CTR070647_Contract_Documents.pdf

1st April Gina Corwin

Digitally signed by Gina Corwin Date: 2024.04.01 17:29:41 -07'00'

PART ONE (1) - Scope of Services

ARIZONA DEPARTMENT

OF HEALTH SERVICES

150 N. 18th Avenue, Suite 530 Phoenix, Arizona 85007

REQUEST FOR PROPOSAL No.: BPM006001

CLIA Laboratory Director and Consultant

*The following table of contents applies to all attachment documents in APP for this Solicitation*

SECTION CONTENT

Part One (1) Notice Page

Table of Contents

Scope of Services

Special Terms and Conditions

Uniform Terms and Conditions

Exhibit: One (1) State Observed Holidays

Exhibit: Two (2) Estimated Hours and Testing

Part Two (2) Special Instructions to Offerors

Uniform Instructions to Offerors

Attachments Located in APP:

● Attachment A: Offer and Acceptance

● Attachment B: Designation of Confidential, Trade Secret and Proprietary

● Attachment C: Notices, Correspondence, Reports, and Payments

● Attachment D: Participation of Boycott of Israel

● Attachment E: Forced Labor of Ethnic Uyghurs Ban

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SCOPE OF SERVICES

1. BACKGROUND

The Arizona Department of Health Services (ADHS), Arizona State Public Health Laboratory (ASPHL) provides testing of patient samples for the detection of infectious and genetic diseases. In addition, patient testing is available for evidence of chemical contamination or adulteration of food products. ASPHL provides both direct clinical and reference testing plus consultation, technical assistance, and training to both government and private laboratories. ASPHL partners with multiple teams, including the ADHS Bureau of Epidemiology and Disease Control, to investigate and protect the health of the entire community.

The ASPHL performs clinical testing that meets the Clinical Laboratory Improvement Amendments (CLIA) requirements of a high-complexity testing laboratory. It is a requirement of the CLIA regulations that a Laboratory Director be in place at all times in order for laboratory testing to be performed and reported. CLIA requires a medical laboratory director who meets the qualifications of §493.1443 (link below).

https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-493/subpart-M/subject-group- ECFR2640b368593bdb0/section-493.1443

2. OBJECTIVES

Provide the ASPHL with a consultant who qualifies as a CLIA Laboratory Director and can assume that role in the event that the ASPHL is without a qualified CLIA Laboratory Director.

3. REQUIREMENTS

The Contractor shall:

3.1 Be qualified to administer and guide the ASPHL personnel to ensure the performance of high complexity tests and shall be eligible to be an operator of a laboratory within the tasks and requirements listed herein and per CLIA §493.1443 (link below). https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part- 493#493.1443

3.2 Possess a current license as a laboratory director issued by the State of Arizona, if such licensing is required.

3.3 Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State of Arizona and be certified in anatomic and/or clinical pathology, by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification.

3.4 Be a doctor of medicine, a doctor of osteopathy or doctor of podiatric medicine licensed to practice medicine, osteopathy or podiatry in the State of Arizona and have at least one (1) year of laboratory training during medical residency (for example, physicians certified either in hematology and medical oncology by the American Board of Internal Medicine or have at least two (2) years of experience directing or supervising high complexity testing.

3.5 Hold an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution and have and keep current certification by a board approved by Health and Human Services (HHS).

https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-493/subpart-M/subject-group-ECFR2640b368593bdb0/section-493.1443 https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-493/subpart-M/subject-group-ECFR2640b368593bdb0/section-493.1443 https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-493#493.1443

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3.6 Have served or be serving as a director of a laboratory per Electronic Code of Federal Regulations (eCFR), section 493.1443 (b) (3) (ii) (see link below), and shall have at least: https://www.ecfr.gov/current/title- 42/chapter-IV/subchapter-G/part-493#493.1443

3.6.1 Two (2) years of laboratory training or experience.

3.6.2 Two (2) years of laboratory experience directing or supervising high-complexity testing.

3.7 Provide a valid Certificate of Liability Insurance (COI) within five (5) business days of notice of contract award that includes all the specific types of insurance and other requirements as listed in the Special Terms and Conditions Insurance Provision 18. ADHS will not be able to issue a Purchase Order for the commencement and continuation of services without a current and valid COI on file with the Procurement Office.

3.8 Provide and maintain valid Licenses and Certifications through the term of the Contract.

4. TASKS

The Contractor shall:

4.1 Assume the role of the CLIA Laboratory Director within twenty-four (24) hours once notified of the need.

4.2 Provide documentation of eligibility in order for the ASPHL to obtain approval from the Centers for Medicare and Medicaid Services (CMS).

4.3 Be accessible to the ASPHL to provide telephonic, electronic consultation or onsite (rare) as needed, Monday through Friday, 8:00 am – 5:00 pm Arizona time. Excluding State holidays: Exhibit One (1).

4.4 Not perform duties for more than five (5) laboratories, including the ASPHL.

4.5 Be accessible to meet with the Technical and General Supervisors, review and consult on the testing menu for each testing area related to CLIA, attend scheduled meetings when requested and available (e.g., management meetings, annual review meetings, etc.), attend CLIA entrance and exit audit meetings, and review documents related to CLIA testing areas. Estimated Monthly Hours: Exhibit Two (2).

