Introduction
A broad consensus on male child preference continues in India, despite the diversity of cultural, social, and religious backgrounds. As a result of which, female infanticide was used to eliminate girl child, which contributed majorly to the skewing of sex ratio of age group specifically under 6 years.[1]
On September 20, 1994, the Pre-Conception and Pre-Natal Diagnostic Techniques (Prohibition of Sex Selection) (PC&PNDT) Act was passed with the intention of prohibiting prenatal diagnostic techniques for determination of the sex of the fetus leading to female feticide and it was legislated in a manner that it could serve as a deterrent for those indulging in sex determination. The Act was amended from PNDT to PC&PNDT (The Pre-conception and Pre-natal Diagnostic Techniques (Prohibition of Sex Selection) Act) in 2003 to accommodate preconception sex-selection techniques. Therefore, under the ambit of this Act, all the equipment and diagnostic techniques capable of detecting and selecting fetal sex are regulated to prevent female feticide or sex selection before or after conception, and all the prenatal diagnostic techniques for the purposes of detecting abnormalities or metabolic disorders or chromosomal abnormalities or certain congenital malformations or sex-linked disorders are regulated.[2]
As an apex institute of medical education and research in the country, with more than 2,500 beds, All India Institute of Medical Sciences (AIIMS), New Delhi, India has got a wide spectrum of equipment as well as users from across the disciplines. As per the statute, it is mandatory to hold a valid PC&PNDT license to render patient and prenatal health care. The renewal of PC&PNDT license after every 5 years poses a unique administrative challenge to timely collect and collate the required documents from the “user” departments and submit their details along with the application form to PC&PNDT Directorate. To seamlessly carry out this extensive exercise, a definite component of meticulous planning is required.
Methods
An observational descriptive study was undertaken at AIIMS, New Delhi with the objective to delineate in detail, the process of PC&PNDT license renewal, and the challenges dealt with while submitting the renewal application. The requisite documents and data were collected from the Hospital Establishment Section and Medical Records Department. The study was conducted from February 2022 to July 2022.
Process of PC&PNDT License Renewal
The process of renewal of license can be broadly divided into three phases, namely:
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Preapplication phase
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Application phase
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Postapplication phase
Preapplication Phase
To submit the application within the stipulated time limit, which is within 30 days prior to date of expiry of license, we started working on it a month prior to the actual date of submission. We drew a planning framework for it with timelines for each step, and factored in it the most plausible constraints. The steps entailed the following;
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Collecting the details of organization and the applicant.
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Sending a communication to all the user departments and centers for the required details and supporting documents.
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Receiving and sorting replies, and sending reminder communications to furnish the deficient documents from the user departments.
Collecting the Details of Organization and Applicant
The details of the organization and applicant as mentioned in [Tables 1] and [2] were collected apart from the number and types of facilities for which the license is required. The types of facilities are: (1) genetic counseling center, (2) genetic counseling laboratory, (3) genetic clinic, (4) ultrasound clinic, (5) imaging center, (6) echocardiography, and (7) in vitro fertilization clinic.
Table 1
Details of organization as per the format
|
SN
|
Details of
|
Particulars to be submitted
|
Additional documents[a]
[b]
|
|
1
|
Organization
|
a. Name
b. Address
c. Email ID
d. Phone number
|
a. Organization address proof (electricity bill from the Engineering Department)
b. Map of organization showing location of machines
c. Present PC&PNDT certificate
d. MTP registration certificate
|
Abbreviations: MTP, Medical Termination of Pregnancy; PC&PNDT, Pre-Conception and Pre-Natal Diagnostic Techniques.
a Layout plan of Premises (for new registration).
b For private organization we need: (a) Memorandum of Understanding (MOU) and Certificate of Incorporation, (b) rent/lease agreement duly registered with competent authority valid for 5 years and copy of address proof of landlord, and (c) Nursing Home registration certificate.
