Attachment B Statement of Need- Med Gas.pdf

ATTACHMENT B

36C24822Q0001

STATEMENT OF NEED (SON)

1. SCOPE OF CONTRACT

The Department of Veterans Affairs, North Florida / South Georgia Veterans Health System (NF/SG VHS), has a requirement for the supply of medical-grade gases and medical gas cylinders for the facilities at each following location:

Malcom Randall VA Medical Center (Gainesville) Lake City VA Medical Center Jacksonville VA Outpatient Clinic Sergeant Ernest I. “Boots” Thomas VA Outpatient Clinic (Tallahassee) The Villages VA Outpatient Clinic Marianna Community Based Outpatient Clinic Middleburg VA Community Based Outpatient Clinic Ocala Community Based Outpatient Clinic Palatka Community Based Outpatient Clinic Perry Community Based Outpatient Clinic St. Augustine Community Based Outpatient Clinic St. Mary’s Community Based Outpatient Clinic Valdosta Community Based Outpatient Clinic Waycross VA Community Based Outpatient Clinic Gainesville VA Dermatology Clinic Gainesville VA Pain Clinic

ACRONYMS

CBOC – Community Based Outpatient Clinic CCF - 100 cubic feet CF – Cubic feet CFR – Code of Federal Regulations CGA – Compressed Gas Association CGMP – Current Good Manufacturing Practices CO – Contracting Officer COR – Contracting Officers Representative DOD – Department of Defense DOT – Department of Transportation FDA – U.S. Food and Drug Administration NFPA – National Fire Protection Association NF/SG VHS – North Florida/South Georgia Veterans Health System OPC – Outpatient Clinic OSHA – U.S. Department of Labor, Occupational Safety and Health Administration PBM – Pharmacy Benefits Management SCF – Standard Cubic Feet SOW – Statement of Need USP – United States Pharmacopeia VA – Department of Veterans Affairs VAMC – VA Medical Center VISN – Veterans Integrated Service Network

The Contractor shall provide all personnel, equipment, tools, materials, cylinders, gases, supervision, facilities, transportation, and delivery of items and services necessary to supply NF/SG VHS with medical gas cylinders and medical gas provision and refilling services related to this Statement of Work (SOW).

The Contractor shall provide all supplies and services for compressed gas and liquid cylinders of industry standard types and sizes, shall ensure that all cylinders are tested using hydrostatic testing, painted and labeled for contents or type, and that valves, stems and seals are in good working condition by industry standards.

The Contractor shall provide all requested gases of industry standard and type. Gas provided by the Contractor shall be of good quality, correct content per cylinder, and meet the full quantity fill requirements for the cylinder(s). Upon request, the Contractor is to provide a certificate of purity from the supplier for any supplied gases.

The Contractor shall provide a monthly statement with detailed invoice information to verify delivery and provide for accurate and prompt payment.

Contractor shall provide all vehicles, personnel, and equipment for delivery of medical gas and cylinders to requested NF/SG VHS locations. Contractor shall provide regularly scheduled deliveries to each location and shall have the ability to provide emergency gas services within six (6) hours of request. The Contractor shall contact the facility with an estimated time of arrival (ETA) and provide itemized copy of the order upon delivery.

The Contractor shall be available to fill emergency requirements 7 days a week to include holidays. Compliance with any certification for transporting of cylinders of any type adhering to Federal, State, or Local regulations is the responsibility of the Contractor and may be requested as proof of the required activity.

As needed The Contractor shall have the ability to perform hydrostatic testing and refilling services on a set aside group of at least two hundred fifty (250) Government owned (Size E) oxygen cylinders to be used for emergency reserve purposes by the VAMC facilities. Cylinders not passing hydrostatic testing or failure for other defects will be reported to the Contracting Officer’s Representative (COR) and if permission is granted, repaired to serviceable condition. Any cylinder that cannot be repaired or is deemed unserviceable shall be reported to the COR for final determination.

