Statment_of_Needs_-_Medical_Waste_Disposal_-_Beale_AFB_-_Apr_19.docx

STATEMENT OF NEED

FOR

FY19 PHARMACEUTICAL/HAZARDOUS WASTE PICK-UP and DISPOSAL

9th MEDICAL GROUP

BEALE AIR FORCE BASE CA

13 Nov 19 – 12 Nov 20

1. DESCRIPTION OF SERVICES The Contractor shall provide all items required to perform work, to include but not limited to; personnel, licensures, equipment, tools, vehicles, materials, employee personnel protection/safety equipment, employee safety training, supervision and any other supplies or services necessary to collect, package, transport and dispose of medical waste in accordance with (IAW) all applicable guidelines and laws. Medical waste consists of but not limited to sharps containers and biohazardous waste bags. Sharps container contents may include but are not limited to: intravenous (IV) devices, lancets, needles, scalpel blades, scissors, biopsy punches, biopsy needles, trocars, medical sharps, glass specimen tubes/slides, and syringes with or without needles. Biohazardous waste bag contents may include but are not limited to: IV bags, IV tubing, suction canisters & tubing, sump drains, pathological waste, dressings, gauzes, bandages, materials saturated with blood or body fluids, hemodialysis tubes, hemovac units & tubing, lab waste, pleuro-vac and chest tubes. The contractor shall comply with all transportation and disposal requirements of biohazardous waste IAW California laws, if disposed in that given state, and all federal laws, regulations and interstate transportation requirements from the 9th Medical Group Medical Treatment Facility (MTF), Beale AFB, CA to a medical waste treatment and disposal facility licensed to accept medical waste.

1.1. SPECIFIC TASKS

1.1.1. The point of collection shall be from Beale AFB, CA, 9th Medical Group, 15301 Warren Shingle Road, building #5700, Room 216A, MTF loading dock. The service is projected for pick up every Wednesday excluding federal holidays throughout the year. For federal holidays, the following business day will be the expected pick up date.

1.1.2. Remove medical waste from MTF utilizing a state-licensed transport vehicle.

1.1.3. Deliver empty, clean, and properly-labeled biohazardous waste containers.

1.1.4. Provide a tracking document of medical waste removed from the Beale AFB MTF. A copy of the signed tracking document must be given to the MTF representative handling the transfer of medical waste. The following information must be included in each tracking document:

1.1.4.1. The name, address, telephone number, and registration number of the transporter.

1.1.4.2. The type of biohazardous waste transported and the quantity or aggregate weight of biohazardous waste transported.

1.1.4.3. The name, address, and telephone number of the generator (Beale AFB MTF).

1.1.4.4. The date the biohazardous waste is collected and removed from Beale AFB MTF.

1.1.4.4.1. The following info is required but will not be available on the copy received by MTF representative: the date the biohazardous waste is received by the transfer station and the date the biohazardous waste is received by the treatment facility.

1.1.5. Transport medical waste to an approved medical waste treatment facility for treatment into a noninfectious solid waste.

1.1.6. Promptly disinfect surfaces of transport vehicles which contain leaked or spilled untreated medical waste.

1.2. Operating Procedures: The Contractor shall submit to the Contracting Officer/Administrator written operating procedures for removal of medical waste within one day after contract award. These procedures shall govern the methods of segregation, packaging, labeling, marking, storing, transportation, disposal, reporting and record keeping according to the California Medical Waste Management Act. The Contracting Officer, prior to their implementation, must approve all changes.

1.3. Tracking Forms: The contractor shall obtain the MTF representative signature verifying the aggregate weight or quantity of containers and type of medical waste. The tracking document will be signed by the Contractor’s representative to verify pick-up and a signed original will be provided to the MTF representative.

1.3.1. Shipping document to include bar coding each container for tracking of destruction of item.

1.4. Invoicing: Contractor will submit monthly invoice via Wide Area Work Flow for processing IAW contract terms and conditions.

2.0. GOVERNMENT FURNISHED PROPERTY AND SERVICES. The Government shall furnish the use of storage area, which is located at MTF Building 5700, room 216A.

