01_Solicitation_621II_R3_20180606.docx

01 - SOLICITATION DOCUMENT

THIS DOCUMENT CONTAINS CLAUSES,

PROVISIONS, AND INSTRUCTIONS PERTINENT

TO THIS SOLICITATION.

READ THIS DOCUMENT IN ITS ENTIRETY.

DO NOT RETURN THIS DOCUMENT

WITH YOUR OFFER.

02 – Solicitation Document

RFP-797-FSS-04-0001-R3

CP-20

NOTICE CONCERNING SOLICITATION

P.O. BOX 76, Bldg. 37 1st Avenue, 1 Block North of Cermak

HINES, IL 60141

CP-FSS-1-C (MAY 2000) Standing Solicitation No. RFP-797-FSS-04-0001-R3 (Refreshed 6/6/2018)

WORLDWIDE FEDERAL SUPPLY SCHEDULE CONTRACT

FOR

621 II: Medical Laboratory Testing and Analysis Services SERVICE CODE: Q301 - Medical - Laboratory Testing ANY INFORMATION THAT MAY BE DESIRED ON THIS PARTICULAR SOLICITATION CAN BE OBTAINED FROM THE ISSUING OFFICE ADDRESS SHOWN HEREIN.

TABLE OF CONTENTS

READ ME FIRST

Important Criteria to Consider:

ADDITIONAL COVER PAGES

Part I – TERMS AND CONDITIONS APPLICABLE TO GOODS AND SERVICES See Continuation of SF 1449 Blocks 19-21, Schedule of Items Document 02 Part II – CONTRACT TERMS AND CONDITIONS_________________________ 52.212-4 Contract Terms and Conditions – Commercial Items (May 2015) (Tailored) 1 Clauses for Addendum 52.212-4:

552.212-71 Contract Terms and Conditions Applicable to GSA Acquisition of

552.216-70 Economic Price Adjustment—FSS Multiple Award Schedule Contracts

CI-FSS-056 Federal Acquisition Regulation (FAR) Part 51 Deviation Authority (Federal

52.212-5 Contract Terms and Conditions Required To Implement Statutes or Executive Orders – Commercial Items (Jan 2018) 45 Part III – VENDOR INSTRUCTIONS_________________________________ 52.212-1 Instructions to Offerors -- Commercial Items (Jan 2017) 51 Provisions for Addendum 52.212-1:

52.215-20 Requirements for Certified Cost or Pricing Data and Data Other Than

Part IV – EVALUATION FACTORS FOR CONTRACT AWARD________________ 552.212-73 Evaluation—Commercial Items (Multiple Award Schedule) (Aug 1997) 63 Part V – OFFEROR REPRESENTATIONS & CERTIFICATION________________ 52.212-3 Offeror Representations and Certifications --Commercial Items (Nov 2017) 63

ADDENDUM: REGULATIONS INCORPORATED BY REFERENCE

INCORPORATED UNDER 52.212-4:

52.202-1 Definitions (Nov 2013) 77

INCORPORATED UNDER 52.212-5:

52.232-34 Payment by Electronic Funds Transfer - Other Than System for Award Management

INCORPORATED UNDER 552.212-71:

552.238-71 Submission and Distribution of Authorized FSS Schedule Pricelists (Jul 2016)

READ ME FIRST

DOING BUSINESS WITH VA

The Department of Veterans Affairs operates a nationwide system of hospitals, clinics, Veterans Integrated Service Networks (VISN), data processing centers, and National Cemeteries, all of which require a broad spectrum of goods and services. These goods and services are purchased on a national, regional, and local level – so no matter how large or small your business, VA is a potential customer. The VA Federal Supply Schedule (FSS) Program establishes long-term governmentwide contracts that allow VA and other government agencies to acquire a vast array of medical equipment and supplies directly from commercial suppliers.

IS A VA FSS CONTRACT RIGHT FOR YOU?

VA awards contracts to responsible companies offering commercial items at fair and reasonable prices. Contracting Officers determine whether prices are fair and reasonable by comparing the prices/discounts that a company offers the government with the prices/discounts offered to commercial customers; this practice is commonly known as “most favored customer” pricing. In order to make this comparison, VA requires offerors to furnish commercial pricelists and disclose information regarding their commercial pricing/discounting practices.

DO YOU QUALIFY FOR A VA FSS CONTRACT?