4.6 Test systems developed and used for each of the tests performed in the ASPHL provide quality laboratory services for all aspects of test performance, which includes the pre-analytical, analytical, and post-analytical phases of testing.

4.7 Ensure the physical plant and environmental conditions of the ASPHL are appropriate for the testing performed and provide a safe environment in which employees are protected from physical, chemical, and biological hazards.

4.8 Ensure the test methodologies selected have the capability of providing the quality of results required for patient care.

4.9 Ensure verification and validation procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method.

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4.10 Ensure all testing methods are performed as required for accurate and reliable results. Laboratory Testing:

Exhibit Two (2).

4.11 Ensure the ASPHL is enrolled in HHS approved proficiency testing programs for the testing performed, including but not limited to the following:

4.11.1 Proficiency testing samples are tested as required by CLIA.

4.11.2 Results are returned within the timeframes established by the proficiency testing program.

4.11.3 Proficiency testing reports received are reviewed by the appropriate staff to evaluate the ASPHL’s performance and to identify any problems that require corrective action.

4.11.4 An approved corrective action plan is followed when any proficiency testing result is found to be unacceptable or unsatisfactory.

4.12 Ensure the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur.

4.13 Establish and maintain an acceptable level of analytical performance for each test system.

4.14 Ensure all necessary remedial actions are taken and documented whenever significant deviations from the ASPHL’s established performance characteristics are identified, and patient test results are reported only when the system is functioning properly.

4.15 Provide reports of test results include pertinent information required for interpretation.

4.16 Ensure consultation is available to the Laboratory’s clients on matters relating to the quality of the test results reported and their interpretation concerning specific patient conditions.

4.17 Ensure a general supervisor provides on-site supervision of high-complexity test performance by testing personnel.

4.18 Based on testing being performed, confirm that an adequate number of laboratory personnel are employed with the appropriate education and either experience or training to provide appropriate consultation while properly supervising and accurately performing tests, and reporting test results in accordance with the personnel responsibilities described in this subpart.

4.19 Confirm, prior to testing patient specimens, all personnel have appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results.

4.20 Confirm policies and procedures are established for monitoring individuals who conduct pre-analytical, analytical, and post-analytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures, and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills.

4.21 Ensure an approved procedure manual is available to all personnel responsible for any aspect of the testing process.

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4.22 Confirm it is specified, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the pre-analytical, analytical, and post-analytical phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results.

5. STATE PROVIDED ITEMS

The State will provide:

5.1 Program contact information.

5.2 Program materials need to be reviewed.

5.3 An onsite and remote workspace.

5.4 Items needed for remote access.

6. DELIVERABLES

The Contractor shall submit to ADHS:

6.1 Provide a review of and/or approval of critical documents such as new and updated Standard Operating

Procedures (SOPs) within seventy-two (72) hours.

6.2 Invoices are due within thirty (30) days once services have been delivered.

7. NOTICES, CORRESPONDENCE, REPORTS AND INVOICES

7.1 Notices, correspondence, reports, invoices, and program-specific requests relative to this Contract from the Contractor to ADHS shall be sent to:

Arizona Department of Health Services

State Public Health Laboratory

ATTN: Kathryn Wangsness

250 N. 17th Avenue

Phoenix, AZ 85007 kathryn.wangsness@azdhs.gov

(602) 364-0724

7.2 All invoices from the Contractor to ADHS shall be sent electronically via email to: invoices@adhs.gov

7.3 AUTOMATED CLEARING HOUSE.

mailto:kathryn.wangsness@azdhs.gov mailto:invoices@adhs.gov

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ADHS may pay invoices for some or all Orders through an Automated Clearing House (ACH). In order to receive payments in this manner, the Contractor must complete an ACH Contractor Authorization Form (form GAO-618) within thirty (30) days after the effective date of the Contract. The form is available online at: https://gao.az.gov/publications/forms

7.3.1 ACH Contractor Authorization Form shall be emailed to Contractor.Payautomation@azdoa.gov

7.4 All notices, and correspondences from ADHS to the Contractor will be sent electronically via email to the individual(s) notated on Attachment B.

https://gao.az.gov/publications/forms mailto:Contractor.Payautomation@azdoa.gov

PART ONE (1) - Special Terms and Conditions

ARIZONA DEPARTMENT OF

HEALTH SERVICES

150 North 18th Ave, Suite 530

SPECIAL TERMS AND CONDITIONS

1. PURPOSE

Pursuant to provisions of the Arizona Procurement Code, A.R.S. 41-2501 Et Seq., the State of Arizona, ADHS intend to establish a Contract for the materials or services as listed herein.

2. TERM OF CONTRACT (1 YEAR)

The term of any resultant Contract shall commence upon final signature and shall continue for a period of one (1) year thereafter, unless terminated, canceled, or extended as otherwise provided herein.

3. CONTRACT EXTENSIONS 5 YEAR MAXIMUM

The Contract term upon final signature and shall continue for a period of one (1) year subject to additional successive periods of twelve (12) months per extension with a maximum aggregate including all extensions not to exceed five (5) years.

