285-14-RFP-0005_Lockport_Pharmacy_Service.pdf

285-14-RFP-0005 LOCKPORT PHARMACY SERVICE

REQUEST FOR QUOTATION FOR A BLANKET PURCHASE AGREEMENT

STATEMENT OF WORK:

BACKGROUND:

The purpose of the Pharmacy Service is to contribute to restoring and maintaining the health of the Lockport Service Unit population by promoting the rational inclusion of pharmaceutical products within community health and patient care management plans, the correct use and administration of pharmaceutical products by patients and others, and the availability of essential pharmaceutical products to respond to authorized prescriptions from contract providers.

SUPERVISION:

Administrative oversight will be provided by the Lockport Service Unit (LSU) Health System Administrator (HSA), in conjunction with LSU Supervisory Health System Specialist.

When necessary, clinical oversight will be provided by the LSU, Health Center Clinic Director.

SCOPE OF WORK:

1. Pharmacist will provide pharmacy services to include prescription dispensing, patient counseling and an electronically integrated retail network for the Lockport S e r v i c e U n i t .

2. Prescription dispensing and patient counseling shall be provided to eligible patients upon receipt of authorized prescriptions from medical, dental and other providers. The Pharmacist individually counsels patients on the purpose and home use of their prescriptions, potential side effects and adverse reactions, and other related factors.

3. Pharmacy services will be made available weekdays, nights and weekends, during normal hours of operation, at any of the Pharmacist sites.

4. Pharmacist services will be provided by a licensed, registered pharmacist in compliance with applicable State and Federal laws, rules and regulations.

5. Pharmaceutical products shall conform to current standards of quality for potency, purity, and efficiency.

6. Prescription containers shall conform to requirements for protecting the integrity of pharmaceutical products, and of the Poison Prevention Packaging Act, except when other containers are more appropriate for meeting the needs of an individual patient.

7. Prescription labeling provides an identifying +number, date dispensed, patient's name, directions for use, including the strength of the pharmaceutical product, prescriber name, the address, and telephone number of the pharmacy; and required cautionary and supplementary labels.

8. The Pharmacist maintains a medication profile for each patient.

REPORTING REQUIREMENTS (Service):

1. All prescriptions filled or refilled, will be placed on the local pharmacy's log. If needed, the log can be reviewed by the Lockport Service Uni t or their representative when prior arrangements are made with the local pharmacy.

2. The Pharmacist provides the prescriber with suggested alternative drug therapy plans when he/she determines that there may be a possibility for complications such as drug interactions, and adverse reactions, during review of patient's medication profile. Such problems and other questions are resolved prior to dispensing.

3. The Pharmacist Health Solutions central database will provide various Drug Utilization Reports to the Lockport Service Un i t on a monthly, quarterly, or more frequent basis, depending on the needs of the health program.

PERIOD OF PERFORMANCE:

The blanket purchase agreement (BPA) base year shall be from date of award- December 31, 2014 with 4 optional years of service. This BPA may be renewed at the conclusion of the performance period wi th b i la te ra l agreement between the Indian Health Service and the contractor. The pharmacy services contract will cover all eligible Tribal members of the Lockport S e r v i ce U n i t and service the needs of the eligible patients during normal hours of operation.

REPORTING REQUIREMENTS (Invoicing):

A. The Contractor shall be required to provide an original and one copy of invoices to Nashville Area Office, Indian Health Services, Financial Management, 711 Stewarts Ferry Pike, Nashville, Tennessee 37214 and one copy to: Lockport Service Unit, 6507 Wheeler Road, Lockport, NY 14094-9416.

B. Each invoice shall include the following minimum information:

1) Contractor's name, tax identification number and Invoice Date;

2) Contract Number or other Authorization for delivery of services;

3) Description, price, quantity, and address of services actually rendered;

4) Payment terms;

5) Other substantiating documentation or information as required by the contract; and

6) Name, title, phone number, and complete mailing address of official to whom payment is to be sent.

C. See also, 52.212-4 Section (g) (1) for a complete list of invoice information required below

BPA CONSIDERATIONS:

This BPA does not commit the government to pay any cost for the preparation and submission of a proposal. Furthermore, the government is under no obligation to procure any supplies or services relative to this request. You are reminded that the Contracting Officer is the only person who can legally commit the government to the expenditure of funds in connection with this requirement.

