Amendment_01_Updated_SON.pdf

W91YTZ24Q0121

SUMMARY OF CHANGES

SOLICITATION/CONTRACT FORM

The required response date/time has changed from 09-Aug-2024 02:00 PM to 12-Aug-2024 05:00 PM.

The following have been modified:

STATEMENT OF NEED

1. Introduction:

The Hematology section located in the Department of Pathology at Blanchfield Army Community Hospital is seeking a Blanket Purchase Agreement for a cost per reportable result hematology analyzer system to replace the current analyzer in use.

2. Background:

On September 30, 2024, the current hematology contract will expire. In the last five years technology has advanced tremendously in the area of hematology analyzer capabilities. Hematology is a branch of medicine concerning the study of blood, blood-forming organs such as bone marrow, and blood-related disorders and diseases.

Hematological tests are used to detect and diagnose diseases such as hemophilia, anemia, leukemia, sickle-cell anemia, lymphomas, and several infections. Without hematology capabilities there will be a break in service in completing even the most basic patient care.

3. Minimum Requirements / Specifications/ Salient Characteristics:

1. Vendor Shall be able to provide an option for a cart/wagon for the instrument(s) to go on to optimize lab workspace and flexibility.

2. System shall have a primary and backup analyzer in a connected single footprint to optimize instrument workload management.

3. Analyzer shall require small aspiration volumes, less than 100 µl to perform full hematology reportable test profile. The analyzer qualification is required due to frequent short samples that are collected and received from the neonate nursery and the emergency center, and multiple published patient safety reports due to specimen rejection for quantity not sufficient samples. Setting a minimum sample volume of 100 uL or less prevents harmful recollections from patients and improved turn-around times for laboratory results.

4. System shall have pre-defined, editable rule set on board software.

5. System shall use state of the art technology, such as fluorescent flow cytometry for WBC, WBC differential, NRBC, reticulocyte and platelet identification and enumeration. The system shall possess fluorescent flow cytometry for differentiation and numeration of WBC, NRBC, Platelet and NRBC parameters including a 6-part differential that includes immature granulocyte populations.

Fluorescent flow cytometry provides a greater clinical picture of what is happening with the patient in-vivo. This also aids in eliminating erroneous errors that cause extra hands-on manual testing and improves result turn-around time.

6. System shall offer fully reportable, FDA approved extended 6-part differential, including Immature Granulocytes, to reduce the need for manual differentials.

7. System shall offer fully reportable, FDA approved reticulocyte hemoglobin measurement, as recommended in the DoD Guidelines for the Management of Chronic Kidney Disease. A reticulocyte panel that includes quantitative and qualitative information may greatly improve patient outcomes.

8. System Shall offer fully reportable, FDA approved extended platelet parameters for the determination of thrombopoiesis to aid in the determination platelet engagement, as well as for chemotherapy decisions.

9. System shall offer fully reportable, secondary on-board platelet methodology to reduce the need for manual platelet reviews. Dual platelet methodologies are required to reduce manual confirmations. Reduction of manual tests will greatly increase the work force utilization and enhance workflow, resulting in quicker results to the clinicians. Platelet clump suspect flags cause extend turnaround times for laboratory results. The secondary method will assist in reducing unnecessary patient recollects especially with neonate specimens, improve patient turn-around times, and eliminate manual work by the hematology staff.

RBC fragments may also produce erroneous platelet counts on analyzers in which a secondary platelet measurement is needed.

10. Shall be able to analyze and report results from the following type of body fluids:

serous, synovial, and CSF.

11. Body Fluid shall provide an FDA Approved WBC, RBC and Total nucleated count with a 2-part WBC differential with every body fluid analysis. Body fluid analysis only takes place in the hematology department of the laboratory. Having a hematology analyzer that is capable of this criterion will reduce manual body fluid counts that require 1+ manual hours of a technician’s time and will eliminate variability between technicians.

