36C24725Q0804-Combined Synopsis-07-10.pdf

Combined Synopsis/Solicitation Notice

*= Required Field Combined Synopsis/Solicitation Notice

SUBJECT* Blood Gas Instrumentation -ABL90 Flex Plus Analyzer Monthly Lease

GENERAL INFORMATION

CONTRACTING OFFICE’S ZIP CODE* 36109-3798

SOLICITATION NUMBER* 36C24725Q0804

RESPONSE DATE/TIME/ZONE 07-21-2025 12pm EASTERN TIME, NEW YORK, USA

ARCHIVE 15 DAYS AFTER THE RESPONSE DATE

RECOVERY ACT FUNDS N

SET-ASIDE SDVOSBC

PRODUCT SERVICE CODE* Q301

NAICS CODE* 334516

CONTRACTING OFFICE ADDRESS Department of Veterans Affairs

Central Alabama Veterans Health Care

215 Perry Hill Road

Montgomery AL 36109-3798

POINT OF CONTACT*

Contract Specialist

Monica Reed

Monica.Reed@va.gov

Email Only

PLACE OF PERFORMANCE

ADDRESS Charleston VA Healthcare System

Ralph H. Johnson VA Medical Center

109 Bee Street

Charleston South Carolina

POSTAL CODE 29401

COUNTRY USA

ADDITIONAL INFORMATION

AGENCY’S URL VA.GOV

URL DESCRIPTION website

AGENCY CONTACT’S EMAIL ADDRESS Monica.Reed@va.gov

EMAIL DESCRIPTION Email

DESCRIPTION

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

534-25-4-025-0152

36C24725Q0804 07-10-2025

Monica Reed Email Only 07-21-2025

12:00 EDT

36C247 Department of Veterans Affairs Central Alabama Veterans Health Care West Campus

Montgomery AL 36109-3798

X 100

X

334516

1000 Employees

N/A

X

Charleston VA Healthcare System Ralph H. Johnson VA Medical Center

109 Bee Street Charleston SC 29401-3798

36C247

Department of Veterans Affairs Central Alabama Health Care System West Campus

Montgomery AL 36109

36C247

Department of Veterans Affairs

FMS-VA-2(101)

Financial Services Center PO Box 149971 Austin TX 78714-9971

See CONTINUATION Page

This requirement is for Blood Gas Instrumentation services as outlined in below in support of the Charleston VA Medical

Center.

Questions are due NLT 07/15 by 11:00am to Monica.Reed@va.gov No late questions will be acknowledged.

Responses to the Solicitation are due NLT 07/21 by 12:00pm to Monica.Reed@va.gov. No late submissions will be accepted.

Please adhere to instructions covered under the ADDENDUM to INSTRUCTIONS TO OFFERORS—COMMERCIAL SERVICES section of the Solicitation. Pages 67-70

All offerors shall complete Section B.2 Price Schedule with Proposed pricing. Page 27

See CONTINUATION Page

534-3650160-025-822300-2633 0100L0090

X X

X 1

Earnest Ellison Contracting Officer, NCO-07

36C24725Q0804

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

STATEMENT OF WORK

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

B.3 DELIVERY SCHEDULE

SECTION C - CONTRACT CLAUSES

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

AND COMMERCIAL SERVICES (NOV 2023)

C.2 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.3 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

C.4 VAAR 852.211-72 TECHNICAL INDUSTRY STANDARDS (NOV 2018)

C.5 VAAR 852.219-73 VA NOTICE OF TOTAL SET-ASIDE FOR CERTIFIED SERVICE-

DISABLED VETERAN-OWNED SMALL BUSINESSES (JAN 2023) (DEVIATION)

C.6 VAAR 852.219-75 VA NOTICE OF LIMITATIONS ON SUBCONTRACTING—

CERTIFICATE OF COMPLIANCE FOR SERVICES AND CONSTRUCTION (JAN 2023)

(DEVIATION)

C.7 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV

2018)

C.8 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020)

C.9 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (JAN 2025) (DEVIATION FEB 2025)

