Far Eastern University – Manila

Institute of Arts and Sciences

Department of Medical Technology

Medical Technology Laws and Bioethics
Final Examination
2nd Semester S.Y. 2019 – 2020

Instructions:
1. Read and understand the instructions and questions properly.
2. Answer briefly and concisely by limiting to a minimum of five sentences and maximum of ten sentences only.
3. Justify your answers by citing your source / reference (limit your reference material based on what
is indicated in the course syllabus which means it should be based on published reading material).
4. Twenty (20) points each item. Refer to the rubrics posted.
5. Not following instructions will have be given a deduction or zero point.
6. Review FEU's Policy on academic integrity, specifically on cheating and plagiarism.
7. Submit your answers here on canvas as file document in pdf format.
8. Deadline of Submission is on May 18, 2020.

1. Discuss: What would you consider if you are going to set-up a screening drug
testing laboratory in terms of:
a. Application and renewal of license (5 points)
If you are going for application and renewal of license, RA 9165 or The
Comprehensive Dangerous Drugs Act of 2002 disclose that certain
requirements (i.e. application form, mayor’s permit, procedure manual, contract
of lease, control form, list of personnel, list of specifications, letter of
endorsement and DTI/SEC registration) must be complied to Bureau of Health
Facilities and Services (BHFS) or Center for Health Development (CHD). When
acquisition of license occurs, documentation for quality control program will be
conducted within the first 6 months in order for the BHFS to decide whether the
standards are met. The BHFS will also conduct a survey within the site so that
they can assess whether they will approve or disapprove the issue of license.
However, the renewal of license should be filed to BHFS or CHD with the
required documents 90 before the expiration date. The BHFS will conduct a
survey again whether the laboratory is maintaining the standards needed, and
will eventually decide whether to allow the renewal of license, or not (Moraleta,
2017, pp. 259-261).

b. The physical plant and the equipment that laboratory should have (5 points)
For physical plant and equipment, there’s also requirements that should
be complied for the laboratory. These are essential in order for proper service
delivery to be done for the patients. It is stated in RA 9165, a screening
laboratory is required to have at least 20 square meters in floor area and a work
are that is at least 10 square meters which also consist a sink, exhaust fan, and

Far Eastern University Manila | Institute of Arts and Sciences | Medical Technology Department
Medtech Laws and Bioethics

 Far Eastern University – Manila
Institute of Arts and Sciences
Department of Medical Technology

storage cabinet. According to Board Regulation No. 2 Series of 2003 each and
every laboratory should have the capability to accommodate at least 5 clients,
and should have hand washing facility, toilet facility, and stall for the collection
of specimen in the premises. Even so, if a laboratory is DOH-licensed hospital
or free-standing secondary/tertiary clinical laboratory, the requirement for 20
square meter for floor are may not be followed on the condition that a
designated area is provided. (Moraleta, p. 255). Screening laboratories has
their own requirements that needs to be complied. The set standards is
mandated to maintain the standard within the laboratory. Screening
laboratories are required to have Thin Layer Chromatography (TLC) or BFAD
registered drug testing kit or BFAD registered drug testing kit. (Moraleta, p.
256). It is essential to follow these requirements because it’s for the betterment
of the patients and healthcare workers.

c. The Head of the Screening Drug testing laboratory and it’s qualification (5
points)
The role of Head of the Screening Drug testing laboratory plays a
vital role when it comes to the activities happening in the laboratory.
Therefore, allocating qualification for this position is a must for the efficiency
of the laboratory. Licensed physician that is also certified in Clinical
Pathology, or certified in Clinical Laboratory Management should be
appointed to be the head of Screening Drug testing laboratory RA 9165
stated. 10 laboratories are the maximum laboratory that a physician certified
in Clinical Laboratory Management can manage. A 5-kilometer radius must
be observed. Testing laboratory can also be managed by a pharmacist,
medical technologist, licensed physician or chemical engineer if the said
laboratory is a unit or section of a clinical laboratory.

d. The personnel and their functions (5 points)

Personnel are also important as much as the head of the laboratory
is. Laboratory personnel is responsible for making the flow of work in a
laboratory is continuous, but without compromising the service quality. As
claimed in RA 9165, the personnel in a laboratory needs to be a full-time
licensed medical technologist, chemist, pharmacist, or chemical engineer
that undergo a training in screening test procedures for dangerous drugs
recognized by Department of Health. Trained administrative personnel
should be assigned for their specific tasks. (Moraleta, p. 256). These will
help the laboratory to function.

Far Eastern University Manila | Institute of Arts and Sciences | Medical Technology Department
Medtech Laws and Bioethics

 Far Eastern University – Manila
Institute of Arts and Sciences
Department of Medical Technology

2. RA 9288
a. Mrs. Jimenez gave birth to twins, Baby Girl Jimenez and Baby Boy Jimenez.
Unfortunately, Baby Girl Jimenez was admitted to the Neonatal intensive
Care Unit (NICU) because of perinatal depression. These babies must
undergo newborn screening. How will the newborn screening be
performed?

