S02 36C25622Q0525 v1.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. 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

36C25622Q0525 04-06-2022

Christopher Vu 713-770-2830 04-18-2022 3:00pm CST

36C256 Department of Veterans Affairs Network Contracting Office 16 Michael E. DeBakey VA Medical Center 2002 Holcombe Boulevard Houston TX 77030 4298

X

621511

$35 Million

N/A

36C580

Department of Veterans Affairs Michael E. DeBakey VA Medical Center Receiving Warehouse Building 100 2002 Holcombe Boulevard Houston TX 77030-4298

36C256

Department of Veterans Affairs Network Contracting Office 16 Michael E. DeBakey VA Medical Center

Houston TX 77030 4298

FSC e-Invoice Payment http://www.fsc.va.gov/fsc/einvoice.asp Invoice Setup Information 1-877-489-6135 Invoice must be submitted electronically

1-877-489-6135 NA

See CONTINUATION Page

Contractor shall provide Anatomic Pathology Referral Laboratory Testing Services in support of the Michael E.

DeBakey Veterans Affairs Medical Center in accordance with the Performance Work Statement.

For solicitation submission requirements and evaluation factors for this solicitation reference page 32 and page 42.

This acquisition is in accordance with Federal Acquisition Regulation (FAR) 12 and 13.5.

See CONTINUATION Page

Frank Mendoza

VA-VHA-2021-60E358EC

36C25622Q0525

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 PRICE/COST SCHEDULE

ITEM INFORMATION

B.3 PERFORMANCE WORK STATEMENT (PWS)

SECTION C - CONTRACT CLAUSES

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

AND COMMERCIAL SERVICES (NOV 2021)

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

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 VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA

ACQUISITION OF COMMERCIAL ITEMS (APR 2020)

C.6 VAAR 852.219-75 SUBCONTRACTING COMMITMENTS MONITORING AND

COMPLIANCE (JUL 2018)

C.7 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020)

C.8 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (JAN 2022) (JUL 2021)

(DEVIATION)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

D.1 QUALITY ASSURANCE SURVEILLANCE PLAN

D.2 PAST PERFORMANCE QUESTIONNAIRE

D.3 WAGE DETERMINATION

D.2 SMALL BUSINESS SUBCONTRACTING PLAN CERTIFICATION

SECTION E - SOLICITATION PROVISIONS

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

COMMERCIAL SERVICES (NOV 2021)

E.2 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

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

E.4 52.216-1 TYPE OF CONTRACT (APR 1984)

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

E.6 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.7 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2021)

E.8 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL

ITEMS (FEB 2021) (JUL 2020) (DEVIATION)

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:

Phone: ____________________________________

Email: ____________________________________

SAM UEI Number: ____________________________

TAX ID: __________________________________

b. GOVERNMENT:

Christopher Vu, Contracting Officer Department of Veterans Affairs Network Contracting Office 16 (NCO 16) 5075 Westheimer Road, Suite 750 (90C) Houston, TX 77056

Phone: 713-770-2830 Email: christopher.vu2@va.gov

Peter Basten, Contracting Officer’s Representative Department of Veterans Affairs Pathology and Laboratory Section 2002 Holcombe Boulevard Houston, TX 77030

Phone: 713-791-1414 x24392 Email: peter.basten@va.gov

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor shall be electronically reimbursed:

[X} 52.232-33, Payment by Electronic Funds Transfer- System For Award

Management

[ ] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly [ ] mailto:christopher.vu2@va.gov mailto:peter.basten@va.gov

b. Semi-Annually [ ]

c. Other [ x ] Monthly in arrears.

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.

5. SECURE FAX: Please review VA Handbook 6500 that requires the following statement on all fax cover sheets be included: This fax is intended only for the use of the person or office to which it is addressed and may contain information that is privileged, confidential, or protected by law. All others are hereby notified that the receipt of this fax does not waive any applicable privilege or exemption for disclosure and that any dissemination, distribution, or copying of this communication is prohibited. If you have received this fax in error, please notify this office immediately at the telephone number listed above.

6. The Contracting Officer will schedule a post award orientation for contract orientation purposes as required by VA Acquisition Manual, Part M842.502-70.

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

AMENDMENT NO DATE

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT

NTE

UNIT PRICE

NTE

AMOUNT

12.00 MO __________________ __________________

Estimated monthly Anatomic Pathology Testing Services Specializing in

Renal Biopsy according to the CPRR firm fixed price list.

