A02 Radiation Survey PWS 06102025.docx

PERFORMANCE WORK STATEMENT

Keller Army Community Hospital (KACH) West Point, New York Medical Physicist (Diagnostic Service Support)

1.0 General

This is a non-personal service requirement for Radiation Survey Service and Certification at Keller Army Community Hospital, West Point, NY. The Contractor will provide Medical Physicist Certification and Testing on radiation producing modalities on equipment listed below to maintain accreditation.

2.0 Scope of Work

Keller Army Community Hospital (KACH) West Point, NY has a requirement for an Annual Medical Physics Survey Service. The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items necessary to perform radiological equipment safety surveys and radiation use evaluations for all medical systems utilizing diagnostic radiography equipment and operation procedures as defined in this Performance Work Statement. The Contractor shall complete annual radiation safety and compliance surveys of all (medical) X-ray equipment at KACH to identify diagnostic x-ray systems that fail to comply with applicable performance standard requirements and to protect the public from unnecessary radiation hazard. The contractor shall complete required re-surveys of all (medical) X-ray equipment after said equipment undergoes repairs.

2.1 Qualified Medical Physicist meets each of the following credentials:

a. Has earned a master’s or doctoral degree in physics medical physics, biophysics, radiological physics, medical health physics, or equivalent disciplines from an accredited college or university; and

b. Has been granted certification in the specific subfield(s) of medical physics with its associated medical health physics aspects by an appropriate national certifying body and abides by the certifying body’s requirements for continuing education.

2.2 The Contractor(s) will provide Physicist Certification and Testing on radiation producing equipment at the following locations:

3.0 Scheduling of Tests and Measurements

For all routinely scheduled inspections, the Government will give at least twenty calendar day notice to the Contractor(s). Scheduling is coordinated through the Equipment Management Branch (EMB) of KACH. (This lead time is also necessary for various clinics to schedule blocks of time to make particular x-ray systems available for testing). If the Contractor require more time than thirty calendar days before testing, they should notify the EMB. The Contractor(s) should take the least time necessary for inspecting any specific device, but if a minimum period is needed, this will be conveyed to the EMB so that coordination between the EMB and clinics can take place to ensure the requested time period is available.

3.1 Special Call-Back Inspection: In some cases, due to sudden failure of x-ray equipment and subsequent repairs, it may be necessary to schedule, on short notice, a “special call-back inspection” in order to place the device back in service at the earliest possible time. In such cases, the Contractor shall provide the inspection within ten calendar days of notification.

3.2 Reporting of Defects, and Written Report Generation and Submission: The Contractor(s) shall provide the following items as noted, within the specified interval(s):

a. For all Mammography Quality Standards Act (MQSA) inspections, reports shall be made within the specified times, and specific actions required for defects found as specified by MQSA requirements. The Contractor shall notify the EMB within one business day of detecting such a deficiency.

b. When x-ray systems fail significant tests (items causing significant degraded images, unnecessary radiation exposure to patients or staff, or if uncorrected would lead to significant and expensive repairs to the equipment), the Contractor shall verbally notify the EMB immediately.

c. For tests that otherwise do not meet the above criteria, notify the EMB before the end of day, and provide the EMB with the information in the final written report.

d. Any other relevant information should be provided, in writing, to the EMB before leaving the facility.

e. All final written reports shall be submitted to the EMB within thirty calendar days of the completion of the test. The written reports submitted to the EMB shall include the summary of deficiencies, a listing of all equipment tested including description/model, serial number and equipment control number (ECN), then by unit tested the comprehensive listing of information as identified above. These written reports may be submitted electronically or in hard copy, or both, at the discretion of the Contractor.

f. When requested, the Contractor shall provide the clarification of reports within thirty calendar days of the request.

4.0 Personnel

As noted in the Scope of Work (Section 2.1), only Physicists that have been determined to be a Qualified Expert.