To qualify for a VA FSS contract you should:

1. Be able to demonstrate that your firm is responsible.

2. Complete the GSA “Pathway to Success” education seminar. Submit a copy of the certificate of completion with your proposal. Please note that this is only required for new offerors without an existing FSS contract.

3. Meet all the requirements of the solicitation.

4. Be able to fulfill all contract obligations outlined in the solicitation.

Contact the VA FSS Help Desk to discuss your firm’s eligibility!

IMPORTANT CRITERIA TO CONSIDER

Assess Your Competition It is recommended that you identify and assess your competition prior to submitting a proposal. This task can be completed by reviewing the Contract Catalog Search Tool, GSA eLibrary or GSA Advantage. These websites contain information regarding the supplies and services that current VA FSS contractors already offer. Your review of the competition should include: competitor’s pricing, delivery times, warranty terms, services, and any other elements that make their offering distinct when compared to your own.

Best Value Determination Schedule buyers award task/delivery orders to FSS contractors based upon a “best value” determination. In FAR 2.101, best value is defined as the “expected outcome of an acquisition that, in the Government’s estimation, provides the greatest overall benefit in response to the requirement.”

Factors that may be considered when making a best value determination include (but are not limited to):

· Price

· Special features of the service or supply required for effective performance

· Past performance records

· Quality of the proposed solutions and cost differences

· Trade-in considerations

· Warranty

· Delivery terms

· Expertise of the offeror

· Socioeconomic status Minimum Sales Criteria VA expects all FSS contractors to exceed $25,000 in sales within the first two years after contract award and $25,000 each succeeding year in order to retain your VA FSS contract. You should consider the difficulty you may have in meeting this performance requirement if your company is newly established or has low sales of the services/supplies you want to offer to the Government. If you decide to submit an offer under the VA FSS program, it is suggested that you draft a business plan covering how you intend to meet this performance requirement.

GETTING ON SCHEDULE

Once you’ve determined that a VA FSS contract is in your company’s best interest you will need to submit an offer for contract award. While not all firms are awarded VA FSS contracts, the VA FSS program is open to all responsible offerors. To be considered for contract award, you must demonstrate that your firm is responsible and is able to meet all Schedule program requirements, including price reasonableness. By following the best practices and understanding the review and award processes discussed in this document, vendors will be well equipped to submit a quality offer and negotiate to receive a Schedule contract.

Prior to submitting a proposal, interested companies should:

1. Choose the Schedule program that best aligns to the supplies and/or services your company wants to offer. Select the appropriate solicitation number to be linked directly to the solicitation files. Download the solicitation, including all corresponding documents, and follow the instructions for completion.

2. Read the entire Schedule solicitation thoroughly and respond to all requirements.

3. Make sure all offered line items fall within the scope of the Schedule solicitation.

4. Make sure the company is financially sound.

5. Be ready to negotiate the company’s best offer.

Other helpful hints:

(1) Obtain a Data Universal Numbering System (DUNS) Number, also known as the unique entity identifier.

(2) Register in the System for Acquisition Management (SAM) database. Vendors must be registered in SAM prior to the award of the Schedule contract (see FAR 52.212-4(t)). Contractors that complete electronic annual representations and certifications via the SAM website must update as necessary, but at least annually, to ensure they are kept current, accurate, and complete.

(3) Submit all required documents including Manufacturer Letter of Supply and proof of insurance as required.

BEST PRACTICES

Key Elements of a Successful Offer:

Ensuring these key elements are included in your proposal may expedite the review and award process:

· Scope – Are the supplies/services within the scope of the Schedule? See the Scope of Solicitation section in the Vendor Response Document 02.

· Past Performance – Does your firm meet its commitments and responsibilities?

· Financial Capability – Is your firm financially sound?

· Pricing – Is your proposed pricing competitive with current market conditions?

· Subcontracting Plan – Required if your firm is considered “other than a small business” and if the estimated value of the contract exceeds $700,000 (including all option periods).

· Other Regulatory Compliance – Is your firm debarred? Are all registration requirements complete? See the Compliance Requirements page for a complete list of all required registrations.

Your regional Procurement Technical Assistance Center (PTAC) offers a wide range of assistance (most free of charge) through one-on-one counseling, classes, seminars, and matchmaking events. Contact your local PTAC for help in

· Determining your firm’s suitability for contracting

· Proposal preparation

· Securing necessary registrations and socioeconomic registrations

· Researching procurement histories

· Networking

· Identifying bid opportunities

· Contract performance issues

· Preparing for audit

PROPOSAL REVIEW & AWARD PROCESS

Review & Award Process

The goal of this review process is to ensure the vendor is responsible, the Government is receiving a fair and reasonable price, and that any potential contract award is in the best interest of the Government.

