9781284209495_SLID_CH02.ppt

Copyright © 2021 by Jones & Bartlett Learning, LLC, an Ascend Learning Company
Chapter 2: Quality Assurance
and Legal Issues in Healthcare

Objectives
1. Demonstrate basic knowledge of terminology for
national organizations, agencies, and regulations that
support quality assurance in healthcare.
2. Define quality and performance improvement
measurements as they relate to phlebotomy, describe
the components of a quality assurance (QA) program,
and identify areas in phlebotomy subject to quality
control (QC).
3. Demonstrate knowledge of the legal aspects associated
with phlebotomy procedures by defining legal
terminology and describing situations that may have
legal ramifications.

Quality Assurance in Healthcare
• Quality: the degree of excellence of something
• Quality assurance (QA): all the activities and
programs in place to guarantee the excellence of patient
care
• Continuous quality improvement (CQI) program:
system put in place to improve quality by continuous
monitoring and analyzing all processes and identifying
those in need of improvement

National Standard and Regulatory
Agencies
• The Joint Commission (TJC)
– Independent, not-for-profit organization
– Oldest & largest healthcare standards--setting body in the
nation
– Establishes standards for operation of hospitals & other
health-related facilities and services
– Seeks to improve healthcare for public through evaluation
– Focuses on improving safety for patients & residents

Agencies (cont.)
• The Joint Commission (TJC) (cont.)
– Survey Analysis for Evaluating Risk (SAFERTM)
implemented in 2017
• Provide visual representation of survey results
• Help HCOs prioritize and focus corrective actions
• SAFERTM MatrixTM illustrates the likelihood of harm because of
an area of noncompliance
– Office of Quality Monitoring
• Evaluate and track complaints from patients, families, &
employees

Agencies (cont.)
• The Joint Commission (TJC) (cont.)
– Sentinel event (SE) policy
• Helps organizations identify safety issues & prevent them
• If sentinel event occurs, organization is required to:
1. Perform a thorough & credible root-cause analysis
2. Develop appropriate action plan
3. Implement improvements to reduce risk
4. Monitor improvements to determine if they are effective

Agencies (cont.)
• The Joint Commission (TJC)
– National Patient Safety Goals (NPSGs)
• Part of the overall CQI requirements
• Overseen by a safety panel, physicians, nurses, risk
managers, and other healthcare professionals
• Patient Safety Goals for 2018
1. Identify patients correctly
2. Improve staff communication
3. Prevent infection

Agencies (cont.)
• Clinical Laboratory Improvement Amendments of
1988
(CLIA)
– Federal regulations passed by Congress
– Establish quality standards that apply
to all laboratories
– Standards address:
• Quality assurance
• Quality control
• Proficiency testing
• Laboratory records
• Personnel qualifications
Specimen collection is an
important part of CLIA
inspections.
Do the WORKBOOK Case
Study 2-1 exercise to
reinforce your understanding
of CLIA and CLIAC.

Agencies (cont.)
• College of American Pathologists (CAP)
– All members are board-certified pathologists
– Offers proficiency testing & continuous lab inspection
– Designed for pathology/lab services only
– Meets Medicare/Medicaid standards
– TJC grants reciprocity to CAP for
laboratory inspection
The CAP requires
documentation in an
employee’s personnel file to
confirm that the employee is
qualified to perform the
responsibilities for which he
or she is assigned.

Agencies (cont.)
• Clinical and Laboratory Standards Institute (CLSI)
– A global, nonprofit, standards-developing organization
– Has representatives from the profession, industry, & government
– Mission: to develop & promote best practices in clinical & laboratory
testing
– Develops voluntary guidelines & standards for all areas of the
laboratory

Agencies (cont.)
• National Accrediting Agency for Clinical Laboratory
Sciences (NAACLS)
– An authority on educational quality
– An autonomous nonprofit organization
– Provides accreditation & approval of clinical laboratory sciences
educational programs
– Accreditation process involves external peer review of the
program
– Phlebotomy program review designed to improve student
outcomes and maintain quality education

Agencies (cont.)
• International Organization for Standardization (ISO)
– Independent, non-governmental organization
– Develop voluntary international standards across industries
– Offer strategic tools for businesses to ensure quality & reliability of
products
Check out Knowledge Drill 2-4 in the
WORKBOOK. This exercise will help you
summarize the functions of the national
agencies and regulations.

Quality Assurance in Phlebotomy
• QA Processes
– Failure Modes & Effects Analysis (FMEA)
– Six Sigma
– Lean Methodology
– Root-Cause Analysis (RCA)

Quality Assurance in Phlebotomy (cont.)
• Quality Indicators
– Guides to monitor all aspects of patient care
– Must be:
• Measurable
• Well defined
• Objective
• Specific
• Clearly related to an
important aspect of care
See the Microbiology
Quality Assessment
Form: Labeling
Exercise 2-1 in the
WORKBOOK to better
understand quality
indicators.

