Phone: 302.658.4265
Delaware Health Law Blog

Delaware Facilities that Perform Invasive Medical Procedures: Prepare for Enforcement

Back in February, the Delaware Department of Health and Social Services published a final rule setting forth standards for never before regulated Delaware health care facilities: medical and dental offices.

Pain management physicians, podiatrists, and dentists that perform “invasive medical procedures” in their respective offices are now required to comply with new patient care, medical record, infection control, patient rights, and physical/environmental standards never before applicable to medical or dental offices. Many Delaware providers may not realize that these regulations could apply to their practices.

An “invasive medical procedure” is defined as any medical procedure, including dental or podiatric procedures, in which the accepted standard of care requires anesthesia, major conduction anesthesia or sedation. As you can see, whether the procedure is actually “invasive” does not factor into the meaning of the term at all. For example, manipulation under anesthesia is not “invasive” in any sense, but the standard of care does require anesthesia.  Finally, “anesthesia” is defined broadly to include anxiolysis, conscious sedation, deep sedation, major conduction anesthesia, minimal sedation, moderate sedation or general anesthesia. The definition of “anesthesia” explicitly excludes (1) local anesthesia, (2) the administration of less than 50% nitrous oxide in oxygen with no sedative or analgesic medications by any route, or (3) a single, oral sedative or analgesic medication administration in doses appropriate for the unsupervised treatment of insomnia, anxiety, or pain.

One of the more strenuous requirements for these offices is accreditation. The regulations, per statutory direction, require any medical or dental office where invasive medical procedures are performed to be accredited by one of five different accrediting organizations.  The accreditation process can be lengthy and can pose considerable costs.  One accreditation organization that has been contacted reported that the minimum survey fee is roughly $4,300, with an application fee of $775. This of course does not take into account the costs on a medical or dental practice for the staff time and effort necessary to help complete the accreditation process. One accreditation organization reported that the accreditation process can take 4-6 months from the submission of an application.

More problematic, however, is that accreditation organizations are not simply certifying Delaware facilities’ compliance with the Delaware regulations; they impose their own requirements.  For example, one accreditation organization requires a facility to have a governing body that is fully and legally responsible for the performance of the organization, which must satisfy a long list of specific governance requirements. One such governance requirement is to establish a system of financial management and accountability and formulate long-range plans in accordance with the goals of the organization. Other requirements govern the actual administration of the organization. Many of the additional requirements not contemplated by Delaware law are entirely foreign to small medical and dental practices that are not accustomed to being treated like larger, formalized entities.

What is clear from correspondence with the Delaware Office of Health Facilities Licensing and Certification is that the standards, including accreditation, are ready to be enforced. There are formalized complaint procedures contained in the regulations, and facilities are subject to sanctions, up to an order of closure or order to cease invasive medical procedures, for violations of the regulations.

All such facilities in operation as of July 5, 2011 were required to submit proof of accreditation or the application for accreditation by August 14, 2014. The deadline has passed, so immediate steps must be taken to achieve compliance.  As for facilities that become operational after July 5, 2011, proof of accreditation must be submitted within 12 months of the first day of operation. Compliance with the remaining requirements of the regulations must be achieved immediately.

  • Navigating Delaware's Legal Landscape