Attachment B PERFORMANCE WORK STATEMENT.pdf

PERFORMANCE WORK STATEMENT

I. Description of Services.

1. Scope of Work. The Contractor shall provide all personnel, transportation, equipment and software to provide health physics consultation and diagnostic medical physicist services in support of the Veterans Affairs Central Texas Veterans Health Care System (CTVHCS)/ Central Texas (CTX) and OFF-SITE CLINICS on as needed basis. This contract is a service contract for CTX each unit has an annual requirement that requires a diagnostic medical physicist to survey and provide a required report for each unit at CTX and offsite clinics. Each unit will need to be schedule by medical physicist on as needed basis for this contract. These services will adhere to the requirements and expectations of the Nuclear Regulatory Commission (NRC), the National Council on Radiation Protection and Measurements (NCRP), the Mammography Quality Standards Act (MQSA), The Joint Commission (TJC), VHA National Health Physics Program (NHPP), the American College of Radiology (ACR), Food and Drug Administration (FDA), and internal requirements of this facility where applicable. The Texas Department of State Health Services regulations contained in 25 TAC §289 are not in force at CTVHCS but shall be followed as closely as practical. Services shall be available Monday through Friday 8- 4:30 excluding Federal holidays by performing the following tasks:

***** Period of Performance will be from April 1, 2023, thru March 31, 2024 plus four Option Periods. Contractor and or staff is responsible for scheduling with each department within 30 days of due date so not to interfere with patient schedules. This contract will include base year (+) plus four option periods (each option period is equal to one year). Invoices shall be received on a QUARTERLY Basis

• Task 1: Annual review of CTVHCS and Off-site clinics overall Imaging Quality Assurance program for diagnostic imaging equipment. [NHPP].

• Task 2: Annual, not to exceed 14 months, quality assurance testing survey and certification of all diagnostic x-ray and imaging equipment (to include MRI and Nuclear Medicine imaging equipment). See Attachment A for list of existing equipment. This list may be modified (equipment added or removed) at any time. [TJC, NHPP]. Individual reports for all annual compliance testing of all equipment systems identified by EE# (Reports shall not be combined into one file). Provide to CTX radiation safety and maintain a list of all equipment requiring quality assurance testing and identify if any deficiencies are identified.

• Task 3: Recertification of imaging equipment prior to first patient use when required due to repairs or modification that may affect the radiation output or image quality. Within 24 hours of contact, the contractor will coordinate with the affected service to have the recertification scheduled. Individual reports for all annual compliance testing of all equipment systems identified by EE# (Reports shall not be combined into one file).

• Task 4: Written reports signed by the diagnostic medical physicist documenting the testing, including a summary of methods, instruments used, measurements and deficiencies identified, for all diagnostic x-ray and imaging equipment. This shall be completed on new diagnostic x-ray equipment prior to first patient use. The Contractor shall provide one copy of the physicist report to the RSO and one copy to the Chief of Biomedical Services within five working days of completion of the work. The report may be in electronic format. [TJC, NHPP]. Individual reports for all annual compliance testing of all equipment systems identified by EE# (Reports shall not be combined into one file)

• Task 5: Deficiencies or non-conformances found during reviews or testing which represent unsafe conditions shall be reported to the RSO immediately. Verbal reports shall be provided after testing to Biomedical Engineering so that CTVHCS will know that equipment can be immediately put into use. The qualified diagnostic medical physicist will perform a follow-up with Biomedical Engineering to verify compliance of any necessary corrective action performed to correct deficiencies found and report result to the RSO; A tracking log with at least EE#, location, Service and deficiency shall be provided at least quarterly

• Task 6: Dose rate surveys in unrestricted areas adjacent to the radiation areas are to be included during testing and in the final report.

• Task 7: A patient exposure chart will be provided for each unit inspected for common projections and procedures.

• Task 8: Shielding design specification calculations for new construction and renovations. [TJC, NHPP]

• Task 9: Shielding certification surveys following new construction, modifications, and replacement of equipment. [TJC, NHPP]

• Task 10: Support the CTVHCS Radiation Safety Office by membership and/or attendance at the appropriate CTVHCS committee meetings (i.e., Radiation Safety Committee, Computed Tomography Working Group, Fluoroscopy Safety Working Group) on a quarterly or as needed basis. The CTVHCS Radiation Safety Office expects the diagnostic medical physicist to be available to attend these meetings not less than 2 hours per quarter. [TJC]

• Task 11: Conduct dose estimates calculations for patient, staff and fetal exposures, sentinel event investigations and any other unusual event requested by the Radiation Safety Officer.

• Task 12: Emergency response time on equipment tests within 24 hours of new or repaired equipment.

• Task 13: Quarterly on-site health physics/regulatory compliance surveys of the Nuclear Medicine, Radiation Safety Office, and of Research locations of use (when applicable).

