RFP 36C24822R0028_09012022.pdf

PAGE 1 OF 1. REQUISITION NO.

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NO. 5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

a. NAME b. TELEPHONE NO. (No Collect Calls) 8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY CODE 10. THIS ACQUISITION IS UNRESTRICTED OR SET ASIDE: % FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ IFB RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE

17a. CONTRACTOR/OFFEROR CODE FACILITY CODE 18a. PAYMENT WILL BE MADE BY CODE

TELEPHONE NO. UEI: EFT:

PHONE: FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19. 20. 21. 22. 23. 24.

ITEM NO. SCHEDULE OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA 26. TOTAL AWARD AMOUNT (For Govt. Use Only)

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA ARE ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________ 29. AWARD OF CONTRACT: REF. ___________________________________ OFFER COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DATED ________________________________. YOUR OFFER ON SOLICITATION DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY (BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION (REV. NOV 2021)

PREVIOUS EDITION IS NOT USABLE Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

36C24822R0028 09-01-2022

Jessica Kiser 407-646-4017 10-14-2022

14:00 EDT

36C248 Department of Veterans Affairs Network Contracting Office 8 (NCO 8) Orlando VA Healthcare System 13800 Veterans Way Orlando FL 32827

X

325413

1250 Employees

N/A

X

36C675

Department of Veterans Affairs Orlando VA Healthcare System 13800 Veterans Way

Orlando Fl 32827

36C248

Department of Veterans Affairs Network Contracting Office 8 (NCO 8) Orlando VA Healthcare System

Department of Veterans Affairs Financial Services Center P.O. Box 149971 Austin TX 78714-9971 Https://www.tungsten-network.com

(877) 353-9791 (512) 460-5429

See CONTINUATION Page

As a result of this solicitation. Only one single award will be made.

All request for clarification are due No Later Than (NLT) September 21, 2022, at 12:00 PM ET.

See CONTINUATION Page

X X

X 1

36C24822R0028

Table of Contents

SECTION A

A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 PRICE COST SCHEDULE

B.3 STATEMENT OF WORK

B.4 IT CONTRACT SECURITY

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES (NOV 2021)

C.2 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.3 52.204-22 ALTERNATIVE LINE ITEM PROPOSAL (JAN 2017)

C.4 52.204-23 PROHIBITION ON CONTRACTING FOR HARDWARE, SOFTWARE, AND

SERVICES DEVELOPED OR PROVIDED BY KASPERSKY LAB AND OTHER COVERED

ENTITIES (NOV 2021)

C.5 52.207-5 OPTION TO PURCHASE EQUIPMENT (FEB 1995)

C.6 52.216-18 ORDERING (AUG 2020)

C.7 52.216-19 ORDER LIMITATIONS (OCT 1995)

C.8 52.216-22 INDEFINITE QUANTITY (OCT 1995)

C.9 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.10 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

C.11 52.219-8 UTILIZATION OF SMALL BUSINESS CONCERNS (OCT 2018)

C.12 52.233-2 SERVICE OF PROTEST (SEP 2006)

C.13 VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA

ACQUISITION OF COMMERCIAL ITEMS (APR 2020)

C.14 VAAR 852.212-71 GRAY MARKET ITEMS (APR 2020)

C.15 VAAR 852.215-70 SERVICE-DISABLED VETERAN-OWNED AND VETERAN-

OWNED SMALL BUSINESS EVALUATION FACTORS (OCT 2019)

C.16 VAAR 852.219-76 SUBCONTRACTING PLANS MONITORING AND COMPLIANCE

(JUL 2018)

C.17 VAAR 852.219-75 SUBCONTRACTING COMMITMENTS MONITORING AND

COMPLIANCE (JUL 2018)

C.18 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV

2018)

C.19 VAAR 852.247-73 PACKING FOR DOMESTIC SHIPMENT (OCT 2018)

C.20 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (JAN 2022) (JUL 2020) (DEVIATION)

C.21 MANDATORY WRITTEN DISCLOSURES

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

D.1 ATTACHMENT A PRICE COST SCHEDULE

D.2 ATTACHMENT B FACILITY REQUIREMENTS

D.3.1 ORLANDO ESTIMATED VOLUMES

D.3.2 DAYTONA ESTIMATED VOLUMES

D.3.3 VIERA ESTIMATED VOLUMES

D.4 ATTACHMENT D LAKE NONA LABORATORY DRAWING

D.5 ATTACHMENT E LAKE NONA LABORATORY DRAWING WITH CLEARANCE

PARAMETERS

D.6 ATTACHMENT F VA DIRECTIVE 6550 FORM

D.7 ATTACHMENT G PAST PERFORMANCE QUESTIONNAIRE

SECTION E - SOLICITATION PROVISIONS

E.1 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.2 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.3 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

E.4 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (NOV 2021)

E.5 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERICAL

SERVICES (NOV 2021)

E.6 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES (NOV 2021) (JUL 2020) (DEVIATION)

E.7 52.216-1 TYPE OF CONTRACT (APR 1984)

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

Name:

Address:

City/State/Zip Code:

Tax ID Number:

Unique Entity Identifier Code:

Point of Contact/Title:

Email:

Telephone Number:

Fax Number

b. GOVERNMENT: 36C248- Contracting Officer: Christopher Bany, Christopher.Bany@va.gov Contract Specialist: Jessica Kiser, Jessica.Kiser@va.gov

Department of Veterans Affairs Network Contracting Office 8 (NCO 8) Orlando VA Healthcare System

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

[X] 52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or [] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] Monthly in arrears

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

5. FSC MANDATORY ELECTRONIC INVOICE SUBMISSION: Contractors are required to submit payment requests in electronic form in accordance with the submission instructions below.

