36C26324Q0870.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

618-24-4-106-0762

36C26324Q0870 07-17-2024

Logan Gahring 319-339-7113 07-31-2024

11:00 AM CDT

Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

1303 5th St, Suite 300 Coralville IA 52241 Logan Gahring logan.gahring@va.gov

X

621511

$41.5 Million

N/A

X

Minneapolis VA Health Care System One Veteran Drive Minneapolis MN 55414

NETWORK 23 CONTRACTING OFFICE

Logan Gahring 1303 5th St, Suite 300 Coralville IA 52241

FMS-VA-2(101)

Financial Services Center PO Box 149971 Austin TX 78714-9971

See CONTINUATION Page

X Stat Referral Laboratory Testing and Consultation Services to support the Minneapolis VA Hospital located at:

One Veteran Drive, Minneapolis, MN 55414.

See the Price/Cost Schedule and Statement of Work for additional information.

This will be a five (5) year IDIQ Contract.

Period of Performance: 09/01/2024-08/31/2029.

Offerors shall be registered and verified as eligible in the System for Award Management (SAM) at the time of submission of quote and prior to contract award.

See FAR 52.212-1 Instructions to Offerors and See FAR 52.212-2 Evaluation Commercial Products and Services for specific documentation to be submitted with offer.

The Department of Labor Service Contract Act applies to all Services provided under the contract.

See CONTINUATION Page

618-3640160-106-822300-2633-0100223P5 618-24-4-106-0762

X X

X -one-

John Becker

VA-VHA-RPOC-2024-0074

36C26324Q0870

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 PERFORMANCE WORK STATEMENT

B.3 PRICE/COST SCHEDULE

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES (NOV 2023)

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

C.3 52.216-18 ORDERING (AUG 2020)

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

C.5 52.216-21 REQUIREMENTS (OCT 1995)

C.6 52.216-21 REQUIREMENTS (OCT 1995) ALTERNATE I (APR 1984)

C.7 52.216-22 INDEFINITE QUANTITY (OCT 1995)

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

C.9 52.232-19 AVAILABILITY OF FUNDS FOR THE NEXT FISCAL YEAR (APR

1984)

C.10 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS

(NOV 2018)

C.11 VAAR 852.201-70 CONTRACTING OFFICER'S REPRESENTATIVE (DEC 2022)

C.12 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

C.13 VAAR 852.215-70 SERVICE-DISABLED VETERAN-OWNED AND VETERAN-

OWNED SMALL BUSINESS EVALUATION FACTORS (JAN 2023) (DEVIATION)

C.14 VAAR 852.215-71 EVALUATION FACTOR COMMITMENTS (OCT 2019)

C.15 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020) . 33

C.16 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (MAY 2024)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

See attached document: D.1 Schedule of Service - Estimated Test Quantity See attached document: D.2 IMMIGRATION CERTIFICATION See attached document: D.3 ORGANIZATIONAL CONFLICT CERTIFICATE See attached document: D.4 WAGE DETERMINATION 2015-4945 HENNEPIN

COUNTY, MN

See attached document: D.5 Quality Assurance Surveillance Plan

SECTION E - SOLICITATION PROVISIONS

E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (SEP 2023)

E.2 ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

E.3 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.4 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.5 52.204-29 FEDERAL ACQUISITION SUPPLY CHAIN SECURITY ACT

ORDERS—REPRESENTATION AND DISCLOSURES (DEC 2023)

E.6 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

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

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

E.9 VAAR 852.215-72 NOTICE OF INTENT TO RE-SOLICIT (OCT 2019)

E.10 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE

RESOLUTION (OCT 2018)

E.11 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

E.12 VAAR 852.239-75 INFORMATION AND COMMUNICATION TECHNOLOGY

ACCESSIBILITY NOTICE (FEB 2023)

E.13 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2021)

E.14 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (MAY 2024)

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 36C263

NETWORK 23 CONTRACTING OFFICE

1303 5th St, Suite 300 Coralville IA 52241

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

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

[] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] Monthly

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

Department of Veteran Affairs Tungsten Electronic Invoicing https://www.tungsten-network.com/customer-campaigns/veteransaffairs/

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

1. Scope of Work The Minneapolis VA Health Care System Pathology and Laboratory Medicine Service located at One Veterans Drive, Minneapolis, MN 55417, hereinafter referred to as MVAHCS, is in need of a contract to support highly specialized STAT referral laboratory testing and consultation services. All services provided shall be in accordance with the costs, terms, and conditions of this contract.