These surveys will take place in the first two weeks of January, April, July, October and include:

o Conduct sealed source inventories of all CTVHCS radioactive materials o Conduct sealed source leak tests (NRC, NHPP) o Conduct performance-based audits of Nuclear Medicine practices/procedures o Review records of research acquisitions, contamination surveys, and disposals (if applicable) o Conduct area surveys of radiation use areas (ambient and contamination) o Conduct ambient surveys of areas adjacent to radioactive materials use o Conduct X-ray areas PPE staff knowledge checks o Conduct X-ray areas performance-based audits of practices/procedures

• Task 14: Semi-annual audits of Nuclear Medicine Written Directive case records.

• Task 15: Provide Public Dose release calculation spreadsheet in accordance with NRC Regulatory Guide 8.39 with annual updates

• Task 16: Develop and train CTVHCS radioactive materials users for transportation of radioactive materials with annual updates to training provided to radiation workers.

• Task 17: Quarterly Dose Calibrator and Well Counter Compliance Checks (4) o Constancy (quarterly review) o Accuracy (annual o Linearity (quarterly) o Geometry (Installation or move of device)

• Task 18: SPECT - SPECT (2)

• Task 19: SPECT - SPECT AFTER REPAIR

• Task 20: SPECT/CT - SPECT PART (2)

• Task 21: SPECT/CT - SPECT PART AFTER REPAIR

• Task 22: SPECT/CT - CT PART (2)

• Task 23: SPECT/CT - CT PART AFTER REPAIR

• Task 24: PET/CT - PET PART (2)

• Task 25: PET/CT - PET PART AFTER REPAIR

• Task 26: PET/CT - CT PART (2)

• Task 27: PET/CT - CT PART AFTER REPAIR

• Task 28: Xray Temple (15)

• Task 29: CBOC Xray Austin Waco Brownwood Bryan College Station Cedar Park

Palestine (12)

• Task 30: Xray EQUIPMENT AFTER REPAIR to include all Xray, DEXA and CR readers

(20)

• Task 31: DEXA Temple Austin (2)

• Task 32: CR Readers Temple Waco Austin Brownwood Bryan College Station Cedar

Park Palestine (9)

• Task 33: Fluoro (13)

• Task 34: Fluoro AFTER REPAIR

• Task 35: CT Temple Austin Waco (7)

• Task 36: CT Temple Austin Waco AFTER REPAIR

• Task 37: Annual Compliance CT Dose Optimization and protocol review

• Task 38: Annual quality assurance testing of Mammography equipment. Temple Austin

[MQSA (7)

• Task 39: Mammography Temple Austin AFTER REPAIR

• Task 40: MRI Temple Austin Waco (4)

• Task 41: MRI Temple Austin Waco AFTER REPAIR

• Task 42: Dental Temple Austin Waco (30)

• Task 43: Dental Cone beam CT Temple Austin Waco (3)

• Task 44: Dental Cone beam CT Temple Austin Waco AFTER REPAIR

• Task 45: Dental EQUIPMENT AFTER REPAIR to include all Dental and handheld (20)

• Task 46 New EQUIPMENT (20)

• Task 47: Quarterly review of patient dose tracking software for patient overexposures.

Provide radiation safety a report quarterly. (4)

• Task 48: Dose Estimate Research Protocol Calculations (10)

• Task 49: CONTRACTOR PERSONNEL SECURITY REQUIREMENTS o In order to carry out contracted duties, the Diagnostic Medical Physicist shall pass Background Investigation Requirements for CTVHCS will be granted computer access to VISTA and NMIS (Nuclear Medicine Information System).

o CTVHCS will provide government equipment along with PIV Personal Identification Verification Card for unescorted access to radiopharmaceutical areas.

• Task 50: Annual medical physicist review of all CT and PET protocols (TJC).

• Task 51: Complete annual EPA compliance report for radioactive material effluent

(EPA).

The annual (not to exceed 14 months) quality assurance testing will include all radiology and dental equipment at CTVHCS – Temple, Waco, Austin, and off-site outpatient clinics – Brownwood, Bryan/College Station, Cedar Park, and Palestine. All quality assurance testing reports and mammography equipment performance evaluations reports shall be submitted to the CTVHCS Radiation Safety Office for review and approval subsequent to the completion of all testing, calibration and surveys of the equipment, facilities and procedures. The reports shall identify all items of noncompliance and include general and specific recommendations for correcting any items of noncompliance. All records (administrative and program specific) created during the period of the contract belong to VA Central Texas Health Care System (CTVHCS) and shall be returned to CTVHCS at the end of the contract or destroyed in accordance to the VHA Record Control Schedule (RCS)10-1.