The Contractor shall provide refilling services for Government owned cylinders upon request. All Government owned cylinders will be marked by the controlling facility with physical identifiers which include, but not limited to labeling, stamp, etc. Contractor shall annotate delivery packing slip with type, size, and quantity of cylinders picked up and returned (filled). The Contractor shall provide a certificate of purity from the supplier for provided gases for all returned cylinders. If a cylinder requires hydrostatic testing or repainting, the contractor must get approval from COR prior to service. If the tested cylinder fails hydrostatic testing or any other damage has rendered the cylinder unserviceable, the Contractor must identify and return the tagged cylinder to the COR assigned to contract.

The Contractor shall provide all initial cylinders to meet the Government requirement for leased cylinders via the initial outfitting of each listed and future facilities in section 4 of this SOW. At the end of the contract or termination of the awarded contract, a listing of all outstanding non-Government owned cylinders shall be returned and charges must be received by COR within 10 business days to reconcile all facility accounts.

The Contractor shall conduct an inventory at the convenience to the Government with participation of the COR prior to the end of the contract to verify current inventory and prepare the closing of the current fiscal year billing. The Contractor shall also provide the facility an annual sales report for individual facilities consisting of the type of tanks, quantity, date of delivery, gases provided, cost per tank and any discrepancy such as lost or missing tanks that could not be identified.

Compliance with any certification of transporting cylinders of any type arising from Code of Federal Regulations (CFR), Department of Transportation (DOT), or Department of Labor, Occupational Safety and Health Administration is the responsibility of the contractor; and may be requested as proof to the requiring activity at any time. Primary contractor must maintain their own certification regardless of whether or not they will use subcontractors.

The contractor shall agree to a minimum 30 calendar day transitional period to allow sufficient time to utilize all medical gas inventory contained in cylinders, while transferring to future post awarded Contractor. The Government facilities shall continue to incur rental charges and pay those charges accordingly under the awarded contract.

A COR will be delegated by the Contracting Officer (CO) and is responsible for local contract administration issues such as ordering and providing specific delivery instructions. A letter of delegation that outlines the COR’s specific responsibilities will be provided to the contractor and COR at the time of contract award. The COR with permission by the CO, will designate limited NF/SG VHS staff amongst the OPC facilities as a point of contact (POC) who shall also have the ability to submit orders for OPC and CBOC locations within their sphere of inventory control. Within 15 days after notification of contract award, the contractor shall meet with the CO and COR to ensure mutual understanding of facilities requirements relating to the location, initial delivery of medical gas types and amounts, the schedule of deliveries and specific details of any delivery instructions that are included in the solicitation. The COR shall forward a written copy of the mutual agreement signed by both parties to the CO for incorporation into the contract by written modification within 30 days after contract award. If an agreement cannot be reached between the Contractor and COR regarding any issue, the matter shall be referred to the CO for resolution.

2. TYPE OF CONTRACT

Firm Fixed Price:

3. PERFORMANCE PERIOD

The Government anticipates the award of a Firm Fixed Price Contract resulting from this solicitation, consisting of a base year and four (4) one (1) year option periods.

Base Period: October 1, 2021 through September 30, 2022

Option Year One: October 1, 2022 through September 30, 2023

Option Year Two: October 1, 2023 through September 30, 2024

Option Year Three: October 1, 2024 through September 30, 2025

Option Year Four: October 1, 2025 through September 30, 2026

4. PLACE OF PERFORMANCE

DELIVERY/PICK-UP FACILITY LOCATIONS AND HOURS OF OPERATIONS:

* Malcom Randall VAMC: 1601 S.W. Archer Road, Gainesville, FL 32608, Monday – Friday: 8:00 am to 4:00 pm

* Lake City VAMC: 619 S. Marion Avenue, Lake City, FL 32025, Monday – Friday: 8:00 am to 4:00 pm

* Jacksonville OPC: 1536 North Jefferson Street, Jacksonville, FL 32206, Monday – Friday: 8:00 am to 4:00 pm

* Sergeant Ernest I. “Boots” Thomas OPC: 2181 East Orange Avenue, Tallahassee, FL 32311, Monday – Friday: 8:00 am to 4:00 pm

* The Villages OPC: 8900 S.E. 165th Mulberry Lane, The Villages, FL 32162, Monday – Friday; 8:00 am to 4:00 pm

