Certification Programs

NABH CERTIFICATION OF ABDM HEALTHCARE SOLUTIONS – Draft Standards

PUBLIC NOTICE FOR COMMENTS ON DRAFT NABH CERTIFICATION OF ABDM HEALTHCARE SOLUTIONS (CAHS-1)  

Announcement from NABH

National Health Authority (NHA) in collaboration with National Accreditation Board for Hospitals (NABH) and Quality Council of India (QCI) has initiated a project, ‘Certification of ABDM Health Solutions – V1.0’ (CAHS-1) to certify HMIS/LMIS/Clinic solutions that have been integrated within Ayushman Bharat Digital Mission (ABDM) Sandbox. This ensures that essential features are provided to support integrated digital healthcare. The first draft of the standards is ready and is being placed for the comments, suggestions, objections by the stakeholders. The comments are invited on the following link. 

Feedback form: https://forms.gle/4CY35qrY5WEndvWr5  

The draft standards are available on the following links: 

1. First version of HMIS essential features 

https://drive.google.com/file/d/1bb3Tj7ylLyFJ5Bu9wYJ7JspsK8mkZ290/view?usp=sharing

2. First version of LMIS essential features  

https://drive.google.com/file/d/1obMLcyhppoX87t6WvZIh0uxjQai94DBK/view?usp=sharing

3. First version of Clinics essential features  

https://drive.google.com/file/d/1TZGkoFbqRVqiUXX7WkM7g2YPgpkiww1_/view?usp=sharing

The last date for receiving comments is 8th February 2023.   

Source – https://nabh.co/Announcement/Public%20Notice%20for%20NABH%20Certification%20Of%20ABDM%20Healthcare%20Solutions%20(CAHS%20-1).pdf

Do refer the draft standards and share your feedback .

Announcement – ICAI issues Social Audit Standards

Social Audit Standards – Sustainability Reporting

The Institute of Chartered Accountants of India (ICAI) has issued the Social Audit Standards (SAS) for the members. These Social Audit Standards will be applicable from the date of their hosting on ICAI website. (SAS 100 should be read in conjunction with the “Preface to the Social Audit Standards” and “Framework for the Social Audit Standards”, issued by the ICAI

This Social Audit Standard relates to the thematic area of “eradicating hunger, poverty, malnutrition and inequality’’. The Standard aims to provide the Social Auditor with the necessary guidance in relation to independent impact assessment engagement of Social Enterprises engaged in eradicating hunger, poverty, malnutrition and inequality and the audit steps and procedures that should be applied while conducting the social impact assessment. The Standard sets out the minimum requirements to be followed while conducting impact assessment. Laws or regulations may establish additional requirements which should be followed, as applicable.

The Social Auditor should conduct a desk review of existing documents to gain further insight into the evaluation procedure and impact assessment.

The social auditor should review the evaluation questions addressed through Questionnaires, In – depth Interviews and Focused Group Discussions to assess the responses received from various stakeholders and to understand what has changed.

The Social Auditor should review the project/program documents to frame the evaluation criteria for assessing impact. Such key metrics may be collated from base-line, mid-line (monthly / quarterly) and end-line assessment (if available), respectively at the beginning, middle and end of the reporting period/project/program to effectively understand and evaluate impact.

The Social Auditor should identify the inherent limitations of the evaluation process which might have an influence on the impact assessment.

Source – https://resource.cdn.icai.org/72658srsb58573.pdf;

Source: https://www.taxscan.in/icai-issues-social-audit-standards/245984/

Webinar on Electrical Safety in Hospitals

Webinar on Electrical Safety in Hospitals and Medical Locations (Part – 2)

The webinar will explain about the safety measures to be adopted in Hospitals and Medical locations to get safety of patients, doctors and nurses working in medical locations and fire due to short circuit.

The webinar is specially designed for Bio Medical Engineers and working professionals in Hospitals.

Dr. Vijay Agarwal, President CAHO will make the opening remarks followed by technical sessions by CAPE Engineers. The program is hosted by Mr. K P Dominic, B&G.

