RFQ_N00183-12-T-0537.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 Check Here: Include a copy your Published or Commercial Price List which contains the items quoted per this Request for Quote.

Naval Medical Center Portsmouth Points of Contact:

Doris Turner, Phone: 757-953-7456 Fax: 757-953-5006 E-Mail: doris.turner@med.navy.mil

Payment in Arrears (Check One): Monthly Quarterly Semi-Annually Annually

Note: Vendor will be required to provide billing electronically via the WAWF Electronic Invoicing Method per Section G of this RFQ. For additional information, a review of the following web sites may be required: https://wawf.eb.mil http://wawftraining Email: wawf@nmlc.med.navy.mil Vendor to reference Request for Quotation (RFQ) Number N00183-12-T-0537 on all correspondence relating to this RFQ.

PROMPT PAYMENT: For Prompt Payment Act purposes, this contract is:

Subject to the 7-calendar day constructive acceptance period.

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 in terms of past performance and technical capabilities. Vendors with superior past performance history may be given 1st consideration.

Section B - Supplies or Services and Prices

Urorisk Diagnostic Profile Testing Kits

FFP

in accordance with Statement of Work, Section C.

Testing Kits shall include:

1) Specimen Collection kits with:

a. One large orange urine collection canister

b. Two specimen vials for mailing samples

c. Specimen mailback box

d. FedEx Diagnostic Specimen envelope

e. Literature packets

f. Large white envelopes

2) Courier services for mailing samples and test results.

Estimated total quantity of 480 each with estimated 40 samples per month

Base Year Period of Performance: 01 Oct 2012 - 30 September 2013

FOB: Destination

MILSTRIP: N0018313RQLC022

PURCHASE REQUEST NUMBER: N0018313RQLC022

NET AMT

FFP

in accordance with Statement of Work, Section C.

Testing Kits shall include:

1) Specimen Collection kits with:

a. One large orange urine collection canister

b. Two specimen vials for mailing samples

c. Specimen mailback box

d. FedEx Diagnostic Specimen envelope

e. Literature packets

f. Large white envelopes

2) Courier services for mailing samples and test results.

Estimated total quantity of 480 each with estimated 40 samples per month

Option Year I Period of Performance: 01 Oct 2013 - 30 September 2014

FOB: Destination

NET AMT

FFP

in accordance with Statement of Work, Section C.

Testing Kits shall include:

1) Specimen Collection kits with:

a. One large orange urine collection canister

b. Two specimen vials for mailing samples

c. Specimen mailback box

d. FedEx Diagnostic Specimen envelope

e. Literature packets

f. Large white envelopes

2) Courier services for mailing samples and test results.

Estimated total quantity of 480 each with estimated 40 samples per month

Option Year II Period of Performance: 01 Oct 2014 - 30 September 2015

FOB: Destination

NET AMT

NOTE:

Due to the nature of this requirement, exact quantities are unknown. Tests are generated as required based upon patient needs. Order will be limited to the “Not to Exceed” dollar value of the resulting contract. The Government does not guarantee any minimum order quantity of tests to be performed.

At no time will the contract dollar limitations be exceeded unless the contracting officer is notified. If there are any issues with the contract, the contracting office must be contacted to verify needed actions.

Section C - Descriptions and Specifications

CLAUSES INCORPORATED BY FULL TEXT

PERFORMANCE WORK STATEMENT

Laboratory Mail Out Services

C.1.

Scope of Work

The Reference Laboratory shall provide in accordance with all applicable federal, state, and local regulations, laws, and ordinances, and in accordance with the specifications outlined for accreditation certification if applicable, patient specimen testing for the specific range of referral testing within their capability.

C.1.1.

Services shall include the performance of analytical testing as defined by the Laboratory’s reference test manual, the reporting of analytical test results and consultative services as required to assimilate the full scope of its laboratory operations to Naval Medical Center Portsmouth Laboratory Medicine Services.

C.1.2.

All requirements and provisions defined in the specification of this solicitation will apply to any laboratory, i.e. branch, division, sub-contractor, etc. performing reference testing on behalf of the Reference Laboratory.

C.2.

Statement of Work The Reference Laboratory shall provide laboratory services to include preanalytic processing as defined in its laboratory manual; analysis, reporting of analytic results, and interpretation.

The Reference Laboratory must provide the following services:

C.2.1 Vendor is responsible for providing requisition forms, special instructions, current list of tests with reference ranges and specimen requirements.