2. Contract Type and Term The MVAHCS will award a 5-year firm, fixed-price, indefinite delivery indefinite quantity commercial services contract for all items listed in the Schedule of Items. Contract use will be limited to the MVAHCS. The Periods of Performance will be:

• Ordering Period 1: 9/1/24-8/31/25

• Ordering Period 2: 9/1/25-8/31/26

• Ordering Period 3: 9/1/26-8/31/27

• Ordering Period 4: 9/1/27-8/31/28

• Ordering Period 5: 9/1/28-8/31/29

3. Statement of Work The MVAHCS requires the services of a contractor to provide highly specialized and specific diagnostic testing needs. Testing needs may consist of but are not limited to STAT and Urgent drug levels, quantitative cryoglobulin levels with identification, HLA typing, special coagulation testing, factor assays, consultation on complex anatomic pathology cases, gross and microscopic neuropathology evaluations, PCR and viral culturing of infectious agents, and enzyme immunoassay on blood, bone marrow, tissue, body fluids, swabs, and other clinical specimens.

These services are not performed at the MVAHCS.

The laboratory must be able to determine levels of the following on a STAT basis:

• Amikacin

• Methotrexate

• Tobramycin

• Beta-2-transferrin

• Ketone Beta hydroxybutyrate

• Osmolality (serum & urine)

The laboratory must be able to determine levels of the following on an Urgent basis:

• Cyclosporine (by HPLC)

• Sirolimus (by HPLC)

• Tacrolimus (by HPLC)

• Everolimus

Contractor’s laboratory shall:

A. Be located within 20 miles of the MVAHCS.

B. Provide services Monday through Sunday, 24 hours a day.

C. Provide the following for transport of specimens:

• Lab test requisition forms (vendor may need to customize forms to include information required by the MVAHCS)

• Special instructions for handling of specimen.

• Specimen collection supplies for specialized testing.

D. Provide the courier service for transport of specimens.

• STAT courier service must be available 24/7, including weekends and Federal holidays. MVAHCS will request services as needed, and pickup is expected to be within 45 minutes of request.

• Routine courier service must include two daily pickups Mon-Fri, then one daily pickup Saturday, Sunday, and Federal Holidays. Morning and afternoon pickup times are preferred.

E. Submit the billing invoice monthly, following the month in which the service was delivered F. Consult with MVAHCS laboratory personnel on test results as needed.

G. Provide the MVAHCS with a means of communication to permit immediate inquiry regarding the status of a pending test.

H. Provide a Laboratory User’s Manual or similar documentation. The manual shall include a list of all tests that the Contractor can provide along with the testing methodology used for each test, test reference ranges, length of time of testing, which days the test is run, specimen requirements and any special handling required.

4. Schedule of Items:

Listed below are estimated annual quantities. The MVAHCS attempts to be as accurate as possible when providing estimated annual quantities, however, actual quantities required may vary from the quantities listed below.

