Rajasthan Government Clinical Establishment
(Registration and Regulation) Rules, 2013
G.S.R. 16. - In exercise of the power
conferred by section 54 of the Clinical Establishment (Registration and
Regulation) Act, 2010 (Central Act No. 23 of 2010), the State Government hereby
makes the following rules, namely:-
Rule - 1. Short title and commencement.?
(1)
These rules may be called the
Rajasthan [***] Clinical Establishment (Registration and Regulation)
Rules, 2013.
(2)
They shall come into force with immediate effect.
Rule - 2. Definitions.?
(1)
In these rules, unless the context otherwise
requires,-
(a)
"Act" means the Clinical Establishments
(Registration and Regulation) Act 2010;
(b)
"Form" means form appended to these
rules;
(c)
"Schedule" means Schedule appended to these
rules; and
(d)
"Section" means section of the Act.
(2)
Words and expressions used and not defined in these
rules, but defined in the Act, shall have the same meanings respective assigned
to them in the Act.
Rule - 3. Conduct of business of State Council.?
(1)
Every meeting of the State Council, constituted
under section 8, shall presided over by the Chairman.
(2)
The meetings of the State Council shall ordinarily
be held at Jaipur on such dates as may be fixed by the Chairman. The State
Council shall meet at least once in three months.
(3)
The notice and agenda of every meeting of the State
Council shalt be circulated by the Member Secretary to each member of the State
Council ordinarily seven days before the meeting;
(4)
The Chairman may, at any time, at his discretion,
convene a special meeting of the State Council at the shortest notice, normally
not less than three days.
(5)
One-third of the total number of members of the
State Council shall form a quorum and all actions of the State Council shall be
decided by a majority of the members present and voting.
(6)
The proceedings of the meetings of the State
Council shall be preserved in the form of minutes which shall be authenticated
by the Chairman.
(7)
A copy the minutes of each meeting of the State
Council shall be submitted to the Chairman within seven days of the meeting and
after having been approved by him/her shall be sent to each member of the State
Council within fifteen days of the meeting. If no objection to their
correctness is received within ten days, any decisions therein shall be given
effect.
Rule - 4. Conduct of business of District Registering Authority.?
(1)
Every mating of the Authority, constituted under
section 10, shall he presided over by-the Chairperson.
(2)
The notice and agenda of every meeting of the
Authority shall be circulated by the Convener to each member of the Authority
ordinarily seven days before the meeting.
(3)
The Chairperson may, at any time, at his
discretion, convene a special meeting of the Authority at the shortest notice
normally not less than three days.
(4)
One-third of the total number of members of the
Authority shall form a quorum and all actions of the Authority shall he decided
by a majority of the members present and voting.
(5)
The proceedings of the meeting of the Authority
shall be preserved in the form of minutes which shall be authenticated by the
Chairperson.
(6)
A copy of the minutes of each meeting of the
Authority shall be submitted to the Chairperson by the Convener within seven
days or the meeting and after having been attested by him shall be sent to each
member of the Authority within fifteen days of the meeting. If no objection to
their correctness is received within ten days, any decisions therein shall be
given effect.
Rule - 5. Provisional registration.?
(1)
The application for provisional registration shall
be made to the Authority, constituted under section 10, in From-1 along with
the fee specified in Schedule, either in person or by post or through web based
online facility.
(2)
The Authority shall not undertake any enquiry prior
to the grant of provisional registration and shall within a period of ten days
from the date of receipt of such application, grant to the applicant a
certificate of provisional registration in Form-2.
(3)
The Authority shall, within a period of forty-five
days from the grant of provisional registration, publish, in two local
newspapers and on the website of the Authority, all particulars of clinical
establishment, so registered provisionally, including the name of the clinical
establishment, address ownership, name of person in charge, system of medicine
offered, type and nature of Services offered and details of the medical staff
(Doctors, Nurses, etc.).
Rule - 6. Permanent Registration.?
