W91YTZ24Q0016-0001.pdf

W40M MRCO EAST

MEDICAL READINESS CONTR OFFICE EAST

POC: FRANK A. WHORTON

6000 MACARTHUR BLVD

BETHESDA MD 20816

0012020589-0001

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

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 (Type or print)

30-105-04EXCEPTION TO SF 30

APPROVED BY OIRM 11-84

STANDARD FORM 30 (Rev. 10-83) Prescribed by GSA

FAR (48 CFR) 53.243

The purpose of this amendment is to revise the Statement of Need based on Government responses to Contractor questions and to extend the due date for quotes.

1. CONTRACT ID CODE PAGE OF PAGES

J 1 10

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

16C. DATE SIGNED

BY 14-Dec-2023

16B. UNITED STATES OF AMERICA15C. DATE SIGNED15B. CONTRACTOR/OFFEROR

(Signature of Contracting Officer)(Signature of person authorized to sign)

8. NAME AND ADDRESS OF CONTRACTOR (No., Street , County, State and Zip Code) X W91YTZ24Q0016

X 9B. DATED (SEE ITEM 11)

01-Dec-2023

10B. DATED (SEE ITEM 13)

9A. AMENDMENT OF SOLICITATION NO.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

X The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offer X is extended, is not extended.

Offer 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:

(a) By completing Items 8 and 15, and returning 1 copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

or (c) By separate letter or telegram 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 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 telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

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

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

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.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(B).

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

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not, is required to sign this document and return copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

10A. MOD. OF CONTRACT/ORDER NO.

2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO.(If applicable)

6. ISSUED BY

3. EFFECTIVE DATE

14-Dec-2023

CODE

W40M MRCO EAST

MEDICAL READINESS CONTR OFFICE EAST

9275 DOERR ROAD BLDG 1221

FORT BELVOIR VA 22060-5580

W91YTZ 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE W91YTZ

FACILITY CODECODE

EMAIL:TEL:

W91YTZ24Q0016

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 1449 - CONTINUATION SHEET

SOLICITATION/CONTRACT FORM

The required response date/time has changed from 02-Jan-2024 04:00 PM to 09-Jan-2024 04:00 PM.

The following have been modified:

STATEMENT OF NEED

STATEMENT OF NEED

Pathology/Cell Stainer Analyzer and Reagents for Blanchfield Army Community Hospital (BAHC), Fort Campbell, KY

1. The manufacturer shall furnish the laboratory analyzer(s), data management system, all other equipment, reagents, supplies and consumables necessary to operate the manufacturer's equipment. The Contractor shall be responsible for furnishing equipment maintenance, preventive services, unscheduled repairs, and parts as required in order to maintain the systems in optimal operating condition as well as training for government personnel necessary to fully perform testing in accordance with vendor specifications.

2. The cost per test results that shall include costs covering:

2.1. Equipment use.

2.2. Data management system.

2.3. Reagents, calibrators, repeats, waste, consumables, accessories, standards, miscellaneous supplies, and the costs associated with normal shipment of those products. Controls will be included for all individual immunostains or batches of like immunostains.

2.4. Delivery and installation of equipment.

2.5. All necessary maintenance to keep the equipment operating; this element includes both preventative maintenance and unscheduled repair. Equipment Troubleshooting: When the Government performs troubleshooting with the Contractor, the Contractor shall replace all reagents, calibrators, controls and any other materials used at no additional cost to the Government.

2.6. Training for equipment operators prior to the first day of the contract’s performance period.

2.7. Additional supplies required for commencing operations and performing validation studies.

2.8. Any service, maintenance, and equipment service charges required for operation.

3. Reagents will be provided bearing the same lot number within the designated shipments.

These items will be of the highest quality, sensitivity, specificity and tested to assure precision and accuracy. The manufacturer must provide stock that meets proficiency testing standards of the College of American Pathologist (CAP), The Joint Commission (TJC), the National Committee for Clinical Laboratory Standards (NCCLS) and be approved by the Food and Drug Administration (FDA). The list of orderable agents, reagents, and associated supplies may be referenced in Appendix A.

4. Testing System will have the following characteristics:

4.1. General instrument characteristics include automated Immunohistochemical stain baking, deparaffinization, cell conditioning and staining, 1- 30 slides with independent temperature control for 25 X 75mm, 1 x 3: or 26 x 76 mm, 35 reagent position in carousel, uses NCCLS Type II water, up to seven bulk reagents, floor mounted using 20-liter waste bottle, CE, and Y2K compliant.

