Performance Work Statement (PWS).pdf

36C24823Q2011

PERFORMANCE WORK STATEMENT

1. Overview: Reverse Distribution services are needed at the VA Caribbean Healthcare System (VACHS). The Contractor shall perform one (1) quarterly pick-up and perform destruction, disposition, or turn-in of pharmaceutical waste for the San Juan In-Patient & Out-Patient Pharmacies, the Mayaguez Out-Patient Clinic (MOPC) Pharmacy & the Ponce Out-Patient Clinic (POPC) Pharmacy. The services required are for four (4) pick-ups per facility, per year, for a total of sixteen (16) pick-ups per year. The pharmaceutical waste shall include controlled and non-controlled pharmaceutical substances, as well as hazardous and non-hazardous pharmaceutical substances.

2. Service Locations: Reverse Distribution services are needed at the following pharmacies:

2.1. VACHS In-patient Pharmacy: located at the second floor of the VACHS main facility, at 10 Calle Casia San Juan, PR 00921-3201

2.2. VACHS Out-patient Pharmacy: located at the first floor of the VACHS main facility, at 10 Calle Casia San Juan, PR 00921-3201

2.3. Mayaguez Out-Patient Clinic (MOPC) Pharmacy: located at 345 Avenida Hostos Mayaguez, PR 00680-1507

2.4. Ponce Out-Patient Clinic (POPC) Pharmacy: located at Paseo del Veterano #1010, Ponce, PR 00716-2001

3. Pick-up Frequency:

3.1. The Contractor shall perform these pick-up services at each of the previously mentioned pharmacies on a quarterly basis, for a total of sixteen (16) pick-ups per year.

3.2. The first pick-up at each pharmacy shall be completed before December 15, 2023.

4. Period of Performance: Period of Performance for the base period of this contract is 12/01/2023 until 11/30/2024, plus four (4) twelve-month option periods. Service hours for pick-ups are Monday to Friday from 7:30 AM to 4:00 PM.

5. Estimated Annual Pharmaceutical Waste: VACHS estimated pharmaceutical expired returns average $1,011,330.00 annually.

6. Additional Requirements:

6.1. In addition to the Reverse Distribution services, the Contractor shall also possess inventory scanning software for use while on-site at each of the previously mentioned pharmacies, so he can generate pharmaceutical product reports that will be compared with the on-hand pharmacy inventory. Any discrepancy between the report generated by the Contractor and the pharmacy shall be resolved prior to the Contractor leaving such pharmacy.

6.2. The Contractor shall be responsible for the return in credits or certificates of destruction for all pharmaceutical waste he picks up.

6.3. Reverse Distribution services shall cover expired pharmaceuticals and pharmaceuticals due to be expire within one-hundred and twenty (120) days from authorized pharmacies approved to participate in the VA’s Pharmaceutical Prime Vendor (PPV) program (listed in section 24 of this

PWS).

6.4. The Contractor shall not hold any expired pharmaceuticals identified as greater than one-hundred and twenty (120) days from expiration and must immediately destroy such pharmaceuticals.

7. Licenses, Permits, Registration, Insurance:

7.1. 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.

7.2. The Contractor shall possess the following registrations:

7.2.1. Active registration as a Reverse Distributor with the Department for the US Drug

Enforcement Agency (DEA)

7.2.2. Active registration as a Reverse Distributor with the PR Department of Health

7.2.3. Active registration as a Controlled Substance Reverse Distributor with the PR Department of Health

7.3. The Contractor shall have proper insurance coverage, including environmental remediation.

8. Regulatory Compliance:

8.1. 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.

8.2. 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.

9. Shipping & Processing Procedures:

9.1. The Contracting Officer’s Representative (COR) will mutually coordinate with the Contractor directly to arrange pick-up dates.

9.2. The Contractor shall provide all forms and labels needed to ship the designated items to the

Contractor's central processing facility or the turn-in location.

9.3. The Contractor shall work on-site to electronically scan and generate a list of all pharmaceuticals that need to be returned or disposed and shall prepare the outdated products for shipment to the reverse distribution facility for processing.

9.4. A copy of the Contractor’s on-site inventory report shall be available in the same format as the

Contractor is supplied, which will be a facility itemized electronic list.

9.5. The Contractor shall be responsible for the shipment and any associated costs from the VA pharmacy up to the Contractor’s reverse distribution facility.

9.6. Any pharmaceutical substance processed during a given pick-up service must be shipped within forty-eight (48) hours through the Contractor’s selected carrier.

