W91YTZ24Q0119 Amendment 1.pdf

W40M MRCO EAST

MEDICAL READINESS CONTRACTING OFFICE - EAST

POC: RONALD D. GOVANS

9275 DOERR ROAD, ROOM 1700

FORT BELVOIR VA 22060

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 modification is to provide Goverment responses to contractor questions. In addition, the Statment of Need (SON) has been revised in response to contractor questions. The due date has been extended.

1. CONTRACT ID CODE PAGE OF PAGES

1 8

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

16C. DATE SIGNED

BY 30-Jul-2024

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 W91YTZ24Q0119

X 9B. DATED (SEE ITEM 11)

24-Jul-2024

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

30-Jul-2024

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:

W91YTZ24Q0119

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 31-Jul-2024 10:00 AM to 01-Aug-2024 10:00 AM.

The following have been modified:

STATEMENT OF NEED

STATEMENT OF NEED (SON)

1. GENERAL.

A fluorescent flow cytometry analyzer is needed at McDonald Army Health Center (MCAHC), Joint Base Langley- Eustis, Fort Eustis, VA. The laboratory requires the fluorescent flow cytometry analyzer using a semi-conductor laser and hydrodynamic focusing in dedicated channels on a cost per reportable test basis for the Ordering Period of 1 September 2024, or date of award, through 31 August 2029. The contractor is responsible for analyzer, reagents, supplies, service, preventive maintenance, unscheduled maintenance, training technicians, and analyzer decontamination and removal after the end of the contract. The analyzer will be located in the hematology section of the laboratory under the management of the Department of Pathology.

Leased equipment will included initial validation methods per Clinical Laboratory Improvement Amendments (CLIA) / National Committee for Clinical Laboratory Standards (NCCLS) guidelines such as, but not limited to the verification of data transmitted between MHS Genesis and the analyzer using automatic download and transfer auto instrument results (TAR). No less than thirty samples will be used to verify the barcode, patient demographics, component tests, normal, abnormal highs/lows, and error flags. The barcode will correctly read each sample and matched this information with the information received from MHS Genesis. The patient demographics will be downloaded from MHS Genesis to the analyzer successfully. The accession date, accession area, and accession number prints as a continuous string, thus creating a unique identifier for each patient. Flags generated and printed on the instrument printout, will also populate corrected in MHS Genesis. Component tests included on the CBC w/diff, CBC w/out diff, CBC w/retic, and retics from MHS Genesis will be verified on the analyzer transmission log. All component tests will be downloaded correctly from MHS Genesis to the analyzer and, upon completion, all results correctly transferred back to MHS Genesis. Quality control peer group studies will be provided or reimbursed. Water quality requirements if needed will be allocated by the vendor or reimbursed. Funding will be allocated annually subject to the availability of funds.

2. Minimum Requirements / Specifications/ Salient Characteristics:

The fluorescent flow cytometry analyzer:

Will use fluorescent flow cytometry using a semi-conductor laser and hydrodynamic focusing in dedicated channels such as The complete blood count (CBC), differential count (DIFF), Platelet fluorescence (PLT-F) , reticulocyte (RET)

Will have a throughput of whole blood of up to 100 samples per hour per module.

Will use a sample volume that will be less than 90 microliters.

Will have a linearity compatible with o WBC: 0.00-440 x 103 per microliter o RBC: 0.00-8.6 x 106 per microliter o PLT: 0-5,000 x 103 per microliter

Will use tri-level QC for all CBC, DIFF, PLT and RET parameters.

Will weigh less than 175 pounds.

Will be no larger than 21” (W) x 27” (D) x 34” (H)

3 . Delivery Terms:

Delivery shall be FOB DESTINATION at McDonald Army Health Center, Build 576 Jefferson Ave, Fort Eustis, VA 23604 and be completed in accordance with the offeror’s commercial schedule, but not later than 4 weeks from date of award.

