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INTRODUCTION
Clinical Physiological Chemistry Laboratory MEDT 413 is designed so that the laboratory sessions will complement the MEDT 403 lecture series and build on the basic techniques and theory learned in MEDT 375/401/411. The goal of this course is for the student to learn, to understand the importance of, and to apply safe and proper laboratory techniques for the quantification of various analytes in body fluids and to assess the accuracy of those results through quality assessment.
The initial laboratory sessions will focus on automation used in the clinical laboratory. These instruments will be used by the student focusing on proper operation, calibration, performance of accurate assays, maintenance, troubleshooting, etc. The quantitative laboratory sessions will include operating automated instrumentation and performing manual methods. Manual methods including such techniques as radioimmunoassay (RIA), and urine extraction for drug identification by thin layer chromatography (TLC) will be performed focusing on technique development, accuracy of results, standard calibration curve construction, assessment of method linearity, disease correlation, etc. The students will also be exposed to the principles of High Performance Liquid Chromatography (HPLC).
Quality assurance will be an active component of each laboratory session throughout the semester and will encompass temperature checks of water baths, refrigerators, etc.; wavelength accuracy checks of spectrophotometers; the inclusion of assayed control materials with each assay of patient samples; and the utilization of statistical tools such as standard deviation, coefficient of variation, Levey-Jennings control charts, etc. Also each student will visit the Wellness Center during the semester to check the quality assurance records of the Cholestech Analyzer.
During the latter third of the course, each student will participate in two all day Simulated Laboratory experiences. The purpose of the simulated laboratory is to introduce the student to the type of daily work routine that would be encountered in the chemistry section of a clinical laboratory, thus approaching a more realistic situation prior to the commencement of clinical rotations.
In addition to participating in simulated laboratory on a technical level, each student will participate in a managerial capacity. This involves supervisory positions, committee members, and committee chairpersons. The objectives of these roles is to expose the student to decision making, management responsibilities, and team building.
Two students from each laboratory section will serve as either the supervisor or assistant supervisor. They will function as the coordinators and planners of the day. Each student will serve on one of three committees. The committee will be given a problem or a situation that they will need to resolve. Sample committees include a quality control committee, a safety inspection and safety training committee, and a procedure manual committee.
By the conclusion of this course, the student will have acquired the
basic laboratory skills required to perform effectively in a clinical
chemistry laboratory and to continue with additional study in the
clinical rotations.
STUDENT LABORATORY RESPONSIBILITIES
The student is required to submit a professional performance evaluation sheet and a completed data sheet, including all calculations, graphs, charts, etc. for each laboratory session. The student is also required to record and plot his quality control values for that day on the master quality control charts which are posted on the bulletin board. Completed assignments are due at the end of each laboratory session unless otherwise stated. Late reports will be penalized 5 points per day.
The student is required to read the assigned laboratory procedure(s) before coming to class and determine the size of test tubes needed, the type and size of pipettes needed, etc. The student should learn to use his time efficiently and profitably in the laboratory. This can only be accomplished by reading the assigned procedures and planning before coming to lab.
Neatness is essential when working in the laboratory. Used pipettes should be placed tips up in the pipette holders which are provided. Used cuvets should be washed in a basin of soapy water, rinsed with deionized water and returned to the plastic racks provided. Dirty test tubes should be placed in a metal basket after their contents have been flushed down the sink with plenty of cold water and after all writing has been removed with acetone. Gauze, pipette tips and paper should be disposed of in the biohazard waste basket. Counter tops should be washed after each laboratory session with the cleaning solution provided. In addition to wearing a clean lab coat, students are required to wear gloves and face shield when working with human body fluids.
Each student will receive a turn during the semester to perform and assess quality assessment. This will consist of refrigerator and water bath temperature checks and spectrophotometer checks. The monthly QC will entail calculating the mean, standard deviation and coefficient of variation of a set of control values.
