Training and Competence Assessment; Quality Management Systems; Continuous Quality Improvement; Validation of Blood Sample Collection Devices; Quality Indicators

The Clinical and Laboratory Standards Institute requests volunteers to carry out revisions to GP21, Training and Competence Assessment. The project description and specific qualifications needed are provided below: 

Description:
Increased examination by regulatory agencies, third-party payers, and the public has brought a renewed interest in quality, productivity, and competition to the delivery of healthcare services.  Fundamental to all quality systems is the development of training and competence assessment programs.

CLSI/NCCLS document GP21, Training and Competence Assessment, provides the necessary background information and processes to permit clinical services to develop training and competence assessment programs that will meet specific quality and regulatory objectives. To be effective, training must be built on a solid foundation of documented operations processes, and procedures with accompanying training documents. This guideline provides a structured approach for using documented processes, related procedures, training guides, and assessment tools for the development of training and competence assessment programs.

Specific Expertise/Work Experience Needed:

• Individuals with strong background in quality management systems.
• National and international representatives familiar with regulatory and accreditation requirements for training of personnel and monitoring of personnel competence.
• An international representative to assist with harmonization and global application of the guidelines.

The deadline to submit a nomination form, including a curriculum vitae and disclosure of interests form, is 1 August 2007. Send to Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, PA 19087.

The Clinical and Laboratory Standards Institute requests volunteers to carry out revisions to HS1, A Quality Management System Model for Health Care and GP26, Application of a Quality Management System Model for Laboratory Services. The project descriptions and specific qualifications needed are provided below: 

Description:
The best contribution a healthcare organization or service can make to improving operations and ensuring patient safety is to understand and document its processes, train people to be competent in following those processes, identify problematic processes, and improve processes where problems exist.

The foundation of a quality management system, with operations under control, provides a platform for continuous improvement and further transition up the quality hierarchy. If a healthcare organization or service implements the quality management system model, the ability to reduce or eliminate medical error, the likelihood of meeting customer requirements, the potential for successful governmental and accreditation assessments, and sustainable attainment of quality objectives are greatly enhanced:

CLSI/NCCLS document HS1, A Quality Management System Model for Health Care, describes a quality management system model that can be developed for any healthcare organization or individual service unit (e.g., laboratory, pharmacy, respiratory, imaging). The quality system essentials are universal and thus can be applied to any service’s operations, whether simple or complex. HS1 is intended for use by laboratory directors, managers, supervisors, the quality manager, and others responsible for implementing and maintaining the policies, processes, procedures, activities, and records that support the quality management activities within their institution.

CLSI/NCCLS document GP26, Application of a Quality Management System Model for Laboratory Services, introduces the clinical laboratory’s path of workflow—that is, the processes that transform a request for a clinical laboratory service through obtaining and transporting the sample, performing the examination, interpreting the results, and providing the patient’s laboratory examination report. GP26 intended for use in conjunction with HS1 when developing a quality management system for the clinical laboratory.

Specific Expertise/Work Experience Needed:

• Individuals with strong background in quality management systems.
• Laboratory directors, managers, supervisors, and the quality managers.
• Representatives from regulatory agencies and accrediting bodies familiar requirements related to quality management systems implementation.
• An international representative to assist with harmonization and global application of the guidelines.

The deadline to submit a nomination form, including a curriculum vitae and disclosure of interests form, is 1 August 2007. Send to Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, PA 19087.

The Clinical and Laboratory Standards Institute requests volunteers to carry out revisions to GP22, Continuous Quality Improvement: Integrating Five Key Quality Systems Components. The project description and specific qualifications needed are provided below: 

Description:
Every clinical service needs ongoing quality improvement. The practicing of continuous quality improvement (CQI) maximizes operational efficiency, effectiveness, and adaptability.

Consequently, a clinical service should focus on systematic continuous quality improvement as measured by customer satisfaction, including profitability. GP22 presents such managerial skills and outlines the importance of the synergistic combination of Quality Planning, Quality Teamwork, Quality Monitoring, Quality Improvement, and Quality Review—all functioning within the whole integrated quality system.  This document presents general managerial concepts that apply to any kind of clinical service—although the guideline often uses the clinical laboratory as an operational model.

Specific Expertise/Work Experience Needed:

• Individuals with strong background in quality management systems.
• Individuals involved in any clinical service including physicians, nurses, and allied health professionals, as well as laboratory, clinical, and support staff
• National and international representatives familiar with regulatory and accreditation requirements for training of personnel and monitoring of personnel competence.
• An international representative to assist with harmonization and global application of the guidelines.

