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

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

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/

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

Pathcon & Lab Expo 2022

6th Annual Conference of the Association of Practising Pathologists, India
(PATHCON & Lab Expo 2022)

Pleasure to invite you all to “6th Annual Conference of the Association of Practising Pathologists, India (PATHCON & Lab Expo 2022), which is going to be held virtually on 17th (Saturday) December 2022 &  in Hybrid mode at The Hotel Vivanta by Taj, Dwarka, New Delhi on 18th (Sunday) December 2022. This conference will bring together all of us who have put in a lifetime of effort to bring this association to this landmark event.

Date: 17th (Saturday) December 2022Virtual Mode
Date: 18th (Sunday) December 2022Hybrid Mode

Participants will learn of the rapid development and spread of technical advancement in recent years, the people who made this possible and the necessary equipment, regulations and other requirements for setting up new centres. The scientific program will cover the latest developments in all disciplines of Lab medicine. The emphasis will be on interactive sessions and panel discussions with clinical colleagues to encourage active participation of all delegates. We hope the students and residents will benefit from the experience of their colleagues and teachers and gather encouragement from the pioneers in research. Several well renowned speakers have confirmed their active participation, and this will add to the academic benefits of this conference. Save the dates in your diary today. We look forward to greeting you in what promises to be an exciting and fruitful meeting with a high scientific standard.

Keeping in mind the interest of our young participants, we shall be inviting posters and abstracts for oral presentation from all across the country and details are available on the website.

This year the venue which we have finalised is situated in Dwarka, New Delhi which is well connected all across Delhi & NCR through Delhi metro and other modes of transportation. It is just 3.5 Kms away from the IGI Airport. Delhi has a wide choice of hotel accommodation for different budgets. Kindly make your arrangements for travel and stay well in advance. The weather in Delhi in December is cool and pleasant, though light jackets may be required in the evenings. The organising committee welcomes all delegates to avail the discounted early registration rates and actively participate in this landmark event in the history of our Association.

Delhi is a historical city & always been a centre of power with many monument, multiple cuisine restaurants & it is a shoppers’ paradise and very well connected by road, rail and air to all major cities of India.

Conference Registration Fee mentioned below in Brochure Please check

ABSTRACT SUBMISSION GUIDELINES

> Abstracts for Oral Presentation/Poster Presentation are to be submitted online through the conference website only.
> You need to register yourself on the online portal for submission of the abstract. You can make the registration payment later, but submission of relevant information is must.
> The presenting author MUST be registered for the conference.
> The number of papers to be accommodated are limited. You can indicate your preference during submission (oral/poster). Some abstract requests for Oral presentations will be shifted to the poster section. Case reports, unless carrying a very novel message, will not be considered for oral presentations.
> It is mandatory that the Presenting author is registered for the conference to be eligible for presentation and for awards.
> The cut-off date will be 31 Oct 2022 by 1700 hrs. No abstracts will be considered after this Deadline.
> Abstracts will be listed on the conference website by 10 Nov 2022. The abstract is restricted to a maximum of 300 words. It should include: Objectives, Methods, Results, Conclusions, and Keywords.
> One participant may submit upto 3 abstracts, and only one abstract would be considered for Oral Presentation.

Conference Manager

Mr. Saurabh Sharma
Phone: +91 9871799136
Email: secretariat.pathcon@gmail.com

Conference Secretariat
Tripti : +91 – 9958697309
Dr Neeraj Jain : +91 – 9810492621
Dr Rajan Verma : +91 – 9999138158

IPC National Conference

National conference on Strengthening Medical Product Safety Surveillance

IPC in association with Ruby Hall Clinic, Pune is organizing a national conference on “Strengthening Medical Product Safety Surveillance” on November 12, 2022 at Sheraton Grand Hotel, Bund Garden Road, Pune- 411001

For more Information Please Check Here: https://bit.ly/3fvDobv

Source:https://www.ipc.gov.in/news-highlights/1048-ipc-in-association-with-ruby-hall-clinic,-pune-is-organizing-a-national-conference-on-%E2%80%9Cstrengthening-medical-product-safety-surveillance%E2%80%9D-on-november-12,-2022-at-sheraton-grand-hotel,-bund-garden-road,-pune-411001.html

HTCT Certification Program

HIV Testing and Counselling Training (HTCT) Certification program

The forthcoming session of a 2-day online HIV Testing and Counselling Training (HTCT) Certification program will be on 15th & 16th (Tuesday and Wednesday) November 2022, this virtual program is conducted between 1.00 PM to 5.00 PM on these 2 days.

This HIV test counselling training certification program (HTCT) is meant for the professionals/staff in the Hospitals, Diagnostic Laboratories and Blood Banks which are NABL (ISO 15189: 2012) / NABH accredited or under preparation for accreditation. This certification program provides training as per the NABL-112 document and NACO guidelines, occupational exposure & post-exposure prophylaxis (PEP), legal and ethical issues related to HIV testing.

Please refer to the attached brochure below for more details about the program and please register via online form using the following link:
https://forms.gle/cVan7oYwvgneje8v7 (this online form needs to be filled in after making the payment)

For queries,
please contact via email: HTCTSAVEETHA@gmail.com / mobile: 7448444221.

World Standards Day 2022 Program

Webinar – World Standards Day (WSD) 2022 Program on Role of Sustainability Standards in International Trade on Oct 14, 2022 – 4 30 pm – 6 00 pm

Sustainable Trade Development and Voluntary Sustainable Standards

Sustainable Development defines international trade as “an engine for inclusive economic growth and poverty reduction, that contributes to the promotion of sustainable development”.

The exponential increase in global trade has enabled many developing countries to pursue economic development through export and export diversification. On the other hand, the nature of trade has changed and that products are now made by bringing parts together from different parts of the world.

Although the expansion of international trade, in the last decade, has brought economic and societal benefits across the globe, it resulted in failing to address the adverse social and environmental and even economic impacts.

Hence, in order for trade to become a ‘sustainable engine’, one approach that seems to be increasingly used is to internalize social, economic and environmental concerns in international trade.

Sustainability Standards play a central role in global trade, and greatly contribute to the improvement of  environmental and social compliance in supply chains. They represent guidelines used by producers, manufacturers, traders, retailers, and service providers to develop good environmental, social, ethical, and food safety practices.

Sustainability standards can unlock new markets for developing countries.

Go Green, Go Sustainable

More and more countries are pursuing green, social and/or sustainable public procurement, therefore standards can play an important role in identifying which products are sustainable.

Adhering to sustainable trade standards can enhance opportunities for market access to retail, corporate and government consumers who are concerned about the sustainability of the products they purchase and the resources they consume in production, use and disposal.

Program Objective

Consultants Consortium of Chennai is organising a Knowledge Session, on the occasion of World Standards Day (WSD), on October 14th 2022.

The program is designed on the topic Sustainability Standards based on the WSD Theme.

Objective of the program is to create awareness to businesses about various National and International Sustainability Standards and hoe implementing the same would increase trade and business opportunities across the globe.

Program Details

Topic – Role of Sustainability Standards in International Trade

Date : October 14th 2022 – Friday

Time : 04 30 pm – 06 00 pm

Meeting Mode – Online / Virtual

Meeting Platform – Zoom

Fee : No Registration Fee.

Program Open for industry and all stakeholders in Conformity Assessment. However, prior registration is a must.

Registration Link

Click the button below for registration

Upon registration, registered delegates will receive meeting link.

Contact

For enquiries, pls email to

contact@ccc-consultants.org

secretariat@ccc-consultants.org