PWS.pdf

Performance Work Statement (PWS)

For

Quantitative COVID-19 Antibody Testing

Medical Treatment Facility, David Grant Medical Center

Travis AFB

19 May 20

Table of Contents

SECTION NO. AND TITLE PAGE NO.

I. Description of Service 3

II. General Information 4

III. Appendices 7

A. Applicable publications and Forms

B. Projected Workload

C. Specimen Testing Services

PERFORMANCE WORK STATEMENT (PWS)

Quantitative COVID-19 Antibody Testing

Medical Treatment Facility, David Grant Medical Center

Travis AFB

I. Description of Services

1. The Contractor shall provide transportation, personnel, equipment, material, management, supervision, administration, labor and all other services listed in this

Performance Work Statement (PWS) for the 60th Medical Group, David Grant Medical

Center (DGMC), Laboratory Flight, Travis Air Force Base when required as described for David Grant Medical Center Travis AFB. Services include clinically validated laboratory tests, quantitative SARS-CoV-2 IgG & IgM Panel, quantitative SARS-CoV-2

IgG, and quantitative SARS-CoV-2 IgM. All services provided shall be performed in accordance with all applicable laws, regulations, standards, local instructions, and commercial practices.

The contractor shall comply with The Joint Commission (TJC), and all Federal, State, and local laws applicable to the performance of work including the Food and Drug

Administration (FDA), and shall provide up to date CAP and CLIA licensure. The terms

“must,” “shall” and “will” denote mandatory actions in this PWS. This includes all direct and indirect resources

1.1. Emergency Use Authorizations (EUAs). Section 564 of the Food, Drug and

Cosmetic Act allows unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when there are no adequate, approved, and available alternatives. This is known as Emergency Use

Authorization - also called EUA. All offers must be in compliance with Section 564 of the Federal Food, Drug, and Cosmetic Act for those medical products intended to be delivered to the Government. Only medical products that have received Emergency Use

Authorization Approval from the U.S. Food and Drug Administration (FDA) shall be considered for award under this solicitation.

1.2. Requirements

1.1.1. The contractor shall provide specimen testing services during regular business hours, Mondays through Fridays, 8am to 5pm EST, not to include Federal Holidays.

1.1.2. Procedures for specimen testing included but not limited to the quantitative SARS-

CoV-2 Antibody testing (see attached Appendix C).

1.1.3. The contractor must incorporate DGMC’s Laboratory patient accession numbering sequence on each report.

1.1.4. The contractor shall provide the DGMC Laboratory the scheduled days of testing for the different test procedures with turnaround times.

1.1.5. The contractor shall provide a Point of Contact client service representative that can be reached by phone during normal business hours, Mondays through Fridays.

1.1.6. The contractor shall provide DGMC Laboratory with a Web-based result reporting that will allow DGMC Laboratory to receive results utilizing a standard Web browser, for example, Internet Explorer. The contractor’s website will also provide access to check the status of test results and provide access to historic results which are available online indefinitely. The contractor’s website shall provide a password-based system in which reports can be accessed by pathologists from any location at any time.

1.1.7. The contractor shall also provide written and faxed test results.

1.1.8. The contractor shall provide all necessary shipping/transport supplies free of charge (i.e., specimen tubes, specimen bags, etc.)

1.1.9. The contractor shall meet the turn-around time required: 7-14 days from the day the specimen is received by the contractor.

II. Service Summary:

Performance Objective PWS Para Performance

Threshold

Surveillance Method

Maintain current certification with TJC and

FDA as well as CAP and

CLIA licensure

Para 1 100% Review of data;

annual inspection of the contractor’s qualification

Specimen testing results within required time

Para 1.2.0 100% of the time Review reports ensuring accurate data is being maintained.