* Middleburg CBOC: 400 College Drive, Suite 200, Middleburg, FL 32068, Monday – Friday: 8:00 am to 4:00 pm

* Marianna CBOC: 4970 Highway 90, Marianna, FL 32446, Monday – Friday: 8:00 am to 4:00 pm

* Ocala CBOC: 4826 SW 49th Road, Ocala, FL 34474, Monday – Friday: 8:00 am to 4:00 pm

* Palatka CBOC: 400 North State Road 19, Suite 48, Palatka, FL 32177, Monday – Friday: 8:00 am TO 4:00 pm

* Perry CBOC: 1224 N. Peacock Avenue, Perry FL, 32347, Tuesday – Friday: 7:00 am to 5:30 pm

* St. Augustine CBOC: 100 Deerfield Preserve Boulevard, St. Augustine, Florida 32086, Monday – Friday: 8:00 am to 4:00 pm

* St. Mary’s CBOC: 205 Lake Shore Point, St. Mary’s, GA 31558, Monday – Friday:

8:00 am to 4:00 pm

* Valdosta CBOC: 348 Enterprise Drive, Suite B, Valdosta, GA 31601, Monday – Friday:

8:00 am to 4:00 pm

* Waycross CBOC: 515B City Boulevard, Waycross, GA 31501, Monday – Thursday:

8:00 am to 4:00 pm

* Gainesville VA Dermatology Clinic: 5571 S.W. 64 Street, Gainesville, FL 32608, Monday –Friday: 8:00 am to 4:00 pm

* Gainesville VA Pain Clinic: 3401 N.W. 98 Street, Gainesville, FL 32606, Monday – Friday: 8:00 am to 4:00 pm

Note: Additional facilities may be added based on NF/SG VHS growth and requirements.

5. DELIVERABLES

All types and quantities listed below are monthly estimates NF/SG VHS requires and may change and/or increase/decrease in quantity and type based on emergency response/crisis management, general need, changes in medical technology or increase of care provided to our veterans:

Description of Supply/Service Cylinder

Size Required Quantity

Unit

MEDICAL GAS/CYLINDER DELIVERY FOR:

MALCOM RANDALL VA MEDICAL CENTER Location 1 MO

Argon (Ultra High Purity) 33 1 CY/MO

Blood Gas (CB 5%CD/5%OX/BAL NI) E 1 CY/MO

Carbon Dioxide E 50 CY/MO

Carbon Dioxide 50 1 CY/MO

Carbon Monoxide (0.3% CD/ 0.3% ME/21% OX/BAL NI): Lung Diffusion H 1 CY/MO

Compressed Air E 1 CY/MO

Compressed Air H 1 CY/MO

Heliox (80%/20%) H 1 CY/MO

Helium E 1 CY/MO

Helium H 1 CY/MO

Nitrogen H 60 CY/MO

Nitrogen (Liquid) 180L 2 CY/MO

Nitrous Oxide E 1 CY/MO

Nitrous Oxide H 6 CY/MO

Nitrous Oxide 20LB 2 CY/MO

Nitrous Oxide (Cryocath) 10LB 2 CY/MO

Oxygen (Aluminum Cylinder) D 1 CY/MO

Oxygen (Aluminum Cylinder) E 30 CY/MO

Oxygen (Aluminum Cylinder w/ Regulator) E 300 CY/MO

Oxygen (MRI w/ Regulator) E 4 CY/MO

Oxygen H 2 CY/MO

MEDICAL GAS/CYLINDER DELIVERY FOR:

LAKE CITY VA MEDCIAL CENTER Location 1 MO

Argon (Ultra High Purity) 33 1 CY/MO

Blood Gas (CB 5%CD/5%OX/BAL NI) E 1 CY/MO

Carbon Dioxide E 6 CY/MO

Carbon Dioxide 50 1 CY/MO

N.O.S. (5% Carbon Dioxide/BAL NI) 200 1 CY/MO

Carbon Monoxide (0.3% CD/ 0.3% ME/21% OX/BAL NI): Lung Diffusion H 1 CY/MO

Helium H 1 CY/MO

Nitrogen H 2 CY/MO

Nitrogen (Liquid) 30L 2 FILL/MO

Nitrous Oxide H 2 CY/MO

Oxygen (Aluminum Cylinder) E 2 CY/MO

Oxygen (Aluminum Cylinder w/ Regulator) E 200 CY/MO

Oxygen H 2 CY/MO

MEDICAL GAS/CYLINDER DELIVERY FOR:

JACKSONVILLE OPC Location 1 MO

Blood Gas (CB 5%CD/5%OX/BAL NI) E 1 CY/MO

Carbon Dioxide E 8 CY/MO

Carbon Monoxide (0.3% CD/ 0.3% ME/21% OX/BAL NI): Lung Diffusion H 1 CY/MO

Nitrogen (Liquid) 20L 2 FILL/MO

Nitrous Oxide H 1 CY/MO

Oxygen (Aluminum Cylinder) E 2 CY/MO

Oxygen (Aluminum Cylinder w/ Regulator) E 4 CY/MO

Oxygen H 36 CY/MO

MEDICAL GAS/CYLINDER DELIVERY FOR:

SERGEANT ERNEST I. “BOOTS” THOMAS OPC

(Tallahassee) Location 1 MO

Blood Gas (CB 5%CD/5%OX/BAL NI) E 1 CY/MO

Carbon Dioxide E 6 CY/MO

Carbon Monoxide (0.3% CD/ 0.3% ME/21% OX/BAL NI): Lung Diffusion H 1 CY/MO

Custom Mix: 5% CO2, 15% O2, BAL. N2;

Cylinder: ED; Valve: CGA 973 E 1 CY/MO

Nitrogen (Liquid) 25L 2 FILL/MO

Oxygen (Aluminum Cylinder w/ Regulator) E 4 CY/MO

Oxygen H 24 CY/MO

MEDICAL GAS/CYLINDER DELIVERY FOR:

THE VILLAGES OPC Location 1 MO

Carbon Dioxide E 10 CY/MO

Compressed Air H 2 CY/MO

Nitrogen (Liquid) 20L 3 FILL/MO

Oxygen (Aluminum Cylinder w/ Regulator) E 6 CY/MO

Oxygen H 6 CY/MO

MEDICAL GAS/CYLINDER DELIVERY FOR:

MARIANA CBOC Location 1 MO

Oxygen (Aluminum Cylinder w/ Regulator) E 2 CY/MO

MEDICAL GAS/CYLINDER DELIVERY FOR:

MIDDLEBURG CBOC Location 1 MO

Nitrogen (Liquid) 20L 3 CY/MO

Oxygen (Aluminum Cylinder w/ Regulator) E 2 CY/MO

MEDICAL GAS/CYLINDER DELIVERY FOR:

OCALA CBOC Location 1 MO

Nitrogen (Liquid) 25L 2 CY/MO

Oxygen (Aluminum Cylinder w/ Regulator) E 2 CY/MO

MEDICAL GAS/CYLINDER DELIVERY FOR:

PALATKA CBOC Location 1 MO

Oxygen (Aluminum Cylinder w/ Regulator) E 2 CY/MO

MEDICAL GAS/CYLINDER DELIVERY FOR:

PERRY CBOC Location 1 MO

Oxygen (Aluminum Cylinder w/ Regulator) E 2 CY/MO

MEDICAL GAS/CYLINDER DELIVERY FOR:

ST. AUGUSTINE CBOC Location 1 MO

Nitrogen (Liquid) 20L 2 CY/MO

Oxygen (Aluminum Cylinder w/ Regulator) E 2 CY/MO

MEDICAL GAS/CYLINDER DELIVERY FOR:

ST. MARY'S CBOC Location 1 MO

Oxygen (Aluminum Cylinder w/ Regulator) E 2 CY/MO

MEDICAL GAS/CYLINDER DELIVERY FOR:

VALDOSTA CBOC Location 1 MO

Nitrogen (Liquid) 20 1 CY/MO

Oxygen (Aluminum Cylinder w/ Regulator) E 2 CY/MO

MEDICAL GAS/CYLINDER DELIVERY FOR:

WAYCROSS CBOC Location 1 MO

Oxygen (Aluminum Cylinder w/ Regulator) E 2 CY/MO

MEDICAL GAS/CYLINDER DELIVERY FOR:

GAINESVILLE VA DERMATOLOGY CLINIC Location 1 MO

Nitrogen (Liquid) 230L 2 CY/MO

MEDICAL GAS/CYLINDER DELIVERY FOR:

GAINESVILLE VA PAIN CLINIC Location 1 MO

Oxygen H 2 CY/MO

Cylinder (Size: D, E, & 20LB) Lease 200 CY/MO

Cylinder (Size: E w/ Regulator) Lease 900 CY/MO

Cylinder (Size E w/ Regulator: MRI Safe) Lease 25 CY/MO

Cylinder (Size G & H) Lease 250 CY/MO

Cylinder (10LB) Lease 10 CY/MO

Cylinder (UHP Argon) Lease 4 CY/MO

Cylinder (Heliox) Lease 10 CY/MO

Dewar (Size 180L & 230L) Lease 4 DW/MO

Emergency Delivery Delivery 1 DEL/MO

Hydrostatic Testing Testing 40 CY/YR

Medical grade gas and medical gas cylinders shall be delivered to each individual facility. Delivery hours are posted for each individual facility but are typically Monday through Friday between 8:00AM and 4:00PM, excluding Federal holidays. In an extremely rare case of emergency, medical center staff will be available for delivery any day, any hour. Federal holidays observed are: New Year’s Day, Martin Luther King Day, President’s Day, Memorial Day, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving Day, Christmas Day. Please note that should a federal holiday fall on a weekend, then the day off typically given to federal employees will be the weekday immediately preceding or following the federal holiday (i.e. Saturday = Friday, Sunday = Monday).

The Contractor shall deliver medical-grade gas and gas cylinders within the time frame specified for each facility. The time frame identified may be either the number of calendar days after receipt of the Government’s order, the specific days of the week for delivery, the specific time intervals between deliveries, a specified reorder point, or other specified ordering and delivery methods. If the time frame for contract or delivery is not identified, the contractor must provide 24-hour notice prior to delivery or upon mutual agreement between the facility and the contractor, alternate ordering/delivery methods such as pre-scheduled deliveries may be arranged. If for any reason the contractor is unable to deliver at the agreed upon day or time, the contractor will provide 24-hour notice to the COR, so that the facility can initiate an alternate backup action.

In accordance with VHA Patient Safety Alert dated April 4, 2004, all deliveries must be monitored by a qualified and trained technical representative that will be designated by the facility. Contractor will be provided with names and contact information of primary and back-up facility representatives. This applies to all deliveries regardless of time or day of execution.

At the time of each delivery, Contractor shall provide a legible signed and dated delivery order that identifies at minimum: type, description, hazard class, quantity ordered, quantity delivered, quantity returned and weight/volume of each individual deliverable.

This document must be counter-signed by the facility representative supervising the delivery.

6. QUALITY ASSURANCE SPECIFICATIONS AND REQUIREMENTS

All medical gas manufactures and fillers of medical gas cylinders must be registered with FDA as drug manufacturers. All medical-grade gases shall be manufactured, processed, packed, transported and stored according to FDA’s Current Good Manufacturing Practices (CGMP) regulations, and all labeling shall comply with FDA’s labeling regulations (21 CFR Part 201).

All medical-grade gases delivered under the contract shall be medical-grade and shall meet or exceed the standards cited in the current edition of the United States Pharmacopoeia/National Formulary (U.S.P.).

A valid certificate of analysis shall be provided with each delivery of medical-grade oxygen. The certificate shall include, at a minimum, the following items:

A. Supplier’s name and complete address

B. Name of the Product (i.e. Oxygen U.S.P.)

C. An Air Liquefaction statement where appropriate

D. Lot number or other unique identification number

E. Actual analytical results for full U.S.P. monograph testing. (A statement that only states that the product meets the minimum purity of 99.5%, etc. is not acceptable.)

F. Test method used to perform the analysis (a statement such as “Meets U.S.P.

specifications” is not acceptable; nor would “Tested via Servomex” be acceptable since the specific model number is not provided)

G. Signature of authorized supplier representative and date.

Safety Data Sheets (SDS) shall be provided to the facility COR upon request.

