Attachment_1-PWS_-_FY14_PATHOLOGICAL_WASTE.pdf

Solicitation Number: FA3010-13-R-0014

Attachment 1

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PERFORMANCE WORK STATEMENT

FOR

PATHOLOGICAL WASTE DISPOSAL

Non-Personal Services

1. DESCRIPTION OF SERVICES AND GENERAL INFORMATION.

1.1. SCOPE OF WORK. The Contractor shall provide all personnel, equipment, tools, materials, supervision, and other items and services necessary to collect, package, and transport medical waste in accordance with (IAW) all Federal, Mississippi, and local laws and regulations.

Medical waste will be picked up from Keesler Medical Center (Building 0468, Room BA117), Dental Clinic (Building 0824, sterilization room), the Clinical Research Laboratory (Building

0404, west loading dock), Blood Donor Center (Building 5901, southeast corner), Veterinary

Clinic (Building 0408, East entrance) and the Satellite Pharmacy (Building 2306), Keesler Air

Force Base (KAFB), Mississippi, twice a week and transported to a waste treatment and disposal facility licensed to accept medical waste. Contractor performance shall meet or exceed commercial standards of the industry.

1.2. SPECIFIC TASKS. The Contractor shall pick up medical waste from KAFB Buildings

0468, 0404, 0824, 5901, 0408, and 2306 during the hours listed in paragraph 1.4.1. below.

Waste to be disposed of includes the following as defined in 40 Code of Federal Regulations

(CFR) Part 62: Cultures and stocks, pathological waste, human blood and blood products, sharps, animal waste, animal carcasses, isolation waste, chemotherapy waste, and non-regulated pharmaceuticals. Waste shall be transported and disposed of IAW all applicable Federal and

State of Mississippi Board of Health regulations. Waste handling and transportation methods must comply with state regulations of any state into which the waste is transported for disposal.

The Contractor shall comply with and fully meet all requirements of the business associate agreement as defined in paragraph 5.1. of this Performance Work Statement.

1.2.1. The Contractor shall place all bagged medical waste present at the collection points into

Contractor-provided containers (See paragraph 3.2.2. below). No bags of medical waste will be opened by the Contractor on KAFB.

1.2.2. The Contractor shall weigh the medical waste from all collection points in the isolation room in Building 0468, KAFB Medical Center. A Government representative from the Medical

Center Environmental Manager or Facility Management Office will be contacted by the

Contractor to observe the weighing procedure. In the event that weighing has to be accomplished outside of the established daily pick-up times, which is 0900 through 1100 hours

(9:00 a.m. through 11:00 a.m.), the Contractor shall wait until the Government representative is present.

1.2.3. Manifests. Manifest shipping documents shall be provided by the Contractor. These manifests shall be approved by the appropriate state regulatory agency/Environmental Protection

Agency (EPA). If multiple (sequential) manifests are required to cover the transportation route

25 Jun 13 of waste from KAFB to the actual disposal facility, copies of each manifest shall be provided to

Keesler Medical Center.

1.2.3.1. The Contractor shall complete a manifest showing the types of materials/medical waste, number of containers, individual container weights, and total shipment weight picked up and transported to the disposal facility. Manifests shall contain the name and address of the Medical

Treatment Facility (MTF), designation of the treatment/disposal site, and a certification that the untreated waste was properly handled, packaged, and labeled. Prior to departure from KAFB, a signed copy of the manifest(s) shall be provided to the Government representative who witnessed the weighing.

1.2.3.2. After the waste has been delivered to its destination, the Contractor shall provide a completed copy of the manifest to the Government no later than sixty days from the date of shipment.

1.2.3.3. Once the medical waste has been treated/destroyed IAW applicable Federal, state, and/or local regulations, the Contractor shall verify the destruction, certify on the manifest that the waste has been properly disposed of, and return a copy signed by the treatment/disposal facility representative to the Medical Center Environmental Office.

1.2.4. The Contractor shall ensure all transport vehicle surfaces that have had untreated medical waste leaked or spilled onto them, are cleaned and disinfected promptly.

