285-17-RFQ-0012.pdf

REQUEST FOR QUOTATION

(THIS IS NOT AN ORDER)

THIS RFQ IS IS NOT A SMALL BUSINESS SET-ASIDE

15. DATE OF QUOTATION

16. SIGNER

a. NAME (Type or print)

c. TITLE (Type or print)

b. TELEPHONE

AREA CODE

NUMBER

STANDARD FORM 18 (REV. 6-95)

Prescribed by GSA-FAR (48 CFR) 53.215-1(a)

AUTHORIZED FOR LOCAL REPRODUCTION

Previous edition not usable

8. TO:

b. COMPANYa. NAME

c. STREET ADDRESS

d. CITY e. STATE f. ZIP CODE

9. DESTINATION

a. NAME OF CONSIGNEE

b. STREET ADDRESS

c. CITY

d. STATE e. ZIP CODE

7. DELIVERY

FOB DESTINATION

OTHER

(See Schedule)

10. PLEASE FURNISH QUOTATIONS TO THE

ISSUING OFFICE IN BLOCK 5a ON OR BEFORE CLOSE OF BUSINESS (Date)

IMPORTANT: This is a request for information and quotations furnished are not offers. If you are unable to quote, please so indicate on this form and return it to the address in Block 5a. This request does not commit the Government to pay any costs incurred in the preparation of the submission of this quotation or to contract for supplies or service. Supplies are of domestic origin unless otherwise indicated by quoter. Any representations and/or certifications attached to this Request for Quotation must be completed by the quoter.

11. SCHEDULE (Include applicable Federal, State and local taxes)

ITEM NO.

(a)

SUPPLIES/ SERVICES

(b)

QUANTITY

(c)

UNIT

(d)

UNIT PRICE

(e)

AMOUNT

(f)

12. DISCOUNT FOR PROMPT PAYMENT

a. 10 CALENDAR DAYS (%) b. 20 CALENDAR DAYS (%) c. 30 CALENDAR DAYS (%) d. CALENDAR DAYS

NUMBER PERCENTAGE

NOTE: Additional provisions and representations are are not attached.

13. NAME AND ADDRESS OF QUOTER

a. NAME OF QUOTER

b. STREET ADDRESS

c. COUNTY

d. CITY e. STATE f. ZIP CODE

14. SIGNATURE OF PERSON AUTHORIZED TO

SIGN QUOTATION

PAGE OF PAGES

1. REQUEST NO. 2. DATE ISSUED 3. REQUISITION/PURCHASE REQUEST NO. 4. CERT. FOR NAT. DEF.

UNDER BDSA REG. 2

AND/OR DMS REG. 1

RATING

5a. ISSUED BY 6. DELIVER BY (Date)

5b. FOR INFORMATION CALL (NO COLLECT CALLS)

NAME TELEPHONE NUMBER

AREA CODE NUMBER

285-17-RFQ-0012

Indian Health Service, Nashville Area Office

Paul Carr

See Section A of solicitation

615 467-1567 Catawba Service Unit

2893 Sturgis Road

Rock Hill

29730SC

08/07/2017

285-27-RFQ-0012 Catawba Lab Testing

The Indian Health Service Catawba Service Unit’s mission is to raise the physical, mental, and spiritual health of the Native American population that lives in the geographic area. The mission is implemented by providing Direct Care Services such as labs to our patients. The Catawba Service Unit, located at 2893 Sturgis Road, Rock Hill, SC 29730, requires outsourced medical diagnostic testing of a variety of specimens that include but are not limited to blood, sputum, tissue, urine, and stool.

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued.

The Solicitation number of this Request for Quote (RFQ) is 285-17-RFQ-0012.

The solicitation document, incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-94/2005-95, January 19, 2017.

This is a combined synopsis/solicitation is a full and open competition with no set aside. The associated North American Industry Classification System code (NAICS) is 621511 Medical Laboratories, and the size standard is $32.5 Million. The Government anticipates awarding a single award issued as Firm Fixed Price Blanket Purchasing Agreement.

A. Supplies or services and prices

Complete section A based on estimated usage worksheet, attachment A. Include a complete catalog of all available test as a separate document.

