RFP 36C25722R0060.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. UEI: EFT:

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. NOV 2021)

PREVIOUS EDITION IS NOT USABLE Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

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

36C25722R0060 10-05-2022

Delphia Schoenfeld 210-694-6310 11-18-2022

15:00 EST

36C257

Department Of Veterans Affairs

Network Contracting Office 17

5441 Babcock Road Ste. 302

San Antonio TX 78240

X

621511

$35 Million

N/A

Department of Veterans Affairs

South Texas Veterans Healthcare System

Laboratory

7400 Merton Minter Blvd.

San Antonio TX 78229-4401

36C257

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

This solicitation is for Specialized Reference Laboratory

Services for the South Texas Veterans Healthcare System.

See Continuation Pages for more information.

See CONTINUATION Page

X X

X 1

36C25722R0060

Table of Contents

SECTION A

A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 STATEMENT OF WORK

B.3 SCHEDULE

B.4 DELIVERY

SECTION C - CONTRACT CLAUSES

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

C.2 52.237-3 CONTINUITY OF SERVICES (JAN 1991)

C.3 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE

ORDERS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (MAY 2022) (JUL 2020) (DEVIATION) .. 25

C.4 52.216-18 ORDERING (AUG 2020)

C.5 52.216-19 ORDER LIMITATIONS (OCT 1995)

C.6 52.216-22 INDEFINITE QUANTITY (OCT 1995)

C.7 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.8 52.222-49 SERVICE CONTRACT LABOR STANDARDS—PLACE OF PERFORMANCE UNKNOWN (MAY

2014)

C.9 VAAR 852.211-72 TECHNICAL INDUSTRY STANDARDS (NOV 2018)

C.10 VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA ACQUISITION OF COMMERCIAL

ITEMS (APR 2020)

C.11 VAAR 852.219-71 VA MENTOR-PROTÉGÉ PROGRAM (DEC 2009)

C.12 VAAR 852.219-76 SUBCONTRACTING PLANS MONITORING AND COMPLIANCE (JUL 2018)

C.13 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020)

C.14 MANDATORY WRITTEN DISCLOSURES

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

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

INSTRUCTIONS TO OFFERORS

E.2 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO

SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.3 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

E.4 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2021)

E.5 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (MAY 2022) (JUL 2020) (DEVIATION)

E.6 52.216-1 TYPE OF CONTRACT (APR 1984)

E.7 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.8 VAAR 852.215-72 NOTICE OF INTENT TO RE-SOLICIT (OCT 2019)

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

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.

This is accomplished through the

Tungsten Network located at: http://fsc.va.gov/einvoice.asp ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

AMENDMENT NO DATE

B.2 STATEMENT OF WORK

BACKGROUND: The purpose of the resulting contract will be to provide a Blanket Purchase Agreement for

Specialized Laboratory Fee Basis Testing for the South Texas Veterans Health Care System (STVHCS), Audie L.

Murphy Division located at 7400 Merton Minter Blvd., San Antonio, TX 78229-4404.

I. SCOPE OF WORK

Contractor agrees to furnish all personnel, labor, transportation, equipment, materials and supplies necessary to provide Specialized Laboratory Fee Basis Testing and guidance in Clinical Pathology procedures as specified herein for eligible VA beneficiaries of the South Texas Veterans Health Care System, Audie L. Murphy Division located at

7400 Merton Minter Blvd., San Antonio, TX 78229-4404.

The contractor shall perform to the standards in this contract and maintain compliance with policies and procedures with the Health Insurance Portability and Accountability Act (HIPAA), Clinical Laboratory Improvement

Act (CLIA) and the College of American Pathologists (CAP) standards.

Services must include:

The contractor’s laboratory must provide inhouse testing and perform analysis for Cytogenetics, Fluorescence in situ hybridization (FISH), Flow Cytometry, Immunohistochemistry (IHC), In situ hybridization (ISH), and Molecular

Testing on an as needed basis. These services require a CAP-certified, CLIA-accredited laboratory with the ability to perform a wide menu of genetic testing.

The contract must meet the following testing requirements:

• All complementary testing methods including morphology, cytogenetics, FISH, flow cytometry, and IHC are available in-house, which maximizes yield from small specimens and minimizes TAT.

• Any Pathological review must be performed by Board Certified Pathologists.

