Wednesday, July 24, 2013

Diagnosis of Death-UK Policy


Policy

All members of the UK HealthCare Medical Staff shall follow the established guidelines set forth in this policy in determining death.

Procedure

Ordinary Circumstances

In ordinary circumstances, the signs of death are:

1.     Unresponsiveness of the limbs and face to deep pressure and painful stimuli applied to all four extremities and over the temporomandibular joint and the supraorbital ridge;

2.     Absence of pulse and heartbeat for a minimum of five minutes;

3.     Absence of spontaneous respiratory movement and all other movement; and

4.     Absence of brain stem reflexes.

Brain Death (Death by Neurologic Criteria)

Brain death is defined as the irreversible cessation of all brain and brain stem functions.  Under Kentucky law, death is deemed to occur when these requirements of brain death are met.  See KRS 397.1005.  Brain death has been recently referred to as death by neurologic criteria.  In the absence of gross anatomic brain damage, neuroimaging shall be performed to explain the cause of the patient’s coma.
Certification of brain death or death by neurologic criteria in adult patients shall be attested to and documented by two physicians who have expertise in the clinical determination of brain death, at least one being a member of the active medical staff (attending).  The second physician may be a properly trained member of the medical staff or a licensed physician in his/her 3rd or higher post-graduate year of training in neurology, neurosurgery, emergency medicine, anesthesiology or general surgery or in his/her  1st or higher year of training in a cardiology or pulmonary fellowship.  Certification of brain death or death by neurologic criteria in connection with a pediatric patient (< 15 years old) shall be attested to and documented by two attending physicians who have expertise in the clinical determination of brain death.

Diagnosis  of Death by Neurologic Criteria

The following prerequsites shall be present when diagnosing death by neurologic criteria:

1.     An irreversible and proximate cause of the presumed brain death shall have been established. This should be supported by neuroimaging (MRI or CT scan studies),  or gross anatomical brain damage by physical examination or craniotomy as assessed by a qualified physician, that indicate that the brain is irreparably damaged, extruded, divided, or destroyed.

2.     The patient should be observed for at least four (4) hours following the onset of the brain insult to minimize the possibility of recovery.

3.     In cases of anoxic brain death, in which no significant structural change is evident on radiography,  a 24 hour period of observation and repeat clinical examination are required.  This interval can be shortened to one hour if a nuclear perfusion scan or cerebral angiogram demonstrate absence of circulation to the entire brain.

4.     In patients who have been resuscitated [“return of circulation” (ROC)] by  CPR for cardiopulmonary arrest (followed with or without therapeutic  hypothermia),  the determination of death by neurologic criteria shall be deferred for 24 hours after returning to normothermia in both adult and pediatric patients, unless absence of  brain blood flow is demonstrated by by ancillary testing.

5.     Temperature ≥36oC [≥35oC in children (<15 years)], systemic arterial systolic blood pressure ≥ 100 mm Hg or in children not less than 2 standard deviations below age appropriate norm.

6.     Confounding factors that could mimic “brain death” have been ruled out. Clinical criteria alone may not be used to establish brain death in the presence of: neuromuscular blockade, shock/severe hypotension, significant levels of sedatives and central nervous system depressants in the patient's serum (e.g., barbiturates, benzodiazepines), severe metabolic disturbance (e.g., hyperosmolar coma, hepatic encephalopathy), severe electrolytes disturbances (glucose < 70 or > 300; Sodium < 110 or > 160; Calcium >12) or acid-base imbalance (pH < 7.20). Demonstration of absent brain blood flow on ancillary testing can confirm brain death in the presence of central nervous system depressants if the remainder of the clinical examination supports the diagnosis of brain death.


In addition, currently acceptable clinical criteria for determination of death by neurologic criteria in the presence of cardiac activity and relatively normal blood pressure, whether or not artificial means are used to maintain the circulation of oxygenated blood, require all of the following:

1.Cerebral unconsciousness and motor unresponsiveness to stimuli which are normally intensely painful (i.e., GCS or EMV of 3).  True decerebrate or decorticate posturing or seizures are inconsistent with the diagnosis of brain death.

2.Absence of spontaneous movements for an observation period of at least one hour, except for spinal reflex activity.  Clinical judgment shall be exercised to determine the appropriate observation period based on the circumstances and condition of the individual patient.

