36C26218R0733-002.pdf

PAGE 1 OF 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 x 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 35

36C26218R0733

TIEN NGUYEN 09-4-2018

10:00 AM PST

00262

Department of Veterans Affairs

Network Contracting Office 22

4811 Airport Plaza Drive

Suite 600

Long Beach CA 90815

621511

$32.5 Million

X

N/A x

Department of Veterans Affairs

4811 Airport Plaza Drive

00262

Department of Veterans Affairs

Network Contracting Office 22

4811 Airport Plaza Drive

Financial Services Center

P.O. Box 149971

Austin TX 78714-9971

See CONTINUATION Page

See CONTINUATION Page

X X

Submission deadline: September 4, 2018 10:00 AM PST

An electronic copy and three (3) hard copies are mandatory. BOTH must arrive by submission deadline.

Electronic copy shall be submitted on CD in MS Word, Excel and PDF format only (no Zip files). See Instructions to Offeror for details.

NOTE:

- It is the Offeror’s responsibility to ensure that documents are complete and submission is viewable/ readable and arrives to the CO/CS by the date and time required. Offeror should take into consideration the delivery response time of the mail carrier utilized.

- Hand delivery may be made between Monday – Friday 7:30 am – 3:00 pm and requires a signature with time and date stamp from an authorized person designated by the CO/CS. It is the Offerors responsibility to plan with the CO/ CS to ensure there will be an authorized person to accept the delivery.

- Any questions are required to be submitted via email within 7 calendar days of release of the solicitation by 10:00 AM PST to: Tien.Nguyen@va.gov

If any required documents are omitted with submission, the offer may be precluded from further consideration.

mailto:Tien.Nguyen@va.gov

Table of Contents

SECTION A

A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

SECTION B – CONTINUATION OF 1449 BLOCKS

B.1 Contract Administration Data

B.4 Statement of Work

B.5 Objective

B.6 Scope of Work

B.7 Participating Healthcare Systems

B.8 Description of Services

B.9 Patient Test Report

B.10 Administrative Reports - Monthly

B.11 Business Review Report:

B.12 Requirement for Courier Services

B.13 Specifications

B.14 Technical Data Requirements

B.15 Security

B.16 General Information

B.17 Price Schedule

B.18 Delivery Schedule

SECTION C - CONTRACT CLAUSES

C.1 52.216-18 ORDERING (OCT 1995)

C.2 52.216-19 ORDER LIMITATIONS (OCT 1995)

C.3 52.216-22 INDEFINITE QUANTITY (OCT 1995)

C.4 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.5 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

C.6 52.232-19 AVAILABILITY OF FUNDS FOR THE NEXT FISCAL YEAR (APR 1984) 18

C.7 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

C.8 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV

2012)

C.9 VAAR 852.237-70 CONTRACTOR RESPONSIBILITIES (APR 1984)

C.10 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.11 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (JAN 2018)

C.12 52.204-4 PRINTED OR COPIED DOUBLE-SIDED ON POST CONSUMER FIBER

CONTENT PAPER (MAY 2011)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (JUL 2013)

E.2 52.216-1 TYPE OF CONTRACT (APR 1984)

E.3 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.4 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION

(JAN 2008)

E.5 VAAR 852.252-70 SOLICITATION PROVISIONS OR CLAUSES INCORPORATED BY

REFERENCE (JAN 2008)

E.6 ADDENDUM TO FAR 52.212-1 – INSTRUCTIONS TO OFFERORS – COMMERCIAL

ITEMS

E.7 52.212-2 EVALUATION—COMMERCIAL ITEMS (OCT 2014)

SECTION B – CONTINUATION OF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C262

Network Contracting Office 22

4811 Airport Plaza Drive Suite 600

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

[X] 52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or

[] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [x] Monthly

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

Department of Veterans Affairs

Financial Services Center via Tungsten Network http://www.tungsten-network.com/customer-campaigns/veterans-affairs/

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the

Solicitation numbered and dated as follows:

AMENDMENT NO DATE

B.4 STATEMENT OF WORK

B.5 OBJECTIVE

The specific objective of this contract is to award a single IDIQ contract to provide reference laboratory testing for all facilities within VISN22 West and East.

The Contractor shall provide the following services to each healthcare system:

A. Sample Processing: Provide specimen collection materials, appropriate transportation, and storage of specimens to ensure specimen integrity for all test orders. Safety Data Sheets will be provided to sites as appropriate for supplies containing hazardous chemicals.

B. Courier: Provide courier transportation with established pick-up times for all facilities

C. Interface: Satisfy all VA Enterprise Cyber Security Infrastructure Project (ECSIP) requirements to establish an interconnection/interface with the VA

D. Monthly Reports and Business Review: Provide a statistical analysis of the VISN22 facilities’ workload test volumes and assist in the monitoring of ordering trends and utilization patterns.

