Seeking Input and Volunteer Participation -- Call for Nominations
Occurrence Management; Proficiency Testing (GP27-A to A2); Quality Management (EP18-A to EP18-A2)

Clinical and Laboratory Standards Institute seeks expert input and volunteer involvement in the following proposed project and project revisions:

Occurrence Management for Improved Patient Safety

This guideline will include practical guidance for implementing the Quality System Essential (QSE) for occurrence management described in the HS1 quality management system model. It will identify a process for detecting, reporting, investigating, analyzing, and correcting occurrences that effect patient safety and impact a healthcare service’s path of workflow.

The guideline will support the following international standards:

• ISO 15189:2003, Medical laboratories – Particular requirements for quality and competence, Section 4.9
• ISO 17025:1999, General requirements for the competence of testing and calibration laboratories, Section  4.9
• ISO 9001:2000, Quality management system – Requirements, Section 8.3
• ISO/PDTR 22367:2004, Medical laboratories – Reduction of error through risk management and continual improvement
  
  Requested Expertise: Members should have knowledge of quality management systems and experience in their implementation, and experience with implementing or working in occurrence management and/or risk management programs. Additional expertise in the development and production of occurrence tracking software is being sought.

EP18-A to EP18-A2, Quality Management for Unit-Use Testing

In revising EP18 the following updates/revisions will be considered:

• Expand document beyond unit-use tests
• Revise as an overall risk assessment document
• Harmonize for consistency with:
  -     Failure Mode and Effects Analysis (FEMA)
  -     ISO 14971:2000  Medical devices – Application of risk management to medical devices.
  -     ISO. International Vocabulary of Basic and General Terms in Metrology. Geneva: International Organization for Standardization; 1993.
  -     International Workshop Agreement 2 (IWA2:2003) Quality Management Systems – Guideline for the application of ISO 9001:2000 in education
  -     The Clinical and Laboratory Standards Institute’s Harmonized Terminology Database

Expertise needed:   Experience using risk management tools, especially FMEA, ISO 14971.  Direct experience with running, maintaining and troubleshooting clinical laboratory tests. 

GP27-A to A2, Using Proficiency Testing (PT) to Improve the Clinical Laboratory

In revising GP27 the following updates/revisions will be considered:

• Harmonize Terminology
• Update with current accreditation language such as root cause analysis and  corrective action
• Add considerations for qualitative analytes
• Add considerations for PT that incorporates pre-analytic sources of error (per ISO 15189)
• Include use of PT for method comparisons
• Update information on common reasons for PT failures

Expertise needed – We are seeking committee participants from PT/EQA Providers, Accrediting Bodies that require participation in PT/EQA, and Laboratories who participate in PT/EQA.  We are looking for experts who have taken innovative approaches to the design and presentation of PT/EQA programs and results, and who are actively using the results for improving laboratory performance, including procedures that allow evaluation of test methods.

The Quality Management System Approach

Clinical and Laboratory Standards Institute subscribes to a quality management system approach in the development of standards and guidelines, which facilitates project management; defines a document structure via a template; and provides a process to identify needed documents. The approach is based on the model presented in the most current edition of CLSI/NCCLS document HS1—A Quality Management System Model for Health Care. The quality management system approach applies a core set of “quality system essentials” (QSEs), basic to any organization, to all operations in any healthcare service’s path of workflow (i.e., operational aspects that define how a particular product or service is provided). The QSEs provide the framework for delivery of any type of product or service, serving as a manager’s guide. The quality system essentials (QSEs) are:

Documents & Records	Equipment	Information Management	Process Improvement
Organization	Purchasing & Inventory	Occurrence Management	Service & Satisfaction
Personnel	Process Control	Assessment	Facilities & Safety

GP27 addresses the quality system essentials (QSEs) indicated by an “X.” For a description of the other Clinical and Laboratory Standards Institute documents listed in the grid, please refer to the CLSI/NCCLS Publications section.

Docu-ments & Records	Organi-zation	Per-sonnel	Equip-ment	Purcha-sing & Inventory	Process Control	Infor-mation Mana-gement	Occur-rence Manage-ment	Asses-sment	Process Improve-ment	Service & Satis-faction	Facili-ties & Safety
							X

Adapted from CLSI/NCCLS document HS1—A Quality Management System Model for Health Care.

Review the objective of the proposed project, and the requested volunteer expertise, and:
Submit a nomination.
The deadline to submit the nomination form, including a curriculum vitae and disclosure of interests form, to the CLSI Executive Offices, 940 West Valley Road, Suite 1400, Wayne, PA 19087 is 11 May 2005.

To provide input on the need for, and utility of, this proposed new project, give us your expert opinion on the value of the project.