The Pre-conception and Pre-nata l Diagnostic Techniques (Prohibition of Sex Selection) (Six Months Training) Rul es, 2014 Ministry of Health and Family W elfare (Department of Health a nd Family ‘Welfare) Notification No. G .S.R. 14(E), dated the 9th J anuary, 2014’ ~In exercise of the powers confer red by clause (i) of sub-sectio n (2) of Section 32 of the Pre-conception and Pre-nata l Diagnostic Techniques (Prohi bition of Sex Selection) Act, 1994 (57 of 1994), the Central Governme nt hereby makes the following rules, namely :—
1. Short title and commencemen conception and Pre-natal Diagn ostic (Six Months Training) Rules,
2014.
(2) They shall come into forc e on the date of their publica tion in the official Gazette. 2, Definitions.—In these rules, unl ess the context otherwise requires ,—
(a) “Act” means the Pre-conc eption and Pre-natal Dia gnostic Techniques (I‘mhibiti on of Se x Selection) Act, 1994 (57 of 19 94);
(b) “pr‘mcipal rules” means the Pre-conception and Pre-natal Diagnostic Techniques (Prohib ition of Sex Selection) Rules, 1 996;
(c) “Six months training” means the training imparted under these rules;
(d) “syllabus” means the syllabus g iven in Schedule I;
(e) “Log book and assessment” means the Log book and assessment as specified in Schedule 15
(f) words and expressions used herein and not defined in t hese rules but defined in the Act or int the prin cipal rules, as the case may be, shall have the meanings, respectivel y, assigned to them in the Act or in the principal rules.
3. Nomenclature of the six mo nths training in ultrasonngrap hy.——'fhe six months training imparted under these rules shall be known as “the Fundamentals in Abdomino-Pel vic Ultra sonography : Level one for MB.B.S. Doctors”.
4. Period of the training—The of training shall be 300 clock h ours.
5. Components of the six mo nths training curriculum. components of the training curri culum shall be— t.—(1) These Rules may be called the Pre- Technigues (Prohibition of Sex Selection) period of training for obtaining a certificate ~—(1) The major + published in Gazette of India { Extraordinary), Part 11, Section 3(3), dated 10-1-2014 Pages 26-4
9.
(61) 62 The Pre-conception and Pre-natal Dingnostic Tedm?uns (Prohibition of Sex Selection) (Six Months Training) Rules, 2014
(a) theory based knowledge to equip registered medical practitioners with the knowledge, professional skills, attitudes and clinical competencies; -
(b) skill based knowledge; . . ' * * {c) . log book and Assessment, ' ST -
(2) The comprehensive syllabus for the said six ‘months training is as specified in Schedule 1. \ v T
(3) The details related to log book and assessment are as specified in Schedule IL. o U . -
6. Eligibility for training.—(1) Any registered medical practitioner shall be eligible for undertaking the said six months training. e 2) The-existing registered .medical practitioners, who.are conduc ting uitrasound procedures in a Genetic Clinic or‘Ultrasound Clinic or lmagin s Centre on the basis of one year experience or six'months training are’exempte: from undertaking the said trainingsprovided they are able to’ qualify the .competency based assessment.as specified in Schedule II. . ey
(3) If a medical practitioner fails to clear the said com etency ‘based examination after three attempts, he shall undertake-the complete six mont hs training, as -provided under these rules, for he ,purpose -of ;renewal of registration.;] o ey Tepeed R ,P_>
7. Aécreditation of inétitiitions’ for six ‘months training and ‘its recognition.—(1) The following teaching institutions would be accredited as training centres to impart the six months training, namely :— _ (a) Centres of Excellence established inder the Acts dfPafiiafielfi; “H{(b) Medical Council of India reBoghiséd institutions offering Post Graduate ~programmes in :C%‘sterfics and Gynaecology -or ‘(c) 'Institutions ‘offering full time tesidendy DNB prégramme in Obstetrics and Gynecology orRadidlogyl] = ¥ +(2) The names of the institutions recognised for this purpose shall-be notified State wise by_the State Health Medical Education Department: ; -
Provided that the training institutes redognised for'impartin g the six months straining: shall. friaintain ‘the standards'o /infrastructure, vequipment and manpower includin&\ the faculty as per apex regulatory. bodies like the Medical Council of India or the National Board of Examination. - i 87 Selection of students.—(1) The sélection and intake of régistéred medical ‘practitionets for admission to such trainings allbe on the basis of the following criteria . v v wEd T pE - _*I{(a) ‘Intake'for admission to such trainings shall be up to 1:4 teacher to .., students ratio; v W < ek
(6) -Selection shall be as“per the Heri st Graduate Entrance Exam. or any-Gther appropiiate merit récognised by the o oim o Central Government /! tate GOVernments; s # . pomeitry o “ " {¢)’ Preference upto 50 percént of ‘the" seats shall ‘be givén to_the - " Government in service candidates; PRLTTTC oy ...(d)" Seats as mutually decided by:the States/Union Territorjes shal l be - provided to the candidates from other States or Union Territories Where there are no accredited institutes for imparting Six Months- Training inUltrasonography.] .. . ... . ... . N L
1. Substituted by Notification No. GSR. 419(E)I‘datcd 26-6-2020, w.e.f. 29-6 -2020.
63 . - The Pre-conception and Pre-natal Diagnostic Techniques (Prohibition of Sex Selection) (Six Months Training) Rules, 2014 J{ Changed criteria to be made prospective.—These rules shall come into force with immediate effect in case of new registrations, However, all registered” medical practitioners employed in a Genetic Clinic or Ultrasound Clinic or Imaging Centre on the basis of one year experience or six months training and failed to qualify the competency based exam as specified in Schedule II shall i have to apply and clear six months training 1[* * *]. - 2[9, (1) The States/Union Territories shall complete the Competency based asseynmt—fora‘lfieady registered medical practitioners within two years of this notification.} - v
10. Fee structure for the training—(1) The training fee for conducting the six months training shall not exceed Rs. 20,000.. . - - : %g:rm:egistered medical practitioners who are already registered for conducting ultra sonography in a Genetic Clinic or Ultrasound Clinic or Imaging _Centre and require to clear a competency based evaluation, the fee shall not exceed Rs. 10,000. 4 :
(3) Fee structure or waiver thereof for in service registered medical practitioners shall be decided by the respective State Governments.