B.6 SCOPE OF WORK

The Contractors shall provide in accordance with the specifications outlined below a full range of reference laboratory services for VISN 22.

VISN 22 is comprised of VA Medical Centers, VA Outpatient Clinics (OPC), and VA Community-Based

Outpatient Clinics (CBOC). Services provided to VISN 22 under the resultant IDIQ contract shall include the transportation of clinical laboratory specimens to the Contractor’s laboratory(s), the performance of analytical testing as defined by the Contractor's reference test manual, the reporting of analytical test results and business review services VISN 22 laboratory operation.

All requirements and provisions defined in the specifications of this solicitation apply to any laboratory (i.e.

branch, division, sub-contractor, etc.) performing reference testing on behalf of the Contractor.

It is possible that during the life of this contract that VISN 22 might add additional facilities within the California, Arizona, or New Mexico geographic areas that will require the services specified in the Statement of Work. The

Government shall have the right to unilaterally modify this IDIQ contract to add any new facilities in those geographic areas during the IDIQ’s period of performance and the Contractor shall provide the services described in the Statement of Work to those facilities. The prices charged for services provided to any new facilities shall adhere to the prices shown in the Price Schedule in Section B.17. When additions occur, a modification to the

IDIQ will be executed notifying the Contractor of the new facility to be serviced.

B.7 PARTICIPATING HEALTHCARE SYSTEMS

VISN 22 WEST HEALTHCARE SYSTEM

VA LONG BEACH HEALTHCARE SYSTEM

5901 E. Seventh St

Long Beach, CA 90822

VA LOMA LINDA HEALTHCARE SYSTEM

11201 Benton Street

Loma Linda, CA 92357

VA SAN DIEGO HEALTHCARE SYSTEM

3350 La Jolla Village Drive

San Diego, CA 92161

VA GREATER LOS ANGELES HEALTHCARE SYSTEM

11301 Wilshire Blvd.

Los Angeles, CA 90073

LOS ANGELES AMBULATORY CARE CENTER

351 E Temple St.

Los Angeles, CA 90012

SEPULVEDA AMBULATORY CARE CENTER

16111 Plummer St.

North Hills, CA 91343

SANTA MARIA COMMUNITY BASED OUTPATIENT CLINIC

1550 E Main St, Santa Maria, CA 93454

BAKERSFIELD COMMUNITY BASED OUTPATIENT CLINIC

1801 Westwind Dr, Bakersfield, CA 93301

VISN 22 EAST HEALTHCARE SYSTEM

VA ALBUQUERQUE HEALTHCARE SYSTEM

1501 San Pedro Dr. SE

Albuquerque, NM 87108

VA NORTH ARIZONA HEALTHCARE SYSTEM

500 AZ-89

Prescott, AZ 86301

VA PHOENIX HEALTHCARE SYSTEM

650 E Indian School Rd.

Phoenix, AZ 85012

VA SOUTHERN ARIZONA HEALTHCARE SYSTEM

3601 S 6th Ave.

Tucson, AZ 85723

B.8 DESCRIPTION OF SERVICES

A. SAMPLE PROCESSING : Each facility will provide properly prepared laboratory specimens, identified and labeled for testing. The Contractor shall provide an adequate supply of specimen collection materials for such testing, including all materials required for specialized handling as dictated by the Contractor’s reference laboratory's specimen collection requirements, (e.g. dry ice, stabilizing tablets, ice packets, etc). The Contractor shall transport and store specimens in such a manner as to insure the integrity of the specimen. The Contractor shall provide additives required for collection of specimens in unit packages to facilitate collection at Community Based

Outpatient Clinic’s (CBOC) and Outpatient Clinics (OPC). Material Safety Data Sheets will be provided by the Contractor to sites as appropriate for supplies containing hazardous chemicals (e.g.

boric acid tablets, acids).

B. SPECIMEN TESTING: The Contractor shall provide testing of patient specimens as requested by VISN

22 facilities.

C. SPECIMEN STORAGE: The Contractor shall store the specimens a minimum of seven (7) days after the test is reported to allow for subsequent action (e.g. problem solving and/or repeat testing).

D. FAR 52.212-4(c) CHANGES : SOW: Services determined by the Contracting Officer to be within the general scope of the contract or PRODUCT ADD-ON: The VA may have a need for additional testing over the life of the contract that are not currently on the Price Schedule or FACILITY: The

VA may add any new location incorporated into VISN 22. Any of these changes shall be made in accordance with FAR 52.212-4(c) Changes, shall not necessitate new solicitation proceedings.

B.9 PATIENT TEST REPORT

A patient test report is defined as a printed final copy of laboratory testing results or host-to-host VPN electronic transmission of test results. This report will be received by VPN computer interfaced to the VistA Laboratory

Package. Contractor shall make all results retrievable via Secure Web Portal; in addition to providing the Web

Portal, Contractor may send also send results via fax to a secure facsimile. Specifications outlining the requirements of the computer interface to the VistA Laboratory Package, including computer hardware, maintenance and supply requirements are defined in Section B.14 Technical Data Requirements – B.

