SOURCES SOUGHT SYNOPSIS (Hematology).pdf

SOURCES SOUGHT SYNOPSIS

The Health Readiness Contracting Office (HRCO), Joint Base San Antonio, Fort Sam Houston, TX is issuing this sources sought synopsis as a means of conducting market research to identify parties having an interest in and the resources to support this requirement to procure a full-service maintenance agreement for two (2) fully automated Hematology Analyzers and Reagents at Keller Army Community Hospital, West Point, NY The result of this market research will contribute to determining the method of procurement. The applicable North American Industry Classification System (NAICS) code assigned to this procurement is 334516 Analytical Laboratory Instrument Manufacturing.

THERE IS NO SOLICITATION AT THIS TIME. This request for capability information does not constitute a request for proposals; submission of any information in response to this market survey is purely voluntary; the government assumes no financial responsibility for any costs incurred.

If your organization has the potential capacity to perform these contract services, please provide the following information: 1) Organization name, address, email address, Website address, telephone number, and size and type of ownership for the organization; and 2) Tailored capability statements addressing the particulars of this effort, with appropriate documentation supporting claims of organizational and staff capability. If significant subcontracting or teaming is anticipated in order to deliver technical capability, organizations should address the administrative and management structure of such arrangements.

[Note: In accordance with FAR 10.001(b), agencies should not request potential sources to submit more than the minimum information necessary.]

The government will evaluate market information to ascertain potential market capacity to provide all personnel, equipment, supplies, facilities, contractor transportation, tools, materials, supervision, other items and non-personal services necessary to procure a full-service maintenance agreement for two (2) fully automated Hematology Analyzers and Reagents at Keller Army Community Hospital, West Point, NY as defined in APPENDIX 1, except for those items specified as government-furnished property and services.

BASED ON THE RESPONSES TO THIS SOURCES SOUGHT NOTICE/MARKET

RESEARCH, THIS REQUIREMENT MAY BE SET-ASIDE FOR SMALL BUSINESSES

OR PROCURED THROUGH FULL AND OPEN COMPETITION, but will be awarded as a single award. Telephone inquiries will not be accepted or acknowledged, and no feedback or evaluations will be provided to companies regarding their submissions.

Submission Instructions: Interested parties who consider themselves qualified to perform the above-listed services are invited to submit a response to this Sources Sought Notice by 6 February 2026 at 2:00PM EST. All responses under this Sources Sought Notice must be emailed to cotrena.y.brownjohnson.mil@health.mil.

mailto:cotrena.y.brownjohnson.mil@health.mil

APPENDIX 1: Excerpt from Statement of Work

STATEMENT OF WORK

Hematology Analyzer Lease and Reagents

Keller Army Community Hospital (KACH) 900 Washington Road West Point, NY 10996

PART 1

GENERAL INFORMATION

1.0 General: This is a non-personnel services requirement to provide a full-service maintenance agreement for two (2) fully automated Hematology Analyzers at Keller Army Community Hospital.

1.1 Scope of Work: The Contractor shall provide Hematology Analyzers, ancillary equipment, maintenance, services, repairs, support parts and training as required to maintain the systems in optimal operating condition.

1.2 Salient Characteristics: The Contractor shall provide Hematology Analyzers that meet the requirements listed below.

1.2.1 Hematology Analyzers must at a minimum have capabilities to perform Red

Blood Cell (RBC) count, White Blood Cell (WBC) count, hemoglobin and hematocrit, RBC indices, retic count, and 6-part WBC differential that includes immature granulocytes. (IG% and IG#). Must also have the capability of WBC and RBC count on body fluids. Must be able to perform reticulocytes including reticulocyte %, Absolute reticulocytes, IRF and RET-Hemoglobin.