Test Name CPT QTY

Acanthamoeba smear/sp stain 87207 1

Activated Protein C Resistance 85307 2

Additional laboratory tests not yet developed or listed in Schedule of Items

TBD 1

AFB Stain 87206 2

Amikacin 80150 37

Anaerobic ID1 87076 1

Bacterial ID (each organism) 87077 69

Beta-2 Glycoprotein 1, IgA 86146 1

Beta-2 Glycoprotein 1, IgG 86146 1

Beta-2 Glycoprotein 1, IgM 86146 1

Beta-2 Transferrin 86334 11

Bethesda Assay for Factor 8 85335 1

Bethesda Assay for Factor 9 85335 1

Bordetella pertussis & paratussis by PCR 87798 5

Cardiolipin Antibodies IgG 86147 1

Cardiolipin Antibodies IgM 86147 1

Cardiolipin Antibody, IgA 86147 1

Chlamydia/Gonorrhea by PCR 87491 4

Chlamydia/Gonorrhea by PCR 87591 4

Citric Acid, 24-hour urine 82507 360

CMV DNA, Quant by PCR 87497 565

Collagen VII Antibodies IgG 83516 10

Complement Activity Total CH50 86162 57

Concentration any type infect agent 87015 2

CRE Culture 87081 7

Cryoglobulin Identification 86334 141

Cryoglobulin, Quantitative 82595 284

Culture Bact Anaerobic 87075 1

Culture Cath tip anaerobic, foreign body 87075 1

Culture CSF Anaerobic 87075 1

Cyclosporine 80158 340

Cytomegalovirus Qual PCR 87496 14

D Dimer, Quantitative 85379 1

Dibucaine Number 82638 10

Electron Microscopy Kidney 88348 1

Enterovirus by PCR on CSF 87498 3

Epstein Barr Virus Qual PCR 87798 3

Epstein-Barr Virus PCR non blood 87799 15

Everolimus 80169 10

Factor 10 Chromogenic 85260 151

Fat Feces, Qualitative Random 82705 20

Fat Feces, Quantitative Timed 82710 8

Fibrinogen, Activity 85384 1

FISH INTERPHASE PROBE 88271 2

FISH Interphase Interp 88275 2

Fungal ID 87107 2

Fungal Susceptibility Test (MIC) 87186 1

Gram Stain 87205 1

Granulocyte Colony Stimulating Factor 83520 6

Granulocyte Macrophage CS Factor 83520 6

Hemoglobin, Plasma 83051 7

HLA ABC DR NGS 81378 59

HLA Class II NGS 81382 295

HPV High Risk and Low Risk Types DNA Tissue or Anal 87624 8

HPV High Risk Types DNA Cervical 87624 150

HSV 1/2 , Qualitative DNA by PCR, Plasma, Bronch Wash

87529 510

HSV 1/2 by PCR Swab 87529 166

IHC/CYTOCHEM stain TC 88342 21

IHC/ICC Technical Component 88341 45

Immunofluorescent stain Addl Kidney 88350 5

Immunofluorescent stain kidney 88346 1

Immunohistochem/immunocytochem PF 88341 45

INR Protime 85610 19

INTERLEUKIN 6 83529 27

Ketone Beta-Hydroxybutyrate Quantitative, Rapid 82010 31

Macroglobulins 85810 10

Malaria Screen, Rapid, Emergency 87899 2

Meningitis Encephalitis Panel 87483 41

Methotrexate 80204 137

MGMT Promoter Methylation testing 81287 3

Microsporidium Stain 87207 4

Morphometric Analysis nerve kdy 88356 1

Mycobact culture isolate 87116 2

Neuropathology Autopsies N/A 15

Non-organism stain Pro Fee 88313 1

Non-organism stain TC 88313 1

Occult Blood Gastric 82771 6

Organism Stain TC 88312 2

Osmo, Serum 83930 10

Osmo, Stool 83935 1

Osmo, Urine 83935 3

Oxalic Acid, 24-hour urine 83945 360

Parasite Culture 87081 2

PARASITE STAIN 87207 5

PARASITES THICK PREP 87015 6

Path block consult Hemepath PF 88323 1

Path block consult Pro Fee 88323 12

Path block consult TC 88323 12

Path block consult, Hemepath TC 88323 1

Path Consultation Slide Review 88321 7

Phenobarbital 80184 9

Plasminogen Chromogenic 85420 1

Platelet Function Closure Time, Collagen/ADP 85576 47

Platelet Function Closure Time, Collagen/Epi 85576 37

Platelet Function P2Y12 (Verify Now) 85576 11

Porphobilinogen Deaminase, RBC 82657 6

Primidone 80188 15

Primidone and Metabolite/Phenobarbital 80184 3

Pseudocholinesterase Total (with Dibucaine) 82480 10

PTT, Activated 85730 2

Rapamycin (Sirolimus) 80195 172

Review outside slides Pro Fee 88321 5

Sensitivities, MIC 87186 31

Special stain for organism Pro Fee 88312 2

Specific Antibiotic Sens Panel 87181 50

Sulfonylurea Screen 80299 11

Surg Path Level IV Kidney 88305 1

Surg Path Level IV TC EM lab 88314 1

Susceptibility Fungus by Broth 87186 16

Synovasure 83516 30

Synovasure CRP 86140 30

Tacrolimus (FK-506) (Prograff) 80197 3269

Tobramycin 80200 7

Ureaplasma species by PCR 87798 2

Urogenital Ureaplasma and Mycoplasma Species by

PCR

87563 4

Varicella Zoster Virus by PCR-Qualitative 87798 130

Viral Culture - Non-Respiratory 87252 271

Viral Culture - Respiratory 87252 138

Yeast ID1 87106 33

5. Licensing and Accreditation The Contractor shall assure compliance of all procedures and practices by the following accrediting agencies, and the facility and employees shall have all licenses, permits, accreditation, professional certifications and qualifications required by federal and state law to provide laboratory testing and consult services. This includes:

A. Accreditation by College of American Pathologists (CAP) B. Accreditation by Clinical Laboratory Improvement Amendment (CLIA)

6. Contractor Qualification Requirements A. The pathologists for interpretive reports and/ or on-site consultation must have an unrestricted license to practice medicine in one of the states or territories of the United States of District of Columbia.

B. The pathologist(s) providing neuropathology consultation must be board-certified in neuropathology. It is desired the pathologist(s) have at least 5 years of experience in neuropathology.

C. Consultant anatomic pathologists must have national reputations in their areas of specialization, as evidenced by ongoing publication in academic journals and/ or presentations at national pathology meetings. Special attention will be paid to expertise in transplant and gynecologic pathology.