A.1. Schedule 1 - Base Year, October 1, 2017 – September 30, 2018

Total $ __________

A.2. Schedule 2 - Option Year 1, October 1, 2018 –September 30, 2019

Total $ __________

A.3. Schedule 3 - Option Year 2, October 1, 2019 – September 30, 2020

Total $ __________

A.4. Schedule 4 - Option Year 3, October 1, 2020 – September 30, 2021

Total $ __________

A.5. Schedule 5 - Option Year 4, October 1, 2021 – September 30, 2022

Total $ __________

B. Description/Specifications

B.1. Specific Services/Deliverables

The following categories of laboratory testing services shall be required:

Histocompatibility Bacteriology Mycobacteriology Mycology Parasitology Virology Syphilis serology General immunology Routine chemistry Urinalysis Endocrinology Toxicology Hematology Abo & RH group Antibody non-transfusion Antibody identification Histopathology Oral pathology Cytology Antibiogram Reports

B.2. Supplies/Materials to be provided by the Contractor

B.2.1. The Contractor shall provide Catawba Service Unit with a laboratory manual which includes the Following:

Directory of available lab services

Requirements for sample collection, preservation, handling and transport including

Special handling requirements

Methods and methodologies

Criteria for sample rejection

Limitations in test methods/tests/procedures

Prior authorization requirements and instructions

Test codes and corresponding CPT codes

B.2.2. The contractor shall provide specialty items for collection such as Pap Smear collection supplies and blood collection supplies as needed by volume of requests.

C. Deliveries and Performance

C.1. Performance

C.1.1. The Period of Performance shall be October, 1 2017 through September, 2018 with (4) four, 12 month option years.

C.1.2. Performance and lab specimen pick-up location is:

Catawba Service 2893 Sturgis Road Rock Hill, SC 29730 (803)366-9090

C.1.3. The contractor shall pick-up specimens Monday through Friday after 5pm with the exception of Federal Holidays. The contractor shall have a demonstrated ability to respond to service unit questions and concerns the same day.

C.2. Delivery Methods

C.2.1. Delivery Methods of Diagnostic Test Results:

Critical: Report via the telephone same day as result is completed. Electronic transmission must follow within twenty-four (24) hours.

Primary: The contractor must transfer test results and auxiliary information to the Catawba Service Unit Electronic Medical Records Systems using such interface languages as required by the applicable Electronic Medical Records System.

Alternate: The contractor shall have the capability to transmit test results reports to designated printer locations or fax machines within the Catawba Service Unit and following up with electronic transmission.

C.2.2. Routine laboratory results should be provided within 24 hours of collection. Complex testing requiring specialty laboratories should be provided within 10 business days. Pap smear Specimens should be provided within 10 business days.

C.3. Reports

C.3.1. The Contractor shall provide Catawba Service Unit with an electronic utilization file that shall be transferred to Catawba Service Unit by the fifth (5) working day of each month for the preceding Month. The Contractor shall add additional data elements as mutually agreed upon by the Contractor and Catawba Service Unit. The electronic utilization file can be in any easily readable format such as Adobe Acrobat Reader (pdf), Microsoft Word, or Microsoft Excel.

C.3.2. The contractor should provide, at a minimum, a quarterly antibiogram report.

D. Contract Administration Data

D.1. Indian Health Service Invoice Submission Instructions

The Contractor shall submit invoice after services received. A complete invoice with all required back-up documentation shall be sent, electronically via e-mail or by regular postal mail to:

Contract Specialist* (CS): Paul Carr, paul.carr@ihs.gov, Indian Health Service, Indian Health Service, Nashville Area, 711 Stewarts Ferry Pike, Nashville, TN 37214

Accounting Tech., Latoya Moss, latoya.moss@ihs.gov, Indian Health Service, Nashville Area, 711 Stewarts Ferry Pike, Nashville, TN 37214

*No other non-invoice related documents (i.e. deliverables, reports, balance statements) shall be sent to the CS or [enter billing office acronym]. Failure to submit directly to the offices listed above will delay prompt payment of your invoice.

