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3. PR-00-10

What the form is

The PR 00 10 Diagnostic Testing Laboratories Professional Liability Coverage Form is an insurance policy form developed by the Insurance Services Office (ISO) that provides professional liability coverage on a claims-made basis. This means the policy covers claims first made against the insured during the policy period or any applicable extended reporting period, provided the wrongful act occurred on or after the retroactive date stated in the declarations and before the end of the policy period. The form is designed to protect diagnostic testing laboratories from financial loss due to legal liability for damages arising out of their professional services. It covers the costs to defend against such claims and any settlements or judgments.

Classes of business it applies to

This form is specifically designed for diagnostic testing laboratories. This includes facilities that perform various medical tests on specimens from the human body to diagnose, prevent, or treat disease or assess health. Examples include:

• Clinical pathology laboratories
• Medical diagnostic imaging centers (e.g., X-ray, MRI, CT scan facilities)
• Genetic testing laboratories
• Independent medical laboratories

For instance, if a diagnostic lab misinterprets a patient's blood test results, leading to a delayed or incorrect diagnosis and subsequent harm to the patient, this policy would respond to the resulting professional liability claim.

Special considerations

• Claims-Made Basis: It's crucial for insureds to understand the implications of a claims-made policy, particularly the importance of the retroactive date and the need for an extended reporting period (tail coverage) if the policy is canceled, non-renewed, or replaced with a policy that has a later retroactive date or is not claims-made.
• Retroactive Date: The policy will not cover incidents that occurred before the retroactive date shown on the declarations.
• Extended Reporting Period (ERP): The form contains provisions for an ERP, which the insured has the right to purchase under specific circumstances, such as policy cancellation or non-renewal.
• Notice of Claim: The insured must notify the insurance company as soon as practicable of any circumstance that may result in a claim. A claim is considered first made when the insured receives notice and reports it in writing to the insurer, or when the insurer receives direct written notice of the claim.
• Nonrenewal: The policy contains a nonrenewal condition typically requiring a thirty-day notice with proof of mailing.
• Stand-Alone Policy: If written as a stand-alone policy, Common Policy Conditions (like IL DS 00) or other amendatory forms must be included to explain policy terms.

Key information for agents and underwriters

• Risk Assessment: Underwriters should carefully evaluate the types of diagnostic tests performed, the qualifications and experience of laboratory personnel, quality control procedures, and historical claims data. The potential for errors in sample handling, testing procedures, or result interpretation are key risk factors.
• Limits of Liability: The policy will have specific limits of liability, which may include an aggregate limit for all claims during the policy period and a per-claim limit. It's important to ensure these limits are adequate for the laboratory's exposure.
• Exclusions: Like all insurance policies, this form will contain exclusions. Common exclusions in professional liability policies might include criminal acts, contractual liability (unless specifically assumed under an insured contract), and employment-related practices. The form excludes injury caused by war.
• Related Endorsements: Various endorsements can modify the coverage. For example, PR 04 00 Products Liability Coverage for Diagnostic Testing Laboratories can extend the definition of a laboratory incident to include the sale of certain therapeutic agents. PR 21 01 Exclusion–Employees as Insureds can be used to remove employees as insureds.
• Coverage Territory: Coverage typically applies to incidents occurring and claims made within the United States, its territories and possessions, Puerto Rico, and Canada. Worldwide coverage may apply under specific circumstances related to the insured's responsibility to pay.