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