2.1. CONTRACTOR FURNISHED PROPERTY AND SERVICES. Except for those items or services specifically stated, as Government Furnished, the contractor shall provide everything else needed to perform this contract. This includes all necessary containers or bins, tape, bags and labels required for the accumulation/transportation of medical waste products.

2.1.1. Container Requirements. The Contractor shall maintain a sufficient supply of medical waste containers at the MTF in room 216A. The Contractor-provided bins/containers/boxes must be rigid, leak-resistant, impervious to moisture, and have sufficient strength to prevent tearing or bursting under normal conditions of use and handling.

3.0. GENERAL INFORMATION:

3.1. HOURS OF OPERATION. The Contractor shall perform the services required on Monday through Friday between 8:00 am - 3:00 pm, excluding Federal Holidays.

3.2. EMERGENCY OR SPECIAL EVENT SERVICE. (DISASTER OR MASS CASUALTY MAY CAUSE FOR ADDED PICK-UPS IN THE EVENT OF A NATURAL DISASTER OR WAR)

3.3. CONTRACT PERSONNEL:

3.3.1. The Contractor’s Point of Contact or alternate shall be available within 4 hours via phone to discuss problem areas.

3.3.2. Access to Installation during Force Protection Conditions (FPCONs):

Contractors will be assigned a mission essential designation IAW requirements contained in Beale Air Force Base Integrated Defense Plan 31-1. Only the installation commander or the unit commander requesting contract support will assign the mission essential designation.

3.3.3. Contractors Working in Controlled or Restricted Areas:

The unit requesting contract support will provide escort (s) for contractors’ at all times within a controlled area. Contractors shall not escort other contractor employees within controlled or restricted areas. In addition, contractors shall fulfill, maintain, and comply with all security requirements IAW Beale Air Force Base Integrated Defense Plan 31-1, and command/local directives.

3.3.4. Access to Government Facilities with Controlled or Restricted Areas:

The contractor shall comply with security regulations imposed by the installation commander and/or the agency responsible for the project location. Due to specific mission requirements inherent in the nature of controlled or restricted areas on Beale AFB, the government may direct the contractor to leave the controlled or restricted areas at any given time.

3.3.5. Contractors Responsibilities while Working within Controlled or Restricted Areas:

Only contractor personnel with proper authority and qualifications shall enter a controlled or restricted area. Certain facilities require the issuance of an AF Form 1199. The government, at any time, may revoke the AF Form 1199. The procedures for the issuance of an AF Form 1199 are contained in Beale Air Force Base Integrated Defense Plan 31-1. Contractors shall not escort other contractor employees within controlled or restricted areas. In addition, contractors shall fulfill, maintain, and comply with all security requirements contained in Beale Air Force Base Integrated Defense Plan 31-1.

3.3.6. Access to Government Facilities with Controlled or Restricted Areas for Replacement Contractors:

The unit requesting contract support will continuously escort replacement contractors, not initially possessing the proper clearances and requiring entry to controlled or restricted areas. Replacement contractors shall submit paperwork within 30 days of being assigned to obtain an approved security clearance or favorable review. Replacement contractor personnel shall obtain a security clearance prior to working with, or having direct access to, classified material. In addition, replacement contractor personnel shall obtain a “Favorable Review” prior to having access to a Controlled Area. The above information shall be submitted to 9 RW/IP.

4.0 HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT (HIPAA) OF 1996

Introduction.

In accordance with 45 CFR 164.502(e)(2) and 164.504(e) and paragraph C.3.4.1.3 of DoD 6025.18-R, “DoD Health Information Privacy Regulation,” January 24, 2003, this document serves as a business associate agreement (BAA) between the signatory parties for purposes of the Health Insurance Portability and Accountability Act (HIPAA) and the “HITECH Act” amendments thereof, as implemented by the HIPAA Rules and DoD HIPAA Issuances (both defined below). The parties are a DoD Military Health System (MHS) component, acting as a HIPAA covered entity, and a DoD contractor, acting as a HIPAA business associate. The HIPAA Rules require BAAs between covered entities and business associates. Implementing this BAA requirement, the applicable DoD HIPAA Issuance (DoD 6025.18-R, paragraph C3.4.1.3) provides that requirements applicable to business associates must be incorporated (or incorporated by reference) into the contract or agreement between the parties.