For invoices submitted by email: the subject line of your email invoice submission shall contain the contractor name, contract/order number, and invoice number (e.g. Company Name, Contract HHSIXXXXX, Invoice #123). The Contractor shall send one email per contract/order after completion. The email may have multiple invoices for the contract. Invoices must be in one of the following formats: PDF, TIFF, or Word. No Excel formats will be accepted. The electronic file cannot contain multiple invoices; example, 10 invoices requires 10 separate files (PDF, TIFF, or Word).

Additionally, the Contractor is required to include its Data Universal Numbering System (DUNS) number on each invoice. For additional information about the Dun & Bradstreet (D&B) DUNS number, please visit http://fedgov.dnb.com/webform.

E. Special Contract Requirements

E.1. Quality Standards

E.1.1. The Contractor’s laboratory facilities must have accreditations by the Clinical Laboratory

Improvement Amendments (CLIA) and licensed by the State Department of Health as applicable. All clinical laboratory tests must be performed at the laboratory facilities under the direction and control of the contractor.

E.1.2. The contractor shall provide these licenses, accreditation and any other applicable certifications along with their proposal. The accreditation and licensing must be maintained current and valid throughout the length of the contract and extension years, if any.

E.1.3. The contractor shall comply with HIPPA/ Privacy Rule Regulations. The contractor shall be expected to treat all proprietary information as confidential and to acknowledge that it is only authorized to disclose or otherwise divulge proprietary information to authorized employees of the Catawba Service Unit. The contractor shall establish and maintain policies and procedures to ensure that its personnel do not disclose test results to any unauthorized individual.

E.2. Accreditation

If the contractor loses the accreditation, licenses and/or any associated certifications during the term of the contract, the Government has the full right to terminate the contract.

The contractor must maintain:

CLIA Waived Certification

College of American Pathologist Certification

Staff performing test should be at the minimum certified Technicians

E.3. Technical Capabilities and Qualifications

E.3.1. The contractor should have the ability to Interface with Indian Health Services Electronic Medical Record/ Resource and Patient Management System already in place.

E.3.2. For further instruction and questions on whether your company can complete the requested interface please see the reference materials listed on the Indian Health Service website located at: http://www.ihs.gov/Lab/.

The RPMS platform is: AIX / Windows It is running on Ensemble The interface should be bidirectional

E.3.3. The contractor shall acknowledge in their quote they meet this technical requirement and can interface with IHS’s Medical Record/ Resource and Patient Management System.

F. Business Associate Agreement Clause

Pursuant to the Health Insurance Portability and Accountability Act (HIPAA) of 1996; its implementing regulations, the Standards of Privacy of Individual Identifiable Health Information at

45 C.F.R. Parts 160 and 164, Subparts A and E (“Privacy Rule”), and 45 C.F.R. Parts 160 and 164, Subparts A and C (“Security Rule”); and the Health Information Technology for Economic and

Clinical Health Act (“HITECH Act”), Title XIII, Subtitle D of the American Reinvestment and Recovery

Act of 2009, Pub. L. No. 111-5, 123 Stat. 115 (2009) (“ARRA”), the Indian Health Service is required to enter into an agreement with the Business Associate, pursuant to which the Business

Associate shall comply with and appropriately safeguard Protected Health Information ("PHI”) that it will use and disclose when performing functions, activities or services ("Services") for the Indian

Health Service pursuant to Contract No. (“Contract”). The BusinessAssociate by signing the Contract shall comply with the following terms in addition to other applicable Contract terms and conditions relating to the safekeeping, use and disclosure of PHI.

F.1. Section 1 - Definitions

Terms used in this Agreement, if not otherwise defined, shall have the same meaning as those terms contained within the Privacy Rule and the HITECH Act.

a. Breach: “Breach” shall mean the unauthorized acquisition, access, use, or disclosure of Protected Health Information (defined hereinafter) which compromises the security or privacy of such information, except where an unauthorized person to whom such information is disclosed would not reasonably have been able to retain such information;

b. Covered Entity: "Covered Entity" shall mean the Indian Health Service (IHS);

c. De-identified protected health information: “De-identified protected health information” shall have the same meaning as the term “de-identified protected health information” in 45 C.F.R. § 164. 514;

d. Designated Record Set: "Designated Record Set" shall mean (1) a group of records maintained by or for a covered entity that is: (i) The medical records and billing records about individuals maintained by or for a covered health care provider, (ii) The enrollment, payment, claims adjudication, and case or medical management record systems maintained by or for a health plan, or (iii) Used, in whole or in part, by or for the covered entity to make decisions about individuals. (2) For purposes of this paragraph, the term record means any item, collection, or grouping of information that includes protected heal information and is maintained, collected, used, or disseminated by or for a covered entity; (45 C.F.R. §

