PWS Radioloty Equipment Services Jun 24 Draft.docx

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Attached to
Radiology Equipment Services / Physicist Survey Federal contract opportunity
Solicitation number
W9114F24Q0065
Issued by
Department of the Army Medical Command

About this file

This document is a Performance Work Statement (PWS) for Radiology Equipment Services/Medical Health Physicist Survey services to be provided to Martin Army Community Hospital in Fort Moore, Georgia.

The key details are: The contractor shall provide inspection, annual radiation safety evaluation (survey) support, repairs, software upgrades, and certified health physicist services for radiology, dental and nuclear medicine equipment. Services must meet or exceed standards established by the Joint Commission, American College of Radiology, FDA, OSHA, and Army regulations. The contractor must have a master's degree and be board certified/eligible in medical physics. The contract is for a base year with four option years. Scheduling of services must be coordinated with the facility at least 30 days in advance. The contractor is required to follow federal security protocols, provide quality control, and submit required reports within 30 days of inspection. The government will conduct quality assurance surveillance on the contractor's performance.

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PERFORMANCE WORK STATEMENT

Radiology Equipment Services / Medical Health Physicist Survey

SECTION C.1 GENERAL

C.1.1. Description of Work. The Contractor shall furnish all necessary travel, labor, materials, tools, parts required for inspection, annual radiation safety evaluation (survey) support, repairs, software upgrades, and certified health physicist for radiology, dental and nuclear medicine physics testing. Services shall be performed at Martin Army Community Hospital, Fort Moore, Georgia 31905-5637 as directed by the Contracting Officer’s Representative (COR).

C.1.2 Performance Measures. This contract shall cover the base period of Date of Award through ONE YEAR plus four (4) option years, in accordance with all terms, conditions, provisions, schedules, and specifications of this solicitation.

C.1.2.1. Outcome. The Contractor shall perform inspections, testing and annual radiological physics surveys as required by Joint Commission (JC), the American College of Radiology (ACR), Food & Drug Administration (FDA) Occupational Safety & Health Administration (OSHA), Army Regulations (MEDCOM 40-42, TB MED 521) and Code of Federal Regulations Title 21 Subpart J that meet or exceed current standards established by JC, ACR, FDA, OSHA.

C.1.2.2. Standards. Services shall be performed by Contractor who is board certified in Diagnostic Radiology by the American Board of Radiology or equivalent in the appropriate disciplines of radiologic physics, including diagnostic, therapeutic, and/or medical nuclear physics or equal, who demonstrates competency in these disciplines. Certification is to be submitted with proposal.

C.1.2.3. How Measured. The Contractor shall furnish annual radiographic surveys as indicated noting a separate “Pass-Fail” entry in the report, or for specific instances where the item is not applicable to the make and model of the system being evaluated, a notation of “N/A” (not applicable). Each failed item shall have a concise explanation of why it failed. For mammography systems, contractor shall include necessary information to fulfill ACR accreditation requirements. The MTFs, DENTAC and VTFs all use digital image systems to acquire images. Performance requirements shall be in accordance with the ACR standards.

C. 1.2.4. Qualifications. Matrix of Inspection and Reporting for Diagnostic X-Ray Systems and Measurement of Assessment Criterion are identified at Technical Exhibit A.

C.1.2.5. For all routine scheduled inspections, the Contractor shall have at least thirty calendar days’ notice to schedule site-visit. Scheduling shall be coordinated with the COR/Radiology Administrator/Radiology NCOIC at all times prior to notification of site visit to the requiring facility.

C.1.3 PERSONNEL QUALIFICATIONS.

C.1.3.1. Degree/Education: master’s degree Graduate from a college in medical physics, radiological physics, health physics, or physics accredited by the Commission on Accreditation of Medical Physics Education Programs, Inc (CAMPEP)

C.1.3.2. Certifications: Board eligible or board certified in diagnostic medical physics or nuclear medical physics or therapeutic medical physics form the American Board of Radiology of medical health physics from the American Board of Medical Physics (ABMP). •Experience: Three (3) years of experience as a Medical Physicist after graduation.

C.1.3.3. Board Certification: See Certifications above.

C.1.3.4. Licensure/Registration: None

C.1.3.5. Credentialing Package for Non-Privileged HCWs: The Contractor shall provide a complete, current, and accurate credentialing packages for Ancillary Services within 30 days before HCW placement.

C.1.3.5.1. Personnel responsible for the inspection of x-ray emitting equipment shall provide documentation of their education, training, and experience to include a full or partial list of current facilities where they conduct tests to be determined qualified to conduct specified tests. The Health Physics Office will evaluate the prospective inspector qualifications and based on the information provided and at our discretion, the prospective inspector (s) 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 shall at any time submit other individuals for evaluation.

C.1.3.5.2. The 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 authorized to conduct the tests. The contractor shall also notify the Health Physics Officer/COR/MTF Radiology Administrator of their intent to use individuals in training status prior using such individual. At the Government’s discretion we may or may not grant authorization.

