P_W_S_Molbile_MRI_-_August_2015.pdf

AVIANO WORKING

PERFORMANCE-BASED WORK STATEMENT

FOR

1.5T MOBILE MAGNET (MRI) SERVICE

AT

AVIANO AIR BASE, Italy

August 2015

SECTION 1

1.0. DESCRIPTION OF SERVICES. The Contractor shall provide a 1.5T Mobile Magnet and all necessities required for the transportation and operation for clinical imaging on a scheduled basis. The contractor shall provide all materials (to include any supplies needed for contrast media injections such as; contrast bottles, saline, alcohol wipes, medical tape and any essential sizes of needles) necessary tools, equipment, dressing room for patients, transportation, personnel, labor, supervision, transportation of equipment and personnel and management to provide Mobile Magnetic Resonance Imaging (MRI) services to the 31st Medical Group (31

MDG), Aviano AB, Italy.

1.1. SCOPE OF WORK (SOW). The Contractor shall provide Mobile MRI services to include a variety of MRI examinations, with and without contrast, for Government beneficiaries and patient coordinator services to assist in patient preparation for the 31st Medical Group. The contractor shall ensure that the MRI machine is delivered for use one day every two weeks, based on a mutually agreed upon schedule. Service shall include all travel, labor, parts, and materials (excluding user consumable supplies), manufacturer’s authorized field modification instructions (FMIs) tools and test equipment required to service and maintain the equipment if applicable. Additionally, service shall include English speaking MRI technician services in the mobile MRI unit with minimal radiologist intervention. The contractor shall perform services in accordance with the requirements contained in this Performance Work Statement (PWS), Joint

Commission on Accreditation of Healthcare Organizations (JCAHO), Health Insurance

Portability and Accountability Act (HIPPA), Infection Control, National Fire Protection

Association (NFPA), and Health Service Inspection (HSI) standards.

1.2. SPECIFIC TASKS:

1.2.1. Mobile MRI

1.2.1.1. Coordinates schedule of availability and delivery of the Mobile MRI for use by the 31st

Medical Group, Diagnostic Imaging for beneficiaries. The delivery will be required twice per month on a consistent basis, based on availability and need. (Contractor shall perform services

10 hours a day one day a week every other week, excluding federal holidays. The Government will notify contractor of required workdays by the 10 th of each month of the preceding month.)

If rescheduling is required, the 31st Medical Group must be notified in advanced due to logistical scheduling of patients.

1.2.1.2. Ensures the Mobile MRI is in-place, functioning and ready for use from 0730 to 1730 on the scheduled day of delivery (to include quality control (QC) procedures, telephone, and connectivity setup).

1.2.1.3. Provides diagnostic quality images for interpretation by the radiologist. Diagnostic quality must be equal to that performed on a 1.5T stationary unit. The adequacy of image quality for diagnosis is determined by the interpreting radiologist.

SECTION II

GOVERNMENT FURNISHED PROPERTY AND SERVICES

2.0. EQUIPMENT. Contract personnel shall have use of all available equipment for performing services required by this contract.

2.1. FORMS. The Medical Treatment Facility (MTF) will provide required Government forms used in the performance of services.

2.2. RECORDS, FILES, DOCUMENTS, AND WORK PAPERS. All records, files, documents, and work papers provided by the government remain Government property. The

Government Representative assigned to this contract will provide guidance to the contract personnel who shall maintain and dispose of these records, files, documents, and work papers in accordance with MTF policy and procedures.

2.3. SPACE, UTILITY, TELEPHONE SERVICES. The government shall provide the contractor all reasonable amounts of electric power and other utilities necessary to perform the service. The government will also provide, in case of emergency only, the following services:

a. Security Police

b. Fire Protection

c. Hospital Emergency Service on a reimbursable basis

The above services can be accessed by dialing 911 on the base phone. The contract manager must report immediately to GR if these services are used.

2.4. CONTRACTOR OWNED/CONTRACTOR OPERATED EQUIPMENT. The

contractor will furnish the Mobile MRI machine and all additional supplies and equipment needed for normal operations necessary for conducting medical imagery.

SECTION III

GENERAL INFORMATION

3.0. HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT (HIPAA)

OF 1996 COMPLIANCE. The Contractor agrees to abide by all the requirements of HIPAA as codified at 45 CFR Part 160 and Part 164, subparts A and E, and implemented by DoD 6025.18-

R regarding the privacy and confidentiality of health records and information being provided and shared under the resulting contract. The Contractor shall also comply with the Business

Associate Agreement listed in section 6.0 of the appendix and hereby incorporated into this performance-base work statement.

