Karnataka Private Medical Establishments (Amendment) Rules, 2018

[27 March 2018]

Whereas the draft of the rules to amend the Karnataka Private Medical Establishments Rules, 2009 in exercise of the powers conferred by section 26 of the Karnataka Private Medical Establishments Act, 2007 (Karnataka Act 21 of 2007) was published as required by sub-section (1) of said section of the said Act in Notification No. HFW 11 FPR 2018, dated 9.2.2018 in Part-IVA No. 259of the Karnataka Gazette (Extra Ordinary Gazette) dated 9.2.2018 inviting objections or suggestions from all persons likely to be affected within fifteen days from the date of its publication in the Official Gazette.

And whereas the said Gazette was made available to public on 09.02.2018.

And whereas the objections and suggestions received from the public have been considered by the Government.

Now, therefore, in exercise of the powers conferred by sub-section (1) of section 26 of the Karnataka Private Medical Establishments Act, 2007 (Karnataka Act 21 of 2007) read with the Karnataka Private Medical Establishments Act, 2017 (Karnataka Act 01 of 2018), Government of Karnataka hereby makes the following rules, namely: -

Rule - 1. Title and Commencement :-

(1)     These rules may be called the Karnataka Private Medical Establishments (Amendment) Rules, 2018.

(2)     They shall come into force on such date as the State Government may by notification in the Official Gazette, may appoint.

Provided that different dates may be appointed for different provisions of these rules and any reference in any such provision to the commencement of these rules shall be construed as a reference to the coming into force of that provision.

Rule - 2. Insertion of Definition :-

In the Karnataka Private Medical Establishments Rules, 2009, (hereinafter referred as the said rules), following definition shall be inserted after the clause (b) of sub-rule(1) of rule 2.

"(b1) Near Relative means spouse, children, parents, siblings, grand-parents and grand-children.

Rule - 3. Amendment of Chapter-2 :-

In Chapter-2 of the said rules, for the heading "CATEGORIES OF PRIVATE MEDICAL ESTABLISHMENTS" the following shall be substituted, namely:-

"CATEGORIES OF PRIVATE MEDICAL ESTABLISHMENTS AND REGISTRATION"

Rule - 4. Amendment to rule 3 :-

In rule 3 of the said rules,-

(i)       for sub-rule (2), the following shall be substituted, namely:-

"(2) Private medical establishments shall be further classified into the following categories, namely:-

(i)       Clinic/Polyclinic Only Consultation

(ii)      Clinic/Polyclinic with Diagnostic Support

(iii)    Clinic/Polyclinic with Dispensary

(iv)     

(v)     Clinic/Polyclinic with Observation

(vi)    Health Check-up Centre

(vii)   Integrated Counselling Centre

(viii)  Hospital (Level 1A)

(ix)    Hospital (Level 1B)

(x)     Hospital (Level 2)

(xi)    Hospital (Level 3)(Non-Teaching with Super Specialty Services)

(xii)   Specialty / Super-Specialty Specific Hospital

(xiii)  Hospital (Level 4)(Teaching)Diagnostic Imaging Centre

(xiv)  Dental Lab or Clinic

(xv)   Allied Health Professional Centre

(xvi)  Ayush Therapy Centre

(xvii) Medical Diagnostic Laboratory

(xviii)   Diagnostic Imaging Centre

(xix)  Blood Bank

Provided that the definition and scope of above categories of establishment shall be the same as recommended by the National Council constituted as under the Clinical establishment (Registration and Regulation) Act 2010 (Central Act 23 of 2010)."

(ii)      sub-rule (3) and (4) shall be omitted.

Rule - 5. Substitution of rule 4 :-

Forrule 4 of the said rules, the following shall be substituted, namely:-

"CHAPTER - III

REGISTRATION OF PRIVATE MEDICAL ESTABLISHMENTS

Rule - 6. Fee for processing of registration or renewal application. -

(1)     The non-refundable fee payable by different categories of private medical establishments for processing of registration application shall be as specified below,-

Provided that the registration processing fee for the hospitals at serial numbers 7 to 9 shall be two times of the fee mentioned in the table above, in case the hospital has more than 50 beds.

