Draft Statement of Work Teleradiology VAMC Philadelphia.pdf

STATEMENT OF WORK

The contractor agrees to provide the Corporal Michael J. Crescenz VA Medical Center (CMCVAMC) professional teleradiology services in diagnostic imaging for the prices specified in the Section titled Schedule of Supplies/Services in this contract. The contractor will provide these services in compliance with this document’s specifications.

GENERAL: The Corporal Michael J. Crescenz Department of Veterans Affairs has the requirement to provide Veterans within the service area with diagnostic imaging services. Much of that care is delivered by VA employees. However, personnel shortages have resulted in the need for additional professional diagnostic interpretive capacity.

BACKGROUND: Physician personnel shortages and turnover in the Diagnostic Radiology Service of the CMCVAMC have created a significant need for additional professional diagnostic interpretive capacity to ensure that both routine and emergent radiology imaging examinations are always available to our Veterans. Contract teleradiologists will provide final radiology interpretations for exams performed during off tours, and in some cases for exams performed during routine tours when other radiologist services are not available or insufficient to meet the clinical demand. The use of Imaging Service teleradiology outsourcing should provide a highly cost effective and expeditious alternative to meet ongoing needs within the CMCVAMC. The CMC AMC uses electronic image and health record management and distribution systems including CPRS, VISTA Imaging, Philips Intellispace PACS, and Nuance Powerscribe.

WORK STATEMENT: The contractor shall provide professional teleradiology services for diagnostic imaging examinations performed at the CMCVAMC. Contract services will include off-campus image interpretation via a secure network connection to the VA informatics systems, and as needed, providing advice by telephone to clinical providers and radiology technologists regarding protocols or for clarifying questions about radiology exams. Contractor will comply with CMCVAMC’s policies related to reporting of examinations, the use of diagnostic codes, and the communication of results. The contractor must be a U.S. based corporation capable of final interpretation and reporting services via the Contractor’s secure Teleradiology network. Interpretation services will be conducted by board certified or board eligible Radiologists. The contractor shall provide all professional personnel and technical support, medical and other equipment, telecommunication, supplies, and supervision necessary to perform, implement and administer these teleradiology services to meet the specific medical needs of the CMCVAMC. The Contractor is responsible for all Contractor personnel, Subcontractors, agents, and anyone acting for or on behalf of the Contractor. Services provided under the contract are not to be performed outside of the United States.

All services SHALL be performed within the territorial borders of the United States.

Teleradiology Services:

1. The Contractor shall be responsible for management of all aspects of the contract, and this includes the following:

a. Provide radiology professional services for the CMCVAMC from offsite. This includes distributing studies electronically to board certified/eligible Radiologists for primary diagnosis and reporting; and as needed, providing advice by telephone to clinical providers and radiology technologists regarding protocols or for clarifying questions about radiology exams.

b. Services will be provided when requested by CMCVAMC staff. Those services are primarily needed for Weekend, Holiday, Evening, and Nights (“WHEN”): that is, on Monday-Friday after 4:30pm, overnight until 8:00am on the subsequent business day, on weekends, and on federal holidays. Less often, teleradiology services may sometimes be needed during regular business hours, Monday-Friday 8:00am-4:30pm, such as during staffing shortages.

c. Interpretations for exams on inpatients, ED patients, and others as requested will be considered as “STAT”. The Contractor will interpret such STAT studies within one hour of receiving the examination. Other outpatient interpretations may be requested as “routine”, with a preferred turnaround of 24 hours and a mandatory turnaround of 48 hours.

d. Imaging procedures will likely include XR, US, CT, CTA, MRI, and MRA cases from all branches of Radiology -- to include imaging of the head, neck, chest, abdomen, pelvis, and extremities. Occasionally, services might also be requested for other imaging exams including mammography, general nuclear medicine, and PET/CT.

e. The teleradiology service must have consistent uptime.

f. The teleradiology service must comply with VA policies and procedures. This includes, but is not limited to, connecting to the VA’s electronic medical record systems through protocols that are compliant with VA policies and appropriately safeguarding Veterans’ health data.

g. Services with experience in connecting to the VISN4 radiology systems are preferred.

h. The teleradiology service must provide oversight of its providers to ensure their clinical competency, interfacing smoothly with the VA’s requirements for Focused and Ongoing Professional Practice Evaluation (FPPE and OPPE).

i. All work will be performed by contract radiologists who have been appropriately credentialed to allow clinical work at the CMCVAMC in the modalities and study types that they interpret. Appropriate credentialing status can be accomplished either by (1) direct credentialing through the CMCVAMC Credentialing and Privileging committee, or by (2) a Teleradiology Sharing Agreement (TSA) if that is subsequently established to allow the sharing of credentials between the CMCVAMC and other VAs working with the teleradiology contractor.

j. Contract radiologists will be available for telephone consultation regarding examinations and will provide recommendations for appropriate procedures to referring clinicians. VA Technologists performing procedures to be interpreted may consult the Radiologist/contractor with questions regarding protocol of exams, possible contrast allergy questions or for direction regarding abnormal laboratory values, or questions regarding premedication.

