S02 36C25721Q0475-RFQ UTSW.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 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 63

549-21-3-115-0018

36C25721Q0475 03-02-2021

Isela Loveless 210-694-6313 03-11-2021

10:00 CST

Department of Veterans Affairs

VISN17 Network Contracting Activity

7400 Merton Minter Blvd. (10N17/90C)

San Antonio TX 78229

X 100

X

621511

$35 Million

N/A

X

VA North Texas Health Care System

Path and Lab Department

4500 South Lancaster Rd

Dallas TX 75216

7400 Merton Minter Blvd. (10N17/90C)

San Antonio TX 78229

This is accomplished through the

Tungsten Network located at:

http://www.fsc.va.gov/einvoice.asp

This is mandatory and the sole method for submitting invoices.

(877) 353-9791 (512) 460-5540

See CONTINUATION Page

Request for Quote: Laboratory/procedures Testing services

Contractor shall preform laboratory testing services in accordance with the attached statement of work.

Wage determination 2015-5227 & 5228 apply.

Evaluation criteria shall be stated in Section E.

This contract will be an Indefinite Delivery Indefinite

Quantity (IDIQ) type contract.

See CONTINUATION Page

X X

X 1

Isela Loveless

Contracting Officer

36C25721Q0475

Table of Contents

SECTION A

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

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

B.3 DELIVERY SCHEDULE ............................................. Error! Bookmark not defined.

SECTION C - CONTRACT CLAUSES

C.1 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.2 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (JAN 2021)

C.3 52.216-18 ORDERING (AUG 2020)

C.4 52.216-19 ORDER LIMITATIONS (OCT 1995)

C.5 52.216-22 INDEFINITE QUANTITY (OCT 1995)

C.6 VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA

ACQUISITION OF COMMERCIAL ITEMS (APR 2020)

C.7 VAAR 852.219-74 LIMITATIONS ON SUBCONTRACTING—MONITORING AND

COMPLIANCE (JUL 2018)

C.8 VAAR 852.219-75 SUBCONTRACTING COMMITMENTS MONITORING AND

COMPLIANCE (JUL 2018)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.2 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (OCT 2020)

E.3 52.212-2 EVALUATION—COMMERCIAL ITEMS (OCT 2014)

E.4 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL ITEMS (FEB 2021)

E.5 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.6 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION

(OCT 2018)

SECTION B - CONTINUATION OF SF 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 36C257

7400 Merton Minter Blvd. (10N17/90C)

San Antonio TX 78229

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

[X] 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.

This is accomplished through the

Tungsten Network located at:

http://www.fsc.va.gov/einvoice.asp

This is mandatory and the sole method for submitting invoices.

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

AMENDMENT NO DATE

EVALUATION CRITERIA

1. The Government intends to make award without discussions. However, it may be determined necessary to conduct clarifications/discussions if award cannot be made on the initial proposals submitted.

2. Contract award will be made resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following non-price factors are listed in descending order of importance. When combined non-price factors are significantly more important than price.

a. Technical

b. Past Performance

c. Price

3. Offerors are cautioned that the award may not necessarily be made to the lowest Price offered or the most highly rated technical proposal.

FACTOR 1: TECHNICAL CAPABILITY (Minimum Requirements)

a. Provide a written plan detailing your firm’s experience and capability of performing work like what is being required in the Statement of Work.

1. Proof of CLIA Accredited laboratory certification.

2. Link to catalog that includes test menu and turnaround times. Testing must be performed on-site at the laboratory.

3. Professional Staff Curricula Vitae.

4. CAP and/or any other Proficiency Exam Participation and Exception Reports for the past two (2) years.

5. Performance improvement monitor data for the previous 12 months that include and are not limited to demonstration of:

6. Number of lost/damaged specimens

7. Number of cancelled specimens

8. Delays in turnaround times (including but not limited to: due to lack of staffing, lack of availability of reagents, instrumentation issues, etc.),

9. Resolution of complaints

10. Number of corrected reports issued

11. Errors in reporting patient results

12. Courier route delays/cancellations

a. Provide information on how your firm will meet the Limitations on Subcontracting, if applicable.

b. In addition, all Contractors must meet the following background investigation requirements: All users with access to the data received from Department of Veterans Affairs (VA) are U.S. Citizens with a valid Contractor's license and current background Investigation or a mutually agreed upon VA level background clearance verified at the National Agency Check with Inquiries, level for laboratory technical staff and business operations staff. Anyone with administrative or programmer access to a Federal computer system will have a background investigation commensurate with the level of access granted to the VA computer system as determined by the Information Security Officer in concert with Human Resources Management Staff and/or the Department of Veterans Affairs Security & Investigations Center. These staff must be operating within the borders of the U.S.A. and its territories.

c. The reference laboratory shall meet VA information security and HIPAA requirements and shall be able to interface with the current or any new interface partner of the Laboratory Information System. The Contractor shall have all users with VA access complete the VHA Privacy and HIPAA Training and the VA Privacy and Information Security Awareness and Rules prior to starting services.

