RFQ N00183-09-T-0583.doc

Section A - Solicitation/Contract Form

CLAUSES INCORPORATED BY FULL TEXT

VENDOR TO COMPLETE THE FOLLOWING:

TIN:

CAGE:

DUNS:

Vendor Point of Contact:

Vendor Phone:

Vendor Fax:

Vendor E-Mail:

Vendor’s Published or Commercial Price List containing the items specified herein, must accompany this RFQ package when submitted for evaluation.

Naval Medical Center Portsmouth Points of Contact:

Doris Turner, Phone: 757-953-7456 Fax: 757-953-5739 E-Mail: doris.turner@med.navy.mil

Credits / Payments shall be issued in Arrears (Check One): Monthly Quarterly

Semi-Annually Annually

Vendor to reference Request for Quotation (RFQ) Number N00183-09-T-0583 on all correspondence relating to this RFQ.

Government Reserves the right to make an award based on an “All or None” evaluation and/or based on the “Best Value” proposed for this requirement. Vendors with superior past performance history may be given 1st consideration.

Section B - Supplies or Services and Prices

Plasma Exchange Agreement for the

FFP

Purchase of Frozen Recovered Human Plasma from

Naval Medical Center Portsmouth in accordance with the Statement of Work, Section C, for the Base Year Period

01 October 2009 through 30 September 2010.

For each Liter of Frozen Recovered Human Plasma accepted during the Base Year period of performance, the

Contractor agrees to credit the Government at the fair market prices established to be

$ (Vendor to specify amount) per liter.

FOB: Destination

MILSTRIP: N0018310RQBL034

PURCHASE REQUEST NUMBER: N0018310RQBL034

NET AMT

Plasma Exchange Agreement for the

FFP

Purchase of Liquid Recovered Human Plasma from

Naval Medical Center Portsmouth in accordance with the Statement of Work, Section C, for the Base Year Period

01 October 2009 through 30 September 2010.

For each liter of Liquid Recovered Human Plasma accepted during the

Base Year period of performance, the Contractor agrees to credit the Government at the fair market prices established to be

$ (Vendor to specify amount) per liter.

FOB: Destination

NET AMT

FFP

Purchase of Frozen Recovered Human Plasma from

Naval Medical Center Portsmouth in accordance with the Statement of Work, Section C, for the Option Year I period

01 October 2010 through 30 September 2011.

For each Liter of Frozen Recovered Human Plasma accepted during the Option Year I period of performance, the Contractor agrees to credit the Government at the fair market prices established to be $ (Vendor to specify amount) per liter.

FOB: Destination

NET AMT

FFP

Purchase of Liquid Recovered Human Plasma from

Naval Medical Center Portsmouth in accordance with the Statement of Work, Section C, for the Option Year I period 01 October 2010 through 30 September 2011.

For each liter of Liquid Recovered Human Plasma accepted during the

Option Year I period of performance, the Contractor agrees to credit Government at the fair market prices established to be

$ (Vendor to specify amount) per liter.

FOB: Destination

NET AMT

FFP

Purchase of Frozen Recovered Human Plasma from

Naval Medical Center Portsmouth in accordance with the Statement of Work, Section C, for the Option Year II

01 October 2011 through 30 September 2012

For each Liter of Frozen Recovered Human Plasma accepted, during the Option Year II period of performance, the Contractor agrees to credit the Government at the fair market prices established to be $ (Vendor to specify amount) per liter.

FOB: Destination

NET AMT

FFP

Purchase of Liquid Recovered Human Plasma from

Naval Medical Center Portsmouth in accordance with the Statement of Work, Section C, for the Option Year II period

01 October 2011 through 30 September 2012.

For each liter of Liquid Recovered Human Plasma accepted during the

Option Year II period of performance, the Contractor agrees to credit the Government at the fair market prices established to be

$ (Vendor to specify amount) per liter.

