CTR075690_Contract_Documents.pdf

PART ONE (1) - Scope of Services

ARIZONA DEPARTMENT

OF HEALTH SERVICES

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

REQUEST FOR PROPOSAL No.: BPM005700

Newborn Screening Reference Laboratory

*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

Part Two (2) Special Instructions to Offerors

Uniform Instructions to Offerors

Attachments Located in APP:

● Attachment A: Offer and Acceptance

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

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

● Attachment D: Participation of Boycott of Israel

● Attachment E: Forced Labor of Ethnic Uyghurs Ban

● Attachment F: Removed

● Attachment G: Removed

● Attachment H: Business Associate Agreement (BAA)

EXHIBIT:

● EXHIBIT A: Annual Sample Estimates

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SCOPE OF SERVICES

1. BACKGROUND

The Arizona Department of Health Services (ADHS), State Public Health Laboratory (ASPHL), Office of Newborn Screening (NBS) provides annual testing services on dried blood spot (DBS) samples from newborn babies for the presence of thirty-five (35) out of the thirty-seven (37) congenital disorders outlined by the Secretary of the Department of Health and Human Services (HSS), the Recommended Uniform Screen Panel (RUSP).

2. OBJECTIVES

The ASPHL is seeking one (1) certified laboratory under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform second tier (2nd) biochemical testing for several newborn screening disorders with out-of-range first (1st) tier testing results obtained by the ASPHL. Results should be returned quickly to the ASPHL for further evaluation and case management.

3. REQUIREMENTS

The Contractor shall:

3.1 Provide second (2nd) tier biochemical testing and report results within turnaround time and test methodology as indicated in the then-current Mayo Clinic Laboratories Test Catalog on newborn dried blood spot (DBS) specimens for the following disorders using the indicated test method and preferred biomarkers;

Disorder Second Tier Test Method Second Tier Preferred Biomarker(s)

Homocystinuria / Methylmalonic acidemia / Propionic acidemia

LC-MS/MS Homocysteine, Methylmalonic Acid, and/or Methylcitric Acid

Glutarylcarnitine LC-MS/MS 2-OH Glutaric acid, 3-OH Glutaric acid, Glutaric acid, Methylsuccinic acid, and/or Ethylmalonic acid

Maple Syrup Urine Disease LC-MS/MS Allo-isoleucine, Leucine, Isoleucine, and/or Valine

Tyrosinemia Type I LC-MS/MS Succinylacetone

MPS I LC-MS/MS Dermatan Sulfate, heparan sulfate and keratan sulfate

MPS II LC-MS/MS Dermatan Sulfate, heparan sulfate and keratan sulfate

Pompe LC-MS/MS Ratio between creatine and creatinine Acid-alpha glucosidase activity

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3.2 Provide the required number of dried blood spots or dried blood spot punches needed for each second (2nd) tier test. Dried blood spot specimens will be sent without attached demographic cards;

3.3 Provide detailed method description of the testing for the disorders in 3.1;

3.4 Provide reference values of the testing methodologies for the disorders in 3.1;

3.5 Provide then-current Mayo Clinic Laboratories Test Catalog reflecting specimen requirements, method description, reference values, and any updates for the disorders in 3.1;

3.6 Provide all certifications, e.g. CLIA, that will be maintained by the Contractor for testing performed as reference laboratory;

3.7 Provide then-current Mayo Clinic Laboratories Test Catalog to indicate results turnaround time;

3.8 Provide the Contractor’s standard of operating if a sample was not received two (2) days after ASPHL submits a test order requisition to the laboratory;

3.9 Provide the Contractor’s method of notification when the laboratory report is ready;

3.10 Provide a template of the laboratory lab report. The lab report should include the following:

3.11.1 Name and address of the laboratory location where the test was performed;

3.11.2 Laboratory’s CLIA certificate number;

3.11.3 Unique sample identification number;

3.11.4 Test report date;

3.11.5 Quantitative value of the tested analyte;

3.11.6 Units of measurement, where applicable;

3.11.7 Interpretation of the test results;

3.11.8 The reference range of the tested analyte;

3.11.9 Signature of the laboratory director or designee who reviews the laboratory report; and

3.11.10 Corrected reports must clearly indicate the corrected result(s) and the fact that the report is a corrected report.

