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Informed Consent, Documentation, Resuming Procedures and COVID-19: New Considerations

April 29, 2020

Informed Consent, Documentation, Resuming Procedures and COVID-19: New Considerations
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In order to avoid further harm from underlying time sensitive conditions or diseases, the Louisiana Department of Health (LDH) has permitted the resumption of some non-emergent surgical procedures and in-office care. A challenge presented to healthcare professionals in the vortex of the coronavirus pandemic is the additional risk that the patient will become ill with COVID-19 during treatment, regardless of the source of exposure. Years ago, the Louisiana Legislature provided approved disclosure forms which give presumptive validity to the written informed consent signed by the patient. 

In addition to the usual discussion for informed consent, you may consider addressing the following:

  • The status of the patient as to COVID-19 (asymptomatic, symptomatic, travel)

  • COVID-19 testing (was it done, is it available, is it appropriate to do)

  • Risk of COVID-19 as a hospital-acquired infection and as community spread

  • Alterations in post-op management and discharge instructions/ procedures because of COVID-19

  • Family/visitor restrictions which may be in place at the facility

  • With all these considerations and others, whether the procedure should proceed and the risk of not doing the procedure at this time

LDH has issued directives and an update to healthcare providers in Louisiana concerning medical and surgical procedures. The Louisiana State Board of Medical Examiners (LSBME) has issued guidance on the elective procedure and surgery ban which suggests clearly documenting in the medical record that the procedure or the occasion of healthcare being delivered is necessary and is in compliance with the LDH current directives and LSBME recommendations. Beginning April 27, 2020, healthcare providers are allowed to use their discretion about the necessity of time sensitive care. (“providers use their best judgment within the scope of their license to make the determination … ”). 

Time sensitive conditions, according to LDH, are those surgical, medical or dental procedures in which a delay, in the opinion of the medical/dental professional, might adversely affect the patient or underlying disease process. Preventive procedures and office visits can be deemed time-sensitive if performed with recommended precautions. Time sensitive medical procedures are those in which a delay may cause pain, distress, or further negative outcomes for the patient. LDH is requiring that the record be documented that the condition or procedure is time sensitive. The healthcare professional should also state the reason that the contemplated healthcare should go forward at this time. 

As an example, a patient calling for a new skin lesion with concern for cancer may require evaluation. Documentation of the reasons the medical care is time sensitive must be placed in the chart. Include in your documentation your pre-treatment clinical evaluation as to the patient’s COVID-19 status and instructions about strict social distancing measures from the time of the in-person clinical evaluation. 

In these unusual times, a balance must be struck between what is in the best interest of the patient, and how the care conforms to the current governmental and licensure restricting mandates. Carefully adhere to measures that protect the patient and the healthcare providers. Follow guidelines recommended by the CDC which can be found on the COVID-19 Resource Page of the LAMMICO website. 

This brief article recommends an addition to informed consent and vigilance to comply with the recent governmental and licensure directives. Questions and requests for clarification are encouraged. Please call 800.452.2120 to speak to a LAMMICO attorney or call your defense attorney. 

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