D. The qualifications of such personnel shall also be subject to review by MVAHCS Medical Center Laboratory Director. MVAHCS reserves the right to approve the assignment of individual personnel furnished by the Contractor to perform the functions specified in the contract.

7. Test Sample Preparation The MVAHCS shall be responsible for providing laboratory specimens prepared in accordance with the contractor’s Laboratory User’s Manual. All specimens will be properly identified and labeled for testing. The contractor’s laboratory shall have the following information available: current test menu with reference ranges, specimen requirements, and special instructions, if any. Paper requisition forms shall be available if requested.

8. Transport of Specimens

Turnaround times are the utmost importance for these testing needs. The MVAHCS requires a laboratory to be local to meet STAT turn around requirements. The contractor’s laboratory is required to be within 20 miles of the MVAHCS. STAT courier service is required to be included for no additional charge and must be available 24/7, including weekends and Federal holidays. MVAHCS will request services as needed, and pickup is expected to be within 45 minutes of request. Routine courier service is required to be included for no additional charge and must include two daily pickups Mon-Fri, then one daily pickup Saturday, Sunday, and Federal Holidays. Morning and afternoon pickup times are preferred.

9. Acceptable Turn Around Times It is essential that turnaround times for test reporting be adequate to meet the patient care needs of MVAHCS. Contractors who can meet or exceed these requirements will be rated more favorably.

A. STAT: Results reported within 3 hours of specimen receipt.

• Tests that fall under this category: Amikacin, Methotrexate, Tobramycin, Beta-2-transferrin, Ketone Beta hydroxybutyrate and Osmolality (serum & urine) B. Urgent: Results reported within 24 hours of specimen receipt.

• Tests that fall under this category: Cyclosporine, Sirolimus, Tacrolimus and Everolimus.

C. Special:

• Quantitative Cryoglobulin levels with identification are to be reported within 7 days of specimen receipt.

• Final surgical pathology consultation reports are to be completed within 4 working days of specimen receipt for cases not requiring additional studies.

D. Routine: To be performed as part of regular testing procedures

• All tests not specified above fall into this category.

10. Reporting of Test Results A report is defined as a printed final copy of pathology interpretive consult. Consult reports shall be sent by contractor to a secured MVAHCS Laboratory FAX # 612-467-5945. If results are telephoned prior to sending, the written report must include the name of the individual notified of the results, date and time of telephone report. Each consult report shall at a minimum indicate the following information:

A. Patient’s name and identification code B. Physician’s name (if supplied) C. VA Medical Center name D. Patient’s location, e.g. clinic, ward (if supplied) E. Test ordered F. Date/time of specimen collection G. Date/time specimen received in Reference Lab H. Date test completed I. Test result J. Flag abnormal results

K. Reference Range L. Toxic and/or therapeutic range where applicable M. Name of testing laboratory (contractor and/or subcontractor) N. Testing laboratory specimen number O. Type of specimen P. Comments related to the test provided by the submitting lab Q. Information that may indicate a questionable validity of test results R. Unsatisfactory specimen shall be reported with reason as to its unsuitability for testing

If the vendor has a web-based portal for ordering and sending results, this can only be utilized by MVAHCS if the ISO (Informational Security Officers) find the web portal to be acceptable for use by MVAHCS. If the ISOs determine the portal is not acceptable, no additional charges will be incurred to the government for the use of FAX and paper copies for ordering and receiving test results.

11. Quality Control To ensure proper handling and test performance, the contractor shall provide the following updated information upon request during the life of the contract:

A. For quality purposes, tests routinely performed in duplicate should be indicated.

B. Coefficient of variation of quality control samples of all tests or specified tests the laboratory performs.

C. Proficiency testing data shall include a list of tests outside of the ± 2 SD range for the past two years. Contractor shall notify the laboratory of any test falling outside ± 2 SD range during the contract period.

D. Contractor shall provide address of processing sites under contract, including subcontracted testing location sites.

E. The contractor(s) facilities, methodologies (defined as the principal of the method and references), and quality control procedures may be examined by representatives of the VA at any time during the life of the contract.

F. Contractor agrees to maintain the minimum acceptable service, reporting systems and quality controls as specified herein. Immediate (within 24 hours) notification must be given to VA upon adverse action by a regulatory agency.

12. Testing Summaries Contractor shall provide the MVAHCS with a testing summary report as requested. At the end of each contract year, a cumulative (year-to-date) report shall be submitted to the MVAHCS providing the name of test ordered, price of test, cumulative totals and a total of all funds spent by the MVAHCS on laboratory testing services.