3.11 Upon request, provide a Certificate of Insurance (COI) within ten (10) days or sooner of Contract award and yearly throughout the term of the Contract that meets the Insurance Requirements as stated in the Special Terms and Conditions. A Purchase Order will not be issued by ADHS unless a COI is on file.

3.12 Remain SOC 2 compliant while working with ADHS to determine their information security needs and discuss concerns as needed.

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4. TASKS

The Contractor shall:

4.1 Provide their laboratory order requisition form to ASPHL;

4.2 Provide instruction on sample’s requisition and shipping to the laboratory;

4.3 Provide the location, i.e. name and address, where the DBS should be sent to;

4.4 Provide notification to ASPHL if a sample was not received two (2) days after ASPHL submits a test order requisition to their laboratory;

4.5 Provide notification to ASPHL if a sample’s quality is not acceptable for testing;

4.6 Provide notification to ASPHL if a laboratory report is ready within twenty-four (24) hours;

4.7 Provide the cost for each test;

4.8 Provide the then-current Mayo Clinic Laboratories Test Catalog to indicate results turnaround time;

4.9 Notify ASPHL immediately if there would be a significant delay in testing, i.e. TAT is greater than five (5) days.

5. STATE PROVIDED ITEMS

The State will provide:

5.1 The estimate of second (2nd) tier tests annually;

5.2 FedEx service to send the DBS to the location stated in 4.3; and

5.3 Necessary patient demographic for testing purposes, if needed.

6. DELIVERABLES

The Contractor shall submit to ADHS:

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

6.2 Provide second (2nd) tier biochemical testing and report results within the TAT as indicated in the then-current Mayo Clinic Laboratories Test Catalog on newborn dried blood spot (DBS) specimens for the following disorders using the indicated test method and preferred biomarkers.

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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 emailed upon a mutually agreed time to:

Arizona Department of Health Services State Public Health Laboratory Office of Newborn Screening ATTN: Trung Hyunh, Office 250 N. 17th Avenue Phoenix, AZ 85007 Trung.huynh@azdhs.gov

(480) 261-9351

7.2 Notification that an invoice is available in the contractor’s online portal shall be sent electronically via email to: invoices@adhs.gov.

7.3 AUTOMATED CLEARING HOUSE.

7.3.1 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 30 (thirty) days after the effective date of the Contract.

The form is available online at: https://gao.az.gov/publications/forms

7.3.2 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.

mailto:Trung.huynh@azdhs.gov mailto:invoices@adhs.gov 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

REQUEST FOR PROPOSAL No.: BPM005048

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, the Contractor shall notify ADHS of any changes in key personnel. The contractor’s key personnel is the Hospital Account Representative.

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. The contractor’s key personnel is the Hospital Account Representative.

7. PRICING

If applicable, throughout the life of the Contract, when discounts are provided, the test list with current fees and proposed fees must be transparent.

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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 for the purpose of assuring that no information 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.

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 Agreement” form transferring contract rights and responsibilities to the new Contractor. ADHS must indicate

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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.

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.

16. INSPECTION AND ACCEPTANCE

Payment will be issued upon approval of all invoices and review of any supporting documentation.

17. AUTHORIZATION FOR SERVICES

A purchase order shall be issued prior to any services being ordered. The program should monitor the purchase order to ensure services do not exceed the obligated amount. ADHS can only request services with an authorized purchase order.

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.

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

https://gao.az.gov/publications/SAAM/

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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.

18.3.2 If applicable, 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 from work performed by or on behalf of the Contractor.

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 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

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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 May 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;

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 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.

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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. The contractor’s insurance may be through a program of self-insurance.

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 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 reserves the right to require complete copies of all insurance policies required by this Contract at any time.

18.8 Approval and Modifications

The Contracting Agency, in consultation with State Risk, reserves the right to request modifications to the insurance limits, required coverages, or endorsements throughout the life of this contract, if deemed necessary. Such action will require a formal Contract amendment.

