36C25721Q0294.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 59

36C25721Q0294

Delphia Schoenfeld 210-694-6336 01-14-2021

15:00 EST

Department of Veterans Affairs

VISN17 Network Contracting Activity

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

San Antonio TX 78229

X

621511

$35 Million

N/A

X

South Texas Veterans Healthcare System

Laboratory

7400 Merton Minter Blvd.

San Antonio TX 78229-4401

VISN17 Network Contracting Activity

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

This solicitation is for the Specialty Genetic Reference

Laboratory Testing Services.

The Government intends to award a Firm Fixed-Price contract to a responsible offeror that provides a quotation at a fair and reasonable price.

See Section B for Statement of Work and Price Schedule.

Any questions must be submitted in writing to Delphia

Schoenfeld at delphia.schoenfeld@va.gov by 1/8/2021, 1:00 PM Eastern Time.

See CONTINUATION Page

X X

X 1

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 PERFORMANCE WORK STATEMENT

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

B.4 DELIVERY SCHEDULE

SECTION C - CONTRACT CLAUSES

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

C.2 52.204-21 BASIC SAFEGUARDING OF COVERED CONTRACTOR INFORMATION SYSTEMS (JUN

2016)

C.3 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.4 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

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

EXECUTIVE ORDERS—COMMERCIAL ITEMS (NOV 2020)

C.6 VAAR 852.211-72 TECHNICAL INDUSTRY STANDARDS (NOV 2018)

C.7 VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA ACQUISITION OF

COMMERCIAL ITEMS (APR 2020)

C.8 VAAR 852.219-74 LIMITATIONS ON SUBCONTRACTING—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 INSTRUCTIONS TO OFFERORS

E.3 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO

SURVEILLANCE SERVICES OR EQUIPMENT (OCT 2020)

E.4 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

E.5 52.212-2 EVALUATION—COMMERCIAL ITEMS (OCT 2014)

E.6 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL ITEMS (NOV

2020)

E.7 52.216-1 TYPE OF CONTRACT (APR 1984)

E.8 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.9 852.215-72 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

VISN17 Network Contracting Activity

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

[] 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

B.2 PERFORMANCE WORK STATEMENT

BACKGROUND: The purpose of the resulting contract will be to provide a base plus four (4) option year contract for Specialized Laboratory Fee Basis Testing for the South Texas Veterans Health Care System

(STVHCS), Audie L. Murphy VA Hospital 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, expert bone marrow and surgical pathology consults. This contract is unique due to the patient population served and the need to maximize usage of irretrievable specimens. Therefore, the vendor must be able to provide inhouse testing for all services listed within the SOW.

Services must include:

The contractor’s laboratory must provide inhouse testing for all testing listed in Attachment A 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.

This is due to the specimens being irretrievable specimens with limited amounts available. These services require a CAP-certified, CLIA-accredited laboratory(High Complexity) with the ability to perform a wide menu of genetic testing 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 testing will be on an as needed basis. 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.

NOTE: Attachment “Specialty Genetic Testing CPT” is an estimate of required testing based upon prior history of actual volumes and are not a guaranteed minimum. This list serves only as base guideline of tests required by the STVHCS.

All requirements and provisions defined in the specifications of this solicitation shall apply to any laboratory, i.e. branch, division, Sub Contractor, etc. performing reference testing on behalf of the

Contractor.

The contract must meet the following testing requirements:

• The Contractor’s Laboratory must provide all complementary and reflex testing methods including morphology, cytogenetics, FISH, flow cytometry, and IHC are available inhouse, which maximizes yield from critical low irretrievable volume specimens(Biopsies etc.) and minimize 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.

• Live webinars and on demand training.

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

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

• 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 resulting.

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

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. DESCRIPTION OF SERVICES

Requirements/Services to Be Provided:

A. Specimen Testing

A.1 The Contractor shall provide timely and appropriate testing of patient specimens as requested by

STVHCS facilities.

A.2 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.

A.3 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.).

A.4 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.).

A.5 In order to minimize the number of tubes drawn, the contractor, annually shall evaluate each site 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

B.1 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.).

B.2 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).

