P09 PWS VACHS Pharmaceutical Reverse Distribution 21 Dec 2022.docx

B.2 PERFORMANCE WORK STATEMENT

PERFORMANCE WORK STATEMENT PHARMACEUTICAL REVERSE DISTRIBUTION SERVICES AT VA CARIBBEAN HEALTHCARE SYSTEM

1.0 Introduction. This is a non-personal services contract to provide Pharmaceutical Reverse Distribution Services at Veterans Affairs (VA) Caribbean Healthcare Systems (VACHS). The contactor shall process damaged, expired, and/or unused drugs at the Inpatient & Outpatient pharmacies in San Juan VA Medical Center, Ponce Outpatient Clinic (POPC), and Mayaguez Outpatient Clinic (MOPC). The government shall not exercise any supervision or control over the contract service providers performing the services herein. Such contract service providers shall be accountable solely to the contractor who, in turn is responsible to the Government. The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services necessary to process credit return and/or arrange for proper disposal of designated pharmaceuticals, including Schedule II through V controlled substances at VACHS as defined in this Performance Work Statement (PWS), section three (3.0) except for those items specified as Government-furnished property and services.

1.1 Mission and Vision. The Pharmacy mission is “To honor America’s veterans by providing exceptional pharmacy care that improves their health and well-being”. The vision of our service is to be a patient-centered service for veterans providing excellent health care, research, and education.

1.2 Background. The VA Caribbean Healthcare System provides services to a population of 150,000 Veterans in Puerto Rico and the U.S. Virgin Islands. In Fiscal Year (FY) 2008, the VA Caribbean Healthcare System registered 66,955 unique patients with 11,428 inpatients treated and provided 927,072 outpatient visits at all clinic areas in Puerto Rico and the U.S. Virgin Islands. The VACHS is located at 10 Casia St. San Juan, Puerto Rico.

1.3 Scope. The Contractor shall perform these requirements in accordance with this PWS, manufacturer's manual, local, state, and federal laws and regulations, and Veteran Affairs (VA) regulations. In addition, the contractor shall be compliant with all applicable regulations related to non-hazardous and hazardous waste and controlled substances handling. In the event of conflict between regulatory guidance, the most stringent requirement shall apply. The contactor shall have destruction capability. The contractor shall be capable of achieving maximum credit returns and in processing any related pharmaceutical waste that may arise out of non-returnable pharmaceuticals.

2.0 General Requirements. This section describes the general requirements for this effort. The following sub-sections provide details of various considerations on this effort.

2.1 Non-Personal Services. The Government shall neither supervise contractor employees nor control the method by which the contractor performs the required tasks. Under no circumstances shall the Government assign tasks to, or prepare work schedules for, individual contractor employees. It shall be the responsibility of the contractor to manage its employees and to guard against any actions that are of the nature of personal services or give the perception of personal services. If the contractor believes that any actions constitute, or are perceived to constitute personal services, it shall be the contractor's responsibility to notify the Contracting Officer (CO) immediately.

2.1.1 Type of Contract. The Government will award a firm-fixed price contract.

2.1.2 Period of Performance. The period of performance for this effort will be a base year of 12 months and four (4) one-year option periods. The base period and options will be established after the effective date of contract award. Each option will be exercised at the government’s discretion. In addition, the resulting contract will have an additional option to extend the services for up to six (6) months at the government’s discretion.

2.1.3 Location and Hours of Work. The contractor shall provide the services at the following locations during the core hours of operation from 7:00 AM to 4:00 PM Monday through Friday, except during Federal Holidays.

Frequency

(Ponce Outpatient Clinic) VA Euripides Rubio Clinic- Ponce OPC- Outpatient Clinic 1802 Navarra St. Ponce, PR 00716 Phone: (787)812-3030, ext. 244154

(Outpatient Pharmacy) VA Caribbean Healthcare System 10 Casia Street San Juan, PR 00921 Phone: (787) 641-7582, ext. 131668

(Inpatient Pharmacy) VA Caribbean Healthcare System 10 Casia Street San Juan, PR 00921 Phone: (787) 641-7582, ext. 147049

(Mayaguez Outpatient Clinic) Mayaguez Outpatient Clinic State Road # 2 Km. 149.9 Ave. Algarrobo, Bo. Sabanetas Mayaguez, PR 00681-1507 Phone: (787) 834-6900, ext. 248473

2.1.4 Recognized Government Holidays. The Contractor will not be required to work on the legal public holidays listed below. Holidays occurring on weekends will be observed as directed by the published United States Office of Personnel Management (OPM) calendar.