1.3. PERSONNEL.

1.3.1. Contract Manager. The Contractor shall provide a contract manager who shall be responsible for the performance of the work and have full authority to act on all matters relating to daily operation of this contract. The name of this person and alternate(s) who shall act for the

Contractor when the manager is absent shall be designated in writing to the Contracting Officer

(CO). The manager may perform services under this contract in addition to contract management duties.

1.3.1.1. The Contract Manager/alternate shall be available during normal duty hours and shall respond within twenty-four hours to meet on the installation with Government personnel designated by the CO to discuss problem areas.

1.3.1.2. The Contract Manager/alternate shall understand, read, speak, and write the English language.

1.3.2. Contractor personnel shall present a neat appearance and be easily recognized as

Contractor employees. Personnel shall be neat and clean, well groomed, and in appropriate clothing. Contractor personnel shall wear Contractor-provided name tags or badges that contain both the company’s and employee’s name.

1.3.3. The Contractor shall ensure that its personnel have a current and valid state vehicle operator license for the type of vehicle they will be operating before starting work.

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1.3.4. The Contractor shall not employ any person who is an employee of the U.S. Government if the employment of that person would create a conflict of interest. In addition, the Contractor shall not employ any person who is an employee of the Department of the Air Force (DAF), either military or civilian, unless such person seeks and receives approval IAW DOD Directive

(DoDD) 5500.7 and Air Force (AF) policy.

1.3.5. The Contractor is cautioned that off duty active military personnel hired under this contract may be subject to permanent change of station (PCS), change in duty hours, or deployment. Military Reservists and National Guard members may be subject to recall to active duty. The abrupt absence of these personnel could adversely affect the Contractor’s ability to perform. Their absence shall not constitute an excuse for nonperformance under this contract.

1.3.6. Contractor Personnel Training.

1.3.6.1. Blood-Borne Pathogen Training. The Contractor shall ensure that its personnel have current and valid training certifications for safety concerning blood-borne pathogens. The

Contractor shall ensure that all Contractor personnel have all required training for ensuring correct packaging and shipment of Department of Transportation-regulated Hazardous Material

IAW state and Federal regulations.

1.3.6.2. Anti-Terrorism (AT) Awareness Training. Level I Anti-Terrorism (AT) Awareness

Training is available upon request and will be conducted by the Installation Anti-Terrorism

Officer (ATO). Contact the 81st Security Forces Squadron (81 SFS/CCA), at 228-376-5677.

1.3.6.3. Environmental Management System (EMS). All Contractor personnel shall complete

Environmental Management System (EMS) Awareness training prior to commencement of any activities. Training is available through the Air Force Advanced Distributed Learning Service

(ADLS) or through the Environmental Office (CSC/CEV).

1.4. HOURS OF OPERATION.

1.4.1. Normal Hours of Operations. The Contractor shall perform the services required under this contract during the following hours: Monday, Wednesday, and Thursday, between 0900 hours (9:00 a.m.) and 1100 hours (11:00 a.m.).

1.4.2. Holidays. The Contractor is not required to provide service on the following Federal holidays:

New Year’s Day (January 1st), Martin Luther King Jr. Birthday (January), Washington’s

Birthday (February), Memorial Day (last Monday in May), Independence Day (July 4th), Labor Day (first Monday in September), Columbus Day (October), Veterans’ Day (11

November), Thanksgiving Day (November), and Christmas Day (December 25th).

1.4.3. The Contractor should make preparations for increased quantities of waste on days following the above holidays.

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1.4.4. Routine Service will be Monday-Friday between 0900 (9:00 a.m.) and 1100 (11:00 a.m.).

The numbers of pick-ups and drop-off of empty containers will be determined based on volume and excess bags awaiting containers. There must be at least 30 empty containers left at the MTF after all bagged waste is removed.

1.4.5. Emergency or Special Event Services. The Government reserves the option to require services between the hours of 0900 (9:00 a.m.) and 1100 (11:00 a.m.) on Tuesdays, Thursdays, and Saturdays. When notified by the CO, the Contractor shall respond for emergency pick-up situations.