Table 2
Details of the applicant as per the format
|
SN
|
Details of
|
Particulars to be submitted
|
Documents Needed (Copies)
|
|
1
|
Applicant[a]
(medical superintendent)
|
a. Name
b. Address (including S/D/W of)
c. Email ID and phone number
d. Date of birth
e. Date of joining
f. Qualification
g. DMC Reg. No. and validity
h. Bank details (account no., name and address of bank)
|
a. Registration and degree certificate
b. Proof of address (either permanent or local)
c. Aadhaar card
d. Latest 6 months' bank account statement
e. Two passport size photographs
f. Declaration[b]
g. Affidavits[b]
|
Abbreviations: DMC, Delhi Medical Council; S/D/W, son/daughter/wife.
a Applicant in private organization can be owner or a representative of the owner.
b Declaration and affidavits - will be mentioned in separate declaration and affidavit section.
Sending a Communication to All the Departments and Centers for the Required Details and Documents
All the departments and centers were informed about the expiry of license of PC&PNDT. The requisite details of machines and users of their department were requested to be furnished to the office of Medical Superintendent to process the application. We sent standardized pro-forma separately for machines and users requesting the users to provide their information in the same ([Supplementary Material S1], online only). The details included are as mentioned in [Table 3].
Table 3
Details of machines and users as per the format
|
SN
|
Details of
|
Particulars to be submitted
|
Documents needed (copies)
|
|
1
|
Machine
|
a. Type of machine (USG/MRI/Echo/CT/X-ray/B-scan)
b. Make and model
c. Serial number
d. Date of installation
e. Location (floor and room no.)
f. Mobile or fixed
|
a. Invoice
b. Installation report
|
|
2
|
User[a]
|
a. Name
b. Address (including S/D/W of)
c. Email ID and phone number
d. Date of birth
e. Date of joining
f. Qualification
g. Designation and department
h. DMC Reg. No. and validity
|
a. Degree certificate
b. DMC/State Medical Council registration certificate
c. Experience Certificate
d. Aadhaar Card
e. Affidavit[b]
f. Passport photographs (2 copies)
|
Abbreviations: CT, computed tomography; DMC, Delhi Medical Council; Echo, echocardiography; MRI, magnetic resonance imaging; S/D/W, son/daughter/wife; USG, ultrasound.
a User – Any doctor who advices or performs or reads the report of prenatal diagnostic tests/procedures.
b Affidavits - will be mentioned in separate declaration and affidavit section.
Receiving and Sorting Replies and Sending Reminder Communications to Furnish the Deficient Documents from the User Departments
The documents sent by the various user departments were sorted and sequenced. Reminder communications were sent to the departments which failed to furnish the complete set of requisite documents.
Application Phase
The process of filing an application was divided in to the following:
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Consolidation of data and documents received
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Preparation of declarations and affidavits
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Filling of application form and payment of fees
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Finalizing application and its submission
Consolidation of Data and Documents Collected
Data pertaining to all the machines and users were collected and pooled onto a master Excel sheet in a standardized format that included the information listed in the tables. The serial numbers on the master sheet for each machine and user was matched to the individual number assigned on their files for the convenience of pagination and archiving.
Preparation of Declaration and Affidavits
A declaration by the applicant was made on the letter head of organization which stated that “Hospital is completely furnished and all statutory requirements like examination table, notice board, signages, board of the center, etc., have been placed.”
Two copies of the affidavits for the applicant were made which included the following as under:
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i. Statement of compliance to the rules of the PC&PNDT Act and no court case is pending related to the aforementioned Act.
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ii. Statement that we will make sure that the facilities and users comply with rules of the Act.
One copy of the affidavit per user was made.
The users were stratified in to two groups for the purpose of making affidavits:
For group I users: Stating that the legislation's regulations shall be followed, that records of prenatal diagnostic procedures shall be kept, that no test or method to discover the fetus' gender shall be ever performed, and that there was no court case pending related to the Act.
For group II users: Stating that the legislation's regulations shall be followed, no procedure/test related to detection of fetal gender shall be ever performed, and that there was no court case pending related to the Act.
For group I users, gynecologists, and all group II users, they have to write in the affidavit itself that they will be using the machines for ultrasound/Doppler/2D echocardiography/ORBIT for their field of patients only.