11. Staff-Faculty.—(1) The institute conducting the said six months training for registered medical practitioners shall appoint the Post graduate teachers in Radiology or Obstetrics or Gynaecology recogriised by the respective regulatory bodies as full time faculty for the said training programme.
(2) The Deans or Head of the respective teaching institutions shall be responsible for monitoring the training programme in entirety.
12. Monitoring requirements.—Monitoring of the training_institutions imparting the six months training shall be as per the,existing norms laid down by the respective apex regulatory bodies. .
13. Competency based evaluation—The final competency based evaluation at the end of the six months training shall be held as per the mechanism specified - in Schedule I. 14, Validity of the training certificate.—Certification of training obtained from any State shall be applicable for the purposes of registration under Act in all States. . M Certificate for qualifying Six Months Training in Ultrasonography and”Competency based assessment shall be issued by Director Medical Education and countersigned by the concerned State Appropriate Authority.] : Schedule-T o FUNDAMENTALS IN ABDOMINO PELVIC ULTRASONOGRAPHY - . Level one § Months Course for M.B.B.S. Doctors Ultrasonography Syllabus . . This training will equip individuals with the knowledge, professional skills, attitudes and clinical competencies to use ultrasound imaging in an appropriate and safe manner.
1. Omitted by Notification No. G.S.R. 419(E) dated 26-6-2020, w.e . 29-6-2020.
2. Inserted by Notification No. G.S.R. 419(E) dated 26-6-2020, w..{. 29-6-2020. v The Pre-conception. dnd Prematal Diaghvstic Techniques (Prohibitior of Sex Selection) (Six:Months TMI?Q ing) Rules, 2014 ic pregn cy, biometery, anomaly scanni) terine Growth Retardation (IUGR) g’gdeptalfv lugtion, Afni lyation, ; color doppler uses and 5 cal ‘uses i T““‘E\Ea‘fi feral 4D, ultr Knowledge based L:'buréévéhdfil@ ”lfi&é 3 outb.ned in the syllabus bove
(i) How\to take measurements of d:mex(slons of pe]vxc structures - oy o) NSRS enieRt (D) Ear]yprw 125 s liraspund Scan appeaffiflfe&‘&s‘ m]y‘”‘p‘fégfiancy- Blagenta fGestational-AgeTiyinpregnancy - 1@\ iagnpsm-—pf scomplications of early ‘pregriancy hcluding .
(a) extra-uterine/pregnancy
(b) mlscamage . © retamed productso oncepfion & Thz Pre-cnnczphm and Pre-natal Diagnostic Techmgucs (Prohibition of Sex Selection) . ix Months Training) Rules, 2014 (E) Identification or Recognition of pelvic _palhology {i) Use of -Ultrasound ‘Scan in managing " menorrhagia, R . intermenstrual bleeding, poshnenopausal bleeding. T (i) . Ultrasound Scan appearances in polycystic ovaries, uterine fibroids, adenomyosis and endometrial polyps L (iif) Ultrasound ‘Scan appearances. of ovarian ‘Cysts-cOrpus luteum, slmple and complex cysts and asses
(w) Comp]ex ‘ovarian masses or ovarian screening - (a) Endometrial pathology in postmenopausal women Y. Tv7(p) Gestational trophoblashcneop]asla “ e — (&)~ ‘Chiofiit pelvic pain ~h —H——= s -« i
(d) The assessment of tubal patency in lnferfillty and follicular tracking for assisted-conception : = /¢ .
(c) ‘The assessment of prolapse, mcunhnence,‘and "anal sphincter damage . PR u"’ . (F) Reproduchvemedxcme e ey R .- (1) "Effect of cor\tracephve hormones and menopause on the ~endometriur. ™ * ¥ n"identification of Intra-uterine (ii) Use of Ultrasound 5 Stefn and".[mp]ano’n pnsifion Device or [ntra-utenn jarra i s opAraEmr (0 need not include any hands-on componem II. SkillBased - _ - - (A) Basx:lmagmg Skills N (i) Machine set-up - (ii) Cuunsellmg for scan
(iii) Decide transabdominal vs. transvagma] totite
(iv) Choice of probe - (V) "Pdtient.positiofing.” -
(vi) Orientdtion ¥ 7" ®Ts. ~ ~ 5", w° . ~(vii) Identify normal endometrium -~
(viii) Identify normal myometrium -
(ix) Identify normal ovaries . .- “(x) - Measure cervical Xength
(xi) “Recording unages’ ’ .
(xii) Note keeping anmocumentahon (B) Early Pregnancy - B I P i) -Confirm vidbility i,." rm'r”« ha
(ii) Date pregnancy : hi' ot » " (iif) , Diagriose corpus luteum cysl -
(iv) Diagnose mulhple pre(gnancy
(v) Determine dlg“ y/Zygosity
(vi) Identify retrGplace
(vii) Diagndse anembryonic prégnancy {viii) Diagngser missed miscarriage * o6 The Pre-conception and Pre-natal Diagnostic Techmgues (Prohibition of Sex Selection) (Six Months Training) Rules, 2014
(ix) Diagnose retained products of conception {x) Counselling for failed pregnancy
(xi) Diagnose ectopic pregnancy (C) Menorrhagia
(i) Identify submucous fibroid
(i) Identify intramural fibroid (iti) Identify subserous and pedunculated fibroid - — - (iv) Identify adenomyosis - (D) Postmenopausal and intermenstrual bleeding (i} Measure endometrial thickness
(ii) Identify atrophic endometrium -
(iii) Identify hyperplastic endometrium
(iv) Identify endometrial polyps
(v) Identify functional ovarian tumours (B} Pelvic Mass
(i) Identify mass as uterine
(i) Identify unilocular ovarian mass (iii} Identify complex ovarian mass
(iv) Identify ascites {F) Reprodictive Medicine
(i) Identify cyclical changes in endometrium
(ii) Identify cyclical changes in ovary
(iii) Identify polycystic ovary
(iv) Locate Intra-uterine Device or Intra-uterine System . position in uterus (G) Extra-Pelvic Scans
(i) Identify normal placement of Implanon
(ii) Locate non-palpable Implanon (H) Contents-Section One
(i) Instrumentations and basics
(ii) Physics for practical applications
(iii) Examination techniques
(iv) Trans-abdominal and Trans-vaginal Scan
1. The knowledge base.—(1) Principles of ultrasound examination :
(i) Physics {ii) Safety
(iii) Machine set-up and operation
(iv) Patient care
(v) Principles of report writing (vi} Consent
(2) /The relevant principles of acoustics, attenuation, absorption, * reflection, speed to sound;
(3) The effect on tissues of pulsed and continuous wave ultrasound beams : biological effects, thermal and non-thermal; safety. ' The Pre-conception and Pre-natal Diagnostic Techniques (Prohibition of Sex Selection) (Six Monthis Training) Rules, 2014
(4) Basic operating principles of medical instruments
(5) Types of transducers :
2. Skill sets.—(1) Use of ultrasound controls :
(i) Signal processing—gray scale—time gain compensation, acoustic output relationship; !