5.0 Federal Holidays

The following federal holidays are observed:

New Year’s Day, January 1 Martin Luther King Jr.’s Birthday, 3rd Monday in January Presidents Day, 3rd Monday in February Memorial Day, Last Monday in May Juneteeth, June 19 Independence Day, July 4 Labor Day, 1st Monday in September Columbus Day, 2nd Monday in October Veteran’s Day, November 11 Thanksgiving Day, 4th Thursday in November Christmas Day, December 25

Note: Any of the above holidays falling on a Saturday will be observed on the preceding Friday; holidays falling on a Sunday will be observed on the following Monday. Any holidays that are declared by Presidential Executive Order shall be observed in the same manner as holidays listed above. Closures of the installation due to inclement weather shall be handled in the same manner.

6.0 Specific Tasks to be Performed:

Radiation and Electromagnetic Survey. The Contractor shall schedule the survey at intervals required by State and Federal Guidelines and coordinate the date with the EMB.

6.1 The Contractor shall perform survey in accordance with the applicable States of New York, Connecticut, New Jersey and Massachusetts DHHS (respectively) and Federal Drug Administration requirements checklist.

6.2 Upon completion of the Survey, the Contractor shall provide the EMB with a verbal and written copy of the results within thirty days.

6.3 Work shall be performed at the equipment location. Equipment shall not be removed from site.

6.4 The Contractor shall complete surveys within thirty days.

6.5 The Contractor shall be responsible for all items of Government equipment throughout the period they are under control of the Contractor. The Contractor shall be responsible for contractor-caused damage to Government-owned property and shall replace or repair at the Contractor’s expense within thirty days. The Contracting Office will approve any replacements or repairs.

6.6 The Contractor shall ensure all areas where equipment is surveyed shall be left in a clean, neat, safe and orderly condition. To prevent safety hazards, no equipment shall be left pulled out or apart at the end of the workday.

6.7 The Contractor shall ensure their actions encompass contract compliance.

6.8 If the Contractor determines that the item being surveyed is not safe for use, the Chief, Equipment Management Branch, shall be notified. The Chief, EMB, will determine the appropriate action and required adjustments and repairs in accordance with US Army Directives.

7.0 Government Responsibility

7.1 For all routinely scheduled inspections, the Government will give at least twenty calendar days notice to the Contractor.

8.0 Contractor’s Responsibility

8.1 Contractor must ensure all systems be tested to the paramedics outlines in TB Med 521, Code of Federal Regulations, Title 21 Subpar J, MQSA Standards and ACR in the absence of the other standards or when other standards are outdated.

The following requirements must be met by the Contractor:

· Contractor who will inspect x-ray emitting equipment must provide documentation of their education and experience (to include a full or partial list of current facilities where they conduct tests) prior to conducting specified tests. The Equipment Management Branch will evaluate the prospective inspector’s qualifications and based on the information provided and at our sole discretion. This will be an on-going assessment and will be a basis for continued used. The successful Contractor may, at any time, submit other individuals for evaluation.

· Contractor may, at their discretion, request that personnel in training status be authorized to conduct inspections, but these inspections shall be under the direction and supervision of an individual the EMB office has authorized to conduct the tests. The Contractor must also notify the EMB of their intent to do this as documentation of existing education, training and experience may be requested before allowing them to work in a training status. Authorization is granted at the sole discretion of the Equipment Management Branch.

· For testing any modality that requires specific education, training and experience requirements, the Contractor shall submit all required documentation to prove the necessary qualifications (and resubmit documentation periodically as required).

· Current certification by recognized accrediting bodies for specified modalities shall be considered evidence of qualification to test x-ray equipment in those specified modalities.

9.0 Definitions and Acronyms:

9.1 Definitions:

9.1.1 ANNUAL: Occurring once every year.

9.1.2 BIENNIAL: Taking place every other year.

9.1.3 CONTRACTOR: A supplier or vendor awarded a contract to provide specific supplies or service to the Government. The term used in this contract refers to the prime.

9.1.4 CONTRACTING OFFICER: A person with authority to enter into, administer, and or terminate contracts, and make related determinations and findings on behalf of the government. Note: The only individual who can legally bind the government.