k. The images will be exported to the contractor from the VA's PACS System (currently Philips Intellispace) through a VA approved Business Partner Gateway (BPG).

l. Relevant prior studies will be made available to the teleradiologist. When clinically warranted, interpretations must compare current and prior studies. Radiologist will either have access to CPRS, or to a health summary, or be able to contact the ordering physician to obtain clinical information such as history, progress notes, medications, and laboratory values, as well as reports from prior radiologic examinations.

m. If a preliminary interpretation is first rendered, then the Radiologist providing the final interpretation must determine whether the final report is different from the preliminary interpretation. Any change or discrepancy between the preliminary and final interpretations must be documented in the report and communicated by phone to the referring clinician or their covering surrogate. The date and time of that communication must be documented in the final report.

n. If the study is technically limited or incomplete, and cannot be interpreted with certainty, the teleradiologist will notify the referring clinician for consideration of repeating the study, as clinically warranted. If repeating the study is not feasible, cannot be done immediately, or is not likely to be productive, the study must be reported, and the technical limitations of the interpretation described in the report.

o. Timeliness of reporting:

a. Routine examinations will preferably be interpreted within 24 hours, and at least within 48 hours of the teleradiology service receiving the request for interpretation.

b. STAT Examinations will be interpreted within one hour (60 minutes) of the teleradiology service receiving the request for interpretation. All studies ordered on ED patients and inpatients will be considered STAT. Other outpatient studies will be considered STAT if they have been thus ordered, or if an expedited interpretation is requested by CMCVAMC staff.

c. Stroke Protocol Examinations. The Contractor will perform expedited imaging interpretations of Non-Contrast Head CT studies for patients presenting within the eligible time window for alteplase administration or those within the extended time window for endovascular treatment. The CMCVAMC staff will work with the Contractor to establish a workflow to identify those cases. The contract teleradiologist will provide a verbal callback within 15 minutes of receipt of such a study. Final written report back to local CPRS will be provided within 30 minutes from receipt of the study.

d. Intraoperative Radiographs. The contractor will perform expedited imaging interpretations for intraoperative radiographs in support of VHA Directive 1103:

“Prevention of Retained Surgical Items” or other intraoperative radiographs requiring emergent radiologist interpretation in support of clinical decision making while the patient is in the operating room. The CMCVAMC staff will work with the Contractor to establish a workflow to identify those cases. The contractor will provide interpretations within 30 minutes from receipt of the complete study. The contractor will provide direct callbacks on these OR cases.

p. Additional notification requirements apply if any exam demonstrates a critical/emergent test result. In the case of a critical finding, results must also be communicated by telephone with readback to the referring physician or a licensed clinician who can address the critical finding. This communication must be documented in the report and include the name of the clinician receiving the report, date, and time communicated. The study must also be coded with the CRITICAL ABNORMALITY diagnostic code.

q. DOCUMENTATION. All image interpretations will either meet or exceed established standards of care in timeliness, accuracy, and content.

(1) Each report will identify the study technique, images reviewed, relevant comparisons, objective findings, the Radiologist’s impression of the patient’s condition, and recommendation for treatment. Any incomplete report will be redictated, transcribed, and verified within 24 hours of notification at no additional cost to CMCVAMC.

(2) All reports are to be in accordance with American College of Radiology (ACR) standards. Interpretations must include the following information (it is acceptable for some of this information to be included in the electronic headers and metadata): patient’s full name, SSN, date of birth, reason for study, exam case number (accession number), date of study, date of interpretation, requesting physician, relevant comparisons, study technique, laterality when applicable, description of the exam and findings (body of the report), impression, diagnostic codes, name of interpreter, and signature of Radiologist providing the interpretation. The report shall list pertinent positive and negative findings. Only CMCVAMC approved abbreviations will be used for documentation of the patient health record.

(3) If the exam has a critical/emergent test result, the report must be communicated by phone to the referring physician as soon as possible, but in no case later than one hour from when it is identified by the interpreting radiologist.

(4) Any significant discrepancies between a preliminary verbal notification and the final report must be documented in the final report. Additionally, the treating team must be notified, and the date and time of that notification must be documented in the final report.

(5) Reporting Imaging Test Results and Critical Results

(i) The Contractor will be responsible for ensuring all Radiologists follow guidelines for the reporting of critical/emergent and abnormal findings. These guidelines are found in the following documents, which are attached for review:

• 2024 New Critical Radiology Results Reporting of Critical Results SOP

• MCP 114-05 Supplementary and Nonstandard Communication of

Imaging Abnormalities

The contractor will distribute these to all Radiologists and obtain signed receipt and acknowledgement of understanding for Radiologists providing interpretation.

These policies may be updated by the CMCVAMC from time to time. The Contractor will be provided with updated versions if their usage changes.

(ii) Critical Results

Critical Test results in Imaging are defined as A Radiology/Nuclear Medicine finding that indicates an immediately life-threatening condition. A minimum list of critical abnormalities in VISN4 are defined in the attached document. Radiologists may designate other abnormalities as critical based on professional judgement.

