PWS Health Physics.pdf

PERFORMANCE WORK STATEMENT:

1. Introduction and Background: The Moncrief Army Health Clinic (MAHC) Radiology Department requests a Health Physics Survey contract. These periodic inspections are required to meet both FDA requirements, Joint Commission, and Army regulations (MEDCOM 40-42, TB MED 521), in order to assure diagnostic x-ray systems, meet technical requirements so that they provide adequate clinical images and reduce radiation exposure to patients and staff to defined or recommended limits.

2. Scope of service and list of units requiring contract service: MAHC Radiology diagnostic x-ray systems include:

• Philips Brilliance 64 Computed Tomography Unit

• GE 450 Magnetic Resonance Imaging Unit

• GE Discovery 670 Gamma Camera/SPECT

• GE Discovery 670 Computed Tomography

• GE Discovery 630 Gamma Camera/SPECT

• GE Discovery 630 Gamma Camera/SPECT

• Siemens E. Cam Gamma Camera/SPECT

• Hologic Dimensions Mammography X-ray

2.1 The number and type of diagnostic x-ray systems vary, depending on patient workload, and whether there is a resident radiation protection staff member capable of some or all the technical testing required. This contract will require that the diagnostic x-ray measurements be taken on-site in the MAHC Radiology Department on the listed devices. Note that the number and type of systems requiring inspection will likely change over time as the health care mission evolves. A listed and type of diagnostic x-ray systems is included for reference; this list does not include future requirements or replacement equipment.

3. Applicable documents: The “working level” document for most diagnostic x-ray system compliance inspections is a U.S. Army document, TB MED 521, “Management and Control of Diagnostic, Therapeutic, and Medical Research X-Ray Systems and Facilities” which implements the requirements of the Food and Drug Administration (Code of Federal Regulations, Title 21, Subpart J). For mammography, the requirements of the Mammography Quality Standards Act of 1992, as implemented by the Food and Drug Administration through the Code of Federal Regulations, Title 21, Subpart I are used, as well as American College of Radiology consensus standards.

4. Performance requirements: Specific test criteria are listed below. In some cases, specific diagnostic x-ray systems will not have full applicability to all the items listed below; this will be documented by the surveyor on the report for each diagnostic x-ray system tested.

Note, that with a few exceptions, MAHC is using digital image systems to acquire images. As of November 2018, there are no specific Army image quality-control verification standards in place for digital image systems. In the absence of applicable standards ACR (American College of Radiology) standards should be used where applicable.

At such time as an Army standard is implemented, the successful contractor(s) will be required to verify system performance against the standard.

Matrix of Inspection and Reporting Requirements for Diagnostic X-ray Systems

Measurement or Assessment Criterion

System Applicability

Expected Reporting Documentation Fi xe d Ra di og ra ph ic

M ob ile R ad io gr ap hi c

Fi xe d Fl uo ro sc op ile F lu or os co pi c

Ra di og ra ph ic

-F lu or og ra

Ra di og ra ph ic

-T om og ra am m og ra

St er eo ta ct ic

B re as t B io ps y

C om pu te d To m og ra ph y

B on e D en sit om et

D en ta l I nt ra or al

(f ix ed o r

D en ta l P an og ra ph ic

Warning Label - 21 CFR 1020.30(j) X X X X X X X X X X X X

Each item listed will have a separate “Pas Fail” (or the like) entry in the report, or fo specific instances where the item is not applicable to the make and model of the system being evaluate, a notation of “not applicable.” Each “failed” item will have concise explanation of why it failed; this be listed in the report at immediate area of the item or may be referenced and reported in a summary area of the report. As applicable, other items should be notated with concise descriptive information pertinent to the item.

For mammographic systems, include necessary information to fulfill ACR accreditation requirements.

Technique factor indication X X X X X X X X X X X Visible beam-on indication X X X X X X X X X X X X Audible exposure indication X X X X X X X X X X X Selected tube indication (if more than one tube in the device)

X

X X X X X

Cooling curves or heat calculator X X X X X X X X X X X X

Tube centering over image receptor X

X X

Means to indicate when beam axis is perpendicular to image receptor

X X X X

Exposure termination after preset time interval, mAs, or pulses

X X X X X X X X X

Source-to-Image Distance indication and accuracy X X X X

Step-less collimator X X X AEC-Phototimer indication+ X X X X

Means to terminate exposure at any time X X X X X X X X X X X X

Cumulative timer not greater than 5 minutes

X X X

Audible indicator at tube X X X

Collimator tracks vertical lR movement

Primary barrier transmission X X X

Continuous audible sound when using high-level control

Minimum SSD appropriate for device X X X X X X

Battery charge indication X Six-foot exposure cord X Light Field Illuminance Level X X X X X Report as stated in TB MED 521, including measurement values, acceptance criteria, whether this passed or failed the acceptant criteria. Add appropriate concise notation

X-ray Field Alignment X X X X X X

PBL Alignment and Functionality X

Expected Reporting Documentation items when necessary. Note whether the specific item was “not applicable” due to specific make and model of the system be evaluated.

