STATEMENT_OF_WORK.pdf

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Statement of Work

Tele-mammography Contract

Non-Personal Services

17 July 2014

DESCRIPTION OF SERVICES:

The contractor shall provide (NON-PERSONAL) professional diagnostic radiological interpretations and reports, by board certified radiologists for the 30th Medical Group (30 MDG), Vandenberg Air Force Base, CA called for under this service contract. Services shall be performed at the contractor's facility. The contractor shall identify one qualified Lead

Interpreting (LI) radiologist to mammography, preferably for entire contract period. Designated

Duty Hours will be coordinated after contract award to best meet the needs of both parties and

30 MDG patients (30 MDG duty hours are Monday-Friday 7:30-4:30).

TYPE OF WORK. The duties include but are not limited to the following:

Services shall include professional preliminary and final interpretation as well as specific consultation as needed. Examinations are screening mammograms (approximately 10-15, these are expected averages, and may increase/decrease on a weekly basis) mammograms per week.

The Mammography LI Radiologist services shall include but are not limited performing LI duties in accordance with (IAW) Mammography Quality Standards Act (MQSA) and American College of Radiology (ACR) regulations and inspections, providing oversight to the Medical Outcomes

Audit Program, and provide adequate supervision for Mammography Quality Control (QC)

Program IAW MQSA/ACR.

Provide written or telephonic advice and professional opinions upon request by the 30 MDG providers for patient care and treatment as it pertains to interpretations conducted by contractor.

Discuss findings with ordering provider if necessary.

Facilitate patient access to medical care by recommending appropriate referrals to other health care providers in accordance with policies and regulations of the medical treatment facility.

Provide electronic diagnostic interpretation of radiological examinations performed by

Government personnel. The signature of the interpreting radiologist shall be clearly noted on all interpretive reports. Email electronic report of patient results within a 96 hour (4-day) period upon receipt of images. Reports must comply with MQSA/ACR regulations (i.e., name of interpreting radiologist, overall final assessment using BI-RADS terminology and recommendations). Lead Mammography Technologist will approve final interpretation template.

Make necessary addendums to reports as needed.

Provide relevant feedback to diagnostic imaging staff, which includes performance and inspections. Recognize discrepancies and communicate with technologist/s.

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The Contractor shall ensure quarterly peer review is performed on the primary contract radiologist in accordance with current Accreditation Association for Ambulatory Health Care guidelines, and MTF and Air Force policies. The contractor shall submit peer review documentation to Lead Mammography Technologist.

MQSA REQUIRMENTS:

The contractor shall submit the following documentations IAW MQSA/ACR regulations to Lead

Mammography Technologist, -State License (must indicate expiration date), -Board Certification in Radiology by American Board of Radiology (ABR) or American

Osteopathic Board of Radiology (AOBR), -*Initial Category I Education: minimum of 60 hrs (40 hrs if interim regulations apply) of documented medical education in mammography, which shall include: Instruction in the interpretation of mammograms and education in basic breast anatomy, pathology, physiology, technical aspects of mammography, and quality assurance and quality control in mammography. All 60 of these hours shall be category I and at least 15 of the category I hours shall have been acquired within the 3 years immediately prior to the date that the physician qualifies as an interpreting physician. Hours spent in residency specifically devoted to mammography will be considered as equivalent to category I continuing medical education credits and will be accepted if documented in writing by the appropriate representative of the training institution, -*Initial Experience: Have interpreted or multi-read, under direct supervision, at least 240 mammographic examinations in the 6 months immediately prior to qualifying as an interpreting physician OR if the physician passed his/her certifying board in diagnostic radiology at the first allowable time the 6 month period could have been anytime in the last two years of the residency program, *Or if unavailable proper attestation will be acceptable upon review

-Continuing Education: Have taught or completed at least 15 category I continuing medical education (CME) during the past 36 months, -Continuing Experience: Have interpreted or multi-read at least 960 mammography exams during the past 24 months, -New Modality, if applicable.

The contractor shall submit Annual Physicists Survey IAW MQSA/ACR regulations to Lead

Mammography Technologist. Survey must meet contractors and 30 MDG manufacturers specifications for equipment used for final interpretation (i.e., viewbox, rolloscope, etc, and/or

FDA approved monitors-5 MP). Contractor shall submit Quality Control documents for FDA approved monitors-5 MP.