Process Time In general, proposals will be reviewed and, if applicable, awarded within six (6) months from the time they are assigned to a Contract Specialist. To further discuss the review process, please contact your assigned contract specialist or the FSS Help Desk. Well prepared offers with competitive pricing are easier to evaluate and, therefore, may expedite the award process. The offer process time can vary depending on:

· The timeliness of your responses to requests for clarification or additional information

· The quality and completeness of the proposal and subsequent clarification responses

· Complexity of the proposal, including number of line items offered

· Quality assurance reviews

TRAINING

Required Training New offerors without an existing FSS contract must successfully complete GSA’s Pathway to Success at GSA’s Vendor Education Center and include a copy of the certificate with their proposal. This seminar is designed to assist prospective Schedule contractors in making an informed business decision as to whether obtaining a GSA Schedule contract is in their best interests.

Please note that the individual whose name appears on the course completion certificate must be an officer of the company and also be designated as an authorized negotiator. This designation is made at K-FSS-1 Authorized Negotiators, located in the Vendor Response section of Document 02. The course must be completed within one year of the date of your proposal (the date listed on the SF 1449).

Recommended Training The VA FSS Service offers extensive training presentations on our VA FSS Training web page. Under our “Webinars” section, you will find presentations outlining the steps involved in getting a VA Schedule contract. These presentations describe:

· How to submit an offer

· How to effectively negotiate your offer

· The post-award contract administration process and reporting requirements

· FSS electronic tools Please utilize the two solicitation guides found in the “Solicitation Assistance” section of our VA FSS Training page. These guides will provide step-by-step instructions for completing the Vendor Response and Commercial Sales Practices sections of the solicitation and will assist you with submitting a more accurately prepared proposal.

Additionally, the FSS Training page offers best practice tip sheets offering information on the various aspects of the VA Schedules program.

GSA offers numerous in-person and virtual training sessions that provide attendees with an in-depth understanding of acquisition vehicles and policies. Visit the GSA Interact Training page as well as GSA’s YouTube channel and Schedule podcast offerings! Additional training is offered by the GSA Vendor Support Center.

Additional Information While VA provides its Government customers with training in “Using VA Schedules,” including information on the benefits of the Schedules Program, VA does not promote the use of any company’s specific Schedule contract. Vendors should be aware that obtaining a VA Schedule contract is not a guarantee of sales. Vendors awarded a VA Schedule contract will need to market their supplies and services to Government customers as they would to commercial customers.

Contact Us Contact the FSS Help Desk for additional information on submitting a proposal or on the VA FSS review and award process!

ADDITIONAL COVER PAGES

ATTENTION!

Offerors are hereby advised to read the entire solicitation document and retain a copy for your records. Offerors will be held accountable and responsible for complying with all of the provisions and clauses located herein. As set forth under the solicitation checklist (see Vendor Response Document 02), offerors need only submit completed applicable sections and supporting documentation. However, all clauses and provisions, including those set forth in this Solicitation Document will be incorporated into the contract award with full force and effect. We do not accept hard copy offers; all offers must be submitted electronically. Please consult our Electronic Acceptance of FSS Offers/Proposals web page for more information.

CP-FSS-2 SIGNIFICANT CHANGES (OCT 1988)

The attention of the offeror is invited to the following changes made since the issuance of the last solicitation:

(1) Regulations / Special Language Changes - Additions, deletions updates, and revisions since the previous solicitation (RFP-797-FS-04-0001-R2), issued May 2012, and its subsequent amendments.