TUNGSTEN ELECTRONIC INVOICE SUBMISSION

FSC e-INVOICE PROGRAM THRU AUSTIN PORTAL https://vaww.aams.ecms.va.gov/AAMS_Production/DAV/mw-vyybjynyjwxyy/Christopher.Bany@va.gov https://vaww.aams.ecms.va.gov/AAMS_Production/DAV/mw-vyybjynyjwxyy/Jessica.Kiser@va.gov

FSC MANDATORY ELECTRONIC INVOICE SUBMISSION FOR AUSTIN PAYMENTS

Vendor Electronic Invoice Submission Methods:

Facsimile, e-mail, and scanned documents are not acceptable forms of submission for payment requests.

Electronic form means an automated system transmitting information electronically according to the accepted electronic data transmission methods below.

1. VA’s Electronic Invoice Presentment and Payment System – The FSC uses a third-party contractor, Tungsten, to transition vendors from paper to electronic invoice submission. Please go to this website: http://www.tungsten-network.com/US/en/veterans-affairs/ to begin submitting electronic invoices, free of charge.

2. A system that conforms to the X12 electronic data interchange (EDI) formats established by the Accredited Standards Center (ASC) chartered by the American National Standards Institute (ANSI). The X12 EDI Web site (http://www.x12.org)

b. Vendor e-invoice Set-Up Information:

Please contact Tungsten at the phone number or email address listed below to begin submitting your electronic invoices to the VA Financial Services Center for payment processing, free of charge. If you have question about the e-invoicing program or Tungsten, please contact the FSC at the phone number or email address listed below.

1. Tungsten e-Invoice Setup Information: 1-877-489-6135

2. Tungsten e-Invoice email: VA.Registration@Tungsten-Network.com

3. FSC e-Invoice Contact Information: 1-877-353-9791

4. FSC e-invoice email: vafsccshd@va.gov

See https://www.fsc.va.gov/einvoice.asp for more information.

6. CONTRACT MODIFICATIONS: The Contractor is advised that only the Contracting Officer, acting within the scope of the contract and his/her duties and responsibilities and after advice and consultation with the Contracting Officer’s Representative (COR), has the authority to make changes that will affect contract prices, quantity, quality, delivery terms and conditions, or the term of the contract. In no event shall any understanding or agreement, modification, change order, or other matters in deviation from the terms of this contract between Contractor and a person other than the Contracting Officer be effective or binding upon the Government. All such actions must be formalized by the proper contractual document executed by the Contracting Office.

7. CONTRACT COORDINATOR: The Contractor shall identify in writing to the CO their contact person(s) who shall serve as liaisons between the Contractor and VA and who shall ensure that services are performed in accordance with the contract specifications. The Contractor’s contact person(s) shall be available during VA regular administrative work hours, exclusive of national holidays.

Name: ____________________________________________________

Phone Number: _____________________________________________

Email: ____________________________________________________ http://www.tungsten-network.com/US/en/veterans-affairs/ http://www.x12.org/ mailto:VA.Registration@Tungsten-Network.com mailto:vafsccshd@va.gov https://www.fsc.va.gov/einvoice.asp

8. AUTHORIZED NEGOTIATORS: The offeror represents that the following persons are authorized to negotiate on its behalf with the Government in connection with this Request for Proposals:

Name/Title: ____________________________________________________

Telephone Number: ______________________________________________

Email Address: __________________________________________________

Name/Title: _____________________________________________________

Telephone Number: _______________________________________________

Email Address: __________________________________________________

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

AMENDMENT NO DATE

B.2 PRICE COST SCHEDULE

See attached document: D.1 ATTACHMENT A PRICE COST SCHEDULE in Section D.

The guaranteed minimum contract amount, including the base year and any option years exercised, is $125,000.00 and the maximum contract amount, including the base year and any option years exercised, shall not exceed, $15,000,000.00.

ESTIMATED QUANTITIES: All quantities listed in the Price Schedule are estimates only and are not to be considered a minimum or maximum. A delivery order shall be issued at the start of each performance period. The Government does not guarantee or imply that any fixed number of orders/referrals for services will be placed under the resultant contract.

GUARANTEED MINIMUM: The Government will order at least $1,000.00 in supplies during the base year of the contract. (Note: The guaranteed minimum order amount applies to the base year only. Award of the additional option years is not guaranteed nor is there a guaranteed minimum order amount in any given option year that is exercised.)

MAXIMUM TOTAL CONTRACT AMOUNT: The potential aggregate contract total over the term of the entire contract (base of twelve months and Four-twelve months option) is $15,000,000.00.

