36C25220Q0188-005.docx

36C25220Q0188

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1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a. PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

DUNS:

DUNS+4:

PHONE:

FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19.

20.

21.

22.

23.

24.

ITEM NO.

SCHEDULE OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA

26. TOTAL AWARD AMOUNT (For Govt. Use Only) 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________

29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. 2/2012)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

36C25220Q0188

YUSUF, MOHAMMAD

414-844-4800 X43284 02-07-2020

11.59 pm 36C252 Department of Veterans Affairs Great Lakes Acquisition Center (GLAC) 115 S 84th Street, Suite 101 Milwaukee WI 53214-1476 X 621511 $35 Million N/A X 36C252 Great Lakes Acquisition Center (GLAC) Department of Veterans Affairs 115 S 84th Street, Suite 101 Milwaukee WI 53214-1476 36C252 Department of Veterans Affairs Great Lakes Acquisition Center (GLAC) 115 S 84th Street, Suite 101 Milwaukee WI 53214-1476

Department of Veterans Affairs Financial Services Center PO Box 149971 Austin TX 78714-9971 877-353-9791 512-460-5540 See CONTINUATION Page Contractor to provide Cytogenetic laboratory services to the William S. Middleton Memorial VA Hospital, Madison, Wisconsin in accordance with the specifications, items and conditions here herein.

The period of Performance is 1 st August 2020 – 31 st July 2025 X x

ONE

Chad M. Turner Contracting Officer 36C25220Q0188 Cytogenetic Laboratory Service

36C25220Q0188

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SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1. CONTRACT ADMINISTRATION DATA

B.1.1 Contract Administration Matters will be handled by:

B.1.1.1 CONTRACTOR’S NAME/ADDRESS/CITY-STATE-ZIP (please print or type):

CONTRACTOR’S PAST PERFORMANCE POINT OF CONTACT (CPARS):

B.1.1.2 GOVERNMENT:

Mohammad Yusuf Contract Specialist Department of Veterans Affairs Great Lakes Acquisition Center 115 South 84th Street, Suite 101 Milwaukee, WI 53214-1476 Telephone: (414) 844-4800 ex 43284 Fax: (414) 844-4891 B.1.2 Contractor Remittance Address

All payments by the Government to the contractor will be made in accordance with Federal Acquisition Regulation (FAR) Clause 52.232-34, Payment by Electronic Funds Transfer--Other than Central Contractor Registration (31 U.S.C. 3332).

B.1.3 Payment

B.1.3.1 The Government agrees to reimburse the Contractor on a monthly basis for services provided and accepted at the price(s) listed in the Price Schedule/Attachment A, less any deductions provided in this contract. Amounts due the Contractor will be paid monthly upon receipt of a properly prepared invoice submitted by the Contractor. Payments will be made in arrears.

B.1.3.2 Payments made by the VA under this contract shall constitute the total price of services provided by the Contractor. The Contractor hereby agrees that in no event, shall contractor bill, charge, collect a deposit from, seek compensation, remuneration, or reimbursement from, or have any recourse against the beneficiary, the beneficiary’s family, private insurer, Medicare or any other entity acting on the beneficiary’s behalf, for services provided pursuant to this contract. Billings rendered by the Contractor to the VA for services furnished a VA beneficiary under the terms of this contract shall be billings in full. This provision shall survive the termination or ending of the contract.

B.1.4 Accounting/Invoices

B.1.4.1 Payments shall be made monthly in arrears upon receipt of a properly prepared invoice.

B.1.4.2 In order to comply with the Improper Payment Elimination and Recovery Act of 2010 (IPERA), the VA has mandated electronic invoice submission to the Veterans Affairs Financial Services Center (VAFSC). VAFSC has partnered with Tungsten Corporation e-Invoicing network for submissions of all electronic invoices to VA. Tungsten Network electronic invoicing is free to all VA vendors. In order to submit electronic invoices, all VA vendors must register with Tungsten Network by submitting an email to VA.Registration@tungsten-network.com or calling 1-877-752-0900 option 2 for Enrollment.

B.1.4.3 Contractor shall submit an electronic invoice by the tenth (10th) of the following month services were performed to the Veterans Affairs Financial Services Center (VAFSC) e-Invoice through the website at https://portal. tungsten-network..com/Login.aspx. For questions regarding the submission of VA electronic invoices, Tungsten Network customer service may be contacted at 1-877-489-6135.

B.1.4.4 All invoices shall reference the vendor name and address, customer name, contract number, appropriate obligation/funding order number, description of services provided, quantity, unit price, and total invoice amount. Invoices shall also include any payment discount terms.