FOB: Destination

NET AMT

FFP

Purchase of Frozen Recovered Human Plasma from

Naval Medical Center Portsmouth in accordance with the Statement of Work, Section C, for the Option Year III

01 October 2012 through 30 September 2013.

For each Liter of Frozen Recovered Human Plasma accepted, during the Option Year III period of performance, the Contractor agrees to credit the Government at the fair market prices established to be $ (Vendor to specify amount) per liter.

FOB: Destination

NET AMT

FFP

Purchase of Liquid Recovered Human Plasma from

Naval Medical Center Portsmouth in accordance with the Statement of Work, Section C, for the Option Year III period 01 October 2012 through 30 September 2013.

For each liter of Liquid Recovered Human Plasma accepted during the

Option Year III period of performance, the Contractor agrees to credit the Government at the fair market prices established to be

$ (Vendor to specify amount) per liter.

FOB: Destination

NET AMT

FFP

Purchase of Frozen Recovered Human Plasma from

Naval Medical Center Portsmouth in accordance with the Statement of Work, Section C, for the Option Year IV period

01 October 2013 through 30 September 2014.

For each Liter of Frozen Recovered Human Plasma accepted, during the Option Year IV period of performance, the Contractor agrees to credit the Government at the fair market prices established to be $ (Vendor to specify amount) per liter.

FOB: Destination

NET AMT

FFP

Purchase of Liquid Recovered Human Plasma from

Naval Medical Center Portsmouth in accordance with the Statement of Work, Section C, for the Option Year IV period 01 October 2013 through 30 September 2014.

For each liter of Liquid Recovered Human Plasma accepted during the

Option Year IV period of performance, the Contractor agrees to credit the Government at the fair market prices established to be

$ (Vendor to specify amount) per liter.

FOB: Destination

NET AMT

Section C - Descriptions and Specifications

STATEMENT OF WORK

Background: This Plasma Exchange Agreement is for a base year period of performance 01 October 2009 through 30 September 2010 with the option to extend the program up to four (4) additional one-year option periods through 30 September 2014. It is for the collection and sale of recovered human plasma, to include frozen recovered plasma (Bar-Code 19701), liquid recovered plasma (Bar-Code 19201) from Naval Medical Center Portsmouth (NMCP), Virginia for non-injectable purposes. The establishment and maintenance of a monetary account from the sale of blood products, for the purchase of donor incentives and related blood donor center materials in accordance with the authority of 10 USC 1095, OPNAVINST 6530.4B and MCO 6530.2.

Period of Performance: Base Year – 01 October 2009 through 30 September 2010

Option Year I – 01 October 2010 through 30 September 2011

Option Year II – 01 October 2011 through 30 September 2012

Option Year III – 01 October 2012 through 30 September 2013

Option Year IV – 01 October 2013 through 30 September 2014 Scope of Work

Naval Medical Center Portsmouth (NMCP) agrees to provide recovered human plasma for the remanufacture in non-injectable products. NMCP collects approximately 6,000 units of whole blood annually. It is anticipated that approximately 50% of the total (about 1020 liters) will result in recovered plasma.

1. CONTRACTOR REQUIREMENTS:

a. The Contractor shall be FDA registered as either a broker, distribution center, or component preparation and collection facility.

b. The Contractor shall credit the recovered plasma to a special account maintained specifically for this agreement. The Contractor shall provide the Designated Government Representative with monthly statements of products ordered against the Plasma Exchange Agreement. Statement shall be itemized and show credits for plasma payments against Government orders placed and balance remaining in the account. Contractor shall furnish a monthly statement of the account to the Designated Government Representative indicating:

i. Credits accumulated for plasma accepted.

ii. Number of destroyed unusable units of plasma specifying NMCP unit identification number.

iii. Cost of items shipped against this NMCP order.

iv. Balance remaining.

c. Products to be ordered:

i. Products to be ordered by the Plasma Exchange Agreement Contractor will be items classified as blood products, blood derivatives, blood bank quality control reagents and/or other blood bank expendables (i.e. Donor Center incentive products), which will be applied against the existing order balance. The Designated Government Representative will identify the recommended sources to obtain the donor products. Invoice shall be provided to the Plasma Exchange Agreement Contractor.