AWARD BASED ON INITIAL OFFERS: Offerors are advised of the possibility that award may be made without discussion. Accordingly, offerors are cautioned to submit their initial offers based on their most favorable terms, pricing and technical factors.

ORDERING PROCEDURES: The VA Contracting Officer may place Delivery Orders utilizing any of the procedures to the Ordering Clause.

B.3 STATEMENT OF WORK

Clinical Laboratory Chemistry Automated Systems

1.0 PURPOSE: Department of Veterans Affairs, Orlando VA Healthcare System (OVAHCS), Pathology and Laboratory Medicine Service at 13800 Veterans Way, Orlando FL 32827, has a requirement for a Clinical Laboratory Chemistry Automated Systems Cost Per Tests (CPT) for the listed items below:

a. Automated integrated track system with backup server

b. Chemistry and immunochemistry analyzers

c. Centrifuges

d. Tube Decapper

e. Tube Desealer/Resealer

f. Input/output module

g. Automated/refrigerated tube storage and retrieval unit

h. Inventory Manager

i. College American Pathologist (CAP) Connect

j. Enterprise (EP) Evaluator™ linearity program or equivalent

k. A deionized water system which includes all replacement parts, labor and backup system for redundancy for all sites, if required to operate the equipment.

l. CPT to include, reagents, Bio-Rad controls, unity real time, calibrators, and any third-party linearity materials, reagents, controls and calibrators (i.e., Oxycodone). Bio-Rad controls should be set up for the life of the lot number for each item with shipments occurring quarterly, or as needed.

m. CPT to include instruments, all automation components, UPS, hardware, software, and middleware including any software upgrades, complete system installation and integration.

n. CPT to include service and maintenance for all equipment, automation, and water systems during hours of operation for each laboratory sites.

o. Operators training for personnel for the term of the contract.

1.1 In addition, the contractor shall provide a Chemistry analyzer, Deionized water system, CAP

Connect, and all items included in the CPT (except automation/track) to the following OVAHCS Lab locations:

Viera Outpatient Clinic (OPC) Laboratory 2900 Veterans Way Viera, FL 32940-8007

William V. Chappell Jr. VA OPC Laboratory 551 National Health Care Drive Daytona Beach, FL 32114

2.0 TERM OF AGREEMENT: The government contemplates awarding a single fixed-price indefinite quantity contract with a 12-months base and four 12-months option. The decision to exercise all options will be at the sole discretion of the government.

3.0 DEFINITIONS:

3.1 Cost per Test (CPT)- The necessary equipment, reagents, supplies, maintenance, repairs and training at a fixed cost per test. The rate for routine tests is generally based on the volume of tests performed.

3.2 Specimen Processing Automation Line: Pre-analytical processing and archival processing equipment that will automate specimen processing functions.

3.3 Specimen Management System: A component of the Processing Automation Line that directs and manages the operation and components of the pre-analytical processing/automation system.

3.4 Contractor Middleware Management system: A server installed with software that interfaces the testing instrumentation to the Laboratory Information system and is able to receive, process and send data following Clinical and Laboratory Standards Institute (CLSI guidelines.

3.5 Throughput: The speed that the equipment processes and/or operates reported in units per hour.

3.6 VistA: VistA is the Hospital Information System (HIS) developed by the Department of Veterans Affairs. VistA is used by clinical staff in every phase of the healthcare delivery process. VistA Imaging is the image-enabling component of the VistA HIS. VistA Imaging is a controlled image management and storage system. No system is permitted to interface with VistA Imaging except through a defined interface that has been validated by the VistA Imaging process. The VistA Imaging Program maintains a list of validated third-party devices that interface to VistA Imaging on the VistA Imaging DICOM page at www.va.gov/imaging/DICOM.asp.

3.7 DB-9 is an analog 9-pin plug of the D-sub miniature (D-sub) connector plug and socket family for computer and communication devices.

3.8 RJ45 stands for Registered Jack-25. Refers to a cable termination specification that specifies physical male and female connectors and pin assignments.

3.9 RS232 is a standard protocol used for serial communication.

4.0 SCOPE OF PROCUREMENT

4.1 The desired instrumentation shall have the capability of performing all tests defined in Attachment A. The instrument shall have random access capability (if discrete testing is required) and be able to simultaneously perform the complete profile meeting the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI).

4.2 Equipment shall be acquired for each of the clinical laboratories located at the Orlando VAMC facilities listed in Sections 1.1.

4.3 The Contractor is required to provide a continuously stocked inventory of reagents and standards. Vendor provided controls, supplies, disposables and any other materials, to include replacement parts, required to properly perform tests on the equipment such that equipment operations are not interrupted. These items shall be of the highest quality, sensitivity, specificity and tested to assure precision and accuracy. Expiration date shall be clearly marked on reagent, standards and control containers. Unexpected changes in methodology/technology shall be at the expense of the Contractor. 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.

4.4 The Contractor will provide a detailed list of all parts and supplies that are to be purchased by the facility and are not included in the CPT contract.

