PWS Hyperbaric Chamber Operator 10 Sep 08.pdf

PERFORMANCE WORK STATEMENT (PWS)

HYPERBARIC CHAMBER OPERATOR

FOR

UNITED STATES SCHOOL OF AEROSPACE MEDICINE

(USAFSAM)

10 SEPTEMBER 2008

TABLE OF CONTENTS

1.0 INTRODUCTION

2.0 DESCRIPTION OF SERVICES

3.0 SERVICE SUMMARY

4.0 GOVERNMENT FURNISHED PROPERTY

5.0 GENERAL INFORMATION

6.0 TRAVEL AND OTHER DIRECT COSTS

7.0 SECURITY REQUIREMENTS

8.0 REPORTS AND DATA REPORTING REQUIREMENTS

9.0 CONTINUATION OF ESSENTIAL DOD CONTRACTOR SERVICES DURING CRISIS

10.0 APPENDICES

1.0 INTRODUCTION:

1.1 The Contractor shall provide non-personal services for Hyperbaric Chamber Operator referred to as “Contract Personnel” at San Antonio Military Medical Center (SAMMC-S), Texas. Locations include Wilford Hall Medical Center (WHMC) at Lackland AFB and United States Air Force School of Aerospace Medicine (USAFSAM) at Brooks City-Base. Contract personnel shall perform services and support compatible with the medical facility’s operating capacity and equipment.

1.2 The Contract Personnel will provide hyperbaric chamber operations for six complex multiplace and monoplace hyperbaric chambers at WHMC and at Brooks City-Base. Performance requirements are contained in this performance of work statement (PWS).

1.3 The responsibilities of the Hyperbaric Chamber Operator are to provide basic and advanced operation of hyperbaric chambers. The Contact Personnel will monitor, assist, coordinate, orchestrates treatment and assists research coordination and data collection.

2.0 DESCRIPTION OF SERVICES

2.1 Specific Tasks. The Contract Personnel shall operate six complex multiplace and monoplace hyperbaric chambers at WHMC and at Brooks City-Base. The Contract Personnel will monitor patients inside the chambers during hyperbaric treatments as the chamber operator, assist in patient treatment process and disposition, coordinate with medical and maintenance personnel on chamber equipment configuration and modification for hyperbaric treatment and hyperbaric medicine research, serves as an inside tender in mutiplace chambers as needed, orchestrates treatment schedules for hyperbaric research patients and assists research coordination including, physician referrals, records management, Institutional Review Board requirements, and data collection.

2.2 Qualifications. The Contract Personnel shall meet the following qualification requirements.

2.2.1 The technician is required to have a working knowledge of computer systems to include operating systems, communications associated peripherals, and one programming language. Technicians will also be required to enter chamber dive data into the Hyperbaric Medicine Program or equivalent program. The technician will have an operational understanding of how all of the above systems function independently and as a single system, and how they are used to test and evaluate patient environments and AF operational system environments.

2.2.2 The technician will be a graduate of an Undersea and Hyperbaric Medical Society (UHMS) Designated Introductory Course in Hyperbaric Medicine or the USAF Clinical Hyperbaric Technician Course. They must be knowledgeable about compression physics and the mechanical effects of pressure change as it relates to the hyperbaric chamber and its occupants. The technician shall understand the physiological basis and clinical aspects of decompression sickness and arterial gas embolism. The technician will understand and use U.S. Navy decompression tables, NOBENDEM decompression tables, and hyperbaric patient treatment tables.

The technician shall set up and operate specialized medical equipment. Additionally, the candidate shall apply chamber safety to the everyday working environment and follow emergency procedure checklists in the event an emergency occurs.

2.2.3 The Contract Personnel shall have and maintain a current Basic Life Support (BLS) certification with the American Heart Association or Red Cross agencies.

2.2.4 Clinical Hyperbaric Technician (CHT) certification from the National Board of Diving and Hyperbaric Medical Technology is desirable but not mandatory.

