RFI-XRAY-Calibration-PANMRA-20-P-0000-002995.pdf

REQUEST FOR INFORMATION

1.0 RFI TITLE: TEST, MEASUREMENT, AND DIAGNOSTIC EQUIPMENT (TMDE) CALIBRATOR

SET, X-RAY

2.0 AGENCY: U.S. Army Medical Materiel and Development Activity (USAMMDA)

3.0 OFFICE: Deployed Medical Systems, Medical Modernization Project Management Office

4.0 LOCATION: Not Applicable

5.0 SUBJECT: The Medical Modernization PMO (MOD PMO) of the U.S. Army Medical Materiel and

Development Activity (USAMMDA) is conducting market research to determine whether a commercial solution can be provided to meet requirements for Test, Measurement and Diagnostic (TMDE) X-Ray Calibrator Set. This market research may also assist with the further development and/or refinement of the requirements.

6.0 DISCLAIMER: This is an RFI as defined in FAR 15.201(e) to ascertain whether a commercial item exists that provides the capabilities described herein.

This RFI is issued solely for information and planning purposes and does not constitute a solicitation. Neither unsolicited proposals nor any other kind of offers will be considered in response to this RFI. Responses to this notice are not offers and will not be accepted by the Government to form a binding contract. In keeping with the standards of FAR Part 10, the Government may request additional information from responders. Responders are solely responsible for all expenses associated with responding to this RFI or any follow-up information request. All information received in response to this RFI or any follow-up information request that is marked Proprietary will be handled accordingly. Responses to the RFI will not be returned. At this time, questions concerning the composition and requirements for a future request for proposal will not be entertained.

7.0 DESCRIPTION: The MOD PMO of the USAMMDA has a requirement to field TMDE for the calibration and safety measure analysis of its deployed radiologic imaging systems. Initial calibration and certification of imaging systems shall be conducted by U.S. Army personnel at the depots after completion of Original Equipment

Manufacturer (OEM) technician training, prior to fielding. Regular calibration of these devices by U.S. Army personnel is required in order to maintain image quality and ensure safety requirements are met in the field.

This RFI addresses the need to procure and make available the next generation X-Ray Calibrator system for use within a wide variety of clinical and environmental conditions, including deployment in austere environments throughout the word and contingency operations.

The device must meet the following Minimum Essential Characteristics:

Minimum Requirement Threshold (T)

Regulatory Approvals

Shall meet IEC standards:

61010-1(1:2010): Testing and Measuring Equipment 61674 (2:2012): Dosimeters with ionization chambers and/or semiconductor detectors as used in X-Ray diagnostic imaging.

Current Measurement

The system shall be able to measure current in radiographic systems in the following parameters:

- mA (milliAmpere)

- mAs (milliAmpere-second)

- Pulse

- Pulse Rate

Minimum Requirement Threshold (T)

Radiography/Fluoroscopy

(R/F) Measurement

The system shall be able to measure the performance of X-Ray and Fluoroscopic devices by the following parameters:

- kVp (kiloVolt potential)

- HVL (Half-Value Layer)

- Dose

- Dose Rate

- Pulse Rate

Mammography Measurement

The system shall be able to measure the performance of Mammographic devices by the following parameters:

- kVp

- HVL

- Dose

- Dose Rate

- Pulse Rate

Computed Tomography (CT)

Measurement

The system shall be able to measure the performance of Computer Tomography (CT) devices by the following parameters:

- Dose

- Dose Length Product

- Dose Rate

Survey Measurement

The system shall be able to measure leakage and scatter resulting from diagnostic X-Ray devices in the following parameters:

- H*(10) (Ambient Dose equivalent)

- H*(10) Rate

- Air Kerma

- Air Kerma Rate

- Mean Energy

Light Measurement The system shall be able to perform luminance and illuminance measurements.

Display The system shall be able to display key measurements and waveforms in real time.

Rechargeable Battery The system shall be able to perform all expected calibration functions per device for 8 hours of continuous use on a single charge.

Operational Power The system shall be able to operate on A/C power when not charged.

Data Generation The system shall be able to export measurement data.

System Sustainment Resources

Vendor shall provide access to all resources necessary to allow the Army to sustain the system at the Tracy and USAMMCE depots. Sustainment shall be IAW the vendor's calibration, services, and repair procedures. Such program shall be validated and approved by the vendor.

The vendor shall provide the Original Equipment Manufacturers (OEM) calibration procedures, Standard Operating Procedures (SOPs), and copy of the NIST standards used.

Field Maintainability Unit will be equipped with tools, supplies, and accessories required for immediate setup and day-to-day operations, to be included in ruggedized case

Weight The system with all accessories and cases for transport should be no more than 15lbs.

Cube The system in its active use configuration shall be no larger than 50 cubic inches.

Accuracy The system shall be able to measure all data with no greater than a 5% error margin.

Precision The system shall be able to demonstrate repeatability of measurements with no greater than a

2% error margin.

Minimum Requirement Threshold (T)

Display Quality The system shall be equipped with a legible display that can show the full array of real-time data.

Internal Memory System shall display, print, store or export the readings from the current test being conducted.

Stand-By Charge The system shall have 48 hours of stand-by power on a single charge.

Calibration Frequency The system shall demonstrate a calibration requirement of no more than once in 12 months.

Calibration Certification The system shall come packaged with a NIST traceable certificate of calibration.

Documentation The system shall come packaged with a hard copy of the operator manual.

8.0 SUBMISSION INSTRUCTIONS: Responses from all capable and qualified sources are encouraged to respond to this request.

White papers should adhere to the following formatting and outline instructions:

1. All submissions shall be made electronically and be in one of the following formats: Microsoft Word or Adobe

PDF.

2. The following information shall be provided as part of the response to the RFI:

Cover Page (1-2 pages) o Title o Organization o Responders technical and administrative points of contact (names, addresses, phone, fax number and email addresses) o Topic area(s) addressed

One (1) Electronic Copy (pdf format) of the service manual and the operator manual

Picture of device with and without packaging

List of consumables needed for each individual patient that includes the part number, country of origin, description, cost, and picture(s)

Brief explanation of training required or offered (if any) for the operator

Brief explanation of training required or offered (if any) for the maintainer

3. Completed Attachment 1 and Attachment 2. Please note that the response shall provide sufficient technical data in order to determine how you fully meet the requirements as specified in Attachment 2.

Please note that responses are due no later than 7 April 2020. The method of submission is via email. The point of contact for this action is Rudolph Spencer at rudolph.j.spencer.civ@mail.mil. Only electronic responses will be accepted. No evaluation letters and/or results will be issued to the respondents. At this time no solicitation exists;

therefore, please do not request a copy of the solicitation. NO PHONE CALLS WILL BE ACCEPTED. It is the responsibility of any potential offeror to monitor this site for the release of any solicitation or synopsis.

9.0 SUBMISSION CONTACT INFORMATION: Interested entities shall forward submissions to Rudolph

Spencer at rudolph.j.spencer.civ@mail.mil no later than the close of business 7 April 2020.

mailto:rudolph.j.spencer.civ@mail.mil mailto:rudolph.j.spencer.civ@mail.mil