4.2. Physical characteristics not to exceed 44 inches width x 34 inches depth x 64 inches height size by WxDxH.

4.3. Electrical characteristics 120 VAC plus or minus 10%, 5-7amps, 50/60 Hz.

Computer system (CPU, Monitor, Keyboard, Printer, Speakers), Ebar label system, and software revision upgrade. The systems should be barcode driven, random access, have a precision reagent delivery, precision heat induced staining reaction, horizontal kinetic mode Immunohistochemistry, and Chromogenic in situ Hybridization.

4.4. The systems shall be modular, flexible, with the ability to reconfigure modules, and scalable to allow for volume increases in throughput and to fit in limited bench space. The systems should utilize self-contained, pre-diluted, Antibodies and Detection kits that are ready to use out of the box.

4.5. Individual slide heating and micro controlled smart carousel with ambient, 37 and

42 deg. -> 100 deg C in under 3 min. and 100 deg ->37 deg C in under 7 minutes.

4.6. Use no more than 100 uL of reagent per slide. Shall have at least 30 slide spaces that can each run IHC. Shall be able to run all protocols during the same slide run.

Shall be able to hold 35 reagents for dispensing.

4.7. Must be able to run paraffin embedded slides (1 protocol) slides using different type 1 cell conditioning (total of 3 protocols) and/or type 2 cell conditioning (total of 5 protocols) with and without enzyme digestion (total of 7 protocols) and enzyme digestion by itself (total of 8 protocols). Must be able to incubate Polyclonal antibodies for up to 2.5 hours.

4.8. The self-contained dispenser vials shall be environmentally safe. The systems shall have a self-contained waste system.

4.9. The systems shall utilize flash memory technology and barcodes on dispensers or other similar system to track reagents and for quality control and quality assurance.

4.10. The systems shall use Liquid Coverslip, Air Vortex Mixing, and Buffer Jet Slide

Washing to include strict protocol timing to assure run-to-run consistency to improve overall staining quality, minimize slide-to-slide variability, and reduce background staining.

4.11. The contractor is required to provide new state-of the art equipment. Discontinued models are not acceptable. The contractor will provide all operational upgrades to the equipment hardware and operating system software that materially affects the performance of the equipment, without additional charge to the government.

These enhancements to the contractor’s equipment shall be delivered to the government site and installed by the contractor within 60 days of their issuance or date of first commercial availability. Instruments shall come with either a warranty for repair within 48 hrs. or service agreement included in the CPT.

5. The contractor shall assure that all supplies provided/ordered for use on their equipment will be of the quality necessary to produce a quality slide product. The reagent quality must be high enough to satisfy proficiency testing standards of the College of American Pathologists (CAP) and the Joint Commission (tJC). If the supplies to include detection kits, stains, and/or consumables are found to be defective and unsuitable for use with the contractor’s equipment or the contractor has failed to comply with the requirements herein, the contractor is required to deliver the supplies within 24 hours of receipt of the verbal order for priority delivery from the government activity. This shall be accomplished at no cost to the government, in sufficient quantity as required to allow operation of the contractor’s equipment for one week (under normal government test load volume).

6. The contractor, without additional charge to the government, shall provide training at a government location for two operating personnel at the time of installation of the contractor’s equipment. Additionally, the contractor, at his/her discretion, may make training available at his/her facility on terms and conditions mutually agreed upon by the agency and the contractor. In addition, the contractor shall provide supplemental operating training to the government personnel, without additional charge to the government, upon installation of the upgrade in equipment hardware or operating system software connected with the operation of an instrument already furnished.

7. The contractor shall provide the services of a qualified technical person, at the time of equipment installation and at such time designated by Contracting Officer (CO) or Contracting Officer's Technical Representative (COTR) to onsite orientation and training to designated personnel in: (1) operation and care of equipment; 2 techniques and procedures recommended by manufacturer to achieve maximum dependable, efficient, and economical utilization of equipment. This training shall include actual demonstration and operation of the equipment including any adjustments or other actions which may be undertaken by operating personnel in the event of failure of equipment, provided that such adjustment or action will in no way jeopardize the Government's rights under contract guarantee clause. This training shall include at least (2) two-day on-site training sessions, all day, upon installation and acceptance of equipment and later, for refresher training.

8. Site Preparation:

8.1. The contractor shall be responsible for installation, which consists of in-house delivery, positioning, and mounting of all equipment listed on the delivery order and connections of all equipment and interconnecting wiring and cabling if applicable. Upon receipt of notice to proceed with installation, it shall be the contractor's responsibility to inform the Contracting Officer of any problems which may be anticipated in connection with installation, or which will affect optimum performance once installation is completed. If progress of the installation is interrupted through no fault of the contractor, the continuous installation referenced in the preceding paragraphs may be terminated until such time as the cause of delay has been eliminated, and then shall be resumed within 24 hours after the contractor has been notified that work may again proceed.

