S.M. Kantikar, Member:— The present Complaint has been filed under section 21(a)(i) of the Consumer Protection Act, 1986 (for short “the Act”) by Mr. Lavkesh Sehgal (hereinafter to be referred as the ‘Complainant’) against CEO, Rockland Hospital, Dwarka and 6 doctors (hereinafter to be referred as the ‘Opposite Parties) seeking compensation of Rs. 2 Crore for act of medical negligence on the part of the Opposite Parties.
2. Facts : The Complainant's wife Mrs. Vimple Sehgal was under Antenatal care (ANC) during her pregnancy at Rockland Hospital (Opposite Party No. 1 - Hospital) under consultant Gynecologist - Dr. Kalpana Agrawal (Opposite Party No. 3). During the assessment of foetal growth and mother's wellbeing, ANC periodic checkup, relevant lab investigations including Ultrasonography (USG) were done. The details of visits and the USG findings at Rockland Hospital are as under:—
S. No. Date of USG Weeks of Pregnancy Nature of USG Test Dr. who conducted the USG Report Provided (in short) Special USG findings wrt to heart 1. 15.02.2014 12 Wks 1 day Pregnancy Growth Scan Dr. Manjul Jain Normal - 2. 11.03.2014 15 Wks 4 days Pregnancy Growth Scan Dr. Manoj Sharma, Normal No Obvious gross congenital anomaly seen. Fetal cardiac activity normal 3. 05.04.2014 19 Weeks 1 Day Ultrasound Level 2 OBS Growth Scan Dr. Gaurav Kapoor Normal Observation with respect to Heart: I. Fetal Cardiac activity normal. II. 4 Chamber view is normal. III. Out flow tracts (LVOT and RVOT) are normal. IV. 3 Vessel view is normal. 4. 14.05.2014 24 Weeks 5 Day Ultrasound Pregnancy Growth Scan Dr. Manjul Jain Normal No Obvious gross congenital anomaly seen. Fetal cardiac activity normal. 5. 03.07.2014 31 Weeks 6 Day Ultrasound Pregnancy Growth Scan Dr. Shiv Kumar Bajoria Normal No Obvious gross congenital anomaly seen. Fetal cardiac activity normal. 6. 01.08.2014 36 Weeks Ultrasound Pregnancy Doppler Dr. Shiv Kumar Bajoria Normal Fetal cardiac activity normal.
3. According to the Complainant, if USG shows any anomaly which in turn risky to mother or foetus, the decision could be taken either to continue or terminate the pregnancy in specific time. Therefore, with the expectations of best treatment the ANC was continued with Opposite Party No. 3 at Rockland Hospital.
4. On 14.08.2014 at 9.33 AM, the Complainant delivered a male baby at Rockland Hospital. Soon after birth, the baby was shifted to Neonatal ICU (NICU) as baby was not breathing properly, and unable to maintain the Oxygen saturation. On 15.08.2014, at around 10.00 pm, the Pediatrician - Dr. Tina Goel (Opposite Party No. 7) called the Complainant to the NICU and informed that the baby had heart disease and asked to shift her immediately to BLK Hospital or Sir Ganagaram Hospital having Pediatric Cardiology facility. Immediately around 1 a.m., by ambulance, the baby was shifted to the NICU of BLK Hospital. In the morning, on 16.08.2014, Dr. Vikas Kohli, Director & HOD, Department of Pediatric Cardiology performed Echo Cardiograph (ECHO) and informed the Complainant that his Baby had ‘Pulmonary Atresia with Ventricular Septal Defect (VSD)' (hole in heart) a Congenital Heart Disease (CHD). Dr. Vikas Kohli immediately over phone spoke to Dr. Kalpana Agarwal, who in turn informed that as per USG done during pregnancy, there were no signs of any Congenital Defect. As all USG reports including level-2 (19 Weeks) scan showed normal findings including heart, therefore, she did not recommend any tests further. Dr. Kohli explained to the Complainant about the future implications of pulmonary atresia and VSD, that up to 5 years, the child needs multiple expensive surgeries and thereafter further treatment is necessary, depending upon the age. On 16.08.2014, the child was discharged from the BLK. The Complainant paid Rs. 35,130/- as hospitalization charges.