Since newborn babies are very prone to diseases for they are
considered sensitive. Newborn screening is done in order to detect the
hereditary conditions or the other possible disease that might infect the
baby. However, this is done under certain guidelines such as the timeframe.
It is stated in RA 9288 or the Newborn Screening Act off 2004 that if the
newborn is not tested within 3 days, it miust be tested within the 7th day of
age (Moraleta, p. 204). The healthcare providers and parents are
responsible in making sure that the newborn is healthy.

b. Mr. and Mrs. Spiering wanted the balance of their religious beliefs included
into the birth of their child. Thus, they refuse newborn screening testing for
their Baby Girl Spiering. Can the parents refuse to do the testing in the
child? Explain.

It is mentioned above that undergoing newborn screening test will be

a great help to keep the baby healthy. However, if the baby’s legal guardian
or parent religious beliefs contradicts with this test, they are allowed to
refuse this. RA 9288 Section 8 mentioned that, a parent or legal guardian
may refuse the newborn screening due to religious beliefs. The parents
must indicate in a written document that despite refusing this test, they
understand the risks. In accordance to this, the said written document must
be indicated in the newborn’s medical record and in the national newborn
screening database. (Moraleta, p. 205).

3. PD No. 856, RA 9275

a. Analiza is a registered medical technologist who has a five years experience
in water analysis. Apparently, she is a current supervisor of a water analysis
laboratory in Sampaloc, manila. A job offer came to Analiza offering her a

Far Eastern University Manila | Institute of Arts and Sciences | Medical Technology Department
Medtech Laws and Bioethics

 Far Eastern University – Manila
Institute of Arts and Sciences
Department of Medical Technology

bigger salary to supervise a laboratory in Quiapo, Manila. Is she allowed to
accept the job offer? Why?
Based on the Administrative Order 2006-0024, water analysis laboratory
can be supervised by a professional with a 3-year experience in the water
testing field and must undergo in a management training. Therefore, Analiza
who is a registered medical technologist and a 5-year experience is
qualified in the job. (Moraleta, p. 332).

4. Bioethics (20 Points) – BINARAO

a. The ethical standards of the Revised Code of Ethics for Medical Technology
and the Major Bioethical Principles cannot guarantee ethical behavior. In
fact, it cannot resolve all ethical issue and dispute, or capture the richness
and complexity involve in striving to make responsible choices within moral
community. If a medical technologist fails to meet these ethical standards
demanded by his profession, or deviates from these standards, and causes
injury to the patient, he may be liable for actionable tort of Malpractice or
Negligence.

b. Enumerate and discuss the four elements of an actionable tort of a Medical

Technologist on the basis of Malpractice or Negligence. (10pts)

According to G.R. No. 171127, the four elements of actionable tort is

duty which means a healthcare provider have qualities to uphold. Breach,
this occurs when a medical technologist have done an action that violates
tha preofessional standards. Injury, occurs when a medical technology
treats the patient unjustly. Proximate causation, proof that the damage is
done. These tort is necessary in order to protect the patient and the medical
technology if ever violence is being depicted.

c. Enumerate and discuss the four major bioethical principles and their impact
in medical technology standpoint. (10pts)
The four major bioethical principles are respect for autonomy,
beneficence, non-maleficence, and justice. Autonomy is giving a person’s
right to decide for his/her life considering each and every patient have
different beliefs when it comes to procedures. Beneficence is something
that is done for the betterment of others. This is necessary in order to give
a quality service to the patients. Non-maleficence is providing the patients
a quality service and accurate results to avoid harms that may happen on
the patients. Justice is treating the people equally and no one gets to
receive special treatment regardless of any condition (Suba & Milanez, 2017).
The mentioned principles delegate the medical technologist to do what is
right for their patients.

Far Eastern University Manila | Institute of Arts and Sciences | Medical Technology Department
Medtech Laws and Bioethics

 Far Eastern University – Manila
Institute of Arts and Sciences
Department of Medical Technology

5. A 45yr old patient with a cardiovascular disease wants to ensure that he will be a
testator to execute a legacy of his organs before he dies. What requirements must
the patient need to meet in order for him to execute an organ legacy and who are
the persons that may become his legatees?

In order to execute organ legacy, RA 7170 or the Organ Donation Act of

1991 must be followed. This law states that a person can become a legatee to a
legacy under any hospital, physician or surgeon, and any accredited medical or
dental school, college or university, and any organ bank storage facility, and any
specified individual (Moraleta, p. 189)

Far Eastern University Manila | Institute of Arts and Sciences | Medical Technology Department
Medtech Laws and Bioethics