1.4.6. Performance of Services during Crisis Declared by the National Command Authority.

According to Department of Defense Instruction (DoDI) 3020.37, performance of this service during crises or natural disasters is determined to be non-essential, and performance will be suspended until reactivated by the Government point of contact.

1.5. QUALITY CONTROL. The Contractor shall establish and maintain a quality control plan to assure the requirements of the contract are provided as specified. The plan shall describe the method(s) for identifying and preventing defects in the quality of service performed before the level of performance becomes unacceptable. One copy of the plan shall be provided to the

CO prior to performance. The CO will notify the Contractor of acceptance or required modifications to the plan before the contract start date. The Contractor shall make appropriate modifications and obtain acceptance of the plan by the CO before the contract start date. The

Contractor shall provide all changes to the plan throughout the contract period.

1.5. QUALITY ASSURANCE. The Government will evaluate the Contractor’s performance under this contract using the method of surveillance specified in the Services Summary (para 2.).

The Government will record all surveillance observations.

1.6. CONTRACTOR MANPOWER REPORTING. The Contractor shall report ALL

Contractor labor hours (including subcontractor labor hours) for performance of services under this contract via a secure data collection site. The Contractor is required to completely fill in all required data fields at http://www.ecmra.mil. Reporting inputs will be for all labor executed during the performance for each Government fiscal year (FY) which runs 1 October through 30

September. While inputs may be reported at any time during the FY, all data shall be reported no later than 31 October of each calendar year. Contractors may direct questions to the CMRA help desk.

1.7. HAZARDOUS MATERIALS. In the event that hazardous materials will be used in the execution of this contract, the contractor will be required to obtain authorization from the

Installation Hazardous Materials Management Program before ordering or purchasing the hazardous product, in accordance with AFI 32-7086, AETC Supplement I, Hazardous Materials

Management. This authorization process may take up to two weeks, which should be considered in the performance period of this contract.

http://www.ecmra.mil/

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1.8. SECURITY CLEARANCE: NATIONAL AGENCY CHECK WITH WRITTEN

INQUIRIES (NACI). As a minimum, Contractor personnel shall successfully complete a NACI before operating Government-furnished workstations that have access to AF automated information systems. Requests for Contractor personnel hired at the beginning of the contract shall be submitted to the Government not later than 45 workdays from the contract start date.

Requests for Contractor personnel hired subsequent to contract start date shall be submitted to the Government not later than ten (10) workdays from the Contractor personnel’s first duty day.

Contractor personnel receiving unfavorable NACIs shall not be employed. The Government will submit requests for investigations on AF IMT 2583, Request for Personnel Security Action, at no additional cost to the Contractor. Any personnel with access to classified material will be submitted by the Contractor’s Facility Security Officer (FSO) for a Secret security clearance.

The Contractor shall comply with the requirements of DoD 5200.2-R, Personnel Security

Program; AFI 31-501, Personnel Security Program Management, 25 Jan 05; and AFI 33-119, Air Force Messaging, 24 Jan 05.

1.8.1. Contractor personnel shall comply with the requirements of AFI 71-101, Volume 1, Criminal Investigations, 01 Dec 99, and AFI 71-101, Volume 2, Protective Service Matters, 18

Nov 02, para 1.1. These regulations require Contractor personnel to report any information or circumstances of which they are aware that may pose a threat to the security of DoD personnel, Contractor personnel, resources, and classified or unclassified Defense information to their immediate supervisor. The immediate supervisor of Contractor personnel will brief on this requirement during initial on-base assignment and as required thereafter.

1.8.2. The Unit Security Manager will assist the Contractor with any Joint Personnel

Adjudication System (JPAS) Joint Clearance and Access Verification System (JCAVS) and eQIP by Design information for inputting NACIs with assistance from 81 TRW Information

Security Office (81 TRW/IP).

1.8.3. Security Monitoring. The Contractor shall comply with all security requirements.

Submit reports, classified if appropriate, of any information coming to their attention concerning any of their employees who have been cleared or are in the process of being cleared for access to classified information, which indicates that such access or determination may not be clearly consistent with the national interest. Reports shall be submitted to the Defense Industrial

Security Clearance Office (DISCO) immediately upon notification of any adverse information, change in employee’s status, official investigation, or any other reason. In addition, a copy of this report shall be furnished to the contract Contracting Officer’s Representative(s) (COR(s))

(see para 1.10., Quality Assurance) and 81 TRW Installation Commander (81 TRW/CC).