4. CONTRACT TYPE

X Fixed Price

5. LICENSES

The Contractor shall maintain in current status, all federal, state and local licenses and permits required for the operation of the business conducted by the Contractor.

6. POINT OF CONTACT

6.1 It is essential that the Contractor provide adequate experienced personnel, capable of and devoted to the successful accomplishment of work to be performed under this Contract. The Contractor must agree to assign specific individuals to the key positions.

6.2 The Contractor agrees that, once assigned to work under this Contract, key personnel shall not be removed or replaced without written notice to the State.

6.3 Key personnel not available for work under this Contract for a continuous period exceeding thirty (30) calendar days, or are expected to devote substantially less effort to the work than initially anticipated, the Contractor shall immediately notify the State, and shall, subject to the concurrence of the State, replace such personnel with personnel of substantially equal ability and qualifications.

7. PRICING

Throughout the life of the Contract, the Contractor shall always offer the State the Most-Favored Customer or Highest Tier Customer price discount rate on contracted product(s) concurrent with a published price discount rate made to other Customers (both Private and Public sectors). The Contractor shall extend to the State that most-favored customer or Highest Tier Customer price discount on all new product lines during the life of the contract.

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8. NON-EXCLUSIVE CONTRACT

Any contract resulting from this solicitation shall be awarded with the understanding and agreement that it is for the sole convenience of the State of Arizona. The State reserves the right to obtain like goods or services from another source when necessary, or when determined to be in the best interest of the State.

9. VOLUME OF WORK

The ADHS does not guarantee a specific amount of work either for the life of the Contract or on an annual basis.

10. INFORMATION DISCLOSURE

The Contractor shall establish and maintain procedures and controls that are acceptable to the State for the purpose of assuring that no information contained in its records or obtained from the state or from others in carrying out its functions under the Contract shall be used or disclosed by it, its agents, officers, or employees, except as required to efficiently perform duties under the Contract. Persons requesting such information should be referred to the State.

The Contractor also agrees that any information pertaining to individual persons shall not be divulged other than to employees or officers of the Contractor as needed for the performance of duties under the Contract, unless otherwise agreed to in writing by the State.

11. EMPLOYEES OF THE CONTRACTOR

All employees of the Contractor employed in the performance of work under the Contract shall be considered employees of the Contractor at all times, and not employees of the ADHS or the State. The Contractor shall comply with the Social Security Act, Workman’s Compensation laws and Unemployment laws of the State of Arizona and all State, local and Federal legislation relevant to the Contractor’s business.

12. ORDER PROCESS

The award of a contract shall be in accordance with the Arizona Procurement Code. Any attempt to represent any material and/or service not specifically awarded as being under contract with ADHS is a violation of the Contract and the Arizona Procurement Code. Any such action is subject to the legal and contractual remedies available to the state inclusive of, but not limited to, Contract cancellation, suspension, and/or debarment of the Contractor.

13. CONTRACTOR PERFORMANCE REPORTS

Program management shall document Contractor performance, both exemplary and needing improvements where corrective action is needed or desired. Copies of corrective action reports will be forwarded to the ADHS Procurement Office for review and any necessary follow-up. The Procurement Office may contact the Contractor upon receipt of the report and may request corrective action. The Procurement Office shall discuss the Contractor’s suggested corrective action plan with the Program for approval of the plan prior to sending it to the Contractor.

14. PAYMENT PROCEDURES

14.1 ADHS accounting will not make payments to any Entity, Group or individual other than the Contractor with the Federal Employer Identification (FEI) Number identified in the Contract. Contractor invoices requesting payment to any Entity, Group or individual other than the contractually specified Contractor shall be returned to the Contractor for correction.

14.2 The Contractor shall review and insure that the invoices for services provided show the correct Contractor name prior to sending them to the ADHS Accounting Office for payment.

14.3 If the Contractor Name and FEI Number change, the Contractor must complete an “Assignment and

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Agreement” form transferring contract rights and responsibilities to the new Contractor. ADHS must indicate consent on the form. A written Contract Amendment must be signed by both parties and a new W-9 form must be submitted by the new Contractor and entered into the system prior to any payments being made to the new Contractor.

15. FINANCIAL MANAGEMENT

15.1 For all contracts, the practices, procedures, and standards specified in the State of Arizona Accounting

Manual https://gao.az.gov/publications/SAAM/ and required by the Arizona Department of Health Services and Guidance for Federal Grant Award Management Manual shall be used by the Contractor in the management of contract funds and by the ADHS when performing a contract audit.

https://azdhs.gov/documents/operations/financial-services/bluebook-2018.pdf The contractor also agrees to abide by the rules as outlined by 2 CFR 200 Uniform Administrative Requirements, Cost Principles and Audit Requirements for Federal Awards. Funds collected by the Contractor in the form of fees, donations, and/or charges for the delivery of these contract services shall be accounted for in a separate fund.

https://ecfr.io/Title-02/cfr200_main

15.2 State Funding Contractors receiving state funds under this Contract shall comply with the certified

Compliance provisions of A.R.S. § 35-181.03.