(1)
The application for permanent registration shall be
made to the Authority, constituted under section 10, in Form-3 along with the
fee specified in Schedule, either in person or by post or through web based
online facility with the necessary information filled and with evidence of
having the requirements of minimum standards and personnel for different
categories of clinical establishments.
(2)
As soon as the clinical establishment submits the
required evidence of having complied with the prescribed minimum standards, the
Authority shall publish notice, in From-4, in two local newspapers and on the
website of the Authority, inviting objection from public at large within a
period of thirty days. Such notice shall contain all particulars of clinical
establishment including the name of the clinical establishment, address,
ownership, name of person in charge, system of medicine offered, type and
nature of services offered, details of the medical staff (Doctors, Nurse, etc).
(3)
If any person has any objection to the information
publishes regarding the clinical establishment, he shall give in writing the
reasons and evidence of objection or non-compliance to the Authority.
(4)
The Authority shall communicate to the clinical
establishment this objections received, if any, for response within a period of
forty five days.
Rule - 7. Application for more than one category of services.?
If a clinical establishment is offering
services in more than one category as classified by the Central Government
under sub-section (1) of section 13 of the Act, it shall apply for a separate
provisional or permanent registration for each category of services offered by
the clinical establishment. However, if a laboratory or diagnostic center is a
part of clinical establishment providing outpatient/inpatient care, no separate
registration shall be required. [Application may also be received and disposed
off through single window clearance system.]
Rule - 8. Acknowledgement of Application.?
The Authority, constituted under
section 10, or any officer/employee authorised by him, shall, acknowledge
receipt of the application for grant/renewal of Provisional/Permanent
registration, in [the duly filled in acknowledgement slip in Form-5], same
day if submitted in person or not later than the next working day, if received
by post and in case of online application, acknowledgement shall be generated
automatically by the system.
Rule - 9. Certificate of registration.?
(1)
The Authority shall grant the applicant a
certificate of permanent registration in Form-6 either by post or
electronically after satisfying itself that the applicant has complied with all
the requirements and criteria, including provisions of minimum standards and
personnel required to run the clinical establishment.
(2)
In case of permanent registration, the Authority
shall pass an order within the period allowed under section 29 of the Act,-
(a)
allowing the application for permanent
registration; or
(b)
disallowing the application:
Provided that the authority shall
record its justifications and reasons, if it disallows an application, for
permanent registration.
Rule - 10. Information about expiry of registration.?
The Authority
shall inform through notice published on web site of the Authority inform the
clinical establishment about date of expiry of its Provisional or Permanent
registration, as the case may be. Such information shall be published, in case
of Provisional Registration Certificate thirty days before date of expiry and
in case of Permanent registration six months before the date of expiry.].
Rule - 11. Fees to be charged.?
(1)
The various fees for provisional and permanent
registration, renewal, late application, duplicate certificate, change of
ownership, management or name of establishment shall be charged as specified in
Schedule.
(2)
The clinical establishments owned, controlled and
managed by the Government (Central State or Local Authority) or Department of
Government, shall be exempted from payment of fees as mentioned in sub-rule
(1).
(3)
The fee shall be paid by a demand draft drawn
online transaction in favour of the Authority concerned as specified under
sub-section(1) of section 14 or section 24 of the Act, as the case may be.
(4)
[All tax and fee etc. imposed by the Government or
any other local authority shall be paid by the Clinical Establishment and after
establishment of Clinical Establishment, if any additional amount of tax or
fees etc. is payable the Authority shall coordinate in payment of such tax or
fees etc.].
Rule - 12. Change of ownership or management.?
In the event of any change of ownership
or management, the clinical establishment shall intimate to the Authority in
writing within one month of such change along with the fees as specified in
Schedule and certificate. for grant of a revised certificate of Provisional or
Permanent registration, as the case may be, incorporating the changes.
Rule - 13. Duplicate certificate.?
In the event of certificate of
registration Provisional or Permanent, as the case may be, being lost
destroyed, mutilated or damaged; the clinical establishment shall apply to the
Authority to issue a duplicate certificate upon payment of fees as specified in
Schedule.
Rule - 14. Renewal of Registration.?
