities, partial/full data, product names, vendors, strengths, sizes, and forms.
3. Quarterly roll-up reports shall be provided to the Program Offices identified below which include, as a minimum the ERV for non-credits (destruction), charges for services, credits received, and credits pending.
All three above referenced reports shall be made available on the reporting website and sent to the following personnel:
VA – Reporting requirement shall be emailed to @va.gov Comment by Lamb, Tammie L.: Create new distribution groups for each site.
VA Reporting Requirements:
format: ^ delimited text file AND Excel Spreadsheet, VA example report headers shown below
(Report only completed transactions within the applicable reporting period) VA Station Number Contractor Name (reverse distributor) Customer Name (facility name) Customer Number (internal contractor customer number) DEA Number (IF APPLICABLE; 9 alpha numeric designator) Job Number (internal job number assigned) Wholesaler Account Number (account number credit routed to) Service Date NDC Number (National Drug Code; 11 digits; no dashes) NDC Package Size UPC (if no NDC exists) Product Name Manufacturer DEA Class (1, 2, 3, 4, or 5; leave field blank if non-controlled) LOT Number (IF APPLICABLE) QTY Returned (As decimal of total number of NDC units) Unit of measure (bottles, tablets, cases, etc.)
Form (SOL – solution; CAP – capsule; TAB – tablet; SYR – syrup; KIT – kit; SGL – soft gels; PDR – powder; PKT – packet; CRM – cream; OIN – ointment; INJ - injection) Expiration Date Processing Fee (on-site / off-site fee assessed) HAZ Disposal Cost NON HAZ Disposal Cost ERV (estimated return value) ARV (actual return value) Credit Date (date credit awarded to customer) Credits (total credit received and credit received by unit of measure) Pending Credits (future credits due) Non-Return Value Returnable (Y/N) (indicate if returnable) Reason For Non-Eligibility (indicate reason for non-returnable items) BO9 Invoice number once credit is issued ** VA-only fields NOTE: VA will have access to all customers’ web-based reporting tools. The reports should be constructed to allow the customers maximum flexibility to sort the data as needed. A typical report should provide the customer’s name, address and phone number, NDC of drug, generic or brand name (when appropriate), manufacturer, quantity returned and unit of issue (e.g., tablets, milliliters, and grams), ERV or non-returnable with a reason code.
DASHBOARD REPORTING REQUIREMENT
The reverse distribution vendor shall provide a web-based corporate level dashboard and reverse distribution information system available to the user at each facility or each agency for the purpose of managing, tracking and comparing the processing of unused pharmaceutical returns across the government service or agency. The web-browser based application is the preferred and required type of digital dashboard specified by this contract. The reverse distribution information system shall provide for multiple levels of access based upon the users’ level within the government service or agency (e.g., office of the surgeons general, regional or local facility) and shall provide data elements based upon standard variables (see paragraph 17, reporting requirements for metric and key performance indicators). The digital dashboard and reverse distribution information system shall be configured to track the flow of business processes associated with the return, destruction, disposal, waste, credit or other disposition of unused pharmaceuticals processed from the agency through the reverse distributor. The system shall provide graphic representation (i.e., dials, graphs, charts, etc.) of high-level processes and allow for drill down into low level data, with the purpose of allowing agency executive level leaders the ability to view and make comparisons of return processes and data across the agency. The dashboard shall use standardized metrics and key performance indicators and display these data points to allow comparison between different levels of the agency (i.e., agency or service level, and regional level). The digital dashboard shall display data elements in both a control panel format and database table format. Users will be able to generate and export data from the control panel into a downloadable spreadsheet (e.g., Excel spreadsheet). The digital dashboard and reverse distribution information system will allow users to monitor the return of unused pharmaceuticals through the vendor and compare the activities of the various levels (i.e., agency or service level, and regional level). Features and benefits of the dashboard and reverse distribution information system shall include visual presentation of performance measures.
ability to identify and correct negative trends; measure of efficiencies/inefficiencies; ability to generate detailed reports showing new trends; overall visibility of the activities across an agency or service.
efficient identification of data outliers and correlations. The dashboard software/application will provide decision makers with the input necessary to manage the reverse distribution business process by providing a web-based graphical user interface designed to display summaries, graphics (e.g., charts, graphs, gauges) in a portal-like framework to highlight important information and benchmark across a corporate, regional and treatment facility level so that the number of pharmaceutical credits across the systems can be maximized.