2.2 Business Relations. Contractor has the responsibility to integrate and coordinate all activity needed to execute the requirement in this procurement. Poor quality performance and potential problems shall be provided with a corrective action plan to be submitted as fast as the situation required. This action include work provided by any subcontractor. All personnel assigned shall provide and maintain satisfactory customer service, professional conduct, and acceptable ethical behavior. Within the bounds of acquisition policy, the VACHS intends to work to find solutions that will be beneficial to both the Government and its Contractors.

2.3 Contract Administration and Management

2.3.1 Post Award Conference/Performance Evaluation Meetings. The Contractor may be required to attend a post award conference convened by the contracting activity or contract administration office in accordance with Federal Acquisition Regulation (FAR) Subpart 42.5. This meeting may be conducted virtually. Written minutes of such meetings will be recorded by the Contractor and signed by the Program/Project Manager and the CO and/or COR and distributed within five (5) workdays after the meeting. Subsequent meetings may be called by either party to reconfirm mutual understandings and/or address deficiencies in the Quality Control (QC) system or procedures which may require corrective action by the Contractor. The Contractor Representative shall meet with the COR and/or CO as required. A mutual effort will be made to resolve all problems identified. The Contractor Representative and the COR shall sign the written minutes of these meetings.

2.3.2 Contract Administration. Notwithstanding the contractor’s responsibility for total management during the performance of this contract, the administration of the contract requires maximum coordination between the government and the contractor.

2.3.2.1 Contracting Officer (CO). The CO is the only person authorized to direct changes in any of the requirements under this contract, and, notwithstanding any provisions contained elsewhere in this contract, said authority remains solely in the CO. In the event the contractor effects any such change at the direction of any person other than the CO, the change will be considered to have been made without authority and solely at the risk of the contractor. All contract administration will be affected by the CO. Communications pertaining to contractual administrative matters shall be addressed to the CO. No changes in or deviation from the terms and conditions shall be affected, without a written modification to the contract, executed by the CO authorizing such changes.

2.3.2.2 Contracting Officer's Representative (COR). In accordance with Veteran Affairs Acquisition Regulation (VAAR) Clause 852.270-1, Representatives of the Contracting Officers, the CO reserve 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. Such designation will be in writing and will define the scope and limitation of the designee’s authority. A copy of the designation shall be furnished to the contractor.

2.3.3 Licenses, Permits, and Registration. The contractor shall have necessary permits and licenses required by Federal, state, and local authorities shall be acquired and maintained at all times 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.

2.3.3.1 The Contractor shall be a licensed DEA registrant to handle Schedule II - V controlled substances. In addition, the contractor shall have the appropriate licenses, permits, and/or certifications as required by the Office of the Auxiliary Secretary for the Regulation and Accreditation of Healthcare Facilities (known as SARAF) and the Puerto Rico Mental Health and Anti-Addiction Services Administration (PR-MHAASA, also known as ASSMCA). A copy of all renewals shall be forwarded to the contracting officer for retention in the contract file.

2.3.3.2 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.

2.3.4 Contractor Employees. The contractor shall accomplish the assigned work by employing and utilizing qualified personnel with appropriate combinations of education, training, and experience. The contractor shall match personnel skills to the work specified herein. The contractor shall ensure the labor categories/occupation code as defined by the Department of Labor are aligned to those tasks delineated in this PWS. The contractor shall comply with the minimum rates established in the applicable wage determination for this service. The Contractor shall provide the necessary resources and infrastructure to manage, perform, and administer the contract.

2.3.4.1 Contractor Identification. All contract personnel shall be identified as a Contractor (i.e., badge, company logo, or uniform). All contract personnel are required to identify themselves such that they avoid creating an impression in the minds of members of the public that they are Government officials. They must also ensure that all correspondence (documents, emails, etc.) or reports produced by the Contractor are suitably marked as Contractor products or that Contractor participation is appropriately disclosed.