FACTOR 2: PAST PERFORMANCE

The Contractor shall provide the following documentation with their offer:

1. Two (2) references of current or prior contracts, two (2) governmental, including one federal, who can attest to the duration of overall service and performance and of documentation of successful interfacing. References to include the facility address, telephone number, email address, and contact person’s name who can validate past experience within the last three (3) years.

a) This factor considers the quality of the Offeror’s past performance in carrying out relevant work. Emphasis will be on recent, relevant past performance. Recent is defined as work performed within the last 3 years. Relevant is defined as work similar in size and scope of the work described in the Statement of Work.

b) Provide (2) references of work, similar in scope with contact information, brief description of the work completed, and contract # (if relevant). References will be checked by the Contracting Officer or Contracting Officers Representative to ensure your company can perform the Statement of Work.

c) Provide a list of all agencies/companies/firms with whom the offeror is performing or has performed relevant work within the last 3 years.

d) The following information should be included. (a) Agency/Company name. (b)

Contract Dollar Value. (c) Period of Performance. (d) Name, Address, e-mail address, telephone & fax number of the reference.

e) Past performance information shall also be obtained from other sources available to the Government to include, but not limited to, CPARS (contractor performance retrieval system) or other databases; interviews with Program Managers, and other

Contracting Officers.

2. The contractor must be able to meet all Enterprise Cyber Security Infrastructure Project

(ECSIP) requirements to establish interconnection with the VA Vista and CPRS systems via the appropriate Laboratory Electronic Data Interchange Protocol.

3. In the case of an offeror without a record of relevant past performance or for whom information on past performance is not available, the offeror may not be evaluated favorably or unfavorably on past performance.

FACTOR 3: PRICE

In this factor, price will be evaluated for reasonableness by comparing the proposed prices with the Independent Government Estimate and prices posed by other offerors.

The techniques and procedures described under FAR 12.209, Determination of Price reasonableness, will be the primary means of assessing proposal reasonableness.

Provide prices on all line item listed on the Price/Cost Schedule and schedule can be altered to ensure a clear and concise quote is received. This is for a 5 year ordering period.

STATEMENT OF WORK

PRICES/COSTS

The purpose of this contract is to provide quality laboratory services to veteran patients.

Contractor is to provide healthcare resources in accordance with Public Law 104.262 and 38

U.S.C. 8153. Contractor agrees to provide the following laboratory procedures/tests and services in support of the VA North Texas Health Care System (VANTHCS) in Dallas, Texas.

Pricing includes all labor, materials, equipment and supplies necessary to perform certain human laboratory procedures/tests.

Contractor shall perform and provide results for, but not limited to, the following specialized procedures and tests. Additional tests may be added or removed as needed during contract period as required.

A. Clinical Test Menu:

SPECIALTY/TEST NAME

CPT

code

Test QTY

(annual estimate)

MOLECULAR DIAGNOSTICS

T CELL RECEPTOR, GENE GAMMA REARR 81342 12

FACTOR V LEIDEN MUT 81421 112

Factor II 20210A 81240 31

CMV PCR 87497 59

FLOW CYTOMETRY

FLOW CYTOMERY STUDIES TOTAL 88184,88185,88187,88188,88189 40

• BLOOD, PNH

• BONE MARROW

• TISSUE

• FLUID

CYTOGENETICS/CHROMOSOMES/CANCER

CHROMOSOME ANALYSIS 88237,88262,88291 etc. 155

FISH PROBE 88271,88275,88291 etc. 270

ELECTRON MICROSCOPY

Electron Microscopy: Embed only 88348-52 10

Electron Microscopy: Complete 88348 10

IMMUNOHISTOCHEMISTRY

Immunohistochemistry - IHC 88342 500

HISTOCOMPATABILITY

HLA I & II TYPING 81370,81376 5

HLA II TYPING 81370,81376 5

HEMOSTASIS

PLATELET AGGREGATION 85576,85396 5

FACTOR VIII Activity 85240 20

HEPARIN INDUCED THROMBOCYTOPENIA 86022 (2), 85390 62

LUPUS ANTICOAGULANT 207

CHEMISTRY/IMMUNOCHEMISTRY

METHOTREXATE 80299 10

SIROLIMUS, STAT 80195 130

CYCLOSPORINE, STAT 80158 85

URINE STONE PROFILE 82507,82140,82340,83735 etc. 320

VIROLOGY/SPECIALTY MICROBIOLOGY/IMMUNOLOGY

MYCOPLASMA TESTING 87109 2

CMV PCR BF Quant 87497 36

CMV PCR Bone Marrow Quant 87497 1

WORK STATEMENT

1. Contractor shall provide laboratory services to the Pathology & Laboratory Medicine

Service of the VA North Texas Health Care System, Department of Veterans Affairs Medical

Center, located at 4500 S. Lancaster Road, Dallas, Texas. Tests will be performed as prescribed by the VA attending physician.