1.1. Quality Assurance Testing

1.1.1. All Quality Assurance Tests shall meet or exceed current and possible future changes in NRC, ACR, MQSA, NCRP, FDA and TJC requirements and recommendations. All Quality Assurance Tests shall meet or exceed the requirements in the following VHA directives and handbooks and future directives and handbooks:

• VHA Directive 1105.01, Management of Radioactive Materials

• VHA Handbook 1105.02, Nuclear Medicine and Radiation Safety Service

• VHA Handbook 1105.03, Mammography Program Procedures and Standards

• VHA Handbook 1105.04, Fluoroscopy Safety

• VHA Handbook 1105.05, MRI Safety

• VHA Directive 1129, Radiation Protection for Machine Sources of Ionizing Radiation

1.1.2. Diagnostic X-ray Equipment (Radiography and Fluoroscopy)

The annual testing shall include, but is not necessarily limited to, the following (as applicable):

Per VHA Handbook 1105.04, Fluoroscopy Safety:

• Measurement of radiation output parameters, including beam intensity and beam quality.

• Testing of all modes of operation used clinically, including automatic exposure rate controls of fluoroscopy systems.

• Assessment of image quality.

• Assessment of technique factors used clinically.

• Measurement of appropriate indices of patient dose output chart must be generated for each survey in accordance 25 TAC. Dose rates at typical clinical technique factors, with comparison to national standards.

Per the American College of Radiology Technical Standard for Diagnostic Medical Physics Performance Monitoring of Radiologic and Fluoroscopic Equipment:

• Integrity of unit assembly

• Collimation and radiation beam alignment

• Fluoroscopic system resolution

• Automatic exposure control system performance

• Fluoroscopic automatic brightness control performance (high-dose-rate, pulsed modes, field-of-view [FOV] variation)

• Image artifacts

• Fluoroscopic phantom image quality

• kVp accuracy and reproducibility

• Linearity of exposure versus Ma or mAs

• Exposure reproducibility

• Timer accuracy

• Beam quality assessment (half-value layer)

• Fluoroscopic entrance exposure rates

• Image receptor entrance exposure

• Equipment radiation safety functions

• Patient dose monitoring system calibration

• Video and digital monitor performance

• Digital image receptor performance

If the review of clinically used technique factors or the comparison of measured dose indices with national standards indicates that an optimum balance has not been achieved between patient dose and image quality or that the dose indices exceed national standards, the technique factors, whether posted in a chart or programmed into the fluoroscope, shall be modified as necessary. [VHA Handbook 1105.04]

Reports shall be generated indicating appropriate indices of patient dose, measured by a diagnostic medical physicist at clinically used technique factors, to be posted near the controls of each fluoroscope. These indices include typical and maximal entrance skin dose or air kerma rate for each fluoroscopic mode of operation (e.g., pulse rate and magnification mode). For each image recording mode used clinically, these include the entrance skin dose or air kerma per image or the entrance skin dose or air kerma per second of imaging (e.g., cinefluorography in the cardiac catheterization laboratory) for a patient of typical thickness. [VHA Handbook 1105.04]

1.1.3. Computed Tomography

The testing shall include, but is not necessarily limited to, the following (as applicable):

Per the American College of Radiology Technical Standard for Diagnostic Medical Physics Performance Monitoring of Computed Tomography (CT) Equipment:

• Alignment light accuracy

• Image localization from scanned projection radiograph (localization image)

• Table incrementation accuracy

• Radiation beam width (collimation)

• Reconstructed image thickness

• Image quality o High-contrast (spatial) resolution o Low-contrast sensitivity and resolution o Image uniformity o Noise o Artifact evaluation

• CT number accuracy

• Acquisition workstation display

• Dosimetry o Radiation output of CT scanner (CT dose index [CTDIvol] or equivalent) o Patient radiation dose estimate for representative examinations

• Protocol review o The Diagnostic Medical Physicist shall become a member of computed tomography working group (CTWG) and review the CT protocols annually.

These should include head and abdomen protocols for adult and pediatric patients as applicable to the facility’s practice. In addition, facility protocols for very high dose procedures (e.g., brain perfusion) should be reviewed.

o Elements reviewed should include documentation of kVp, Ma, rotation time, detector configuration, pitch, reconstructed image thickness, and use of automatic exposure control (including ensuring documentation of reference settings used), and the indicated dose indices (CTDIvol) resulting from each examination

• Safety Evaluation o Visual inspection o Workload assessment o Scatter and stray radiation measurements (if work load and other related parameters have changed since acceptance testing) o Audible/visual signals o Posting requirements

• Other tests as required by state or local regulations

Per the TJC Revised Requirements for Diagnostic Imaging Services (Prepublication Requirements dated January 9, 2015; subject to change):

• Image uniformity

• Slice thickness accuracy

• Slice position accuracy (when prescribed from a scout image)

• Alignment light accuracy

• Table travel accuracy

• Radiation beam width

• High-contrast resolution

• Low-contrast resolution

• Geometric or distance accuracy

• CT number accuracy and uniformity

• Artifact evaluation

• Dosimetry o The diagnostic medical physicist measures the radiation dose (in the form of volume computed tomography dose index [CTDIvol]) produced by each diagnostic CT imaging system for the following four CT protocols: adult brain, adult abdomen, pediatric brain and pediatric abdomen, as applicable. If one or more of these protocols is not used by the hospital, other commonly used CT protocols may be substituted.

o The diagnostic medical physicist verifies that the radiation dose (in the form of CTDIvol) displayed by the CT imaging system for each tested protocol is within 20 percent of the CTDIvol displayed on the CT console. The dates, results, and verifications of these measurements are documented.

• Image acquisition display monitors o Maximum luminance o Minimum luminance o Luminance uniformity o Resolution o Spatial accuracy

1.1.4. Mammography

The annual testing shall comply with the MQSA, and the latest requirements posted on the ACR Website for the manufacturer of the digital mammography being inspected. It shall include, but is not necessarily limited to, the following (as applicable):

• Unit assembly evaluation

• Collimation assessment

• Artifact evaluation

• kVp accuracy and reproducibility

• Bean quality assessment – HVL measurements

• Evaluation of system resolution

• Automatic Exposure Control (AEC) function performance

• Breast entrance exposure, AEC reproducibility, and average glandular dose

• Radiation output rate

• Phantom image quality evaluation

• Signal to noise ratio and contrast to noise ratio measurements

• View box luminance and room illuminance

• Review workstation (RWS) tests

1.1.5. MRI Equipment

The testing shall include, but is not necessarily limited to, the following (as applicable):

Per the American College of Radiology Technical Standard for Diagnostic Medical Physics Performance Monitoring of Magnetic Resonance Imaging (MRI) Equipment:

• Magnetic field homogeneity

• Slice position accuracy

• Slice thickness accuracy

• Radiofrequency (RF) calibration for all coils o Frequency and gain/attenuator verification (prescan values) o Image signal–to-noise ratio (SNR) for all coils o Intensity uniformity for all volume coils o Phase stability and image artifact assessment for all coils

• Softcopy (monitor) fidelity

• Evaluation of quality control (QC) program

Per the TJC Revised Requirements for Diagnostic Imaging Services (Prepublication Requirements dated January 9, 2015; subject to change):

• Image uniformity for all radiofrequency (RF) coils used clinically

• Signal-to-noise ratio (SNR) for all coils used clinically

• Slice thickness accuracy

• Slice position accuracy

• Alignment light accuracy

• High-contrast resolution

• Low-contrast resolution (or contrast-to-noise ratio)

• Geometric or distance accuracy

• Magnetic field homogeneity

• Artifact evaluation

• Image acquisition display monitors o Maximum luminance o Minimum luminance o Luminance uniformity o Resolution o Spatial accuracy

1.1.6. Nuclear Medicine Cameras

The annual testing shall include, but is not necessarily limited to, the following (as applicable):

Per the TJC Revised Requirements for Diagnostic Imaging Services (Prepublication Requirements dated January 9, 2015; subject to change):

• Evaluation of all nuclear medicine image types by each NM scanner and include the use of phantoms to assess the following imaging metrics:

o Image uniformity/system uniformity o High-contrast resolution/system spatial resolution o Sensitivity o Energy resolution o Count-rate performance o Artifact evaluation o Low-contrast resolution or detectability for non-planar acquisitions

(recommended not required)

1.1.7. Computed Radiography (CR) and Digital Radiography (DR)

The annual testing shall comply with the AAPM Report Number 93, Acceptance Testing and Quality Control of Photostimulable Storage Phosphor Imaging Systems and include, but is not necessarily limited to, the following (as applicable):

• Component and imaging plate physical inspection and inventory

• Imaging plate dark noise and uniformity

• Exposure indicator calibration

• Linearity and auto-ranging response

• Laser beam function

• Limiting resolution and resolution uniformity

• Noise and low-contrast resolution

• Spatial accuracy

• Erasure thoroughness

• Aliasing/grid response

• IP throughput

• Positioning and collimation errors.

1.1.8. Dental

The physics inspection shall conform to the Conference of Radiation Control Program Directors (CRCPD), Quality Control Recommendations for Diagnostic Radiography Volume 1 Dental Facilities July 2001. The annual testing shall include, but is not necessarily limited to, the following (as applicable):

• Collimation

• Beam quality (HVL)

• Timer accuracy and reproducibility

• kVp accuracy and reproducibility

• mA or mAs linearity

• Exposure reproducibility

• Entrance skin exposure evaluation, with comparisons to published diagnostic reference levels and achievable doses (e.g. NCRP Report No. 172)

• Technique chart evaluation

• Image uniformity (artifact evaluation)

1.1.9. Dental CBCT

If the manufacturer has provided a phantom and procedures to perform specific tests but the tests are not included in this SOW, then the manufacturer’s machine-specific QA tests shall be performed in addition to the QA tests in this SOW. The annual performance testing shall include, but is not necessarily limited to, the following (as applicable):

• Radiation output repeatability and reproducibility

• kVp accuracy, repeatability, and reproducibility

• Bean quality

• Radiation field of view (FOV)

• Image quality

• Accuracy of linear measurements

• Accuracy of patient dose metric indication

• Patient dose assessment

• Review of the technical QA program

• Display monitor evaluation o Test pattern evaluation o Monitor brightness o Viewing conditions

1.1.10. PET/CT

The annual physics inspection shall conform to the ACR PET Phantom Instructions for Evaluation of PET Image., ACR Nuclear Medicine Accreditation Program PET Module.

Regarding the CT component, this evaluation should include items of the CT inspection, but not be limited to the following tests (as applicable):

• Uniformity

• Spatial resolution

• SUV analysis

1.2. Structural Shielding

1.2.1. For any room in which a fluoroscopic imaging system is installed, or in which a mobile fluoroscopic imaging system is frequently used, the doses to persons in adjacent areas, including any areas above and below, shall be evaluated by a qualified diagnostic medical physicist. Structural shielding shall be installed as necessary to maintain doses to persons in these areas ALARA and within regulatory limits. [VHA Directive 1129 and VHA Handbook 1105.04]

1.2.2. For the structural shielding of rooms containing x-ray imaging devices, the shielding design goal shall be 5 milligray (mGy) in a year to any person in a controlled area. For uncontrolled areas, the shielding design goal needs to be 1 mGy in a year to any person, and 0.02 mGy in any hour. [VHA Handbook 1105.04]

1.2.3. The qualified diagnostic medical physicist shall provide shielding design calculations for each new, replaced, or relocated x-ray imaging system. The calculations of shielding for each for and acceptance testing surveys of imaging rooms shall conform to National Council on Radiation Protection and Measurements (NCRP) Report No. 147, Structural Shielding Design for Medical X-ray Imaging Facilities and for dental units, NCRP Report No. 145. The calculations and testing shall be documented in a written report which includes a diagram showing the adjacent areas. The qualified diagnostic medical physicist shall perform a shielding survey to verify the structural shielding was installed per the shielding design report and complies with the design goals. A written report of the shielding survey shall be provided to the RSO within 5 working days after the shielding survey has been completed. [VHA Handbook 1105.04]

2.1. Qualifications. Prior to commencing work, all contractor employees shall meet certain criteria to perform work under this contract as a Diagnostic Medical Physicist. Qualification documents shall be submitted as part of the bid to the Contracting Officer and be approved by the RSO or his/her designee. All qualifications are subject to review by the CTVHCS Radiation Safety Committee.

2.1.1. Diagnostic Medical Physicist:

2.1.1.1. The Diagnostic Medical Physicist who performs the work at CTVHCS shall meet the following education, certification, and qualification standards:

• Hold a graduate degree in physics, medical physics, biophysics, radiological physics, medical health physics, or a closely related science or engineering discipline from an accredited college or a university.

• Formal graduate level college coursework in the biological sciences with at least one course in biology or radiation biology and one course in anatomy, physiology, or a similar topic related to the practice of medical physics.

• Documented 3 years of clinical experience in CT, nuclear medicine, PET/CT, or MRI. The physicist shall document the 3 years of experience for the modality being inspected.

• Hold current Board Certification by the American Board of Radiology or American Board of Medical Physics.

• Licensed by the State of Texas as a Professional Medical Physicist.

• Meet all respective NRC, ACR, MQSA, FDA and TJC requirements for a qualified diagnostic medical physicist.

• A physicist in training or under a temporary license shall be accompanied at any visit by and directly supervised by a fully licensed qualified diagnostic medical physicist.

2.1.1.2. The Diagnostic Medical Physicist shall have current knowledge, understanding, and recent experience in the following:

• All Texas Department of State Health Services, Radiation Control Regulations,

• All current NRC regulations,

• All current FDA regulations (including MQSA),

• Current recommendations of the ACR and TJC on diagnostic x-ray and imaging equipment

• Current recommendations of the NCRP and AAPM on medical imaging facility design and shielding,

• Current techniques for the calibration and testing of diagnostic x-ray equipment.

3.1 Period of Performance will be from April 1, 2023, thru March 31, 2024. This contract will include four option periods (each option period is equal to one year).