1.8.4. Listing of Employees. The Contractor shall maintain a current listing of all Contractor personnel. The list shall include Contractor personnel’s names, Social Security numbers, and level of security clearance. The list will be validated and signed by the FSO and provided to the

CO, COR, Base Visual Information Manager (BVIM), 81 TRW/IP, Unit Security Manager, and

FSO prior to the contract start date. Updated listings shall be provided when a Contractor personnel’s status or information changes.

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1.8.5. Traffic Laws. The Contractor and its employee’s shall comply with all state and base traffic regulations.

1.9. PASS AND IDENTIFICATION REQUIREMENTS. Contractor personnel whose duties require access to KAFB computer system are required to obtain a Common Access Card

(CAC). To obtain a CAC, Contractor personnel shall coordinate with their gaining unit’s security manager or the 81st Communications Squadron Consolidated Client Support Activity

(CSA) at 228-376-4335. Paras. 1.9.1.-1.9.2.8. below, are not applicable to Contractor personnel who obtain a CAC.

1.9.1. Entry/Access requirements for Contractor personnel requiring access to KAFB when

CAC is not issued.

1.9.2. Applicability.

a. These requirements apply to Contractor personnel requiring entry/access to KAFB for service contracts with periods of performance (POP) exceeding 60 days when a CAC is not issued.

(1) Contract POP begins at performance start date. The POP end date is based on the contract completion date.

(2) These requirements shall be included (flow down) to subcontracts at every tier.

b. These requirements do not apply to Contractor personnel requiring entry/access to KAFB with a POP of 60 days or less. Entry/Access to KAFB for Contractor personnel with a POP of

60 days or less will be coordinated between the Contractor and the 81st Security Forces

Squadron (81 SFS).

c. When work under this contract requires unescorted entry to controlled or restricted areas, the Contractor shall comply with AFI 31-101 Integrated Defense, 8 Oct 09, and AFI 31-501, Personnel Security Program Management, 27 Jan 05, as applicable.

d. Contractor personnel are not covered by Federal Acquisition Regulation (FAR) 52.222-3, Convict Labor, for the purposes of entry/access to installations/locations.

1.9.3. Badging System Data Requirements.

a. The Contractor shall provide the following to the Contracting Office:

(1) “Listing of personnel requiring access/entry.” Documents shall be marked as

FOUO as a minimum. The list shall contain the following:

(a) Contract number.

(b) Contract award date.

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(c) POP dates.

(d) Work site(s) or location(s).

(e) Each employee’s full name and Social Security Number (SSN). For those without SSNs, a working visa or Permanent Resident Card with a Resident Alien number must be provided, or base entry will be denied.

(f) Identify up to two (2) Contractor personnel for designation as “sponsor” authorities. Badges will identify the Contractor personnel with sponsorship privileges.

(2) Completed KAFB Form 299 (see Appendix C, Application for KAFB Identification

Card) shall authorize Security Forces to fingerprint Contractor personnel and conduct additional background checks. The consent form will outline the following:

(a) The Contractor personnel for the purpose of the KAFB Form 299.

(b) The information on the form is collected IAW 18 U.S.C. 1382 and DoD

Directive 5200.8, both of which permit installation commanders to limit access to installations for security reasons.

(c) Completion of the form is voluntary.

(d) Agreement to provide a specimen of fingerprints.

(e) Awareness of a list of “disqualifying factors.”

(f) Consent and authorization for Security Forces to conduct background screening and to compare fingerprints against State and Federal criminal databases.

(g) Knowing and willful false statements on the form can be punished by a fine, imprisonment, or both (10 U.S.C. 1001).

(h) The consent form shall remain valid for 24 months after the end of the contract.

b. The Contractor personnel list and consent form(s) shall be submitted as follows:

(1) 81 SFS/PASS & ID e-mail account: keeslerpassandid@keesler.af.mil. Personnel list must be submitted IAW the PWS. The signed KAFB Form 299 must be submitted in person to the 81 SFS/PASS & ID office.