2.3.5 Key Personnel. The contractor shall provide a point of contact to administer this contract. All key personnel shall have means of verbal and e-mail communication with the COR. Key personnel and alternates must be able to communicate fluently in English both verbally and in writing.

2.3.6 Personnel Qualification:

2.3.6.1 Contractor personnel shall be trained and certified to provide the services requested under this PWS.

2.3.5 Standards of Conduct. Standards of Conduct. Contractor personnel’s conduct shall not reflect discredit upon the Government. The Contractor shall ensure that personnel present a professional appearance. Contractor’s employees shall observe and comply with all local policies and procedures concerning fire, safety, environmental protection, sanitation, security, and possession of firearms or other lethal or illegal weapons or substances. The Contractor is responsible for ensuring that any contractor employees providing services under this contract conduct themselves and perform services in a professional, safe, and responsible manner. The contractor shall remove, from the job site, any employee for reasons of misconduct or security. The contractor shall ensure employee conduct complies with 41 U.S.C. 423, Procurement Integrity. The contractor shall also ensure that no contractor employees conduct political related activities or events on VACHS facilities.

2.3.6 Contractor personnel and property shall be subject to search and seizure upon entering and leaving the confines of VACHS facilities. The Contractor shall be responsible for assuring that all personnel authorized to perform work under this contract obtain facilities’ access as required. The Contractor shall provide to the COR a personnel roster listing. The Contractor shall always maintain an updated listing. New employees shall comply with the minimum requirements listed in this PWS. Contractor access to the VA facilities shall be exclusively for work in connection with this contract.

2.3.7 Contractor is responsible for the supervision of all their employees while on government property. It is the Contractor's responsibility to assure compliance with this PWS and requirements referenced in this contract. Provisions provided in the PWS are not intended to relieve the Contractor of this responsibility.

2.3.8 Contractor personnel may be required to interrupt their work at any time so as riot to interfere, with the normal functioning of the facility, including utility services, fire protection systems, and passage of facility patients, personnel, equipment, and carts.

2.3.9 Health and Safety. The contractor and its subcontractors, if any, shall comply with Public Law 91-596, Occupational Safety and Health Act (OSHA). In addition, the contractor shall comply with 29 CFR 1910, Occupational Safety and Health Standards, and all other applicable federal, state, and local requirements for protecting the safety of the contractor's employees, building occupants and the environment. All applicable standards of the OSHA shall be followed when working in accordance with this service.

2.3.9.1 In performance of this contract, the Contractor shall follow Veterans Affairs Central Office (VACO) Directive 7710, Occupational Safety and Health, for safe work practices. The Contractor shall comply with VACHS smoking policy, which designates all space as non-smoking areas.

2.3.9.2 The Contractor is responsible to identify, provide and maintain all personal protective equipment (PPE) required to perform the duties outlined in the contract. In addition, the contractor is responsible for identifying and providing all applicable safety programs required to perform the work. Training on required safety programs and the proper use of PPE's shall be provided, and documentation maintained by the contractor.

2.3.10 Injury or Accident Reporting. The Contractor shall maintain an accurate record of accidents resulting in injury or death and accidents resulting in damage to government property, supplies, and equipment.

2.3 Environmental Requirements.

2.4.1 Executive Orders (EOs) 13990, Protecting Public Health and the Environment and Restoring Science to Tackle the Climate Crisis and 14057, Catalyzing Clean Energy Industries and Jobs Through Federal Sustainability applies to this service. A copy of EO 13990 can be found at the Federal Register webpage at https://www.federalregister.gov/documents/2021/01/25/2021-01765/protecting-public-health-and-the-environment-and-restoring-science-to-tackle-the-climate-crisis; EO 14057 can be found at https://www.federalregister.gov/documents/2021/12/13/2021-27114/catalyzing-clean-energy-industries-and-jobs-through-federal-sustainability.

2.4.2 Environmental Compliance. The Contractor shall comply with all federal, state, local and facility environmental laws, rules, and plans.

2.5 Other Regulatory Compliance. Schedule II-V returns are not permitted from outside the Customs Territory of the United States. 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 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 the Contractor's central processing facility.