5. The Complainant alleged that, his wife throughout pregnancy was under ANC care of Opposite Party No. 3 but no ANC card was prepared. It was alleged that the hospital and Opposite Party No. 3 discriminated with his wife as CGHS patient. It was known that for CGHS the consultant Gynecologist will be paid only Rs. 50/- per OPD consultation, whereas the Private Patients pay Rs. 500/-. The Opposite Party No. 3 gave less time and attention during every consultation. Therefore, she forgot to prescribe Fetal ECHO to know about Cardiac activity. The Complainant and his wife confronted Dr. Kalpana Agarwal and Dr. Gaurav Kapoor Radiologist (Opposite Party No. 2) about the baby's problem but did not receive satisfactory reply. The Complainant alleged that the three Radiologists working at Hospital namely (i) Dr. Manjul Jain - Opposite Party No. 4 (ii) Dr. Manoj Sharma - Opposite Party No. 5 and (iii) Dr. Shiv Kumar Bajoria - Opposite Party No. 6 were grossly negligent, who carelessly performed periodic USGs and just casually signed the reports.
6. It was further alleged that the Pediatrician on the basis of Chest X-ray Dr. Tina Goel was aware of baby's heart condition on 14.08.2014 itself, but it was her criminal intention to evict the child in wee hours. Thus, she shall be criminally liable for deliberately endangering the life of a new born. The baby was resuscitated in NICU, but the details were not revealed. The Complainant took second opinion from Dr. Raja Joshi - the Paediatric Cardiologist at Gangaram Hospital and as per his advice, CT Angiography was carried out on 26.08.2014 and the diagnosis of Pulmonary Atresia was confirmed. On 08.12.2014, the Complainant approached Narayana Hrudalaya at Jaipur and consulted Dr. Prashant Mahwawar, Paediatric Cardiologist, who confirmed the diagnosis and advised for need of complex ‘Unifocalization’ surgery, which very few doctors in India do and results are varied.
7. Being aggrieved by the alleged gross medical negligence of the hospital and team of doctors (Gynecologist, Radiologist (Sonologist) and Pediatrician) the instant Complaint was filed with the prayer of exemplary compensation of Rs. 2 Crore.
Defense:
8. The Opposite Parties filed their respective written statements (WS) versions and denied the allegations of negligence. The insurance co. also denied negligence of hospital or doctors.
The Opposite Party No. 1-Rockland Hospital (thr' CEO)
9. The preliminary objections raised on maintainability of the complaint. The hospital denied negligence or deficiency in service. It was further submitted that the Complainant's wife being eligible beneficiary under CGHS took treatment during ANC and her delivery. The Opposite Party No. 3 referred her for USG on different dates which were performed by four Radiologists and issued the reports (chart supra). All the Radiologists are qualified and having vast experience in diagnostic radiology including pregnancy Ultrasound. After the birth of child, pulmonary atresia with VSD was diagnosed. From the literature, it was rare congenital anomaly and progressive in nature, which could not be revealed, while screening the heart during USG. The Complainant failed to understand limitations of USG. Every diagnostic technique, including the USG, has limitations and all fetal CHD cannot be detected on USG. Every radiology report bears printed remark about the limitation that:
“all congenital anomalies cannot be ruled out on ultrasound specially those pertaining to heart, limbs and face. Detailed fetal echo has not been done.”
The Opposite Party Nos. 2, 4, 5 and 6 : Radiologists
10. The Radiologists filed their respective replies and denied the allegations of negligence. It was submitted that all the USGs of the wife of the complainant were performed as per standard accepted medical protocol and as per the international standard guidelines. The Opposite Party No. 2 performed level II USG scan at 19 weeks 1 day. The fetal heart including the 4 chamber view, outflow tracts and three vessel view did not indicate any obvious abnormality. The fetal skull, spine, orbits, lips, nose, kidney, urinary bladder, stomach, limbs and 3 vessel umbilical cord did not show any abnormality. Nuchal fold thickness was within normal range. They further submitted that USG procedures and reporting had certain limitations; same are printed at the bottom of every USG report. The extensive literature also mentioned about fetal ECHO study that though the detection of CHD is higher than routine USG, however, it is not 100%.
