PMLS 2-CHAPTER 3 Prepared by: SHERWIN P.

GAMMAD, RMT, LPT, MSPH

REGULATORY, ETHICAL, AND LEGAL ISSUES
This chapter is designed to stress to phlebotomists the important role they play in the
health-care system. Along with importance comes responsibility.
Therefore, phlebotomists must understand the regulatory, ethical, and legal aspects
associated with the performance of phlebotomy.
REGULATORY ISSUES
The health-care regulation systems include both governmental and public agencies.
All agencies have the same goal, which is to provide safe and effective health care
CLINICAL LABORATORY IMPROVEMENT
AMENDMENTS OF 1988 (CLIA’88)
CLIA is a governmental regulatory agency administered by the Centers for Medicare
and Medicaid Services (CMS) and the Food and Drug Administration (FDA).
CLIA stipulates that all laboratories that perform testing on human specimens for the
purposes of diagnosis, treatment, monitoring, or screening must be licensed and
obtain a certificate from the CMS.
This includes all independent and hospital laboratories, physicianoffice laboratories,
rural health clinics, mobile health screening entities such as health fairs, and public
health clinics.
CLIA classifies laboratory tests into four categories: waived, provider performed
microscopy, and nonwaived testing.
Nonwaived testing is separated in to the categories of moderate and high complexity
with regard to requirements for personnel performing the tests (Box 3-1).
Phlebotomists are subject to CLIA regulations when they are performing point-of-care
testing (POCT). Laboratories with CLIA certification are inspected to document
compliance with the regulations.
The inspections may be performed by CMS personnel or an accrediting agency
recognized by CMS including the College of American Pathologists (CAP), the Joint
Commission (JC), and the Commission on Laboratory Assessment (COLA).
CLINICAL AND LABORATORY STANDARDS
INSTITUTE (CLSI)
The CLSI is a nonprofit organization that publishes recommendations by nationally
recognized experts for the performance of laboratory testing.
CLSI standards are considered the standard of carefor laboratory procedures. These
standards are referred to throughout the text.
In a legal situation, they would be considered the standard of care that should have
been met.
JOINT COMMISSION (JC)
The JC is an independent, not-for-profit organization that accredits and certifies more
than 15,000 health-care organizations and programs in the United States.
The mission of the JC is to continuously improve the safety and quality of care
provided to the public through the provision of health-care accreditation and related
services that support performance improvement in health-care organizations.
The JC has recently published the Joint Commission Patient Safety Goals.
It is essential that healthcare organizations adhere to these goals to maintain their
accreditation.
Goals pertaining to the laboratory are: Goal1 Improving the Accuracy of Patient
Identification Goal 2 Improving the Effectiveness of Communication among
Healthcare Givers Goal 7 Reduce the Risk of Healthcare-Associated Infections Goal
13 Encourage Patients’ Active Involvement in Their Own Case as a Patient Safety
Strategy All of these goals are important to phlebotomy and are included throughout
the text.
COLLEGE OF AMERICAN PATHOLOGISTS (CAP)
The CAP is an organization of board-certified pathologists that advocates high-
quality and cost-effective medical care.
The CAP provides laboratory accreditation and proficiency testing for laboratories.
For accreditation purposes, CAP-trained pathologists and laboratory managers and
technologists perform on-site laboratory inspections on a biennial basis.
Inspectors examine the laboratory’s records and quality control of procedures for the
preceding 2 years. Also examined are the qualifications of the laboratory staff
including continuing education attendance, the laboratory’s equipment, facilities,
safety program, and laboratory management.
CAP accreditation is accepted by both the CMS and the JC and fulfills
Medicare/Medicaid requirements.
Laboratories that subscribe to the proficiency program receive periodic samples to
analyze and return their results to the CAP.
The laboratory receives a report on how its results compared with other laboratories
performing the procedures in a similar manner.
Failure to perform satisfactorily on a proficiency test can result in a laboratory losing
its CLIA certificate to perform the failed test.
Phlebotomists are included in a CAP inspection and also in proficiency testing when
performing POCT.
ETHICAL AND LEGAL ISSUES
Principles of right and wrong, called the code of ethics, provide the personal and
professional rules of performance and moral behavior as set by members of a
profession.
Medical ethics or bioethics focus on the patient to ensure that all members of a
health-care team possess and exhibit the skill, knowledge, training, professionalism,
and moral standards necessary to serve the patient.
Professional agencies such as the American Society for Clinical Pathology (ASCP),
American Society for Clinical Laboratory Science (ASCLS), and the National
Phlebotomy Association (NPA) have developed codes of ethics for laboratory
personnel.
