SPECIAL NOTICE
65 -- Notice of Intent to Sole Source - Hematology Analyzer Naval Health Clinic Hawaii
- Notice Date
- 1/5/2023 3:59:19 PM
- Notice Type
- Special Notice
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- DEFENSE HEALTH AGENCY FALLS CHURCH VA 22042 USA
- ZIP Code
- 22042
- Solicitation Number
- HT941022N0009
- Response Due
- 1/20/2023 10:00:00 AM
- Point of Contact
- Jane Pamintuan, Phone: 2109527084
- E-Mail Address
-
jane.v.pamintuan.civ@health.mil
(jane.v.pamintuan.civ@health.mil)
- Description
- Reference#: HT941023N0009 The Defense Health Agency Contracting Activity (DHACA) Western Markets - Contracting Division (WM-CD) on behalf of Naval Health Clinic Hawaii (NHCH) intends to negotiate on a sole source basis (IAW FAR 13.501(a), Only One Responsible Source. The proposed source is Sysmex America, Inc., 577 Aptakisic Road Lincolnshire, IL 60069-4325. Equipment This is a supply requirement for two (2) hematology analyzers, reagents, quality control, maintenance, and consumables for NHCH.� One analyzer will be located at Branch Health Clinic Makalapa and one analyzer will be located at Branch Health Clinic Kaneohe Bay. Each analyzer shall meet the following minimum requirements: Must be capable of performing complete blood count (CBC), WBC, cell differential, blood film differential, reticulocyte (retic) analysis and nucleated red blood cell (NRBC) with 6-part differential, including FDA Approved Immature Granulocyte (IG) parameter Must be a single model platform Must be capable of performing general hematology testing for a minimum annual workload of 7,800 specimens for Makalapa and a minimum workload of 3,900 for Kaneohe Bay Must be capable of processing a minimum of 60 samples per hour Must be capable of general hematology testing for the management of chronic kidney disease (CKD) and anemia management. Must be capable of advanced measures of hematopoiesis, eliminating the need for whole blood count (WBC) corrections. Testing for CKD shall utilize a non- cyanide reagent for Hemoglobin (Hgb) Must be utilized for early detection of sepsis, inflammatory response or myeloproliferative disorders Must be able to test small aspiration volumes of less than 101 ?l Must provide real-time results with rerun/reflex testing capabilities Must be capable of creating scatter plots of WBC differential populations, NRBC and retic populations Must be able to report RBC and WBC data to three (3) decimal places Must be able to qualitatively indicate (via suspect flag) cell abnormalities Must be capable of positively identifying patient samples using bar codes Must be capable of pre-diluted sample access mode Must include pre-defined rules of the International Society for Laboratory Hematology (ISLH) Must consist of onboard Quality Control (QC) for all CBC, retic, NRBC and differential results Must connect with the existing floor drain to evacuate wastewater Must include an uninterruptable power supply (UPS) Due to the configuration of the laboratories, the dimensions for the hematology analyzers shall not exceed 17.72x25.98x17.72 inches (WxDxH). The electrical requirements are 115 VAC and 60 Hz. The vendor shall provide installation, validation testing, onsite user training and preventive maintenance coverage. The vendor shall provide validation of the analyzers, including: normal range verification, demonstration of linearity, reportable range, replication studies, recovery studies and establishment of initial control ranges using control materials. Corrective maintenance coverage shall be provided and include response times. Training shall be provided by the vendor. The system shall bi-directionally interface with the Military Healthcare System (MHS) Genesis and the laboratory information system (LIS). The vendor shall provide two (2) operational and two (2) service manuals, each in English. Support shall be provided for the following period of performance: Base: 01 May 2023 � 30 April 2024 Option Year 1: 01 May 2024 � 30 April 2025 Option Year 2: 01 May 2025 � 30 April 2026 Option Year 3: 01 May 2026 � 30 April 2027 Option Year4: 01 May 2027 � 30 April 2028 The system, including claims made for the product, shall be compliant with Food and Drug Administration (FDA) regulations, with respect to marketing and delivering medical products for use in the United States of America.� These requirements shall apply even if delivery is requested outside of the United States of America. The system shall be installed in compliance with OSHA requirements. Vendor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor, or authorized reseller for the proposed equipment/system such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty, and service associated with the equipment/system shall be in accordance with the OEM terms and conditions. Upon delivery, the vendor shall be responsible for uncrating the unit/system, transporting it through the facility to the location of intended use for installation, and removing of all trash created in this process. If interim storage is required, the vendor shall make arrangements for the storage. The vendor is also responsible for the initial instrument operational and performance validations. Reagent and Supply Delivery All supplied items and reagents shall be certified for use with the vendor equipment provided. All supplied items and reagents shall have a minimum shelf life of 6 months upon receipt by the Government. All supplied items and reagents that require special handling (e.g. refrigeration, time sensitive, immediate open, etc.) will be marked in a clear manner with a label that is easily read, understandable, and a minimum of 3� x 3� (9 sq. inches). The label will be placed in three (3) or more locations on the container (top & two sides). Supplies/items that require refrigeration will have both the required Celsius and Fahrenheit temperature identified. The vendor shall provide deliveries to the delivery point identified below: ����������������������������������� ����������� Naval Health Clinic Hawaii ����������� Makalapa Laboratory ����������� 1253 Makalapa Road, Bldg 1407, Room 284 ����������� JBPHH, HI 96860 ����������� Naval Health Clinic Hawaii ����������� MCBH Kaneohe Bay Laboratory ����������� Harris Avenue, Bldg 6905, Room 1G09 ����������� MCBH Kaneohe Bay, HI 96863 Maintenance The vendor shall provide OEM-trained, experienced, English-speaking personnel. The vendor shall provide all labor, tools, diagnostic equipment, software, material, supplies, transportation, parts, and equipment necessary to perform Preventive Maintenance (PM), Calibration (CAL), Safety Testing (ST), and corrective maintenance. The vendor shall provide telephonic communications with the Government to discuss technical matters relating to the performance of this contract. A systems operator shall be made available to answer technical questions regarding system operations and applications. Equipment listed in this contract will be maintained to meet and retain the original equipment manufacturer�s (OEM�s) specifications/equipment certification. The vendor shall provide maintenance services Monday through Friday from 0700-1700 local time, excluding Federal Government holidays. This includes annually required performance maintenance. Customer and Technical support should be available by phone 24 hours, 7 days a week. There are no set-aside restrictions for this requirement.� The intended procurement will be classified under North America Industry Classification System (NAICS) 334516.� This notice of intent is not a request for competitive proposals and no solicitation document exists for this requirement.� However, parties interested in responding to this notice will need to submit technical data sufficient to determine capability in providing the same product.� All capability statements received by the closing date of this synopsis will be considered by the Government.� A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government.� Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. If a vendor challenges the basis of this requirement, please email product capability statements (formats for submission: PDF, MS Word, or MS Excel) to Jane Pamintuan at jane.v.pamintuan.civ@health.mil Closing date for challenges is no later than 0800 PST on 20 January 2023.� No phone calls will be accepted.
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/26e884959979433eb30fb4ad8c3baafa/view)
- Place of Performance
- Address: HI 96860, USA
- Zip Code: 96860
- Country: USA
- Zip Code: 96860
- Record
- SN06556816-F 20230107/230105230105 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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