13. Testing or Contract Changes The Contractor shall advise the MVAHCS of any changes in assay methodology, procedures, reference ranges and any new tests introduced. If the contractor changes the assay procedures or a critically important component of an assay (e.g., an antibody, purified antigen, etc.) the contractor shall notify the VA Contracting Office and the MVAHCS prior to the intended change. Documentation shall be provided that the quality and efficacy of the test will remain unchanged or be improved. Changes that have not been reviewed and pre-approved by MVAHCS and mutually agreed upon in writing between the contractor and the VA Contracting Officer, may be sufficient cause for the MVAHCS to use an alternate contractor for that specific test for the duration of the contract.

The MVAHCS may require a test not listed in the Schedule of Items but is available from the contractor’s Laboratory User’s Manual. In this event, MVAHCS will send it out under the contract using the open market list price and apply it towards the Misc Line Item.

MVAHCS will track usage and submit annual requests to VA contracting to update the Schedule of Items via a contract modification. These tests will be considered part of the overall contract value and together with the other tests cannot exceed the total estimated contract value.

Changes in the terms and conditions of this contract may be made only by written agreement of both parties. Contractor must submit requests for changes in writing to the VA Contracting Office. All modifications to this contract must be approved and prepared by the VA Contracting Officer for signature.

14. Contractor Telephone Numbers Contractor shall provide telephone number(s) and contact person(s) to be used by the MVAHCS for specimen inquiries, and Lab Technical/Pathologist consultation. There must be someone available at the number(s) always provided including weekends and holidays.

Phone Number Specimen Inquiries: __________________________

Lab Technical Director/Pathologists: __________________________

15. Subcontracting Approval If Contractor intends to use a subcontractor to provide any of the testing required under this contract, Contractor shall be responsible for finding a subcontractor laboratory with appropriate licensure and accreditation. Contractor shall notify the VA Contracting Office of any plan to use a subcontractor or make a subcontractor change, and request a prior acceptance and approval from VA.

Contractor will use the following subcontractor(s):

16. Quality Assurance

The government will evaluate the Contractor’s performance under this contract and the Contractor performance will be monitored to determine if it meets the contract standards. A variety of methods may be used. Nonperformance or substandard task performance will be documented if and when it occurs. The Technical Representative will follow the methods of surveillance specified in the Performance Measures.

17. Government Roles and Responsibilities The MVAHCS shall designate a Technical Representative to coordinate and monitor the work to be completed under this contract. Rachel Pike, Laboratory Contract Liaison has been designated as the representative to coordinate these services. Her contact information is listed below.

Technical Representative:

Rachel Pike, MLS (ASCP)

Laboratory Contract Liaison / Lead Medical Technologist

Minneapolis VA Health Care System

One Veterans Drive

Minneapolis, MN 55417

612-467-5989

Rachel.pike@va.gov

18. Performance Measures The following performance measures will be regularly tracked and monitored throughout the effective period of this contract by the Technical Representative and reported to the Contracting Officer. Acceptable performance on these measures, along with other factors, will be primary indices of contractor performance and a key consideration in contract renewal decisions. Performance will be monitored using the following criteria:

Action/Test/Report Turnaround time (TAT) Acceptable Performance

STAT test for drug levels (Amikacin, Tobramycin, Methotrexate, Beta-2-

Transferrin, Ketone Beta Hydroxybutyrate and

Osmolality (serum & urine))

Within 3 hours of specimen receipt.

80% of all stat tests submitted

Urgent drug levels

(Cyclosporine, Sirolimus, Tacrolimus and Everolimus)

Within 24 hours of specimen receipt.

80% of all urgent tests submitted

Quantitative Cryoglobulin levels with identification

Within 7 days of specimen receipt 80% of all tests

Final surgical pathology consultation report completion

Within 4 working days of specimen receipt for cases not requiring additional studies

80% of all consults

19. Ordering Procedures This contract does not obligate any funding; therefore, the Contractor shall provide services under this contract only as directed in task orders. Task orders for bulk dollar amounts will be issued during the contract period. Any warranted VA Contracting Officer is authorized to issue task orders under this contract. The Minneapolis laboratory personnel may place verbal orders with the contractor to meet their testing needs, up to the bulk task order total. The contractor will be required to inform the VA contract specialist or contracting officer when each task order reaches 80% of the total bulk dollar amount.

In accordance with FAR 16.505, each task order will include the following: (i) Date of order

(ii) Contract number and order number (iii) Contract item number and description, quantity, and unit price or estimated cost or fee (iv) Delivery or performance date (v) Place of delivery or performance (including consignee) (vi) Packaging, packing, and shipping instructions, if any

(vii) Accounting and appropriation data (viii) Method of payment and payment office, if not specified in the contract (ix) Any other pertinent information.