B.1.4.5 For questions regarding invoice receipt or payment, please call VAFSC directly at 1-877-353-9791 or email vafsccshd@va.gov.

B.1.4.6 The Contractor shall submit two (2) monthly invoices, per account number as follows:

B.1.4.6.1 One (1) combined-sum invoice for cytogenetic laboratory services to the Financial Service Center in Austin, TX. Patient information must be excluded.

B.1.4.6.2 One (1) detailed invoice (including patient information) to the CO and COR at the Government facility.

B.1.4.6.3 The two invoices shall be sent at the same time. The combined-sum invoice sent to Austin shall equal the total amount on the invoice sent to the CO and COR at the Government facility.

B.1.4.6.4 The invoices shall be accurate and the detailed invoice from section B.1.4.6.2 shall display chronologically by date of specimen collection: the name of the patient, the date of specimen collection, date of specimen receipt, detailed list of the test (s) performed, unit price, and total invoice amount.

B.1.4.6.5 The Contractor shall not charge the Government for repetitive testing performed on a specimen to verify questionable initial results.

B.1.5 Limitation of Subcontracting

B.1.5.1 The Contractor must perform the cytogenetic laboratory testing themselves without subcontracting. All specifications, terms, conditions, clauses, and provisions contained in this solicitation will apply to any laboratory, i.e. branch, division, etc., performing reference laboratory testing services on behalf of the Contractor. It is the responsibility of the prime Contractor to ensure all employees comply with the requirements herein and perform testing services in accordance with industry standards.

B.1.6 Acknowledgement of Amendments

B.1.6.1 The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

B.1.7 Question

B.1.7.1 Questions to this solicitation must be submitted in writing to the Contract Specialist no later than 11:59 PM local Time, 04 February 2020 to the following email address: Mohammad.Yusuf@va.gov. No other form of communication will be accepted.

[End of Contract Administration Data]

B.2 SCHEDULE OF SERVICES AND PRICE

B.2.1 Under the authority of Title 38 U.S.C. 513 and pursuant to FAR Part 13.5 Test Program for Certain Commercial Items, the Great Lakes Acquisition Center is seeking quotations for Cytogenetic Laboratory Services. As such, the Government will utilize simplified procedures for soliciting competition, evaluation, award documentation, and notification.

B.2.1.1 Contractor shall provide the full range of requested Cytogenetic Laboratory Services as specified herein, for the following medical facility of the Department of Veterans Affairs (VA) - Veterans Integrated Service Network (VISN) 12 – VA Great Lakes Health Care System.

William S. Middleton Memorial Veterans Hospital (VAH) 2500 Overlook Terrace, Madison, WI, 53705

B.2.1.2 Required services include but are not limited to: specimen preparation and storage, transportation of clinical laboratory specimens, performance of analytical testing, reporting of analytical test results, and consultative services.

B.2.2 Government’s Minimum & Maximum Quantity

The VA attempts to be as accurate as possible when providing estimated quantities; however, actual quantities may vary from quantities listed in Attachment A. The Government’s guaranteed minimum to be ordered during the life of this contract is $5,000.00. The Government’s ceiling amount to be ordered during the life of this contract is $350,000.00.

B.2.3 Price Schedule

Contractor shall provide unit pricing for all Diagnostic Tests listed on Attachment A in order to be eligible for contract award. The total extended estimated pricing (from Attachment A) for the five-years period should be reflected in the table below. Test Prices listed in Attachment A shall be all-inclusive.

Laboratory processing personnel at the Madison VAH are authorized to place orders for specimen tests listed in Attachment A. The list of personnel authorized to place orders will be provided by the Contracting Officer at the time of award.

TOTAL ESTIMATED PRICE (FOR ALL FIVE YEARS) = $

· Flat fee associated with the transportation of the clinical specimens from the Madison VA Hospital to the commercial testing laboratory. Most of the Government requested pick-ups of clinical specimens will occur before 8:00pm.

· Flat fee associated with the return of the clinical specimen, (anatomic pathology material only), from the commercial testing laboratory to the Madison VA Hospital in accordance with section B.3.6.2 The estimated quantity is based on the quantity of tissue specimens in Attachment A.

B.3 PERFORMANCE WORK STATEMENT

B.3.1 Overview

Contractor shall provide all labor, supplies, equipment, maintenance, information technology, transportation, and supervision necessary to provide Cytogenetic Laboratory Services to the William S. Middleton Memorial Veterans Hospital located in Madison, WI. Cytogenetic Laboratory Services include but are not limited to: specimen preparation and storage, transportation of clinical laboratory specimens, performance of analytical testing, reporting of analytical test results, and consultative services.