164.501)

e. Electronic Health Record: “Electronic Health Record” shall mean an electronic record of health-related information on an individual that is created, gathered, managed, and consulted by authorized health care clinicians and staff;

f. Individual: "Individual" shall have the same meaning as the term

"individual" in 45 C.F.R. § 164.501 and shall include a person who qualifies as a personal representative in accordance with 45 C.F.R. § 164.502(g);

g. Limited Data Set: “Limited Data Set” shall have the same meaning as the term “limited data set” in 45 C.F.R. § 164. 514(e)(2);

h. Privacy Rule: "Privacy Rule" shall mean the Standards for Privacy of Individually

Identifiable Health Information at 45 C.F.R. Parts 160 and 164, Subparts A and

E;

i. Protected Health Information: "Protected Health Information" or “PHI” shall have the same meaning as the term "protected health information" in 45 C.F.R.

§ 160.103;

j. Required By Law: "Required By Law" shall have the same meaning as the term

"required by law" in 45 C.F.R. § 164.501;

k. Secretary: "Secretary" shall mean the Secretary of the United States

Department of Health and Human Services or her designee;

l. Unsecured Protected Health Information: “Unsecured Protected Health

Information” or “Unsecured PHI” shall mean protected health information that is not rendered unusable, unreadable, or indecipherable to unauthorized individuals through the use of a technology or methodology specified by the

Secretary in guidance on the HHS website issued under section 13402(h)(2) of the HITECH Act.

F.2. Section 2 - Compliance

The Business Associate agrees to comply with the business associate contract requirements under the Privacy Rule, the HITECH Act and the provisions of this Agreement throughout the term of this Agreement. The Business Associate agrees that it will require all of its agents, employees, subsidiaries, affiliates and subcontractors, to whom the Business Associate provides PHI, or who create or receive PHI on behalf of the Business Associate for the IHS, to comply with the Privacy Rule and the HITECH Act, and to enter into written agreements w I t h the

Business Associate that provide the same restrictions, terms and conditions as set forth in this Agreement.

In the event the Business Associate awards a subcontract under the Contract pursuant to which the Business Associate will disclose PHI to the subcontractor, notwithstanding any clause to the contrary contained in the Contract, the Business Associate agrees to obtain the IHS Contracting Officer’s written consent prior to awarding such subcontract.

F.3. Section 3 - Permitted Uses and Disclosures

The Business Associate shall not use or disclose PHI except to perform functions, activities or services for or on behalf of the IHS as provided for in this Agreement, the Privacy Rule, the

HITECH Act or other applicable law. The Business Associate agrees that it may use or disclose

PHI on behalf of the IHS only (1) upon obtaining the authorization of the patient to whom the

PHI pertains (45 C.F.R. §§ 164.502(a)(1)(iv) and 164.508(b)); (2) for the purpose of treatment, payment or health care operations (45 C.F.R. §§ 164.502(a)(1)(ii), and 164.506)), unless disclosure has been restricted pursuant to the HITECH Act at § 13405(a), or (3) without an authorization or consent, if in accordance with 45 C.F.R. §§ 164.506, 164.5 10, 164.512, 164.514(e), 164.514(f) or 164.514(g). The Business Associate shall use and disclose PHI in compliance with each applicable requirement of 45 C.F.R. § 164.504(e), which section is fully incorporated herein. Except as otherwise limited in this Agreement, the Business Associate may use PHI for the management and administration of the Business Associate or to carry out responsibilities that are required of it by law (45 C.F.R. § 164.502(e)(4)(i)).