Removed:

52.203-11 Certification and Disclosure Regarding Payments to Influence Certain Federal Transactions (Sep 2007) 52.203-12 Limitation on Payments to Influence Certain Federal Transactions (Oct 2010) 52.203-15 Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (Jun 2010) 52.209-2 Prohibition on Contracting with Inverted Domestic Corporations – Representation (May 2011) 52.209-11 Representation by Corporations Regarding Delinquent Tax Liability or a Felony Conviction under any Federal Law (Feb 2016) 52.212-5 Contract Terms & Conditions Required to Implement Statutes or Executive Orders - Commercial Items (Alternate II – Oct 2015) 52.222-1 Notice to the Government of Labor Disputes (Feb 1997) 552.229-71 Federal Excise Tax – DC Government (Sep 1999) 552.238-76 Definition (Federal Supply Schedules) - Recovery Purchasing (Feb 2007) 552.238-80 Use of Federal Supply Schedule Contracts by Certain Entities - Recovery Purchasing (Feb 2007) 852.219-71 VA Mentor-Protégé Program (Dec 2009) AS1508 Option to Extend the Term of the Contract (Mar 2005) CP-FSS-4-A Solicitation Copies (Mar 1996, Tailored) I-FSS-969 Economic Price Adjustment - FSS Multiple Award Schedule (Jan 2002, Tailored) ACH Vendor / Miscellaneous Payment Enrollment Form & Instructions American Recovery and Reinvestment Act Program Participation Supplemental Commercial Sales Practices Added:

52.203-19 Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) 52.204-7 System for Award Management (Oct 2016) 52.204-13 System for Award Management Maintenance (Oct 2016) 52.204-21 Basic Safeguarding of Covered Contractor Information Systems (Jun 2016) 52.204-22 Alternative Line Item Proposal (Jan 2017) 52.207-6 Solicitation of Offers from Small Business Concerns and Small Business Teaming Arrangements or Joint Ventures (Multiple-Award Contracts) (Oct 2016) 52.217-9 Option to Extend the Term of the Contract (Mar 2000) 52.222-62 Paid Sick Leave Under Executive Order 13706 (Jan 2017) 52.224-3 Privacy Training (Jan 2017) 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (Dec 2013) 52.242-5 Payments to Small Business Subcontractors (Jan 2017) 552.238-79 Use of Federal Supply Schedule Contracts by Non-Federal Entities (Jul 2016) Alternate Contact for Contract Administration (Aug 2017) Ordering Contact (Mar 2018) Scope of Solicitation (May 2018) Utilization of Subcontractors / Test Send Outs (Jan 2018) Updated/Revised:

52.202-1 Definitions (Nov 2013) 52.204-10 Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2016) 52.204-15 Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Jul 2016) 52.204-16 Commercial and Government Entity Code Reporting (Jul 2016) 52.204-18 Commercial and Government Entity Code Maintenance (Jul 2016) 52.212-1 Instructions to Offerors - Commercial Items (Jan 2017) 52.212-3 Offeror Representations and Certifications - Commercial Items (Nov 2017) 52.212-4 Contract Terms and Conditions - Commercial Items (Jan 2017) 52.212-5 Contract Terms & Conditions Required to Implement Statutes or Exec. Orders - Commercial Items (Jan 2018) 52.216-22 Indefinite Quantity (Oct 1995) 52.219-8 Utilization of Small Business Concerns (Nov 2016) 52.219-9 Small Business Subcontracting Plan (Jan 2017, Alternate II – Nov 2016) 52.219-14 Limitations on Subcontracting (Jan 2017) 52.222-26 Equal Opportunity (Sep 2016) 52.225-5 Trade Agreements (Oct 2016) 552.211-78 Commercial Delivery Schedule (Multiple Award Schedule) (Feb 1996, Tailored, Notes) 552.212-71 Contract Terms and Conditions Applicable to GSA Acquisition of Commercial Items (Jun 2016) 552.219-71 Notice to Offerors of Subcontracting Plan Requirements (Oct 2016, Tailored) 552.219-72 Preparation, Submission, and Negotiation of Subcontracting Plans (Oct 2016, Tailored) 552.238-71 Submission and Distribution of Authorized FSS Schedule Pricelists (Jul 2016, Tailored) 552.238-74 Industrial Funding Fee and Sales Reporting (Jan 2016, Tailored) 552.238-75 Price Reductions (Jul 2016) 552.238-78 Scope of Contract (Eligible Ordering Activities) (Jul 2016, Tailored) 552.238-81 Modification (Federal Supply Schedule) (Apr 2015, Alt I - Jun 2016, Tailored) 852.237-7 Indemnification & Medical Liability Insurance (Jan 2008) A-FSS-11 Consideration of Offers under Standing Solicitation (Jan 2016, Tailored) CP-FSS-2 Significant Changes (Oct 1988) CSP-1 (Tailored, Notes – Feb 2016) G-FSS-900-C Contact for Contract Administration (Jul 2003, Tailored) I-FSS-600 Contract Price Lists (Oct 2016, Tailored) L-FSS-400 Introduction of New Services /Products (INSP) (Nov 2000, Tailored) Additional Discounts / Concessions Offered to the Government Agent Authorization (Mar 2018) Business Size Determination & NAICS Code Designation (Aug 2017) Compliance Confirmation (Aug 2017) Continuation of SF1449 Instructions for Pre-Award Review Process (Aug 2017) Minimum Acceptable Order Proposal (Aug 2016) Notice Regarding Prime Vendor Sales and Distribution and Pricing Agreements (DAPA) Pricelist Proposal Preparation (Doc 03 Excel Spreadsheet) Proposed Pricing – Required Format Signatory Authority (Jan 2018) Small Business Subcontracting Plan (Aug 2017) Technical Proposal (May 2018)

