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Detailed
Rules on the Implementation of the Provisions of Shenzhen
Special Economic Zone on the
Implementation of
the Administrative Regulations on Medical Institution
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(Promulgated
by Decree No.65 of the Shenzhen Municipal People' s Government
on November 7, 1997,
as revised and promulgated by Decree No.118
of the Shenzhen Municipal People' s Government on July 23,
2002)
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Article 1 These detailed rules are formulated according
to the provisions of Article 51 of the provisions of Shenzhen
Special Economic Zone on the Implementation of the
Administrative Regulations on Medical Institution
(hereinafter
referred to as the Provisions).
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Article 2 The municipal administrative department of
health shall carry out the control of total quantity of medical
institutions according to the principle, that the medical
institutions shall be set up for every 10,000
population
(including the temporary resident population). Every district
shall draw the set-up
plan of medical institutions in
this district, combining with the actual circumstances of
the population distribution, medical resources, medical
needs,
distribution of the existing medical institutions, and shall
submit the set-up plan to the
municipal administrative
department of health for appraisal and decision.
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The
municipal administrative department of health shall draw the
set-up plan of medical institutions
in the whole city, basing on
the plans of all districts, and according to the principle of
overall
planning.
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Article 3 The district administrative department of
health shall uniformly accept applications for initiating
medical institutions in the accepting period published by the
municipal administrative department of health.
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The
unit or individual applying for initiating a medical institution
shall submit an application
for preparing the establishment of
the medical institution to the district administrative
department
of health, where the medical institution to be
established will locate.
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Article 4 The citizen applying for initiating an
individual or partnership clinic shall satisfy the following
requirements:
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(1)
Having obtained the professional technical qualification of
higher than the physician, and having
acquired the Qualification
Certificate of Practice;
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(2)
Being healthy, and being able to preside over the medical work
personally;
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(3)
Having not caused any medical accident worse than second rank in the last 2 years before the application
date.
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Article 5 The unit or individual applying for initiating a
outpatient department or clinic shall submit materials
containing the following information to the administrative
department of health:
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(1)
The name and address of the medical institution planned to be
set up;
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(2)
The conditions of the subjects to be established, medical
equipments and professional health
workers;
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(3)
The built-up area for the medical institution planned to be set
up;
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(4)
The scheme for the treatment of polluted matters and sewage.
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Article 6 the Feasibility Report submitted to the
administrative department of health by the unit or individual
applying for initiating a hospital shall include the following
contents:
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(1)
The name and address of the medical institution planned to be
set up;
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(2)
The service mode, service time and diagnosis subjects of the
medical institution to be set up;
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(3) The built-up
area for the medical institution to be set up, and the number of
beds of the hospital
to be set up;
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(4) The
organizational structure and the conditions of the professional
health workers of the medical
institution to be set up;
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(5)
The instruments and equipments of the medical institution to be
set up;
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(6)
The scheme for the treatment of polluted matters and sewage.
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Article
7
The district administrative department of health shall refer the
applications for initiating medical
institutions and other
materials that shall be provided, to the Expert Appraisal
Committee of Medical
Institution for appraisal.
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When
the Expert Appraisal Committee of Medical Institution makes
appraisal, the number of the committee
members participating in
the appraisal shall exceed one half of the total number of the
members
of the Expert Appraisal Committee. The application shall
not be up to standard, until it passes the appraisal with
consent of more than two- thirds of the committee members who
are present at the appraisal meeting.
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Article
8 The
district administrative department of health shall check the
application appraised to be up
to standard by the Expert
Appraisal Committee of Medical Institution according to the
set-up plan
of medical institutions, and make a decision on
approving or not approving the application.
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The
district administrative department of health, where the domicile
of the applicant locates, shall
grant the Approval Certificate
of Establishing Medical Institution to the applicant, whose
application
is approved. The district administrative department
of health shall give reason in writing to the unapproved
application, and inform the applicant.
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Article
9
The validity of the Approval Certificate of Establishing Medical
Institution shall last from the
granting date:
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(1)
Five years for the hospital of the third grade;
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(2)
Three years for the hospital of the second grade;
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(3)
One year for the hospital of the first grade;
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(4)
One year for the outpatient department; or
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(5)
Half a year for the clinic.
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If
the applicant applying for preparing to establish a hospital,
and can not complete the preparation
work within the validity
period of the Approval Certificate of Establishing Medical
Institution,
he may apply for extension to the district
administrative department of health in 30 days before the
expiration of the validity period. The validity period may be
extended for half a year to one year, after
the application is
examined and approved.