Interface Telecommunication Requirements.

A. PATIENT TEST REPORT: At a minimum, the Contractor shall provide the following information on each laboratory test report/result:

1. Patient's name and/or identification number

2. VA accession number

3. Physician's name

4. VA medical record number

5. The submitting facility name

6. Patient's location, if provided to include clinic/ward

7. Test ordered

8. Date/time of specimen collection

9. Date/time test completed

10. Test result

11. Reference intervals

12. If applicable, toxic and therapeutic ranges

13. Flagged abnormal,

14. Critical Value

15. Reference laboratory specimen number

16. Name and address of testing laboratory

17. Any other information that may indicate a questionable validity of test results

18. Unsatisfactory specimen shall be reported with documentation supporting its unsuitability for testing

The Contractor shall provide test results, either by hard copy or electronic report transmission, within 24 hours following specimen pick-up. Any test that will require a longer turnaround time (TAT) than the 24 hours, the Contractor shall provide test results no later than 20 minutes after the verification of the test.

The Contractor shall immediately provide notification of a test result that has been identified in the Contractor’s laboratory as a critical value by telephone and fax to the submitting VISN 22 laboratory upon verification of the critical test result. Critical values are test results that indicate a dire/serious situation with a patient where intervention is required imminently. The hard copy result must follow any critical value notification and it will be documented to show who provided the notification, who received the notification and the time and date of the notification.

The Contractor shall report STAT test results within 4 hours or less of specimen pick-up (unless a longer test

TAT is specifically allowed on a case-by case basis).

PICK UP shall be between 2:00 pm – 5:00 pm local time at each facility. If there will be delays, the Contractor shall notify the COR and/ or Designee as soon as possible.

Contractor shall provide by 12:00 P.M., daily, a report listing all incomplete tests and their processing status.

CLIENT SERVICES: Contractor shall provide Client Services 24 hours per day, 7 days per week to address inquires such as test availability, specimen collection, storage, transport requirements, addition or cancellation of testing, and the ordering of supplies. During normal business hours, the Contractor shall provide access to medical experts to address laboratory test interpretation, testing recommendations, and education regarding new testing options.

B.10 ADMINISTRATIVE REPORTS - MONTHLY

MONTHLY REPORTS: The Contractor shall provide the reports listed below in a downloadable Excel format.

Each healthcare system shall receive a facility specific report and VISN22 Leadership shall receive a single cumulative document to include all VISN22 healthcare system.

A. TEST UTILIZATION REPORT: Contractor shall provide a statistical analysis of the VISN 22 facilities workload testing volumes to assist in the monitoring of ordering trends and utilization patterns. The analysis shall include:

1. Tests performed

2. Test Order Code

3. Test volumes

4. Associated cost per test

5. Associated cost per reflex test

B. TEST CODE CHANGES REPORT: Contractor shall provide a listing of test code changes which occurred during the previous month to include the reason for the change and test cost

1. Current test code number

2. Current test name

3. Current test cost

4. New test code number

5. New test name including panel test names, and when applicable reflex testing information

6. Effective date of change

C. NON-FEE SCHEDULE TEST REPORT: The Contractor shall provide a report itemizing the tests ordered that were not on the original price schedule as well as and the cost associated with this test.

1. Test name

2. Test code

3. Test cost

D. NEW TEST REPORT: The Contractor shall provide a report indicating new tests that have been added to the Contractor’s test menu.

1. Test name

2. Test code

3. Test cost

4. Specimen collection, storage, and stability

5. Transportation requirements

6. Reflexed test information, if applicable

7. Cost of reflex testing, if applicable

B.11 BUSINESS REVIEW REPORT:

A. BUSINESS REVIEW: The Contractor shall provide a bi-annual business review in downloadable MS

Excel format. Each healthcare system shall receive a facility specific report and VISN22 Leadership shall receive a single cumulative document to include all VISN22 healthcare system.

In the Business Review Report, the Contractor shall provide actionable recommendations for improvement along with the following information:

1. Test ordering trends

2. TAT overview and test that exceeds the TAT

3. Exception overview

4. Number of support calls

5. Per facility, a test utilization comparison from the previous Business Review Report

6. List of test code changes

7. Per site, list of tests ordered not listed on test menu and cost associated with those tests

8. Per site, listing of reflex testing and cost associated

9. Test cancellation due to specimen integrity

B.12 REQUIREMENT FOR COURIER SERVICES

A. GENERAL

The Contractor shall provide courier services for all VISN 22 facilities for which Contractor provides laboratory services.

1. The Contractor shall provide specimen pickup and transport services with clearly defined special handling procedures.

2. All requirements and provisions defined in the specifications of this solicitation shall apply to any entity, i.e. branch, division, sub-contractor, etc. performing courier services on behalf of the Contractor.

