ECTS credits ECTS credits: 4.5
ECTS Hours Rules/Memories Hours of tutorials: 2 Expository Class: 21 Interactive Classroom: 23 Total: 46
Use languages Spanish, Galician
Type: Ordinary Degree Subject RD 1393/2007 - 822/2021
Departments: Biochemistry and Molecular Biology
Areas: Biochemistry and Molecular Biology
Center Faculty of Pharmacy
Call: Second Semester
Teaching: With teaching
Enrolment: Enrollable
The general objective of the course is to provide an overview of the professional practice in the specialties of Clinical Biochemistry, thus it is intended to complement the training in Biological Analysis and Biochemical Diagnosis by deepening the activities and tasks of the laboratory, and an approach to the topics of semiology with more interest (analysis of biological fluids, hormones and tumor markers).
THEORY
Two weekly sessions. The content is divided into two thematic groups:
Thematic Group I: The Clinical Laboratory Inside
Topic 1. Overview of the clinical laboratory.
Topic 2. The Pre-analytical Phase.
Topic 3. The Analytical Phase and Automation.
Topic 4. Quality Control of an Analytical Process.
Topic 5. Production of Reference Values
Topic 6. Molecular Diagnostic Techniques in Clinical Analysis
Thematic Group II: Biochemical-Clinical Semiology
Topic 7. Clinical Usefulness of Some Biological Fluids
Topic 8. Serum Tumor Markers
Topic 9. Preliminary Considerations in Hormone Analysis
Topic 10. Evaluation of Pituitary Function
Topic 11. Evaluation of Thyroid Function
Topic 12. Evaluation of Adrenal Function
Topic 13. Evaluation of Gonadal Function
Topic 14. Therapeutic Drug Monitoring, TDM
INTERACTIVE SESSIONS:
Organized in one in-person class every two weeks throughout the semester:
CI-1: Calculation of Diagnostic Indices and ROC Curves.
CI-2: Evaluating Carryover Error and Mathematical Calibration Models.
CI-3: Calculation of population reference limits for a biomarker.
CI-4: Quality control of laboratory results.
CI-5: Design of DNA primers/probes for molecular diagnosis.
CI-6: Clinical scenarios: handling of diagrams and algorithms for specialized functional assessment.
PRACTICES
Sessions in the practice laboratory located in the Biochemistry Department facilities in Pavilion A of the Pharmacy building (1st floor) in morning and afternoon shifts. Organized by the coordinator in February-March.
Practice 1. Evaluation of analyst imprecision.
Practice 2. Investigation of in vitro interference caused by medications.
Practice 3. Obtaining and purifying genomic DNA.
Practice 4. Amplification and detection of a polymorphism.
Basic:
a) Principles of Clinical Biochemistry and Molecular Pathology. Álvaro González Hernández. 3rd edition. Elsevier. Barcelona-2019. ISBN 978-84-9113-389-6
Book with a high degree of agreement with the approach to the topics and contents. Suitable as a textbook for the study of the subject.
b) Contemporary Practice of Clinical Chemistry. 4th edition. William Clarke and Mark A. Marzinke. Elsevier-Academic Press, 2020. ISBN978-0-12-815499-1.
Advanced text that updates and delves into the latest trends in laboratory medicine.
c) Clinical Laboratory: Indications and Interpretation of results. Kathleen Pagana, Timothy Pagana. First edition in Spanish. Translated by Martha Elena Buschbeck for Editorial El Manual Moderno S.A. Mexico-2015. ISBN 978-607-448-508-0
Text translated from the English version that reviews pathophysiological and molecular aspects of the processes that affect bones.
organs and systems of the human body.
d) Online labtest. (https://labtestsonline.es/acerca-de-esta-web)
Website of the Spanish Society of Clinical Chemistry (SEQC) and free consultation. This is a Spanish translation made by the SEQC of the namesake originating from the American Association of Clinical Chemistry (AACC). Contains continuously updated information on laboratory tests in different physiological and pathological scenarios. Useful from a guides perspective.