(i) Artefacts, interpretation and avoidance—reverberation— side lobes—edge effects—registration~—shadowing— enhancement; .
(iii) Measuring systems—linear, circumference, area and volume—Doppler ultrasound—flow;
(iv) Imaging recording, storage and analysis;
(v) Interpretation of acoustic output information and its clirical relevance;
(vi) Patient information and preparation reporting (D Contents—Section Two
(i) Ultrasound anatomy of the abdomen, pelvis and fetus
(ii) Embryology or pathophysiology in short as applied to abdpelvis
1. The knowledge base " (i) Knowledge of normal ultrasound appearances of the endometrium, myometrium and ovaries throughout a menstrual cycle. |
(i) Understanding of techniques to measure the uterus, endometrium. . (iii} Knowledge of normal ultrasound appearances of the ovaries and adnexa.
(a) Gynaecological abnormalities : uterine
(i) Knowledge of the ultrasound appearances of fibroids and adenomyosis. .
(i) Knowledge of endometrial pathology.
(iii) Intra-uterine Contraceptive Device localisation. {b) Gynaecological abnormalities : ovarian lesions
(i) Knowledge of the differential diagnosis of ovarian and para-ovarian lesions.
(i) Knowledge of typical ultrasound findings of common ovarian appearances such as polycystic ovaries. (iif) Knowledge of ultrasound features of ovarian cancer and the features of advanced disease
(c) Extraovarian lesions
(i) Knowledge of the principles of conducting ultrasound examination in chronic pelvic pain.
(i) Knowledge of typical morphological features of endometriosis, and pelvic adhesions. The Pre-conception and Pre-natal Diagnosti c Tedm(x:g ues (Prokibition of Sex Selection) ix Months Training) Rules, 2014 @ Gi)
(i) @v) W)
(vi)
(vii)
(viii)
(ix) (] 1)
(xii)
(xiii)
(d) Ultrasonography Anatomy of Abdomen
(i) Knowledge Base—Normal appearance
(ii) Abnormalities commonly found (iii} Reporting of Mass lesions @iv) Measurements—specific locations and Proper Techniques
2. Skill sets Ability to consistently identify and examine th e uterus, ovaries, adnexa and pouch of Douglas. Ability to assess cyclical endometrial chang es and endometrial responses to the combined pill and other hormo nal preparations Ability to. assess the uterine size and to accurately measure endometrial thickness. . Ability to assess ovarian volume and functi onal changes in the ovaries and adnexa during menstru al cycle : follicular appearances, variation in the morphology of corpora lutea, functional cysts, fluid in pouch of Douglas. Ability to diagnose uterine fibroid s, measure their size and assess their relation to the endometrial cavity. :Correlate ultrasound findings to clinical symptoms. Ability to assess fibroids and adenomyosis and differentiate where possible. ; Ability to interpret the measurement of endo metrial thickness in the clinical context. » Ability to differentiate between focal and global endometrial To be able to identify Intra-uterine Contraceptive Device and its location within the uterus. Ability to perform ultrasound examinat ion combined with palpation in order to accurately identify the origin of pelvic lesion and interpret this in the dlinical context . . Ability to assess the size of adnexal le sions including mean -diameter and volume. . Ability to approach the assessment of ad nexal lesions in a . systematic way. Familiarity with stand ardised terms and " definitions to describe sonographic features of adnexal lesions. Ability to diagnose simple functional and haemor rhagic cysts, polycystic ovaries, dermoids and endomet riomas based on -subjective assessment alone. -
(xiv) Ability to recognise abnormal pelvic fluid/ascites.
(xv) Ability to take a good clinical histo ry in order to facilitate differential diagnosis of pelvic pain. The Pre-conception and Pre-natal Diagnostic Te ‘echniques (Pro hibition of Sex Selection) il (. gr.’:l Months Tminir{g) Rules, 2014
(xvi) Be able to assess tenderness and mobility of pelvic organs including the pouch of Douglas on transvaginal u ltrasound scan.
(xvi) Ability to recognise ovarian endometriomas, hydr osalpinges, the consequences of pelvic adhesions and peritoneal pseudocysts on ultrasound scan..
(a) (1) Gynaecological ultrasound
(i) Accurate measurement of the
(ii) endometrium in the accepted sagittal plane
(iii) Assessment of the adnexal regions : accurate identification of the normal ovaries, n ormal . fallopian tube, normal pelvic fluid
(iv) Accurate measurement of normal and abno rmal adnexal structures; mean diameter and volume
(v) Recognise and evaluate common endom etrial and myometrial abnormalities
(vi) Recognise and evaluate common ov arian abnormalities
(vii) Recognise and evaluate complex ovaria n masses and refer on appropriately
(vili) Communicating normal results to patients . (ix) Communicating appropriate abnormal results to patients
(x) Producing written summary and interpretation of results
(xi) Issue structured written repori
(xii)~ Atranging appropriate follow up or intervention
(2) Skill Set . . () Ability to consistently identify and exam in Abdominal structures
(ii) Identify Normal
(i) Identify Common Pathological Lesions
(iv) How and When to seek further opinion () Liver and Spleen or Biliary System or Gall Bladder. of Pancreas Patient preparation and Scaning Techniques —Sonographic Anatomy : () Liver—Diffuse liver disease, Fatty Liver, Grades, Acute hepatitis, cirrhosis and portal hyperten sion, Focal Mass lesions—Cystic Lesions or Solid Le sions
(ii) Spleen—Splenomegalyor Focal splenic mass—S olid mass, cysts, subphrenic abscess .