4. TECHNICAL DEFINITIONS.

4.1 Safety Data Sheets (SDS). A document that contains information on the potential health effects of exposure to chemicals, other potentially dangerous substances, and on safe working measures when handling chemical or hazardous substances.

4.2 . Preventive Maintenance Checks and Services (PMCS). Those actions taken by the contractor in order to maintain equipment in this contract in a "like new" operational condition in accordance with the manufacturer's specifications. Accomplished by providing systematic inspections, Calibration Verification Certification (CVC), detection and correction of incipient failures before they occur or before they develop into a major defect, replacement of cracked or worn buttons, covers, etc. Cleaning and lubrication will be included as needed on all internal parts as well as external cleaning after services are performed.

4.3. Service Call. Those actions taken by the government to initiate services for repairs that require a representative of the contractor to visit the laboratory to perform service, repairs, or maintenance by the contractor in order to restore the equipment under contract to operational.

4.4 . Troubleshooting. Those actions taken by the contractor to assist the government equipment operator in resolving any technical deficiencies with the equipment under the contract to maintain or restore the equipment to operational.

5. Training:

5.1 Contractor will provide local training to at least 3 personnel in the base contract year and then the Contractor will provide advanced training on the equipment off-site at no cost additional cost to the government, to include travel, lodging, meals, and tuition for two technicians per analyzer per fiscal year.

5.2 Contractor will provide unlimited virtual instructor lead training and on-line training tutorials.

6. Documentation:

The contractor Shall provide new or updated user manuals when changes are made at no additional cost. If the information is available online, the offeror must provide the link or any other required information to download the required information. If the Government is required to register the equipment, the offeror must provide the necessary information to do the registration. Documentation shall be provided in English in hard copy and/or CD/DVD ROM.

7. Installation The system/components/equipment shall be installed by the contractor to meet contract specifications within 2 weeks after delivery of the system. Installation shall include uncrating/un-packaging of all equipment, hardware set-up and hook-up of the system, demonstration of all specifications/features, and removal of trash. Onsite installation shall be done at McDonald Army Health Center, Build 576 Jefferson Ave, Fort Eustis, VA 23604; Monday-Friday between the hours of 0730 and 1630. A visitor’s pass is required to gain access to the installation. The POC is the laboratory OIC who can be reached at (757) 314-7580 via front desk transfer.

8. Inspection and Acceptance:

Inspection and acceptance shall be performed by the Government personnel at the Government Facilities.

9. CONTRACTOR FURNISHED ITEMS AND SERVICES.

9.1. The contractor will furnish all materials required to perform maintenance (scheduled and unscheduled), repairs, or service. Any costs associated with travel, lodging or meals to conduct services or maintenance will be at the cost of the contractor.

9.2. Completion of Service. Upon completion of services, a written service report will be provided to the Biomedical Maintenance Branch located in Logistics. The service report shall be completely filled out, provide detailed information regarding the cause of equipment malfunction and corrective action taken, to include the time required to complete the work, price of labor (hourly rate), and a list of parts replaced with a price for each part. In the event all information is not available to contractor’s representative when services are performed, the initial service report shall include all information stated above except for price. Contractor shall provide the balance of the required information in writing to the Biomedical Maintenance Branch within 10 days after the services are completed.

9.3. Contractor will report all contractor manpower, including subcontractor manpower, required for performance of this contract. The contractor is required to completely fill in the information in the format provide at the following web address: https://www.sam.gov. This requirement is mandatory and required by the assistant secretary of the army, Manpower & Reserve Affairs. This is an Army data collection site operated and maintained by this office.

Reports are to be completed by 31 October annually.

9.4. Contractor will provide new and/or refurbished parts that are certified and documented to meet Original Equipment Manufacturers (OEM) specifications on all manufacturers’ mandatory modifications and apply recalls by

FDA.

9.5. Contractor will provide new or updated user manuals when changes are made at no additional cost.

9.6. Contractor shall furnish all applicable SDS for reagents, equipment and supplies utilized under this contract at no additional cost.