B.1. Specimen Collection

a) 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.

b) 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.2. Testing

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

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

B.3. Technical Expertise

a) 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.

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

c) 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.

d) 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.

C. Reporting of Results

C.1 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 of this solicitation.

C.2 Each test report shall at minimum indicate the following information:

- Patient's name and/or identification number

- Physician's name (if supplied)

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

- VISN 17 submitting facility name

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

- Test ordered

- Date/time of specimen collection (when available)

- 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, if other than Contractor

- 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

C.3 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.

C.4 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.

C.5 Contractor shall provide daily, by 12:00 PM, a report listing all incomplete specimens and their processing status.

C.6 The Contractor shall state their policy and any associated fees for repeat testing if requested by the provider.

III. LICENSURES

Only fully licensed/accredited laboratories actively engaged in providing the specific services and laboratory testing outlined in this solicitation and all requirements listed in VHA Handbook 1106.1 and

42 CFR Part 493 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, Food and Drug Administration (FDA), CLIA and/or other state regulatory agencies as mandated by federal and state statutes as well as VHA Handbook

1106.1. In addition, the reference laboratory shall be certified and accredited as a High

Complexity Laboratory as meeting the requirements of the Clinical Laboratory Improvement Act

(CLIA)of 1988 and comply with the National Standards to Protect the Privacy of Personal Health

Information (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 in response to this solicitation. In addition, if these documents for the Contractor facilities are reissued for accreditation, reworded, or renewed the awarded Contractor shall supply a copy to the STVHCS facilities annually.

IV. 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 and its subcontractors(if applicable) shall provide the following documentation with their offer:

a) Professional Staff Curricula Vitae

b) Technical Staff Competency Skills Assessment

c) Technical and Courier Staff Shipping and Handling of Laboratory Specimens/Hazardous Materials

Training and Assessment

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

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

f) Policy, list of tests and associated results for critical and alert value notification

g) Description of Performance Improvement (Quality Assurance) Program/Plan

h) 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

i) Other Quality Assurance Monitors as defined by STVHCS.

j) Implementation Plan.

V. TELECOMMUNICATION AND COMPUTER SERVICES:

a) The vendor must be able to fax results to the STVHCS secure Private line(provided upon award).

b) Interfacing will not be required at this time for this requirement due to the specialized Laboratory

Reports.

c) The vendor must offer Online access to Images, Slides and ordering to all STVHCS P&LMS

Pathologists.

VI. IMPLEMENTATION TIME FRAME

The implementation of the services/requirements described in this solicitation shall be completed no later than 1 month 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)

VII. 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.

D. Customer Service

D.1 The Contractor shall provide in response to this solicitation 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:

D.2 Telephone Inquiries:

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.

Account Follow-up

a) 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.

D.3 Data Management System

a) 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.

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

c) 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.

d) 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.

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

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

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

D.4 The notification of critical values shall be determined by each individual facility.

D.5 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.

D.6 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.

D.7 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

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

F.1 The Contractor shall provide in response to this solicitation a detailed plan describing their proposal for performance improvement activities that are specific to the VISN 17 facilities identified in this solicitation. 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.

F.2 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.

F.3 The Contractor shall provide the STVHCS facilities with a quarterly report of the Contractor’s PI monitors and data.

F.4 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.

F.5 The Contractor may offer presentations/webinars/ teleconferences of new technology updates or services.

G. Utilization Reports

G.1 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:

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

b) 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.

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

G.2 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:

a) 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.

b) 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.

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

G.3 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.

G.4 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.

G.5 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.

G.6 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

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.

INVOICING: 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.

WORK HOURS: 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, Independence

Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving Day, Christmas Day and any other day specifically designated as a national holiday by the President of the United States.

CONTRACTING OFFICER’S REPRESENTATIVE:

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.

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.

Government Inherent Functions:

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.

General Duties, Requirements, and Expectations:

a) Be professionally competent to handle required duties.

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

c) 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 all other State and Federal Agencies applicable, as well as VHA Handbook 1106.1.

Information Systems Officer, Information Protection:

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 nonvolatile memory units will remain in VA control and will not be removed from VA custody.