The Opposite Party No. 3-Dr. Kalpana Agrawal (Gynecologist):
11. Dr. Kalpana Agrawal, in her reply, denied the allegation about no ANC card prepared or discrimination with CGHS patient. She submitted that the ANC card is not a mandatory requirement. It is nothing but short summary of the treatment and management given to the patient that does not change the course of treatment. In the instant case, Mrs. Vimple Sehgal herself was systematic and organized, who used to carry all her previous medical record in the shape of a file. She submitted that the allegations of the Complainant are vague, denied that she gave less time/attention to Vimple Sehgal, which missed foetal ECHO investigation. She submitted that proper care was given for every patient irrespective of CGHS or Consultation fees. The couple neither made any complaints in this regard nor consulted any other doctor if they were not happy with her. The USG were recommended according to individual patient's requirements. After availing complete ANC follow-up with satisfaction, Complainant raising such allegations appears be an afterthought, just to make out a case.
12. She further submitted that as per practice guidelines formulated by the American Institute of Ultrasound in Medicine (AlUM), the fetal ECHO to be done based on certain, variety of parental and fetal risk factors for CHD. In the instant case, there was no indication for fetal ECHO. She further submitted following points:
i. the wife of complainant had no history of diabetes mellitus and her blood sugar tests were normal. No history of drug exposure.
ii. Patient's first child had absolutely normal heart and there was no congenital heart defect,
iii. No family history of first degree relatives had any CHD or Marfan's syndrome, seizure disorders.
iv. It was normal spontaneous pregnancy, no assisted reproductive methods like IVF or ICSI. This was a singleton pregnancy and not case with monochorionic twins or multiple gestation and suspicion of twin-twin transfusion syndrome,
v. No history or signs or symptoms suggestive of auto immune disease
vi. Patient's AFI on ultrasound was always normal and there was no hydrops or unexplained severe polyhydramnios.
13. Thus, the allegations of Complainant were vague and intentional.
The Opposite Party No. 7 - Dr. Tina Goel - Pediatrician
14. The Pediatrician - Dr. Tina Goel filed her reply and denied the allegations. She submitted that there was no cause of action qua her. She further submitted that on 14.08.2014 at 9.33 am, a male baby was delivered by LSCS and after the delivery. She examined the newborn as per standard newborn protocol and gave appropriate treatment. Dr. Sunil Bhasin, Sr. Consultant Pediatrics and Head of Unit examined the baby. He recorded the findings that the baby required bag and mask ventilation for 30 seconds immediately after birth. APGAR score was 5, 8 and 9 at 1, 5 and 10 minutes. After bag and mask ventilation baby's cry and activity was fair. Heart rate was 160/min. Respiratory rate was 54/min. Capillary filling time (CFT) was < 3 secs. Systemic examination was normal and the baby shifted to nursery for observation.
15. She denied the allegations that on at 7.30 pm, on 14.08.2014 itself, she knew the problem of the new born and in connivance with the hospital, she waited, kept the baby till midnight of 15.08.2014 to evict him at the dead of night. She submitted that, on 15.08.2014 at 8.30 pm, for the first time she noticed systolic murmur. The Arterial Blood Gas (ABG) report revealed significant drop in P02 and an increase in PC02 (pH 7.37, p02 62.6, pC02; 36.5, bicarbonate 21.6). The case was discussed telephonically with Dr. Sunil Bhasin (the Head of Unit). Based on the murmur and the ABG values, a suspicion of cardiac etiology was made and immediately explained to the Complainant about need for urgent pediatric cardiac ECHO and cardio respiratory support. But, the Complainant took almost an hour to convey final decision to her. The ambulance from BLK came at 11.00 pm and the baby was shifted along with the Neonatologist - Dr. Kumar Ankur to BLK. All the steps were taken keeping in view of baby's wellbeing.
The Opposite Party No. 8 : United India Insurance Company
16. In its reply submitted that the complainant has neither made any allegation nor prayed any relief against the Insurance Co. Therefore, the present complaint is not maintainable qua Insurance co.
Arguments:
17. Heard the arguments from the learned Counsel for both the sides. Perused the material on record, inter alia, the Medical Record.