2.2.5 The contractor should have experience handling body fluid soiled patient linens. International infection control safety precautions shall be used at all times.

2.2.6 Contractor shall be able to lift 40 lbs.

2.3 Health Requirements and Immunizations. All Contractor personnel shall control and prevent disease in accordance with AFI 48-105 Surveillance Prevention and Control of Diseases and Conditions of Public Health or Military Significance, and the American Public Health Association Publication, Control of Communicable Diseases Manual, and the Centers for Disease Control and Prevention (CDC) publication, Morbidity and Mortality Weekly Report, Air Force Policy (as applicable) and its supplements.

2.3.1 The Contractor shall provide proof of immunization or immunity from or screening for the following diseases according to Air Force guidelines equivalent to that provided to active duty armed forces: Hepatitis B, MMR (Measles, Mumps, and Rubella), Varicella, Tdap (Tetanus, Diphtheria, and Pertussis), Tuberculosis (TB), HIV (Contract Personnel who have direct patient care) and influenza (IAW 1.2.8.2.) for all personnel prior to contract performance. For the TB screening, the Contractor shall provide proof of negative TB 2-step skin testing in accordance with (IAW) CDC recommendations outlined in attachment one (1) of this document. If an individual has a past positive TB skin test, the Contractor shall provide proof of a negative chest X-ray within twelve (12) months prior to personnel performing. The Government reserves the right to require more frequent Tuberculosis testing of personnel based on the facilities’ annual TB risk assessment. Additional vaccines as they are made mandatory for health care workers may also be required in unusual circumstances.

2.4 Staffing. The Contractor shall provide qualified and trained Contract Personnel to cover the required hours of performance. The Contractor shall staff and Contract Personnel to meet the requirements in this PWS and ensure continuity of performance. If the Contract Personnel are absent for more than three (3) consecutive working days, the Contractor shall initiate replacement action on the fourth day.

3.0 SERVICE SUMMARY

Performance Objective PWS

Para Performance Threshold Surveillance

Method Operate six complex multiplace and monoplace hyperbaric chambers

2.1 Not more than one (1)

substantiated complaint per month.

Customer Feedback

Monitor patients inside the chambers during hyperbaric treatments

2.1 Not more than one (1)

substantiated complaint per month.

Customer Feedback

Orchestrates treatment schedules for hyperbaric research patients

2.1 Not more than one (1)

substantiated complaint per month.

Customer Feedback

Provide proof of immunization or immunity

2.3.1 100% compliance.

100% Inspection

Provide coverage during requested hours of performance

5.2 Not more than one (1)

substantiated complaint per month.

Customer Feedback

4.0 GOVERNMENT FURNISHED PROPERTY AND SERVICES

4.1 Facilities and Support Services. The Government will provide use of all available Military Treatment Facility (MTF) facilities and support services, materials, publications and forms, equipment, and specialty clothing required for contract performance (except as designated in the contract).

4.2 The Contract Personnel shall keep Government furnished supplies, equipment, and work areas in a safe, orderly and clean condition. The Contract Personnel shall notify the hyperbaric supervisory staff whenever maintenance of equipment is required. The Contract Personnel shall not use Government facilities or other Government property for personal or other business not related to this contract.

4.3 Personal Protective Equipment (PPE). The Government will furnish the Contract Personnel with appropriate common use PPE (e.g., face shield, gloves). The Government will be responsible for any repair, cleaning, and inventory required for the PPE. Items used shall be returned as directed by the hyperbaric supervisory staff. This does not include any type of personal uniform items such as safety glasses or earplugs which are the Contractor’s responsibility.

4.4 MTF Orientation. The Contract Personnel shall attend the MTF Orientation at the outset of their working at MTF. The MTF Orientation will familiarize the Contract Personnel with the policies and procedures of the MTF and will be scheduled by the designated government representatives within two months of employment. Orientation attendance shall be required of the Contract Personnel during government-paid duty hours.