Date and Time of the program : 21 Jan 2023 11 Am onwards

ISO 15189:2022 FOR MEDICAL LABS PUBLISHED

ISO 15189:2022 – Medical laboratories — Requirements for quality and competence

This document specifies requirements for quality and competence in medical laboratories.

This document is applicable to medical laboratories in developing their management systems and assessing their competence. It is also applicable for confirming or recognizing the competence of medical laboratories by laboratory users, regulatory authorities and accreditation bodies.

This document is also applicable to point-of-care testing (POCT).

NOTE : International, national, or regional regulations or requirements can also apply to specific topics covered in this document.

This document was prepared by Technical Committee ISO/TC 212, Clinical laboratory testing and in vitro diagnostic test systems, in collaboration with the European Committee for Standardization (CEN) Technical Committee CEN/TC 140, In vitro diagnostic medical devices, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).

This fourth edition cancels and replaces the third edition (ISO 15189:2012), which has been technically revised. It also replaces ISO 22870:2016.

The main changes are as follows:

  • Alignment with ISO/IEC 17025:2017 resulted in the management requirements now appearing at the end of the document;
  • Requirements for point-of-care testing (POCT), previously in ISO 22870, have been incorporated;
  • Increased emphasis on risk management.

Introduction

The objective of this document is to promote the welfare of patients and satisfaction of laboratory users through confidence in the quality and competence of medical laboratories.

This document contains requirements for the medical laboratory to plan and implement actions to address risks and opportunities for improvement. Benefits of this approach include: increasing the effectiveness of the management system, decreasing probability of invalid results, and reducing potential harm to patients, laboratory personnel, the public and the environment.

The requirements for risk management are aligned with the principles of ISO 22367.

The requirements for laboratory safety are aligned with the principles of ISO 15190.

The requirements for sample collection and transport are aligned with ISO 20658.1

This document contains the requirements for point-of-care testing (POCT) and supersedes ISO 22870, which will be withdrawn upon publication of this document.

The format of this document is based on ISO/IEC 17025:2017.

The medical laboratory is essential to patient care; activities are provided within an ethical and governance framework, that recognizes the obligations of healthcare providers to the patient. These activities are undertaken in a timely manner to meet the needs of all patients and the personnel responsible for the care of those patients. Activities include arrangements for examination requests, patient preparation, patient identification, collection of samples, transportation, processing of patient samples, selection of examinations that are fit for intended use, examination of samples, sample storage, as well as subsequent interpretation, result reporting and advice to laboratory users. This may also include the provision of results to the patient, arrangements for urgent testing and the notification of critical results.

While this document is intended for use throughout the currently recognized medical laboratory disciplines, it can effectively be applied to other healthcare services, such as diagnostic imaging, respiratory therapy, physiological sciences, blood banks and transfusion services.

The use of this document facilitates cooperation between medical laboratories and other healthcare services, assists in the exchange of information, and in the harmonization of methods and procedures.

The comparability of patient examination results between medical laboratories, regardless of city or country, is facilitated when medical laboratories conform to this document.

When a laboratory seeks accreditation, it should select an accreditation body which operates in accordance with ISO/IEC 17011, and which takes into account the particular requirements of medical laboratories.

Comparisons between this document, ISO 9001:2015 and ISO/IEC 17025:2017 are in Annex B. The comparison of ISO 15189:2012 to ISO 15189:2022 (this document) is in Annex C.

Source : https://www.iso.org/standard/76677.html

Transition Timeline Announcement

ILAC Announcement – 8th

ISO 15189:2022 Medical Laboratories – Requirements for quality and competence has now been published.

Further a resolution was endorsed at the ILAC General Assembly to allow a 3-year implementation period from the date of publication of this revised standard (ie now December 2025) as shown below:

ILAC Resolution GA 26.08

As the revised version of ISO 15189 is scheduled for publication in 2022 or early 2023, the General Assembly endorses the recommendation of the AIC that a transition period of 3 years from the date of publication be adopted. 

Noting that the requirements for Point of Care Testing (POCT) contained in ISO 22870:2016 have been incorporated into the revised ISO 15189, ISO 22870:2016 in conjunction with ISO15189:2012 will still be recognised as a Level 4 standard for POCT for the duration of the transition period

At the end of the transition period, accreditation of a medical laboratory to ISO 15189:2012 and accreditation of POCT to ISO 22870:2016 in conjunction with ISO15189:2012 will not be recognised under the ILAC Arrangement.