Quick reference clinic for clinical laboratory diagnostic tests as basic information.
complementary
a) Medical Biochemistry. John W. Baynes and Marek H. Dominiczak. 5th Edition. Elsevier. -Barcelona-2019. ISBN 978-84-9113-406-0
Useful review of knowledge of general biochemistry applied to medicine. It has examples of some illness explained.
b) Química Clínica Edición 1: Fundamentos y Técnicas de Laboratorio. Donna Larson Eds. Elsevier-2016. ISBN: 9781455742141
It is based on knowledge of the pathophysiology of the most common diseases to present the diagnostic approach from the clinical laboratory and includes a section dedicated to the fundamentals of analytical techniques.
c) Clinical diagnosis and management of Henry by laboratory methods. 23rd edition. Richard A. McPherson and Matthew R. Pincus. Elsevier-Saunders, 2017. ISBN 978-0-323-29568-0.
Specialized text aimed at knowledge of analytical methodology and diagnostic interpretation from the laboratory point of view.
d) Tietz Fundamentals of Clinical Chemistry and Molecular Diagnostics. Rifai N, Horvath A, Wittwer C. 8th edition. Elsevier-2019. ISBN: 978-0-323-53044-6.
Considered a reference in Clinical Analysis and Laboratory Diagnostics. It deals with analytical procedures and breaks down diagnostic tests by organs and tissues in different pathophysiological situations.
c) Henry’s Clinical Diagnosis and Management by Laboratory Methods. 23rd Ed. Richard A. McPherson & Matthew R. Pincus. Elsevier-Saunders, 2017. ISBN 978-0-323-29568-0
Knowledge:
Con 01. Know the origin, nature and how to design, obtain, analyze, control and produce active ingredients, drugs and medications, as well as other products and raw materials of health interest for human or veterinary use.
Con 02. Know the therapeutic and toxic effects of substances with pharmacological activity.Con 06. Acquire basic knowledge in clinical management, health economics and efficient use of health resources to promote the rational use of medicines and health products.
Con 06. Acquire basic knowledge in clinical management, health economics and efficient use of health resources to promote the rational use of medicines and health products.
Con 07. Know, evaluate and assess problems related to drugs and medications, as well as participate in pharmacovigilance activities.
Con 08. Know the activities of clinical and social pharmacy, following the pharmaceutical care cycle.
Con 10. Know one's own limitations and the need to maintain and update professional competence, giving special importance to self-learning of new knowledge based on available scientific evidence.
Con-17. Know how to design experiments based on statistical criteria.
Con-18. Know how to evaluate scientific data related to medicines and health products. Use statistical analysis applied to pharmaceutical sciences.
Con 19. Know the structures of biomolecules and the transformations in the cell.
con- 21. Know the properties of cell membranes and the distribution of drugs.
Con 32. Know and understand the basic fundamentals of clinical analyzes and the characteristics and content of diagnostic laboratory reports.
Con 33. Know the effects of substances with pharmacological activity.
Con 37. Know the structure and function of the human body, as well as the general mechanisms of the disease, the molecular, structural and functional alterations, the syndromic expression and the therapeutic tools to restore health.
Con 39. Know the analytical techniques related to laboratory diagnosis, toxins, food and the environment.
Con 44. Know the ethical and deontological principles and act in accordance with the legislative, regulatory and administrative provisions that regulate professional practice, collaborating with other health professionals and acquiring teamwork skills.
Con 48. Know the oral and written communication techniques that allow users of pharmaceutical establishments to be informed in intelligible terms appropriate to different cultural levels and social environments.
Skills or abilities:
S/Ab 01. Intervene in health promotion activities, disease prevention, at the individual, family and community level; with a comprehensive and multiprofessional vision of the health-disease process.
