Survey
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
APPLICATION For ACCREDITATION OF MEDICAL IMAGING SERVICES Issue No.: 03 Issue Date: April 2012 NATIONAL ACCREDITATION BOARD FOR HOSPITALS & HEALTHCARE PROVIDERS 1 NATIONAL ACCREDITATION BOARD FOR HOSPITALS & HEALTHCARE PROVIDERS Assessment criteria and Fee structure for Medical Imaging Services Practice Category Assessment Criteria Preassessment (based on no. of modalities present) Assessment Accreditation Fee Surveillance Application Fee Annual Fee Small Practice, 1 modality One man day Two man days (2x1) One man day Rs. 10,000/- Rs. 30,000/- Medium Practice, 2 modalities One man day Two man days (2x1) One man day Rs. 15,000/- Rs. 40,000/- Large Practice, 3 or more than 3 modalities Two man days (2x1) Four (2x2) man days Two man days (2x1) Rs. 20,000/- Rs. 60,000/- NOTE: The man days given above for assessment and surveillance are indicative and may change depending on the facilities and size and type of services. Service Tax: w.e.f. 15.11.2015 a service tax of 14.50% will be charged on all the above fees. You are requested to please include the service tax in the fees accordingly while sending to NABH. Guidance notes: 1. Five copies of Application Forms to be submitted along with fees as per NABH Standards for Medical Imaging Services.Fees are non-refundable. 2. Fees to be paid through Demand Draft/ local cheque in favour of ‘Quality Council of India’ payable at New Delhi. 3. Self Assessment Toolkit dully filled in is to be submitted by the MIS along with the application form 4. Other relevant documents be submitted by the MIS are detailed in Annexure I 5. The accreditation fee does not include expenses on travel, lodging/ boarding of assessors, which will be borne by the Medical Imaging Services on actual basis. 2 6. The application fee includes pre-assessment charges. 7. The accreditation, once granted will be valid for three years, after which Medical Imaging Services may apply for renewal as per NABH policy. 8. The first annual fee is payable after pre-assessment visit and before assessment visit. 9. 10% discount will be admissible in case MIS pays the accreditation fee for three year in one installment 10. The surveillance visit will be planned during 2nd year of accreditation which is usually after 18 months. 11. NABH may call for un-announced visit, based on any concern or any serious incident reported upon by any individual or organization or media. 3 Guidelines for filling the application form (Please read this carefully before filling this form) 1. For Sl. No. 3- Kindly mention if the organization is a public/ government establishment or an independent/ private sector provider. 2. For Sl. No. 7- Please specify e.g. clinical establishment, shop, etc. 3. For Sl. No. 8 & 9 – Please provide all the detail in the prescribed format, separately for each equipment. Please submit scanned copies of all the statutory requirements while submitting the documents. 4. For Sl. No. 10- If a particular license is not required in your region or is not applicable for your set up kindly mention the same in “Remarks” column. You can also use this column to state “applied for” ; “pending approval”; “applied for renewal on….” etc. 5. For Sl. No. 11 – The services listed under A if existing are mandatory to apply for. However application for services listed under B and C are optional. 6. For Sl. No. 14 a. Please indicate if there are individuals holding recognized degrees managing the department. Please mention full time and part time consultants separately as X + Y=Z b. Please include list of Doctors, Nursing and technical staff with credentials and privileges. 7. Documents to be submitted to NABH shall be inclusive of but not limited to as per list mentioned in Annexure1. The MIS shall ensure that it shall send an updated application form to NABH in case of any changes especially before preassessment and final assessment Definition: Medical Imaging Services (MIS) Medical Specialty that uses X-rays, gamma rays, high frequency sound waves , magnetic fields or isotopes to produce images of organs and other internal structure of the body. The specialty aims to detect & diagnose disease as well as to carry out interventional procedures to confirm the diagnosis and treat certain diseases and abnormalities. 