7. MEASUREMENTS AND CONVERSION COMPUTATIONS

Density data and volume measurement equivalents published in Compressed Gas Association Pamphlet No. P-6, titled “Standard Density Data, Atmospheric Gases and Hydrogen,” shall be used when necessary to convert measurement of gases from one form to another.

8. APPLICABLE REGUALTIONS AND STANDARDS

The following is a list of some of the regulations and standards that are applicable to this contract. The list is not comprehensive, and the contractor is responsible for ensuring that all products, equipment and services provided under the contract are in compliance with applicable Federal, state and local regulations. If applicable, the editions in effect as of the date of this solicitation are listed. Contractor is responsible for remaining compliant with any future revisions that are effective at the time of contract performance.

Title 21 CFR, Part 210 - CGMP in Manufacturing, Processing, Packing, or Holding of Drugs: General

Title 21 CFR, Part 211 - CGMP for Finished Pharmaceuticals

Title 29 CFR, Part 1910, Subpart H - Hazardous Materials

Title 49 CFR, Transportation

Federal Food, Drug, and Cosmetic Act (FD&C Act)

U.S. Food and Drug Administration: Current Good Manufacturing Practices (CGMP)

NFPA 55: Compressed Gases and Cryogenic Fluids Core, 2020 Edition

NFPA 99: Standard for Health Care Facilities, 2015 Edition

United States Pharmacopeia – National Formulary (USP-NF) 2019 Edition

Compressed Gas Association Pamphlet No. P-6, Standard Density Data, Atmospheric Gases and Hydrogen, (Published Oct. 2012/Reaffirmed October 2018)

VA-FDA Interagency Agreement

9. SPECIAL SECURITY REQUIREMENTS

VA Police shall issue photo identification badges directly to contractors’ and sub-contractors’ superintendents and foremen. These ID badges must be worn by these individuals at all times while on VA property.

Contractors’ supervisory personnel shall be responsible for acquiring temporary ID badges from VA’s Engineering Service, for all other staff, employees, and visitors associated with this project. These temporary ID badges shall be managed in accordance with procedures described in Engineering’s Badge Control Agreement (attached), and must be worn by Contractor’s non-supervisory staff, employees, and visitors at all times while on VA property.

Engineering’s Badge Control Agreement shall be initiated at the start of the project, when Contractors’ supervisory personnel acquire temporary ID badges for the first time.

Final payment and project close-out shall be contingent upon satisfactory execution of this Badge Control Agreement.

The Contractor’s employee(s) shall wear contractor ID badge at all times while on the premises of NF/SGVHS.

10. QUALIFICATIONS, CERTIFICATION AND TRAINING

Contractor shall be fully licensed and accredited to provide medical gas services in the states of Florida and Georgia for the duration of the resulting contract. * Provide current licensing with Technical Quote.

The contractor shall be qualified and have the required levels of professional and technical experience to perform the work required.

The contractor shall provide records of training and practical competency assessment of contractor personnel involved with the performance of this contract in relation to the transportation and delivery of medical-grade gas. All new contractor personnel will have completed all required training prior to delivery of any medical-grade gases to a NF/SGVHS facility. Documentation will be provided to the VA Contract Officer at time of solicitation submission and whenever requested by COR.

Compliance with all required certifications for the provision or transportation of gas services of any type in relation to all Federal, State, or Local regulations is the responsibility of the Contractor who shall provide proof on request by the Government.

Contractor will provide initial training and annual refresher training, at no extra cost, to any of the following NF/SG VHS personnel: VA Police, COR, Logistics and/or Engineering staff involved with the procedure of accepting deliveries whether during normal business hours or emergencies. This training may need to be conducted at various times to accommodate different shifts.

11. PERFORMANCE BASED REVIEWS

Contractor’s Past and Present Performance shall be reviewed by the Contracting Officer (CO) and Contracting Officer’s Representative (COR) prior to award and on an annual basis. This survey shall be documentation of the contractor acceptable or unacceptable performance during the contract period.

