Attachment-1-SOW-Checklist.xlsx
XLSX spreadsheet 20 KB Posted
- Solicitation number
- GSA-RFQ1787669
- Issued by
-
Defense Health Agency
About this file
This document is a Statement of Work (SOW) Checklist for a Cost Per Test (CPT) contract for two automated immunohematology analyzers for Naval Medical Center Portsmouth (NMCP). The procurement requires two identical benchtop blood grouping analyzers capable of performing comprehensive immunohematology testing, including ABO/Rh typing, antibody screening, crossmatching, and various other specialized tests with a minimum daily throughput of 140 tests. The contract covers a one-year performance period from January 1, 2026 through December 31, 2026, with specific requirements for FDA compliance, installation, maintenance, training, and ongoing technical support.
Key requirements include providing two analyzers with specific capabilities such as gel technology, no-wash antiglobulin procedures, compatibility with various sample types, and the ability to process different specimen modes. The vendor must supply associated reagents, quality control materials, consumables, and support infrastructure, including six patient sample racks, two printers, and two tables. The contract mandates 24/7 telephonic support, on-site maintenance within 24 hours of trouble calls, preventive maintenance, software updates, and user training for two staff members. The total annual testing volume includes minimums for 26,400 ABORh typings, 2,400 antibody identifications, and other specified test types, with a comprehensive service and support model focused on maintaining continuous operational capability.
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MEC Checklist
| Attachment 1 - SOW Checklist | |||||
| RFQ #: | RFQ1787669 | ||||
| Number | Document | PWS Section | Description | Offeror Confirms the PWS Section Can be Met (Answer "YES" or "NO" | Comments: If the vendor cannot meet the SOW section please explain why in this column. |
| 1 | SOW | 2.1 | The proposed action is for a Cost Per Test (CPT) contract for two (2) analyzers – laboratory – immunohematology - blood grouping - automated, reagents, quality control, maintenance, and consumables for NMCP. These analyzers shall be the same model and perform the same tests to provide redundancy to form a blood grouping analyzer system. If a vendor solution requires more than one model analyzer to provide all required tests, vendors shall propose two of each model analyzer to meet the required redundancy. | ||
| 2 | SOW | 3.1 | Period of Performance / Delivery Period: 01 January 2026 through 31 December 2026. | ||
| 3 | SOW | 3.2 | Number of Option Periods: No options are required for this effort. | ||
| 4 | SOW | 4.1 | Two (2) Analyzers, Laboratory, Immunohematology, Blood Grouping, Automated | ||
| 5 | SOW | 5.1 | The vendor shall ensure the analyzers and cost-per-test meet the following essential characteristics. | ||
| 6 | SOW | 5.1.1 | The blood grouping analyzers shall be fully automated, benchtop type analyzers capable of performing routine blood cross matching, ABO grouping and subgrouping, Rh and other red cell phenotyping, and antibody detection. | ||
| 7 | SOW | 5.1.2 | The automated blood grouping analyzers shall have a minimum daily throughput of 140 tests per day, or better. | ||
| 8 | SOW | 5.1.3 | The blood grouping analyzers shall be capable of gel technology. | ||
| 9 | SOW | 5.1.4 | The analyzers shall be capable of pre-transfusion and compatibility testing for patients in the emergency room, operating rooms, labor and delivery, hematology oncology, and pediatric and adult intensive care units (ICU). | ||
| 10 | SOW | 5.1.5 | The analyzers shall be capable of ABO/Rh/Grouping, ABO/Rh Confirmation, Antibody Screens, Antibody Identification, Selected Cell Panel, Rh Phenotype (C, c, E, e), Donor Confirmation, Crossmatch (Anti-Human Globulin (AHG), Antigen Typing, Serial Dilutions for Titration Studies, Direct Antiglobulin Test (DAT) (Polyspecific), DAT (IgG), and Cord Blood Testing. | ||
| 11 | SOW | 5.1.6 | The analyzers shall be capable of no-wash antiglobulin procedures to reduce testing time and liquid waste. | ||
| 12 | SOW | 5.1.7 | The analyzers shall not require antiglobulin control cells. | ||