9.7. The Contractor shall provide product status via a web-based reporting system within three (3) business days after the pharmaceuticals processing is complete.

9.8. The Contractor shall contact the COR to coordinate on-site servicing of each of the pharmacies at least ten (10) business days prior to the service date. These services include controlled and non-controlled pharmaceutical substances, as well as hazardous or non-hazardous pharmaceutical substances.

9.9. The Contractor shall not separate returnable from non-returnable pharmaceuticals on-site.

Instead, the Contractor shall package the designated returns and transport them to their own facility where the determination will be made concerning whether a pharmaceutical product is returnable or if it shall be disposed.

9.10. The Contractor shall prepare chain of custody paperwork for controlled pharmaceutical substances and shall provide such paperwork to the returning pharmacy at the time each package is prepared for shipment.

9.11. Within thirty (30) days of picking up pharmaceutical substances from each pharmacy, 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.

9.12. The Contractor shall comply with the necessary security requirements to access each facility.

10. Pharmaceutical Products that Qualify for Return to Manufacturer:

10.1. Products qualifying for manufacturer’s return are pharmaceutical substances, including partial pharmaceuticals, that are in the original manufacturer containers.

10.2. Every pharmaceutical product that cannot be returned to its manufacturer is considered pharmaceutical waste and shall be disposed of by the Contractor in accordance with any applicable federal and state regulations.

10.3. Any pharmaceutical substances picked-up during a pharmacy’s service shall be processed and associated to a single order that is unique to that service event.

11. Pharmaceutical Products Ineligible for Return to Manufacturer:

11.1. The Contractor shall list pharmaceutical substances designated for disposal (which shall consist of controlled and non-controlled pharmaceutical substances, as well as hazardous and non-hazardous pharmaceutical substances) on a disposal manifest.

11.2. This list shall include the product name, National Drug Code (NDC) or catalog number, quantity, total estimated return value, and reason for non-eligibility for credit.

11.3. Separate manifests shall be provided for the disposal of Schedule II through V controlled substances, and when disposing of hazardous waste products as defined by the EPA Resource Conservation and Recovery Act (RCRA) regulations.

11.4. A Certificate of Destruction including the disposal date, destruction method, destruction location, weight, disposal company name and proof of destruction shall be available to the respective pharmacy and maintained on the reporting website upon completion of destruction.

11.5. All manifests shall be available to the respective pharmacy within thirty (30) calendar days of the service date, with the exception of those pharmaceutical substances for which a Certificate of Destruction is needed. In that case, the manifest shall be provided within thirty (30) days of the completion of destruction.

11.6. Shipments made by 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.

11.7. Spills or releases of toxic/hazardous substances into the environment shall be reported to the respective pharmacy and the COR.

12. Credits for Pharmaceutical Waste: The Contractor is responsible for contacting the manufacturer of the pharmaceutical waste to ensure that credits are received for the pharmaceutical waste turned in.

13. Web-based Tracking of Credits:

13.1. 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 pharmaceutical product manufacturers on a monthly basis.

13.2. To ensure full visibility of all credit amounts against the item(s) credited, the Contractor shall also be a Reverse Distributor for the PPV.

13.3. The Contractor shall instruct pharmaceutical manufacturers to issue all credits directly to the PPV since the PPV has credit accounts established for each authorized user of the PPV for purposes including reverse distribution.

13.4. Any credits received by the Contractor from the manufacturer shall be forwarded to the PPV within ten (10) business days from the date of receipt.

13.5. In addition, each pharmacy that receives credits directly from the pharmaceutical manufacturers because of Reverse Distribution processing will notify the Contractor of the receipt of such credits, to allow the Contractor to update their electronic reporting system.

13.6. Credits shall be deposited into the individual pharmacy’s account by the PPV upon receipt of itemized credit statements for each individual facility provided by the Contractor.

13.7. The credit statements provided by the Contractor to the PPV shall include each pharmacy’s account number and the appropriate invoice number to facilitate this process and for tracking purposes.

13.8. Based on the above, any arrangements to facilitate the processing of credits through the PPV must be made between the Reverse Distributor and the PPV.

13.9. Any fees associated with the credits shall be invoiced to the PPV, and not to VACHS.

14. Reports:

14.1. The Contractor shall prepare a return detail report by manufacturer to each returning facility within (30) calendar days after processing all credit returns. Such report must be available at the Contractor’s web-based reporting tool.

14.2. This report shall include 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.

14.3. An additional credit report shall be provided showing both the estimated credits and actual credits received, including the total actual credit received by unit of measure for each NDC, as well as the date that the credit was issued, and any fees taken for each pharmaceutical return.