The implementation of this transition period for ISO 15189:2022 by the signatories to the ILAC MRA for the accreditation of medical laboratories will be monitored by the ILAC AMC to ensure the deadline is achieved. The process used by the AMC to monitor this implementation of the revised standard will be similar to that used during the implementation of ISO/IEC 17025:2017

Posted on 08th December 2022

Source :https://ilac.org/latest_ilac_news/iso-151892022-for-medical-labs-published/

Transition Timeline Announcement of NABL

NABL has released transition announcement for Accredited Medical Testing Labs in the country

Buyer Seller Meet

Indian Business Delegation for Buyer Seller Meet (BSM) in ASEAN Region covering Vietnam, Cambodia, Philippines & Indonesia from 20th Feb– 04th Mar 2023

SEPC with the support of Department of Commerce, Ministry of Commerce & Industry, Government of India and recommendation by EP Services Division, India is organizing India’s services sector trade delegation Buyer Seller Meet (BSM) to ASEAN region covering Vietnam, Cambodia, Philippines & Indonesia from 20th Feb. – 04th Mar. 2023 covering following sectors which have demand in ASEAN region:

➢Hotel & Tourism Services
➢Educational Services
➢Healthcare Services
➢Architectural, Construction & Related Engineering Services
➢Entertainment Services (Including AVCG)

Benefits to participants on participating at BSM to ASEAN region.

• Focused prescheduled B2B meetings in each country
• Understand the market potential from experts in ASEAN region.
• Networking Opportunities with potential buyers in ASEAN region.
• Generate business leads and sign MOUs for collaborations.
• Meetings with relevant government and related stakeholders

The tentative programme for this BSM is given in Annexure A for your kind reference.

An estimate of expenditure heads which has to be managed by the participants are –

  • Flight tickets: For 4 countries, approximate cost would be INR ,1,59,000
  • Hotel stay: Approximately USD 130 -165 USD per night.
  • Total Cost approximately for all 4 Countries – INR3,35,000.

SEPC shall share the details of travel partners for this delegation with participants separately.

MAI Support to Participants:

SEPC registered Members whose export turnover during the previous financial year is less than/up to Rs.50 crores and who have completed one year of membership with SEPC will be eligible for assistance under new MAI scheme up to a maximum of Rs. 75,000/- towards economy class air fare, subject to terms and conditions of new MAI scheme and approval by the Ministry of Commerce & Industry.

Registration Link: https://tinyurl.com/7v5byhr6

Announcement – Digital Health Incentive Scheme (DHIS) by NHA

Digital Health Incentive Scheme (DHIS) by NHA

The National Health Authority (NHA) has announced a Digital Health Incentive Scheme (DHIS) for the stakeholders of the digital health ecosystem. The scheme aims to give a further boost to digital health transactions in the country under the Ayushman Bharat Digital Mission (ABDM). The incentives under this scheme would be provided to hospitals and diagnostic labs and also to the providers of digital health solutions such as Hospital/ Health Management Information System (HMIS) and Laboratory Management Information System (LMIS).

Under the DHIS, the eligible health facilities and digital solutions companies shall be able to earn financial incentives of up to Rs. 4 crores based on the number of digital health records they create and link to ABHA (Ayushman Bharat Health Account). This incentive can be availed by the health facilities (hospitals and diagnostic labs) registered with ABDM’s Health Facility Registry (HFR) and fulfilling the eligibility criterion specified under the scheme.