Provided further that the registration processing fee for the hospitals at serial numbers 10 and 11 shall be two times of the fee mentioned in the table above, in case the hospital has more than 150 beds.

Provided also that the registration processing fee for a charitable establishment providing free treatment to all patients shall be twenty-five percent of the fee specified above.

(2)     The non-refundable fee for processing of renewal application shall be fifty percent of the fee specified under sub-rule (1).

(3)     The fee for processing of registration or renewal application specified under sub-rule (1) shall stand enhanced by twenty-five percent, rounded off to nearest hundred rupees, every five years from the date of commencement of the Karnataka Private Medical Establishments (Amendment) Rules, 2018.

(4)     The registration or renewal processing fee shall be paid online on the website https://k2.karnataka.gov.in of Khajane-II, Integrated Financial Management System of Government of Karnataka.

Rule - 7. Amendment to Rule 5 :-

In rule 5 of the said rules, following sub-rule (2) shall be inserted.

"(2) In the event of change in the information provided at the time registration or renewal, the concerned establishment shall update the information in Form A or Form B, as the case may be, on the IT portal of Health and Family Welfare Department with Aadhaar based electronic signing within one month from the date of such change."

Rule - 8. Amendment to rule 6 :-

In rule 6 of the said rules, in sub-rule (1),-

(a)     for the words and letter "shall apply for registration in Form-A", the words and letters "shall apply online on the IT portal of Health and Family Welfare Department for registration in Form A with Aadhaar based electronic signing" shall be substituted.

(b)     after sub-rule (1), so amended the following provisos shall be inserted, namely:-

"Provided that the existing establishments already holding the registration also shall provide the details in Form A with Aadhaar based electronic signing within three months from the date of commencement of the Karnataka Private Medical Establishments (Amendment) Rules, 2018.

Provided further that Aadhaar, Mobile Number and Email details provided in Form A shall not be put in the public domain and shall be shared with other departments and agencies of the State Government and Government of India only for implementation of the Act."

Rule - 9. Amendment to rule 7 :-

In rule 7 of the said rules, in sub-rule (1) for the words and letter "shall apply for registration in Form B", the words and letters "shall apply online on the IT portal of Department of Health and Family Welfare for registration in Form A with Aadhaar based electronic signing" shall be substituted.

Rule - 10. Insertion of new rules 7A, 7B, 7C and 7D :-

After rule 7 of the said rules, the following shall be inserted, namely

"7A. Renewal of Registration. -

(1)     A registered private medical establishment shall apply for renewal of its registration minimum three months prior to due expiry of its five-year registration validity period.

(2)     The application for the renewal shall be made online on the IT portal of Health and Family Welfare Department in Form B with Aadhaar based electronic signing along with fee specified in rule 4.

Provided that Aadhaar, Mobile Number and Email details provided in Form B shall not be put in the public domain and shall be shared with other departments and agencies of the State Government and Government of Indiaonly for implementation of the Act.

7B. Reporting of Notified Diseases. -

Every private medical establishment shall be required, as part of its registration conditions, to furnish details of the incidence of notified diseases among its patients to the Commissioner for Health and Family Welfare Services, Karnataka in the manner as may be notified by the Commissioner.

Provided that the details thus furnished shall be used by the government departments and its agencies solely for purpose of disease surveillance, management and research.

7C. Composition of Registration and Grievance Redressal Authority.-

(1)     The non-official members of the Authority of a district shall have the qualification specified below.

(a)     The members representing Indian Medical Association and one more association shall be medical professional with postgraduate degree with experience of minimum ten years in medical profession.

(b)     The woman member shall have a graduate degree with experience of minimum twenty years in field of social work or academic profession or medical profession.

(2)     The non-official members of the Authority of a district shall be nominated by the Chairman in the manner specified below.

(a)     The member representing Indian Medical Association shall be the nominee of the Chapter of the Association having the largest membership in the district.

