TAB 3 - STATEMENT OF WORK.pdf

STATEMENT OF WORK

PHARMACY MEDICATION REVERSE DISTRIBUTION SERVICES

RX RETURN SERVICE

CROWNPOINT SERVICE UNIT

CROWNPOINT, NM

INTRODUCTION:

The purpose of this service is to maintain compliance with Joint Commission and Federal Regulations and provide proper disposal of non-controlled and controlled substances that are deemed damaged, expired, returned, unusable, or otherwise unwanted that are lawfully possessed by registrant. Crownpoint Service Unit is an Indian Health Service (CPSU) facility located on the Navajo Reservation in Crownpoint. The clinic serves three communities:

Crownpoint, Pueblo Pintado, Thoreau. The Pharmacy department routinely has medications expire due to manufacturer expiration dates. These expired medications are then pulled from the shelves and quarantined until they can be picked up for return and destruction by a reverse distribution company. The purpose of this solicitation is to establish a contract with a reverse distributor with destruction capability, hereafter referred to as the Contractor, capable of achieving maximum credit return. The reverse distribution process would provide Crownpoint Pharmacy department a source of return via credits from controlled substances and non-controlled substances in the most optimal way. A process to track the credits turned in and received back shall be in place. Any software containing such information shall be made available to the COR or designees with unlimited access. Disposal of controlled substance stock held for destruction are required to be completed at least quarterly. A DEA-licensed destruction company should be scheduled at least quarterly to meet this requirement but are not limited to the quarterly scheduled appointments

OBJECTIVES/REQUIREMENTS:

The service prices quoted should cover all the contractors’ (RxReturns) costs and fees to include but not limited to materials such as; packaging, shipping, packaging labels, boxes, tape and etc., processing, waste disposal, and any other applicable costs or fees incurred in performance of reverse distribution and waste disposal services for both onsite services and mail in services.

Returns to be processed will cover expired and soon to expire within 30 days from authorized agencies approved to participate in the VAs Pharmaceutical Prime Vendor (PPV) program. The contractor may not hold any expired pharmaceuticals identified as greater than 30 days from expiration and must immediately destroy identified product. Any contractor that reverse distributes a controlled substance shall be registered as a reverse distributor and must be compliant with all applicable federal, state and local laws and regulations governing reverse distribution. Services required under this contract shall be performed in accordance with Federal Laws, 21 U.S.C 827. Provides DEA form 41 copy within 30 days to keep for CPSU Pharmacy records on file.

PERIOD OF PERFORMANCE:

Base with four options.

LOCATION OF WORK:

1. Crownpoint Service Unit Junction Rd 371 Rt 9, Crownpoint, NM 87313

2. Thoreau Health Station 3 E Navarre Blvd, Thoreau, NM 87323

3. Pueblo Pintado Clinic #10 Pueblo Pintado Rd HCR 79 Box 3071, Cuba, NM 87013

ON-SITE PROCESS:

This service shall be conducted during normal business hours of the Pharmacy Department, which is Monday through Friday, 8:00 AM to 4:30 PM, excluding federal holidays. Non-controlled substances held for reverse distribution shall be invoiced and acquired by reverse distributor on-site representative. Prior to boxing items, a pharmacy employee shall review with the contractor during on-site service a list of items to ensure it matches that of what is actually acquired by reverse distributor and ensure there are no discrepancies between the pharmacy’s list of items and contractors list of items.