12. Shall provide a NRBC count with every CBC analysis.

13. Tri Level controls shall include all instrument measurements for all whole blood parameters on system.

14. It is preferred that QC peer group data is reported in real time, with automatic electronic data upload capability to analyzer quality control. This is best practice in hematology. Being able to recognize QC peer group deficiencies, provides a good overview on the functionality of the analyzer, as opposed to waiting until the end of the month for comparison.

15. Vendor shall provide online user training for all analyzers.

16. Shall provide option of manufacturer-assisted calibration verification, either onsite or remotely. This is best performed by manufacturer service engineers. They are are responsible for servicing the analyzer due to system malfunctions or preventative maintenance. A faulty calibration can cause erroneous patient results and is best handled by the service experts.

17. System shall be able to provide a fully integrated instruments capable of workload balancing and maximizing efficiency by operating two or more analyzers simultaneously.

18. Shall offer the option of automatic rerun/reflex testing on a different, connected analyzer.

19. System shall provide the capability of analyzing low volume BD MAP pediatric capillary tubes with a minimum of 250 uL in a fully automated cassette mode.

20. All models shall perform satisfactorily at any laboratory temperature between 68 and 80 degrees Fahrenheit and at any laboratory relative humidity between 30 and 80%.

21. The testing system shall be fully automated to allow for walk away operations.

22. The system shall have a Data management system for storage of patient results, quality control and preventative maintenance data. System shall have a bi-directional interface to the analyzer and to the hospital information system (MHS Genesis/Cerner). The Data management system shall have sufficient data storage and printing capability to accommodate and provide immediate access to more than 2,000 patient records per day. The vendor shall provide back-up network data management handling. The Data management system shall include control of the operation of the analyzers, management of the quality control program, management of the on-instrument useful life of the reagents/reagent packs, patient results, and a printer for the production of hard copy patient reports and other reports generated via the data management system. The vendor shall provide back-up network data management handling. This is a best practice in hematology. Currently all backup is handled “in house” and should additionally be directed offsite in case of catastrophic failure events. This is a College of American Pathology requirement that back up data management takes place offsite in case of a catastrophic event. (GEN.43946 Requirement:

The laboratory follows written procedures for the preservation of data and equipment in case of an unexpected destructive event (eg, fire, flood, malicious incident), software failure and/or hardware failure, and these procedures allow for the timely restoration of service, including data integrity check.)

23. The analyzers shall be fully automated with direct loading and unloading capabilities for samples and include barcode reading for all reagents and samples. All analyzers and associated parts and accessories shall be new. The testing system shall come equipped with an un-interruptible power supply capable of providing all necessary electrical power to each analyzer system, to operate the data management system and testing system for at least 15 minutes.

The cost per reportable 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 shall be included for all hematology and body fluid analytes.

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 required correlation, precision, carry-over, validation, and population studies.

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

24. Reagents shall be provided bearing the same lot number within the designated shipments. These items shall be of the highest quality, sensitive, specific and tested to assure precision and accuracy. The manufacturer shall 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).

25. The contractor shall provide a fully automated, discrete random access hematology analyzer system capable of performing all of the required assays listed in Appendix 1. The two analyzer systems and all assays listed in Appendix 1 shall be Food & Drug Administration (FDA) approved prior to contract award.

All assays listed in Appendix 1 shall be FDA approved to be run on the two identical analyzers (redundancy) that the contract is awarded to. All analyzers and associated parts Shall be new. The hematology analyzer system shall provide a link between platforms that allows for automated transfer of specimens from one analyzer to the other.

26. The analyzers shall have the on-board stability to maintain reagents at the proper storage temperatures for the assays listed in Appendix 1. The analyzer shall be capable of maintaining calibration curves for all of the assays listed in Appendix 1 simultaneously. There shall be the capability to load and process STAT specimens ahead of routine specimens regardless of when the STAT specimens are put on and how many routines are currently processing on the analyzers.

27. After award the contractor shall provide one set of paper copy and two electronic copies on Compact Disk (CD) of SDS of all reagents and consumables to be used on the system as well as all assays found in Appendix 1 package inserts and SOP’s.