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Computer hardware utilized for viewing images shall be capable of resolution display quality in accordance with the MQSA/ACR Teleradiology Standard.

CREDENTIALING AND PRIVILEGING:

Physicians will not provide any patient care until they have been appropriately credentialed and privileged by the 30 MDG Credentialing Department.

QUALITY ASSURANCE/CONTROL.

The Government shall monitor the contractor’s performance under this contract using quality assurance procedures established by the MQSA/ACR regulations and 30 MDG. Additionally, the contractor’s performance is subject to scheduled and unscheduled review.

The contractor shall have an internal quality control procedure, which shall ensure the contractor’s performance/medical care evaluation will be at a level commensurate with standards of the medical profession and the MQSA/ACR. Major discrepancies that would result in a change to a patients care plan should be minimized. The Contractor’s QC plan must be submitted with their initial proposal and any site-specific plan shall be included with a proposal resulting from this contract.

SERVICES SUMMARY

Performance Objective Ref

Performance Threshold

Ensure all breast examinations are completed/received by 30 MDG within 96 hours of receipt of images.

100%

Maintains 960 mammography examinations at all times.

100%

Utilize BIRADS terminology in all inputted breast examinations.

100%

CONFLICT OF INTEREST. The Contractor shall not employ any person who is an employee of the United States Government if the employment of that person would create a conflict of interest. The Contractor shall not employ any person who is an employee of the Department of the Air Force, either military or civilian, unless such person seeks and receives approval in accordance with DoD Directive 5500.7 and Air Force policy.

POINT OF CONTACT. The Contractor shall provide a point of contact that shall have full authority to act for the Contractor on all matters relating to the operation of this contract via telephone and/or fax.

CONTINUITY OF SERVICES/REPLACEMENT STAFF. The contractor shall ensure sufficient staffing and resources to provide all required services and support throughout the term of the contract. The Contractor’s POC shall notify the Lead Mammography Technologist as early as

Attachment 1 Page 4 possible of programmed absences of the radiologist to allow for planning of service coverage and scheduling changes.

RELATIONSHIP OF THE PARTIES. This is a non-personal service contract. Contract personnel are not subject to the supervision and control of a Government officer or personnel

[FAR 37.104(a)(1)(ii)]. Rather, contractor personnel perform their duties IAW specific tasks outlined in the PWS. Supervisory functions such as hiring, directing, counseling, and firing of contractor personnel are not performed by the Government. The contracted personnel who furnishes services under this contract is subject to Government technical oversight of the services provided. The Government retains the right to reject services for contractual nonperformance.

RELEASE OF MEDICAL INFORMATION. The Contractor shall release medical information obtained during the course of this contract to Military Treatment Facility (MTF) staff involved in the care and treatment of that individual patient only in accordance with Appendix A.

SECURITY. The Contractor is responsible for maintaining the security of patient information in accordance with HIPAA guidelines. Unauthorized access to Contractor controlled data will be reported to the CO and 30 MDG QAP immediately. See Appendix A.

PROCEDURE GUIDANCE. Contractor shall perform procedures compatible with the medical facility's operating capacity and equipment. New medical procedures/services shall not be introduced without prior recommendation to, and approval of the CO.

COMMUNICATION. Contractor personnel shall maintain open and professional communication with members of the MTF staff. Complaints validated by the Chief of Service shall be reported in writing to the COR to the CO and Contractor for action. Failure of the Contractor to correct validated complaints will be considered a failure to perform.

DOCUMENTATION. Contractor personnel shall prepare all documentation to meet or exceed established standards of the 30 MDG, to include, but not limited to, timeliness, accuracy, content and signature.

GOVERNMENT AND CONTRACTOR PROPERTY AND SERVICES.

Contractor. The contractor shall provide all uniforms, labor, transportation and supervision necessary to provide: Radiology Services. Radiologist will utilize his/her own equipment for performing services required by this contract.