3. Courier transportation time is inclusive to the required TAT of test result.

4. All report data the Contractor exports and submits to the facility shall be Health

Information Portability and Accountability Act (HIPAA) compliant.

B. DESCRIPTION OF SERVICES

1. Transported items shall be primarily biological substances (patient specimens). These items are classified as Hazard Materials Class 6, Division 6.2 and are defined in 49 CFR

Part 173.134 as those materials that contain or could contain etiologic agents. The

Contractor shall transport microbiology cultures, stocks and regulated medical waste that are also in Division 6.2. Other incidental items (not included in Division 6.2) that may be transported include laboratory testing reagents (of limited size and quantity), patient reports or other paper work.

2. VISN 22 facilities shall be responsible for the processing of biological substances in preparation for transportation. Each VISN 22 facility will provide a shipping manifest minimally detailing the dates and times of receipt and delivery of specimen and the number of specimens transported by temperature category.

3. Contractor shall provide point to point specimen tracking and specimen reconciliation for each individual specimen, such as, barcoding or any other pre-approve method.

C. REQUIREMENTS

1. The Contractor shall provide safe transport of all biological substances. This shall include the proper receipt, distribution, storage and security of patient specimens in accordance with all federal regulations governing the safe transport of these materials including the following, which are incorporated herein by reference:

a. Department of Transportation 49 CFR Parts 171-180 – Hazardous Materials:

Infectious Substances; Harmonization with the United Nations Recommendations, Final Rule.

b. Department of Health and Human Services 42 CFR Parts 72 and 73 – Interstate

Shipment of Etiologic Agents and Select Agents and Toxins

c. Department of Labor/OSHA 29 CFR, Section 1910.1030-Bloodborne Pathogens

d. HIPAA Privacy Rule 45 CFR Parts 160 1nd 164.

2. Contractor shall comply with all state and local regulations that are applicable to the services it provides.

3. The Contractor shall implement procedures that ensure the accountability and integrity of all biological substances from the point of possession to the point of delivery.

4. The Contractor shall ensure that all transport personnel are properly trained and that their competency is regularly assessed in the appropriate safety, packaging and environmental control procedures suitable to specimen type and distances transported.

5. The Contractor shall implement a training program for Contractor personnel that adheres to the regulations for the transport of hazardous materials as cited in 49 CFR 172 Subpart

H, which are incorporated herein by reference, and shall minimally include:

a. Education on the types of biological materials transported including definitions of an infectious substance and a biological product.

b. Education on appropriate hazardous material packaging and labeling to recognize non-compliance.

c. Requirements for the appropriate receipt of the packages including the availability of shipping manifest.

d. The use of appropriate containers to transport specimens between the point of origin to the transport motor vehicle and, likewise, from the transport motor vehicle to the destination point.

e. Appropriate installation, use and security of environmental temperature control devices that maintain ambient, refrigerated, frozen or incubated conditions that insure the integrity of the specimens and avoid loss or breakage of the containers.

f. Identification of specimens requiring environmental temperature control storage.

g. Certified education (hazmat training) on appropriate decontamination and notification procedures in case of accident or spills. This includes the identification and appropriate use of personal protective equipment and the use of mitigation and disinfection products.

h. Education on procedures for hazardous spill communication, i.e. contact telephone numbers.

i. Education on the protection of the privacy and confidentiality of the personally-identifiable information

6. The Contractor shall provide an adequate supply of materials necessary for the efficient, organized and coordinated receipt, transport, and delivery of specimens (e.g. bags, temperature condition stickers, transportation receipt forms, rigid-sided containers, dry ice, coolers, incubators, etc.). Upon request, the Contractor shall provide temperature integrity tracking data.

B.13 SPECIFICATIONS

A. LICENSURES: Contractor shall perform specimen testing only in fully licensed/accredited laboratories actively engaged in providing the specific services and laboratory testing described in this IDIQ contract. The reference laboratory must be licensed/accredited by the College of

American Pathologists (CAP), the Nuclear Regulatory Commission, and Center for Disease

Control, Medicare, as well as any other state regulatory agencies as mandated by federal and state law. In addition, the Laboratory must be certified as meeting the requirements of the Clinical

Laboratory Improvement Act (CLIA) of 1988 and comply with the National Standards to Protect the

Privacy of Personal Health Information in accordance with Health Insurance Portability and

Accountability Account of 1996 (HIPAA) and VA Directives 1106, 1106.01 and 1106.2

For each laboratory used, Contractor shall provide copies of all relevant permits/licenses and certification inclusive of any sanctions current or pending throughout the United States of America.

As these documents are reissued or reworded, the Contractor shall supply a copy to the

Contracting Officer and each VISN 22 facilities. The above documents must also be supplied for each reference laboratory that is a subcontractor of the Contractor.