C.1.3.5.3. For testing any modality that requires specific education, training and experience requirements shall be current, i.e., mammography and stereotactic breast biopsy. The contractor shall submit all required documentation to prove the necessary qualifications and resubmit documentation periodically as required.

C.1.4 PHYSICAL SECURITY.

C.1.4.1 HCWs shall be subject to the following additional security investigative processes, to include appointments with Security Managers: Darrell B. Beasley, darrell.b.beasley.civ@health.mil 762-408-0308

C.1.4.2. The contractor representative(s) dispatched to the MTF shall report upon arrival to MACH to the Security Office to receive a Visitor badge which shall be worn for the duration of their stay on campus. The Visitor badge shall be turned in to the MACH Security office upon leaving the facility when the inspection is completed.

C.1.4.3. Access to Installation and Facilities: Contractor personnel are required to meet military installation access requirements. This includes personal identification (i.e., a valid current driver’s license or other U.S. state government issued identification), and for vehicle operators, having 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 individual facilities will require personal identification, as well as possible additional access requirements, including issuance of a facility identification card.

C.1.5 QUALITY CONTROL.

C.1.5.1 The contractor shall establish and maintain a complete Quality Control Plan to ensure that the requirements of the contract are provided as specified at Technical Exhibit A.

C.1.6 QUALITY ASSURANCE. The government will evaluate the contractor’s performance under this contract using the method of surveillance specified in the Quality Assurance Surveillance Plan (QASP) at Technical Exhibit B. All surveillance observations will be recorded by the government. When an observation indicated defective performance, the COR will obtain the contractor’s initials on the record of observation.

C.1.7 HOUR OF OPERATION.

C.1.7.1 Normal Hours. Although MACH Department of Radiology is a facility that operates 24 hours, the Department will only be available for survey inspections during the hours of 0730 to 1700 Monday through Friday. The facility observes all Federal Holidays as follows:

January 1New Year’s Day
3rd Monday in JanMartin Luther King, Jr. Birthday
3rd Monday in FebPresidents Day
Last Monday in MayMemorial Day

Monday in June closest to 19 June Juneteenth July 4th Independence Day

1st Monday in SepLabor Day
2nd Monday in OctColumbus Day

November 11th Veterans Day 4th Thursday in Nov Thanksgiving December 25th Christmas Day

The facility also observes various Minimal Manning Days, when there will be reduced staff, in conjunction with Federal Holidays.

MACH observed Minimal Manning Days are updated annually. Contact the COR for the current list of observed Minimal Manning Days.

C.1.7.2. For all routine scheduled inspections, the Contractor shall have at least thirty calendar days’ notice to schedule site-visit. Scheduling shall be always coordinated with the MTF Radiology Administrator prior to notification of site visit to the requiring facility.

C.1.7.2.1. Scheduling of compliance testing shall be conducted at times to be mutually agreed upon by MTF Radiology Administrator. A written report of this survey and evaluation shall be submitted to the MTF Radiology Administrator, no later than 30 days after survey completion. For all equipment requiring corrective action, or special call-back inspection, the MTF Radiology Administrator will coordinate with the contractor for necessary repairs, inspections and/or adjustments as needed. In such cases, the contractor shall provide the inspection within ten calendar days of notification by MTF Radiology Administrator.

C.1.7.2.2. Special Call -Back Inspections. 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” to place the equipment back in service at the earliest possible time. In such cases, the contractor shall provide the inspection within ten calendar days of notification by the Health Physics Officer/COR/MTF Radiology Administrator.

C.1.7.3. Emergency Services. The contractor shall be able to provide and comply with a 24-hour emergency, urgent on-site response when required.

C.1.8. CONSERVATION OF UTILITIES. The contractor will be required to participate in government energy conservation programs.

SECTION C.2 DEFINITIONS

C.2.1STANDARD DEFINITIONS

C.2.1.1. Contracting Officer (KO): A person duly appointed with the authority to enter into and administer contracts on behalf of the U.S. Government.

C.2.1.2. Contracting Officer Representative (COR): An individual designated by the contracting officer to act as his representative to assist in the administering a contract. The source and authority for a COR are contained in the written letter of designation.

C.2.1.3. Customer Complaint: A means of documenting certain kinds of contract service problems. A government program that is explained to every organization that receives service under this contract which is used to evaluate contractor’s performance.

C.2.1.4. Defective Performance: A service output that does not meet the standard of performance associated with it in the Performance Requirements Summary (PRS).

C.2.1.5. Government Property: All property owned or leased to the government or acquired by the government under the terms of the contract. Government property includes both government furnished property and contractor acquired property as defined in the Federal Acquisition Regulation (FAR) 45.101.

C.2.1.6. Performance Requirements Summary (PRS): Identifies the key service outputs of the contract that will be evaluated by the government to assure contract performance standards are met by the contractor.

C.2.1.7. Quality Assurance (QA): Those actions taken by the government to assure services meet the requirements of the Performance Work Statement (PWS) and all other service outputs.