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.

Records Manager:

1. 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.

2. 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.

3. 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.

4. 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.

5. 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).

6. 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.

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

8. 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.

9. 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.

10. 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.

11. 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.

SPECIAL CONTRACT REQUIREMENTS

1. STX-HCR671-04 GENERAL INFORMATION SECURITY REQUIREMENTS /RECORDS

1.1. 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, handwritten 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.

1.2. 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.

1.3. 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.

1.4. 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.

1.5. 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.

1.6. 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.

1.7. 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.

1.8. 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.

1.9. 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 protected by either 38 USC 5705 or 7332 in response to a court order, and shall immediately refer such court orders to VA for response.

1.10. Prior to any disclosure pursuant to a court order, the Contractor shall promptly notify VA of the court order upon its receipt by the Contractor, provide VA with a copy by fax or email, whichever is faster, and notify by telephone the VA individual designated in advance to receive such notices. If the Contractor cannot notify VA before being compelled to produce the information under court order, the Contractor will notify VA of the disclosure as soon as practical and provide a copy of the court order, including a copy of the court order, a description of the records provided pursuant to the court order, and to whom the Contractor provided the records under the court order. The notice will include the following information to the extent that the Contractor knows it, if it does not show on the face of the court order:

the records disclosed pursuant to the order, to whom, where, when, and for what purpose, and any other information that the Contractor reasonably believes is relevant to the disclosure. If VA determines that it is appropriate to seek retrieval of information released pursuant to a court order before

Contractor notified VA of the court order, Contractor will assist VA in attempting to retrieve the VA information involved.

1.11. The Contractor will inform VA by the most expeditious method available to Contractor of any incident of suspected or actual access to, or disclosure, disposition, alteration or destruction of, VA information not authorized under this Contract (“incident”) within one hour of learning of the incident. An incident includes the transmission, storage or access of VA information by

Contractor employees in violation of applicable VA confidentiality and security requirements.

To the extent known by the Contractor, the Contractor’s notice to VA will identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information was placed at risk or compromised), and any other information that the contractor considers relevant.

1.12. Contractor will simultaneously report the incident to the appropriate law enforcement entity of jurisdiction. The Contractor, its employees, will cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The Contractor also will cooperate with

VA in any civil litigation to recover VA information, to obtain monetary or other compensation from a third party for damages arising from any incident, or to obtain injunctive relief against any third party arising from, or related to, the incident.

1.13. VA will provide the Contractor with the name, title, telephone number, fax number and email address of the VA official to whom the Contractor will provide all notices required by this

Contract.

1.14. VA has the right during normal business hours to inspect the Contractor’s facility, information technology systems and storage and transmission equipment, and software utilized to perform the contract to ensure that the Contractor is providing for the security of VA data and computer systems in accordance with the terms of this Contract.

1.15. Contractor will receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with all applicable Federal Information Processing

Standards (FIPS) and Special Publications (SPs) issued by the National Institute of Standards and Technology (NIST) concerning VA information that is the subject of this contract. If NIST issues or updates an applicable FIPS or SP after execution of this contract, the parties agree to negotiate in good faith to implement the FIPS or SP in this contract.

1.16. A determination by VA that the Contractor has violated any of the information confidentiality and security provisions of this contract, including a violation of any applicable FIPS or SP, shall be a basis for VA to terminate the contract for cause.

1.17. If anyone performing this contract, accesses VA computer systems or data in the performance of the contract, VA may monitor and record all such access activity. If VA monitoring reveals any information of suspected or potential criminal law violations, VA will refer the matter to the appropriate law enforcement authorities for investigation.

1.18. Contractor shall inform its employees and other individuals performing any part of this contract that VA may monitor their actions in accessing or attempting to access VA computer systems and the possible consequences to them for improper access, whether successful or not. The Contractor shall ensure that employees, associates or others acting on their behalf that VA may monitor their access activities. Execution of this contract or agreement constitutes consent to VA monitoring.

1.19. The Contractor will ensure that all individuals who will access VA data or systems in performing the contract are appropriately trained in the applicable VA confidentiality and security requirements.