All supplies and materials available for shipping

Para 3.1.1.9 95% Customer complaint

HIPAA Compliance Para 3.1.5 100% Customer complaint

III. General Information

1. Privacy Act Program: The Contractor shall comply with the Privacy Act of 1974 (the

Act) and AFI 33-332, the Air Force Privacy Act Program and the agency rules and regulations issued under the Act in the design, development operation of any system of records. Operation of a system means performance of any of the activities associated with maintaining the system of records, including the collection, use and dissemination of personal information. Systems of Records on individuals are defined as a group of any records under the control of an agency from which information is retrieved by the name of the individual or by some identifying number, symbol or other identification unique to the individual.

a. All records generated during the performance of the contract are considered

Government records and shall be turned over to the Government upon termination of the

Contract.

b. Records are considered to be all books, papers, maps, photographs, machine-readable materials or other documentary materials, regardless of physical form or characteristics, made or received by any agency of the Government under federal laws, or in connection with the transactions of public business, and preserved or appropriate for preservation by any agency, or its legitimate successor, as evidence of the organization, functions, policies, decisions, procedures, operations or other activities of the

Government or because of the informational value of data in them. This includes all electronic records.

1.2. FOR OFFICIAL USE ONLY (FOUO). The Contractor shall create and Maintain

FOUO material IAW DoD 5400-7, DoD Freedom of Information Act Program, Chapter

4; AFI 33-129, Web Management and Internet Use; and AFI 33-201, Communications

Security (COMSEC), Table 1. Mark all documents meeting the requirements identified in DoD Regulation 5400.7/Air Force Supplement, paragraphs C3.2.1.2 thru C3.2.1.9 as

“For Official Use Only” IAW instructions. Safeguard all sensitive data IAW DoD

Regulation 5400.7/Air Force Supplement. When documents containing FOUO material are authorized for destruction, shred the records so that the pieces cannot be reconstructed. Degauss or overwrite magnetic tapes or other magnetic media. Records

Disposition shall be IAW with the Records Management Program, AFI 33-322.

1.3. DoD Freedom of Information Act (FOIA) Program: If the Contractor receives a

FOIA request the Contractor shall immediately hand-carry it to the base FOIA manager for processing. The FOIA manager will task a Government official. When tasked, 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 Government records.

1.4. Functional Requests: A written request for DoD records that does not cite either the FOIA or Privacy Act may be received from any person (including a member of the public), or organization, or a business. 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 Government records.

1.5. Health Insurance Portability and Accountability Act (HIPAA). In accordance with DoD

6025.18-R “Department of Defense Health Information Privacy Regulation,” January 24, 2003, the Contractor meets the definition of Business Associate. Therefore, a Business Associate

Agreement is required to comply with both the Health Insurance Portability and Accountability

Act (HIPAA) Privacy and Security regulations. This clause serves as that agreement whereby the

Contractor agrees to abide by all applicable HIPAA Privacy and Security requirements regarding health information as defined in this clause, and in DoD 6025.18-R and DoD 8580.02-R, as amended. Additional requirements will be addressed when implemented.

(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 or DoD 8580.02-R.

Individual has the same meaning as the term “individual” in 45 CFR 160.103 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 160.103, limited to the information created or received by the Contractor from or on behalf of the Government pursuant to the Contract.

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

164.103.

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 Clause shall have the same meaning as those terms in 45 CFR 160.103, 164.501 and 164.304.

(b) The Contractor shall 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 shall 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 Clause.

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

(g) The Contractor shall 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.

(h) The Contractor shall 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 shall 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 shall provide access, at the request of the Government, and in the time and manner reasonably 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 shall 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, and in the time and manner reasonably designated by the

Government.

(l) The Contractor shall 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 reasonably designated by the Government or the Secretary, for purposes of the Secretary determining the Government’s compliance with the

Privacy Rule.

(m) The Contractor shall 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 shall provide to the Government or an Individual, in time and manner reasonably 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.

NIST Special Publication 800-88 Rev 1- Destroy paper using cross cut shredders which produce particles that are 1 x 5 millimeters in size (reference devices on the NSA paper Shredder

EPL), or to pulverize/disintegrate paper materials using disintegrator devices equipped with 3/32 inch security screen (reference NSA Disintegrator EPL.) and maximum particle size after shredding of no more than 1/32" by 7/16" to meet the DoD HIPAA standards.