2. Specimens submitted are human blood, body fluids, and tissue for diagnostic testing.

Results are to be accessible through the contractor’s electronic database by P&LMS personnel.

3. Contractor shall provide analysis and reporting of analytic results, and consultation regarding specimen selection, collection, and result interpretation.

4. No courier service is required in this acquisition.

5. Contractor will supply specialized test kits and collection containers as indicated.

Supplies will be delivered at no charge at the request of P&LMS personnel and/or through vendor’s automated inventory system.

6. Contractor shall provide the following services:

• Pathology consultative services for surgical pathology and cytopathology available 24/7.

Pathology staff must be available to VHANTHCS pathologists and clinicians for consultation

24/7. Contractor shall provide on-call schedules (hard copy and electronic copy) and update when appropriate.

• On-call afterhours (weekend) STAT access for hematopathology and flow cytometry for new leukemia cases.

• STAT access to on-call pathologist and histology for Rule/Out transplant rejection cases.

7. Contract shall be a IDIQ type contract.

8. The test and/or volumes listed are independent government estimates and VANTHCS makes no guarantee as to what tests or volume of tests, if any, the contractor may receive.

VANTHCS reserves the right to request additional tests other than those listed within. If additional tests are added, either by the contractor or VANTHCS, the contractor will provide appropriate CPT and LOINC codes, pricing, and sample reports for the new tests. Contractor shall provide to the methodology and ranges for results on any tests that are requested by representatives of VANTHCS.

9. The contractor shall ensure that time sensitive specimens are tested within acceptable timeframes for optimal testing. Time sensitive specimens/testing include, but is not limited to the following:

TIME-SENSITIVE SPECIMENS <1 HOUR TRANSIT

TIME FROM COLLECTION TO PERFORMING SITE

PLATELET AGGREGATION

TIME-SENSITIVE SPECIMENS <2 HOUR TRANSIT

TIME FROM COLLECTION TO PERFORMING SITE

BONE MARROW

MUSCLE BIOPSY

MUSCLE/NERVE BX, HISTOCHEM

NERVE BX/ADDNL DET ENZ HISTOCHEM

SLIDE CONSULT

NERVE BX, TEASED FIBER PREP

MUSCLE/NERVE BX, HISTOCHEM

LYMPH NODE TISSUE

TIME SENSITIVE TESTING < 24 HOUR TRANSIT

TIME FROM COLLECTION TO PERFORMING SITE

FLOW CYTOMETRY

CYTOGENETICS

TRANSPLANT LIVER

SIROLIMUS

CYCLOSPORINE

10. All lab results shall be ordered and reported electronically through the contractor’s secured on-line website and pushed to VistA through Data Innovations or LEDI.

11. If the contractor’s test menu differs from that of the current VistA test menu, the contractor shall provide staff dedicated to conduct the initial build of tests into the VistA test database for tests performed at the reference lab and tests sub-contracted by the reference lab.

12. The Contractor shall furnish a schedule to show a customizable implementation plan of the required services (telecommunications, interface connectivity and validation, client service support, ordering, supplies, specimen processing services, reporting, quality assurance, billing, etc.).

13. These procedures/tests shall be performed to the satisfaction of Quality Assurance

Surveillance Plan (QASP) outlined in this document. Services rendered will be verified by a record keeping system maintained by Pathology & Laboratory Medicine Service and Fiscal

Service at VANTHCS, which assures that the VA pays for only those services requested, and only for valid patients of VANTHCS.

14. Security Requirements: VA Protected Health Information is provided to the vendor under this contract. This contract is to enable a HIPAA Covered Entity to provide clinical services on behalf of VA. A patient’s consent is not required (1605.1P24). The vendor is required to secure the PHI as required by HIPAA.

REQUIREMENTS/SPECIFICATIONS

1. If the contractor’s test menu differs from that of the current VistA test menu, the contractor shall provide staff dedicated to conduct the initial build of tests into the VistA test database for tests performed at the reference lab and tests sub-contracted by the reference lab.

A VistA test file includes specimen collection and processing information, reference lab test code, CPT and LOINC codes, price, result template and other pertinent information specific to the test (ex. standard comments, ASR comments, etc.). Test files contain one test per file. VistA does not allow batch entries for test builds.

A. Interfacing requirements to be provided by the vendor:

Brief Summary of VistA Functionality - VistA is a public domain system to the VA whose functionality includes:

• Management of patient information through a database,

• Acceptance of test ordering information,

• Transmittal of patient laboratory test results.

• Storage and retrieval of patient laboratory test results.

(Note: VistA is very limited in its functionality to manage laboratory quality control, provide Levy-

Jennings plots or administer an instrument maintenance program.)

