When medical tragedies occur, one of the very first questions asked by patients, families, the legal system, the press, and the public is: "were appropriate care standards met?"
The death of Joan Rivers reminds us that the medical standard of care being applied by the surgical center, anesthesiologist and the gastroenterologist may not be the same. What should the applicable medical standard of care be? How should this be defined?
Although hospitals typically seek accreditation from The Joint Commission, ambulatory centers can receive accreditation from a variety of organizations. For example, The American Association for Accreditation of Ambulatory Surgery Facilities ("AAAASF") accredits ambulatory surgery facilities like the one in which Joan Rivers underwent her medical procedure.
The AAAASF standard of care provides that qualified personnel administer anesthetics provided to the patient:
All anesthetics other than topical or local anesthetic agents are delivered by either an anesthesiologist or by a CRNA (under physician supervision if required by state or federal law or by a policy adopted by the facility), or by an anesthesiology assistant (as certified by the National Commission for the Certification of Anesthesiologist Assistants) under direct supervision of an anesthesiologist. Parenteral sedation, other than propofol, may be administered by a registered nurse under the supervision of a qualified physician.
In addition, the AAAASF standard of care also stipulates the type of monitoring equipment that must be used. AAAASF standards require specific assessment for oxygenation of patients when receiving anesthesia:
Patient monitoring during anesthesia will consist of ... pulse oximetry. [para. 900.030.010 and 900.030.020]
In requiring assessment for oxygenation, AAAASF standards therefore mandate that the patient's oxygenation and circulation be monitored:
Pulse oximeters must be present in both the procedure room and recovery area if both rooms are being used simultaneously. [para. 200.080.040]
Circulation may be monitored by one or several of the following [para. 900.40]:
- Continuous EKG during procedures.
- Arterial blood pressure.
- Heart rate every five (5) minutes (minimum).
- Heart auscultation.
- Temperature should be monitored when clinically significant changes in body temperature are expected.
The American Society of Anesthesiologists ("ASA") also requires trained personnel be present for the delivery of moderate sedation. Trained professional personnel should be credentialed in terms of defined competencies in the application of monitoring as well as ability to intervene if a physiological patient crisis should occur:
Only physicians, dentists or podiatrists who are qualified by education, training and licensure to administer moderate sedation should supervise the administration of moderate sedation. Nonanesthesiologist sedation practitioners may directly supervise patient monitoring and the administration of sedative and analgesic medications by a supervised sedation professional. Alternatively, they may personally perform these functions, with the proviso that the individual monitoring the patient should be distinct from the individual performing the diagnostic or therapeutic procedure
Of significance, the ASA standards differ from that of the AAAASF in a key aspect - all of the physiological parameters specified, and not just "one or several" must be monitored. ASA's Standards for Basic Anesthetic Monitoring provides:
During all anesthetics, the patient's oxygenation, ventilation, circulation and temperature shall be continually evaluated. [Standard II]
Consequently, the ASA like AAAASF requires the use of monitoring equipment to assess the patient's oxygenation:
During all anesthetics, a quantitative method of assessing oxygenation such as pulse oximetry shall be employed. [para. 2.2.2]
However, unlike the AAAASF, ASA standards mandate that the patient's adequacy of ventilation be monitored and provides:
During regional anesthesia (with no sedation) or local anesthesia (with no sedation), the adequacy of ventilation shall be evaluated by continual observation of qualitative clinical signs. During moderate or deep sedation the adequacy of ventilation shall be evaluated by continual observation of qualitative clinical signs and monitoring for the presence of exhaled carbon dioxide unless precluded or invalidated by the nature of the patient, procedure, or equipment. [para. 3.2.4]
How might the use of differing monitoring standards have affected the outcome in the procedure Joan Rivers underwent?
Details of the medical examiner's report on Joan Rivers provides "the cause of Ms. Rivers's death, on Sept. 4, was brain damage caused by low blood oxygen, or 'anoxic encephalopathy due to hypoxic arrest.'" Hypoxia occurs when the body or a region of the body is deprived of adequate oxygen supply. Moreover, the report also provides that the procedure was performed under sedation with proposal.
What is instructive in terms of gained knowledge in the Joan Rivers' death is the differing patient safety measures in place by the application of standards when a sedative is delivered to the patient.
The AAAASF standard would have monitored for oxygenation by pulse oximeter, which measures the amount of oxygen in blood. Measuring oxygenation provides a very late indicator of hypoventilation, or ineffective breathing. In other words, there would have been a delay in the detection of low blood oxygenation by pulse oximeter.
The ASA standards provide an extra level of patient safety by requiring that the adequacy of ventilation be monitored in addition to oxygenation. The ASA standards therefore call for the "continual observation of qualitative clinical signs and monitoring for the presence of exhaled carbon dioxide".
Even in hospitals, however, multiple standards of care may exist. Although anesthesiologists, the recognized experts in providing safe sedation, are required to monitor adequacy of breathing by measuring exhaled carbon dioxide, non-anesthesiologists such as gastroenterologists, surgeons, and radiologists are not required to provide this extra measure of safety. For example, American Society for Gastrointestinal Endoscopy "Guidelines for safety in the gastrointestinal endoscopy unit" does not require monitoring for adequacy of ventilation by Capnography, as required by the ASA.
If you were a lawyer defending an outpatient surgery center like the one in which Joan Rivers died, would you prefer that center have used the AAAASF or the ASA standards?
We know which standard we would choose.
Our loved ones - our patients - deserve the higher level of protection to ensure safe outcomes from medical procedures.