The Radiologist will communicate critical results to the ordering practitioner or surrogate practitioner immediately during interpretation, but at least within an hour of detecting the finding. If the ordering provider is unavailable, the critical result will be directly communicated to the ordering provider’s designated surrogate. If the designated surrogate cannot be reached, a call cascade protocol will be followed.

The provider receiving the result confirms the patients’ identity and result by writing the information down and reading it back to the Radiologist. The interpreting Radiologist will document in the radiology report that the critical result was directly communicated to the provider, the name of the provider, and the date and time of the communication.

Additionally, the Radiologist will insert the CRITICAL ABNORMALITY diagnostic code (detailed below).

Critical/Emergent Test results for Imaging Service will include, but not be limited to:

• Ectopic Pregnancy

• Testicular or Ovarian Torsion

• Pneumoperitoneum-not postoperative

• Acute Intracranial Hemorrhage

• Unstable Cervical Spine Fracture

• Thoracic or Lumbar Spine Fracture with cord compression

• Aortic Dissection

• Mediastinal or Retroperitoneal Hematoma

• Intracranial Mass with New Herniation

• Acute Pulmonary Embolism or Acute above the knee DVT

• Hemoperitoneum

• Acute laceration of the Liver, Spleen or Kidney

• Acute cord compression

• Appendicitis

• Abscess requiring medical/surgical attention or intervention

• Bowel Necrosis

• Portal Venous Gas

• Acute Arterial Embolism/Occlusion

• Tension Pneumothorax

• Significantly Mal-positioned line or tube or unexpected foreign body

Electronic Communication (view alerts) will be used to communicate important/abnormal study findings that require attention by the ordering practitioner, but not necessarily in an immediate time frame.

(ii) The contract radiologist will code all studies (both normal and abnormal studies) with a diagnostic code which is inserted at the time of report generation. Inline below are the diagnostic codes to be used.

1000 NO ALERT REQUIRED

1001 SIGNIFICANT ABNORMALITY, ATTN NEEDED

1002 CRITICAL ABNORMALITY

1003 POSSIBLE MALIGNANCY

Some of the diagnostic codes will generate view alerts which can convey important study findings that may require a change in patient management, but not necessarily within an immediate timeframe.

These codes will be used as follows:

1000 NO ALERT REQUIRED

Print code on report: NO Generates a View Alert: NO Usage: The code indicates that no alert needs to be sent to the ordering physician. The code would be used if there was nothing urgent to report, or if the ordering physician was already aware of the results.

1001 SIGNIFICANT ABNORMALITY, ATTN NEEDED

Print code on report: YES Generates a View Alert: YES Usage: This code is selected if a finding requires follow up action, but not urgently. If the abnormality is already known to the ordering physician, then the radiologist need not set this code.

1002 CRITICAL ABNORMALITY

Print code on report: YES Generates a View Alert: YES Usage: This code is used to indicate a finding that must be addressed immediately according to TJC definition of a critical test result.

The teleradiologist must also call the ordering provider or a covering surrogate provider, as was detailed above.

1003 POSSIBLE MALIGNANCY

Print code on report: YES Generates a View Alert: YES Usage: This code should be used whenever a study has a finding that might represent a malignancy, or a finding that definitely represents a malignancy (it should be used for both undiagnosed and known cancers). Common indications include a pulmonary nodule that warrants follow-up, a renal mass, or a suspicious hepatic lesion.

The diagnostic codes and their usage may be updated from time to time. The Contractor will be provided with updated instructions if their usage changes.

(iii) A method will be established to allow the teleradiologist to contact a provider or a covering surrogate provider at the CMCVAMC by phone. This will allow the teleradiologist to seek additional relevant clinical information when needed, as needed for discussion about the patient’s clinical status, and to allow the teleradiologist to relay critical results.

The CMC staff will provide the Teleradiology operations team with contact information for ordering providers, either through electronic lists (e.g. Amion) and/or through the submission of relevant information through an electronic portal. As a backup, calls about urgent findings will be routed through the CMCVAMC Emergency Room.

r. Contractors will be responsible for transcription services, report corrections, and sign reports electronically.

s. Contractor will provide peer review data (quality assurance cross reads) on a quarterly basis for each Radiologist providing interpretations to CMCVAMC. A copy will be provided to CMCVAMC for review. The number of cases reviewed will comply with the VA’s requirements about Focused and Ongoing Professional Practice Evaluation (FPPE and OPPE).

t. Contractor will be responsible for ensuring that all providers/subcontractors complete training required by CMCVAMC (including but not necessarily limited to Ethics, Cybersecurity, Privacy, etc.). The CMCVAMC will require documentation of completion.

u. Contractor will appoint one Radiologist to serve as a trainer for other Radiologists assigned to work for the CMCVAMC.

v. The Contractor will assist the CMCVAMC facility in site preparation and support during transition. To that end, the contractor will provide relevant configuration of the environment within the CMCVAMC for connectivity and communications of the system.

w. The Contractor providing teleradiology interpretation may temporarily store copies of reports and images but must delete or destroy all copies after the contract has expired, excepting records required for billing and reimbursement purposes.

x. Contractor will install, secure, and maintain external communication systems required for image study delivery to remote Radiologists. Configure, install, and maintain Virtual Private Network all remote workstation software on the remote reading Radiologist workstations. These connections must comply with specification in VA Handbook 6500.