(a) Catchall Definition. Except as provided otherwise in this BAA, the following terms used in this BAA shall have the same meaning as those terms in the DoD HIPAA Rules: Data Aggregation, Designated Record Set, Disclosure, Health Care Operations, Individual, Minimum Necessary, Notice of Privacy Practices (NoPP), Protected Health Information (PHI), Required By Law, Secretary, Security Incident, Subcontractor, Unsecured Protected Health Information, and Use.

Breach means actual or possible loss of control, unauthorized disclosure of or unauthorized access to PHI or other PII (which may include, but is not limited to PHI), where persons other than authorized users gain access or potential access to such information for any purpose other than authorized purposes, where one or more individuals will be adversely affected. The foregoing definition is based on the definition of breach in DoD Privacy Act Issuances as defined herein.

Business Associate shall generally have the same meaning as the term “business associate” in the DoD HIPAA Issuances, and in reference to this BAA, shall mean [INSERT NAME OF BUSINESS ASSOCIATE].

Agreement means this BAA together with the documents and/or other arrangements under which the Business Associate signatory performs services involving access to PHI on behalf of the MHS component signatory to this BAA.

Covered Entity shall generally have the same meaning as the term “covered entity” in the DoD HIPAA Issuances, and in reference to this BAA, shall mean 9th Medical Group Medical Treatment Facility.

DHA Privacy Office means the DHA Privacy and Civil Liberties Office. The DHA Privacy Office Director is the HIPAA Privacy and Security Officer for DHA, including the National Capital Region Medical Directorate (NCRMD).

DoD HIPAA Issuances means the DoD issuances implementing the HIPAA Rules in the DoD Military Health System (MHS). These issuances are DoD 6025.18-R (2003), DoDI 6025.18 (2009), and DoD 8580.02-R (2007).

DoD Privacy Act Issuances means the DoD issuances implementing the Privacy Act, which are DoDD 5400.11 (2007) and DoD 5400.11-R (2007).

HHS Breach means a breach that satisfies the HIPAA Breach Rule definition of breach in 45 CFR 164.402.

HIPAA Rules means, collectively, the HIPAA Privacy, Security, Breach and Enforcement Rules, issued by the U.S. Department of Health and Human Services (HHS) and codified at 45 CFR Part 160 and Part 164, Subpart E (Privacy), Subpart C (Security), Subpart D (Breach) and Part 160, Subparts C-D (Enforcement), as amended by the 2013 modifications to those Rules, implementing the “HITECH Act” provisions of Pub. L. 111-5. See 78 FR 5566-5702 (Jan. 25, 2013) (with corrections at 78 FR 32464 (June 7, 2013)). Additional HIPAA rules regarding electronic transactions and code sets (45 CFR Part 162) are not addressed in this BAA and are not included in the term HIPAA Rules.

Service-Level Privacy Office means one or more offices within the military services (Army, Navy, or Air Force) with oversight authority over Privacy Act and/or HIPAA privacy compliance.

I. Obligations and Activities of Business Associate

(a) The Business Associate shall not use or disclose PHI other than as permitted or required by this Agreement or as required by law.

(b) The Business Associate shall use appropriate safeguards, and comply with the DoD HIPAA Rules with respect to electronic PHI, to prevent use or disclosure of PHI other than as provided for by this Agreement.

(c) The Business Associate shall report to Covered Entity any Breach of which it becomes aware, and shall proceed with breach response steps as required by Part V of this BAA. With respect to electronic PHI, the Business Associate shall also respond to any security incident of which it becomes aware in accordance with any Information Assurance provisions of this Agreement. If at any point the Business Associate becomes aware that a security incident involves a Breach, the Business Associate shall immediately initiate breach response as required by part V of this BAA.