(2) Scope of Solicitation – Please see our new Scope of Solicitation located in Vendor Response Document 02 after the Continuation of SF1449.

(3) Acceptance of eOffers (Aug 2017) - Beginning on January 1, 2015, VA FSS ceased accepting paper offers and began the acceptance of eOffers. Any paper offers will be returned without consideration. The following protocol must be followed to avoid the return of your offer.

· File Format

· Fill-in documents may be submitted as Word or pdf documents. However, documents requiring a wet signature must be submitted separately in a pdf format if the offeror chooses to submit the fill-in documents in Word.

· Excel files should be submitted in their original Excel format.

· EMail Address: All potential contractors are required to submit an FSS offer electronically to vafssoffers@va.gov.

· eMail Subject Line: Identify in the subject line FSS-Offer-Schedule ID-Company Name.

· eMail Attachments: We can no longer accept zip files which may require you to submit your offer files in multiple e-mails. It is essential that you identify the number of emails you are sending in the subject line to ensure that we receive your entire offer.

EXAMPLE: FSS-Offer-Schedule ID-Company Name-1 of # (FSS-Offer 65IIA-ABC Medical – 1 of 4)

· CD-ROM: CD-ROM will only be accepted if your proposal is so large that it can’t be compressed and it is unmanageable to send multiple emails. Any offer where the Document 03 - Proposed Price List exceeds 5MB shall be submitted on CD in its entirety. Submission of offers on thumb drives is prohibited and will be rejected and returned.

· Documents Requiring Signature: Documents requiring signature include, but are not limited to, SF-1449, Signatory Authority, FMS Vendor File Request Form 10091, letters of supply, etc. Please note that the Signatory Authority Form and SF1449 signature date must be no later than 10 calendar days from submission of the proposal via the eOffer e-mail process. Failure to comply with this date restriction will result in your proposal being returned to you without further consideration. Please also note that we cannot accept digital/electronic signatures at this time, including .jpeg or other picture formats of signatures inserted into the document. Please apply a wet signature and submit a pdf copy of the signed document.

(4) 508 Compliance Section 508 of the Rehabilitation Act of 1973, as amended in 1998, requires Federal agencies to make their electronic and information technology (EIT) accessible to people with disabilities. With the requirement to submit all VA FSS offers electronically, effective January 1, 2015, you must ensure that all of the documents (e.g. Microsoft word documents, pdf documents, Excel files, etc.) you submit as part of your proposal are 508 compliant. A guide to 508 compliance for electronic documents is found on the Section508.gov website at https://www.section508.gov/content/build/create-accessible-documents. This guide provides information on formatting and testing and includes helpful checklists. You can find further information on Section 508 standards at https://www.section508.gov/content/learn/standards. This standards web page also includes a Quick Reference Guide to Section 508.

(5) Financial Services Center (FSC) Mandatory Electronic Invoice Submission Program The Department of Veterans Affairs published a final rule in the Federal Register on November 27, 2012 (https://federalregister.gov/a/2012-28612), to require contractors to submit payment requests in electronic form in order to enhance customer service, departmental productivity, and adoption of innovative information technology, including the appropriate use of commercial best practices. The rule was effective December 27, 2012, and will apply only to orders placed by VA ordering activities.

Benefits of e-Invoicing Electronic invoicing offers simple and secure solutions, complying with HIPAA, to eliminate the cost and time of processing paper invoices. The benefits of e-Invoicing include:

· Delivery of invoices directly into the FSC payment system and routed nationally for approval

· Elimination of mail processing time, postage, and invoice receipt inquires

· Elimination of data error and lost or misplaced invoices

· Verification of invoice receipt or rejection through automated notification reports

· No installation of hardware or software required VA’s Electronic Invoice Presentment and Payment System The FSC uses a third-party contractor, Tungsten, to transition vendors from paper to electronic invoice submission, a free invoice submission process. The Tungsten system conforms to the X12 electronic data interchange (EDI) formats established by the Accredited Standards Center (ASC) chartered by the American National Standards Institute (ANSI). The X12 EDI Web site is found at http://www.x12.org.

Vendor e-Invoice Set-Up Information While most VA Vendors already use Tungsten, new vendors can contact Tungsten at the phone number or email addressbelow to begin submitting their electronic invoices to the VA Financial Services Center for payment processing, free of charge. If they have question about the e-invoicing program or Tungsten, please contact the FSC at the phone number or email address listed below:

· Tungsten e-Invoice Setup Information: 1-877-489-6135

· Tungsten e-Invoice email: VA.Registration@Tungsten-Network.com

· FSC e-Invoice Contact Information: 1-877-353-9791

· FSC e-invoice email: vafsccshd@va.gov Additional Information:

http://www.tungsten-network.com/VeteransAffairs/ http://www.fsc.va.gov/FSC/FSC/Tungsten_Support_Videos_Ref_2014.pdf

CP-FSS-3 NOTICE: REQUESTS FOR EXPLANATION OR INFORMATION (MAR 1996)

Oral or written requests for explanation or information regarding this solicitation should be directed to:

Dept. of Veterans Affairs, National Acquisition Center (003B6B) P.O. Box 76 1st Avenue, 1 Block North of Cermak Rd., Bldg. 37 Hines, IL 60141 Phone: FSS Helpdesk (708) 786-7737 E-mail: FSS Helpdesk helpdesk.ammhinFSS@va.gov

CP-FSS-19 PRICING (DEC 1998) FSS A/L FC-98-2

Offerors are advised that separate pricing may be submitted for different countries if separate pricing is consistent with the offeror’s commercial sales practice.

INSTRUCTIONS FOR PRE-AWARD REVIEW PROCESS (AUG 2017)

All offers may be subject to a pre-award review at the discretion of the Contracting Officer (CO). A pre-award review will be requested from the Office of Contract Review (OCR) within the Department of Veterans Affairs’ Office of Inspector General for all offers with an estimated contract value (for a 10-year contract period) that exceeds $3,000,000 per year for a total of $30,000,000 for the base contract period plus the 5-year option period.

The purpose of performing a pre-award review is to assist the CO in making a determination as to the reasonableness of the offer. This is accomplished by reviewing the contractor’s proposal and additional documents to: (i) determine if the proposal and the supporting data are accurate, complete, and current; (ii) verify the contractor is offering the government most favored commercial customer (MFC) discounts; (iii) verify the validity of disclosed information relating to rebates, incentive programs, and other concessions: and, (iv) address other issues as deemed necessary by the CO or OCR. To help facilitate the process, the CO will notify the Offeror of those proposals forwarded to OCR for a pre-award review. OCR will contact the Offeror and issue a Request for Information for those reviews accepted by OCR. The Offeror is expected to provide the requested data and documents to OCR within 15 business days. Delays in receiving this information will delay the pre-award review process and could ultimately delay the negotiations and award of a contract under this solicitation.

Request for Electronic Data To respond to a pre-award review, you will be required to submit certain data, including sales transaction data. The sales transaction should include all products sold to all customers for the 6-month (minimum) period as determined by OCR. The transactions will include all transactions for FSS customers and non-FSS customers. This data must reconcile to your financial accounting records. The data should include all direct and indirect sales, if applicable. The direct and indirect sales can be provided in separate data tables. Although not required, it will expedite the process, if all data tables use the same record layout leaving fields that do not apply blank.

Please provide a record layout for the data describing field position, length, format (e.g. numeric, number of decimals, alpha, etc.) and a descriptive field name. We will need complete descriptions of all codes used in the data. Below is a sample record layout which describes the types of information needed in the electronic data. After reviewing this information, OCR suggests a discussion take place regarding the specifics of your data prior to extracting the data for the review.

