MLAB 2360 Clinical I

Teaching Laboratory Procedure

Objectives

  1. Correctly perform a kit test procedure by following the instructions in a package insert.
  2. Write a basic laboratory procedure using the package insert.
  3. Present the laboratory procedure to the class.

Introduction

One of the entry-level competencies for MLT students is to teach fellow employees about a procedure they may be required to perform. The MLT may also be required to write a basic laboratory procedure using a template for a new test procedure for the laboratory. The procedure is known as a “Standard Operating Procedure” or SOP.

This activity will introduce you to the basics of writing the laboratory procedure. Clinical laboratories review the manufacturer’s written procedures and create their own written SOP in compliance with regulatory agencies, which inspect and accredit the laboratory. The laboratory procedure must have the following:

SOP Sections / Points
  1. Title
/ 1
  1. Revision number and date

  1. Effective date of SOP
/ 1
  1. Principle and/or Purpose
/ 2
  1. Sample requirements/collection methods
/ 2
  1. Reagents, standards, controls (quality control)
/ 2
  1. Instrumentation/calibration procedures

  1. Materials
/ 2
  1. Equipment

  1. Safety precautions
/ 2
  1. Test procedure (simple, direct, step-by-step procedure)
/ 10
  1. Method performance specifications

  1. Calculations

  1. Forms, diagrams, and drawings

  1. Interpretation of results
/ 2
  1. Reference ranges/critical values
/ 2
  1. Limitations
/ 2
  1. Attachments (i.e. product inserts)

  1. References
/ 1
  1. Definitions

  1. Author
/ 1
  1. Approval signature, usually the laboratory director

  1. Yearly review and document change history

Total / 30

For this exercise, you will only include the highlighted areas in your laboratory procedure.

The best way to prepare to write the procedure is to perform the procedure. This will allow you to determine which parts of the manufacturer’s instructions are difficult to follow and may require rewording. Rewording is allowed as long as this done only to add clarification. Under no circumstances can the procedure itself be changed. For example, you decide that two drops of sample would work better than one. This would be a conflict with the procedure and inaccurate, providing inaccurate results for the patient.

Procedure

  1. Each student will perform the following steps:
  2. The instructor will provide information regarding the sections of the SOP required.
  3. Gather the test kit and controls.
  4. Write a standard operating procedure (SOP) for their test kit based on the requirement listed on page one.
  5. Demonstrate teaching the test procedure to a “new employee”, including:
  6. Explaining the procedure
  7. Demonstration of the procedure
  8. Answer questions

References:

This link provides a detailed description of what is expected in the field . A standard operating procedure (SOP) will take several days to write. The laboratory director and the pathologist including documentation of the approval must approve the SOP.

MLAB 2360 Clinical I
Teaching a Procedure

Name: ______Date: ______Points: ____/50

Instructions: Complete this form for the test kit name, manufacturer, lot number, expiration date, controls, lot numbers and results.

Information / Points
Test Kit Name / 1
Manufacturer / 1
Lot Number / 1
Expiration Date / 1
Controls and lot numbers / Expected Results
Positive / 3
Negative / 3
INSTRUCTOR USE ONLY
Strongly Disagree / Disagree / Neutral / Agree / Strongly Agree
  1. The summary was well written and easy to understand

  1. The principle was well written and easy to understand

  1. Materials list was complete

  1. Reagents and controls were listed

  1. Sample requirements clearly explained

  1. The written procedure was well written and easy to follow

  1. Interpretation of results clear and concise

  1. The procedure was performed correctly

Points / Possible / Awarded
  1. Total points for performance of the test procedure
/ 10
  1. Total points for proper recording of info and results
/ 10
  1. Total points for written procedure
/ 30
  1. Total points possible
/ 50

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MLAB 2360
Revised 10/2016