4 Application Form for Accreditation of Medical Imaging Services First Accreditation Renewal of Accreditation 1. Name of the Centre/HCO: _______________________________________________________________________ 2. Address: _______________________________________________________________ ______________________________________________________________________ ______________________________________________________________________ 3. Ownership: _____________________________________________________________ 4. Name of Parent Organization: _____________________________________________ (if part of any other organization) Telephone No. _____________________ Fax No. __________________ e-mail ______________________ 5. Name to appear on Certificate if Accreditation is granted: _______________________________________________________________________ 6. Contact person(s): (Please indicate [] with whom correspondence be made) Chief Executive Officer/ Head of Department/ equivalent Mr./Ms./Dr. ___________________________________________________________ Designation: __________________________________________________________ Tel: ___________________________ Mobile: _______________________________ Fax: _________________________________________________________________ E-mail: _______________________________________________________________ Accreditation Coordinator: Mr./Ms./Dr. ___________________________________________________________ Designation: __________________________________________________________ Tel: ___________________________ Mobile: _______________________________ Fax: _________________________________________________________________ E-mail: _______________________________________________________________ 5 7. Whether the Medical Imaging Service is registered with Local Authorities:(Where applicable as per the State or Central Norms) ______________________________________________________________________ 8. Details regarding Ultrasound Equipment registration with PC-PNDT: Equipment 9. Registration number and date Valid Upto Remarks (if any) Details regarding AERB approval of equipment, facility design and installation, Operation certificate and Personnel: Name of Equipment License/Certificate Number and Date Valid Upto Remarks (if any) NOC/Type-approval certificate of Equipment Site Layout approval Installation/Operation Certificate Personnel(RSO) 10. List of other relevant legal documents applicable to MIS with date, number & validity of registrations/license *. License/Certificate Number and Date Valid Upto Remarks (if any) General: Bio-medical Waste Management and Handling Authorization Employee Provident Fund Employee State Insurance NOC for Import of Equipment PAN/TAN Registration of Company (ROC) Registration Under Clinical Establishment Act (or similar) Registration With Local Authorities Facility management: 6 Building Occupancy / Completion Certificate Fire (NOC) License for Diesel Storage License for Electrical Installations License to Store Compressed Gas Sanction for Lifts Prevention and Control of Pollution Act (For generator) Pharmacy (if over multiple locations license for each of them separately) Drugs-Bulk license Drugs-Retail license License for Possession and Use of Methylated Spirit, Denatured spirit, Methyl alcohol and Ethyl Alcohol Narcotic license Nuclear Medicine and Radiation therapy: Authorization to Use Radiopharmaceuticals in Humans Authorization for Radionuclide Imaging NOC for procurement of Radiopharmaceuticals Any other: Canteen/ F & B license *Please submit scanned copies of all the statutory requirements while submitting the documents 11. Modalities: (Please indicate [] on modalities existing at your Diagnostic Centre/HCO/SHCO) 1. Category A: Following Imaging Services if provided at the centre/HCO, they are mandatory to be applied for :Radiography Fluoroscopy based Radiographic Procedures Interventional Procedures 7 Ultrasound Mammography Magnetic Resonance Imaging (MRI) Computed Tomography (CT) scan Nuclear Medicine Others 2. Category B: Following Imaging Services may be excluded from the scope of Accreditation if desired :Bone Mineral Densitometry OPG Dental X-ray 3. Category C: Non- Imaging Services which may be included in the scope of Accreditation if desired Electrocardiogram. (ECG). Holter Monitoring Echocardiogram (ECHO) Tread Mill Testing (TMT) Electroencephalography (EEG) Electromyography (EMG)/Evoke Potential (EP). Nerve Conduction Velocity (NCV) Spirometry Audiometry Uroflowmetry (UF) Any other, please specify ………………………………………….. 