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H O W I T B E N E F I T S O U R L A B I N J A M A I C A
B A R B A R A H E N D R I K SB I O M E D I C A L C A L E D O N I A M E D I C A L
L A B O R A T O R YJ A M A I C A W . I .
ISO 15189 ACCREDITATION
JAMAICA
Jamaica is the largest English-speaking island in the Caribbean, located south of Cuba and west of Haiti.
The population is estimated to be about 2.8 million
Obama’s Visit to the Jamaica
Bob Marley Museum
Posing with Usain Bolt
LABS IN JAMAICA
In Jamaica there are approximately 75 laboratories including Public and Private.
BIOMEDICAL CALEDONIA MEDICAL LABORATORY WAS THE FIRST MEDICAL LABORATORY TO BE ACCREDITED IN JAMAICA
Today November 3,2015 we are still the ONLY Accredited Medical Laboratory in Jamaica
Branches Island Wide
Introduction
Biomedical/Caledonia Medical Laboratory Ltd is a private multi disciplinary medical laboratory that provides service to customers both in the private and public sectors through collection centers in hospitals, insurance companies, medical centers, doctors’ offices.
The Laboratory has over 45 collection centers island wide.
History of Process
The process of preparation to obtain external recognition of the laboratory’s standard of performance began in the 1990s.
The laboratory felt it was doing well and needed validation by an independent party
Initially involved contacts to North America for information on ISO 9000 certification
Began participation in MLE proficiency testing program which has been consistently maintained and the menu expanded
Driving Forces
The advent of ISO 17025 and 15189 built greater awareness, created excitement for some management personnel
Requirements of customers - asked if the laboratory was accredited
Programs offered by national, professional, educational agencies provided opportunities for training
Internal quality team provided guidance and impetus
National Quality Infrastructure
National Quality Infrastructure (NQI)project was implemented by the Government of Jamaica and the Swedish Board of Accreditation and Conformity Assessment (SWEDAC)
Purpose of NQI Project was to assist Jamaica to upgrade its NQI and bring it in line with WTO
Biomedical Caledonia Medical was part of the pilot project and participated in training workshops
JAMAICA NATIONAL AGENCY FOR ACCREDITATION (JANAAC)
JANAAC is a signatory to the International Laboratory Accreditation Cooperation(ILAC) Mutual Recognition Arrangement(MRA) for testing Laboratories to ISO 17025 (2013) and Medical Laboratory Accreditation to ISO 15189 (2015).
At present Accreditation is not compulsory in Jamaica, however nationally and internationally, legislation is being developed that makes it mandatory to use accredited facilities.
Accreditation
Biomedical Caledonia Medical Laboratory was accredited with the ISO 15189 standard on May 28, 2013.
Accreditation of the lab better positions Jamaica for medical outsourcing and tourism.
Accreditation
Management Team
Challenges Encountered
Financing Accommodation Supplies and Equipment Quality Assurance Safety Maintaining the standard
Challenges
Challenges Encountered
Educating our clients – Distributing literature on pretesting and procedure
Equip the relevant personnel with the resources needed to clarify concerns relating to current and new tests offered
Maintaining published turnaround time
Challenges - Human Resources
Retention of trained staff – Maintaining morale. Attitude and aptitude of staff Implementing documentation Ensuring adherence to confidentiality Appraisals and competency evaluation
Challenges - Quality Assurance
Training staff to establish and interpret quality control data
Rejection criteria Daily QC’s running with clinically relevant controls;
levels must be accepted before patient samples are analyzed.
Quality Data Analysis – Levy Jennings Graph is reviewed after QC’s are done
Policy for non-conformity of quality control results
Challenges - Safety
The International Standard for Laboratory Safety (ISO 15190) is used as a guideline. Fire Drills Safety rules upheld – procedures for spillage and breakage,
decontamination and accident investigation done Fire extinguishers are placed in convenient easy to reach areas Eye wash stations First Aid kits in all departments and in all collection centers
External Proficiency Programs
MLE…………… QUARTERLY RIQAS………….MONTHLY API………………THREE TIMES PER YEAR UK-NEQAS……SIX TIMES PER YEAR
Challenges -Documentation
Handling the volume and range of documentation required
Challenges-Pre-examination phase
Current economic challenges impact some suppliers causing increased lead time, increase in lab’s reorder level to cover its needs
Statistics for work volume and reagent usage difficult to align - it is challenging to ensure that stock-out does not occur
New protocols mean longer time to process patients, requiring staff to explain to them reasons for delay
Challenges –Examination Phase
Tracking expiration dates of reagents Generating and analyzing cumulative QC results Troubleshooting when results are out of range
Challenges- Management of Time, People and Change
Executing responsibility by senior leadership to analyze, interpret and give corrective action to more junior staff for implementation
Managing time to maintain timely delivery of examination results balanced with executing additional requirements for implementation of standard
Inconsistent adherence to requirements of standard as revealed by discrepancies, lead to feeling that hurdles previously overcome are recurring
Challenges- Management of Time, People and Change
Total ownership of the process needs to grow Dealing with the frustration, irritation when persons
are unwilling to adhere to instructions given to achieve compliance with requirements of standards
Inconsistent following of procedures for a newly instituted measure that is meant to ensure accountability
Benefits
Benefits
We are now experts at using the Fish Bone Cause and effect Diagram.
We brainstorm using the major categories of the problem.
Continue to ask ‘why?” to generate deeper levels of causes.
Then we put in Corrective Action.
Benefits- Documentation
Preparation of SOPs forced research, raised level of understanding of principles of test methods
Process has produced more standardized procedures available to staff at every level
Improved the ease of traceability of information generated in the laboratory and provided written evidence of incidents
Recognition of the importance of documentation has become a life skill not just a lab skill
Benefits-Examination Phase
Persons and things are more organised for easier access
Better scrutiny of QC results increases the likelihood of recognising errors
Improvement in turn around time of reports
Benefits – Knowledge & Skills Upgrade
Learning new things, overcoming fear of IQC and EQAS analysis has led to greater confidence in interpretation of results
Produced a drive to learn more about the laboratory as a business and see how it measures up to international standards
Increased appreciation and alertness to pathological conditions and how to relate to work in the lab
Benefits – Knowledge & Skills Upgrade
Greater understanding of impact and purpose of implementation of rejection criteria
Demands greater accountability by persons to whom specific tasks have been assigned
Increased training has provided beneficial sources of new and revised information for sharing with members of department who may not be able to attend training event
Benefits – Knowledge & Skills Upgrade
Better appreciation for getting things right and working in an orderly way
Improved team work, better flow of work Increased desire to relate requisition information
with results obtained and gain knowledge to better converse with physicians when they have questions
Summary 0f Benefits
Standardization of processes Decreased operating costs with increased efficiency An international reputable image for quality
assurance and management, differentiating our lab at a high level for global competitiveness
Better communication with partners Growth of customer satisfaction with better service
provided Confidence in results Better profit hence better compensation for staff
In Closing….
Though costly the benefits of accreditation far outweigh the costs
Accreditation and the linked periodical surveillance are a stimulant for keeping the Quality System alive.
We have had two successful surveillances with the third due in 2016.
Re-assessment is due in 2017. Keys to Benefits: Do the right things right Describe how you do it Do the things how you describe it Evaluate
THANKS FOR YOUR ATTENTION