(iii) Gall Bladder—Cholelithiasis or GB filled with calculi or Atypical calculus or Pitfalls T U W 70 ‘The\Pfe-bncepfian and Pre-natal Diagnostic Techmgues ( Prohibition of Sex Selection) ; (Six Months Training) Rules, 2014
(iv) Pancreas—Inflammatory Acute pancreatitis _ (pancreatic and extrapancreatic m anifestation " (a) Pseudocystor ‘Chronic Pancreatitis or Neoplasms (solid.and cystic looking) {c) Prostate
(i) Sonographic anatomy (prostate, s eminal vesicles)
(i) Technique (transabdominal approach)
(iii) To identify central zone and periphe ral zone or Measurement of prostate volume
(iv) Pathology
(a) - Benign hypertrophy Prostatitis ‘(b) Prostatic abscess Cancer of prostate (@) Urinary System Kidneys & ureters...scanning technique
(e) Kidneys
(i) Sonographic anatomy
(i) Echogenicity, corticomedullary demarcation, rena sinus, Hypertrophied
(iii) Column of Bertin
(iv) UREIERS Congenital anamolies (agenesis, ectopia duplex collecting system and uretroce le)
(v) Hydrpnephrosisor Renal calculus or Infection o Tumours or Mimics of calculus
(vi) Nephrocalcinosis or Pyelonephiotis, pyonephrosi: rénal and perinephric abscess; chr. Py elonephritis ¢ Tuberculosis or Renal cell carc inoma, spectrum ¢ : sonographic appearance or Angio lipoma | (vii) Benign Cystic lesions (simplecorica l cyst, : ,# cortical cyst, parapelvic cyst)
(viil) Polycystic kidney disease i) Bladder . (i) Bladder calculus, bladder vol ume measurement.
(i) Bladder wall (technique of thickness measurement
(i) Bladder mass, cy stitis [\)} Conten‘;s—Section Three : Basics of obstetric scanning al interpretation in all trimesters—3 Modiiles ;
1. Modile 1 Early pregnancy : Trans -abdominal ultrasound examinatio r early pregnancy comple - e T m — — T i T — 72 The Pre-conception and Pre-natal Diagnos tic Techn(x‘gyes (Prohibition of Sex Selecti on) ix Months Training) Rules, 2014 placenta Tl Module 2—Basic : Uitrasound assessment o f fetal size,
(ii) Ability to measure gestational sa c size and crown-rump length.
(ii) Ability to identify early cardiac ac tivity using B- mode.
(iv) Identify fetal number
(v) Ultrasound diagnosis of early embr yonic demise
(vi) Ultrasound assessment of a woman with suspected ectopic pregnancy
(vii) Ability to establish the diagnosi s of multiple pregnancy with confidence a nd to assess chorionicity and amnionicity.
(viii) -Ability to diagnose early e mbryonic demise based on assessment of gestat ional sac size and/ or crown-rump length. Ide ntify, assess and measure retained products of conception in women with incomplete miscarriag es.
(ix) Ability to correlate clinical, morp hological and biochemicat findings.
(x) Ability to evaluate adnexa in a systematic and effective way and to interpret the findings in a Cinical context. Identify the si te and the number of corporalutea.
(xi) Identify tubal and non-tubal ectopic pregnancy and examine for the presence ofa yolk sac or an embryo. Assess the amount and quality of fluid in the pouch of Douglas. (xif) Seek help with confirmation of diagnosis and further management.
(xiii) Recognise limits of competency .
(xiv) Know limits of ow n ability and when to re fer for further opinion Accurate documentation of measurements.
(xv) Producing written summary and interpretation of results.
(xvi) Communicating normal resul ts to parents.
(xvii) Communicating abnorm al results to parents.
(xviii) Arranging appropriate ref erral, follow up or intervention. liguor and the 73 The Pre-conception and Pre-natal Dingnostic Tzchnis:]ues (Prohibition of Sex Selection) (Six Months Training) Rules, 2014 (@) The aims of the module : To gain basic competences that are potentially useful in dayto-day obstetric practice, including lie, presentation, placental site and liquor assessment. Basic biometry techniques will be taught but competence to the level of ‘independent practice’ is not required.
(b) The knowledge base
1. Biometry
(i) Awareness of the various lies and presentations
(ii) Fetal growth or Physiology
(iii) Pathology (A) Maternal (B) Placental (C) Fetal “(iv) Fetal biometry or Anatomical landmarks or Reference charts or Interpretation (including variability) {v) Calculation and value of : (A) Ratios (B) Estimated fetal weight
2. Amniotic fluid
(i) Amniotic fluid volume or Physiology or Change with gestation or Pathology
(ii) Ultrasound measurement (iti) Subjective vs. objective
(iv) Max vertical pocket or Amniotic Fluid Index
(v) Reference charts .
