6640--Sources Sought | Flow Cytometry Analyzer Closes August 11, 2020 at 12:00pm EST
THIS IS NOT A SOLICITATION ANNOUNCEMENT. THIS IS A REQUEST FOR INFORMATION ONLY. This Request for Information (RFI) is intended for information and planning purposes only at this time; and shall not be construed as a solicitation or as an obligation on the part of the Department of Veterans Affairs. Because this is a Request for Information announcement, no evaluation letters and/or results will be issued to the respondents. No solicitation exists. Therefore, do not request a copy of a solicitation.
The Department of Veterans Affairs (VA), VISN 4, Network Contracting Office 4 (NCO 4), is seeking information and potential qualified sources capable of meeting the following minimum requirements and salient characteristics below for brand name or equal Flow Cytometry Analyzer for the VA Pittsburgh Healthcare System, Pathology & Laboratory Medicine Service Line, University Drive, Pittsburgh, PA 15240.
VA Pittsburgh Healthcare System
PATHOLOGY& LABORATORY MEDICINE SERVICE
STATEMENT OF WORK
Flow Cytometry Analyzer
SCOPE:
The contractor shall provide all equipment, reagents, standards, controls, supplies, and any other items required for the proper operation of the contractor owned analyzers and peripherals necessary for flow cytometry testing of blood, bone marrows, lymph nodes, and body fluids. VA Pittsburgh HCS Pathology and Laboratory Medicine service requires a flow cytometry analyzer to conduct a variety of tests on a Cost-Per-Reportable-Result (CPRR) or Reagent Rental basis for our patient population. Commodities/Services shall be required for a base year period of October 2020 through September 2021 with the option to extend for up to four additional one-year terms.
2. DEFINITIONS:
2.1 Reagent Rental Contract
Reagent rental contracts are arrangements between diagnostics companies and laboratories in which an analyzer is placed in a laboratory in exchange for the guaranteed purchase of reagents over a period of time. Alternative but similar arrangements include that in which the analyzer would be placed in the laboratory with the agreement that the laboratory would pay a specified amount per test run on the analyzer, based on the laboratory s estimated test volume by type. The contractors are required to furnish the laboratory analyzer, all supplies and consumables necessary to operate the contractor s equipment, training for personnel and equipment maintenance (emergency repair and preventive service) necessary to fulfill the test requirements. It will also include the material to perform, as well as all other costs associated with, quality control, calibration, normal range, and correlation study testing that is prescribed by the Clinical and Laboratory Standards Institute (CLSI).
2.2 Cost-Per-Reportable-Result
The per reportable result price shall include costs covering
a. Equipment use
b. All reagents, calibrators, controls and their inter-laboratory comparison program, supplies, consumable/disposable items, parts, accessories and any other item required for the proper operation of the contractor s equipment and necessary for the generation of a patient reportable result. This does not include those items approved for exclusion by the government such as printer paper, labels etc. This per patient reportable result price shall also encompass all costs associated with dilutions, repeat and confirmatory testing required to produce a single patient reportable result. It will also include the material to perform, as well as all other costs associated with, quality control, calibration, normal range, and correlation study testing that is prescribed by the Clinical and Laboratory Standards Institute (CLSI).
c. All necessary maintenance to keep the equipment in good operating condition
d. Training for Government personnel.
e. Delivery, installation and removal of equipment.
3. GENERAL REQUIREMENTS:
3.1 The clinical laboratory flow cytometry analyzers must have at a minimum of 6 or 8 color Flow Cytometry analyzer and capable of producing accurate and reproducible test assay results on biological specimens by established in-vitro diagnostic methods and performs up to the manufacturer's defined maximum capacity without excessive malfunctions, breakdowns, or service calls.
3.2 The contractor shall provide all supplies starting from validation and services as described herein to the VA Pittsburgh Health Care System.
3.3 All equipment provided shall be multicolor new and state-of-the-art analyzer with loader and sample prep analyzer to include software and middleware; remanufactured, refurbished, or discontinued models will not be accepted.
3.4 The contractor shall provide all upgrades to the equipment hardware and operating system software, at no additional cost to the Government. These enhancements shall be delivered and installed at VA Pittsburgh HCS within 60 days of issuance to the commercial market.
3.5 All equipment shall be in current production as of the date this offer is submitted. Current production shall mean that the Flow Cytometry analyzer model is being manufactured as new equipment. Discontinued models that are only being made available as remanufactured equipment are unacceptable.
3.6 Contractor offered equipment shall perform satisfactorily at temperatures between 50 and 90 degrees Fahrenheit and relative humidity between 10 and 85 percent.
