P01 - PWS HTME Inspection Services 2.0_20260127.docx

PERFORMANCE WORK STATEMENT (PWS)

1. TITLE OF PROJECT:

High Tech Medical Equipment (HTME) Inspection Services for the Veterans Administration Radiology and Imaging Systems Program

1.1 BACKGROUND:

The Department of Veteran Affairs (VA) purchases High Tech Medical Equipment (HTME) for radiology and imaging systems (modalities) from original equipment manufacturers (OEMs) and distributors. The equipment is delivered and installed at VA Medical Centers (VAMCs) but requires a detailed inspection and recommendation before the VA will verify the acceptance inspection. In determining if the equipment will function in accordance with OEM and VA specifications, tolerances, FDA requirements, and to ensure that the equipment will operate within all federal guidelines, the equipment must be inspected by a Qualified Medical Physicist (QMP). The resulting contract will provide the VA with a continuous source for the inspection of HTME systems listed in section 1.2 of this PWS.

1.2 SCOPE OF CONTRACT:

Contractor shall provide all necessary labor, supervision, and equipment for inspection services by a QMP for the following types of equipment modalities:

· Computed Tomography (CT)

· CT Patient Simulator (CT)

· Mobile Computed Tomography (Inside Vehicle/Trailer) (CT)

· Positron Emission Tomography/Computed Tomography (PET/CT)

· Positron Emission Tomography/Magnetic Resonance Imaging (PET/MRI)

· Single Photon Emission Computed Tomography/Computed Tomography; Magnetic (SPECT/CT)

· Single Photon Emission Computed Tomography (SPECT)

· Magnetic Resonance Imaging (MRI)

· Mammography (MAMMO)

· Mobile Mammography (Inside Vehicle/Trailer) (MAMMO)

· Fixed Radiographic System (RAD)

· Fixed Radiographic/Fluoroscopic System (RAD)

· Digital Radiograph Conversion (PACS)

· Generic (Base) Fixed C-Arm (RAD)

· Multi-Modality Fixed C-Arm (RAD)

· Multiple types of Labs to include Fluoroscopy:

· Angiography Lab (Fixed C-Arm)

· Cardiac Cath Lab (Fixed C-Arm)

· Electrophysiology Lab (Fixed C-Arm)

· Interventional Lab (Fixed C-Arm)

· Vascular Lab (Fixed C-Arm)

· Urology Lab (Fixed C-Arm)

· Lithotripter (Fixed C-Arm)

· Portable Computed Tomography (PORT CT)

· Portable Fluoroscopic System (PORT RAD)

· Portable Radiographic System (PORT RAD)

· Magnetic Resonance Imaging [Inside Vehicle/Trailer] (Mobile MRI)

These inspection services are for newly installed systems at VAMCs throughout the United States, territories, and the federal district. This contract shall not be used for periodic inspection of HTME systems already inspected and accepted. All work shall be performed in accordance with this PWS, attachments, and associated clauses and provisions.

2.0 DESCRIPTION OF SERVICES:

A. Upon request for inspection services, the contractor shall provide all necessary labor, equipment, supervision, and other resources to inspect newly installed HTME systems at the specified VA location. The VA shall require inspection services at facilities within the United States, to include inhabited territories and the federal district. For the purpose of this contract, Contiguous United States (CONUS) means the 48 contiguous States and the District of Columbia. Outside the Contiguous United States (OCONUS) is defined as States and territories that are not part of the continental United States such as Hawaii, Alaska, Guam, Puerto Rico, America Samoa, and U.S. Saipan. The resultant contract will be used as a continuous source for the inspection services of modalities listed herein, both located in CONUS and OCONUS. Inspection services will be ordered on an as needed basis from time to time in such quantities as may be needed to fulfill any inspection requirement.