B. GENERAL TEST INFORMATION: The general test information shall be present on all test.

1. Requisition form requirements

2. Alphabetized test name list

3. Reference lab test number

4. Specimen collection requirements

5. Test method used

6. Test reference intervals

7. Test critical values, if any

8. Policy for critical value notification

9. CPT cod ing

10. LOINC Codes

11. Test TAT (minimum and maximum times indicated); where the TAT is defined as the time between pick-up of specimen by the Contractor and receipt of results by a VISN 22 facility.

12. Frequency of test performance (specific days of week indicated)

13. All associated reflex tests as applicable to the ordered test

B.14 TECHNICAL DATA REQUIREMENTS

A. COMMUNICATION AND INFORMATION SERVICES

The Contractor shall meet all VA Enterprise Cyber Security Infrastructure Project (ECSIP) requirements to establish and maintain an interconnection/interface with the VA. The Contractor shall transfer the laboratory test results directly into the site VA computer system via the Laboratory Electronic Data Interchange (LEDI) protocol utilizing an approved Client-to-Site VPN method to the site VistA Laboratory Package Client-to-

Site VPNs. The Contractor shall comply with VA cyber security and privacy training, background investigations and participate in 2-factor authentication for access to VA networks.

Any equipment provided by the Contractor to VA which contains a storage device such that when the device is powered down, VA sensitive data remains on it, shall become the property of the Federal Government and shall remain on Federal property, or must be destroyed by VA and in accordance with Department of

Veterans Affairs regulations at the time of removal (device decommissioning). The Contractor shall safeguard data required by the Health Insurance Portability and Accountability Account of 1996 (HIPAA) to remain on equipment located on Contractor's property in accordance with HIPAA and the Contractor shall destroy this information in accordance with VA requirements when it is no longer required to be held by the

Contractor per HIPPA regulations. The reference laboratory must meet HIPAA requirements and must be able to interface with the current version of the VistA System.

B. INTERFACE TELECOMMUNICATION REQUIREMENTS

The Contractor shall assume all costs associated with meeting and testing interface requirements with VA systems to ensure that laboratory test results are reported to the Laboratory Information System (LIS)

(VistA).

VistA supports the Universal Interface (UI) and the Generic Interface Manager (GIM). The GIM is a commercial hardware and software product that provides electronic connection between instruments and the

VistA host computer. The Contractor shall provide such an interface system to electronically transmit orders, specimen status and test results between the VA and the Contractor’s system. The transmission protocol shall conform to VistA Health Level Seven (HL7) V1.6 and Laboratory’s HL7 V1.0 technical specifications.

The Contractor shall provide the VA with all necessary laboratory test parameters to ensure accurate test result transmission between the VA and the Contractor’s database. This will occur during post-award meeting(s). Required test parameters include:

1. Ordering code

2. LOINC code

3. CPT code

4. Interface code

5. Test cost

6. Reference ranges

7. Units of measurement

8. Test result interpretation or interpretive remarks, if appropriate

9. Testing site (if not performed at the vendor’s main laboratory facility

10. Test methodology

11. Specimen types

12. Specimen collection and handling requirements

13. Instrument performing test (if more than one instrument)

14. Parameter values for any required calculation or data conversion

If the test is a panel or profile test, list all the tests included (NOTE: above parameters are required for each test contained in a panel, such as test in panels, reflex tests and any appropriate test comment interpretations)

The parameters for all laboratory tests in the Contractor’s database shall be kept current and be available to the VA sites throughout the life of the contract. The Contractor shall provide updates to the test parameter information to VA sites prior to any testing changes in the following situations: when new tests are developed, and introduced into the Contractor’s test menu, testing parameters have changes or when tests are discontinued or replaced by other tests. Contractor shall provide, at a minimum, 2-weeks’ notice prior to the implementation of the test change. The Contractor shall provide information to sites as it becomes available.

The Contractor will push the information the site by electronic notification with annotations of tests that have been ordered by the site in the past. To maintain accurate and timely test information, the Contractor shall provide telephone access to any of the laboratory test parameter information. The Contractor shall provide a plan for providing, implementing and maintaining test information parameters in the VA LIS (VistA) database.

The Contractor shall provide all required hardware, software and related consumable supplies to support the transmission of electronic data.

VistA Laboratory Electronic Data Interchange (LEDI) will provide technical specification for message format, content and encoding tables and HL7 message protocol conventions. The LEDI specification follows very closely the HL7 V2.3.1 standard. LEDI shall provide encoding tables and HL7 message protocol conventions. The LEDI specification can be negotiated at the technical level only. Health Level 7 (HL7) is a registered trademark of Health Level Seven, Inc, and is a Standards Developing Organization accredited by the American National Standards Institute to author consensus-based standards.

Information regarding HL7 transmission protocols may be accessed through the Health Level Seven, Inc web-site: www.HL7.org.

The Contractor shall be responsible for the preventive maintenance and repair of the furnished hardware, software and associated communication lines. In addition, throughout the life of the contract, the

Contractor shall be responsible for the replacement/ upgrade of hardware and software of those items furnished.