| 13 | SOW | 5.1.8 | The analyzers shall be capable of processing various sample types including sedimented blood, plasma or serum. | ||
| 14 | SOW | 5.1.9 | The analyzers shall be capable of operating in various modes including continuous, random STAT and batch specimen. The analyzers shall be capable of processing various adult and pediatric test tubes. | ||
| 15 | SOW | 5.1.10 | The vendor shall provide two (2) printers. | ||
| 16 | SOW | 5.1.11 | The vendor shall provide six (6) patient sample racks per analyzer. | ||
| 17 | SOW | 5.1.12 | The vendor shall provide two (2) tables, each with a maximum dimensional footprint of 6 feet high x 9 feet wide (H x W). | ||
| 18 | SOW | 5.1.13 | The system, including claims made for the product, shall be compliant with FDA regulations, and shall be FDA approved, 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. | ||
| 19 | SOW | 5.1.14 | The system shall be installed in compliance with Occupational Safety and Health Administration (OSHA) requirements. | ||
| 20 | SOW | 5.1.15 | The hematology blood-grouping analyzers shall be capable of performing at least, but not be limited to, the tests listed below. The blood grouping analyzers shall be capable of performing each test at least at the minimum workload indicated in the table located in the SOW. | ||
| 21 | SOW | 6.1 | The vendor shall ensure to provide the following delivery, transportation, and installation requirements. | ||
| 22 | SOW | 6.1.1 | The vendor shall be responsible for the delivery, transportation, and installation of all required items. This includes uncrating, transporting the analyzers through the facility to the designated location, and removing all packaging waste. If interim storage is required, the vendor must arrange and manage storage until installation is completed. The vendor must also perform initial instrument operational validation. The vendor is also responsible for the initial instrument operational and performance validations. | ||
| 23 | SOW | 6.1.2 | To ensure continuous operation, deliveries must be structured based on the required testing volume. The monthly supply packages should support a minimum of: |
| • | 2200 ABORh typing, | ||||
| • | 200 antibody identification, | ||||
| • | 700 antibody screening, | ||||
| • | 100 antibody titers, | ||||
| • | 100 antigen typing, | ||||
| • | 400 direct antiglobulin test, | ||||
| • | 300 crossmatch, | ||||
| • | 100 fetal maternal hemorrhage screen, and | ||||
| • | 100 RhIG workup tests per month. | ||||
| 24 | SOW | 6.1.3 | Vendors must specify their package sizes and quantities, ensuring alignment with the required number of tests per month. | ||
| 25 | SOW | 6.1.4 | Each delivery shall include automated blood grouping reagents, quality control materials, consumables necessary for operations, including but not limited to test cartridges, sample racks, pipettes and other necessary lab accessories. | ||
| 26 | SOW | 6.1.5 | The vendor must define their unit of measure for containers, test kits, reagent bottles, etc., ensuring consistency in the delivery schedule. | ||
| 27 | SOW | 6.1.6 | The total annual supply must support a minimum of: |
• 26,400 ABORh typings,
• 2,400 antibody identifications,
• 8,400 antibody screenings,
• 1,200 antibody titers,
• 1,200 antigen typings,
• 4,800 direct antiglobulin tests,
• 3,600 crossmatches,
• 1,200 fetal maternal hemorrhage screens, and
• 1,200 RhIG workups
| 28 | SOW | 6.1.7 | Upon installation, the vendor shall provide: | ||
| 29 | SOW | 6.1.7.1 | A 30 -day validation period to confirm operational accuracy, including normal range verification, linearity studies, and replication tests. | ||
| 30 | SOW | 6.1.7.2 | User training for at least two staff members upon installation and annually thereafter. | ||
| 31 | SOW | 6.1.7.3 | Preventive maintenance coverage and Laboratory Information system (LIS) integration support. | ||
| 32 | SOW | 6.1.7.4 | Shipping shall be Free Onboard Shipping (FOB) Destination | ||
| 33 | SOW | 6.1.8 | Reagent and Supply Delivery: | ||
| 34 | SOW | 6.1.8.1 | All supplied items and reagents shall be certified for use with the equipment provided by the selected vendor. | ||
