36C24824Q0012 0002.docx

36C24824Q0012 Questions and Answers 10-05-2023

5. PROJECT NUMBER (if applicable)

CODE

7. ADMINISTERED BY

2. AMENDMENT/MODIFICATION NUMBER

CODE

6. ISSUED BY

8. NAME AND ADDRESS OF CONTRACTOR

4. REQUISITION/PURCHASE REQ. NUMBER

3. EFFECTIVE DATE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED

PAGE OF PAGES

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED

BPA NO.

1. CONTRACT ID CODE

FACILITY CODE

CODE

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

E. IMPORTANT:

is extended,

(a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY is not extended.

12. ACCOUNTING AND APPROPRIATION DATA

(REV. 11/2016)

is required to sign this document and return ___________ copies to the issuing office.

is not, A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

15C. DATE SIGNED

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER

Contractor

16C. DATE SIGNED

14. DESCRIPTION OF AMENDMENT/MODIFICATION

16B. UNITED STATES OF AMERICA

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER

16A. NAME AND TITLE OF CONTRACTING OFFICER

15B. CONTRACTOR/OFFEROR

STANDARD FORM 30

PREVIOUS EDITION NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.243 (Type or print) (Type or print) (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

(Number, street, county, State and ZIP Code) (If other than Item 6) (Specify type of modification and authority) (such as changes in paying office, appropriation date, etc.)

(If required)

(SEE ITEM 11)

(SEE ITEM 13)

(X)

CHECK

ONE

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

(Signature of person authorized to sign) (Signature of Contracting Officer) 10-05-2023 573-24-1-2114-0023 36C248 Department of Veterans Affairs Network Contracting Office 8 (NCO 8) North Florida/South Georgia VHS 1601 SW Archer Road Gainesville FL 32608-1197

To all Offerors/Bidders

36C24824Q0012 09-26-2023

X X X ** HOUR & DATE for Receipt of Offers is EXTENDED to: 10-16-2023 4:30 PM ET The purpose of this amendment is to answer vendor additional vendor questions and provide an updated Statement of Need.

1. Vendor submitted questions and answers located on page 2 of this document.

2. Updated Statement of Need is starts on page three of this amendment.

3. This solicitation is hereby extended to close on October 16, 2023 at 4:30 PM ET.

4. No further questions will be addressed.

Heidi Parrish Contracting Officer

1. Question: Will FDA-approved In Vitro Diagnostic (IVD) regulatory status be required on the instrumentation proposed in the vendor’s response?

Answer: No

1. Question: The industry standard is to provide IVD assays whenever possible, which are available for flow cytometry. For example, there are multiple vendors who can provide IVD-cleared T cell subset assays thereby promoting competition and providing the government with best pricing/value. Can you please clarify whether laboratory developed tests will be acceptable when IVD FDA-approved options are available? Please see FDA draft guidance speaking specifically to this topic Federal Register :: Medical Devices; Laboratory Developed Tests. As this is a Base plus 4-Option Year contract, this potential change to FDA guidance around IVD vs LDT topic seems pertinent to end-use requirements.

Answer: Laboratory developed tests will be acceptable.

1. Question: We would also like clarification on the use of acceptable reagents in the Laboratory Developed Tests (LDTs) space. Will Research Use Only (RUO) reagents be accepted when there are industry standard Analyte Specific Reagents (ASRs) available?

Answer: Yes- RUO reagents will be accepted in situations in which ASRs are not available

1. Question: The solicitation requires a 10-color analyzer for testing. Will the responding vendor have to maintain a reagent catalog that contains 10 distinct fluorochrome options in order to build panels that utilize all 10 fluorescent channels if needed?

Answer: We do not need every listed antibody to be available in all 10 fluorescent channels. We would have to construct panels that would have to make up for limitations in availability of antibodies in certain fluorescent colors.

A.1 STATEMENT OF NEED

1. INTENT

2. DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK

2.1 The desired instrumentation/system 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).

3. DEFINITIONS

3.1 Cost per Test (CPT) – Contractors are required to provide a price for each test that can be performed on its equipment. The per test price shall include costs covering (a) equipment use, (b) all reagents, standards, controls, supplies, consumable/disposable items, parts, accessories and any other item required for the proper operation of the contractor’s equipment and necessary for the generation and reporting of a test result, (c) all necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs) and (d) training for Government personnel. Contractors are required to provide delivery, installation, and removal of equipment at no additional charge.

3.2 Primary analyzer(s) – Base equipment offered that shall fully support the scope of operations (minimal requirements). Depending upon the technical functionality and the capabilities of the individual manufacturer’s instrumentation/system, one analyzer or multiple analyzers may be required to meet the productivity specifications defined herein. In those instances, the additional analyzer(s) shall, likewise, be considered primary instrumentation/system and must meet all of technical specifications of this solicitation. Those additional analyzer(s) offered meeting the definition of a primary analyzer shall be equivalent to a back-up analyzer (see definition below) and shall replace the requirement for offering that category of equipment.

3.3 Business Associate Agreement (BAA)- A business associate is an entity, including an individual, company, or organization that, on behalf of the VHA facility, performs or assists in the performance of functions or activities involving the use or disclosure of PHI, or that provides certain services involving the disclosure of protected health information (PHI). VHA is a covered entity under the HIPAA Privacy Rule (Privacy Rule). HIPAA regulations require VHA to execute HIPAA-compliant BAAs with everyone that receives, uses, or discloses VHA PHI in order to perform some activity for VHA. These BAAs obligate VHA business associates to provide the same protections and safeguards to PHI that is required of VHA under the Privacy Rule.