The following offices are hereby authorized to place orders under this BPA:

OFFICE POINT OF CONTACT

Lockport Service Unit _ Myles Jones, Health System Administrator

IHS, Nashville Area Office Andrew Rhoades, Contracting Officer

The Indian Health Service, Nashville Area Office will establish a Blanket Purchase Agreement (BPA) resulting from this solicitation to the quoter whose offer represents the best value to the government, price and other factors considered. Cost will be considered in making a best value determination; however, it is not a weighted factor. Accordingly, the government may establish a BPA with other than the lowest priced offer. The importance of price as an evaluation factor will increase with the degree of technical equality of the proposals. The evaluation factors for this BPA are in descending order of importance and include the following: ability to interface with RPMS, technical acceptance, past performance, quality, and cost.

Indian Health Service will evaluate the degree to which vendors demonstrate the ability to accomplish the efforts in the SOW using the evaluation criteria provided.

Provide an example of the factors mentioned above for evaluation consideration including references for past performance. Use the space below or attach quote and accompanying materials to be evaluated.

BUSINESS ASSOCIATE AGREEMENT:

H-l 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 Business Associate 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.

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 health 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.

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 with 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.

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)).

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.

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.

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.

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.

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.

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 the “date of award” the Business Associate shall account for all disclosures of PHI for treatment, payment and health care operational purposes.

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.

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.

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.

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.

Section 14 - Material Breach; Termination

a) Breach by Business Associate

a. 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 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

a. 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 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.

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).

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 IHS 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.

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.

Section 18 – Term

The term of this Agreement shall begin on the date of award and end with the termination of the Contract, except as provided in Section 14.

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.

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.

SUPPLIES OR SERVICES AND PRICE/COSTS:

Provide pricing information for the following items to be utilized in comparison purposes. The items allowable under an award would be limited to the current Indian Health Service approved formulary unless specially approved in writing by the HSA and clinical director (See Attachment 1 for formulary).

ITEM PACKAGE SIZE PRICE

Clindamycin 150 mg

Doxycycline 100 mg Sulfameth/TMP 800 mg Cephalexin 250 mg Ciprofloxacin 250 mg Levofloxacin 250 mg Amoxicillin 250 mg Amoxicil/Clavulanate 875mg 125mg Azithromycin Z-pack 250 mg

Metronidazole 250 mg

ADDITIONAL COMMENTS AND SPECIFICATIONS BY OFFEROR:

Note any minimum ordering amounts here:__________________________________________________

CLAUSES INCORPORATED BY FULL TEXT:

Full text of the Federal Acquisition Regulation (FAR) and Health and Human Services Acquisition Regulations (HHSAR) can be accessed on the Internet at:

www.hhs.gov/policies/hhsar https://www.acquisition.gov/

52.212-3 Offeror Representations and Certifications—Commercial Items (NOV 2013).

An offeror shall complete only paragraph (b) of this provision if the offeror has completed the annual representations and certifications electronically via http://www.acquisition.gov. If an offeror has not completed the annual representations and certifications electronically at the System for Award Management (SAM) website, the offeror shall complete only paragraphs (c) through (o) of this provision.

(a) Definitions. As used in this provision— “Economically disadvantaged women-owned small business (EDWOSB) concern” means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States and who are economically disadvantaged in accordance with 13 CFR part 127. It automatically qualifies as a women-owned small business eligible under the WOSB Program.

“Forced or indentured child labor” means all work or service—

(1) Exacted from any person under the age of 18 under the menace of any penalty for its nonperformance and for which the worker does not offer himself voluntarily; or

(2) Performed by any person under the age of 18 pursuant to a contract the enforcement of which can be accomplished by process or penalties.

http://www.hhs.gov/policies/hhsar http://www.acquisition.gov/

“Inverted domestic corporation”, as used in this section, means a foreign incorporated entity which is treated as an inverted domestic corporation under 6 U.S.C. 395(b), i.e., a corporation that used to be incorporated in the United States, or used to be a partnership in the United States, but now is incorporated in a foreign country, or is a subsidiary whose parent corporation is incorporated in a foreign country, that meets the criteria specified in 6 U.S.C. 395(b), applied in accordance with the rules and definitions of 6 U.S.C. 395(c). An inverted domestic corporation as herein defined does not meet the definition of an inverted domestic corporation as defined by the Internal Revenue Code at 26 U.S.C.

7874.

“Manufactured end product” means any end product in Federal Supply Classes (FSC) 1000-9999, except—

(1) FSC 5510, Lumber and Related Basic Wood Materials;

(2) Federal Supply Group (FSG) 87, Agricultural Supplies;

(3) FSG 88, Live Animals;

(4) FSG 89, Food and Related Consumables;

(5) FSC 9410, Crude Grades of Plant Materials;

(6) FSC 9430, Miscellaneous Crude Animal Products, Inedible;

(7) FSC 9440, Miscellaneous Crude Agricultural and Forestry Products;

(8) FSC 9610, Ores;

(9) FSC 9620, Minerals, Natural and Synthetic; and

(10) FSC 9630, Additive Metal Materials.