4.5 Training. The Government will schedule and furnish initial and annual training to include various applicable software, data base systems, quality assurance policies, radiation safety, local in-service, safety briefings, compliance, patient safety, performance improvement, risk management, infection control, fire protection, security, and patient sensitivity training. The classes may be scheduled individually throughout the year or scheduled at one time.

4.6 Specialty Training. The Government may provide voluntary specialty training to Contract Personnel in a non-paid status.

4.7 Space. Any space used by Contract Personnel in performance of this contract may be used for other purposes during their absence. Items of clothing, personal effects, or equipment may not be able to be secured at the MTF. The Government will not incur any liability for theft, damage to, or loss of such personal items.

4.8 Telephone. The Government will provide local telephone service, Class-A telephone lines and Defense Switching Network lines limited to matters related to the performance of this contract. Personal long distance calls are not authorized.

4.9 Badges. The government will provide MTF ID badges and will be worn/displayed at all times.

4.10 Pager. When on-call, the Contract Personnel shall use the communication device (pager) or other electronic device issued by

MTF.

4.11 Uniforms. The MTF shall furnish surgical scrubs. These items will be cleaned at the MTF’s expense.

5.0 GENERAL INFORMATION

5.1. Contractor Representative. The contractor shall identify the name and local telephone number of the contractor’s local point of contact to the contracting officer (CO) in writing prior to beginning performance. The contractor shall identify in the designation letter any limitations on its representative's authority to act on behalf of the contractor. The contractor shall provide an updated designation letter whenever any changes occur. The contractor representative may be required to meet with the government during the performance of this contract at the request of the CO.

5.1.1 The Contractor Representative shall respond to a request to meet with the CO within 24 hours of notification under routine circumstances. Crisis situations shall be handled on a case by case basis as circumstances dictate.

5.2 Hours of Performance. Normal daily hours for all duty locations are between 0655 and 1600 with the following exceptions:

Required duty hours may vary depending on the work demand, however, the duty week per person shall not exceed forty (40) hours in seven (7) calendar days. The contractor shall provide on-demand coverage of up to three Contract Personnel during the normal duty hours. The Contractor shall provide full coverage (continuous presence) during the requested hours of performance. Advanced notification of at least ten (10) business days shall be provided to the contractor for the work request. The Contractor shall maintain personnel continuity to the maximum extent consistent with efficient resource management. Due to unique circumstance of research operation, flexible manning and working hours are desired.

5.2.1 Scheduled Absences. Scheduled absences shall be scheduled thirty (30) calendar days in advance and mutually agreed upon by the quality assurance (QA) or government designated representative, and the contractor.

5.2.2 Unscheduled Absences. Unscheduled absences shall be reported to the contractor or Program Manager no later than two (2) hours prior to the start of shift by the Contract Personnel. Contractor shall communicate unscheduled absences to the QA or government designated representative.

5.3 Family/Down Days. Typically, a “Family Day/Down Day” is associated with the federal holidays. The Contractor shall not bill the Government for the Family Day/Down Day unless the Contract Personnel are required to report to work. The following is a list of legal federal holidays: New Year’s Day, January 1st; Martin Luther King’s Birthday, 3rd Monday in January; President’s, Day, 3rd Monday in February; Memorial Day, last Monday in May; Independence Day, July 4th; Labor Day, 1st Monday in September;

Columbus Day, 2nd Monday in October; Veteran’s Day, November 11th; Thanksgiving Day, 4th Thursday in November; Christmas Day, December 25th.

5.4 Inclement Weather. In the event of inclement weather (snow, ice, etc.), the government will notify the contractor whether its personnel shall report and, if so, when. The contractor will instruct its personnel scheduled to report for duty (who have not yet begun their shift) whether to report and, if so, when. If the government directs the contractor not to report for any shift, the government will not pay the contractor for that shift or those shifts.

