PNDT Guidelines; nursing home; diagnostic centre, rules; violations: Dr. Sanjeev Mani
M3 India Newsdesk Oct 24, 2018
Dr. Sanjeev Mani, a prominent Radiologist explains the guidelines and standard operating procedures that need to be followed by doctors, hospitals, and sonography centres as part of the Pre-Natal Diagnostic Techniques (PNDT) act.
These are the guidelines that are required for ultrasound owners for registration and use of ultrasound machines and are applicable across India. A brief description of the violations and penalties has also been listed.
Registration and Use of Machines
- The owner needs to register, at least 3 months in advance (if he/she has decided on a particular time-bound start to the centre), all the places where a USG machine, whether a black and white or colour Doppler machine, is to be used. This applies to medical/surgical nursing homes/intensive cardiac care unit and wherever a USG machine is used.
- The registration is compulsory and is regardless of the type of studies intended to be performed on that machine, whether pregnancy scans, abdominal scans, or only 2D echocardiograms. All centres should be registered.
- Hospitals that are starting a sonography clinic/centre also need to register. The name of the Hospital Director/Owner will be listed as “owner” in the Certificate.
- All radiologists/sonologists/doctors using USG machines need to have their names entered in the PC-PNDT certificate or on a separate sheet that must be displayed along with the PC-PNDT registration certificate.
- These doctors should be qualified to perform ultrasound according to their degree/ diploma certificate.
- At present, under the PC-PNDT Act, a Radiologist should have a degree or diploma, that is MD or DNB in Radiology, and DMRE in certain states for students who have passed from CPS
- Gynaecologists & Obstetricians who have an MD or DGO qualification are also qualified to perform an ultrasound
- For all other doctors, a 6-month certification course is required to be able to perform an ultrasound
Recent rulings in High Courts of various states have prevented certain institutes from conducting 6-month courses as was being done in the past, and the Government has created a 6-month training program to be conducted in certain hospitals across the country. A case is currently in progress in the Supreme Court of the IRIA versus other medical bodies with regards to who can perform an ultrasound.
Hence in many states, status quo is being applied, while some states are asking for 6-month certification course from Government registered institutes for new registrations The registrations for Radiologists & Gynecologists continues without any interference if all documentation criteria have been met.
- No doctor other than the one registered in that particular centre may use the machine installed there and other qualified doctors may use the machine at that centre only after notifying the appropriate authority (AA).
- In the case of a locum doctor, the doctor's name and personal details, state council registration number, and his/her degree certificate need to be sent to the AA/ward office, accompanied by a covering letter from the clinic owner requesting permission for the use of the machine by the locum on the specified dates. Some cities and states may give this acknowledgement only after a month, so prior intimation for locum is always better. Any doctor performing an ultrasound without being registered in that centre constitutes a major violation of the law.
A recent Gazette notification has stated that application for locum for adding a doctor's name to the Registration Certificate needs to be done 30 days in advance; this gazette has been challenged by IRIA in Delhi High Court, and interim relief has been given of 7 days.
- The USG machine should not be shifted from one centre to another.
- One centre can have multiple USG machines, but the manufacturer's name and the makes and models of the machines should be noted in the PC-PNDT registration certificate (all ultrasound machines available at that centre should be registered on the certificate or on a separate attached sheet).
- In hospitals, the USG machine can be moved from one floor to the other (i.e. from an ultrasound department to the ICU), but should be brought back to the department once the test has been completed.
- Any changes in the centre (e.g., change in machine or place of use) should be intimated to the AA 30 days in advance.
- Any change of the doctor operating the machine should be intimated to the AA within 30 days.
Record keeping and Information to be displayed at the clinic/centre
- All records (including images) of all the patients are to be maintained for a minimum of 2 years. If any legal case against the centre is pending then the concerned records should be maintained till the same case is disposed of.
- The PC-PNDT registration certificate has to be displayed in original in the reception area and the USG room. If there are more than two rooms where sonography is performed, the original has to be displayed in both rooms as well as the reception area (request for more originals can be submitted to the AA/ward office). Usually, some AAs do not issue more than 3 or 4 certificates (this varies from state to state), so a colour photocopy of the same can be placed in each USG room (both in the scan room as well as reception area). The law states that the certificate needs to be displayed in a prominent place, but usually, AA s ask for it to be displayed in the waiting room as well as the USG room.