1. As needed, Contractor shall provide in-service training for the routine loading and care of printers and other hardware located on-site. The training shall ensure that VA can perform routine servicing of hardware.

2. If used, the Generic Instrument Manager (GIM) shall be in a VA secured area. The

Contractor shall have access to the GIM during normal business hours, any other times require prior arrangements with the facility.

3. The Contractor is responsible for installation and, if necessary, removal of all telecommunication equipment and associated hardware.

http://www.hl7.org/

If a GIM is required, the Contractor shall provide, program and maintain the GIM. The GIM provides the connectivity between the VistA computer host and the Contractor’s host computer. VistA provides a single network communication line to the GIM for passing electronic data. The connectivity between the GIM and the contractor’s host system is of the Contractor’s choosing. The expense of the electronic message connectivity is born by the Contractor and must be approved and assessed per current VA standard defined in VA Handbook 6500 in an approved MOU/ISA.

VistA-side test configuration, conversion and mapping is the responsibility of the VA and individual site

Laboratory Information Managers. Contractor may propose VistA-side configuration, conversion, mapping, testing and validation support for consideration. Contractors wishing this consideration must demonstrate VistA Laboratory Information Package competence in the areas of test configuration, coding, conversion, test mapping and data validation. Contractors working in this capacity must have a current

Client-to-site connectivity Master Account, which requires a minimum NACI Background Investigation.

The Contractor shall provide the following information for any interface order(s) or downtime:

1. Date and time of downtime

2. Systems involved

3. Expected system restoration

4. Scope of impact

5. Cause or Information around scope of downtime and resolution

Contractor shall provide 24/7 interface and electronic order/resulting support for all equipment and software.

C. DATA MANAGEMENT SYSTEM

95% of all laboratory test count shall be provided via VistA interface. All hardware and software needed for the interface shall be provided by the Contractor. The Contractor shall use the manifest and test labels of the collecting laboratory to receive orders and send results via a LEDi HL7 interface with VistA in both single site and multi-divisional facilities. Printed copies of results will also be made available via an in-house printer located at each sending site to confirm interfaced data. Results must also be available electronically via secure web portal.

D. IMPLEMENTATION TIMEFRAME

The implementation/ interface of the services/requirements described within the SOW shall be completed no later than 120 days after the award of the contract. The eight (8) Healthcare Systems are on their own database/ platform and a single build out cannot be accomplished. Failure to provide timely implementation may result in termination of this IDIQ contract.

B.15 SECURITY

A. DATA SECURITY REQUIREMENTS

The Contractor shall be responsible for the security and integrity of specimens and for the compliance of all Health Insurance Portability and Accountability Act (HIPAA) provisions. Additionally, the Contractor shall be afforded access to the VISN 22 VistA and shall be responsible for ensuring the proper credentialing of employees interacting with VISN 22 personnel. Contractor shall adhere to all Information Technology

Security requirements as set forth in VA Handbook 6500.6, which is incorporated herein by reference;

vendor shall adhere to Appendix C and Appendix D and submit proper documentation as required.

B. CONTRACTOR PERSONNEL SECURITY REQUIREMENTS

Contractor shall adhere to the security requirements in the approved MOU/ISA established between the

Contractor and VA.

B.16 GENERAL INFORMATION

A. CONTRACTOR’S PROGRAM MANAGER: The Contractor shall provide a Program Manager who shall be responsible for managing the performance of work. The name of this person shall be designated in writing to the Contracting Officer. The Contractor’s program manager shall have full authority to act for the Contractor on all matters relating to daily operations of this contract.

B. CONTRACTOR EMPLOYEES: The Contractor shall not employ any person for work on this contract if such employee is identified to the Contractor as a potential threat to the health, safety, security, and general well-being of the public.

C. PARKING: It is the responsibility of Contractor personnel to park only in designated parking areas.

Not every VISN 22 facility to be serviced under this IDIQ will have on-site parking available for contractor personnel. The Contractor shall make alternate arrangements for its personnel to park off-site if motor vehicles are required to access those facilities. Parking information is available from the VA Police & Security Service Office. The VA will not invalidate or make reimbursement for parking violations of the Contractor's personnel under any circumstances. The Contractor assumes full responsibility for any parking violations

D. SMOKING: Contractor personnel may smoke only in designated areas. There shall be no smoking within twenty-five (25) feet of all entrances to buildings. Smoking is allowed in all outside areas that are twenty-five (25) feet away from entrances to buildings unless indicated otherwise.

Enclosed patios connected to facility buildings are considered part of the building and as such are non-smoking areas.

E. INVOICING & PAYMENT

The Contractor shall assign an account number to each VISN 22 facility.

The Contractor shall submit a monthly invoice per account number for services rendered following the close of the month in which the test result was reported. The invoice shall be accurate and shall display chronologically by date of receipt by the Contractor the name of the patient, the date of specimen was picked up by the Contractor from the VISN 22 facility, detailed list of the test performed on each patient, and the unit and total testing costs.