9.1.5 CONTRACTING OFFICER'S REPRESENTATIVE (COR): An employee of the U.S. Government appointed by the contracting officer to administer the contract. Such appointment shall be in writing and shall state the scope of authority and limitations. This individual has authority to provide technical direction to the Contractor as long as that direction is within the scope of the contract, does not constitute a change, and has no funding implications. This individual does NOT have authority to change the terms and conditions of the contract.

9.1.6 DEFECTIVE SERVICE: A service output that does not meet the standard of performance associated with the Performance Work Statement.

9.1.7 DELIVERABLE: Anything that can be physically delivered, but may include non-manufactured things such as meeting minutes or reports.

9.1.8 KEY PERSONNEL: Contractor personnel that are evaluated in a source selection process and that may be required to be used in the performance of a contract by the Key Personnel listed in the PWS. When key personnel are used as an evaluation factor in best value procurement, an offer can be rejected if it does not have a firm commitment from the persons that are listed in the proposal.

9.1.9 PHYSICAL SECURITY: Actions that prevent the loss or damage of Government property.

9.1.10 QUALITY ASSURANCE: The Government procedures to verify that services being performed by the Contractor are performed according to acceptable standards.

9.1.11 QUALITY ASSURANCE SURVEILLANCE PLAN (QASP): An organized written document specifying the surveillance methodology to be used for surveillance of contractor performance.

9.1.12 QUALITY CONTROL: All necessary measures taken by the Contractor to assure that the quality of an end product or service shall meet contract requirements.

9.1.13 SUBCONTRACTOR: One that enters into a contract with a prime contractor. The Government does not have privity of contract with the subcontractor.

9.1.14 TRIENNIEL: Recurring every three years.

9.1.15 WORK DAY: The number of hours per day the Contractor provides services in accordance with the contract.

9.1.16 WORK WEEK: Monday through Friday, unless otherwise specified.

9.2 Acronyms:

10.0 Applicable Directives/Documents: Documents applicable to this PWS are listed below and all Army publications and forms will be available from the Chief, Equipment Management Branch upon request.

10.1 Army Regulations:

· AR 40-61 Medical Logistics Policies and Procedures

· AR 190-13 Army Physical Security Program

· AR 190-51 Security of Army Property at Unit and Installation Level

10.2 Army Pamphlet: DA PAM 710-2-1 Using Supply System Manual Procedures

10.3 Code of Federal Regulation: 21 CFR Code of Federal Regulations, Title 21, Food and Drugs, Part 0800 to 1299 (includes regulations for the Administration and Enforcement of Radiation Control for Health and Safety Act of 1968) Army Forms

10.4 Other Regulatory Documents: Standards for the Joint Commission.

10.5 Forms:

· DD1150 Request for Issue or Turn-in

· DD2163 Medical Equipment Calibration/Verification

· DD2164 X-Ray Verification/ Certification Worksheet

· DD2579 Report of Assembly of a Diagnostic X-Ray System

11.0 Technical Exhibits/ Attachments

11.1 Technical Exhibit 1: Performance Requirements Summary

The Contractor service requirements are summarized into performance objectives that related directly to mission essential items. The performance threshold briefly describes the minimum acceptable levels of service required for each requirement. These thresholds are critical to mission success.

Performance Objective (The Service required—usually a shall statement)

PRS # 1.

The contractor shall provide fully certified contractor personnel.

PRS # 2

The contractor shall complete the surveys within 30 days of request.

Inspection.

PRS #3

The Contractor shall provide written survey results within 30 days of test completion

Inspection.

11.2 Technical Exhibit 2: Deliverables Schedule

Hard Copy address:

Keller Army Community Hospital 900 Washington Road West Point, NY 10996 ATTN: Equipment Management Branch, Room 2A09

are required.

11.3 Attachment: Equipment List

Fluoroscopic Unit, Portable

Fluoroscopic Unit, Portable

Fluoroscopic Unit, Portable