F.4. Section 4 - Safeguards

The Business Associate shall develop and use appropriate procedural, physical and electronic safeguards to protect against the use or disclosure of PHI in a manner not permitted by the

Privacy Rule or this Agreement. The Business Associate will limit any use, disclosure or request for use or disclosure of PHI to the minimum amount necessary to accomplish the intended purpose of the use, disclosure or request in accordance with the applicable requirements of the Privacy Rule. As mandated by the HITECH Act, Privacy Rule sections 164.308

(administrative safeguards requirements), 164.310 (physical safeguards requirements),

164.312 (technical safeguards requirements) and 164.316 (policies and procedures and documentation requirements) shall apply to the Business Associate in the same manner that such sections apply to covered entities under the Privacy Rule.

F.5. Section 5 – Minimum Necessary

Prior to the Secretary issuing guidance on what constitutes “minimum necessary” for purposes of the Privacy Rule, the Business Associate will limit, to the extent practicable, any use, disclosure or request for use or disclosure of PHI (other than those uses, disclosures or requests for use or disclosure of PHI set forth at 45 CFR section 164.502(b)(2)) , to the Limited

Data Set, or, if needed, to the minimum amount necessary to accomplish the intended purpose of such use, disclosure or request, respectively. Upon the effective date of the

Secretary’s ”minimum necessary” guidance, the Business Associate will limit any use, disclosure or request for use or disclosure of PHI, to the minimum amount necessary as set forth in such guidance.

F.6. Section 6 - Safeguards for Electronic PHI

The Business Associate shall implement administrative, physical, and technical safeguards that reasonably and appropriately protect the confidentiality, integrity and availability of any electronic PHI that it creates, receives, maintains, or transmits on behalf of the IHS as required by 45 C.F.R. Part 164, subpart C, Security Standards for the Protection of Electronic Health

Information. Section 4 above shall apply in full to this Section 6.

F.7. Section 7 - Reporting of Unauthorized Uses or Disclosures

The Business Associate shall promptly report to the IHS any knowledge of uses or disclosures of PHI that are not in accordance with this Agreement or applicable law. In addition, the

Business Associate shall mitigate, to the extent practicable, any harmful effect that is known to the Business Associate of a use or disclosure of PHI by the Business Associate in violation of the requirements of the Privacy Rule or the HITECH Act. For those uses or disclosures that involve a breach of the security of any unsecured PHI received from, or created or received on behalf of, the IHS, the Business Associate shall comply with the requirements set forth in

Section 8 below.

F.8. Section 8 - Reporting of Breach of Unsecured PHI

The Business Associate shall notify the IHS of a breach of the security of any unsecured PHI that the Business Associate received from, or created or received on behalf of, the IHS within thirty

(30) calendar days after the discovery of the breach by the Business Associate, its employees, officers and/or other agents unless a law enforcement official has determined that such notification would impede a criminal investigation or cause damage to national security, in which case the notification shall be delayed in accordance with the requirements of 45 C.F.R. §

164.412.. Such notice shall include, to the extent possible, the identification of each individual whose unsecured PHI has been, or is reasonably believed by the Business Associate to have been, accessed, acquired, or disclosed during such breach; a brief description of the circumstances of the breach of security, including the date of the breach and the date of the

Business Associate’s discovery of the breach; and the type of unsecured PHI involved in the breach. In the event notification is delayed, evidence demonstrating the necessity of the delay shall accompany the notification. A breach shall be treated as discovered as of the first day on which such breach is known to Business Associate (including any person, other than the individual committing the breach that is an employee, officer or other agent of Business

Associate) or should have reasonably been known to Business Associate (or person) to have occurred.

F.9. Section 9 – Maintenance of Records and Accounting of Disclosures

The Business Associate shall maintain records of PHI received from or created or received on behalf of the IHS and shall document subsequent uses and disclosures of such information by the Business Associate. The Business Associate shall, within 5 calendar days after receiving a request from the IHS, provide to the IHS such information as the IHS may require to fulfill its obligations to provide access to, provide a copy of, and account for disclosures with respect to

PHI pursuant to the Privacy Rule (e.g., 45 C.F.R. § 164.528) (individual request for an accounting of PHI disclosures), the HITECH Act and other applicable law.

In accordance with the requirements of HITECH Act section 13405(c), beginning on [need to determine if BA already has EHR system and then put in applicable date based on requirement of HITECH section 13405(c)(4)], the Business Associate shall account for all disclosures of PHI for treatment, payment and health care operational purposes.