B.3.2 Start of Work Meeting

The Contractor shall attend a Start of Work meeting to be held within 15 business days following contract award. The mode and venue of the meeting will be decided by the Contracting Officer prior to the starting of work. The Contractor shall have the following representation at the Start of Work Meeting:

Customer Service Representative Contracting Representative Lead Pathologist

The Contractor will be given at least a 10-business day notice of the time, date, mode of conduct and location of the Start of Work Meeting. The Contractor will be limited to five individuals representing the Contractor at the Start of Work Meeting due to limited space. Three days following the receipt of the Government’s Start of Work Meeting notification, the Contractor shall provide the names, titles, and email addresses of the individuals who will be attending the Start of Work Meeting to the Contracting Officer.

B.3.3 Qualifications/Requirements of Laboratory & Contractor Personnel

B.3.3.1 Laboratory

B.3.3.1.1 Contractor must have at least three years of experience in providing rapid response and cytogenetic laboratory testing services.

B.3.3.1.2 Contractor must have cytogenetic testing laboratory within a 75-mile radius of Madison VAH. Each laboratory must be within this radius.

B.3.3.1.3 Contractor must continuously hold a Certificate of Compliance or Certificate of Accreditation from the Centers for Medicare & Medicaid Services as meeting the requirements of the Clinical Laboratory Improvement Amendments of 1988 or must demonstrate accreditation by a regulatory agency(s) with deemed status from the Centers for Medicare & Medicaid Services, e.g. The College of American Pathologists, and/or other state regulatory agencies, as appropriate, and as mandated by federal and state statutes. The reference laboratory(ies) must maintain valid certifications during the entire performance period of this contract. The contractor must furnish copies of certificate as evidence of compliance or accreditation.

B.3.3.1.4 Any new requirement from the accrediting institution or organization shall be completed, and upon reissue or re-certification the Contractor must supply a copy of the certification(s) to the Contracting Officer’s Representative assigned to the contract.

B.3.3.1.5 Contractor must immediately notify the Contracting Officer’s Representative (COR), in writing, upon loss of any required certification, accreditation, or licensure.

B.3.3.1.6 Contractor shall maintain safety and health standards consistent with the requirements set forth by the Occupational, Health, and Safety Administration (OSHA) and the Center for Disease Control (CDC) and Prevention.

B.3.3.2 Personnel

B.3.3.2.1 Contractor shall ensure all testing and supervisory personnel at all Contractor-owned, or affiliate, laboratories assigned to work under this contract meet and maintain the applicable personnel qualifications set forth under the Clinical Laboratory Improvement Amendments (CLIA) of 1988 regulations, the College of American Pathology (CAP) accreditation standards, or other accrediting organizations’ and State standards.

B.3.3.2.2 Contractor shall ensure its employees can perform the applicable duties consistent with their license and certification.

B.3.3.2.3 Personnel assigned by the Contractor to perform the services covered by this contract shall be proficient in written and spoken English (38 USC 7402).

B.3.3.2.4 Any new requirements for mandatory education and/or competency reassessment, which occur during the contract period, shall be completed by the individual contractor employee(s), documented, and available upon request.

B.3.3.2.5 Contractor representatives (i.e. courier) entering any Government facility must be attired in a Contractor issued uniform that bears the name of the Contractor company. In addition, Contractor representatives shall prominently display a Contractor-issued identification badge.

B.3.4 Specimen Preparation and Storage for Reference Testing Specimens

B.3.4.1 The Contractor shall provide the Government facility with its current commercial laboratory reference test manual (Hard Copy) to ensure that the collection and storage of specimens are in accordance with Contractor’s requirements.

B.3.4.2 If the Contractor requires specialized specimen collection containers/media, the Contractor shall supply the Government facility with the appropriate collection container/media and Safety Data Sheets (SDS) to ensure proper specimen integrity and chemical spill clean-up efforts.

B.3.4.3 The Contractor shall be responsible for storing specimens in such a manner to ensure the integrity of the specimen.

B.3.5 Specimen Transportation/Testing Laboratory Locations

B.3.5.1 The Contractor shall be responsible for all services related to the transportation of the specimens from the Madison VAH Laboratory to the commercial testing laboratory.

B.3.5.2 The Contractor shall have at least one year of experience in providing transportation of biomedical materials transportation services.