- There should be a board, prominently displayed, with the message in English and the local language that 'Sex selection and detection is not done in this centre and is punishable under the PC-PNDT Act'. This should be displayed in the waiting area and the USG room. No specific size for the message is suggested. There is no particular size designated for this. Some AA’s believe it should be 3 x 2 square feet, while for some an A4 size page will do. According to the law, any size is fine but the sign should be displayed prominently, where it can be read clearly.
- A copy of the PC-PNDT Act should be maintained in the centre and needs to be displayed in the waiting room/reception area as well as in the USG room. This is important, and it should be of the latest Act, that includes all recent amendments. The Act is almost always updated yearly, so its best to take a download from the website, or order from any official publisher.
- Form 'D' is to be maintained by genetic counselling centres only.
- Form 'E' is to be maintained by genetic laboratories.
- Form 'F' is to be maintained by USG centres/genetic clinics for pregnant patients only.
- All columns in form 'F' should be filled up; no column should be left blank, write "No" or "Not Applicable" wherever required. Please do not write short forms. Write Not Applicable and not “NA’.
- Previous obstetric history of patients, with the number of children and the sex of each child, should be mentioned in form 'F.'
- Form 'F' is to be filled up in duplicate: one copy is to be given to the AA (i.e., Medical Officer of Health of the ward) and one copy has to be kept at the clinic (records to be kept for 2 years).
- In the case of online submission of form 'F,' either a printout of the form with the patient's signature or another form 'F' has to be maintained at the centre (i.e., a hard copy has to be preserved at the clinic when form 'F' is submitted online.) Many AA’s tend to not take the monthly F form or Form F because many states have now gone online with the submission of data, but ideally, at least a monthly report form should be sent to the AA as hard copy.
- The name of the referring doctor and the indications and results of the USG examination must be mentioned in the form. This is important. It is mandatory to have a request letter from the referring doctor, with his/her name and degree, patient name, and reason for ultrasound clearly mentioned. In case of an emergency, if the patient comes directly to the clinic for ultrasound, the Radiologists/Doctor on duty in the clinic can make a request form on his/her letterhead, examining the patient, giving reason for the ultrasound, signing it with the stamp pad, and attaching it to Form F of the patient.
- Form 'F' should be signed by the doctor conducting the sonographic examination and not by the owner of the centre. The Radiologist/ Sonologist doing the test should sign the form and no one else.
- As per the Act, before the USG examination, a full explanation of the procedure must be given to the patient in her own language and a declaration of consent must be obtained, signed by both the patient and the doctor.
- All blank areas should be labelled as 'Not Applicable' / 'Nil'.
- A monthly report should be sent to the AA by the 5th of the month by all PC-PNDT-registered centres.
- For renewal of registration, an application has to be sent in advance (preferably 1 month in advance) to the AA. If this is not received the centre will be considered as unregistered and a penalty of Rs.15,000/- can be charged. The centre will also have to apply afresh for registration.
- Application form 'A' is to be submitted in duplicate, along with the documents of the USG machine and an undertaking, duly notarized, stating sex selection and sex detection will not be done at the centre. The undertaking should also state that the centre will display a message in English and the local language that sex selection and detection are not done at the centre and that the same is punishable under the Act.
- Advertisement of any sort is banned and is punishable under the Act with a fine of up to Rs.1 lakh and/or imprisonment for 5 years.
- The sex of the fetus should not be disclosed to the patient, relatives, referring doctor, or anyone else.
Part 2 covers quick FAQs and answers related to the PNDT act by Dr. Sanjeev Mani. Click on Do I need to give a notice for arranging locum sonologist? Dr. Sanjeev Mani answers FAQs on PNDT guidelines to read.
Dr. Sanjeev Mani is a Radiologist and Incharge of the Department of Imaging at Holy Family Hospital and the Chief Editor of Indian Radiologist. This article was written for the special PNDT issue of the IJRI in 2012, and has been updated according to current guidelines.
Disclaimer-The information and views set out in this article are those of the author(s) and do not necessarily reflect the official opinion of M3 India. Neither M3 India nor any person acting on their behalf may be held responsible for the use which may be made of the information contained therein.
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