Medical Negligence. Standard of Care 2/25/2014. Medico Legal Risk Reduction in Obstetrics

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1 Medico Legal Risk Reduction in Obstetrics James E. Looper, Jr. Hall Booth Smith, PC Medical Negligence To prevail on a medical-malpractice claim, a plaintiff must prove: 1) the appropriate standard of care, 2) the doctor s deviation from that standard, and 3) a proximate causal connection between the doctor s act or omission constituting the breach and the injury sustained by the plaintiff. Breland v. Rich, 69 So. 3d 803 (Ala. 2011) (quoting Pruitt v. Zeigler, 590 So. 2d 236, 238 (Ala. 1991) Standard of Care In performing professional services for a patient, a physician s, surgeon s, or dentist s duty to the patient shall be to exercise such reasonable care, diligence and skill as physicians, surgeons, and dentists in the same general neighborhood,, and in the same general line of practice, ordinarily have and exercise in a like case. In the case of a hospital rendering services to a patient, the hospital must use that degree of care, skill, and diligence used by hospitals generally in the community. Code of Ala (a) 1

2 Causation To prove causation in a medical negligence case, the plaintiff must demonstrate that the alleged negligence probably caused, rather than only possibly caused, the plaintiff s injury. Lyons v. Vaughan Reg l Med. Ctr., LLC, 23 So. 3d 23, (Ala. 2009) Compensatory Damages Those damages which make the plaintiff whole In any civil action based upon tort and any action for personal injury the damages assessed by the factfinder shall be itemized as follows: (1) past damages, (2) future damages, (3) punitive damages. Code of Ala Shoulder Dystocia Cases Risk Factors for Shoulder Dystocia Prior shoulder dystocia Maternal obesity Maternal diabetes Excessive weight gain in mother Prolonged deceleration phase Prolonged 2 nd stage of labor Fetal birth weight > 4000 grams 2

3 Shoulder Dystocia Protocol An overt and unequivocal announcement by the obstetrician or midwife when a shoulder dystocia is recognized, A simplified approach to summoning additional personnel (i.e. nurses, additional attending obstetrician, anesthesiologist, pediatrician, and obstetric residents) to the shoulder dystocia through both overhead notification and a paging tree, The declaration of duration since delivery of the fetal head at 30- second intervals The establishment of role clarity for different providers at the shoulder dystocia, and A structured documentation tool that was available in every room Grobman WA et al, AJOG 2011 : *One Suggested Method* PRENATAL RISK Q: Isn t it true that such things as obesity, excessive weight gain, diabetes, large fundal heights are risk factors for shoulder dystocia? A: Those are considered to increase the chance of shoulder dystocia. 3

4 BEST APPROACH Q: Isn t it true that such things as obesity, excessive weight gain, diabetes, large fundal heights are risk factors for shoulder dystocia? A: Not without evidence that the baby has become macrosomic, no. In general those factors only increase the incidence of macrosomia not shoulder dystocia, which is not predictable even in situations where you have a macrosomic baby. PRENATAL ISSUES Common thread is macrosomia, not obesity, excessive weigh gain, diabetes, etc. see Williams textbook. Increased incidence of shoulder dystocia with macrosomia is still such a small % that it is not of useful clinical value, nor does it make shoulder dystocia predictable it is a rare event See Acog Practice Bulletin #40 STANDARD OF CARE Definition of Macrosomia is Irrelevant!!! Offer C section if: Diabetic and EFW greater than 4500gms Diabetic and EFW greater than 4500gms Non Diabetic and EFW greater than 5000gms Acog Bulletins all 4

5 LABOR CURVE Q: Isn t it true that a protracted labor, protracted 1st stage, or a slow second stage is consistent with an increased risk of shoulder dystocia? A: Those have historically been related to shoulder dystocia. BEST ANSWER Q: Isn t it true that a protracted labor, protracted 1st stage, or a slow second stage is consistent with an increased risk of shoulder dystocia? A: The labor curve does not assist in predicting or warning the physician that shoulder dystocia might occur there is no reliable correlation. LABOR CURVE No part of the labor curve, 1st or 2nd stage, assists in predicting shoulder dystocia event if the curve is prolonged. It may assist in predicting CPD but not shoulder dystocia. See Acog Dystocia bulletin #40 and Lurie et al., AMJofPerin., 1995:12: page 61 Watch old studies that use association Increased incidence doesn t prove predictability Increase of 1 in 10,000 to 5 in 10,000 makes the incidence 5X but is still useless clinical information 5