| 35 | SOW | 6.1.8.2 | All supplied items and reagents that require special handling (e.g. refrigeration, time sensitivity, immediate open, etc.) will be marked in an explicit manner with a label that is easily read, understandable, and a minimum of 3 inches x 3 inches (9 sq. inches). The label will be placed in three (3) or more locations on the container (top & two sides). Supplies or items that require refrigeration will have both the required Celsius and Fahrenheit temperature identified. | ||
| 36 | SOW | 6.1.8.3 | The contractor shall provide deliveries to the delivery point identified below: | ||
| 37 | SOW | 7.1 | <Reserved> | <Reserved> | <Reserved> |
| 38 | SOW | 8.1 | The dimensions of the available space for the two (2) analyzers shall not exceed 84 inches x 102 inches x 48 inches (H x W x D) collectively. | ||
| 39 | SOW | 9.1 | See Section 6.1.8.2. | ||
| 40 | SOW | 10.1 | The electrical requirements for each analyzer are 120V and 60 Hz. | ||
| 41 | SOW | 11.1 | The contractor shall be an 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. | ||
| 42 | SOW | 12.1 | The vendor shall provide user training for two (2) staff members upon installation. | ||
| 43 | SOW | 12.2 | The vendor shall provide user training for a minimum of two (2) staff members for each exercised option period. | ||
| 44 | SOW | 12.3 | The vendor shall provide two (2) operational and two (2) service manuals. | ||
| 45 | SOW | 12.4 | Off-site training is preferred. On-site training shall be available. | ||
| 46 | SOW | 12.5 | Online training shall also be available on the vendor’s website. | ||
| 47 | SOW | 13.1 | The vendor shall provide LIS support and training for auto-validation of assays. | ||
| 48 | SOW | 13.2 | The vendor shall respond to corrective maintenance calls within one (1) hour of initial complaint via telephone. | ||
| 49 | SOW | 13.3 | If the issue cannot be corrected over the telephone, the vendor shall provide on-site support to correct the issue within 48 hours. | ||
| 50 | SOW | 13.4 | The Vendor Field Service Engineers shall be original equipment manufacturer (OEM) trained, experienced, and 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 (CM). | ||
| 51 | SOW | 13.5 | The Vendor shall provide telephonic communications to discuss technical matters relating to the performance of this contract. An English-speaking systems operator shall be made available to answer technical questions regarding system operations and applications. | ||
| 52 | SOW | 13.6 | Equipment listed in this contract will be maintained to meet and retain the OEM’s specifications and/or equipment certification. | ||
| 53 | SOW | 13.7 | Normal Business Hour Maintenance Coverage will be Monday through Friday, between 8:00 A.M. to 5:00 P.M. EST. The vendor shall provide full-service preventive maintenance. | ||
| 54 | SOW | 13.8 | Preventive maintenance shall be performed in accordance with OEM recommendations. | ||
| 55 | SOW | 13.9 | The vendor shall perform preventive maintenance service checks during the base contract period at the OEM’s recommended intervals. Vendor will also perform preventive maintenance service checks during each option year at a date and time mutually agreed upon by the vendor and the Government. | ||
| 56 | SOW | 13.10 | All test equipment used in the performance of this contract shall be calibrated, as required by the OEM, and shall be in compliance with The Joint Commission (JC), OEM, the College of American Pathologist’s (CAP), and Food and Drug Administration (FDA), and National Institute for Standards and Technology (NIST) standards. | ||
| 57 | SOW | 13.11 | Corrective Maintenance | ||
| 58 | SOW | 13.11.1 | Vendor shall provide on-site corrective maintenance between the hours of 8:00 A.M. and 5:00 P.M. EST, Monday-Friday, to include unlimited service calls. Telephonic support shall be available 24 hours per day, 7 days per week, 365 days a year, excluding Federal Government holidays, which are identified online at the following site: https://www.opm.gov/policy-data-oversight/pay-leave/pay-administration/fact-sheets/holidays-work-schedules-and-pay. | ||
| 59 | SOW | 13.11.2 | A vendor service technician shall respond via telephone within two (2) hours after receipt of trouble call and provide on-site service within twenty-four (24) hours. Equipment shall be operational within forty-eight (48) hours of the initial trouble call. | ||
| 60 | SOW | 13.11.3 | Government request for corrective maintenance will be placed by NMCP Biomedical Engineering Division (BIOMED) personnel, to the Vendor. Corrective maintenance shall be completed during the hours specified in the contract. | ||
| 61 | SOW | 13.11.4 | The vendor’s response to requests for service may include telephone consultation with the equipment user/operator and a Vendor Field Service Engineer (FSE). Telephone consultation 1) shall provide instruction in determining operator error; 2) shall determine the most likely cause of the problem; 3) shall determine if resolution of the problem requires the dispatch of a Field Service Engineer (FSE); and 4) should identify replacement parts likely to be required to return the equipment to 100% operational condition as specified by the OEM. | ||
| 62 | SOW | 13.11.5 | The vendor’s pricing shall be inclusive of all costs including parts, consumables, labor, travel, and shipping. | ||
| 63 | SOW | 13.11.6 | The vendor FSE shall have his/her own service manuals, specifications, schematic diagrams, and parts lists to assist in the evaluation and repair of all equipment included in this contract. | ||
| 64 | SOW | 14.1 | The vendor shall have ready-access to unique and/or high-mortality replacement parts. All parts supplied shall be compatible with the existing system. In the event replacement parts are required to be shipped, shipping shall be performed in the fastest reasonable means possible at no additional cost to the Government. | ||
| 65 | SOW | 14.2 | The vendor shall replace all worn or defective parts necessary to restore the equipment to 100% operational condition as specified by the OEM. | ||
| 66 | SOW | 14.3 | Freight, postage, and storage charges associated with shipment and receipt of replacement parts and the return of parts shall be the responsibility of the vendor. | ||
| 67 | SOW | 14.4 | All replacement parts shall be new, non-refurbished, and certified as OEM replacement parts. | ||
| 68 | SOW | 14.5 | The vendor shall install software revisions and updates (field service changes) that are required by FDA- or manufacturer-announced safety hazards, alerts, or recalls, including the FDA Year 2000 (Y2K) Compliance Directive, as part of the contract at no additional cost to the Government. Updates and revisions shall be performed as soon as possible after release, no later than the first scheduled Preventative Maintenance inspection after release. For any updates that have been identified as critical or required for the proper operation of equipment by the OEM, the vendor shall provide installation within 30 days of release regardless of preventative maintenance schedules. | ||
| 69 | SOW | 14.6 | With prior approval from the Government, the vendor may perform hardware/software upgrades as they become available. | ||
| 70 | SOW | 15.1 | The Government will be responsible for maintaining the proper environment, including utilities and site requirements necessary for the system to function properly as specified by the OEM. | ||
| 71 | SOW | 15.2 | The Government will operate the system in accordance with the instruction manual provided by the OEM. | ||
| 72 | SOW | 15.3 | The Government will not be responsible for the damage or loss due to fire, theft, accident, or other disaster of Vendor supplies, materials, or for the personal belongings brought onto Government property by Vendor’s personnel. | ||
| 73 | SOW | 16.1 | The vendor shall provide all service literature, reference publications, laptop computers, and diagnostic software to be used by the vendor FSE as required for the completion of the services in accordance with this contract. | ||
| 74 | SOW | 17.1 | During normal duty hours, vendor FSE personnel shall check-in with the Biomedical Engineering Division upon arrival at the Government site and again prior to departure. The vendor FSEs shall personally notify BIOMED personnel of problems that result in the equipment being left disabled upon their departure. If equipment is left disabled, a method of physical use prevention of the disabled equipment shall be implemented, and the disabled equipment shall be locked out with a letter of intent in compliance with OSHA regulation to prevent any patient hazards. After normal duty hours, vendor FSEs shall notify the Officer of the Day Desk and the Duty BIOMED personnel. | ||
| 75 | SOW | 17.2 | The vendor shall provide a full-service report to BIOMED and the blood bank representative within two (2) days of completion of all services performed. Each service report shall at a minimum document the following data legibly, in complete detail, and in English. | ||
| 76 | SOW | 18.1 | The vendor shall be responsible for the repair/replacement of damaged Government-owned equipment and property due to the negligence of the vendor or its representatives. All such replacements or repairs shall be at the vendor's expense and shall be inspected to the satisfaction of the Contracting Officer’s Representative (COR) or appointed BIOMED technical representative. | ||
| 77 | SOW | 19.1 | No equipment shall be removed without the approval of the Materials Management Department of the Medical Treatment Facility (MTF). Property passes for equipment removal shall be obtained by the vendor via the Materials Management Department of the MTF. Any failure to obtain such passes which results in detainment or prosecution of vendor FSE personnel are the sole responsibility of the service vendor personnel. | ||
| 78 | SOW | 19.2 | The vendor shall provide a detailed description of removed items in writing on the vendor’s company letterhead. For associated items/accessories, the vendor will provide a detailed written description and quantities of items to be removed. This description will include, as a minimum, the manufacturer’s serial numbers and facility equipment control numbers (ECNs) of all equipment and/or items removed. In the event items/sub-assemblies/accessories are “repaired by replacement,” a detailed description of replaced items is to be included upon return of repaired components. | ||
| 79 | SOW | 19.3 | No additional charge shall be allowed for work performed off-site, or any additional time required. All charges resulting from a vendor-determined requirement to transport Government-owned property, covered by this contract, to and from an alternate repair location shall be the responsibility of the vendor. The vendor shall provide insurance coverage for damage to or loss of equipment while in vendor custody. | ||
| 80 | SOW | 19.4 | In regard to patient information confidentiality and privacy, all vendors shall not remove equipment containing patient information from the Government site. The equipment hard drive(s) and/or solid-state drive(s) shall be removed at the MTF prior to removal. Furthermore, equipment removed from the MTF will be prorated from the date of removal for service maintenance fees. If hard drives are to be replaced, they shall be left at the MTF for disposal. | ||
| 81 | SOW | 19.5 | Hard Disk and Solid-State Drives (HDD & SSD): Regarding patient information confidentiality and privacy, all Contractors and/or service Contractors shall not remove equipment containing patient information from the NMC Portsmouth. HDD nor SSD shall ever be removed from the MTF, by the Contractor under this maintenance agreement. Removal of protected health information (PHI) and personally identifiable information (PII) from the equipment prior to removal from site must be properly coordinated with the COR and Command Equipment Manager. | ||
| 82 | SOW | 20.1 | The vendor shall immediately, but no later than 24 consecutive hours after discovery, notify BIOMED in writing of the existence of or of the development of any defects in, or repair required to, the contracted equipment, for which the vendor considers they are not responsible under the terms of this contract. | ||
| 83 | SOW | 20.2 | At the same time of this written notification, the vendor shall furnish BIOMED with a written cost estimate to make the necessary repairs. Repairs considered by the Contracting Officer to be outside the scope of this contract shall not be covered under this contract but shall be ordered under a separate purchase order. | ||
| 84 | SOW | 21.1 | List any specifications for Authorization to Operate (ATO) approvals for this equipment. | ||
| 85 | SOW | 21.1.1 | The vendor’s proposed system may require ATO approval prior to installation. The system shall bi-directionally interface with the DoD LIS, Military Health System (MHS) Genesis. |
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