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Defending your care

Presented by: RUSSELL BAYLISS

ACT Government Solicitor June 2014

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Outset

The purpose of this presentation is to describe practices which you should consider following in the circumstances of an expected or unexpected poor birth outcome. These practices will decrease the potential for litigation to arise from those events.

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Birth Claims •  Around seven out of every 1000 babies born will suffer

an injury during the birth process. •  CP litigation most common in US and Australia. •  We are seeing a greater number of birth cases even

though there has been no change in the incidence of cerebral palsy over the past 40 years and despite:

• changes to the practice of obstetrics/midwives –increased C/S rate and better care;

• changes to the training of obstetricians/midwives •  increased use of technology CTGs, foetal scalp

tests, chromosomal studies; • use of risk management processes –

documentation, consent forms, communication.

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Harvard Medical Practice Study of medical records in cases of

alleged negligence In litigation arising from birth cases there was a

high incidence of: •  poor or inadequate notes; •  poor choice of terms; •  poor use of support testing processes (e.g.

cord gases) ; and •  poor communication

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Protocol for the Response to a Sick Newborn

1.  Proactive management of documentation issues 2.  Proactive investigations

•  Pathology: toxicology, thyroid, thrombophilia, placenta •  Two blood gases arterial/venous •  Sequester CTG strips, scans, films etc

3.  Communicate with other birth staff, CNC, neonatologists

4.  Communicate with family 5.  Inform Hospital risk manager

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Documentation Issues •  The medical record is the story of the care provided to the

patient. •  Entries should be contemporaneous, frequent and timed •  Records form the basis for the chronology of the care given •  Use same time piece •  Entries should be objective, legible, discrepancy-free and

unchanged. •  Each note should have a comment concerning fetal wellbeing •  There should be a plan of management – with patient

involvement noted. •  There should be a rationale noted for each intervention. •  A delivery note as detailed as necessary to describe the events;

a more difficult birth requires a more detailed note. •  There should be detailed comment about the cord and the

placenta. •  Document any calls made to on call consultants or others

Relative recollections

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The words you use •  Avoid superlatives “severe haemorrhage” “deep variables”

“blood gases were terrible” “prolonged second stage”

•  Avoid criticism/ resolve disputes before writing up notes

•  Apgar scores should not need to be amended

•  Avoid using BLAME words: »  “ “erroneously” »  “accidentally” »  “inadvertently”

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Foetal Distress Perinatal asphyxia

Birth trauma Intrapartum Asphyxia

Birth injury HIE

•  These terms should not be used based on the non-specific findings of:

» Meconium presence or staining » Abnormal foetal heart rate » Low Apgar scores » Neonatal encephalopathy » Individually or combined they can have a

significant false positive rate

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Documentation Issues

•  It is important to ensure that any CTGs are saved (and copied, because they tend to fade). MRI’s and CT Scans should also be copied and saved.

•  What is the time to which your CTG is set?

•  Pathology results can become separated from the clinical notes

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Documentation Issues

Instrumental deliveries should include the following in the written or dictated note:

–  Evidence of a consent discussion

–  Type of vacuum or forceps –  Station when applied,

verification of position –  Application site - verification

of application

–  # Pulls, # Contractions, # Pop offs with vacuum

–  Comment of descent with traction

–  Pressure: amount and whether decreased between contractions with vacuum

–  Total length of time of application

–  Markings on face, condition of scalp.

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Altering Medical Records after the event

•  Still happens •  It’s a crime (similar to perjury) •  Sophisticated ways to detect:

– Paper analysis (watermarks, laser pressure analysis)

–  Ink analysis – Comparing original to other distributed records

Investigations – cord blood and gases •  Routine for any baby born flat, depressed

or requiring admission to CNC/NICU

•  Arterial cord gases and lactate: measure of acid base status at point of cord cutting – do within 60 minutes.

•  Venous gases and lactate: helps confirm that the arterial was taken from the right vessel and fends off hired guns who try to explain normal cord pH by suggesting it was taken from the wrong vessel.

•  The blood gas parameters of interest are the pH value, which reflects total body acid status, the pCO2 value which reflects the respiratory acid status, and the Base excess which is a proxy for the body's metabolic acid status, which, in the context of perinatal asphyxia reflects a lactic acidosis, itself reflecting recent hypoxia-ischaemia and reliance on anaerobic

metabolism. •  Most blood gas machines now actually

provide a measured lactate and this is really the key measure as it is a direct measurement of the severity of a recent hypoxic-ischemic event.

•  Lactate levels > 10 mmol/L are of concern.

•  The value of taking both umbilical venous and arterial specimens is that marked differences between the two are consistent with an episode of cord occ lus ion , wh ich may he lp i n understanding the process of injury.

•  Cord blood glucose may also be of interest with low levels being perhaps a concern - this is new stuff.

Investigations - blood

•  Early Full blood count: Nucleated red cells (often called normoblasts on the lab report) are immature red cells and a high count suggest hypoxia evolving over a longer period of time. Low platelets are also a marker of prolonged hypoxic stress, probably suggesting more advanced process than just raised NRBCs.