18.9 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. If applicable, the Contractor will sign any documents that are reasonably necessary to keep

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ADHS and the 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 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.

ADHS will notify the Contractor if federal funds are used.

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, the Contractor and ADHS will develop a transition plan together per Section 23.3. The continuity of services shall not be interrupted until the transition is complete;

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

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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.

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

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The following Special Terms and Conditions modify the Uniform Terms and Conditions. It can modify them by replacing, deleting, appending to, or revising the text of an existing provision or by inserting a new paragraph into an existing article. No other document modifies or adds to the Uniform Terms and Conditions, except as may subsequently be otherwise and expressly agreed and incorporated by Contract Amendment.

1. This provision clarifies the Definition of Terms in Section One (1) of the Uniform Terms and Conditions.

1.1. Clarifies Subsection 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. If exceptions to the Uniform Terms and Conditions are granted, they will be reflected in the Standard Terms Conditions, which come first in the order of precedence.

1.2. Clarifies Subsection 1.3. "Contract Amendment" means a written document signed by both parties for the purpose of making changes in the Contract.

1.3. Clarifies Subsection 1.5. “Data” means invoice records and laboratory testing results. The term does not include information incidental to contract administration, such as financial, administrative, cost or pricing, or management information.

1.4. Clarifies Subsection 1.11. “Services” means the laboratory testing services provided to the State as described under this Contract.

2. This provision clarifies the Contract Interpretation in Section Two (2) of the Uniform Terms and Conditions.

2.1. Clarifies Subsection 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.) The applicable provisions are in the Arizona Revised Statues Title 41, Chapter 23, and the Arizona Administrative Code (A.A.C.) Title 2, Chapter 7.

2.2. Clarifies Subsection 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. The applicable provisions are in the Arizona Revised Statues Title 41, Chapter 23, and the Arizona Administrative Code (A.A.C.) Title 2, Chapter 7.

2.3. Clarifies Subsection 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. If exceptions to the Uniform Terms and Conditions are granted, they will be reflected in the Standard Terms Conditions, which come first in the order of precedence.

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

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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.

3. This provision clarifies the Contract Administration and Operation in Section Three (3) of the Uniform Terms and

Conditions.

3.1. Clarifies Subsection 3.1. Records. Under A.R.S. § 35-214 and § 35-215, the Contractor shall retain 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 invoice records shall be subject to inspection by the State at reasonable times.

Upon request, the Contractor shall produce a legible copy of any or all such records.

3.2. Clarifies Subsection 3.4 Facilities Inspection and Materials Testing. ADHS has the right to confirm work is being conducted in an appropriate setting/environment and that procedures are being followed. ADHS will not request personal health information (PHI) from samples that do not fall under this contract. If an inspection were determined necessary, it would be specific to ADHS samples, and ADHS shall not have access to any systems or areas that may expose PHI for non-ADHS samples.

3.3. Clarifies Subsection 3.8 Other Contractors. If ADHS needs to transition work to another contractor, the following will apply: 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.

3.4. Clarifies Subsection 3.9 Ownership of Intellectual Property. The provisions in this section solely relate to test results. The contractor does not have any supporting documentation.

3.5. Clarifies Subsection 3.10 Property of the State. The provisions in this section solely relate to test results. The contractor does not have any supporting documentation.

3.6. Clarifies Subsection 3.11 Federal Immigration and Nationality Act. The contractor shall comply with all applicable federal, state, and local immigration laws and regulations relating to the immigration status of their employees during the term of the contract.

3.7. Clarifies Subsection 3.12. E-Verify Requirements. In accordance with A.R.S. § 41-4401, the Contractor warrants compliance with all Federal immigration laws and regulations relating to employees and warrants its compliance with Section A.R.S. § 23- 214, Subsection A. ADHS shall comply with the statutory requirements of this provision.

3.8. Clarifies Subsection 3.14. Protection of State Cybersecurity Interests. If applicable, the Contractor shall comply with State Executive Order No. 2023-10, which includes, but is not limited to, a prohibition against (a) downloading and installing of TikTok on all State-owned and State-leased information technology; and (b) accessing TikTok through State information technology.