3.7 Contractor s offered flow cytometry analyzer system shall conform to the VA Pittsburgh Health Care System existing space.
3.8 Contractor shall provide a colored printer for the analyzer and provide replacement printer as needed.
3.9 Contractor will provide samples required and assist during validation of instrument and perform necessary requirements for validation before analyzer will be useful for patient testing.
4. TECHNICAL REQUIREMENTS:
4.1 The Contractor shall provide the facility with Food and Drug Administration (FDA) approved analyzers/equipment, reagents, applicable controls, calibrators, disposables, any consumable part (inclusive of replacement parts per manufacturers maintenance guidelines, cap piercing needles, specimen racks, sample holders, etc.), necessary for analyzing/testing on the analyzer. All linearity material and any commercial system correlation samples needed shall be provided to meet CAP and the Joint Commission requirements.
4.2 The contractor shall provide, at a minimum, the following equipment:
Workstation software and interface bundle
Monitors (high resolution)
Color Printer
Other equipment may include:
Lyse and wash sampler (sample preparation support)
Loader
Barcode reader and stand
4.3 The contractor shall provide acceptable levels of whole blood commercial quality controls to be analyzed on the analyzer for daily operational. The contractor shall state the control stability and expected frequency of adjustments of ranges within lot numbers.
4.4 The Contractor shall provide manufacturer-verified documentation of sample stability for specimens up to 48 hours after collection.
4.5 The system shall provide simple fluidics system that will minimize startup time and maximize reproducibility.
4.6 The Contractor shall define the actual hands on maintenance time required for daily, weekly, monthly, and as-needed maintenance. The Contractor shall include the analyzer time required to perform each maintenance task. Contractor shall list which tasks are user level and which tasks are service level.
4.7 The Contractor shall provide a comprehensive Quality Control (QC) program included in the CPRR/CPT price, which includes the following options:
QC files that can be edited or corrected for errors
On-board quality control data storage and reporting capabilities
Printable daily and monthly QC results and Levy-Jennings graphs
Visual alerts of QC failures.
QC program that has peer participation of at least 50 participants with peer data reports available online.
Transmittal of QC to the Quality Assurance Plan through a modem.
4.8 The Contractor shall establish a peer group for CAP Proficiency survey (equipment/reagent system) numbering at least 25 labs.
4.9 The Contractor shall remove all equipment within 90 days of the expiration of the contract, but not until the completion of the new Contractor s equipment installation inclusive of completed cross over studies.
4.10 Equipment must meet the volume and turnaround time of One (1) hour for all STAT requirements, if specified.
4.11 Contractor s Flow Cytometry system shall be capable of performing the following Flow Cytometry Assays but not limited to the following markers classified as Laboratory Developed Test (LDT) and validated in accordance with FDA standards:
a. Panels
1. Leukemia/Lymphoma Panels
B Cell (K,L,CD5,CD19,CD10,CD23, FMC-7, CD20, CD19/CD38, CD45, CD2, CD3, CD7, CD22, CD56) - 9/month
T Cell Lymph/Leukemia (CD2, CD3/CD4, CD3/CD8, CD5, CD7, CD25, CD45, CD56) - 1/month
Hairy Cell Leukemia (K, L, CD22, CD11c, CD103, CD25, FMC-7, CD19, CD45, CD23) 1/month
AML (cMPO, CD7, CD13, CD14, CD33, HLS-DR, CD34, CD117, CD 64, CD45, CD15, CD38, CD10) 1/month
Myeloma (K/L, CYTOPLASMIC K/L, CD38, CD38/138, CD56, CD19, CD45) 1/month
2. CD4/CD8-done with Tetra-4 antibodies-LSA (CD3, CD4, CD8, CD45) 25/month
3. T&B done with Tetra-6 antibodies (CD3, CD4, CD8, CD16, CD19, CD45, CD20) 2/month
Our existing panels:
4. CLL Panel--(IgG1, CD38/CD10/CD19/CD5, CD8/CD4/CD3/CD56, Kappa/Lambda/CD23/CD20, HLADR/CD13/CD34/CD14)- 6 per month
5. Lymphoma/LN Panel-- (IgG1, CD38/CD10/CD19/CD5, CD8/CD4/CD3/CD56, Kappa/Lambda/CD23/CD20) 2 per month
Add on T-Cell FMC-7-- (FMC-7/CD7/CD19/CD2) 6 per month
Add on B-Cell CD22 (CD22/CD10/CD19/CD20) 1 per month
6. AML/ALL Panel-- (IgG1, CD33/CD13/CD34/CD117, Kappa/Lambda/CD19/CD5, CD8/CD4/CD3/CD56, HLADR/CD10/CD34/CD14) 1 per month
7. MDS Panel-- (IgG1, CD33/CD13/CD34/CD117, HLADR/CD11b/CD16/CD14, CD33/CD7/CD16/CD56) 2 per month
Option: CD38/CD10/CD19/CD5 1 per month
4.12 The flow cytometry systems shall meet the following global criteria:
Equipment shall consist of an easy-to-use benchtop analyzer that delivers with proven performance, accuracy, and high-quality performance.