“Place of manufacture” means the place where an end product is assembled out of components, or otherwise made or processed from raw materials into the finished product that is to be provided to the Government. If a product is disassembled and reassembled, the place of reassembly is not the place of manufacture.

“Restricted business operations” means business operations in Sudan that include power production activities, mineral extraction activities, oil-related activities, or the production of military equipment, as those terms are defined in the Sudan Accountability and Divestment Act of 2007 (Pub. L. 110-174).

Restricted business operations do not include business operations that the person (as that term is defined in Section 2 of the Sudan Accountability and Divestment Act of 2007) conducting the business can demonstrate—

(1) Are conducted under contract directly and exclusively with the regional government of southern Sudan;

(2) Are conducted pursuant to specific authorization from the Office of Foreign Assets Control in the Department of the Treasury, or are expressly exempted under Federal law from the requirement to be conducted under such authorization;

(3) Consist of providing goods or services to marginalized populations of Sudan;

(4) Consist of providing goods or services to an internationally recognized peacekeeping force or humanitarian organization;

(5) Consist of providing goods or services that are used only to promote health or education; or

(6) Have been voluntarily suspended.

“Sensitive technology”—

(1) Means hardware, software, telecommunications equipment, or any other technology that is to be used specifically—

(i) To restrict the free flow of unbiased information in Iran; or

(ii) To disrupt, monitor, or otherwise restrict speech of the people of Iran; and http://uscode.house.gov/ http://uscode.house.gov/

(2) Does not include information or informational materials the export of which the President does not have the authority to regulate or prohibit pursuant to section 203(b)(3) of the International Emergency Economic Powers Act (50 U.S.C. 1702(b)(3)).

“Service-disabled veteran-owned small business concern”—

(1) Means a small business concern—

(i) Not less than 51 percent of which is owned by one or more service-disabled veterans or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more service-disabled veterans; and

(ii) The management and daily business operations of which are controlled by one or more service-disabled veterans or, in the case of a service-disabled veteran with permanent and severe disability, the spouse or permanent caregiver of such veteran.

(2) Service-disabled veteran means a veteran, as defined in 38 U.S.C. 101(2), with a disability that is service-connected, as defined in 38 U.S.C. 101(16).

“Small business concern” means a concern, including its affiliates, that is independently owned and operated, not dominant in the field of operation in which it is bidding on Government contracts, and qualified as a small business under the criteria in 13 CFR Part 121 and size standards in this solicitation.

“Subsidiary” means an entity in which more than 50 percent of the entity is owned—

(1) Directly by a parent corporation; or

(2) Through another subsidiary of a parent corporation.

“Veteran-owned small business concern” means a small business concern—

(1) Not less than 51 percent of which is owned by one or more veterans (as defined at

38 U.S.C. 101(2)) or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more veterans; and

(2) The management and daily business operations of which are controlled by one or more veterans.

“Women-owned business concern” means a concern which is at least 51 percent owned by one or more women; or in the case of any publicly owned business, at least 51 percent of its stock is owned by one or more women; and whose management and daily business operations are controlled by one or more women.

“Women-owned small business concern” means a small business concern—

(1) That is at least 51 percent owned by one or more women; or, in the case of any publicly owned business, at least 51 percent of the stock of which is owned by one or more women; and

(2) Whose management and daily business operations are controlled by one or more women.

“Women-owned small business (WOSB) concern eligible under the WOSB Program” (in accordance with 13 CFR part 127), means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States.

(b)

(1) Annual Representations and Certifications. Any changes provided by the offeror in paragraph

(b)(2) of this provision do not automatically change the representations and certifications posted on the SAM website.

(2) The offeror has completed the annual representations and certifications electronically via the SAM website accessed through http://www.acquisition.gov. After reviewing the SAM database information, the offeror verifies by submission of this offer that the representations and certifications currently posted electronically at FAR 52.212-3, Offeror Representations and Certifications—Commercial Items, have been entered or updated in the last 12 months, are current, accurate, complete, and applicable to this solicitation (including the business size standard applicable to the NAICS code http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t37t40+200+2++%2838%29%20%20AND%20%28%2838%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t37t40+200+2++%2838%29%20%20AND%20%28%2838%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t37t40+200+2++%2838%29%20%20AND%20%28%2838%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 http://www.acquisition.gov/ referenced for this solicitation), as of the date of this offer and are incorporated in this offer by reference (see FAR 4.1201), except for paragraphs ______________.

