Training Program on ISO 15189:2022 Standard

Medical Education and Learning Point (MELAP) is conducting the following Training programs in Chennai

4 days Onsite Training program on IA&QMS as per ISO 15189:2022 standard

Medical Education and Learning Point (MELAP) in collaboration with Dept of Biochemistry – Madras Medical College ( MMC ) is conducting 4 Day IA & QMS / QC training program as per the New version of standard ISO 15189 : 2022. This course is Accredited by NBQP, Division of QCI

Program Details are given below:

Date & Time    : 27th – 30th March  2023  9.30 am to 4.00 pm

Venue              : Madras Medical college – Chennai

Regn Fee         : For Doctors / Senior Resident – Rs.11000 (incl of tax)

                          For Technical staff / PG Students – Rs.9000 (incl of tax)

For Registration/Query : kindly contact

Mr .Anil Saini #7042949292 &9899869683

Ksaini.anil@gmail.com

Ms.Tripti Madan – 9958697309

Onsite 2 day Refresher course as per ISO 15189:2022  Standard for those who have already done 2012 version (Accredited by NBQP, Division of QCI)

Medical Education and Learning Point (MELAP) in collaboration with Department of Regenerative Medicine & Research, Govt Stanley Hospital Chennai is conducting a 2 day refresher course as per ISO 15189:2022  Standard

Program details are given below

Date                :           24th & 25th March2023

Venue             :           Department of Regenerative Medicine & Research, Govt Stanley

Hospital Chennai

Regn fee          :           Rs.6500 (incl of tax)

For Registration/Query : kindly contact

Mr .Anil Saini #7042949292 &9899869683

Ksaini.anil@gmail.com

Ms.Tripti Madan – 9958697309

Seats are limited & available on first come basis only

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

Notification – UGC asks higher education institutions to get registered on BioRRAP

Biological Research Regulatory Approval Portal (BioRRAP)

The integrated portal – Biological Research Regulatory Approval Portal (BioRRAP)-has been initiated by the Government of India (GOI) to provide regulatory information to researchers and to facilitate approvals.

The University Grants Commission (UGC) has asked higher educational institutions and their affiliated colleges/institutions to get registered on Biological Research Regulatory Approval Portal (BioRRAP).

According to UGC, it is one-of-a-kind digital gateway intended to make science and scientific research more accessible as well as make it easier to create businesses. The information on international research projects as approved by all line Ministries/Departments of GOI is expected to be integrated with BioRRAP (with unique BioRRAP ID for each proposal).

With regard to Research Projects by entities falling under the category of Central/State Government, the relevant approvals will be dealt with by the concerned Ministry of the Government of India. State Governments have been requested to forward all such proposals to the concerned line Ministry of Government of India

In respect of Non-Government Organizations, the Health Ministry’s Screening Committee, operated by DHR/ICMR, that has been reconstituted by the Ministry of Health and Family Welfare will review the research projects involving international collaboration/funding in health research including studies in humans, animals, plants & environment.

UGC advised the higher educational institutions to follow the above provisions strictly and get registered on the portal

Source:https://odishatv.in/news/education/ugc-asks-higher-education-institutions-to-get-registered-on-biorrap-193363

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/

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

HIV Testing and Counselling Training

Online HIV Testing and Counselling Training (HTCT) Certification Program – 6th & 7th (Tuesday and Wednesday) December 2022 (1.00 PM to 5.00 PM)

ABOUT THE COURSE DETAILS
As per the World Health Organization (WHO) Geneva, HIV testing and counselling is a package service intended to allow people to make informed decisions regarding knowledge of their HIV status and the implications of those decisions. HIV testing and counselling helps people to cope with their HIV sero-status, make informed choices about their future practices and modify risk behaviours. Importantly, it is a gateway to prevention, care, treatment and support.

As per the National AIDS Control Organization (NACO), Government of India, New Delhi the health care settings should offer a service to protect an individual and their families by practicing the “5 Cs – Consent, Confidentiality, Counselling, Correct test results and Connection)”. This is also implemented through the standards and guidelines of the National Accreditation Board for Testing and Calibration Laboratories (NABL) and National Accreditation Board for Hospitals & Healthcare Providers (NABH) in public and private health care settings.

Program Organiser :
SDC, Saveetha University, Chennai (https://www.saveetha.com) is a not-for-profit private organization recognized by the DSIR, conducts this training program on HIV test counselling as part of its social commitment and educational services. This HIV Testing and Counselling Training (HTCT) program consists of 5 core components:
1. Pre-test counselling that outlines the testing process
2. A risk-behaviour assessment
3. Informed consent of each participant
4.Administration of the HIV test
5. Post-test counselling based on the test result(s). This course is based on the NACO guidelines.