5.4.1 The contractor’s personnel on duty at the onset of inclement weather (as declared by local base officials) shall remain on duty until the end of their scheduled shift unless otherwise directed by their employer.

5.4.2 In the event that the contractor’s personnel are on duty and cannot leave the installation due to inclement weather (as declared by local base authorities), the contractor will be allowed to invoice for overtime hours.

5.5 Compliance. The Contract Personnel shall complete the Initial profile package requirements refer as Attachment 1. The Contract Personnel shall comply with all applicable Air Force Instructions (AFI), Department of Defense (DoD) Regulations, and Medical Wing Instructions (MDWI) as outlined in Attachment 2.

5.5.1 Documentation. The Contract Personnel shall prepare all documentation to meet or exceed established standards as set forth in the most current version of Air Force Instruction (AFI) 41-217, Health Information Assurance for Military Treatment Facilities.

5.5.1.1 The Contractor shall manage all data created for Government use or legally controlled by the Government, in support of the functional activity or required by AF publication, IAW with the AF records management procedures in AFI 33-322, Records Management Program, Air Force Manual (AFMAN) 37-123, Management of Records, and the Air Force Records Disposition Schedule (AF RDS) located at https://afrims.amc.af.mil/rds_series.cfm or http://www.amc.af.mil/shared/media/document/AFD- 060803-003.pdf

5.5.2 Medical Tests. The Contractor shall not obtain medical tests or procedures at the MTF, unless identified in Section three (3);

the Contractor shall be responsible for the cost of any emergency medical services received.

5.5.3 Influenza Immunization. Contractor Personnel shall receive the current influenza immunization, at contractor’s expense, equivalent to that provided to active duty armed forces personnel unless contraindicated by allergy; as an example, to eggs as evidenced by hives, difficulty breathing, itching, and other symptoms of anaphylactic hypersensitivity and/or physician’s diagnosis.

At Government’s discretion it can be accomplished as stated in paragraph 1.9.2.1 of the PWS.

5.5.4 Vaccine. Influenza vaccine will be provided by the Government, if available as determined by the MTF. Although this vaccine may be provided by the Government, it may be obtained at other facilities with the cost being borne by the Contractor. Unless vaccinated by the Government, proof of vaccination will be required.

5.6 Conduct Requirements. The government reserves the right to restrict the performance on this contract by any individual who is identified as a potential threat to the health, safety, security, general well-being, or operational mission of the MTF and its population.

The Contract Personnel shall not advise, recommend, or suggest to persons eligible to receive medical care at Government expense that such person should receive care at an outside agency or provider at any place other than as designated under this contract.

5.6.1 The Contract Personnel shall not respond to any media inquiries nor provide interviews, comments, or any other responses to the media. All inquiries or complaints from the media or other sources shall be immediately relayed to the QA or designated government representatives.

5.7 Removal of Contractor Personnel. The government reserves the right to require immediate temporary or permanent removal of any individual whose actions raise reasonable suspicion that patient care or services may be compromised in any way or that pose a threat of harm to other contractor/government personnel or self. Removal of any individual does not relieve the contractor of any performance requirement.

5.7.1 If a removal occurs, the QA will contact the CO and the contractor’s representative within twenty-four (24) hours. A meeting may be required with the CO, QA and Contractor representative to discuss further action. Notification of all removals will be made by the CO.

5.7.2 The CO will notify the Contractor if and when permanent removal is required. In the event of disagreements between the Government and the Contractor, the decision of the CO will be final. During the period of time between the removal and the final decision of the CO, the Contractor agrees to provide backup/replacement Contract Personnel in accordance with the terms of this contract.

5.8 Physical Security. Areas accessed by the Contract Personnel shall comply with base instructions for FPCON procedures, Random Antiterrorism Measures, and local search/identification requirements.

https://afrims.amc.af.mil/rds_series.cfm http://www.amc.af.mil/shared/media/document/AFD-060803-003.pdf http://www.amc.af.mil/shared/media/document/AFD-060803-003.pdf

5.9 Internal Operating Instructions. The Contractor/Contract Personnel shall abide by host unit’s current Operating Instructions (OIs) for internal circulation control, protection of resources, and regulated entry into Air Force controlled areas during normal, simulated, and actual emergency operations.