4.5 Special handling for emergency orders of supplies: In the event that the supplies 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 is required to deliver https://vaww.aams.ecms.va.gov/AAMS_Production/DAV/mw-vyybjynyjwxyy/www.va.gov/imaging/DICOM.asp the supplies within 24 hours of receipt of a verbal order for emergency delivery. If either circumstance has occurred, the Contractor shall deliver to the Government site in the most expeditious manner possible without additional cost to the Government, the necessary consumables in sufficient quantity as required to allow operation of the Contractor’s equipment for one week (under normal Government test load volume). If additional requests for emergency supply delivery are required by the Government, they shall be honored by the Contractor until the arrival at the laboratory of the monthly standing order/routine supplies delivery

5.0 GENERAL REQUIREMENTS

5.1 Primary Analyzer(s): Base equipment offered shall be new and shall fully support the scope of operations (minimal requirements). Depending upon the technical functionality and the capabilities of the individual manufacturer’s instrumentation, one analyzer or multiple analyzers may be required to meet the productivity specifications defined herein. Analyzers offered per facility shall provide sufficient capacity and throughput to meet the volume and service demands as listed in Attachment A. In those instances, the additional analyzer(s) shall, likewise, be considered primary instrumentation and shall meet all of the technical specifications of this solicitation.

5.2 Test Menu: Contractor shall meet the test menu demands as listed in Attachment A. Test menu requirement may be met by using, within reasonable limits, alternate Food and Drug Administration (FDA) approved reagents adapted to the proposed analytical solution. Annual test volumes provided with this contract are based upon prior history and are not a guaranteed minimum. New tests will be added as requested to the menu with all the reagents for test validation supplied at no additional cost.

6.0 OPERATIONAL AND TECHNICAL FEATURES

The instrumentation offered shall be approved by the Food and Drug Administration (FDA) and have the following:

6.1 Primary Processing Automation Line Instrumentation: Offering for an Integrated Clinical Laboratory Chemistry/Immunochemistry Instrumentation and Robotics System (Automated track) in accordance with the requirements of Orlando Lake Nona laboratory, as listed in Attachment A, shall have the following listed below. Please include a clear description regarding how samples are transported on the automation track system.

6.1.1 Sufficient capacity and throughput to meet the volume and service demands as listed in Attachment A & B.

6.1.2 Includes a specimen management system to manage and track sample progress and position. Vendor to supply system that records arrival time, directs the scheduling, routing, and tracking of specimen carriers on the conveyor system from loading to final disposition. The information system component of this laboratory automation system shall be able to communicate with Hospital Information System for ordering information to be sent from Hospital Information System to the System manager and shall include but not be limited to order code or name, tube type, accession number, container id, and receipt date and time.

6.1.3 Specimen archival through mapping of specimen location; for easy retrieval once moved off-line. (Specimen Management System). System shall be able to retrieve specimens from the storage module. Storage capability for minimum of 15,000 specimens shall be included for online or offline storage. Automated delivery and organization of specimens to outlet station based on bar-coded information. Storage and retrieval module will handle waste disposal. Should have archive capabilities to locate samples. This shall be programmable by department or tube type.

6.1.4 The ability, based on test requests, to sort and route specimens. (Line/track system/Specimen Management System) Vendor to provide input/output station for sorting specimen tubes into appropriate racks based on the tests to be done and archives specimens.

6.1.5 The ability to send the primary tube or processed aliquots by means of a tracking system to the proper testing instrumentation to maximize efficiency and to maintain and standardize turnaround times of results. (Line/track system/Specimen Management System)

6.1.6 Automation line shall have the capability of allowing Specimen Turnaround Time (STAT) samples to move in front of routine samples for immediate processing.

6.1.7 The ability to detect processing errors and provide error notification. (Specimen Management System)

6.1.8 Centrifuge: The ability to separate the serum/plasma from the blood cells through the process of centrifugation. Minimum of 2 temperature-controlled centrifuges with adjustable spin time and Revolutions per Minute (RPM) settings, with the option to bypass the centrifuge without manual intervention, which is important for pre-spun samples. Centrifuges shall be able to be programmable to set spin and dwell times and shall be able to spin multiple tube types and sizes simultaneously. Automated placement of specimens into and removal from centrifuges with minimum loading and unloading times for maximum productivity.

6.1.9 Decapper: The ability to remove caps from blood collection tubes in an enclosed environment to prevent distribution of biohazardous aerosols.

6.1.10 Desealer: Unseals the tube in an enclosed environment to prevent distribution of biohazardous aerosols.

6.1.11 Resealer: The ability to reseal - tubes.

6.1.12 The ability to connect all testing analyzers offered in accordance with

Attachment A.

6.1.13 The ability to perform all assays on all analyzers by way of introduction of specimens through automation track.

6.1.14 Ensure immediate availability of primary tube after initial testing is completed.

6.1.15 The ability to auto-archive, store and retrieve specimens. Capacity to be determined by Attachment A.

6.1.16 Barcode reader stations shall have the following capabilities:

6.1.16.1 The accuracy of the barcode reading shall have less than a 1.0 % failure rate.

6.1.16.2 Equipment shall be able to support multiple barcode formats (Code 39, Code 128) that may be enabled concurrently.