3.Absence of reflexes which involve cranial nerves, which includes the following: 

a. The pupils must be fixed at midpoint or larger in diameter and nonreactive to sharp changes in the intensity of incipient light.

b. No ocular responses or eye movements to head turning or irrigation of ear with ice water.

c.Absence of corneal reflexes.

d..No gag, cough, or retching reflex in response to pharyngeal or tracheal stimulation with suction catheter.

4. Apnea. No respiratory movements after the patient is disconnected from the mechanical ventilator and the arterial carbon dioxide level has risen to sufficient  level.   See box below for detail on performance of apnea study.After meeting all of the above criteria for brain death, demonstration of apnea is the final and essential component of the clinical determination of brain death.

Adequate testing for apnea is very important.  An accepted method is:

1.     Ventilation with 100% oxygen and 5 cm PEEP at an appropriate rate (for normal PaCO2) for a 10-minute period

2.     Thereafter, obtain a baseline arterial blood gas.  PaO2 should be > 200, and PaCO2 should be between 35 and 45 without acidosis.

3.     Thereafter, place on a t-piece with 5-10 cm of CPAP and an oxygen flow of 12 L/min.

4.     Observe abdomen and chest for any respiratory activity for 8-10 minutes.

5.     Obtain an arterial blood gas at the termination of the apnea test, then resume ventilation.


Testing of arterial blood gases shall be used to confirm that the PaCO2 is above 60 or 20 mm above the patient’s usual baseline PaCO2.  Any spontaneous breathing efforts indicate that part of the brainstem is functioning and that the patient is not brain dead.

If the systolic pressure falls below 90 mm Hg or the SpO2 falls below 85% the test shall be aborted.  Unless an appropriate rise in PaCO2 has already occurred, the test shall be considered uninterpretable and an ancillary test shall be performed.

Caution should be used in interpreting apnea in patients with high levels of central nervous system depressant drugs, severe neuromuscular disease, high spinal cord injury, or severe COPD with a reduced carbon dioxide drive (carbon dioxide retainers) (“confounding factors”.). If there is doubt, consider performing an ancillary test.   Only one apnea test is required in adults which may be done at the time of either clinical examination. Two apnea tests are required in children, one with each clinical examination.
The above four (4) conditions (clinical criteria for determination of death by neurologic criteria-unconsciousness, absence of movement, absence of reflexes, apnea) must persist unchanged for at least one (1) hour in adults, for 24 hours in full term infants under 31 days of age , and for 12 hours in children 31 days to 14 years of age.

Ancillary Testing to assist with the Determination of Brain Death

An ancillary test is recommended to assist with determination of brain death when the preceding clinical exam (including apnea test) cannot be adequately assessed and documented. 
If any part of the full brain death exam or apnea test cannot be adequately performed or is not tolerated, it shall be documented in the medical record and an ancillary test shall be utilized to support the diagnosis.
Ancillary testing is not a substitute for performing a clinical examination as completely as is possible.
Ancillary testing shall only be performed if the clinical examination is consistent with death by neurologic criteria (“brain death”).  Brain death shall not be determined based on an ancillary test if the clinical examination is not compatible with brain death. 

Prior to performing ancillary testing, the following prerequisites must be present:

1.     An irreversible and proximate cause of brain death has been established

2.     The patients temperature is ≥36oC [≥35oC in children (<15 years)]

3.     The patient’s systemic blood pressure is ≥100 systolic or MAP is ≥ 60 mm Hg or in children systolic BP is not less than 2 standard deviations below age appropriate norm.

4.     The patient has a Glasgow Coma Score (GCS)/EMV of 3.

5.     The patient meets all of the clinical criteria for brain death (listed above) as can be assessed.

The following are indications that ancillary testing should be performed to assist with determination of brain death.

1.     Portions of the complete clinical  examination for brain death cannot be done.

2.     Presence of residual movement or spinal reflexes that are the subject of differing interpretation by clinicians performing the examination.

3.     Apnea test could not be interpreted because of high levels of central nervous system depressant drugs, severe neuromuscular disease or high cervical spine injury or possible chronic carbon dioxide retention (“confounding factors”.)