All the affidavits along with the user's documents were forwarded to the individual user's departments for their signatures and stamping. It is pertinent to note that all user's documents and photographs were self-attested, and certificates were countersigned and stamped by the applicant. Rest of the enclosures was self-attested and stamped by the applicant. The stamps which were used included: (1) seal of the organization with address, (2) seal of the applicant, and (3) seal of the users.
Filling of Application Form and Payment of Fees
After compiling all the necessary materials, we began filling the application form obtained from the Office of the Chief District Medical Officer, South District, Directorate of Health Services located at Malviya Nagar, New Delhi, India. The application form included a checklist and Form A. It was mandatory to submit the Form A (in duplicate).
A payment of 17,500 INR was made toward the renewal fee through NEFT (National Electronic Fund Transfer) as per the stipulated fee requirement under the desired category, the details of which are given in [Table 4].
Table 4
Details of fee for the new license and its renewal
|
Number of facilities
|
New application
|
Renewal application
|
|
Single
|
25,000 INR
|
12,500 INR
|
|
More than One
|
35,000 INR
|
17,500 INR
|
Note: Mode of payment can be DD/NEFT/RTGS Transfer: DAA (Documents against acceptance - A/c no., Name and Address of Bank).
Finalizing Application and Submission
Checklist was filled and documents were double-checked for any missing signatures, stamps, or pagination. The application, completed in all the respects, was submitted to the appropriate authority (by hand) in the Office of the Chief District Medical Officer, South District, Directorate of Health Services located at Malviya Nagar, New Delhi.
Postapplication Phase
Appropriate authority from the Office of the Chief District Medical Officer after a due notice of intimation inspected departmental areas where the machines were located. The areas were inspected for the proper maintenance of records, scan areas, and filling of Form F as per the guidelines stipulated in the Act. Form F with its data has to be mandatorily preserved for 2 years for inspection by the authorities as per the stipulations under the Act. The receipt of data of every month, which is to be submitted by 5th of every month, is also required to be mandatorily preserved for 2 years.
It is pertinent to highlight that all the fields in Form F are to be completely filled and the copies of following documents are to be preserved along with Form F; (1) copy of ID of pregnant woman self-attested (stating “self-attested for ultrasound scan”), (2) copy of referral slip with clear details of referring doctor, (3) copy of ultrasound report, (4) copy of thermal film, and (5) copy of outpatient department card clearly showing details of last menstrual period.
Challenges Faced in the Process of PC&PNDT License Renewal and Planning Leads Gathered
The renewal of license of PC&PNDT of such a large tertiary care teaching hospital was fraught with numerous challenges. Every stage described in the process of PC&PNDT license renewal had its own challenges due to a large number of machines and their locations, various departments spread across the main hospital and its centers, and most importantly the huge and wide spectrum of users. The challenges faced during various stages of its renewal and the planning leads gathered to deal with them are enumerated below.
Discussion
Collection of documents pertaining to the users and machines and preparation of requisite affidavits were the tedious exercise which can be attributable to the wide spectrum of machines and users across various disciplines.
Albeit the intent of the Act is laudable and the need of hour, however, tedious documentation involved in obtaining the license and patient care metamorphosing in to insurmountable impediments in delivery of care. In consonance with digitization with advent of technology, it is imperative for the competent authority to take an environment-friendly green initiative of making a provision of e-filing of application similar to the initiative undertaken by the Government of Uttar Pradesh.[3] Further, it is essential to pay heed to curb superfluous documentation.
As per the PC&PNDT Act, the validity of license is 5 years and is to be renewed within the prescribed time to avoid violation of the statutory rules and its dire consequences. The current study is an attempt to highlight and address the challenges involved in the renewal of PC&PNDT license of a large tertiary care teaching hospital and how the Department of Hospital Administration dealt with them through meticulous planning and a systematic effort as mentioned in [Fig. 1], to get it renewed within the stipulated timeline and to preclude duplication of work and an iota of deficiency in documentation. The most important takeaways are the planning leads gathered while going through different phases of application process and dealing with challenges specific to each phase.
*As per Rule 8(6) under the PNDT Rules - In the event of failure of the Appropriate Authority to renew the certificate of registration or to communicate rejection of application for renewal of registration within a period of ninety days from the date of receipt of application for renewal of registration, the certificate of registration shall be deemed to have been renewed.
