6630--Albany | *SPECIAL*528-24-1-8307-0018|FY'24 REQUEST FOR BPA FOR QUALITY CONTROMATERIALS/CARDIAC MARKERS

Introduction:

THIS IS A PRE-SOLICITATION NOTICE ONLY. THE SOLICITATION WILL BE POSTED AT A LATER TIME (AT LEAST 15 DAYS AFTER THIS NOTICE). INTERESTED CONTRACTORS ARE RESPONSIBILE FOR CHECKING CONTRACTING OPPORTUNITIES FOR THE SOLICITATION INFORMATION AND POSTING. PLEASE WAIT FOR THE SOLICITATION POSTING FIRST BEFORE REACHING OUT TO THE CONTRACTING OFFICER FOR MORE INFORMTAION.Â

PURSUANT TO FAR Subpart 5.2 Synopses of Proposed Contract Actions, THIS IS A PRE-SOLICITATION NOTICE OF A PROPOSED CONTRACT ACTION.

The Department of Veterans Affairs is seeking to award a single firm fixed price (FFP) indefinite delivery indefinite quantity (IDIQ) contract to provide QA materials and software for 5 locations in VISN 2.

GENERAL REQUIREMENTS

The contractor shall provide in a narrative format how they will provide the following technical aspects for the Statement of Work (SOW). The contractor will be responsible to provide the requirements below in accordance with this Statement of Work (SOW) which includes at a minimum the following:

Provide Quality Control Software that shall have the following characteristics:

Compatible with Data Innovations Instrument Manager.

Ability to provide real time, online peer group statistics with peer review and qc report capability for national and VISN 2 North peer groups.

Levy Jennings graphing and Westgard rules capability.

Six Sigma graphing and analysis

User defined parameters to assist with auto-verification of test results.

Moving averages.

Ability to incorporate third party controls such as analyzer reagent kit controls.

Customizable to each site.

Ability to hold patient test results if quality controls are unacceptable or haven t been run in the last 24 hours.

W7 compatibility and hardware/software functionality for direct network connectivity.

Vendor responsible for any licensing or hardware used to connect to Data Innovations/network.

Any connections from the software back to the vendor will follow VA guidelines and must be FIPS 140-2 and CRISP compliant.

State the ability of proposed software to hold results if Quality Controls have not been run in more than 24 hours or results are unacceptable.

Capabilities of the Quality Control Software. Compatible with Data Innovations Instrument Manager, Levy Jennings graphing capability, Westgard rules capability, Sigma analysis capability. Moving averages, Ability to incorporate third party controls such as analyzer reagent kit controls.

The software capabilities must be automated. The data needs to transferable from the analyzer or the middleware software.

The ability to accept third party control data for statistic and peer group analysis is preferred but not required.

Provide QC Material for the tests listed below with lot outdates of at least one year.

Capability of providing quality control material for the list of required tests provided in Exhibit A. Clearly identify any test NOT able to be included.

Clearly identify the number and types of quality control material available, to include serum/plasma, urine, body fluids, and cerebrospinal fluid.

Provide QC Material with a minimum open bottle stability of five days. Include a list of QC Material with listed analytes and outdates of the QC material for each analyte if different from the open bottle stability.

Provide QC Material lot sequestering with the ability for VISN 2 North sites to be on the same lots of QC Material.

Ability for VISN 2 North sites to form their own peer group and receive peer group statistics and qc reports in addition to national/international peer groups statistics and reports.

Ability to automatically sequester new lot numbers with the longest outdates when the current sequesters run out without intervention from the VISN.

All Software upgrades shall be provided at no additional cost to VA and as they become available.

Any hardware components, if applicable, shall be provided at no additional cost to VA

All hardware upgrades shall be provided at no additional cos to VA as they become available.

Hard drives, if necessary, shall be removed and turned over to VA for destruction at the completion of the contract or replacement of a hard drive.

Online ordering capabilities via email or website.

Vendor shall replace any QC material damaged in shipping or that arrives outside the appropriate temperature range within 24 hours at no additional cost to the VA.

Provide electronic copies of operators manuals, procedures, and chemical safety data sheets.

Vendor must have an ISO/MOU security agreement and current Business agreement with the VA.

Vendor must provide training for all applicable staff on the use of the software.

