Assignent Solutionnurs

– Manual Butyrate Esterase disk test to distinguish h Moraxella catarrhalis from the Neisseria spp. (THIS IS THE TOPIC OF CHOICE)
General Information
For this project, you will develop a written procedure for an analytical assay or method used in
the clinical laboratory. The written procedure must be for the performance of a manual method
(e.g., ictuses, gram stain, dna extraction, master mix preparation) and not an automated
method. You may pick a method that has an automated component like PCR, but your project
must focus on the manual procedural requirements of the assay.
Your evaluation will be based on adherence to the CLSI guidelines, clarity, accuracy, validity and
completeness. Prepare the procedure as a Microsoft Word document and include your last name
in the filename, e.g., LubyProcedure.doc. Submit the assignment via the drop box section of the
course website. See the syllabus “Assignment Due Dates” for the due date/time information.
Late submissions will be penalized 10% per day.
Notes: Be sure to adhere to the CLSI guidelines presented in the Unit 5 and 8 materials.
Remember that the CLSI format is a guideline only. You should use only those sectionsthat apply
to your particular procedure.
Important Sections
At a minimum, procedures must contain the following elements:
• Title
• Purpose or Principle
• Procedure Instructions
• References (provide your references (AMA style) as a Reference list at the end of the
document. You do not need to provide in‐text citations.)
• Author
• Approval Signatures
Additionally, procedure instructions must be written to address preanalytical, analytical and
postanalytical processes in the laboratory.
• Preanalytical must include:
• Order entry
• Patient preparation
• Specimen collection
• Specimen handling
• Analytical must include:
• Step‐by‐step instructions required for actual testing
• Postanalytical must include:
• Reporting critical values
• Reporting results (manually or via a computer system)
• Storage of results
• Storage of samples
Procedure Writing Assignment
Clinical Laboratory Management (CLSC 620)
 Additional Section Requirements: Analytical Procedures must include any of the following
that apply in each individual process:
 Safety: Any procedure that deals with the handling of potentially hazardous materials
(body fluid or chemical) must have a section on safety.
 Specimen Information: Type, amount required, transport or storage instructions, cause
for rejection, etc.
 Test Method: Step‐by‐step instructions for performing the analysis
 Reagents and/or media
 Supplies: Items needed to perform the analysis such as pipettes and tips
 Special Safety Precautions: Anything above and beyond general lab safety
 Equipment Calibration and Maintenance: Should only be included in a procedure for a
particular assay if it is done every time the assay is performed. A separate procedure is
required for maintenance and calibration that is done any time other than during
actual testing – e.g., daily, weekly, or monthly preventative maintenance on an
automated analyzer and should be referenced in the procedure (e.g. Calibration: See
Advia Calibration procedure for details).
 Quality Control: Should be included in a procedure for a particular assay if it is done
every time the assay is performed. A separate procedure is required for QC performed
other than during actual patient testing – e.g., daily, at the beginning of the shift, etc.
and should be referenced in the procedure.
 Calculations: Should include all necessary formulas and step‐by‐step instructions for
using the formulas. An example should also be included.
 Expected Values: Should include different values for age, sex or race, if applicable.
 Interpretation of Results: Information about possible meaning of final results should
include information about possible indeterminate results and what to do in those cases
and when and how to report critical results. May include educational information
about certain disease states resulting in abnormal results.
 Method Limitations: Should include assay sensitivity and specificity, reportable range,
whether or not to dilute samples with results above the reportable range and
instructions on how to do so if necessary, and a list of possible interfering substances.
From: www.clsi.org
Clinical Laboratory Management (CLSC 620)
MAKE SURE TO FOLLOW CLSI GUIDLINES