For mammographic systems, include necessary information to fulfill ACR accreditation requirements.

Fi xe d Ra di og ra ile R ad io gr ap hi c

Fi xe d Fl uo ro sc ile F lu or os co pi c

Ra di og ra ph ic

-F lu or og ra og ra ph ic

-T om og ra m og ra eo ta ct ic

B re as t B io ps y

C om pu te d To m og ra ph y

B on e D en sit om ta l I nt ra or al

(f ix ed o r

D en ta l P an og ra ph ic

Collimation Assessment X X Timer Accuracy X X X X X X X X X X X kVp Accuracy and Reproducibility X X X X X X X X X X mA linearity X X X X X X X X X X X X Beam Quality X X X X X X X X X X X X Focal Spot Resolution X X X X Phototimer Evaluation X X X Entrance Skin Exposure X X X X X X X X X X Fulcrum height X Slice thickness X Uniformity of motion X Beam Alignment X X X High/Low Contrast values X X X Entrance Exposure Rates X X X

Primary Barrier Transmission Rate

Focal Spot Performance X X

Automatic Exposure Control (AEC) System Performance

Uniformity of Screen Speed X X

Phantom Image Quality Evaluation

Breast Entrance Exposure, Average Glandular Dose and Output Rate

Viewbox Luminance and Room Illuminance

Digital Receptor Uniformity X Localization Accuracy Test X Tube Head Leakage X X X X X X X X X X X X Include measurement values preferably on simple layout diagram of the room. Add appropriate concise notation for items when necessary. Note whether the specific item was “not applicable” due to the specific m and model of the system being evaluated. Applicable radiation protection standards, when applicable, should be stated, and if results are in excess of these standards, they should be noted.

Scatter radiation at operator's position X X X X X X X X X X X X

Scatter radiation at head of table X

Scatter radiation at foot of table X

Scatter radiation at Control Booth entry

Expected Reporting Documentation For mammographic systems, include necessary information to fulfill ACR accreditation requirements.

Fi xe d Ra di og ra ile R ad io gr ap hi c

Fi xe d Fl uo ro sc ile F lu or os co pi c

Ra di og ra ph ic

-F lu or og ra og ra ph ic

-T om og ra m og ra eo ta ct ic

B re as t B io ps y

C om pu te d To m og ra ph y

B on e D en sit om ta l I nt ra or al

(f ix ed o r

D en ta l P an og ra ph ic

Scatter radiation at boundary walls to uncontrolled areas, floor, and ceiling

Mammography-Stereotactic Breast Biopsy Unit Assembly Evaluation

Include necessary information to fulfill A accreditation requirements for the specific modality.

Artifact Evaluation

If images are obtained during testing of a system (preferably, this should be done), a concise descriptive assessment of any identified artifacts observed should be giv Any deficiencies should be noted, along w specific corrective action recommendation tha will return the program to compliance when followed.

accreditation requirements.

Site technologist’s QC Program assessment

A concise descriptive assessment of the program should be given. Any deficiency should be noted, along with specific corrective action recommendations that will return the program to compliance when followed.

accreditation requirements.

Mechanical indexing X

Report as stated in TB MED 521, including measurement values, acceptance criteria, whether this passed or failed the acceptance criteria. Add appropriate concise notation items when necessary. Note whether the specific item was “not applicable” due to specific make and model of the system be evaluated.

Table indexing X

Radiation Field Profile:

Collimation Accuracy

Gantry Tilt Accuracy X

Table Isocenter/Sagittal Alignment Light Congruence

Isocenter Alignment X

Accuracy of Scan Prescription from Scout Localization image

Image Scan Width Accuracy X

CT Number Uniformity with typical measured values

Noise X

Expected Reporting Documentation Fi xe d Ra di og ra ile R ad io gr ap hi c

Fi xe d Fl uo ro sc ile F lu or os co pi c

Ra di og ra ph ic

-F lu or og ra og ra ph ic

-T om og ra m og ra eo ta ct ic

B re as t B io ps y

C om pu te d To m og ra ph y

B on e D en sit om ta l I nt ra or al

(f ix ed o r

D en ta l P an og ra ph ic

Spatial Resolution (high and low contrast resolution)

CTDI, DLP, and Effective Dose

5. Access and General Protection/Security Policy and Procedures: This standard language text is for contractor employees with an area of performance within an Army controlled installation, facility or area. Contractor and all associated subcontractor employees shall comply with applicable installation, facility, and area commander installation and/or facility access and local security policies and procedures (provided by government representative). The contractor shall also provide all information required for background checks to meet installation access requirements to be accomplished by installation Provost Marshal Office, Director of Emergency Services, or Security Office. Contractor workforce must comply with all personal identity verification requirements as directed by DOD, HQDA and/or local policy. In addition to the changes otherwise authorized by the changes clause of this contract, should the Force Protection Condition (FPCON) at any individual facility or installation change, the Government may require changes in contractor security matters or processes.