(b)     The member representing another Association shall be the nominee of a registered Association representing private medical establishments having the largest membership in the district.

(c)      The woman member of the authority relevant for purpose of grievance redressal only shall be selected on recommendations of three-member committee consisting of Deputy Commissioner of the district, Chief Executive Officer of the Zilla Panchayat and Deputy Director of Women and Child Development Department.

Provided that the non-official member shall recuse one-self in case of any conflict of interest when the authority considers any such case.

(3)     The term of each non-official member shall be two years and the incumbent shall not be nominated again.

7D. Composition of Inspection Committee.

The inspection committee shall consist of two medical professionals with minimum experience of ten years with one of them being in the Government service and another being one of the two members representing the associations in the Authority.

Provided that in the event of none of the two non-official members representing the associations in the authority belonging to the system of medicine of the applicant establishment, the medical professional from the government service belonging to that system shall be chosen as one of the two members on the inspection committee."

Rule - 11. Insertion of new Chapter-IV :-

After rule 9 of the said rules, the following shall be inserted, namely:-

"CHAPTER-IV

STANDARDS OF INFRASTRUCTURE, STAFFING PATTERN AND QUALIFICATION OF STAFF

9A. Minimum Standards in Interim Period. -

Till such time the minimum standards are prescribed by the State Government in accordance with sub-section (2) of section 9A of the act, the minimum standards as recommended by the National Council under the Clinical establishment (Registration and Regulation) Act 2010 (Central Act 23 of 2010) shall apply mutatis mutandis to the private medical establishments registered under the Act:

Provided that the existing establishments shall have a grace period of one year to comply with the minimum standards as per this rule.

Provided furtherthat the minimum standards in respect of infrastructure as per this rule shall be optional for the existing establishments. The minimum standards in respect of other aspects shall be mandatory with the grace period mentioned in the first proviso."

Rule - 12. Insertion of new Chapters :-

After the rule 11 of the said rules, the following shall be inserted, namely:-

"CHAPTER - V

EXPERT COMMITTEES

Rule - 13. Expert Committee for recommending classification, standards of infrastructure, staffing pattern and staff qualification.

(1)     The State Government shall constitute the Expert Committeefor the purpose of section 9 and 9A of the Act, standards of infrastructure, staffing pattern and staff qualification shall have the consisting of the following members, namely:-

(i)       The Commissioner, Health and Family Welfare - Ex-officio chairman

(ii)      The Director, Health and Family Welfare: - Ex-officio member Secretary

(iii)    The Director, Ayush Department - Ex-officio member

(iv)    The Director, Medical Education - Ex-officio member

(v)     One Representative of a tertiary care public health institution - Ex-officio member

(vi)    One Representative of the State Government from Public Health Foundation of India - Non-official Member

(vii)   One Representative of the State Government from National Accreditation Board for Hospitals and Healthcare Providers - Non-official Member

(viii)  One Representative of thePrivate Medical Establishments from Indian Medical Association - Non-official Member

(ix)    One Representative of thePrivate Medical Establishments froma tertiary care private hospital - Non-official Member

(x)     One Representative of the Private Medical Establishments from Private Hospital and Nursing Homes Association - Non-official Member

(2)     As far as possible, the committee shall use as reference the classification and minimum standards asrecommended by the National Council under the Clinical establishment (Registration and Regulation) Act 2010 (Central Act 23 of 2010).