3.2 Location and Hours of Work

Normal business hours of coverage are: Monday through Friday from 8:00am to 4:30pm, excluding Federal holidays as listed below. All service will be performed during normal business hours of coverage requested and approved by the Program manager or designee.

New Year’s: Day 1 January Martin Luther King Jr. Birthday: 3rd Monday in January Washington’s Birthday: 3rd Monday in February Memorial Day: Last Monday in May Juneteenth: 19 June Independence Day: 4th of July Labor Day: 1st Monday in September Columbus Day: 2nd Monday in October Veterans Day: 11th of November Thanksgiving Day: 4th Thursday in November Christmas Day: 25 December Any other day specifically declared by the President of the United States to be a national holiday.

FEDERAL HOLIDAYS:

When a holiday falls on a Sunday, the following Monday shall be observed as a legal holiday by U.S. Government agencies. When a holiday falls on a Saturday, the preceding Friday shall be observed as a legal holiday by U.S. Government agencies. Also included would be any other day specifically declared by the President of the United States as a National Holiday. Observance of such days by Government personnel shall not be cause for additional period of performance or entitlement to compensation except as set forth in the contract. If the contractor's personnel work on a holiday, no form of holiday or other premium compensation will be reimbursed either as a direct or indirect cost. The contractor agrees to continue to provide enough personnel to perform round-the-clock requirements of critical tasks already in operation or scheduled and shall be guided by the instructions issued by the contracting officer or his/her duly authorized representative.

4. Influenza vaccine.

4.1 “Flu Shot” is mandatory for all VHA employees and contractors as per VHA Directive

1192.0. Contractor shall provide a list of employees under contract performance with their vaccination compliance. This requirement is to be submitted annually. Employees and Contractors who are not vaccinated as per authorized exclusions on VHA Directive are to be documented as such and always required to wear healthcare face mask while on VHA premises.

5. VHA SUPPLEMENTAL CONTRACT REQUIREMENTS FOR ENSURING ADEQUATE

COVID-19 SAFETY PROTOCOLS FOR FEDERAL CONTRACTORS:

Contractor employees who work in or travel to VHA locations must comply with the following:

Documentation requirements:

If fully vaccinated, shall show proof of vaccination.

NOTE: Acceptable proof of vaccination includes a signed record of immunization from a health care provider or pharmacy, a copy of the COVID-19 Vaccination Record Card (CDC Form MLS-319813_r, published on September 3, 2020), or a copy of medical records documenting the vaccination.

If unvaccinated and granted a medical or religious exception, shall show negative COVID-19 test results dated within three calendar days prior to desired entry date. Test must be approved by the Food and Drug Administration (FDA) for emergency use or full approval. This includes tests available by a doctor’s order or an FDA approved over-the-counter test.

Documentation cited in this section shall be digitally or physically maintained on each contractor employee while in a VA facility and is subject to inspection prior to entry to VA facilities and after entry for spot inspections by Contracting Officer Representatives (CORs) or other hospital personnel.

Documentation will not be collected by the VA; contractors shall, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information.

Contractor employees are subject to daily screening for COVID-19 and may be denied entry to VA facilities if they fail to pass screening protocols. As part of the screening process contractors may be asked screening questions found on the COVID-19 Screening Tool. Check regularly for updates.

Contractor employees who work away from VA locations, but who will have direct contact with VA patients shall self-screen utilizing the COVID-19 Screening Tool, in advance, each day that they will have direct patient contact and in accordance with their person or persons who coordinate COVID-19 workplace safety efforts at covered contractor workplaces.

Contractors shall, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information.

Contractor must immediately notify their COR or Contracting Officer if contract performance is jeopardized due to contractor employees being denied entry into VA Facilities

6. Performance requirement standards All 1-51 Tasks;

Task 1: Annual review of CTVHCS and Off-site clinics overall Imaging Quality Assurance program for diagnostic imaging equipment. [NHPP].

100% Compliant with all Regulations

100% No deviations allowed

Task 2: Annual, not to exceed 14 months, quality assurance testing survey and certification of all diagnostic x-ray and imaging equipment (to include MRI and Nuclear Medicine imaging equipment). See Attachment A for list of existing equipment. This list may be modified

(equipment added or removed) at any time. [TJC, NHPP]. Individual reports for all annual compliance testing of all equipment systems identified by EE# (Reports shall not be combined into one file). Provide to CTX radiation safety and maintain a list of all equipment requiring quality assurance testing and identify if any deficiencies are identified.