6. Access to installations and facilities: Contractor personnel operating vehicles must have proof of current insurance and vehicle registration or a current and valid vehicle lease/rental contract. Vehicle or personal searches may be required at any time for entry, and during emergency exercises or actual emergencies, access to an installation may be restricted indefinitely with little or no notice. Access to the facility will require personal identification, as well as possible additional access requirements, including issuance of a facility identification card.

7. Personnel qualifications: The following requirements must be met by the successful contractor(s):

7.1 Personnel who will inspect x-ray emitting equipment must provide documentation of their education, training, and experience (to include a full or partial list of current facilities where they conduct tests) in order to be determined qualified to conduct specified tests. The Medical Maintenance or Health Physics Office will evaluate the prospective inspector’s qualifications and based on the information provided at our sole discretion, the prospective inspectors will either be authorized to conduct the tests or denied permission to conduct the tests. This will be an on-going assessment and will be a basis for continued use. The successful contractor(s) may, at any time, submit other individuals for evaluation.

7.2 Successful contractor(s) 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 our office has authorized to conduct the tests. The successful contractor(s) must also notify our office of their intent to do this as we may request documentation of their existing education, training, and experience before allowing them to work in a training status. At our sole discretion, we may or may not grant authorization.

7.3 For testing any modality that requires specific education, training, and experience requirements

(currently mammography and stereotactic breast biopsy) the successful contractor(s) shall submit all required documentation to prove the necessary qualifications (and resubmit documentation periodically as required). If, in the future, requirements (such as those currently required for mammography) are implemented for inspecting other modalities, the successful contractor(s) will present these qualifications to our office for review and approval by the implementing date of these requirements for the modality.

7.4 Current certification by recognized accrediting bodies (e.g. ACR) for specified modalities shall be considered evidence of qualification to test x-ray equipment in those specified modalities.

8. Scheduling of tests and measurements: For all routinely scheduled inspections, the Government will provide at least thirty calendar day notice to the contractor. Scheduling will be coordinated through the Moncrief Army Health Clinic Medical Maintenance Office (MAHCMMO) or Contracting Officer Representative (COR). (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(s) require more time than thirty calendar days before testing, they should notify the Medical Maintenance Office or the COR. The contractor shall take the least time necessary for inspecting any specific device, but if a minimum period is required, this shall be conveyed to the Medical Maintenance Office or the COR for coordination with the specific clinics.

9. “Special call-back inspection”: In some cases, due to sudden failure of x-ray equipment and subsequent repairs, it may be necessary to schedule, a short notice, “special call-back inspection” 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 by MAHCMMO or the COR.

10. Reporting of defects, and written report generation and submission: The contractor(s) shall provide the following items as noted, within the specified interval(s):

10.1 For all MQSA inspections, reports shall be made within the specified times, and specific actions required for defects found (especially breast dose and phantom image quality) as specified by MQSA requirements. Responsible personnel in the clinic, and facility medical maintenance personnel shall be verbally notified immediately of such deficiencies. The contractor shall notify the Health Physics Office one business day of detecting such a deficiency.

10.2 When x-ray systems fail significant tests (items causing significantly 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 clinic personnel of this immediately;

facility medical maintenance personnel within two hours, and the Health Physics Office within one business day.

10.3 For tests that otherwise do not meet the above criteria, notify clinic and medical maintenance personnel before the end of the current day, and provide the Health Physics Office with the information in the final written report.

10.4 Any other relevant information should be provided, in writing, to the clinic or clinical engineering personnel before leaving the facility.

10.5 All final written reports shall be submitted to the Health Physics Office, Medical Maintenance Office, and Mammography, a copy of the final written report shall be sent directly to facility, within thirty calendar days of the completion of the test. The written reports submitted to the Health Physics Office and Medical Maintenance Office shall include the summary of deficiencies, a listing of all equipment tested including description/model, location, serial number, and equipment control number, then by unit tested the comprehensive listing of information as identified above. These written reports may be submitted electronically (in Adobe Acrobat .pdf format) or in hard copy, or both, at the discretion of the contractor.

