Biological analysis and biochemical diagnosis

The subject aims for the future pharmacist to be able to interpret the state of health from the results of biomarkers in a clinical laboratory tests, fulfiling one of the following objectives:
a) Provide information for a better understanding of the health problem.
b) Guide the patient towards a quick recovery.
c) Recommend a visit to a doctor/specialist, when appropriate.

Each topic issue presents the biochemical tests, the appropriate specimen, the interpretation of the results and the limitations that must be considered in order to achieve a detection, a diagnosis, the prognosis or the follow-up of a certain clinical picture.

EXPOSITORY classes: In-person scheduled in the classroom, divided into two blocks:

Thematic Group I: General Operating Principles of the Biochemical Clinical Analysis Laboratory.
This first group of topics reviews generic aspects of sampling and the analytical process, comments on the main sources of error and gives the keys to begin interpreting the results based on simple rules:

Topic 1. The application and samples.
Topic 2. Rapid tests in the Pharmacy Office: self-diagnosis devices.
Topic 3. Sources of variation in results.
Topic 4. Fundamentals of clinical interpretation.


Thematic Group II: Functional Exploration of Organs and Systems.
Presents biochemical tests for functional evaluation of the main organs and systems. Each topic focuses on the biochemical profile, the biological material to be analyzed and the conditions to be considered before discussing a functional research strategy.

Topic 5. Exploration of acid-base balance
Topic 6. Exploration of hydroelectrolyte balance.
Topic 7. Evaluation of bone and mineral metabolism.
Topic 8. Evaluation of kidney function.
Topic 9. Evaluation of liver function and integrity.
Topic 10. Clinical usefulness of plasma proteins.
Topic 11. Investigation of dyslipidemias.
Topic 12. Exploration of pancreatic and intestinal disease.
Topic 13. Diagnosis and monitoring of Diabetes Mellitus.
Topic 14. Biochemical evaluation of cardiac ischemia.
Topic 15. Early detection program for endocrine diseases.

INTERATIVITY classes (IC): In-person classes distributed in 8 one-hour sessions. They present practical aspects of the interpretation of the analysis. Most sessions focus on a clinical scenario.

IC-1: Sampling. Viewing containers and procedures.
IC-2: Detection of the possible existence of errors in the results.
IC-3: Clinical case. Diagnostic extraction in acid-base balance.
IC-4: Clinical Case. Investigation of a possible kidney problem.
IC-5: Clinical case. Differential diagnosis of a liver problem.
IC-6: Clinical case: Approach to dysproteinemia
IC-7: Clinical case. Pharmaceutical monitoring of dyslipidemia.
IC-8: Clinical case. Analytical management of diabetes.

PRACTICAL (Experimental) classes: Week-long sessions in the practical laboratory organized by the Faculty Management Team, to be carried out in the Clinical Biochemistry laboratory, located in Pavilion A of the Pharmacy building (Floor 1) in morning and afternoon shifts. late, preferably in the month of November.

Practice 1. Performance and Interpretation of the standard Urinalysis.
Practice 2. Biochemical analysis: Quantification of enzymatic activity: FAL as an example.
Practice 3. POCT systems: phenotypic assignment of dyslipidemia and cardiovascular risk
Practice 4. Determination of HbA1c. Diagnosis and monitoring of patients with diabetes.
On the last day of each shift an individual practical evaluation will be carried out (see Evaluation System).

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 in the approach to themes and content. 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 the processes,
organs and systems of the human body.

d) LabTest online. (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 the perspective of quick guides on analytical testing.

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) Best & Taylor: Physiological bases of medical practice. MA Dvorkin, DP Cardinali and RH Iermoli. 14th edition. Ed. Pan-American Medicine-Buenos Aires -2010. ISBN: 978-950-06-0253-2
Suitable for reviewing knowledge of Physiology and Pathophysiology. In many topics it provides a justification of the interest of the tests used in each clinicopathological condition that it addresses.

c) Henry's Clinical Diagnosis and Management 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.

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 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 19. Know the structures of biomolecules and the transformations in the cell.
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 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 09. Estimate the risks associated with the use of chemical substances and laboratory processes.
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 20. Evaluate the toxicological effects of substances and design and apply the corresponding tests and analyses.

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.

The methodology uses four training elements:

A) Expository classes. They are sessions lasting 55 minutes and adjusted to the calendar and schedules approved by the Center. Designed to be taught by the teacher in the classroom, and with the support of presentations, diagrams or videos.
The students participate by following the explanations, raising any doubts that arise and responding individually, and in a limited time, to the questions that arise in relation to what is being explained. To answer, access to your own class notes is allowed, but you cannot share any type of information from, or with, your classmates, since these questions are part of the continuous evaluation.

B) Interactive classes. They are face-to-face sessions and last 55 minutes. duration, with calendar and distribution organized by the Academic Center.
In them, the teacher presents a context of pharmaceutical care by asking a question about the analysis results in which he must put into practice the knowledge and strategies developed in the theoretical classes. There will also be questions for continuous evaluation under conditions similar to the previous point.

C) Practical laboratory classes: Designed as a face-to-face activity in the facilities of the clinical practice laboratories used by the Department of Biochemistry of the Faculty of Pharmacy. They have a variable duration, one week, according to the calendar and distribution prepared by the Center.
In them, the teacher introduces the practice within the framework of the syllabus. He directs the group's progress through the stages of the analytical process, calculations and interpretations. Continuous evaluation questions may also be asked about theoretical knowledge applicable to practice.
Students will have a brief guide to the analytical processes, which they can complete and take with them when they attend the practical evaluation round at the end of the practical shift.