(d) In accordance with 45 CFR 164.502(e)(1)(ii)) and 164.308(b)(2), respectively, and corresponding DoD HIPAA Issuances, as applicable, the Business Associate shall ensure that any subcontractors that create, receive, maintain, or transmit PHI on behalf of the Business Associate agree to the same restrictions, conditions, and requirements that apply to the Business Associate with respect to such PHI.

(e) The Business Associate shall make available PHI in a Designated Record Set, to the Covered Entity or, as directed by the Covered Entity, to an Individual, as necessary to satisfy the Covered Entity obligations under 45 CFR 164.524 and corresponding DoD HIPAA Issuances.

(f) The Business Associate shall make any amendment(s) to PHI in a Designated Record Set as directed or agreed to by the Covered Entity pursuant to 45 CFR 164.526, or take other measures as necessary to satisfy Covered Entity’s obligations under 45 CFR 164.526, and corresponding DoD HIPAA Issuances.

(g) The Business Associate shall maintain and make available the information required to provide an accounting of disclosures to the Covered Entity or an individual as necessary to satisfy the Covered Entity’s obligations under 45 CFR 164.528 and corresponding DoD HIPAA Issuances.

(h) To the extent the Business Associate is to carry out one or more of Covered Entity's obligation(s) under the HIPAA Privacy Rule, the Business Associate shall comply with the requirements of the HIPAA Privacy Rule that apply to the Covered Entity in the performance of such obligation(s); and

(i) The Business Associate shall make its internal practices, books, and records available to the Secretary for purposes of determining compliance with the HIPAA Rules.

II. Permitted Uses and Disclosures by Business Associate

(a) The Business Associate may only use or disclose PHI as necessary to perform the services set forth in this Agreement or as required by law. The Business Associate is not permitted to de-identify PHI under DoD HIPAA issuances or the corresponding 45 CFR 164.514(a)-(c), nor is it permitted to use or disclose de-identified PHI, except as provided by this Agreement or directed by the Covered Entity.

(b) The Business Associate agrees to use, disclose and request PHI only in accordance with the HIPAA Privacy Rule “minimum necessary” standard and corresponding DHA policies and procedures as stated in the DoD HIPAA Issuances.

(c) The Business Associate shall not use or disclose PHI in a manner that would violate the DoD HIPAA Issuances or HIPAA Privacy Rules if done by the Covered Entity, except uses and disclosures for the Business Associate’s own management and administration and legal responsibilities or for data aggregation services as set forth in the following three paragraphs.

(d) Except as otherwise limited in this Agreement, the Business Associate may use PHI for the proper management and administration of the Business Associate or to carry out the legal responsibilities of the Business Associate. The foregoing authority to use PHI does not apply to disclosure of PHI, which is covered in the next paragraph.

(e) Except as otherwise limited in this Agreement, the Business Associate may disclose PHI for the proper management and administration of the Business Associate or to carry out the legal responsibilities of the Business Associate, provided that disclosures are required by law, or the Business Associate obtains reasonable assurances from the person to whom the PHI is disclosed that it will remain confidential and used or further disclosed only as required by law or for the purposes for which it was disclosed to the person, and the person notifies the Business Associate of any instances of which it is aware in which the confidentiality of the information has been breached.

(f) Except as otherwise limited in this Agreement, the Business Associate may use PHI to provide Data Aggregation services relating to the Covered Entity’s health care operations.

III. Provisions for Covered Entity to Inform Business Associate of Privacy Practices and Restrictions

(a) The Covered Entity shall notify the Business Associate of any limitation(s) in the notice of privacy practices of the Covered Entity under 45 CFR 164.520 and the corresponding provision of the DoD HIPAA Issuances, to the extent that such limitation may affect Business Associate’s use or disclosure of PHI.

(b) The Covered Entity shall notify the Business Associate of any changes in, or revocation of, the permission by an Individual to use or disclose his or her PHI, to the extent that such changes affect the Business Associate’s use or disclosure of PHI.