B.3.5.3 Due to the critical importance of maintaining the viability of the specimen cells, the specimen must arrive at the Contractor’s testing laboratory within eight hours of the telephone request by the Government facility.

B.3.5.4 The Government will request specimen transportation services via telephone to the Contractor or designee on an as needed basis, Monday through Friday, 8:00 a.m. – 4:30 p.m., including federal holidays. The Contractor shall provide same day specimen pickup as requested by the Government facility. Historically, the Madison VAH requests specimen testing services three times a week and sends out one to two packages each time.

B.3.5.5 The Contractor shall implement and maintain specimen transportation in accordance with the transportation plan submitted with the offer, for the transportation of specimens from the Madison VA Medical Center to the testing laboratory.

B.3.5.6 The Contractor shall receive a copy of the orders following notification by the Government. The orders will be provided via a secure fax to the contractor. Contractor’s fax machine to receive these orders shall be in a secure location. The orders will contain, at a minimum, the information below:

B.3.5.6.1 Patient’s Full Name

B.3.5.6.2 Patient’s identification number, e.g. social security number (SSN)

B.3.5.6.3 Physician’s name

B.3.5.6.4 Test(s) ordered

B.3.5.6.5 Date/time of specimen collection

B.3.5.6.6 Specimen type

B.3.6.1 The Contractor shall provide the full range of clinical and/or anatomic pathology diagnostic testing capabilities to execute all required tests as annotated in Attachment A. Contractor shall make available the test information below:

B.3.6.1.1 Requisition form

B.3.6.1.2 Alphabetized test name list

B.3.6.1.3 Test order code

B.3.6.1.4 Specimen collection and preservation requirements

B.3.6.1.7 Test specific sensitivity, specificity and interferences, when required

B.3.6.1.8 Test critical values, if any

B.3.6.1.9 Policy for critical value notification

B.3.6.1.10 CPT coding

B.3.6.1.11 Test turnaround times (minimum and maximum times in hours indicated); where the turnaround time is defined as the time between receipt of specimen at the Contractor’s testing facility and receipt of results by a Government facility.

B.3.6.1.12 Schedule of test performance (specific days of week indicated)

B.3.6.1.13 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 (sub-contracted) laboratory must be cited).

B.3.6.2 Preliminary Result Interpretation

The Contractor shall provide preliminary test result interpretation of the ordered test. The Contractor shall provide recommendations for reflex testing and/or cancellation of Government requested testing.

B.3.6.3 Contractor shall notify the Contracting Officer/Contract Specialist and the COR of any test information modifications no later than two weeks prior to the implementation date of the test change.

B.3.6.4 Any new test(s) not listed in Attachment A must be added to the contract through a formal contract modification by the Contracting Officer prior to specimen being tested. Unauthorized orders or changes to the contract may not be reimbursed.

B.3.6.5 All reference laboratory testing shall be executed in accordance with standard industry practices. It is preferred that test methods are FDA approved. Any non-FDA approved method being performed shall have a disclaimer and documented validation plan. Upon request, the validation plan and validation results shall be made available to the COR or designee.

B.3.6.6 The Contractor shall ensure the accurate and timely performance of laboratory testing services.

B.3.7 Specimen Retention

B.3.7.1 The Contractor shall store the specimens a minimum of three (3) calendar days after the test is reported or in accordance with the retention requirements of their regulatory body, whichever is longer, in the event that subsequent action is necessitated, e.g. problem solving and/or repeat testing.

B.3.7.2 All anatomic pathology materials (e.g., histology blocks, slides, or other anatomic pathology material) generated by the VA shall be returned within 7 calendar days after final report is issued.

B.3.8 Reporting of Results

B.3.8.1 Contractor shall provide timely and appropriate testing of patient specimens as requested by the Government facility. Due to the criticality of the diagnostic information that results from this testing, the turnaround times (defined as the time from receipt of the specimen in the testing laboratory to the receipt of test results by the Madison VAH facility and based on specimen type), shall be minimal and are defined in Attachment A.

B.3.8.2 A final report of laboratory testing results must be issued as a printed hard copy. Contractor shall deliver the reports without an additional charge by expedited overnight courier shipping, mailing, and/or transportation services by hand within 24 hours, or by telephone facsimile to a protected machine identified to the Contractor by the VA. Contractor’s fax machine to transmit the test results shall be in a secure location. Delivery by electronic mail, i.e. MS Outlook, etc., is prohibited.