The system shall deliver timely, accurate information to clinicians and staff.
The flow cytometry system shall be capable of delivering high sensitivity based on excitation, emission and collection optics
The flow cytometry system shall possess the following features and capabilities:
Flexibility in Blood Collection Tubes of different sizes can be accommodated
Quick processing speed and reducing reagent consumption optimization to reduce reagent waste using single dispense mode
Excitation source with multiple lasers.
High efficiency test output with minimum sample
Auto-sampler
Primary tube cap piercing sampling
Bar-code reading capability for samples, reagents and controls
Bi-directional software interface for Data Innovations and VISTA
Ability to recall and re-transmit test results to host computer
Easily accommodate STAT tests
Ability to analyze small volume samples
On-board Reagent Inventory including an alert when consumables, supplies are insufficient to process requested tests and identify outdated reagent
On-board user-friendly Quality Control program
Long shelf life for reagents and controls, including on-board stability
Minimal, user-friendly maintenance procedures (priming, rinsing and cleaning) managed by predefined software settings.
Automated probe change procedure using software interface to reduce biohazard exposure
Editable assay procedures available in CLSI format available on disk or on the internet (secured)
Operators Manual on disk or the internet
Upgradable software at no cost to the Government
Uninterruptible Power supply for each instrument if recommended by the manufacturer; UPS shall be maintained or replaced by the Contractor
Modem access for aid in troubleshooting, Provide Linearity for assay tests.
Ability to use automated or manual sample introduction;
Minimal sample carryover %
Adjustable flow rates.
4.13 Upon completion of installation at the VA Pittsburgh VAMC, the contractor shall assist/perform as appropriate all validation procedures including linearity, precision, correlation, and reference range studies to the facility s satisfaction at the contractor s expense.
4.14 The flow cytometry shall be trackable over time by Levy-Jennings graphs to monitor cytometer performance. These features must be automated to ensure consistent data integrity and reproducibility of results on a daily basis. Integrated quality control features must support data integrity by notifying operators if an assay fails predefined standards.
4.15 Calibrations shall be performed by contractor Field Service Representatives.
4.15 Software: The Contractor shall provide compatible Laboratory Information System (LIS) software which will readily connect with the existing VA Pittsburgh Health Care System LIS to enable direct, bi-directional transfer data. This software will simplify laboratory workflow by customizing data reporting, securing validation, and transferring data to reduce manual transcription. The software shall automate the process from pre-analysis to post analytical reporting to help reduce errors and improve data quality and laboratory productivity.
4.16 Facility Specific Requirements:
a. Equipment shall be warrantied for the first year and a service contract must be offered for the remaining four option years. Service coverage includes labor to make repairs, travel time, parts, and all other expenses, excluding consumable items. Preventive maintenance inspections will be performed as required by the manufacturer and accrediting agencies. Unlimited service repair visits will be provided Monday through Friday excluding holidays during the terms of the contract, as well as unlimited telephone support.
b. The contractor is required to provide delivery, installation and removal of equipment at no additional charge.
c. In the event that the consumables are found to be defective and unsuitable for use with the contractor's equipment, or the contractor has failed to comply with the requirements for routine supply delivery, the contractor shall deliver the consumable supplies within a period of twenty-four (24) hours after receipt of the verbal order for priority delivery from the Government activity. If either circumstance has occurred, the contractor shall deliver one week s worth of consumable items (under normal Government test load volume) to the VA Pittsburgh Health Care System in the most expeditious manner possible. If additional requests for an emergency supply delivery are required by the Government, they will be honored by the contractor until the arrival at the Government site of the monthly standing order/routine supplies delivery. Failure to reserve adequate inventory may result in default.
d. The contractor shall pay all routine shipping fees for supplies, consumables, and equipment to perform testing at initial installation and with routine supply delivery. These items shall be of the highest quality ensuring sensitivity, specificity and tested to assure precision and accuracy. The quality of the products shall be sufficient to satisfy proficiency testing standards of the College of American Pathologists (CAP) and the Joint Commission on Accreditation of Health Care Organizations.