(c) The Covered Entity shall notify the Business Associate of any restriction on the use or disclosure of PHI that the Covered Entity has agreed to or is required to abide by under 45 CFR 164.522 and the corresponding DoD HIPAA Issuances, to the extent that such changes may affect the Business Associate’s use or disclosure of PHI.

IV. Permissible Requests by Covered Entity

The Covered Entity shall not request the Business Associate to use or disclose PHI in any manner that would not be permissible under the HIPAA Privacy Rule or any applicable Government regulations (including without limitation, DoD HIPAA Issuances) if done by the Covered Entity, except for providing Data Aggregation services to the Covered Entity and for management and administrative activities of the Business Associate as otherwise permitted by this BAA.

V. Breach Response

(a) In general.

(1) In the event of a breach of PII/PHI held by the Business Associate, the Business Associate shall report the breach to the Covered Entity in accordance with Section VII, assess the breach incident, take mitigation actions as applicable, and notify affected individuals, as directed by the Covered Entity.

(2) The Business Associate shall coordinate all investigation actions with the Covered Entity, and at a minimum, follow the breach response requirements set forth in this Part V, which is designed to satisfy both the Privacy Act and HIPAA as applicable. If a breach involves PII without PHI, then the Business Associate shall comply with DoD Privacy Act Issuance breach response requirements only; if a breach involves PHI (a subset of PII), then the Business Associate shall comply with both Privacy Act and HIPAA breach response requirements. A breach involving PHI may or may not constitute an HHS Breach. If a breach is not an HHS Breach, then the Business Associate has no HIPAA breach response obligations. In such cases, the Business Associate must still comply with breach response requirements under the DoD Privacy Act Issuances.

(3) The Business Associate shall, at no cost to the government, bear any costs associated with a breach of PII/PHI that the Business Associate has caused or is otherwise responsible for addressing.

(b) Government Reporting Provisions

(1) If the Covered Entity determines that a breach is an HHS Breach, then the Business Associate shall comply with both the HIPAA Breach Rule and DoD Privacy Act Issuances, as directed by the Covered Entity, regardless of where the breach occurs.. If the Covered Entity determines that the breach does not constitute an HHS Breach, then the Business Associate shall comply with DoD Privacy Act Issuances, as directed by the applicable Service-Level Privacy Office.

(2) This Part V is designed to satisfy the DoD Privacy Act Issuances and the HIPAA Breach Rule as implemented by the DoD HIPAA Issuances. In general, for breach response, the Business Associate shall report the breach to the Covered Entity, assess the breach incident, notify affected individuals, and take mitigation actions as applicable. Because DoD defines “breach” to include possible (suspected) as well as actual (confirmed) breaches, the Business Associate shall implement these breach response requirements immediately upon the Business Associate’s discovery of a possible breach.

(3) The following provisions of Part V set forth the Business Associate’s Privacy Act and HIPAA breach response requirements for all breaches, including but not limited to HHS breaches.

(i) The Business Associate shall report the breach within one hour of discovery to the US Computer Emergency Readiness Team (US CERT), and, within 24 hours of discovery, to the Covered Entity, and to other parties as deemed appropriate by the Covered Entity. The Business Associate is deemed to have discovered a breach as of the time a breach (suspected or confirmed) is known, or by exercising reasonable diligence would have been known, to any person (other than the person committing it) who is an employee, officer or other agent of the Business Associate.

(ii) The Business Associate shall submit the US-CERT report using the online form at https://forms.us-cert.gov/report/. Before submission to US-CERT, the Business Associate shall save a copy of the on-line report. After submission, the Business Associate shall record the US-CERT Reporting Number. Although only limited information about the breach may be available as of the one hour deadline for submission, the Business Associate shall submit the US-CERT report by the deadline. The Business Associate shall e-mail updated information as it is obtained, following the instructions at http://www.us-cert.gov/pgp/email.html. The Business Associate shall provide a copy of the initial or updated US-CERT report to the Installation Privacy Act Officer, MTF HIPAA Privacy Officer, and the Contracting Officer (if applicable), if requested. Business Associate questions about US-CERT reporting shall be directed to the Installation Privacy Act Officer or MTF HIPAA Privacy Officer, not the US-CERT office.