B.3.8.3 Each test report shall, at minimum, include the following information:

B.3.8.3.1 Patient's full name

B.3.8.3.2 Patient’s identification number, e.g. social security number (SSN)

B.3.8.3.3 Physician’s name (if supplied)

B.3.8.3.4 Government laboratory accession number (if supplied)

B.3.8.3.5 Submitting facility name

B.3.8.3.6 Submitting facility account number

B.3.8.3.7 Patient's location (clinic/ward) (if supplied)

B.3.8.3.8 Test(s) ordered

B.3.8.3.9 Date/time of specimen collection (when available)

B.3.8.3.10 Date and time specimen was received at the testing facility

B.3.8.3.11 Date/time test completed

B.3.8.3.12 Test result

B.3.8.3.13 Reference intervals (adjusted for age, sex or race, when appropriate)

B.3.8.3.14 Toxic and therapeutic ranges, if applicable

B.3.8.3.15 Flagged abnormal results

B.3.8.3.16 Reference laboratory accession number

B.3.8.3.17 Name and address of testing laboratory

B.3.8.4 Test results determined by the contractor to be critical shall be communicated by telephone to a designated Government contact person(s) at the originating Government laboratory facility upon verification of the critical test result. The telephonic report shall be followed by a final report issued as a printed (hard) copy as required in B.3.8.2.

B.3.9 Customer Service

B.3.9.1 Contractor shall provide customer service, Monday – Friday, 8:00a.m. – 4:30 p.m. & Saturday 8:00a.m. – noon, including federal holidays, which is accessible by telephone to assist Government staff for tracking and resolving related issues/problems that may arise in the performance under this contract.

B.3.9.2 The Contractor shall notify the originating laboratory, by telephone, of specimens cancelled due to unacceptability for reasons relating to volume, specimen container, identification, loss of specimen, etc. Government notification shall be provided within 24 hours from when the specimen was received at the testing laboratory.

B.3.10 Consultative Services/Utilization Reports

B.3.10.1 Contractor shall provide professional consultative services that are consistent with the services offered commercially to other customers at no cost to the Government. These services may include consultations by laboratory professionals or experienced physicians/PhDs on test or methodology selection and/or test result interpretation.

B.3.10.2 Contractor shall provide direct communication with the Government Pathologist in order to provide additional assistance in the interpretation, recommendation of additional testing, and assist in the diagnosis of clinical illnesses.

B.3.10.3 Contractor shall provide, to the COR, a monthly report detailing the date and time of specimen receipt at the testing laboratory.

B.4 SPECIAL CONTRACT REQUIREMENTS

B.4.1 Services

B.4.1.1 The services specified herein may be changed by written modification to this contract. The VA Contracting Officer will prepare the modification (reference FAR clause 52.212-4(c), Changes) and, prior to becoming effective, shall be signed by both parties. Only the Contracting Officer is authorized to make commitments or issue changes that affect price, quantity, or quality of performance of this contract. In the event the Contractor effects any such change at the direction of any person other than the Contracting Officer, the change shall be considered unauthorized and no adjustment will be made in the contract price to cover any increase in costs incurred as a result thereof.

B.4.1.2 This is a non-personal services contract as defined in FAR 37.101. There is no employer-employee relationship between the Government and the Contractor or the Contractor’s employee(s). Contractor personnel are not subject to the supervision and control of a Government officer or employee. Supervisory functions such as hiring, firing, directing, and counseling of contractor personnel are not performed by the Government. The healthcare Contractor who furnishes services under this contract is subject to Government technical oversight of the services. The Government retains the right to reject services for contractual non-performance.

B.4.1.3 The Government may evaluate the quality of professional and administrative services provided but retains no control over the medical and professional aspects of services rendered.

B.4.1.4 Contractor is required to maintain medical liability insurance for the duration of this contract. Medical Liability insurance shall cover the Contractor for services in all states where services are rendered by the Contractor. Contractor shall indemnify the Government for any liability producing act or omission by the Contractor, its employees and agents occurring during contract performance.

B.4.1.5 Contractor shall, in writing, keep the Contracting Officer informed of any unusual circumstances in conjunction with the contract.

B.4.1.6 Contractor shall not, under any circumstances, furnish reports directly to patients.

B.4.2 Term of Contract

B.4.2.1 This contract is effective for five (5) years from the date of award.