C.2.1.8. Quality Assurance Surveillance Plan (QASP): An organization written document used for the quality assurance surveillance. The document contains specific methods to perform surveillance of the contractor.

C.2.1.9. Quality Control (QC): Those actions taken by a contractor to control the performance of services so that they meet the requirement of the PWS.

SECTION C.3. GOVERNMENT FURNISHED PROPERTY AND SERVICES

C.3.1 The government property made available under this contract shall be for use only in the performance of the resulting contract.

SECTION C.4. CONTRACTOR FURNISHED ITEMS AND SERVICES

C.4.1 The contractor shall provide all labor and equipment necessary to perform the required services.

C.4.2. Additional Requirements: Non-Technical Information.

Any information observes, overhead, recorded in data obtained, or provided in reports is “FOR OFFICIAL USE ONLY” and shall not be disclosed to a third party except on the written authorization of the Government, i.e., COR or the Contracting Officer or their assignee.

All contractors and or employees are expected to maintain a reasonable security posture for all information maintained in electronic format. If there is a breach in such information the contractor is responsible for notifying the Health Physics Officer/COR and Contracting Officer of such discovery.

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), Updated versions. If a 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 in accordance with the HIPAA Act (June 2012).

SECTION C.5. SPECIFIC TASKS

C.5.1 Contractor Representative Duties: The duties for the Contractor Representative are as follows:

Core Duties: Maintain calibration of all contracted machines and radiation sources according to accepted industry protocols and practices. Provide clinical expertise for acceptance testing, commissioning, calibration, and periodic quality assurance of contracted equipment. Measure and analyze bean data for contracted machines and assure that beam and source data are correctly entered into system and beam data is tabulated in a form that usable by technologists. Perform and direct the determination of radiation dose distributions for patients. Meet radiation monitoring requirements, quality assurance, and safety requirements to ensure compliance with federal and Army requirements, hospital radiation safety regulations, and national standards of performance. Inspect contracted machines to include computerized tomographic (CT) units, magnetic resonance (MRI) units, mammography units, stereotactic biopsy units, gamma cameras, SPECT CT cameras, cone bean CT units, bone densitometer(s), multiple fluoroscopy units, multiple C-Arm units, multiple mini-C-Arm units, and any other additional units at the contract site according to acceptable standards and guidelines.

C.5.2. The contractor representatives dispatched to the MTF shall complete equipment inspections according to accepted standards for imaging equipment to include tasks listed in the matrix of inspection and reporting requirements as listed in EXHIBIT A and as included in typical Performance Testing Reports from professional Medical Physicist Services.

C.5.3. The contractor shall send the final Medical Physicist Services report AND the most current, updated Curriculum Vitae of the Certified Medical Physicist who performed the inspection of the equipment inspection to the Radiology Administrator within 30 days of the completed inspection. The final report shall include the following sections:

a. Summary of Deficiencies, Recommendations and Comments
b. Physics Survey Report
c. Certificate of Services
d. Curriculum Vitae (CV) for the medical Physicist who performed the survey

C.5.4. The Contractor’s reporting of defects, and written report generation and submission shall include all MQSA inspections, reports shall be made within the specified times, and specific actions required for defects found as specified by MQSA requirements. Contractor shall provide notification to the MTF Radiology Administrator one business day of detecting deficiencies in equipment and provide immediate verbal and written notification to the onsite facility clinic personnel of such deficiencies.

C.5.5. All final written reports shall be submitted to the MTF Radiology Administrator, and for mammography, a copy of the final written report shall be sent directly to facility, within thirty calendar days of the completion of the test. Reports submitted to the MTF Radiology Administrator shall include summary of deficiencies, a list of all equipment tested including description/model, location, serial number, and equipment control number. Reports shall be submitted electronically in Adobe.pdf format AND in hard copy. When requested, the contractor shall provide clarification of reports within thirty calendar days of the request.

C.5.6. Billing for Services: The Contractor will only be paid for each survey completed via WAWF.

SECTION C.6 APPLICABLE PUBLICATION AND FORMS

C.6.1. Army Regulation MEDCOM 40-42

C.6.2. TB MED 521

C.6.3. Code of Federal Regulations Title 21 Subpart J, Mammography Quality Standards Act (MQSA) C.6.4. Joint Commission on Accreditation of healthcare Organizations C.6.5. American College of Radiology (ACR) C.6.6. Occupational Safety & Health Administration (OSHA)