15.3 Federal Funding Contractors receiving federal funds under this contract shall comply with the certified finance and compliance audit provision of the Office of Management and Budget (OMB) Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards (2 CFR 200), if applicable. The federal financial assistance information shall be stated in a Change Order or Purchase Order.

16. INSPECTION AND ACCEPTANCE

All services, data, and required reports are subject to final inspection, review, evaluation, and acceptance by the ADHS. The ADHS may withhold payment for services that are deemed to not meet contract standards.

17. AUTHORIZATION FOR SERVICES

Authorization for purchase of services under this Contract shall be made only upon ADHS issuance of a Purchase Order that is signed by an authorized agent. The Purchase Order will indicate the Contract number and the dollar amount of funds authorized. The Contractor shall only be authorized to perform services up to the amount on the Purchase Order. ADHS shall not have any legal obligation to pay for services in excess of the amount indicated on the Purchase Order. No further obligation for payment shall exist on behalf of ADHS unless a) the Purchase Order is changed or modified with an official ADHS Procurement Change Order, and/or b) an additional Purchase Order is issued for purchase of services under this Contract.

18. INSURANCE REQUIREMENTS

18.1 Contractor and subcontractors shall procure and maintain, until all of their obligations have been discharged, including any warranty periods under this Contract, insurance against claims for injury to persons or damage to property arising from, or in connection with, the performance of the work hereunder by the Contractor, its agents, representatives, employees or subcontractors.

18.2 The Insurance Requirements herein are minimum requirements for this Contract and in no way limit the indemnity covenants contained in this Contract. The State of Arizona in no way warrants that the minimum limits contained herein are sufficient to protect the Contractor from liabilities that arise out of the performance of the work under this Contract by the Contractor, its agents, representatives, employees or subcontractors, and the Contractor is free to purchase additional insurance.

https://gao.az.gov/publications/SAAM/ https://azdhs.gov/documents/operations/financial-services/bluebook-2018.pdf https://ecfr.io/Title-02/cfr200_main

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18.3 Minimum Scope and Limits of Insurance

Contractor shall provide coverage with limits of liability not less than those stated below.

18.3.1 Commercial General Liability (CGL) – Occurrence Form

Policy shall include bodily injury, property damage, and broad form contractual liability coverage.

18.3.1.1 General Aggregate $2,000,000.00

18.3.1.1.1 Products – Completed Operations Aggregate $1,000,000.00

18.3.1.1.2 Personal and Advertising Injury $1,000,000.00

18.3.1.1.3 Damage to Rented Premises $ 50,000.00

18.3.1.1.4 Each Occurrence $1,000,000.00

18.3.1.2 Policy shall be endorsed, as required by this written agreement, to include the State of

Arizona, and its departments, agencies, boards, commissions, universities, officers, officials, agents, and employees as additional insureds with respect to liability arising out of the activities performed by or on behalf of the Contractor.

18.3.1.3 Policy shall contain a waiver of subrogation endorsement, as required by this written agreement, in favor of the State of Arizona, and its departments, agencies, boards, commissions, universities, officers, officials, agents, and employees for losses arising from work performed by or on behalf of the Contractor.

18.3.2 Business Automobile Liability

18.3.2.1 Bodily injury and Property Damage for any owned, hired, and/or non-owned automobiles used in the performance of this contract.

18.3.2.1.1 To Combined Single Limit (CSL) $1,000,000.00

18.3.2.2 Policy shall be endorsed, as required by this written agreement, to include the State of

Arizona, and its departments, agencies, boards, commissions, universities, officers, officials, agents, and employees as additional insureds with respect to liability arising out of the activities performed by, or on behalf of, the Contractor involving automobiles owned, hired and/or non-owned by the Contractor.

18.3.2.3 Policy shall contain a waiver of subrogation endorsement as required by this written agreement in favor of the State of Arizona, and its departments, agencies, boards, commissions, universities, officers, officials, agents and employees for losses arising

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18.3.3 Workers; Compensation and Employers’ Liability

18.3.3.1 Workers Compensation Statutory

18.3.3.2 Employers’ Liability

18.3.3.2.1 Each accident $1,000,000.00

18.3.3.2.2 Disease – Each employee $1,000,000.00

18.3.3.2.3 Disease – Policy Limit $1,000,000.00

18.3.3.3 Policy shall contain a waiver of subrogation endorsement, as required by this written agreement, in favor of the State of Arizona, and its departments, agencies, boards, commissions, universities, officers, officials, agents and employees for losses arising

18.3.3.4 This requirement shall not apply to each Contractor or subcontractor that is exempt under A.R.S. § 23.901 and when such Contractor or subcontractor executes the appropriate waiver form (Sole Proprietor or Independent Contractor).

18.3.4 Professional Liability (Errors and Omissions Liability)

18.3.4.1 Each Claim $2,000,000.00

18.3.4.2 Annual Aggregate $2,000,000.00

18.3.4.3 In the event that the Professional Liability insurance required by this Contract is written on a claims-made basis, Contractor warrants that any retroactive date under the policy shall precede the effective date of this Contract and, either continuous coverage will be maintained, or an extended discovery period will be exercised, for a period of two (2) years beginning at the time work under this Contract is completed.