1.2.2 Reagents for hemoglobin detection must be cyanide-free.

1.2.3 Hematology Analyzers must have autoloader walk away capabilities.

1.2.4 Hematology Analyzers must have secondary aspiration capabilities for bullet tubes.

1.2.5 Hematology Analyzers must have advanced software for detecting possible WBC, RBC, and PLT interferences.

1.2.6 Hematology Analyzers must be FDA approved

1.2.7 Analyzer must have automatic rerun and reflex capabilities.

1.2.8 Hematology Analyzers must allow for 48-hour sample stability.

1.2.9 Hematology Analyzers must have minimal routine maintenance.

1.2.10 Due to facility constraints, the analyzer footprint must be small enough to be placed on laboratory countertop with no more than 40” wide, 40” tall and 34” depth with the ability to store any reagents or waste in a similar size space.

1.2.11 Quality Control system must include an inter-laboratory quality assurance program.

1.2.12 A Service contract for all parts and labor must be included.

1.2.13 Hematology Analyzers must have ability to interface with MHS Genesis and operate on the DHA network (Must have an approved Authorization to Operate

(ATO).

1.2.14 Reagents must have clearance to be flushed into hospital waste lines when diluted with water as current analyzer has been previously cleared.

1.3 Workload Requirements: The contractor shall provide Hematology Analyzers that meet the workload requirements listed below.

TEST NAME ANNUAL

USAGE

Complete Blood Count (CBC) 5500 Body Fluid (BF) 25 Reticulocyte (Retic) 260

REAGENT WEEKLY

USAGE

Cellpack 30mL/test 3750mL Lysercell 1mL/test 125mL Sulfolycer 1mL/test 125mL Fluorocell 1mL/test 125mL CellClean 14mL Controls 6.1mL

1.4 Quality Assurance: The Government shall evaluate the Contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan. This plan is primarily focused on what the Government must do to ensure that the Contractor has performed in accordance with the performance standards. If defines how the performance standards will be applied, the frequency of surveillance and the minimum acceptable defect rate(s).

1.5 Recognized Holidays: The following federal holidays are observed:

New Year’s Day, January 1 Martin Luther King Jr.’s Birthday, 3rd Monday in January Presidents Day, 3rd Monday in February Memorial Day, Last Monday in May Juneteeth, June 19 Independence Day, July 4

Labor Day, 1st Monday in September Columbus Day, 2nd Monday in October Veteran’s Day, November 11 Thanksgiving Day, 4th Thursday in November Christmas Day, December 25

Note: Any of the above holidays falling on a Saturday will be observed on the preceding Friday;

holidays falling on a Sunday will be observed on the following Monday. Any holidays that are declared by Presidential Executive Order shall be observed in the same manner as holidays listed above. Closures of the installation due to inclement weather shall be handled in the same manner.

PART 2

GENERAL SECURITY POLICIES AND REQUIREMENTS

2.0 Security Requirements: Contractor personnel performing work under this contract must have either an access base pass or a DBIBS ID card submitted by the COR or ACOR and approved by U.S. Army Garrison West Point at time of the proposal submission and must maintain the level of security required for the life of the contract.

2.1 Physical Security: The contractor shall be responsible for safeguarding all government equipment, information and property provided for contractor use. At the close of each work period, government facilities, equipment, and materials shall be secured.

2.2 Key Control. The Contractor shall establish and implement methods of making sure all keys/key cards issued to the Contractor by the Government are not lost or misplaced and are not used by unauthorized persons. NOTE: All references to keys include key cards. No keys issued to the Contractor by the Government shall be duplicated. The Contractor shall develop procedures covering key control that shall be included in the Quality Control Plan. Such procedures shall include turn-in of any issued keys by personnel who no longer require access to locked areas. The Contractor shall immediately report any occurrences of lost or duplicate keys/key cards to the Contracting Officer.

2.3 In the event keys, other than master keys, are lost or duplicated, the Contractor shall, upon direction of the Contracting Officer, re-key or replace the affected lock or locks; however, the Government, at its option, may replace the affected lock or locks or perform re-keying. When the replacement of locks or re-keying is performed by the Government, the total cost of re-keying or the replacement of the lock or locks shall be deducted from the monthly payment due the Contractor. In the event a master key is lost or duplicated, all locks and keys for that system shall be replaced by the Government and the total cost deducted from the monthly payment due the Contractor.