8.2. Upon completion of installation the equipment will be turned over to the hospital for use. Final acceptance of the equipment and installation will be based upon an inspection and test to be performed within ten (10) calendar days from date of installation. If equipment passes inspection or if acceptance inspection is not conducted within ten (10) calendar days from installation, the Government shall accept installation with guaranteed date commencing ten calendar days after installation.

8.3. Any alteration or modifications in site preparation, which are attributable to incomplete or erroneous specifications provided by the manufacturer, which would involve additional expense to the government, shall be made at the expense of the manufacturer.

9. Ownership of Equipment:

9.1. The manufacturer, at termination and/or replacement of equipment, shall remove the equipment at no cost to the government. The manufacturer will disconnect the equipment and will be responsible for all packing and shipping required to remove the equipment within seven (7) calendar days.

10. The contractor shall provide maintenance (labor and parts) to keep the equipment in good operating condition and subject to security regulations. The government shall provide the contractor access to the equipment to perform maintenance services. Preventive maintenance by contractor will provide regular, scheduled maintenance to assure the continued reliable operation of the equipment. These preventive maintenance visits shall be of a frequency that conforms to the manufacturer’s operation and maintenance instructions for the supported equipment. Emergency repairs shall be performed after notification that the equipment is inoperative. The contractor shall provide the government with a designated point of contact and shall arrange to enable his maintenance representative to receive such notification.

11. Unscheduled Repair:

11.1. The contractor will make its best efforts to perform emergency repair service within 48 hours of the time of notification of the malfunction except when an ordering facility elects reduced service at contract agreed reduction. The contractor will provide all parts and labor needed to repair the malfunction.

Travel, per diem and other expenses associated with the repair will be borne by the contractor.

11.2. The contractor shall furnish a malfunction incident report to the installation upon completion of each maintenance call. The report shall include, as a minimum, the following: (a date and time of notification, (b) date and time of arrival, (c) serial number type and model number(s) of equipment, (d) time spent for repair, (e) description of malfunction and (f) proof of repair. Parts (e) and (f) shall be written verification of quality control for a sample run.

12. Any additional costs associated with equipment or supplies not disclosed in the contract, by the manufacturer, needed for full operation of this equipment, will be paid by the manufacturer at no cost to the government.

13. Integrating Antiterrorism (AT) and Operations Security (OPSEC) Contract Support:

13.1 AT Level I Training. This provision/contract text is for contractor employees with an area of performance within an Army controlled installation, facility or area.

All contractor employees, to include subcontractor employees, requiring access Army installations, facilities and controlled access areas shall complete AT Level I awareness training within 30 calendar days after contract start date or effective date of incorporation of this requirement into the contract, whichever is applicable. The contractor shall submit certificates of completion for each affected contractor employee and subcontractor employee, to the Contracting Officer’s Representative (COR) or to the contracting officer, if a COR is not assigned, within 15 calendar days after completion of training by all employees and subcontractor personnel. AT level I awareness training is available at the following website: https://atlevel1.dtic.mil/at.

13.2 Access and General Protection/Security Policy and Procedures. This standard language text is for contractor employees with an area of performance within an Army controlled installation, facility or area. Contractor and all associated sub-contractors employees shall comply with applicable installation, facility and area commander installation/facility access and local security policies and procedures (provided by government representative). The contractor shall also provide all information required for background checks to meet installation access requirements to be accomplished by the BACH Personnel Security Specialist.

Contractor workforce must comply with all personal identity verification requirements as directed by DOD (Department of Defense), Headquarters Department of Army (HQDA) and/or local policy. In addition to the changes otherwise authorized by the changes clause of this contract, should the Force Protection Condition (FPCON) at any individual facility or installation change, the Government may require changes in contractor security matters or processes.

13.3 OPSEC (Operations Security) Training. Per AR 530-1, Operations Security, all contract employees must complete Level I OPSEC Training within 30 calendar days of commencing performance and annual OPSEC Awareness training thereafter. Training completion will be reported to the COR within 30 calendar days.

13.4. iWATCH Training. This standard language is for contractor employees with an area of performance within an Army controlled installation, facility or area.

The contractor and all associated sub-contractors shall brief all employees on the local iWATCH program (training standards provided by the requiring activity ATO). This locally developed training will be used to inform employees of the types of behavior to watch for and instruct employees to report suspicious activity to the COR. This training shall be completed within 30 calendar days of contract award and within 05 calendar days of new employees commencing performance with the results reported to the COR NLT 30 calendar days after contract award.