2. ORDERING AND REPORTING OF LAB REPORTS RESULTS: All lab results shall be ordered and reported electronically through the contractor’s secured on-line website and pushed to VistA through Data Innovations or LEDI. If electronic retrieval of lab reports is unavailable for an extended period, results may be sent by secured fax and retransmitted electronically when the issue is resolved. Test reports that cannot be transmitted to VistA, such as those that contain graphs, symbols, or colors that are integral to the result shall be available via the vendor’s website for download.

3. ELECTRONIC SECURITY: The Contractor shall meet all Enterprise Cyber Security

Infrastructure Project (ECSIP) requirements to establish an interconnection with the VA for transfer of laboratory test results directly into a VA computer system via the appropriate

Laboratory Electronic Data Interchange protocol. There are three basic types of authorized connections. The ECSIP team will have the ultimate decision on which connection type is appropriate. The connection types are described below. More information can be obtained from the VA Information Security Officer at any facility or directly from the ECSIP team.

A. External users shall be classified in one of three distinct categories: 1) client-to-site VPN,

2) site to-site VPN, or 3) Business Partner Gateways. Table 1 can be utilized in assisting users to determine which category a connection may best be identified.

1) Client-to-Site VPNs satisfy remote connectivity for small groups of external users (IE

<50) that require access to VA internal resources. Non- VA users are restricted to specific internal IP addresses identified by the Contracting Officer Representative (COR). External business partners should have access to the minimum resources required to meet contractual obligations.

2) Site-to-Site VPNs are connections to external business partners, which terminate in an

ECSIP gateway. These connections will then be routed across the VA WAN to the requisite VA facility resources as defined by firewall policy.

3) Business Partner Gateways (BPGs) are connections to external business partners, which terminate at the requisite VA facility and do not traverse the VA WAN. These connections will be limited in number based on CIO requirement definitions.

Table 1:

VistA Connectivity Requirement Client-to-

Site VPN

Site-to-

Site VPN

Business

Partner

Gateway

Small Number of Users- If the number of user accounts the ISO must administer is manageable. A client-to-site connection will usually suffice.

X

Numerous Users - Having a significant number of client-to-site user accounts to manage may justify a site-to-site VPN.

X

Persistent Connection Required - The need to maintain continuous connectivity can usually be supported with a site- to-site VPN.

X X

High Bandwidth- A large volume of traffic may be a valid need to establish or maintain a Business Partner Gateway (BPG) connection (0 prevent certain traffic from traversing the VA WAN. As an example, a medical teaching University supported by a VA Hospital that sends large radiological images on a regular basis. This could have a detrimental impact on the VA WAN if that traffic traverses the WAN through a VPN connection.

X

Service Level Agreements- SLAs that guarantee specific levels of support to contracted agencies that could not be provided using a One-VA VPN may also justify a BPG connection.

X

High Availability- Availability of critical business processes, such as financial and medical applications, may justify maintaining a BPG to minimize the risk of financial and personal health data loss.

X

Sensitive Information- Every effort should be made to protect sensitive information. Although protection mechanisms are in place, there are still risks associated with transmitting sensitive data across any network, to include the VA WAN. Although the One-VA VPN satisfies this requirement, the sensitivity of the data may be such that additional precautions are warranted.

Server-to-Server Connections - In most cases, a site-to-site VPN can be used to support external server connections.

B. 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 be sanitized prior to removal from the VA premises, shall become the property of the Federal Government, and remain on Federal property or shall be destroyed in accordance with Department of Veterans

Affairs regulations at the time of removal (device decommissioning). Data required by the Health

Insurance Portability and Accountability Account of 1996 (HIPAA) to remain on equipment located on Contractor's property shall be safeguarded in accordance with HIPAA and this information shall be destroyed in accordance with VA requirements when no longer required by

HIPAA to be held by the contractor.

1) Equipment shall be able to store and retransmit records (24 hours of maximal instrument throughput) in case of interface downtime.

2) The reference laboratory shall meet VA information security and HIPPA requirements and shall be able to interface with the current or any new interface partner of the Laboratory

Information System.

3) The Contractor shall have all users with VA access complete the VHA Privacy and

HIPAA Training and the VA Privacy and Information Security Awareness and Rules prior to starting services.

4) The Contractor shall notify the facility Privacy Officer immediately with the list of patient names if any breach of computer security or privacy incident is accessed.

C. The Contractor shall provide the following interfacing requirements:

1) LIS physical connection and translation (drivers)

2) Any required (additional) interface connection license(s)

3) Web-based electronic ordering and resulting

4) Provide documentation of successful interfacing with a minimum of 2 references including 1 federal agency, state or local government agency/institution and 1 private sector.

References to include the facility address, telephone number, email address, and contact person’s name which can validate past experience within the last two (2) years.

5) Interface shall transmit test results to the host computer via automatic upload.

6) Automatic printing of laboratory results to a dedicated reference lab printer, supplied by the reference lab.