Government. The Government will provide prior and current mammography images (CD-ROM or films) via mail to the contactor for diagnostic radiological interpretations along with any clinical information available to the radiologic technologist. If available, ultrasound images will be provided. CD-ROM or films will be placed in a shipping box and shipped to the contract radiologist via overnight Federal Express.

All digital images and accompanied data shall remain the property of, and subject to the exclusive control of the U.S. Government. All related reports, images, and documents prepared by the contractor for diagnostic imaging interpretation and support in fulfillment of this contract will become the property of the U.S. Government.

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This is not intended to be a comprehensive list of all contractor/government furnished property, it covers the core components that are possibly involved in a complete personnel equipment, and service solution. The contractor is required to assess the full extent of support necessary to provide the required services, equipment, and/or personnel for this contract. Compliance with the elements of this section are only relevant to the extent it is applicable to this contract.

GENERAL INFORMATION

Maintenance of computer hardware to ensure capability and submission of those maintenance records if requested by the Government.

No work shall be performed outside of the United States.

Qualified applicants will be invited for an interview (in person or by telephone).

After receipt of contract award, the contractor shall furnish a list of qualified radiologists, including name and telephone number, scheduled to perform services during the performance of this contract.

The contractor shall communicate any problems encountered during the performance of the contract to the CO, who will seek a timely resolution of the problem.

APPENDIX A

HIPAA BUSINESS ASSOCIATE AGREEMENT

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HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT (HIPAA) OF 1996

HIPAA is comprised of several different sections, each to be implemented by the Dept. of

Health and Human Services. The medical facilities of the military services and the DOD health plans are specifically listed as covered by HIPAA. Currently, HIPAA Privacy and

Security Rules, as set forth in the Code of Federal Regulations, are in effect for all MTFs.

The specific implementation of HIPAA Privacy for DOD medical facilities is set forth in

DOD 6025.18-R, and for HIPAA Security, the requirements for AF MTFs are contained in

DOD 8580.02-R and AFI 41-217, which also contains additional Information Assurance requirements for all AF MTFs. DOD 6025.18-R, DOD 8580.02-R and AFI 41-217 are incorporated herein by reference. MTFs are responsible to insure overall compliance with HIPAA requirements, which includes incorporation of certain requirements in contracts entered or amended after the respective implementation dates.

IAW these regulations, the Contractor and its personnel meet the definition of Business

Associates. Therefore, a Business Associate Agreement is required by law to comply with both the HIPAA Privacy and Security regulations. This clause serves as that agreement for each MTF, whereby the Contractor and its personnel agree to abide by all

HIPAA Privacy and Security requirements regarding health information as defined in this clause, DoD 6025-18-R, DOD 8520.02-R and AFI 41-217. Additional HIPAA requirements will be addressed when implemented.

Introduction

(a) Definitions. As used in this clause generally refer to the Code of Federal Regulations (CFR) definition unless a more specific provision exists in DOD 6025.18-R, DOD 8520.02-R or AFI 41-

217.

Individual has the same meaning as the term “individual” in 45 CFR 164.50 1 and 164.103 and shall include a person who qualifies as a personal representative in accordance with 45 CFR

164.502(g).

Privacy Rule means the Standards for Privacy of Individually Identifiable Health Information at

45 CFR part 160 and part 164, subparts A and E.

Protected Health Information has the same meaning as the term “protected health information” in 45 CFR 164.501, limited to the information created or received by The Contractor from or on behalf of the Government.

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

Required by Law has the same meaning as the term “required by law” in 45 CFR 164.501 and

164.103.

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

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

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

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

c) The Contractor agrees to use appropriate safeguards to prevent use or disclosure of the

Protected Health Information other than as provided for by this Contract.

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

(e) The Contractor agrees to mitigate, to the extent practicable, any harmful effect that is known to the Contractor of a use or disclosure of Protected Health Information by the Contractor in violation of the requirements of this Contract.

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

(g) The Contractor agrees to report to the Government any use or disclosure of the Protected

Health Information not provided for by this Contract of which the Contractor becomes aware of.

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

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

(j) The Contractor agrees to provide access, at the request of the Government, and in the time and manner designated by the Government to Protected Health Information in a Designated

Record Set, to the Government or, as directed by the Government, to an Individual in order to meet the requirements under 45 CFR 164.524.