8 12. Scope of Accreditation (in detail) For Category A: Scope of service Inclusive of Radiography General Radiography Dental Radiography Fluoroscopy based Radiographic Procedures Fluoroscopy based Investigative Procedures Interventional Procedures Fluoroscopy Guided Vascular Procedures Fluoroscopy Guided Non-Vascular Procedures Angiography/Cardiovascular Labs setups for vascular imaging and interventional procedures Mammography Mammography Interventional Procedures Ultrasound General Ultrasound Colour Doppler flow imaging Interventional procedures USG guided HIFU MR imaging MR guided procedures MR guided HIFU CT Imaging Cone Beam Computed Tomography CT guided procedures Magnetic Resonance Imaging (MRI) Computed Tomography (CT) scan Nuclear Medicine Others Plainer Gamma Camera SPECT/SPECT CT Positron Emission Tomography(PET)/PET-CT Radionuclide therapy Radio frequency ablation(RFA) and Laser / Cryoablation / Thermoablation Tele radiology Any other imaging service For Category B: Scope of service Bone mineral Densitometry OPG Dental X-ray Inclusive of Dual Energy X Ray Absorptiometry (DEXA) Quantitative Computed Tomography (QCT) Quantitative Ultrasound(QUS) OPG Dental X-ray For Category C Refer to point 11 13. Organization Chart: Provide Organogram 9 14. Staff Information: Details with educational qualification and experience of all Imaging Personnel(Radiologist and technicians) Sl. No. Name Designation Qualification Experience in Medical Imaging Services (yrs) *Note: Separate list of personnel working in X-radiation environment should also be included with TLD batch numbers. 15. Equipment: Details of all equipments in the Medical Imaging Services Sl.No Name of Equipment Make/ Model Date Installation of AMC/CMC status Average patient load *Note: Each equipment should be listed separately. 16. Details of Self-assessment : Date of Self-assessment __________________________________________________ Done by __________________________________________________ 10 17. Date of completion of application: __________ Day __________ Month ________Year 18. Litigation, if any: ______________________________________________________________________________ Medical Director/ Authorized Signatory Name: ___________________________ Designation: ______________________ NATIONAL ACCREDITATION BOARD FOR HOSPITALS & HEALTHCARE PROVIDERS (NABH) Quality Council of India Institution of Engineers’ Building, IInd Floor, Bahadur Shah Zafar Marg New Delhi - 110002, India. Tel/ Fax: 91-11-2337 9321, 91-11-2337 9621 Website: www.qcin.org; www.nabh.co 11 Annexure I Reference list of Documents for MIS Accreditation Programme 1. Statutory and legal obligation as applicable with date, number & validity of registrations/license (attach the Photocopies of all legal documents) 2. Manuals: (Apex Manual to be submitted to NABH and all other to be prepared and kept ready for review during assessment): Apex Manual Safety Manual Infection Control Manual For Guidance Purpose the content of manual may include(but not limited to) following: Content of Apex/Quality Manual a. Introduction to organization b. Vision, Mission, AIM, Quality Policy c. Quality Objectives d. List of Committees e. Organogram f. Status of Statutory requirements g. NABH MIS chapter wise documentation (CS, CPP, CE,CP, CDR, RCS) h. Continuous Quality Improvement Programmes (verification processes, validation processes, adverse event reporting, and quality indicators monitored i. Performance/Quality indicators(at least on quality indicator related to patient service and one for each modality) Content of Safety Manual a. Introduction to centre b. Medical codes (code blue, code red etc) c. Safety committee d. Fire Safety (fire preventive and extinguishing methods, fire & safety trainings, Emergency Evacuation procedures etc.) e. Electrical safety f. Radiation safety g. Equipment safety h. Medical gas safety i. Water safety j. Building safety k. Patient safety l. Vulnerable patient safety m. Geriatrics patients safety n. Anesthesia safety o. Falls and falls reduction programme p. Employee safety q. Personal protective equipments r. Risk management s. Sentinel events Content of Infection Control Manual 12 a. b. c. d. e. f. g. h. i. j. k. l. m. Introduction of MIS Introduction to MIS Infection Control Programme (MIS-ICP) MIS Infection Control Committee (MIS-ICC) Infection Control Team Goals and Objectives of MIS ICP Responsibilities of MIS- ICP Hand Hygiene Procedures related Protocols (E.g. Personal hygiene, injection, oxygen administration etc) Equipment related Protocols Environment related Protocols (high risk areas, water quality, pest control etc) Employee related Protocols (employee Health Programme, post exposure prophylaxis etc) Surveillance and reporting of Infection Bio medical waste (law & rule, BMW management at MIS) 5. List of Committees with frequency of meeting and date of last meeting held 6. List of trainings held 13