Mobile MRI PWS_Final_ Aug 2020.pdf

PERFORMANCE-BASED WORK STATEMENT

FOR

1.5T MOBILE MAGNET (MRI) SERVICE

AT

AVIANO AIR BASE, Italy

August 2020

SECTION TITLE

I. DESCRIPTION OF SERVICES

II. SERVICE DELIVERY SUMMARY

III. EQUIPMENT, SUPPLIES, AND SERVICES

IV. GENERAL INFORMATION

V. APPENDIX

SECTION 1

DESCRIPTION OF SERVICES

1.0. GENERAL. The Contractor shall provide a 1.5T Mobile Magnetic Resonance Imaging (MRI) Scanner and all necessities required for the transportation and operation for clinical imaging on a scheduled and as needed 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 MRI services to the 31st Medical Group (31 MDG), Aviano AB, Italy.

1.1. SCOPE OF SERVICES. The Contractor shall provide Mobile MRI services to include a variety of MRI examinations 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 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. 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 Mobile MRI is scheduled to come out up to three times per month. We will call to set up an appointment as needed. Requiring the Mobile MRI truck to arrive no later than three days from the time we make an appointment.

1.2.1.2. Ensures the Mobile MRI is in-place, functioning and ready for use by 0730 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.

1.2.1.4. If rescheduling is required, the 31st Medical Group must be notified 48 hours in advanced due to logistical scheduling of patients.

1.3. ADMINISTRATIVE. Basic knowledge level includes: principles of customer service, guidelines for release of medical information, medical and legal ethics, infection control concepts, applicable systems technology, supply procedures, and information systems.

SECTION II

SERVICE DELIVERY SUMMARY (SDS)

SDS # and Performance Objectives

SOW

Para

Performance Threshold Yes No

Method of Surveillance

SDS 1: Did the service provider mutually agree upon an appropriate schedule for delivery?

1.2.1.1 100% 100%

Inspection

SDS 2: Was the service provider in place and ready to perform/shoot images on-time?

1.2.1.2 100% 100%

Inspection

SDS 3: Did reasonable coordination take place regarding availability and delivery of the Mobile MRI on an as needed basis if needed more frequently?

1.2.1.3 100% 100%

Inspection

SDS 4: Was the image quality provided equal to a 1.5T stationary unit and were the images diagnostic according to the interpreting radiologist?

1.2.1.4 100% 100%

Inspection

SDS 5: If rescheduling was required, was the 31st Medical Group notified 48 hours in advanced?

1.2.1.5 100% 100%

Inspection

SECTION III

EQUIPMENT, SUPPLIES, AND SERVICES

3.0. GENERAL. Except for those items or services specifically stated in Section 3.2 to be Government furnished, the Contractor shall furnish everything required to perform this contract in accordance with all of its terms.

3.1. 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.

3.1.1. INITIAL INSPECTION. All contractor owned equipment shall be inspected and approved by the biomedical equipment maintenance section prior to use in the facility.

3.1.2. REPLACEMENT OF CONTRACTOR EQUIPMENT. If, in the judgment of the biomedical equipment maintenance section personnel, a piece of contractor owned and operated equipment is unsafe, based on diagnostic testing and established industry standards, it shall be tagged as unserviceable and removed from use. Replacement of equipment shall be at the contractor’s expense.

3.2. GOVERNMENT EQUIPMENT/SUPPLIES. The Government will provide the following equipment, supplies, and services listed below:

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

3.2.2. ORIENTATION/TRAINING. The Government will provide training on Government provided forms and equipment, universal precautions, initial orientation and continuing orientation. Participates in evaluation of the quality and effectiveness of activities and services of the unit.

3.2.3. 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.

3.2.4. 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

SECTION IV

GENERAL INFORMATION

4.0. PERSONNEL REQUIREMENTS. General Information applies to all personnel unless stated otherwise.

4.1. EDUCATION, TRAINING, LICENSURE, AND EXPERIENCE. The Contractor shall ensure that personnel performing services shall meet the minimum requirements established by the Italian Society of Medical Radiology for the performance of MRI examinations.

4.2. ENGLISH LANGUAGE REQUIREMENT. Contractor personnel must read, write, speak, and understand English fluently.

4.3. IDENTIFICATION. All contract personnel shall be clearly identifiable while on duty.

4.3.1. All contract personnel shall wear a contractor provided nametag with the company name, individual’s name, and specialty displayed:

e.g., XXX Company

JANE A. SMITH, R.N

4.3.2. The nametag shall be worn on the outermost garment.

4.4. 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.

4.5. HEALTH REQUIREMENTS: Certification of current physical examination for each employee. The certification shall contain a signed statement by the examining physician stating that the employee is free of any contagious diseases. Physical examination must be current within 12 months prior to application for privileges. Initial documentation is required for: MMR (immunization or titer levels for Rubella and Rubeola), history of chicken pox disease or positive titer (varicella vaccination must be accomplished if lack of immunity), Tetanus Diphtheria (Td), TB Mantoux skin test (IPPD) if positive, minimum requirement will be follow-up with the Contractor’s physician and a chest x-ray. A physician must provide documentation of “no active respiratory disease.”