SECTION C.7 REPORTS AND CLAUSES

C.7.1 Contractor Manpower Reporting (CMR) ACCOUNTING FOR CONTRACT SERVICES-The Office of the Assistant Secretary of the Army (Manpower & Reserve Affairs) operates and maintains a secure Army data collection site where the contractor will report ALL contractor manpower (including subcontractor manpower) required for performance of this contract. The contractor is required to completely fill in all the information in the format using the following web address: https://cmra.army.mil. The required information includes: (1) Contracting Office, Contracting Officer, Contracting Officer’s Technical Representative; (2) Contract number, including task and delivery order number; (3) Beginning and ending dates covered by reporting period; (4) Contractor name, address, phone number, e-mail address, identity of contractor employee entering data; (5) Estimated direct labor hours (including sub-contractor); (6) Estimated direct labor dollars paid this reporting period (including sub-contractor); (7) Total payments (including subcontractor); (8) Predominant Federal Service Code (FSC) reflecting services provided by contractor (and separate predominant FSC for each sub-contractor if different); (9) Organizational title associated with the Unit Identification Code (UIC) for the Army Requiring Activity (the Army Requiring Activity is responsible for providing the contractor with its UIC for the purposes of reporting this information); (10) Locations where contractor and subcontractors perform the work (specified by zip code in the United States and nearest City, Country, overseas location, using standardized nomenclature provided on website); (11) Presence of deployment or contingency contract language, and, (12) Number of contractor and sub-contractor employees deployed in theater this reporting period (by country). (13) As part of its submission, the contractor will also provide the estimated total cost (if any) incurred to comply with this reporting requirement. Reporting period will be the period of performance not to exceed 12 months ending September 30 of each government fiscal year and must be reported by 31 October of each calendar year. The contractor shall notify the Contracting Officer’s Representative (COR) by the 5th working day of November whether or not they have completed this report. If the COR is unavailable, the contractor will notify the Contracting Officer."

C.7.2. HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT (June 2012) In accordance with DoD 6025.18-R “Department of Defense Health Information Privacy Regulation,” January 24, 2003, the Contractor meets the definition of Business Associate. Therefore, a Business Associate Agreement is required to comply with both the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security regulations. This clause serves as that agreement whereby the Contractor agrees to abide by all applicable HIPAA Privacy and Security requirements regarding health information as defined in this clause, and in DoD 6025.18-R and DoD 8580.02-R, as amended. Additional requirements will be addressed when implemented.

(a) Definitions. As used in this clause generally refer to the Code of Federal Regulations (CFR) definition unless a more specific provision exists in DoD 6025.18-R or DoD 8580.02-R.

Individual has the same meaning as the term “individual” in 45 CFR 160.103 and shall include a person who qualifies as a personal representative in accordance with 45 CFR 164.502(g).

Privacy Rule means the Standards for Privacy of Individually Identifiable Health Information at 45 CFR part 160 and part 164, subparts A and E.

Protected Health Information has the same meaning as the term “protected health information” in 45 CFR 160.103, limited to the information created or received by the Contractor from or on behalf of the Government pursuant to the Contract.

Electronic Protected Health Information has the same meaning as the term “electronic protected health information” in 45 CFR 160.103.

Required by Law has the same meaning as the term “required by law” in 45 CFR 164.103.

Secretary means the Secretary of the Department of Health and Human Services or his/her designee.

Security Rule means the Health Insurance Reform: Security Standards at 45 CFR part 160, 162 and part 164, subpart C.

Terms used, but not otherwise defined, in this Clause shall have the same meaning as those terms in 45 CFR 160.103, 160.502, 164.103, 164.304, and 164.501.

(b) The Contractor shall not use or further disclose Protected Health Information other than as permitted or required by the Contract or as Required by Law.

(c) The Contractor shall use appropriate safeguards to prevent use or disclosure of the Protected Health Information other than as provided for by this Contract.

(d) The Contractor agrees to use administrative, physical, and technical safeguards that reasonably and appropriately protect the confidentiality, integrity, and availability of the electronic protected health information that it creates, receives, maintains, or transmits in the execution of this Contract.

(e) The Contractor shall, at their own expense, take action to mitigate, to the extent practicable, any harmful effect that is known to the Contractor of a use or disclosure of Protected Health Information by the Contractor in violation of the requirements of this Clause. These mitigation actions will include as a minimum those listed in the TMA Breach Notification Standard Operating Procedure (SOP), which is available at: http://www.tricare.mil/tma/privacy/breach.aspx.

(f) The Contractor shall report to the Government any security incident involving protected health information of which it becomes aware.

(g) The Contractor shall report to the Government any use or disclosure of the Protected Health Information not provided for by this Contract of which the Contractor becomes aware.

(h) The Contractor shall ensure that any agent, including a subcontractor, to whom it provides Protected Health Information received from, or created or received by the Contractor, on behalf of the Government, agrees to the same restrictions and conditions that apply through this Contract to the Contractor with respect to such information.

(i) The Contractor shall ensure that any agent, including a subcontractor, to whom it provides electronic Protected Health Information, agrees to implement reasonable and appropriate safeguards to protect it.

(j) The Contractor shall provide access, at the request of the Government, and in the time and manner reasonably designated by the Government to Protected Health Information in a Designated Record Set, to the Government or, as directed by the Government, to an Individual to meet the requirements under 45 CFR 164.524.

(k) The Contractor shall make any amendment(s) to Protected Health Information in a Designated Record Set that the Government directs or agrees to pursuant to 45 CFR 164.526 at the request of the Government, and in the time and manner reasonably designated by the Government.