A set of objectives for each laboratory session has been included in
the manual. The purpose of these objectives is to guide the
student in
the understanding of each method and to aid the student in preparing
for
each laboratory session. It is recommended that the objectives be
thoroughly reviewed before coming to lab.
Academic Dishonesty
The Department of Medical Technology supports and enforces the
University of Delaware policy and procedures on academic honesty as
stated in the UD Student Guide to University Policies.
The policy is available online at http://www.udel.edu/stuguide/current
under Code of Conduct.
Academic Services
The University of Delaware offers services for students with learning
disabilities. Students are encouraged to contact the Academic
Enrichment Center (831-1639 or 831-2805) to take advantage of these
services. The Academic Enrichment Center website is located at http://www.udel.edu/AEC
GRADING AND ATTENDANCE POLICY
A. Written Final Exam - 20%
A written final exam covering laboratory methods and quality control/assessmente will be administered at the end of the semester, on December 6, 2006. The exam counts for 20% of the final grade.
B. Written Review Exam covering MEDT 411 - 10%
A written review exam covering materials learned during MEDT 375/411 will be administered at the beginning of the semester, on September 6, 2006. This material will include laboratory methods from MEDT 411, graphing, and dilutions. This exam will count 10% of the final grade.
C. Instrumentation Practical I - 15%
An instrumentation practical will be conducted on October 16, 2006. This will consist of the student doing startup procedures, including daily maintenance and any necessary troubleshooting, calibration if necessary, and the running of control material and patient samples on one of the following instruments: Synchron CX3, Synchron CX4, Cobas Fara, Dade Dimension. This will need to be done within a specified time limit. The instrumentation practical will count for 15% of the final grade. The details of the instrumentation practical will be discussed prior to the scheduled date.
D. Instrumentation Practical II-15%
An instrumentation practical will be conducted on October 18, 2006.
This practical will consist of the student performing calibration
procedures
for one method on the Dade Dimension. At the completion of a successful
calibration, the student will also run Quality Control material for
that
method and interpret the results. This will need to be done within a
specified
time limit. The practical counts for l5% of the final
grade.
The details of the performance practical will be discussed prior to the
scheduled date.
E. Laboratory Data, Simulated Laboratory Experience, Quality Control and Daily Maintenance - 15%
1. Laboratory Data.
For some laboratory sessions, the student will be given unknown specimens, controls and standards to analyze. The student's results will be evaluated based on the +/- 2 standard deviation limits that have been established for the test. A student receiving less than 65% on any laboratory procedure may repeat the assay (provided there is sufficient reagent material) outside of scheduled laboratory time. The repeated assay will be performed at the discretion of the laboratory instructor. A student repeating an assay will receive a revised grade which will be calculated according to the following formula:
l.5 (original grade) + (repeat grade)
2.5
For other laboratory sessions the students will be given lab study
questions to answer. These will count as a lab grade for that
day.
2. Quality Control and Daily Maintenance.
Each student will be responsible for monitoring Quality Assessment in the laboratory once during the semester. This includes spectrophotometer wavelength calibration checks, centrifuge maintenance, refrigerator temperature checks, statistical analysis of control material and performing daily maintenance on one of our automated chemistry analyzers. In addition, each student will check the Quality Assessment records of the cholestech analyzer at the Wellness Center. This section counts as one lab grade.
3. Simulated Laboratory Experience.
Each laboratory section will participate in three days of a simulated laboratory experience. The first day will encompass the set up of the laboratory with the two successive days entailing functioning as if one were in a hospital laboratory situation. On the day of simulated laboratory, the students should arrive to "work" at 7 a.m. to perform QC, daily maintenance procedures on the instruments and do accessioning of "patient" samples. At 8 a.m., the students will go to their lecture class and then return to the laboratory at 10 a.m. and "work" until 5 p.m. In addition to performing a multitude of chemistry tests, the students will also participate in several managerial experiences. Each day of simulated lab will count as one lab data grade. Grading will be based on professional performance criteria.