(2) Refer questions regarding the Contractor personnel list and KAFB Form 299 to

81 SFS/PASS & ID at 228-377-1845 or 228-377-3844.

1.9.4. Background Checks.

mailto:keeslerpassandid@keesler.af.mil

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1.9.4.1. Upon receipt of the KAFB Form 299 with a copy of Drivers License and Social

Security card, a background check will be accomplished. Background checks will be categorized as favorable or unfavorable. Unfavorable background checks contain any one of the

“disqualifying factors.” Any person with an unfavorable background check will be denied entry/access to the installation.

1.9.4.2. “Disqualifying factors” include:

a. Barred from entry/access to any military installation or facility.

b. Wanted by federal or civil law enforcement authorities.

c. Name appears on any federal agencies “watch list” or “hit list” for criminal behavior or terrorist activity.

d. Conviction of firearms or explosives violation within the past seven (7) years.

e. Incarcerated regardless of offense or violation.

f. Conviction of aggravated assault, armed robbery, felony drug possession, drug possession with intent to sell, or drug distribution within the past seven (7) years.

g. Conviction of espionage, sabotage, treason, terrorism, murder, sexual assault, rape, or child molestation.

h. Terrorist or terroristic threats or repetitive history of criminal history.

i. Currently serving parole or probation for a felony case.

j. U.S. citizenship, immigration status, or Social Security Account Number cannot be verified.

1.9.4.3. An unfavorable background check/denial may be appealed through the 81 SFS/PASS &

ID. The appeal shall include a signed letter of rebuttal and any associated supporting documentation to the 81 SFS/PASS & ID.

1.9.4.4. Given a reasonable cause, condition, or reason, these requirements do not circumvent the installation/location commander’s unilateral authority to deny or withdraw any individual’s entry/access to an installation/location.

1.9.5. Badge and Fingerprint Schedule. 81 SFS/Pass & ID will notify the Contractor upon completion of background checks. Badging and fingerprinting shall be scheduled by contacting the Contractor by phone. Contractor personnel shall report to the 81 SFS/Pass & ID with a photo

ID issued by a federal/state organization (i.e. Drivers License, State ID card, U.S. Passport, etc.).

If no photo ID is shown, a badge will not be issued.

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1.9.6. Change in Employee Entry/Access Status (Deletions).

a. No later than five (5) workdays after a change in status for Contractor personnel requiring entry/access, the Contractor shall return identified badges to the 81 SFS/Pass & ID.

b. The Contractor shall notify the Contractor personnel of their change in status for entry/access.

c. Unfavorable fingerprints shall constitute immediate deactivation of the issued badge(s) to the disqualified Contractor personnel.

(1) 81 SFS may confiscate badge(s) of the Contractor personnel present on base at the time of the unfavorable result notification. 81 SFS may escort the Contractor personnel from

KAFB IAW Security Forces guidelines.

(2) 81 SFS/Pass & ID will notify Contractor of an unfavorable fingerprint result and request the Contractor to return the badge IAW this PWS (unless already confiscated).

1.9.7. Badge Loss/Replacement.

a. Contractor personnel requiring a replacement badge shall contact the 81 SFS/Pass &ID at

228-377-1845 to schedule a badge appointment.

b. Lost badge(s) require a signed letter from the Contractor and Contractor personnel that lost the badge requesting replacement of badge(s) due to loss or damage.

1.9.8. Contract Completion, Return of Badges. No later than five (5) workdays after contract completion, the Contractor shall return all badges to 81 SFS/Pass & ID. All badges are returned collectively by the Contractor, not incrementally/individually by the Contractor personnel. The badge turn-in shall identify the contract name.

1.10. OPERATIONAL SECURITY (OPSEC).

1.10.1. OPSEC Training.

1.10.1.1. New Contractor personnel shall complete Level 1 OPSEC training along with unit

OPSEC orientation training within 30 calendar days of reporting for duty.