2.4 The Contractor shall abide by federal and local MTF regulations and requirements concerning the nature of personnel reliability programs. They shall also abide by federal and local MTF regulations concerning the confidentiality of patient records, to include but not limited to the Privacy Act of 1974 and the Health Insurance Portability & Accountability Act (HIPAA) of 1996. All regulations referenced are available for review from the COR, MTF, or the KO. All medical records and reports will remain property of the Government.

PART 3

GOVERNMENT FURNISHED PROPERTY, EQUIPMENT, AND SERVICES

3.0 Facilities: The Government shall provide a safe area where the Contractor will perform services.

3.1 Secure Internet Access: The Government shall provide secure internet access for diagnosing software issues and installing software updates and upgrades.

3.2 Equipment: The Government shall provide the Contractor with access to equipment covered under the contract.

3.3 Protective Clothing: The Government will supply protective clothing and shoe covers when required.

3.4 Property: The Contractor shall not use property provided by the Government for any purpose other than in the performance of this contract. The contractor shall be responsible for safeguarding all Government equipment information and property provided for contractor use. At the close of each work period, Government facilities, equipment, and materials shall be secured.

PART 4

CONTRACTOR FURNISHED ITEMS AND RESPONSIBILITIES

4.0 General: The Contractor shall furnish all supplies, equipment, facilities and services required to perform work under this contract that are not listed under Part 3 of this SOW.

4.1 Off Duty Employees: The Contractor shall not hire off-duty Government employees who serve as inspector or COR’s in their Government position, or any other persons whose employment would result in a conflict of interest.

4.2 Contractor Items: The Government will not be responsible for any damages or loss of Contractor supplies, materials, or equipment nor is the Government responsible for any damages or loss of the Contractor employees’ personal belongings, due to fire, theft, accidents, or other causes.

4.3 The Contractor shall ensure its personnel comply with all installation and MTF safety regulations. Such regulations include, but are not limited to, general safety, fire prevention, and waste disposal. Copies of these regulations are on file in the medical activity safety office or may be obtained through the Government Representative. The use of cellular phones and 2-way radios is expressly forbidden in all Medical Treatment Facilities and Health Clinics. “The Government and the contractor’s service representative will exchange hazard communication information before the commencement of any repair." “When required, the contractor’s service representative will comply with the Office of Safety and Health Administration (OSHA) lockout/tag-out standards while performing sustainment on

MD/MDS.”

4.4 The contractor shall report immediately to the Government Point of Contact, or the Chief of Equipment Management Branch (EMB), all accidents which may arise out of or in connection with the performance of services required within the scope of this contract.

4.5 Physical Security: The contractor shall be responsible for safeguarding all Government equipment, information and property provided for contractor use. At the close of each work period, Government facilities, equipment, and materials shall be secured.

PART 5

SPECIFIC TASKS

5.0 Basic Services: The Contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services necessary to perform preventive maintenance and repair service for the equipment referenced in this SOW. All labor, travel, and expenses during the performance of on-site service is included with the cost of the contract. On-site services must be performed during normal business hours.

5.1 Lab Standards: The Contractor shall ensure reagents are delivered in a timely manner and meet or exceed the standard of performance by the FDA and CAP.

5.2 Reagents shall have a minimum shelf life of three (3) months, and controls will have a minimum shelf life of four (4) weeks upon receipt by the Government.

5.3 Routine or scheduled orders will arrive within one week before or after the scheduled date of delivery. Emergency orders will be delivered within 24 hours after the order is placed.

5.4 Recalls: The contractor shall notify the serviced activity within 24 hours if there is a recall on reagents needed for patient testing.

5.5 Technical and Application Telephone Assistance: The Contractor shall provide 24/7 technical and application telephone assistance. The Contractor shall use reasonable efforts to respond telephonically within 30 Minutes during normal duty hours and within 2 Hours after normal duty hours.

5.6 On-Site Service and Support: Field service and support will be provided by OEM trained authorized service technicians.

5.7 Preventative Maintenance: The Contractor shall provide preventive maintenance services and parts necessary for equipment to remain in compliance to OEM standards as defined by the manufacturer and /or College of American Pathologists (CAP) standards at no additional cost to the Government.