Acceptable media/methods: CD-ROM, DVD, Internet Download; E-Mail (PGP Encryption available) Acceptable formats: ASCII Text (fixed width or delimited); Excel Sample Record Layout:

METRIC SYSTEM OF MEASUREMENT

Section 5164 of the Omnibus Trade and Competitiveness Act of 1988 (Public Law 100-418) designates the metric system of measurement as the preferred system of weights and measures for United States trade and commerce. It requires that each Federal agency use the metric system of measurement in its procurements, grants and other business-related activities. Offerors are advised that the use of the metric system of measurement is highly encouraged and that offers should be provided utilizing the metric system of measurement.

Offerors are also advised that, at the ordering activity level or as a result of a standardization effort, they may be required to submit all units of measure for products offered utilizing the metric system of measurement, or they may be required to identify the conversion on a separate document.

GENERAL INFORMATION

Please pay particular attention to all italicized, bolded notes. Several clauses have been limited in application to direct delivery orders or have been adapted to fit with the operations of the Government Prime Vendor (PV) program.

STATEMENT OF WORK__________________________________________

Please consult the definitions section at the end of this document for an explanation of terminology used in this solicitation.

I. GENERAL REQUIREMENTS

The Contractor shall be responsible for performing preanalytic processing, analysis, and result interpretation for clinical and anatomical pathology specimens as requested by Government Medical Treatment Facilities (MTF), VA Medical Centers (VAMC), clinics and/or other government healthcare access points. Services shall include the transportation of clinical laboratory specimens to the contractor’s laboratory(ies) (including providing the shipping/pickup containers), the performance of analytical testing as defined by the Contractor’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 the ordering facility.

Services to be furnished under this contract shall be ordered by issuance of a task order by the ordering activity for results to be delivered to the site designated on the task order and in accordance with standards, clauses and provisions of this document.

The Contractor shall provide an Authorized FSS Price List pursuant to clause I-FSS-600 Contract Price Lists (located in Document 01 – Solicitation Document). The FSS Price List shall also include the following additional elements:

· LOINC – Logical Observation Identifier Names and Codes, if applicable.

· Specimen Collection And Handling Requirements – Price list must indicate whether test demographic information is available upon request in either hardcopy or electronic format, listing any e-mail addresses or web links necessary to obtain the Requirements.

· Turnaround Time (TAT) Table, as proposed by the contractor in Document 02 – Vendor Response Document and agreed upon by the contract award (in lieu of #11 in I-FSS-600)

· Hours of Operation, as proposed by the contractor in Document 02 – Vendor Response Document and agreed upon by the contract award. This should detail the hours of operation upon which the turnaround times are based.

· Use of Subcontractors (i.e. Test Send Outs) - Provide the names of subcontractors, their testing site(s), and the names of tests to be performed by each subcontractor, if applicable, as proposed in Sub Factor B.2 of the Technical Proposal and the “Utilization of Subcontractors/Test Send Outs section located in Vendor Response Document 02 (in lieu of #22 in I-FSS-600). Additionally, the Test Send Out Proposal tab of Pricelist Proposal Preparation Document 03 must be completed.

Please note that the contractor is responsible for performing a minimum of 90% of the test menu items throughout the life of the contract. No more than 10% of the test menu shall be performed by subcontractors.

II. GENERAL QUALIFICATIONS

A. Licensing and Accreditation Only fully licensed/accredited laboratories actively engaged in providing the specific services and laboratory testing outlined in this solicitation will be considered. The Contractor must continuously hold a Certificate of Compliance or Certificate of Accreditation from the Centers for Medicare and Medicaid Services as meeting the requirements of the Clinical Laboratory Improvement Amendments of 1988 or must demonstrate accreditation by a regulatory agency with deemed status from the Centers for Medicare and Medicaid Services, e.g. The College of American Pathologists, and/or other state regulatory agencies, as appropriate, and as mandated by federal and state statues. The Contractor must maintain valid certifications throughout the performance period of this contract.

The Contractor shall provide a copy of all relevant permits/licenses and certifications inclusive of any sanctions current or pending throughout the United States of America prior to contract award. In addition, the Contractor shall be responsible for providing a written guarantee or evidence that all subcontractors have appropriate licensure and accreditation to perform tests that the primary contractor cannot perform prior to contract award. Any proposed subcontractor changes during the contract performance period must have prior approval by the Contracting Officer (CO). Changes to the requirements will be executed by a bilateral modification to the contract. Each subcontractor must maintain the same certifications, accreditations, and Medical Malpractice Insurance as required of the Contractor (see Technical Proposal, Sub Factor B.1 in the Vendor Response Document 02).

Contractor policies and procedures shall comply with Health Insurance Portability and Accountability Act (HIPPA).