1.10.1.2. All Contractor personnel shall complete annual refresher OPSEC awareness training.

1.10.2. Disclosure of Information.

1.10.2.1. The Contractor shall not release to anyone outside the Contractor’s organization any unclassified information, regardless of medium (e.g., film, tape, document, etc.), pertaining to or execution of any part of this contract or any program related to this contract, unless:

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(a) The CO has given prior written approval; or

(b) The information is otherwise in the public domain before the date of release.

1.10.2.2. Requests for approval shall identify the specific information to be released, the medium to be used, and the purpose for the release. The Contractor shall submit the request to the CO at least 45 days before the proposed date for release.

1.10.2.3. The Contractor agrees to include a similar requirement in each subcontract under this contract. Subcontractors shall submit requests for authorization to release through the prime

Contractor to the CO.

1.10.2.4. The Contractor shall be provided a unit and wing critical information list (CIL) and procedures to safeguard information contained therein. The Contractor shall ensure the unit is provided any additional items required to be added to the CIL.

1.11. HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT

(HIPAA) OF 1996.

1.11.1. 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.

1.11.2. 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.

1.11.3. 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.

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(1) HITECH Act shall mean the Health Information Technology for Economic and Clinical

Health Act included in the American Recovery and Reinvestment Act of 2009.

(2) 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).

(3) Privacy Rule means the Standards for Privacy of Individually Identifiable Health

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

(4) 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.

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

(6) Required by Law has the same meaning as the term “required by law” in 45 CFR

164.501 and 164.103.

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

(8) Security Incident shall have the same meaning as the term “security incident” in 45

CFR 164.304, limited to the information created or received by Contractor from or on behalf of the Covered Entity.

(9) Security Rule means the Health Insurance Reform: Security Standards at 45 CFR part

160,162 and part 164, subpart C.

b. Terms. 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.

(1) 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.

(2) The Contractor agrees to use appropriate safeguards to maintain the privacy of the

Protested Health Information and to prevent use or disclosure of the Protected Health

Information other than as provided for by this Contract.

(3) The HIPAA Security administrative, physical, and technical safeguards in 45 CFR

164.308, 164. 310, and 164.312, and the requirements for policies, procedures and documentation in 45 CFR 164.316 shall apply to the Contractor. The additional requirements of

Title XIII of the HITECH Act that relate to security and that are made applicable with respect to covered entities shall also be applicable to the Contractor. The Contractor agrees to use administrative, physical, and technical safeguards that reasonably and appropriately protect the

25 Jun 13 confidentiality, integrity, and availability of the electronic protected health information that it creates, receives, maintains, or transmits in the execution of this Contract.

(4) 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.

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

(6) 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.

(7) 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.

(8) 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.

(9) 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.

(10) 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.

(11) 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.

(12) 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.

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(13) 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.

c. 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. The additional requirements of Title XIII of the HITECH Act that relate to privacy and that are made applicable with respect to covered entities shall also be applicable to the Contractor.

d. Specific Use and Disclosure Provisions.

(1) 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.

(2) 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.

(3) 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).

(4) 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).

e. Obligations of the Government. Provisions for the Government to Inform the Contractor of Privacy Practices and Restrictions

(1) Upon request the Government will 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.

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(2) The Government will 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.

(3) The Government will 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.

f. Permissible Requests by the Government.

The Government will 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.

g. 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.

(1) Effect of Termination.

(a) 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.

(b) 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.

(c) 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.

f. Miscellaneous.

(1) 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

25 Jun 13 provision means the section as currently in effect or as amended, and for which compliance is required.

(2) 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.

(3) 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.

