Formulate stringent guidelines to regulate Antenatal USG protocols: NCDRC directs NMC upholding Medical Negligence of doctor

New Delhi: The National Consumer Disputes Redressal Commission (NCDRC) has recently asked the National Medical Commission (NMC) for formulating stringent guidelines for regulating Antenatal USG protocols, especially TIFFA Scan, to avoid litigations on related matters.

Apart from this, the Apex consumer court has also told NMC to ensure that TIFFA Scan (level-II scan), should be done by the Specialist like qualified Radiologist or Fetal Medicine Expert.

Such directions were issued by the top consumer court as it upheld the order of the Haryana State Consumer Court, which had held a doctor guilty for medical negligence for being unable to detect congenital anomaly during the pregnancy of the patient.

Upholding the order directing the doctor to pay Rs 3 lakh lumpsum compensation to the patient, the NCDRC bench held that "it was the failure of duty of care of the OP-1 during the level II (Target scan). We affirm the reasoned Order of the State Commission, which needs no interference."

"At this stage, to avoid such litigations, we would like to request the National Medical Council to formulate stringent guidelines to regulate Antenatal USG protocols to especially the TIFFA Scan (level-II scan), which should be done by the Specialist like qualified Radiologist or Fetal Medicine expert," further read the order.

The matter concerned a pregnant woman who sought treatment from Dr Mukhi, who had performed USG seven times on the patient. However, for the earlier six occasions, the doctor could not detect the congenital abdominal wall defect. The complainant alleged that the doctor was not a qualified Radiologist and she did not even seek the opinion from any qualified Radiologist for USG to defeat congenital anomaly. 

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Alleging that she had continued such abnormal pregnancy and avoided unnecessary sufferings and expenses for the treatment, the Complainant filed the Complaint before the District Forum, Sonepat. After the district forum dismissed the complaint, the Complainant approached the State Commission.

Allowing the appeal, the State Commission had directed the doctor to pay a lumpsum amount of Rs 3 lakh to the patient along with interest @ 9% from the date of filing the complaint till payment. It also awarded compensation of Rs 21,000 for mental and physical harassment and Rs 11,000 as litigation expenses. 

Challenging the order of the State Commission, the doctor approached the NCDRC bench and the complainant had approached the Apex consumer court seeking enhancement of the compensation.

The counsel for the doctor argued that the foetal position was breech i.e. dorso anterior and therefore it was very difficult to detect the front portion (abdomen) of the baby. Due to technical limitations of USG the Congenital anomalies cannot be detected all the times depending upon gestation period, fetal position and quantity of liquor etc., argued the counsel for the doctor.

It was further submitted by the doctor that the subtle defect may not be seen in all scans. The Level-II Scan is a detailed time devoted anomaly scan but it does not guarantee to detect all the congenital anomalies, claimed the doctor.

Providing further details regarding the treatment procedure, the doctor argued that the patient had been admitted in emergency with the history of severe intermitted pain and history of leaking. It was 32 weeks breach presentation and the movements were absent and there was rupture of sac with thick meconium-stained liquor.

Ultrasound was performed and it showed distended loops of intestines outside the abdominal wall due to abdominal wall defect. The patient and her attendants were properly counselled regarding the pre-term baby and the baby was referred to a higher centre in Paediatric Surgery Department on urgent basis. However, the patient allegedly did not follow the advise and kept the baby in the hospital of Dr Mukhi. Despite providing all kinds of treatment, the baby died, submitted the doctor as she denied any negligence on her part.

After considering the arguments by both the sides, the NCDRC bench also perused the medical record, the USG reports and the medical literature on congenital wall defect.

Although the doctor submitted that during the USG, it was breach presentation, the NCDRC bench opined that "anterior abdominal wall defect during the target scan shall not be missed as it could be easily visible."

"The Ultrasonography is a sensitive technique, but it remains operator dependent. A definitive diagnosis of omphalocele (abdominal wall defect) is possible only beyond 12 weeks' gestation. The Ultrasound scan is done every 4 weeks to measure the fetal biometry. It is to monitor fetal growth and amniotic fluid. It is best to monitor growth through estimation of fetal weight by the Sieme formula, which uses biparietal diameter, occipitofrontal diameter and femur length, rather than formulas using abdominal circumference[1]. Thus the detection of congenital anomalies needs expertise, training and competency in Radio Diagnosis," further noted the bench.

Referring to the anomaly scan i.e. TIFFA ITargeted Imaging for Fetal Anomalies), the bench noted that it is the most important scan during the second trimester to examine if the baby is developing normally. 

"The main purpose of the scan is to check that your baby is developing normally, and look at where the placenta is lying. The findings of this scan help the doctor to take the necessary decisions to manage the rest of the pregnancy. It is beneficial to the pregnant woman or the parents to take decision for medical termination of pregnancy as per MTP Act," noted the bench.

Opining that qualified and experienced Radiologist can detect the congenital anomalies, the bench observed,

"It should be borne in mind that the detection of certain congenital anomalies is the domain of competent, qualified and experienced Radiologist or fetal medicine specialist. In the instant case, the OP-1 is a Gynaecologist & Obstetricians, who failed to detect the anterior abdominal wall defect during the target scan (18 to 20 weeks), but the same was diagnosed by OP-1 at 32 weeks of pregnancy."

The Apex Consumer Court also perused the opinion of Board constituted by Civil Surgeon and the opinion of HOD, Radiology, PGIMS, Rohtak. The Radiologist members of the Medical board opined that "the disease cannot be 100% detected from the Ultrasound. Only in 60-70% of the anomaly like exomphlaus can be diagnosed in 2 nd trimester in expert hands and some cases are diagnosed in perinatal period.

Referring to the expertise of the treating doctor, the bench observed,

"In the instant case, the USG Scans were performed by the Obstetrician, no doubt she possesses 30 years of experience in Obstetrics, the question before us is that whether OP-1 was competent enough or failed in her duty of care to report the Target scan – (level – II USG). Even the Medical Board and the PGIMS, Rohtak stated that such anomalies are diagnosed in expert hands. Admittedly, the OP-1 missed to detect abdominal defect."

"The Target scan (level II scan) detects development and position of the fetal organs. The abdominal wall defect could easily be detected irrespective of breach presentation. In our view, any Radiologist of ordinary prudence, could have detected such abnormality and it could have averted the patient’s sufferings. She could have aborted the baby within 20 weeks of pregnancy," further noted the bench.

The bench referred to the Supreme Court order in the case of Spring Meadows Hospital & Anr. v. Harjol Ahluwalia through K.S. Ahluwalia & Anr in this context. 

"Based on the discussion above, it was neither a bona fide mistake nor error of judgment of the OP-1, but it was the failure of duty of care of the OP-1 during the level II (Target scan). We affirm the reasoned Order of the State Commission, which needs no interference. Also, there is no merit in the Revision Petition filed by the Complainant. In our view, the State Commission awarded just and adequate compensation to the Complainant, thus there is no reason to enhance the further compensation," noted the bench as it held the doctor guilty of negligence.

"At this stage, to avoid such litigations, we would like to request the National Medical Council to formulate stringent guidelines to regulate Antenatal USG protocols to especially the TIFFA Scan (level-II scan), which should be done by the Specialist like qualified Radiologist or Fetal Medicine expert," further noted the bench.

To read the order, click on the link below:

https://medicaldialogues.in/pdf_upload/medical-negligence-ncdrc-198150.pdf

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