The need of quality management systems in clinical laboratories.

1. Quality ManagementQuality Management
SystemSystem
A Key to SurvivalA Key to Survival
By Mojgan TalebianBy Mojgan Talebian

2. It is not necessary toIt is not necessary to
change. Survival is notchange. Survival is not
mandatory.mandatory.
W. Edwards DemingW. Edwards Deming

3. Clinical LaboratoriesClinical Laboratories
 Highly complex operationsHighly complex operations
 Highly regulated health care servicesHighly regulated health care services
 Stringent national and international requirementsStringent national and international requirements
 High level of accountability for the management and staffHigh level of accountability for the management and staff
 Satisfaction of customers and usersSatisfaction of customers and users
 patient confidentiality and safety issuespatient confidentiality and safety issues
 Cost and time effectivenessCost and time effectiveness

4. To Err is HumanTo Err is Human
 99% accuracy means 1% error;99% accuracy means 1% error;
 1% error rate would mean everyday:1% error rate would mean everyday:
 14 minutes without water or electricity14 minutes without water or electricity
 50,000 parcels lost by postal services50,000 parcels lost by postal services
 22 newborns falling from22 newborns falling from
midwives’ handsmidwives’ hands
 600,000 lunches contaminated600,000 lunches contaminated
by bacteriaby bacteria
 3 bad landings at airport3 bad landings at airport
WHO collaborating center Power PointWHO collaborating center Power Point

5. Errors in Laboratory TestingErrors in Laboratory Testing
 Unnecessary treatment; treatment complicationsUnnecessary treatment; treatment complications
 Failure to provide the proper treatmentFailure to provide the proper treatment
 Delay in correct diagnosisDelay in correct diagnosis
 Additional and unnecessary diagnostic testingAdditional and unnecessary diagnostic testing
 Increased cost in time, personnel effortIncreased cost in time, personnel effort
 Legal actions from patients and communityLegal actions from patients and community

6. Laboratory ErrorsLaboratory Errors
 1-3 per 5,000 samples, Sigma 4.8 - 5.11-3 per 5,000 samples, Sigma 4.8 - 5.1
 In the United States 600,000 Significant LE perIn the United States 600,000 Significant LE per
yearyear
 In British Columbia 6,000 SLE per yearIn British Columbia 6,000 SLE per year
 Laboratory errors are more common in non-Laboratory errors are more common in non-
monitored laboratoriesmonitored laboratories

7. QMS, Why me!?QMS, Why me!?
 1922 - Walter Shewhart, Statistical Process Control1922 - Walter Shewhart, Statistical Process Control
 It is defined over a span of 80 yearsIt is defined over a span of 80 years
 Applicable to manufacturing and industryApplicable to manufacturing and industry
 It is not laboratory-specific;It is not laboratory-specific;
 It is the infrastructure of any type, size, scope, or specialty of anyIt is the infrastructure of any type, size, scope, or specialty of any
health care servicehealth care service
 ““70% of clinical medicine decision making is predicted upon, or70% of clinical medicine decision making is predicted upon, or
confirmed by, or documented by medical laboratory testconfirmed by, or documented by medical laboratory test
results”,results”, Semin Diagn Pathol 2007Semin Diagn Pathol 2007

8. Why QMS?Why QMS?
 looks at the entire systemlooks at the entire system
 highest level of accuracy and reliabilityhighest level of accuracy and reliability
 Improves organizational effectiveness andImproves organizational effectiveness and
cultureculture
 Improves customer satisfactionImproves customer satisfaction
 Simplifies compliance; complacence to standardsSimplifies compliance; complacence to standards
and regulationsand regulations
 Improves documentationImproves documentation

9. BenefitsBenefits
 Aligns your laboratory daily activities of operations andAligns your laboratory daily activities of operations and
processesprocesses
 saves costssaves costs
 paves the way for meeting licensure and accreditationpaves the way for meeting licensure and accreditation
requirementsrequirements
 Encourage active and effective leadershipEncourage active and effective leadership
 Staff will clearly understand their responsibilitiesStaff will clearly understand their responsibilities
 Focuses on root cause of problemsFocuses on root cause of problems
 Rework is minimizedRework is minimized

10. Cost of Implementing QMSCost of Implementing QMS
 Management and employee time and effortManagement and employee time and effort
 Upgrading and creating documentationUpgrading and creating documentation
 Training employeesTraining employees
 Registration feesRegistration fees
 MaintenanceMaintenance
But…But…