TRAINING REQUIREMENTS
The Contractor shall provide, at no cost to the Government, orientation and training down to the facility level on the various reports and functionality of reports to assist the facilities in monitoring and tracking potential credits. Training shall include actual demonstration and operation of the web-based electronic service request ordering system. In addition, the Reverse Distributor shall provide updates and system changes, and training prior to the adoption of changes as they occur throughout the term of the contract. Training should be provided on-site at each participating customer’s facility. The contractor shall notify all sites 14 calendar days before the date of their scheduled training. Training shall cover at a minimum the following:
• Full web access and reports training, including targeted data extrapolation.
• Reconciliation reports between estimated and actual credits.
• Potential inventory management strategies.
An instructional user guide with step-by-step instructions on the above topics shall also be provided via a link on the reporting website. A contact person and telephone number shall be provided to each facility in the event additional instruction is necessary or if there is a change in personnel.
CONTRACT ADMINISTRATION AUTHORITY
(a) The NCO 15 Contracting Officer is the only person authorized to approve changes or modifications to the requirements under this contract on behalf of the Government.
(b) In the event the Contractor makes any changes at the direction of any person other than the NCO 15 Contracting Officer, such changes shall be considered to have been made without authority and any adjustments in price involved as a result of unauthorized changes to the contract will not be ratified.
(c) Each facility will have a designated Contracting Officer’s Representative (COR) who will serve as a point of contact for all matters pertaining to the technical aspects of the contract. At time of contract award, or upon appointment the Contractor will be furnished with a copy of the COR’s appointment letter. CORs have limited authority as delineated by the cognizant Contracting Officer in their appointment letter and cannot make any commitment obligating the Government.
(d) In addition to designated CORs that will be responsible for all technical aspects of the contract, each facility will have a designated Ordering Officer or Contracting Officer. Only VA personnel officially designated as Ordering Officers under the Reverse Distribution contract or warranted contracting officers may place orders under this contract. Ordering Officers do not have the authority to negotiate, make any commitments or changes that will affect the terms and conditions of this contract. Ordering Officer Designations pertain only to the CMOP’s.
FEDERAL GOVERNMENT HOLIDAYS
The following information is provided to assist the Contractor in scheduling returns when on-site service is required:
New Year's Day January 2nd Martin Luther King's Birthday Third Monday in January President's Day Third Monday in February Memorial Day Last Monday in May Juneteenth June 19 Independence Day July 4th Labor Day First Monday in September Columbus Day Second Monday in October Veterans Day November 10th Thanksgiving Day Fourth Thursday in November Christmas Day December 25th *If these holidays fall on a Saturday or Sunday, the contractor should contact the returning facility to determine on which day (Friday or Monday) they will be observed.
Annual Federal Holiday schedule may be attained at https://www.opm.gov/policy-data-oversight/pay-leave/federal-holidays/
The following represents the current VA Pharmaceutical Prime Vendor as of the date of this solicitation.
The Contractor will be given notice via e-mail within 90 days when a change occurs.
McKesson Corp. Pharm. Group 1220 Senlac Drive Carrollton, TX 75006 Point of Contact:
Ms. Lori White, V.P. National Accounts Phone: 972-446-5758 Fax: 972-446-5337 I. General Information
a. Offerors shall submit a list of names and telephone numbers of persons authorized to conduct negotiations.
b. Delivery & Submission Method
i. Electronic Delivery of Proposals. Electronic submission to @va.gov is acceptable, and preferred. Timeliness of proposals will be determined IAW 52.212-1(f) or 52.215-1(c)(3)(ii)(A). Be advised that large electronic files are problematic due to limitation on Government email inboxes. In addition .zip files are stripped from e-mails and cannot be submitted. Utilization of AMRDEC SAFE at https://safe.amrdec.army.mil/safe/Welcome.aspx, is acceptable transmission tool. Send early and verify receipt. AMRDEC SAFE supports file sizes up to 2GB. USB and CD submissions are unacceptable as the VA has technical restrictions/limitations on the use of those technologies.