6.1.16.3 6.1.16.3 Equipment shall accept, at a minimum, 10 characters in specimen identifier that is alpha, numeric, and/or alphanumeric concurrently.

6.1.17 Pre/post analytical processor shall fit within currently allocated space. Current space is limited by support columns and access hallways in the laboratory and defined in an area that is 11’ x 21’ x 40’ (feet). (Reference Attachment C and D) Contractor shall provide non-linear or linear configuration of conveyor system for transportation of specimens to analyzers for optimal space utilization in lab and minimal disruption of current workflow and space. Water system will be in separate location.

6.1.18 Vendor shall provide automation track that shall produce speeds of at least 6.9 inches/second, or according to the track manufacturer.

6.1.19 Capable of differentiating spun and un-spun samples with minimal operator intervention.

6.1.20 Due to size restraints, all electrolyte testing shall be internal to analytics on the line testing chemistry/immunoassay menu and not a separate instrument on the automation line.

6.1.21 The automation line shall use Radio Frequency Identification (RFID) to track specimens on the system, reducing barcode readers and providing increased reliability of the track system.

6.1.22 Automated receipt of orders and patient information by reading RFID specimens and interfacing information into Hospital Information System.

6.1.23 Vendor to provide all utility requirements to operate all equipment.

6.1.24 OVAHCS requires optimized automated delivery of specimens to Chemistry and

Immunochemistry analyzers for parallel processing to provide best turnaround times and meet specimen handling requirements.

6.1.25 Vendor to provide “point in space” sampling on their automation solution. For example, primary tubes shall have the ability to be sampled out of the primary tube and the tube move onto further testing.

6.2 Testing Instrumentation: The testing instrumentation shall be an integrated platform with flexible, components that can be upgraded and or reconfigured on site and is approved by the Food and Drug Administration (FDA) at the time of proposal submission and shall have the following:

6.2.1 The Contractor shall ensure all proposed instruments/systems that requires Remote Connection capability shall be included under the current active MOU interconnection Security Agreement.

6.2.2 The capability of performing analysis on 100% of the tests listed in Attachment B with no more than 10% repeats of CPT.

6.2.3 Sufficient capacity and throughput to meet the volume and service demands as listed in Attachment A. Acceptable reagent capacity: Minimum 70 reagent test slots per chemistry analyzer and 40 for immunoassay analyzer.

6.2.4 An instrument management system (internal to testing instrumentation) that provides/maintains the following:

6.2.5 Ability to monitor instrument performance.

6.2.6 Continuous monitoring of vital functions with immediate operator notification of failure(s) and on-board of storage of these records.

6.2.7 Capability to detect and alert operator of out-of-range Quality Control (QC) results via flagged results on QC printout and visual alerts on display monitor.

6.2.8 Ability to store and retransmit patient records to the VA Laboratory Information system for a minimum 48 hours in case of interface outage.

6.2.9 Capability to record, store and print the following information:

6.2.9.1 Required QC and instrument maintenance information.

6.2.9.2 Patient demographic information and specimen results.

6.2.9.3 On board reagent inventory system.

6.2.10 A bi-directional, bar-coded computer interface compatible with the current VA laboratory information system. The fully operational interface (both hardware and software) shall be immediately available for implementation to the VA computerized hospital information system.

6.2.11 The accuracy of the barcode reading shall have less than a 1.0 % failure rate.

6.2.12 Equipment shall be able to support multiple barcode formats (Code 39, Code

128) that may be enabled concurrently.

6.2.13 Equipment shall accept, at a minimum, characters in specimen identifier that is alpha and/or numeric depending on site that may be enabled concurrently.

6.2.14 Bar coding of reagents and the ability to track reagent containers throughout the testing process using bar code technology.

6.2.15 Ability to prioritize Specimen Turnaround Time (STAT) testing without compromising existing programmed testing.

6.2.16 Minimal operator intervention to introduce STAT specimens or to change a routine specimen to a STAT specimen, as well as introduce STAT specimens during a test run without aborting a run. Vendor will outline STAT procedure.

STAT test results available in <15 minutes is preferred.

6.2.17 On board reagent stability, sufficient to accommodate both high and low volume use. See Attachment B.

6.2.18 The ability to detect and alert operator of low reagent levels and the potential of depletion.

6.2.19 The ability to load and unload all reagents from the equipment during operation without interrupting testing in progress or have sufficient capacity to enable a complete 24 hours of testing.

6.2.20 The ability to support multiple reagent lots of the same reagent on the equipment at the same time with active, valid calibrations.

6.2.21 The ability to maintain multiple calibrations per analyte.

6.2.22 The capability to calibrate assays during test run without aborting the run;

minimal calibration requirements for all tests; ensure ease of calibration with extended calibration stability and minimal calibration frequency (vendor to provide list of calibration frequency). Calibration stability shall adhere to manufacture’s specifications. Calibrators should be liquid and ready to use.

6.2.23 The capabilities to store, print, and retrieve calibration data.

6.2.24 For routine (general) chemistry tests, when more than one lot of as given reagent has a valid calibration and QC material is programmed to run as a control (in the control mode):

6.2.24.1 Operator shall be notified if a new lot number is about to be run to ensure that QC material is performed.

6.2.24.2 QC results will be easily distinguishable i.e., identified by reagent lot number or similar mechanism, on instrument printout or display monitor.