4. This provision clarifies the Costs and Payments in Section Four (4) of the Uniform Terms and Conditions.

4.1. Removes Subsection 4.2. Delivery. Unless stated otherwise in the Contract, per A.R.S. § 47-2319, all prices shall be F.O.B. (“free on board”) Destination and shall include all freight delivery and unloading at the destination.

OF HEALTH SERVICES

4.2. Clarifies Subsection 4.4.4 I.R.S. W9 Form. In order to receive payment the Contractor shall have a current I.R.S.

W9 Form on file with the State of Arizona, unless not required by law. W9 is a requirement for payment.

5. This provision clarifies the Risk and Liability in Section Six (6) of the Uniform Terms and Conditions.

5.1. Clarifies Subsection 6.1. Risk of Loss. If applicable, the Contractor shall bear all loss of conforming Materials covered under this Contract until received by authorized personnel at the location designated in the purchase order or Contract. Mere receipt does not constitute final acceptance. The risk of loss for nonconforming Materials shall remain with the Contractor regardless of receipt.

5.2. Clarifies Subsection 6.2.1. Contractor/Contractor Indemnification (Not Public Agency).To the fullest extent permitted by law, Contractor shall defend, indemnify, and hold harmless the State of Arizona, and its departments, agencies, boards, commissions, universities, officers, officials, agents, and employees (hereinafter referred to as “Indemnitee”) from and against any and all claims, actions, liabilities, damages, losses, or expenses (including court costs, attorneys’ fees, and costs of claim processing, investigation and litigation) (hereinafter referred to as “Claims”) for bodily injury or personal injury (including death), or loss or damage to tangible or intangible property caused, or alleged to be caused, in whole or in part, by the negligent or willful acts or omissions of Contractor or any of its owners, officers, directors, agents, employees or Subcontractors. This indemnity includes any claim or amount arising out of, or recovered under, the Workers’ Compensation Law or arising out of the failure of such Contractor to conform to any federal, state, or local law, statute, ordinance, rule, regulation, or court decree. It is the specific intention of the parties that the Indemnitee shall, in all instances, except for Claims arising solely from the negligent or willful acts or omissions of the Indemnitee, be indemnified by Contractor from and against any and all claims. It is agreed that Contractor will be responsible for primary loss investigation, defense, and judgment costs where this indemnification is applicable. This indemnity shall not apply if the Contractor or Subcontractor(s) is/are an agency, board, commission or university of the State of Arizona.

5.3. Clarifies Subsection 6.3. Indemnification - Patent and Copyright. The Contractor shall indemnify and hold harmless the State against any liability, including costs and expenses, for infringement of any patent, trademark or copyright arising out of Contract performance or use by the State of Materials furnished or work performed under this Contract. The State shall reasonably notify the Contractor of any claim for which it may be liable under this paragraph. If the Contractor is insured pursuant to A.R.S. § 41-621 and § 35-154, this paragraph shall not apply.

This paragraph does not cover the State’s misuse of materials. This paragraph is limited to third-party claims. This paragraph requires notification of a claim within ten (10) days of the State’s receipt of the claim.

6. This provision clarifies the Warranties in Section Seven (7) of the Uniform Terms and Conditions.

6.1. Clarifies Subsection 7.1 Liens. If applicable, the Contractor warrants that the Materials supplied under this Contract are free of liens and shall remain free of liens.

6.2. Clarifies Subsection 7.2. Quality. Unless otherwise modified elsewhere in the Special Terms and Conditions and if applicable, the Contractor warrants that, for one (1) year after acceptance by the State of the Materials, they shall be:

6.3. Clarifies Subsection 7.3.1. If applicable, the contractor warrants that, unless expressly provided otherwise elsewhere in the Contract, the Materials and Services will for one (1) year after acceptance and in each instance:

6.4. Clarifies Subsection 7.4. Inspection/Testing. If applicable, the warranties set forth in this Section 7, Warranties, are not affected by inspection or testing of or payment for the Materials or Services by the State.

6.5. Clarifies Subsection 7.6. Compliance With Applicable Laws. The Services supplied under this Contract shall comply with all applicable federal, state, and local laws.

