The North Texas VA Health Care System (NTVAHCS) in Dallas, Texas is seeking Service Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB), or Small Business sources capable of meeting the requirement listed below. The acquisition will be accomplished using commercial item procedures in accordance with FAR Part 12.

NOTE: TO QUALIFY SDVOSB AND VOSB VENDORS MUST BE CERTIFIED IN THE VA VENDOR INFORMATION PAGES (VIP) DATABASE.

The North American Industry Classification System (NAICS) is 621511. Any SDVOSB, VOSB, or Small Business firms who wish to identify their interests and capability to provide this product must provide product specifications, performance and delivery information by notifying the Contract Specialist no later than NOON PM Central Time, January 6, 2021. Notification shall be e-mailed to Robyn Nussbaum, at robyn.nussbaum@va.gov.

Any vendor who responds to this Notice must provide credentials to perform the requirement as outlined in the below scope.

DISCLAIMER

This Sources Sought Notice is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this Notice that is marked as proprietary will be handled accordingly. In accordance with the Federal Acquisition Regulation, responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this Notice.

SCOPE:

SECCTION A:

The purpose of this contract is to provide to veteran patients quality laboratory services. Contractor is to provide healthcare resources in accordance with Public Law 104.262 and 38 U.S.C. 8153. Contractor agrees to provide the following laboratory procedures/tests in support of the VA North Texas Health Care System (VANTHCS) in Dallas, Texas.

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

Contractor shall perform and provide results for, but not limited to, the following procedures/tests:

CPT Code
Service Description
Est. Annual Quantity
034521
Cytology Pap Gyn
2160
034004
HPV High Risk
1150

Contractor shall provide laboratory services to the Pathology & Laboratory Medicine Service of the VA North Texas Health Care System, Department of Veterans Affairs Medical Center, located at 4500 S. Lancaster Road, Dallas, Texas. Tests will be performed as prescribed by the VA attending physician.

Contractor shall provide laboratory services to include analysis, reporting of analytic results, and consultation regarding selection, collection, transportation and result interpretation.

Contractor will consult with VANTHCS laboratory personnel on test results as needed.

Contract shall cover a one-year base period and will be renewable for (4) option years. Pricing will be provided for the base year and each option year.

The volumes listed are independent government estimates and VA North Texas Health Care System (VANTHCS) makes no guarantee as to what volume of tests, if any, the contractor may receive. VANTHCS reserves the right to request additional tests other than those listed within. If additional tests are added, either by the contractor or VANTHCS, the contractor will provide appropriate CPT codes for the new tests.

Contractor shall provide all labor, equipment, and materials required to perform procedures/tests as stated herein.

These procedures/tests shall be performed to the satisfaction of VA North Texas Health Care System (VANTHCS) Pathology & Laboratory Medicine Service, Chief of Staff, and the Contracting Officer s Representative (COR).

Services rendered will be verified by a record keeping system maintained by Pathology & Laboratory Medicine Service and Fiscal Service at VANTHCS, which assures that the VA pays for only those services requested, and only for valid patients of VANTHCS.

Contractor shall provide to the COR the methodology and ranges for results on any tests that are requested.

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

SECTION B: DESCRIPTION/SPECIFICATIONS

DEFINITIONS:

LAB ADVISORY COMMITTEE: An individual or group of laboratory directors (Chiefs) or their designees that evaluate the medical/technical/service/quality qualifications of offerors labs. During the life of the contract, this group monitors the quality and service provided by the contractor.

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

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

VA North Texas Health Care System
Contracting Officer
4500 S. Lancaster Road
Dallas, Texas 75216

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

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

Patient s full name
Physician name
Type of specimen
Patient s Social Security Number
Patient Date of Birth
Requesting Facility

REPORTING OF LAB REPORTS RESULTS: All lab reports shall be reported via fax, and a hard copy of all lab results shall be sent via mail.

CLINIC CONTACTS: Contractor shall consult with the VANTHCS Laboratory Manager on test results via phone as needed. The contractor can contact the providers at: (214) 857-0666.

CONTRACTOR POINT OF CONTACT: Contractor shall provide the following point (s) of contact when immediate inquiry regarding the status of a pending test (s) is required:

Person (s) name (s): TBD
Telephone number: TBD
Fax number: TBD

PAYMENT: The VA shall not be responsible for payment for services which were not requested in accordance with contract.

TRANSPORTATION OF SPECIMENS: Contractor shall transport specimens in such a manner as to ensure the integrity of the specimen. Frozen specimens shall be shipped on dry ice, provided by contractor. Contractor is also responsible for completing hazardous goods forms and proper labeling.

LICENSING AND ACCREDITATION:

Contractor shall have all licenses, permits, accreditation and certificates required by law.
Personnel assigned by the contractor to perform these services covered under this contract shall be licensed in a State, Territory or Commonwealth of the United States or the District of Columbia.
The lab must be accredited by the College of American Pathologist (CAP) or have Joint Commission and Clinical Laboratory Improvement Amendments (CLIA) (Public Law 100-578) certifications or CLIA waiver. Contractor must submit proof of Joint Commission and CLIA certifications/waiver along with their offer.
Laboratory Director shall be a licensed pathologist, physician, or biologist.

QUALITY CONTROLS:

By the 20th of each month following the end of the quarter, the contractor shall provide to the COR a cumulative (year-to-date) summary report by test. The report shall include the TAT for each test order during that quarter.
The VA shall have access to inspect the contractor s facilities, equipment and records. The results of these inspections shall be published and given to the contractor.
Contractor shall immediately advise the COR of any changes in methodology, procedure, reference ranges and any new test introduced, including CPT code.
Contractor shall provide the following information upon request during the life of the contract:

For quality purposes, tests routinely performed in duplicate should be indicated.
Indication of average monthly volume of specified tests listed in this contract.
Coefficient of variation of quality control samples of all tests or specified tests the laboratory performs.
Provide address of processing sites under contract, including subcontracted testing location sites.
Proficiency testing data shall include a list of tests outside of the -+2SD range for the past two (2) years. Contractor shall notify lab of any test falling outside -+2SD range during contract period.
The contractor(s) facilities, methodologies (defined as the principal of the method and the references), and quality control procedures may be examined by representative of the VA at any time during the life of the contract.

The contractor shall always provide telephone number(s) and contact personnel to the VANTHCS laboratory to make specimen problem inquiries and problem solving, including weekends and holidays.

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

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

Contractor shall assign a specific local account representative to each facility.

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

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

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

Contract number
Patient(s) Name(s)
Social Security Number
Proper CPT and LOINC Code
Unit Cost
Total Cost
Date of Service

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

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

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

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

NARA Records Management Language for Contracts (May 2017)

1. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

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

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

4. VA North Texas and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of VA North Texas or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701.
In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to VA North Texas. The agency must report promptly to NARA in accordance with 36 CFR 1230.

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

6. The Contractor is required to obtain the Contracting Officer’s approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and VA North Texas guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

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

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

9. The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.

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

11. Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take VHA-provided records management training, Talent Management System (TMS) Item #3873736, Records Management for Records Officers and Liaisons. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

References:
VHA Directive 6300
VA Handbook 6300.1
North Texas VA Medical Center Policy
VA Directive 6500
36 CFR Part 1222.32 (b)