2.6 Physical Security. The Contractor shall conduct his operations to cause the least possible interference with normal operations of the government because the facilities will remain in operation during the entire maintenance period.

2.7 Liability and Responsibility for Damaged Property.

2.7.1 Damage to Government Property. The contractor shall be held responsible for cleaning up all spillage and/or leakage at no additional cost to the government. The contractor shall be held liable for damage or destruction of Government property (e.g., buildings, vehicles, sidewalks, fences, etc.) caused by the contractor, contractor personnel or representatives of the contractor in the performance of services on this contract. The contractor shall submit their damage report to the COR within 24 hours of damage and shall include the repairs and corrective action plan, as applicable. If the contractor fails to take the required corrective action, the government retains the right to exercise other rights or remedies available to the CO.

2.7.2 Damage to Privately-Owned Property. The Contractor shall be held liable for damage or destruction of privately owned property (e.g., privately owned vehicles), as defined in this PWS, caused by the contractor, contractor personnel or representatives of the contractor in the performance of services in this contract. The contractor shall take corrective action within 5 working days to repair damages or replace destroyed property. Contractor shall purchase and always maintain a general third-party liability insurance policy of not less than $500,000 per event coverage (See FAR Clause 52.228-5).

2.7.3 Damage Reports. The contractor shall submit a damage report to the CO and designated representative within 24 hours of damage or destruction to government property or privately owned property caused by the contractor, contractor personnel or representatives of the contractor. The damage report shall detail the facts and the extent of damages or destruction, and the corrective action taken by the contractor to repair damages or replace destroyed property.

2.8 Fraud, waste, and abuse. The Contractor shall be responsible for maintaining proper conduct and good discipline within the government premises. Contractor personnel shall be encouraged to be alert to, and report suspected situations of fraud, waste, and abuse, or other intentionally dishonest conduct against the government observed during or in the performance of this contract. The contractor lines of communication are with the COR and the CO.

2.9 Influenza vaccine.

2.9.1 “Flu Shot” is mandatory for all VHA employees and contractors as per VHA Directive 1192.0. Contractor shall provide a list of employees under contract performance with their vaccination compliance. This requirement is to be submitted annually. Employees and Contractors who are not vaccinated as per authorized exclusions on VHA Directive are to be documented as such and always required to wear healthcare face mask while on VHA premises.

2.10 Ensuring Adequate COVID-19 Safety Protocols for Federal Contractors.

2.10.1 Contractor employees who work in or travel to VHA locations must comply with the following:

2.10.1.1 Documentation requirements:

2.10.1.1.1 If fully vaccinated, shall show proof of vaccination.

NOTE: Acceptable proof of vaccination includes a signed record of immunization from a health care provider or pharmacy, a copy of the COVID-19 Vaccination Record Card (CDC Form MLS-319813_r, published on September 3, 2020), or a copy of medical records documenting the vaccination.

2.10.1.1.2 If unvaccinated and granted a medical or religious exception, shall show negative COVID-19 test results dated within three calendar days prior to desired entry date. Test must be approved by the Food and Drug Administration (FDA) for emergency use or full approval. This includes tests available by a doctor’s order or an FDA approved over-the-counter test.

2.10.1.1.3 Documentation cited in this section shall be digitally or physically maintained on each contractor employee while in a VA facility and is subject to inspection prior to entry to VA facilities and after entry for spot inspections by Contracting Officer Representatives (CORs) or other hospital personnel.

2.10.1.1.4 Documentation will not be collected by the VA; contractors shall, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information.

2.10.2 Contractor employees are subject to daily screening for COVID-19 and may be denied entry to VA facilities if they fail to pass screening protocols. As part of the screening process contractors may be asked screening questions found on the COVID-19 Screening Tool. Check regularly for updates.

2.10.2.1 Contractor employees who work away from VA locations, but who will have direct contact with VA patients shall self-screen utilizing the COVID-19 Screening Tool, in advance, each day that they will have direct patient contact and in accordance with their person or persons who coordinate COVID-19 workplace safety efforts at covered contractor workplaces. Contractors shall, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information.

2.10.3 Contractor must immediately notify their COR or Contracting Officer if contract performance is jeopardized due to contractor employees being denied entry into VA Facilities.