(iii) The Business Associate shall comply with the Breach Timeline and Notification Flow Chart processes attached to this Agreement, to include the timelines established for completing the DD Form 2959 and the HIPAA Privacy Incident Report.

(4) If multiple beneficiaries are affected by a single event or related set of events, then a single reportable breach may be deemed to have occurred, depending on the circumstances. The Business Associate shall inform the Covered Entity as soon as possible if it believes that “single event” breach response is appropriate; the Covered Entity will determine how the Business Associate shall proceed and, if appropriate, consolidate separately reported breaches for purposes of Business Associate report updates, beneficiary notification, and mitigation.

(i) When a Breach Report Form initially submitted is incomplete or incorrect due to unavailable information, or when significant developments require an update, the Business Associate shall submit a revised form or forms, stating the updated status and previous report date(s) and showing any revisions or additions in red text. Examples of updated information the Business Associate shall report include, but are not limited to: confirmation on the exact data elements involved, the root cause of the incident, and any mitigation actions to include, sanctions, training, incident containment, and follow-up. The Business Associate shall submit these report updates within three (3) business days after the new information becomes available. Prompt reporting of updates is required to allow the Covered Entity to make timely final determinations on any subsequent notifications or reports. The Business Associate shall provide updates to the same parties as required for the initial Breach Reporting Form. The Business Associate is responsible for reporting all information needed by the Covered Entity to make timely and accurate determinations on reports to HHS as required by the HHS Breach Rule and reports to the Defense Privacy and Civil Liberties Office as required by DoD Privacy Act Issuances.

(ii) In the event the Business Associate is uncertain on how to apply the above requirements, the Business Associate shall consult with the Covered Entity and Contracting Officer (if applicable) when determinations on applying the above requirements are needed.

(c) Individual Notification Provisions

(i) If the Covered Entity determines that individual notification is required, the Business Associate shall provide written notification to individuals affected by the breach as soon as possible, but no later than 10 working days after the breach is discovered and the identities of the individuals are ascertained. The 10 day period begins when the Business Associate is able to determine the identities (including addresses) of the individuals whose records were impacted.

(ii) The Business Associate’s proposed notification to be issued to the affected individuals shall be submitted to the parties to which reports are submitted under paragraph VII. for their review, and for approval by the Contracting Officer, in consultation with the Covered Entity. Upon request, the Business Associate shall provide the Contracting officer and Covered Entity with the final text of the notification letter sent to the affected individuals. If different groups of affected individuals receive different notification letters, then the Business Associate shall provide the text of the letter for each group (PII shall not be included with the text of the letter(s) provided). Copies of further correspondence with affected individuals need not be provided unless requested by the Contracting Office or Covered Entity. The Business Associate’s notification to the individuals, at a minimum, shall include the following:

(A) The individual(s) must be advised of what specific data was involved. It is insufficient to simply state that PII has been lost. Where names, Social Security Numbers (SSNs) or truncated SSNs, and Dates of Birth (DOBs) are involved, it is critical to advise the individual that these data elements potentially have been breached.

(B) The individual(s) must be informed of the facts and circumstances surrounding the breach. The description should be sufficiently detailed so that the individual clearly understands how the breach occurred.

(C) The individual(s) must be informed of what protective actions the Business Associate is taking or the individual can take to mitigate against potential future harm. The notice must refer the individual to the current Federal Trade Commission (FTC) web site pages on identity theft and the FTC’s Identity Theft Hotline, toll-free: 1-877-ID-THEFT (438-4338); TTY: 1-866-653-4261.

(D) A brief description of what the covered entity involved is doing to investigate the breach, to mitigate harm to individuals, and to protect against any further breaches; and

(E) Contact procedures for individuals to ask questions or learn additional information, which shall include a toll-free telephone number, an e-mail address, Web site, or postal address

(F) The individual(s) must also be informed of any mitigation support services (e.g., one year of free credit monitoring, identification of fraud expense coverage for affected individuals, provision of credit freezes, etc.) that the Business Associate may offer affected individuals, the process to follow to obtain those services and the period of time the services will be made available, and contact information (including a phone number, either direct or toll-free, e-mail address and postal address) for obtaining more information. The Contracting Officer, in consultation with the Covered Entity will determine the appropriate level of support services.

