Diagnostic Accreditation Program

1. Diagnostic Accreditation Program Annual Report: Trends in Facility Performance Sharmen Vigouret Lee, Executive Director May 12, 2008

2. New Accreditation Standards Laboratory Medicine – 2007 • Sample Collection, Transport & Accessioning • Chemistry • Hematology • Microbiology • Transfusion Medicine • Anatomic Pathology • Laboratory Informatics • Point of Care Testing – Field Testing • Cytology – in development • Cytogenetics – in development

3. New Accreditation Standards Diagnostic Imaging – 2007 • Radiology • Ultrasound • Echocardiography • Mammography • CT • MRI • Nuclear Medicine • Bone Densitometry • Imaging Informatics • Digital Mammography – field testing • PET/CT– development to start Summer 2008

4. New Accreditation Standards Neurodiagnostic Services – 2007 • EEG • Evoked Potentials • EMG & Nerve Conduction Studies Pulmonary Function – Field Testing June 2008 • Hospital Based Services Polysomnography • Development to start Summer 2008

5. Advisory Committees Advisory Committees • Laboratory Medicine – 7 • Cytology • Cytogenetics • Diagnostic Imaging – 10 • PET/CT • Hospital Based Neurodiagnostic Services – 2 • Hospital Based Pulmonary Function • Polysomnography

6. On-site Surveys, Focused Visits, Initial Assessment Accreditation Assessments

7. Accreditation Assessments Accreditation Status – 2006 and 2007 Laboratory Medicine 73 Accreditation with Report 5 Full Accreditation Diagnostic Imaging 76 Accreditation with Report 10 Full Accreditation

8. Trends in Performance:Most frequently cited by Surveyors Leadership & Management • Lack of position descriptions for medical and administrative leadership • Management of adverse events and critical incidents • Lack of definitions, policies & procedures, investigation process, monitoring changes implemented, staff communication & training • Reporting process in place, but no feedback or trend analysis • Litigation preparation focus instead of continuous improvement

9. Trends in Performance:Most frequently cited by Surveyors Human Resources • Significant recruitment challenges: medical, technical and administrative staff • Outdated job descriptions • Continuing education challenges – funding & backfilling • Performance reviews and competency assessments not occurring • Outdated or no contract in place between the facility and the medical professionals

10. Trends in Performance:Most frequently cited by Surveyors Patient & Client Focus • Excellent knowledge of the patient populations served • Demonstrated commitment to patients and providing the best possible care with the resources availalble • Well defined knowledge of who referring physicians are • Effective communication and established relationships • Performance based contracts with 3rd party payers

11. Trends in Performance:Most frequently cited by Surveyors Suppliers & Partners • Health authorities – centralized process for capital and consumable purchasing • Diagnostic service has significant input into selection process • Capital planning processes regionally based • Community based services – more informal purchasing practices

12. Trends in Performance:Most frequently cited by Surveyors Quality Improvement • Lack of a comprehensive approach to quality management and quality improvement • No linkage between specific quality activities • Use of indicators for monitoring – very limited • Lack of available & knowledgeable staff to develop quality programs

13. Trends in Performance:Most Frequently Cited Mandatory Requirements Safety – Laboratory Medicine • Eyewash stations are conveniently located and regularly flushed • Emergency lighting is available • Safety manual is readily available to staff • Items for patient consumption are stored separately from sample, reagents and supplies • Safe and effective cleaning and disinfection • Chemical and biological spill kits and procedures are available • Personal protective and other safety equipment (e.g. splashguards) • Sufficient, well marked “clean” sinks for hand washing

14. Trends in Performance:Most Frequently Cited Mandatory Requirements Safety – Diagnostic Imaging • Safety program in place including documentation and staff education • Ongoing staff education to prevent and control infections • Policies in place for dealing with emergency procedures (cardiopulmonary arrest) • Policy for staff working alone • Action plan for emergency evacuation has been developed and communicated to staff • MSDS are posted where toxic and corrosive agents are used • Radiation safety • Eyewash stations conveniently located

15. Laboratory MedicineMost Frequently Cited Mandatory Requirements Sample Collection: Sample rejection criteria established Acceptable time limits between collection and processing of standards are established and monitored Policies and procedures to deal with unlabeled, mislabeled, lost or compromised samples Proficiency Testing/QC: When mandated PT is not available, alternative PT is used to validate performance QC policies and procedures are documented and maintained

16. Laboratory MedicineMost Frequently Cited Mandatory Requirements Document Control: All procedures are documented, communicated to and available to staff performing the analysis Invalid or obsolete documents are promptly removed from all points of use Master index of all laboratory documents identifying current version and distribution is in place Documents are reviewed and approved by the medical leader or designate prior to use Instrumentation and Equipment: Process for correction action when temperatures deviate from the acceptable ranges

17. Diagnostic ImagingMost Frequently Cited Mandatory Requirements Patient and Staff Needs: Patient information cannot be viewed by other patients or visitors Secure and private location for storage of personal belongings Information Management: Processes to ensure confidentiality, security and integrity of data are provided at the beginning of employment as well as on an ongoing basis Data stored on-site is accessible, but protected from unauthorized access and safeguarded from harm Downtime procedures are documented and readily available Policy for the use and disclosure of personal information

18. Diagnostic ImagingMost Frequently Cited Mandatory Requirements Radiology: Radiation safety policies & procedures Mammography: Appropriate consenting process prior to invasive procedures - indications, risks, alternatives Equipment performance is evaluated and monitored and quantitative dose determination conducted by a qualified medical physicist

19. Diagnostic ImagingMost Frequently Cited Mandatory Requirements Ultrasound/Echocardiography: MSDS are posted where toxic and corrosive agents are used Policy of appropriate use of gel as per Health Canada Computed Tomography: Policies and procedures are in place where Transfer of Function duties are performed MRI Safety Policies: Policies/procedures in the event of an inadvertent magnet quench Controlling access to MRI environment with appropriate signage

20. Diagnostic ImagingMost Frequently Cited Mandatory Requirements Nuclear Medicine: Radiopharmaceutical agent is identified including dosage, time, route of administration and individual administering Policies and procedures are in place where Transfer of Function duties are performed Routine performance of documented schedule for QC procedures Radiation warning labels/signage are posted at entrance of rooms that may contain a source of ionizing radiation Education regarding hazards of radiation and reducing exposure for nursing and ancillary staff Bone Densitometry : Precision determinations are done in-house according to standard protocol

21. Best Practices Laboratory Medicine • Document control program • Occurrence management Diagnostic Imaging • Random daily audit of general procedures by supervisor • Retrospective review using electronic medical record and images to identify process errors

22. Conclusions • Prior to 2006 on-site surveying of facilities was sporadic • “First” accreditation on-site survey provides a baseline • expect several mandatory requirements and opportunities for improvement to be noted • Accreditation standards are far more comprehensive • Surveyors use detailed survey protocols using “tracers”– more comprehensive assessment of the diagnostic care process Accreditation needs to be incorporated into the facility’s overall quality management program Quality improvement is a process and takes time