Important points under ABDM’s Digital Health Incentive Scheme are:

  1. Incentives would be provided to the following entities:
    1. Health Facilities having 10 or more beds
    2. Laboratory/radiology diagnostics centres
    3. Digital Solution Companies (entities providing ABDM enabled digital solutions)
  2. The incentives shall be provided on the basis of the number of ABHA-linked transactions i.e. the digital health records created and linked to ABHA.
Healthcare FacilityBase Level Criteria   Incentives
Hospitals50 Transactions per bed per monthRs. 20 per additional transaction above the base level
Diagnostic facilities /Labs500 Transactions per monthRs. 15 per additional transaction above the base level
  1. Digital Solution Companies (DSCs) will be given an incentive of 25% of the incentive amount received by the eligible health facilities using their digital solutions.
  2. For the ABHA linked transactions done by facilities not eligible for direct incentives (Clinics/ Small Hospitals/ Health Lockers/ Teleconsultation Platforms etc.), an incentive would be provided to Digital Solution Companies.
Cost Incentives for Digital solution (HMIS and LMIS) Companies
For every Transaction by hospitals/labs using their software and receiving incentives under this policy25% of the corresponding incentive amount received by the eligible facilities
For other Transactions (including by health lockers, Teleconsultation platforms, small clinics etc.), provided the transactions are more than 200 per monthRs. 5 per Transaction

NHA is organising public webinars starting from Dec 23, 2022 to provide detailed overview of the scheme. The schedule and link for the webinars will be available on the website https://abdm.gov.in/dhis

Source: https://abdm.gov.in/DHIS

Post Graduate Certificate Programme in Digital Health

Certified Digital Health Professional (CDHP) course

The CDHP™ is jointly offered by the leading institutions across Digital Health and Management – Digital Health Academy and Indian Institute of Management (IIM) Raipur

Certified Digital Health Professional’ (CDHP) course blending the fields of Health, Technology and Management, will equip clinicians, paramedics, healthcare professionals, and managers to understand the Digital Health domain and the deployment of digital health tools.

Ideated in 2020 by Digital Health Academy, CDHP is the result of two years of research, brainstorming, and extensive consultation with around 60 global leaders across the healthcare domain working in hospitals, the pharmaceutical industry. research & development, med-tech, information technology, regulators, and policy makers across the countries. The course is a unique blend of the world’s best faculty and use cases in digital health. This Course jointly offered by Digital Health Academy and Indian Institute of Management, Raipur.

The year-long course will be completely online specifically designed for healthcare and management professionals. The CDHP course has three levels; Basic, Advanced and Professional. This course aims to provide knowledge on theoretical, technological, management and application aspects of digital health acorss the continuum of care.


The course certificate will be awarded by IIM Raipur and Digital Health Academy

Source: https://health.economictimes.indiatimes.com/news/health-it/treating-a-patient-with-pills-alone-is-over-it-is-time-for-digital-health/96474796

Admission Open – ISO 13485:2016 – Lead Auditor Training

ISO 13485:2016 – Lead Auditor Training Program (Medical Device Quality Management Systems )

Indian Biomedical Skill Consortium (IBSC) is conducting Lead Auditor Training Program on ISO 13485:2016 standard.

Program Details are given below:

Program: ISO 13485:2016 – Lead Auditor Training (Medical Device Quality Management Systems )

Certificate: CQI & IRCA Certified Course

Duration: 5 Days (23rd – 27th January 2023)

Last date for Registration : 12th January 2023

Location: Kalam Convention Center, AMTZ Campus, Vizag

Program Details: https://ibsc-amtz.in/coursedetails/23

For quotation send email to n.nareshkumar@ibsc_amtz.in
➖➖➖➖➖➖➖➖➖➖
For more information, please contact
Mr. Nitturi Naresh Kumar
Mobile: 8897330990
WhatsApp Link: https://wa.me/918897330990
n.nareshkumar@ibsc-amtz.in

Source: https://ibsc-amtz.in/

Announcement from NABH

LATEST NOTIFICATION FROM NABH ON IMPLEMENTATION PLAN OF 3RD EDITION OF NABH SHCO ACCREDITATION STANDARDS

Announcement from NABH

NABH has released a notification on implementation of 3rd Edition of NABH SHCO Accreditation Standards.

Key information from the notification is shared below :

The 3rd Edition of NABH SHCO Accreditation Standards along with the Guidebook has been released on 31st August 2022.