Contract Period: Base POP Begin: 06-01-2022 POP End: 05-31-2023 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories PRODUCT/SERVICE CODE: Q301 - Medical - Laboratory Testing MANUFACTURER PART NUMBER (MPN): None

LOCAL STOCK NUMBER: N/A

Renal Biopsy according to the CPRR firm fixed price list.

Contract Period: Option 1 POP Begin: 06-01-2023 POP End: 05-31-2024 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories PRODUCT/SERVICE CODE: Q301 - Medical - Laboratory Testing

Renal Biopsy according to the CPRR firm fixed price list.

Contract Period: Option 2 POP Begin: 06-01-2024 POP End: 05-31-2025 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories PRODUCT/SERVICE CODE: Q301 - Medical - Laboratory Testing

Renal Biopsy according to the CPRR firm fixed price list.

Contract Period: Option 3 POP Begin: 06-01-2025 POP End: 05-31-2026 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories PRODUCT/SERVICE CODE: Q301 - Medical - Laboratory Testing

Renal Biopsy according to the CPRR firm fixed price list.

Contract Period: Option 4 POP Begin: 06-01-2026 POP End: 05-31-2027 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories PRODUCT/SERVICE CODE: Q301 - Medical - Laboratory Testing

GRAND TOTAL

Six (6) Month Extension: As indicated in contract clause FAR 52.217-8, the Government will have the option to extend the performance of the contract up to an additional six (6) months when the contractor is provided written notice. Six (6) Months extension pricing will be based on the current Option period the six (6) months extension is exercised. For purposes of the award of this contract, the Government intends to evaluate the option to extend service under FAR 52.217-8 as follows: The evaluation will consider the possibility that the option can be exercised at any time and can be exercised in increments of one (1) to six (6) months, but for no more than a total of six (6) months during the life of the contract. The evaluation will assume that the prices for any option exercised under FAR 52.217-8 will be at the same price as those in effect under the contract at the time/period the option is exercised. This evaluation will not obligate the Government to exercise any options under FAR 52.217-8.

B.3 PERFORMANCE WORK STATEMENT (PWS)

Anatomic Pathology Referral Laboratory Testing Services Specializing in Renal Biopsy

Michael E. DeBakey VA Medical Center (“MEDVAMC”)

Houston, TX 77030

1. GENERAL: This is an acquisition for non-personnel services to provide Anatomic Pathology Laboratory Testing Specializing in Renal Biopsy for Veterans at the Michael E. DeBakey VA Medical Center (“MEDVAMC”). The MEDVAMC shall not exercise any supervision or control over the contract service providers performing the services herein. Such contract service providers shall be accountable solely to the Contractor who, in turn is responsible to the MEDVAMC. As a tertiary care medical center with a complex Nephrology Section and a stand-alone VA transplant center the MEDVAMC has the Nephrology and Transplant expertise to take care of Veterans with complex renal treatment requirements, organ failure, has on-site highly successful United Network for Organ Sharing (“UNOS”) – approved kidney and liver transplant programs (catering to Veterans from all over the country), which further enhances the acuity of care provided at the MEDVAMC.

1.1 Description of Services/Introduction: The contractor shall provide all personnel, equipment, supplies, tools, materials, and supervision necessary to perform Anatomic Pathology Laboratory Testing Specializing in Renal Biopsy. The contractor shall perform to the standards in this contract.

1.2 Scope: The contractor shall provide all Anatomic Pathology Laboratory Testing Specializing in Renal Biopsy and be able to perform the following services and stains in house due to the critical nature, possible long-term complications, and the ability to determine what additional studies/stains are required or not for accurate diagnosis, at each step in the process, based on their pathological finding seen during analysis.

Full Service Light Microscopy, Immunofluorescence, Electron Microscopy (EM) for Renal Biopsy Specimens CPT Code Light Microscopy Only (x1) 88305

TC*

PC*

Special Stains (x5) (2 PAS, 1 Jones Silver, 1 SMMT, 1 Gomori Trichrome) 88313

TC*

PC*

Immunofluorescence (x1) (first antibody) 88346

TC*

PC*

Immunofluorescence Additional (x8) (IgG, IgM, IgA, C3, C1Q, Albumin, Fibrinogen, Kappa and Lambda Light Chains)

88350

TC*

PC*

Electron Microscopy Only (x1) 88348

TC*

PC*

Additional Stains (price per each) for Renal Biopsy Specimens CPT Code Additional Special Stain - each 88312

TC*

PC*

Additional Immunofluorescence (Direct) Stain - each 88350

TC*

PC*

Immunohistochemical Stain - each 88342

TC*

PC*

Additional Immunohistochemical Stain - each 88341

TC*

PC*

Note: TC is the Technical Component of the process and includes the cutting, imbedding and staining of the tissue. PC is the Professional Component of the process and includes the renal pathologist and their interpretation.