5.10 Keys and Lock Combinations. The Contract Personnel shall abide by all current MTF key control and lock combination procedures. The Contractor shall be responsible for any keys issued to the Contract Personnel. The keys shall not be duplicated. The Contractor shall ensure its Contract Personnel do not allow government-issued keys to be used by personnel other than those currently authorized. No unauthorized personnel shall be allowed entry into the locked area. Keys shall not be used to open work areas for personnel other than personnel engaged in performance of their tasks, unless authorized by the Government functional area chief. The Contract Personnel shall use keys issued to them to secure/open areas only as directed by the QA and/or functional area chief. Lost keys and/or locks shall be reported to the issuing party and QA immediately upon recognition of the loss. The QA shall notify the CO of the lost key. The Contract Personnel shall be responsible for the replacement costs of any lost keys and any associated locks.

Reimbursement shall be provided before the Government replaces lost keys or performs re-keying.

5.11 Emergency Healthcare. The MTF will provide emergency healthcare for injuries occurring while on duty. The Contractor shall reimburse the government for such services. This includes blood borne exposure protocols after start of work. The Government will provide initial testing at no cost, but the Contractor shall provide follow-up testing or reimburse the government for such services performed within the MTF. The Contractor will provide the MTF with documentation for follow-ups performed outside the MTF as required by MTF policy. The Government will provide post-exposure tuberculosis testing at no charge to the Contractor when required (ex. following exposure to active TB case with in MTF) to avoid testing delays.

5.12 Period of Performance. The period of performance for this effort is 12 months from date of award.

6.0 TRAVEL AND OTHER DIRECT COSTS

6.1 The Contract Personnel is responsible for transportation to and from the assigned duty facility.

7.0 SECURITY REQUIREMENTS

7.1. Security Training. The Contract Personnel shall be trained in accordance with AFI 31-501, AFI 31-401; AFI 33-202, Computer Security; AFI 31-101 Installation Security; AFI 33-203, Emission Security (EMSEC) and AFI 33-204, Information Protection Security Awareness, Training, and Education (SATE) Program.

7.2 Contractor Notification Responsibilities. The Contractor shall notify the 37 SFS Industrial Security Office at each operating location prior to the performance of the contract of the performance on Lackland AFB. The notification shall include the contract number, contracting agency, the date service performance begins and ends, location(s) of service performance and future performance, and the reason for the contract (i.e., work to be performed).

7.3 Obtaining Pass and Identification Items. The Contractor shall ensure that the pass and identification items required for contract performance are obtained for the Contract Personnel providing service. The contractor shall coordinate and schedule appointments with the MTF Security Manager prior to performance. The Government will provide MTF ID badges which will be displayed while performing tasks in the MTF.

7.4 Investigation Requirements. The contractor shall have proof of U.S. citizenship (certified copy of birth certificate or naturalization papers) or a valid U.S. Immigration Form 1-151 and Alien Registration Card (“Green Card”). All contractor personnel require a minimum of a NACI/SF85 for any position that requires access to the internet, use of automated systems or unescorted entry into restricted or controlled areas prior to reporting for duty in support of any contract issued. The investigation is not for a security clearance; it is for a position of trust. This is a mandatory requirement set forth in DOD 5200.1-R and AFI 31-501 Information Security. All documentation required for security certification shall be the responsibility of the contractor. No foreign nationals shall be employed for any award issued under this contract without prior approval of the Government. The contractor shall notify the 711th Human Performance Wing's Security Manager when the NAC has been initiated and completed. The contractor shall be required to wear contractor identification badges and maintain currency in all Privacy Act Laws.