B. The Contracting Officer (CO) will issue a Task Order against the resulting contract that will detail the type of equipment to be inspected and the location where the equipment is to be inspected. The contractor shall coordinate the inspection with the facility in advance to ensure minimal disruption to the facility’s workflow. The contractor may have access to OEM proprietary information. This information shall not be shared or disclosed to any party not involved in the inspection process.

C. Upon receipt of each Task Order, the contractor shall confirm receipt of the inspection request within twenty-four (24) hours via email. All parties included within the initial Task Order distribution shall be copied on the confirmation email.

D. The Inspector shall inspect the equipment to ensure that it meets the VA’s General Specification and testing protocol requirements in addition to all OEM specifications or performance guidelines identified and all applicable Federal Government safety and performance requirements at 21 CFR Chapter I, Subchapter J, and the Diagnostic X-ray Performance Standards for Electronic Products. Specific regulations under "Diagnostic x-ray systems and their major components" (21 CFR 1020.30), "Radiographic equipment" (21 CFR 1020.31), "Fluoroscopic equipment" (21 CFR 1020.32), and "Computed tomography (CT) equipment" (21 CFR 1020.33). These regulations cover the manufacturing, importing, and installation of equipment that emits electronic product radiation to achieve its intended purpose or as a byproduct of meeting its intended purpose.

E. Inspection Report templates shall be provided for each modality listed in Section 1.2 with submission of initial proposal. The VA may approve these templates after the time of a contract award or request revisions as deemed necessary. Only the CO may request changes to these reports, and only approved report templates may be used for inspection under this contract. Approved report templates are subject to change during the contract period as required by the CO. If requested, the contractor shall provide a revised template to the CO within 72 hours.

F. Inspection report templates shall verify acceptance inspection and make a recommendation for government acceptance or rejection of the equipment. The attachments provided for each modality shall be followed. Each inspection report shall include information on each item or guideline listed. Inspection report templates shall, at minimum, include the following criteria:

1. The testing guidelines utilized.

2. The type of equipment inspected.

3. The inspecting equipment utilized.

4. Any deficiencies with the equipment and any adjustment required to equipment tolerances.

5. Any other problems with the equipment’s performance.

6. Verification that all items ordered delivery order and any subsequent modifications have been delivered and installed.

7. Clearly identify the Task Order and Delivery Order number.

G. A list of all QMP’s who will be performing these Inspection Testing Services must be provided to the CO with submission of initial proposal. The offeror must submit a resume or curriculum vitae (CV) for each of the QMP’s to perform inspections under the contract. The CO must approve these personnel before they will be allowed to perform inspections under the contract. During performance of the contract, only CO approved personnel may perform inspections. During contract performance, if the contractor wishes to revise (add or remove personnel) from their list of QMP’s, they must submit a request in writing to the CO for approval. This request shall be accompanied by a resume or CV for any additions to the list. New personnel must be approved by the CO before they are authorized to perform any inspections.

3.0 PERFORMANCE PERIOD:

A. This contract shall have a one-year ordering period with four one-year option periods.

B. The contractor will not be required to provide services on the following recognized Federal Holidays:

Independence Day

4.0 TECHNICAL & REPORTING REQUIREMENTS:

A. Qualified Medical Physicists (QMP):

1. Must be board certified in Diagnostic Radiology Physics by the American Board of Radiology and in Diagnostic Imaging Physics by the American Board of Medical Physics, or they must meet the following requirements:

2. Possess a Master’s or Doctoral degree in physics, medical physics, biophysics, radiological physics, medical health physics, or an equivalent discipline physical science or engineering discipline from an accredited institution or hold an equivalent degree from an accredited college or university,

3. Possess certification in a relevant subfield(s) of medical physics and its associated medical health physics aspects from an appropriate national certifying body, and

4. Comply with the continuing education requirements of that certifying body,

5. Possess a minimum of three years of documented experience in a clinical CT environment,

6. Possess a contractors confirmation of competency for each modality in section 1.2.

B. All inspection services must be completed at a mutually agreed upon time and date between the Contractor and the facility within the timeframe specified in the Task Order. If no specific timeframe is stated within the Task Order, the contractor has 30 days from the Task Order award date to complete the inspection and submit the inspection report to the government. Inspection reports must be submitted to the government by replying to all recipients in the original Task Order distribution email and be received by the government within 30 days of the Task Order award date, unless otherwise stated within the Task Order. Inspection reports shall be submitted to the government within 10 days of the inspection date.