The remote Connection to the VA will be through a VA approved Business Partner Gateway (BPG). Teleradiologists performing work under this contract may also connect remotely to the VA using the Citrix Access Gateway VPN. Contractors must ensure that their own specific computers are capable of diagnostic interpretation and at the same time adhere to all VA security requirements. The extension of the network is fully functional.

y. Contractor will access current and prior comparison studies (if comparison studies exist) utilizing a secure VA Business Partner Gateway or similarly functional, rapid, and secure technology. Contractor will provide and maintain the means for enabling this access.

z. Contractor will install and maintain external communication systems required for secure, VA-compliant image and data delivery to its teleradiologists and will configure, install, and maintain all remote workstation software at its teleradiologists’ reading stations and will ensure the security of VA Data. Contractor will expeditiously provide all requested information to CMCVAMC Information Security Officer (ISO) and Information Resources Management (IRM).

aa. Implement a Vista Rad/Vista Imaging/Philips Intellispace compatible DICOM appliance for transfer of images from Philips Intellispace to the DICOM server. Contractor Proposal shall include the specific hardware and software to be utilized by the contractor.

bb. Provide training on the new workflow for location activated.

cc. Provide maintenance on all contractor provided equipment and installed systems. The contractor shall make provisions for the proper maintenance and functioning of all imaging, teleradiology and associated equipment, facilities and fixtures as may reasonably be required by Physicians to perform services hereunder.

dd. Provide security as required by Health Insurance Portability and Accountability Act of 1996 (HIPAA) and maintain the security and integrity of patient information in accordance with applicable VA regulations and HIPAA. Contractor will be required to comply with all U.S. Laws and VA regulations regarding sensitive information, patient confidentiality, and information security, as set forth in; Privacy Act of 1974, Computer Security Act of 1987, Clinger Cohen Act of 1996, OMB A-130 Appendix IIIk and VA, VHA Directives 6500, and all other applicable regulations. See FAR clauses 52.224-1 and 52.224-2 included herein.

ee. Develop a project implementation strategy with the CMCVAMC to include preparing building, establishing telecommunications VISTA interface, policies and procedures transfer, credentialing, privileging, and training staff, reporting procedures, operational readiness, and phase in schedule.

ff. The Contractor shall provide a system that maintains a minimum of 99% up time performance rate. Failure to provide this may result in contract termination.

gg. Contractor shall provide hardware and selected software to be utilized at contractor site.

(1) Contractor to provide Facsimile, telephone, networking and other telecommunications equipment to be utilized at contractor facility.

(2) Contractor to provide all supplies, services, maintenance, repairs, and upgrades required at contractor facility to provide services as described above.

(3) Contractor’s equipment hardware, software and supplies must be compatible with the VA’s software (CPRS, Vista Imaging, Powerscribe, Philips Intellispace) and hardware used during performance of this contract, including critical patches and antivirus updates.

Contractor shall provide proof of installation of critical patches and/or antivirus updates to the VA upon request.

(4) Contractor’s network and security system must be compatible with the VA’s network and security system.

(5) Contractor’s system must be able to receive DICOM images to the Contractor server via secure VA facility-initiated VPN connection over the Internet.

2. The CMC VA Medical Center shall be responsible for:

(a) CMCVAMC will be responsible for credentialing doctors to work in a timely fashion. An application package will be provided by the VA to be completed by the candidate. This includes Curriculum vitae, current references, signed release of information from candidate, and statement that candidate does not have any physical or mental health condition that would adversely affect his/her ability to carry out assigned duties, and additional credentialing and privileging forms.

Candidate will also be required to make application through the VET-PRO Internet process.

Candidate will need to be enrolled in VET-PRO by the Credentialing and Privileging Coordinators.

The website address is: http://fcp.vetpro.org/

(b) Prepare site for installation of the system. Obtain VA Authorization for installation of a separate network connection, located inside the hospital but outside the firewall, and a network connection of the DICOM store and Forward device that will be installed inside the CMCVAMC. The VA will establish accounts and authorize radiology module privileges for the use by contractor.

IF REQURED c through e.

(c) Floor space, workspace, and power adequate for a PC tower computer, monitor and keyboard http://fcp.vetpro.org/ at customer site.

(d) 19" Rack space equivalent to 6u in computer room (to accommodate the server and IPS) and an outlet.

(e) Physical space in computer/Telco room for installation of Contractor-provided router and any remote connectivity devices typically used by communications providers.

(f) Physical security to computer systems.

(g) Access to server and object forge devices for the installation of Category 5 cabling, if required.