c. Proposal Format. Format of the proposal volumes shall be as follows:
i. Text size shall be no smaller than what is equivalent to Microsoft Word, Times New Roman, 10 point, uncompressed fond.
ii. Pages shall be dated and numbered sequentially by volume. A cover sheet shall be included with each volume clearly marking the volume number, title, solicitation identification and the offeror’s name.
iii. Each volume shall contain a glossary of all abbreviations and acronyms used and an explanation for each.
iv. Elaborate format, color representations, and bindings are not desirable. If submitted via hard copy three-ring binders are preferred. The pages in binders shall be easily removed to facilitate scanning. Any pages that are changed (as a result of negotiations) should have changed information clearly marked by a vertical line in the right margin of the page and/or circling if changing data in a chart. The offeror shall indicate the new date on revised pages.
v. Legible tables, charts, graphs and figures shall be used when necessary to depict organizations, systems and layout, implementation schedules, plans, etc. These displays shall be uncomplicated, legible, and shall not exceed 11 by 17 inches in size as submitted hard copy or printed. Foldout pages shall fold entirely within the volume and count as one page. Foldout pages may only be used for large tables, charts, graphs, diagrams, and schematics, not for pages or text. For tables, charts, graphs, and figures, the text shall be no smaller than 8 point, Times New Roman.
II. Technical
a. Technical Capability Information and Management Approach shall be submitted as Volume I and shall be no more than 50 pages. The technical volume shall be provided as follows:
i. Identify any “exceptions” to the solicitation’s technical requirements and state precisely how the offered supplies/services differ.
ii. Address Technical Capability including the ability to serve all required areas and website reporting services (including the ability to roll-up data to local, regional and national levels).
iii. Provide the Management Approach to schedules (including the implementation schedule, technical risk, on-site visits and processing) and the proposed contingency plan.
iv. The information provided should be specific, detailed, and complete as to clearly and fully demonstrate that the prospective contractor has a thorough knowledge and understanding of the requirement and has valid and practical solutions to technical problems. Comment by Lamb, Tammie L.: What and where is Volume II
III. Past Performance
a. The Past Performance portion of the proposal shall be submitted as Volume III and shall be no more than a maximum of five (5) pages for the narrative summary and 1 page for the matrix.
b. The offeror shall provide a minimum of three (3) and a maximum of five (5) past performance references. (see paragraph e below re additional requirements) The offeror shall contact past performance references directly and request that they complete and submit the Contractor Performance Questionnaire (Attachment hereto) to the address in Block 9 of SF 1449, Page 1 of the solicitation or to @va.gov in accordance with the timeline set in Block 8 of SF1449, Page 1 of the solicitation. The completed questionnaires shall be sent directly from the POC to the contracting officer, Under no circumstances shall the questionnaires be returned to the offerors. Any information provided by the offeror’s references is subject to verification/validation by the Government during the evaluation process. In the event references are not received by the close of the solicitation, the Government may make but is not required to contact and follow up with the listed references identified on the Contractor Past Performance Data matrix.
c. Offerors shall provide a one (1) page matrix identifying the following information for each of the
i. Past Performance Questionnaires sent out: Organization/Customer
ii. Brief Description
iii. Contract Number
iv. Telephone & Email of Organization/Customer Point of Contact (POC) The offeror’s matrix shall contain a minimum of three (3) and a maximum of five (5) references to contracts that are recent and relevant to this requirement. Proposals must prove PPQs have been sent to each POC; Failure to send the PPQ to each POC will be considered a proposal deficiency and may result in exclusion of the offeror’s proposal from consideration for award. The offeror shall exert its best efforts to ensure that at least two POCs per relevant contract submit a completed Present/Past Performance Questionnaire directly to the Government.
d. Up to five (5) one-page summaries of each contract reference identified in the past performance summary matrix may be submitted. Offerors should include a discussion of any significant achievements and explain any Past Performance problems that it considers relevant to the proposed efforts. Offerors should also discuss past and present efforts to identify and manage program risk.