(iii) Business Associates shall ensure any envelope containing written notifications to affected individuals are clearly labeled to alert the recipient to the importance of its contents, e.g., “Important information – do not destroy,” and that the envelope is marked with the identity of the Business Associate and/or subcontractor organization that suffered the breach. The letter must also include contact information for a designated POC to include, phone number, e-mail address, and postal address.

(iv) If the Business Associate determines that it cannot readily identify, or will be unable to reach, some affected individuals within the 10 day period after discovering the breach, the Business Associate shall so indicate in the initial or updated Breach Report Form. Within the 10 day period, the Business Associate shall provide the approved notification to those individuals who can be reached. Other individuals must be notified within 10 days after their identities and addresses are ascertained. The Business Associate shall consult with the Covered Entity, which will determine which media notice is most likely to reach the population not otherwise identified or reached. The Business Associate shall issue a generalized media notice(s) to that population in accordance with the Covered Entity approval.

(d) Breaches are not to be confused with security incidents (often referred to as cyber security incidents when electronic information is involved), which may or may not involve a breach of PII/PHI. In the event of a security incident not involving a PII/PHI breach, the Business Associate shall follow applicable DoD Information Assurance requirements under its Agreement. If at any point the Business Associate finds that a cyber security incident involves a PII/PHI breach (suspected or confirmed), the Business Associate shall immediately initiate the breach response procedures set forth here. The Business Associate shall also continue to follow any required cyber security incident response procedures to the extent needed to address security issues, as determined by DoD/DHA.

VI. Termination

(a) Termination. Noncompliance by the Business Associate (or any of its staff, agents, or subcontractors) with any requirement in this BAA may subject the Business Associate to termination under any applicable default or other termination provision of the underlying Contract

(b) Effect of Termination.

(1) If this Agreement has records management requirements, the Business Associate shall handle such records in accordance with the records management requirements. If this Agreement does not have records management requirements, the records should be handled in accordance with paragraphs VI.(2) and (3) below. If this Agreement has provisions for transfer of records and PII/PHI to a successor Business Associate, or if the Covered Entity gives directions for such transfer, the Business Associate shall handle such records and information in accordance with such Agreement provisions or the Covered Entity’s direction.

(2) If this Agreement does not have records management requirements, except as provided in the following paragraph (3), upon termination of this Agreement, for any reason, the Business Associate shall return or destroy all PHI received from the Covered Entity, or created or received by the Business Associate on behalf of the Covered Entity that the Business Associate still maintains in any form. This provision shall apply to PHI that is in the possession of subcontractors or agents of the Business Associate. The Business Associate shall retain no copies of the PHI.

(3) If this Agreement does not have records management provisions and the Business Associate determines that returning or destroying the PHI is infeasible, the Business Associate shall provide to the Covered Entity notification of the conditions that make return or destruction infeasible. Upon mutual agreement of the Covered Entity and the Business Associate that return or destruction of PHI is infeasible, the Business Associate shall extend the protections of this Agreement to such PHI and limit further uses and disclosures of such PHI to those purposes that make the return or destruction infeasible, for so long as the Business Associate maintains such PHI.

VII. Notices. Any notices to be given hereunder will be made in the most expedient manner, via e-mail, facsimile, U.S. Mail, or express courier to such party’s address given below.

Attn:

Title:

Company:

Address:

Beale AFB, CA 95903

Phone:

Fax:

E-mail:

With a copy to:

Name:

Name:

Company:

Address:

Address:

Phone:

Phone:

Fax:

Fax:

Email:

Email:

Each party named above may change its address and that of its representative for notice by the giving of notice thereof in the manner provided in this subsection.