(h) Availability of technician for two hours of assistance.

(i) IRM designated staff for testing and approval of installed remote connectivity solution.

(j) Provide pertinent historical and demographic information on each patient sufficient for

Contractor to perform its services.

3. PROCEDURE FOR TRANSMISSION OF IMAGES:

Patient images along with exam Request forms for each patient will be transmitted electronically, such as by a push from the VA's PACS (Intellispace PACS or VISTA IMAGING) through a data line provided by the Contractor. The request forms can be provided either through an online portal or through other electronic transmission. The requests will include patient and study information, CPT codes, study urgency (STAT versus routine), and other relevant information.

The Contractor will interpret an exam and provide the Radiologist's final report and transmit using hardware/software provided by Contractor.

Contractor will use systems that allow for communication with those that are used at the CMCVAMC (CPRS, VISTA, Intellispace PACS, Powerscribe, and other related systems).

CONTRACTOR REQUIREMENTS

The Contractor shall provide all services specified in this contract for any person determined eligible by the Chief Medical Director, or Designee, regardless of the race, color, religion, sex, or national origin of the person for whom such services are ordered. The Contractor further warrants that he/she will not resort to subcontracting as a means of circumventing this provision. Contractor must have a mininum of three years of experience providing off routine teleradiology interpretations for VA Medical Centers. Contractor must be able to demonstrate consistent coverage (> 99% uptime for 3-year period).

MEDICAL RECORDS STANDARDS: The Contractor shall comply with the Medical Record Compliance Standards of the VHA. Medical center staff will provide Privacy Act training to appropriate contractor staff. The contractor, contractor employees, and subcontractors shall be subject to the Privacy Act of 1974 and HIPAA of 1996. The Contractor is not authorized to release any medical record information. The CMCVAMC is the sole entity authorized to release this information upon written request submitted via facsimile or mail from the patient. The CMCVAMC will provide the Contractor with access to pertinent patient medical information, within the existing privacy rules and regulations for the purpose of providing coordinated comprehensive primary care. Contractors shall ensure the confidentiality of all patient information and shall be held liable in the event of the breach of confidentiality.

GUIDELINES: The Contractor will perform the functions required under this contract in accordance with the rules of medical ethics, Federal, State and local laws, rules and regulations, Joint Commission, and American College of Radiology (ACR) for communication and teleradiology. The Contractor will not participate nor be a party to any activities, which conflict with Federal and/or State guidelines. In the event the Contractor encounters said conflicting situations, the Contractor will notify the COR or the Contracting Officer to resolve such issues. The Contracting Officer will document and be responsible for resolution of any such situations. Neither the VA nor the Contractor will be responsible for any delays or failures to perform due to causes beyond each party's control. The VA and the Contractor may upon mutual consent, modify the timing and schedule of services.

The Contractor shall follow Joint Commission standards and shall submit a copy of either their Joint Commission accreditation OR comparable statement with their proposal. Complications review, double reading, and other appropriateness monitors must be conducted, and report forwarded to CMCVAMC quarterly. Failure to provide required documentation would be a breach of the contract and subject to the contract being revoked. Any occurrence of a sentinel event or potential sentinel event involving a VA patient will be reported to the facility as soon as the event is detected. Comprehensive review of the case will be provided to the appropriate VA facility.

QUALITY MONITORING PROGRAM: The Contractor shall have a quality monitoring program and shall agree to comply with the requirements for meeting the JCAHO program as outlined by the VA radiology programs. Quarterly data will be provided to the CMCVAMC Diagnostic Radiology Service Chief/Supervisor for each Radiologist credentialed at CMCVAMC. Contractor must perform quality assurance cross reads and monitor appropriate communication of critical/emergency results. Both sets of data will be provided to CMCVAMC quarterly.

QUALITY CONTROL: The Contractor's facilities, methodologies, and quality control procedures may be examined by the VA Contracting Officer or his (her) designee at any time during the life of the contract.

QUALITY ASSURANCE AND PERFORMANCE MONITORING:

Performance Objective SOW Paragraph

Performance Measure

1. Prompt delivery of interpretations and return of films.

1.c. and 1.o..

Zero tolerance for late reports

2. Availability of Radiologist that is credentialed to perform clinical work at the

CMCVAMC

1.a. and 1i Zero tolerance for non-availability

3. Maintains patient privacy/confidentiality.

Special Contract Requirements

Standard is zero breaches of privacy

4. Maintains appropriate Federal, state licensure/ certification requirements

Special Contract Requirements

Mandatory prior to performance of duties

5. All documentation will meet or exceed standards, to include but not limited to accuracy and content.

1.q. Zero tolerance for violations

6. Timeliness – Patient Records. Reports are to be completed and verified within timeliness metrics. Stat reports must be communicated to requesting clinicians within one hour of when the contractor receives request. All critical/emergent

1.o. 95% Compliance Acceptable Quality Level COR will monitor Zero tolerance for violations.