The Contractor shall not charge VISN 22 for repetitive testing performed on a specimen to verify questionable initial results.

The Contractor shall submit in arrears a properly completed itemized invoice in accordance with FAR clauses 52.212-4(g) Contract Terms and Conditions – Commercial Items via Tungsten Network:

No advance payments shall be authorized. Payment shall be made monthly for services provided during the billing month in arrears in accordance with FAR 52.212-4, para. (i). Upon submission of a properly prepared invoice for prices stipulated in this contract for services delivered and accepted in accordance with the terms and conditions of the contract, less any deductions stipulated in this contract.

Name:

Address:

Phone No.:

Fax No.:

Email:

Payment of invoices may be delayed if the appropriate invoices as specified in the contract are not completed and submitted as required.

F. REQUIRED REGISTRATIONS: Contractor shall be registered and maintain an active account for the following sites during the duration of the contract.

1. SYSTEM FOR AWARD MANAGEMENT: WWW.SAM.GOV

2. DATA UNIVERSAL NUMBERING SYSTEM (DUNS): In accordance with FAR Provision

52.212-1 paragraph (j), the Contractor shall provide the Dun and Bradstreet number assigned to his/her firm in the space provided below:

DUNS#: - -

B.17 PRICE SCHEDULE

The guaranteed minimum award amount for this contract is $1,000.00. The maximum aggregate value of orders that can be placed under this contract is $50,000,000.00. The Government does not guarantee that it will place any orders under this contract in excess of the guaranteed minimum award amount.

SEE ATTACHMENT A – FEE SCHEDULE

B.18 DELIVERY SCHEDULE

Base Year: October 1, 2018 – September 30, 2019

Option Year 1: October 1, 2019 – September 30, 2020

Option Year 2: October 1, 2020 – September 30, 2021

Option Year 3: October 1, 2021 – September 30, 2022

Option Year 4: October 1, 2022 – September 30, 2023 http://www.sam.gov/

SECTION C - CONTRACT CLAUSES

ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS

Clauses that are incorporated by reference (by Citation Number, Title, and Date), have 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 following clauses are incorporated into 52.212-4 as an addendum to this contract:

C.1 52.216-18 ORDERING (OCT 1995)

(a) Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery orders or task orders by the individuals or activities designated in the Schedule. Such orders may be issued from IDIQ contract award date through expiration of contract.

(b) All delivery orders or task orders are subject to the terms and conditions of this contract. In the event of conflict between a delivery order or task order and this contract, the contract shall control.

(c) If mailed, a delivery order or task order is considered "issued" when the Government deposits the order in the mail. Orders may be issued orally, by facsimile, or by electronic commerce methods only if authorized in the Schedule.

(End of Clause)

C.2 52.216-19 ORDER LIMITATIONS (OCT 1995)

(a) Minimum order. When the Government requires supplies or services covered by this contract in an amount of less than $1, the Government is not obligated to purchase, nor is the Contractor obligated to furnish, those supplies or services under the contract.

(b) Maximum order. The Contractor is not obligated to honor—

(1) Any order for a single item in excess of $1.00

(2) Any order for a combination of items in excess of $50,000,000; or

(3) A series of orders from the same ordering office within 30 days that together call for quantities exceeding the limitation in paragraph (b)(1) or (2) of this section.

(c) If this is a requirements contract (i.e., includes the Requirements clause at subsection 52.216-21 of the

Federal Acquisition Regulation (FAR)), the Government is not required to order a part of any one requirement from the Contractor if that requirement exceeds the maximum-order limitations in paragraph

(b) of this section.

(d) Notwithstanding paragraphs (b) and (c) of this section, the Contractor shall honor any order exceeding the maximum order limitations in paragraph (b), unless that order (or orders) is returned to the ordering office within 1 day after issuance, with written notice stating the Contractor's intent not to ship the item (or items) called for and the reasons. Upon receiving this notice, the Government may acquire the supplies or services from another source.

(End of Clause)

C.3 52.216-22 INDEFINITE QUANTITY (OCT 1995)

(a) This is an indefinite-quantity contract for the supplies or services specified, and effective for the period stated, in the Schedule. The quantities of supplies and services specified in the Schedule are estimates only and are not purchased by this contract.

(b) Delivery or performance shall be made only as authorized by orders issued in accordance with the

Ordering clause. The Contractor shall furnish to the Government, when and if ordered, the supplies or services specified in the Schedule up to and including the quantity designated in the Schedule as the

"maximum." The Government shall order at least the quantity of supplies or services designated in the

Schedule as the "minimum."

(c) Except for any limitations on quantities in the Order Limitations clause or in the Schedule, there is no limit on the number of orders that may be issued. The Government may issue orders requiring delivery to multiple destinations or performance at multiple locations.

