Guidelines for ultrasound owners and owners of clinics, diagnostic centres, nursing homes and hospitals

 

Registration and Use of Machines

  1. The owner needs to register, at least 3 months in advance, all the places where a USG machine, whether a black and white or color Doppler machine, is to be used; this applies to medical/surgical nursing homes/intensive cardiac care unit and wherever a USG machine is used. This 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 centers should be registered.

  2. 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.

  3. No doctor other than the one registered in that particular center may use the machine installed there. 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.

  4. The USG machine should not be shifted from one Centre to another. One center 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 center should be registered on the certificate or on a separate attached sheet).

  5. Any changes in the center (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. A recent Gazette notification has stated that application for locum to 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.

Record Keeping and Information to be displayed at the Clinic

  1. 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.

  2. 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).

  3. 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.

  4. A copy of the PC-PNDT Act should be maintained in the center and needs to be displayed in the waiting room/reception area as well as in the USG room.

  5. Form ‘D’ is to be maintained by genetic counseling Centres only.

  6. Form ‘E’ is to be maintained by genetic laboratories.

  7. Form ‘F’ is to be maintained by USG Centres/genetic clinics for pregnant patients only.

    1. All columns in form ‘F’ should be filled up; no column should be left blank, write “No” or “Not Applicable” wherever required

    2. Previous obstetric history of patients, with number of children and the sex of each child should be mentioned in form ‘F.’

    3. 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 center (i.e., a hard copy has to be preserved at the clinic when form ‘F’ is submitted online.)

    4. The name of the referring doctor and the indications and results of the USG examination must be mentioned in the form.

    5. Form ‘F’ should be signed by the doctor conducting the sonographic examination and not by the owner of the center.

    6. 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.

    7. All blank areas should be labeled as ‘Not Applicable’ / ‘Nil’.

  8. A monthly report should be sent to the AA by the 5th of the month by all PC-PNDT-registered centers. (This is not needed if form ‘F’ is filled up online.).

  9. 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 as per the table shown below. The Centre will also have to apply afresh for registration.

  10. 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 center. The undertaking should also state that the center will display a message in English and the local language that sex selection and detection are not done at the center and that the same are punishable under the Act

    Miscellaneous

    1. 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.
    2. The sex of the fetus should not be disclosed to the patient, relatives, referring doctor, or anyone else.

 

VIOLATIONS

SECTION/RULE

OF

THE PNDT ACT

PENALTIES

Minor Offences

Non-availability of copy of the PNDT Act in the

registered centre

Non- Display of registration certificate in the centre.

Non-Display of Board in the premises in English and

Local Language that ‘Disclosure of the sex of the

foetus is prohibited under law’.

Rule No. 17(2)

Rule No. 6(2)

Rule No. 17(1)

For Minor Offences:

Case may be launched in the court of JMIC u/s 25 of the Act. Punishment may extend to 3 months or with fine, which may extend to Rs. 1,000/-for first offence. Additional fine upto Rs. 500/- per day for the period of contravention for subsequent offence.

Or

Show cause notice u/s 20(1),(2) for temporary suspension of registration.

Or

Under Section 20(3)

2. Advertisement relating to pre-conception and pre-natal determination of sex.

Section 22(1), (2).

U/s 22(3) of the PNDT Amendment Act, imprisonment which may extend to 3 years and with fine which may extend to Rs. 10,000/-.

Case is to be launched in the court u/s 28 of the Act

3. Unregistered centres. It includes all such centres

where any portable equipment capable of detecting s

ex before or after conception is used. The owner

of such equipment may be having a registered facility

somewhere else.

Section 3

under SECTION/RULE OF THE PNDT ACT it should be Section 23 instead of 3 and in penalties it should be u/s 23 instead of 28.

4. Irregularities in registered centre

Owner/employee conducting the ultrasonography

 not qualified.

More ultra sound Machines /equipments where

as less number register.

Minor deficiency in record

Keeping.

Section 3(2) and Rule

3(b).Under Rule 4.6

and as per Form ‘A’.

 Sr. No. 8

Under rule 9.

The Appropriate Authority or person authorized thereupon may:

Issue show cause notice u/s 20(1)(2) of the Act and with the endorsement of the Advisory Committee, may suspend (for a reasonable period) or cancel the registration, as per the magnitude of the violation.

May take Suo Moto action u/s 20(3) and suspend the registration without issuing show cause notice.

Note:

1.During the period of suspension of registration, the equipment needs to be sealed and signed and kept with the owner. After cancellation of the registration, the equipment has to be sealed and seized.

Any body aggrieved by the above decision may appeal to the higher-level Appropriate Authority within 30 days of the action. The appeal shall be disposed of by the higher authority within 60 days of its receipt.

5.Record Keeping

Irregularities in record keeping

 as per revised form ‘F’ are a major offence.

Section 4, 29 and

 Rule-9.

Contravention (a major offence) of provision of section 5 and 6 of the Act and punishable U/s 23(1) of the PNDT Act.

 

6. Sex Selection

 

 

 

Section 3A. 4(5). 6 read  with section 2(0)

Violation of section 5 and 6 of the Act and punishable u/s 23 of the Act. 

 

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