1.3 Reserved

1.4 Estimated Number of Renal Biopsy Specimens:

Base Period: 75 Option Period 1: 90 Option Period 2: 108 Option Period 3: 129 Option Period 4: 154

1.5 Hours of Operation: Contractor MUST assure adequate staffing to provide same day (Monday through Friday) continuous diagnostic and reporting capabilities for all Anatomic Pathology Laboratory Testing Specializing in Renal Biopsy at all times with Emergency weekend and Holiday cases accepted with prior arrangements. In addition, the laboratory shall provide accessibility to an Anatomic Pathologist who Specializes in Renal Biopsy to discuss clinical implications of the reported test(s).

Services shall be performed during the VA normal business hours, 8:00 a.m. through 4:30 p.m., Monday through Friday, excluding Federal holidays any scheduled work at the Government site shall not take place on Federal holidays or weekends unless directed by the Contracting Officer (CO). VA follows all Federal holidays that are set by law (USC Title 5 Section 6103).

The Government hereby provides notice and Contractor hereby acknowledges receipt that Government personnel observe the listed days as holidays:

New Year's Day January 1 Martin Luther King's Birthday Third Monday in January President's Birthday Third Monday in February Memorial Day Last Monday in May Juneteenth National Independenc Day June 19 Independence Day July 4 Labor Day First Monday in September Columbus Day Second Monday in October Veterans Day November 11 Thanksgiving Day Fourth Thursday in November Christmas December 25

*If a holiday falls on a Saturday, the preceding Friday will be treated as a holiday for pay and leave purposes. If a holiday falls on a Sunday, for most Federal employees, the following Monday will be treated as a holiday for pay and leave purposes.

In addition to the days designated as holidays, the Government observes the following days:

1. Any other day designated by Executive Order;

2. Any other day designated by the President’s Proclamation; and

3. Any other day designated by Federal Statute.

1.6 Place of Performance: The work to be performed under this contract shall be performed at the Contractors fully licensed and accredited laboratory in full compliance with the Clinical Laboratory Improvement Amendments (CLIA). Due to the critical nature Renal Biopsy Specimens cannot be sent to a subcontractor as possible long-term complications, and the Renal Pathological requirements essential to determine what additional studies/stains (if any) are critical for accurate diagnosis the contractor must have the technical expertise and extensive experience Specializing in Renal Biopsy. Renal Biopsy Specimen Test Results are extremely time sensitive as the Veteran is treated based upon the results from the Renal Biopsy Test Report. Dependent upon the Veteran’s current medical state this is a potentially life-threatening condition.

2. MEDVAMC FURNISHED ITEMS AND SERVICES:

2.1 The Contracting Officer’s Representative (“COR”) assists the Contracting Officer (“CO”) by monitoring compliance with all contract terms and conditions. The COR delegation will be issued to the contractor after award. The memorandum clearly states the role, responsibilities, and limitation of authority imposed on the COR. Only the Contracting Officer shall have the authority to negotiate changes or to modify the contract. The COR is not authorized in any way to authorize, obligate or commit any changes from the contract on behalf of the Government.

2.2 Services: Authorized personnel within the Histology department at the MEDVAMC will place the specimen into the contractor provided biopsy kit, complete the included documentation and requisition form, include pertinent clinical information and prepare the pre-paid packet for contractor pickup.

3. CONTRACTOR FURNISHED ITEMS AND RESPONSIBILITIES:

3.1 General: Contractor shall furnish all supplies, equipment and services required to perform work under this contract.

The Anatomic Pathologist Specializing in Renal Biopsy for interpretive reports must have an unrestricted license to practice medicine in one of the states or territories of the United States or District of Columbia.

The Anatomic Pathologist Specializing in Renal Biopsy analysis 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 specializing in Renal Biopsy. Sponsorship of renal pathology fellowship programs is also desirable.

Testing and Analysis must be performed by an Anatomic Pathologist Specializing in Renal Biopsy.