(d) Any order issued during the effective period of this contract and not completed within that period shall be completed by the Contractor within the time specified in the order. The contract shall govern the

Contractor's and Government's rights and obligations with respect to that order to the same extent as if the order were completed during the contract's effective period; provided, that the Contractor shall not be required to make any deliveries under this contract after expiration of contract.

(End of Clause)

C.4 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 3 days.

(End of Clause)

C.5 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 1 day;

provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 3 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 five (5) years.

C.6 52.232-19 AVAILABILITY OF FUNDS FOR THE NEXT FISCAL YEAR (APR 1984)

Funds are not presently available for performance under this contract beyond the current fiscal year provided. 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 issuance of the task order provided, until funds are made available to the Contracting Officer for performance and until the Contractor receives notice of availability, to be confirmed in writing by the

Contracting Officer.

(End of Clause)

C.7 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

The Contractor shall not make reference in its commercial advertising to Department of Veterans Affairs contracts in a manner that states or implies the Department of Veterans Affairs approves or endorses the

Contractor’s products or services or considers the Contractor’s products or services superior to other products or services.

(End of Clause)

C.8 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2012)

(a) Definitions. As used in this clause—

(1) Contract financing payment has the meaning given in FAR 32.001.

(2) Designated agency office has the meaning given in 5 CFR 1315.2(m).

(3) Electronic form means an automated system transmitting information electronically according to the

Accepted electronic data transmission methods and formats identified in paragraph (c) of this clause.

Facsimile, email, and scanned documents are not acceptable electronic forms for submission of payment requests.

(4) Invoice payment has the meaning given in FAR 32.001.

(5) Payment request means any request for contract financing payment or invoice payment submitted by the contractor under this contract.

(b) Electronic payment requests. Except as provided in paragraph (e) of this clause, the contractor shall submit payment requests in electronic form. Purchases paid with a Government-wide commercial purchase card are considered to be an electronic transaction for purposes of this rule, and therefore no additional electronic invoice submission is required.

(c) Data transmission. A contractor must ensure that the data transmission method and format are through one of the following:

(1) VA’s Electronic Invoice Presentment and Payment System. (See Web site at http://www.fsc.va.gov/einvoice.asp.)

(2) Any system that conforms to the X12 electronic data interchange (EDI) formats established by the

Accredited Standards Center (ASC) and chartered by the American National Standards Institute (ANSI).

The X12 EDI Web site (http://www.x12.org) includes additional information on EDI 810 and 811 formats.

(d) Invoice requirements. Invoices shall comply with FAR 32.905.

(e) Exceptions. If, based on one of the circumstances below, the contracting officer directs that payment requests be made by mail, the contractor shall submit payment requests by mail through the United States

Postal Service to the designated agency office. Submission of payment requests by mail may be required for:

(1) Awards made to foreign vendors for work performed outside the United States;

(2) Classified contracts or purchases when electronic submission and processing of payment requests could compromise the safeguarding of classified or privacy information;

(3) Contracts awarded by contracting officers in the conduct of emergency operations, such as responses to national emergencies;

(4) Solicitations or contracts in which the designated agency office is a VA entity other than the VA

Financial Services Center in Austin, Texas; or

(5) Solicitations or contracts in which the VA designated agency office does not have electronic invoicing capability as described above.

(End of Clause)

C.9 VAAR 852.237-70 CONTRACTOR RESPONSIBILITIES (APR 1984)

The contractor shall obtain all necessary licenses and/or permits required to perform this work. He/she shall take all reasonable precautions necessary to protect persons and property from injury or damage during the performance of this contract. He/she shall be responsible for any injury to himself/herself, his/her employees, as well as for any damage to personal or public property that occurs during the performance of this contract that is caused by his/her employees fault or negligence, and shall maintain personal liability and property damage insurance having coverage for a limit as required by the laws of the State of which the service is rendered. Further, it is agreed that any negligence of the Government, its officers, agents, servants and employees, shall not be the responsibility of the contractor hereunder with the regard to any claims, loss, damage, injury, and liability resulting there from.

(End of Clause)

C.10 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

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

http://www.acquisition.gov/far/index.html http://www.va.gov/oal/library/vaar/

FAR

Number

Title Date

52.203-17 CONTRACTOR EMPLOYEE WHISTLEBLOWER RIGHTS AND

REQUIREMENT TO INFORM EMPLOYEES OF WHISTLEBLOWER

RIGHTS

APR 2014

52.204-9 PERSONAL IDENTITY VERIFICATION OF CONTRACTOR

PERSONNEL

JAN 2011

52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE

MAINTENANCE

JUL 2016

52.232-18 AVAILABILITY OF FUNDS APR 1984

52.232-40 PROVIDING ACCELERATED PAYMENTS TO SMALL BUSINESS

SUBCONTRACTORS

DEC 2013

52.237-3 CONTINUITY OF SERVICES JAN 1991

(End of Addendum to 52.212-4)

C.11 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES

OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (JAN 2018)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by…