7.5 Listing of Contract Personnel. The contractor shall provide the CO, 37 SFS/SFAD (Lackland, AFB) and 711th Human Performance Wing's Security Manager (Brooks City-Base) a list of Contract Personnel within five (5) calendar days after receiving award or Notice of Award. The list shall include the name, social security number, and date of NAC investigation if contract work involves unescorted entry to Air Force-restricted or other sensitive areas designated by the installation commander. The list shall be validated and signed by the Contractor Representative. The Contractor shall maintain this listing throughout the tenure of this contract. Updated listings shall be provided when Contract Personnel status or information changes.

7.6 Badges. The government provided MTF ID badges and will be worn/displayed at all times.

7.7 Pager. When on-call, the Contract Personnel shall use the communication device (pager) or other electronic device issued by

MTF.

7.8 Uniforms. The surgical scrubs furnished by MTF shall be worn.

8.0 REPORTS AND DATA REPORTING REQUIREMENTS

8.1 Initial, Quarterly and Annual Reports. The Contractor shall submit initial, quarterly, and annual reports to the QA and/or credentials office (as applicable) for use in monitoring performance. Such reports include:

8.1.1 Health and Immunization requirements (initially)

8.1.2 Personnel Changes (quarterly)

8.1.3 Basic Life Support (BLS) or Heartsavers + AED – (initially and renewal)*. As accepted by American Heart Association (AHA) or American Red Cross

8.1.4 Competency and currency of licensure/registration (initially and renewal)

8.1.5 Security (initially)

8.1.6 Timesheets (monthly) in WAWF

*Note: In accordance with Military Training Bulletin NO. 07-003 (7 Feb 07), this will not be provide by the government.

9.0 CONTINUATION OF ESSENTIAL DOD CONTRACTOR SERVICES DURING CRISIS:

9.1 The performance of these services is not considered to be mission essential during time of crisis. Should a crisis be declared, the Contracting Officer or his/her representative will verbally advise the Contractor of the revised requirements, followed by written direction.

10.0 APPENDICES:

10.1 Attachment 1. CONTRACT SPECIFIC REQUIREMENTS PRIOR TO PERFORMANCE WILFORD HALL MEDICAL

CENTER/59TH MDW

10.2 Attachment 2. REFERENCED AIR FORCE INSTRUCTIONS, DEPARTMENT OF DEFENSE REGULATIONS, AND

MEDICAL WING INSTRUCTIONS

10.3 Attachment 3. HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT (HIPAA) OF 1996

ATTACHMENT 1

CONTRACT SPECIFIC REQUIREMENTS

PRIOR TO PERFORMANCE

WILFORD HALL MEDICAL CENTER/59TH MDW

FAXED TO: __________________________FAX: __________________DATE: _____________

Contract Position: __________________________________________

Name:____________________________________________________

The following items are Contract Specific requirements provided by the Contractor prior to performance:

_______Pre-employment medical exam (no earlier than 45 days before start date)

_______Immunization Record

_______Varicella (serologic evidence of immunity or documentation of 2-shot series)

_______Tdap Documentation of tetanus/diphtheria vaccination within 2 years or current Tdap vaccine.)

_______TB- 2 Step Testing or Neg. Chest X-Ray for Past Positive Tests (see screening criteria below) Screening Criteria Required Testing No Previous Documented TST result Two-step baseline TST Previous documented Neg TST >12 months before new employment Two-step baseline TST Previous documented Neg TST < 12 months before new employment Single TST > 2 previous documented Neg TST but most recent TST >12 months Single TST Previous documented Positive TST Chest X-Ray (negative)

_______MMR (Serologic evidence of immunity or documentation of 2-shot series)

_______Hepatitis B (Serologic evidence of immunity or documentation of 3-shot series)

_______HIV (direct contact with patients or body fluids)

(Frequency shall be based on exposure risk per hospital employee program)

_______Influenza (current series)

_______Drug Testing

_______Security Background Check ____SF 86 (If applicable) ____ State ____NAC ____LFC

Affidavit signed and dated by the Contractor. Copy of signed AF FM 2583 or Sentinel Key verification printout from a Security Manager.