4. LAB REPORTS: All lab reports shall contain at a minimum the following information:

• Patient's full name

• Patient’s identification number

• Patient’s Date of Birth

• Physician's name (if supplied)

• Patient's location (clinic/ward) (if supplied)

• Test ordered

• Date/time of specimen collection

• Date/time test completed

• Test result

• Reference intervals

• Toxic and therapeutic ranges, if applicable

• Flagged abnormal test results

• Reference laboratory specimen number

• Name of testing laboratory

• Any other information the laboratory has that may indicate a questionable validity of test results

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

A. Notification of a test result that has been identified in the commercial reference

Contractor laboratory as a critical or alert value shall be communicated by telephone to

VANTHCS upon verification of the critical or alert test result. A hard copy result must follow any telephonic reporting either by fax or computer-generated report.

B. Contractor shall provide daily, a report listing all delayed results and an updated completion estimate.

C. The Contractor shall state their policy and any associated fees for repeat testing if requested by the provider.

5. TURNAROUND TIMES: The Contractor shall provide timely (defined by the minimum and maximum) turnaround times detailed in the description of requirements and appropriate testing of patient specimens as requested by VANTHCS.

The status and the results of testing are available within published timeframes and easily retrievable by the use of varying options. Examples of these options are through a patient search, a sort by timeframe, a sort by test, a sort of incomplete tests, etc. Incomplete tests shall have an indication of the pending time until completion. Alert messages are generated when testing is delayed beyond published timeframes, when specimens require additional testing

(reflex), or when specimens are cancelled due to unacceptability.

Test results shall be received within 24 hours following specimen pick-up either by electronic report transmission (or by hard copy in the event of downtime). It is recognized that certain test procedures will require a longer turn-around time than the 24 hours. The Contractor shall provide a list of the estimated turn-around time for any tests that require longer than 24 hours to complete.

Contractor shall provide daily, by 12:00 PM, a report listing all incomplete specimens and their processing status.

Reports of test results shall be immediately available upon verification of the test result. The computer must be able to print test results upon request and reprint retrospective test results according to a defined timeframe.

6. TEST SELECTION AND CHANGES: VANTHCS reserves the right to select other testing methodologies than offered by the Contractor's laboratory for appropriate reasons, i.e. better clinical quality, research studies or those determined for performance at VANTHCS centers of excellence. The contractor shall identify in advance any test code, methodology and/or sample requirement changes for tests that are ordered specifically by VANTHCS. The contractor shall provide CPT and LOINC codes and pricing changes when applicable. Sample test reports for the new or changed test shall be made available to VANTHCS staff within 48 hours of the request.

7. SPECIMEN IDENTIFICATION: VANTHCS will provide laboratory specimens properly collected identified with both the Patient’s Identification (as utilized by each facility) and requested tests.

8. CUSTOMER SUPPORT: Telephone inquiries are divided into four major categories with additional subcategories defining the type of inquiry and the VA minimum time expectation for meeting this service:

A. Specimen Collection

1) Routine inquiries where the reference laboratory performs the actual testing - if further clarification on the collection requirements are needed, shall be addressed at the time of the inquiry.

2) Esoteric inquiries, where the information on the availability and/or requirements of the questioned test requires further research, shall be addressed within ½ hour of the initial inquiry.

B. Testing

1) Status of Ordered Testing - inquiries regarding the status of pending orders shall be addressed at the time of the inquiry.

2) Esoteric inquiries where information is requested regarding methodology, correlation, interferences, reflex tests, etc. shall be addressed within two (2) hours of the initial inquiry.

C. Technical Expertise

1) Test utilization inquiries where information is required as to the most appropriate test to be ordered shall be addressed within two (2) hours of initial inquiry.

2) Result interpretation inquiries shall be addressed within four (4) hours of initial inquiry.

3) Consultative services where information is required regarding the clinical significance of test or inquiries by the provider into what is the best test to order for more effective patient care shall be addressed within twenty-four (24) hours of the initial inquiry.

4) The contractor must also include names and telephone numbers of technical directors and pathologists available for consultation.

D. Account Follow-up

1) Account follow-up that requires information general in nature yet specific to the account, e.g. test pricing, specimen results discrepancy issues, equipment repair, supply ordering, etc.

shall be addressed within four (4) hours of the initial inquiry.

2) Computer interface questions where information is required to update, maintain, and support the services of the host-to-host linkage between the VA and the Contractor shall be addressed within two (2) hours of the initial inquiry.

9. TEST CONTRACTOR POINT OF CONTACT: Contractor shall assign a specific account representative. Contractor shall provide the following point (s) of contact for immediate inquiries:

• Person (s) name (s): ____________________________________________________

• Telephone number: ____________________________________________________

• Fax number: _________________________________________________________

10. LICENSING AND ACCREDITATION: Contractor shall be licensed, accredited, and inspected by the Laboratory Accreditation Program (LAP) of an accrediting agency [i.e.