(k) The Contractor agrees to make any amendment(s) to Protected Health Information in a

Designated Record Set that the Government directs or agrees to pursuant to 45 CFR 164.526 at the request of the Government or an Individual, and in the time and manner designated by the Government.

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(1) The Contractor agrees to make internal practices, books, and records relating to the use and disclosure of Protected Health Information received from, or created or received by the

Contractor on behalf of, the Government, available to the Government, or at the request of the

Government to the Secretary, in a time and manner designated by the 'Government or the

Secretary, for purposes of the Secretary determining the Government's compliance with the

Privacy Rule.

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

(n) The Contractor agrees to provide to the Government or an Individual, in time and manner designated by the Government, information collected in accordance with this Clause of the

Contract, to permit the Government to respond to a request by an Individual for an accounting of disclosures of Protected Health Information in accordance with 45 CFR 164.528.

General Use and Disclosure Provisions

Except as otherwise limited in this Agreement, the Contractor may use or disclose Protected

Health Information on behalf of, or to provide services to, the Government for treatment, payment, or healthcare operations purposes, in accordance with the specific use and disclosure provisions below, if such use or disclosure of Protected Health Information would not violate the

HIPAA Privacy Rule, DOD 6025.18-R, the HIPAA Security Rule, or DOD 8580.02-R if done by the Government.

Specific Use and Disclosure Provisions

(a) Except as otherwise limited in this Agreement, the Contractor may use Protected Health

Information for the proper management and administration of the Contractor or to carry out the legal responsibilities of the Contractor.

(b) Except as otherwise limited in this Agreement, the Contractor may disclose Protected Health

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

(c) Except as otherwise limited in this Agreement, the Contractor may use Protected Health

Information to provide Data Aggregation services to the Government as permitted by 45 CFR

164.504(e)(2)(i)(B).

(d) Contractor may use Protected Health Information to report violations of law to appropriate

Federal and State authorities, consistent with 45 CFR 164.502(j)(1).

Obligations of the Government

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

Restrictions

(a) Upon request the Government shall provide the Contractor with the notice of privacy practices that the Government produces in accordance with 45 CFR 164.520, as well as any changes to such notice.

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

(c) The Government shall notify the Contractor of any restriction to the use or disclosure of

Protected Health Information that the Government has agreed to in accordance with 45 CFR

164.522.

Permissible Requests by the Government

The Government shall not request the Contractor to use or disclose Protected Health

Information in any manner that would not be permissible under the HIPAA Privacy Rule, DOD

6025.18R, the HIPAA Security Rule, or DOD 8580.02-R, if done by the Government, except for providing Data Aggregation services to the Government and for management and administrative activities of the Contractor as otherwise permitted by this clause.

Termination

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

(b) Effect of Termination.

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

(2) If this contract does not have records management requirements, except as provided in paragraph (3) of this section, upon termination of this Contract, for any reason, the Contractor shall return or destroy all Protected Health Information received from the Government, or created or received by the Contractor on behalf of the Government. This provision shall apply to

Protected Health Information that is in the possession of subcontractors or agents of the

Contractor. The Contractor shall retain no copies of the Protected Health Information.

(3) If this contract does not have records management provisions and the Contractor determines that returning or destroying the Protected Health Information is infeasible, the

Contractor shall provide to the Government notification of the conditions that make return or destruction infeasible. Upon mutual agreement of the Government and the Contractor that return or destruction of Protected Health Information is infeasible, the Contractor shall extend the protections of this Contract to such Protected Health Information and limit further uses and

Attachment 1 Page 10 disclosures of such Protected Health Information to those purposes that make the return or destruction infeasible, for so long as the Contractor maintains such Protected Health

Information.

Miscellaneous

(a) Regulatory References. A reference in this Clause to a section in DOD 6025.18-R, HIPAA

Privacy Regulation or DOD 8580.02-R, HIPAA Security Regulation, or any CFR or AFI provision means the section as currently in effect or as amended, and for which compliance is required.

(b) Survival. The respective rights and obligations of Business Associate under the "Effect of

Termination" provision of this Clause shall survive the termination of this Contract.

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

8520.02-R, the CFR HIPAA Security Rule and AFI 41-217.