The effective date of Implementation of the third edition standards for SHCO would be as below:

a.     All accredited SHCOs must be in full compliance with third edition by 1st March 2023 and shall submit the documentary compliance for the same by this date. The onsite compliance shall be verified during next on-site assessment (which can be either surveillance or renewal assessment).

b.     All the assessments (Pre, Final, Renewal, Surveillance) shall be based on Third Edition w. e. f. 1st March 2023.

c.      For all the assessments before 1st March, 2023, decision shall be based on Second Edition. However, such SHCOs would require to comply with the Third edition in next six months from the date of accreditation.

d.     NABH will not accept any application (New as well as Renewal) on Second Edition Standard after 31st December 2022.

The whole process of transition will be completed 1st September 2024.

Source: https://nabh.co/

European Green Deal

European Green Deal: Carbon Border Adjustment Mechanism (CBAM) Agreement

European Green Deal Announcement

Agreement reached on the Carbon Border Adjustment Mechanism (CBAM)
Brussels, 13 December 2022

The Commission welcomes the political agreement reached this morning between the European Parliament and the Council on the Carbon Border Adjustment Mechanism (CBAM). The CBAM is the EU’s landmark tool to put a fair price on the carbon emitted during the production of carbon intensive goods that are entering the EU, and to encourage cleaner industrial production in non-EU countries.

Today’s agreement will be complemented by the revision of the Emissions Trading System (ETS), with negotiations taking place later this week, and that will align the phase-out of the allocation of free allowances with the introduction of CBAM to support the decarbonisation of EU industry.

Climate change is a global problem that needs global solutions. As the EU raises its own climate ambition, and as long as less stringent climate policies prevail in many non-EU countries, there is a risk of so-called ‘carbon leakage’. Carbon leakage occurs when companies based in the EU move carbon-intensive production abroad to countries where less stringent climate policies are in place than in the EU, or when EU products get replaced by more carbon-intensive imports.

By making sure that a price is paid for the embedded carbon emissions generated in the production of certain goods imported into the EU, the CBAM will make sure the carbon price of imports is equivalent to the carbon price of domestic production, thereby ensuring that the EU’s climate objectives are not undermined. The CBAM is designed in such a way that it is compatible with WTO rules.

President von der Leyen said: “I welcome the political agreement reached this morning on the Commission’s proposal for a Carbon Border Adjustment Mechanism. This is a central part of our European Green Deal, preventing the risk of carbon leakage. It is a huge step forward, as we raise our climate ambitions.”

Key elements :

The CBAM will initially apply to imports of certain goods and selected precursors whose production is carbon intensive and at most significant risk of carbon leakage: cement, iron and steel, aluminium, fertilisers, electricity and hydrogen. With this enlarged scope, CBAM will eventually – when fully phased in – capture more than 50% the emissions of the ETS covered sectors. Under this political agreement, the CBAM will enter into force in its transitional phase as of 1 October 2023.

The gradual phasing in of CBAM over time will allow for a careful, predictable and proportionate transition for EU and non-EU businesses, as well as for public authorities. During this period, importers of goods in the scope of the new rules will only have to report greenhouse gas emissions (GHG) embedded in their imports (direct emissions), without making any financial payments or adjustments. The agreement foresees that indirect emissions will be covered in the scope after the transitional period, on the basis of a methodology to be defined in the meantime.

Once the permanent system enters into force, according to a schedule to be defined in the revised EU ETS rules currently under negotiation, importers will need to declare each year the quantity of goods imported into the EU in the preceding year and their embedded GHG. They will then surrender the corresponding number of CBAM certificates. The price of the certificates will be calculated depending on the weekly average auction price of EU ETS allowances expressed in €/tonne of CO2 emitted.

A review of the CBAM’s functioning during its transitional phase will be concluded before the entry into force of the definitive system. At the same time, the product scope will be reviewed to assess the feasibility of including other goods produced in sectors covered by the EU ETS in the scope of the CBAM mechanism, such as certain downstream products and those identified as suitable candidates during negotiations. The report will include a timetable setting out their inclusion by 2030.

Next steps

Given the close links between the new CBAM and the review of the EU ETS, currently under negotiation in ‘trilogue’ between the co-legislators, the final technical details of the mechanism’s functioning will need to be clarified. Once the text has been finalised, the European Parliament and the Council will have to formally adopt the new Regulation before it can enter into force.

Download here for full announcement

Source : https://ec.europa.eu/commission/presscorner/detail/en/ip_22_7719