F.10. Section 10 - Maintenance of Records and Accounting: Individual Access

The Business Associate shall maintain a Designated Record Set for each patient for which it has

PHI. In accordance with a patient's right to access his/her PHI under the Privacy Rule, the

Business Associate shall make available all PHI in the patient's Designated Record Set to the patient to whom that information pertains, or, upon the request of the patient, to that patient's authorized representative, in compliance with 45 C.F.R. § 164.524. Availability shall be made within 5 calendar days of receipt of a request.

F.11. Section 11 – Disclosure for Purposes of Verifying Compliance

Upon request, the Business Associate shall make available to the IHS or to the Secretary, PHI and the Business Associate's internal practices, books and records, including its policies and procedures and any agreements required by Section 2 herein that it has with subcontractors, vendors and other agents relating to the use and disclosure of PHI received from the IHS, or created or received by the Business Associate on behalf of the IHS, for purposes of determining both the Business Associate’s and the IHS’s compliance with the

Privacy Rule and the HITECH Act and its implementing regulations. The Business Associate shall not disclose PHI to any requesting party other than as provided for in this Section and

Sections 3 and 10 above. The Business Associate shall forward all other disclosure requests to the IHS for processing, except those it receives directly from individuals in accordance with Section 10 above.

F.12. Section 12 - Amendments of Information

The Business Associate shall, within 5 calendar days of a request by the IHS, make PHI available to the IHS for the IHS to fulfill its obligations pursuant to the Privacy Rule to amend

PHI and shall, as directed by the IHS, within 5 calendar days of receipt of such direction, incorporate any amendments into PHI held by the Business Associate. The Business Associate shall ensure incorporation of any such amendments into PHI held by its agents or subcontractors within 10 days of its request that they do so, and shall notify the IHS within

5 calendar days of when those agents or subcontractors have completed the incorporation of the amendments. The Business Associate shall not make any amendments to PHI except upon request of the IHS. The Business Associate shall forward to the IHS Contracting Officer for approval all requests to amend PHI that it may receive directly from individuals within 5 calendar days of its receipt of the request.

F.13. Section 13 - Obligations of IHS

The IHS Contracting Officer shall provide the Business Associate with its notice of privacy practices, produced under 45 C.F.R. § 164.520 and any changes to the notice. The IHS

Contracting Officer shall also provide the Business Associate with any changes in, or revocation of, individuals' authorizations to use or disclose PHI of which the IHS becomes aware, if such changes affect the Business Associate's permitted or required uses or disclosures of PHI. The

IHS Contracting Officer shall notify the Business Associate of any restrictions to the use or disclosure of PHI with which IHS must comply pursuant to an individual's request for restriction of disclosure of the individual’s PHI pursuant to 45 C.F.R. § 164.522 and § 13405(a) of the HITECH Act. The IHS shall not request that the Business Associate use or disclose PHI in any manner that would violate either the Privacy Rule or the HITECH Act if used or disclosed by the IHS.

F.14. Section 14 - Material Breach; Termination

a. Breach by Business Associate

If the Business Associate breaches a material obligation of this Agreement or fails to comply with the Privacy Rule or the HITECH Act, the IHS will give the Business Associate an opportunity to cure the breach, but if the Business Associate fails to cure the breach, the

IHS will terminate the Agreement, as provided in 52.212-4 (m) of the Contract. If, in the determination of the IHS Contracting Officer, neither cure nor termination is feasible, the

IHS shall report the material breach to the Secretary. Termination of this Agreement shall not affect any provision of this Agreement which, by its wording or nature, is intended to remain in effect and continue to operate in the event of termination. Termination of the

Contract between the parties will result in the termination of this Agreement.

b. Breach by IHS

If the IHS breaches a material obligation of this Agreement or fails to comply with the

Privacy Rule or HITECH Act, the Business Associate will give the IHS an opportunity to cure the breach, but if the IHS fails to cure the breach, the Business Associate will terminate the Agreement, as provided in 52.212-4 (m) of the Contract. If, in the determination of the Business Associate, neither cure nor termination is feasible, the

Business Associate shall report the material breach to the Secretary. Termination of this

Agreement shall not affect any provision of this Agreement which, by its wording or nature, is intended to remain in effect and to continue to operate in the event of termination. Termination of the Contract between the parties will result in the termination of this Agreement.