Commission of Laboratory Accreditation (COLA), College of American Pathologists (CAP)] with deemed status from the Center for Medicare and Medicaid Services (CMS), the Nuclear

Regulatory Commission, Center for Disease Control, Medicare and/or other state regulatory agencies as mandated by federal and state statutes. In addition, the reference laboratory shall be certified as meeting the requirements of the Clinical Laboratory Improvement Act of 1988 and comply with the National Standards to Protect the Privacy of Personal Health Information

(HIPPA).

A. Laboratory Director shall be a licensed pathologist, physician, or biologist.

B. Copies of all relevant permits, licenses and certification of the Contractor shall be supplied in response to this solicitation. In addition, as these documents for the Contractor are reissued for accreditation, reworded, or renewed the awarded Contractor shall supply a copy to

VANTHCS annually.

11. CONTINUITY OF SERVICES: The Contractor recognizes that the services under this contract are vital to the Government and must be continued without interruption and that, upon contract expiration, a successor, either the Government or another contractor, may continue them. The Contractor agrees to (1) furnish phase-in training and (2) exercise its best efforts and cooperation to affect an orderly and efficient transition to a successor.

12. QUALITY ASSURANCE SURVEILLANCE PLAN (QASP): By the end of each month following the end of the quarter, the contractor shall provide to the Laboratory Manager and

COR a cumulative (year-to-date) summary report by test. The report shall include at minimum the following by month:

• Number of tests performed

• Number of test rejections with reason for rejection

• TAT for each test order during that quarter

• The top 20 tests performed for VANTHCS by month each quarter.

• Monthly summary sheet by dollar volume for each test in descending order of dollar volume with volume of tests ordered, unit charge for each test, total charges for each month and year to date.

A. Contractor shall provide the following information annually during the life of the contract:

1) Indication of average monthly volume of specified tests listed in this contract.

2) Provide address of processing sites under contract.

3) Proficiency testing data shall include a list of tests outside of the -+2SD range for the past two (2) years.

B. Contractor agrees to maintain the satisfactory service, reporting systems and quality control as specified herein. Acceptable performance will be determined annually by the criteria listed below.

Scoring – Average score value per category:

• Exceptional – 4

• Very Good – 3

• Satisfactory – 2

• Marginal – 1

• Unsatisfactory <1

Standard Task ID

(CPARS) Indicator Acceptable Quality Level Method of Surveillance

Incentive

Minimal unsuccessful performance due to instrument or reagent issues. Quality Assurance

1.1 Successful peer group comparison 90% satisfactory performance to peer group.

Exceptional: 100%

Very Good: 95-99%

Satisfactory: 90-94%

Marginal: 85-89%

Unsatisfactory: <85% • CAP survey reports Exercise of Option Period

Result delays are minimal. 1.2 Turnaround time 90% within established turnaround time annually.

Exceptional: 100%

Very Good: 95-99%

Satisfactory: 90-94%

Marginal: 85-89%

Unsatisfactory: <85% • Problem records

Standard Task ID

(CPARS)

Indicator Acceptable Quality

Level

Method of Surveillance Incentive

Minimal unsuccessful performance due to instrument or reagent issues.

Quality

Assurance

1.1 Successful

peer group comparison

90% satisfactory performance to peer group.

Satisfactory: 90-94%

Marginal: 85-89%

Unsatisfactory: <85%

• CAP survey reports Exercise of

Option Period

Result delays are minimal.

1.2 Turnaround

time

90% within established turnaround time annually.

Satisfactory: 90-94%

• Problem records

• Sendout records

• TAT reports

Marginal: 85-89%

Unsatisfactory: <85%

Telephone

Support is responsive.

1.3 Telephone

inquiries

100% Issues resolved

Exceptional: 100%

Very Good: 98-99%

Satisfactory: 95-97%

Marginal: 85-89%

Unsatisfactory: <85%

• Problem records Exercise of

Option Period

Corrected reports are minimal.

1.4 Quality

reporting

0 corrected reports per quarter.

Very Good: 98-99%

Satisfactory: 95-97%

Marginal: 85-89%

Unsatisfactory: <85%

• Report review

• Problem records

Exercise of

Option Period

Specimen integrity is maintained.

1.5 Quality

monitoring

0 specimen rejections due to transportation or laboratory issues

• Problem records Exercise of

Option Period

Invoices are submitted monthly.

Cost Control

3.1 Invoice

Accountability

100% Invoices received through OLCS via

Austin, Texas

• Invoice records Exercise of

Option Period

Invoices are itemized by service or product received.

3.2 Invoice

Verification

80% Invoices contain all necessary information for proper processing.

Excellent: 95-100%

Very Good: 90-94%

Satisfactory: 85-89%

Marginal: 80-84%

Unsatisfactory: <80%

• Invoice records Exercise of

Option Period

Contractor will provide proactive notification of changes.

3.3 Notification of

significant changes in reagent and equipment modifications

100% Proactive notifications.

• Quality Bulletins

• Customer Letters

• Customer Contact

Exercise of

Option Period

Timely recall notification of reagent and supplies.

3.4 Recall

Notification

100% Recall notifications within 1 month of issuance.