• The contractor will need to provide a comprehensive testing menu with expert bone marrow and surgical pathology consults; cancer cytogenetics with short turnaround times; hematologic and solid tumor FISH testing at minimum 10-color flow cytometry; histology supported by an extensive IHC antibody library;

and >120 molecular oncology tests with comprehensive combination of multi-method tumor profiles and targeted biomarker tests.

• The vendor must offer programs that feature on-demand or live training and are available to pathologists who wish to sign out FISH, flow cytometry, and/or IHC, ISH.

• The vendor must offer Online access to Images, Slides and ordering to all STVHCS P&LMS Pathologists.

Cytogenetics Testing:

• Turnaround time of 3-5 days for blood and bone marrow analysis.

• Must be able to process standard and special specimen types including solid tumors and products of conception.

• Must provide In-house Single Nucleotide Polymorphism array for detection of cryptic abnormalities and

Uniparental disomy.

• Must have an extensive in-house FISH probe library to allow efficient case follow-up when needed

• Automated metaphase identification

• Analysis by two independent board-certified cytogenetic technologists with an additional quality control check for each case

• Result sign-out by a board-certified cytogeneticist

Fluorescence in situ hybridization (FISH):

• Must have an extensive hematologic probe library

• A comprehensive solid tumor menu that must include HER2 Equivocal testing for breast cases

• Tech-Only FISH options for >95% of probes

• Live webinars and on-demand training library

• Must utilize the following scoring systems (SWOG/ECOG, IPSS-R, and IMWG respectively)

• Must perform Plasma Cell Enrichment upon request.

Flow cytometry:

• At minimum 10-color flow cytometry

• Precise characterization of various cell populations

• Improved detection of low-frequency abnormalities

• Reduced redundancy in use of antibodies

• Fast signal acquisition

• Methods available to reduce cell drift and increases consistency in serial testing of patients

• Minimum of two options for full leukemia/lymphoma phenotyping - standard with 24 markers and extended with 31 markers

• Must provide follow-up panels with highly focused marker sets for monitoring known diagnoses

• High-sensitivity PNH evaluation with 0.01% detection limit

• Complete tech-only options with cytospin images and access to hands-on regating to help tech-only clients increase confidence in result interpretation.

Broad IHC, ISH, and Digital Pathology:

• Must have a broad in-house menu with over 300 IHC antibodies and stains

• Multiple in-house test platforms

• Must have Digital pathology options for quantitative and qualitative analysis

• Must maintain a Highly developed and well-staffed QA/QC program that includes CAP proficiency testing.

Molecular:

• Must have a comprehensive combination of single-gene and multi-parameter tumor profiles

• Full range of molecular diagnostic technologies including Next-Gen sequencing, quantitative PCR, gold-standard Sanger sequencing, and SNP microarray.

• Must have available testing enhancements to improve detection of low-level abnormalities in select assays using plasma analysis and high-sensitivity sequencing.

II. LICENSURES

Only fully licensed/accredited laboratories actively engaged in providing the specific services and laboratory testing outlined shall be considered. The reference laboratory 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), American Associates of Blood Banks (AABB), Joint Commission (JC), Center for Disease Control

(CDC), 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).

Copies of all relevant permits, licenses and certification of the Contractor, inclusive of any sanctions current or pending throughout the United States of America shall be supplied to the STVHCS facilities annually.

III. QUALITY

The Government reserves the right to physically inspect the reference laboratory(s) prior to a contract award and at any time during the award period to ensure the reference laboratory's compliance with accreditation and quality assurance practices and requirements.

In addition, the reference laboratory shall provide the following documentation with their offer:

1. Professional Staff Curricula Vitae

2. Technical Staff Competency Skills Assessment

3. Technical and Courier Staff Shipping and Handling of Laboratory Specimens/Hazardous Materials Training and Assessment

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

5. Proficiency Examination Exception Reports for the past two (2) years

6. Policy, list of tests and associated results for critical and alert value notification

7. Description of Performance Improvement (Quality Assurance) Program/Plan

8. Current year performance improvement monitors that include and not limited to demonstration of number of lost/damaged specimens, number of cancelled specimens, delays in turnaround times

(including but not limited to: due to lack of staffing, lack of availability of reagents, instrumentation issues, etc.), resolution of complaints, errors in reporting patient results, and courier route delays/cancellations

9. Other Quality Assurance Monitors as defined by STVHCS.

IV. TELECOMMUNICATION AND COMPUTER SERVICES:

The Contractor shall meet all Enterprise Cyber Security Infrastructure Project (ECSIP) requirements in order 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. See attachment: “CHECKLIST FOR INFORMATION SECURITY IN THE

INITIATION PHASE OF ACQUISITION” from the VA HANDBOOK 6500.6 APPENDIX A which must be completed with the contractor’s quote.