S/Ab 02. Design, apply and evaluate clinical analysis reagents, methods and techniques, knowing the basic foundations of clinical analyzes and the characteristics and contents of laboratory diagnostic reports.
S/Ab 03. Evaluate the toxicological effects of substances and design and apply the corresponding tests and analyses.
S/Ab 05. Develop communication and information skills, both oral and written, for dealing with patients and users of the center where the professional activity is carried out.
S/Ab- 07. Select the appropriate techniques and procedures in the design, application and evaluation of reagents, methods and analytical techniques.
S/Ab- 08. Perform standard laboratory processes including the use of scientific analysis and synthesis equipment, including appropriate instrumentation.S/Ab 09. Estimate the risks associated with the use of chemical substances and laboratory processes.
S/Ab- 09. Estimate the risks associated with the use of chemical substances and laboratory processes.
S/Ab- 10. Apply knowledge of Physics and Mathematics to pharmaceutical sciences.
S/Ab 14. Estimate the biological risks associated with the use of substances and processes of the laboratory involved.
S/Ab 18. Promote the rational use of medicines and health products.
S/Ab- 21. Organize and manage the operation of a pharmacy office.
Competencies:
highlight:
Comp 01. Capacity for analysis and synthesis.
Comp 07. Problem solving.
Comp 08. Decision making.
Comp 13. Ability to communicate with experts from other areas.
Comp 16. Ethical commitment.
Comp 17. Ability to apply knowledge in practice.
Comp 19. Ability to learn.
Comp 20. Ability to adapt to new situations.
Comp 24. Ability to work independently.
Comp 27. Concern for quality.
Comp 28. Achievement motivation.
Four formative elements are used:
A) Lectures. 55-minute in-person sessions tailored to the schedule and timetable approved by the Center. Designed to be taught by the instructor in the classroom, with audiovisual support.
Students participate by following the explanations, asking questions, and responding orally to reasoning questions posed by the instructor, or by writing to graded questions about the content already explained in the topic. Access to personal class notes is allowed in order to answer, but because the questions will be grade as a part of continuous assessment, interaction with other students is not allowed.
B) Interactive classes. They are face-to-face sessions of 55 minutes duration, with a calendar and distribution organized by the Academic Center. In them, the teacher presents a clinical case, or content similar to a pharmaceutical care consultation on analysis results, with which to put into practice aspects of the theory. Questions are also included for continuous assessment.
C) Practical laboratory classes. Conceived as a mandotory face-to-face activity for acquiring or improving laboratory skills and interpreting results. They are carried out in the facilities available to the Department of Biochemistry of the Faculty of Pharmacy.
The practical sessions extend over a week, with daily sessions of variable duration. They are organized by the subject coordinator.
For each practice, the teacher presents it in the context of the subject, guides the group through the stages of the analytical process and clarifies the calculations and interpretations. Each student will be given a summary guide for each practice, which they must complete with the information necessary to create a laboratory procedures notebook.
These sessions also include evaluation questions on the theoretical and practical contents covered in the exercises.
D) Blackboard tutorials. Conceived as face-to-face sessions in the classroom lasting 55 minutes in seminar subgroups, intended to clarify doubts about the theoretical-practical content seen so far. Attendance this sessions are not mandatory for students. This sessions are scheduled in the calendar established by the Center's Management.
For the grading of the subject, three blocks of information about the students' learning status will be taken into consideration:
a) Continuous Assessment (CA) up to a maximum of 15 points. This includes the points earned by each student in the scoring questions, or for their outstanding participation in activities offered during in-person sessions. Class attendance will not be scored (adopting that criterium point in section "d" of article 1.2 of the Class Attendance Regulations of 24/11/2024). In the event of justified absenteeism to an scoring activity, the CA score will be prorated based on participation and the level of success achieved in the CA (in accordance with article 3.1 of the aforementioned Attendance Regulations).
b) Practical exam (PE): It consists of the individual execution of parts of the development carried out during the practices. It will be necessary to reproduce processes and calculations, as well as evaluate the results obtained.
