AERB COMPLIANCE IN UTTAR PRADESH DR VED PRAKASH

AERB COMPLIANCE IN UTTAR PRADESH DR VED PRAKASH, GENERAL MANAGER ( PROCUREMENT ) , NATIONAL HEALTH MISSION, UTTAR PRADESH 4 th National Summit on Good, Replicable Practices and Innovations in Public Health Care Systems in India 8 th July 2017

BACKGROUND (1/1) § To ensure compliance to AERB norms in all Radiological Units. § UP is the first state to publish RFPs for AERB Safety Regulation in such a large scale. § The Model RFP was developed , with technical support from Health Care Technology Division of NHSRC and UPTSU. We extend sincere thanks to both organizations. § The work will be completed in three phases : q Part 1 - Compliance Study q Part 2 – Infrastructure Development q Part 3 – Issuance of Licence of Operation from AERB § Scope of work : Compliance Study, Infrastructure development and Issuance of Licence for Operation as per AERB regulations. in 479 Diagnostic Radiation Installations across 75 Districts of Uttar Pradesh. 2

CLUSTERING DETAILS District No. of Installations in DH Facility No. of Installations in CHC Facility Sub. Total Cluster 1 Agra, Aligarh, Auraiya, Etah, Etawah, Farrukhabad, Firozabad, Hathras, Jalaun, Jhansi, Kannauj, Kanpur Dehat, Kanpur Nagar, Kasganj, Lalitpur, Mainpuri, Mathura 21 62 83 Cluster 2 Amroha, Badaun, Baghpat, Bareilly, Bijnor, Bulandshahar, Gautam Budha Nagar (Noida), Ghaziabad, Hapur, Meerut, Moradabad, Muzzaffarnagar, Pilibhit, Rampur, Saharanpur, Sambhal, Shahjahanpur, Shamli 21 89 110 Cluster 3 Allahabad, Banda, Bhadohi, Chandauli, Chitrakoot, Fatehpur, Ghazipur, Hamirpur, Jaunpur, Kaushambi, Mahoba, Mirzapur, Pratapgarh, Sonebhadra, Varanasi 18 82 100 Cluster 4 Azamgarh, Ballia, Basti, Deoria, Gorakhpur, Kushinagar, Maharajganj, Mau, Sant Kabir Nagar, Siddharthnagar 13 62 75 Cluster 5 Ambedkar Nagar, Amethi, Bahraich, Balrampur, Barabanki, Faizabad, Gonda, Hardoi, Lakhimpur Kheri, Lucknow, Raebareli, Shravasti, Sitapur, Sultanpur, Unnao 10 101 111 83 396 479 Cluster Total 3

AERB CONCEPTS (1/2) steps to be followed for registering each Installation of the facility on the e-LORA 1 website. Step 1 Facility Registration 2 Declaration of Diagnostic Radiation Equipment 3 Availability of Qualified Radiation Workers Description § The Facility details and Employer details are required to be entered on the website § After approval of the details, Username and Password is sent to registered Email ID of Facility § Details of Type Approved Equipment currently running at the Facility need to be entered on the website § Details of Radiation Workers currently working at the Facility need to be entered on the website § Details for TLD Card 2 Number of each Radiation Worker is required for this step e-LORA (e-Licensing of Radiation Applications), portal from AERB to facilitate issuance of licenses. 1 2 TLD Card: Thermoluminescent dosimeter is a passive radiation detection device that is used for personal dose monitoring 4

AERB CONCEPTS (2/2) Step 4 Availability of required Safety Tools 5 Layout and Shielding Details 6 Quality Assurance (QA) Test Report Description § Details of all the mandatory Safety Tools for a Facility to be entered on the website § Safety Tools are Protective Barrier with viewing Window, Protective Lead Apron § Details of Layout and Shielding : Wall Dimensions, Wall Thickness, Wall/Shielding material, distance of all Wall/Shielding from the Installation, Couch Position, Control Console/Control Room, Protective Barrier, Door(s), Window(s), Occupancy around the Installation Room § The QA Test confirms the Installation is in satisfactory working condition and in accordance with Quality and Safety norms of AERB Safety Code § The QA Test includes Calibration, Radiation Levels, Leakage and Linearity of Installation and associated equipment § Approved RSO should be available in the Facility 7 Approved RSO AERB Licence for Operation § In-case Approved RSO isn’t available, then a person should be designated as RSO for the Installation § Upon Completion of all above steps an AERB Licence will be issued for the Installation of the Facility 5

SCOPE OF WORK FOR CONSULTANT (1/2) Part 1: Compliance Study The Consultant will conduct the safety regulations survey across all facilities in scope of study. The study will identify gaps from the AERB regulations: q Data Collection in the prescribed format for all the facilities in scope of study q Submission of Survey Report and Work plan for Infrastructure Development q Enlist the infrastructure augmentation requirement q Describe the implementation guidelines for infrastructure augmentation q Submit a list of Installations which are not type approved to the authority § The Consultant shall make its own arrangements related to travel expenses for conducting compliance study across all the facilities in scope 6