4.17 Instrument Down Time:
a. The flow cytology analyzer, and all associated equipment, shall be fully operable at least ninety percent of the business days in every month of the contract term.
5. MAINTENANCE AND REPAIRS:
a. Emergency repairs shall be performed after initial telephone notification that the equipment is inoperative. The contractor shall provide the Government with a designated point of contact and telephone number and shall make arrangements to enable the maintenance representative to receive such notification.
(1) VA Pittsburgh Health Care System requires business hours (on-site M-F 5 days per week, 8:00 am 5:00 pm) service.
(2) The contractor shall be on-site to perform emergency repair service within twenty-four (24) hours after receipt of initial telephone notification of a malfunction.
(3) Contractor shall provide technical support services to assist in troubleshooting 24 hours per day, seven days per week including Federal holidays.
b. The contractor shall furnish a malfunction incident report to the installation upon completion of each repair call. The report shall include, as a minimum, the following:
(1) Date and time notified;
(2) Date and time of arrival;
(3) Serial number, type and model number(s) of equipment;
(4) Time spent for repair;
(5) Description of malfunction and repair; and
(6) Proof of repair that includes documentation of a sample run of quality control verifying acceptable performance.
c. During the term of the service, should the repair record of any individual piece of laboratory equipment reflect a downtime of 5% or greater of the normal working days in one calendar month, a determination will be made by the designated representative of the Government at the using facility to replace the initial laboratory equipment with new equipment. The responsibility for maintaining the equipment furnished in good condition in accordance manufacturer s instruction shall be solely that of the contractor. Each instrument provided by the contractor shall maintain an uptime of 95% in each month of the term of the agreement.
d. The contractor shall not leave a service call open pending verification that repairs completed by the contractor s maintenance personnel. For each instrument provided the contractor shall treat each notification for an emergency/repair service call from the Government as a separate and new service call.
6. TRAINING:
a. The contractor shall provide operator training course for two VA Pittsburgh Health Care System medical technologists at the contractor s site at no cost to the Government. Training must be offered and take place within a four-year period from the date of installation. The contractor will provide transportation, lodging, breakfast, and lunch at the training site.
b. The contractor shall provide initial in-depth training for operators at the VA Pittsburgh Health Care System, all expenses paid by the contractor. Annual training shall be provided for VA Pittsburgh Health Care System equipment operator.
7. TRANSITION PERIOD:
a. The transition period for the contractor to have all flow cytometry equipment and peripherals installed and operational at the VA Pittsburgh Health Care System shall be 60-90 calendar days after award. During this same period all initial training of VA Pittsburgh Health Care System personnel in the operation and maintenance of said equipment shall also be completed.
b. No later than 60-90 calendar days after award, the contractor shall have completed full transition of all services under this agreement to include all correlation studies, validations, etc., and shall have full and sole responsibility for services under the awarded order.
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ITEM NO. DESCRIPTION QUANTITY UNIT
OR STOCK NO.
--------------------------------------------------------------------------------
supplies:
1 flowcytometry equipment supplied at
no charge 1 EA
8546929 2 COULTER CLENZ 10 EA
6607023 3 Cyto-Comp Cell kit 11 EA
A07800 4 IO Test 3 Fixative Solution, IQ Test 16 EA
6605359 5 Flow-Check Fluorospheres 3 EA
7547053 6 Flow-Count Fluorospheres 12 EA
6607077 7 Flow-Set Fluorospheres 3 EA
7546999 8 Immuoprep A/B/C 5 EA
6607077 9 Immuno-Trol Cells W/B control 6 EA
6607098 10 Immuno-Trol low Cells 6 EA
8547008 11 isoflow sheath fluid 15 EA
A07799 12 IO test 3 lysing fluid solution 15 EA
177017 13 quick comp 4 kit, 50 tests 3 EA
6607013 14 Cyto-Stat Tetrachrome, CD45-FITC/
CD4-RD1/CD8-ECD/CD3-PC5 6 EA
IM0639U 15 IgG1 FITC 4 EA
IM06451U 16 CD8 FITC 4 EA
IM0779U 17 CD22 FITC 2 EA
IM1135 18 CD33 FITC 2 EA
IM0775U 19 CD38 FITC 2 EA
IM0782U 20 CD45 FITC 3 EA
IM1364U 21 FMC7 FITC 3 EA
IM1638U 22 HLA-DR FITC 3 EA
PN A64828 23 Kappa FITC 3 EA
PN A64827 24 Lambda PE 3 EA
IM0670U 25 IgG1PE 4 EA
IM0449U 26 CD4PE 3 EA
IM1429U 27 CD7PE 2 EA
IM1915U 28 CD10PE 2 EA
IM2581U 29 CD11bPE 2 EA
IM1427U 30 CD13PE 3 EA