[Offeror to identify the applicable paragraphs at (c) through (o) of this provision that the offeror has completed for the purposes of this solicitation only, if any.

These amended representation(s) and/or certification(s) are also incorporated in this offer and are current, accurate, and complete as of the date of this offer.

Any changes provided by the offeror are applicable to this solicitation only, and do not result in an update to the representations and certifications posted electronically on SAM.]

(c) Offerors must complete the following representations when the resulting contract will be performed in the United States or its outlying areas. Check all that apply.

(1) Small business concern. The offeror represents as part of its offer that it □ is, □ is not a small business concern.

(2) Veteran-owned small business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents as part of its offer that it □ is, □ is not a veteran-owned small business concern.

(3) Service-disabled veteran-owned small business concern. [Complete only if the offeror represented itself as a veteran-owned small business concern in paragraph (c)(2) of this provision.] The offeror represents as part of its offer that it □ is, □ is not a service-disabled veteran-owned small business concern.

(4) Small disadvantaged business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents, for general statistical purposes, that it □ is, □ is not a small disadvantaged business concern as defined in 13 CFR 124.1002.

(5) Women-owned small business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents that it □ is, □ is not a women-owned small business concern.

(6) WOSB concern eligible under the WOSB Program. [Complete only if the offeror represented itself as a women-owned small business concern in paragraph (c)(5) of this provision.] The offeror represents that—

(i) It □ is, □ is not a WOSB concern eligible under the WOSB Program, has provided all the required documents to the WOSB Repository, and no change in circumstances or adverse decisions have been issued that affects its eligibility; and

(ii) It □ is, □ is not a joint venture that complies with the requirements of 13 CFR part 127, and the representation in paragraph (c)(6)(i) of this provision is accurate for each WOSB concern eligible under the WOSB Program participating in the joint venture. [The offeror shall enter the name or names of the WOSB concern eligible under the WOSB Program and other small businesses that are participating in the joint venture: __________.] Each WOSB concern eligible under the WOSB Program participating in the joint venture shall submit a separate signed copy of the WOSB representation.

(7) Economically disadvantaged women-owned small business (EDWOSB) concern. [Complete only if the offeror represented itself as a WOSB concern eligible under the WOSB Program in (c)(6) of this provision.] The offeror represents that—

(i) It □ is, □ is not an EDWOSB concern, has provided all the required documents to the WOSB Repository, and no change in circumstances or adverse decisions have been issued that affects its eligibility; and

(ii) It □ is, □ is not a joint venture that complies with the requirements of 13 CFR part 127, and the representation in paragraph (c)(7)(i) of this provision is accurate for each EDWOSB concern https://acquisition.gov/far/current/html/Subpart%204_12.html%23wp1073667 participating in the joint venture. [The offeror shall enter the name or names of the EDWOSB concern and other small businesses that are participating in the joint venture: __________.] Each EDWOSB concern participating in the joint venture shall submit a separate signed copy of the EDWOSB representation.

Note: Complete paragraphs (c)(8) and (c)(9) only if this solicitation is expected to exceed the simplified acquisition threshold.

(8) Women-owned business concern (other than small business concern). [Complete only if the offeror is a women-owned business concern and did not represent itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents that it □ is a women-owned business concern.

(9) Tie bid priority for labor surplus area concerns. If this is an invitation for bid, small business offerors may identify the labor surplus areas in which costs to be incurred on account of manufacturing or production (by offeror or first-tier subcontractors) amount to more than 50 percent of the contract price:____________________________________

(10) [Complete only if the solicitation contains the clause at FAR 52.219-23, Notice of Price Evaluation Adjustment for Small Disadvantaged Business Concerns, or FAR 52.219-25, Small Disadvantaged Business Participation Program—Disadvantaged Status and Reporting, and the offeror desires a benefit based on its disadvantaged status.]

(i) General. The offeror represents that either—

(A) It □ is, □ is not certified by the Small Business Administration as a small disadvantaged business concern and identified, on the date of this representation, as a certified small disadvantaged business concern in the SAM Dynamic Small Business Search database maintained by the Small Business Administration, and that no material change in disadvantaged ownership and control has occurred since its certification, and, where the concern is owned by one or more individuals claiming disadvantaged status, the net worth of each individual upon whom the certification is based does not exceed $750,000 after taking into account the applicable exclusions set forth at 13 CFR 124.104(c)(2); or

(B) It □ has, □ has not submitted a completed application to the Small Business Administration or a Private Certifier to be certified as a small disadvantaged business concern in accordance with 13 CFR 124, Subpart B, and a decision on that application is pending, and that no material change in disadvantaged ownership and control has occurred since its application was submitted.

