DRAFT_Performance_Work_Statement.pdf

PERFORMANCE WORK STATEMENT

Next Generation Genetic Testing

Department of Pathology, Madigan Army Medical Center (MAMC), Fort Lewis, WA

1. DESCRIPTION OF SERVICES: The Contractor shall plan, program, administer, manage, and execute the work necessary to provide the required services. The Contractor shall utilize personnel, management, labor, supplies, and equipment necessary to provide next generation genetic testing to support Madigan Army Medical Center (MAMC), Tacoma, WA. The laboratory services will not be conducted on JBLM or in Department of Pathology, MAMC. All information networks utilized by the contractor will be organic to the Contractor for patient reporting. The laboratory testing services to be provided shall include, but not be limited to the following: next generation genetic testing to include genetic deletions and duplications.

2. TESTING TO BE PERFORMED:

2.1 Specimens to be submitted for testing are solely at the discretion of MAMC. MAMC reserves the right to withhold, at any time, tests previously sent to the Contractor, or to add tests not previously sent.

2.2 All tests shall be performed entirely on the premises of the Contractor or within its network of laboratories.

Contractor referrals to a secondary laboratory shall be done only with the express permission of the COR, for the MAMC Laboratory, and concurrence by the Contracting Officer. Handling fees or additional charges for referrals to secondary laboratories shall not be allowed.

2.3 The specific genetic panels and tests required include, but are not limited to the tests listed in the IGE. Estimated annual quantity amounts are not indicative of future requirements.

3. LABORATORY SERVICES

3.1 The Contractor shall have extensive capabilities and shall already have established all of the analytic test procedures required for the tests listed in the IGE and shall be able to perform them upon request. The Contractor shall be an accredited laboratory. The Contractor shall provide:

Specific specimen requirements for each analysis;

Specific method and interpretation where specified;

Sensitivity and detection limits where specified;

Provide next generation genetic testing utilizing panel-based tests in the areas of cardiology, hereditary cancer, neurology, pediatric genetics and hematology;

Provide genetic testing for rare diseases;

Be able to detect gene deletions and duplications by calculating the statistical likelihood of each copy number state by comparing depth of sequence coverage at targeted exons to depth measured from a set of baseline samples;

Offer one re-requisition for additional genetic testing at no additional charge within 90 days of the original report release date;

Reviews the available literature and public database entries for each gene;

Analyze genetic disorders associated with each gene and include disease penetrance, inheritance and known pathogenic variants;

regions to assay;

ed gene structures, and challenging

Follow the American College of Medical Genetics guidelines for variant classification during reporting

3.2 Specimen Collection and Test Ordering: Tests will be requested on forms provided by the Contractor. Upon award, the Contractor shall provide five (5) copies of test directories which shall include all tests available, specimen requirements, normal ranges, interpretive information, and any other instruction necessary to order tests from the Contra

3.3 Shipping: Contractor will provide FedEx number for FedEx overnight shipment to Contractor.

3.4 Turnaround Time: A turnaround time of less than 4 weeks from receipt of specimen by Contractor laboratory to receipt of result by MAMC is required for all requested testing unless otherwise identified in paragraph 3.4.1. . All results require appropriate interpretive explanations. Each report shall be reviewed and signed by a Board Certified Laboratory Director.

3.5 Handling of Specimen or Request Discrepancies: Specimen loss due to breakage, spillage, misplacement, mishandling, or any other Contractor-related problem will be considered unacceptable if more than two (2) specimens are lost or otherwise compromised per month. Repeated problems with specimen loss may be grounds for termination of the contract for cause. The contractor shall resolve request discrepancies (i.e. illegible request, missing patient information, or other clerical errors) via telephone or e-mail with MAMC laboratory personnel before canceling test or discarding specimen.

3.6 Specimen Retention: Contractor shall hold, under appropriate storage conditions, all specimens not consumed in testing for 90 days after completion of testing.

3.7 Specimen Result Reporting: The contractor shall report all results to the MAMC Laboratory via fax. Telephone numbers and facsimile numbers will be provided on the test requisition form.

3.8 Customized Reports: The contractor shall provide a monthly utilization report to the Contracting Officer Representative (COR).