5.8 PM shall be performed before expiration of previous preventative maintenance certification.

Preventative maintenance services shall be performed Monday through Friday between the hours of 8:00am to 5:00pm.

5.9 Unscheduled Repair Services: The Contractor shall make all reasonable efforts to have a field service technician dispatched by the next business day.

5.10 Unscheduled on-site services will be performed Monday through Friday between the hours of 8:00am to 5:00pm.

5.11 Parts: Contractor shall repair or replace any parts that need repair or replacement.

Replacement parts will be OEM new, or OEM reconditioned.

5.12 Contractor shall provide Government POC with the approximate date of availability for parts required but not in stock. Contractor shall make all reasonable efforts to have out of stock replacement parts provided within 5 days.

5.13 Freight: Postage and storage charges associated with shipment and receipt of replacement parts and the return of work or defective parts shall be the responsibility of the Contractor.

5.14 Software Updates/Upgrades: Contractor shall provide authorized product updates and modifications for improved product performance reliability. Software updates that cannot be performed by the user will be furnished by the Contractor at no cost to the Government.

5.15 Calibration Documentation: If applicable, upon completion of calibration, Contractor shall remove and replace DD Form 2163 (Calibration/Verification) sticker, confirming system serviceability. Contractor must specify completion date along with their initials.

5.16 Service Reports: The Contractor shall submit reports to the Government Representative or Contracting Officer as requested for use in monitoring Contractor performance.

5.17 Upon completion of scheduled and unscheduled services by the contractor’s service representative, an initial service report shall be provided in writing or via email to the Clinical Engineering staff before the close of business on the service completion date. The initial service report shall include at a minimum:

5.17.1 Contractor’s name (full printed and signed name), Equipment Control Number and/or serial number of MD/MDS being sustained.

5.17.2 Detailed information regarding MD/MDS malfunction and corrective action(s) taken, preventive maintenance, and calibrations verified and/or performed.

5.17.3 A list of parts replaced with part numbers, and/or serial numbers.

5.18 The contractor shall provide the balance of the required information to the Government Representative no later than 48 hours after services are completed. The complete service report will include the information listed above as well as the information listed below:

5.18.1 Contract number

5.18.2 Equipment identification data.

5.18.3 System nomenclature, site name, model.

5.18.4 Start date/time and completion date/time.

5.18.5 The time required to complete the work. Hours are in tenths and rounded up to the nearest tenth of an hour.

5.18.6 Explanations of any deferred or delayed repair action with a projected completion date.

PART 6

DEFINITIONS & ACRONYMS

6.0 Definitions & Acronyms

6.1 Definitions:

6.1.1 CONTRACTOR: A supplier or vendor awarded a contract to provide supplies or service to the government. The term used in this contract refers to the prime.

6.1.2 CONTRACTING OFFICER. A person with authority to enter into, administer, or terminate contracts, and make related determinations and findings on behalf of the government. Note: The only individual who can legally bind the government.

6.1.3 CONTRACTING OFFICER'S REPRESENTATIVE (COR). An employee of the U.S. Government appointed by the contracting officer to administer the contract.

Such appointment shall be in writing and shall state the scope of authority and limitations. This individual has authority to provide technical direction to the Contractor as long as that direction is within the scope of the contract, does not constitute a change, and has no funding implications. This individual does NOT have authority to change the terms and conditions of the contract.

6.1.4 DEFECTIVE SERVICE. A service output that does not meet the standard of performance associated with the Performance Work Statement.

6.1.5 DELIVERABLE. Anything that can be physically delivered but may include non-manufactured things such as meeting minutes or reports.

6.1.6 KEY PERSONNEL. Contractor personnel that are evaluated in a source selection process and that may be required to be used in the performance of a contract by the Key Personnel listed in the PWS. When key personnel are used as an evaluation factor in best value procurement, an offer can be rejected if it does not have a firm commitment from the persons that are listed in the proposal.