100% Compliant with all Regulations

100% No deviations allowed

Task 3: Recertification of imaging equipment prior to first patient use when required due to repairs or modification that may affect the radiation output or image quality. Within 24 hours of contact, the contractor will coordinate with the affected service to have the recertification scheduled. Individual reports for all annual compliance testing of all equipment systems identified by EE# (Reports shall not be combined into one file). 100% Compliant with all Regulations

100% No deviations allowed

Task 4: Written reports signed by the diagnostic medical physicist documenting the testing, including a summary of methods, instruments used, measurements and deficiencies identified, for all diagnostic x-ray and imaging equipment. This must be completed on new diagnostic x-ray equipment prior to first patient use. The Contractor shall provide one copy of the physicist report to the RSO and one copy to the Chief of Biomedical Services within five working days of completion of the work. The report may be in electronic format. [TJC, NHPP]. Individual reports for all annual compliance testing of all equipment systems identified by EE# (Reports shall not be combined into one file)

100% Compliant with all Regulations

100% No deviations allowed

Task 5: Deficiencies or non-conformances found during reviews or testing which represent unsafe conditions shall be reported to the RSO immediately. Verbal reports shall be provided after testing to Biomedical Engineering so that CTVHCS will know that equipment can be immediately put into use. The qualified diagnostic medical physicist will perform a follow-up with Biomedical Engineering to verify compliance of any necessary corrective action performed to correct deficiencies found and report result to the RSO; A tracking log with at least EE#, location, Service and deficiency shall be provided at least quarterly

100% Compliant with all Regulations

100% No deviations allowed

Task 6: Dose rate surveys in unrestricted areas adjacent to the radiation areas are to be included during testing and in the final report. 100% Compliant with all Regulations

100% No deviations allowed

Task 7: A patient exposure chart will be provided for each unit inspected for common projections and procedures.

100% Compliant with all Regulations

100% No deviations allowed

Task 8: Shielding design specification calculations for new construction and renovations. [TJC, NHPP]

100% Compliant with all Regulations

100% No deviations allowed

Task 9: Shielding certification surveys following new construction, modifications, and replacement of equipment. [TJC, NHPP]

100% Compliant with all Regulations

100% No deviations allowed

Task 10: Support the CTVHCS Radiation Safety Office by membership and/or attendance at the appropriate CTVHCS committee meetings (i.e., Radiation Safety Committee, Computed Tomography Working Group, Fluoroscopy Safety Working Group) on a quarterly or as needed basis. The CTVHCS Radiation Safety Office expects the diagnostic medical physicist to be available to attend these meetings not less than 2 hours per quarter. [TJC]

100% Compliant with all Regulations

100% No deviations allowed

Task 11: Conduct dose estimates calculations for patient, staff and fetal exposures, sentinel event investigations and any other unusual event requested by the Radiation Safety Officer.

100% Compliant with all Regulations

100% No deviations allowed

Task 12: Emergency response time on equipment tests within 24 hours of new or repaired equipment.

100% Compliant with all Regulations

100% No deviations allowed

Task 13: Quarterly on-site health physics/regulatory compliance surveys of the Nuclear Medicine, Radiation Safety Office, and of Research locations of use (when applicable). These surveys will take place in the first two weeks of January, April, July, October and include:

o Conduct sealed source inventories of all CTVHCS radioactive materials o Conduct sealed source leak tests (NRC, NHPP) o Conduct performance-based audits of Nuclear Medicine practices/procedures o Review records of research acquisitions, contamination surveys, and disposals (if applicable) o Conduct area surveys of radiation use areas (ambient and contamination) o Conduct ambient surveys of areas adjacent to radioactive materials use o Conduct X-ray areas PPE staff knowledge checks o Conduct X-ray areas performance-based audits of practices/procedures 100% Compliant with all Regulations

100% No deviations allowed

Task 14: Semi-annual audits of Nuclear Medicine Written Directive case records.

100% Compliant with all Regulations

100% No deviations allowed

Task 15: Provide Public Dose release calculation spreadsheet in accordance with NRC Regulatory Guide 8.39 with annual updates

100% Compliant with all Regulations

100% No deviations allowed

Task 16: Develop and train CTVHCS radioactive materials users for transportation of radioactive materials with annual updates to training provided to radiation workers. 100% Compliant with all Regulations

100% No deviations allowed

Task 17: Quarterly Dose Calibrator and Well Counter Compliance Checks (4) o Constancy (quarterly review) o Accuracy (annual o Linearity (quarterly) o Geometry (Installation or move of device) 100% Compliant with all Regulations

100% No deviations allowed

Task 18: SPECT - SPECT (2)

Task 19: SPECT - SPECT AFTER REPAIR

100% Compliant with all Regulations

Task 20: SPECT/CT - SPECT PART (2)

Task 21: SPECT/CT - SPECT PART AFTER REPAIR

Task 22: SPECT/CT - CT PART (2)

Task 23: SPECT/CT - CT PART AFTER REPAIR

100% Compliant with all Regulations

100% No deviations allowed

Task 24: PET/CT - PET PART (2)