IM2705U 31 IgG1ECD 4 EA
IM2705U 32 CD3ECD, 100 tests 6 EA
A33098 33 CD16ECD 3 EA
IM2708U 34 CD19ECD 4 EA
IM2709U 35 CD34ECD, 100 tests 4 EA
IM2663U 36 IgG1PC5 4 EA
IM2634U 37 CD2PC5, 100 tests 2 EA
IM2637U 38 CD5PC5 3 EA
IM2640U 39 CD14PC5 4 EA
IM2644 40 CD20PC5 3 EA
IM2654U 41 CD5PC5, 100 tests 3 EA
IM2643U 42 CD19PC5 2 EA
IM2733U 43 CD117PC5 2 EA
IM3548U 44 CD45PC7, 100 tests 15 EA
IM3422 45 7AAD Viability Dye, 150 tests 3 EA
6912942 46 sheath filter 3 EA
6603473 47 Immuno Brite Standards Kit 3 EA
IM3609U 48 CD23ECD 3 EA
The information identified above is intended to be descriptive, not restrictive and to indicate the quality of the supplies/services that will be satisfactory. It is the responsibility of the interested source to demonstrate to the government that the interested parties can provide the supplies/services that fulfill the required specifications mentioned above.
Responses to this RFI should include company name, address, point of contact, phone number, and point of contact e-mail, DUNS Number, Cage Code, size of business pursuant to North American Industrial Classification System (NAICS) 334516 (size standard of 1000 employees). Please answer the following questions:
(1) Please indicate the size status and representations of your business, such as but not limited to: Service-Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB), HUBZone, Woman Owned Small Business (WOSB), Large Business, etc.)?
(2) Is your company considered small under the NAICS code identified under this RFI?
(3) Are you the manufacturer, distributor, or an equivalent solution to the items being referenced above?
(4) If you are a large business, do you have any designated distributors? If so, please provide their company name, telephone, point of Contact and size status (if available).
(5) If you re a small business and you are an authorized distributor/reseller for the items identified above or an equivalent solution, do you alter; assemble; modify; the items requested in any way? If you do, state how and what is altered; assembled; modified?
(6) If you intend to subcontract any work on this contract, what portion of the total cost will be self-performed/will be performed by your organization? Please provide estimated detailed percentage breakdowns related to sub contracted work and completion of job.
(7) Does your company have an FSS contract with GSA or the NAC or are you a contract holder with any other federal contract? If so, please provide the contract number.
(8) If you are an FSS GSA/NAC contract holder or other federal contract holder, are the items/solution you are providing information for available on your schedule/contract?
(9) General pricing of your products/solution is encouraged. Pricing will be used for the purpose of market research only. It will not be used to evaluate for any type of award.
(10) Please submit your capabilities in regard to the salient characteristics detailed above and any information pertaining to equal to items to establish capabilities for planning purposes?
(11) Please review salient characteristics/statement of work (if applicable) and provide feedback or suggestions. If none, please reply as N/A.
(12) Please provide your DUNS number.
*** Submissions addressing number (10) should show clear, compelling and convincing*** evidence that all equal to items" meet all the salient characteristics.
This RFI will be conducted in accordance with Federal Acquisition Regulation (FAR) Part 13. Telephone responses will not be accepted. Responses must be received via e-mail to justin.erdley@va.gov no later than, 12:00 PM Eastern Standard Time (EST) on August 11, 2020. This notice will help the VA in determining available potential sources only. Do not contact VA Medical Center staff regarding this requirement, as they are not authorized to discuss this matter related to this procurement action. All questions will be addressed by the Contracting Specialist, Justin Erdley.
All firms responding to this Request for Information are advised that their response is not a request for proposal, therefore will not be considered for a contract award.
If a solicitation is issued, information will be posted on the FedBizOpps (FBO) web site for all qualified interested parties at a later date and interested parties must respond to the solicitation to be considered for award. This notice does not commit the government to contract for any supplies or services. The government will not pay for any information or administrative cost incurred in response to this Request for Information. Information will only be accepted in writing by e-mail to Contracting Specialist at justin.erdley@va.gov.
DISCLAIMER
This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. 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 RFI.
End of Document
36C24420Q0929 Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 4
8/5/20, 9:35 AM