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66--FY18 LINEARITY KITS FOR AUTOPSY PATHOLOGY TESTING POP 12/1/2017 - 11/30/2018

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VA24617Q1935Federal

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The Durham VA Medical Center plans to enter into an intent to sole source procurement agreement with the College of American Pathologists (CAP) for the supply of linearity kits necessary for autopsy pathology testing over the period from December 1, 2017, to November 30, 2018. This fixed-price contract will cover the provision of supplies, test kits, reagents, and consumables required to conduct proficiency testing that meets regulatory and accreditation requirements under CLIA and CLSI standards. The contract emphasizes timely delivery, with purchase orders required by November 30, 2017, to ensure availability of kits for upcoming tests. It also includes provisions for rapid replacement delivery within 24 hours at no additional cost if defective supplies are identified or delivery failures occur. The supplier is responsible for providing high-quality materials including reagents, controls, disposables, and instructions for use, and must provide printed and online testing results and reports that can be shared with relevant VHA regional, national, or federal regulatory agencies. The annual workload for the facility is expected to increase by 5-10%, so tiered pricing or volume discounts should be submitted alongside the offer. The procurement action falls under NAICS code 541380 and is subject to simplified acquisition procedures with no public solicitation issued; however, interested parties may submit capability statements by a stated deadline. The contract aims to ensure uninterrupted support for proficiency testing by securing a reliable sole source vendor compliant with all technical and regulatory requirements.

General Info

Durham VA sole source contract with CAP for autopsy pathology kits, supplies, and reporting.

Agency

N/A

NAICS

541380 - Testing Laboratories and Services

Place of Performance

Not specified

Set-Aside

NONE

Documents

0

No documents available

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Timeline

Posted

special-notice

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Organization & Contact Information

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AgencyN/A
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Full Description

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The Durham VA Medical Center intends to enter an Intent to Sole Source procurement with College of American Pathologist (CAP) 325 Waukegan Road Northfield, IL 60093-2750 for Linearity Kits for Autopsy Pathology testing. Period of Performance December 1, 2017 through November 30, 2018. Purchase order required by 11-30-17 to allow for delivery of kits for the next testing. PROFICIENCY TESTING STATEMENT OF WORK FOR THE DURHAM VA MEDICAL CENTER DEPARTMENT OF PATHOLOGY AND LABORATORY MEDICINE SERVICE SCOPE: Contractor(s) shall provide in accordance with the specifications outlined below, supplies, test kits and reagents to perform linearity and autopsy studies as part of proficiency testing to meet regulatory and accreditation requirements. PRICING: A schedule of items offered and per item cost with any tiered pricing for volumes and/or percentage of use should be included as a separate attachment to your offer. NOTE: The Durham VA Medical Center workload increases an average of 5-10% each year. STATEMENT OF WORK/SERVICES TO BE PROVIDED: GENERAL REQUIREMENTS: 1.1 The contractor(s) shall provide supplies, test kits, and reagents to the Durham VAMC facilities in accordance with the applicable Federal Supply Schedule contract. This BPA will be fixed-price for the duration of the contract in accordance with the terms and conditions of the vendor's Federal Supply Schedule Contract and FAR Part 13.303. 1.2 The Contractor shall provide Clinical Laboratory Standards Institute (CLSI) approved reagents, controls, linearity material, disposables, and any consumable part necessary for supporting laboratory proficiency testing. These materials shall also be acceptable by the Clinical Laboratory Improvement Act of 1988 (CLIA 1988). 1.3 The Contractor shall provide both printed and on-line results with a summary report on all linearity and proficiency testing performed by the laboratory. 1.4 The Contractor shall be able to send linearity and proficiency testing reports to VHA Regional or National agencies as well as any other Federal regulatory agency as required. SUPPLIES: 2.1 The Contractor is required to provide reagents, standards, controls, supplies, disposables and any other materials on a scheduled basis required to support proficiency testing. These items shall be of the highest quality, sensitivity, specificity and tested to assure precision and accuracy. Expiration dates must be clearly marked on supplies, reagents, standards and control containers. Alert/Notification of any delays in shipment as well as any or all technical advisory/ recalls/ alerts, prior to or simultaneously with field alerts should be forwarded to the designated individuals determined at contract award. 2.2 In the event consumables are found to be defective and unsuitable for use, or the vendor has failed to comply with the requirements for routine supply delivery, the vendor shall deliver the consumable supplies within a period of 24 hours after receipt of the verbal order for priority delivery from the facility. If either circumstance has occurred, the vendor will deliver to the facility, in the most expeditious manner possible, without additional costs to the facility, the necessary consumable in sufficient quantity until the arrival of the standing order/routine supply delivery. 2 2.3 The Contractor shall supply all necessary package inserts, instructions for use (IFU), and SDSs (also available on CD format or on-line). ITEM DESCRIPTION 1 LN11 SERUM ETHANOL CVL 2 LN13C CRITICAL CARE CVL 3 LN15 HEMOGLOBIN A1C ACCURACY CVL 4 LN16 HOMOCYSTEINE CVL 5 LN18 RETICULOCYTE 6 LN2 CHEMISTRY/LIPID/ENZYME CVL 7 LN20 ALBUMIN CVL 8 LN21 HIGH SENSITIVITY C-REACTIVE PROTEIN 9 LN23 PROSTATE-SPECIFIC ANTIGEN CVL 10 LN25 TROPONIN I CVL 11 LN3 TDM CVL 12 LN30 BNP CVL 13 LN32 AMMONIA CVL 14 LN39 HIV VIRAL LOAD CVL 15 LN40 VITAMIN D CVL 16 LN41 PROCALCITONIN CVL 17 LN5 LIGAND CVL 18 LN6 URINE CHEMISTRY CVL 19 LN8 REPRODUCTIVE ENDOCRINOLOGY CVL 20 LN9 HEMATOLOGY CVL 21 LPX LABORATORY PREPAREDNESS EXERCISE 22 Fuel Estimated Fuel Surcharge 23 AUCD AUTOPSY PATHOLOGY CD AR#140170101 24 ACUD1 AUTOPSY PATHOLOGY CD Additional Path NAICS code 541380 applies to this procurement. The proposed contract action is for supplies/services for which the Government intends to solicit and negotiate with only one source under the authority of FAR 6.302. Interested persons may identify their interest and capability to meet this requirement. This notice of Intent is not a request for quotations. Interested parties who believe they can meet this requirement must submit information about their capabilities no later than 7:00AM EST, September 15, 2017 to: contact@example.gov. Telephone inquiries will not be accepted. All information shall be furnished at no cost or obligation to the Government. This award will be made using simplified acquisition procedures. No solicitation will be made available. Information received will normally be considered solely for the purpose to determine whether to conduct a competitive procurement. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government.

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