General Use and Disclosure Provisions

Except as otherwise limited in this Clause, 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, the HIPAA Security Rule, DoD 6025.18-R or DoD 8580.02-R if done by the Government.

Specific Use and Disclosure Provisions

(a) Except as otherwise limited in this Clause, 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 Clause, 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 Clause, 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) The Government shall provide the Contractor with the notice of privacy practices that the Government produces in accordance with 45 CFR 164.520.

(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, the

HIPAA Security Rule, or any applicable Government regulations (including without limitation, DoD 6025.18-R and 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, DoD 8580.02-R, Privacy Rule or Security Rule means the section currently in effect or as amended, and for which compliance is required.

(b) Survival. The respective rights and obligations 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, DoD 8580.02-R, the HIPAA

Privacy Rule or the HIPAA Security Rule.

III. Appendices

APPENDIX A

Applicable Instructions, Directives and Regulations

Publications and forms applicable to this Performance Work Statement (PWS) are listed below, and are mandatory. The contractor shall follow those publications to the extent specified (that is, the specific procedure in a paragraph, section, chapter or volume) to meet requirements in this PWS. Applicable publications are located at http://www.e-publishing.af.mil/pubs. The Government may issue supplements or amendments to listed publications from any organizational level during the life of the contract. The contractor shall keep all issued publications up-to-date. The contractor shall immediately implement those changes in publications that result in a decrease or no change in the contract price. Before implementing any such revision, supplement, or amendment that will result in an increase in contract price, the contractor shall submit to the contracting officer a price proposal for approval. Price proposals shall be submitted within 30 calendar days from the date the contractor receives notice of the revision, supplement, or amendment-giving rise to the increase in cost of performance. The Government and the contractor will negotiate the changes into the contract under provisions of the Changes clause. The Contractor will continue to supply the Government forms needed for daily operations. Upon completion of the contract, the contractor shall return to the

Government all issued publications and unused forms.

Publications Code:

AFI--Air Force Instruction

AMC-Air Mobility Command

DoDI-DoD Instruction

MDGI -60th Medical Group Instruction

DEPARTMENT OF DEFENSE and AIR FORCE PUBLICATIONS:

Number Title of Directive

DoDI 3020.37 Continuation of Essential DOD Contractor Services

During Crises

DoDI 5400.7-R DoD Freedom of Information Act

Para, C.4.2.1, C.4.4C3.2.1.2 - C3.2-1.9

Air Force Sup DoD Freedom of Information Act

DoDI 5500.7-R Joint Ethics Regulation (JER)

DoDR 6025.18-R Health Information Privacy Regulation

AFI 33-129 Transmission of Information Via the Internet

AMC Sup 1 Transmission of Information Via the Internet

AFI 33-201 Communications Security (COMSEC)

AFI 33-332 Air Force Privacy Act Information http://www.e-publishing.af.mil/pubs http://www.e-publishing.af.mil/pubs

AMC Sup 1 Air Force Privacy Act Information

Travis Air Force Base Environmental Management Policy for Contractors available at <http://www.travis.af.mil/pages/60cons/ReadingRoom.htm>.

Records Disposition Schedule

WebRIMSs website at <https://webrims.amc.af.mil/login.cfm>

Privacy Act Systems of Records Notice(s) at <http://www.defenselink.mil/privacy/notices/usaf>

Health Insurance Portability and Accountability Act (HIPAA)

APPENDIX B

WORKLOAD ESTIMATES

Projected Workload

1. Projected Workload

1 May 2020 – 31 Dec 2020: 3,000 patient specimen requests.

Future year numbers may increase or decrease by 10% per year, based on number of patient’s visits and admissions.

APPENDIX C

Specimen Testing Services

TEST DESCRIPTION HCPCS CODE

Quantitative SARS-CoV-2 IgG & IgM Panel 6400

Quantitative SARS-CoV-2 IgG 642

Quantitative SARS-CoV-2 IgM 641 http://www.travis.af.mil/pages/60cons/ReadingRoom.htm https://webrims.amc.af.mil/login.cfm http://www.defenselink.mil/privacy/notices/usaf