2.10.4 All contractors’ employees and its representative, to include subcontractors, are required to wear surgical masks face covering during their time at the VACHS.

2.10.5 Vendors that are located outside of Puerto Rico must comply with the entry requirements established by the Government of Puerto Rico and by VACHS to access the hospital premises. Requirements may vary; therefore, the contractor shall comply with the stringent one.

2.11 Addition and/or removal of work areas and services. VA reserves the right to add and/or remove locations within this contract. All changes, if any, will be made via a supplemental agreement to the contract.

3.0 Performance Requirements. The following section specifies the Performance Objectives and Performance Elements for the contract. 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 through a system of inventory controls and report analytics, while maintaining all necessary internal controls to ensure accuracy throughout the entire process. The Contractor shall provide an inventory scanning software as a service for use by the site and the vendor so a report can be generated to identify and address any item and its box location for any discrepancies so identified discrepancies can be addressed prior to expired inventory leaving the site. Returns to be processed will cover expired pharmaceuticals and pharmaceuticals due to be expire within 120 days from authorized facilities approved to participate in the VA’s Pharmaceutical Prime Vendor (PPV) program. The contractor may not hold any expired pharmaceuticals identified as greater than 120 days from expiration and must immediately destroy identified product.

3.1 The contractor shall provide services at the locations and frequencies listed in paragraph 2.1.3 above.

3.2 Pharmaceutical Credit Processing. 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 because of reverse distribution processing shall be instructed to notify the Contractor of receipt of such credits so that the Contractor can update their electronic reporting system. Credits shall 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 shall be made solely between the Reverse Distributor and the PPV. The current PPV is:

McKesson Corp. Pharm. Group 2975 Evergreen Drive Duluth GA 30096 Point of Contact:

Ms. Anita Robinson, Account Executive Phone:678.471.0632

3.2.1 The Contractor will be given notice within 90 days if a change in the PPV occurs.

3.3 Shipping/Processing Arrangements. Contractor shall visit each site to electronically scan and generate a list of all pharmaceuticals and prepare their outdated products for shipment to the reverse distribution facility for processing. A copy of the contractor’s on-site inventory report will be available in the same format as the contractor’s supplied, facility itemized electronic list. Contractor shall also provide software as a service and/or electronic methods to cross reference site electronic record against contractor electronic record to identify discrepancies. Reverse distributor product shall not leave site until all discrepancies have been resolved. The Contractor is responsible for the shipment and associated costs from the facility to the Contractor’s reverse distribution facility. Product status shall be provided via the contractor’s web-based reporting system within three (3) business days after processing is complete.

3.3.1 The Contractor shall provide on-site servicing in accordance with the line items schedule (LINs). The Contractor shall 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 arrange for pick-up of controlled substance returns from the facility within 1 business day of service unless a delay is requested by site. The Contractor shall arrange for pick-up of non-controlled substance returns from the facility within 5 business days of service unless a delay is requested by site. 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 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.

3.4 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. Any items removed during a facility’s service event will be processed and associated to a single order that is unique to that service event.

3.5 Pharmaceuticals Ineligible for Credit from Manufacturer(s). 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. The list shall 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 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 available to the returning facility and maintained on the reporting website upon completion of destruction. All Manifests shall be available to the returning facility within 30 calendar days of Contractor's item receipt, except for 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.

3.6 Payment. Payments will be made in accordance with the LINs schedule and not through credits for returnable pharmaceutical items.

3.6.1 The firm fixed site visit service fee should cover the contractor’s costs including, but not limited to, packaging, shipping, processing, software as a service application, waste disposal, and any other applicable costs or fees incurred in performance of reverse distribution and waste disposal services.

3.6.2 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. The site service fee is fixed and there will be no adjustments based on credits received.

3.6.3 NOTE: There may be instances where more favorable return good policies have been negotiated on Federal Government contracts. To take advantage of more favorable return policies, the 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 quotes, those manufacturers that will not accept products through this Reverse Distribution Program.