14.4. As part of the report, the Contractor shall also provide credit memos from the pharmaceutical products manufacturer to ensure adequate tracking of credits from inception to disposition.

14.5. Separate reports shall be provided for Schedule II through V controlled substances and for hazardous waste to include the weight of the disposal.

15. Web-Based Reporting Tool: The Contractor shall provide a web-based reporting tool that will generate the following reports:

15.1. Job Order Credit

15.2. Job Credit Detail (Open vs. Closed)

15.3. Returns Analysis

15.4. Returns Dashboard

15.5. Non-Returnable Products

15.6. In-Dated Items Report

15.7. Top Dollar Report

15.8. Schedule 2 Item Report

15.9. Aging Dashboard

15.10. Manufacturer Analysis Detail

15.11. Master Store Detail

16. VA Reporting Requirements: Each NDC processed should contain the minimal data points:

16.1. Contract Number

16.2. Account Number

16.3. ITAG Number

16.4. Order Number

16.5. Receive Date

16.6. Original Process Date

16.7. NDC

16.8. Product Name

16.9. Manufacturer Name

16.10. DEA Class

16.11. Expiration Date

16.12. Returnable Flag

16.13. Waste Reason Code

16.14. Hazardous Flag

16.15. Unit Price

16.16. Quantity

16.17. Estimated Return Value (Extended Price)

16.18. Recall Flag

16.19. Aged Flag

16.20. Unaged Flag

16.21. Aging Processing Date

16.22. Manufacturer Debit Memo Number

16.23. Return Authorization Number

16.24. Item Disposition (if available)

16.25. Item Status

16.26. Amount Credited

16.27. Prime Vendor Credit Memo Number

16.28. Amount Waiting Credit

17. Reports Access: The following VACHS personnel shall have access to the web-based reporting tool to be able to generate reports:

17.1. VACHS In-patient Pharmacy: Dayna Quinones & Edmarielis Santiago, Supervisors

17.2. VACHS Out-patient Pharmacy: Mariel Pagan & Edmarielys Gonzalez, Supervisors

17.3. POPC Pharmacy: Hilda Torres, Supervisor

17.4. MOPC Pharmacy: Christopher Gomez, Supervisor

18. Training Requirements:

18.1. Once the contract is awarded, the Contractor shall provide training down to the pharmacy level on the various reports and functionality of reports to assist the facilities in monitoring and tracking potential credits.

18.2. This training shall include an actual demonstration and operation of the web-based electronic service request ordering system.

18.3. In addition, the Contractor shall provide training prior to any future updates and system changes, prior to the implementation of such.

18.4. Training should be provided on-site at each of the pharmacies.

18.5. The Contractor shall provide notification to all pharmacies fourteen (14) calendar days before the date of their scheduled training.

18.6. Training shall cover the following:

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

18.6.2. Credit detail reports displaying estimated and actual credits.

18.6.3. Potential inventory management strategies.

18.6.4. An instructional user guide with step-by-step instructions on the above topics shall also be provided via a link on the reporting website, or a stand-alone document.

18.7. A Point of Contact (POC) along with an email and telephone number shall be provided to each pharmacy in the event additional instructions are needed, or if there is a change in Government personnel.

19. Non-Personal Services: Contractor employees performing services under this contract will be controlled, directed, and supervised by the Contractor. Contractor management will ensure that employees properly comply with the performance standards outlined in the PWS. Contractor employees will perform their duties independent of, and without the supervision of, any Government official.

20. Post Award Conference/Periodic Progress Meetings: The Contractor shall attend any post award conference convened by the CO in accordance with Federal Acquisition Regulations Subpart 42.5. The CO and COR may meet periodically with the Contractor to review the contractor’s performance. At these meetings, the CO will appraise the Contractor of how the Government views the Contractor’s performance and the Contractor will appraise the Government of problems, if any, being experienced.

Appropriate action shall be taken to resolve outstanding issues within five (5) working days. These meetings shall be at no additional cost to the Government.

21. Increase or Decrease of the Quantity of Services: Service frequencies may increase or decrease, due to unforeseen circumstances. If such situation arises, these service frequencies shall be adjusted via supplemental agreement.