C.2.2 Provide services during normal working hours unless otherwise specified according to special services provided by that Reference Laboratory.

C.2.3.

If applicable, transport samples in such a manner as to insure the integrity of the specimen.

C.2.4.

Analyze samples. The Reference Laboratory will comply with reporting test results within the specified time frame in accordance with the nature of the testing, following all regulatory requirements for reporting of patient results. Test results shall be reported within the specified times established by the Reference Laboratories. Hard copy results will fax, mailed or sent via a secure Internet report, in compliance with HIPPA guidelines.

C.2.5.

Consult with laboratories on test result by telephone as needed.

C.2.6.

Provide the Naval Medical Center Portsmouth Laboratory Medicine Services laboratories with a means of communication to permit immediate inquiry regarding the status of pending tests.

C.2.7.

Reference Laboratory to receive customer generated work documents to order tests in lieu of individual requisition per request, if applicable.

C.3.0.

Specimen Collection Kits

Contractor to provide UroRisk Diagnostic Profile Specimen collection kits for the periods of performance as specified in Schedule B.

C.3.1.

Collection kits to include:

One large orange urine collection container

Two plastic specimen vials for mailing urine samples

Specimen mail back box (to hold plastic specimen vials)

FedEx diagnostic specimen envelope

Literature packet to include Stone Diagnostic Requisition Form; Special Patient Instructions; Patient Financial Responsibility Information Card

FedEx return label

Large white envelope

C.4.0. Specific Tasks

Analytical tests to be measured include:

Total Calcium – Atomic absorption spectrometry

Magnesium – Atomic absorption spectrometry

Total Volume – Patented kit contains a volume maker

Uric Acid – Autoanalyzer – colorimetric/Uri case & chromogen

Phosphorus – Autoanalyzer – colorimetric/Ammonium molybdate

Creatinine – Autoanalyzer – colorimetric/picric acid

Citrate – Autoanalyzer (Citrate lyase/NADH-NAD)

Potassium – Flame photometry

Sodium – Flame photometry

Oxalate – HPLC Ion exchange chromatography

PH – Glass electrode/reference electrode pH meter

C.4.1.

Courier services will be used for mailing samples and test results.

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-2013

LABORATORY MAILOUTS

BLDG 3

620 JOHN PAUL JONES CIRCLE

PORTSMOUTH VA 23708

757-953-1580

FOB: Destination N00183

30-SEP-2014

N00183

30-SEP-2015

N00183

Section G - Contract Administration Data

252.232-7006 WIDE AREA WORKFLOW PAYMENT INSTRUCTIONS (JUN 2012)

(a) Definitions. As used in this clause--

“Department of Defense Activity Address Code (DoDAAC)” is a six position code that uniquely identifies a unit, activity, or organization.

“Document type” means the type of payment request or receiving report available for creation in Wide Area WorkFlow (WAWF).

“Local processing office (LPO)” is the office responsible for payment certification when payment certification is done external to the entitlement system.

(b) Electronic invoicing. The WAWF system is the method to electronically process vendor payment requests and receiving reports, as authorized by DFARS 252.232-7003, Electronic Submission of Payment Requests and Receiving Reports.

(c) WAWF access. To access WAWF, the Contractor shall--

(1) Have a designated electronic business point of contact in the Central Contractor Registration at https://www.acquisition.gov; and

(2) Be registered to use WAWF at https://wawf.eb.mil/ following the step-by-step procedures for self-registration available at this Web site.

(d) WAWF training. The Contractor should follow the training instructions of the WAWF Web-Based Training Course and use the Practice Training Site before submitting payment requests through WAWF. Both can be accessed by selecting the “Web Based Training” link on the WAWF home page at https://wawf.eb.mil/.

(e) WAWF methods of document submission. Document submissions may be via Web entry, Electronic Data Interchange, or File Transfer Protocol.

(f) WAWF payment instructions. The Contractor must use the following information when submitting payment requests and receiving reports in WAWF for this contract/order:

(1) Document type. The Contractor shall use the following document type(s).

2 IN 1 SERVICES ONLY

(2) Inspection/acceptance location. The Contractor shall select the following inspection/acceptance location(s) in WAWF, as specified by the contracting officer.

DESTINATION / DESTINATION

(3) Document routing. The Contractor shall use the information in the Routing Data Table below only to fill in applicable fields in WAWF when creating payment requests and receiving reports in the system.

