QUALITY ASSURANCE AND LEGAL ISSUES Chapter 2 QUALITY ASSURANCE AND LEGAL ISSUES

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

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

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)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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