ii. Each order placed by NMCP will clearly be identified as “Plasma Exchange Agreement Order. The contractor shall provide payment to the designated source within seven days following the request for payment.

iii. Delivery will be made directly to NMCP.

d. Credit Application:

i. The Plasma Exchange Contractor agrees to credit NMCP in the amount of (Contractor to specify amount in this Request for Quote) per liter for acceptable Frozen Recovered Plasma within 0-24 hours after phlebotomy – Bar Code 19701

ii. The Plasma Exchange Contractor agrees to credit NMCP in the amount of (Contractor to specify amount in this Request for Quote) per liter for Liquid Recovered Plasma – Bar Code 19201.

iii. The Plasma Exchange Agreement will run per fiscal year. Credits accumulated during the current fiscal year will transfer to the subsequent fiscal year. Transfer of this credit balance shall be provided in a monthly statement to the Designated Government Representative.

e. The Contractor shall credit NMCP in the negotiated amount per liter of acceptable plasma. Unit price may be adjusted at the current national market rate at the six-month mark. Market value will be established by a mean average of the national average. The Contractor will furnish a letter stating the current market pricing to the Contracting Officer prior to the commencement of renegotiations. The Contracting Officer will evaluate contract price and current market price and issue a written modification to this Agreement to reflect a change in the new rate as mutually agreed upon.

f. Contractor shall furnish all boxes and labels for preparing products for shipment. Contractor labels shall conform to Section 351 of the Public Health Service Act (PHS) and contain the statement, “Caution- for Use in Non-Injectable Products Only.” Contractor shall provide for pick up or pay all shipping costs associated with transport of recovered plasma. Contractor shall respond to the verbal notification for pick-up within five (5) working days.

g. Contractor shall weigh and record volume of each shipment with the donor number and donation date. Packing lists shall be submitted with each shipment. A copy of the plasma record shall be furnished to the Designated Government Representative within three (3) weeks after receipt of each individual shipment.

h. Contractor shall provide proof of destruction to the Designated Government Representative of any Government-furnished plasma rejected by vendor as unusable. Contractor shall identify each unusable unit by donor number. A copy of this record will be provided to the Designated Government Representative and NMCP Blood Bank Officer.

i. Shipping.

i. Frozen Recovered Plasma: All shipments shall be from NMCP, via a designated frozen transport company and will be picked up on a routine basis, approximately once a month.

ii. Liquid Recovered Plasma: For shipments less than 100 lbs, ship via FEDEX and for shipments over 100 lbs., shipment by a designated transport company.

2. GOVERNMENT REQUIREMENTS.

a. Government shall furnish recovered plasma, either frozen recovered plasma or liquid recovered plasma that are tested negative for all viral marker screening tests and other testing as required by current FDA guidelines for the blood-banking industry.

b. Government will insure donor recorded include: donor number, collection date, and type of anticoagulant used.

c. Government will furnish a Certificate of Analysis signed by the Designated Government Representative, the Blood Bank Supervisor or their designee stating that all units are tested negative for;

i. Anti-HIV I / II

ii. Anti-HCV

iii. HbsAg

iv. Anti-Hbc

v. Anti HTLV I

vi. STS

vii. HCV and HIV by Nucleic Acid Test (NAT)

viii. West Nile Virus (WNV) by Nucleic Acid Test (NAT)

d. Government will insure that plasma is only from donors whose blood is acceptable for transfusion where CPD, CDPA-1, CP2D, AS-1, AS-3 or AS-5 have been used as the anticoagulant.

e. Government will ensure that plasma is separated from in-date whole blood units within 24 hours of collection

f. Government will ensure that recovered plasma will be retained in single collection bags and will not be pooled.

g. Government will collect, label pack and maintain record keeping responsibilities for these products.

h. Government will label each plasma container with the following:

i. Name of Donor Center

ii. Blood Unit Number or Donation ID

iii. Testing per Recovered Specifications

iv. Date of blood extracted

v. Date of plasma extracted

vi. Volume of plasma in container

vii. Label shall state “Recovered Plasma Caution: For use in Manufacturing of Non-Injectable Products Only – subject to license number Section 351 of Public Health Service Act.”

