Core Lab/Toxicology Reagents and Supplies

Special Notice – Notice of Intent to Award a Sole Source Procurement 

The Department of Veterans Affairs, Veterans Health Administration, Network Contracting Office 17, intends to award a firm-fixed priced contract to Fisher Healthcare, for procurement of the following requirement: Procurement of Reagents, Kits and supplies for Core Lab/Toxicology Testing

1. Purpose: The North Texas Veterans Health Care System (VANTHCS) is requesting a contract for the procurement of reagents and supplies for Core Lab/Toxicology testing for the period of a base plus four option years.

2. Scope and Location: Contractor shall deliver all reagents and supplies listed below for VANTHCS Pathology & Laboratory Medicine Service to Dallas, Core Lab at 4500 Lancaster Rd., Dallas, Texas 75216. 
    
Catalog #    Description of Item    Quantity
23278401    DRI URINE CALIBRATOR NEG 25ML    12.00
23278415    DRI MULTIDRUG CALIB 2 LOW 25ML    12.00
23278413     DRI MULTIDRUG CALIB 1 25ML    12.00
23139332    DOA TOTAL QC LVL 2 6X18ML/PK     6.00
23139333    DOA TOTAL QC LVL 3 6X18ML/PK    6.00
23139334    DOA TOTAL QC LVL 4 6X18ML/PK    6.00
23139335    DOA TOTAL QC LVL 5 6X18ML/PK    6.00
23278298    DRI MULTIDRUG LO URINE CAL 5ML    12.00
23278217    CEDIA BUPRNORPHN NEG CAL 7.5ML    16.00
23278213    CEDIA BUPRENORPHN CAL 5NG 5ML    16.00
23278211    CEDIA BUPRENORPHN CAL 20NG 5ML     16.00
23278212    CEDIA BUPRENORPHN CAL 50NG 5ML    16.00
23278214    CEDIA BUPRENORPHN CAL 75NG 5ML     16.00
23278386    DRI OXYCODONE 100 CALIB 10ML    12.00
21200414    DRI COTININE CAL KIT 6X5ML    12.00
10028874    DRI FNTNYL II NEG CAL 1X10MLRX    12.00
10028873    DRI FNTNYL II C/O CAL 1X10MLRX     12.00
21200425    CEDIA BUP II CAL 10 NG/ML 5ML     12.00
21200427    CEDIA BUP II LO HI CTRL 2X5ML     12.00
21200430    CEDIA NEG CAL II 1X75ML RX    12.00
23278278    CEDIA THC CALIBRATOR 50 15ML     12.00
23278284    CEDIA THC CTRL 50 2LVL 2X15ML    12.00
23278269    CEDIA PPX/METHDN CAL C/O 5ML    16.00
23278401    CEDIA MLTIDRUG CAL SEC LC 15ML     12.00
23278252    CEDIA NEGATIVE CALIB SC 5ML     16.00
23278262    DRI THC CALIBRATOR 50NG 25ML    12.00
23278403    CEDIA NEGATIVE CALIB LC 15ML    12.00
23278261    CEDIA MLTIDRG CAL CLIN LC 15ML    12.00
23278246    DRI ETH ALC CAL KIT 100MG 5ML     16.00
23278316     Expredia Resolve Immersion Oil    3.00
1236519    Streck Laboratories SPERM-CHEX POSTVC CTL POSNEGRX    12.00
23-285-000    Fisherbrand Superfrost Disposable Microscope Slides. Standard metric size.    40.00
12-550-143    Fisherbrand ColorFrost Microscope Slides with Clipped Corners-Blue Clipped    150.00
22-037-160    Microbiologics Microbiology QC Slides-Blood Parasite    4.00
SL90-10    HemoCue America StatSpin  SafeCrit Plastic Microhematocrit Tubes    5.00
22-274914    Abbott iCassette™ Dx Urine Drug Screen    150.00
22-911-027    BD BBL Prepared Saline Solution- 100x 5mL    3.00
L21819    BD BBL Prepared Saline Solution- 100x 1mL    5.00
L97815    Abbott BinaxNOW Legionella Urinary Antigen Test Kit    15.00