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:

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.

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.

X X

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

X X

LAN Extensions- LAN extensions to the VA WAN may be supported with a site-to-site VPN. In order to qualify for a LAN extension, VA must control both physical AND logical security at the site.

X

Requirements- A requirement for protocols not currently supported in the VA firewall policy and would be a significant security risk 10the VA

WAN is a candidate for a site-to-site VPN connection.

X X

In addition, all Contractors shall 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.

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.

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. 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.

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.

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 VA references (not within VISN 17) and 2 private sector, other federal agency, state or local government agencies/ institutions. References to include the facility address, telephone number, email address, and contact person’s name which can validate past experience within the last three (3) 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.

V. IMPLEMENTATION TIME FRAME

The implementation of the services/requirements shall be completed no later than the day after the award of the contract. Failure to provide timely implementation may result in termination of the contract. The Contractor shall furnish a schedule to show a customizable implementation plan of the required services (telecommunications, interface connectivity and validation, client service support, courier/logistics, ordering, supplies, specimen processing services, reporting, quality assurance, billing, etc. as applicable).

VI. PRODUCT ADD-ONS

The Government may add new tests to the base contract over the course of the contract performance as test volumes increase or as new technology becomes available on the market. A contract modification shall be executed adding these new products to the contracted schedule of items before the Contractor can provide these products to the VISN 17 facilities. Since not all tests may be listed on the contract, due to low volume testing or facility preferences, any test that appears on the Federal Supply Schedule (FSS) fee schedule shall be billed at the

FSS fee schedule amount. The Contractor shall supply a list of all tests on the FSS with their associated costs. Tests ordered from each VA facility that do not appear on either schedule shall be offered by the Contractor and will be billed at the fair/open market rate. The Contractor shall send tests to another reference facility that is not offered in-house, and the Contractor shall provide the shipping at a fair market cost.

VII. DESCRIPTION OF SERVICES

Requirements/Services to Be Provided:

A. Specimen Testing

i. The Contractor shall provide timely and appropriate testing of patient specimens as requested by STVHCS facilities.

ii. The STVHCS facilities reserve 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 STVHCS centers of excellence. STVHCS facilities that identify such a testing methodology not meeting their testing criteria must submit a request for review to a STVHCS adjudicating panel with sufficient justification to warrant an exemption from the contract. These rare test exemptions will be re-referred to another reference laboratory and the costs borne by the requesting STVHCS facility.

iii. The STVHCS facilities reserve the right to identify testing issues with the Contractor’s laboratory test results due to inconsistent results and/or testing accuracy (i.e., positive blood culture that has a final report of no growth, false positive screen that is reported as negative, inconsistent gram stain result when compared to the final report, etc.).

iv. The STVHCS facilities reserve the right to identify testing concerns with the Contractor’s laboratory due to testing delays (i.e., no notification of sample issues, reports not labeled correctly, or an increase noted in the number of corrected reports, etc.).

v. In order to minimize the number of tubes drawn, the contractor, annually shall evaluate each sites commonly ordered tests, working with the individual sites, develop a test order numbers that shall combine applicable tests; therefore, reducing the number of reference test samples drawn.

B. Sample Processing

i. Each STVHCS facility will provide laboratory specimens properly collected identified with both the Patient’s Identification (as utilized by each facility) and requested tests. For those specimens that require special handling, the Contractor shall provide at no additional charge an adequate supply of specimen collection materials for such testing that is destined to the commercial reference laboratory for analysis (i.e., dry ice, stabilizing tablets, ice packets, 24-hour collection container with preservatives, special collection tubes, etc.).

ii. The Contractor shall be responsible for transporting and storing specimens in such a manner as to ensure the integrity of the specimen. Safety Data Sheets will be provided to sites as appropriate for supplies containing hazardous chemicals (e.g., boric acid tablets, acids).