4.6. 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 5.1 of the appendix and hereby incorporated into this performance-based work statement.

4.7. PROCEDURE GUIDANCE. The Contractor shall perform services compatible with the medical facility’s operating capacity.

4.8. PATIENT LISTS. Patient lists, no matter how developed shall be treated as privileged information. Lists and/or names of patients shall not be disclosed to or revealed in any way for any use outside the MTF without prior written permission by the Government.

4.9. PATIENT SENSITIVITY. Contract personnel shall respect and maintain the basic rights of patients, demonstrating concern for personal dignity and human relationships. Contract personnel receiving complaints validated by the Quality Assurance Evaluator (QAE) and Flight Commander shall be subject to counseling and, depending on the nature and severity of the complaint, separation from performing service under this contract.

4.10. SECURITY REQUIREMENTS. The contractor shall achieve the same level of trustworthiness for contractor or subcontractor personnel as required for Government personnel with similar access to automated information systems (AISs) and networks containing DoD Sensitive Information (SI). The contractor shall meet the personnel security requirements for Automated Data Processing (ADP) access in DoD 5200.2-R, Personnel Security, for employees and subcontractor employees that require access to Government (IT) systems or DoD SI, or are involved in developing, delivering, or supporting IT systems and services, or safeguarding DoD sensitive information within Government or contractor systems. The contractor shall classify ADP/IT or related positions, submit appropriate paperwork for background investigations or proof of a favorable adjudication, ensure individuals receive requisite training, and document compliance. Personnel background investigations and training must be initiated before access to DoD AIS/networks or DoD SI is allowed. Following contract award, details for completing and forwarding forms for requesting an investigation will be coordinated with the Government IT Security Officer designated for the networks and systems being accessed.

4.10.1. The contractor shall use Protected Health Information (PHI) for their designated project only. This information shall not be used to create databases or any other product not intended for use specifically for this project. All PHI related to the project, but not delivered to the Government, shall be destroyed at the conclusion of the tasking.

Destruction of the information shall comply with The Deputy Secretary of Defense Memorandum, subject: “Destruction of DoD Computer Hard Drives Prior to Disposal,” dated January 8, 2001. The Memorandum requires that all hard drives containing unclassified data being disposed of outside DoD be removed and destroyed through sanitation of SI from storage media in a manner that gives assurance that the information is unrecoverable by technical means.

4.10.2. All PHI processed and hard copy output by government and contractor Information Systems, ISs, and networks is considered SI and will be treated as “For Official Use Only”, FOUO, information, as directed by DoD 5400.7, “Freedom of Information Act,” September 1997. Any SI (e.g., PHI and privacy data, processed, printed, stored, or manipulated on government and contractor ISs and networks will be protected, marked, and labeled in accordance with DoD 5200.1-R.

4.10.3. The contractor shall maintain, transmit, retain in strictest confidence, and prevent the unauthorized duplication, use, and disclosure of PHI in accordance with Standards for Privacy of Individually Identifiable Health Information, Final Rule, December 28, 2000, DoD Health Information Privacy Regulation (DoD 6025.18-R), the Privacy Act, and DoD Privacy Program (DoD 5400.11-R). The Contractor shall provide patient information only to employees, Contractors, subcontractors, and Government personnel having a need to know such information in the performance of their duties for this project. The Contracting Officer’s representative or QAE shall approve the release of any patient information prior to the release.

4.11. COMMUNICATION. The contractor shall ensure contract personnel maintain open and professional communication with members of the MTF. Complaints validated with the QAE and Flight Commander shall be reported in writing to the contract administrator and the contractor for action. Failure of the contractor to correct validated complaints shall result in writing to the contract administrator and the contractor for action. Failure of the contractor to correct validated complaints raised by the MTF staff and the CO shall be considered a failure to perform.

4.12. PERSONNEL.

4.12.1. POINT OF CONTACT. The Contractor shall provide a point of contact who 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.

4.12.2. 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.

4.12.3. WORK ROSTER. The point of contact shall provide a list by date and time with individual contract employees for those days the contractor shall be providing services.

This list shall be provided to the Government Representative by the 20th of each month of the preceding month. Proposed work schedule changes shall be submitted to the QAE at least 48 hours in advance.

4.12.4. CONTINUITY OF SERVICES. If routine services are disrupted for more than three (3) consecutive scheduled shifts the Government reserves the right to procure such services from another source, until the contractor restores routine services. When the Government exercises its right to procure these services from another source, the

Government will reduce the contractor’s invoice at an equivalent amount to that incurred.

A copy of the other source’s service ticket will be used as the basis for this reduction. The Government will furnish the contractor a copy of this ticket upon the contractor’s request.

4.13. 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.

4.14. HOURS OF OPERATION. Contractor service shall be made available Monday through Friday, 0730-1630, or as negotiated with the MTF, equal to a minimum delivery of an 8 hour period of time up to three times per month, excluding federal holidays. The Government will notify contractor of required workdays by the 15th of each month of the preceding month.