C.10 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

WAGE DETERMINATION

SECTION E - SOLICITATION PROVISIONS

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

COMMERCIAL SERVICES (SEP 2023)

ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

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

SERVICES (NOV 2021)

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

PRODUCTS AND COMMERCIAL SERVICES (MAY 2024) (DEVIATION FEB 2025)

E.4 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.5 52.204-29 FEDERAL ACQUISITION SUPPLY CHAIN SECURITY ACT ORDERS—

REPRESENTATION AND DISCLOSURES (DEC 2023)

E.6 52.216-1 TYPE OF CONTRACT (APR 1984)

E.7 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

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:

b. GOVERNMENT: Contracting Officer 36C247-Earnest Ellison

Department of Veterans Affairs

Central Alabama Veterans Health Care

West Campus

215 Perry Hill Road

Montgomery AL 36109-3798

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; After services performed

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.

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

AMENDMENT NO DATE

STATEMENT OF WORK- FDA Approved Blood Gas Instrumentation

PURPOSE: The Ralph H. Johnson VA Medical Center, located at 109 Bee Street, Charleston South Carolina 2940-5703, has a requirement to establish a Cost-Per-Reportable Result (CPRR) or Cost-Per-Test (CPT) agreement for Blood Gas Instrumentation. It is the intent of the Government to award this contract to a single contractor for Blood Gas Instrumentation services as a single award, firm-fixed price contract with a one-year base plus three option years.

PRICES AND TERMS: The Ralph H. Johnson VA Medical Center will provide an estimated volume of tests performed as reflected in TEST MENU for the Medical Center. The Government estimates the volumes listed in the test menu but does not guarantee volumes as listed; they are estimates ONLY.

SCOPE OF WORK CAPABILITIES

1. The desired instrumentation shall have the capability of performing or reporting the clinical parameters as defined in the statement of work. The instrument shall have random access capability and be able to simultaneously perform the complete profile as described below and meet 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).

2. Equipment must maintain or preferably reduce the number of workstations or overall labor required to accomplish the required testing by each facility.

3. Equipment shall be acquired for the clinical laboratory located at the following facility listed below:

Facility Name Delivery Location Hours of

Operation Telephone #

Ralph H. Johnson

VAMC

109 Bee Street, Charleston, SC 29401

24/7 843-789-7510

4. The Contractor is required to provide a continuously stocked inventory of reagents, standards, controls, supplies, disposables and any other materials required to properly perform tests on the equipment such that equipment operations are not interrupted. These items will be shipped free of charge. These items shall be of the highest quality, sensitivity, specificity and tested to assure precision and accuracy. The expiration date must 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.

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 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 regularly scheduled standing order/routine supplies delivery.

B. TEST MENU – The Blood Gas Instrument shall have the capability of performing and reporting the following parameters at a minimum on arterial, venous, or mixed venous whole blood specimens with an annual volume of ~6000 tests per year:

• pH

• pO2

• pCO2

• Bicarbonate (HCO3)

• Base excess (BE)

• Total Carbon Dioxide (tCO2)

• Oxygen Saturation (SO2)

• Ionized Calcium (iCa++)

• Co-Oximetry – Carboxyhemoglobin (COHb), Methemoglobin (MetHB), Oxyhemoglobin (O2Hb), Deoxyhemoglobin (HHb), Oxygen Saturation (SO2%)

The Contractor may list any other parameter that is currently available to be analyzed on their proposed equipment.

C. GENERAL REQUIREMENTS

1. Analyzers: Base equipment offered shall fully support the scope of operations (minimal requirements). Depending upon the technical functionality and the capabilities of the individual manufacturer’s instrumentation, two (2) mirror-image analyzers are required to meet the productivity specifications defined herein.

a) The contractor shall provide the facility, for the duration of the contract, all linearity material, calibration verification material, or any commercial system correlation samples needed to validate equipment performance to meet CAP requirements for accreditation.

b) The system shall have standardization of software, hardware, reagents, and consumables between the analyzers.

c) The contractor shall provide external and/or internal on-board commercial quality control material to meet the daily quality control requirements for every 24 hours of operation.