C. Reporting of Results

i. A report 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.

ii. Each test report shall at minimum indicate the following information:

1. Patient's name and/or identification number

2. Physician's name (if supplied)

3. VISN 17 medical record number or laboratory accession number (if supplied)

4. VISN 17 submitting facility name

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

6. Test ordered

7. Date/time of specimen collection (when available)

8. Date/time test completed

9. Test result

10. Reference intervals

11. Toxic and therapeutic ranges, if applicable

12. Flagged abnormal test results

13. Reference laboratory specimen number

14. Name of testing laboratory, if other than Contractor

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

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

iii. Test results shall be received within 24 hours following specimen pick-up either by hard copy or electronic report transmission. 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.

iv. 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 the submitting VISN

17 laboratory 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.

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

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

D. Customer Service

i. The Contractor shall provide in a detailed plan describing their customer service strategies for

STVHCS if Contractor's specimen processing personnel are located on site at the facility or if they are not located on site at the facility. This plan shall address the capability and/or availability of the commercial reference laboratory Contractor to provide the following services and, if applicable; specify how this service will be accomplished, by whom, and within what timeframe:

ii. Telephone Inquiries:

1. 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

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

ii. 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

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

ii. 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

i. 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.

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

iii. 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.

iv. 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.

d. Account Follow-up

i. Account follow-up that requires information general in nature yet specific to the account, e.g., test pricing, courier service problems, specimen results discrepancy issues, equipment repair, supply ordering, etc. shall be addressed within four (4) hours of the initial inquiry.

iii. Data Management System

1. Test ordering is easily accomplished through a menu that is intuitive, has minimal options and uses a mouse or touch screen. Upon selection of the test, the computer shall alert (flag) the user to the type of specimen required and the storage conditions. It shall also alert the user to the location of the laboratory that will be performing the test.

2. Test definitions, test information and test requirements are complete, available, and easily accessible.

3. 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.

4. 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.

5. Shipping manifest is generated that identifies the specimens sent to the commercial reference laboratory, transportation conditions, and testing ordered.

6. The ordering of specimen collection and transportation supplies is accomplished through direct on-line ordering.

7. Current STVHCS contracted price information is available through the computer or through other electronic modes.

iv. Notifications

1. The notification of critical values shall be determined by each individual facility.

2. The notification of rejected samples shall be determined by each individual facility. The

Contractor needs to specify the process their facility performs in trying to locate additional sample before rejecting a test.

3. Telephone notification of specimens cancelled due to unacceptability, i.e., volume, specimen container identification, loss of specimen, etc. shall be determined by each individual facility.

v. Test Catalog:

1. A hard copy test catalog shall be published on an annual basis and a sufficient number of copies shall be distributed to each account within the STVHCS. Addendums/ updates to the test catalog shall be made available (either electronically or in hard copy) to each

STVHCS account in a reasonable timeframe (no less than two weeks) prior to the effective change of the test so that adequate preparations can be made to facilitate the test transition. The test catalog shall include all test information as required by the regulatory requirements of the College of American Pathologists. A reference guide to test interpretation shall also be available.

E. Specimen Storage

i. The Contractor shall store the specimens a minimum of seven (7) to ten (10) days after the test is reported in the event that subsequent action is necessary (i.e., problem solving, add-on test, and/or repeat testing). The Contractor shall state their specimen retention time.

F. Performance Improvement (PI) and Quality Assurance Activities

i. The Contractor shall provide a detailed plan describing their proposal for performance improvement activities that are specific to the STVHCS. This plan shall minimally address the quality aspects representative to the testing process, i.e., pre-analytical, analytical, and post-analytical variables and include a description of monitoring and evaluation activities.

ii. The Contractors PI plan shall also include a description of their procedure for responding to issues, problems and/or concerns identified by the VISN 17 laboratories and specific information as to whom and in what time frame the matters will be reconciled. The issues that may need to be addressed may be general in nature or specific to an incident or event.

iii. The Contractor shall provide the STVHCS facilities with a quarterly report of the Contractor’s PI monitors and data.

iv. The Contractor shall provide a detailed plan describing their Quality Assurance monitors to include completeness, accuracy, and reliability of tests results. The quality control processes should be in place for all phases of testing. The monitors may include positive identification of patient and specimen, acceptability of specimens received for testing, accuracy of data entry of test orders, accuracy of data entry of test results, revised reports, and/or lost specimens.

v. The Contractor may offer presentations/webinars/ teleconferences of new technology updates or services.