10.6 When requested, the contractor shall provide clarification of reports within thirty calendar days of the request.

11. Evaluation Criteria: The following will be used for evaluating the acceptability of a bidder, or the continued performance of a contractor:

11.1 The evaluation criteria, noted above, will be used either as a partial basis for accepting a contractor as qualified to work, and in whole to determine the ability for a contractor to continue work. No specific numeric grading will occur, only whether the requirements are met or not (essentially a “pass-fail” system).

Qualifications, experience, and presentation of example reports will receive higher weighting for new contractors. For existing contractors, reporting detail and schedule adherence will also become important review factors.

11.2 Note that in several instances, the Health Physics and/or Medical Maintenance Office retains the right to authorize or prevent any individual from conducting any of the tests listed, in part or in whole. The Regional Health Physics Consultant makes this evaluation in accordance with the TB Med 521 definition of

“Qualified expert.” While the contractor may submit additional information to be reviewed, the suitability determination of the Regional Health Physics Consultant is final.

11.3 When specific qualifications are required by Federal regulation (e.g., mammography systems), and the contractor fails to meet, maintain, or is otherwise disqualified from performing these inspections in accordance with regulations or an accrediting body, the contractor shall notify the Health Physics Office immediately. The notification shall include the effective date of the disqualification.

12. Additional requirements: The following non-technical requirements are, or may be imposed, during the course of the contract:

12.1 Any information observed, overheard, recorded in data obtained, or provided in reports is “For Official Use Only” and may not be disclosed to a third party except on the written authorization of

MAHCMMO.

12.2 All contractors are expected to maintain a reasonable security posture for all information maintained in electronic format. If the information is otherwise compromised, the contractor will notify our office and MAHCMMO as soon as possible after the information breach is discovered.

12.3 All patient information is subject to the requirements of the Privacy Act of 1974, as well as the Health Insurance Portability and Accountability Act of 1996 (HIPAA). If any patient information is observed at a medical treatment facility, the contractor personnel are obligated to comply with the requirements of these laws, and not disclose this information. Contractors should contact the MACH Medical Maintenance Office or the COR for further information if needed.

12.4 A contractor has no need for and shall not record or maintain protected health information from any facility.

12.5 Contractors may be required to take and pass training required by MAHCMMO. Reimbursement for training shall be as stipulated in the contract.

Supplemental information – current “snapshot” of types and quantities of diagnostic x-ray systems (May 2025) – for planning purposes only, and subject to change

Location and Quantity Fi xe d

Ra di og ra ile R ad io gr ap hi c

Fi xe d Fl uo ro sc ile F lu or os co pi c

Ra di og ra ph ic

-F lu or og ra og ra ph ic

-T om og ra m og ra eo ta ct ic

B re as t B io ps y

C om pu te d To m og ra ph y (C

T)

B on e D en sit om ta l I nt ra or al

(f ix ed o r m ob ile

D en ta l P an og ra ph ic

D en ta l C on e

B ea m C

T

SP

EC

T/

CT

SP

EC

T

RI

Moncrief AHC / Ft. Jackson

* # # @ # # 1 @ 1 @ * * 3 1 3 1

* -- Indicates that facility has resident Health Physics personnel who normally conduct these inspections.

# -- Indicates there are not currently any of these type units at the installation.

@ -- Indicates these units may be done by the Regional Health Physics Office, or at their discretion by the contractor.

(End of PWS)

TOBACCO FREE CAMPUS

In accordance with Army Regulation 600-63, paragraph 7-3, 14 April 2015; Operations Order 15-48 (Army Medical Command (MEDCOM) Tobacco Free Living – USAMEDCOM), 8 May 2015; and any Operations Order, regulation or other instruction implementing, defining or otherwise addressing the Tobacco Free Medical Campus (TFMC) on any military installation or DoD-controlled location, Contractor personnel are prohibited from using any tobacco product on or within any TFMC while performing under this contract. TFMCs are established at each installation or DoD-controlled location and include: (1) any property or non-residential building that is operated, maintained or assigned to support medical activities, including but not limited to, hospitals, medical laboratories, outpatient clinics (including medical, dental, and veterinary facilities), or aid stations operating for the primary purpose of delivering medical care and services for DOD eligible beneficiaries and /or meeting the mission of the Army Medical Command; (2) all other facilities in which medical activities or administration take place, to include HQ MEDCOM and Defense Health Headquarters; (3) all internal roadways, sidewalks and parking lots; and (4) all sidewalks, parking lots and grounds external but adjacent to the building or related to the migratory corridors surrounding the medical facility. The Contractor shall obtain from the COR any orders, regulations, instructions or other documents implementing, defining or otherwise addressing the TFMC for any given installation or do controlled location where Contractor personnel may perform under this contract and shall instruct Contractor personnel on the TFMC limitations for installations or DoD-controlled locations where they may perform under this contract.