(l) The Contractor shall make internal practices, books, and records relating to the use and disclosure of Protected Health Information received from, or created or received by the Contractor, on behalf of the Government, available to the Government, or at the request of the Government to the Secretary, in a time and manner reasonably designated by the Government or the Secretary, for purposes of the Secretary determining the Government’s compliance with the Privacy Rule.

(m) The Contractor shall document such disclosures of Protected Health Information and information related to such disclosures as would be required for the Government to respond to a request by an Individual for an accounting of disclosures of Protected Health Information in accordance with 45 CFR 164.528.

(n) The Contractor shall provide to the Government or an Individual, in time and manner reasonably designated by the Government, information collected in accordance with this Clause of the Contract, to permit the Government to respond to a request by an Individual for an accounting of disclosures of Protected Health Information in accordance with 45 CFR 164.528.

General Use and Disclosure Provisions Except as otherwise limited in this Clause, the Contractor may use or disclose Protected Health Information on behalf of, or to provide services to, the Government for treatment, payment, or healthcare operations purposes, in accordance with the specific use and disclosure provisions below, if such use or disclosure of Protected Health Information would not violate the HIPAA Privacy Rule, the HIPAA Security Rule, DoD 6025.18-R or DoD 8580.02-R if done by the Government.

Specific Use and Disclosure Provisions

(a) Except as otherwise limited in this Clause, the Contractor may use Protected Health Information for the proper management and administration of the Contractor or to carry out the legal responsibilities of the Contractor.

(b) Except as otherwise limited in this Clause, the Contractor may disclose Protected Health Information for the proper management and administration of the Contractor, provided that disclosures are required by law, or the Contractor obtains reasonable assurances from the person to whom the information is disclosed that it will remain confidential and used or further disclosed only as required by law or for the purpose for which it was disclosed to the person, and the person notifies the Contractor of any instances of which it is aware in which the confidentiality of the information has been breached.

(c) Except as otherwise limited in this Clause, the Contractor may use Protected Health Information to provide Data Aggregation services to the Government as permitted by 45 CFR 164.504(e)(2)(i)(B).

(d) Contractor may use Protected Health Information to report violations of law to appropriate Federal and State authorities, consistent with 45 CFR 164.502(j)(1).

Obligations of the Government Provisions for the Government to Inform the Contractor of Privacy Practices and Restrictions

(a) The Government shall provide the Contractor with the notice of privacy practices that the Government produces in accordance with 45 CFR 164.520.

(b) The Government shall provide the Contractor with any changes in, or revocation of, permission by Individual to use or disclose Protected Health Information, if such changes affect the Contractor’s permitted or required uses and disclosures.

(c) The Government shall notify the Contractor of any restriction to the use or disclosure of Protected Health Information that the Government has agreed to in accordance with 45 CFR 164.522.

Permissible Requests by the Government The Government shall not request the Contractor to use or disclose Protected Health Information in any manner that would not be permissible under the HIPAA Privacy Rule, the HIPAA Security Rule, or any applicable Government regulations (including without limitation, DoD 6025.18-R and DoD 8580.02-R) if done by the Government, except for providing Data Aggregation services to the Government and for management and administrative activities of the Contractor as otherwise permitted by this clause.

Termination

(a) Termination. A breach by the Contractor of this clause, may subject the Contractor to termination under any applicable default or termination provision of this Contract.

(b) Effect of Termination.

(1) If this contract has records management requirements, the records subject to the Clause should be handled in accordance with the records management requirements. If this contract does not have records management requirements, the records should be handled in accordance with paragraphs (2) and (3) below

(2) If this contract does not have records management requirements, except as provided in paragraph (3) of this section, upon termination of this Contract, for any reason, the Contractor shall return or destroy all Protected Health Information received from the Government, or created or received by the Contractor on behalf of the Government. This provision shall apply to Protected Health Information that is in the possession of subcontractors or agents of the Contractor. The Contractor shall retain no copies of the Protected Health Information.

(3) If this contract does not have records management provisions and the Contractor determines that returning or destroying the Protected Health Information is infeasible, the Contractor shall provide to the Government notification of the conditions that make return or destruction infeasible. Upon mutual agreement of the Government and the Contractor that return or destruction of Protected Health Information is infeasible, the Contractor shall extend the protections of this Contract to such Protected Health Information and limit further uses and disclosures of such Protected Health Information to those purposes that make the return or destruction infeasible, for so long as the Contractor maintains such Protected Health Information.

Miscellaneous

(a) Regulatory References. A reference in this Clause to a section in DoD 6025.18-R, DoD 8580.02-R, Privacy Rule or Security Rule means the section currently in effect or as amended, and for which compliance is required.

(b) Survival. The respective rights and obligations of Business Associate under the “Effect of Termination” provision of this Clause shall survive the termination of this Contract.

(c) Interpretation. Any ambiguity in this Clause shall be resolved in favor of a meaning that permits the Government to comply with DoD 6025.18-R, DoD 8580.02-R, the HIPAA Privacy Rule or the HIPAA Security Rule.

EXHIBIT A

MATRIX OF INSPECTION REQUIREMENTS

The following performance Matrix of Inspection and Reporting Requirements for Diagnostic X-ray System are required on this TO:

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

Measurement or Assessment Criterion System Applicability

Expected Reporting Documentation

Fixed Radiographic
Mobile Radiographic
Fixed Fluoroscopic
Mobile Fluoroscopic
Radiographic-Fluorographic
Radiographic-Tomographic
Mammographic
Stereotactic Breast Biopsy
Computed Tomography
Bone Densitometer
Dental Intraoral (fixed or mobile)
Dental Panographic, Cephalometric, Pan- Ceph
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 “Pass-Fail” (or the like) entry in the report, or for 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 a concise explanation of why it failed; this may 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

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

Tube centering over image receptor

Means to indicate when beam axis is perpendicular to image receptor

Exposure termination after preset time interval, mAs, or pulses

Source-to-Image Distance indication and accuracy

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

Cumulative timer not greater than 5 minutes

Audible indicator at tube

X
X
X

Collimator tracks vertical lR movement

Primary barrier transmission

X
X
X

System Applicability

Fixed Radiographic
Mobile Radiographic
Fixed Fluoroscopic
Mobile Fluoroscopic
Radiographic-Fluorographic
Radiographic-Tomographic
Mammographic
Stereotactic Breast Biopsy
Computed Tomography
Bone Densitometer
Dental Intraoral (fixed or mobile)
Dental Panographic, Cephalometric, Pan- Ceph

Continuous audible sound when using high- level control

Minimum SSD appropriate for device

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, and whether this passed or failed the acceptance criteria. Add appropriate concise notation for items when necessary. Note whether the specific item was “not applicable” due to the specific make and model of the system being evaluated.

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

X-ray Field Alignment
X
X
X
X
X
X
PBL Alignment and Functionality
X
X
X

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

X
X
X

Focal Spot Performance

X
X

Automatic Exposure Control (AEC) System Performance

Uniformity of Screen Speed

X
X

System Applicability

Fixed Radiographic
Mobile Radiographic
Fixed Fluoroscopic
Mobile Fluoroscopic
Radiographic-Fluorographic
Radiographic-Tomographic
Mammographic
Stereotactic Breast Biopsy
Computed Tomography
Bone Densitometer
Dental Intraoral (fixed or mobile)
Dental Panographic, Cephalometric, Pan- Ceph

Phantom Image Quality Evaluation

X
X

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 a 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 make 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, this should be noted.

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

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

X

X
X
X
X
X
Scatter radiation at foot of table
X

X

X
X
X
X
X

Scatter radiation at Control Booth entry

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

Mammography- Stereotactic Breast Biopsy Unit Assembly Evaluation

Include necessary information to fulfill ACR 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 given. Any deficiencies should be noted, along with specific corrective action recommendations that will return the program to compliance when followed.

Include necessary information to fulfill ACR accreditation requirements.

System Applicability

Fixed Radiographic
Mobile Radiographic
Fixed Fluoroscopic
Mobile Fluoroscopic
Radiographic-Fluorographic
Radiographic-Tomographic
Mammographic
Stereotactic Breast Biopsy
Computed Tomography
Bone Densitometer
Dental Intraoral (fixed or mobile)
Dental Panographic, Cephalometric, Pan- Ceph

Site technologist’s QC Program assessment

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

Include necessary information to fulfill ACR accreditation requirements.

Mechanical indexing

X

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

Spatial Resolution (high and low contrast resolution)

CTDI, DLP, and Effective Dose

X

EXHIBIT B

DELIVERABLES

Deliverable
Frequency
# of

Copies

Medium/Format
Submit To

Key Personnel List

NLT 30 business days of TO award

Electronic copy via email Radiology Administrator & MACH Health Physics Officer

Initial Placement of Physicists: Qualifying Documentation (i.e., qualifying package; credentialing package)

NLT 30 days before the required start date

Electronic copy via email Radiology Administrator & MACH Health Physics Officer

Replacement of Physicists:

Qualifying documentation (i.e., qualifying package; credentialing package) NLT 15 days after vacancy occurs for non-credentialed HCWs;

Electronic copy via email Radiology Administrator & MACH Health Physics Officer

Quality Control Plan

Within 30 days of TO award

1
Electronic copy

via email

Radiology Administrator & MACH Health Physics Officer

Complete Nuclear Medicine SPECT CT Annual Medical Physics Survey
Annual NLT 30 days past prior inspection

Electronic copy

Radiology Administrator & MACH Health Physics Officer

Complete Nuclear Medicine Gamma Cameras (2) Annual Medical Physics Survey
Annual NLT 30 days past prior inspection

Electronic copy

Radiology Administrator & MACH Health Physics Officer

Complete CT Cone Beam at Oral Surgery Clinic Annual Medical Physics Survey
Annual NLT 30 days past prior inspection

Electronic copy

Radiology Administrator & MACH Health Physics Officer

Complete CT Cone Beam at Love Dental Clinic Annual Medical Physics Survey
Annual NLT 30 days past prior inspection

Electronic copy

Radiology Administrator & MACH Health Physics Officer

Complete MRI 1.5 T Annual Medical Physics Survey
Annual NLT 30 days past prior inspection

Electronic copy

Radiology Administrator & MACH Health Physics Officer

Complete Bone Densitometer Annual Medical Physics Survey
Annual NLT 30 days past prior inspection

Electronic copy

Radiology Administrator & MACH Health Physics Officer

Complete CT Annual Medical Physics Survey
Annual NLT 30 days past prior inspection

Electronic copy

Radiology Administrator & MACH Health Physics Officer

Complete Mammography (2 FFD Units, 1 Stereotactic Unit) Annual Medical Physics Surveys Annual NLT 30 days past prior inspection

Electronic copy

Radiology Administrator & MACH Health Physics Officer

Complete MRI 3.0 T Annual Medical Physics Survey
Annual NLT 30 days past prior inspection

Electronic copy

Radiology Administrator & MACH Health Physics Officer

Complete Fluoroscopy Unit in MACH Core Annual Medical Physics Survey Annual NLT 30 days past prior inspection

Electronic copy

Radiology Administrator & MACH Health Physics Officer

Complete Fluoroscopy Unit in Urology Clinic Annual Medical Physics Survey

Annual NLT 30 days past prior inspection
1
Electronic copy
Radiology Administrator & MACH Health Physics Officer

Complete various C-Arm Units Annual Medical Physics Survey

Annual NLT 30 days past prior inspection
1
Electronic copy
Radiology Administrator & MACH Health Physics Officer

Complete various Mini-C-Arm Units Annual Medical Physics Survey

Annual NLT 30 days past prior inspection
1
Electronic copy
Radiology Administrator & MACH Health Physics Officer

EXHIBIT C

PERFORMANCE REQUIREMENTS SUMMARY (PRS)

The following performance outcome acceptable quality levels (AQLs) for minimum quality levels of service are required on this TASK ORDER:

Performance Objective Performance Standard

Acceptable Level of Performance (ALP)
Exceeds Standards
Fails to Meet Standard
Monitoring Method

1. Completed Nuclear Medicine SPECT CT Medical Physics Annual Surveys Equipment surveys performed in accordance with FDA, ACR and Army regulations (MEDCOM

40-42,TB MED 521)

Completed the inspection survey

ON THE

EXPIRATION

date of inspection.

Scheduled & completed survey WELL BEFORE expiration date of previous survey.

Completed inspection AFTER previous inspection expiration date. There was a gap between surveys.

100% MACH Rep sees survey being completed; receives completed inspection report each time task is performed

2. Completed Nuclear Medicine Gamma Cameras (2) Annual Medical Physics Survey
Equipment surveys performed in accordance with TJC, FDA, ACR and Army regulations (MEDCOM 40-42,TB MED 521)
Completed the

inspection survey

ON THE

EXPIRATION

date of inspection.

Scheduled & completed survey WELL BEFORE expiration date of previous survey.

Completed inspection AFTER previous inspection expiration date. There was a gap between surveys.

100% MACH Rep sees survey being completed; receives completed inspection report each time task is performed

3. Completed CT Cone Beam at Oral Surgery Clinic Annual Medical Physics Survey.
Equipment surveys performed in accordance with TJC, FDA, ACR and Army regulations (MEDCOM 40-42,TB MED 521)
Completed the

inspection survey

ON THE

EXPIRATION

date of inspection.

Scheduled & completed survey WELL BEFORE expiration date of previous survey.

Completed inspection AFTER previous inspection expiration date. There was a gap between surveys.

100% MACH Rep sees survey being completed; receives completed inspection report each time task is performed

4. Completed CT Cone Beam at Love Dental Clinic Annual Medical Physics Survey.
Equipment surveys performed in accordance with TJC, FDA, ACR and Army regulations (MEDCOM 40-42,TB MED 521)
Completed the

inspection survey

ON THE

EXPIRATION

date of inspection.

Scheduled & completed survey WELL BEFORE expiration date of previous survey.

Completed inspection AFTER previous inspection expiration date. There was a gap between surveys.

100% MACH Rep sees survey being completed; receives completed inspection report each time task is performed

5. Completed MRI 1.5 T Annual Medical Physics Survey.
Equipment surveys performed in accordance with TJC, FDA, ACR and Army regulations (MEDCOM 40-42,TB MED 521)
Completed the

inspection survey

ON THE EXPIRATION

date of inspection.

Scheduled & completed survey WELL BEFORE expiration date of previous survey.

Completed inspection AFTER previous inspection expiration date. There was a gap between surveys.

100% MACH Rep sees survey being completed; receives completed inspection report each time task is performed

6. Completed Bone Densitometer Annual Medical Physics Survey.

First year = 2019

Equipment surveys performed in accordance with ACR, AAPM and Army regulations (MEDCOM 40-42,TB MED 521)
Completed the

inspection survey

ON THE EXPIRATION

date of inspection.