Invoices shall be sent to:

Financial Services Center P O Box 149971 Austin TX 78714-9971 Customer Service Phone: 877-353-9791

Contractor must furnish a designated point of contact for placing orders. Orders for laboratory testing services shall be sent to Contractor through the contact person listed below at the following address:

(Offeror to complete)

Vendor’s Contact Person: ____________________

Telephone Number: _______________

FAX Number: ______________

Address: _____________________

20. Safety and Security Requirements

Contractor will adhere to the applicable provisions of Public Law 104-191, Health Insurance Portability and Accountability Act (HIPAA) of 1996 and the National Standards to Protect the Privacy and Security of Protected Health Information (PHI). As required by HIPAA, the Department of Health and Human Services (HHS) has promulgated rules governing the security, use and disclosure of protected health information by covered entities, including the Department of Veterans Affairs (VA). As defined in the Health Insurance Portability and Accountability Act (HIPAA) Public Law 104-191, your company may be required to execute a Business Associate Agreement.

VA Information and Information System Security / Privacy Language

VA HANDBOOK 6500.6 APPENDIX C MARCH 12,2010

1. GENERAL

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

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

a. A contractor / subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

b. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

c. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness.

d. Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor.

e. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor’s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.

B.3 PRICE/COST SCHEDULE

FILL OUT/COMPLETE ATTACHMENT D.1 SCHEDULE OF SERVICES Per FAR 16.504 The Department of Veterans Affairs has set the ceiling limitation for this IDIQ at $2,000,000.00 for the lifetime of this contract. The total of all orders placed against this IDIQ will not exceed this ceiling of $2,000,000.00. The guaranteed minimum value of this contract is set at $200,000.00

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

1.00 YR __________________ __________________

Specialized laboratory testing and consultation services for the Minneapolis VA.

(See Attached D.1 Schedule of Service for individual CLINs) Contract Period: Base POP Begin: 09-01-2024 POP End: 08-31-2025 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories PRODUCT/SERVICE CODE: Q301 - Medical - Reference Laboratory Testing

Minneapolis VA.

(See Attached D.1 Schedule of Service for individual CLINs) Contract Period: Option 1 POP Begin: 09-01-2025 POP End: 08-31-2026 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories

Minneapolis VA.

(See Attached D.1 Schedule of Service for individual CLINs) Contract Period: Option 2 POP Begin: 09-01-2026 POP End: 08-31-2027 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories

Minneapolis VA.

(See Attached D.1 Schedule of Service for individual CLINs) Contract Period: Option 2 POP Begin: 09-01-2027 POP End: 08-31-2028 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories

Minneapolis VA.

(See Attached D.1 Schedule of Service for individual CLINs) Contract Period: Option 3 POP Begin: 09-01-2028 POP End: 08-31-2029 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories

GRAND TOTAL __________________

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES (NOV 2023)

(a) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The Government must exercise its post-acceptance rights—

(1) Within a reasonable time after the defect was discovered or should have been discovered;

and

(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.

(b) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in accordance with the Assignment of Claims Act (31 U.S.C. 3727). However, when a third party makes payment (e.g., use of the Governmentwide commercial purchase card), the Contractor may not assign its rights to receive payment under this contract.

(c) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of the parties.

(d) Disputes. This contract is subject to 41 U.S.C. chapter 71, Contract Disputes. Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal or action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause at Federal Acquisition Regulation (FAR) 52.233-1, Disputes, which is incorporated herein by reference. The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract.

(e) Definitions. The clause at FAR 52.202-1, Definitions, is incorporated herein by reference.

(f) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence such as, acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify the Contracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the Contracting Officer of the cessation of such occurrence.

(g) Invoice.

(1) The Contractor shall submit an original invoice and three copies (or electronic invoice, if authorized) to the address designated in the contract to receive invoices. An invoice must include—

(i) Name and address of the Contractor;

(ii) Invoice date and number;

(iii) Contract number, line item number and, if applicable, the order number;

(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading;

(vi) Terms of any discount for prompt payment offered;

(vii) Name and address of official to whom payment is to be sent;

(viii) Name, title, and phone number of person to notify in event of defective invoice; and

(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract.

(x) Electronic funds transfer (EFT) banking information.

(A) The Contractor shall include EFT banking information on the invoice only if required elsewhere in this contract.

(B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the Contractor shall have submitted correct EFT banking information in accordance with the applicable solicitation provision, contract clause (e.g., 52.232-33, Payment by Electronic Funds Transfer—System for Award Management, or 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management), or applicable agency procedures.