The estimated duration of the test is 10-15 minutes and access to the "laboratory notebook" will be allowed, which will also be evaluated by the examiner.
In order to pass this evaluation several criteria will be taken into account: those made in the assigned shift, as well as attitude, quality, depth and clarity of the interpretation is positively valued, as well as the quality of what is collected in the Laboratory notebook. The grade obtained will be communicated in terms of APTO (positive grade valid for the next 5 years) or NOT APTO, in which case recovery will be postponed to the next opportunity, unless you have passed your turn.
c) Theory Exam (TE): An individual exam without access to the subject's content. It consists of 45 multiple-choice questions and 5 short-answer questions, to be completed within a maximum of 105 minutes, for a maximum score of 50 points. None of the questions will be awarded a negative answer, and a minimum of 25% correct answers per topic or grouping is required to be taken into consideration.
At all times, and for the different types of evaluation tests, the provisions of the Institution's Regulations for the “Evaluation of the Academic Performance of Students and Review of Grades” will be followed, which establishes that the fraudulent performance of activities or evaluation tests are sanctioned with a grade of Fail (0.0) in the OPPORTUNITY; without ruling out the application of any other disciplinary measure.
The final grade for the course takes into account the Assessment Opportunity and the student type, as described:
1st OPPORTUNITY:
Under the "ordinary procedure," passing the course requires a minimum score of 35 points on the TE and also meeting two conditions:
1) Obtaining the minimum score for each topic/grouping indicated on the exam.
2) Obtaining a PASS grade on the practical exam (PE).
The decimal value of the grade is obtained by adding the points accumulated in the theory and continuous assessment (P = TE + CA), which will be transformed into a decimal grade using the following algorithm: [Grade = 0.0013 * P^2 + 0.102 * P - 0.23]. The maximum grade of Honor Rol (HR) may be awarded, in accordance with the provisions established by the USC, among grades above Outstanding (9.5).
If the student fails the assessment, the overall grade will be assigned based on the score obtained in the TE, without considering the CA score, and its decimal value will be obtained by applying the aforementioned algorithm. Also, if conditions (1 and 2) are not met, the maximum grade on the student's transcript will be Fail (4.0).
For this First Opportunity, two special assessment types are considered:
1) Student with Teaching Exemption (awarded by the center). Students will be graded based on the TE and must meet the same conditions as the regular procedure. Their grade is generated as described for the Second Opportunity in its first exception (see below), and in accordance with the criteria agreed upon by the Faculty Board.
2) Repeating Student. Students must inform the coordinator, through the corresponding link on the Virtual Campus, of the assessment method they choose: "Ordinary Procedure" or "Student with Teaching Exemption." If option was not register properly the "ordinary procedure" will be applied by default.
2nd OPPORTUNITY:
As a rule, the procedure to be followed is similar to that described for the 1st Opportunity with two differences:
a) Continuous assessment (CA) is not used. Taking the TE, it will be raised up in a maximum value of 10 as after a requalification (RQ) procedure, in which "one extra point" is added for each of the answers to the 10 most difficult questions.
b) On this occasion, the highest grade of the Honor Roll (HR) will not be awarded.
Regarding special types of assessment:
On this occasion, the special case of any student who in the 1st OP had been qualified with a Fail (4.0) as a result of a "NOT PASS" in the PE and having an overall score of 48 or more P points (TE+CA). Now, if he obtains an APTO grade in the retake PE, he will qualify with the grade that would have corresponded him/her in the 1st OP, except for his maximum HR grade.