VIII. Miscellaneous

(a) Survival. The obligations of Business Associate under the “Effect of Termination” provision of this BAA shall survive the termination of this Agreement.

(b) Interpretation. Any ambiguity in this Agreement shall be resolved in favor of a meaning that permits the Covered Entity and the Business Associate to comply with the HIPAA Rules and the DoD HIPAA

APPENDIX 1

1. DEFINITIONS:

2. TECHNICAL DEFINITIONS:

2.1. These definitions may vary from state to state. If the state law is more inclusive, it should take precedence. Regulated Medical Waste includes the following classes of waste:

2.2. Cultures and Stocks. Cultures and stocks of infectious agents and associated biologicals, including: cultures from medical and pathological laboratories; cultures and stocks of infectious agents from research and industrial laboratories; waste from the production of biologicals; discarded live and attenuated vaccines; and culture dishes and devices used to transfer, inoculate, and mix cultures.

2.3. Pathological Waste. Human pathological waste, including tissues, organs, body parts and body fluids that are removed during surgery or other medical procedures, and specimens of body fluids and their containers.

2.4. Human Blood and Blood Products. (1) Liquid waste human blood; (2) products of blood; (3) items saturated and/or dripping with human blood; (4) items that were saturated and/or dripping with human blood that are now caked with dried human blood; including serum, plasma, and other blood components, and their containers, which were used or intended for use in either patient care, testing and laboratory analysis or the development of pharmaceuticals. Intravenous bags are also included in this category.

2.5. Sharps. Sharps that have been used in animal or human patient care or treatment or in medical, research, or industrial laboratories, including hypodermic needles, syringes (with or without the attached needle), Pasteur pipettes, scalpel blades, blood vials, needles with attached tubing, and culture dishes (regardless of presence of infectious agents). Also included are other types of broken or unbroken glassware that were in contact with infectious agents, such as used slides and cover slips.

2.6. Animal Waste. Contaminated animal carcasses, body parts, and bedding of animals that were exposed to infectious agents during research.

2.7. Isolation Waste. Biological waste and discarded materials contaminated blood, excretion, exudates, or secretions from humans who are isolated to protect others from certain highly communicable diseases, or isolated animals known to be infected with highly communicable diseases.

APPENDIX 2

APPLICABLE PUBLICATIONS AND FORMS:

Publications and forms applicable to this performance work statement are listed below. The publications and forms have been coded as mandatory or advisory. The Contractor is obligated to follow those publications and use those forms coded as mandatory to the extent specified in other sections of this PWS. The Contractor shall be guided by those publications or use those forms coded advisory to the extent necessary to accomplish requirements in the PWS. The Government shall provide all publications and forms listed at the start of the contract. "IT IS THE RESPONSIBILITY OF THE CONTRACTOR TO ESTABLISH FOLLOW-ON REQUIREMENTS WITH THE PUBLICATIONS DISTRIBUTION OFFICE (PDO) 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 that result in a decrease or no change in the contract price and notify the CO in writing of such change. Should a decrease in contract price result; the Contractor shall provide a proposal for a reduction in the contract price to the CO. Before implementing any change that will result in an increase in contract price, the Contractor shall submit to the CO a price proposal within 30 calendar days following 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 calendar days following receipt of the change entitles the Government to performance according to such change at no increase in contract price (unless the time requirement is waived by the CO according to Para (c) of the Changes clause).

PUBLICATION NO. TITLE/DATE MANDATORY/

ADVISORY

40 CFR Part 60 Subpart Ce Emission Guidelines and Compliance M Times for HMIWIs

40 CFR Part 60, Subpart Ec Standard Performance for HMIWIs M

California Health and Safety Medical Waste Management Act Code Sections 117600-118360

TECHNICAL EXHIBIT 1

WORKLOAD ESTIMATE

1. It is estimated that the Contractor will be required to dispose of approximately 200 pounds per month of regulated medical waste during the contract period but on rare occasions may pick up an estimated 275 pounds due to a military canine death. An estimate of each type follows:

a. Regulated Medical Waste: 200.

b. Pathological Waste (Rare - may not happen for months or years): 75.