(C) EFT banking information is not required if the Government waived the requirement to pay by EFT.

(2) Invoices will be handled in accordance with the Prompt Payment Act (31 U.S.C. 3903) and Office of Management and Budget (OMB) prompt payment regulations at 5 CFR part 1315.

(h) Patent indemnity. The Contractor shall indemnify the Government and its officers, employees and agents against liability, including costs, for actual or alleged direct or contributory infringement of, or inducement to infringe, any United States or foreign patent, trademark or copyright, arising out of the performance of this contract, provided the Contractor is reasonably notified of such claims and proceedings.

(i) Payment.—

(1) Items accepted. Payment shall be made for items accepted by the Government that have been delivered to the delivery destinations set forth in this contract.

(2) Prompt payment. The Government will make payment in accordance with the Prompt Payment Act (31 U.S.C. 3903) and prompt payment regulations at 5 CFR part 1315.

(3) Electronic Funds Transfer (EFT). If the Government makes payment by EFT, see 52.212- 5(b) for the appropriate EFT clause.

(4) Discount. In connection with any discount offered for early payment, time shall be computed from the date of the invoice. For the purpose of computing the discount earned, payment shall be considered to have been made on the date which appears on the payment check or the specified payment date if an electronic funds transfer payment is made.

(5) Overpayments. If the Contractor becomes aware of a duplicate contract financing or invoice payment or that the Government has otherwise overpaid on a contract financing or invoice payment, the Contractor shall—

(i) Remit the overpayment amount to the payment office cited in the contract along with a description of the overpayment including the—

(A) Circumstances of the overpayment (e.g., duplicate payment, erroneous payment, liquidation errors, date(s) of overpayment);

(B) Affected contract number and delivery order number, if applicable;

(C) Affected line item or subline item, if applicable; and

(D) Contractor point of contact.

(ii) Provide a copy of the remittance and supporting documentation to the Contracting Officer.

(6) Interest.

(i) All amounts that become payable by the Contractor to the Government under this contract shall bear simple interest from the date due until paid unless paid within 30 days of becoming due. The interest rate shall be the interest rate established by the Secretary of the Treasury as provided in 41 U.S.C. 7109, which is applicable to the period in which the amount becomes due, as provided in (i)(6)(v) of this clause, and then at the rate applicable for each six-month period as fixed by the Secretary until the amount is paid.

(ii) The Government may issue a demand for payment to the Contractor upon finding a debt is due under the contract.

(iii) Final decisions. The Contracting Officer will issue a final decision as required by 33.211 if—

(A) The Contracting Officer and the Contractor are unable to reach agreement on the existence or amount of a debt within 30 days;

(B) The Contractor fails to liquidate a debt previously demanded by the Contracting Officer within the timeline specified in the demand for payment unless the amounts were not repaid because the Contractor has requested an installment payment agreement; or

(C) The Contractor requests a deferment of collection on a debt previously demanded by the Contracting Officer (see 32.607-2).

(iv) If a demand for payment was previously issued for the debt, the demand for payment included in the final decision shall identify the same due date as the original demand for payment.

(v) Amounts shall be due at the earliest of the following dates:

(A) The date fixed under this contract.

(B) The date of the first written demand for payment, including any demand for payment resulting from a default termination.

(vi) The interest charge shall be computed for the actual number of calendar days involved beginning on the due date and ending on—

(A) The date on which the designated office receives payment from the Contractor;

(B) The date of issuance of a Government check to the Contractor from which an amount otherwise payable has been withheld as a credit against the contract debt; or

(C) The date on which an amount withheld and applied to the contract debt would otherwise have become payable to the Contractor.

(vii) The interest charge made under this clause may be reduced under the procedures prescribed in FAR 32.608-2 in effect on the date of this contract.

(j) Risk of loss. Unless the contract specifically provides otherwise, risk of loss or damage to the supplies provided under this contract shall remain with the Contractor until, and shall pass to the Government upon:

(1) Delivery of the supplies to a carrier, if transportation is f.o.b. origin; or

(2) Delivery of the supplies to the Government at the destination specified in the contract, if transportation is f.o.b. destination.

(k) Taxes. The contract price includes all applicable Federal, State, and local taxes and duties.

(l) Termination for the Government's convenience. The Government reserves the right to terminate this contract, or any part hereof, for its sole convenience. In the event of such termination, the Contractor shall immediately stop all work hereunder and shall immediately cause any and all of its suppliers and subcontractors to cease work. Subject to the terms of this contract, the Contractor shall be paid a percentage of the contract price reflecting the percentage of the work performed prior to the notice of termination, plus reasonable charges the Contractor can demonstrate to the satisfaction of the Government using its standard record keeping system, have resulted from the termination. The Contractor shall not be required to comply with the cost accounting standards or contract cost principles for this purpose. This paragraph does not give the Government any right to audit the Contractor's records. The Contractor shall not be paid for any work performed or costs incurred which reasonably could have been avoided.