• Quality Bulletins

• Customer Letters

• Customer Contact

Exercise of

Option Period

Works with customer to resolve complaints.

Customer

Satisfaction

7.1 Substantiated

complaints

No unresolved substantiated customer complaints per year

• Order records

• Invoice records

• Customer communications

• Problem records

• Troubleshooting records

Exercise of

Option Period

Timely follow-up on complaints.

7.2 Complaint

Handling

90% Complaint follow-up within 24 hours of initial complaint or within agreed upon timeframe.

Satisfactory: 90-94%

Marginal: 85-89%

Unsatisfactory: <85%

• Order records

• Invoice records

• Customer communications

• Problem records

• Troubleshooting records

Exercise of

Option Period

C. The Government may evaluate the quality of the professional and administrative services provided but retains no control over the medical professional aspects of services rendered (e.g. professional judgments, diagnosis for specific medical treatment).

13. CANCELLATION: The government may terminate this contract at any time upon at least

30 days written notice by the contracting officer to the contractor. The contractor, with written consent of the contracting officer, may terminate this contract upon at least 30 days written notice to the contracting officer.

14. INVOICING: Invoices must contain at a minimum the following information. Contractor shall provide this information on one original invoice:

A) Invoice number

B) Contract number

C) Proper CPT and LOINC Code

D) Unit Cost

E) Total Cost

F) Date of Service

15. GOVERNING LAW: This contract shall be governed, construed and enforced in accordance with Federal Law.

16. MARKETING: Contractor shall not advertise or use any marketing material, logos, trade names, service marks, or other material belonging to the VANTHCS without the VANTHCS’ consent.

17. ORDER OF PRECEDENCE: The terms, conditions, and attachments referenced herein, including any formal written modifications thereto, constitute the complete agreement between the parties and take precedence over any other language, oral or written.

18. RECORDS MANAGEMENT: All records (administrative and program specific) created during the period of the contract belong to VA North Texas Health Care System (VANTHCS) and must be returned to VANTHCS at the end of the contract.

19. DEFINITIONS:

LAB ADVISORY COMMITTEE: An individual or group of laboratory directors (Chiefs) or their designees that evaluate the medical/technical/service/quality qualifications of offerors labs.

During the life of the contract, this group monitors the quality and service provided by the contractor.

SPECIAL HANDLING: Unusual circumstances may dictate the need for a specimen to be picked up specially, run out of sequence or at a special time, or reported within a shorter than usual time.

CONTRACTING OFFICER: The Contracting Officer (CO) named below is responsible for the overall administration of this contract. Contractor is advised that only the Contracting Officer, acting within the scope of his/her duties and responsibilities, has the authority to make changes to the contract, which affect contract prices, terms and conditions of this contract:

VA North Texas Health Care System

Contracting Officer 90C

4500 S. Lancaster Road

Dallas, Texas 75216

CONTRACTING OFFICER TECHNICAL REPRESENTATIVE: A Technical Representative of the Contracting Officer (COTR) will be designated to represent the Contracting Officer in furnishing technical guidance and advice under this contract. The foregoing is not to be construed as authorization to interpret or furnish advice and information to Contractor relative to the financial or legal aspects of the contract. Those matters are the responsibility of the

Contracting Officer and shall not be delegated.

TEST REPORT OR TEST RESULT: A test report (test result) is defined as a printed final copy of the laboratory testing results or host-to-host electronic transmission of test results. This report as defined by the individual facility shall be received by either: computer interface, fax, and /or messenger delivery. Specifications outlining the requirements of this computer interface including computer hardware, maintenance and supply requirements are defined in the

Telecommunication Requirements section of this solicitation.

NARA RM Language Clause to be included in contracts, as necessary:

1. Citations to pertinent laws, codes and regulations such as 44 U.S.C Chapter 21 , 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR

Part 1222 and Part 1228.

2. Contractor shall treat all deliverables under the contract as the property of the U.S.

Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

3. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government ‘IT’ equipment and/or Government records.

4. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the

Freedom of Information Act.

5. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract or identified in the RCS 10-

1.

6. The Government Agency owns the rights to all data/records produced as part of this contract.

7. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

8. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy

Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.].

9. No disposition of documents will be allowed without the prior written consent of the

Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.

10. Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under or relating to this contract. The Contractor (and any sub-contractor) is required to abide by Government and

Agency guidance for protecting sensitive and proprietary information.

References:

VHA Directive 6300

VA Handbook 6300.1

North Texas VA Medical Center Policy

VA Directive 6500

36 CFR Part 1222.32 (b)

This is a Single Award, Firm-Fixed Price, Indefinite Delivery Indefinite Quantity (IDIQ)

Contract.

The guaranteed minimum award amount for this contract is $1000.00. The maximum aggregate value of orders that can be placed under this contract is $4,000,000.00. The

Government does not guarantee that it will place any orders under this contract in excess of the guaranteed minimum award amount.