9.7 Contractor will provide a fluorescent flow cytometry analyzer using a semi-conductor laser and hydrodynamic focusing in dedicated channels that is smaller than or equal TO 21” x 27” x 33.5” (W x D x H) in order to fit in designated area.

9.8. Contractor will ensure that the automated analyzer includes the following Components per System:

Command Center

Sample Management Center Reagent Management Center

Barcode Sample Identification Unit Mixing Units Reading Unit Powerware/UPS On Board Computer with Printer Software Operator‘s Manual Maintenance Manual

9.9 Contractor will provide equipment that has a valid authority to operate (ATO) in place.

9.10 Contractor will provide unlimited virtual instructor lead training and on-line training tutorials.

9.11 Contractor will ensure that the following items, but not limited to, reagents, calibrators, QC, and all consumables will be provided at no additional charge and sent on a scheduled and unscheduled basis:

DESCRIPTION QTY

CELLPACK DCL 20L 40

CELLCLEAN AUTO 20 X 4 mL 24 XN CHECK 12x3.0 ml LEVEL 1, 2, 3 (4 EA) 23 FLUOROCELL PLT 2x12 mL 5 FLUOROCELL ret 2x12 mL 5 CELLPACK DFL 2x1.5L 6 FLUOROCELL WDF 2x42mL 6

LYSERCELL WDF 5L 7

FLUOROCELL WNR 2x82 mL 5

LYSERCELL WNR 5L (WNR-210A) 8

SULFOLYSER (5L) 7

10. Deliverables.

10.1. Contractor will provide on-site technical support for installation of analyzers to bring to and maintain at a fully operational status throughout the period of performance.

10.2. Contractor will ensure the analyzers do not require a water purification/ filtration system or modification of the facility’s plumbing for a water supply.

10.3. The contractor will ensure proper packaging of reagents, supplies, and equipment and that they are shipped at proper refrigerated or frozen temperatures according to manufacturer specifications.

10.4. Contractor will ensure all shipments arrive Monday through Friday between the hours of 8:00am and 3:00pm EST; excluding holidays and weekends according to paragraph 1.6.2 above.

10.5. The contractor shall respond to phone calls regarding shipment discrepancies the same day of notification and discrepancy will be corrected within 24 hours.

10.6. Contractor will provide customer notification of updates on any reagents in writing within 5 business days and ensure continuity of services and availability of reagents during reagent revision when required.

10.7. Reagents must meet quality control guidelines set forth by manufacturer. Reagents must be shipped in a manner that will preserve the proper storage temperature during transportation.

10.8. The contractor will provide all software or hardware upgrades at no additional cost.

10.9. The contractor will notify the laboratory if there is a recall on any reagents or equipment within 24 hours.

10.10. Contractor will respond to service calls within four hours when one analyzer is not working or the morning of the next duty day if after 5:00pm Monday through Friday and correct deficiencies within 24 hours after arrival on-site.

10.11. Contractor will respond to service calls within two hours when both analyzers are not working or the morning of the next duty day if after 5:00pm Monday through Friday and correct deficiencies on at least one analyzer immediately and all deficiencies within 36 hours after arrival on- site.

10.12. Contractor will perform all on-site scheduled service as specified by the manufacturers published maintenance manual as necessary to keep system in good condition including lubrications, cleaning (other than those performed at the operator’s level), calibrations, and diagnostics, during the lease period at no additional cost.

10.13. The contractor will provide 24 hour telephonic troubleshooting.

10.14. The contract shall ensure that equipment can perform the following test: WBC; RBC; HGB; HCT; MCV;

MCH; MCHC; PLT (PLT-I, PLT-F); NEUT#, NEUT%; IG#, IG%; LYMPH#, LYMPH%; MONO#, MONO%;

EO#, EO%; BASO#, BASO%; NRBC#, NRBC%; RDW-SD; RDW-CV; MPV; RET#, RET%; IRF, RET-He; IPF#, IPF%.

10.15 The contract shall ensure that equipment has daily maintenance that averages less than 10 minutes.

10.16 The contractor shall ensure that quality control peer group studies are provided monthly or will provide reimbursement if not able to provide.