Rule - 14. Expert Committee for recommending standard protocols for treatments, procedures and prescription audit.-

(1)     The Expert Committee constituted by the State Government for recommending standard protocols for treatments, procedures and prescription audit shall have the following composition, namely:-

(i)       The Director of a Government super-specialty hospital or medical college - Ex-officio Chairman

(ii)      One Medical specialist in allopathic system of medicine in Government service. - Ex-officio MemberSecretary

(iii)    One Medical specialist in Indian system of medicine in Government service - Ex-officio member

(iv)    One Representative of Ministry of Health and Family Welfare or Director - Ex-officio member General of Health Services, Government of India

(v)     One Representative of a tertiary care public health institution - Ex-officio member

(vi)    One Representative of the Rajiv Gandhi University of Health Sciences - Ex-officio member

(vii)   One Representative of the State Government from National Accreditation Board for Hospitals and Healthcare Providers - Non-official member

(viii)  One Representative of thePrivate Medical Establishmentsfrom Indian Medical Association - Non-official member

(ix)    One Representative of thePrivate Medical Establishmentsfrom a tertiary care private hospital - Non-official member

(x)     One Representative of thePrivate Medical Establishmentsfrom a secondary care private hospital - Non-official member

Provided that the committee may co-opt one relevant medical specialist each from public health institution and private medical establishment while formulating recommendations for any specialized types of treatment.

(2)     As far as possible, the committee shall use as reference the standard treatment guidelines recommended by the National Council under the Clinical establishment (Registration and Regulation) Act 2010 (Central Act 23 of 2010).

Rule - 15. Expert Committee for recommending uniform package rates for healthcare assurance schemesin participating establishments.

(1)     The Expert Committee constituted by the State Government for recommending uniform package rates for healthcare assurance schemes of the State Government for participating private medical establishments shall consist of following members, namely:-

(i)       The Additional Chief Secretary, Principal Secretary / Secretary to Government, Department of Medical Education - Ex-officio Chairman

(ii)      The Executive Director, SAST - Ex-officio member Secretary

(iii)    The Commissioner, Department of Health and family Welfare Services - Ex-officio member

(iv)    The Director, Medical Education - Ex-officio member

(v)     Additional Chief Secretary / Principal Secretary / Secretary to Government, Finance Department or his representative not below the rank of Deputy Secretary - Ex-officio member

(vi)    One Representative of a tertiary care public health institution - Ex-officio member

(vii)   One Representative of the StateGovernment from Public Health Foundation of India - Non-official member

(viii)  One Representative of the StateGovernment from IIMB - Non-official member

(ix)    One Representative of the Private Medical Establishments from Indian Medical Association - Non-official member

(x)     One Representative of the Private Medical Establishmentsfrom a tertiary care private hospital - Non-official member

(xi)    One Representative of the Private Medical Establishmentsfrom a secondary care private hospital - Non-official member

Provided that the committee may co-opt one relevant medical specialist each from public health institution and private medical establishment and one cost accountant while formulating recommendations for package rates for specific types of treatment.

(2)     As far as possible, the committee shall use as reference the standard costing template recommended by the National Council constituted under the Clinical establishment (Registration and Regulation) Act 2010 (Central Act 23 of 2010).

Provided that the recommended rates shall have reference tomedian rates notified by the private medical establishments as per section 10 of the Act.

Provided further that the recommended rate for a treatment as per the standard treatment guidelines shall cover the estimated cost of drugs, consumables, implants, tests, professional fee, OT charges, bed charges in general ward, and rental expenses of the hospital, but not the cost of land and building and debt-servicing.

Rule - 16. Allowance for Members. -

All non-official members shall be entitled for a sitting fee of rupees five thousand for each meeting of the committee in addition to travelling allowance and daily allowance as applicable to Group-A officers of the State Government."

"CHAPTER-VI

INFORMATION DISCLOSURE

Rule - 17. Notification of Establishment Details.

(1)     Every private medical establishment shall display its details in Form C with Aadhaar based electronic signing on the IT portal of the Health and Family Welfare Department and on its own website in case the establishment has one:

Provided that the operational guidelines for the display and secured access to the IT portal shall be provided by the department.

(2)     Notwithstanding anything contained in second proviso to sub-rule (1) of rule 6, Mobile Number and E-mail details of the establishment administrator or manager shall be available in the public domain.

(3)     Every private medical establishment shall update the details displayed as per sub-rule (1) on monthly basis before fifth day of each month.

(4)     Every private medical establishment shall display prominently at its reception area the system of medicine which the establishment is authorized to practice.