e. For the purposes of this solicitation, current contracts are defined as those on which performance occurred during the last three (3) years. In determining relevancy, the offeror should consider the type and value of the contract, and the type of requirement compared to this solicited requirement. The offeror should also consider the level or amount of effort. Only past performance dealing with the type of work noted in the statement of work included in the solicitation will be considered relevant. The offeror must detail (if using the “related technology” as a reference) how the “related technology” is applicable to the solicited effort. Should the offeror not explain how the related technology is applicable, the reference may not be considered relevant. If an offeror has no current or relevant past performance information, they should so state that in this volume.
f. Each offeror shall submit present and past performance information for itself on projects of similar size, scope, and technical complexity. The Offerors may choose to submit present and past performance information for major proposed subcontractors, team members, and/or joint venture partners that have experience in projects of similar size, scope, and technical complexity with its proposal. The total number of past performances references for each offeror shall not exceed five (including any references submitted by subcontractors, team members and/or joint ventures). This volume shall provide a list of current and relevant contracts on which the offeror has performed in the format requested in the Proposal Requirements portion of this document. This information, as well as other information the Government may obtain elsewhere via Government databases (CPARs, PPIRs etc.) and other government agencies (DCMA, DCAA etc.), will be used to evaluate the offeror's past performance. The Government reserves the right to solicit feedback beyond what is identified in the questionnaire. Offerors are notified that the Government will use the data provided in this volume that is determined to be current and relevant to the effort at hand and data obtained from other sources in the development of performance risk assessments.
IV. Price – The offeror shall complete the pricing tables in the schedule.
EXCEPTIONS
Offerors are not encouraged to take exceptions to this solicitation, however, any exceptions taken to the specifications, statement of work, or terms and conditions of this solicitation shall be explained in detail and set forth in a cover letter as well as in the cost proposal. Offerors are to detail the section, clause paragraph and page to which they are taking exception. OFFERS THAT DO NOT CONFORM
TO THE REQUIREMENTS OR THAT TAKE EXCEPTION TO ANY TERM IN THE
SOLICITATION MAY BE DETERMINED UNACCEPTABLE AND MAY BE REJECTED
WITHOUT FURTHER EVALUATION.
ATTACHMENT “A” – Estimated Annual Requirements by Agency ATTACHMENT “B” – CMOP Facility Listing ATTACHMENT “C” – Wage Determination Information ATTACHMENT “D” – Sample Wage Determination ATTACHMENT “E” – Past Performance Information ATTACHMENT “F” – VA Pharmaceutical Prime Vendor Contractor
52.212-2 EVALUATION—COMMERCIAL ITEMS (OCT 2014)
(a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation requirements, is determined to provide the “best value” to the Government. The “best value” determination will be based on the merits of the offer and the offeror’s capability. The “best value” may not necessarily be the proposal offering the lowest cost, nor receiving the highest technical rating. As specified in the FAR 52.215-1 “Instructions to Offerors--Competitive Acquisition” provision, the Government intends to evaluate proposals and award a contract without discussions. An offer must be acceptable for the offeror to be eligible for award. OFFERS THAT DO NOT CONFORM TO THE REQUIREMENTS OR THAT TAKE
EXCEPTION TO ANY TERM IN THE SOLICITATION MAY BE DETERMINED
UNACCEPTABLE AND MAY BE REJECTED WITHOUT FURTHER EVALUATION.
(b) Proposals will be evaluated on technical approach, past performance and price as listed in the factors below. Evaluation factors when combined (other than cost/price) are more important than cost/price.
However, cost is an important factor and should be considered when preparing proposals. In summary, technical/price/past performance tradeoffs will be made.
(c) The offeror’s proposal shall be in the format prescribed by, and shall contain a response to, each of the areas identified in the proposal instructions. The evaluation factors and associated subfactors for the award decision are listed below. The Factors and Subfactors are listed in descending order of importance. Factors I-IV, when combined, are slightly more important than Factor V (price).
FACTOR I - Technical Capability (The subfactors are in descending order of importance)
SUBFACTOR A – Compliance with the Drug Supply Chain Security Chain Act.
SUBFACTOR B – Debit Memo.
SUBFACTOR C – Transparency of Process
a. List of what is and is not returnable. Product return list. Tell us onsite what is and not returnable.
b. How long process takes and accountability/chain of custody until we get the return. Knowing how long it will take to get the return.
c. Knowing which batch, the credit is for.
d. Communication of the process.
e. Ability to serve all required areas
f. Website reporting services (including…
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