(1)
The clinical establishment shall apply for renewal
of provisional registration thirty days before the expiry of the validity of
the certificate of provisional registration. In case the application for
renewal is not submitted within the stipulated period, the Authority shall
allow for renewal of registration on payment of the renewal fee and late fee as
specified in Schedule.
(2)
The clinical establishment shall apply for renewal
of permanent registration six months before the expiry of the validity of the
certificate of permanent registration. In case the application for renewal is
not submitted within the stipulated period, the Authority shall allow for
renewal of registration on payment of the renewal fee and late fee as specified
in Schedule.
Rule - 15. Information to be provided by Clinical establishment.?
(1)
The Clinical establishments shall maintain medical
records of patients treated by it and health information and statistics in
respect of national programmes and furnish the same to the Authorities. The
minimum medical records to he maintained and nature of information to be
provided by the clinical establishments shall be as per the formats developed
by the National Council.
(2)
Copies of all records and statistics shall be kept
by the clinical establishment concerned at least for three years or in
accordance with any other relevant law. All clinical establishments shall be
responsible for submission of information and statistics in the time of
emergency or disaster or epidemic situation.
(3)
[The State Government may notify, from time to
time, the nature of information required to be furnished by the Clinical
Establishments including other disease notified for this purpose. Such
information shall be uploaded on the web site of the department in the manner
and with in such interval as may be specified by the State Government.]
Rule - 16. Power to Enter.?
(1)
Entry and search of the clinical establishment may
be made by the Authority or an officer or team duly authorised by it or subject
to such general or special orders, issued by the Authority.
(2)
Such entry and search of clinical establishments
may be made, if anyone is carrying on a clinical establishment without
registration or does not adhere to the prescribed minimum standards or has
reasonable cause to believe that the clinical establishment is being used for
purposes other than it is registered or contravenes any of the provisions of
this Act and rules.
(3)
The Authority or an officer or team duly authorised
by it shall intimate the clinical establishment in writing about the date or
visit and reasons fro the inspection and shall examine all record, register,
document, premises used or proposed to be used for the clinical establishment
and inspect the equipments, furniture and other accessories and enquire into
the professional qualifications of the technical staff employed or to be
employed and shall make any such other enquires as they consider necessary to
verify the statements made in the application for grant of certificate of
registration.
(4)
The inspecting officer or inspecting team, as the
case may be, shall submit its report in Form-8, within a period of seven days
of inspection, to the Authority, with a copy to the State Council. In case the
inspection is made by the Authority, it shall submit inspection report within a
period of seven days of inspection, to the State Council in Form-7.
Rule - 17. Penalty.?
For the purpose of adjudging monetary
penalty under the Act, the Authority shall hold an inquiry and provide
opportunity of being heard. While holding an inquiry the Authority shall summon
and enforce the attendance of any person acquainted with the fact and
circumstances of the case to give evidence or to produce any document which in
the opinion of the Authority, may be useful for or relevant to the subject
matter of the inquiry, and if, on such inquiry, the Authority is satisfied that
the person has failed to comply with the provisions of the Act and liable for
monetary penalty, it may by order impose the monetary penalty specified in the
Act.
Rule - 18. Appeals.?
(1)
Any person, aggrieved by an order of the
Authority,-
(i)
refusing to grant or renew a certificate of
registration or revoking a certificate of registration, may file an appeal in
Form-8 to the State Council within thirty days from the date of receipt of such
order along with a fee as specified in Schedule.
(ii)
passed under section 41 or 42, may file an appeal
in Form-8 to the State Council within a period specified in the said section
along with a fee as specified in Schedule.
(2)
After receipt of the appeal, the State Council
shall fix the time and date for hearing and inform the same to the appellant
and other concerned by a registered letter giving at least fifteen days time
for hearing of the case.
(3)
The appellant may represent by himself or
authorised person or a Legal practitioner and submit the relevant documentary
material if any in support of the appeal.
(4)
The State Council shall hear all the concerned,
receive the relevant oral/documentary evidence submitted by them, consider the
appeal and communicate its decision preferably within 90 days from the date of
filling the appeal.