C. All equipment to be used for inspection testing services shall be calibrated and certified for use. This equipment is subject to inspection by local biomedical engineers at the VAMC.

D. Contractor personnel shall wear and properly display a visible “Contractor Badge” identification at all times while on the premises of the VA property.

E. Contractor shall park in the appropriate designated parking areas. Contractor may receive parking information from the VA’s point of contact at the respective VAMC. The VAMC will not invalidate or make reimbursement for parking violations of the contractor under any conditions. Smoking is prohibited on all VA properties, including parking areas. Possession of weapons is prohibited on VA property. Enclosed containers, including tool kits, shall be subject to search. Violations of VA regulations may result in citation answerable in the United States (Federal) District Court, not a local district, state, or municipal court.

5.0 QUALITY ASSURANCE:

A. The contractor’s Quality Control Plan (QCP) shall be submitted with their initial quote and be approved by the CO prior to commencement of services. The approved QCP will be monitored periodically by the CO to address any issues or concerns. Any issues or concerns with the original QCP shall be addressed by the CO prior to commencement of services. Failure to submit a QCP with the initial quote may eliminate the offeror from consideration.

B. The contractor is responsible for the quality of all work performed. The contractor shall measure their quality of work through the contractor’s CO approved QCP for all work performed. The contractor’s QCP will set forth the procedures for ensuring all Performance Standards listed in the 6.0 Performance Standards section below are met. The contractor will develop and implement a performance management system with processes to assess and report its performance to the Contracting Officer. All Performance Standards shown in the section below must be captured and monitored on the QCP.

C. The QCP shall include a section which tracks customer complaints, implemented remedies, and records the resolution of complaints and/or issues within seven (7) calendar days of receipt of notification. Each customer complaint or issue shall be given a unique tracking number and must be retained by the contractor for the entire duration of the contract. This retained record must include all information relevant to the complaint (i.e., name of VA representative which made complaint, date, and time of receipt of complaint, name(s) of contractor personnel involved in complaint and its resolution, remedies taken to resolve, and resolution/closeout of complaint/issue). Compliance with this section shall be evaluated by the CO on an annual basis.

D. The CO shall monitor quality and performance through monthly, annual, and random inspections. The CO will ensure results are shared with the contractor and uploaded to contract file.

E. The contractor shall maintain a copy of the most current QCP and provide a copy of it to the CO upon request. The Contractor shall update or revise the QCP upon request of the CO at no additional cost to the government.

6.0 PERFORMANCE STANDARDS:

A. The contractor shall maintain performance standards in accordance with the Performance Standards table below.

B. The contractor shall immediately notify the CO of any disruptions or delays that will prevent completion of the inspection within the task order’s timeframe. This notification shall be in writing and include:

1. The reason for the delay,

2. The expected duration of the delay,

3. Any mitigating factors associated with the delay, and

4. The projected completion date.

7.0 PHYSICAL & INFORMATION SECURITY:

A. The VA will provide reasonable access to the systems and equipment to be inspected. Inspection services must be scheduled in advance with the VAMC, and the OEM of the system or equipment must also be invited to attend.

B. Contractor personnel will not have access to patient records or VA information systems. VAMC personnel will escort contractor personnel to testing location.

C. In the case of systems serving patient care areas, it may not be possible to inspect a given system on a particular day because of clinical reasons. VAMC’s are requested to provide a minimum of 48 hours’ notice to the contractor when it is necessary to reschedule. Should this occur, the inspection will be rescheduled by the contractor and facility. The inspection will be performed by the contractor at a later date at no additional cost to the Government.