Arguments on behalf of Complainants:
a) The Complainant vehemently argued in person. He reiterated the facts and evidence on record. He submitted that for his pregnant wife USG were performed for six times by the four Radiologists working in the hospital. They failed to detect CHD, just reported the USGs in a causal and negligent manner. If it would have been detected prenatally, they (couple) could have opted for timely medical termination of pregnancy (MTP) and avoided the cruel ordeal and unexplainable agony to them. The Complainant brought our attention to the judgment of this Commission in case titled Anil Dutt v. Vishesh Hospital (CC No. 221 of 2010), wherein it was held that:
“foetal USG is the most important tool to provide prenatal diagnoses of the foetal anomalies. Had the anomaly been detected the parents would have been referred to a tertiary foetal medicine unit for further investigations which would have revealed the presence of other anomalies in addition to the abnormalities of foetal limbs. The existence of two serious anomalies would have resulted in the pregnancy being terminated. The doctor is bound by ethical obligations to examine patient thoroughly with all his competence. Therefore, the radiologists should not shirk away from their responsibility and professional obligations”.
(b) The Complainant relied upon the opinion of Committee of Experts constituted by Union Ministry of Health & Family Welfare to examine the negligence in the treatment of his son (new born). The Committee opined that:
The pick up rate on Ante Natal Ultrasound is 50% approx. for Four Chamber view, about 60% in Four chamber is combined with outflow view and about 70% in case of four chamber, outflow, three vessel view & trachea is combined.
(c) The hospital was mis-representing as accredited by National Accredited Board of Hospitals (NABH), but yet the NABH accreditation has not been granted. The Opposite Party No. 1 was silent about ethical obligations of their four radiologists. He brought our attention to the information displayed on hospital's website about the role of ultrasound in pregnancy, which inter alia states as:
“this modality plays a vital role in obstetrical imaging, fetal anatomic development can be thoroughly evaluated, allowing early diagnosis of many fetal anomalies.
(d) The Complainant argued against the gynecologist Dr. Kalpana Aggarwal - Opposite Party No. 3 that during entire period of ANC (25.01.2014 to 09.08.2014) he and his wife visited Dr. Kalpana Agarwal, Gynecologist 12 times, but the Opposite Party No. 3 failed to prescribe fetal ECHO. He further argued it was unfair trade practice of the hospital that not providing ANC card and discriminatory attitude with CGHS patient. He relied upon RTI information from Delhi Health Department which inter alia informed that; “it is mandatory to make ANC Card during pregnancy by hospital/doctor”, Further, Union Health Ministry in a RTI Reply on the issue also stated that; “It has been made mandatory to the States to issue Mother & Child Protection Card (MCP Card) when pregnant women makes it first contact with public health facility and all public health facilities from sub-center to district hospital to issue such cards at the time of ANC Registration”. Thus it was deficiency in service from the hospital and treating Gynecologist.
(e) The Complainant argued against the Radiologists that all the ultrasounds, starting from early pregnancy till last week of pregnancy, have been reported to be fetal activity normal and stated that ‘No obvious gross congenital anomaly is seen’. He relied on the hospital website information wherein the Radiologist Dr. Anmol Sethi stated that; Level-2 ultrasound is often recommended when the first ultrasound detects certain abnormalities in the fetus. He brought our attention to the newspaper clipping of Times of India dated 05.01.2015 wherein Dr. Bisoi, Cardiologist, AIIMS inter alia opined about need of ANC for early diagnosis of CHD. The Complainant brought our attention to the article from the Heart Medical Journal which mentioned that:
“If cardiac screening is confined to Four Chamber View, about 60% of major heart disease seen in infants and if great arteries are also examined, over 90% of major heart would be detectable prenatally”. Journal for Ultrasound in Medicine inter alia concluded that; “The sensitivity of the Combination of 4-Chamber View and 3-Vessel view was 81.3% and specificity was 99.9%”.
In the instant case, Pulmonary atresia the anomaly was missed in five ultrasounds performed during ANC by 3 Radiologists. It clearly establishes the carelessness, negligence and deficiency in service. All the radiologists have just signed on the formatted USG reports; it was an unethical act as well breach of their duty of care.