4. QUALITY STANDARDS:

Pathologists (CAP) and maintain accreditation for the duration of this contract. The laboratory shall also certify that it is in full compliance with the requirements of the Clinical Laboratory Improvement Act of 1988 (CLIA 88) as they exist as of the date that the solicitation. Contractor shall notify MAMC immediately in the event of loss of any accreditation or membership. Loss of any accreditation, certification, or membership may, at the Contracting Officer

4.2 Personnel. The Laboratory Director shall be a fully licensed MD or PhD who is an active, full-time Director.

The Contractor shall have a full-time staff of in-house professional scientists and consultants at the MD and PhD levels. Medical doctors should have specialty or subspecialty boards in areas of expertise.

4.3 The Contractor shall, at no additional cost, provide MAMC with consultative service concerning interpretation of tests. This consultative service shall meet the minimum requirements listed below:

One (1) telephone number for MAMC healthcare providers to call regarding all results.

Provide patient educational materials for genetic testing.

5. MANAGEMENT REPORTS: The Contractor shall provide monthly reports of tests performed under this contract. The info during the month reported, number performed year to date, individual test cost, monthly total cost, and cost year to date. . This report shall be provided within thirty (30) days or sooner after the end of the month being reported..

Billing invoices received from the Contractor shall include the patient name, date of service, procedure name, CPT code of procedure, and the amount billed.

6. OTHER RESPONSIBILITIES:

6.1 The contractor shall keep the COR informed of the most recent developments in clinical laboratory methods and medical interpretation through periodic newsletters, reports and data sheets.

6.2 The Contractor shall have a representative available during normal business hours to assist in problem solving at no additional cost to the Government. Access to knowledgeable laboratory professionals shall be rapid with minimal call transfers and holding.

6.3 The Contractor shall provide periodic visits and/or telephonic contact from an account representative/consultant for troubleshooting, servicing account, introducing new tests, etc.

7.1 ACCOUNTING FOR CONTRACT SERVICES

7.2 The Office of the Assistant Secretary of the Army (Manpower & Reserve Affairs) operates and maintains a secure Army data collection site where the contractor will report ALL contractor manpower (including subcontractor manpower) required for performance of this contract. The contractor is required to completely fill in all of the information in the format using the following web address: https://contractormanpower.army.pentagon.mil

Representative; (2) Contract number, including task and delivery order number; (3) Beginning and ending dates covered by the reporting period; (4) Contractor name, address, phone number, e-mail address, identify of contractor employee entering data; (5) Estimated direct labor hours (including subcontractor); (6) Estimated direct labor dollars paid this reporting period (including subcontractor); (7) Total payments (including subcontractor); (8) Predominant Federal Service Code (FSC) reflecting services provided by the contractor (and separate predominant FSC for each subcontractor, if different); (9) Estimated data collection costs; (10) Organizational title associated with the Unit Identification Code (UIC) for the Army Requiring Activity (the Army Requiring Activity is responsible for providing the contractor with its UIC for the purposes of reporting the information); (11) Locations where the contractor and subcontractor(s) perform the work (specified by zip code in the United States and nearest city, country, when in an overseas location, using standardized nomenclature provided on website); (12) Presence of deployment or contingency contract language; and (13) Number of contractor and sub-contractor employees deployed in theater this reporting period (by country). As part of its submission, the contractor will also provide the estimated total cost (if any) incurred to comply with the reporting requirement. Reporting period will be the period of performance not to exceed 12 months, ending 30 September of each government fiscal year and must be reported by 31 October of each calendar year. Contractors may use a direct XML data transfer to the database server or fill in the secure web site without the need for separate data entries for each required data element at the web site. The specific formats for the XML direct transfer may be downloaded from the web site. The contractor will notify the resentative (COR) by the 5th working day of November whether or not they have completed this report. The contractor shall furnish to the COR a copy of the system email confirming report submission before the invoice for CMR charges will be processed for payment by the Receiver/Acceptor. If the COR is unavailable, the contractor will notify and provide the submission confirmation to the Contracting Officer.

UICs for reports are:

UIC FACILITY

W0Q1AA Madigan Army Medical Center and Associated Clinics

Repo cycle. Report cycles are as follows for any reporting year in which performance occurs:

Report #1: 1 October 2016 through 30 September 2017 Report due no later than 31 October 2017 Report #2: 1 October 2017 through 30 September 2018 Report due no later than 31 October 2018 Report #3: 1 October 2018 through 30 September 2019 Report due no later than 31 October 2019 Report #4: 1 October 2019 through 30 September 2020 Report due no later than 31 October 2020 Report #5: 1 October 2020 through 30 September 2021 Report due no later than 31 October 2021

HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT OF 1996, PRIVACY AND SECURITY OF PROTECTED HEALTH INFORMATION (Apr 2005)

(a) Definitions. As used in this clause:

Electronic Protected Health Information in 45 CFR 160.103.