(5)
If the State Council considers that an interim
order is necessary in the matter, it may pass such order, pending final
disposal of the appeal.
(6)
The decisions of State Council shall be final and
binding.
From-1
[See
Rule 5]
Application from for provisional Registration of
Clinical Establishments
1.
Name of the Establishment/Doctor (in case of single
practitioner): ___________________________________________________
2.
Address: _____________________________________
Village/Town: _____________________________________________________________________
Taluka: _____________________________ District:
________________________________ State: _____________________________________
Pin Code _______________________________ Tel. No. (with STD Code):
____________________________________ Mobile: ____________________________
Website (if any): _________________________________
3.
Name Of The Owner:
_______________________________________ Address:
__________________________________________ Village/town:
______________________________________________________ Taluka:
_______________________district: _____________________________________ State:
____________________________________ Pin Code
_____________________________________ Tel. No. (with STD Code): ________________________________
Mobile: ___________________________________ Email Id:
______________________________
3a. Name of Person in charge and
Qualification: ______________________
4.
Ownership
(a)
Public Sector: Central Government
State Government
Local Government
Public Sector
Undertaking any other (plearc
specify):
(b)
Private Sector: Individual
Proprietorship Registered
Partnership Registered Company
Co-operative Society
Trust
Charitable
any other (please
specify):
5.
Systems of Medicine offered: (please tick whichever
is epplicable):
Allopathy Ayurveda
Unani
Siddha
Homeopatliy
Yoga
&
Naturopathy
6.
Services Provided: (please tick whichever is
applicable)
Inpatient Outpatient
Laboratory
Imaging Centre
any other (please
specify): _____________________
(a)
Category of Clinical Services: General
Single Specialty
Multi Specialty
Super Specialty
7.
Type of Establishment: (please tick whichever is
applicable)
(a)
Inpatient: Hospital Nursing Home
Maternity Home
Primary Health
Centre Community Health
Center Sanatorium
Day Care centre
(b)
Number of Beds:
_____________________________________
(c)
Outpatient: Single Practitioner
Polyclinic
Sub-Centre
Physiotherapy Clinic
Occupational Therapy
Infertility clinic
Dental clinic
Dispensary
Dialysis Centre
Any other (please
specify): ___________________________________________
(d)
Laboratory: Pathology
Hematology Biochemistry Microbiology
Genetics
Collection Centre Any other (please
specify): _________________________________
(e)
Imagine Centre: please specify:
Special diagnostics: Please specify:
________________________________
I hereby declare that the statement
above are correct and true to the best of my knowledge and shall abide by all
the rules and a declarations under the Clinical Establishment (Registration and
Regulation) Act, 2010. I undertake that I shall intimate to the appropriate
registering authority any change in the particulars given above.
|
Date &Place: |
Signature of the Authorized Signatory |
Form-2
(See
Rule 5)
Provisional
Certificate For Registration Of Clinical Establishment
Provisional
registration No: (Computer Generated)
Date of
issue: (Computer Generated)
Valid up to:
(Computer Generated)
1.
Name of the Clinical Establishment:
_____________________________________
2.
Address: _____________________________________
3.
Owner of the Clinical Establishment:
_____________________________________
4.
Name of Person in Charge:
_____________________________________
5.
System of Medicine :
_____________________________________
6.
Type of Establishment:
_____________________________________
is hereby provisionally registered
under the provisions of Clinical Establishments
(Registration and Regulation) Act 2010 and the Rules made thereunder.
This authorization is subject to the
conditions as specified in the rules in force under the Clinical Establishments
(Registration and Regulation) Act 2010 and the Rules made thereunder.
Designation & Signature
of the Issuing Authority (Computer Generated)
Place & Date:.(Computer Generated)
From-3
[See
Rule 6]
Application from for Permanent
Registration of Clinical Establishments
Provisional
Registration No. ______________________________________
Date of issue
of Provisional Registration: _______________________________
Valid upto: ____________________________
1.
