CROSQ/AFENET/CDC LQMS — SIP Project
Laboratory Quality Management Systems — Step wise Improvement Process
Health and social care seeks to provide a competent service to doctors, patients, families, the public and regulators. The primary purpose of health and social care accreditation is to ensure that users of the service receive a consistent high level of care; medical laboratories play a vital role in this service.
LQMS-SIP and ISO 15189 Medical Laboratory Accreditation
The Laboratory Quality Management Systems Stepwise Improvement Project (LQMS-SIP) is a comprehensive system to strengthen medical and public health laboratory services throughout CARICOM. LQMS-SIP is supported by the United States Government Centers for Disease Control and Prevention (CDC)/PEPFAR funding. The LQMS-SIP supports Caribbean countries in their efforts to strengthen medical laboratory services through a stepwise quality improvement process towards fulfillment of the ISO 15189. The ISO 15189: 2012 is the international standard for Medical Laboratories.
Medical laboratory services play a pivotal role in ensuring that patients receive accurate test results and the best treatment and care. It is important that medical laboratories meet the needs of all patients and clinical personnel.
Accreditation against the global standard ISO 15189, allows medical laboratories to demonstrate, the technical competence of that laboratory to all users of the laboratory services. When patients use an accredited medical laboratory they can be assured that they will receive the level of high quality care.
LQMS-SIP encourages, supports and recognizes the implementation of Quality Management Systems in medical laboratories as they seek to provide accurate, timely and reliable results for patient care and public health purposes in a safe environment. LQMS-SIP will recognize laboratories in the process of quality improvement, support them through assessments, provide technical assistance, monitor and reward progress towards meeting internationally accepted standards.
The Laboratory Quality Management Systems Stepwise Improvement Process (LQMS-SIP) Towards Accreditation
The LQMS-SIP is supported by the United States Government President’s Emergency Plan for AIDS Relief (PEPFAR) through the U.S. Centers for Disease Control and Prevention (CDC), Caribbean Regional Office. The LQMS-SIP is supporting CARICOM countries in their efforts to strengthen national laboratory services through the stepwise quality improvement process towards fulfilment of the ISO 15189:2012 requirements for international accreditation.
- The LQMS-SIP is a system that assists medical laboratories in working towards achieving their accreditation.
- ISO 15189: 2012 – International Standard for Medical Laboratory Accreditation.
- ISO 15189 explains the requirements for diagnostic laboratories to show their competence to deliver reliable services.
- Medical laboratory services are essential in the diagnosis and assessment of the health of patients.
- The LQMS-SIP conducts independent assessments of the medical laboratories to determine competence, impartiality and consistency. LQMS-SIP looks at the qualifications and on-going competency of staff involved in medical laboratory examinations, laboratory accommodation, equipment, reagents and supplies, testing, and quality assurance.
- LQMS-SIP Technical and Management Assessors evaluate all factors in the laboratory that affect the production of test results e.g. staff competence, test methods, sample collection and sample handling, reporting , maintenance of test equipment and time taken to complete test results.
- By being accredited, medical laboratories confirm that there is consistency in the quality of care, the laboratory has up-to-date-technologies and its procedures/techniques reflect current best practice, and medical staff are competent to undertake the tasks they perform.
- Accreditation provides proof that a laboratory complies with best practice, gives international recognition to the laboratory and most of all, improves the quality of the results for the patients.
Steps to Medical Laboratory Accreditation to ISO 15189
Medical laboratory accreditation based on ISO 15189 involves precise requirements that are based on the area of work for which the medical laboratory is pursuing accreditation. The medical laboratory must demonstrate its credibility and ability to produce accurate and reliable results in order to receive its international accreditation. Laboratories go through the following steps in order to become accredited:
- The Laboratory submits a application form, questionnaire, quality management system manual and other necessary documents to the ILAC MRA signatory which then assesses and accredit conformity assessment bodies (medical laboratory) according to the ISO 15189
- The ILAC MRA signatories agree to accept the results of each other’s conformity assessment bodies under the ILAC MRA. Hence, the results from the conformity assessment bodies accredited by the ILAC MRA signatories are able to be recognised internationally
- The ILAC MRA signatory conducts a review of the applicants submitted documents; and may request additional information and/or clarification.