10.17 The contractor will assist with initial method validations per CLIA/NCCLS guidelines and included but not limited to, normal range verification, demonstration of linearity with establishments of limits of quantization (reportable range), correlation with current methods (comparison of methods study), validation of analytical measurement range (AMR), validation of precision (replication study) and accuracy (recover study), and establishment of initial control ranges. All reagents, calibrators and linearity materials will be provided by the vendor in the course to validate instruments to manufacturer recommendations.

10.18 The Contractor shall provide the reagents/reagent packs, calibrators/standards, user-replaceable maintenance items and analyzer specific tools/supplies to include consumables.

10.19 Annual test volume able to service approximately 12,000 CBCs and approximately 120 retics per year.

10.20 The contractor shall ensure that repair technicians have been trained on the specific analyzers under contract and have enough experience in order to maintain and repair the analyzers under contract.

10.21. Contractor shall ensure that employees that perform work on this contract do not pose a potential threat to the health, safety, security, general well-being or operational mission of the installation and its’ population.

10.22. Contractor shall ensure employees present a neat appearance and can be easily recognized as a contractor employee by a distinguishable uniform or badge on the exterior of their clothing while performing any service at this facility.

10.23. Contractor shall not employ any person who is an employee of the US Government or Department of Defense, either military or civilian, unless such person seeks and receives approval according to DOD 5500.7R, “Joint Ethics Regulation” or if such employment would be contrary to local policies.

10.24 Contractor will provide local training to at least 3 personnel in the base contract year and then the Contractor will provide advanced training on the equipment off-site at no cost additional cost to the government, to include travel, lodging, meals, and tuition for two technicians per analyzer per fiscal year.

11. PHYSICAL SECURITY.

11.1. Contractor personnel or any representative of the contractor entering Joint Base Langley-Eustis shall abide by all security regulations and shall be subject to security checks. Contractor and all associated sub-contractors employees shall comply with applicable installation/ facility access and local security policies and procedures (provided by Government representative as needed). The contractor shall also provide all information required to meet installation access requirements if required including background checks to be accomplished by installation Provost Marshall Office, Director of Emergency Services or Security Office. Contractor workforce must comply with all personal identity verification requirements (FAR clause 52.204-9 (Personal Identity Verification of Contractor Personnel) as directed by DOD, 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.

12. Maintenance Service:

After the manufacturer’s warranty expires, the contractor shall provide all parts and service maintenance support for an additional 4 years. At a minimum, the parts and service maintenance support shall include:

Telephone support for diagnosis and repair of operational and control/electronics issue will be available 24/7, to include hotline telephone service, and direct connect remote instrument diagnostic capability to assist operators in correcting equipment operation problems.

On site/off-site technical support will be available 24/7.

Parts replacement/exchange within 10 calendar days.

One full service visit that would include inspection, test, and calibration of the system annually.

Attachment 1

AT Level I training. This standard language 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 and annually thereafter. The contractor shall submit certificates of completion for each affected contractor employee and subcontractor employee, to the COR or to the contracting officer, if a COR is not assigned, within 05 calendar days after completion of training by all employees and subcontractor personnel. AT level I awareness training is available at the following website: http://jko.jten.mil OPSEC Level I Training Access and general protection/security policy and procedures. This standard language is for contractor employees with an area of performance within Army controlled installation, facility, or area.

Contractor and all associated sub-contractors employees shall provide all information required for background checks to meet installation access requirements to be accomplished by installation Provost Marshal Office, Director of Emergency Services or Security Office. Contractor workforce must comply with all personal identity verification requirements (FAR clause 52.204-9, Personal Identity Verification of Contractor Personnel) as directed by DOD, 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.