(vi) Interpretation (including variability)
(vii) Oligohydramnios
(viii) Definition and associations
(ix) Polyhydramnios {x) Definition and associations
3. Placenta
(i) Ultrasound assessment of site
(i) Indication for Transabdominal and transvaginal ultrasound (iii} Placenta praevia
(iv) Classification {v) Management The Pre-conception and Prenatal Diagnostic Tzchm'gyes (Prohibition of Sex Selectio n) (Six Months Training) Rule s, 2014
(c) Skill Sets
(i) Accurate measurem Circumference, Ab Length i
(i) Accurate d | observations, i
(i) Assessment of liquor volume L
(iv) Be able to perform and int erpret assessment o f | Amniotic Fluid Volume , ‘meximum vertical pool depth i and Amniotic Fluid In dex using ultrasound ent of Bi—parietal D iameter, Head dominal Circumferen ce, Femur ocumentation of measurements and including chart plotting
(v) Measurement of Am niotic Fluid Index
(vi) Assessment of liqu or vols
(vii) Measurement of Maximal
(viii) Assessment of placental positi on using abdominal route
(ix) Arranging appropria te follow up or referr al
(x) Producing written summary and inte rpretation of results
(xi) Communicating normal results to pa rents .'I
(xii) Maintain awarene ss of limitations of o wn competence . I, Module3: Interm ediate : Uttrasoun d of normal fetal ana torny
(a) The aims of the mo dule : The overall aim of this module is to e nsure that the trai nee i understands the indi cations for a fetal an atomy scan is able to perform the scan safely and compete ntly and to report the findings of the sca n.
(b) Learning outcomes The trainee should b e ableto:
(i) take aproper clini cal history-
(ii) carry out ultraso und examination in the appropriate . - environment wi th respect to th e patients priva cy, . cultural and religio us needs.
(i) understand the normal morphol ogical ultrasou nd _appearances of the fetus and it s environment. anatomy. @(iv) " diagnose norma l fetal
(v) -beaware of the n ormal anatomical var iants.
(vi) understand the Y imits of their co mpetence an need to seek advice where appropriate . {vit) Communica te the results to the parents.
(vii) writea structure d report-
(x) learnwhento refe r patients where a ppropriateume Vertical Pool Depth g the transd the T ——————— 75 The Pre-conception and Pre-natal Diagnostic thhn?ues (Prokiibition of Sex Selection) (Six Months Traininig) Rules, 2014
(c) The knowledge base () Know anatomical landmarks for pérforming standard fetal measurements Bi-parietal Diameter, Head Circumference, Abdominal Circumference, Femur Length.
(i) Recognise normal appearance of fetal structures and appreciate different appearance at different gestations.
(iii) Know the detection rates of common anomalies.
(iv) Provide parents with necessary information in a form they understand.
(v) Communicate scan findings and information given to parents to other health professionals,
(d) Skill sets
(i) Identify fetal position within uterus
(ii) Be able to move probe with purpose to identify
(i) fetal structures :
(iv) Be able to consistently and systematically identify the features described in an “optimal” anomaly scan. Be able to perform standard fetal measurements Bi- parietal Diameter, Head Circumference, Abdominal Circumference, Femur Length including and also transcerebellar diameter, ventricular atrial diameter and Antero-posterior diameter of the renal pelvis
(v) Identify placental site -
(vi) Recognise limits of competency
(vii) Recall patients appropriately for further scans if structures not seen clearly
(vili) Accurate measurements of Bi-parietal Diameter, Head Circumference, Abdominal Circumference, Femur Length, Transverse Cerebral Diameter and lateral atrial diameter of the cerebral ventricles
(ix) Confirm normal anatomy of head and face
(x) Confirm normal anatomy of spine
(xi) Confirm normal anatomy of heart and chest
(xii) Confirm normal anatomy of abdomen
(xiii) Confirm normal anatomy of limbs {xiv) Perform full anomaly scan
(xv) Recognise common structural anomalies .
(xvi) . Locate and assess placenta .
(xvii) Assess liquor volume \
(xvii) Provide parents with information about
(xix) Normal scan findings 76 The Pre-conception and Pre-natal Diagnostic Technigues (Profiibition of Sex Selection) (Six Months Training) Rules, 2014
(o) Abilities and limitations of ultrasound
(xxi) To be aware of the limitations of this technique and know when to refer (Ocxif) o be able to discuss with parents the possibility of an abnormality and the need for a further opinion (K) Contents— Section Four “The Pre-conception and Pre-n
1. Introduction to the problem of declining child sex ratio and provisions of the Pre-conception and Pre-natal Diagnostic Techniques (Prohibition of Sex Selection) Act. Continuous decline in child sex ratio since 1961 Census is a matter —of concern for the country. Beginning from 976 in 1961 Census, it declined to 927 in 2001. As per Census 2011 the Child Sex Ratio (13 6 years) has dipped further to 919 against 927 girls per thousand boys recorded in 2001 Census. Child sex ratio has declined in 18 States and 3 UTs and except for the States of Himachal Pradlesh (909), Punjab (846), Chandigarh (880), Haryana (834), Mizoram (970), Tamil Nady (943), Karnataka (948), Delhi (871), Goa (942), Kerala (964), Gujarat (890), Arunachal Pradesh (972), and Andaman and Nicobar Islands (968) showing marginal improvement, rest of the 21 States/ UTs have shown decline. atal Diagnostic Techniques (Prohibition of Sex Selection) Act.” “An Act to provide for the prohibition of sex selection, before or after 2 conception, and for regulation of pre-natal diagnostic techniques for the purposes of detecting abnormalities or metabolic disorders or chromosomal abnormalities or certain congenital malformations or sex-linked disorders and for the prevention of their misuse for sex determination leading to female foeticide and for matters connected therewith or incidental thereto.” Implementation of the Pre-conception and Pre -natal Diagnostic Techmiques (Prohibition of Sex Selection) Act, 1994 : The Pre-natal Diagnostic Techriiques (Regulation and Prevention of Misuse) Act was enacted on September 20, 1994 and the Act was further amended in 2003. The Act provides for the prohibition of sex selection, before or after conception, and for regulation of pre- natal diagnostic techniques for the purposes of detecting genetic abnormalities or metabolic _disorders or chromosomal abnormalities or certain congenital malformations or sex linked disorders and for the prevention of their misuse for sex determination leading to female foeticide and for matters connected therewith or incidental thereto. The Act is implemented through the following implementing bodies :
(i) Central Supervisory Board