3.2 Contractor Qualifications:

Only fully licensed and accredited laboratories in full compliance with CLIA regulations shall actively engage in providing the specific Anatomic Pathology Referral Laboratory Testing Services Specializing in Renal Biopsy outlined in this contract. The contractor shall have all licenses, permits, accreditations, and certificates required by law to perform the required testing in place and effective at the time of offer submission. In addition, the laboratory must be certified as meeting the requirements of the Department of Health and Human Services Clinical Laboratory Improvement Act of 1988 (CLIA), a certificate of registration is not sufficient.

The contractor shall provide a copy of all relevant permits/licenses and certifications inclusive of any sanctions, current or pending, throughout the USA, with offering. Copies shall be provided with offeror submission.

The contractor shall maintain current accreditation and notify the CO immediately of any lapse or change in status of state license, Regulatory agency accreditation, CLIA certification, or clinical pathology certification. Should any license/certificate be due for renewal during the performance period of the contract, the contractor shall provide a copy of the renewed licenses/certificates to the CO prior to their expiration.

4. SPECIFIC TASKS:

4.1 Contractor shall provide all Anatomic Pathology Laboratory Testing Specializing in Renal Biopsy for the Department of Veterans Affairs at the MEDVAMC.

4.2 Contractor shall provide all necessary supplies not limited to the following (12 specimen kits at time of fully funded and executed Task Order award):

a. All forms necessary for specimen requisition

b. Kits containing all items needed to store and ship renal biopsy specimens including, but not limited to shall be provided at time of award:

i. Test Requisition Form

ii. Fixatives

iii. Containers

iv. Pre-paid FedEx Pak

v. Appropriate outer packaging

c. Special instructions for sample collection, storage, and shipment

d. Replacement of any needed supplies will be provided within 1 business day of request placed by the COR of the MEDVAMC Pathology and Laboratory Medicine Service.

4.3 Contractor shall provide services in a manner that:

a. Assures consistency of Anatomic Pathology Laboratory Testing Specializing in Renal Biopsy, quality control, and patient safety;

b. Assures adequate staffing to provide continuous availability of Anatomic Pathology Laboratory Testing Specializing in Renal Biopsy:

i. Same day Renal Biopsy Service Monday through Friday;

ii. Emergency weekend and Holiday cases accepted with prior arrangements.

c. Provides effective administration of the Testing Services Specializing in Renal Biopsy;

d. Development of effective policies and procedures for implementation of quality services;

e. All results, including EM, are available on the same day that the biopsy is received at the fully licensed and accredited laboratory in full compliance with CLIA.

4.4 Contractor shall perform to the standards in this contract for all Anatomic Pathology Referral Laboratory Testing Services Specializing in Renal Biopsy.

a. All testing performed must be FDA approved.

b. All testing must be performed according to the manufacturer’s instructions or, changes to manufacturers’ instructions have been appropriately validated and documented as required by accrediting agencies.

c. All Biopsy Services performed under this agreement shall be performed at the Contractors fully licensed and accredited laboratory in full compliance with CLIA.

d. Test result and/or report corrections shall be made with corrected reports faxed to the ordering location within 2 business days of correction request.

e. Contractor will ensure transport of sample shipment in such a manner as to ensure the integrity of the specimens (refer to section 4.2.b).

f. All results, including EM, are available on the same day that the biopsy is received at the fully licensed and accredited laboratory in full compliance with CLIA.

4.5 Contractor shall Report ALL Anatomic Pathology Laboratory Testing Specializing in Renal Biopsy Results as follows:

a. Renal Biopsy Test results shall be faxed to a secure line. Fax number will be provided following award. Reports for results previously communicated by telephone shall include the name of the individual notified of the result as well as date and time of notification.

b. Results for Renal Biopsy Specimens shall be received within 1 working day of receiving the specimen (Monday through Friday). Prior arrangements should be made for Emergency weekend and Holiday cases for the specimens sent from the Histology and/or Send Out Section of the MEDVAMC P&LMS.

c. Each test report shall include at a minimum:

• Patient’s name

• Identification number (social security number)

• Submitting Physician’s name

• Test Accession Number assigned by VA

• VA Laboratory name

• Patients’ location clinic/ward (if supplied)

• Date/Time specimen received in reference lab

• Test ordered

• Date/Time of specimen collection

• Date test completed

• Case report

• Contractor laboratory specimen number

• Name, address and CLIA number of Contractor laboratory

• Type of specimen

• Any additional comments related to case

d. Unsatisfactory specimen shall be reported with regard to its unsuitability for testing

e. The contractor shall provide all repeat testing, upon the request of the ordering facility, at no additional charge to the government.

