ISO 15189 Accreditation

Benita I.Haines
Corporate Compliance and Quality
Manager for Valley Health
July 19, 2009
 Objectives
„ Decision to pursue ISO 15189
„ How the standard was implemented
„ Registrar information
„ Benefits gained from the ISO 15189
standard
„ Future endeavors – benefits for
hospital systems
 Piedmont Medical Laboratory
Profile
„ Full service CAP accredited reference
laboratory established in 1991
„ Performs approximately 1 million billable
test procedures annually
„ Testing platform includes
• Chemistry and hematology
• Limited andrology
• Limited blood bank
• Microbiology and limited mycobacteriology
• Molecular Pathology
 Piedmont Medical Laboratory
Profile
„ A variety of value-added services are
also provided
„ PML staff is approximately 100
employees
„ Patient service centers
 Implementing the Standard
„ Presentation to PML Board of
Directors and PML management
team
„ Presentation and education to
general staff
„ Hiring a consultant
„ Quality Manual – creation, education
and cross references
 Implementing the Standard
„ Document Control
„ Importing documents, training, and
implementation of paradigm
„ Departmental education for
paradigm users
„ Training and education of general
staff of the
ISO 15189 standard and TR 22869
 Registrar information
„ Research
„ Looking abroad
„ Final decision/application
CAP 15189 Process
 Benefits from ISO 15189
„ Standardized work
„ Reduced waste
„ Improved tracking
„ Improved staff morale
„ Comparison with international
laboratories – learn best practices
 Benefits from ISO 15189
„ Process improvement projects
• Courier re-routing
• Scanning requisition and patient results
• Auto-verification
• Requisition design
• Lean processing department – first in, first out,
specimen integrity
• Broadcast fax
„ Increased work load by 30%; lost 3
medical technologists to attrition
 Benefits from ISO 15189
350,000

300,984
300,000
272,461
241,148
Accessions

250,000 235,600 232937

230,381 230,613

200,000

150,000

100,000
1
Year
2001 2002 2003 2004 2005 2006 2007
Future Endeavors for PML
„ Continued process
improvement
„ Contract benefits
„ Branding
„ Possible additional
business lines
Future Endeavors for Valley Health
„ Mission of VH : Trusted to delivery
the best experience, every place,
every time

„ Enhance patient care and reduce

costs, while improving the patient
experience
ISO 15189 benefits to a hospital
system laboratory
Quality of Healthcare
Decrease Errors
Patient Returns
Quality Safety Patient Complaints
Safety of Employees and
Patients
Infectious Diseases
Nosocomial Infections
Cost of Care
Cost Reductions
Budget Constraints
New Methodologies,
Instrumentation
Delivery Cost Delivery of Care
Patient Waiting Time
Provider Waiting Time
Nurse Waiting Time
System Start
•Document Control
•Common Language
•Education to general 
Staff
•Decision to pursue 
Accreditation