6.1.7 PHYSICAL SECURITY. Actions that prevent the loss or damage of Government property.

6.1.8 QUALITY ASSURANCE. The government procedures to verify that services being performed by the Contractor are performed according to acceptable standards.

6.1.9 QUALITY ASSURANCE Surveillance Plan (QASP). An organized written document specifying the surveillance methodology to be used for surveillance of contractor performance.

6.1.10 QUALITY CONTROL. All necessary measures taken by the Contractor to assure that the quality of an end product or service shall meet contract requirements.

6.1.11 SUBCONTRACTOR. One that enters into a contract with a prime contractor. The Government does not have privity of contract with the subcontractor.

6.1.12 WORK DAY. The number of hours per day the Contractor provides services in accordance with the contract.

6.1.13 WORK WEEK. Monday through Friday, unless specified otherwise.

6.2 Acronyms

ACOR Alternate Contracting Officer's Representative AFARS Army Federal Acquisition Regulation Supplement AR Army Regulation

BES Biomedical Engineering Services BF Body Fluid CAP College of American Pathologist CBC Complete Blood Count CCE Contracting Center of Excellence CFR Code of Federal Regulations CONUS Continental United States (excludes Alaska and

Hawaii) COTR Contracting Officer's Technical Representative COTS Commercial-Off-the-Shelf DA Department of the Army DD250 Department of Defense Form 250 (Receiving

Report) DD254 Department of Defense Contract Security

Requirement List DFARS Defense Federal Acquisition Regulation

Supplement DMDC Defense Manpower Data Center DOD Department of Defense EMB Equipment Management Branch FAR Federal Acquisition Regulation FDA Food & Drug Administration G-POC Government Point of Contact HIPAA Health Insurance Portability and Accountability

Act of 1996 KO Contracting Officer OCI Organizational Conflict of Interest OCONUS Outside Continental United States (includes

Alaska and Hawaii) ODC Other Direct Costs PIPO Phase In/Phase Out POC Point of Contact PRS Performance Requirements Summary PWS Performance Work Statement QA Quality Assurance QAP Quality Assurance Program QASP Quality Assurance Surveillance Plan QC Quality Control QCP Quality Control Program SOW Statement of Work TE Technical Exhibit

PART 7

TECHICAL EXHIBIT LISTING

7.0 Technical Exhibit List

7.1 Technical Exhibit 1—Performance Requirements Summary

7.2 Technical Exhibit 2—Deliverable Schedule

7.1 PERFORMANCE REQUIREMENT SUMMARY MATRIX (PRS)

The contractor service requirements are summarized into performance objectives that relate directly to mission essential items. The performance threshold briefly describes the minimum acceptable levels of service required for each requirement. These thresholds are critical to mission success.

PERFORMANCE

OBJECTIVE

STANDARD PERFORMANCE

THRESHOLD

(This is the maximum error rate. It could possibly be “Zero deviation from standard”)

METHOD OF

SURVEILLANCE

PRS #1

The Contractor shall ensure reagents are delivered in a timely manner and meet or exceed the standard of performance by FDA and

CAP.

Para. 5.1 Zero defects Observation by

COR/COTR

PRS #2

Field Service Engineer or Technical Specialist or any other technical resource that works on the instrumentation will be properly trained and certified to perform work.

Para. 5.6 Zero defects Observation by

PRS #3

Contractor will provide emergency telephone support 24/7.

Para. 5.5 Zero defects Observation by

PRS #4

The contractor shall notify the serviced activity within 24 hours if there is a recall on reagents needed for patient testing.

Para. 5.4 Zero defects Observation by

PRS #5 Para. 5.9 Zero defects Observation by

Contractor shall arrive on site within 24 hours of service call being placed.

7.2 DELIVERABLE SCHEDULE

DELIVERABLE FREQ. # OF

COPIES

MEDIUM/

FORMAT

SUBMIT TO

Maintenance Service Report

After every scheduled service

1 copy Email PDF copy (preferred) or hard copy.

Emails:

Schedule confirmation of scheduled service

Two weeks prior to the beginning of the month in which scheduled services are required.

1 copy Email confirmation

Emails: