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Crow Service Unit Coagulation Analyzer and Reagent Lease

Location

Montana

Publication Date

06/05/2024 01:14 PM EDT

Closing Date

06/14/2024 06:30 PM EDT

Issuing Organization

HEALTH AND HUMAN SERVICES, DEPARTMENT OF - INDIAN HEALTH SERVICE - BILLINGS AREA INDIAN HEALTH SVC

Solicitation Number

Registered members only

Description

SOURCES SOUGHT NOTICE

Sources Sought Number: 75H709-CR24Q-009

This is a Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. Pursuant to 48 CFR Part 326, Subpart 326.603-3 and IHM 5.5-6, Indian Health Service must use the negotiation authority of the Buy Indian Act, 25 U.S.C. 47, to give preference to Indian Economic Enterprises (IEE) whenever the use of that authority is authorized and practicable.

The Government is seeking to identify Indian Small Business Economic Enterprises (ISBEEs), Indian Economic Enterprises (IEE), and any other category of vendor capable of performing the below Indian Health Services (IHS) requirement. Any vendor responding to this notice should submit their capability statement as well as the Buy Indian Act Indian Economic Enterprise Representation Form (attached).

Consistent with the revised Buy Indian Act, HHS/IHS adopted the definition of an Indian Economic Enterprise (IEE) set forth in 48 CFR 1480.201. This definition includes the following requirement, amongst others: “the Indians or Indian Tribes must, together, receive at least a majority of the earnings from the contract.”

Instructions for submission are outlined further below.

DEFINITIONS

INDIAN ECONOMIC ENTERPRISE (IEE):

Any business activity owned by one or more Indians, Federally Recognized Indian Tribes, or Alaska Native Corporations provided that:

The combined Indian, Federally Recognized Indian Tribe or Alaska Native Corporation ownership of the enterprise constitutes not less than 51%;
The Indian, Federal Recognized Indian Tribes, or Alaska Native Corporations must, together, receive at least 51% of the earnings from the contract; and
The management and daily business operations must be controlled by one or more individuals who are Indians.

DESCRIPTION OF REQUIREMENT

NAICS:

325413 In-Vitro Diagnostic Substance Manufacturing

Size Standard: 1250 Employees

Duration:

One (1) Year with Four (4) Option Years

Services needed include but are not limited to the following:

Background – There is a need to install a clinical coagulation analyzer used for patient testing at the Crow Northern Cheyenne Hospital Laboratory (Crow Agency, MT). The coagulation analyzer must be capable of performing PT/INRs (about 1500 annually), PTTs (about 200 annually), and D-dimers (about 200 annually) with STAT capability of interrupting a current test run and placing the patient sample onto the analyzer. The Crow/Northern Cheyenne Hospital laboratory is open 24hrs/7days a week performing routine patient testing with occasional STAT and ASAP test order requests by the medical staff.
Description – The Contractor shall enter into a lease reagent rental (cost per test) contract with the Crow/Northern Cheyenne Hospital Laboratory located in Crow Agency, Montana.
Pricing shall include an automated clinical coagulation analyzer, barcode reader, printer, testing supplies/consumables, reagents, external quality control reagents and service support. The Contractor shall only provide FDA-approved tests. A key operator training must be provided by the Contractor. A service agreement shall be included on the Cost Per Test contract to provide on-site service 7 days per week, 24/7.
Justification – The automated clinical coagulation analyzer is used to perform Prothrombin Time (PT), Activated Partial Thromboplastin Time (APPT), International Normalized Ratio (INR), and D Dimer testing required to maintain health and treatment of patients being served. The tests are needed within the same day to provide treatment decisions by the medical staff.
Impact – In-house clinical coagulation testing method is a requirement, as a CAH, hospital with an emergency department. Sending these test out to a reference laboratory for testing is not optional.

Analyzer Operational Requirements

Quality control performance is required once per day 8 hour shift.
Contractor shall provide assayed quality control material at a minimum of two levels; normal and elevated/abnormal levels.
Assayed control plasma for PT and APTT are the preferred products to assess test quality.
The product information must specify an appropriate ISI for the instrument and reagent lot number combination
The ISI value for PT reagents must be between 1.0‐1.3. The variance of the ISI value between reagent lots must not exceed 0.2.
A bi‐directional, bar‐coded computer interface compatible with the current IHS RPMS laboratory information system. The fully operational interface (both hardware and software) shall be immediately available for implementation to the IHS RPMS computerized hospital information system.
Minimal daily, monthly, and periodic maintenance.
On-board documentation and help function keys
Ability to handle lipemic or icteric samples.
Minimum twenty‐four (24) hour on‐board stability of PT and APTT reagents.
Positive patient identification via barcode scanner
Able to program for STAT testing as well as routine testing
Minimum eight (8) hour stability of quality control (QC) material.
Capability to detect out of range quality control.
Ability to automatically program the performance of QC testing
On‐board QC data management system with a minimum storage capacity of 30 QC files and includes Levy‐Jennings graphs. Analyzer must have the ability to capture, store and electronically transfer QC data, multiple reagent lot capability.
Ability to monitor instrument performance.
Minimal reagent, calibrator, and control preparation.
No specimen pre‐treatment required for PT and APTT testing.
An on‐board monitor/screen that is easily readable.
A printer that has the capability of printing a patient report with patient demographic information that includes minimally the accession or unique identifier number (UID).
D Dimer testing must be FDA approved for exclusion of PE and DVT.
Method performance/comparison shall be at the expense of the Contractor, shall include linearity material and reagents as required or recommended based on manufacturer’s specifications, and be consistent with current CLSI guidelines and related documents, College of American Pathologists (CAP) standards and Federal regulations. Acceptable accuracy and precision for PT and APTT

<10% CV and D‐Dimer will be <5% CV.

Analytical Measurement Range (AMR) Validation shall be performed on proposed instrument(s) for each analytic to validate the reportable range when applicable. The material must have values, which are near the low, mid, and high values of the AMR and be of appropriate matrix for the clinical specimens assayed by that method. A minimum 5‐point linearity analysis that adheres to the Beer‐Lambert Law and spans the entire range shall be performed as a minimum.
The method validation Correlation studies for each analytic spanning the reportable range, shall be run by the present and the proposed method. Contractor shall analyze results and provide statistical data to support acceptance of the new method. Statistics shall consist of at least mean, bias, slope, y‐intercept, correlation coefficient, and meet current standards defined by CLSI CLSI.
Updates and upgrades as available.

Data Management Requirements

Must be capable of interfacing with the Data Innovations middleware and utilize HL7 format (ASTM protocol) and be bi-directional interfaced with the VA Laboratory Package 5.1 RPMS.

There are two options for instrument interfacing: Large Scale Integrated (LSI) Device or Universal Interface (UI). The main operational difference between the two interfaces is that LSI requires a program routine to convert the RPMS data, whereas the UI uses downloadable drivers. At this time, the majority of IHS Interfaced Sites use the UI manufactured by Data Innovations called the Instrument Manager (IM).

Deliverables:

Equipment, Reagents and Quality Control Materials

- Analyzer and printer and parts
- Uninterruptible Power Supply
- Test Reagents and Calibrators and Control Materials (QC must be enrolled in a Quality Assurance Program)
- Estimated Annual Patient Test Volumes only:
  - PT/INRs (about 1500 annually)
  - PTTs (about 200 annually),
  - D-dimers (about 200 annually)
- Maintenance Kit for the Analyzer
- Start-up Kit to include test reagents for validation/verification studies per CLIA requirements.

All items to ship with longest dating possible – no short dated items will be accepted. All items shipped with single lot number per shipment. Mixed lot numbers will not be accepted.

Contract will include all other supplies and calibrators necessary to run the above mentioned testing on the coagulation analyzer.

Training:

The contractor will provide annual on-site training session for laboratory technical staff and installation studies and materials at no charge to the Government.

Service/Maintenance

The contractor shall provide technical support by telephone or on-site service engineer at no extra charge to the Government and to occur between 7 days a week, 24/7, 365. The contractor will callback within 1 hour of the service call placed. Annual preventive maintenance will be performed by the contractor that will include travel, labor, and non-consumable parts at no extra charge to the Government.

Warranty:

The contractor shall provide a one-year warranty on the instrumentation with replacement if necessary at no extra charge to the Government.

Price Schedule:

Only new equipment with a one year manufactures warranty will be accepted, used or refurbished equipment will not be accepted. Items Brand Name or Equal will be accepted.

Base Year

Lease of analyzer 12 months @$_______ per month = $________