F.15. Section 15 – Prohibition on Sale of EHR or PHI

As of February 18, 2011, or beginning six (6) months following the Secretary’s promulgations of regulations to carry out the requirements of HITECH Act section 13405(d), whichever is earlier, the Business Associate shall not directly or indirectly receive remuneration in exchange for any PHI of an individual unless: (1) the IHS has previously obtained from the individual, in accordance with 45 C.F.R. § 164.508, a valid authorization that includes in accordance with such section, a specification of whether the PHI can be further exchanged for remuneration by the entity receiving that individual’s PHI; or (2) such remuneration falls under an exception set forth in HITECH Act section 13405(d)(2).

F.16. Section 16 - Indemnification

In the event the Business Associate is investigated and/or becomes a party to a civil or criminal cause of action in any forum relating to its failure to comply with the Privacy Rule or the HITECH Act, the Business Associate shall reimburse IH S all reasonable costs and expenses the IHS may incur relating to such investigation and/or cause of action, and will otherwise hold IHS harmless for any and all reasonable costs and expenses relating to the foregoing.

F.17. Section 17 - Return or Destruction of Information

When the Contract terminates, the Business Associate, at the IHS's option, shall either return to the IHS, or destroy, if the IHS agrees that destruction is feasible, all PHI received from, or created or received by it that it still maintains in any form and it shall keep no copies of PHI except as requested by the IHS or required by law. The IHS Contracting Officer shall notify the

Business Associate whether the Business Associate must return or destroy any PHI in its possession. If the Business Associate or its agent or subcontractor destroys any PHI, the

Business Associate will provide the IHS with documentation evidencing such destruction within 30 days of completion of destruction. The Business Associate shall extend the protections of this Agreement to any PHI that is not feasible to either return or destroy for as long as it maintains the PHI. The Business Associate shall limit further uses and disclosures of this PHI to those purposes that rendered the return or destruction of the PHI infeasible.

F.18. Section 18 - Term

The term of this Agreement shall begin on date of award and end with the termination of the

Contract, except as provided in Section 14.

F.19. Section 19 - Amendments of Agreement

Upon learning that material changes have been made to the Privacy Rule and/or the HITECH

Act, the parties agree to promptly amend this Agreement to ensure that it remains in compliance with the Privacy Rule and/or the HITECH Act, as amended.

F.20. Section 20 - Miscellaneous Provisions

(1) This Agreement is attached to and fully incorporated into the Contract.

(2) All notices under this Agreement shall be provided by certified mailing, and shall require proof of date of receipt.

(3) This Agreement shall be binding upon, inure to the benefit of and be enforceable by and against the parties and their successors and assigns. Any novation, assignment, or other transfer of rights, interests, or duties under this Agreement by Business Associate shall be as provided in the Contract and Section 2 of this

Agreement, as applicable.

(4) Any ambiguity in this Agreement shall be resolved in a manner that brings the

Agreement into compliance with the most current versions of the Privacy Rule and the

HITECH Act.

(5) If a court of competent jurisdiction deems any provision of this Agreement unenforceable, such provision shall be severed from this Agreement and every other provision of the Agreement shall remain in full force and effect.

G. Attachments

Attachment A – Lab utilization estimate worksheet

H. Terms and Conditions

H.1. Provision 52.212-1, Instructions to Offerors – Commercial (Oct 2015), applies to this acquisition.

H.2. Offers shall include a completed copy of the provisions FAR 52.212-3 Offeror Representation and Certifications – Commercial Items (JAN 2017) with their offer. This is available electronically at the following address: http://www.acquisition.gov/far/index.html

Note, unless exempt per Federal Acquisition Regulation [FAR] Part 4.11, all contractors must be registered and have an active registration in the System for Award Management (SAM) to be considered for an award against this solicitation. SAM combines data that was formerly contained in the Central Contractors Registration (CCR) and Online Representation and

Certifications (ORCA) systems. For information please review the SAM website at https://www.sam.gov. A Data Universal Numbering System (DUNS) number is utilized for registration. To register go to https://www.acquisition.gov.