18.3.4.4 The policy shall cover professional misconduct or negligent acts for those positions defined in the Scope of Work of this contract.

18.3.4.5 Coverage to Include:

18.3.4.5.1 Systems analysis;

18.3.4.5.2 Software design;

18.3.4.5.3 Systems programming;

18.3.4.5.4 Data processing;

18.3.4.5.5 Systems integration;

18.3.4.5.6 Outsourcing including outsourcing development and design;

18.3.4.5.7 Systems design, consulting, development and modification;

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18.3.4.5.8 Training services relating to computer software or hardware;

18.3.4.5.9 Management, repair and maintenance of computer products, networks and systems;

18.3.4.5.10 Marketing, selling, servicing, distributing, installing and maintaining computer hardware or software; and

18.3.4.5.11 Data entry, modification, verification, maintenance, storage, retrieval or preparation of data output.

18.4 Additional Insurance Requirements

The policies shall include, or be endorsed to include, as required by this written agreement, the following provisions:

18.4.1 The Contractor’s policies as applicable, shall stipulate that the insurance afforded the Contractor shall be primary and that any insurance carried by the Department, its agents, officials, employees or the State of Arizona shall be excess and not contributory insurance, as provided by A.R.S. § 41-621 (E).

18.4.2 Insurance provided by the Contractor shall not limit the Contractor’s liability assumed under the indemnification provisions of this Contract.

18.5 Notice of Cancellation

Applicable to all insurance policies required within the Insurance Requirements of this Contract, Contractor’s insurance shall not be permitted to expire, be suspended, be canceled, or be materially changed for any reason without thirty (30) days prior written notice to the State of Arizona. Within two (2) business days of receipt, Contractor must provide notice to the State of Arizona if they receive notice of a policy that has been or will be suspended, canceled, materially changed for any reason, has expired, or will be expiring. Such notice shall be sent directly to the Department and shall be mailed, emailed, or hand delivered to Arizona Department of Health Services, 150 N 18th Ave, Suite 530, Phoenix, AZ 85007.

18.6 Acceptability of Insurers

Contractor’s insurance shall be placed with companies licensed in the State of Arizona or hold approved non-admitted status on the Arizona Department of Insurance List of Qualified Unauthorized Insurers.

Insurers shall have an “A.M. Best” rating of not less than A- VII. The State of Arizona in no way warrants that the above-required minimum insurer rating is sufficient to protect the Contractor from potential insurer insolvency.

18.7 Verification of Coverage

Contractor shall furnish the State of Arizona with certificates of insurance (COI) (valid ACORD form or equivalent approved by the State of Arizona) evidencing that Contractor has the insurance as required by this Contract. An authorized representative of the insurer shall sign the certificates.

18.7.1 All such certificates of insurance and policy endorsements must be received by the State before work commences. The State’s receipt of any certificates of insurance or policy endorsements that

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do not comply with this written agreement shall not waive or otherwise affect the requirements of this agreement.

18.7.2 Each insurance policy required by this Contract must be in effect at, or prior to, commencement of work under this Contract. Failure to maintain the insurance policies as required by this Contract, or to provide evidence of renewal, is a material breach of contract.

18.7.3 All certificates required by this Contract shall be sent directly to the Department. The State of Arizona project/contract number and project description shall be noted on the certificate of insurance. The State of Arizona reserves the right to require complete copies of all insurance policies required by this Contract at any time.

18.8 Subcontractors

Contractor’s certificate(s) shall include all subcontractors as insureds under its policies or Contractor shall be responsible for ensuring and/or verifying that all subcontractors have valid and collectable insurance as evidenced by the certificates of insurance and endorsements for each subcontractor. All coverages for subcontractors shall be subject to the minimum Insurance Requirements identified above. The Department reserves the right to require, at any time throughout the life of this contract, proof from the Contractor that its subcontractors have the required coverage.

18.9 Approval and Modifications

The Contracting Agency, in consultation with State Risk, reserves the right to review or make modifications to the insurance limits, required coverages, or endorsements throughout the life of this contract, as deemed necessary. Such action will not require a formal Contract amendment but may be made by administrative action.

18.10 Exceptions

In the event the Contractor or subcontractor(s) is/are a public entity, then the Insurance Requirements shall not apply. Such public entity shall provide a certificate of self-insurance. If the Contractor or subcontractor(s) is/are a State of Arizona agency, board, commission, or university, none of the above shall apply.

19. HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT OF 1996

19.1 If applicable, the Contractor warrants that it is familiar with the requirements of HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (HITECH Act) of 2009, and accompanying regulations and will comply with all applicable HIPAA requirements in the course of this Contract. Contractor warrants that it will cooperate with the Arizona Department of Health Services (ADHS) in the course of performance of the Contract so that both ADHS and Contractor will be in compliance with HIPAA, including cooperation and coordination with the Arizona Department of Administration-Arizona Strategic Enterprise Technology (ADOA-ASET) Office, the ADOA-ASET Arizona State Chief Information Security Officer and HIPAA Coordinator and other compliance officials required by HIPAA and its regulations. Contractor will sign any documents that are reasonably necessary to keep ADHS and Contractor in compliance with HIPAA, including, but not limited to, business associate agreements.