- A medical laboratory assessment is conducted using a team of technical and management assessors that visit the laboratory to evaluate the level of conformance of its equipment, methods and staff to the required standards, thereby verifying the laboratory’s competence.
- If non-conformances are identified during the assessment, corrective action is requested and assessors carry out follow-up visits or other activities to verify the effectiveness of the corrective action implemented by the medical laboratory. The laboratory is given the opportunity to work towards fulfilling requirements.
- The assessors produce a laboratory assessment report and make a recommendation about whether or not to grant the accreditation. The recommendation is reviewed and a final decision made whether or not to grant the medical laboratory accreditation.
- The medical laboratory after being granted accreditation is subject to surveillance visits a re-assessment during the accreditation cycle. These visits are conducted to verify the maintenance, extension, reduction or withdrawal of the laboratory’s scope of accreditation.
LQMS-SIP Project Progress
From 2010 until 2013, a series of stakeholder meetings were held to advance the LQMS-SIP and determine the way forward as well as gather information and prepare implementation documents. From 2014 until the 2015, the LQMS-SIP had progressed significantly by updating the LQMS-SIP Checklist from the 2007 to 2012 version of the International standard ISO 15189- Medical Laboratories: Requirements for Quality and Competence, obtaining copyright permission from the ISO for the updated Checklist, creation of an electronic version of the Checklist, creation of a Laboratory Non-conformance Report and Laboratory Action Plan, execution of the LQMS-SIP Pilot Study, convening several Stakeholders’ Meetings, constitution and mobilization of the LQMS-SIP Project Steering Committee, further laboratory assessments and preparation for the initial award of Certificates of Recognition of Tier Achievement to laboratories.
The LQMS-SIP Project Steering Committee (PSC) was constituted in March 2015 and functions as the policy setting and technical advisory body for the LQMS-SIP. The PSC provides oversight to the LQMS-SIP, guides the project and provide inputs on behalf of the sectors that Committee Members represent.
An LQMS-SIP Strategic Plan 2015 -2018 (Including Marketing and Communications Agenda) was developed; the document was approved by the CROSQ Council at its 27th Council Meeting in October 2015. The strategic agenda, vision and mission of the LQMS-SIP respectively are: “To encourage each CARICOM Member State to have all Medical Laboratories accredited to ISO 15189” and “To advance patient care in CARICOM through improved laboratory systems and services, stakeholder consultation and policy advocacy”
Laboratory Improvements and Public Health in the Caribbean Region
The goals and objectives of the LQMS-SIP are linked to that of CARPHA and the Strategic Plan for the Caribbean Community which has as a priority to “Advance Initiatives for Health and Wellness”. Medical laboratories are an integral part of the health care system.
Call to Action for Access to Quality HIV related Diagnostics as a Human Rights Entitlement of Residents of the Caribbean Region
The National HIV Programme Managers and Laboratory Managers of countries in the Caribbean Region, in collaboration with CARPHA, PANCAP, CDC/PEPFAR, WHO/PAHO, UNAIDS and other partners, convened a meeting in Port of Spain, Trinidad and Tobago in 2014 to review HIV care and treatment targets and discuss ways to improve access and quality of HIV-related point of care testing (POCT). An important declaration came out of that meeting the text of which is appended here.
This current phase of the project is of seven (7 months) duration and finishes on the 30th September 2016.
For further information, contact the Project Coordinator – Dr. Claire Durant, LQMS-SIP Secretariat at: firstname.lastname@example.org
CARICOM Accreditation Bodies
JANAAC(Jamaica National Agency for Accreditation)
The Mission of the Jamaica National Agency for Accreditation is to support the effective development of the Jamaican economy by providing Conformity Assessment Bodies with internationally recognized training and accreditation services through teamwork, highly committed, competent and motivated employees.