• Thresholds & Data
– Threshold value: a level of acceptable practice beyond which
quality patient care cannot be assured
– Exceeding threshold should trigger evaluation that collects data
from patient records, laboratory results, incident reports, patient
satisfaction reports, & direct patient observation
– Corrective action preventative action (CAPA) plan may be
established

• Process & Outcomes
– Both process & outcomes must be reviewed to improve
outcome
– Process must be followed from start to finish
– Measurement & evaluation must be standardized
• Quality Control (QC)
– Uses operational checks to ensure procedures are performed
correctly

Areas of Phlebotomy Subject to QA
• Patient Preparation Procedures
• Specimen Collection Procedures
– Patient identification (use of bar codes)
– Puncture devices
– Evacuated tubes
– Labeling
– Technique
– Collection priorities
• Delta Checks

Areas of Phlebotomy Subject to QA (cont.)
Tube, containers, &
slide with bar codes
for patient ID

Documentation
• The Patient’s Record
– A chronologic documentation of medical care given
– Required by law for hospital patients
– Every notation should be legible, precise, & complete
– Purposes
• To aid practice of medicine
• To aid communications between healthcare providers
• To serve as a legal document (may be used in court)
• To help hospital evaluate performance outcomes

Documentation (cont.)
• Test Catalogs and Reference Manuals
– Detail how to prepare the patient to obtain a high-quality sample
– List test, CPT code, type of specimen, amount needed, special
handling requirements, transport temperature, container type, &
causes for specimen rejection
• Procedure Manual
– States policies & procedures for each test/practice
– Must be available to all laboratory employees
– Must be updated at least annually

• Safety Manual
– Contains procedures related to:
• Chemical, electrical, fire, & radiation safety
• Exposure control
• Disaster plans
• Handling hazardous materials
• Infection Prevention and Control Manual
– Handwashing & other decontamination procedures
– Precautions when dealing with patients or handling specimens
– Procedures to implement after exposure incidents

• QA Forms
– Equipment check forms
– Internal (incident) reports
• Identify problem, state consequence, describe correction
• Should state facts, not feelings

Risk Management
• Definition
– Identifying & minimizing risks to patients & employees
– Two ways of managing risk:
• Controlling risk to avoid incidents
• Paying for occurrences after they happen
• Steps
1. Identification of risk
2. Treatment of risk using policies and procedures
3. Education of employees & patients
4. Evaluation of what should be done in the future

Risk Management (cont.)
• Individualized Quality Control Plan (IQCP)
– QC approach tailored to the laboratory’s specific
testing, population, & other unique factors
– Allows labs to use whatever PI tools necessary to
manage risk

Sexual Harassment
• A form of sexual discrimination
• Violation of Title VII of the Civil Rights Act
• Defined: persistent or offensive conduct related to a
person’s sex that negatively affects a reasonable
person’s job
• Not limited by gender or relationship
• Different than workplace harassment called “hostile
work environment”

Legal Issues in Healthcare
A hospital, as an employer, cannot
escape liability for a patient’s
injury simply by subcontracting
out various services to other
persons and claiming it is not
responsible because the party
that caused the injury is not on
its payroll.
• Tort:
– A wrongful act against
person, property,
reputation
– Committed without just
cause, intentional or not
Do Knowledge Drill 2-5 in the
WORKBOOK to better understand
the difference between criminal and
civil actions.

Legal Issues in Healthcare (cont.)
• Tort actions
– Assault
– Battery
– Fraud
– Invasion of privacy
– Malpractice
– Negligence
– Res ipsa loquitur
(obvious negligence)
– Respondeat superior
(employer liability)
– Standard of care
– Statute of limitations
– Vicarious liability

• Malpractice Insurance
– Compensates insured in the event of malpractice liability
– Individual workers are not typically targets of lawsuits
– Workers may be named as codefendants
– Depending on risk, worker may need professional liability policy

• Avoiding Lawsuits
1. Acquire informed consent before collecting specimens
2. Meticulously identify patients & specimens
3. Carefully monitor patient
4. Respect a patient’s right to confidentiality
5. Strictly adhere to accepted procedures & practices
Do Knowledge Drill 2-7 in the
WORKBOOK to remember the ways
to avoid lawsuits.

• Avoiding Lawsuits (cont.)
6. Use proper safety containers & devices
7. Listen & respond appropriately to patient’s request
8. Accurately & legibly record all patient info
9. Document incidents or occurrences
10. Participate in continuing education to maintain proficiency
11. Perform at prevailing standard of care
12. Never perform procedures you are not trained to do

• Informed Consent
– Requires voluntary & competent permission
– Requires adequate information given to patient
– Nontechnical terms
– Obtained before procedure

• Expressed Consent
– Should be specific & cover all procedures to be performed
– Verbal: should be followed by entry in patient’s chart
– Written
• Gives best possible protection
• Must be signed by provider & patient
• Must be witnessed by third party

• Implied Consent
– Patient’s actions imply consent
– May be necessary in emergencies
– Laws vary from state to state
• HIV Consent
– Most states have legislation for consent for HIV tests
– Client must be advised on:
• Test & its purpose
• How test will be used
• Meaning of test & its limitations
When you have finished
reading this section, do
Matching Exercise 2-2 in the
WORKBOOK to reinforce
your understanding of the
different types of consent.

• Consent for Minors
– Minors cannot give consent for medical treatment
– Parental or guardian consent is required
– Personnel who violate this rule are liable for assault & battery
• Refusal of Consent
– Patient has constitutional right to refuse medical procedure
– Refusal may be based on religious or personal beliefs
– Refusal usually must be verified in writing

• Litigation Process
– Phase 1: Patient incident occurs or injury is recognized
– Phase 2
• Injured party consults attorney
• Attorney requests medical records, takes case
• Negotiations for settlement
• If no settlement, complaint is filed
• Discovery: taking depositions & interrogating witnesses
– Phase 3: Trial
– Phase 4: Appeal

NAACLS Entry-Level Competencies Met in
This Chapter
• 4.1 Describe the legal and ethical importance of proper
patient/sample identification.
• 8.1 Describe quality assurance in the collection of blood
specimens.
• 8.2 Identify policies and procedures used in the clinical
laboratory to assure quality in the obtaining of blood
specimens.
• 9.8 Define and use medicolegal terms and discuss
policies and protocol designed to avoid medicolegal
problems.

Questions?

9781284209495_SLID_CH02.ppt

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