Task 25: PET/CT - PET PART AFTER REPAI

Task 26: PET/CT - CT PART (2)

Task 27: PET/CT - CT PART AFTER REPAIR

100% Compliant with all Regulations

100% No deviations allowed

Task 28: Xray Temple (15)

100% Compliant with all Regulations

100% No deviations allowed

Task 29: CBOC Xray Austin Waco Brownwood Bryan College Station Cedar Park Palestine (12)

100% Compliant with all Regulations

100% No deviations allowed

Task 30: Xray EQUIPMENT AFTER REPAIR to include all Xray, DEXA and CR readers (20)

100% Compliant with all Regulations

100% No deviations allowed

Task 31: DEXA Temple Austin (2)

100% Compliant with all Regulations

100% No deviations allowed

Task 32: CR Readers Temple Waco Austin Brownwood Bryan College Station Cedar Park Palestine (9)

Task 33: Fluoro (13)

Task 34: Fluoro AFTER REPAIR

100% Compliant with all Regulations

100% No deviations allowed

Task 35: CT Temple Austin Waco (7)

Task 36: CT Temple Austin Waco AFTER REPAIR

100% Compliant with all Regulations

100% No deviations allowed

Task 37: Annual Compliance CT Dose Optimization and protocol review

100% Compliant with all Regulations

100% No deviations allowed

Task 38: Annual quality assurance testing of Mammography equipment. Temple Austin [MQSA (7)

Task 39: Mammography Temple Austin AFTER REPAIR

100% Compliant with all Regulations

100% No deviations allowed

Task 40: MRI Temple Austin Waco (4)

Task 41: MRI Temple Austin Waco AFTER REPAIR

100% Compliant with all Regulations

100% No deviations allowed

Task 42: Dental Temple Austin Waco (30)

100% Compliant with all Regulations

100% No deviations allowed

Task 43: Dental Cone beam CT Temple Austin Waco (3)

Task 44: Dental Cone beam CT Temple Austin Waco AFTER REPAIR

Task 45: Dental EQUIPMENT AFTER REPAIR to include all Dental and handheld (20)

100% Compliant with all Regulations

100% No deviations allowed

Task 46 New EQUIPMENT And OR Repaired Equipment (20)

100% Compliant with all Regulations

100% No deviations allowed

Task 47: Quarterly review of patient dose tracking software for patient overexposures. Provide radiation safety a report quarterly. (4)

100% Compliant with all Regulations

100% No deviations allowed

Task 48: Dose Estimate Research Protocol Calculations (10)

100% Compliant with all Regulations

100% No deviations allowed

Task 49: CONTRACTOR PERSONNEL SECURITY REQUIREMENTS o In order to carry out contracted duties, the Diagnostic Medical Physicist must pass Background Investigation Requirements for CTVHCS will be granted computer access to VISTA and NMIS (Nuclear Medicine Information System).

100% Compliant with all Regulations

100% No deviations allowed o CTVHCS will provide government equipment along with PIV Personal Identification Verification Card for unescorted access to radiopharmaceutical areas.

100% Compliant with all Regulations

100% No deviations allowed

Task 50: Annual medical physicist review of all CT and PET protocols (TJC).

100% Compliant with all Regulations

Task 51: Complete annual EPA compliance report for radioactive material effluent (EPA).

SOW - VA SENSITIVE INFORMATION

1. GENERAL

Contractors, contractor personnel, and or personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

a. A contractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

b. All contractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness.

Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor

The contractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor’s employ. The Contracting Officer must also be notified immediately by the contractor prior to an unfriendly termination.

3. VA INFORMATION CUSTODIAL LANGUAGE

a. Information made available to the contractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1).

b. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor’s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA’s information is returned to the VA or destroyed in accordance with VA’s sanitization requirements. VA reserves the right to conduct on site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

c. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract.

d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies.

If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.

e. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.

f. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.

g. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.

h. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated.

i. The contractor/subcontractor’s firewall and Web services security controls, if applicable, shall meet or exceed VA’s minimum requirements. VA Configuration Guidelines are available upon request.

j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA’s prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response.

k. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus.

If the contractor/subcontractor is in receipt of a court order or other requests for the above-mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response.

l. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COR.

4. LIQUIDATED DAMAGES FOR DATA BREACH

a. Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract.

b. The contractor/subcontractor shall provide notice to VA of a “security incident” as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis.

Failure to cooperate may be deemed a material breach and grounds for contract termination.

c. Each risk analysis shall address all relevant information concerning the data breach, including the following:

(1) Nature of the event (loss, theft, unauthorized access);

(2) Description of the event, including:

(a) date of occurrence.

(b) data elements involved, including any PII, such as full…