The Jamaica National Agency for Accreditation JANAAC, signed an ILAC mutual recognition agreement on September 18th 2015 for testing ISO 15189 and is therefore able to accredit CARICOM medical laboratories.
Documents for Download
The LQMS-SIP Secretariat is providing several documents that can be used to support the work of laboratories. ISO/IEC15189:2012 Medical laboratories- Requirements for Quality and Competence specifies requirements for competence and quality that are particular to medical laboratories.
- The Caribbean Guidance on the Stepwise Improvement Process for Strengthening Laboratory Quality Management Systems towards Accreditation 2nd Edition (January 2016)
- This document provides information and guidance for the implementation of a Laboratory Quality Management System (LQMS) through a Stepwise Improvement Process towards Accreditation (SIP) in the Caribbean. It describes the laboratory quality improvement process and explains how countries and partners will implement the LQMS strengthening initiative.
- LQMS-SIP Checklist
- The LQMS-SIP Checklist text is taken from the ISO 15189:2012, Medical Laboratories – Requirements for Quality and Competence and is reproduced with the permission of the International Organization for Standardization, ISO. The requirements given in the Checklist are not the exact clauses in the ISO 15189: 2012; however the numbering corresponds to the relevant sections of the standard. The copyright of the LQMS-SIP Checklist is owned by CROSQ.
- The LQMS-SIP Checklist contains 15 Management requirements and 10 Technical requirements based upon the ISO 15189. In each of the main sections the requirements are separated into 3 distinct tiers, based upon relative importance/complexity. The requirements noted in “black” represent Tier 1, “blue” represent Tier 2 and “green” represent Tier 3.
- The LQMS-SIP Pilot Study Report
- In July – September 2014, the LQMS-SIP successfully conducted a pilot study among ten CARICOM laboratories. The pilot study results showed that in general, all of the participating laboratories were able to achieve some proportion of the requirements in each of Tier 1, 2 and 3. The LQMS-SIP Checklist results were reported as cumulative percentages. No laboratory obtained 100% of the requirements for any of the individual Tiers. The best performing laboratory succeeded in getting 71.1% of Tier 1, 66.7% of Tier 2 and 69.7% of Tier 3 requirements (technical and management).
- The LQMS-SIP Strategic Plan
- The strategic agenda, vision and mission of the LQMS-SIP respectively are: “To encourage each CARICOM Member State to have all Medical Laboratories accredited to ISO 15189” and “To advance patient care in CARICOM through improved laboratory systems and services, stakeholder consultation and policy advocacy”.
- The Impact of Strengthening of Laboratory Management Toward Accreditation (SLMTA) in improving Laboratory Quality Systems in the Caribbean Region
- Guevara G, Gordon F, Irving Y, et al. The impact of SLMTA in improving laboratory quality systems in the Caribbean Region. African Journal of Lab Medicine. 2014; 3(2), Art. #199, 9 pages. http://dx.doi. org/10.4102/ajlm.v3i2.199
- Strengthening National Laboratory Health Systems in the Caribbean Region
- George A. Alemnji, Songee Branch, Anton Best, et al (2012): Strengthening national laboratory health systems in the Caribbean region, Global Public Health: An International Journal for Research, Policy and Practice, OI:10.1080/17441692.2012.6708
- Impact of mentorship on WHO-AFRO Strengthening Laboratory Quality Improvement Process Towards Accreditation (SLIPTA)
- Maruta T, Motebang D, Wanyoike J, Peter T, Rotz PJ. Impact of mentorship on WHO-AFRO Strengthening Laboratory Quality Improvement Process Towards Accreditation (SLIPTA). Afr J Lab Med. 2012;1(1), Art. #6, 8 pages. http://dx.doi.org/10.4102/ ajlm.v1i1.6