The next session of a 2-day Online HIV Testing and Counselling Training (HTCT) Certification Program will be held on 6th & 7th (Tuesday and Wednesday) December 2022 (1.00 PM to 5.00 PM).

This HTCT program is meant for the professionals/staff in the Hospitals, Diagnostic Laboratories and Blood Banks which are accredited to be accredited by the NABL (ISO 15189: 2012) or NABH.

This certification program provides training as per the NABL-112 document and NACO guidelines, occupational post-exposure prophylaxis (PEP), legal and ethical issues related to HIV testing

Lectures, case studies and interactive sessions. Professionals including laboratory experts, clinicians, scientists with years of HIV/AIDS training experience will facilitate the program.

The participants can enrol for the program by paying Rs. 1,500/- per person and the payment can be done using net-banking or from GooglePay account to the following bank account:

Account No. 1248135000009037,
Account Name: SDC Microbiology CME,
Bank: Karur Vysya Bank,
IFSC Code: KVBL0001248,
Branch: PH Road,
Chennai600077 or scanning the QR Code as shown in the program brochure

Please refer to the attached brochure for more details about the program and please register via online form using the following link:
https://forms.gle/cVan7oYwvgneje8v7

About academic partnering institutions:
Ashakirana Hospital, Centre for AIDS Care and Research, Mysuru (https://www.ashakirana.org) is a not-for-profit private organization recognized by the DSIR and providing out-patient and in-patient services as HIV speciality tertiary care centre.
Adolescent Health Foundation of India, Chennai (https://www.ahfi.in) is a not-for-profit private organization working on adolescent health, sexuality and related infections.

About Course Coordinator:
Dr. Pachamuthu Balakrishnan (http://micro.sdc.saveetha.com/faculty) has more than 25 years of experience in the field of HIV research and diagnostics. He was trained at the HIV Branch, Centre for Disease
Control and Prevention (CDC), Atlanta, USA and, also contributed to the international (World Health Organization, WHO) and national (National AIDS Control Organization, NACO) guidelines as an expert, which are accessible online.

For queries, please contact via email:
Dr. Pachamuthu Balakrishnan
HTCTSAVEETHA@gmail.com
Mobile: +91 7667444221

Download the program brochure from here

Eat Right Campus Certification Program

Eat Right Campus Certification Program from Andhra Chamber of Commerce –
Nov 3rd 2022 – 10 am – 1 pm

Program Announcement from Andhra Chamber of Commerce
Training Session on Eat Right Campus Certification

Greetings from Andhra Chamber of Commerce!

We have the pleasure of inviting you to the Program on “Eat Right Campus Certification “@ Chamber’s conference Hall, Chennai on the 03rd November 2022 (Thursday) from 10 am to 1 pm.

Mr Prem Kumar, Principal Consultant & MD, Jayvin Management Systems & Solutions P Ltd will be the Faculty for the Training Program and Ms Rama Venugopal , the Chairman of the Quality Systems & Productivity Sub Committee of the Chamber will be the session coordinator.

We are pleased to attach herewith the soft copy of the brochure for the Program, and the draft programme schedule, for your information.

Please register through https://Registration form to participate.

Participation Fee (Inclusive of Lunch, Refreshments & Course Kit)

For Members : Rs .600/- (Inclusive of taxes) per person
Non Members : Rs.750/- (Inclusive of taxes) per person

Delegates will be issued a Certificate of Participation .

Payment Instructions :

Mode of Payment : NEFT / DD / Cheque / GPAY – 9940267991

NEFT Payment Details :
Andhra Chamber of Commerce
Name of the bank : Indian Bank
Branch & Address : South Usman Road Branch, T. Nagar, Chennai – 600 017
Current Account Number : 701020952
IFSC Code Number : IDIB000T115

Program Brochure

Contact :

Chennai Office
ANDHRA CHAMBER OF COMMERCE
“Velagapudi Ramakrishna Bldg”,
New No.23, 3rd Cross Street, West CIT Nagar P.B.No.3368,
Nandanam, Chennai – 600 035.
Telephone: Office: 24315277

Secretary General : R.Vijayalakshmi
Tel : (Per)24315278 Fax : 24315279

Email – andhrachamber1@gmail.com

acc@andhrachamber.com