3.7 Dashboard Reporting Requirement and Web-Based Tracking.

3.7.1 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 for the purpose of managing, tracking, and comparing the processing of unused pharmaceutical returns across the VACHS. The web-browser based application is the preferred and required type of digital dashboard specified by this contract. 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 facility. 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 shall 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 shall 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 application shall 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.

3.7.2 Web-based Tracking. To ensure adequate tracking of credits from inception to disposition, the Contractor shall make available the PPV confirmation of itemized credit statements received from the manufacturers at least monthly. To ensure full visibility of all credit amounts against the item(s) credited.

3.7.3 Reports. The Contractor shall provide a return detail report by manufacturer to each returning facility within (30) calendar days after processing all credit returns. The 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 make available 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.

3.7.4 At minimum, the web-based reporting tool shall provide the following reports:

a. Job Order Credit

b. Job Credit Detail (Open vs. Closed)

c. Returns Analysis

d. Returns Dashboard

e. Non-Returnable Products

f. In-Dated Items Report

g. Top Dollar Report

h. Schedule 2 Item Report

i. Aging Dashboard

j. Manufacturer Analysis Detail

k. Master Store Detail

VA Reporting Requirements:

a. Each NDC processed should contain the minimal data points:

b. Contract Number

c. Account Number

d. ITAG Number

e. Order Number

f. Receive Date

g. Original Process Date

h. National Drug Code (NDC)

i. Product Name

j. Manufacturer Name

k. DEA Class

l. Expiration Date

m. Returnable Flag

n. Waste Reason Code

o. Hazardous Flag

p. Unit Price

q. Quantity

r. Estimated Return Value (Extended Price)

s. Recall Flag

t. Aged Flag

u. Unaged Flag

v. Aging Processing Date

w. Manufacturer Debit Memo Number

x. Return Authorization Number

y. Item Disposition*

z. Item Status

aa. Amount Credited

ab. Prime Vendor Credit Memo Number

ac. Amount Waiting Credit

3.7.4.1 The following VACHS staff shall have access to the dashboard to generate reports:

3.7.4.1.1 VACHS, San Juan (Outpatient Clinic)- Reporting requirements shall be e-mailed to (to be provided upon award).

3.7.4.1.2 VACHS, San Juan (Inpatient Clinic)- Reporting requirements shall be e-mailed to (to be provided upon award).

3.7.4.1.3 Ponce Outpatient Clinic (POPC)- Reporting requirements shall be e-mailed to (to be provided upon award).

3.7.4.1.4 Mayaguez Outpatient Clinic (MOPC)- Reporting requirements shall be e-mailed to (to be provided upon award).

3.7.5 Training. The Contractor shall provide 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:

a. Full web access and reports training, including targeted data extrapolation.

b. Credit detail reports displaying estimated and actual credits.

c. Potential inventory management strategies.

d. 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.

3.8 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.

4.0 Performance Requirements Summary (PRS) Matrix

4.1 The Contractor service requirements are summarized into performance objectives that relate directly to mission essential items. The performance threshold briefly describes the minimum acceptable levels of service required for each requirement. These thresholds are critical to mission success. The government expects the contractor to perform at a minimum, the identified acceptable levels throughout the life of the contract, and the contractor’s performance shall be given significant consideration when evaluating recommendations for future government contracts and or awards.

4.2 Method of Surveillance: The Government performs surveillance to determine if the Contractor exceeds, meets, or does not meet these standards. The Government shall use these standards to determine Contractor performance and shall compare Contractor performance to the Acceptable Quality Level (AQL). Acceptable surveillance methods include: 100% inspection, random inspections, joint inspections, customer’s complaints, or any other appropriate method typically used in this industry. The government may use one or a combination of any of these surveillance methods.

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4.3 Quality Assurance. The Government will evaluate the Contractor’s performance under the contract, IAW the PRS Matrix. The Government retains the right to inspect and test all services called for by the contract. The Government will perform inspections and tests in a manner that will not unduly delay the work. If any of the services performed do not conform to contract requirements, the Government may require the Contractor to perform the services again in conformity with contract requirements, at no increase in contract amount.

4.4 Whenever the COR notifies the contractor of any deficiencies detected in the work performed, the contractor shall correct cited deficiencies within three (3) business days, or as otherwise authorized by the COR, after the notification in writing by the COR without affecting the regularly scheduled work.