(m) Termination for cause. The Government may terminate this contract, or any part hereof, for cause in the event of any default by the Contractor, or if the Contractor fails to comply with any contract terms and conditions, or fails to provide the Government, upon request, with adequate assurances of future performance. In the event of termination for cause, the Government shall not be liable to the Contractor for any amount for supplies or services not accepted, and the Contractor shall be liable to the Government for any and all rights and remedies provided by law. If it is determined that the Government improperly terminated this contract for default, such termination shall be deemed a termination for convenience.

(n) Title. Unless specified elsewhere in this contract, title to items furnished under this contract shall pass to the Government upon acceptance, regardless of when or where the Government takes physical possession.

(o) Warranty. The Contractor warrants and implies that the items delivered hereunder are merchantable and fit for use for the particular purpose described in this contract.

(p) Limitation of liability. Except as otherwise provided by an express warranty, the Contractor will not be liable to the Government for consequential damages resulting from any defect or deficiencies in accepted items.

(q) Other compliances. The Contractor shall comply with all applicable Federal, State and local laws, executive orders, rules and regulations applicable to its performance under this contract.

(r) Compliance with laws unique to Government contracts. The Contractor agrees to comply with 31 U.S.C. 1352 relating to limitations on the use of appropriated funds to influence certain Federal contracts; 18 U.S.C. 431 relating to officials not to benefit; 40 U.S.C. chapter 37, Contract Work Hours and Safety Standards; 41 U.S.C. chapter 87, Kickbacks; 49 U.S.C. 40118, Fly American; and 41 U.S.C. chapter 21 relating to procurement integrity.

(s) Order of precedence. Any inconsistencies in this solicitation or contract shall be resolved by giving precedence in the following order:

(1) The schedule of supplies/services.

(2) The Assignments, Disputes, Payments, Invoice, Other Compliances, Compliance with Laws Unique to Government Contracts, and Unauthorized Obligations paragraphs of this clause;

(3) The clause at 52.212-5.

(4) Addenda to this solicitation or contract, including any license agreements for computer software.

(5) Solicitation provisions if this is a solicitation.

(6) Other paragraphs of this clause.

(7) The Standard Form 1449.

(8) Other documents, exhibits, and attachments

(9) The specification.

(t) [Reserved]

(u) Unauthorized Obligations.

(1) Except as stated in paragraph (u)(2) of this clause, when any supply or service acquired under this contract is subject to any End User License Agreement (EULA), Terms of Service (TOS), or similar legal instrument or agreement, that includes any clause requiring the Government to indemnify the Contractor or any person or entity for damages, costs, fees, or any other loss or liability that would create an Anti-Deficiency Act violation (31 U.S.C. 1341), the following shall govern:

(i) Any such clause is unenforceable against the Government.

(ii) Neither the Government nor any Government authorized end user shall be deemed to have agreed to such clause by virtue of it appearing in the EULA, TOS, or similar legal instrument or agreement. If the EULA, TOS, or similar legal instrument or agreement is invoked through an “I agree” click box or other comparable mechanism (e.g., “click-wrap” or “browse-wrap” agreements), execution does not bind the Government or any Government authorized end user to such clause.

(iii) Any such clause is deemed to be stricken from the EULA, TOS, or similar legal instrument or agreement.

(2) Paragraph (u)(1) of this clause does not apply to indemnification by the Government that is expressly authorized by statute and specifically authorized under applicable agency regulations and procedures.

(v) Incorporation by reference. The Contractor’s representations and certifications, including those completed electronically via the System for Award Management (SAM), are incorporated by reference into the contract.

(End of Clause)

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

PRODUCTS AND COMMERCIAL SERVICES

Clauses that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

The following clauses are incorporated into 52.212-4 as an addendum to this contract:

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

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

https://www.acquisition.gov/browse/index/far https://www.va.gov/oal/library/vaar/

(End of Clause)

FAR

Number

Title Date

52.203-17 CONTRACTOR EMPLOYEE WHISTLEBLOWER RIGHTS NOV 2023

52.204-13 SYSTEM FOR AWARD MANAGEMENT MAINTENANCE OCT 2018

52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE

MAINTENANCE

AUG 2020

C.3 52.216-18 ORDERING (AUG 2020)

(a) Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery orders or task orders by the individuals or activities designated in the Schedule. Such orders may be issued from 09/01/2024 through 08/31/2029.

(b) All delivery orders or task…