1.12. RECORDS. The Contractor shall create, maintain, and provide Government-owned/Contractor-held records, regardless of media, in performance of this contract IAW the following directives:

- AFI 33-119, Air Force Messaging, 24 Jan 05

- AFI 33-322, Records Management Program, 4 Jun 12

- AF Manual (AFMAN) 33-363, Management of Records, 1 Mar 08

- AFI 33-364, Records Disposition—Procedures and Responsibilities, 22 Dec 06

- AFI 10-701, Operations Security, 8 Jun 11

- AF Information Management System database (AFRIMS) (access through the AF Portal)

- AF Electronic Records Management Solution

1.12.1. The Contractor shall segregate the Government-owned records from the Contractor-owned records and identify all records required to be created by the PWS on the AFRIMS file plans. The 81st Infrastructure Division functional area records manager (FARM) will provide records management guidance and support. The Contractor shall create and maintain paper and electronic records (52mahg-fs-106) as appropriate. The Contractor shall maintain the software and background data to retrieve official electronic Government records throughout the lifecycle of the records.

1.12.2. The Contractor shall operate AFRIMS. The Contractor shall designate a Contractor personnel to become the records custodian. In the event of a Contractor personnel change that creates a vacancy in the records custodian position, the Contractor shall designate a replacement records custodian. The records custodian shall complete the initial and annual records management training within 90 days of appointment. The chief of the office completes on-line training within the same time period.

1.12.3. The Contractor maintains and disposes of records IAW the AF records disposition schedules.

1.12.4. Electronically Stored Information (ESI). The Contractor shall maintain Government owned electronic non-official records on the organizational shared network drive according to the subjective categories (example: template, common, reference material, and working files). The

Contractor shall grant the base records manager access to all files located on the organizational shared network drive. The Contractor shall maintain the official electronic records on the base designated shared network drive (52mahg-fs-106) IAW the Air Force Electronic Records

25 Jun 13

Management System and AFMAN 33-363, Chapter 6. The Contractor shall forward a listing to the organizational functional area records manager (FARM) identifying assigned personnel and their required access rights (ERM – read and write; RC – read, write, and modify).

1.12.5. Upon completion of this contract, all Government-owned/Contractor-held records

(regardless of media) received, created, maintained, or provided in the performance of the PWS shall be turned over to the Government. Background electronic data and records specified for delivery to the contracting agency must be accompanied by sufficient technical documentation and software to permit the AF to use the data. In the event of default or non-performance, the

Government will have access to all records in order to ensure mission support is not interrupted.

1.12.6. DOD Freedom of Information Act (FOIA) Program. The Contractor shall comply with the requirements of DoD Regulation 5400.7-R/AFMAN 33-302, Freedom of Information

Act Program, 21 Oct 10, IC1, 24 Apr 12. If the Contractor receives a FOIA request, the

Contractor shall ensure it is delivered immediately to the base FOIA manager, 81st

Communications Squadron (81 CS/SCOK) for processing. The FOIA manager will task a

Government official who, as the authorized official, will make the decision on releasing

Government records.

1.12.7. Privacy Act Program. The Contractor shall create, maintain, and destroy Privacy Act data IAW AFI 33-332, Privacy Act Program, 16 May 11; and Privacy Act systems of records notice(s) (http://dpclo.defense.gov/privacy/SORNs/component/airforce/index.html). The

Contractor shall not create or maintain a Privacy Act system of records prior to public notice. If the Contractor receives a Privacy Act request, the Contractor shall be responsible for searching for the records and providing those records to a Government official who, as the authorized official, will make the decision on releasing the Government records.

1.12.8. Functional Requests. A functional request is a written request for DoD records received from any person (including a member of the public), or a business that does not cite either the FOIA or Privacy Act. The Contractor shall be responsible for searching for the records and providing those records to a Government official who, as the authorized official, will make the decision on releasing the Government records.

http://dpclo.defense.gov/privacy/SORNs/component/airforce/index.html

25 Jun 13

2. SERVICES SUMMARY (SS).

Performance Objectives Para in PWS Performance Thresholds

1. Removal of all waste accumulated from individual facilities.

1.2 100% --The Contractor shall pick up medical waste from KAFB Buildings 0468, 0404, 0824, 5901, 0408, and 2306 during the hours listed

2. Adequate shipping containers provided for next accumulation period.

1.4.4 100%-- There must be at least 30 empty containers left at the MTF after all bagged waste is removed.

3. Meeting schedule for pick-up of generated waste from buildings.

1.2 95%-- Pickups shall be scheduled 3 days per week. If an insufficient amount of waste is available the contractor will be notified

4. Insure all generated waste is properly packed for shipment in accordance with

Department of Transportation regulations.

