CLSI/APHL: Performance Specifications Series

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CLSI/APHL: Performance Specifications Series

CLSI/APHL: Performance Specifications Series
Teleconference
588-655-09
Sponsored by the Clinical and Laboratory Standards Institute and the Association of Public Health Laboratories
Register for the series or individual programs
http://www.aphl.org/courses/Pages/clsi09.aspx 
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CLSI/APHL: Performance Specifications Series (4 programs) 10% savings
February 19, 2009 How to Improve Lab Inspection Outcomes Using CLSI Documents
May 7, 2009           Doing It By the Numbers: Making Reference Intervals Manageable
May 21, 2009         Comparability Testing: Exploring Theoretical and Practical Issues
June 18, 2009        Objective Decisions: Verify and Validate Laboratory Testing
 
CLSI/APHL: Performance Specifications Series (4 programs) 10% savings
Registration Deadline : May 1, 2009
 
How to Improve Lab Inspection Outcomes Using CLSI Documents
Program Date :   February 19, 2009
Program Time:  1:00 - 2:00 PM (ET)                       
Location: Teleconference
Registration Deadline : February 17, 2009
Description:
CLSI guidelines represent laboratory standards, established through the consensus process including laboratory professionals, industry experts, and government representatives. Guidelines should not be interpreted so narrowly that may prohibit laboratories from adopting innovative techniques or emerging technologies. A performance-based approach must be taken when using CLSI documents for establishing laboratory policies and procedures. Laboratory inspectors may use CLSI documents to assess the standard of care provided by laboratories, provided that laboratories are evaluated against regulation or accreditation standards, not a verbatim interpretation of the guideline. Standards of practice evolve as they should, when laboratory directors adopt and modify professional guidelines to meet their laboratory specific requirements, and the needs and expectations of the clients they serve. 
Objectives:
At the conclusion of this program, the participants will be able to:
·        Describe the relationship between regulations and professional standards.
·        Discuss the practical considerations associated with the use of CLSI documents when establishing laboratory policies and procedures.
·        Describe how a performance-based approach to inspections may be taken when using recommendations found in guidelines as a reference.
Faculty:
John J. Murphy, M.H.S.
Supervising Medical Laboratory Consultant
Facility Licensing & Investigations Section
Connecticut Department of Public Health
Hartford, CT 
 
Doing It By the Numbers: Making Reference Intervals Manageable
Program Date :   May 7, 2009
Program Time:  1:00 - 2:00 PM (ET)                       
Location: Teleconference
Registration Deadline : May 5, 2009
Description:
Every laboratory faces the issue of providing reference intervals for its measurements. Although all of us might aspire to establish our own reference, the techniques involved seem far too complicated and beyond our capabilities. Instead, most of us simply adopt the reference intervals provided by the manufacturers of our instrumentation. In this session, using the recently updated CLSI guidelines (C28-A3), we will de-mystify the process of establishing reference intervals, provide instruction on how to verify reference intervals with as few as 20 samples from reference individuals, and identify those tests where our focus should be on accuracy rather than on reference intervals (and they’re among the most commonly done tests!). 
Objectives:
At the conclusion of this program, the participants will be able to:
·         Perform reference interval validation studies with as few as 20 samples.
·         Identify 5 commonly performed tests where conventional reference intervals are not relevant.
·        List 3 resources that can be used to help with reference interval determinations in their own laboratories.
Faculty:
Gary L. Horowitz, MD
Director, Clinical Chemistry Laboratory
Beth Israel Deaconess Medical Center
Boston, MA
 
Comparability Testing: Exploring Theoretical and Practical Issues
Program Date :   May 21, 2009
Program Time:  1:00 - 2:00 PM (ET)                       
Location: Teleconference
Registration Deadline : May 19, 2009
Description:
Good laboratory practice requires that the comparability of test results produced by different measurement systems within a healthcare system be verified periodically. This teleconference will address the theoretical and practical issues that confront a laboratory that must meet this quality requirement with finite resources including considerations of establishing frequency of the comparison interval, materials and concentrations appropriate for comparison testing and the role of sample commutability in selecting testing materials. In addition, for consideration is can laboratories conduct efficient, statistically valid comparability testing with limited monetary and human resources, and how does clinically relevant criteria used to interpret the results of comparison testing events.  
Objectives:
At the conclusion of this program, the participants will be able to:
·        Define criteria for conducting comparison testing events for an analyte.
·        Identify appropriate materials for comparison testing design an efficient comparison test protocol using the C54-A Guideline document.
·        Evaluate comparison test results in a clinically relevant manner using the C54-A Guideline document
Faculty:
Christopher M. Lehman, MD
Pathology Department
University of Utah Health Sciences Center
Salt Lake City, UT 
 
Objective Decisions: Verify and Validate Laboratory Testing
Program Date :   June 18, 2009
Program Time:  1:00 - 2:00 PM (ET)                       
Location: Teleconference
Registration Deadline : June 16, 2009
Description:
A wide range of CLSI guidelines are available to aid manufacturers who are performing evaluations for submitting new methods and instruments to regulatory authorities and for developing performance claims. Recent CLSI guidelines describe laboratory experiments that users can perform over a few days’ time to verify and validate manufacturer’s performance claims. These guidelines, when paired with CLSI guidelines for manufacturers, provide a format for making objective decisions about whether the performance a user observes is consistent with the claimed performance. This session describes CLSI method evaluation guidelines designed for user verifications of performance.
Objectives:
At the conclusion of this program, the participants will be able to:
·        Describe the experiments used in CLSI EP15-A2 to verify precision.
·        Describe the approach used in EP15-A2 to verify trueness using reference materials.
·        Describe tests for nonlinearity in CLSI EP6-A.
·        Perform the data analysis to verify a reference range using the experiment described in CLSI C28-A3.
Faculty:
R. Neill Carey, Ph.D., F.A.C.B.
Clinical Chemist
Peninsula Regional Medical Center
Salisbury, MD 
 
Who Should Attend:
This intermediate-level program is appropriate for pathologists, residents, students, and laboratory scientists working in clinical, public health, and academic settings.
Continuing Education Credit : The Association of Public Health Laboratories (APHL) is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E. ® Program. Participants will be awarded 1.0 contact hour for each program they successfully complete. P.A.C.E. ® is accepted by all licensure states except Florida. Florida continuing education credit will be offered based on 1.0 hour of instruction.
Site Registration:
·        Registration fee per site (for one phone line): $675.00 for series plus access to the archived programs for six months (>10% savings) or $195 for each teleconference plus access to archived program for six months.
·        Select a Site Facilitator. This needs to be someone who can receive all communication via e-mail.
·        Site Facilitator must register.
·        If you have difficulty with the online registration process, please e-mail registrar@aphl.org or call 240.485.2727 between 8:00 a.m. – 4:30 p.m. (ET). After your facility’s registration is confirmed, the Site Facilitator will receive all necessary instructions and paperwork via e-mail.
·        You may pay online using a credit card. If you would like to pay by check, please request a registration form from the APHL Registrar at 240-485-2727. Send a check made out to “APHL” to PO Box 79117, Baltimore, MD, 21279-0117.  Be sure to attach a registration form and include the number of the course on the check.  If no registration form is received your check will be deposited but you may not be registered for the course or get a confirmation notice.  We do not accept purchase orders. We are unable to offer refunds for cancellations
Special Needs and Information:
In compliance with the Americans with Disabilities Act, individuals needing special accommodations should notify the NLTN at least two weeks prior to the course. For more information call 800-536-NLTN or 240.485.2727.