4.     Apnea test could not be completed because patient developed severe (as defined above) hypoxemia or hypotension

5.     Presence of high dose hypnotic/narcotic drugs (e.g., pentobarbital >10 mcg/mL)

6.     Post cardiac arrest with or without therapeutic hypothermia.

7.     Physician or family discomfort/doubt  with the results of the clinical determination


When ancillary testing is indicated, the preferred  tests to confirm brain death are:

1.     a.Cerebral scintigraphy (nuclear cerebral blood flow scanning) demonstrating no evidence of brain perfusion following the SNM Practice Guidline for Brain Death Scintigraphy 2.0 (Donohoe 2012)

b.Catheter four vessel cerebral angiography with contrast demonstrating absence of circulation to the entire brain.


If the preferred tests cannot be performed, the following is an acceptable test to confirm brain death:

1.     Transcranial Doppler (TCD) demonstrating cerebral circulatory arrest (CCA) in both middle cerebral arteries and the basilic artery as manifested by either oscillating (“reverberating”) flow, or short systolic spikes.

The following test is considered unreliable and thus not recommended to confirm brain death:

1.     EEG

Pediatrics (See Appendix 2).

1.     In cases of patients under 15 years of age, the following criteria shall be followed:

(a)  In full-term (> 37 weeks gestation) patients under the age of 31 days, the first exam may be performed no sooner than 24 hours and two clinical examinations performed 24 hours apart are required.  Each clinical examination shall include an apnea test.

(b)  In patients age 31 days up to 14 years, two clinical examinations performed 12 hours apart are required.  Each clinical examination shall include an apnea test. 

2.     There is a required waiting period of at least 24 hours prior to the initiation of a brain death examination following cardiopulmonary resuscitation or acute hypoxic  brain injury (e.g., drowning, asphyxiation, prolonged respiratory arrest, hanging).

3.     A core temperature of  ≥ 35 degrees Celsius is required.

4.     Both clinical examinations shall be performed by attending physicians

5.     Criteria for determining brain death in premature infants (< 37 weeks gestation) have not been established and therefore such an examination is not permitted prior to 38 weeks gestation

Special Circumstances

Pronouncing Cardio Pulmonary Death

1.     The patient’s physician shall arrive within one hour of cessation of cardio-respiratory activity to pronounce a patient dead. Pronouncement of death may also be made for any patient on the hospice service by a registered nurse or an advanced practice provider who has received training in death pronouncement.

2.     Notification of death shall be provided to Admitting within one hour of pronouncement of death.

3.     The physician who makes the pronouncement of death shall document the pertinent clinical findings in a note which is signed, timed and dated.

4.     Kentucky Revised Statute KRS 446.400 Determination of Death states the minimal conditions to be met for the diagnosis of death. For all legal purposes, the occurrence of human death shall be determined in accordance with the usual and customary standards of medical practice, provided that death shall not be determined to have occurred unless the following minimal conditions have been met:

(a)  When respiration and circulation are not artificially maintained, there is an irreversible cessation of spontaneous respiration and circulation;

(b)  Or, when respiration and circulation are artificially maintained, and there is a total and irreversible cessation of all brain and brain stem functions and that such determination is made by two (2) licensed physicians, experienced in the clinical determination of brain death as described in the section on brain death criteria above.

Pronouncing Brain Death in Cases in Which Artificial Ventilation is Employed

1.     In cases in which artificial ventilation is employed, the fact of death and the presumptive cause of death shall be determined by evidence which, in the opinion of the physicians making the determination, is current, acceptable, and adequate to demonstrate irreversible cessation of cerebral and brain stem function.

(a)  The pronouncement of death in these cases shall be made on the basis of the foregoing criteria by no fewer than two licensed physicians (one of whom shall be an attending who is a member of the active medical staff; the other shall be a member of the medical staff or a licensed physician in her/his 3rd or higher post-graduate year of training), except in the case of children under 15 years in which case, 2 two attending must make the attestation. 

(b)  In the uncommon circumstance of a required ancillary test, the attending physician interpreting the ancillary test may provide information leading to the documentation of brain death but the primary attending of record for the patient at the time of death shall sign the death certificate. 

(c)   The time of death shall be determined by the physicians who attend the patient death or, if none, by the physicians who certify the death.

2.     Before cessation of artificial ventilation, the physician (either an attending or a licensed physician in her/his 3rd or higher post-graduate year of training) will make reasonable efforts to inform the patient’s next of kin, surrogate, or responsible party of the pronouncement of death and that ventilation will be ceased.  If the patient is pregnant, the attending physician will obtain the consent of the guardian ad litem (via UK Healthcare Legal) for the fetus prior to terminating artificial ventilation.