OF HEALTH SERVICES

6.6. Clarifies Subsection 7.7. Removed. Intellectual Property. Contractor warrants that the Materials and Services do not and will not infringe or violate any patent, trademark, copyright, trade secret, or other intellectual property rights or laws, except only to the extent the Specifications do not permit use of any other product and Contractor is not and cannot reasonably be expected to be aware of the infringement or violation.

6.7. Clarifies Subsection 7.10.2 Performance in Public Health Emergency. Provide a copy of its current plan to State within three (3) business days after State’s written request. If Contractor claims relief under paragraph 6.4 [Force Majeure] for an occurrence of force majeure that is a declared public health emergency, then that relief will be conditioned on Contractor having first implemented its plan and exhausted all reasonable opportunity for that plan implementation to overcome the effects of that occurrence, or mitigate those effects to the extent that overcoming entirely is not practicable. The contractor will provide a redacted copy upon request.

7. This provision clarifies the State’s Contractual Remedies in Section Eight (8) of the Uniform Terms and Conditions.

7.1. Clarifies Subsection 8.5. Right of Offset. The State shall be entitled to offset against any sums due the Contractor, any expenses or costs incurred by the State, or damages assessed by the State concerning the Contractor’s non-conforming performance or failure to perform the Contract, including expenses, costs and damages described in the Uniform Terms and Conditions. Both parties will work together and take reasonable steps before determining whether outside services will be necessary.

8. This provision clarifies the Contract Termination in Section Nine (9) of the Uniform Terms and Conditions.

8.1. Clarifies Subsection 9.4. Termination for Convenience. The State reserves the right to terminate the Contract, in whole or in part at any time when in the best interest of the State, without penalty or recourse. Upon receipt of the written notice, the Contractor shall stop all work, as directed in the notice, notify all Subcontractors of the effective date of the termination and minimize all further costs to the State. In the event of termination under this paragraph, all documents, Data and reports prepared by the Contractor under the Contract shall become the property of and be delivered to the State upon demand. The Contractor shall be entitled to receive just and equitable compensation for work in progress, work completed, and Materials or Services accepted before the effective date of the termination. The cost principles and procedures provided in A.R.S. § 41-2543 and A.A.C. Title 2, Chapter 7, Article 7, shall apply. A thirty (30) day written notice will be provided by the ADHS prior to termination. ADHS is responsible for requesting testing, so if ADHS sends the contractor’s samples, the contractor shall test them. The State only owns the results.

8.2. Removes Subsection 9.5.2. Upon termination under this paragraph, all goods, Materials, documents, Data, and reports prepared by the Contractor under the Contract shall become the property of and be delivered to the State on demand.

8.3. Clarifies Subsection 9.5.3. Upon termination under this paragraph, all goods, Materials, documents, Data, and reports prepared by the Contractor under the Contract shall become the property of and be delivered to the State on demand. The Contractor shall be liable to the State for any excess costs incurred by the State in procuring Materials or Services in substitution for those due from the Contractor. If the contract was terminated due to default by the contractor the State has the right to seek payment. The liability timeframe is ninety (90) days, or the State has the ability to terminate without cause with ninety days' notice or less. ADHS items sent for testing will be completed or returned. If the contractor does not receive samples, the contractor will not be responsible for any cost incurred by ADHS for testing on samples that go to another laboratory.

OF HEALTH SERVICES

9. This provision clarifies the Offer Preparation in Section Three (3) of the Uniform Instructions to Offerors.

9.1. Clarifies Subsection 3.11. Federal Immigration and Nationality Act. If applicable, by signing of the Offer, the Offeror warrants that both it and all proposed subcontractors are in compliance with federal immigration laws and regulations (FINA) relating to the immigration status of their employees. The State may, at its sole discretion require evidence of compliance during the evaluation process. Should the State request evidence of compliance, the Offeror shall have thirty (30) days from receipt of the request to supply adequate information. Failure to comply with this instruction or failure to supply requested information within the timeframe specified shall result in the Offer not being considered for contract award.

Part ONE (1) Uniform Terms and Conditions

HEALTH SERVICES

Phoenix, AZ 85007

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.

HEALTH SERVICES

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.