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Any
one, who has not acquired the Approval Certificate of
Establishing Medical Institution or holds
an invalid Approval
Certificate of Establishing Medical Institution, may not
undertake the preparation
for establishing medical institution.
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Article
10 The
unit or individual having acquired the Approval Certificate of
Establishing Medical Institution
shall apply for registration of
practice to the district administrative department of health,
after
the preparation work of establishment is completed. The
applicant applying for the practice registration of the
medical
institution shall submit relevant certification materials
according to the Article 10 of
the Provisions.
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Article
11 The
district administrative department of health shall carry out the
examination and the on-the-spot
check according to the
Provisions within 30 days from the date when it accepts the
application
for the practice registration of the medical
institution. The applicant shall be issued the Practicing
License of Medical Institution, if his application satisfies the
requirements of practice. The applicant
shall be ordered to make
correction within a time limit, if his application does not
satisfy the
requirements of practice.
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Article
12 If
a medical institution plans to change its name, address, person
in charge, diagnosis subject,
number of beds, or registered
capital, it shall file an application to the district
administrative
department of health, and submit the following
materials:
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(1)
Application for Registration of the Change of the Medical
Institution;
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(2)
The cause and reason of applying for registration of change;
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(3)
Other materials that shall be submitted according to the
requirement of the administrative department
of health.
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The
district administrative department of health shall make the
decision on whether to approve the
change or not within 30 days
from the date when it accepts the application. But if the change
involves
the person in charge, diagnosis subject or number of
beds, the district administrative department of health shall
refer it to the Expert Appraisal Committee of Medical
Institution for appraisal, and make the decision
on whether to
approve the change or not according to the appraisal conclusion
of the Expert Appraisal
Committee of Medical Institution and the
set-up plan of the medical institutions.
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Article
13 The
administrative department of health shall carry out examination
and check to medical institutions:
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(1)
A hospital shall be examined and checked every three years from
the date when the Practicing
License of Medical Institution is
granted;
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(2)
The outpatient department or clinic shall be examined and
checked every year from the date when
the Practicing License of
Medical Institution is granted.
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Article
14 The
medical institution shall file the application for a new
examination and check to the district
administrative department
of health one month before the expiration of the period of
examination
and check, and submit the following materials:
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(1)
The medical institution' s application for examination and
check;
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(2)
The duplicate of the Practicing License of Medical Institution;
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(3)
The name lists of the persons in charge and the health technical
persons.
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The
district administrative department of health shall complete the
examination and check within
30 days from the date when it
accepts the application for examination and check.
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Article
15
The district administrative department of health shall announce
the establishments, changes, cancellations,
examinations and
checks of medical institutions in this district to the public
periodically.
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Article
16
A medical institution may only use one name generally. The name
use shall accord with the following
principles:
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(1)
The name shall be consisted of the identification title and
exclusive title. The exclusive title
shall be adaptable to the
medical institution' s scale and diagnosis subjects;
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(2)
The medical institution established by the enterprise,
institution or mass organization shall
use the name of the
establishing unit as its identification title; the medical
institution established
by the individual or partners shall use
the individual full name or surname as its identification title;
No medical institution may use the name of an administrative
division as the identification title of medical
institution.
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Article
17 If
different applicants apply for using the same name, the unit or
individual who firstly applies
may use it.
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Article
18
The individual and partnership clinic shall not employ health
technical person to undertake the
medical work.
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If
other medical institution employs health technical person to
undertake the medical work, it shall
report the employment to
the district administrative department of health, where it
locates, for
record within 7 days from the employment, and
submit the following materials:
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(1)
The Practicing License of Medical Institution of the employer;
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(2)
The identification card of the employee, the original and copy
of the Qualification of Practice;
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(3)
The retirement certification, unemployment certification or
resignation certification of the
employee and other relevant
certification materials;
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(4)
The employment contract concluded by the medical institution and
the employee.
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Article
19
The medical institution shall practice according to the
permitted subjects, and shall not set up
a subject beyond the
scope to undertake diagnosis activities.
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Article
20 The
medical institution shall not withhold the infectious patient of
plague, cholera, or tuberculosis,or
other infectious patient who
is prohibited by the State to be withheld.
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Article21
The medical institution shall set up the drugstore according to
relevant provisions, and distribute
the medicine according to
the paper of prescription, and shall not sell the medicine to
the outside.