6.2.24.3 Operator may select to run a test on only a specified lot of reagents even though more than one lot has a valid calibration.

6.2.24.4 QC frequency not to exceed once/24 hours/instrument platform.

Minimum QC frequency for Sodium (NA)/Potassium (K)/Chloride (CL) not to exceed once/8 hours/instrument platform.

6.2.24.5 The analyzers shall have a comprehensive QC Program for all tests which include at minimum the following options:

6.2.24.5.1 QC files may be edited or corrected for errors manually

6.2.24.5.2 On-board QC data storage and reporting capabilities

6.2.24.5.3 Ability to view and print daily and monthly QC results

6.2.24.5.4 Ability to view and print Levy Jennings graphs

6.2.24.5.5 On-line documentation of out-of-range QC

6.2.24.5.6 Read barcoded QC

6.2.24.5.7 Westgard rules built in

6.2.24.5.8 If QC fails, instrument will stop running samples.

6.2.25 Quality methods with Coefficient of Variation (CV) acceptability on College American Pathologist (CAP) proficiency testing evaluations.

6.2.26 The ability to continuously load patient specimens.

6.2.27 The ability to detect short samples and interfering indices i.e., hemolysis, lipemia, and icterus, on all systems including Chemistry, Immunochemistry and pre-analytics.

6.2.28 Clot detection with alert notification.

6.2.29 Primary tube sampling from various manufacturers and sizes of evacuated tubes.

6.2.30 The instrumentation shall be capable of handling all routine sample collection tubes e.g.: 13x75, 13x100, 16x100. plus, other various sized sample containers i.e., sample cups (0.5, 1.0, and 2.0 ml), carrier tubes and tube inserts.

6.2.31 Automatically repeat testing when defined limits are exceeded via auto dilution or sample volume adjustment.

6.2.32 The capability to program a test as a repeat with interfacing of results to overlay initial result.

6.2.33 Safety features to avoid unnecessary exposure to biohazardous and chemical material. The exposure to and the volume of biohazardous and chemical material generated by the equipment shall be minimal and require a minimum amount of handling.

6.2.34 Calibration stability adheres to manufacture’s specifications.

6.2.35 User defined/Open Channel test capability. In the event that the contractor cannot provide desired assays, the contractor will provide application development support for open channel test implementation.

6.2.36 Minimal daily, weekly, and monthly maintenance downtime. Provide total maintenance times, including washes and wait time, for daily, weekly and monthly maintenance. Include any hands on, automated non-maintenance activities. Quarterly and triannual maintenance to be performed by contractor’s service engineers on a scheduled basis.

6.2.37 All instruments will be supported by an uninterruptible power supply (UPS) power supply to maintain power in the event of a power outage that provides at least five (5) minutes of service.

6.2.38 Shall meet space limitations of 48” x 127” x 49” (water system to be in separate location) at Viera and Daytona Outpatient Clinics.

6.2.39 All instruments will have large onboard capacity for reagents which are ready to use. It provides on board test inventory and measures the number of tests remaining. The chemistry reagents can be used interchangeably between the OVAHCS (Lake Nona), William V. Chappell and Viera laboratories.

6.2.40 For Immunoassay testing, contractor shall provide Ultra-sensitive reagent-based assay when possible, alleviating interferences.

6.2.41 The contractor shall provide and maintain all utility requirements to operate all equipment (i.e., air compressor, transformers, UPS).

7.0 CONTRACTOR MIDDLEWARE MANAGEMENT SYSTEM

7.1 The Contractor shall provide instrumentation and middleware that is compatible with VistA or interfaces directly with Data Innovations Middleware Instrument Manager, most recent version.

7.2 The contractor shall supply a Middleware system and/or software (Instrument Manger - Data

Innovations), that is compatible with the VISTA Hybrid Lower-Level Protocol Receiver/Sender M routine Interface for Health Level 7 (HL7) version 1.6 used at the VA for Laboratory Information Systems and supports Auto-Verification. The contractor shall include all required licenses for instruments, thin clients, QC programs and provide newly/updated IM versions and instrument drivers available.

7.3 The Contractor shall provide all licensing fees to Instrument Manager middleware and any workstations and instruments connected to contractor’s required middleware.

7.4 Middleware for clinical chemistry systems should be open for bidirectional interfacing of front-end automation, reference laboratories, and laboratory /clinical information systems, third party middleware applications, and laboratory instrumentation, current and future generations, for all other vendors and/or laboratory sections at no additional cost.

7.5 The Contractor shall provide the server(s) (or utilize the VA virtual server) and Data Innovations’ Instrument Manager Middleware software or other middleware that is compatible with VistA, and provide technical support for the virtualization of the virtual server for the duration of the contract.

7.6 All driver development shall be provided by the respective vendor, free-of-charge.

7.7 The middleware should have the ability to interface with regulatory agency applications. i.e., CAP.

7.8 The Contractor shall assist in the provision of the appropriate software drivers and interfaces for effective use of automated regulatory agency reporting features.