The quality control material shall include:

• 3 levels for blood gases,

• 3 levels for co-oximetry

Quality control material is to be analyzed on each analyzer for every 8 hours of operational shift or for troubleshooting as needed. The daily control material shall represent both high and low levels on each day of patient testing. The contractor shall explain the internal and/or external QC testing process and its frequency for their proposed equipment.

d) The equipment shall have online documentation for quality control outliers, instrument issues, troubleshooting, etc.

e) The blood gas instruments shall perform within the defined Limits of Acceptability on the College of American Pathologists (CAP) Proficiency Testing (PT) surveys: AQ - Critical Care/Aqueous Blood Gas and SO - Blood Oximetry. The Contractor shall provide information if the PT samples have to be tested or handled in a different way for proficiency testing.

2. Operational Features: The instrumentation offered shall have the following:

a. The capability to perform analysis on the tests listed in the test menu.

b. Sufficient capacity to meet the volume and service demands as defined in the test menu.

c. Sufficient safety features to avoid unnecessary exposure to biohazardous and chemical materials. The exposure to and the volume of biohazardous and chemical material generated by the equipment must be minimal and require a minimum amount of handling.

d. Blood gas shall have a windows-based computer interface that is compatible with the current VA laboratory information system (VistA) and existing universal interface (Data Innovations). The fully operational interface (both hardware and software) shall be immediately available for implementation to the VA computerized hospital information system.

e. The equipment shall have positive sample identification, random access, and accurate barcode reading to reduce possible sources of errors and to improve laboratory efficiency.

f. The instrument must be able to support multiple barcode formats (including but not limited to: Code 39, Code 128) that may be enabled concurrently.

g. The instrument must accept, at a minimum, a 10-character specimen identifier that is alphanumeric (letters and numbers).

h. The blood gas system shall require minimal time to perform daily, monthly and periodic maintenance. Daily maintenance should be automated and involve minimal operator involvement. The Contractor defines the actual hands-on time required to perform each task and what materials and/or items are required/provided to perform each task. The Contractor is to include the analyzer time required to perform each maintenance task.

i. The blood gas equipment shall have the ability to store and retransmit records (24 hours of maximal instrument throughput) in case of interface outage. The equipment shall have the ability to edit the sample/patient identifier after interface downtime and then be able to resend the sample/patient information to the host for verification.

j. The blood gas analyzer(s) shall perform system checks and/or system calibrations in accordance with the regulatory requirements. The calibration shall compensate for the influence of barometric pressure. The system shall have a diagnostic error detection system that will alert the operator of a calibration drift. The Contractor shall specify the frequency of a one point, two point, and system calibration.

k. The Contractor shall supply ready to use reagents for the blood gas equipment that has an on-board reagent stability greater than or equal to 30 days.

l. The blood gas analyzer(s) shall have on board reagent monitoring. The system shall be capable of monitoring reagent usage and provide reagent inventory upon request, in real time.

m. Reagents shall have long on-board stability. The Contractor shall list all reagents used for blood gas, chemistry, and co-oximetry analysis and state the on-board stability/expiration date for all reagents, controls, and calibrators.

n. The blood gas equipment shall have easy reagent management. The Contractor shall state the size of the reagents, controls, and calibrators and if they are stored at room temperature or refrigerated. The Contractor may state if the reagents are color coded.

Packaging should be maximized to accommodate the workload volume and reduce the amount of storage space needed. The Contractor shall monitor reagent inventory to prevent overstock.

o. Reagents shall be interchangeable between the primary analyzer and the back-up analyzer.

p. The blood gas system shall have the ability to detect and alert the operator of low liquid levels and the potential of depletion for any supply on the analyzer. On board reagent inventory system, in real time, that can be printed at selected time intervals for reagent documentation.

q. The contractor shall be flexible in reference to changing standing orders or adding additional supplies. The contractor shall state what their policy is in regards to adjusting a standing order or ordering an additional shipment of supplies (i.e. Is there an additional fee charged for changing the standing order, is there a limit to the number of times you can adjust a standing order or is there a fee for the additional shipment of supplies?).