22. List of Federal Holidays: Legal holidays recognized by the Federal Government in accordance with 5

U.S.C. 6103, Executive Order 11582 and Public Law 94-97 or any other by the President of the United States to be a national holiday, the following national holidays are observed and for the purpose of this contract is defined as "Legal Federal, official holidays" as follows:

New Year’s Day January 1

Martin Luther King Day Third Monday in January

Presidents’ Day Third Monday in February

Good Friday Last Friday in March

Memorial Day Last Monday in May

Juneteenth June 19

Independence Day July 4

Labor Day First Monday in September

Columbus Day Second Monday in October

Veterans’ Day November 11

Thanksgiving Day Fourth Thursday in November

Christmas Day December 25

23. VA Pharmaceuticals Prime Vendor: The current VA pharmaceuticals prime vendor can be seen below.

In the event that this vendor changes, the COR will inform the Contractor within ninety (90) days of the effective date of such change.

McKesson Corp. Pharm. Group 2975 Evergreen Drive Duluth GA 30096 Point of Contact: Ms. Anita Robinson, Account Executive Phone: (678) 471-0632

24. Reverse Distribution Pharmacies:

PPV Account number

Facility Address DEA# Contact Person

035211 VACHS Out-

Patient Pharmacy

VA Caribbean Healthcare System

10 Casia Street

San Juan, PR 00921

Phone: (787) 641-7582, ext.

131668

BD2256990

Mariel Pagan & Edmarielys

Gonzalez, Supervisors

391386 VACHS In-

Patient Pharmacy

VA Caribbean Healthcare System

10 Casia Street

San Juan, PR 00921

Phone: (787) 641-7582, ext.

147049

BD2256990

Dayna Quinones &

Edmarielis Santiago, Supervisors

925977

MOPC

(Mayaguez Outpatient

Clinic) Pharmacy

Mayaguez Outpatient Clinic

State Road # 2 Km. 149.9

Ave. Algarrobo, Bo. Sabanetas

Mayaguez, PR 00681-1507

Phone: (787) 834-6900, ext.

248473

BV0366787

Christopher Gomez, Supervisor

332928

POPC

(Ponce Outpatient

Clinic) Pharmacy

VA Euripides Rubio Clinic- Ponce OPC- Outpatient Clinic

Paseo Del Veterano #1010

Ponce, PR 00716-2001

Phone: (787)812-3030, ext. 244154

BV1501700 Hilda Torres, Supervisor

25. Influenza Vaccination:

25.1. All contract employees shall comply with VHA Directive 1192.01, Seasonal Influenza Vaccination

Program for VHA Healthcare Personnel. This policy applies to all individuals who, during the influenza season, work in VHA locations or who come into contact with VA patients or other Health Care Personnel (HCP) as part of their duties.

25.2. Masking requirements for unvaccinated HCP: HCP who do not receive influenza vaccination due to medical or religious exemptions must designate this at the VA Employee Health Unit on the HCP Influenza VA Form 10-9050 and wear a face mask while in any VHA location, including both clinical and non-clinical areas. In addition, HCP are required to wear a face mask during performance of their assigned duties and responsibilities. The face mask shall be worn throughout the influenza season, or until the individual HCP receives a flu vaccination and completes the required VA Form 10-9050.

26. COVID-19 Precautions: The Contractor shall follow facility procedures for guidance regarding precautions to reduce the spread of COVID-19.

27. Contingency Plan: Ten (10) days after contract award, 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 PWS under emergency and/or contingency conditions.

28. Quality Control Plan (QCP): The Contractor shall establish a complete QCP to ensure the requirements of the contract are provided as specified. This QCP shall be submitted to the CO/COR ten (10) days after contract award.

29. Performance Requirement Summary (PRS):

Performance

Objective (Task)

Performance

Standard

Acceptable Quality Level

(AQL)

Surveillance Method Remedies

Any discrepancies between generated report and VA internal report resolved prior to the Contractor leaving the pharmacy

PWS Section 6.1

100% Through validation from the pharmacy

Re-perform tasks within 2 working days at no additional costs to the

Government.

Pharmaceutical substances shipped no

PWS Section 9.6

100% Through validation from the pharmacy

Re-perform tasks within 2 working days at no additional later than 48 hours after being processed costs to the Government.

Certificates of Destruction is provided

PWS Section 11.4

100% Through validation from the pharmacy

Re-perform tasks within 2 working days at no additional costs to the

Government.

Credits are processed through VA PPV

PWS Section

100% Through validation from the pharmacy

Re-perform tasks within 2 working days at no additional costs to the

Government.

Reports are made available within 30 days of service

PWS Section 14.1

100% Through validation from the pharmacy

Re-perform tasks within 2 working days at no additional costs to the

Government.

B.2 PERFORMANCE WORK STATEMENT