Phlebotomists are expected to follow this code by performing the duties specified in
their job description, adhering to established standards of performance, and
continuing to improve their knowledge and skills
THE PATIENT’S BILL OF RIGHTS
A document first published by the American Hospital Association (AHA) in 1973 and
amended in 1992 called the Patient’s Bill of Rights specified what the patient has a
right to expect during medical treatment.
A patient’s rights and dignity must be protected in the process of providing quality
care. It was provided to patients upon hospital admission. The document addresses
the following 12 areas:
1. Patients have the right to considerate and respectful care.
2. Patients have the right to obtain from their health-care provider complete current
information about their diagnosis, treatment, and prognosis in terms that patients can
be reasonably expected to understand.
3. Patients have the right to receive from a healthcare provider the information
necessary to give informed consent before a procedure.
The information should include knowledge of the proposed procedure, with risks and
probable duration of incapacitation.
In addition, the patient has a right to information about medically significant
alternatives.
4. Patients have the right to refuse treatment to the extent permitted by law and to
be informed of the medical consequences of their action.
5. Patients have the right to privacy in their medical care. Case discussion,
consultation, examination, and treatment should be conducted discreetly.
Those not directly involved with a patient’s care must have the patient’s permission to
be present.
6. Patients have the right to expect that all communication and records pertaining to
their care be treated as confidential.
7. Patients have the right to expect the hospital to make a reasonable response to
their request for services and to provide evaluation, service, and referral as
indicated.
8. Patients have the right to obtain information as to any relationship of their hospital
with other health-care and educational institutions, insofar as their care is concerned,
and to the professional relationship among individuals who are treating them.
9. Patients have the right to be advised if the hospital proposes to engage in or
perform human experimentation affecting their care or treatment. Patients have the
right to refuse to participate in research projects.
10. Patients have the right to expect continuity of care, including future appointments
and instructions on continuing health-care requirements after discharge.
11. Patients have the right to examine and receive an explanation of their bill,
regardless of the source of payment. 12. Patients have the right to know what
hospital rules and regulations apply to their conduct as a patient
THE PATIENT CARE PARTNERSHIP
In 2003 the AHA published a revision to the Patient’s Bill of Rights titled The Patient
Care Partnership: Understanding Expectations, Rights and Responsibilities.
This revision is published as a brochure to be given to patients.
A major goal of the revision was to provide information in plain, straightforward
language to better communicate with patients. Notice the emphasis on improving
communication that is in the JC Patient Safety Goal 2.
All of the patients’ rights from the original documents are covered in the brochure
under new headings shown in Box 3-4.
LEGAL ISSUES RELATING TO MEDICINE
Failure to respect patients’ rights and performing beneath the standard of care can
result in legal action initiated by the patient or the patient’s family.
Medical law regulates the conduct of members of the health-care professions.
It differs from ethics, which are recommended standards, by being legally required
conduct.
Litigation initiated because of illegal actions can be at the local, state, or national
level and can result in criminal or civil prosecution.
Penalties may include revocation of professional licenses, monetary fines, or
imprisonment.
A criminal lawsuit is an action initiated by the state for committing an illegal act
against the public welfare and can be punishable by imprisonment.
A civil lawsuitis a court action between parties seeking monetary compensation for an
offense.
In a lawsuit, the person who brings the lawsuit or action is the plaintiff, and the
health-care worker or institution against whom the action or lawsuit is filed is the
defendant.
TORT LAW
A wrongful act committed by one person against another that causes harm to the
person or his or her property is called a tort.
Torts are classified as intentional and unintentional.
Assault, battery,and defamation are considered intentional torts, whereas negligence
and malpractice are considered unintentional torts.
● Assault is the threat to touch another person without his or her consent and with the
intention of causing fear of harm.
● Battery is the actual harmful touching of a person without his or her consent.
● Defamation is spoken or written words that can injure a person’s reputation.
● Libel is false defamatory writing that is published.
● Slander is false and malicious spoken word.
● Invasion of privacy is the violation of the patient’s right to be left alone and the
right to be free from unwanted exposure to public view.
● Release of confidential information is considered an invasion of privacy. Entering a
patient’s room without asking permission may be considered a physical intrusion and
an invasion of privacy.
Other examples of invasion of privacy would be using a patient’s laboratory
requisition for classroom instruction purposes without removing the identification
criteria or releasing patient information to a local newspaper or television reporter.
THE HEALTH INSURANCE PORTABILITY AND
ACCOUNTABILITY ACT OF 1996
The Health Insurance Portability and Accountability Act of 1996 (HIPAA) legislation
encompasses a variety of health-care issues, not all of which directly affect the
laboratory. Primary goals of the legislation are to:
● Protect workers with pre-existing conditions from losing health insurance when
changing jobs
● Provide easier detection of fraud and abuse
● Reduce paperwork by requiring electronic data transactions
● Guarantee the privacy of individual health information
In addition to developing approved methods of data transmission, health-care
workers are most affected by the requirement to guarantee privacy of individual
health information.
The release of patient test results now falls under the HIPAA.
In general, release of patient information, even between healthcare providers, must
be kept to the minimum required for care, and written patient consent to release the
information must be obtained.
Standards for complying with HIPAA continue to be developed. Phlebotomists can
expect to encounter continually evolving methods and regulation of data transfer.
CONFIDENTIALITY
Long before HIPAA was enacted health-care workers were legally responsible to
respect the confidentiality of patient information.
This information includes patient or health-care provider communications, the patient’s
verbal statements, or the patient’s chart or laboratory results.
All information acquired through the care of a patient must be kept confidential and
given only to health professionals who have a medical need to know.
Laboratory results may be given only to the health-care provider, and the patient
must give permission to release the test results.
Phlebotomists collect samples for employee or athlete drug or alcohol screening, as
well as screening for human immunodeficiency virus (HIV) or other sexually
transmitted diseases.
Care must be taken that this information not be discussed where it can be overheard
by unauthorized people.
With the use of computers in health care, confidentiality and accessibility must be
addressed.
HIPAA has mandated that health-care professionals become familiar with information
security standards and ensure that policies exist to control access to and release of
patient-identifiable health information.
MALPRACTICE
Medical malpractice is misconduct or lack of skill by a health-care professional that
results in injury to the patient.
Negligence, which is defined as failure to give reasonable care by the health-care
provider, must be proven in a malpractice suit.
Reasonable care requires that the health-care professional understand and practice
a specific standard of care, which essentially means that he or she performs the
duties with the same skill and knowledge as other workers with the same training and
experience would.
State statutes, licensing requirements, and regulatory and professional agencies
establish standards of care. Four factors must be proven to claim negligence:
1. Duty: Indicates that there was an established standard of care and proof that it
was not followed.
The standard of care can be for the procedure and for the training and evaluating
protocols of the phlebotomist performing the procedure.
2. Breach of Duty: The plaintiff (patient) must show what actually happened and that
the defendant (phlebotomist) failed to perform.
It has to be proven that the defendant knew or should have known that this failure
could cause harm.
3. Causation: Indicates that the breach of duty directly caused the injury and that no
other factors could have contributed.
4. Damages: Actual physical, emotional, or financial injury had to occur to the
plaintiff (patient) because of the negligent act.
The most common phlebotomy events that may initiate litigation are nerve injury,
hemorrhage from an accidental arterial puncture or inadequate pressure to the vein,
drawing from inappropriate locations such as the same side as a mastectomy, injuries
occurring when a patient faints, or death of a patient caused by misidentification of
a patient or sample and wrong diagnosis or mistreatment of a patient due to sample
collection errors.
Examples of actual phlebotomist involvement in malpractice suits that resulted in
awards to the plaintiff are shown in Box 3-5.
PATIENT CONSENT
Patients must give consent prior to any procedure and the type of consent depends
on the type of procedure to be performed.
Different types of patient consent in health care include informed consent, expressed
consent, minor consent, implied consent, and HIV consent.
Informed Consent
Informed consent requires that the health-care professional explain what the medical
procedure is; how it is to be performed, including possible risks; and the expected
results.
The procedure must be explained in a manner that the patient will understand. Vital
to consent is the patient’s belief that the health-care professional is competent to
perform the procedure.
Health-care professionals may be legally liable for failing to offer information to
patients and for not obtaining informed consent. Consent may be expressed or
implied.
Expressed Consent
Expressed consent is primarily required for invasive procedures but can include
phlebotomy.
The healthcare worker explains the procedure as discussed under informed consent.
The patient then gives consent in writing or verbally.
The most commonly used and safest method for obtaining expressed consent is in
writing.
Verbal consent must be documented in the patient’s chart.
Implied Consent
Implied consent is very common in blood collection.
The phlebotomist must explain the procedure that will be used to collect the blood
sample, stressing that the patient’s health-care provider ordered the test.
The patient expects that the phlebotomist is competent in blood collection procedures
and gives consent to collect the blood samples by extending the arm or rolling up the
sleeve.
Implied consent also exists when emergency procedures must be performed to save a
person’s life or prevent permanent impairment to the patient.
The law implies consent for treatment for these patients without consent from the
responsible party.
Implied consent is a state statute, and the limitations vary from state to state.
Consent for Minors and Incapacitated Patients
Blood collection in minors requires consent of their parents or legal guardians.
A legally responsible person must give consent for patients who cannot communicate,
persons who are mentally incompetent, patients in shock or trauma, demented
patients, or those under the influence of drugs or alcohol.
A legal guardian who can give consent may have to be appointed by the courts.
Consent for Testing for Human Immunodeficiency Virus
State legislation may require informed consent be obtained before HIV testing is
performed.
The laws dictate what type of information must be provided to the patient.
The patient may have to receive an explanation of the test and its purpose, possible
uses of the test, the limitations of the test, and the meaning of the test results.
In 2006 the Centers for Disease Control and Prevention (CDC) issued a new screening
recommendation for HIV testing on all persons between the ages of 13 and 64
receiving treatment at health-care facilities.
The procedure is called opt-out screening or opt-out testing.
This means that the patient is told that the HIV screening test is part of their routine
care and covered by their general consent for treatment.
Patients have the right to ask questions about the procedure and the right to decline
(opt-out of) the procedure.
This differs from opt-in testing where the health-care provider recommends that the
patient have the test and the patient must give written consent.
Based on state laws the procedure of opt-out screening may vary or not be an option
for the facility to use.
In some states an accidental needlestick is considered a significant exposure to the
health-care worker, and HIV testing can be ordered by a healthcare provider without
patient consent. In this situation, the HIV results are not entered into the patient’s
chart.
Respondeat Superior
The Latin phrase respondeat superior, “let the master answer,” establishes that
employers are responsible for their own acts of negligence as well as their
employees’ acts.
Institutions are responsible for ensuring that their employees perform only those tasks
that are within the scope of their knowledge and training.
However, this does not diminish the responsibility of the employee.
Both the institution and the employee can be found liable if injury occurs to the
patient because of the employee’s actions.
Professional liability should be a concern for all health-care workers.
Malpractice Insurance
Most institutions have policies covering all workers, and the phlebotomist should
confirm this coverage at the time of employment.
Phlebotomists who work independently for insurance companies or home health-care
agencies may need to be covered by personal malpractice insurance.
Liability insurance can be purchased at a reduced rate through professional
organizations.
By consistently practicing good patient care standards, the phlebotomist can avoid
the trauma of a lawsuit (Box 3-6).
Risk Management
The potential for injury exists in the health-care profession, and the phlebotomist
should be aware of these risks and the precautions necessary to minimize them.
Risk is inherent with every venipuncture.
Risk management departments develop policies to protect patients and employees
from preventable injuries and the employer from financial loss.
Risk management programs must identify the risk; determine policies and procedures
to prevent the risk; educate employees, patients, and visitors; and evaluate changes
that may be necessary for improvement.
Various tools are available to identify risks and determine methods for reducing risk
and the financial loss incurred by paying for the occurrences after they have
happened.
One commonly used tool in the phlebotomy department is the incident report.
The employee who detects the incident describes both the incident and the corrective
action taken.
Each step of the follow-up should be clearly documented.
This form is used to investigate the occurrence and is signed by the employee’s
supervisor and reviewed by the quality assessment (QA) coordinator.
New policies and procedures are continually being developed and instituted as
incidents are investigated.
Effective communication and education in the new policies must be available for
employees for successful implementation.
Preventing Medical Errors
In November 1999, the National Academy of Sciences’ Institute of Medicine (IOM)
issued a report entitled “To Err is Human: Building a Safer Health System.”
The report stimulated considerable public and governmental concern by stating that
most adverse medical events were caused by preventable medical errors.
Health-care institutions, accrediting agencies, and government agencies are placing
increased emphasis on the designing of safe medical practices.
The IOM report stresses that most of the medical errors are system related and are
not caused by individual negligence or misconduct.
Sentinel Events
As part of the JC’s mission to improve safety and quality of health care, the
commission has adopted a standard referred to as Sentinel Event Policies and
Procedures.
A sentinel event is defined as an unexpected occurrence involving death or serious
physical or psychological injury, or the risk thereof.
Serious injury specifically includes loss of limb or function. A list of sentinel events
designated by the JC is shown in Box 3-7.
The list is updated periodically as the JC becomes aware of additional events.
Sentinel events must be documented for the JC.
The report must include a root cause analysis and an action plan.
Acceptable root cause analyses identify basic or causal factors that underlie
variation in performance, including the occurrence or possible occurrence of a sentinel
event and focus primarily on systems and processes rather than individual
performance.
A report concerning the event must be prepared for the JC.
It can be sent at the time of the event and must be available for the JC for an
accreditation renewal.
Format for the report includes:
1. The event
2. A root cause analysis of the processes leading to the event
3. An action plan to be taken as a result of the event
As the JC analyzes sentinel event reports, it periodically publishes lists of specific
sentinel event causes to alert the health-care community of areas to evaluate in their
institutions.
A significant number of sentinel events involve incorrect patient identification.
This problem directly affects the phlebotomist and serves to stress again the
importance of this first step in any phlebotomy procedure. Remember that the first
Patient Safety Goal addresses patient identification.
Of equal concern to the phlebotomist should be the improper labeling of samples
delivered to the laboratory and in particular the blood bank, because this can be the
root cause of a hemolytic transfusion reaction.
THANK YOU!