(5)     Every private medical establishment shall display prominently at its reception area contact details of its own internal grievance redressal mechanism and that of the Registration and Grievance Redressal Authority."

Rule - 18. Notification of Schedule of Charges. -

(1)     Every private medical establishment shall display its schedule of charges in Form D with Aadhaar based electronic signing on the IT portal of Health and Family Welfare Department and on its own website in case the establishment has one:

Provided that the operational guidelines for the display and secured access to the IT portal shall be provided by the Department.

(2)     Every private medical establishment shall update the schedule of charges displayed as per sub-rule (1) at least one week before the date on which the revision is planned to be effective."

"CHAPTER-VII

PATIENT CHARTER AND PRIVATE ESTABLISHMENT CHARTER

Rule - 19.Manner of making complaint. -

(1)     A complaint in respect of violation of any of the provisions of the Patient Charter, Private Medical Establishment Charter, or these rules shall be made online with Aadhaar based electronic signing on the IT portal of the Department within three months from the date of treatment in case of an out-patient or from the date of discharge of the patient from the private medical establishment in case of an in-patient:

Provided that the application can be made by the patient or his near relative only.

(2)     The complaint may also be made in physical form on Aadhaar authentication at the office of the Chairman or Member-Secretary of the Registration and Grievance Redressal Authority. It shall be obligatory for the office to record the complaint in the IT portal in presence of the complainant and provide a portal generated acknowledgment at the same time."

Rule - 20. Substitution of Form A, B and C :-

For Form A, Form B and Form-C of the said rules, the following shall be substituted, namely:-

"Form-A

(See sub-rule (1) of rule 6 and sub-rule (1) of rule 7)

Application for Registration of existing or new medical Establishment

(1)     Name of Establishment

(2)     Address of Establishment

(3)     GIS Co-ordinates

(4)     Category of Establishment (See rule 3) 2

(a)     System of medicine

(b)     Number of beds

(c)      Details of specialties or super-specialties

(5)     Current Status: Already functioning / To be started

(6)     Date of starting the Establishment / Proposed date of starting

(7)     Nature of Ownership (Proprietary / Partnership / Company / Society / Trust / LLP)3

(8)     Details of proprietor / partners / directors / executive committee members / trustees,-

(a)     Name

(b)     Sex and Age

(c)      Aadhaar Number (mandatory for person applying on behalf of the establishment)

(d)     Contact details: Mobile / email

(9)     Details of Administrator or Manager,-

(a)     Name

(b)     Sex and Age

(c)      Aadhaar Number (mandatory for person applying on behalf of the establishment)

(d)     Photograph

(e)     Contact details: Mobile / email

(10)   Contact details of the Establishment,-

(a)     Email

(b)     Phone

(11)   Details of Infrastructure,-

(a)     Land Area

(b)     Building Area (total built-up area)

(c)      Floor plans4

(d)     Front view photograph

(e)     Occupancy certificate

(f)      Fire safety certificate

(12)   Details of Staff,-

(i)       Details of all medical staff,-

(a)     Name

(b)     Qualification

(c)      Sex and Age (optional)

(d)     KMC10 or KAUP Board or KBHSM

(e)     Photograph

Registration Number (mandatory)

(f)      Contact details: Mobile / email

(ii)      Details of all para-medical staff (nursing, pharmacy, diagnostic, etc),-

(i)       Name

(ii)      Qualification

(iii)    Sex and Age (optional)

(iv)    KSNC13 or KSPC

(v)     Photograph Registration Number (mandatory)

(vi)    Contact details: Mobile / email

(13)   Internal Grievance Redressal Mechanism - Brief description and contact details of grievance redressal person (14) Details of fee paid - Challan Number, Date and Amount

 

Form-B

(See sub-rule (2) of rule 7A)

Application for Renewal of Registration of Existing Medical Establishment

(1)     Registration Number

(2)     Name of Establishment

(3)     Address of Establishment

(4)     GIS Coordinates

(5)     Category of Establishment (See rule 3)