12. SCHEDULING AND HOURS OF WORK

The Contractor or representative shall conduct business during normal NF/SGVHS working hours unless specifically authorized by the COR, or otherwise specified in the contract. NF/SG VHS normal duty hours are 8:00 AM to 4:30 PM, Monday through Friday with the exception being Federal holidays. Federal holidays observed are: New Year’s Day, Martin Luther King Day, President’s Day, Memorial Day, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving Day, Christmas Day.

Upon the Government’s request and mutual agreement with the Contractor, pick-up/deliveries may be required outside of normal hours at charges stated in the price schedule, if applicable. If weather conditions exist which prevents Contractor’s delivery within the specified hours or operations, the affected NF/SG VHS facilities POC and COR shall be notified within one hour of the estimated time of arrival. An alternate method of pickup and delivery of gas services shall be provided by the Contractor should this situation arise. Additionally, the Government, as proof of the performing service, shall retain a copy of the pick-up/delivery ticket.

13. COR RESPONSIBILITIES

The Contractor will be provided with updated contact information by a COR prior to the start date if any COR contact information related to this SOW has changed prior to award of this contract.

Performance of work under this contract shall be subject to the technical direction of the COR, or a representative designated in writing. Technical direction MUST be within the scope of the contract. The COR does not have authority to issue technical direction that:

A. Constitutes a change of assignment or additional work outside the specification(s)/work statement

B. Constitutes a change as defined in the clause entitled “Changes”

C. In any manner cause an increase or decrease in the contract price, or the time required for contract performance

D. Changes any of the terms, conditions, or specification(s)/work statement of the contract

E. Interferes with the Contractors right to perform under the terms and conditions of the contract

F. Direct, supervise or otherwise control the actions of the Contractor’s employees.

Technical direction may be oral or in writing. The COR shall confirm oral direction in writing within three (3) workdays, with a copy to the CO.

The Contractor shall proceed promptly with technical direction issued by the COR. If, in the opinion of the Contractor, any direction of the COR, or his/her designee, falls within the limitations in (13.2) above, the contractor shall immediately notify the CO no later than the beginning of the next work day.

Failure of the Contractor and the CO to agree that technical direction is within the scope of the contract shall be subject to the terms of the contractual clause entitled “Disputes”

14. CONTRACTOR RESPONSIBILITIES

The contractor shall be required to provide a telephone number that is available during their normal working hours as well as an emergency telephone number for afterhours, weekends, and holidays. The Contractor shall designate a least one company official and one alternate official, as a point of contact (POC) or account manager for the duration of the contract for all logistical and contractual support at the time of the contract award.

The contractor shall meet or exceed, in all parts, the needs of the Government set forth in this SOW or terms of contract.

15. CONTRACTOR LIABILITIES

Responsible for Government Property: The Contractor assumes full responsibility for and shall indemnify the Government for any and all loss or damage whatsoever in kind and nature to any and all Government property, including any equipment, supplies, accessories, or parts furnished while in custody and care for storage, repairs, or services to be performed under the terms of this contract, resulting in whole or in part from the negligent acts or omissions of Contractor, any subcontractor or any employee, agent, or representative of Contractor or subcontractor.

Hold Harmless and Indemnification Agreement: The Contractor shall save and hold harmless and indemnify the Government against any and all liability, claims, and cost of whatsoever kind and nature for injury to or death of any person or persons and for loss or damage to any property occurring in connection with or in any way incident to or arising out of the occupancy, use, service, operations, or performance of work under the terms of this contract, resulting in whole or in part from the negligent acts or omissions of Contractor, any subcontractor, or any employee, agent or representative of Contractor or subcontractor.

Damage to Government Property from Causes Other than Contractor's Negligence:

Nothing in the above paragraphs shall be considered to preclude the Government from receiving the benefits of any insurance the Contractor may carry which provides for indemnification for any loss, or destruction or damage to Government property. The Contractor shall do nothing to prejudice the Government's right to recover against third parties for any loss, destruction of, or damage to Government property and upon the request of the CO shall, at the Contractor’s expense, furnish to the Government all reasonable assistance and cooperation (including assistance in prosecution of suit and the execution of instruments of assignment in favor of the Government) in obtaining recovery.

