Can a Diagnostic Laboratory Be Considered a Healthcare Provider When it Comes to Malpractice Lawsuits?
Learning Objectives and CME/Disclosure Information
This activity is intended for healthcare providers delivering care to women and their families.
After completing this activity, the participant should be better able to:
1. Restate that statute of limitations for medical malpractice lawsuits vary from state to state 2. Recognize that some states allow injured patients time to discover their injuries if not known at the time that the injury occurred
Estimated time to complete activity: 0.25 hours
Susan J. Gross, MD, FRCSC, FACOG, FACMG
President and CEO, The ObG Project
Disclosure of Conflicts of Interest
Postgraduate Institute for Medicine (PIM) requires faculty, planners, and others in control of educational content to disclose all their financial relationships with ineligible companies. All identified conflicts of interest (COI) are thoroughly vetted and mitigated according to PIM policy. PIM is committed to providing its learners with high quality accredited continuing education activities and related materials that promote improvements or quality in healthcare and not a specific proprietary business interest of an ineligible company.
The PIM planners and others have nothing to disclose. The OBG Project planners and others have nothing to disclose.
Faculty: Susan J. Gross, MD, receives consulting fees from Cradle Genomics, and has financial interest in The ObG Project, Inc.
Planners and Managers: The PIM planners and managers, Trace Hutchison, PharmD, Samantha Mattiucci, PharmD, CHCP, Judi Smelker-Mitchek, MBA, MSN, RN, and Jan Schultz, MSN, RN, CHCP have nothing to disclose.
Method of Participation and Request for Credit
Fees for participating and receiving CME credit for this activity are as posted on The ObG Project website. During the period from Aug 27 2018 through Jan 25 2023, participants must read the learning objectives and faculty disclosures and study the educational activity.
If you wish to receive acknowledgment for completing this activity, please complete the post-test and evaluation. Upon registering and successfully completing the post-test with a score of 100% and the activity evaluation, your certificate will be made available immediately.
For Pharmacists: Upon successfully completing the post-test with a score of 100% and the activity evaluation form, transcript information will be sent to the NABP CPE Monitor Service within 4 weeks.
Joint Accreditation Statement
In support of improving patient care, this activity has been planned and implemented by the Postgraduate Institute for Medicine and The ObG Project. Postgraduate Institute for Medicine is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.
Physician Continuing Medical Education
Postgraduate Institute for Medicine designates this enduring material for a maximum of 0.25 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Continuing Nursing Education
The maximum number of hours awarded for this Continuing Nursing Education activity is 0.2 contact hours.
In a 2007 case in South Carolina, plaintiff parents had sued Quest Diagnostics and Athena Diagnostics for wrongful death, alleging a misclassification of an SCN1A mutation in their son as a variant of unknown significance (VUS). Several months after that report, the child had a fatal seizure and died.
South Carolina code defines healthcare providers as “physicians and surgeons; directors, officers, and trustees of hospitals; nurses; oral surgeons; dentists; pharmacists; chiropractors; optometrists; podiatrists; hospitals; nursing homes; or any similar category of licensed health care providers.” The question facing the court was whether the lab is acting as a healthcare provider “when, at the request of a patient’s treating physician, the laboratory performs genetic testing to detect an existing disease or disorder”.
The court answered ‘yes’, meaning that the genetic testing laboratory is functioning as “a licensed healthcare provider” when performing diagnostic testing at the request of a treating physician for the purpose of diagnosis and treatment, which isa core function of hospitals in diagnosing and treating patients. Another section of the South Carolina code states that “an institution providing health care services…for the diagnosis, prevention, treatment, cure, or relief of a health condition, illness, injury, or disease…including, but not limited to, hospitals and . . . diagnostic, laboratory, and imaging centers.” One judge dissented and wrote that the laboratory’s services were too limited and specialized to make it a healthcare provider.
In this case, the report was written in 2007. The plaintiff alleges she did not learn about the 2007 report until 2014 and that is when the timeline begins. If this is a case of negligence, then there is a concept of ‘discovery’, and the clock can start ticking from the time one recognizes an error. On the other hand, Quest asserts that if they are being considered a health care provider, then the timeline must begin in 2007 when the report was issued to the child’s medical geneticist.
The timeline ruling is critical for the plaintiff because the time to file a medical malpractice lawsuit against a licensed healthcare provider in South Carolina is within three years, with the right to sue lost entirely after six years.
This case is being watched closely because the inclusion of laboratories within the broader definition of healthcare providers could have implications in terms of responsibilities and potential liability. There was an important footnote by the judges – one can still sue a healthcare provider for negligence (which includes the ‘discovery’ principle) so this case may not yet be over.
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Disclosure of Unlabeled Use
This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The planners of this activity do not recommend the use of any agent outside of the labeled indications.
The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the planners. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.
Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information
presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.
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