i. The Government will insure that recovered plasma will appear normal in color (straw to amber color) and contain only a minimal amount of fatty material, hemoglobin or red cells. Any deviation will be rejected.

j. The Government will store recovered frozen plasma at -20◦C or colder and recovered liquid plasma at 20◦ - 24◦C.

k. Plasma will be collected from FDA approved Donor Centers.

l. The Designated Government Representative shall monitor this Plasma Exchange Agreement and audit credit accounts.

3. Termination: This agreement shall remain in effect for a period of one year increments for the base year plus four (4) additional one-year option periods unless cancelled by either party. Either party may cancel this agreement without cause by notifying the other party in writing, sixty (60) days in advance of the effective date of cancellation. The Government will have a period of sixty (60) days after the termination date of the agreement to use any remaining credits.

4. Cash Payment: Check or money order made payable to Naval Medical Center Portsmouth, VA for un-liquidated credits.

5. Authorization: The following individuals are authorized to place orders against the credit account:

a. Name: LCDR David H. Koch

Position: Head, Blood Bank

Telephone No: 757-953-1674 Fax: 757-953-0817

Email: david.koch@med.navy.mil

b. Name: Donald Sansoucy

Position: Lab Management Analyst & Designated Government Representative

Telephone No: 757-953-1684 Fax: 757-953-1693

Email: donald.sansoucy@med.navy.mil c.

Name: CAPT C. L. Howe

Position: Head, Laboratory

Telephone No: 757-953-1712 Fax: 757-953-0818

Email: christine.howe@med.navy.mil

Section E - Inspection and Acceptance

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

Section F - Deliveries or Performance

DELIVERY INFORMATION

30-SEP-2010

BLOOD BANK DONOR CENTER, 1ST FLOOR

620 JOHN PAUL JONES CIRCLE

PORTSMOUTH VA 23708-2297

757-953-1625

FOB: Destination N00183

30-SEP-2010

N00183

30-SEP-2011

N00183

30-SEP-2011

N00183

30-SEP-2012

N00183

30-SEP-2012

N00183

30-SEP-2013

N00183

30-SEP-2013

N00183

30-SEP-2014

N00183

30-SEP-2014

N00183

Section G - Contract Administration Data

Credits issued by the Contractor under this Plasma Exchange Agreement will be used to purchase blood products, derivatives, or other blood bank expendables for the Naval Medical Center Portsmouth as specified within this Agreement.

For any Unliquidated Credits at the expiration of the contract period of performance, the Plasma Exchange Contractor shall make payment via check or money order payable to Naval Medical Center Portsmouth and mailed to:

Naval Medical Center Portsmouth

Attn: Plasma Exchange, Laboratory, Blood Bank Government Designated Representative

620 John Paul Jones Circle

Portsmouth, VA 23708-2297

Telephone: 757-953-1684 or 757-953-1674 Section H - Special Contract Requirements

CLAUSES INCORPORATED BY FULL TEXT

INFORMATION ONLY: This document has been designated for posting to the Navy Electronic Commerce Online (NECO) at http://www.neco.navy.mil

Section I - Contract Clauses

CLAUSES INCORPORATED BY REFERENCE

52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 30 days.

(End of clause)

52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor within 30 days); provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 60 days before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 30 September 2014.

(End of clause)

52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

http://www.arnet.gov/far

(End of clause)

Department of Defense Business Associate Agreement Introduction

In accordance with DoD 6025.18-R “Department of Defense Health Information Privacy Regulation,” January 24, 2003, the Contractor meets the definition of Business Associate. Therefore, a Business Associate Agreement is required to comply with both the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security regulations. This clause serves as that agreement whereby the Contractor agrees to abide by all applicable HIPAA Privacy and Security requirements regarding health information as defined in this clause, and in DoD 6025.18-R and DoD 8580.02-R, as amended. Additional requirements will be addressed when implemented.