Contractor shall be responsible for boxing up items acquired by the pharmacy and arranging for pick-up by carrier. Controlled substance items held for destruction are placed in an evident tamper bag. All bags shall be opened at the time of the transfer to a DEA-licensed destruction company and must be verified in the presence of the representative of the reverse distributor, CPSU Pharmacy staff, and representative from destruction company must sign the document listing of the controlled substances transferred from VA to the destruction company. The reverse distributor must provide a signed receipt for all CIII-V and DEA Form 222 for all CII products taken at the time of transfer. The CIII-V receipt and DEA Form 222 must include drug name, dosage form, strength, quantity and date of transfer. The pharmacy must maintain these records for three years in a readily retrievable manner. Once the on-site representative of the contractor verifies counts with the pharmacy staff and accountable officer and completes the paperwork of the transfer, and preparation for shipping the reverse distributor shall assume the title and responsibility to the products. On-site representative shall arrange for immediate pick up by trusted carrier or shall have a DEA compliant transport process. The DEA registered reverse distributor who destroys the controlled substance must submit a DEA Form 41 to the DEA when the controlled substances have been destroyed. The DEA Form 41 should not be used to document the transfer of controlled substances from the pharmacy to the reverse distributor. A copy of the DEA Form 41 should be sent to CPSU Pharmacy point of contact, Pharmacist Supervisor, Technical Point of Contact (TPOC), and Contracting Officer Representative (COR) within 30 days. A reverse distributor shall acquire controlled substances from a registrant at the registrant's registered location or receive controlled substances delivered by common or contract carrier. Controlled substances for destruction shall occur no later than 30 calendar days after receipt. A method of destruction shall render controlled substances for destruction non-retrievable in compliance with federal regulations.

DESCRIPTION OF ITEMS ELGIBLE FOR TRANSFER:

Vendor shall accept any opened or unopened package of OTC, prescription in original containers and Scheduled CII-V medications being held for destruction obtained through return mail or otherwise deemed unusable or expired. All forms of medication shall be accepted such as tablets, capsules, suppositories, liquids, refrigerated items, patches, films, topicals, unused syringes containing medication but may not be limited to this list.

Scheduled CII-V medications not contained in original manufacturer bottle packaging shall provide education and guidance to designated staff if there are any applicable means to obtaining more credits for returned product.

A complete list of medications processed for reverse distribution shall be provided by on site representative. Access to software shall be provided to designated individuals to track credit processing and credit reconciling. Vendor shall take all reasonable efforts to pursue and obtain credits through manufacturers and wholesalers, including but not limited to following up with manufacturers or wholesalers not responding or processing credits in a timely fashion (within 30 days of receipt). Vendor shall help facilitate the processing and crediting of returned product. Vendor shall work with manufacturers and customer's wholesaler to facilitate the disbursement of checks or credits.

SUPPLIES AND SERVICES:

The vendor shall be fully licensed to perform the work and shall take responsibility to complete details of the contract from start to finish. The responsibilities of the contractor shall include the ability to provide on-site and off-site services and provide all equipment, materials, and labor needed to process credit return and/or arrange for proper disposal of designated pharmaceuticals, including Schedule II-V controlled substances. The vendor shall bring all necessary supplies including equipment or software for their own use to perform their work as reverse distributor to each on-site pick-up. Vendor shall be responsible for their supplies and equipment including any loss or damage. Reverse distributor shall be responsible for packaging products transferred to them if shipping through carrier, including but not limited to generating shipping labels and providing compliant packaging. Vendor will provide 4 visits per year. Vendor will provide a list of Reverse Distributor Representatives to CPSU Acquisitions for internal Human Resource background checks before starting services. If the representative changes, vendor should immediately inform CPSU Pharmacy or Acquisitions Department.

PERFORMANCE STANDARDS:

Vendors shall have recent proven past experience as a pharmaceutical reverse distributor to perform reverse distribution processing and waste disposal services in the volume required by CPSU Pharmacy Service.

Vendor shall meet all requirements as listed in this contract as well as perform all processes compliantly with all federal laws and regulations.

Vendor shall be able to communicate efficiently for all CPSU Pharmacy needs of this contract.

Vendor shall be available for any inquiries by CPSU Pharmacy staff. Invoicing shall be timely and provided within 30 days of each on-site service.