(i) State Superviso, ry Boards and Union Territory Supervisory Boards 77 The Pre-conception and Pre-natal Diagnestic Techniques (Prohibition of Sex Selection) grx Months Training) Rules, 2014 — - —~=~{iii) Appropriate Authority for the whole or a part of the State or Union Temtory . . . - T = iv)" Staté Advisory Commmee and Umon Territory Advisory . Committee S -Advisory Committees for deslgnatedtareas (pan ‘of the Stxte) . attached to each Appropnate Authonty ppropriate Authorities at the levels "Rzgrstranon ppropnaleAuthonty—ofthe dlstflct espons le - = yrof ultrasound dmgnosnc facilities. A -Applxmtmn feern . I~ - i Counsellmg Cenh-e, ‘Genetic ¢, Ultrasound Cllmc or Imagmg Gnmc or Imagmg Cemre orany. combi 2 )Manda ory Displays at ultmsuumi f 1) .-Pre-conception and P i chmques (PC . d PNDT) Certificate : 1t i manaatory for every clinic or he I’re—concepuan Act'to display the a vconsp:cuous iplace at such and.local language ed’a tlhe concerned . Te=Cofcept éption hd” Pr es Act mus
(1) . Every cemficatev G emYeAs a ((2) Renewal | of registration 1 to expu-y "of the Certificate’of F eglstran ) Mnndalcry mmhtz i:freoo)fls Regzsrer’s
(1) Narnes ard ddresses ij'flen’(’)r womeén. subfiflt pre- natal W 11 diagnostic procedure or test; IR 2B FI5(2) + Names of their ’s:pouses or fatheré, e W«V? v 1 #(3) Dite jon Which they‘ *reported forEudh tounselling, FF B {procedure or test. . 1 o3 7 1 e R i@ arsk Ty ERFTE 8 {8 :7A ‘morithly teport shou]d ‘bersibmitied to'the Appropriate e a1 Authority regularly; before the Sthof every:month. A copy e of -same” monthly” reports with the (sighatire of the " Appropriaté Aut onty acknowledg recenpk must be preserved. : 1 e gy 78 The Pre-conception and Pre-nntal Diagnostic Teclmigues (Prohbition of Sex Selection) glx Montits Training) Rules, 2014
8. Preservation of the following duly completed forns (i} FormF
(ii) Referral Slips of Doctors
(iii) Forms of consent
(iv) Sonographic plates or slides
9. Record storage : All above records should be preserved for 2 years
10. Powers of Appropriate Authority : i
(1) Appropriate Authority can enter freely.into any clinic or . __facility for search and seizure, _ e LT (2) ‘Examine and inspect the registers, records mcludmg consent ERRE forms, referral slips, Forms, sonographic plates or slides and . .. equipment like ultrasonography machines. .. s (3) Toensure presence of at Jeast two independent witnesses of . thesame locality or different locality during the search. 11 For further Do’s and Dor'ts about following the Pre-conception and Pre-natal Diagnostic Techniques (Prohibition of Sex Selection) Act and rules a Handbook of Pre-conception and Pre-natal D:agnosnc Techmques Act fules with' Amendments published by 4 mxstry of Henllh, Government of India has made avallable online on P 1" S e : SSchedule-ll ¥ - ) IR ‘LOGBOOKANDASSESSM'ENT
1. TheLngbock T e e v “The Logbook fecords’ the” h'ammg achvnty, tuforials and self-directed VT Aeatning undertaken'and competenciés achieved. Maintenance and regularreview of the logbooks during interim assessments will allow the Principal Trainer and Traineejto monitor progress and .« + identify deficiencies over the course of training. The Trainer will sign the - fipproprlate sections of the Logbook documenis with regard to attendance, skill and competence. Itis lmperatwe that all participants appreclate that the Trainee's progress "has to.meet standards that satisfy the Trainers, At'the end of the training programme, the Principal Trainer - has'tocertify that the competencies and skills attained by the Tramee are / I/iher satisfaction. - ene 2 . i) Training Plan Level 1 exercise to be performed under direct supervision : At this initial assessment; a training plan should be agreed between the ;_‘Prmcnpal Trainer and the Trainee, using the competency, skills and attitudes lists to set the leaining ob]echvés *(This should include, identifying a theory course to be attended within 6 months of induction assessment, if not already ‘undertaken. ) The initial learning objectives ‘and the’aétivity ‘plan to ineét thesé should be'tailored to the-individual +Jedrning néeds of the Trainee: Subsequent learning objectives should be v LAt ) 79 The Pre-conception and Pre-natal Diagnostic Techmgus (Prohibition of Sex Selection) ix Months Training) Rulcs, 2014 @ set at interim assessments until the Trainee has attained all the competencies, skills and attitudes on the lists. It is the Trainee’s responsibility to undertake this planned learning. The Principal Trainer should guide this, but need not undertake all training themselves. In addition to the recording of competence, the logbook also contains sections for the recording of ultrasound images and basic clinical details of clients seen by the trainee. The ultrasound images should be of high quality and demonstrate aspects of the ultrasound scan which are pertinent to the clinical case and should have been obtained by the trainee. The trainee should review suitable images with the Trainer, prior to attaching them to the logbook. This logbook is intended to record experience of ultrasound imaging in clinics where clients are referred for ultrasound imaging as part of the management of their abdomino-pelvic and gynaecological conditions (early pregnancy clinics, pre-abortion assessment clinics, etc.) either in hospital or community setting. It also: {a) Provides a summary of the syllabus in the form of a list of necessary competencies.
(b) Records the outcomes of the learning objectives agreed between you and your Trainers.
(c) Provides a record of your achievements as you attain competence in the required areas.
(d) Records the certified assessment of your competence when applying for the Certificate. .
(e) Provide a permanent record of interesting cases to act as a reference for future practice. Minimum Number of Scans for Level-1 Training (Total 200 cases) Obstetric Scans Viable Pregnancies 10 Non-Viable Pregnancies 10 Normal Biometry 10 Growth Restrictions 10 Abnormal Pregnancy 10 {ectopic or multiple etc.) Gynaec 10 IUCD’s 5 Fibroids 10 Ovarian Cysts 10 Gynaec Disorders 10 Non-Obstetric Scans Normal abdominal Scan Gall Stone Disease 20 10 80 The Pre-conception and Pre-natal Diagnostic Techm ‘gues (Prohibition of Sex Selection) (Six Months Trainiig) Rules, 2014 Extra hepatic Biliary Channel 5 Hepatic Solid Masses 5 Hepatic Cystic Lesions 5 Pancreas 5 Urinary 25 Normal Scan 10 Cystic lesions of Kidney including Hydronephrosis 5 Solid lesions of Kidneys 5 Ureteric and Bladder Stones 5 Prostate 5 Observations— Transvaginal Scan 10 Color Doppler Studies Obstetric 10
2. Assessment As well as the initial assessment, the Pri ncipal Trainer must perform at least one interim assessment to check t he Trainee’s progress and the summative (final) assessment of compete nce. The Principal Trainer has to certify that the competencies and skill s attained by the Trainee are to his/ her satisfaction. It is the responsibility of the independen t examiner to be nominated by Director, Medical Education Department of the concerned State to certify final competence, in order to exit the traini ng programme.