(a) The Government will periodically evaluate the Contractor’s performance by appointing a representative(s) to monitor performance to ensure services are received. The Government may inspect each task as completed or increase the number of quality assurance inspections if deemed appropriate because of repeated failures or because of repeated customer complaints. Likewise, the Government may decrease the number of quality assurance inspections if performance dictates.

CMCVAMC Quality Assurance Personnel will validate any complaints and report to the Government Contracting Officer who will then take necessary action to enforce contract compliance.

(b) If any of the services do not conform to contract requirements, the Government may require the Contractor to perform the services again in conformity with contract requirements, at no increase in contract amount. When the defects in services cannot be corrected by re-performance, the Government may result in contract termination.

CONTRACTOR STANDARDS: Contractor is responsible for developing and maintaining written policies and procedures for licensure and certifications, competency evaluations, orientation, and continuing education, that are appropriate for the scope of care and services provided by employees and subcontractors under this contract.

SPECIAL CONTRACTOR RESPONSIBILITIES: The Contractor must possess all licenses, permits, accreditation and certificates as required by law. The Contractor must perform the required work in accordance with Joint Commission, VHA and other regulatory standards. Joint Commission standards may be obtained from the Joint Commission on Accreditation of Healthcare Organizations, One Renaissance Blvd, Oakbrook Terrace, IL 60181.

SUBCONTRACTOR PROVIDED SERVICES: All personnel that provide services under this contract and are not employees of the Contractor will be regarded as Subcontractors. The Contractor shall be responsible and accountable for the quality of care delivered by all its Subcontractors. The Contractor shall hold the Subcontractor accountable for the requirements for availability and accessibility of services as outlined in this contract. The Contractor shall use a systematic approach to monitoring the availability and accessibility of services of the Subcontractor as they relate to the quality-of-care monitoring.

CONTRACTOR EQUIPMENT/SOFTWARE: Upon completion or termination of the contract VPN software will be removed from contractor’s equipment. Any network accounts will be disabled. All VA data gathered, created, received, or processed during the performance of the contract will be returned to the VA or certificate of destruction provided. No data will be retained by contractor or their subcontractors.

CONTRACTOR NETWORK ACCESS: The VA network is protected from unauthorized access by assigning a distinct Access and Verify code to each user of the network. Each Contractor staff person, hereinafter referred to as “user”, must agree to the VA standard user application. Violation of the agreement in whole or in part may result in permanent revocation of access for the user.

REGULATORY INFORMATION: The Food and Drug Administration classifies VistARad as a exam results must be called to requesting clinician and this communication must be documented in the final report (clinician name, date, and time).

7. Adheres to all HIPAA requirements.

Special Contract Requirements

Standard is zero breaches of HIPAA requirements.

8. Adequate Coverage 1.a, 1.j, 1.e, 1.ff 100% Acceptable Quality Level COR will monitor.

Zero tolerance for violations.

medical device. As such, it may not be changed except as directed by the Vista Imaging SD&D group.

Modifications to this software may result in an adulterated medical device under 21CFR820, the use of which is considered to be a violation of US Federal Statutes. To ensure compliance the VA will implement measures, including but not limited to, security policies, anti-virus devices, anti-intrusion devices, and periodically monitor the equipment. Any attempt to defeat or circumvent any of these measures may constitute a breach of this contract and result in revocation.

SPECIAL CONTRACT REQUIREMENTS

1. SERVICES: The services specified herein of this Work Statement may be changed by written modification to this contract. The modification will be prepared by the VA Contracting Officer. The services to be performed by the contractor will be performed in accordance with VA policies. The services performed by the contractor will be under the direction of the Chief of Staff, and the Chief, Imaging Service.

2. RESPONSIBILITY OF THE CONTRACTOR: The Contractor must obtain authorization from the Contracting Officer for any services required outside the scope of work provided herein.

3. TERM OF CONTRACT AND PRICING: This contract is projected to start no later than 90 days after contract award and be effective for twelve months. The contract is subject to the availability of VA funds.

Pricing will be based on a flat fee for type of procedure. One invoice will be submitted to CMCVAMC for interpretations performed for radiology monthly, listing all studies interpreted, time and date of receipt by the contractor and time and date of final interpretation provided by the contractor for each.

PERIOD OF PERFORMANCE: CMCVAMC is requesting the period of performance to be for a total of 4 years after the date of award (Base year plus 3 option years)

4. HOURS OF WORK: The Contractor as defined herein shall furnish the services covered by this contract. The Contractor is required to furnish teleradiology services after business hours, on weekends, on national holidays, as requested, and intermittently at other times and dates including some M-F routine hours.

(a) National Holiday: The eleven holidays observed by the Federal Government: New Years Day, Martin Luther King's Birthday, President's Day, Memorial Day, Juneteenth, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving Day, and Christmas Day and any other day specifically declared by the President of the United States to be a national holiday.

5. QUALIFICATIONS: The Contractor will be responsible to ensure that Contractor personnel providing work under this contract are fully trained and completely competent to perform the required work.