The deadline to submit a nomination form, including a curriculum vitae and disclosure of interests form, is 1 August 2007. Send to Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, PA 19087.

NEW PROJECT:
Validation of Blood Sample Collection Devices

Description:
Specimen collection devices, especially blood collection tubes, are classified as in vitro diagnostic devices.  Because these devices are used to collect patient blood samples that are analyzed on highly sensitive clinical instrumentation, it is critical that these collection devices be validated for use on this instrumentation to ensure accuracy of test results.

Clinical laboratories are being challenged by accrediting organizations to assure the acceptability and compatibility of their blood collection devices with current instrumentation and patient population. 

This type of validation will help the clinical laboratories assure accurate and precise test results for their collection device/instrumentation system.

Currently, there is no one guideline available for clinical laboratories to use that assesses the acceptability/compatibility of the various blood collection tubes used for collection within each of the disciplines (i.e., Chemistry, Immunochemistry, Hematology, Coagulation and Immunhematology).

This guideline will provide step-by-step recommendations to conduct this type of device validation and guidance for evaluating the acceptability/ compatibility of the various blood collection devices for clinical performance across all laboratory disciplines. The information provided will be used to document accurate and precise patient test results are obtained for the device/instrumentation system used in each laboratory.

Table of Contents:
1. Introduction
2. Scope
3. Definitions
4. Preanalytical Considerations
5. Expected Analytic Performance
     5.1 Blood collection device
     5.2 Instrument related characteristics (calibration, linearity, quality control)
     5.3 Data Analysis Measures
     5.4 Clinical Acceptance criteria
6. Clinical Evaluation: Planning and Design
7. Conducting the Clinical Evaluation
8. Analysis of the Clinical Evaluation Data
9. References

Specific Expertise/Work Experience Needed:
The subcommittee will require representatives as specified below:

• IVD manufacturers and regulatory personnel with expertise in instrument and blood collection devices
• US and EU regulatory expertise for data acquisition and analysis
• Statistician or equivalent for data analysis and display of data
• Laboratory personnel to verify recommended process can be implemented in a clinical laboratory without constraint

Familiarity with previous or existing standards/guidelines is helpful.

The deadline to submit a nomination form, including a curriculum vitae and disclosure of interests form, is 1 August 2007. Send to Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, PA 19087.

Description:
Objective measures of performance are essential tools for management and for quality improvement.  Quality indicators are requirements for accreditation to ISO or CLIA requirements, but there is little further consensus guidance on developing indicators.  Accreditation requirements are for the indicators that are specific to the laboratory and its customers, but there are many other types of indicators that may be used, such as national indicators, indicators requested by customers or corporate owners, or they may be self-directed quality tools. 

Quality indicators should have certain characteristics, and procedures for gathering data need to be specific.  Data should be monitored in a consistent manner in order to be useful.  Best practices have not been developed.  Benefits would be improved tools for quality monitoring and improvement as well as a more uniform data analysis process. 

This document will provide guidance on development of quality indicators, and their use in the medical laboratory. These indicators include measures developed in a single laboratory for their customers and practice settings, and indicators developed by other organizations and national bodies.   The document includes criteria for development of quantitative, ordinal, and qualitative indicators; it also includes procedures for gathering data, interpreting results, for monitoring performance over time, and for comparing with other laboratories or national measures.

Table of Contents:
1. Forward
2. Scope
3. Introduction
4. Definitions
5. Quality Indicators
   5.1 Accreditation requirements
   5.2 Current national and international programs
   5.3 General Considerations for Indicators
6. Development of Quality Indicators in a laboratory
    6.1  Criteria for selection
    6.2  Documented procedure
    6.3   Pilot trial, revisions
7. Development of Quality Indicators for Multiple Laboratories
8. Use of Indicators
    8.1 One Time Assessment
    8.2 Monitoring Over Time
    8.3 Data Analysis Methods
9. Reporting indicator performance
10. Examples

Specific Expertise/Work Experience Needed:
The subcommittee will require representatives as specified below:

• Laboratory service providers, users, regulators, accrediting agencies
• IVD manufacturers interested in indicators related to instrument performance, or those that are used in post-market surveillance
• Individuals from fee-based, interlaboratory indicator programs

Familiarity with previous or existing standards/guidelines is helpful.

The deadline to submit a nomination form, including a curriculum vitae and disclosure of interests form, is 1 August 2007. Send to Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, PA 19087.

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