(a) Definitions. As used in this clause generally refer to the Code of

Federal Regulations (CFR) definition unless a more specific provision exists in DoD 6025.18-R or DoD 8580.02-R.

Individual has the same meaning as the term “individual” in 45 CFR

160.103 and shall include a person who qualifies as a personal representative in accordance with 45 CFR 164.502(g).

Privacy Rule means the Standards for Privacy of Individually Identifiable Health Information at 45 CFR part 160 and part 164, subparts A and E.

Protected Health Information has the same meaning as the term

“protected health information” in 45 CFR 160.103, limited to the information created or received by the Contractor from or on behalf of the Government pursuant to the Contract.

Electronic Protected Health Information has the same meaning as the term “electronic protected health information” in 45 CFR 160.103.

Required by Law has the same meaning as the term “required by law” in 45 CFR 164.103.

Secretary means the Secretary of the Department of Health and Human Services or his/her designee.

Security Rule means the Health Insurance Reform: Security Standards at

45 CFR part 160, 162 and part 164, subpart C.

Terms used, but not otherwise defined, in this Clause shall have the same meaning as those terms in 45 CFR 160.103, 164.501 and 164.304.

(b) The Contractor shall not use or further disclose Protected Health

Information other than as permitted or required by the Contract or as Required by Law.

(c) The Contractor shall use appropriate safeguards to prevent use or disclosure of the Protected Health Information other than as provided for by this Contract.

(d) The Contractor agrees to use administrative, physical, and technical safeguards that reasonably and appropriately protect the confidentiality, integrity, and availability of the electronic protected health information that it creates, receives, maintains, or transmits in the execution of this Contract.

(e) The Contractor agrees to mitigate, to the extent practicable, any harmful effect that is known to the Contractor of a use or disclosure of Protected Health Information by the Contractor in violation of the requirements of this Clause.

(f) The Contractor shall report to the Government any security incident involving protected health information of which it becomes aware.

(g) The Contractor shall report to the Government any use or disclosure of the Protected Health Information not provided for by this Contract of which the Contractor becomes aware.

(h) The Contractor shall ensure that any agent, including a subcontractor, to whom it provides Protected Health Information received from, or created or received by the Contractor, on behalf of the Government, agrees to the same restrictions and conditions that apply through this Contract to the Contractor with respect to such information.

(i) The Contractor shall ensure that any agent, including a subcontractor, to whom it provides electronic Protected Health Information, agrees to implement reasonable and appropriate safeguards to protect it.

(j) The Contractor shall provide access, at the request of the Government, and in the time and manner reasonably designated by the Government to Protected Health Information in a Designated Record Set, to the Government or, as directed by the Government, to an Individual in order to meet the requirements under 45 CFR 164.524.

(k) The Contractor shall make any amendment(s) to Protected Health

Information in a Designated Record Set that the Government directs or agrees to pursuant to 45 CFR 164.526 at the request of the Government, and in the time and manner reasonably designated by the Government.

(l) The Contractor shall make internal practices, books, and records relating to the use and disclosure of Protected Health Information received from, or created or received by the Contractor, on behalf of the Government, available to the Government, or at the request of the Government to the Secretary, in a time and manner reasonably designated by the Government or the Secretary, for purposes of the Secretary determining the Government’s compliance with the Privacy Rule.

(m) The Contractor shall document such disclosures of Protected

Health Information and information related to such disclosures as would be required for the Government to respond to a request by an Individual for an accounting of disclosures of Protected Health Information in accordance with 45 CFR 164.528.

(n) The Contractor shall provide to the Government or an Individual, in time and manner reasonably designated by the Government, information collected in accordance with this Clause of the Contract, to permit the Government to respond to a request by an Individual for an accounting of disclosures of Protected Health Information in accordance with 45 CFR 164.528.

General Use and Disclosure Provisions

Except as otherwise limited in this Clause, the Contractor may use or disclose Protected Health Information on behalf of, or to provide services to, the

Government for treatment, payment, or healthcare operations purposes, in accordance with the specific use and disclosure provisions below, if such use or disclosure of Protected Health Information would not violate the HIPAA Privacy Rule, the HIPAA Security Rule, DoD 6025.18-R or DoD 8580.02-R if done by the Government.