D) Whiteboard tutorials. Conceived as sessions in very small groups to clarify doubts about the theoretical-practical contents, they will not be scored, and in any case they are face-to-face in the classroom and scheduled in the teaching calendar by the Center Management.

For the grading of the subject, three blocks of information about the students' learning status will be taken into consideration:
a) Continuous Evaluation (CE): up to a maximum of 20 points. It is based on the accumulated score in the answers given to the questions asked with this denomination in the classroom. It is only used in the 1st OPPORTUNITY of the course.

b) Practical exam (PE): Carried out individually by each student before the teacher at the end of the practice shift. You will have to recognize biological materials, reproduce processes and calculations, and interpret the results of the analyzes developed in practical classes. The estimated duration of the test is 10 to 15 minutes and you can use the accompanying procedure guide. The attitude, quality of execution, depth and clarity of interpretation, order and cleanliness will be taken into account. At the end of the test, the grade achieved will be communicated, whether it is PASS (valid for the next 5 years) or NOT PASS; in which case a new evaluation test will be taken in the next Opportunity that decides to appear.

c) Theory and Knowledge Exam (TE): Exam on the theoretical content (including practices) of the subject. It consists of 45 multiple choice questions and 5 short answer questions, to be solved in 100 minutes to reach a maximum score of 50 points. None of the questions will have a negative value due to error or lack of response, but a minimum of 25% correct answers are required per topic, or group of topics, which is specified in each Opportunity exam.

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 of the subject takes into account the type of students and the Evaluation Opportunity as described:

At the 1ST CHANCE:

Pass status in the subject is achieved with a score of 37 or more points on the TE, and if the following is also met:
1) achieve the minimum score established by topics or groups of topics.
2) have a PASS in the PE test.

The final grade is obtained from the Score = TE+ CE points and their corresponding transformation to a decimal grade with the algorithm: [Grade= (0.150*Score-0.518]. The maximum MH grade may be awarded, according to those available for the subject, among the final grades higher than Outstanding (9.5).

In the case of obtaining TE= 36 points or less, or the minimum score in the topics was not reached, or the PE was classified as No PASS, the grade of Fail will be granted and up to a maximum grade value of 4.0 after the transformation decimal.

There are special types of evaluation in this 1st Opportunity:
1) Student with Teaching Exemption (when accepted by the Center). It is qualified on TE and PE according to what is described for the 2nd Opportunity (see below), given the impossibility of having CE.

2) Repeat student. You will be able to choose the evaluation system to which you submit between the "general procedure" and the "Student with Teaching Exemption". It must be recorded in a timely manner through the Virtual Campus. If no election is made, the "general procedure" described above applies.

On the 2nd CHANCE:

The procedure to follow is similar to that described for the 1st Opportunity with three differences:
1) The continuous evaluation (CE) is not used, which will be replaced by a requalification of the TE, consisting of obtaining 1 extra point for each correct answer to each of the 10 most difficult questions of the exam, and is only applied when the exam is passed, that means the TE equals to or greater than 37 points. So re-score= TE+ dificult questions.
2) The Final Grade results from transformation based on an algorithm adjusted to the new maximum (re-score) of the Opportunity (60 points) and in any case similar to that of the 1st OP.
3) In the 2nd OPPORTUNITY the maximum qualification of Honor Roll (MH) is not granted.

Regarding the special types of evaluation, this Opportunity is considered the case of students who in the 1st OP qualified with a Sunpenso (4.0) as a result of a “Not PASS” in EP, having achieved an overall score of 53 or more points ( ET+EC). In this case, the repetition of the ET of the 2nd OP is exempt, and you must only perform the EP test. If you pass the PASS, you will be graded with the decimal grade that would have corresponded in the 1st OP.

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-20
....................................... 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-03; S/Ab-05; S/Ab-09; 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-03; S/Ab-09; S/Ab-14; S/Ab-20
....................................... Competence................. Comp-01; Comp-08; Comp-16; Comp-17; Comp-24; Comp-27; Comp-28

IN-PERSON WORK................................ DURATION
Teaching Theory in the classroom .................. 30
Interactive classes in small groups ................... 8
Individual tutoring............................................ 2
Laboratory practices. .....................................16
Exams and reviews.......................................... 4
Total hours of face-to-face work.....................60

PERSONAL WORK OF THE STUDENT,……………….DURATION
Self-study, individual or group, ................................66
Solution of exercises, practical cases...................... 16
Guidance and resolution of doubts.............................4
Preparation of the laboratory notebook.....................2
Taking and reviewing the exam .................................2
Total hours of personal work of the student.............90

Learning to interpret the information contained in clinical analyzes is like learning a new language, in which the vocabulary and grammatical rules are, respectively, the biochemical parameters and the algorithms and strategies that, like paragraphs, contain the information that we can understand.

Analyzes are useful if we are able to recognize the information they contain and will be useful to solve a problem or to report on the evolution of people's health status.
To be successful in the subject it is necessary to understand the "why?", the "for what?". and how?" biochemical markers are altered, since it will be easier to remember "where to use them" and "what information" they provide.

It is very convenient to actively participate in the scheduled classes and review the material every day or, failing that, on a weekly basis, and all of this for a double interest:
1.- Have the necessary information for Continuous Evaluation activities
2.- Identify the points that are most problematic for you when requesting tutoring.

It is also advisable to frequently visit the virtual supplement of the subject that serves as a communication channel between teachers and students.

To take this subject, sufficient knowledge of Analytical Chemistry and Instrumental Techniques is required, as well as Biochemistry I and II, Immunology, Human Physiology I and II and Pathophysiology.