Prospective providers must present appropriate credentialing information including, but not limited to, the following:

(a) Possess the M.D. (medical doctor) or O.D. (Doctor of Osteopathic Medicine) degree

(b) Board certification or eligibility in Diagnostic Radiology by the American Board of Radiology

(c) Current licensure in state of practice

(d) Clinical practice experience of at least two years

(e) General Liability and Malpractice insurance

(f) Barrier free office environment, equipment, and space to meet JCAHO, Federal and State standards.

Radiologists must be fully credentialed and privileged for work at both the VA facility where the exam and procedure are performed and at the facility where the exam is read (when applicable). Radiologists will only interpret those study types and modalities for which they are credentialed and privileged. Privileges at the facility, or facilities where the procedure is performed will terminate at the time of contract termination or expiration.

Contracting to Radiologists outside of the territories of the USA is prohibited.

The qualifications of teleradiology professional personnel shall also be subject to review by the VA Chief of Staff and/or Chief, Imaging Service and approved by the VA Facility Director at CMCVAMC.

Credentials will be updated annually during the term of the contract to insure there has been no lapse in licensure, insurance coverage, etc. No changes of employee will be allowed without prior authorization by the Contracting Officer in WRITING, thirty (30) days in advance. VA reserves the right to approve the assignment of individual personnel furnished by the Contractor to perform the functions specified in the contract.

Residents are not permitted to provide preliminary or final interpretations.

The Contractor is required to maintain records that document competence/performance levels of Contractor personnel working on this contract in accordance with JCAHO, and other regulatory body requirements. The Contractor will provide a current copy of the competence assessment checklist and semi-annual performance evaluation to the COR for each Contractor's personnel working on this contract.

VA may request the personnel records of any employee providing services under this contract for competency review. The VA reserves the right to request copies of current certifications and/or licenses at any time during the duration of the contract.

6. LIABILITY

a. Radiologists are responsible for the accuracy of their reports. Transcriptions must be corrected by the Radiologist before report verification.

b. Radiologists are responsible for the accuracy of preliminary reports and notifications made directly to clinicians.

c. Residents are not permitted to provide preliminary or final reports.

d. Radiologists must carry their own malpractice insurance. Coverage for malpractice claims is required when final reports are provided, and when notifications or preliminary reports are communicated directly to non-Radiologist clinicians.

7. PERSONNEL POLICY:

(a) General: The Contractor shall assume full responsibility for the protection of its personnel furnishing services under this contract in accordance with the personnel policy of the Contractor, such as providing worker's compensation, professional liability insurance, health examinations, income tax withholding, and social security payments.

(b) Worker's compensation and employer's liability:

(c) In accordance with FAR clause 28.307-2, the following applies:

The Contractor is required to comply with applicable Federal and State workers compensation and occupational disease statues. If occupational diseases are not compensable under those statues, they shall be covered under the employer's liability, except when contract operations are so commingled with the Contractors commercial operations that it would not be practical.

Employer's liability coverage of at least $100,000 is required except for states that do not permit workers' compensation to be written by private carriers.

1. General Liability: $500,000 per occurrence

2. Professional Medical Liability: One (1) million

8. EXCHANGE OF DATA: Patient medical records shall be exchanged as needed by both facilities and remain confidential.

9. INSURANCE - EVIDENCE OF COVERAGE: Before commencing work under this contract, the Contractor shall furnish certification to the Contracting Officer that the coverage required has been obtained and such Policy shall state "THIS POLICY MAY NOT BE CHANGED OR CANCELED WITHOUT WRITTEN NOTICE TO THE VA." Said policy must bear an appropriate "loss payable clause" to the United States as its interest may appear. Such evidence of insurance will not be waived.

10. CONTRACT MONITORING: Radiology Service will appoint a Contracting Officer Representative (COR) upon award of this contract. Pursuant to the Delegation of Authority to be issued, the COR will be responsible for verifying contract compliance.

Monitors of Clinical Performance: Peer review of interpretations may be performed periodically. Errors in interpretation or incompleteness in documented communication of urgent findings may be aggregated and compared to other Radiologists. Complaints and compliments regarding interactions with other care givers, availability and responsiveness and usefulness of consultations may be reviewed. Timeliness of teleradiology STAT results notification, and report verification will be monitored. Radiologists will be expected to participate in focus reviews and morbidity and mortality reviews of those incidents in which they provided care.

The COR’s will periodically evaluate workload accomplished during the contact period to assure necessary services are consistently provided.

After contract award, any incident of contractor noncompliance shall be forwarded immediately to the Contracting Officer.

11. PAYMENTS: The Contractor will submit all invoices electronically by creating an account with Tungsten. This account must be created by calling the Financial Service Center (FSC) at 877-353-9791 and choosing option 3. Once the Tungsten account has been set up and services has been performed, the contractor will submit one invoice each month for image interpretations and procedures performed for diagnostic imaging services for CMCVAMC. The Contractor will be paid within 30 days of the approved invoice. The invoice submitted must include the Company's name, tax ID number, contract number, funding obligation number (purchase order number), description of services (to include all services performed for each Veteran), period of services, amount, and remit to address.