Specific Use and Disclosure Provisions

(a) Except as otherwise limited in this Clause, the Contractor may use

Protected Health Information for the proper management and administration of the Contractor or to carry out the legal responsibilities of the Contractor.

(b) Except as otherwise limited in this Clause, the Contractor may disclose Protected Health Information for the proper management and administration of the Contractor, provided that disclosures are required by law, or the Contractor obtains reasonable assurances from the person to whom the information is disclosed that it will remain confidential and used or further disclosed only as required by law or for the purpose for which it was disclosed to the person, and the person notifies the Contractor of any instances of which it is aware in which the confidentiality of the information has been breached.

(c) Except as otherwise limited in this Clause, the Contractor may use

Protected Health Information to provide Data Aggregation services to the

Government as permitted by 45 CFR 164.504(e)(2)(i)(B).

(d) Contractor may use Protected Health Information to report violations of law to appropriate Federal and State authorities, consistent with 45 CFR 164.502(j)(1).

Obligations of the Government

Provisions for the Government to Inform the Contractor of Privacy Practices and Restrictions

(a) The Government shall provide the Contractor with the notice of privacy practices that the Government produces in accordance with 45 CFR 164.520.

(b) The Government shall provide the Contractor with any changes in, or revocation of, permission by Individual to use or disclose Protected Health

Information, if such changes affect the Contractor’s permitted or required uses and disclosures.

(c) The Government shall notify the Contractor of any restriction to the use or disclosure of Protected Health Information that the Government has agreed to in accordance with 45 CFR 164.522.

Permissible Requests by the Government

The Government shall not request the Contractor to use or disclose

Protected Health Information in any manner that would not be permissible under the HIPAA Privacy Rule, the HIPAA Security Rule, or any applicable Government regulations (including without limitation, DoD 6025.18-R and DoD 8580.02-R) if done by the Government, except for providing Data Aggregation services to the Government and for management and administrative activities of the Contractor as otherwise permitted by this clause.

Termination

(a) Termination. A breach by the Contractor of this clause, may subject the

Contractor to termination under any applicable default or termination provision of this Contract.

(b) Effect of Termination.

(1) If this contract has records management requirements, the records subject to the Clause should be handled in accordance with the records management requirements. If this contract does not have records management requirements, the records should be handled in accordance with paragraphs (2) and (3) below

(2) If this contract does not have records management requirements, except as provided in paragraph (3) of this section, upon termination of this Contract, for any reason, the Contractor shall return or destroy all Protected Health Information received from the Government, or created or received by the Contractor on behalf of the Government. This provision shall apply to Protected Health Information that is in the possession of subcontractors or agents of the Contractor. The Contractor shall retain no copies of the Protected Health Information.

(3) If this contract does not have records management provisions and the Contractor determines that returning or destroying the Protected Health

Information is infeasible, the Contractor shall provide to the Government notification of the conditions that make return or destruction infeasible. Upon mutual agreement of the Government and the Contractor that return or destruction of Protected Health Information is infeasible, the Contractor shall extend the protections of this Contract to such Protected Health Information and limit further uses and disclosures of such Protected Health Information to those purposes that make the return or destruction infeasible, for so long as the Contractor maintains such Protected Health Information.

Miscellaneous

(a) Regulatory References. A reference in this Clause to a section in DoD 6025.18-R, DoD 8580.02-R, Privacy Rule or Security Rule means the section currently in effect or as amended, and for which compliance is required.

(b) Survival. The respective rights and obligations of Business Associate under the “Effect of Termination” provision of this Clause shall survive the termination of this Contract.

(c) Interpretation. Any ambiguity in this Clause shall be resolved in favor of a meaning that permits the Government to comply with DoD 6025.18-R, DoD 8580.02-R, the HIPAA Privacy Rule or the HIPAA Security Rule.