H.3. 52.252-1 Solicitation Provisions Incorporated by Reference (Feb 1998)

The Following FAR and HHSAR clauses are incorporated by Reference:

52.203-6 Restriction on Subcontractor Sales to the Government SEPT 2006 52.204-4 Printed or Copied Double-Sided on Postconsumer Fiber MAY 2011 Content Paper 52.204-7 System for Award Management OCT 2016 52.204-8 Annual Representations and Certifications JAN 2017 52.212-1 Instructions to Offerors—Commercial Items JAN 2017 52.212-4 Contract Terms and Conditions—Commercial Items JAN 2017 52.212-5 Contract Terms and Conditions Required to Implement JAN 2017 Statutes or Executive Orders—Commercial Items 52.216-18 Ordering OCT 1995 52.216-22 Indefinite Quantity OCT 1995 52.217-8 Option to Extend Services NOV 1999 52.217-9 Option to Extend the Term of the Contract MAR 2000 52.222-3 Convict Labor June 2003 52.222-21 Prohibition of Segregated Facilities APR 2015 52.222-26 Equal Opportunity SEP 2016 52.222-36 Equal Opportunity for Workers with Disabilities JUL 2014 52.222-50 Combating Trafficking in Persons MAR 2015 52.223-5 Pollution Prevention and Right-to-Know Information MAY 2011 52.223-6 Drug-free Workplace MAY 2001 52.224-1 Privacy Act Notification APR 1984 52.224-2 Privacy Act APR 1984 52.229-3 Federal, State, and Local Taxes FEB 2013 52.232-3 Payments under Personal Services Contracts APR 1984 52.232-33 Payment by Electronic Funds Transfer—System JUL 2013 for Awards Management 52.232-40 Providing Accelerated Payments to Small Business DED 2013 http://www.acquisition.gov/far/index.html https://www.sam.gov/ https://www.acquisition.gov/

Subcontractors 52.237-2 Protection of Government Buildings, Equipment, APR 1984 and Vegetation 52.237-3 Continuity of Services JAN 1991 52.237-7 Indemnification and Medical Liability Insurance JAN 1997 52.242-15 Stop-Work Order AUG 1989 52.242-17 Government Delay of Work APR 1984 52.245-1 Government Property JAN 2017 52.249-12 Termination (Personal Services) APR 1984 352.215-70 Late Proposals and Revisions JAN 2006 352.223-70 Safety and Health JAN 2006 352.224-70 Privacy Act JAN 2006 352.270-2 Indian Preference APR 1984 352.270-3 Indian Preference Program JAN 2006

Signature Block

I, the undersigned, do hereby attest that all representations and certifications made in this Section are true.

Also, I, the undersigned, am aware of the penalties prescribed in 18 U.S. Code 1001 for making false statements in offers; and I am legally authorized to bind the company or organization represented.

(Signature) (Date)

(Typed or Printed Name)

(Title)

(Solicitation Number)

(Name of Company/Organization Represented)

(Address, including Zip Code)

(Telephone Number, including Area Code)

Proposal are due by 12:00 pm CST, AUGUST 28, 2017 and must be delivered to the Indian Health Service, Attn: Paul Carr, 711 Stewarts Ferry Pike, Nashville, TN 37214 or by email at paul.carr@ihs.gov. Questions concerning this solicitation may be addressed to Paul Carr at 615-467- 1567 - Contracting Office Address: 711 Stewarts Ferry Pike. Nashville, TN 37214.

I. Evaluation Factors

I.1. How to respond

I.1.1. Complete Attachment A and complete section A of this proposal. Carefully review all sections of this proposal and return any questions to paul.carr@ihs.gov.

I.1.2. Multiple sections of this proposal require additional documentation be provided. Please include them as separate attachments in your quotes.

I.1.3. No consideration will be given for incomplete proposal packets. Items unaddressed, including signature blocks, will be considered nonresponsive and weighted accordingly

I.2. Received proposals will be evaluated in descending order of precedence. Cost, Section E, and past performance.

mailto:paul.carr@ihs.gov