19.2 If applicable, and requested by the ADHS Procurement Office, Contractor agrees to sign a “Pledge To

Protect Confidential Information” and to abide by the statements addressing the creation, use and disclosure of confidential information, including information designated as protected health information and all other confidential or sensitive information as defined in policy. In addition, if requested, Contractor agrees

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to attend or participate in HIPAA training offered by ADHS or to provide written verification that the Contractor has attended or participated in job related HIPAA training that is: (1) intended to make the Contractor proficient in HIPAA for purposes of performing the services required and (2) presented by a HIPAA Privacy Officer or other person or program knowledgeable and experienced in HIPAA and who has been approved by the ADOA-ASET Arizona State Chief Information Security Officer and HIPAA Coordinator.

20. Unique Entity Identifier (UEI)

Pursuant to 2 CFR 25.100 et seq., no entity (defined as a Governmental organization, which is a State, local government, or Indian tribe; foreign public entity; domestic or foreign nonprofit organization; domestic or foreign for-profit organization; or Federal agency, but only as a sub-recipient under an award or sub-award to a non-Federal entity) may receive a sub-award from ADHS unless the entity provides its Unique Entity Identifier Number to ADHS.

The number can be created in SAM.gov. If already registered the UEI has been assigned and can be viewed in SAM.gov

21. NEW SERVICES

The State, at its sole discretion may allow new services identified by the Contractor or ADHS to be incorporated.

The request may be submitted at any time during the Contract period. The requested services shall align with the current Scope of Work, Requirements, Deliverables, and Price List.

22. THE FEDERAL FUNDING ACCOUNTABILITY AND TRANSPARENCY ACT (FFATA OR TRANSPARENCY ACT

- P.L.109-282, AS AMENDED BY SECTION 6202(A) OF P.L. 110-252), FOUND AT HTTPS://WWW.FSRS.GOV/

If applicable, the subrecipient or sub-awardee is required to abide by the Federal Funding Accountability and Transparency Act (FFATA or Transparency Act – P.L. 109-282, as amended by section 6202(a) of P.L. 110-252), found at https://www.fsrs.gov/. The associated Grant Reporting Certification Form and completion instructions will be sent to the subrecipient from ADHS Program(s) responsible for the specific contract. The subrecipient or sub-awardee must return the completed form to ADHS Program(s) by the 15th of the month following that in which the award was received. Failure to complete a required Grant Reporting Certification Form may result in loss of funding.

23. TRANSITION ACTIVITIES

23.1 The Contractor shall support the transfer of the Evaluation Reports at the conclusion of its Contract;

23.2 Upon termination of this Contract, if ADHS anticipates a continued need for the Contract Services specified herein and a contract is awarded to a new Contractor, there shall be a transition of services period of not less than thirty (30) days. During this period, the existing Contractor shall work closely with the new Contractor, or Contractors, personnel and/or staff to ensure a smooth and complete transfer of duties and responsibilities;

23.3 An authorized representative from ADHS shall coordinate all transition activities. A transition plan will be developed in conjunction with the outgoing Contractor to assist the new Contractor, or Contractors, personnel and/or staff to implement the transfer of duties;

23.4 ADHS reserves the right to determine which projects nearing completion will remain with the current

Contractor of record.

23.5 The Contractor shall return all ADHS equipment, reports, and any other documentation developed during the term of the Contract that ADHS deems necessary to maintain ongoing operations.

https://www.fsrs.gov/ https://www.fsrs.gov/

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24. FRAUD, WASTE, AND ABUSE

24.1 ADHS requires all employees to abide by the State’s Personnel System Rules, R2-5A-501; Standards of Conduct which includes maintaining high standards of honesty, integrity, and impartiality, free from personal considerations and/or favoritism, and Code of Conduct for individuals engaged in Accounting, Financial and Budgeting Activities which depicts the moral, ethical, legal and professional aspects of personal conduct. ADHS requires the same conduct of its consultants, Contractors, contractors, subrecipients, or persons doing business with the agency.

24.2 Any State employee, consultant, Contractor, contractor or subrecipient or person doing business with the

Agency who receives a report of improper activity must report the information within one (1) business day.

Note: Federal Award policy denotes awardees must disclose, in a timely manner, in writing to ADHS all violations of Federal Criminal Law, involving fraud, bribery, or gratuity violations potentially affecting Federal Awards.

24.3 Anyone suspecting Fraud, Waste, or Abuse related to ADHS activities are required to report Fraud, Waste, or abuse through any of the following reporting channels:

24.3.1 ADHS Ethics Action Hotline at (602) 542-2347,

24.3.2 ADHS Ethics Action Email at reportethics@azdhs.gov ,or

24.3.3 General Accounting Office (GAO) Fraud Reporting Email at reportfraud@azdoa.gov to report Fraud, Waste, or Abuse incidents].

mailto:reportethics@azdhs.gov mailto:reportfraud@azdoa.gov

Part ONE (1) Uniform Terms and Conditions

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Phoenix, AZ 85007

Uniform Terms and Conditions

UNIFORM TERMS AND CONDITIONS

1. Definition of Terms. As used in this Solicitation and any resulting Contract, the terms listed below are defined as follows:

1.1. “Attachment” means any item the Solicitation which requires the Offeror to submit as part of the Offer.