G. Utilization Reports

i. One copy of the following reports shall be available to each STVHCS VA facility by the 20th of the month following the close of the reporting month:

1. Monthly cumulative summary alphabetically by patient for each STVHCS VA facility indicating name, test ordered, date specimen received and ordering physician

2. Monthly summary sheet by test frequency for each STVHCS VA facility listing patient name, volume of tests ordered, unit charge, total charges for this month and year to date.

3. Summary sheet listing the type and volume of testing sent to a sub-contracted reference laboratory.

ii. One copy of the following reports shall be available to the network office by the 20th of the month following the close of the reporting month:

1. Monthly summary sheet by dollar volume for each STVHCS VA facility listing tests in descending order of dollar volume with volume of tests ordered, unit charge for each test, total charges for months and year to date.

2. Summary sheet by test frequency of the entire STVHCS laboratory utilization listing by

STVHCS Primary VA facility all test ordered, the volume of tests ordered, unit charge per tests, total charges, and percent abnormal results for the period.

3. Summary sheet listing the type and volume of testing sent to a sub-contracted reference laboratory.

iii. The Contractor shall provide access-on-demand utilization reports – Utilization details and utilization spend report where each facility will have access to self-service customizable reports to analyze utilization patterns and costs. The ability to view these reports will make it faster and easier to identify improvement opportunities, promote clinically appropriate test selection, and track ongoing metrics to monitor progress for more uniform and cost-effective care.

iv. The Contractor shall annually provide a statistical analysis of the STVHCS VA facilities workload testing volumes to assist in the monitoring of ordering trends and utilization patterns.

v. The Contractor may annually offer a consultation with recommendations for each facility where they analyze the facility’s testing patterns and compare them against benchmarks by time, age, and geographic site.

vi. The Contractor is encouraged to offer a spectrum of value-added incentives. Such incentives may include customer and professional service programs that assist the VISN 17 facilities with the usage of the Contractor's products in the most cost-efficient manner

H. Period of Performance

i. Single -award firm fixed price 5-year IDIQ.

I. Deliverables/Supplies

Reference Lab testing for Cytogenetics, Fluorescence in situ hybridization (FISH), Flow Cytometry, Immunohistochemistry (IHC), In situ hybridization (ISH), and Molecular Testing on an as needed basis.

J. Invoicing:

i. Payment to be made monthly in arrears by certified invoices and must contain the contract number and obligation number in addition to the requirements detailed in 52.212-4 (G) to be considered valid. Invoices shall also contain a line item for each test and quantities billed for and include detail on the Time the invoice covers. STVHCS will not pay for tests that are not clearly identified by accession number on the Contractors invoice.

K. Work Hours:

i. Contractor shall be responsible for providing services in between the hours of 8:00am and 4:30pm Monday through Friday excluding Federal Holidays. Federal Holidays are as follows:

New Year’s Day

Martin Luther King’s Birthday

President’s Day

Memorial Day

Juneteenth

Independence Day

Labor Day

Columbus Day

Veterans Day

Thanksgiving Day

Christmas Day

Any other day specifically designated as a national holiday by the President of the United States.

L. Contracting Officer’s Representative:

i. Prior to contract award, the Contracting Officer shall designate a VA Medical Center employee as the Contracting Officer's Representative (COR). All work coordination shall be made through the COR. The Contractor shall be provided a copy of the letter of delegation authorizing the COR at the commencement of the term of this agreement. No other person shall be authorized to act in such capacity unless appointed in writing by the Contracting Officer.

ii. The Contracting Officer is the only person authorized to approve changes or modify any of the requirements under this contract. The contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the Contracting Officer is authorized to make commitments or issue changes, which will affect price, quantity, or quality of performance of this contract. In the event the Contractor effects any such changes at the direction of any person other than the Contracting Officer, the change shall be considered to have been made without authority and no adjustment will be made in the contract price to cover any increase in costs incurred as a result thereof.

M. Government Inherent Functions:

i. Contractor shall not perform inherently governmental functions. This includes, but is not limited to, determination of agency policy, determination of Federal program priorities for budget requests, direction and control of government employees, selection or non-selection of individuals for Federal Government employment including the interviewing of individuals for employment, approval of position descriptions and performance standards for Federal employees, approving any contractual documents, approval of Federal licensing actions and inspections, and/or determination of budget policy, guidance, and strategy.