The evaluation ensures that the student achieves the Knowledge, Skills and Competencies described above, as indicated in the following table:
Test type_____________ Result type_______Result code___________________________
Continuous Evaluation...... Knowledge.............. Con-07; Con-08; Con-10; Con-37; With 39; Con-44; Con-48
....................................... Skill/Ability................S/Ab-01; S/Ab-05; S/Ab-18; S/Ab-21
....................................... Competence........... Comp-01; Comp-07; Comp-08; Comp-13; Comp-19; Comp-20; Comp-27; comp-28
Theory Exam.................... Knowledge............. Con-01; Con-02; Con-06; Con-07; Con-08; Con-10; Con-19; Con-32; Con-33; Con-37;
.................................................. ............ .......Con-39; Con-44; Con-48
........................................ Skill/Ability..............S/Ab-01; S/Ab--02; S/Ab-03; S/Ab-05; S/Ab-07; S/Ab-09; S/Ab-10; S/Ab-14; S/Ab-18; S/Ab-20
...................................... Competence........... Comp-01; Comp-07; Comp-08; Comp-13; Comp-16; Comp-17 Comp-19; Comp-20; .
.................................................. ................... Comp-27; Comp-28
Practice exam................... Knowledge............. Con-06; Con-08; Con-32; Con-37; Con-39; Con-48
........................................ Skill/Ability...............S/Ab-01; S/Ab-02; S/Ab-03; S/Ab-09; S/Ab-10 S/Ab-14; S/Ab-20
....................................... Competence........... Comp-01; Comp-08; Comp-16; Comp-17; Comp-24; Comp-27; Comp-28
PRESENTIAL WORK, ................................ HOURS
Expository classes in large groups, ..............23
Interactive classes in small groups …………….… 6
Tutorials in very small groups …………………….....2
Laboratory practices …………………………………….12
Examinations and revisions …………………………...2
Total hours of work ……………………………………….45
PERSONAL STUDENT WORK, ............................. HOURS
Individual or group independent study, ……..............46
Resolution of exercises, other works, ……………........10.5
Resolution of exercises, practices with a computer, ..8
Orientation and resolution of doubts, ……………...........1
Conducting and reviewing the exam, ………………….......2
Total hours of personal work of the student, ………….67.5
Interpreting analytical clinical information depend on the sequence and combination of tests in an algorithm and in the quality of results, on which the information is based . This information can be useful, from the perspective of a professional pharmacist, to detect a health problem, monitoring the progression of the disease, or evaluating the effectiveness of the therapeutic response.
I highly recommend understanding "why?", "what for?", and "how?" of changes in biochemical markers in different clinic-pathological situations, as this will make it easier to remember "where to use them" and "what information" they provide.
Active participation and reviewing the study material daily, or failing that, weekly, are highly recommended. This serves two aims:
1. Have the necessary information for the Continuous Assessment activities, which will improve the final grade of those who pass the theory exam.
2. Identify the most difficult sections of the syllabus that require tutoring.
It is also advisable to frequently visit the online course supplement, which, in addition to serving as a communication channel between faculty and students, also contains articles and other information that complements the explanations given in class.
To study this subject, it is desirable to have taken the core subject Biological Analysis and Biochemical Diagnosis, since they share the same design and are complementary in their objectives and competencies.
In addition, it is recommended to have sufficient knowledge of Analytical Chemistry, Instrumental Techniques, along with Biochemistry, Immunology, Human Physiology, Pathophysiology and Biostatistics.
Manuel Felix Camiña Darriba
Coordinador/a- Department
- Biochemistry and Molecular Biology
- Area
- Biochemistry and Molecular Biology
- Phone
- 881814933
- felix.camina [at] usc.es
- Category
- Professor: University Lecturer
Lisa Kay Busch
- Department
- Biochemistry and Molecular Biology
- Area
- Biochemistry and Molecular Biology
- lisa.busch [at] usc.es
- Category
- Professor: Temporary PhD professor
Thursday | |||
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15:00-16:00 | Grupo /CLE_01 | Galician | 5035 Classroom 7 Faculty of Law |
Friday | |||
15:00-16:00 | Grupo /CLE_01 | Galician | 5035 Classroom 7 Faculty of Law |