16. RECALLS

If at any time during the term of the contract awarded as a result of this solicitation, the U.S. Food and Drug Administration (FDA) or the individual contractor initiates a drug recall or FDA withdraws their approval to manufacture a drug, the following steps will immediately be taken by the appropriate contractor:

A. Important notices not requiring immediate attention and drug product hazard alerts, recalls and product notices requiring immediate attention and dissemination should be sent via overnight express to:

VA National Center for Patient Safety (10X)

24 Frank Lloyd Wright Drive Lobby M

PO Box 486 Ann Arbor, MI 48106-048

B. Forward one copy of any notification along with any pertinent information to the Contract Specialist and COR.

17. MANUFACTURING FACILITIES

Only offers from contractors and/or suppliers that have on record at time of proposal submission with the Department of Veterans Affairs, Pharmacy Benefits Management (PBM), a Quality Assurance Evaluation that has found those facilities, listed below, to be in compliance with the laws that FDA enforces and capable of marketing all currently manufactured products that meet applicable quality standards, will be accepted. Where FDA does not perform quality assurance testing, the VA reserves the right to perform its own quality assurance evaluation or to hire a contractor to perform this task.

Arrangements for a Quality Assurance evaluation are obtained by contacting PBM.

Evaluations will be performed by FDA in accordance with Paragraph V.4 of the VA-FDA Interagency Agreement, by which the FDA is responsible for providing quality assurance for drugs, biologics, chemicals, and/or reagents being offered. Quality Assurance evaluation must have been received by the VA prior to the effective date of the contract as shown within this solicitation.

If at any time during the life of the contract, the contractor’s facility, or the source from which the contractor obtains any of the item(s) listed under this contract, fails to meet Current Good Manufacturing Practice Regulations (CGMPRs)(21 CFR Part 210 and 211), and/or a negative Food and Drug Administration Quality Assurance Evaluation is received, the CO may apply the procedures outlined in paragraph (17.5).

Any products manufactured during this period of CGMPRs deficiencies shall not be shipped without written authorization from the CO, and material which has been received without this authorization shall be returned as rejected goods at the contractor’s risk and expense. The contractor will have 30 days in which to correct the deficiencies that caused the negative evaluation and notify the CO and COR to have a reevaluation completed by the FDA. If upon reevaluation, the results are still negative, the contract shall be reviewed for termination in accordance with 52.212-4(m). The failure or inability of the contractor or contractor’s source to correct CGMPR deficiencies in a timely fashion shall not constitute or give rise to an “excusable delay” in performance pursuant to 52.212-4(f).

Offeror must indicate in Attachment A and, if additional space is needed, (a) exact product(s) offeror desires to furnish to the Government, (b) whether the offeror manufactures the product(s) and/or the offeror is a distributor of the product(s) manufactured by another firm. The contractor will only be able to utilize the manufacturer(s) provided in response to this clause for the duration of the contract, unless a substitution of the manufacturing facility is approved by the VA.

Offerors Please Fill out Attachment A, “Manufacturing Facilities,” and submit with your response.

Notes:

A. If the product(s) are to be manufactured at more than one location, each location should be identified, and product(s) manufactured at the facility should be identified. Also list the names and locations of all subcontractors (packager, labelers, etc.,) who participate in the production of product(s) to be furnished to the Government.

B. Products may be identified by the solicitation item number or Special Item Number (SIN) as listed on the Standard Form (SF) 1449 or Continuation Sheet(s) of the SF 1449 per authority of FAR (48 CFR) 53.212

C. In addition, when the finished product to be offered is of foreign manufacture, the complete name and address of the manufacturer shall also be listed.

In case of any facility relocation, the contractor agrees to notify the CO and COR of the change and request approval to supply contract items from the new location.

Any prospective company with additional products not listed (in the product list below), may include those products on a separate list (labeled - non contracted items) to be considered for future procurement needs.

ATTACHMENT “A”

Directions: Please complete the following information and return with your quote.

Manufacturing Facilities

Sol

Item

Mfg/Production

Point

Complete

Name Address and Phone

Number

FDA

Registration

Repacking/Packaging

Point

Complete Name

Address and Phone

Number

FDA

Registration

Ordering Address &

Phone Number