_______Copy of certifications (if applicable)

ATTACHMENT 2

REFERENCED AIR FORCE INSTRUCTIONS, DEPARTMENT OF DEFENSE REGULATIONS, AND MEDICAL WING

INSTRUCTIONS

(NOTE: IN ALL INSTANCES, MOST CURRENT VERSION APPLIES.)

AFI 31-101, The Air Force Installation Security Program. (IAW MOA: CONS & 37SF)

AFI 31-401, Information Security Program Management. (IAW MOA: CONS & 37SF)

AFI 31-501, Personnel Security Program Management. (IAW MOA: CONS & 37SF)

AFI 33-202, Network and Computer Security. (IAW MOA: CONS & 37SF)

AFI 33-203, Emission Security. (IAW MOA: CONS & 37SF)

AFI 33-204, Information Assurance Awareness Program. (IAW MOA: CONS & 37SF)

AFI 41-210, Patient Administration Functions, Chapters 2 through 10

AFI 33-322, Records Management Program, Paragraphs 1 & 2

AFI 33-332, Air Force Privacy Act Program. (Entire instruction applies)

AFI 33-364, Records Disposition - Procedures and Responsibilities. (Entire instruction applies)

AFI 41-217, Health Information Assurance for Military Treatment Facilities (Entire instruction applies)

AFI 48-105, Surveillance, Prevention and Control of Diseases and Conditions of Public Health or Military Significance, paragraph 1.10.10.

AFI 71-101VI, Criminal Investigations. (IAW MOA: CONS & 37SF)

AFI 71-101V2, Protective Service Matters. (IAW MOA: CONS & 37SF)

AFMAN 37-123, Management of Records. (Entire manual applies)

MDWI 10-4, Codes and Alarms. (Entire instruction applies)

MDWI 32-6, Fire Prevention, Fighting and Evacuation Program. (Entire instruction applies)

MDWI 40-1, Plan for Provision of Patient Care. (Entire instruction applies)

MDWI 44-9, Infection Control Program. (Entire instruction applies)

MDWI 44-102, Medical Care Management (Paragraph 3.7.2 to 3.7.5)

MDWI 44-142, Code Blue Management (Paragraph 8.4.1.)

MDWI 48-8, Hazardous Materials, Waste Disposal Spill Prevention & Management (Entire instruction applies)

DoD Directive 5400.7, Freedom of Information Act Program, paragraphs 2 & 3

DoDI 6040.40, Military Health System Data Quality Management Control Procedures, paragraph 2.

DoDI 6040.42, Medical Encounter and Coding at Military Treatment Facilities, paragraph 2.1

DoDI 6040.43, Custody and Control of Outpatient Medical Records, paragraph 2.1.

DoDI 6025.8, Ambulatory Procedure Visit (APV) paragraphs 2.2., 2.3., and 2.4.

ATTACHMENT 3

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 AFMS and its components are specifically listed as covered entities (CE) under HIPAA. Currently, HIPAA Privacy and Security Rules, as set forth in the Code of Federal Regulations, are in effect for all AFMS CEs. 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 the AFMS are contained in DOD 8580.02-R and AFI 41-217, which also contains additional Information Assurance requirements. DOD 6025.18-R, DOD 8580.02-R and AFI 41-217 are incorporated herein by reference. AFMS organizations are responsible to insure overall compliance with HIPAA requirements, which includes incorporation of certain requirements in contracts entered into or amended after the respective implementation dates.

IAW these regulations, the Contractor and its employees meet the definition of Business Associate. 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 this contract, 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 8580.02-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 8580.02-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 6025.18-R, 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 provisions 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 8580.02-R, the CFR HIPAA Security Rule and AFI 41-217.