In a narrative format the contractor must provide how they will assist with the installation and set-up of the Quality Control Software including connectivity to each applicable assay system at each site.

In a narrative format the contractor must describe how they will ensure that the turnaround time for orders will be processed within 48 hours and shipped.

In a narrative format the contractor must describe how they can sequester the same lots for all VISN 2 North sites. As well as how the contractor will establish a mini-peer group for the VISN including automatic sequester of new lots of control material for the VISN based on the usage of the individual site.

In a narrative format the contractor must describe how they can provide real time, online peer group statistics with peer review and QC report capability for national and VISN 2 North peer groups. The contractor shall provide sample reports.

In a narrative format the contractor must describe how they can provide online ordering and how the sequestered lots will be specified during the ordering process

ORDERS

All products ordered under the contract are subject to the terms and conditions of the awarded Agreement. The awarded contract does not obligate any funds. The Government is obligated only to the extent of authorized orders issued under the Delivery Orders and Purchase Orders by the Contracting Officer Representatives (COR s) as assigned.

PRICING

Please use the data provided below in Exhibits A to determine Cost Per Test (CPT) pricing.

ITEMS TO BE ORDERED UNDER THIS BPA:

COST PER TESTS AT A CONSOLIDATED PRICE

PROVIDE TABLE OF PRICE GROUPINGS AND IMMUNOASSAY KIT PRICING BELOW:

EXHIBIT A: Laboratory Tests for Fiscal Year 2022

A1AT

Ceruloplasmin

Gentamicin

LDL Direct

Acetaminophen

Chloride

GGT

LH

AFP

Cholesterol

Glucose

Lipase

Albumin

CK

Haptoglobin

Lithium

Alcohol

CKMB

HDL

Magnesium

Alkaline Phosphatase

Cocaine

Hemoglobin A1c

Methadone

Ammonia

Cortisol

Hepatitis A IgM

Microalbumin

Amphetamines

Covid Antibody, Total

Hepatitis A Total

Microglobulin, Beta-2

Amylase

Covid Antibody, IgG

Hepatitis B Core Ab

Opiates

Barbiturates

C-Reactive Protein

Hepatitis B Surface Ab

Osmolality, serum & urine

Benzodiazepines

Creatinine

Hepatitis B Surface Ag

Oxycodone

B-HCG

Cystatin C

Hepatitis C

PCP

B-Hydroxybutyrate

Digoxin

High Sensitivity Troponin

Phenobarbital

BNP

Direct Bilirubin

HIV 1

Phenytoin

BUN

Estradiol

HIV 2

Potassium

Buprenorphine

Ferritin

IgA

Pre-Albumin

C3

Folate

IgG

Procalcitonin

C4

Free Kappa Light Chains

IgM

Prolactin

Calcium

Free Lambda Light Chains

Inorganic Phosphate

PTH Intact

Cannabinoids

Free T3

Iron

Rheumatoid Factor

Carbamazepine

Free T4

Lactic Acid

Salicylates

Carbon Dioxide

FSH

LDH

SGOT (AST)

SGPT (ALT)

TIBC

Transferrin

Uric Acid

SHBG

Total Bilirubin

Triglycerides

Valproic Acid

Sodium

Total Protein

TSH

Vancomycin

Testosterone

TPSA

Urine/CSF Protein

Vitamin B12

Theophylline

Triiodothyronine

Urine Fentanyl

Vitamin D

The table above provides the tests performed within VISN 2 Facilities for fiscal year 2022. Every test is not performed at each facility.

The offeror will be responsible to provide the product(s) (Controls) that will allow for all QA/QC testing to be provided for all the above laboratory test and the format shall be as follows:

Clin item (starting with 0001) test name, what test(s) that the control covers, and price.

Example:

Clin item 0001, Test ABC, This control covers test(s), and price is $xxx per (control, box, case, ect)

PERIOD OF PERFORMANCE:

This contract expires 60 months from the date the analyzers are placed in use for patient testing. The maximum term of this contract shall be five (5) years from the date the analyzers are placed in use for patient testing of this contract which shall consist of one (1) base period and four (4) option years. A review of the contract will be done annually IAW 8.405-3(e). The VA will review the estimated purchases and the corresponding discounts for this contract annually. The maximum term of this contract pursuant to FAR 52.217-8 is five years. The VA will review the estimated purchases and the corresponding discounts for this contract annually.