Routing Data Table*

(4) Payment request and supporting documentation. The Contractor shall ensure a payment request includes appropriate contract line item and subline item descriptions of the work performed or supplies delivered, unit price/cost per unit, fee (if applicable), and all relevant back-up documentation, as defined in DFARS Appendix F, (e.g. timesheets) in support of each payment request.

(5) WAWF email notifications. The Contractor shall enter the email address identified below in the “Send Additional Email Notifications” field of WAWF once a document is submitted in the system.

WAWF Acceptor/COR Email Address: To Be Determined At time of Contract Award

(g) WAWF point of contact.

(1) The Contractor may obtain clarification regarding invoicing in WAWF from the following contracting activity's WAWF point of contact.

wawf@med.navy.mil

(2) For technical WAWF help, contact the WAWF helpdesk at 866-618-5988.

(End of clause)

Section H - Special Contract Requirements

CLAUSES INCORPORATED BY FULL TEXT

N00183-0004 Privacy and Security of Protected Health Information

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.

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 10 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 10; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 10 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 Sep 2015.

(End of clause)

52.232-18 AVAILABILITY OF FUNDS (APR 1984)

Funds are not presently available for this contract. The Government's obligation under this contract is contingent upon the availability of appropriated funds from which payment for contract purposes can be made. No legal liability on the part of the Government for any payment may arise until funds are made available to the Contracting Officer for this contract and until the Contractor receives notice of such availability, to be confirmed in writing by the Contracting Officer.

(End of clause)

Section J - List of Documents, Exhibits and Other Attachments

CLAUSES INCORPORATED BY FULL TEXT

CONTRACT ADMINISTRATION APPOINTMENTS AND DUTIES

See Attachment I, Contract Administration Plan

In order to expedite administration of this contract/order, the following delineation of duties is provided including the names, addresses and phone numbers for each individual or office as specified. The individual/position designated as having responsibility should be contacted for any questions, clarifications or information regarding the functions assigned.

1. PROCURING CONTRACTING OFFICER (PCO) is responsible for:

a. All pre-award information, questions, or data;

b. Change/question/information regarding the scope, terms or conditions of the basic contract document.

Name: Doris Turner

Address:

Naval Medical Center Portsmouth

Materiel Management Department, Contracts Div.

54 Lewis Minor Street, Bldg 250

Portsmouth, VA 23708

Phone: 757-953-7456

2. CONTRACT ADMINISTRATION OFFICE (CAO) is responsible for matters specified in FAR 42.302 and DFARS 242.302 except in those areas otherwise designated herein.

Name:

Same as PCO information

3. CONTRACTING OFFICERS REPRESENTATIVE (COR) is responsible for:

a. Liaison with personnel at the Government installation and the contractor personnel on site;

b. Technical advice/recommendations/clarification on the statement of work;

c. The Performance Work Statement for delivery/task orders placed under this contract

e. Quality assurance of services performed and acceptance of the services or deliverables;

f. Government furnished property;

g. Security requirements on Government installation;

h. Certification of invoice for payment.

NOTE: When, in the opinion of the Contractor, the COR requests effort outside the existing scope of the contract (or delivery/task order), the Contractor shall promptly notify the Contracting Officer (or Ordering Officer) in writing. No action shall be taken by the contractor under such direction until the Contracting Officer has issued a modification to the contract or, in the case of a delivery/task order, until the Ordering Officer has issued a modification of the delivery/task order; or until the issue has otherwise been resolved. THE COR IS NOT AN ADMINISTRATIVE CONTRACTING OFFICER AND DOES NOT HAVE THE AUTHORITY TO DIRECT THE ACCOMPLISHMENT OF EFFORT WHICH IS BEYOND THE SCOPE OF THE STATEMENT OF WORK IN THE CONTRACT OR DELIVERY/TASK ORDER.

CONTRACTING OFFICER’S REPRESENTATIVE – To Be Announced

Section K - Representations, Certifications and Other Statements of Offerors

CLAUSES INCORPORATED BY REFERENCE

Section L - Instructions, Conditions and Notices to Bidders

CLAUSES INCORPORATED BY REFERENCE

52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)

This solicitation incorporates one or more solicitation provisions 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. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es):

FAR Clauses http://acquisition.gov/comp/far/index.htm DFAR Clauses http://www.acq.osd.mil/dpap/dars/dfars/index.htm (End of provision)

Section M - Evaluation Factors for Award

CLAUSES INCORPORATED BY REFERENCE