BNX852000    Abbott  BinaxNOW Legionella Urinary Antigen Test Control Swab    4.00
BNX852010    Alere Instant Technologies Inc ISCREEN UDS CONTROL LC    6.00
22-034-729    Abbott BinaxNOW Streptococcus pneumoniae Antigen Card Test Kit    15.00
BNX710000    Abbott BinaxNOW Streptococcus pneumoniae Control Swab Pack    4.00
BNX710010    Thermo Scientific MAS UA Controls-1 (60mL)    4.00
23-038-384    Thermo Scientific MAS UA Controls-2 (60mL)    4.00
23-038-381    Siemens Healthineers Multistix and Uristix Reagent Strips    60.00
AM-2166    VistaLab Technologies Pipette Tips: Macro- 10mL    25.00
22-146-323    VistaLab Technologies Pipette Tips: Macro- 5mL    60.00
22-146-688    Thermo Scientific Finntip Pipette Tips- 10µL    2.00
21-377-208    Fisherbrand Standardization Pipet Tips    10.00
02-681-135    VistaLab Technologies Pipette Tips: Sterile, Non-Filtered    10.00
22-146-358    Thermo Scientific Finntip Pipette Tips-1000µL    8.00
21-377-840    Kova Plastics by Alltrista Economy Tubes    4.00
VT87138    Kova Plastics by Alltrista Glasstic Slide 10    4.00
22-749754    Starplex Scientific False Bottom Analyzer Tube    4.00
14-375-439    Starplex Scientific False Bottom Analyzer Tube    4.00
14-375-441    Fisherbrand Sterile Disposable Standard Serological Pipets-25mL    4.00
13-678-14B    Fisherbrand Sterile Disposable Standard Serological Pipets-10mL    4.00
13-678-12E    Falcon Bacteriological Petri Dishes with Lid    10.00
08-757-100B    Methanol (HPLC), Fisher Chemical-4L    10.00
A452-4    Fisherbrand Qualitative Grade Plain Filter Paper Circles - P8 Grade    8.00
09-795J    Buffer, Reference Standard, pH 4.00 ± 0.01 at 25°C (Color Coded Red), Ricca Chemical    15.00
1501-32    Buffer, Reference Standard, pH 7.00 ± 0.01 at 25°C (Color Coded Yellow), Ricca Chemical    15.00
1551-32    Advanced Instruments Osmometer Calibration Standards-50 mOsm/kg    6.00
22-046746    Advanced Instruments Osmometer Calibration Standards-850 mOsm/kg    6.00
22-046752    Clinitrol 290 Reference Solution; Advanced Instruments    6.00
22-046749    Amcor Parafilm™ M Laboratory Film    10.00
13-374-12    Fisherbrand™ Slide Holders    10.00
12-588-25    Globe Scientific Rectangle Cover Glass    5.00
22-170-389    Fisherbrand Lens Paper    5.00
11-996    IPA (Isopropyl Alcohol), 70% v/v, Fisher Chemical    4.00
A459-500    Thermo Scientific Samco Fine Tip Transfer Pipettes. 5.4 mL, Non-sterile, 3.1 mL    4.00
13-711-29    HemoCue America Iris Sample Processing StatSpinExpress 3 and 4 Accessories: Bowl Liner    2.00
22-269-330    SEKISUI Diagnostics OSOM hCG Serum Controls    15.00
22-071-091    SEKISUI Diagnostics OSOM hCG Urine Controls    15.00
22-071-066    Fisherbrand Blood Bank Saline 0.85% - 0.9%    40.00
23-535435    Thermo Scientific Orion pH Buffer Bottles 475 mL, 4.01 ± 0.01 pH    15.00
13-301-133    Thermo Scientific Orion pH Buffer Bottles 475 mL, 10.01 ± 0.02 pH    15.00
13-079-319    Thermo Scientific Orion pH Buffer Bottles 475 mL, 7.00 ± 0.01 pH    15.00
13-641-857    Sodium Chloride, 5% w/v, Reagents    10.00