(1) Guidelines for Assessors
(a) Assessors may be Ultrasonographers, Obstetricians or Gynaecologists or doctors experience d in ultrasonography.
(b) Assessor should explain to the pers on being assessed, that the purpose of this exercise is to assess te chnical competence. (¢) The trainee should perform the procedu re based on his/her usual practice. The trainee and trainer should fill in the forms separately and use them to inform discussion foillowing observation of the trainee. The assessment is designed to assess technical skills. It enables discussion on technique and wi ll allow discussion on why the trainee acted as she/he did.
(d) It is planned that each trainee sh ould be assessed by Objective Structured Assessment of Technical Skills at least twice in 2 training programme; by different asses sors, one of whom should be the Independent Examiner, as part of the summative assessment. (¢) Trainees must already have achieved competence (direct supervision), in the procedure being eva luated. For each procedure, the following mus t be completed : The Pre-conception and Pre-natal Diagnosti c Techniguzs (Prohibition of Sex Selection) (Six Months Training) Rules, 2014
(a) Itemised Checklist Score
(b) Objective Structured Assessment of Technical Skills assessment sheet It is not necessary to obtain written consent from patients, but it would be prudent to say that the Trainee is part aking in an assessment with full supervision. Patients may choose n ot to be part of the assessment pl'OCESS. 3 copies of the forms should be kept;
(a) One for the trainee’s portfolio
(b) One for the Principal Trainer {c) One to go back to the Faculty with all forms when the certificate is applied for.
(2) Objective Structured Assessmen t of Technical Skills (OSATS) (A) BASICSKILLS Level 1 Level 2 Trainer to sign and skill date when competence achieved Super- Indepenvised dent Machine set-up Counselling for scan Decide transabdominal vs. Transvaginal route Choice of probe Patient positioning Orientation Identify normal Endometrium Identify normal Myometrium Tdentify normal ovaries ‘Moeasure cervical length Recording images Note keeping Special Remarks (B) EARLY PREGNANCY | Levell Level 2 Trainer to sign and date when il sk competence achieved Supervised Independent Confirm viability | | - The Pre-conception an d Pre- -natal Diagnostic Te:l m(igue s (Prohibition of Sex Sel ection) ‘Months Training) Rules , 2014 (B) EARLY. I’REGNAN CY ‘Levél T skl - - s 1 PR - Level2 Trainer to sign and date when . competence “; achieved T | Supervised | Independent Date pregnancy Diagnose corpus lute um cyst D\agnost;. multiple—- pregnancy-r. P Tdentify retroplacemal }\aematoma B pregnancy Dlagnosenusse iiscarriage & 2 =~ D;agnosuetamed pro ducts of conception —«= 3] Counselling for faxled -~ pregnancy A DT B "Diagnose ectépxc p regnancy”] f rec\alRemarks I D 1 (C) MENORRHAGIA Sklll "Lé:vel‘l* b ] “level 2377 Supervised - 1dennfy subriiicous fibroxd*‘ Idenhfy‘mh'amural fibrmd = 7 Tdentify subserou s and ~ ! penduncnlafied f ibroid * . ] Idenhfyaflenomyos ns st !‘ Gpecial Remarks - T 1 D) "POSTMENOPS A AND: .-Ta-mner tosxgl'\fi NSTRUAL Sy ", - ;fi{ N I 'yand datewhen Y BlrEEDING 6 A ‘ T ! compe!ence i i . i achxeved i ) Measure endumemal vl S amsuiet SN -thickness 83 The Pre-conception and Pre-natal Diagnostic Tz:h mgues { ‘Prohibition of Sex Selection) fonths Training) Rules, 2014 (D) POSTMENOPSA AND INTERMENSTRUAL BLEEDING Skill Level1 Level 2 ‘Trainer to sign and date when competence achieved Supervised Independent Identify atrophic endometrium Identify hyperplastic endometrium Identify endometrial polyps Identify functional ovarian tumours rSpecial Remarks ] (E) PELVIC MASS Skill Level 1 Level 2 Trainer to sign and date when competence achjeved Supervised Independent Identify mass as uterine Identify unilocular ovarian mass Identify complex ovarian mass Identify ascites [ Special Remarks ] (F) REPRODUCTIVE MEDICINE Skill Level 1 Level 2 Trainer to sign and date when competence achieved Supervised Independent Tdentify cyclical changes in endometrium Tdentify cychical changes in ovary Tdentify polycystic ovary Locate Intra-uterine Device or Intra-uterine System position in uterus 84 The Pre-conception and Pre-natal Diagnostic Techniques (Prohibition of Sex Selection) (Six Months Training) Rules, 2014 i (F) REPRODUCTIVE Level 1 Level 2 Trainer to sign MEDICINE and date when ! il competence skl achieved Supervised | Independent EXTRA PELVIC SCANS Identify normal placement of Implanon Locate non-palpable Implanon [Special Remarks ] ] (G) GENERAL ABDOMEN | Level1 Level 2 Trainer to sign Skill . - | and date when competence achieved Supervised | Independent LIVER AND SPLEEN or BILIARY SYSTEM . - ) 7] - Patient preparation and Scanning Techniques- Sonographic Anatomy ~ Diffuse liver disease Fatty Liver, Grades i Acute hepatitis, cirrhosis K | and portal hypertension - Focal Mass lesions-Cystic . : .o - - Lesions or Solid Lesions Spleen-Splenomegaly or | E -~ - Focal splenic mass-Solid mass, cysts, subphrenic abscess [ Special Remarks - - - ] (H) GENERAL ABDOMEN | Levell Levet 2 Trainer to sign i Skill and date when