1.2.1 100%-- No bags of medical waste will be opened by the Contractor on KAFB.

5. Weigh and provide documentation prior to removing waste from the installation.

1.2.2 100% --The Contractor shall weigh the medical waste from all collection points in the isolation room in Building 0468, KAFB Medical Center.

A Government Rep will be contacted and will be present.

6. Prepare all shipping paperwork to insure

Department of Transportation compliance

1.2.3.1 100% --The Contractor shall complete a manifest showing the types of materials/medical waste, number of containers

7. Provide paperwork to demonstrate chain of custody and proof of disposal.

1.2.3.1-

1.2.3.3

100% -- Contractor shall verify the destruction, certify on the manifest that the waste has been properly disposed of, and return a copy signed by the treatment/disposal facility representative to the Medical Center Environmental Office

8. Obtain signature of competent government representative with appropriate Department of

Transportation training on shipping papers.

1.2.3.1 100% -- Prior to departure from KAFB, a signed copy of the manifest(s) shall be provided to the Government representative who witnessed the weighing.

3. GOVERNMENT AND/OR CONTRACTOR-FURNISHED PROPERTY AND/OR

SERVICES.

3.1. GOVERNMENT-FURNISHED PROPERTY (GFP). The Government will provide the facilities, equipment, materials, and/or services listed below.

25 Jun 13

3.1.1. Cargo Scales. The Government will provide a cargo scale at the Keesler Medical Center

(Building 0468, Room BA1 17) for weighing all containerized waste prior to off-base transportation.

3.2. CONTRACTOR-FURNISHED ITEMS AND SERVICES. Except for those items or services specifically stated to be Government-furnished above, the Contractor shall furnish everything required to perform the contract requirements, including all containers and labels.

3.2.1. Container Requirements. The Contractor shall provide the following quantity of containers at the following locations:

a. Building 0468, Medical Center – 30 containers (50 containers at initial start-up)

b. Building 0824, Dental Clinic – 1 container

c. Building 0404, Clinical Research Laboratory – 4 containers

d. Building 0408, Veterinary Clinic – 1 container

e. Building 5901, Arnold Annex Blood Donor Center – 1 container

f. Building 2306, Satellite Pharmacy – 1 container

3.2.2. The Contractor-provided containers must have a lid which locks onto the container, be delivered fully assembled and ready for use, and meet or exceed the following standards:

- Constructed of rigid plastic (polyethylene or polypropylene)

- Leak resistant (void of holes or imperfections contributing to leaks)

- Impervious to moisture. Container materials or material density which allows moisture to compromise container integrity or rigidity are not allowed

- Red in color with an infectious waste insignia on the side

- Minimum capacity of 80 gallons

- Sufficient strength to prevent tearing or bursting under normal conditions of use and handling

25 Jun 13

APPENDIX A

WORK LOAD ESTIMATE

The Contractor shall dispose of approximately 16,590 pounds per month of regulated medical waste and chemotherapy waste during the contract period. An estimate of each type follows:

a. Regulated Medical Waste: 15,240 lbs/month.

b. Chemotherapy Waste: 675 lbs/month.

c. Other Regulated Waste: 675 lbs/month - expired non-regulated/non-controlled pharmaceuticals.

25 Jun 13

APPENDIX B

TECHNICAL DEFINITIONS

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

Animal Waste. Contaminated animal carcasses, body parts, and bedding of animals that were exposed to infectious agents during research (including research in veterinary hospitals), production of biologicals, or testing of pharmaceuticals.

Chemotherapy Waste. Waste from Antineoplastic Drug (AD) agents or chemicals that occurs as remnants in containers or tubes or is waste due to accidents or spills. Also includes outdated

ADs that need to be disposed of as waste. ADs are also known as cytotoxic, chemotherapy, or anticancer drugs.

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.

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.

Isolation Waste. Biological waste and discarded materials contaminated by 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.

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

Sharps. Shams 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.

25 Jun 13

APPENDIX C

APPLICATION FOR KAFB IDENTIFICATION CARD