1. Forms
2. PR
3. PR-00-09

What the form is

The PR 00 09 Diagnostic Testing Laboratories Professional Liability Coverage Form is an insurance policy form that provides coverage for liability arising from the professional services rendered by a diagnostic testing laboratory. It is designed to address claims related to a "laboratory incident," which generally involves a breach of professional care in the context of diagnostic testing. This form provides coverage on an occurrence basis, meaning it covers incidents that occur during the policy period, regardless of when the claim is reported (subject to statutory limitations).

Classes of business it applies to

This form is specifically designed for businesses operating as diagnostic testing laboratories or facilities. This includes, but is not limited to:

• Medical laboratories performing tests on human specimens to diagnose, prevent, or treat disease (e.g., blood analysis labs, pathology labs).
• Imaging centers that conduct diagnostic tests such as X-rays, MRIs, or CT scans for diagnostic purposes.

For example, if a lab incorrectly analyzes a blood sample leading to a misdiagnosis and subsequent harm to the patient, this form would be triggered to cover the lab's liability.

Special considerations

There are important distinctions and limitations to consider with this form:

• Diagnostic vs. Therapeutic: The PR 00 09 form specifically covers diagnostic activities (identifying a disease or illness). It explicitly excludes liability arising from any therapeutic treatment rendered by or at the direction of the insured. If a facility provides both diagnostic and therapeutic services, additional coverage would be necessary for the therapeutic exposures.
• Acts as a Doctor of Medicine: The form also excludes liability arising from an insured's acts or omissions as a doctor of medicine. If an insured is a doctor who also runs a diagnostic lab, they would likely need separate coverage, such as the PR 00 01 (Physicians, Surgeons and Dentists Professional Liability Coverage Form), for their professional medical acts.
• Claims-Made Alternative: While PR 00 09 is an occurrence form, ISO also offers a claims-made version for diagnostic testing laboratories, which is form PR 00 10.

Key information for agents and underwriters

Agents and underwriters should be aware of the following when dealing with the PR 00 09 form:

• Scope of Coverage: The definition of "laboratory incident" is crucial in determining the scope of coverage. It pertains to the taking of diagnostic tests and the subsequent reporting or reliance upon the results.
• Exclusions: While many exclusions are similar to those found in other professional liability forms like PR 00 03, the PR 00 09 has specific exclusions for therapeutic treatment and acts as a doctor of medicine. It notably does not contain an antitrust law exclusion or an auto exclusion found in some other professional liability forms.
• Comparison with Other Forms: It's important to compare this form with other related forms. For instance, PR 00 09 shares the same supplementary payments, "who is an insured" clauses, limits of insurance clauses, and conditions as the PR 00 03 form. However, definitions may vary; for example, PR 00 09 does not define "ambulance" or "auto" but does define "laboratory incident".
• Risk Assessment: Underwriters should carefully assess the nature of the laboratory's operations, the types of tests performed, the qualifications of staff, and quality control procedures. The potential for errors in sample handling, testing procedures, or result interpretation are key risk factors.
• Other Insurance: The form states that if other valid and collectible insurance is available for a loss covered by this form, this coverage is primary.