f. Test results that are impacted because of shipping or contractor caused delays/damages shall be retested at the expense of the Contractor.

g. Test result and/or report corrections shall be made with corrected reports sent to the ordering location within 2 business days of correction request.

h. Critical Values (for example renal transplant rejection) will be verbally communicated by telephone to the submitting Pathologist &/or Nephrologist of the MEDVAMC

i. Notification by telephone to the submitting Pathologist &/or Nephrologist of the MEDVAMC of delays in testing, unsatisfactory samples, labeling or requisition errors shall be made within 24 hours of receipt of the samples from the Anatomic Pathology section of the MEDVAMC P&LMS laboratory.

j. Access to a web portal for real-time specimen status tracking. Portal shall also support reprinting of test results on an as needed basis. This shall not be the primary method of reporting test results.

4.6 Contractor shall submit invoices monthly in arrears covering the services performed under this contract to the VA’s Electronic Invoice Presentment and Payment System (IPPS) – The FSC uses a third-party contractor, Tungsten, Vendor Electronic Invoice Submission Methods.

Facsimile, e-mail, and scanned documents are not acceptable forms of submission for payment requests. Electronic form means an automated system transmitting information electronically according to the accepted electronic data transmission methods below:

• VA’s Electronic Invoice Presentment and Payment System – The FSC uses a third-party contractor, Tungsten, to transition vendors from paper to electronic invoice submission.

Please go to this website: http://www.tungsten-network.com/US/en/veterans-affairs/ to begin submitting electronic invoices, free of charge.

• A system that conforms to the X12 electronic data interchange (EDI) formats established by the Accredited Standards Center (ASC) chartered by the American National Standards Institute (ANSI). The X12 EDI Web site (http://www.x12.org).

• The Contractor shall provide an itemized invoice to the required VA invoicing address or submission online through the appropriate website within 30 days of the end of each month services were provided. The invoices shall contain the following information at a minimum:

i. Contract Number

ii. Purchase Order Number

iii. CPT Code

iv. Test Description

v. Quantity

vi. Price

4.7 Contractor shall, upon completion of testing, retain all specimens as required by Regulatory agencies. Tissue will be available for retrieval by the VA upon request.

5. QUALITY ASSURANCE:

5.1 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.

5.2 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 on a quarterly basis by the Contracting Officer Representative. 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:

No

Performance Objective Task

Performance Standard

Acceptable (minimal) Quality Level

(AQL)

Monitoring Method Met AQL

Did not meet AQL

1 Necessary supplies readily available (specimen collection kits/containers, prepaid mailers, Section 4.3.b 95%

Weekly Visual Verification by the Supervisory Histotechnologist at the

MEDVAMC

Favorable Contractor Performance Evaluation

Unfavorable Contractor Performance Evaluation etc.).

2 Verbal notification of Critical Values to ordering facility in timely manner with appropriate documentation on report. (Use N/A if no critical values for quarter)

Section 4.5.h 99% Daily review send-out log for record of deviations

Favorable Contractor Performance Evaluation

Unfavorable Contractor Performance Evaluation

3 Laboratory contacted in a timely manner, if specimen was unacceptable or test was canceled

Section 4.5d 95% Daily review send-out log for record of deviations

Favorable Contractor Performance Evaluation

Unfavorable Contractor Performance Evaluation

4 Maintains patient privacy and confidentiality and adheres to all HIPPA requirements

Zero Breaches of

HIPAA

Requirements

99%

Substantiate 100% of complaints or reported occurrences weekly

Favorable Contractor Performance Evaluation

Unfavorable Contractor Performance Evaluation

6. SAFETY AND SECURITY REQUIREMENTS:

6.1 Health Insurance Portability and Accountability Act (HIPAA) Compliance and Requirements: Contractor will adhere to the applicable provisions of Public Law 104-191, 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. If contractor’s facility is an entity that is not covered under the provisions of Public Law 104-191 HIPAA, then contractor will be required to execute a Business Associates Agreement.

Contractor certifies that his facility ( ) is ( ) is not an entity that is covered under applicable provisions of Public Law 104-191 HIPAA.