r. The blood gas analyzer(s) must have a sampling system that has the ability to aspirate directly from a syringe or an evacuated blood collection tube that can accommodate any sample type without any additional adapter devices. The sampling system must have the capability of walk away processing that negates the need for additional instrument prompting. The Contractor shall state the sample size required for patient testing and if a specific sample syringe has to be used for patient testing.

s. The sampling system shall have an early clot detection that alerts the operator to the suspected existence of a fibrin clot in the specimen. The Contractor shall explain the mechanism to detect a clotted specimen. The Contractor shall explain the mechanism to remove a clot from the analyzer and if it is performed automatically.

t. The analyzer shall immediately alert the operator that a sample is not positioned properly or if there is insufficient sample quantity, The Contractor shall explain the mechanism to detect insufficient blood volume for testing or a short sample. The Contractor is to explain how short samples are analyzed on the proposed analyzer.

u. The blood gas system shall be capable of being programmed to perform and execute auto quality control without operator intervention, detecting and flagging out of range quality control, perform automatic corrective action (i.e. rerun QC) if the QC is unacceptable, and have the ability to lock out/suppress a test if there is a QC failure.

3. Technical Features: The instrumentation must be approved by the Food and Drug Administration (FDA) and shall have the following:

a. Comprehensive on-board QC data management system with a minimum storage capacity of 90 days of QC files and include Levy-Jennings graphs. Analyzer must have the ability to capture, store, and automatically transfer QC data.

b. Ability to edit or correct errors in QC files manually with or without password protection.

c. Ability to have on-board documentation for out-of-range QC and instrumentation problems.

d. Ability to view and print daily and/or monthly QC results and Levy-Jennings graphs.

e. Ability to visually alert the operator of QC (Westgard and user defined rules) failures.

f. Ability to electronically transfer QC without any additional cost to the Contractor’s peer program without the need for manual entry or to download data to a disc.

g. The system shall have a design that removes the possibility of sample carryover. The Contractor shall provide documented evidence confirming the system design removes the possibility of any sample carryover.

h. The blood gas instrument(s) shall be calibrated per CAP Guidelines: CHM.34200 Calibration Materials, using materials that are either in conformance with the manufacturer’s specifications or traceable to NIST Standard Reference Materials for pH, CO2, and O2 sensors.

i. The blood gas instruments shall be calibrated, per CAP guidelines: CHM.34300 Calibration – Blood Gas Instruments, according to the manufacturer’s specifications and at least as frequently as recommended by the manufacturer.

j. The blood gas system may have on-board maintenance records that can be modified for additional user defined maintenance tasks and printed at selected time intervals for maintenance documentation.

4. Hardware Features: The instrumentation shall have the following:

a. The Contractor shall list the utility requirements for the proposed equipment (i.e.

electrical, plumbing, reagent and/or waste biohazardous disposal, water, etc.).

b. The blood gas system offered shall have an on-board monitor/screen that is easily readable in addition to built-in speakers, a keyboard and optical mouse. The analyzer may have a touch-screen interface.

c. An uninterruptible power supply (UPS) with line conditioner for each instrument provided. Each UPS shall provide electrical power after electrical power fails. The Contractor shall state how long the UPS will provide back-up for each piece of equipment. The Contractor shall be responsible for replacing the UPS, should it become dysfunctional and provide battery replacement as needed.

d. The Contractor shall list any routine or special items that are required to operate or maintain the proposed equipment in optimal condition. Any items excluded by the Contractor shall be delineated in their proposal. The cost of the excluded items shall be incorporated in the price proposal.