(f) The Complainant argued against Opposite Party No. 7 (Dr. Tina Goel, Pediatrician) that, the baby was born on 14.08.2014 at 9.33 AM. Soon after birth, the baby was shifted to NICU, reason stated that baby was not breathing properly. Chest X-Ray was carried out in the evening at 7.35 PM. The Opposite Party No. 7 in reply to Delhi Health Department inter alia stated that; the X Ray was grossly unremarkable with doubtful upper lobe streaky pacifications. The Complainant's grouse that ‘X Ray can be interpreted only by the Radiologist and the Pediatrician can only see it grossly, since the report of Radiologist was awaited, before taking decision to shift the child to a higher medical Centre. As no radiologist was available on 15/08/2014 being a holiday, the reporting was late. Therefore, it was a breach of duty and deficiency of Opposite Party No. 7. The newborn was kept in NICU for 27 hours. Complainant also argued that his child was not provided the mandatory vaccination at birth, thus Opposite Party No. 7 is liable for unfair trade practice. The Complainant concluded his arguments that the Foetal USG is the most important tool to diagnose fetal anomalies. The hospital along with all answering radiologists has washed off its hands. It was the prime duty of all four Radiologists to examine Complainant”s wife carefully, however they failed to exercise reasonable degree of care and skill. They have even not raised doubt of impending anomaly during six ultrasounds performed from 12 to 36 weeks of pregnancy. The higher standard of care was expected from tertiary care hospital and their Radiologists failed in the reasonable degree of care and skill. The grief of Complainant family has been compounded by not finding any treatment for his son. Complainant predicament was succinctly reported by ‘Navbharat Times’ dated 12.11.2014.
Arguments on behalf of Opposite Parties:
18. The learned Counsel for the Opposite Parties reiterated their evidence and stressed upon the contents of their written versions/replies filed by them. The Counsel filed number of literatures and texts from the standard books on Ultrasonology, Cardiac Anomalies and Pediatric Cardiology. He also filed few judgments of Hon'ble Supreme Court and this Commission.
Discussion:
Medical Literature on Pulmonary Atresia and indications for Fetal ECHO:
19. We have gathered information from the standard text books and articles on the Pulmonary Atresia and VSD as below:
• Pulmonary atresia (uh-TREE-zhuh) is a heart defect present at birth (congenital) that's usually diagnosed soon after birth. In pulmonary atresia, the valve that lets blood out of the heart to go to the lungs (pulmonary valve) doesn't form correctly. It occurs due to under or maldevelopment of the right ventricular outflow tract along with atresia of the pulmonary valve and trunk. Moreover, Pulmonary atresia with ventricular septal defect (PAVSD) is one of the cyanotic congenital heart diseases.
• The during ANC prenatal ultrasound can give information about whether the fetal heart has developed all four chambers. Most unborn babies do not require any further testing. Thus a fetal ECHO is not necessary for all pregnant women.
20. The list of common fetal and maternal conditions associated with an increased risk of CHD AIUM Practice Parameter for the Performance of Fetal Echocardiography E6 J Ultrasound Med 2020
• Fetal Factors : Fetal ECHO is indicated if there is:
• Suspected cardiac structural anomaly
• Suspected abnormality in cardiac function
• Hydrops fetalis
• Persistent fetal tachycardia (heart rate > 180 beatsper minute)
• Persistent fetal bradycardia (heart rate < 120 beats per minute) or a suspected heart block
• Frequent episodes or a persistently irregular cardiac rhythm
• Major fetal extracardiac anomaly
• Nuchal translucency of 3.5 mm or greater or at or above the 99 percentile for gestational age
• Chromosomal abnormality by invasive genetic testing or with cell-free fetal DNA screening
• Monochorionic twinning
21. Fetal ECHO may be considered if there is:
• Systemic venous anomaly (eg, a persistent right umbilical vein, left superior vena cava, or absent ductus venosus)
• Greater-than-normal nuchal translucency measurement between 3.0 and 3.4 mm
• Maternal or Familial Factors:
• Pregestational diabetes regardless of the hemoglobin A1C level 13
• Gestational diabetes diagnosed in the first or early second trimester
• In vitro fertilization, including intracytoplasmic sperm injection 14,15
• Phenylketonuria (unknown status or a peri-conceptional phenylalanine level > 10 mg/dL)16
• Autoimmune disease with anti-Sjogren syndrome-related antigen A antibodies and with a prior affected fetus
• First-degree relative of a fetus with CHD (parents, siblings, or prior pregnancy)
• First-or second-degree relative with disease of Mendelian inheritance and a history of childhood cardiac manifestations