Ordering Period: POP Begin: 04/01/2021 POP End: 03/31/2026

DELIVERY – Dallas VA Veterans Health Care System.

Dallas VA Medical Center

Dallas VA Medical Center

4500 S. Lancaster Rd.

Dallas, Texas 75216

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBE

R

DESCRIPTION OF

SUPPLIES/SERVIC

ES QUANTITY UNIT UNIT PRICE AMOUNT

5.00 YR _____________ ________________

Provide & send out reference laboratory testing not performed in-house at VANTHCS' Pathology & Laboratory Medicine Service. Contractor will provide all labor, supplies, equipment, insurance, and supervision to provide the items. Items are to be ordered on an as needed basis exact quantities of each item cannot be determined in advance as they are based upon physician's orders.

POP Begin: 04-01-2021 POP End: 03-31-2026

GRAND TOTAL ________________

SECTION C - CONTRACT CLAUSES

C.1 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/

(End of Clause)

FAR

Number

Title Date

52.203-16 PREVENTING PERSONAL CONFLICTS OF INTEREST JUN 2020

52.203-17 CONTRACTOR EMPLOYEE WHISTLEBLOWER RIGHTS

AND REQUIREMENT TO INFORM EMPLOYEES OF

WHISTLEBLOWER RIGHTS

JUN 2020

52.204-4 PRINTED OR COPIED DOUBLE-SIDED ON

POSTCONSUMER FIBER CONTENT PAPER

MAY 2011

52.204-13 SYSTEM FOR AWARD MANAGEMENT MAINTENANCE OCT 2018

52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE

MAINTENANCE

AUG 2020

52.204-21 BASIC SAFEGUARDING OF COVERED CONTRACTOR

INFORMATION SYSTEMS

JUN 2016

52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL

ITEMS

OCT 2018

52.232-40 PROVIDING ACCELERATED PAYMENTS TO SMALL

BUSINESS SUBCONTRACTORS

DEC 2013

52.237-3 CONTINUITY OF SERVICES JAN 1991

C.2 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO

IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS

(JAN 2021)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or

Executive orders applicable to acquisitions of commercial items:

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or

Statements (JAN 2017) (section 743 of Division E, Title VII, of the Consolidated and Further

Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2) 52.204–23, Prohibition on Contracting for Hardware, Software, and Services Developed or

Provided by Kaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L.

115–91).

(3) 52.204–25, Prohibition on Contracting for Certain Telecommunications and Video

Surveillance Services or Equipment. (AUG 2020) (Section 889(a)(1)(A) of Pub. L. 115–232).

(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (NOV 2015).

(5) 52.233-3, Protest After Award (Aug 1996) (31 U.S.C. 3553).

(6) 52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004) (Public Laws 108-77 and 108-78 (19 U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting

Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

[X] (1) 52.203–6, Restrictions on Subcontractor Sales to the Government (JUN 2020), with

Alternate I (OCT 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402).

[] (2) 52.203–13, Contractor Code of Business Ethics and Conduct (JUN 2020) (41 U.S.C.

3509).

[] (3) 52.203–15, Whistleblower Protections under the American Recovery and Reinvestment

Act of 2009 (JUN 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the

American Recovery and Reinvestment Act of 2009.)

[X] (4) 52.204–10, Reporting Executive Compensation and First-Tier Subcontract Awards

(JUN 2020) (Pub. L. 109–282) (31 U.S.C. 6101 note).

[] (5) [Reserved]

[X] (6) 52.204–14, Service Contract Reporting Requirements (OCT 2016) (Pub. L. 111–117, section 743 of Div. C).

[] (7) 52.204–15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts

(OCT 2016) (Pub. L. 111–117, section 743 of Div. C).

[X] (8) 52.209–6, Protecting the Government’s Interest When Subcontracting with

Contractors Debarred, Suspended, or Proposed for Debarment. (JUN 2020) (31 U.S.C. 6101 note).

[X] (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters

(Oct 2018) (41 U.S.C. 2313).

[] (10) [Reserved]

[] (11)(i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (MAR 2020) (15

U.S.C. 657a).

[] (ii) Alternate I (MAR 2020) of 52.219-3.

[] (12)(i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business

Concerns (MAR 2020) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

[] (ii) Alternate I (MAR 2020) of 52.219-4.

[] (13) [Reserved]

[X] (14)(i) 52.219-6, Notice of Total Small Business Set-Aside (NOV 2020) (15 U.S.C. 644).

[] (ii) Alternate I (MAR 2020) of 52.219-6.

[] (15)(i) 52.219-7, Notice of Partial Small Business Set-Aside (NOV 2020) (15 U.S.C. 644).

[] (ii) Alternate I (MAR 2020) of 52.219-7.

[X] (16) 52.219-8, Utilization of Small Business Concerns (Oct 2018) (15 U.S.C. 637(d)(2) and (3)).

[] (17)(i) 52.219–9, Small Business Subcontracting Plan…