5. Instrumentation and Software:

a. The blood gas system shall have the ability to manage patient information through a data manager that electronically links to the testing instrumentation. The data manager shall allow users to monitor and analyze data.

b. The data manager computer, at a minimum, shall be used for the acceptance of test ordering information, transmittal of patient laboratory results, storage and retrieval of patient laboratory results.

c. The middleware shall allow the user to define/set-up decision rules for analyzer flags, linearity, delta checks, and critical values and provide a proactive alerting system (i.e.

visual and audible) for alerts, unusual or pending test results.

d. The Contractor shall assist the facility throughout all 5 years of the contract with optimizing operation and utilization of the data management support software (to include building rules) to enhance productivity and the management of workflow.

e. The Contractor shall provide, support, maintain, and upgrade the antivirus software, and any Microsoft security updates for the duration of the contract to the data manager and analyzer(s).

f. The Contractor shall provide all upgrades to the equipment hardware, software, and operating systems without additional charge to the Government (i.e. upgrades that correct either a mechanical or software deficiency of the system). These enhancements to the Contractor’s equipment shall be delivered and installed at the site within 2 months of their issuance or date of first commercial availability.

g. The blood gas system may have the ability to auto-verify results.

6. Method Performance/Comparison: Shall be at the expense of the Contractor, shall include validation 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 all types of acceptable patient samples as applicable. These validation requirements are applicable to all new testing analyzers.

a. Correlation studies for each analyte: A minimum of 30 samples, spanning the reportable range, shall be run by the present and proposed method. Contractor shall analyze results and provide applicable statistical data to support acceptance of the new method.

b. Precision study: Using positive and negative control material. This shall include at a minimum, within-run precision study of 10 positive and 10 negative controls on a day-to-day precision study of positive controls and negative controls.

c. Sensitivity Studies: Sensitivity may be validated concurrently with correlation studies. Mathematical calculations to determine efficiency, sensitivity, false positive rate and false negatively rated are applied.

d. Specificity Studies: A review of product literature and assay inserts to determine any adverse effects for increased bilirubin, hemolysis, lipemia, or other interfering substances.

e. Carryover Studies: Successful carryover studies shall be completed by the contractor on all analyzers during installation. These studies shall be performed using either contractor developed program(s) or program(s) developed by a third party (CAP/CLSI). The program(s) shall be provided to each laboratory at no charge.

7. Support Features:

a. Commercial Marketing: The equipment models being offered shall be in current production as of the date this offer is submitted. For purposes of this solicitation, “current production” shall mean that the clinical laboratory analyzer model is being offered as new equipment. Discontinued models that are only being made available as remanufactured equipment are not acceptable.

b. Start-Up Reagents: The Contractor shall provide all reagents, calibrators, controls, consumable/disposable items, parts, accessories and any other item included on the list of supplies defined in the Federal Supply Schedule contract and required to establish instruments for operation for performance of acceptance testing. This applies to all equipment as well as additional or replacement equipment placed under the terms and conditions of this SOW. The Contractor shall perform/assist, to the satisfaction of the Government, all validation studies including precision, method comparison with current analyzer, accuracy (recovery), linearity (reportable range), calibration verification, verification of reference interval, and determination of sensitivity and specificity (where applicable). All materials and reagents needed for such studies are at no cost to the Government. The Contractor shall perform all of the statistical analysis as stated in the Method of Performance Validation section above and provide a hard copy of the data in an organized, clearly comprehensible format. This process shall be completed at each site and shall be consistent with current CLSI and related documents, CAP Standards and Federal Regulations.

c. Training: The Contractor shall provide an instrument training program that is coordinated with and timely to the equipment installation, sufficient to the size and scope of the facility’s services and minimally equivalent to the terms and conditions for training defined in the Contractor’s Cost Per Reportable Result Federal Supply Schedule FSC Group 66, Part III, Cost-Per-Test Clinical Laboratory Analyzers contract. This shall include training on the operation of the system, data manipulation, and basic trouble shooting and repair. In addition to the training described above, the Contractor shall provide training on-site for all operators on all shifts, as applicable. A training program that involves off-site travel shall include the cost of airfare, room and board for each participant.

d. Any future training or educational events such as ‘lunch and learn’ for new technologies or advancements will be provided at no additional cost the VA.

e. Equipment Preventative Maintenance/Repair Service: Preventative maintenance will be performed as frequently as published in manufacturer’s operator’s manual and within 2 weeks of the scheduled due date.

• A technical assistance center shall be available by telephone 24 hours per day, 7 days per week with a maximum callback response within 1 hour.

