Quality Management Quality Management SystemSystem

A Key to SurvivalA Key to Survival

By Mojgan TalebianBy Mojgan Talebian

It is not necessary to It is not necessary to change. Survival is not change. Survival is not

mandatory. mandatory.

W. Edwards Deming W. Edwards Deming

Clinical LaboratoriesClinical Laboratories

Highly complex operationsHighly complex operations Highly regulated health care services Highly 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 effectiveness Cost and time effectiveness

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 from 22 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

Errors in Laboratory Testing Errors in Laboratory Testing

Unnecessary treatment; treatment complications Unnecessary treatment; treatment complications Failure to provide the proper treatment Failure to provide the proper treatment Delay in correct diagnosis Delay in correct diagnosis Additional and unnecessary diagnostic testingAdditional and unnecessary diagnostic testing Increased cost in time, personnel effort Increased cost in time, personnel effort Legal actions from patients and communityLegal actions from patients and community

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 per In 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

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 any It 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, or 70% 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

Why QMS? Why QMS?

looks at the entire systemlooks at the entire system highest level of accuracy and reliability highest level of accuracy and reliability Improves organizational effectiveness and Improves organizational effectiveness and

cultureculture Improves customer satisfaction Improves customer satisfaction Simplifies compliance; complacence to standards Simplifies compliance; complacence to standards

and regulations and regulations Improves documentation Improves documentation

BenefitsBenefits

Aligns your laboratory daily activities of operations and Aligns your laboratory daily activities of operations and processesprocesses

saves costs saves costs paves the way for meeting licensure and accreditation paves the way for meeting licensure and accreditation

requirementsrequirements Encourage active and effective leadership Encourage 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

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…

……

In the United States there are between 7 and 10 Billion In 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 of The Institute of Medicine estimates that the cost of system errors is between $17 and $29 billion per year system errors is between $17 and $29 billion per year

15% of patients in a 5 country study receive either 15% of patients in a 5 country study receive either incorrect or delayed reports on abnormal results. Boone incorrect or delayed reports on abnormal results. Boone DJ, IQLM, 2005DJ, IQLM, 2005

Cost of implementing QMS in NHF in 2003, with Cost 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

The Bright SideThe Bright Side

QMS is not an ongoing expense QMS is not an ongoing expense Cost Saving;Cost Saving; Reduces number of position descriptions, procedures Reduces number of position descriptions, procedures Reduces time to train new employeesReduces time to train new employees Reduces waste, TATReduces waste, TAT Employee satisfaction scores increased Employee satisfaction scores increased Testing timeliness Testing timeliness

Patient and physician satisfactionPatient and physician satisfaction can be easily updated and refinedcan be easily updated and refined

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 recorded Activities and processes are clearly recorded Rewarded by improved financial performance Rewarded 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

Financial BenefitsFinancial Benefits

Cost-effective management practices within the Cost-effective management practices within the organizationorganization

Improvements in the overall worth and health of the Improvements 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

Stories of SuccessStories of Success

Implementing QMS in 5 laboratories, ASCP Implementing 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 Clinical The 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-management-systems-in-clinical-laboratoryhttp://www.darkdaily.com/special-report-the-growing-role-of-quality-management-systems-in-clinical-laboratory

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/

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 the Have a consultant to guide you through the

process and manage deadlinesprocess and manage deadlines Leverage the information you learn and the Leverage the information you learn and the

resources you use as you move through the resources you use as you move through the implementation and maintenance process implementation and maintenance process

The cost is long The cost is long forgotten but the forgotten but the

quality is remembered quality is remembered forever forever