• Retinoid exposure
• First-trimester rubella infection
• Maternal Drug Exposure and Diseases
• Women with seizure disorders taking anti-convulsants
• Women taking lithium for depression
• Women taking insulin for diabetes
• Women who have phenylketonuria
• Women exposed to Rubella
• Family History of Congenital Heart Disease
Previous child with CHD, new risk is 1 in 20 to 1 in 100
Previous two children with CHD, new risk is 1 in 10 to 1 in 20
Mother has CHD, new risk is as high as 1 in 5 to 1 in 20
Father has CHD, new risk 1 in 30
• Chromosomal abnormalities and CHD
Down syndrome
Trisomy 18 and Trisomy 13
Turner's syndrome
Cri du chat syndrome
Wolf-Hirshhorn syndrome
DiGeorge syndrome (deletion 22q11)
22. We gave our thoughtful consideration to the arguments, perused the medical literature on the subject. The allegation was that hospital did not maintain ANC card as a mandatory requirement. In our view, it was casual approach of the hospital and it was neither a breach in duty of care nor the causa causans i.e. alleged injury was not a result of such breach. The medical record revealed that the Complainant's wife was advised for screening tests (Double and Triple Marker study) to rule out fetal chromosomal anomaly, but the she did not undergo the same. The Opposite Party No. 2 in his evidence stated that he did not find any abnormal signs related to heart during level-II scan. The foetus showed normal three vessel cord and the 4 chambered heart. It was adequate without any signs of cardiac anomaly; therefore, there was no need of fetal ECHO. During routine USG for pregnant woman, the fetal ECHO was not done and also the Gynecologist would not advice for it routinely. On careful perusal of all USG reports, we do not find any extra-cardiac anomaly in the instant case. The findings did not show any chamber asymmetry, altered cardiac axis, altered position of the fetal heart, enlarged fetal heart, arrhythmia, and echogenic cardiac focus. The fetus showed normal Nuchal Translucency (NT) of 2 mm (less than 3.5 mm). From the literature, it is known that if, the first trimester USG shows increased NT to 3.5 mm or more, and then fetal ECHO with further evaluation is necessary. Admittedly, in the instant case, the NT was within normal limits. Thus in entirety and from (para 17) there was no indication to perform Fetal ECHO.
23. We have perused the order of the Delhi Medical Council (DMC), which did not hold Dr. Gaurav Kapoor negligent. He has reported USG as Fetal Cardiac activity, 4 chamber views, Out Flow Tracts (LVOT and RYOT) and 3 Vessel view were normal. Based on the normal USG findings, the fetal ECHO was not suggested, therefore not advising Fetal ECHO was not medical negligence. It is known from the published data that with fetal ECHO, the detection of CHD is not 100%. The Pulmonary Atresia with VSD is rare condition having very low antenatal detection rate. As per the UK national data published in LANCET in 1999, pre-natal diagnostic rate of pulmonary atresia with VSD is only 10%.
24. We would like to rely upon the judgment of Hon'ble Supreme Court in the case of S.K. Jhunjhunwala v. Dhanwanti Kaur (2019) 2 SCC 282, which held that there has to be direct nexus with these two factors to sue a doctor for negligence. It was further held that in every case where the treatment is not successful or the patient dies during surgery, it cannot be automatically assumed that the medical professional was negligent. Similarly in the recent decision on April 20, 2022, in the case of Dr. (Mrs.) Chanda Rani Akhouri v. Dr. MA Methusethupathi 2022 LiveLaw (SC) 391, Hon'ble Supreme Court has laid down in no uncertain terms that merely because doctors could not save the patient, he/she cannot be held liable for medical negligence. The Hon'ble Supreme Court held in para (27) that:
25. It clearly emerges from the exposition of law that a medical practitioner is not to be held liable simply because things went wrong from mischance or misadventure or through an error of judgment in choosing one reasonable course of treatment in preference to another. In the practice of medicine, there could be varying approaches of treatment. There could be a genuine difference of opinion. However, while adopting a course of treatment, the duty cast upon the medical practitioner is that he must ensure that the medical protocol being followed by him is to the best of his skill and with competence at his command. At the given time, medical practitioner would be liable only where his conduct fell below that of the standards of a reasonably competent practitioner in his field.
26. Based on foregoing discussion, we are unable to conclusively attribute negligence or deficiency on the part of the Opposite Parties.
27. The Complaint is dismissed. There shall be no Order as to costs.