If services do not conform to contract requirements, the government may require the contractor to perform services again at no additional cost to the government. If defect in services may not be corrected by reperformance, the government shall have authority to reduce contract price to reflect the reduced value of the service performed.

REGULATORY COMPLIANCE

The Contractor shall be required to provide all materials and labor needed to process credit return and/or arrange for proper disposal of designated pharmaceuticals, including Schedule II-V controlled substances for 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. Accordingly, the Contractor shall arrange for, recommend, and/or advise the returning drug distribution point and Project Manager of the proper means of transporting the returned products to the Contractor's central processing facility.

SOFTWARE SYSTEM

Vendor shall provide the COR and designated pharmacy staff access to software programs to identify which products should be accepted by manufacturers for third party returns, which products are not eligible for return, products which have potential for return or potentially creditable products. This software can help separate waste to appropriate route prior to the scheduled reverse distribution pick-ups. This software should be able to track progress on credit process such as pending manufacturer response, or credits already received. Web-based system shall provide status of credits, credit reconciliation and reporting capabilities for purpose of managing, tracking and comparing the processing of unused pharmaceutical returns across the government service or agency and arrange the facilitation of processing proceeds. Training shall be provided to COR and designated staff on utilization of this software.

Representative or customer service should be available and able to provide efficient service support for staff for as needed assistance or questions at no additional charge for the entire duration of the resulting contract.

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 nonhazardous 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.

PHARMACEUTICALS QUALIFYING FOR MANUFACTURER'S RETURN

Products qualifying for manufacturers return are pharmaceuticals, including partial 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 mailed-in during a facility’s service event will be processed and associated to a single order that is unique to that service event.

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), quantity, and total estimated return value. Separate manifests shall be provided for the disposal of Schedule II - V controlled substances. If required by federal, state or local law, manifests shall be provided 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 calendars 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.

INVOICE AND CHARGES:

The Vendor shall not add or substitute service fees without prior approval from the contracting officer.

Contract fee is to include the service fee of the vendor which includes services of the representative on the days of on-site services, consultation/training on software use or inquiries regarding credits or processes, shipping costs, destruction fees, and manufacturer processing fees.

Invoices shall be issued within ninety days after each on-site service date. Each invoice fee shall not exceed previous quoted agreement as agreed to in this contract to be billed by flat service fee. Payment receipts shall be confirmed by contractor in writing via email or confirmation process.

Any inquiries that CPSU Pharmacy may have through representative or customer service shall be provided at no additional charge at any time. Access to software should be available at any available time at no additional charge. Meetings in person, virtual or by phone including but not limited to discussion about process of returns or credit tracking shall be provided as necessary to CPSU pharmacy at no additional charges.

COMMUNICATION:

The Contractor shall conduct on-site services in a timely manner so that the proper shipping labels are provided, and the proper personnel are available, if needed. Scheduling of services will be coordinated through the Pharmacy Supervisor or Staff. All documents will be provided by the Contractor to the Project Manager, who will certify that a quality and timely delivery of services has been provided and satisfactorily completed.

CONFIDENTIALITY:

Contractor shall be compliant with all security statutes including HIPAA {Health Insurance Portability and Accountability Act}. Failure to comply with security statutes and confidentiality of patient information may result in financial sanctions and contractor shall be held liable if they are the cause of the breach of information

PROJECT MANAGER:

LCDR Jackline Yembu, Pharmacy Supervisor Crownpoint Healthcare Facility Junction Rd 371 Rt 9, Crownpoint, NM 87313 Phone: 505-786-6344 Email: Jackline.Yembu@ihs.gov

COR: LCDR. Antoine Bondima, COR- Level 1 Email: Antoine.Bondima@ihs.gov

TPOC: Guanita Tahe, Pharmacy Secretary Email: Guanita.Tahe@ihs.gov mailto:Jackline.Yembu@ihs.gov mailto:Antoine.Bondima@ihs.gov