•  With prolonged fetal hypoxic stress (of at least several days duration), the foetus responds by producing as many red blood cells as possible in order to increase blood oxygen content; in the foetus, this can result in the release of very primitive red cells (nucleated red blood cells - NRBC) into the fetal circulation, with the number reflecting the severity and duration of the hypoxic stress.

•  Early Blood coagulations studies: particularly if platelets low. Can point to a d i s s e m i n a t e d i n t r a v a s c u l a r coagulation, again a marker of a pretty advanced and prolonged intra-uterine process.

•  Day 1 Urine for blood: Marker of kidney injury.

•  No much point in keeping cord blood but other blood may need to be stored for DNA testing if a genetic condition is suspected.

•  An early complete blood picture to look for evidence of anaemia, infection etc, but particularly to look for evidence of prolonged fetal hypoxic stress - this relates to the nucleated red cell count and the platelet count.

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Investigations – blood (continued) •  The nucleated red cell count is

typically expressed as the number of NRBC per 100 white cells on a blood film. The normal is < 10, with high levels (even into the hundreds) suggesting pre-existing (i.e.: pre-labour) hypoxic-stress (though not necessarily injury).

•  A low platelet count is related to this phenomenon; in simple terms it is felt that when the fetal bone marrow is driven to produce extra red blood cells, other aspects of marrow function are suppressed with this suppression resulting in low platelet counts - typically what one sees is a lowish level at birth (60-80,000) which may drop over the first few days and then recover.

•  As with the high NRBC count this suggests longstanding fetal hypoxic stress (i.e. well before labour) release of very primitive red cells (nucleated red blood cells NRBC) into the fetal circulation, with the number reflecting the severity and duration of the hypoxic stress. The nucleated red cell count is typically expressed as the number of NRBC per 100 white cells on a blood film. The normal is < 10, with high levels ( e v e n i n t o t h e h u n d r e d s ) suggesting pre-existing (i.e: pre-labour) hypoxic-stress (though not necessarily injury).

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Investigations - placenta

LMNOP assessment •  Look at the placenta •  Measure the cord •  Note in the chart •  Obtain pathology •  Polaroid/digital camera •  Placenta should always be sent for pathology. Ideally the placenta

should be reviewed by a perinatal pathologist. •  Particular interest being the presence of chorioamnionitis (a strong

predictor of injury, with inflammation felt to augment or amplify hypoxic-ischaemic injury), or fetal thormobotic vasculopathy (clots within the veins on the fetal side of the placenta, a risk factor for fetal stroke) or various other placental pathologies which are known to affect placental function.

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Investigations – genetic and imaging

•  Metabolic/genetic testing: 11% of babies born flat and who have had MRI investigation had major brain malformations.

•  Brain activity monitoring with some form of integrated EEG monitor. This monitors severity of neural depression and timing of seizures, which may be of help with timing.

•  Neuroimaging - most centres do an MRI scan at around 7 days to document the extent of any injury, though with respect to timing, a study on day 1 may be of interest, particularly if there is a suggestion that the injury may have occurred in the days preceding birth. This is because

brain swelling after an injury is usually not obvious until beyond 24 hours (or longer) so the presence of established swelling on a day 1 scan would argue against an intrapartum episode of injury. This argument has surfaced in a number of cases, particularly when there is evidence of ante partum stress (i.e. high NRBC count, abnormal coags etc). A high quality cranial ultra sound study on day 1 could probably also help to identify or exclude early oedema (swelling).

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Investigations - other

•  Early Liver enzymes: Aspartate transaminase (AST) and alanine transaminase (ALT) are released from hypoxia damaged liver cells

•  Cardiac Troponin T: Is released from hypoxic damaged cardiac muscle cells.

•  Serial creatinine: marker of kidney injury if continues to rise. Often normally high on early testing but usually falls. If continues to rise suggest liver injury.

•  Tests for evidence of co-lateral organ injury - serial tests over the first few days to monitor for renal (creatinine), liver (liver enzymes) and heart (troponin) injury/dysfunction. Included with these tests would be coagulation studies, which, in the context, are really just a test of liver function (because the liver produces most of the clotting factors), with abnormal coagulation studies suggesting longer standing stress (provided there is no trauma/bleeding associated with the delivery).

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Communication with other Professionals

•  Nurses

•  Obstetrician – should check in daily with neonatologist: clarify information etc: follow the baby into the NICU tell the Neonatologist what happened and when, rather than having them surmise from the notes .

•  Paediatricians

•  Neonatologists

•  Paediatric Neurologists

•  Paediatric Neuroradiologists

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Poor Communication Leads To This

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Communicate with Family/Patients

•  Who should do this? The most senior clinician in charge of care. Do it with support not alone

•  Part of your skill set and ethical practice •  Explanation is important in our society •  Geared to help the patient and family through the crisis •  Removes suspicion factor •  An apology is not an admission of liability ( Civil Law Wrongs Act

(2002) ACT – section 14 , Civil Liability Act (2002 ) NSW -section 69(2), Wrongs Act (1958 ) VIC - section 14J, Civil Liability Act (2003) QLD, Civil Liability Act ( 1936 )SA - section 75)