4.5 Upon satisfactory completion by the Contractor and acceptance by the COR of the work completed by the contractor in accordance with this Performance Work Statement, payment will be approved. Failure to complete the work stated in this PWS may result in unfavorable Contractor Performance Assessment Reporting System (CPARS) ratings and/or deduction to be determined by the CO.

4.6 Quality Control. The contractor shall maintain an effective Quality Control Program to ensure services are performed IAW this PWS. The purpose of this program is to identify, prevent, and ensure non-recurrence of defective services. At a minimum, the program shall include the following:

a. The name(s) of the individual(s) who will perform the services described in contract.

b. A checklist used in the inspection and performance verification of the services. The checklist shall include every requirement included in this PWS.

c. A schedule of the dates programmed for the service requested.

d. A system for identifying and correcting deficiencies in the quality of services before the level of performance becomes unacceptable and/or the COR identifies the deficiencies.

e. In addition to providing the documentation at the end of each service, the contractor is responsible to maintain the required documents of all the services conducted by the Contractor and the corrective actions taken. All documentation shall be made available to the Government during the term of the contract.

5.0 Deliverables

Implementation Plan

7.0 Definitions, Acronym, and Applicable Directives and Publications

7.1 Definitions

CONTRACTING OFFICER (CO): A Contracting Officer is a government employee who has authority to enter into, administer, and or terminate contracts, as well as make related determinations and findings on behalf of the Government. (Note: The only individual who can legally bind the Government.)

CONTRACTING OFFICER’S REPRESENTATIVE (COR) - A representative from the requiring activity appointed by the CO to perform surveillance and to act as liaison to the contractor

CONTRACTOR: A supplier or vendor awarded a contract to provide specific supplies or service to the Government. The term used in this contract refers to the prime.

DEFECTIVE SERVICE: A service output that does not meet the standard of performance associated with it in the Performance Work Statement

DELIVERABLE: A tangible or intangible object produced as a result of the project that is intended to be delivered to a customer (either internal or external). Examples of a deliverable are a report, a document, a server upgrade, or any other building block of an overall project.

FISCAL YEAR: A period beginning on October 1 and ending September 30 of the consecutive calendar year. The fiscal year is designated by the calendar year in which it ends.

GOVERNMENT FURNISHED PROPERTY (GFP): All equipment, goods and land possessed by the government and subsequently delivered or otherwise made available to the Contractor.

INSPECTION. Examining and testing supplies or services (including, when appropriate, raw materials, components, and intermediates assemblies) to determine whether they conform to contract requirements

MATERIAL. Property that may be consumed or expended during the performance of a contract, component parts of a higher assembly, or items that lose their individual identity through incorporation into an end-item. Material does not include equipment, special tooling, and special test equipment or real property.

NON-PERSONAL SERVICES. The personnel rendering the services are not subject, either by the contract's terms or by the manner of its administration, to the supervision and control usually prevailing in relationships between the government and its employees. Non personal service contracts are authorized by the government in accordance with FAR 37.012, under general contracting authority, and do not require specific statutory authorization.

OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION (OSHA): Government agency part of the US Department of Labor with the primary responsibility for administrating the Occupational Safety and Health act of 1970. This act has the purpose of preservation of human resource.

PHYSICAL SECURITY. Actions that prevent the loss or damage of Government property.

PROPERTY. All tangible property, both real and personal.

QUALITY ASSURANCE (QA): A procedure or set of procedures taken by the Government to ensure that services acquired under government contracts conform to the contract’s quality and quality requirements.

QUALITY ASSURANCE SURVEILLANCE PLAN (QASP): A plan specifying the surveillance methodology used by the COR for surveillance of the contractor’s performance.

QUALITY CONTROL (QC): Task performed by the contractor to ensure excellence of the organization’s output.

REPAIR. The correction of a malfunction or non-conformance that cannot be accomplished without significant time and/or material, as determined by the COR.

SUBCONTRACTOR. One that enters into a contract with a prime contractor. The Government does not have privity of contract with the subcontractor.

7.2 Acronym

7.3 Applicable Directives and Publications

The following laws, regulations, policies, and procedures in effect on date of contract issuance and all subsequent changes or…