3.1. PERSONNEL.

3.1.1. POINT OF CONTACT. The Contractor shall provide a point of contact that shall be responsible for the performance of the work (primary & alternate). The point of contact shall have full authority to act for the contractor on all matters relating to the daily operation of this contract. The point of contact may be an individual providing service/delivery in accordance with this SOW. The contractor shall designate this individual, in writing, to the Contracting

Officer (CO) and Government Representative before the contract start date. An alternate may be designated, but the contractor shall identify those times when the alternate shall be the primary point of contact.

3.1.2. AVAILABILITY. The Contractor shall provide a point of contact and/or telephone number by which the contractor shall be contacted. Pagers, answering services or answering machines are acceptable, provided messages are returned the same or following duty day from the date left by the Government.

3.2. PHYSICAL SECURITY. The contractor shall be responsible for safeguarding all medical information provided for contractor use. At the close of each work period, information shall be secured.

3.3. EMERGENCY HEALTH CARE. The MTF will provide emergency health care for contract personnel for injuries occurring while on duty in the MTF. These services will be billed to the Contractor at the current full reimbursement rate.

SECTION IV

HIPAA

4.0. 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 employees 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 employees 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.

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.

(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

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 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.

APPLICABLE PUBLICATIONS AND FORMS

Publications and forms applicable to the statement of work (SOW) are listed below. The

Contractor is obligated to follow those publications. These publications are available in the MTF and maintained by the Government. Supplements or amendments to listed publications from any organizational level may be issued during the life of the contract. The Contractor shall immediately implement those changes in publications, which result in a decrease or no change in the price and notify the Contracting Officer (CO) in writing of such change. Should a decrease in contract price result, the Contractor shall provide a proposal for reduction in the price to the

CO. Prior to implementing any change that will result in an increase, the Contractor shall submit to the CO a price proposal within 30 days of receipt of the change by the Contractor. The CO and the Contractor shall negotiate the change into the contract under the provisions of the contract clause entitled "Changes". Failure of the Contractor to submit a price proposal within

30 days from receipt of the change shall entitle the Government to performance in accordance with such change at no increase in price.

Applicable Technical, Regulations, References, Manuals, Specifications, and

Documentation. This list includes, but is not limited to the following:

Alcohol, Drug Abuse, and Mental Health Administration Reorganization Act of 1992

Privacy Act of 1974

Title VI of the Civil Rights Act of 1964

Section 504 of the Rehabilitation Act of 1973

DoD Directive 5400.11-R, “The Freedom of Information Act of 1967”

Health Insurance Portability and Accountability Act of 1996 (HIPAA)

Electronic and Information Technology Accessibility Standards (36 CFR 1194)

DOD Regulation 5200.2-R, “DoD Personnel Security Program,” January 1987

Standards for Privacy of Individually Identifiable Health Information, Final Rule, December 28, 2000 and adopted modifications of the Rule on August 14, 2002.

5 U.S.C. § 552a, as amended

32 CFR 199

Rehabilitative Act of 1973, Section 508 as amended (29 U.S.C. §794d)Appointment Standardization

Commander’s Guide to Access Success dated May 15, 2002 TRICARE Operations Manual, 6010.51-M, February 1, 2008, Chapter 21, Section 3

TRICARE Systems Manual, 7950.1-M, February 1, 2008, Chapter 1

Accreditation Process (DITSCAP)

DoD Health Information Privacy Regulation (DoD 6025.18-R)

DOD Privacy Program (DoD 5400.11-R)Title 10, U.S.C., Chapter 55

DOD Instruction 1402.5, Criminal History, Jan 93

Background Checks on Individuals in Child Care Services

DOD Directive 5500.7, Standards of Conduct, Mar 87

AIR FORCE REGULATIONS/MANUALS/INSTRUCTIONS

AFMAN 33-152, User Responsibilities and Guidance for Information Systems

AFI 36-2108, Classification of Military Personnel

AFI 41-210, Patient Administration Functions

AFI 44-119, Medical Service Quality Improvement and Risk Management, Aug 2011

OTHER REFERENCES

Joint Commission on Accreditation of Healthcare Organizations (JCAHO) Accreditation Manual for Hospitals, current edition http://www.jointcommission.org/