a . ]l competence - . +achieved l . Supervised | Independent e URINARY SYSTEM ’ b Kidneys & ureters... B scanning technique : 8 The Pre-conception and Pre-natal Diagnostic Tedm(rgues (Prohibition of Sex Selection) ix Months Training) Rules, 2014 (H) GENERAL ABDOMEN Skill . Level 1 Level 2 Trainer to sign and date when competence achieved Supervised Independent Sonographic anatomy Echogenicity, corticomedullary demarcation, renal sinus, Hypertrophied Column of Bertin URETERS Congenital anamolies (agenesis, ectopia, duplex collecting system and uretrocele) Hydronephrosisor Renal calculus or Infection or Tumours or Mimics of calculus Nephrocalcinosisor Pyelonephrotis, pyonephrosis, renal and perinephric abscess, chr. Pyelonephritis or Tuberculosis or Renal cell carcinoma, spectrum of sonographic appearance or Angiolipoma Benign Cystic lesions (simple corical cyst, complex cortical cyst, parapelvic cyst) Polycystic kidney disease [Special Remarks = (I). GENERAL ABDOMEN Skill Level 1 Level 2 Trainer to sign and date when competence achieved Supervised Independent BLADDER Bladder calculus, bladder volume measurement 86 The Pre-conception and Pre-natal Diagnostic Tzclznigues (Prohibition of Sex Selection) (Six Months Trainiig) Rules, 2014 (I) GENERAL ABDOMEN Level 1 Level 2 Trainer to sign Skill and date when competence achieved Supervised | Independent Bladder wall (technique of thickness measurement) Bladder mass, cystitis [Special Remarks ] (J) GENERAL ABDOMEN Level 1 Level 2 Trainer to sign Skill and date when Cumpetence achieved Supervised | Independent GALL BLADDER or ' PANCREAS Gall Bladder— Cholelithiasis GB filled with calculi or Atypical calculus or Pitfalls Pancreas—Inflammatory Acute pancreatitis pancreatic and extra pancreatic manifestation Pseudocystor Chronic Pancreatitis or Neoplasms (solid and cystic looking) [ Special Remarks | (K) GENERAL ABDOMEN Level 1 Level 2 Preceptor to sign Skill and date when competence achieved Supervised | Independent PROSTATE Sonographic anatomy (prostate, seminal vesicles) Technique (transabdominal approach) To identify central zone and peripheral zone or Measurement of prostate volume wes (Prokibition of Sex Sele ction) 87 The Pre-conception and Pr e-natal Diagnostic Techm'g _ 0 - (Six Months Training) R ules, 2014 (K) GENERAL AB DOMEN Level 1 Level 2 Preceptor to sign ! skill and date when ' : ‘| competence achieved ‘ Supervised Independent Pathology—Benign hypertrophy Prostatitis Prostatic abscess—Canc er of prostate | I Special Remnarks i GUIDELINES FOR A SSESSMENT FOR FI NAL EXAMINATION Minimum pass marks —TFor practicals 60 an d Theory 50°
1. THEORY ASSES SMENT
(a) 100 marks—two ‘ho urs .
(b) 50 multiple choice quest ions of one mark each = 5 0 marks ks each = 50 marks
(c) 10 short answers with fi ve mar’
(d) Short Question will ha ve a defined space for the candidate to fit answer . (@ PRACTICAL ASSESSMENT FINAL EXAMINATION
(a) 20 marks forlog book
(b) 50 marks for demonstrations .
(c) .30 marks viva Rl (») PRACTICAL ASSESSMENT coM ASSESSMENT
(a) 60 marks for demonstrations
(b) 40 marks viva Note : The examiner can choose any FIVE for Fin al Examination and SIX for Competency Based Assessment of th ese TEN for demo and allot 10 mar ks each] 1L PETENCY BASED H 3 Step1: Preparation %
1.1 Equipment preparation - 12 Patient preparation
1.3 Operator preparation 14 Expose the lower abdomen and apply the gel 15 Select the transducer Step 2: Commence the growth and high-risk pregnancy scanning
2.1 Patient position 22 Scanplane protocol
1. Substituted by Notific ation No. GSR. 419(E ) dated 26-6-2020, w.e f. 29-6:2020. The Pre-conception and Pre-natal Diagnostic Techn(iguzs (Prohibition of Sex Selection) ix Months Training) Rules, 2014
2.2 Transabdominal scan plane Endovaginal scan plane
2.3 Standard second and third trimester protocol image requirements
1. Fetal lie, life, number, presentation and situs
2. Maternal uterus and adnexae
3. Amniotic fluid and placental location
4. Fetal biometry .
5. Fetal anatomy Step 3 :Overview of second and third trimester routine ultrasound Step4: Step5: Step 6: Step7: Step 8: Step 9: examination Perform targeted scan relevant to clinical condition of fetus and/or mother
4.1 Scan for multiple pregnancy Scan for intrauterine growth restriction
5.1 Fetal biometry, growth, and weight Scan for amniotic fluid and membranes
6.1 Calculate the amniotic fluid volume Scan for placenta and umbilical cord abnormalities
7.1 Placenta
7.2 Umbilical cord Scan for fetal biophysical prefile Scan for fetal complications of maternal disease
9.1 Fetal hydrops
9.2 Maternal diabetes
9.3 Maternal hypertension and pre-eclampsia
9.4 Other maternal diseases Step 10 Demonstrate—to assess general abdominal scan—maternal liver/gall bladder/kidneys 1[IIl. VIVA—30 marks on three case situations ‘for Final Examination and 40 marks on four case situations for Competency Based Assessment] Clinicosonographic co-relation Video clip and case studies
1V. CASESTUDY [ Case Number : ) ] Date : I Preliminary data rUltrasonography Findings rlmpressior\s I Key Learnings Substituted by Notification No. GSR. 415(E) dated 26-6-2020, we.£. 29-6-2020,