(a)     System of medicine

(b)     Number of beds

(c)      Details of specialties or super-specialties

(6)     Date of expiry of current registration

(7)     Nature of Ownership (Proprietary / Partnership / Company / Society / Trust / LLP)

(8)     Details of proprietor / partners / directors / executive committee members/trustees,-

(a)     Name

(b)     Sex and Age

(c)      Aadhaar Number (mandatory for person applying on behalf of the establishment)

(d)     Contact details: Mobile / email

(9)     Details of Administrator or Manager,-

(a)     Name

(b)     Sex and Age

(c)      Aadhaar Number (mandatory for person applying on behalf of the establishment)

(d)     Photograph

(e)     Contact details: Mobile / email

(10)   Contact details of the Establishment,-

(a)     Email

(b)     Phone

(11)   Details of Infrastructure,-

(a)     Land Area

(b)     Building Area (total built-up area)

(c)      Floor plans

(d)     Front view photograph

(vii)   Occupancy certificate

(viii)  Fire safety certificate

(12)   Details of Staff,-

(i)       Details of all medical staff,-

(a)     Name

(b)     Qualification

(c)      Sex and Age (optional)

(d)     KMC or KAUP Board or KBHSM

(e)     Photograph Registration Number (mandatory)

(f)      Contact details: Mobile / email

(ii)      Details of all para-medical staff (nursing, pharmacy, diagnostic, etc),-

(a)     Name

(b)     Qualification

(c)      Sex and Age (optional)

(d)     KSNC or KSPC

(e)     Photograph Registration Number (mandatory)

(f)      Contact details: Mobile / email

(13)   Internal Grievance Redressal Mechanism - Brief description and contact details of grievance redressal person

(14)   Details of fee paid - Challan Number, Date and Amount

Form C

(See sub-rule (1) of rule 16)

Establishment Details for Display to the Public

(1)     Name of Establishment

(2)     Address of Establishment

(3)     GIS Coordinates

(4)     Category of Establishment (See rule 3)

(a)     System of medicine

(b)     Number of beds

(c)      Details of specialties or super-specialties

(5)     Details of Administrator or Manager,-

(a)     Name

(b)     Sex and Age

(c)      Photograph

(d)     Contact details:

(i)       Mobile (mandatory)

(ii)      Email (mandatory)

(6)     Contact details of the Establishment,-

(a)     Email

(b)     Phone

(7)     Infrastructure,-

(a)     Land Area

(b)     Building Area (total built-up area)

(c)      Front view photographcertificate

(d)     Occupancy certificate

(e)     Fire safety certificate

(8)     Details of Staff,-

(i)       Details of all medical staff,-

(a)     Name

(b)     Qualification

(c)      KMC or KAUP Board or KBHSM

(d)     Sex and Age (Optional)

(ii)      Registration Number (mandatory)

(a)     Photograph

(b)     Contact details:

i.         Mobile (optional)

ii.        Email (optional)

(iii)    Details of para-medical staff (service head only, eg, nursing, pharmacy, diagnostic, etc),-

(a)     Name

(b)     Qualification

(c)      Sex and Age (Optional)

(d)     Photograph

(e)     KSNC or KSPC

(f)      Contact details:

Registration Number (mandatory)

(i)       Mobile (optional)

(ii)      Email (optional)

(9)     Internal Grievance Redressal Mechanism - Brief description and contact details of grievance redressal person

(10)   Details of DigiLocker service, if provided.

(11)   Number of Patients and major treatments during the Year and Month (..........),-

(a)     Outpatients

(b)     Inpatients

(c)      Major Surgeries

(d)     Minor Surgeries

(12)   Date of last update

******"

(13)   Insertion of Form D :-

After Form-C so substituted, the following new Form shall be inserted at the end, namely:-

 

"Form D

(See sub-rule (1) of rule 17)

Schedule of Charges for Display to the Public

(1)     Name of the Establishment

(2)     Registration Number

(3)     Date of effect of the Schedule of Charges

Schedule of Charges