1.2. “Contract” means the combination of the Solicitation, including the Instructions to Offerors, the Uniform and Special Terms and Conditions, and the Specifications and Statement or Scope of Work; the Offer and any Best and Final Offers; and any Solicitation Amendments or Contract Amendments.

1.3. "Contract Amendment" means a written document signed by the Procurement Officer that is issued for the purpose of making changes in the Contract.

1.4. “Contractor” means any person who has a Contract with the State.

1.5. “Data” means recorded information, regardless of form or the media on which it may be recorded.

The term may include technical Data and computer software. The term does not include information incidental to contract administration, such as financial, administrative, cost or pricing, or management information.

1.6. “Days” means calendar days unless otherwise specified.

1.7. “Exhibit” means any item labeled as an Exhibit in the Solicitation or placed in the Exhibits section of the Solicitation generally containing maps, schematics, examples of reports, or other documents that will be used to perform the requirements of the Scope of Work after contract award.

1.8. “Gratuity” means a payment, loan, subscription, advance, deposit of money, services, or anything of more than nominal value, present or promised, unless consideration of substantially equal or greater value is received.

1.9. “Materials” means all property, including equipment, supplies, printing, insurance and leases of property but does not include land, a permanent interest in land or real property or leasing space.

1.10. “Procurement Officer” means the person, or his or her designee, duly authorized by the State to enter into and administer Contracts and make written determinations with respect to the Contract.

1.11. “Services” means the furnishing of labor, time or effort by a Contractor or Subcontractor which does not involve the delivery of a specific end product other than required reports and performance, but does not include employment agreements or collective bargaining agreements.

1.12. “State” means any department, commission, council, board, bureau, committee, institution, agency, government corporation or other establishment or official of the executive branch or corporation commission of the State of Arizona that executes the Contract.

1.13. “State Fiscal Year” means the period beginning with July 1 and ending June 30.

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1.14. “Subcontract” means any Contract, express or implied, between the Contractor and another party or between a Subcontractor and another party delegating or assigning, in whole or in part, the making or furnishing of any Materials or any Services required for the performance of the Contract.

1.15. “Subcontractor” means a person who contracts to perform work or render Services to a Contractor or to another Subcontractor as a part of a Contract with the State.

2. Contract Interpretation

2.1. Arizona Law. The Arizona law applies to this Contract including, where applicable, the Uniform Commercial Code as adopted by the State of Arizona and the Arizona Procurement Code, Arizona Revised Statutes (A.R.S.) Title 41, Chapter 23, and its implementing rules, Arizona Administrative Code (A.A.C.) Title 2, Chapter 7.

2.2. Implied Contract Terms. Each provision of law and any terms required by law to be in this Contract are a part of this Contract as if fully stated in it.

2.3. Contract Order of Precedence. In the event of a conflict in the provisions of the Contract, as accepted by the State and as they may be amended, the following shall prevail in the order set forth below:

2.3.1. Special Terms and Conditions;

2.3.2. Uniform Terms and Conditions;

2.3.3. Statement or Scope of Work;

2.3.4. Specifications;

2.3.5. Attachments;

2.3.6. Exhibits; then

2.3.7. Any other documents referenced or included in the Solicitation including, but not limited to, any Bid or Offer documents provided by the Contractor that do not fall into one of the above categories.

2.4. Relationship of Parties. The Contractor under this Contract is an independent Contractor. Neither party to this Contract shall be deemed to be the employee or agent of the other party to the Contract.

2.5. Severability. The provisions of this Contract are severable. Any term or condition deemed illegal or invalid shall not affect any other term or condition of the Contract.

2.6. No Parol Evidence. This Contract is intended by the parties as a final and complete expression of their agreement. No course of prior dealings between the parties and no usage of the trade shall supplement or explain any terms used in this document and no other understanding either oral or in writing shall be binding.

2.7. No Waiver. Either party’s failure to insist on strict performance of any term or condition of the Contract shall not be deemed a waiver of that term or condition even if the party accepting or

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acquiescing in the nonconforming performance knows of the nature of the performance and fails to object to it.

3. Contract Administration and Operation

3.1. Records. Under A.R.S. § 35-214 and § 35-215, the Contractor shall retain and shall contractually require each Subcontractor to retain any and all Data and other “records” relating to the acquisition and performance of the Contract for a period of five (5) years after the completion of the Contract.

All records shall be subject to inspection and audit by the State at reasonable times. Upon request, the Contractor shall produce a legible copy of any or all such records.

3.2. Non-Discrimination. The Contractor shall comply with State Executive Order Nos. 2023-09, 2023- 01, 2009-09, and any and all other applicable Federal and State laws, rules and regulations, including the Americans with Disabilities Act. Contractor shall include these provisions in contracts with Subcontractors when required by Federal or State law.