B.4.3 Availability of Funds during a Continuing Resolution

B.4.3.1 At the beginning of each new fiscal year (October 1st) the federal government or parts thereof may be operating under a Continuing Resolution and only be funded for a limited period rather than for the entire fiscal year. If, at any time, funds for this contract are provided under a Continuing Resolution (CR), funds will only be available for performance under this contract up to and including the expiration date of the CR, and any extension thereof. The Government's obligation for performance of this contract beyond that date 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 for performance under this contract beyond the expiration date of the CR, and any extension thereof, until funds are made available to the Contracting Officer for performance and until the Contractor receives notice of availability.

B.4.4 Federal Holidays

B.4.4.1 Contractor is required to provide transportation and analytical testing of specimens on federal holidays, if requested. The 10 holidays observed by the Federal Government are: New Year’s Day (January 1st), Martin Luther King’s Birthday (3rd Monday in January), Presidents’ Day (3rd Monday in February), Memorial Day (last Monday in May), Independence Day (July 4th), Labor Day (1st Monday in September), Columbus Day (2nd Monday in October), Veterans Day (November 11), Thanksgiving Day (4th Thursday in November), Christmas Day (December 25th) and any other day specifically declared by the President of the United States to be a national holiday.

B.4.4.2 When one of the above designated legal holidays falls on a Sunday, the following Monday will be observed as a legal holiday. When a legal holiday falls on a Saturday, the preceding Friday is observed as a holiday by U.S. Government agencies.

B.4.5 HHS/OIG

To ensure that the individuals providing services under the contract have not engaged in fraud or abuse regarding Sections 1128 and 1128A of the Social Security Act regarding federal health care programs, the contractor is required to check the Health and Human Services - Office of Inspector General (HHS/OIG), List of Excluded Individuals/Entities on the OIG Website (www.hhs.gov/oig) for each person providing services under this contract. The listed parties and entities may not receive Federal Health Care program payments due to fraud and/or abuse of the Medicare and Medicaid programs. During the performance of this contract the contractor is prohibited from using any individual or business listed on the List of Excluded Individuals/Entities. Any healthcare provider or entity that employ or enter into contracts with excluded individuals or entities may have a Civil Monetary Penalty (CMP) imposed against them. By signing this offer, the Contractor certifies that all persons or entities listed in the contractor’s offer have been compared against the OIG list and are NOT listed as of the date the offer was signed.

B.4.6 Record Keeping – Contractor

Contractor shall establish a record keeping system of all tests performed.

B.4.7 Medical Records

Clinical or other medical records (i.e. test results) of VA veteran patients treated by the Contractor under this contract are owned by the VA and the Contractor is not authorized to release or utilize this data for any use other than contract performance. If requested, test results will be mailed to the VA at no additional cost to the Government. Mail shall be sent in accordance with VA Directive 6609, Mailing of Sensitive Personal Information. Contractor may obtain a copy of VA Directive 6609 at the following website: http://www1.va.gov/vhapublications/index.cfm.

If a subpoena or court order is received to produce a medical record/test result, the contractor shall notify the Contracting Officer that a subpoena or court order was received.

B.4.8 Confidentiality of Patient Records

B.4.8.1 The Contractor is a VA contractor and will assist in the provision of health care to patients seeking such care from or through VA. As such, the Contractor is considered as being part of the Department health care activity. Contractor is considered to be a VA contractor for purposes of the Privacy Act, Title 5 U.S.C. 552a. Further, for the purpose of VA records access and patient confidentiality, Contractor is considered to be a VA contractor for the following provisions: Title 38 U.S.C. 5701, 5705, and 7332. Therefore, Contractor may have access, as would other appropriate components of VA, to patient medical records including patient treatment records pertaining to drug and alcohol abuse, HIV, and sickle cell anemia, to the extent necessary to perform its contractual responsibilities. However, like other components of the Department, and not withstanding any other provisions of the sharing agreement, the Contractor is restricted from making disclosures of VA records, or information contained in such records, to which it may have access, except to the extent that explicit disclosure authority from VA has been received or disclosure is required by law. The Contractor is subject to the same penalties and liabilities for unauthorized disclosures of such records as VA.

B.4.8.2 The records referred to above shall be and remain the property of VA and shall not be removed or transferred from VA except in accordance with U.S.C.551a (Privacy Act), 38 U.S.C. 5701 (Confidentiality of claimants records), 5 U.S.C. 552 (FOIA), 38 U.S.C. 5705 (Confidentiality of Medical Quality Assurance Records) 38 U.S.C. 7332 (Confidentiality of certain medical records) and federal laws, rules and regulations. Subject to applicable federal confidentiality or privacy laws, the Contractor, or their designated representatives, and designated representatives of federal regulatory agencies having jurisdiction over Contractor, may have access to VA ‘s records, at VA’s place of business on request during normal business hours, to inspect and review and make copies of such records.