F. Simulated Laboratory Managerial Experience.
Im addition to performing a variety of chemistry tests during the two days of simulated laboratory, all students will participate in a managerial exercise. Students will be assigned to management teams that will train and educate their classmates about the following laboratory functions: quality control, safety, and standard operation procedures. The focus is to transform the student laboratory into a functional working laboratory. Details of this project will be discussed in class. Oral presentations will be on November 1, 2006. Each committee's presentation and report will count as two lab grades.
G. Quizzes -15%
Periodically announced laboratory quizzes will be conducted. The quizzes may include but are not limited to questions from the following areas: principles of methods, type of specimen required, reagents used, calculations, interpretation of laboratory data, situational problems, quality assurance, use of equipment, etc. The student should review the laboratory objectives prior to taking each quiz.
Quiz Schedule:
Quiz 1 - September 25, 2006
Quiz 2 - October 11, 2006
Quiz 3 - November 8, 2006
H. Senior Project - 10%
During some laboratory sessions, students will utilize their time to access a new laboratory product. The process may involve method comparison, instrument troubleshooting, calibration, quality control and method evaluation. Further details will be provided in class. An oral presentation of each team's project will be on December 4, 2006. This will count for 10% of the final grade.
I. Exam Policy
A make-up performance practical exam will be given only if the student has made prior arrangements with the laboratory instructor due to a personal emergency or if the student presents a note from a physician or the student health center verifying the student's illness. The Department Office (831-2849) must be notified before the scheduled time.
A make-up final exam will be given only by permission of the laboratory instructor, on the basis of a physician's written excuse or a personal emergency. The Department Office (831-2849) must be notified before the scheduled time. Once the examination is taken, the grade will stand.
Grade Minimal Requirement
A
90% average or above
B
80% average or above
C
70% average or above
J. Attendance
Attendance at ALL laboratory sessions is mandatory. Laboratory sessions are scheduled on Monday and Wednesday between the hours of 10:10 AM to 1:10 PM and 2:00 PM to 5:00 PM. Although every attempt will be made to adhere to these scheduled hours, students should be aware that occasionally some laboratory sessions may require additional time. Excused absences will be permitted only if the student has made prior arrangements with the laboratory instructor due to a personal emergency or if the student presents a note from a physician or the student health center verifying the student's illness. The Department office (831-2849) must be notified prior to the scheduled laboratory session for any absence. Any missed lab session must be made-up within one week of the missed session outside of scheduled laboratory time. The student is to arrange with the laboratory instructor for the make-up laboratory. Any unexcused absence will result in a grade of 0 for that laboratory session.
K. Professionalism
Professional Performance Evaluation will affect the final grade
after all
cognitive and psychomotor evaluations are completed using the following
scale:
Outstanding = 4
Contribution far exceeds what is normally expected of a student. Personal commitment to a high level of performance and professionalism is clear. The attribute assessed is never in question even under the most challenging workloads.
Excellent = 3
Seizes initiative in development and implementation of challenging procedures and projects. Accomplishments exceed requirements. Requires minimal direction.
Fully satisfactory = 2
Performance is what is expected of a student in student laboratory. Does not require significant improvement. If improvement occurs, it is a plus. Errors are minimal and seldom repeated. Student prioritizes work goals and problems well. Requires only normal supervision and follow-up.
Less than satisfactory = 1
Performance does not meet minimum requirements. Needs pushing and requires close surveillance and guidance.
Unacceptable Performance = 0
Has had sufficient exposure to have shown better performance.
Does not grasp basic concepts no matter how many times they are
explained. Does not demonstrate commitment to this aspect of
professional development.
LABORATORY SCHEDULE - FALL, 2006
Date
August 30 Laboratory Safety; Review of MEDT 411/375; Operation, Maintenance and Calibration of Synchron CX3-CX4; Operation and Maintenance of Dade Dimension
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WEB SOURCES
The following web sites are to be used during the semester to gain further knowledge about the companies that make the instruments we have in our student laboratories.
Beckman Coulter
Dade Behring
Johnson and Johnson
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