Name of the Establishment/Doctor (in case of single
practitioner): ___________________________________________________
2.
Address:
________________________________________________________ Village/Town:
_____________________________________________________________________ Taluka:
_____________________________ District: ________________________________ State:
_____________________________________ Pin Code _______________________________
Tel. No. (with STD Code): ____________________________________ Mobile:
____________________________ Website (if any): _________________________________
3.
Name of The Owner:
_______________________________________ Address:
__________________________________________ Village/town:
______________________________________________________ Taluka:
_______________________ District: _____________________________________ State:
____________________________________ Pin Code
_____________________________________ Tel. No. (with STD Code):
________________________________ Mobile: ___________________________________
Email Id: ______________________________
3a. Name of Person in charge and
Qualification: ______________________
4.
Ownership
(a)
Public Sector: Central Government
State Government
Local Government
Public Sector
Undertaking any other (please
specify):
(b)
Private Sector: Individual
Proprietorship Registered
Partnership Registered Company
Co-operative Society
Trust
Charitable
any other (please
specify):
5.
Systems of Medicine offered: (please tick whichever
is applicable):
Allopathy Ayurveda
Unani
Siddha
Homeopatliy
Yoga &
Naturopathy
6.
Services Provided: (please tick whichever is
applicable)
Inpatient Outpatient
Laboratory
Imaging Centre
any other (please
specify): _____________________
(a)
Category of Clinical Services: General
Single Specialty
Multi Specialty
Super Specialty
7.
Type of Establishment: (please tick whichever is
applicable)
(a)
Inpatient: Hospital Nursing Home
Maternity Home
Primary Health
Centre Community Health
Center Sanatorium
Day Care centre
(b)
Number of Beds:
_____________________________________
(c)
Outpatient: Single Practitioner
Polyclinic
Sub-Centre
Physiotherapy Clinic
Occupational Therapy
Infertility clinic
Dental clinic
Dispensary
Dialysis Centre
Any other (please
specify): ___________________________________________
(d)
Laboratory: Pathology
Hematology Biochemistry Microbiology
Genetics
Collection Centre
Any other (please
specify): _________________________________
(e)
Imagine Centre: please specify:
Special diagnostics: Please specify:
________________________________
I hereby declare that the statement
above are correct and true to the best of my
knowledge and shall abide by all the
rules and a declarations under the Clinical Establishment (Registration and
Regulation) Act, 2010. I undertake that I shall intimate to the appropriate
registering authority any change in the particulars given above.
Detail information:- Any complain and
adverse report by inspection team after issue of Provisional Registration.
Enclosed: Photo copy of Provisional
Registration.
|
Date & Place |
Signature of the Authorized Signatory |
Form-4
[See
Rule 6]
Display
of registration status for filing objections
I, ............................ being
the authority under the Clinical Establishments Act, 2010 after considering the
applications received during the period; from .................... to
....................... under Section 24 satisfying the provisions of the
Clinical Establishments (Registration & Regulation) Act, 2010 and the
Establishments (Registration & Regulation) Rules, 2013 made their under,
hereby publish the list of Clinical Establishment; within the jurisdiction of
................... district.
|
Serial No. |
Name of Clinical Establishment with
address |
Ownership/In charge |
System of medicine |
Date on which application was
submitted |
Category & standards complied
with |
Objections if any, in writing to the above list may be addressed in duplicate
to ............................ (address of the authority) within 30 days.,
from the date of this notice, as required under section 26 of the Act.
|
Date: |
Signature |
[Form-5]
[See Rule 8]
Acknowledgement
Registration of Clinical Establishment
The application in Form ..............
for Grant/Renewal of Provisional/Permanent registration of the Clinical
Establishment submitted by ..................... (Name and address or Owner)
has been received by the District Registration Authority on ...............
(date) and found to be.
Complete
or
Incomplete.
This acknowledgement does not confer
any rights on the applicant for grant or renewal of registration.
Signature and Designation of
Registration Authority or authorized person in the Office of the Appropriate
Authority.