Individual has the same meaning as th 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 limited to the information created or received by the Contractor from or on behalf of The Government.

Required by Law

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

Security Rule means the Security Standards for the Protection of Electronic Protected Health Information at 45 CFR part 160 and part 164, subpart C.

Terms used, but not otherwise defined, in this Agreement shall have the same meaning as those terms in 45 CFR

160.103 164.103, and 164.304 and 164.501.

(b) The Contractor agrees to not use or further disclose Protected Health Information other than as permitted or required by the Contract or as Required by Law.

(c) The Contractor agrees to use appropriate safeguards to prevent use or disclosure of the Protected Health Information other than as provided for by this Contract. The Contractor agrees to implement 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 on behalf of the Government.

(d) 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.

(e) The Contractor agrees to report to the Government any use or disclosure of the Protected Health

Information not provided for by this Contract. The Contractor agrees to report to the Government any security incident of which it becomes aware.

(f) The Contractor agrees to ensure that any agent, including a subcontractor, to whom it provides Protected

Health Information, in any format, that it creates, receives, maintains, or transmits 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.

(g) 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.

(h) 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.

(i) 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 the Privacy Rule.

(j) 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.

(k) The Contractor agrees to provide to the Government or an Individual, in time and manner designated by the Government, information collected in accordance with this Clause of the Contract, to permit the Government to respond to a request by an Individual for an accounting of disclosures of Protected Health Information in accordance with 45 CFR 164.528

General Use and Disclosure Provisions

(l) 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 the following purposes, if such use or disclosure of Protected Health Information would not violate the Privacy Rule or the Department of Defense Health Information Privacy Regulation if done by the Government: any purposes contemplated by this contract.

Specific Use and Disclosure Provisions

(a) Except as otherwise limited in this Agreement, the Contractor may use Protected Health Information for the proper management and administration of the Contractor or to carry out the legal responsibilities of the Contractor.

(b) Except as otherwise limited in this Agreement, the Contractor may disclose Protected Health

Information for the proper management and administration of the Contractor, provided that disclosures are required by law, or the Contractor obtains reasonable assurances from the person to whom the information is disclosed that it will remain confidential and used or further disclosed only as required by law or for the purpose for which it was disclosed to the person, and the person notifies the Contractor of any instances of which it is aware in which the confidentiality of the information has been breached.

(c) Except as otherwise limited in this Agreement, the Contractor may use Protected Health Information to provide Data Aggregation services to the Government as permitted by 45 CFR 164.504(e)(2)(i)(B).

(d) Contractor may use Protected Health Information to report violations of law to appropriate Federal and State authorities, consistent with 45 CFR 164.502(j)(1).

Obligations of the Government

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

(a) Upon request, the Government shall provide the Contractor with the notice of privacy practices that the

Government produces in accordance with 45 CFR 164.520, as well as any changes to such notice.

(b) The Government shall provide the Contractor with any changes in, or revocation of, permission by Individual to use or disclose Protected Health Information, if such changes affect the Contractor's permitted or required uses and disclosures.

(c) The Government shall notify the Contractor of any restriction to the use or disclosure of Protected

Health Information that the Government has agreed to in accordance with 45 CFR 164.522.

Permissible Requests by the Government

The Government shall not request the Contractor to use or disclose Protected Health Information in any manner that would not be permissible under the Privacy Rule 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 record 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 the Privacy Rule means the section as in effect or as amended, and for which compliance is required.

(b) Survival. The respective 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 the Privacy Rule and Security Rule.

NOTE:

HIPAA does not require a Business Associate Agreement when Protected Health Information (PHI) is shared by a Covered Entity (e.g. MAMC ) with a health care provider for the treatment of an individual patient or for the payment activities of the health care provider. 45 C.F.R. Part/Paragraph 164.506(c) expressly permits a Covered Entity to disclose PHI for its own treatment or payment activities or for the treatment or payment activities of a health care provider. (In this case, Seattle Cancer Care Alliance will be engaging in treatment and payment activities with respect to clinical laboratory services.) In light of this, Seattle Cancer Care Alliance will not be required to become a Business Associate of MAMC in connection with this contract and will not be required to comply with the foregoing requirements to the extent applicable to Business Associates.