SCOPE OF WORK FOR CONSULTANT (2/2) Part 2: Infrastructure Development § Based on the results of Gap Analysis, the Consultant shall upgrade the non-compliant installation, as per AERB norms q Ensure Availability of patient (1 no. ) and Healthcare worker (2 No. ) Lead Apron gown q Provision of Warning Lights q Lead Lining for Doors & Windows as per AERB Regulations q Mobile Barriers for Healthcare Workers q Availability of Chest Stand (1 No. ) q Civil Work like closure of Windows, Shifting of Entrance Door, Increase in wall thickness as per AERB Regulations q Proper Display of Radiation Hazard Signage q Conduct Quality Assurance and Calibration of all Installation Part 3: Issuance of Licence for Operation from AERB § After ensuring upgradation of the non-compliant installation in the facilities , the Consultant shall facilitate Licence for Operation from AERB of each Diagnostic Radiation Installation. 7

PROJECT COST The Average Cost for a Single Installation would be approximately Rs. 1 Lakhs (Construction & Infrastructure Development per unit equals to Rs 2 lakhs approx. will be additional, on actual basis ) Major Cost Heads Civil Work like closure of Windows, Shifting of Entrance Door, Increase in wall thickness as per AERB Regulations Protective Equipments (Lead Aprons, Warning Lights, Chest Stands, Mobile Barriers) & TLD Cards Lead lining of Doors and Windows Calibration and Quality Assurance 8

PAYMENT TERMS & TIME LINES (1/2) Gap Analysis Timeline (T 5 + 60) days Payment Milestone Submission and Verification of Gap Analysis Report Facilitation of AERB Certification Infrastructure Upgradation (T + 180) days Completion of Infrastructure Upgradation (T + 210) days Final Inspection of Installations in the Licence for Operation from AERB Facilities • 10% of payment on obtaining Licence for Operation of 50% Facilities • 10%: Completion of Registration of each Facility & it’s Installation Payment 10% • 10%: Upon Provision of Safety Tools in each Facility • 10%: Completion of QA Test Reports & Registration of Approved RSO 20% • 10%: Upon Registration of Radiation Workers (TLD Cards) & Lead Lining Work Penalty (T + 365) days • 10% of payment on obtaining Licence for Operation of remainder of 40% of Facilities • 10% of payment on obtaining Licence for Operation of all Facilities • 0. 5% of Contract Value of each Cluster for up to 15 days of delay • 1% of contract value for delay between 16 -30 days of delay • Contract termination and forfeiture of Performance Security for > 30 days of delay Payment for Civil Work (Layout Work) will be as per the applicable Pw. D Rates, payment will be made basis invoices raised on monthly basis 5 T: The date of Signing of Contract between the Authority and the Successful Bidder(s) for each cluster. 9

PAYMENT TERMS & TIME LINES (2/2) Payment Methodology: § The Consultant shall submit an invoice of the Civil Work (Layout) for the facilities in a Cluster as per the applicable Pw. D Rates to the Paying Authority on the Monthly basis. § The Consultant shall submit a Self-Declaration Form for completion of each milestone (in previous slide) which make the basis for payment as defined in to the Paying Authority on the Monthly basis. § The Paying Authority can raise objection within 15 days of receipt of invoice/Self-Declaration Form and on 16 th day the verification claim will be considered approved; in case no objection is raised. § In case of objection raised by Paying Authority, the same will be resolved through verification from the Inspection Committee formed by the Nodal Authority. § After verification of invoices/Self-Declaration Form, the Paying Authority will make the payment within 30 days of verification of the Invoices or after 30 days of resolution of dispute, whichever is later, for all invoices/Self-Declaration Form raised. 10

THANK YOU

APPENDIX I: REQUIRED HUMAN RESOURCES FOR EACH DIAGNOSTIC RADIATION INSTALLATION Human Resource Staffing: Below are the minimum qualifications required for Radiation workers according to AERB mandate. For obtaining License for X-ray equipment installation and operation, availability of adequate no. of Operator/Radiologists is mandatory: # Resource / Staff Qualification 1. Radiologist/ Medical Practitioner Related Medical Practitioners such as MD/MS/DNB/BDS/MDS/ equivalent associated with the use of X-ray equipment 2. Radiographer/ Technician/ Operator Qualified X-ray technologist/Radiographers OR Medical Practitioner (as above) 3. Radiation Safety Officer Any person having valid AERB RSO approval for your Institute/facility. In case, no person is having valid AERB RSO approval for the Institute/facility then any Medical Practitioner (as above) OR Qualified X-ray technologist (with three years experience in the field of CT/Interventional Radiology) can be nominated for RSO approval after registering as Radiation Professional (RP) in e-LORA (Online licensing portal for AERB). §Complete guideline and application form for RP registration is available in e-LORA home page. §A person need to submit RP registration form for Practice: ‘Diagnostic Radiology’ and Professional Role: ‘Radiation Safety Professional’. Source: Medical Diagnostics Radiology Module, e-LORA System Guidelines (July 14, 2016) 12

APPENDIX II: MODEL LAYOUT FOR X-RAY INSTALLATION Source: Medical Diagnostics Radiology Module, e-LORA System Guidelines (July 14, 2016) 13

APPENDIX III: MODEL LAYOUT FOR CT SCAN INSTALLATION Source: Medical Diagnostics Radiology Module, e-LORA System Guidelines (July 14, 2016) 14

APPENDIX IV: MODEL LAYOUT FOR MAMMOGRAPHY INSTALLATION Source: Medical Diagnostics Radiology Module, e-LORA System Guidelines (July 14, 2016) 15