Healthcare Clinical Lab Agreement

HEALTHCARE CLINICAL LAB AGREEMENT

This Clinical Laboratory Services Agreement (the "Agreement") is entered into by and between Laboratory Name: (the "Laboratory") and Ordering Facility / Provider: (the "Provider"). Effective Date:

RECITALS

WHEREAS, Laboratory is qualified and holds necessary certifications, permits and accreditations to perform clinical laboratory testing in accordance with applicable federal and state law, including but not limited to applicable clinical laboratory regulations; and

WHEREAS, Provider desires to submit patient specimens to Laboratory for diagnostic testing under the terms set forth herein.

SCOPE OF SERVICES

Laboratory shall perform clinical laboratory testing services for specimens submitted by Provider in accordance with Laboratory's standard operating procedures. Services include testing, quality control, reporting of results, and maintenance of test records. The specific tests and methods to be performed are those described in Laboratory's test menu and fee schedule, which may be amended by Laboratory upon prior written notice to Provider.

ORDERING, SPECIMEN SUBMISSION AND REQUISITION

Provider shall submit specimens accompanied by a completed laboratory requisition or electronic order that contains sufficient patient identification and clinical information. Patient information must include Full Name, Date of Birth and unique identifier. Provider attests that patient consent and authorization for testing and release of protected health information have been obtained as required by law.

PATIENT REQUISITION (SAMPLE SUBMISSION)

LABORATORY RESPONSIBILITIES

Laboratory warrants that it will perform testing in accordance with accepted laboratory standards and applicable regulations. Laboratory shall maintain appropriate licenses, certifications, and accreditations; perform quality control and proficiency testing; and retain test records for the period required by law. Laboratory will notify Provider of test method changes that materially affect test performance.

TURNAROUND TIMES, REPORTING AND REPORT DELIVERY

Laboratory will use commercially reasonable efforts to meet published turnaround times for tests. Laboratory shall report results to Provider via the agreed delivery method and shall include relevant interpretive comments, units and reference ranges. Emergency or STAT testing may be subject to additional fees and must be indicated at time of order.

SPECIMEN HANDLING, REJECTION AND CORRECTION

Provider shall label, package, and transport specimens in accordance with Laboratory's specimen collection and transport requirements. Laboratory reserves the right to reject specimens that are improperly labeled, stored, transported, or otherwise unsuitable. Rejected specimens will be disposed of or returned according to Laboratory policy and applicable law. Laboratory will notify Provider of a rejected specimen and recommended corrective action.

FEES, BILLING AND PAYMENT

Provider shall be responsible for all fees for services performed by Laboratory. Laboratory will bill Provider and/or third-party payers as agreed. Provider remains responsible for payment for services not reimbursed by third-party payers. Fees are set forth in Laboratory's fee schedule; Laboratory may amend fees upon thirty (30) days' prior written notice to Provider. Payment terms: net thirty (30) days from invoice date unless otherwise agreed in writing.

COMPLIANCE, CONFIDENTIALITY AND HIPAA

Each party shall comply with applicable federal and state laws and regulations, including but not limited to privacy and security requirements for protected health information. Laboratory acknowledges its obligations as a business associate when applicable and shall implement administrative, physical and technical safeguards to protect PHI. Laboratory will use PHI only for purposes of performing services under this Agreement and will not disclose PHI except as permitted by law.

INDEMNIFICATION AND LIABILITY

Each party shall indemnify, defend and hold harmless the other party from and against claims arising out of its negligence or willful misconduct in connection with this Agreement. Laboratory's aggregate liability for claims arising from Laboratory's performance shall be limited to direct damages not to exceed the total fees paid by Provider to Laboratory under this Agreement for the six (6) months preceding the claim. Neither party shall be liable for consequential, incidental, punitive or special damages.

RECORDS, OWNERSHIP AND RETENTION

Laboratory shall retain test records, quality control records and other documentation as required by law. Patient records and original medical records remain the property of Provider or the patient as required by law. Upon termination of this Agreement, Laboratory shall, at Provider's direction, return or transfer patient records in accordance with applicable law and reasonable costs.

TERM, TERMINATION AND TRANSITION

This Agreement shall commence on the Effective Date and continue for an initial term of unless earlier terminated as provided herein. Either party may terminate for material breach if the breach is not cured within thirty (30) days after written notice, or immediately for regulatory noncompliance or loss of required licensure.

NOTICES

All notices required or permitted under this Agreement shall be in writing and delivered to the addresses designated below. Notices are effective upon receipt.

MISCELLANEOUS

This Agreement constitutes the entire agreement between the parties with respect to the subject matter hereof and supersedes all prior agreements. Any amendment must be in writing and signed by authorized representatives of both parties. This Agreement shall be governed by the laws of the state specified below, without regard to conflict of law rules.

AUTHORIZATION AND PATIENT CONSENT ACKNOWLEDGMENT

Provider represents that it has obtained all necessary consents and authorizations from patients for the Laboratory to perform testing and to receive and disclose patient information as required for the provision of services. Provider authorizes Laboratory to bill payors in accordance with billing instructions provided by Provider.

The parties acknowledge that this Agreement may require exchange of Protected Health Information and agree to take reasonable steps to limit such exchange to the minimum necessary to perform duties under this Agreement.

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