Designation & Signature
of the Issuing Authority (Computer Generated)
Seal
Receipt number
Place, Date and Time (Computer
Generated)
From-6
[See
Rule 6]
Permanent
Certificate For Registration of Clinical Establishment
Permanent
registration No: (Computer Generated)
Date of
issue: (Computer
Generated)
Valid up to: (Computer Generated)
1.
Name of the Clinical Establishment:
_____________________________________
2.
Address: _____________________________________
3.
Owner of the Clinical Establishment: _____________________________________
4.
Name of Person in Charge:
_____________________________________
5.
System of Medicine :
_____________________________________
6.
Type of Establishment:
_____________________________________ is hereby provisionally registered under
the provisions of Clinical Establishments (Registration and Regulation) Act,
2010 and the Rules made thereunder.
This authorization is subject to the
conditions as specified in the rules in force under the Clinical Establishments
(Registration and Regulation) Act 2010 and the Rules made thereunder.
Designation & Signature
of the Issuing Authority (Computer Generated)
Seal
Place & Date:(Computer Generated)
District Registration Authority
Authority
Phone numbers in case of Grievances
From
7
[See
Rule 16]
Format
for Submission of Inspection Report
Number of visit made with dates
Names and details of members of the
inspection team Name of clinical establishment visited
Address and contact details of clinical
establishment visited Process followed for inspection (e.g. kindly outline who
was met with what records were examined, etc)
Salient Observations/Findings
Conclusions
Specific Recommendations:
(1)
To the Clinical Establishment
(2)
To the District Registering Authority
*In case of lack of consensus amongst
numbers of the inspection team, the same may be kindly indicated.
Signature
(of all members of the inspection team)
Date:
Place:
Form-8
[See
Rule 18]
Application
for Appeal
To
The State Council.
Government of ...........................
Sir,
I, Dr ............................ of
......................... had applied for registration / holder of registration
certificate number ........................ under the Clinical Establishment
(Registration and Regulation) Act, 2010, for my ...............................
located at ......................
I was communicated by the district
authority as per letter no. .................. dated ......................
that either;
(i)
That my application was rejected
(ii)
That my registration is cancelled
(iii)
That I am restrained from carrying on with the
running of clinical establishment
(iv)
Thai I am charged with a penalty for an offence
under the Act
(v)
Any other
..................................................
The above decision or the district
authority appears to be not valid. I request you to consider my application as
per the justifications mentioned below:
(i)
................................................
(ii)
...............................................
(iii)
..............................................
I am willing to appear before you for a
personal hearings, if necessary. I am enclosing herewith a draft of Rs. 5000/-.
|
Thanking you, |
Signature |
[Schedule]
[See rule
11]
Fees to be Charged
|
Description |
Urban Provisional |
Urban
Permanent |
Rural
Provisional |
Rural
Permanent |
Metro
Provisional |
Metro
Permanent |
|
Out Patient Care |
- |
200 |
- |
100 |
100 |
500 |
|
In Patient Care |
||||||
|
1 to 30 beds |
- |
200 |
- |
100 |
100 |
500 |
|
30 to 100 beds |
100 |
500 |
50 |
250 |
200 |
1000 |
|
Above 100 beds |
200 |
1000 |
100 |
300 |
300 |
1500 |
|
Testing & Diagnostic: |
100 |
500 |
50 |
250 |
200 |
1000 |
|
Laboratories |
1000 |
100 |
300 |
300 |
1500 |
|
|
Diagnostice & Imaging Centre |
200 |
Other Fees:
(i)
For Renewal half the amount of registration fee
(Provisional/Permanent)
(ii)
For Late Application, along with the renewal fee,
Rs. 50/-per day late fee upto the date of filling application for renewal of
the registration (Provisional/Permanent) shall be charged.
(iii)
For Duplicate Certificate, the amount shall be Rs.
100/-.
(iv)
For change of ownership, management or name of
establishment, shall be Rs. 100/.
(v)
For any appeal the amount shall be Rs. 1000/-.
Note. - If a laboratory or diagnostic
center is a part of a establishment providing outpatient/Inpatient care no
separate registration is required.