• Equipment repair service shall be provided during core business hours between 8am

– 5:00pm EST, Monday-Friday. Certain circumstances may dictate the need for repair service to be conducted outside routine business hours. All such arrangements shall be coordinated between the contractor and VA laboratory personnel.

• Equipment repair response time shall be no more than 2 hours.

• A malfunction incident report shall be furnished to the Laboratory upon completion of each repair call. The report shall include, as a minimum, the following:

- Date and time notified

- Date and time of arrival

- Serial number, type and model number of equipment

- Time spent for repair, and

- Proof of repair that includes documentation of a sample run of quality control verifying acceptable performance.

- Each notification for an emergency repair service call shall be treated as a separate and new service call.

• In the rare instance that both analyzers shall go down and not be serviceable by

Laboratory personnel after consultation with the technical assistance center, service shall come immediately to the Medical Center to repair the analyzers regardless of the time of day.

f. Upgrades: The Contractor shall provide upgrades to both the equipment hardware and software in order to maintain the integrity of the system and the state-of –the art technology, at no additional charge to the Government. These shall be provided as they become commercially available and at the same time as they are being provided to commercial customers. This requirement only applies to “system upgrades” that enhance the model of equipment being offered, i.e. new version of software, correction of hardware defect, upgrade offered to commercial customers at no additional charge, upgrade to replace model of equipment no longer Contractor supported, etc. This does not refer to replacing the original piece of equipment provided within the SOW; however, it does refer to significant changes in the hardware operational capability.

g. Ancillary Support Equipment: The Contractor shall provide, install and maintain through the life of the contract, as indicated, any and all ancillary support equipment to fully operate the analyzer as defined in these specifications, e.g. cabinetry to support/house the analyzer (if necessary), water systems (including consumable polishers, filters, preventative maintenance and repair, etc.), printers and universal interface equipment, etc. In addition, the Contractor shall include all ancillary components that are customarily sold or provided with the model of equipment proposed, e.g. starter kits, tables/stands, etc.

h. Interface Requirements:

• The Contractor shall be responsible for providing all hardware required for the connection; implementation and operation of the interface to the universal interface and any incremental fee that is required each time an instrument is added to an existing universal interface system.

• The Contractor shall provide any and all necessary software support for ensuring that successful interfacing has been established. Specific requirements for the communication of the data streams will be unique to the instrument system involved and dictated by the manufacturer itself.

• If a site already has a universal interface, the Contractor is responsible for everything leading up to the connection including any incremental fee required to add additional equipment (e.g. licenses, ports/cards, cables, software, etc.) to the universal interfacing system.

• If a site does not have a universal interface and one is needed to optimally interface the instrument, then the Contractor is responsible for the acquisition of the universal interface box and everything else needed to connect with VA computerized hospital information system.

• If there are any software upgrades in the instrument during its life, the Contractor is responsible for seeing that the interface can accommodate any changes in the data stream going to the VA computerized hospital information system.

h. Commercial Offerings: The Contractor shall provide any additional support material that is routinely provided to equivalent commercial customers and assists in regulatory compliance, e.g. Computer disc containing their procedure manual in CLSI format or an on-line procedure manual in the instrument software.

i. Characterization of Waste: The Contractor shall provide documentation that it has characterized the hazardous nature of all wastes produced by all equipment, devices, reagents, and discharges in accordance with the requirements of the Code of Federal Regulations Title 40 “Protection of the Environment” Part 261 et seq. and applicable state and local requirements. Documentation shall include a description of the characteristics of the hazardous waste produced as a byproduct of the instrument operations, Safety Data Sheets (SDS) meeting the requirements of the Occupational Safety and Health Administration (OSHA) and Environmental Protection Agency (EPA), the analytical process used to determine the hazardous nature and characteristics of the waste, and the analytical test results. Testing of hazardous waste is to be done in accordance with testing protocol specified for each individual waste as described in the Code of Federal Regulations Title 40 to make a determination if the waste is a hazardous waste or otherwise regulated.