7.9 The Contractor shall assist in the establishment, mapping, rule development/creation support, testing, deployment, and troubleshooting of the full capacity of the Middleware before implementation date.

7.10 The Middleware shall contain systems that facilitate the analysis of laboratory pre-analytic, analytic, and post-analytic processes and the generation of summary reports for quality improvement and monitoring efforts.

7.11 Summary reports shall be interactive, customizable, and accessible on-demand.

7.12 Reports shall have, at a minimum, the flexibility to display information organized by department, workflow unit, desired time frame, production phase and priority. Software shall have the capability to drill down within the summary reports, identify problematic data and generate corrective action plans.

7.13 Canned summary reports shall include, at a minimum: Turnaround time, specimen and test volumes, instrument QC, specimen quality indicators, and % auto-verification, % (and number) repeat tests.

7.14 The Middleware shall include moving averages system. The Contractor shall establish, test, deploy and troubleshoot the functionality of the moving averages system.

7.15 The moving average system should have real-time, failure notification capability and an auto verification interrupt function at the analyte, specimen, and patient or instrument level.

7.16 The Middleware shall include Boolean logic rule writing applications and vendor developed drivers or functionality that enable the use of auto-validation/auto-verification in accordance with CAP regulations.

7.17 The Middleware shall facilitate the development of compound, nested rules with multiple event actions.

7.18 The middleware rule-writing application should have a visual (point-&-click) graphical user interface consistent with Microsoft Windows application and not require complex programming or coding. It should provide sufficient data elements & granularity so criteria can be defined for patient, specimen and test-level conditions.

7.19 The Middleware shall be able to query incoming orders and outgoing results and hold either for user review or action.

7.20 The Middleware shall contain a specimen management system that allows the user to quickly locate any specimen in the system.

7.21 The Middleware shall have the ability to transmit QC data directly to Bio-Rad Unity Real Time or any other comparable online QC program. The instrument shall have the capacity for Westgard rules and Levey Jennings charts, printing capability shall be available.

7.22 The software shall have a system for inventory management that facilitates the tracking of consumables and ordering of supplies, and include pertinent information about the consumables, including, lot numbers, expiration dates, and item numbers.

7.23 The server(s) or virtual servers shall have sufficient memory to store all middleware records for a minimum of 14 days with downloading capability to an external medium for long term storage of patient records and other information.

7.24 The contractor shall provide an accessible medium for long term storage of patient records, results and other information with storage capacity to maintain 2 years’ worth of information on VA servers or VA approved storage devices that the VA will own and retain. Information should be stored in a format that is readable by standard software.

7.25 Patient status display for technologist review and workflow management for all integrated

(linked) testing instrumentation.

7.26 Ability to retransmit patient records to universal interface system in case of interface outage.

7.27 Technology to automatically repeat testing based on customer configurable testing criteria

(repeat testing) and have add-on demand.

7.28 Technology to automatically direct additional specimen testing based on customer-configurable testing criteria (reflex technology).

7.29 If contractor shall provide middleware and server, a backup server (shadow) capable of taking over system functionality in event of primary server failure is provided at no cost.

7.30 Test Environment or Test Instance of the Middleware in order to be utilized as an isolated environment for testing new systems, configuration changes, instrument interfaces, upgrades, etc. Test System should have the ability to interface with VistA and VistA test Account.

7.31 Provide a completed copy of the Manufacturer Disclosure Statement for Medical Device

Security (MDS2) and VA Form 6550.

7.32 Contractor shall collaborate with each lab to write/develop protocols to establish customer configurable rules to enhance workflow management and productivity. Vendors will define level and type of support offered.

7.33 Contractor shall assist customer with optimizing operation and utilization of the data management system to fully integrate desired testing instrumentation enhancing productivity and management of workflow.

7.34 The Contractor shall provide all hardware, software, lines, adapters, and devices required to connect all Laboratory instruments to the Middleware, including, but not limited to, Lantronix devices or equivalent that are capable of converting DB9 serial to RJ45 Ethernet following RS232 protocols.

7.35 The Contractor shall provide 24/7 technical support for all hardware and software of the Middleware and its connections.

7.36 The Contractor shall provide all updates, upgrades, revisions, patches, and fixes at no cost to the government.

7.37 The Contractor shall utilize the VA national site-to-site VPN or work with the VA Officer of

Cyber and Information Security and Information Security Officers to establish a client-based

VPN.

7.38 The Contractor shall ensure all proposed instruments/systems that requires Remote Connection capability shall be included under the current active MOU interconnection Security Agreement.

7.39 The Contractor shall provide an Orders connection and a Results connection to our Laboratory

Information System (LIS) systems. If more than two (2) connections are required, vendor shall provide all connections to our LIS.

7.40 The Contractor shall provide all necessary licenses and support for licenses in order for the

Laboratory to optimize the utility of the Middleware, including but not limited to licenses for Unity Real Time QC software and transmission of College of American Pathologists (CAP) proficiency testing results using Instrument Manager.

7.41 Remote access to server for multiple VA users, either with dedicated workstation terminals or via Windows Remote Desktop Connection.