Scheduled & completed survey WELL BEFORE expiration date of previous survey.

Completed inspection AFTER previous inspection expiration date. There was a gap between surveys.

100% MACH Rep sees survey being completed; receives completed inspection report each time task is performed

7. Completed CT Annual Medical Physics Survey.

Equipment surveys performed in accordance with ACR, AAPM and Army regulations (MEDCOM 40-42,TB MED 521)
Completed the

inspection survey

ON THE

EXPIRATION

date of inspection.

Scheduled & completed survey WELL BEFORE expiration date of previous survey.

Completed inspection AFTER previous inspection expiration date. There was a gap between surveys.

100% MACH Rep sees survey being completed; receives completed inspection report each time task is performed

8. Completed Mammography (2 FFD Units, 1 Stereotactic Unit) Annual Medical Physics Survey.

Equipment surveys performed in accordance with ACR, AAPM and Army regulations (MEDCOM 40-42,TB MED 521)
Completed the

inspection survey

ON THE

EXPIRATION

date of inspection.

Scheduled & completed survey WELL BEFORE expiration date of previous survey.

Completed inspection AFTER previous inspection expiration date. There was a gap between surveys.

100% MACH Rep sees survey being completed; receives completed inspection report each time task is performed

9. Completed MRI 3.0 T Annual Medical Physics Survey.

Equipment surveys performed in accordance with ACR, AAPM and Army regulations (MEDCOM 40-42,TB MED 521)
Completed the

inspection survey

ON THE

EXPIRATION

date of inspection.

Scheduled & completed survey WELL BEFORE expiration date of previous survey.

Completed inspection AFTER previous inspection expiration date. There was a gap between surveys.

100% MACH Rep sees survey being completed; receives completed inspection report each time task is performed

10. Completed Fluoroscopy Unit in MACH Core Annual Medical Physics Survey
Equipment surveys performed in accordance with ACR, AAPM and Army regulations (MEDCOM 40-42,TB MED 521)
Completed the

inspection survey

ON THE

EXPIRATION

date of inspection.

Scheduled & completed survey WELL BEFORE expiration date of previous survey.

Completed inspection AFTER previous inspection expiration date. There was a gap between surveys.

100% MACH Rep sees survey being completed; receives completed inspection report each time task is performed

11. Completed Fluoroscopy Unit in MACH Urology Clinic Annual Medical Physics Survey
Equipment surveys performed in accordance with ACR, AAPM and Army regulations (MEDCOM 40-42,TB MED 521)
Completed the

inspection survey

ON THE

EXPIRATION

date of inspection.

Scheduled & completed survey WELL BEFORE expiration date of previous survey.

Completed inspection AFTER previous inspection expiration date. There was a gap between surveys.

100% MACH Rep sees survey being completed; receives completed inspection report each time task is performed

12. Completed multiple C-Arm Annual Medical Physics Surveys as required.
Equipment surveys performed in accordance with ACR, AAPM and Army regulations (MEDCOM 40-42,TB MED 521)
Completed the

inspection survey

ON THE

EXPIRATION

date of inspection.

Scheduled & completed survey WELL BEFORE expiration date of previous survey.

Completed inspection AFTER previous inspection expiration date. There was a gap between surveys.

100% MACH Rep sees survey being completed; receives completed inspection report each time task is performed

13. Completed multiple mini-C-arm Annual Medical Physics Surveys as required.
Equipment surveys performed in accordance with ACR, AAPM and Army regulations (MEDCOM 40-42,TB MED 521)
Completed the

inspection survey

ON THE

EXPIRATION

date of inspection.

Scheduled & completed survey WELL BEFORE expiration date of previous survey.

Completed inspection AFTER previous inspection expiration date. There was a gap between surveys.

100% MACH Rep sees survey being completed; receives completed inspection report each time task is performed

14. Any additional piece(s) of equipment added to the MACH inventory OR any pieces of equipment that require Special Call-Back inspections
Equipment surveys performed in accordance with TJC, FDA, ACR and Army regulations (MEDCOM 40-42,TB MED 521)
Completed the

inspection survey

ON THE

EXPIRATION

date of inspection.

Scheduled & completed survey WELL BEFORE expiration date of previous survey.

Completed inspection AFTER previous inspection expiration date. There was a gap between surveys.

100% MACH Rep sees survey being completed; receives completed inspection report each time task is performed

15. Completed any Emergent Medical Physics Surveys as required.
Equipment surveys performed in accordance with TJC, FDA, ACR and Army regulations (MEDCOM 40-42,TB MED 521)
Completed the

inspection survey within 1 week of call for inspection as an emergent case.

n/a
Completed inspection

AFTER 1 week of initial call for inspection as an emergent case.

100% MACH Rep sees survey being completed; receives completed inspection report each time task is performed

File details come from the government source that posted it. Updated .