7. INDEMNIFICATION AND MEDICAL LIABILITY:

7.1 In accordance with FAR clause 52.237-7, the Contractor must have all necessary insurance coverage to operate a Pathology Laboratory. Contractor healthcare professionals and physicians providing services under this contract must be covered by medical liability insurance. Contractor must furnish the VA Contracting Officer, prior to award of contract, with a certificate of insurance from his insurance company indicating that the coverage outlined in this document has been obtained. The certificate of insurance shall demonstrate the contract physicians and facility have medical malpractice insurance, general liability, and any other pertinent special insurance certificates. (See FAR clause 52.237-7 Indemnification and Medical Liability Insurance in section C of this document.) The insurance coverage may not be changed or canceled without a thirty (30) day written notice to the VA Contracting Officer.

SECTION C - CONTRACT CLAUSES

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

PRODUCTS AND COMMERCIAL SERVICES (NOV 2021)

(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; 41 U.S.C. 4712 and 10 U.S.C. 2409 relating to whistleblower protections; 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):

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

(End of Clause)

FAR

Number

Title Date

52.203-17 CONTRACTOR EMPLOYEE WHISTLEBLOWER RIGHTS

AND REQUIREMENT TO INFORM EMPLOYEES OF

WHISTLEBLOWER RIGHTS

JUN 2020

52.204-4 PRINTED OR COPIED DOUBLE-SIDED ON

POSTCONSUMER FIBER CONTENT PAPER

MAY 2011

52.204-13 SYSTEM FOR AWARD MANAGEMENT MAINTENANCE OCT 2018

52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE

MAINTENANCE

AUG 2020

52.227-14 RIGHTS IN DATA—GENERAL MAY 2014

52.232-40 PROVIDING ACCELERATED PAYMENTS TO SMALL

BUSINESS SUBCONTRACTORS

NOV 2021

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

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 30 days of contract expiration.

(End of Clause)

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

2000)

(a) The Government may extend the term of this contract by written notice to the Contractor within 30 days of contract expiration; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 60 days before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed five (5) years.

C.5 VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA

ACQUISITION OF COMMERCIAL ITEMS (APR 2020)

(a) The Contractor agrees to comply with any provision or clause that is incorporated herein by reference to implement agency policy applicable to acquisition of commercial items or components. The following provisions and clauses that have been checked by the Contracting Officer are incorporated by reference.

[X] 852.203–70, Commercial Advertising.

[] 852.209–70, Organizational Conflicts of Interest.

[] 852.211–70, Equipment Operation and Maintenance Manuals.

[] 852.214–71, Restrictions on Alternate Item(s).

[] 852.214–72, Alternate Item(s). [Note: this is a fillable clause.]

[] 852.214–73, Alternate Packaging and Packing.

[] 852.214–74, Marking of Bid Samples.

[X] 852.215–70, Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factors.

[X] 852.215–71, Evaluation Factor Commitments.

[] 852.216–71, Economic Price Adjustment of Contract Price(s) Based on a Price Index.

[] 852.216–72, Proportional Economic Price Adjustment of Contract Price(s) Based on a Price Index.

[] 852.216–73, Economic Price Adjustment—State Nursing Home Care for Veterans.

[] 852.216–74, Economic Price Adjustment—Medicaid Labor Rates.

[] 852.216–75, Economic Price Adjustment—Fuel Surcharge.

[] 852.219–9, VA Small Business Subcontracting Plan Minimum Requirements.

[] 852.219–10, VA Notice of Total Service-Disabled Veteran-Owned Small Business Set-Aside.

[] 852.219–11, VA Notice of Total Veteran-Owned Small Business Set-Aside.

[] 852.222–70, Contract Work Hours and Safety Standards—Nursing Home Care for Veterans.

[] 852.228–70, Bond Premium Adjustment.

[] 852.228–71, Indemnification and Insurance.

[] 852.228–72, Assisting Service-Disabled Veteran-Owned and Veteran-Owned Small Businesses in Obtaining Bonds.

[X] 852.232–72, Electronic Submission of Payment Requests.

[X] 852.233–70, Protest Content/Alternative Dispute Resolution.

[X] 852.233–71, Alternate Protest Procedure.

[] 852.237–70, Indemnification and Medical Liability Insurance.

[] 852.246–71, Rejected Goods.

[] 852.246–72, Frozen Processed Foods.

[] 852.246–73, Noncompliance with Packaging, Packing, and/or Marking Requirements.

[X] 852.270–1, Representatives of Contracting Officers.

[] 852.271–72, Time Spent by Counselee in Counseling Process.

[] 852.271–73, Use and Publication of Counseling Results.

[] 852.271–74, Inspection.

[] 852.271–75, Extension of Contract Period.

[] 852.273–70,…