6 Maneuvers/Excessive Force Q: Isn t it true that when performing the delivery maneuvers, the doctor should only use gentle traction and avoid excessive downward lateral traction? A: That s what ti did. We only use gentle traction ti excessive traction is avoided. Q: I am correct then, that the standard of care would be violated if excessive force is used. A: I agree with that. BEST ANSWER Q: Isn t it true that when performing the delivery maneuvers, the doctor should only use gentle traction and avoid excessive downward lateral traction? A: We do what htis reasonable and necessary to maneuver and get the baby delivered to avoid death or brain damage. This action is reasonable and necessary, not excessive. We are mindful to try to avoid injury if possible, but it is paramount that we avoid death or brain damage. MANEUVER/FORCE TIPS Each maneuver has similar % of complications some babies are too big Can t say a different maneuver would have made a difference even if done Never downplay the severity of the dystocia witness should describe it as a significant impaction Some force is always necessary, stuck babies won t just drop out witness must describe force as reasonable and necessary in the doctor s judgment to get the baby delivered 6

7 ALTERNATIVE CAUSATION Prep witness as to inutero events: Malpositioning can cause B.P. Impairment see surgical position and nerve injury cases from only a few hours of compression or stretch Expulsive Forces (contraction plus push) are enormous forces can break bones in baby: Turtle sign is evidence of a stretch of shoulder to head event! Compression of nerve between clavicle and humeral head occurs in surgery cases therefore baby is exposed to compression of nerve against pubic bone and then stretched as turtle sign event occurs (see Gonik article) ALTERNATIVE CAUSATION Do not admit that the delivery process was the cause If no evidence that the baby has bruises on head/neck etc., take the position that the impairment existed before hands on of the physician If adjunct impairment (facial palsy, etc.) this more likely fits inutero event per Gherman and Jennet (pressure event inutero pushing on a bone UNDERSTANDING FHR MONITORING COMMON ALLEGATIONS Failure to accurately assess maternal and fetal status. Failure to recognize a deteriorating fetal condition. Failure to appropriately treat nonreassuring FHR pattern. Failure to communicate to the physician / midwife changes in maternal or fetal status. Failure of the physician / midwife to respond appropriately to nonreassuring FHR patterns. Failure to follow the chain of command. 7

8 Fetal Heart Monitoring Strips Evaluation of strips in order to determine: Baseline heart rate Variability Periodic changes Non-periodic changes Fetal Heart Tracings Witness Preparation *One Suggested Method* What is non reassuring? There are only two consensus patterns that are nonreassuring: 1. Severe repetitive variable decels with no variability; 2. Repetitive Late Lt decelswith no variability (NIH Consensus 1997, AMJOBGYN, VOL., 177, # AT 1389) 8

9 Two Ominous Patterns: Lates/No Variability Freeman 3rd, p71 Variables/No Variability Freeman 3rd, p76 What is non reassuring? Everything else has reassurance because it does not fit the consensus pattern consistent with metabolic acidosis!! Absence of an ominous pattern is a good thing. Remember the progression to pathological acidemia: Normal O2 Decreased O2 but cells OK Actual Hypoxia decreased delivery to the cells but well compensated Anaerobic Metabolism and Metabolic acidemia Damage 9

10 Pathway to Metabolic Acidosis p. 111 of Freeman 3rd Keys to Remember about FHT Testimony Acute hypoxia in labor must start with a pattern of decels/brady anything else is not acute hypoxia (Freeman 3rd, p111) Hypoxic patterns occur in many labors, is a normally expected event, but is not a reason to expedite delivery (Freeman 3rd, p110) Only when the pattern progresses to metabolic acidosis (no accels, no variability) is delivery expedited (Freeman 3rd, p110) Common Mistakes to Avoid: Identifying lesser patterns as possibly consistent with hypoxia or non reassuring Forgetting that acute hypoxia must start with persistent decels/brady Declaring that tachycardia, decreases in variability, or non repetitive patterns could be consistent with hypoxia Forgetting that intervention is not required with the appearance of occasional hypoxic decels, but is required only when metabolic acidosis appears possible 10