4.15. QUALITY CONTROL

4.15.1. PERFORMANCE EVALUATION MEETINGS. The CO shall require the contractor or representative to meet with the CO, contract administrator, QAE, and other government personnel as deemed necessary. The contractor shall request a meeting with the CO when deemed necessary. Meetings shall be documented in the contract file with written minutes signed by the contract manager and the CO, or contract administrator. If the Contractor does not concur with the minutes, the non-concurrence shall be provided in writing to the CO within 3 calendar days of receipt of the minutes. (3-4 days should be enough unless specified in an instruction)

4.15.2. In compliance with the contract clause entitled Inspection of Services, the contractor shall provide a Quality Control (QC) Plan.

4.15.3. The Contractor QC program shall include:

4.15.3.1. Continuing review of the contract performance including compliance with regulations referenced in the contract. Review shall be accomplished and recorded on a schedule as dictated by the contractor's written QC Plan. Records shall be made available to the Government Representative upon Government request throughout the contract performance period and for the period after contract completion until final settlement of any claims under this contract.

4.15.3.2. A method of identifying deficiencies in the quality of service before the level of performance deteriorates to an unacceptable level. Audit results shall be made available to the QAE upon Government request.

4.15.3.3. Subsequent changes thereto shall be provided to the CO for review and acceptance before implementation.

4.16. ADMINISTRATIVE QUALITY ASSURANCE (QA). In accordance with the Inspection of Services clause, the Government will evaluate the Contractor's performance under this contract. The Government will record all surveillance observations. When an observation indicates defective performance, the Government Representative will require the contractor's representative at the site to initial the observation documentation. The contractor's representative initialing the observation documentation does not necessarily constitute concurrence with the observation, only acknowledgment. Government surveillance of tasks may occur at any time during the performance period.

4.17. FEDERAL HOLIDAYS. Contractor personnel shall not be required to provide service on federal holidays. Federal holidays are defined in Section 5 Appendix.

4.18. 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.

4.19. OTHER.

4.19.1. SMOKING POLICY. Smoking is not permitted within the MTF. Smoking is permitted outside the MTF buildings in designated areas only.

4.19.3. The Contractor shall submit only complete applications for processing. Incomplete applications (those that do not fully comply with the requirements) will not be accepted by the Government and will be returned without action.

4.19.4. The Contractor shall submit applications for only those contract personnel who can reasonably be anticipated to render the actual, substantial performance on the contract. The submission of primary contract personnel for approval who lack the requisite qualifications, or who will not work at all, is unacceptable and will be considered a failure to perform.

4.19.5. All personnel under this contract will understand and be aware of their responsibility to protect critical information, utilize Operations Security (OPSEC), and abide by installation OPSEC requirements as outlined in AFI 10-701.

4.20. PERIOD OF PERFORMANCE: 30 Sep 2020 through 29 Sep 2021 (12 months from date of contract award) for the base year, plus 2 option years.

SECTION V

APPENDIX

5.0. DEFINITIONS. As used throughout this work statement, the following terms shall have the meaning set forth below:

CONTRACTING OFFICER (CO). A person duly appointed with the authority to enter into, administer, and terminate contracts on behalf of the Government.

FEDERAL HOLIDAYS. There are ten (10) federal holidays each year. They are New Year’s Day (observed 1 January), Martin Luther King, Jr’s Birthday (observed the third Monday in January), President’s Day (observed the third Monday in February), Memorial Day (observed the fourth Monday in May), Independence Day (observed 4 July), Labor Day (observed the first Monday in September), Columbus Day (observed the second Monday in October), Veterans Day (observed 11 November), Thanksgiving Day (observed the fourth Thursday in November), and Christmas Day (observed 25 December). If New Year’s Day, Independence Day, Veterans Day or Christmas Day falls on a Saturday, it is observed on Friday; if it falls on Sunday, it is observed on Monday.

GOVERNMENT. The federal government of the United States of America.

GOVERNMENT QUALITY ASSURANCE. Those actions taken by the Government to assure services meet the requirements of the contract.

LICENSURE. Documents providing evidence of education, training, license, experience, certification and/or expertise.

MEDICAL TREATMENT FACILITY (MTF). Air Force hospitals or clinics, including all activities providing outpatient and/or in-patient health care services for authorized personnel.

GOVERNMENT REPRESENTATIVE. Government employee responsible for evaluating the administrative performance of the Contractor.

QUALITY CONTROL (QC). Those actions taken by a Contractor to control the quality of output to ensure that they conform to contract requirements and reasonable standards of medical care.

STATEMENT OF WORK (SOW) or PERFORMANCE-BASED WORK STATEMENT (PWS). A document that accurately describes a service in terms of the output requirements.

5.1. 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.

5.2. APPLICABLE PUBLICATIONS AND FORMS

Publications and forms applicable to the PWS 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.

5.2.1. TECHNICAL REGULATIONS, 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, 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

5.2.2 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

5.2.3. OTHER

Joint Commission on Accreditation of Healthcare Organizations (JCAHO)

Accreditation Manual for Hospitals, current edition http://www.jointcommission.org/