N. General Duties, Requirements, and Expectations:

i. Be professionally competent to handle required duties.

ii. Work with staff to ensure safety measures are in place and documented.

iii. Services provided under the terms of this contract are required to be in compliance with the

American Association of Blood Banks (AABB) and College of American Pathologists (CAP) and VHA Handbook 1106.1.

O. Information Systems Officer, Information Protection:

i. The contractor will not have access to VA Desktop computers, nor will they have access to online resources belonging to the government while conducting services. If removal of equipment from the VA is required, any memory storage devices, such as hard drives, solid state drives and non-volatile memory units will remain in VA control and will not be removed from VA custody.

P. Privacy Officer:

The contractor will have access to Patient Health Information (PHI) but will not have the capability of accessing patient information from the VA System during the services provided to the VA.

Q. Records Manager:

i. Contractor shall comply with all applicable records management laws and regulations, as well as

National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII

Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

ii. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

iii. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

iv. STVHCS and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of STVHCS or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity.

Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to STVHCS. The agency must report promptly to NARA in accordance with 36 CFR 1230.

v. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records, or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to STVHCS control, or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

vi. The 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, contracts.

The Contractor (and any sub-contractor) is required to abide by Government and STVHCS guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

vii. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with STVHCS policy.

viii. The Contractor shall not create or maintain any records containing any non-public STVHCS information that are not specifically tied to or authorized by the contract.

ix. The 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 from public disclosure by an exemption to the Freedom of Information Act.

x. The STVHCS owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which STVHCS shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

xi. Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take VHA-provided records management training, Talent

Management System (TMS) Item #10176, Privacy and Information Security, Rules of Behavior.

The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

R. SPECIAL CONTRACT REQUIREMENTS

i. STX-HCR671-04 General Information Security Requirements /Records

1. All information and records provided to Contractor by VA, in whatever medium, as well as all information and documents, including drafts, emails, back-up copies, hand-written notes and copies that contain such information and records gathered or created by

Contractor (collectively referred to as “VA information”) in the performance of this contract, regardless of storage media, are the exclusive property of VA. Contractor does not retain any property interest in these materials and will not use them for any purpose other than performance of this contract.

2. Upon completion or termination of the contract, Contractor will either provide all copies of all VA information to VA or certify that it has destroyed all copies of all VA information as required by VA in a method specified by VA, at VA’s option. Medical records of any kind including notes shall be returned to the VA. The Contractor will not retain any copies of VA information. Where immediate return or destruction of the information is not practicable, Contractor will return or destroy the information within

30 days of completion or termination of the contract. All provisions of this contract concerning the security and protection of VA information that is the subject of this contract will continue to apply to VA information for as long as the Contractor retains it, regardless of whether the contract has been completed or terminated.

3. Prior to termination or completion of this contract, Contractor will not destroy VA information received from VA or gathered or created by Contractor in the course of performing this contract without prior written approval by VA.

4. Contractor will receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in accordance with the terms of this contract and applicable federal and VA information confidentiality and security laws, regulations, and policies.

5. The Contractor shall not make copies of VA information except as necessary to perform this agreement or to preserve electronic information stored on Contractor electronic storage media for restoration in case any electronic equipment or data used by the

Contractor needs to be restored to an operating state.

6. Contractor shall provide access to VA information only to employees, and affiliates only:

(1) to the extent necessary to perform the services specified in this Contract, (2) to perform necessary maintenance functions for electronic storage or transmission media necessary for performance of this contract, and (3) only to individuals who first satisfy the same conditions, requirements, and restrictions that comparable VA employees must meet in order to have access to the same VA information. These restrictions include the same level of background investigations, where applicable.

7. Contractor will store, transport, or transmit VA information only in an encrypted form, using an encryption application that meets the requirements of FIPS 140-2, and is approved for use by VA.

8. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor may use and disclose VA information only in two other situations: (i) in response to an order of a court of competent jurisdiction, or (ii) with VA’s prior written authorization. The contractor will refer all requests for, demands for production of, or inquiries about, VA information to VA for response.

9. If VA information subject to the contract includes information protected by 38 USC

7332, or 5705, include the following after the last sentence of the paragraph immediately above: Contractor shall not release information…