11 Patterns that are Not Significant, Acute Hypoxia, but are often identified as Such: Tachycardia without preceding, persistent decels Episodes of lesser variability without concomitant ominous decels Decels that are not persistent, and not accompanied by loss of accels and loss of variability Flatliner on entry to Hospital chronic, not acute brain has already made a change CATEGORIES OF FETAL HEART RATE TRACINGS Category I (Normal) Tracing CATEGORIES OF FETAL HEART RATE TRACINGS Category II (Indeterminate) Tracings 11

12 CATEGORIES OF FETAL HEART RATE TRACINGS Category III (Abnormal) Tracings LEGAL WORD v MEDICAL WORD Patient Relationships 3 Functions of the medical provider: Gathering information Developing and maintaining a therapeutic relationship Communicating information Importance in establishing relationship with patient in order to get complete medical history to provide better overall care Mutual trust 12

13 Patient Relationships Informed Consent Duty to disclose to patient all known risks or dangers inherent in the treatment that has been proposed so that the patient will be in a position to make an intelligent decision as to whether to undergo the proposed treatment. Documentation Documentation vitally important to informed consent process forms allow for patient signature and show patient is aware and consents to all procedures and treatments being performed. Health Information Management The advent of medical record documentation began in the 1920 s as a basis for improvement of healthcare The progression to electronic health records (EHR) has allowed for ease of access to health information by healthcare providers The Government s Centers for Medicare and Medicaid (CMS) stated that electronic health records allow: providers to make better decisions and provide better care reduce incidence of medical error by improving the accuracy and clarity of medical records. the health information to be readily available, reducing duplication of tests, reducing delays in treatment, and patients to be well informed to take better decisions. Risk Management Prevention is the best defense Know what to avoid and how Documentation Failure to Chart Incomplete Documentation Charting before doing Doing and then charting later 13

14 Issues with Electronic Health Records Most EHR have time saver features which allow for ease of use by the medical provider these features include the check box option, which self-populates the record with the patient s pre-entered information. Some medical records allow for an entire patient assessment to be carried forward simply by selecting a check box. Providers must be careful that what is being checked off in the medical records has actually been done, i.e. each visit note is tailored to the actual visit performed. Particularly in scenarios where a review of systems may not include the chief complaint, or where review of systems does not change from visit to visit Issues with Electronic Health Records Risks of inconsistent documentation Information that is populated retrospectively must be consistently checked for accuracy Example: If electronic medical record defaults to include a statement such as, patient presents without pain, but the narrative portion of the record states patient c/o severe pain, there are internal inconsistencies which could hinder patient care, as well as payment by the insurer 1 1 Compliance in the Age of Electronic Medical Records by Ranjan Sachdev, M.D., Abby Pendleton, Esq. and Jessica L. Gustafson, Esq. Defending Claims Through Documentation Clear documentation of findings associated with causation events 14

15 Neonatal Assessment and Documentation Clinical signs in the delivery room of a depressed infant should prompt immediate effort to gather and document information to understand the etiology 1 Examination of the placenta, membranes & umbilical cord Samples of umbilical artery blood for ph and base deficit Culture between the membranes, after splitting the amnion from the chorion Close review of the maternal and family history Newborn blood cultures and C-reactive protein Evaluation for maternal and fetal thrombophilia 1 Neonatal Encephalopathy and Cerebral Palsy: Defining the Pathogenesis and Pathophysiology ACOG Task Force on Neonatal Encephalopathy Umbilical Cord Prolapse Blood Gas Arterial/venous ph of 7 or greater Placental Pathology Chorioamnionitis? Meconium? Physician/Nurse Interaction Necessary to timely respond to calls from nurses Nurses are the first avenue to the patient importance in maintaining open relationship with nursing staff 15