28. The contactor shall pay for the delivery charges for shipping and handling to include overnight deliveries at no additional cost to the government. Contractor shall sequester appropriate quantity of materials required to perform testing volumes estimated in Appendix 1 to ensure that not more than three lot changes are required per period of performance. Shipments shall be of not more than one lot number of like products.

4. Delivery Terms:

Delivery shall be at 650 Joel Dr. Fort Campbell, KY 4223 if items are shipped.

This shall be completed in accordance with the offeror’s commercial schedule.

5. Training:

The manufacturer shall provide basic and advanced training. During initial set up and installation of the analyzers, the manufacturer shall provide on-site training, at no cost, to all personnel who will operate the equipment. The manufacturer shall provide advanced training at the manufacturer’s training facility for two Government personnel during performance of the basic period, and training of two Government personnel during each option period, at no cost to the Government. The contractor shall agree that their proposal specifically includes that they will be responsible for all costs regarding lodging, transportation, meals and incidentals of the Government travelers in accordance with the Department of Defense Joint Travel Regulation. It is agreed that the Government traveler will be reimbursed for all authorized expenses upon presentation of a valid receipt to the contractor and payment shall be made to the Government traveler within ten business days. It is agreed that the Government traveler shall be personally responsible for all costs above the limits or unauthorized expenses established in the Joint Travel Regulation. The manufacturer shall provide supplemental training to the above government personnel, without charge to the government, upon installation of upgrade(s) in equipment hardware or operating system software connected with the operation of an instrument already furnished. Training for equipment operators prior to the first day of the contract’s performance period.

6. Documentation:

The vendor shall provide two (2) copies of the operating manual and two (2) copies of the service manual.

7. Installation:

The manufacturer shall be responsible for all delivery and installation of equipment.

The manufacturer shall perform complete correlation, precision, carry-over, linearity, and validation studies at the time of installation and for all new tests added throughout the contract period on manufacturer supplied and 3rd party assays. Population Studies shall consist of 200 samples for high volume tests and 50-100 samples for low volume tests. All studies shall meet recommended NCCLS guidelines. Method Validation shall be conducted in accordance with method validation protocols established by the Clinical Laboratory Standards Institute (CLSI) and/or required by the College of American Pathologists (CAP).

Method Validation shall include but not limited to, correlation with current methods (comparison of methods study), validation of analytical range (AMR), validation of precision (replication study), linearity studies, and establishment or verification of quality control ranges. All reagents, quality control material, calibrators, and linearity materials used to perform all validation studies shall be provided by the manufacturer at no cost to the Government to include manpower to perform the validation studies and to input validation studies into statistical reports such as EP Evaluator for evaluation of supervisor.

8. Inspection and Acceptance:

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

9. Extended Warranty / Maintenance Service:

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.

The instrument manufacturer Shall provide the purchasing customer the following support and services to ensure a guaranteed uptime of at least 99% on each analyzer: 24/7 telephonic technical support. We prefer two identical analyzers to provide redundancy so that NEVER should both analyzers be down/inoperable at the same time.

The vendor shall perform linearity studies on all analytes initially and every 6 months for the duration of the contract period to include providing all linearity materials required at no cost to the government and providing the statistical reports to the supervisor for review.

Provide automated assay linearity with no manual steps is preferred to perform linearity studies.

In the event that the contract is terminated for any reason, the manufacturer shall allow the analyzer(s) to remain in place for a period not to exceed 60 days at no additional cost to the government beyond the contracted price, for the purpose of meeting regulatory requirements of performing correlation and validation studies.

Appendix 1 – Test Menu and Workload

BACH Lab Test Menu Estimated Annual Usage

1. CBC W/Auto Diff 40,000

2. Retic Count 240

3. H&H 600

4.

Body Fluid Cell Count

Appendix 2 – Minimum Acceptable Standards for Performance of Regulated

Analytes Regulated Analyte Acceptable Performance Erythrocyte Count Target value ± 6% Hematocrit Target value ± 6% Hemoglobin Target value ± 7% Leukocyte Count Target value ± 15% Platelet Count Target value ± 25% MCV Target value ± 2 fL

(End of Summary of Changes)