PRINCIPLES OF

MEDICAL TECHNOLOGY
PRACTICE 2

Faculty of Pharmacy
Department of Medical Technology
 Faculty of Pharmacy
Department of Medical Technology

Prepared by: Joemarie T. Malana, RMT, MSMT

 Contents

A. Definition of compliance
B. Laws that regulate compliance
C. Phlebotomy-Related Compliance Policies
D. Medicolegal Problems
E. Ethical Considerations
 LEARNING OUTCOMES

◉ Explain the laws that regulate compliance.

◉ Discuss why it is essential that laboratories
maintain compliance and follow these laws.
◉ Define ethics and describe a situation in
which a phlebotomist would need to make
an ethical decision.
 LEARNING OUTCOMES (Cont’d)

◉ Demonstrate knowledge of the legal aspects

associated with phlebotomy procedures by
defining legal terminology and describing
situations that may have legal ramifications.
◉ Discuss the best way for a phlebotomist to
avoid injury-related lawsuit.
 Compliance
 the state or fact of according with
or meeting rules or standards
 Organizations that Set Standards
for Laboratory Testing

◉ Local (Philippines)
○ Department of Health-Health Facilities and
Services Regulatory Bureau (DOH-HFSB)
 Standards Relevant to Phlebotomy
on the DOH Assessment Tool

◉ Proof of qualifications:
○ PRC ID and Certificate
○ Training certificates
○ Annual Health Status

◉ Policy on Continuing Program for Staff

Development and Training
◉ Policies, procedures and QAP on POCT
 Organizations that Set Standards
for Laboratory Testing (Cont’d)
◉ International
○ The Joint Commission International (formerly
JCAHO)
■ Standards for the laboratory: Standard AOP.5
■ Aim of Hospitals: to receive the Gold Seal of
Approval™,
 Organizations that Set Standards
for Laboratory Testing (Cont’d)
◉ International (US Based)
○ Clinical Laboratory Improvement Amendments
of 1988 (CLIA ‘88)
■ Aim: to ensure the accuracy, reliability, and
timeliness of patient test results regardless of
the location, type, or size of the laboratory
■ Developed the Good Clinical Laboratory
Practices
 Organizations that Set Standards
for Laboratory Testing (Cont’d)
◉ International
○ Clinical and Laboratory Standards Institute (CLSI)
Mission:
■ develop best practices in clinical and
laboratory testing and promote their use
throughout the world, using a consensus-
driven process that balances the viewpoints
of industry, government, and the healthcare
professions.
 Organizations that Set Standards
for Laboratory Testing (Cont’d)
◉ International
○ College of American Pathologist (CAP)
■ influences quality improvement in
phlebotomy through standards
■ Standards designed for pathology/
laboratory services only
 Organizations that Set Standards
for Laboratory Testing (Cont’d)
◉ International
○ National Accrediting Agency for Clinical
Laboratory Sciences (NAACLS)
■ authority on educational quality
■ Committed to serving the international
healthcare community through the
involvement of volunteer experts
 Ethics
◉ moral principles that govern a person's
behavior or the conducting of an activity
 Legal Issues

◉ Criminal Action – concerned with laws

designed to protect all members of society
from unlawful acts by others
○ Example: felonies, misdemeanors
 Legal Issues
◉ Civil Action – Concerned with actions
between two private parties, such as
individuals or organizations
**constitute the bulk of the legal actions
dealt with in the medical office or other
healthcare facilities.
 Applicable Laws
◉ Tort Law – basis for the most common
civil actions in healthcare
◉ Tort - wrongful act other than breach of
contract committed against someone’s
person, property, reputation, or other
legally protected right, for which the
individual is entitled to damages awarded
by the court.
 Definitions of Tort Actions and
Legal Terminology

1. Assault: An act or threat causing another to be

in fear of immediate battery (harmful touching).
**Battery does not necessarily have to follow an
assault; however, the victim must believe the
ability to carry out the threat is there.
 Definitions of Tort Actions and
Legal Terminology

2. Battery: An intentional harmful or offensive

touching of, or use of force on, another person
without consent or legal justification.
**Legal Justification for infant/ pediatric
phlebotomy: mother gives permission to have
blood drawn from her child
 Definitions of Tort Actions and
Legal Terminology

3. Fraud: A deceitful practice or false

portrayal of facts either by words or by
conduct, often done to obtain money or
property.
Ex: Billing for services that have not been
provided.
 Definitions of Tort Actions and
Legal Terminology

4. Invasion of privacy: The violation of one’s right

to be left alone.
**can involve a physical intrusion or the
unauthorized publishing or release of private
information (breach of confidentiality).
 Definitions of Tort Actions and
Legal Terminology

5. Breach of confidentiality: The failure to keep

privileged medical information private.
Ex: unauthorized release of patient information
such as laboratory results.
 Definitions of Tort Actions and
Legal Terminology

6. Malpractice: A type of negligence committed by

a professional.
◉ The training and experience of the accused
individual is taken into consideration when
deciding whether an act resulting in injury
should be labeled negligence or malpractice.
 Definitions of Tort Actions and
Legal Terminology

7. Negligence: The failure to exercise due care, the

level of care that a person of ordinary intelligence
and good sense would exercise under the given
circumstances.
 Definitions of Tort Actions and
Legal Terminology

7. Negligence (cont’d)
◉ To claim negligence, the following must be
present:
1. A legal duty or obligation owed by one person to
another
2. A breaking or breach of that duty or obligation
3. Harm done as a direct result of the action
 Definitions of Tort Actions and
Legal Terminology

7. Res ipsa loquitur

◉ Latin: “the thing speaks for itself,”

◉ Applies to the rule of evidence in a case of

negligence.
 Definitions of Tort Actions and
Legal Terminology

7. Res ipsa loquitur (cont’d)

Ex: a homebound patient sitting on a kitchen
barstool faints while having blood drawn and falls,
hitting his head (head injury develops due to the
fall)
**If a lawsuit results, the burden of proof is shifted
to the phlebotomist, who must prove that he or she
was not negligent.
 Definitions of Tort Actions and
Legal Terminology

7. Respondeat superior:
◉ Latin: “let the master respond.”

◉ An employer is liable (legally responsible) for the

actions of an employee, even though the
employee is the one at fault.
 Definitions of Tort Actions and
Legal Terminology

8. Standard of care
◉ The normal level of skill and care that a
healthcare practitioner would be expected to
adhere to in order to provide due care for
patients.
◉ established by standards of the profession and
the expectations of society
 Definitions of Tort Actions and
Legal Terminology

9. Statute of limitations
◉ A law setting the length of time after an alleged
injury in which the injured person is permitted
to file a lawsuit.
 Applicable Laws
◉ REPUBLIC ACT NO. 4688 - An Act
Regulating the Operation and
Maintenance of Clinical Laboratories and
Requiring the Registration of the Same
with the Department of Health, Providing
Penalty for the Violation thereof, and for
Other Purposes
 Applicable Laws
◉ REPUBLIC ACT NO. 5527 - An Act
Requiring the Registration of Medical
Technologist, Defining their Practice, and
for Other Purposes
 Applicable Laws
◉ REPUBLIC ACT NO. 5527
Section 21. Issuance of Certificate of
Registration

…The duly registered medical technologists

shall be required to display his certificate of
registration in the place where he works…
 Applicable Laws
◉ REPUBLIC ACT NO. 5527
Section 24. Administrative Investigation-
Revocation or Suspension of Certificates.
- The Board may….reprimand an erring medical
technologist or revoke or suspend his certificate of
registration … for unprofessional conduct, malpractice,
incompetency, or serious ignorance or gross negligence in
the practice of medical technology.
- No penalty of revocation shall be imposed unless there is
a unanimous vote of all the three members of the Board.
 Avoiding Lawsuits

◉ Always respect the right of patients.

◉ This gives them control over the situation and
makes them less likely to feel that they have
been treated poorly.
 Guidelines to Avoid Lawsuits

• Acquire informed consent before collecting specimens.

• Respect a patient’s right to confidentiality.
• Strictly adhere to accepted procedures and practices.
• Use proper safety containers and devices.
• Listen and respond appropriately to the patient’s
requests.
 Guidelines to Avoid Lawsuits
(Cont’d)
• Accurately and legibly record all information
concerning patients.
• Document incidents or occurrences.
• Participate in continuing education to maintain
proficiency.
• Perform at the prevailing standard of care.
• Never perform procedures that you are not trained
to do.
 Patient Consent
Informed Consent
◉ voluntary and competent permission for a medical procedure,
test, or medication.
◉ Requires that a patient be given adequate information
regarding the method, risks, and consequences of a procedure
before consenting to it.
◉ Information in nontechnical terms
◉ Must be obtained before initiating any medical procedure.
◉ Minors require consent of their parents or legal guardians.
 Patient Consent
Expressed Consent
◉ required for treatment that involves surgery, experimental
drugs, or high-risk procedures.
◉ given verbally or in writing.
◉ should cover what procedures are going to be performed
◉ not in a general form
 Patient Consent
Implied Consent
◉ The patient’s actions imply consent without a verbal or
written expression of consent.
◉ may be necessary in emergency procedures (e.g. CPR)
 Patient Consent
HIV Consent

The client must be advised on:

◉ the test and its purpose

◉ how the test might be used

◉ the meaning of the test and its limitations

DOH NEC Form A
 Patient Consent
Consent for Minors
◉ A minor cannot give consent for the administration
of medical treatment.
◉ Parental or guardian consent is required.
◉ Healthcare personnel who violate this rule are
liable for assault and battery.
 Patient Consent
Refusal of Consent
◉ An individual has a constitutional right to refuse a
medical procedure such as venipuncture.
◉ May be based on religious or personal beliefs and
preferences.
 Assignment
Read pages 59-60 of the “Phlebotomy Essentials” by
McCall for examples of actual legal cases involving
phlebotomy procedures.
 Suggested Learning Activity: Case Study

Case:
A Stafford, Virginia woman goes to the phlebotomy lab at Johns Hopkins
Hospital in Baltimore, Maryland. She is scheduled to give an autologous
blood donation in preparation for a bone marrow donation.
When the phlebotomist places the needle in her right arm to initiate the
donation, she immediately feels pain and numbness causing her to yell. A
resident physician tells her that the needle likely struck a nerve, and
advises her to call back in a few days if the symptoms persist. After
experiencing several days of pain, numbness, burning, and tingling, the
woman contacts Johns Hopkins and is referred for evaluation and
treatment.
 Suggested Learning Activity: Case Study

After evaluation, it is determined that the woman suffered an injury

to the lateral antebrachial cutaneous nerve in her right arm. This
nerve is the sensory continuation of the musculocutaneous nerve
which supplies the flexor muscles of the elbow. Notwithstanding
medical treatment, medication, and the passing of time, the woman
continues to experience neurological symptoms in her right upper
extremity, including pain and numbness. She is still undergoing
regular medical care and treatment.
The woman files a lawsuit against Johns Hopkins Hospital in
Baltimore City.
 Suggested Learning Activity: Case Study

The woman continues to experience significant pain, numbness,

disability, loss of enjoyment of life, emotional distress and loss of
wages and wage-earning capacity as a result of her injury, which is
likely to be permanent in nature.
 Suggested Learning Activity: Case Study

Guide Questions:
1. What tort action/s where committed in the case? Explain.
2. Who should be blamed for the incident? Explain.
3. What measures should have been done to prevent the
incident?