-The determination and description shall address the following:

• Waste toxicity (Reference 40 CFR §261.11 and 40 CFR §261.24)

• Waste ignitability (Reference 40 CFR §261.21)

• Waste corrosivity (Reference 40 CFR §261.22)

• Waste reactivity (Reference 40 CFR §261.23)

• Hazardous waste from non-specific sources (F-listed) (Reference 40 CFR

§261.31)

• Discarded commercial products (acutely toxic or P-listed and toxic or U-listed)

(Reference 40 CFR §261.33)

• Solid Waste (Reference 40 CFR §261.2)

• Exclusions (Reference 40 CFR §261.4)

j. The Contractor will provide written instructions and training material to ensure VHA laboratory staff are trained as needed to properly operate devices with special emphasis to managing and disposing of hazardous waste in accordance with EPA and state requirements. Additionally, the training provided by the Contractor must fulfill Resource

Conservation and Recovery Act (RCRA) requirements for training as applicable to devices.

k. Contractor shall provide a description of all wastes the process or equipment may discharge so that the facility can determine whether the discharge meets Local Publicly Owned Treatment Works (POTW), State and Federal discharge requirements. At a minimum the characteristics of ignitability, corrosivity, reactivity and toxicity as defined in 40 CFR §261 must be determined and documented. Any mercury containing reagents must be identified in any concentrations. All test results shall be provided. All listed chemicals (F, U, K and P) found in 40 CFR §261 shall be provided in product information and their concentrations documented. For those materials with positive hazardous waste determination, a mechanism for the laboratory to meet local discharge requirements (i.e. mercury, thimerosal and formaldehyde) must be developed and SDS sheets must be provided in advance for review. At a minimum, documentation shall include, but not be limited to the concentration/measures of the elements and parameters listed below and must be included with Contractor response:

• Barium (Total)

• Cadmium (Total)

• Chromium (Total)

• Copper (Total)

• Cyanide (Total)

• Lead (Total)

• Mercury (Total)

• Nickel (Total)

• Silver (Total)

• Zinc (Total)

• Arsenic (Total)

• Selenium (Total)

• Tin (Total)

• pH

• Flash point (to higher than 200oF)

• BOD; biochemical oxygen demand

l. The documentation the Contractor provides will be used to work with the VAMC and the public and/or private organization (e.g., POTW) to determine whether or not the waste from each device can legally be disposed of via the sewerage system.

m. Implementation/transition timeframe: The implementation of the services/requirements described in this solicitation shall be completed no later than 120 days after the award of the contract. This timeline is based on a reasonable attempt of the Contractor to complete all of the necessary implementation requirements within the stated timeframe. Contractors shall not be penalized for implementation timelines that extend beyond the 120-day timeframe, if the extension is through no fault of the Contractor and is a result of delays due to the Government.

• Upon award of the contract, the transition period to have all equipment and peripherals installed and operational shall be from date of award through 120 days. During this same period, all initial training of VA personnel in the operation and maintenance of said equipment shall also be completed.

• Contractor shall provide with its quotation, an implementation plan for installation of new equipment. Contractor’s submitted plan shall not exceed 120 days for the transition of all services under the awarded BPA including installation and training of personnel, transition of all testing materials, reagents and supplies, etc., performance of all correlations and validations. Failure of the contractor to conform to the transition period shall be considered as sufficient to terminate BPA for cause under the Termination for Cause clause of the BPA.

• At the end of 120 days from award of the contract, the awarded contractor shall have full and sole responsibility for services under the award.

n. Standard and Quality of Performance: This paragraph establishes a standard of quality performance that shall be met before any equipment listed on the delivery order is accepted by the Government. This also includes replacement, substitute machines and machines that are added or field modified after a system has demonstrated successful performance. The acceptance period shall begin on the installation date. It shall end when the equipment has met the standard of performance for a period of 30 consecutive calendar days by operating in conformance with the Contractor’s technical specification or as quoted in any proposal at an effectiveness level of 90% or more.

• In the event that equipment does not meet the standard of performance during the initial 30 consecutive calendar days, the standard of performance tests shall continue on a day-by-day basis until the standard of performance is met for a total of 30 consecutive days.