7.42 The Contractor shall provide training for the Middleware prior to implementation, annually thereafter and anytime there is an upgrade where additional training would be beneficial.

7.43 The Contractor is responsible to provide hardware and software support to LIS interface to include patches, updates, enhancements, and new versions of software and drivers. Information Technology (IT) support is included to provide management, consultation or troubleshooting to any problem and/or situation within a reasonable time frame.

8.0 HARDWARE FEATURES

8.1 A total equipment footprint that when installed in the laboratory shall not impact the functionality/operations of that laboratory.

8.2 All monitors/screens will clearly display information in all light conditions.

8.3 A printer(s) for each instrument that has the capability of printing a patient report with patient demographic information that includes minimally the patient’s name and accession or Unique Identifier Number (UID).

8.4 An UPS with line conditioner for each instrument provided. (This includes UPS units for sites with automation lines, specimen management systems, data management systems, refrigerated archive storage, etc.,) Each UPS shall provide electrical power for a minimum of 15 minutes after electrical power fails and the system shall allow for an automatic controlled shutdown to prevent damage to the instrument and data records. Replacement of UPS and parts shall be included in the contract.

8.5 If the proposed instrument requires an independent water system to operate, the vendor will include the water system, all parts, service and maintenance of the system in the CPT package.

9.0 SPECIFIC SYSTEM REQUIREMENTS

9.1 All equipment and reagents shall be FDA approved at the time of award.

9.2 Single lot of reagents for each test/analyte per shipment with a minimum dating of 90 days.

9.3 User defined option for patient testing to be disabled if QC failure occurs.

9.4 STAT Troponin I assay with a ≤ 15 min analyzer (Turnaround Time) TAT. Contractor shall provide an FDA-cleared, High-Sensitivity Troponin with package claims of ≤ 10% precision at the 99th percentile for both males and females.

9.5 Both chemistry and immunoassay Instruments shall perform accurate automatic dilutions on out-of-range results.

9.6 The systems shall be able to assess the level of common interferents (hemoglobin, lipemia, and icterus) for each sample without significantly decreasing overall sample throughput. List sample volume requirements and time to result.

9.7 Vendor to provide an excel spreadsheet delineating the following parameters for each assay:

Calibration frequency, type of calibration, number of calibration points, linearity range, Limit of Quantification (LOQ) and Limit of Detection (LOD), sample type, time to result, reagent and calibration storage requirements and number of tests per kit.

9.8 The vendor shall provide connections and licenses for Bio-Rad Unity Real Time and Enterprise (EP) Evaluator™ linearity program or some other form of linearity evaluation system.

9.9 The printer should be user defined to print the results real-time or on demand as well as option to print exceptional reports held in the middleware for auto verification purposes.

9.10 Equipment installation and possible reinstallation should the equipment need to be moved due to construction or laboratory redesign at no additional cost for one (1) location within each site.

9.11 Inventory Management System: The Contractor shall provide an inventory management system for OVAMC at Lake Nona location that simplifies inventory check-in, check-out, consumption tracking and ordering using cloud-based software and Radio Frequency Identification (RFID) technology. The system shall be an open system able to generate RFID tags and track inventory of any boxed third-party consumable. System shall be able to automate ordering and send low-stock alerts. System shall be able to record inventory usage, lot numbers, expiration dates, and tracking information. Vendor shall provide/install/train users on the Inventory Management system to all laboratory staff as needed.

9.12 Remote Instrument monitor: Contractor shall provide remote access method to meet Health Insurance Portability and Accountability Act (HIPPA) and VA confidentiality requirements for customer support staff and remote diagnostic services.

• The vendor shall have/obtain a VPN to be able to configure the system to allow for diagnostics and troubleshooting/support services. Vendor staff with access to VA medical records shall provide satisfactory documentation of receiving HIPAA training and complying with all HIPAA and VA patient confidentiality requirements.

• An approved remote network communication system shall be provided, that continuously collects and monitors performance data of the analytical systems following all the policies and procedures outlined in VA Directive 6500, Information Security Program, and its handbooks to ensure appropriate security controls are in place.

10.0 METHOD PERFORMANCE/VALIDATION REQUIREMENTS

10.1 Method performance/comparison shall be at the expense of and performed by the Contractor, shall include linearity material and reagents, and be consistent with current CLSI guidelines and related documents, College of American Pathologists (CAP) standards and Federal regulations. All studies performed will be appropriate for the test menu of the respective laboratory to include serum, plasma, urine and body fluids as applicable. All studies shall be approved by the local Laboratory Medicine Medical Director and made electronically available. These requirements shall be in effect during installation and any future changes to the test menu and/or method updates.

10.2 Correlation studies for each analyte. A minimum of 40 samples, spanning the reportable range, shall be run by the present and the new contracted method. Contractor shall analyze results and provide statistical data to support acceptance of the new method. Statistics shall consist of at least mean, bias, slope, y-intercept, correlation coefficient, regression analysis and meet current standards defined by CLSI. Differences among instruments from all sites need to be 10% or less.

10.3 Analytical Measurement Range (AMR) or Linearity analysis shall be performed on new contracted instrument(s) for each analyte to determine reportable range with data reduction in accordance with CLSI guidelines.