01-333-760    Thermo Scientific Orion pH Buffer Bottles 475 mL, 9.18 ± 0.01 pH    15.00
13-643-004    Thermo Scientific Orion pH Electrode Storage Solutions ROSS pH Electrode, 475 mL    5.00
13-303-160    Thermo Scientific Orion pH Electrode Filling Solution Surfactant Electrode Fill, 5 x 60 mL    5.00
13-641-755    Thermo Scientific Orion pH Electrode Cleaning Solutions il and Grease Removal (D), 4 x 60 mL    3.00
13-642-587    Quantimetrix Spinalscopics Spinal Fluid Cell Count Control Level 1    6.00
NC9643558    Quantimetrix Spinalscopics Spinal Fluid Cell Count Control Level 2    6.00
NC9643559    Med Vet International McKesson Capillary Tube Holding Tray, 24 Place, 553, 10/Box    4.00
50-304-3928    Fisherbrand™ Urine Transfer Straw    15.00
23-555-801    Sarstedt Round Bottom Polystyrene Tube without Cap    40.00
NC9054471    Sarstedt Inc Tube, 5 ml, (LxØ): 75 x 13 mm, PS, 500/pack    50.00
NC1215924    Globe Scientific Square Cover Glass    4.00
22-170-374    Sigma Aldrich Fine Chemicals Biosciences Hyaluronidase from Bovine Testes | 37326-33-3 | MFCD00131351 | 100mg    8.00
50-178-0251    Buffer, Reference Standard, pH 9.18 ± 0.01 at 25°C, Ricca Chemical    15.00
1595-16    IUPAC pH Standards, Hach Lange™ (pH 7.0)    15.00
50-199-8093    pH Buffer Standard Solutions pH 10.012, Hach Lange    15.00
50-199-8096    Advanced Instruments CAL STD 2000 MOSM 2MLX10/PK    6.00
23-046-773    Optics Planet Inc Advanced Instruments Thermal Printer Paper, FLA835    6.00
NC1155937    Advanced Instruments Micro-Sample Test Kit    20.00
22-047-530    Simport™ Scientific Polyethylene Flange Plug Caps    15.00
22-045-425    Uline 1131 Labels/Flred(8Rolls/2500)    10.00
NC0436185    Viva Products BJP-10/40 Clinical Concentrator, with pipettes    20.00
50-311-843    Sigma Aldrich Fine Chemicals Biosciences Giemsa stain    6.00
50-290-2186    Sigma Aldrich Fine Chemicals Biosciences Wright stain certified by the Biological Stain Commission | 68988-92-1 | MFCD00082143 | 100g    6.00
501784487    Methanol (Certified ACS), Fisher Chemical™ Poly Bottle    300.00
A412-4    Hach Company Filling Solution KCl 100mL    5.00
50-002-07066    Fisherbrand Premium Microcentrifuge Tubes: 1.5mL    10.00
23278300    DRI ETHYL ALC ASSAY 100ML    60.00
100040    AMPHETAMINE/ECSTASY LC     18.00
23278229    CEDIA METHADN METAB ASSAY 65ML    60.00
23278202    CEDIA AMPHET ECSTASY ASSY 65ML    50.00
23278210    CEDIA BUPRENORPHN ASSAY 65ML    60.00
23278385    DRI OXYCODONE RGT DAU 68ML    60.00
21200433    CEDIA BARB RGT KT 495ML RX    12.00
21200434    CEDIA COCANE RGT KT 1X495ML RX     12.00
21200435    CEDIA OPIATE RGT KT 1X495ML RX    12.00
21200436    CEDIA THC RGT KT 1 X 495ML    12.00
21200437    CEDIA METHADN RGT KT 495ML RX    12.00
21200438    BENZODIAZ ASSAY 1 X 495 ML     12.00
21200439    CEDIA PCP RGT KT 1 X 495ML RX    12.00
23278319    DRI COTININE ASSAY KIT 100ML    30.00
10028872    DRI FENTANYL II ASSY 1X115MLRX    60.00
*ALL reagents and supplies must perform according to manufacturer’s guidelines.