• If the equipment fails to meet the standard of performance after 90 calendar days from the installation date, the user may, at his/her option, request a replacement or terminate the order in accordance with the provisions of FAR.52.212-4 entitled “Termination for cause.” (The contractor shall receive revenue for tests reported during the 90-day acceptance period.)

• Operational use time for performance testing for a system is defined as the accumulated time during which the machine is in actual use. System failure downtime is that period of time when any machine in the system is inoperable due to equipment failure. Downtime for each incident shall start from the time the Government makes a bona fide attempt to contact the Contractor’s designated representative at the prearranged contact point until the system or machine(s) is returned to the Government in proper operating condition.

• During the performance period for a system, a minimum of 100 hours of operational use time with productive or simulated work shall be required as a basis for computation of the effectiveness level. However, in computing the effectiveness level, the actual number of operational use hours shall be used when in excess of the minimum of 100 hours.

• The Government will maintain daily records to satisfy the requirements of the Standard and Quality of Performance section and shall notify the Contractor in writing of the date of the first day of the successful period of operation.

Operations use time and downtime shall be measured in hours and whole minutes.

• During the term of the contract, should the repair record of any individual piece of laboratory equipment reflect a downtime of 10% or greater of the normal working days in one calendar month, a determination shall be made by the COR and/or contracting officer to replace the malfunctioning equipment with new equipment. The responsibility for maintaining the equipment furnished in good condition in accordance with manufacturer’s instructions, shall be solely that of the Contractor. Each instrument provided by the Contractor shall maintain an uptime of 90% in each month of the term of the agreement for equipment. The same terms and conditions apply to ancillary/support equipment provided under this SOW, i.e., water system UPS, etc.

o. Government’s Responsibility: The user will perform routine maintenance and cleaning as required in the manufacturer’s operation and maintenance instructions.

The user shall maintain appropriate records to satisfy the requirements of this paragraph.

p. Ownership of Equipment: Title to the equipment shall remain with the Contractor.

All accessories (unused consumables, etc.) furnished by the Contractor shall accompany the equipment when returned to the Contractor. The Contractor, upon expiration of order(s), at termination and/or replacement of equipment, shall remove the equipment. The Contractor shall disconnect the analyzer (gas, water, air, etc.)

and shall be responsible for all packing and shipping required to remove the analyzer.

q. The Contractor will identify if removable media is required to perform their duties.

The Clinical Engineering Department will ensure the removable media is scanned with anti-virus software running current virus definitions prior to connection to any medical device/system. Any Contractor with patient sensitive information that is imported into the removable media device for any reason must purge all patient sensitive information prior to departure from the facility.

r. Prior to termination or completion of this contract, Contractor/subcontractor must not destroy information received from VA, or gathered/created by the Contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a Contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the Contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination or completion of the contract.

s. All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the contract or (ii) disposal or return of the IT equipment by the Contractor/subcontractor or any person acting on behalf of the Contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the Contractors/subcontractors that contain VA information must be retained by the VA for sanitization or destruction or the Contractor/subcontractor must self-certify that the media has been disposed of per

6500.1 requirements. This must be completed within 30 days of termination or completion of the contract or disposal or return of the IT equipment, whichever is earlier.

t. Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the contractor at the end of lease, for trade-in, or other purposes. The options are:

• Contractor must accept the system without the drive;

• VA’s initial medical device purchase includes a spare drive which must be installed in place of the original drive at time of turn-in; or

• VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase.

u. Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then;

• The equipment contractor must have an existing BAA if the device being traded in has protected health information stored on it and hard drive(s) from the system are being returned physically intact; and

• Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation.

Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools.

Applicable media sanitization specifications need to be pre-approved and described in the purchase order or contract.

• A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The Information Security Officer (ISO) needs to maintain the documentation.

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE FOR

INCLUSION INTO CONTRACTS, AS APPROPRIATE

1. GENERAL

Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

a. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

b. All contractors, subcontractors, and third-party services and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

c. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness.

d. Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S.

may be an evaluation factor.

e. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor’s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.

3. VA INFORMATION CUSTODIAL LANGUAGE

a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1).

b. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor’s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA’s information is returned to the VA or destroyed in accordance with VA’s sanitization requirements.