4. TEST MENU

Malcom Randall VAMC Laboratory Estimated Annual Volumes for Flow Cytometry

TEST PANELS

(Refer to Required Panel Tests in Section 5.1 J below)

Malcom Randall VA Test 10-01-2023 to 09-30-2024

Malcom Randall VA Test 10-01-2024 to 09-30-2025

Malcom Randall VA Test 10-01-2025 to 09-30-2026

Malcom Randall VA Test 10-01-2027 to 09-30-2028

Malcom Randall VA Test 10-01-2028 to 09-30-2029

Note: All quantities are estimated – an increase of 10% has been added to each option year to plan for anticipated increase in quantities. The Government estimates the volumes listed in the test menu per facility but does not guarantee volumes as listed; they are ESTIMATES ONLY.

5. GENERAL REQUIREMENTS

5.1 Operational Features - The instrumentation/system offered shall have the following:

5.2 Technical Features – The instrumentation/system shall have the following:

2. A real time compensation, data analysis and gating

3. A fully digital electronics for linear, log, etc. for all collected parameters, with post- acquisition electronics

4. The ability to create custom test panels

5. Software for remote data analysis, manipulation and interpretation by technologists and Hematopathologists (optional).

6. A quality control package used for daily monitor of system performance and operator notification upon QC failure B. Automated Sample Preparation and Management with:

1. Features that can verify and track barcode labeled specimens and tubes through the sample process.

2. Full bi-directional LIS connectivity and user-friendly interface.

3. Cap piercing probe.

4. Continuous processing – can load and unload carousels and samples without halting operation.

5. Closed-tube sampling; ability to run whole blood and body fluids.

6. Capacity to have full range of on-board reagents including antibodies, lysing reagent, flow-count, buffers and diluents.

6. Minimal sample carryover % for sample pipetting

7. Adjustable flow rates

8. An integrated sample prep module, automated reagent monitoring and barcode scanning, continuous loading with pipeline sample processing, data analysis, bidirectional LIS connectivity and automated QC; or

9. A fully load/walk-away continuous, random capability for automated lymphocyte enumeration or CD4/CD8 counts with no sample preparation required and minimal maintenance or analyzer start up. This should be available for 24/7 operation and run safely with minimal specialty training or experience required, and approved for use in the USA.

5.3 Hardware Features - The instrumentation/system shall have the following:

5.5 Support Features

In addition, the Contractor shall provide additional on-site training 6-12 months after test implementation, if requested.

All training shall be provided by the Contractor at no additional cost to the Government.

D. Equipment Preventative Maintenance/Repair Service. The Contractor shall be able to provide emergency equipment repair and preventative maintenance on primary and back-up instrumentation/system (if available) and any incremental support equipment, e.g. water system, offered according to the following terms:

· A technical assistance center must be available by telephone 24 hours per day, 7 days per week with a maximum call back response time of 2 hours.

· Equipment repair service must be provided during core business hours. Business hours are defined as Monday-Friday, 7:30AM-4:00PM . 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 4 hours.

· 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 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.

· During the term of the CPT, 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 designated representative of the Government 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.

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

· Waste toxicity (Reference 40CFR261.11 and 40CFR261.24)

· Waste ignitability (Reference 40CFR261.21)

· Waste corrosivity (Reference 40CFR261.22)

· Waste reactivity (Reference 40CFR261.23)

· Hazardous waste from non-specific sources (F-listed) (Reference 40CFR261.31)

· Discarded commercial products (acutely toxic or P-listed and toxic or U-listed) (Reference 40CFR261.33) I. Implementation/transition timeframe - The implementation of the services/requirements described in this solicitation shall be completed no later than 90 days after the award of the CPT. 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 90 day timeframe, if the extension is through no fault of the Contractor and is a result of delays due to the Government.

A. Upon award of a CPT, the transition period for the awarded CPT to have all equipment and peripherals installed and operational shall be from date of award through 90 days. During this same period, all initial training of VA personnel in the operation and maintenance of said equipment shall also be completed.

B. Offerors shall provide with its quotation an implementation plan for installation of new equipment. Contractor’s submitted plan shall not exceed 90 days for the transition of all services under the awarded CPT 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 confirm to the transition period shall be considered as sufficient cause to terminate CPT for cause under the Termination for Cause clause of the CPT.

C. At the end of 90 days from award of the CPT, the awarded contractor shall have full and sole responsibility for services under the awarded CPT.

· 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 equipment is in actual use. System failure downtime is that period of time when any equipment 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 equipment 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 shall maintain appropriate daily records to satisfy the requirements of this paragraph and shall notify the contractor in writing of the date of the first day of the successful performance period. Operations use time and downtime shall be measured in hours and whole minutes.

· During the term of the CPT, 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 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.

· The vendor/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 vendor/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.

· Prior to termination or completion of this CPT, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this CPT 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 CPT.

· 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 CPT 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 returned to 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 CPT or disposal or return of the IT equipment, whichever is earlier.

· 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 vendor at the end of lease, for trade-in, or other purposes. The options are:

· 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 U.S. Department of Veterans Affairs (VA) located at the Malcom Randall VA Medical Center in Gainesville, FL is seeking a contractor who can provide Flow Cytometry Testing.

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