(ii) □ Joint Ventures under the Price Evaluation Adjustment for Small Disadvantaged Business Concerns. The offeror represents, as part of its offer, that it is a joint venture that complies with the requirements in 13 CFR 124.1002(f) and that the representation in paragraph (c)(10)(i) of this provision is accurate for the small disadvantaged business concern that is participating in the joint venture. [The offeror shall enter the name of the small disadvantaged business concern that is participating in the joint venture: ________________.]

(11) HUBZone small business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents, as part of its offer, that—

(i) It □ is, □ is not a HUBZone small business concern listed, on the date of this representation, on the List of Qualified HUBZone Small Business Concerns maintained by the Small Business Administration, and no material changes in ownership and control, principal office, or HUBZone employee percentage have occurred since it was certified in accordance with 13 CFR Part 126; and

(ii) It □ is, □ is not a HUBZone joint venture that complies with the requirements of 13 CFR Part 126, and the representation in paragraph (c)(11)(i) of this provision is accurate for each HUBZone small business concern participating in the HUBZone joint venture. [The offeror shall enter the names of each of the HUBZone small business concerns participating in the HUBZone joint venture: __________.] Each https://acquisition.gov/far/current/html/52_217_221.html%23wp1136333 https://acquisition.gov/far/current/html/52_217_221.html%23wp1136374

HUBZone small business concern participating in the HUBZone joint venture shall submit a separate signed copy of the HUBZone representation.

(d) Representations required to implement provisions of Executive Order 11246—

(1) Previous contracts and compliance. The offeror represents that—

(i) It □ has, □ has not participated in a previous contract or subcontract subject to the Equal Opportunity clause of this solicitation; and

(ii) It □ has, □ has not filed all required compliance reports.

(2) Affirmative Action Compliance. The offeror represents that—

(i) It □ has developed and has on file, □ has not developed and does not have on file, at each establishment, affirmative action programs required by rules and regulations of the Secretary of Labor (41 cfr parts 60-1 and 60-2), or

(ii) It □ has not previously had contracts subject to the written affirmative action programs requirement of the rules and regulations of the Secretary of Labor.

(e) Certification Regarding Payments to Influence Federal Transactions (31 U.S.C. 1352). (Applies only if the contract is expected to exceed $150,000.) By submission of its offer, the offeror certifies to the best of its knowledge and belief that no Federal appropriated funds have been paid or will be paid to any person for influencing or attempting to influence an officer or employee of any agency, a Member of Congress, an officer or employee of Congress or an employee of a Member of Congress on his or her behalf in connection with the award of any resultant contract. If any registrants under the Lobbying Disclosure Act of 1995 have made a lobbying contact on behalf of the offeror with respect to this contract, the offeror shall complete and submit, with its offer, OMB Standard Form LLL, Disclosure of Lobbying Activities, to provide the name of the registrants. The offeror need not report regularly employed officers or employees of the offeror to whom payments of reasonable compensation were made.

(f) Buy American Act Certificate. (Applies only if the clause at Federal Acquisition Regulation (FAR) 52.225-1, Buy American Act—Supplies, is included in this solicitation.)

(1) The offeror certifies that each end product, except those listed in paragraph (f)(2) of this provision, is a domestic end product and that for other than COTS items, the offeror has considered components of unknown origin to have been mined, produced, or manufactured outside the United States. The offeror shall list as foreign end products those end products manufactured in the United States that do not qualify as domestic end products, i.e., an end product that is not a COTS item and does not meet the component test in paragraph (2) of the definition of “domestic end product.” The terms “commercially available off-the-shelf (COTS) item” “component,” “domestic end product,” “end product,” “foreign end product,” and “United States” are defined in the clause of this solicitation entitled “Buy American Act—Supplies.”

(2) Foreign End Products:

Line Item No. Country of Origin

52.212-4 Contract Terms and Conditions—Commercial Items (SEP 2013).

(a) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of https://acquisition.gov/far/current/html/52_223_226.html%23wp1168995 nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The Government must exercise its post-acceptance rights—

(1) Within a reasonable time after the defect was discovered or should have been discovered; and

(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.

(b) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in accordance with the Assignment of Claims Act (31 U.S.C. 3727). However, when a third party makes payment (e.g., use of the Governmentwide commercial purchase card), the Contractor may not assign its rights to receive payment under this contract.

(c) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of the parties.

(d) Disputes. This contract is subject to the Contract Disputes Act of 1978, as amended (41 U.S.C. 601-613). Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal or action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause at FAR 52.233-1, Disputes, which is incorporated herein by reference.