B.4.9 HIPAA Compliance

Contractor must adhere to the provisions of Public Law 104-191, Health Insurance Portability and Accountability Act (HIPAA) of 1996 and the National Standards to Protect the Privacy and Security of Protected Health Information (PHI). As required by HIPAA, the Department of Health and Human Services (HHS) has promulgated rules governing the security and use and disclosure of protected health information by covered entities, including the Department of Veterans Affairs (VA). The VA has recognized Diagnostic Laboratory Facilities as healthcare providers and that the PHI is being disclosed and/or used for treatment. Therefore, no BAA is required for Reference Laboratory Services.

B.4.10 Designation of Contract Representative

The Madison VAH General-Diagnostics Laboratory Supervisor will be designated as the Contracting Officer Representative (COR) to represent the Contracting Officer in furnishing guidance and advice regarding the work being performed under this contract. The COR will provide technical guidance, verify services were performed, and verify that documentation for services performed is received prior to certifying payment. The foregoing is not to be construed as authorization to interpret or furnish advice and information to the Contractor relative to the financial or legal aspects of the contract. Enforcement of these segments is vested in and is the responsibility of the Contracting Officer. The extent and limitations of the COR designation will be provided in the COR Delegation Memo.

B.4.11 Contract Performance Monitoring

B.4.11.1 Monitoring of contractor’s performance shall be demonstrated through clinical and administrative record reviews. COR will be responsible for verifying contract compliance. Contracting Officer's Representative (COR) will designate appropriate VA personnel to monitor services through one or a combination of the following mechanisms:

B.4.11.2 Departments being served will monitor Contractor performance to ensure that services called for in the contract have been received by VA in a timely manner. Any incidents of Contractor noncompliance as evidenced by the monitoring procedures will be forwarded immediately to the Contracting Officer.

B.4.11.3 Documentation of services performed will be reviewed prior to certifying payment. The COR will perform periodic spot checks and document with the using service to ensure records monitoring. VA will pay only for services provided, and in strict accordance with the Price Schedule/Attachment A. Contract monitoring and recordkeeping procedures will be sufficient to ensure proper payment and allow audit verification that services were provided.

B.4.11.4 Departments being served, through the COR, will provide a written statement annually to the Contracting Officer to include a summary of Contractor actions and a statement that all requirements of the contract have been fulfilled as agreed. This summary evaluation will be submitted 45 days prior to expiration of contract (and/or prior to election of option year renewals, if applicable).

B.4.12 Quality Assurance Monitoring

B.4.12.1 Contractor shall maintain a Quality Assurance Program related to Reference Laboratory services covered under this contract.

B.4.12.2 Contractor shall also participate in a joint quality assurance surveillance program (QASP) with the Government facility. This program must minimally address the quality aspects representative to the testing process, i.e. pre-analytical, analytical, and post-analytical variables and include a description of monitoring and evaluation activities. There must be a mutually agreed upon procedure for responding to issues, problems and/or concerns identified by the Government with details as to whom and in what timeframe the matters will be reconciled. The issues that may need to be addressed may be general in nature or specific to an incident or event. The contractor will meet or communicate with the facility staff for process review and improvement of contract performance on an as needed basis.

B.4.12.3 Copies of licensure/certifications are also required to be submitted upon request by the VA.

B.4.12.4 Quality factors that VA may consider when monitoring quality of care may include, but are not limited to: patient medical records, security/privacy, adverse event reporting, turn-around times, timeliness to customer service requests, and adherence to transportation requirements.

B.4.12.5 These monitoring procedures for contractor’s meeting these tasks are further illustrated in the following Performance Requirements Summary Matrix:

PERFORMANCE OBJECTIVE

Tasks:

MONITORING METHOD

B.4.12.6 If the contractor believes there are excusable circumstances, the contractor shall inform the Contracting Officer and the COR and provide a detailed explanation with the excusable delay request. Excusable circumstances may result in adjustment in the Performance Matrix based upon the Contracting Officer’s Determination and Findings.

B.4.13 Contractor Certification

B.4.13.1 Citizenship-Related requirements: Contractor must adhere to and return the signed certification Attachment B found in Section D of this solicitation. This certification concerns a matter within the jurisdiction of an agency of the United States and the making of a false, fictitious, or fraudulent certification may render the maker subject to prosecutions under 18 U.S.C. 1001.

