1. QUALITY ASSURANCE AND LEGAL ISSUES
Chapter 2
QUALITY ASSURANCE AND LEGAL ISSUES

2. OBJECTIVES
Define the key terms and abbreviations listed at the beginning of this chapter
Identify national organizations, agencies, and regulations that support quality assurance in healthcare
Define quality and performance improvement measurements as they relate to phlebotomy
List and describe the components of a quality assurance (QA) program and identify areas in phlebotomy subject to QC
List areas in phlebotomy subject to QC and identify quality control procedures associated with each
Demonstrate knowledge of the legal aspects associated with phlebotomy procedures by defining legal terminology and describing situations that may have legal ramifications

3. Quality Assurance in Healthcare
Healthcare institutions search for ways to guarantee quality patient care by identifying and minimizing situations that pose risks to patients and employees
Guidelines are developed for all processes used, all personnel involved, and when formally adopted, they become the institution’s quality improvement (QI) program
One of the ways to improve quality is through compliance with/use of national standards and regulations

4. National Standards and Regulatory Agencies
QI is enforced through standards and regulations from the following agencies:
Joint Commission on Accreditation of Healthcare Organizations (JCAHO)
College of American Pathologists (CAP)
Clinical Laboratory Improvement Amendments (CLIA)
Clinical and Laboratory Standards Institute (CLSI)
National Accrediting Agency for Clinical Laboratory Sciences (NAACLS)

5. Quality Improvement Initiated by JCAHO
To standardize measurements of performance nationally
Expectations
To demonstrate the ability to collect dependable data
To conduct reliable analyses of the data
To initiate appropriate system and process improvements

6. Quality Improvement (cont’d)
Hospital core measurements
Identified ways to measure performance that support the objectives of the organization’s CQI
Examples
Heart attack
Community-acquired pneumonia
Pregnancy and related conditions
Heart failure

7. Quality Improvement (cont’d)
Measures quality & timeliness of phlebotomy
Community-acquired pneumonia
Blood culture collection before giving antibiotics
How collection, processing, and reporting affect the outcome
Heart attack
Time intervals between collection of specimens
Treatment based on the results of the test

8. Patient Safety and Sentinel Events
A sentinel event is one that signals the need for immediate investigation and response
Includes any unfavorable event that is unexpected and results in death or serious physical or psychologic injury, or any deviation from practice that increases the chance that an undesirable outcome might recur
If a sentinel event occurs, the healthcare organization is required to
Perform a thorough and credible analysis of the root cause
Put improvements to reduce risk into practice
Monitor improvements to determine if they are effective

9. Quality Assurance in Phlebotomy
QA Defined
A program that guarantees quality patient care by tracking outcomes
QA Indicators
Measurable, well-defined, specific, objective, and clearly related to important aspects of care
Threshold and Data
A level of acceptable practice beyond which quality patient care cannot be ensured
Process and Outcomes
To improve an outcome, the process needs to be reviewed

10. Areas in Phlebotomy Subject to QC
QC is a component of a QI program and a form of procedure control
Patient preparation procedures
Specimen collections procedures
Identification
Equipment
Technique
Collection priorities
Delta checks
Documentation
Collection manuals
Procedure, safety, and infection control manuals
QA forms, equipment check forms, internal reports
Risk management

11. Legal Issues
As healthcare providers go about their daily activities, there are many practices that if performed without reasonable care and skill could result in a lawsuit
It has been proven in past lawsuits that persons performing phlebotomy can and will be held legally accountable for their actions
Although most legal actions against healthcare workers are civil actions in which the alleged injured party sues for monetary damages, willful actions by healthcare workers with the intent to produce harm or death can result in criminal charges

12. Legal Issues (cont’d) Divisions of law Criminal law
Involves crimes against the state
Civil actions
Involve crimes against a person

13. Civil Actions
Actions between two private parties, ex. individuals, corporations, or organizations
Tort action
Civil wrong committed against a person or property
Damages may be awarded in court of law
May be willful or accidental

14. Tort Actions Assault Battery Fraud Invasion of privacy
Breach of confidentiality
Malpractice
Negligence
Res ipsa loquitur
Respondeat superior
Vicarious liability

15. Criminal Law
Designed to protect all members of society from injurious acts by others
Criminal acts
Felonies—crimes punishable by death or imprisonment
Misdemeanors—considered lesser offenses, carrying a fine or less than 1 year in jail

16. Tort Actions Breach of confidentiality
Failure to keep medical information confidential
Negligence
Doing something that a reasonable person would not do or not doing something that a reasonable person would do

17. Tort Actions (cont’d) Malpractice
A type of negligence committed by a professional
A term associated with any professional misconduct
A claim implies that a greater standard of care was owed to injured person

18. Legal Terms Standard of care
Established standards by profession and expectations of society
Respondeat superior
“Let the master respond,” which means employers are liable for the actions of employees
Statute of limitations
All malpractice actions have a limited length of time for filing a lawsuit

19. Legal Terms (cont’d) Vicarious liability
Healthcare facility that hired the person is liable for any negligent act committed by that person
Malpractice insurance
Personal insurance to protect against civil actions
Avoiding lawsuits

20. Patient Consent Informed consent Expressed consent Implied consent
HIV consent
Consent of minors
Refusal of consent

21. Risk Management Definition of risk The chance of loss or injury
Definition of risk management
An internal process focused on identifying and minimizing situations that pose risk to patients and employees

22. The Litigation Process
Phase 1—Incident occurs
Phase 2—Consultation with attorney
Plaintiff
Defendant
Discovery
Deposition
Phase 3—The trial
Phase 4—Appeal

23. Risk Management (cont’d)
Steps in managing risk
Identification of the risk
Treatment of the risk
Education of employees and patients
Evaluation of what should be done in the future

24. Patient Safety and Sentinel Events
Definition of sentinel event
One that signals the need for immediate investigation and response
Required procedure to follow
Analysis of root cause
Improvements to reduce risk
Monitoring improvements to see if effective

25. Legal Cases A negligence case settled through binding arbitration
Jones vs. Rapids General Hospital
Congelton vs. Baton Rouge General Hospital
Montgomery vs. Opelousas General Hospital
Martin vs. Wentworth Douglass Hospital