3.3. Audit. Pursuant to A.R.S. § 35-214, at any time during the term of this Contract and five (5) years thereafter, the Contractor’s or any Subcontractor’s books and records shall be subject to audit by the State and, where applicable, the Federal Government, to the extent that the books and records relate to the performance of the Contract or Subcontract.

3.4. Facilities Inspection and Materials Testing. The Contractor agrees to permit access to its facilities, Subcontractor facilities, and the Contractor’s processes or services, at reasonable times for inspection of the facilities or Materials covered under this Contract as required under A.R.S. § 41- 2547. The State shall also have the right to test, at its own cost, the Materials to be supplied under this Contract. Neither inspection of the Contractor’s facilities nor Materials testing shall constitute final acceptance of the Materials or Services. If the State determines non-compliance of the Materials, the Contractor shall be responsible for the payment of all costs incurred by the State for testing and inspection.

3.5. Notices. Notices to the Contractor required by this Contract shall be made by the State to the person indicated on the Offer and Acceptance form submitted by the Contractor unless otherwise stated in the Contract. Notices to the State required by the Contract shall be made by the Contractor to the Solicitation Contact Person indicated on the Solicitation, stated in the Contract, or listed on the State’s eProcurement system. An authorized Procurement Officer and an authorized Contractor representative may change their respective person to whom notice shall be given by written notice to the other and an amendment to the Contract shall not be necessary.

3.6. Advertising, Publishing and Promotion of Contract. The Contractor shall not use, advertise or promote information for commercial benefit concerning this Contract without the prior written approval of the Procurement Officer.

3.7. Continuous Improvement. Contractor shall recommend continuous improvements on an ongoing basis in relation to any Materials and Services offered under the Contract, with a view to reducing State costs and improving the quality and efficiency of the provision of Materials or Services. State may require Contractor to engage in continuous improvements throughout the term of the Contract.

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3.8. Other Contractors. State may undertake on its own or award other contracts to the same or other suppliers for additional or related work. In such cases, the Contractor shall cooperate fully with State employees and such other suppliers and carefully coordinate, fit, connect, accommodate, adjust, or sequence its work to the related work by others. Where the Contract requires handing-off Contractor’s work to others, Contractor shall cooperate as State instructs regarding the necessary transfer of its work product, Materials, Services, or records to State or the other suppliers. Contractor shall not commit or permit any act that interferes with the State’s or other suppliers’ performance of their work, provided that, State shall enforce the foregoing section equitably among all its suppliers so as not impose an unreasonable burden on any one of them.

3.9. Ownership of Intellectual Property

3.9.1. Rights In Work Product. All intellectual property originated or prepared by Contractor pursuant to the Contract, including but not limited to, inventions, discoveries, intellectual copyrights, trademarks, trade names, trade secrets, technical communications, records reports, computer programs and other documentation or improvements thereto, including Contractor’s administrative communications and records relating to the Contract, are considered work product and Contractor’s property, provided that, State has Government Purpose Rights to that work product as and when it was delivered to State.

3.9.2. “Government Purpose Rights” are:

3.9.2.1. the unlimited, perpetual, irrevocable, royalty free, non-exclusive, worldwide right to use, modify, reproduce, release, perform, display, sublicense, disclose and create derivatives from that work product without restriction for any activity in which State is a party;

3.9.2.2. the right to release or disclose that work product to third parties for any State government purpose; and

3.9.2.3. the right to authorize those to whom it rightfully releases or discloses that work product to use, modify, release, create derivative works from the work product for any State government purpose; such recipients being understood to include the federal government, the governments of other states, and various local governments.

3.9.3. “Government Purpose Rights” do not include any right to use, modify, reproduce, perform, release, display, create derivative works from or disclose that work product for any commercial purpose, or to authorize others to do so.

3.9.4. Joint Developments. The Contractor and State may each use equally any ideas, concepts, know-how, or techniques developed jointly during the course of the Contract, and may do so at their respective discretion, without obligation of notice or accounting to the other party.

3.9.5. Pre-existing Material. All pre-existing software and other Materials developed or otherwise obtained by or for Contractor or its affiliates independently of the Contract or

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applicable Purchase Orders are not part of the work product to which rights are granted State under subparagraph 3.9.1 above, and will remain the exclusive property of Contractor, provided that:

3.9.5.1. any derivative works of such pre-existing Materials or elements thereof that are created pursuant to the Contract are part of that work product;

3.9.5.2. any elements of derivative work of such pre-existing Materials that was not created pursuant to the Contract are not part of that work product; and

3.9.5.3. except as expressly stated otherwise, nothing in the Contract is to be construed to interfere or diminish Contractor’s or its affiliates’ ownership of such pre-existing Materials.

3.9.6. Developments Outside Of Contract. Unless expressly stated otherwise in the Contract, this Section does not preclude Contractor from developing competing Materials outside the Contract, irrespective of any similarity to Materials delivered or to be delivered to State hereunder.

3.10. Property of the State. If there are any materials that are not covered by Section 3.9 above created under this Contract, including but not limited to, reports and other deliverables, these materials are the sole property of the State. The Contractor is not entitled to a patent or copyright on those materials and may not transfer the patent or copyright to anyone else.