B.4.14 Required Registration with Contractor Performance Assessment System (CPARS)

B.4.14.1 As prescribed in Federal Acquisition Regulation (FAR) Part 42.15, the Department of Veterans Affairs (VA) evaluates contractor past performance on all contracts that exceed the thresholds outlined in FAR Part 42.15 and shares those evaluations with other Federal Government contract specialists and procurement officials through the Past Performance Information Retrieval System (PPIRS). The FAR requires that the contractor be provided an opportunity to comment on past performance evaluations prior to the posting of each report. To fulfill this requirement VA uses an online database, the Contractor Performance Assessment Reporting System (CPARS). The CPARS database information is uploaded to the Past Performance Information Retrieval System (PPIRS) database, which is available to all Federal agencies.

B.4.14.2 Each contractor whose contract award is estimated to exceed the thresholds outlined in FAR Part 42.15 is required to provide to the Contracting Officer contact information for the Contractor’s representative with their response to the solicitation. The Contractor is responsible to notify the Contracting Officer of any change to the Contractor’s representative during the contract performance period. Contractor’s representative contact information consists of a name and email address.

B.4.14.3 The Government will register the contract within thirty days after contract award. For contracts with a period of one year or less, the Contracting Officer will perform a single evaluation when the contract is complete. For contracts exceeding one year, the Contracting Officer will evaluate the Contractor’s performance annually. Intermediate reports will be filed each year until the last year of the contract, when the final report will be completed. Each report shall be forwarded in CPARS to the Contractor’s designated representative for comment. The Contractor’s representative will have 30 days to submit any comments and return the report to the VA Contracting Officer. Failure by the Contractor to respond within those 30 days will result in the Government’s evaluation being placed on file in PPIRS without Contractor’s comments.

[End of Special Contract Requirements]

B.5 CONTRACT SECURITY REQUIREMENTS

B.5.1 General

B.5.1.1 Contractors, contractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

B.5.2 Contractor Personnel Security Requirements

B.5.2.1 Failure to comply with the Government’s personnel security requirements may result in termination of the contract for default.

B.5.2.2 Contractor shall have a current process in place for conducting employee screening/background checks as a condition of employment with the contractor. Contractor shall also provide a certification memo indicating that all its employees having access to VA sensitive information (i.e. laboratory technicians and/or technologists, administrative personnel) during the performance of this contract have successfully passed through this process to their standards. The certification memo shall be provided to the Contracting Officer and COR on an annual basis (employee screening/background checks are not required to be re-conducted annually).

B.5.3 Security Training

B.5.3.1 Due to the increased emphasis on privacy and information security, the following special contract requirements are established and hereby made part of the contract entered into with the Department of Veterans Affairs. All contractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems:

B.5.3.2 Privacy & Information Security Training: Contractor and their sub-contractors assigned work under the contract are required to receive annual training on patient privacy as established by HIPAA statues. Training must meet VHA’s and/or the Department of Health and Human Service’s Standards for Privacy of Individually-identifiable health information. For contractors and sub-contractors who do not have access to VHA computer systems, this requirement is met by receiving VHA National Privacy Training, other VHA approved privacy training, or contractor furnished training that meets the requirements of the HHS standards. Contractor shall provide certification to the VA upon request that all employees and sub-contractor employees assigned work and/or having access to Protected Health Information have received annual training.

B.5.3.3 Rules of Behavior: Contractor personnel having access to VA systems are required to read and sign a Rules of Behavior statement, which outlines rules of behavior related to VA contracts.

B.5.3.4 Failure to complete mandatory annual training and/or sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete. Information on fulfilling the training requirements as stated in sections B.5.3.2 and B.5.3.3 can be found at the VA Talent Management System (TMS) at https://www.tms.va.gov/plateau/user/login.jsp. Once there, follow the steps to create an account, launch the mandatory training, and complete the content. The training will provide information regarding privacy, information security, rules of behavior, and other pertinent topics relevant to work at the VA. If any difficulty is experienced while creating an account or completing the mandatory content, contact the VA MSE Help Desk at 1.888.501.4917 or via email at VAMSEHelp@gpworldwide.com.

B.5.3.5 As VA routinely reviews and updates policies and procedures covering contractor computer access, security requirements may change during the term of this contract and new policies and procedures may be implemented unilaterally during the term of this contract.

B.5.4 VA Information Custodial Language

B.5.4.1 Information made available to the contractor by VA for the performance or administration of this contract or information developed by the contractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1).

B.5.4.2 VA information should not be co-mingled, if possible, with any other data on the contractor’s…