Contractor shall be solely responsible for compensating physicians and all employees or contractors who perform services hereunder, making all tax withholdings, including paying such payroll or other employment related taxes, as required by law.

12. CONFIDENTIALITY: The Contractor understands and agrees that the information in the medical records of all patients is confidential. Strict confidentiality is to be maintained; Rules of Confidentiality expected to be conformed with are delineated in 38 USC. 3301, 38 USC 4132, 5 USC 552 (a) et. seq.

The Contractor and its personnel shall be held liable in the event of breech of confidentiality. Any person, who knowingly or willingly discloses confidential information from the authorizing VA facility, may be subject to fines. The Contractor will be HlPAA compliant.

(a) The contractor will comply with all confidentiality rights regarding patient information contained in patient medical records. Any disclosure of protected health information will be limited to that portion of the medical record needed to fulfill the specific purpose of the disclosure.

(b) Unless expressly authorized by the patient or the patient’s duly appointed and authorized representative, the CMCVAMC will not release any records regarding psychiatric care, alcoholism/alcohol abuse, drug abuse, HIV virus or HIV virus test results. The CMCVAMC will be solely responsible for securing, verifying, and approving authorization for the reproduction of records regarding psychiatric care, alcoholism/alcohol abuse, drug abuse HIV virus or HIV virus test results.

(c) The contractor assumes no responsibility for any losses or liability that result, directly or indirectly, from inaccurate information, incorrectly dated material, insufficient or improper authorization, or any type of faulty medical record documentation furnished by the CMCVAMC.

(d) The contractor will not provide copies of health information to any person other than the authorized requesting party.

(e) Upon request, the contractor’s representative will undergo all HIPAA/confidentiality related training and comply with all rules and regulations regarding protected health information.

(f). Contractor represents and warrants that it complies with applicable electronic data transmission standards required by the U.S. government agencies for transmission of protected health information.

(g). The contractor maintains an “Errors and Omissions” liability insurance policy which insures against a negligent act, error, or omission and the oral or written publication of material that violates a person’s rights of privacy. The contractor also maintains a Commercial General Liability Policy. Evidence of coverage will be provided to the CMCVAMC credentialing departments upon request.

13. ACCESS TO RECORDS: Contractor personnel who obtain access to hardware or media which may store drug or alcohol abuse data, sickle cell anemia treatment records, records or tests or treatment for or infection with HIV, medical quality assurance records, or any other sensitive information protected under 38 USC §4132 or §3305, as defined by the Department of Veterans Affairs, shall not access the records unless absolutely necessary to perform their contractual duties. Any individual who has access to these data will disclose them to no one, including other personnel of the Contractor not involved in the performance of the contractual duty for which access was obtained. Violation of these statutory provisions, as stated in department regulations by the Contractor's personnel may involve imposition of criminal penalties.

14. COMPUTER SYSTEM SECURITY: The Contractor shall provide VHA with the full assurance that security measures have been implemented which are consistent VA Departmental Standards.

In accordance with the Federal Information Security Management Act (FISMA), the Privacy Act of 1974, as amended, the Health Insurance Portability and Accountability Act of 1996 (HIPAA), as applicable, and Public Law 109-461, §5725, contractor access to VA information and information systems must be maintained at the highest level of protection in order to thwart unauthorized disclosure of sensitive information (as defined in VA Handbook 6500, Information Security Program).

Federal Acquisition Regulation part 2.101 provides the following definition of contract.

"Contract means a mutually binding legal relationship obligating the seller to furnish the supplies or services (including construction) and the buyer to pay for them. It includes all types of commitments that obligate the Government to an expenditure of appropriated funds and that, except as otherwise authorized, are in writing. In addition to bilateral instruments, contracts include (but are not limited to) awards and notices of awards; job orders or task letters issued under basic ordering agreements; letter contracts; orders, such as purchase orders, under which the contract becomes effective by written acceptance or performance; and bilateral contract modifications. Contracts do no not include grants and cooperative agreements covered by 31 U.S.C. 8301, et. seq."

Per OMB M-07-19, FY 2007 Reporting Instructions for FISMA and Agency Privacy Management, there are five primary categories of contractors as they relate to securing systems and information: 1) service providers, 2) contractor support, 3) Government owned, contractor operated facilities, 4) laboratories and research centers, and 5) management and operating contracts.

The requirements document provides standardized security/privacy requirements for VA contractors that support activity involving access to, and use of, sensitive information across the Department. The requirements apply to:

(1) All VA or contracted services and information resources located and operated at contract facilities, at other government agencies that support VA mission requirements, or any other third-party using VA sensitive information in order to perform a VA authorized activity.

(2) All contracts in which VA sensitive information is used, stored, generated, transmitted, or exchanged by VA, a contractor, subcontractor or a third party, or on behalf of any of these entities, regardless of format (e.g., paper, microfiche, electronic or magnetic portable media) or whether it resides on a VA owned system or contractor/subcontractor's system operating for or on behalf of VA.

To obtain a copy of the requirements document…