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Article
22
The medical institution without the preparation permit shall not
compound medicines. The medical
institution with the preparation
permit may only provide the medicines compounded by it to the
patients, who are treated by this medical institution, and shall
not sell the compounded medicines by any means.
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Article 23
The medical institution shall not use the measurement instrument
that is not calibrated or calibrated
to be unqualified.
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Article 24
The advertisement on medical care shall observe relevant
provisions of the State and local administration
on
advertisement.
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Article 25
The name board of medical institution shall be made according to
the standard provided by the municipal
administrative department
of health.
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Article 26 The
health worker or health technical person of medical institution
in the work shall wear uniform
dress and the duty card uniformly
made by the administrative department of health.
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Article 27
Any one, who undertakes the activity of preparing the
establishment of a medical institution without
the Approval
Certificate of Establishing Medical Institution or with an
invalid Approval Certificate
of Establishing Medical
Institution, shall be ordered to stop the illegal preparation
activity,
and be imposed a fine of 3,000 yuan by the
administrative department of health.
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Article 28
If a medical institution set up a subject beyond the scope
approved in the Practicing License of
Medical Institution, the
administrative department of health shall order it to cancel the
subject
illegally set up, confiscate the medicines and
instruments using for the subject illegally set up, and the
illegal gains, and impose a fine of 5,000 to 20,000 yuan. If the
medical institution refuses to make
correction, it shall be
revoked the Practicing License of Medical Institution.
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Article 29
If a medical institution arbitrarily changes its name,
registered capital or person in charge without
being approved,
it shall be imposed of a fine of 3,000 yuan by the
administrative department of
health. If it arbitrarily changes
its address, it shall be ordered to make correction and imposed
a fine of 10,000 yuan by the administrative department of
health. If it refuses to make correction, it shall
be revoked
the Practicing License of Medical Institution.
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Article 30
If a medical institution does not apply for examination and
check according to relevant provisions,
and continues to
undertake the diagnosis activities, it shall be ordered to apply
for supplementary
examination and check within a time limit, and
be imposed a fine of 5,000 yuan by the administrative department
of health. If it refuses to apply for supplementary examination
and check within the time limit,
it shall be revoked the
Practicing License of Medical Institution.
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Article 31
If the name of a medical institution doesn' t accord with the
requirements of relevant provisions,
the administrative
department of health shall order it to make correction. If it
refuses to make
correction, it shall be imposed a fine of 3,000
yuan, and be compulsorily corrected by the administrative
department of health.
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Article 32
If a medical institution employs person to undertake the medical
or technical work of health in
violation of relevant provisions,
it shall be ordered to make correction, and be imposed a fine of
5,000 to 10,000 yuan by the administrative department of health.
If the circumstances are serious, it shall
be ordered to stop
business for internal rectification, or be revoked the
Practicing License of
Medical Institution.
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Article 33
If a medical institution withholds the infectious patient of
plague, cholera, tuberculosis, or
other infectious patient who
is prohibited by the State to be withheld, it shall be imposed a
fine
of 10,000 yuan by the administrative department of health.
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Article 34
If a medical institution doesn' t use the medical record book,
medical handbook, prescription paper
or certification uniformly
printed by the municipal administrative department of health, it
shall
be ordered to make correction, and be imposed a fine of
1,000 yuan by the administrative department of health.
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Article 35
If a medical institution installs drugstore, or distributes
medicine without prescription paper,
or sells medicine to the
outside, in violation of relevant provisions, it shall be
ordered to make
correction, and be imposed a fine of 5,000 yuan
by the administrative department of health.
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Article 36
If a medical institution installs its name board in violation of
relevant provisions, it shall
be ordered to make correction by
the administrative department of health. If it refuses to make
correction, it shall be imposed a fine of 1,000 yuan. The
administrative department of health may take compulsory
correction measures, and the expenses of the compulsory
correction measures shall be borne by the
medical institution.
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Article 37
If a medical institution fails to pay the administrative fee to
the administrative department of
health exceeding 3 months, it
shall pay a extra overdue fine of 5бы of the fee for every
exceeding
day.
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Article 38
The medical institution committing illegal act shall be punished
by the administrative department
of health, which firstly finds
out the illegal act in the examination. The municipal and
district
administrative departments of health shall not make
punishments to the same illegal act repeatedly.
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Article 39
These detailed rules shall go into effect as of the date of
promulgation. |