Access and General Protection/Security Policy and Procedures The contractor and all associated subcontractors’ employees shall comply with all applicable installation and facility security policies and procedures. Access to West Point requires a valid state driver’s license, state identification card with photo, a valid U.S. passport, or a valid passport from other countries cleared by the State Department. Upon notification of contract award, the primary contractor will submit a photocopy of the front and back of each employee’s driver’s license or state identification card with photo, to include all subcontractors, within three working days to the COR. Employees hired, after the contract start date, shall also furnish the required identification to the COR within three working days.

Subcontractors who start phased work later in the contract are also bound by the three working days submission requirement. The information contained therein shall be used to vet contractor personnel for entry onto the installation. The Directorate of Emergency Services will require three business days to vet the employee’s. Until that process is completed, there may be a delay for contractor personnel as they are vetted at a West Point Point-of- Entry. In addition to the changes otherwise authorized by this contract, should the Force Protection Condition (FPCON) in or around an individual facility or on the installation as a whole change, the Government may require changes in contractor security matters or processes.

iWATCH Training. All contractor employees, including subcontractor employees, shall view an iWATCH program video. This video will inform employees of the types of suspicious behavior to watch for and instruct employees to report suspicious activity to their supervisor who in turn will report it to the COR. This training shall be completed within 30 calendar days of contract award and within seven calendar days of new employees’ commencing work, with the written results reported to the COR no later than seven calendar days after applicable deadlines. This provision is also applicable to subcontractors who start phased work later in the contract. The iWatch training video is available at http://www.knox.army.mil/partners/902d/Default.aspx Department of Defense (DoD) Cyber Awareness Challenge. The purpose of the Cyber Awareness Challenge is to influence behavior, focusing on actions that authorized users can engage to mitigate threats and vulnerabilities to DoD Information Systems. This training is current, designed to be engaging, and relevant to the user. The Cyber Awareness Challenge is the DoD baseline standard for end user awareness training by providing awareness content that addresses evolving requirements issued by Congress, the Office of Management and Budget (OMB), the Office of the Secretary of Defense, and Component input from the DoD CIO chaired Cyber Workforce Advisory Group (CWAG). This course provides an overview of current cybersecurity threats and best practices to keep information and information systems secure at home and at work. The training also reinforces best practices to protect classified, controlled unclassified information (CUI), and personally identifiable information (PII). A Knowledge Check option is available for users who have successfully completed the previous version of the course. After each selection on the incident board, users are presented one or more questions derived from the previous Cyber Awareness Challenge. If all questions are answered correctly, users will skip to the end of the incident. If any questions are answered incorrectly, users must review and complete all activities contained within the incident.

HIPAA and Privacy Act Training. This course provides an overview of two critical privacy laws - the Health Insurance Portability and Accountability Act (HIPAA) of 1996 and the Privacy Act of 1974 - and discusses how these laws are applicable to the Military Health System (MHS). This training provides high-level regulatory standards that apply the same to operations staff, clinical staff, and senior management. It is divided into five modules followed by end-of-module exam. Module 1 provides a general overview of HIPAA, then explores the HIPAA Privacy Rule and correlating DoD Privacy Standards in greater detail. Module 2 focuses on the HIPAA Security Rule as well as DoD's implementation standards. Module 3 provides information about HIPAA

Enforcement and HIPAA complaints. Module 4 focuses on the Privacy Act and the DoD Privacy Act Program. And, the final module, Module 5, covers Breach Response at DoD.

Attachment 2 List of Materials and Supplies

Product name Estimated Annual Quantity

1st Year Price

2nd Year Price

3rd Year Price

4th Year Price

5th Year Price

CELLPACK DCL

20L

CELLCLEAN

AUTO 20 X 4 mL

XN CHECK 12x3.0 ml LEVEL 1, 2, 3 (4

EA)

FLUOROCELL PLT

2x12 mL

FLUOROCELL ret 2x12 mL

CELLPACK DFL

2x1.5L

FLUOROCELL

WDF 2x42mL

LYSERCELL WDF

5L

FLUOROCELL

WNR 2x82 mL

LYSERCELL WNR

5L (WNR-210A)

SULFOLYSER (5L) 7

(End of Summary of Changes)