13.5 For contracts that require OPSEC Training. Per AR 530-1 Operations

Security, the contractor employees must complete Level I OPSEC Awareness training. New employees must be trained within 30 calendar days of their reporting for duty and annually thereafter. OPSEC Awareness for Military Members, DoD Employees and Contractors is available at the following website:

http://cdsetrain.dtic.mil/opsec/index.htm

13.6 For Cyber Awareness (Information assurance (IA)/information technology

(IT)) training. All contractor employees and associated sub-contractor employees must complete the DoD Cyber awareness training before issuance of network access and annually thereafter. All contractor employees working IA/IT functions must comply with DoD and Army training requirements in DoDD 8570.01, DoD

8570.01-M and AR 25-2 within six months of appointment to IA/IT functions.

DoD Cyber Awareness Challenge Training is available at the following website:

https://ia.signal.army.mil/DoDIAA/

APPENDIX A

Material Description Projected Annual Quantity

10X EZ PREP SOLUTION, 2L

Anti-Keratin, Pan (AE1/AE3 & PCK26) PAB 3

Benchmark ULTRA CC1 9 BenchMark Ultra LCS 28

BLUING REAGENT 7

CD-138 (B-A38) PAb, Cell Marque 3

CEA (CEA31) PAb, Cell Marque 1

CELL MARQUE, MUSCLE SPECIFIC ACTIN 6

CINtec HISTOLOGY (50) 5

CONFIRM anti-CD20 (L26) PAB 1

(QBEnd/10) Primary Ant 4

CONFIRM anti-CD45 (LCA) (RP2/18) PAB 1

Primary Antibod 2

(34E12) Mouse Mono 4

(HMB45) Mouse M 4

CONFIRM Calretinin (SP65) RbmAb 1

CONFIRM Cytokeratin 20 Rabbit Mono 1

CONFIRM Cytokeratin7 RabbitMono 3

CONFIRM EMA (E29) Mouse mAb 3

(A103) Primary An 2

Cytokeratin 5/6 (D5/16B4) 3

HEMATOXYLIN 4

Hematoxylin II 4

KIT PACK, EBAR (US/EUROPE) 2

NEGATIVE CONTROL MONOCLONAL 1

MARQUE, S.M.MYOSIN 1

Reaction Buffer Concentrate (10X) 12 ultraView Universal DAB Detection Kit 7

VENTANA anti-CD10 (SP67) 1

VENTANA Anti-E Cadherin (36)

VENTANA ANTI-P63 (4A4) 2

iView DAB Detection Kit 1

CONFIRM anti-Desmin (DE-R- 11) PAb 2

CONFIRM anti-Kappa Rabbit Polyclonal Pri

CONFIRM anti-Lambda Rabbit Polyclonal Pr 1

CONFIRM anti-S100 (polyclonal) PAB 2

CELL MARQUE, FACTOR 8-R AG. 1

VENTANA H. PYLORI (SP48) PAB 11

CONFIRM ANTI-KI-67 (30-9) RABBIT MONOCLO

CD163 (MRQ-26) PAb, Cell Marque 1

ULTRAVIEW UNIVERSAL AP RED DETECTION KIT 2

CD31 (JC70) PAb, Cell Marque 1

Ventana Basal Cell Cocktail (34BE12+p63) 2

10X SSC SOLUTION, 2L (5353947001) 6

anti-p504s (SP116) Rabbit Monoclonal PAb 4

OptiView DAB Detection Kit 2

PROTEASE 1 1

Factor XIIIa (AC-1A1) PAb, Cell Marque 1

CONFIRM ANTI-ER (SP1) 1

CONFIRM ANTI-PR (1E2) 1

FACTOR XIIIa (EP3372) PAb CELL MARQUE 1

SOX -10 (SP267) Rabbit Monoclonal Pab, Cell Marque 1

CONFIRM ANTI-P53 (DO-7) 1

ANTI-P53 (Bp53-11) PaB 1

P57 (KP10) PAB, CELL MARQUE 1

VENTANA ANTI-P120 CATENIN (98) 1

Cytokeratin (CAM 5.2) PAB 1

CDX-2 (EPR2764Y) PAb, Cell Marque 1

Anti-CHROMOGRANIN A (LK2H10) PAB 1

CONFIRM anti-Synaptophysin (SP11) Rabbit 1

SYNAPTOPHYSIN (MRQ-40) PAb CELL MARQUE

(End of Summary of Changes)