4. Period of Performance:
Base year: June 1,2026 -May 31,2027
Option Year 1: June 1, 2027- May 31,2028
Option Year 2: June 1, 2028- May 31,2029
Option Year 3: June 1, 2029- May 31,2030
Option Year 4: June 1, 2030- May 31,2031

5. Deliverables/Supplies:
All items listed in the document are to be supplied by one vendor. No substitutions of kits, supplies or reagents, or components as the request is for items used for current validated testing. Items will be ordered as needed by Core Lab staff.

6. Vendor Security Contract Requirements: This vendor requires no access to VANTHCS or any VA information system.

NO VA DATA OF ANY TYPE SHALL BE TRANSFERRED FROM THE VA.

7. 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. 

8.PERSONNEL QUALIFICATIONS: The Contractor shall be responsible for employing technically qualified personnel to perform the work specified in this SOW. The Contractor shall maintain the personnel, organization, and administrative control necessary to ensure that the work delivered meets the contract specifications and requirements. The working history of each contractor employee must contain experience directly related to the task and functions he/she intends to perform under this contract. The Government reserves the right, during the life of the resulting contract, to request work histories on any contractor employee for the purpose of verifying compliance with the above requirements; additionally, the Government reserves the right to review resumes of contractor personnel proposed to be assigned. Personnel assigned to, or utilized by, the Contractor in performance of work shall be fully capable of performing the requirements contained in the /SOWPWS in an efficient, reliable, and professional manner. The normal manner of dress is business casual.

a. Specific Personnel Qualifications Requirements –Personnel assigned to or utilized by the contractor in the performance of this contract shall, as a minimum: 
Be qualified by the contractor as capable of performing as a field service representative.

9. PERFORMANCE STANDARDS AND QUALITY MEASUREMENT: 

a.    Performance standards define desired services.  The Government performs surveillance to determine if the Contractor exceeds, meets, or does not meet these standards.  The Government shall use these standards to determine Contractor performance and shall compare Contractor performance to the Acceptable Quality Level (AQL).  The Quality Assurance Surveillance Plan (QASP) method of surveillance will be by random inspection.

b.    Performance Evaluation: After acceptance of the contract the system will be monitored for equipment performance including but not limited to; safety (recall Notifications and changes in reagents and equipment notifications), quality assurance (emergency repairs response, hot line troubleshooting response, quality of results compared to peer groups and CAP performance) and documentation (invoice accountability and invoice verification, equipment specification and user manuals), customer satisfaction (response to complaints and laboratory employees training).

10. NARA RM LANGUAGE CLAUSE: 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. 

a.    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. 

b.    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. 

c.    VA North Texas Health Care System 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 Health Care System 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. 

d.    In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to VA North Texas Health Care System.  The agency must report promptly to NARA in accordance with 36 CFR 1230.

e.    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 Health Care System 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).

f.    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 Health Care System guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

g.    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 Health Care System policy. 

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

i.    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. 

j.    The VA North Texas Health Care System 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 Health Care System shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

11. TRAINING: All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take VHA-provided records management training, Talent Management System (TMS) Item #10176, Privacy and Information Security, Rules of Behavior. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training. 

12. PRIVACY: Contractors and subcontractors must adhere to the provisions of Public Law 104-191, Health Insurance Portability and Accountability Act (HIPAA) of 1996.  This includes both the Privacy and Security Rules published by the Department of Health and Human Services (HHS).  

a.    As required by HIPAA, HHS has promulgated rules governing the use and disclosure of protected health information by covered entities, Veterans Health Administration (VHA). In accordance with HIPAA, the contractor may be required to enter into a Business Associate Agreement (BAA) with VHA.  

b.    Business associates must follow VHA privacy policies and practices when applicable. All contractors and business associates must receive privacy training annually.  

c.    For contractors and business associates who do not have access to VHA computer systems, this requirement is met by completing VHA National Privacy Policy training, other VHA approved privacy training or contractor furnished training that meets the requirements of the HHS Standards for Privacy of Individually Identifiable Health Information as determined by VHA.  

d.    For contractors and business associates who are granted access to VHA computer systems, this requirement is met by completing VHA National Privacy Policy training or other VHA approved privacy training.  Proof of training is required upon request.

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

Delivery address: VA North Texas Health Care System, 4500 S Lancaster Road, Dallas, Texas, 75216

The requesting activity has submitted a sole source justification request that states that vendor is the only one that can provide the necessary required supplies and services.  Market research did not find an alternate approved vendor that can provide the required supplies and services. 
This notice is not to be considered a request for quotations or proposals. No contract will be awarded on the basis of offers received in response to this notice; however, all responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency.  Proposals or offers received will be used to determine if a comparable source is available and more advantageous to the government. No phone calls of any nature regarding this notice will be accepted. There will be no automated email notification of receipt of capability statement, proposal, or quotation. If no affirmative written response is received within 5 business days from the publication of this notice, a contract will be issued to PROAIM Americas, LLC without any further notice. 
The anticipated statutory authority permitting other than full and open competition for the requirement is 41 U.S.C. 3304(a)(1), as implemented by FAR 6.302-1, Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.     

End of Document