11. ……
 In the United States there are between 7 and 10 BillionIn the United States there are between 7 and 10 Billion
laboratory tests reported annually.laboratory tests reported annually. Boone DJ, IQLMBoone DJ, IQLM, 2005, 2005
 The Institute of Medicine estimates that the cost ofThe Institute of Medicine estimates that the cost of
system errors is between $17 and $29 billion per yearsystem errors is between $17 and $29 billion per year
 15% of patients in a 5 country study receive either15% of patients in a 5 country study receive either
incorrect or delayed reports on abnormal results. Booneincorrect or delayed reports on abnormal results. Boone
DJ, IQLM, 2005DJ, IQLM, 2005
 Cost of implementing QMS in NHF in 2003, withCost of implementing QMS in NHF in 2003, with
150, 000 customers and 34 employees:150, 000 customers and 34 employees:
First year $18, 000 ; Annual $5000First year $18, 000 ; Annual $5000

12. The Bright SideThe Bright Side
 QMS is not an ongoing expenseQMS is not an ongoing expense
 Cost Saving;Cost Saving;
 Reduces number of position descriptions, proceduresReduces number of position descriptions, procedures
 Reduces time to train new employeesReduces time to train new employees
 Reduces waste, TATReduces waste, TAT
 Employee satisfaction scores increasedEmployee satisfaction scores increased
 Testing timelinessTesting timeliness

Patient and physician satisfactionPatient and physician satisfaction
 can be easily updated and refinedcan be easily updated and refined

13. What’s in it for Me?What’s in it for Me?
 QMS goes beyond QA and QCQMS goes beyond QA and QC
 Enables standardization to “best practice”Enables standardization to “best practice”
 Activities and processes are clearly recordedActivities and processes are clearly recorded
 Rewarded by improved financial performanceRewarded by improved financial performance
 Minimized level of miscommunicationMinimized level of miscommunication
 Providing confidence to regulatory bodiesProviding confidence to regulatory bodies
 Optimization of costs and resourcesOptimization of costs and resources

Positive impacts on laboratory reputationPositive impacts on laboratory reputation
 Proficiency testing success rates increasedProficiency testing success rates increased

14. Financial BenefitsFinancial Benefits
 Cost-effective management practices within theCost-effective management practices within the
organizationorganization
 Improvements in the overall worth and health of theImprovements in the overall worth and health of the
organizationorganization
 improved budgetary performanceimproved budgetary performance
 reduced costsreduced costs
 improved return on investmentimproved return on investment
 Proper management of purchasing and inventoryProper management of purchasing and inventory

15. Stories of SuccessStories of Success
Implementing QMS in 5 laboratories, ASCPImplementing QMS in 5 laboratories, ASCP
http://wwwn.cdc.gov/cliac/pdf/Addenda/cliac0208/Addendum%20T.pdfhttp://wwwn.cdc.gov/cliac/pdf/Addenda/cliac0208/Addendum%20T.pdf
The Growing Role of Quality Management Systems In ClinicalThe Growing Role of Quality Management Systems In Clinical
Laboratory Accreditation and LicensureLaboratory Accreditation and Licensure
Henry Ford Health Laboratories,Henry Ford Health Laboratories,
LabCorp Tampa, FLLabCorp Tampa, FL
http://www.darkdaily.com/special-report-the-growing-role-of-quality-managemehttp://www.darkdaily.com/special-report-the-growing-role-of-quality-manageme
Cost Effectiveness of Adopted Quality Requirements in Hospital LaboratoriesCost Effectiveness of Adopted Quality Requirements in Hospital Laboratories
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC374425/http://www.ncbi.nlm.nih.gov/pmc/articles/PMC374425/

16. RecommendationsRecommendations
 Arm yourself with knowledge about the processArm yourself with knowledge about the process
 Design a plan based on realistic objectives,Design a plan based on realistic objectives,
adequate resources, and a time scheduleadequate resources, and a time schedule
 Have a consultant to guide you through theHave a consultant to guide you through the
process and manage deadlinesprocess and manage deadlines
 Leverage the information you learn and theLeverage the information you learn and the
resources you use as you move through theresources you use as you move through the
implementation and maintenance processimplementation and maintenance process

17. The cost is longThe cost is long
forgotten but theforgotten but the
quality is rememberedquality is remembered
foreverforever