B. Documentation of Accreditation/Licensure The Contractor shall maintain current accreditation and notify the Contracting Officer of any lapse in state license, CLIA certification, or clinical pathology certification. The Contractor shall provide a copy of the renewed licenses/certificates to the Contracting Officer before expiration. Immediate (within 24 hours) notification must be given to ordering activity upon adverse action by a regulatory agency.

C. Malpractice Liability Insurance Malpractice liability insurance shall be by a commercial insurance company in the business of providing the required insurance coverage of not less than $1,000,000.00 per occurrence (see Clause 852.237-7 located within this document). The Contractor shall provide a copy of the Medical Malpractice Insurance Certificate before award of the contract.

The Contractor shall notify the contracting officer in writing of any malpractice investigation or licensure or certification suspension which concerns the Contractor or any employees, within 24 hours of notification of an investigation or suspension.

Any Subcontractor performing under this contract must also have malpractice liability insurance in the amount of $1,000,000.00 per occurrence, and a copy of the Medical Malpractice Insurance Certificate must be provided before award/performance of the contract. Please also see Vendor Response Document 02, Technical Proposal, Sub-factor B.1

III. CONTRACTOR’S RESPONSIBILITIES

A. Procedure Guidance The Contractor shall make available either through its electronic catalog or upon request the following information:

· Specimen collection and handling requirements

· Test reference intervals adjusted for ages, sex, or race, when required

· Test specific sensitivity, specificity, and interferences, when required

· Result code (electronic transmissions only)

· Test critical values, if any

· Location of test performance by test name (i.e. name of primary laboratory, name of separate branch division of primary lab, name and address of secondary/subcontracted laboratory must be cited).

B. Sample Preparation Each ordering activity will prepare (collect and handle) and package laboratory specimens in accordance with the requirements defined in the Contractor's commercial specimen collection guide. The packaging and transportation procedures must be of a quality that ensures the integrity of the specimen throughout the shipment process.

C. Supplies The Contractor shall provide all necessary supplies for collecting, preserving, packaging, and transporting/shipping specimens normally provided to its commercial customers, not limited to the following:

· Forms

· Specimen containers

· Special media or culture tubes for samples

· Specimen preservatives

· Dry ice and appropriate container

· Shipping and packaging containers

· Specimen carriers

· Labels as required by transportation guidelines If a medicolegal specimen is submitted, the Contractor shall provide its own special forms and special handling procedures to maintain valid “chain of custody possession” and develop the formal documentation necessary for that purpose. The Contractor’s testing personnel that performed the analysis may be required to provide Court testimony. Contractor testimony shall be provided as required at no additional expense to the Government.

The Contractor shall contact the COR within a maximum of five (5) calendar days after award of task order or Blanket Purchase Agreement, to coordinate the furnishing and delivery of specimen collection and transportation supplies, terminal or data fax and supplies, and the installation of equipment. The COR will request replenishment of supplies from the Contractor on an as needed basis.

D. Transportation Services Proper tracking of specimen must be maintained from the initial pickup/shipping of the specimens from the ordering activity throughout the testing process at the Contractor’s laboratory.

STAT/Emergency Pickup The Contractor shall pick up STAT/emergency pick up services, when available, as consistent with the Contractor’s commercial practices and within a time frame agreed upon at the task order level.

Routine Pickup The Contractor shall provide routine scheduled specimen pickup as consistent with the Contractor’s commercial practices and within a time frame agreed upon at the task order level. The ordering activity COR or designee shall notify the Contractor during weekends and Federal holidays, via telephone, if a pick-up courier is required.

E. Testing The testing methodology and reference ranges for a test must be defined in the laboratory user manual. The Contractor shall advise facility of any changes in methodology, procedure, reference ranges and any new tests introduced no later than two weeks prior to test change implementation.

In the event that the Contractor discontinues and/or substitutes a new test, the Contractor shall notify the CO prior to the intended change. Any such change may be sufficient cause for changing to an alternate contractor for the assay(s) for the duration of the contract at the sole discretion of the CO.

All clinical reference laboratory testing shall be executed in accordance with standard industry practices. All test methods shall be FDA approved. Any non-FDA approved method being performed shall have a documented validation plan. Upon request the validation plan and validation results shall be made available.

F. Test Result Reporting A report is defined as a final copy of laboratory testing results. This report shall be received by remote terminal where applicable.