Objectives
1. Define the key terms and abbreviations listed at the
beginning of this chapter.
2. Identify national organizations, agencies, and
regulations that support quality assurance in healthcare.
Chapter 2: Quality Assurance 3. Define quality and performance improvement
and Legal Issues measurements as they relate to phlebotomy.
4. List and describe the components of a quality assurance
(QA) program and identify areas in phlebotomy subject
to quality control (QC).
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National Standard and Regulatory
Objectives (cont’d) Agencies
5. List areas in phlebotomy subject to QC and identify QC • The Joint Commission
procedures associated with each.
– Voluntary, nongovernmental agency
6. Demonstrate knowledge of the legal aspects associated – Oldest & largest healthcare standards-setting body in
with phlebotomy procedures by defining legal nation
terminology and describing situations that may have
legal ramifications. – 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
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National Standard and Regulatory National Standard and Regulatory
Agencies (cont’d) Agencies (cont’d)
• The Joint Commission • The Joint Commission
– New Accreditation Measurements implemented in 2009 – Sentinel event policy
– Using the following program-specific screening criteria • Helps organizations identify safety issues & prevent them
• Direct Impact Standards Requirement • If sentinel event occurs, organization is required to:
• Indirect Impact Standards Requirement 1. Perform a thorough & credible analysis of root cause
• Situational Decision Rules 2. Put improvements to reduce risk into practice
• Immediate Threat to Health and Safety 3. Monitor improvements to determine if they are effective
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National Standard and Regulatory National Standard and Regulatory
Agencies (cont’d) Agencies (cont’d)
• The Joint Commission • College of American Pathologists (CAP)
– National Patient Safety Goals (NPSGs) – All members are board-certified pathologists
• Part of the overall CQI requirements – Offers proficiency testing & continuous lab inspection
• Overseen by a safety panel, physicians, nurses, risk – Designed for pathology/lab services only
managers, and other healthcare professionals
– Meets Medicare/Medicaid standards
• Patient Safety Goals for 2010
• Identify patients correctly
• Improve staff communication
• Prevent infection
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National Standard and Regulatory National Standard and Regulatory
Agencies (cont’d) Agencies (cont’d)
• Clinical Laboratory Improvement Amendments of 1988 • Clinical and Laboratory Standards Institute (CLSI)
• (CLIA ‘88) – A global, nonprofit, standards-developing organization
– Federal regulations passed by Congress – Has representatives from the profession, industry, & government
– Establish quality standards that apply to all laboratories – Mission: to develop & promote best practices in clinical &
laboratory testing
– Standards address:
– Develops voluntary guidelines & standards for all areas of the
• Quality assurance laboratory
• Quality control
• Proficiency testing
• Laboratory records
• Personnel qualifications
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National Standard and Regulatory
Agencies (cont’d) Quality Assurance in Phlebotomy
• National Accrediting Agency for Clinical Laboratory • Definition of Quality Assurance (QA)
Sciences (NAACLS) – A program that guarantees quality patient care by tracking
– An authority on educational quality outcomes through scheduled reviews of the following elements of
patient care:
– An autonomous nonprofit organization
• Appropriateness
– Provides accreditation & approval of clinical laboratory sciences
educational programs • Applicability
– Accreditation process involves external peer review of the • Timeliness
program
– Phlebotomy program review designed to improve student
outcomes and maintain quality education
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Quality Assurance in Phlebotomy (cont’d) Quality Assurance in Phlebotomy (cont’d)
• QA Indicators • Quality System Essentials (QSEs)
– Guides to monitor all aspects of patient care – 12 fundamental components identified by CLSI
– Must be: – Used to develop a quality management process
– Are universal: can be applied to simple or complex operations
• Measurable
– Require processes, policies, & procedures be written & monitored
• Well-defined
– Three processes of “path of workflow”:
• Objective
1. Preanalytical
• Specific
2. Analytical
• Clearly related to an important aspect of care
3. Postanalytical
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Quality Assurance in Phlebotomy (cont’d) Quality Assurance in Phlebotomy (cont’d)
• Threshold Value • Process and Outcomes
– A level of acceptable practice beyond which quality patient care – Both process & outcomes must be reviewed to improve outcome
cannot be assured
– Process must be followed from start to finish
– Must be established for all quality indicators
– Measurement & evaluation must be standardized
– Exceeding threshold should trigger evaluation
• Quality Control (QC)
– Corrective action plan may be established
– Component of a QA program & a form of procedure control
– Uses operational checks to ensure procedures are performed
correctly
– Quality results when standards are met all of the time
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Areas of Phlebotomy Subject to QA
Areas of Phlebotomy Subject to QA (cont’d)
• Patient Preparation Procedures • Tube, containers, & slide with bar codes for patient ID
• Specimen Collection Procedures
– Patient identification (use of bar codes) Video: Proper
identification
– Equipment
• Puncture devices
• Evacuated tubes
• Labeling
– Technique
– Collection priorities
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Documentation Documentation (cont’d)
• The Patient’s Record • QA Documents for Blood Collectors
– A chronologic documentation of medical care given – Nursing Services Manual/Specimen Collection Manual
– Required by law for hospital patients • Detail how to prepare patient & special collection instructions
– Every notation should be legible, precise, & complete – Contain in chart form:
– Purposes • Type & minimum amount of specimen needed
• To aid practice of medicine • Special handling required
• To aid communications between healthcare providers • Reference values for test
• To serve as a legal document (may be used in court) • Days testing is available
• To help hospital evaluate performance outcomes • Normal turnaround time
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Documentation (cont’d) Documentation (cont’d)
• Laboratory Procedure Manual Infection Control Procedure Manual
• Most effective way to break the chain of infection: HANDWASHING!!!
– States policies & procedures for each test/practice
– Hand washing & other decontamination procedures
– Must be available to all laboratory employees
– Precautions when dealing with patients or handling specimens
– Must be updated at least annually
– Procedures to implement after exposure incidents
• Safety Manual • QA Forms
– Contains procedures related to: – Equipment check forms
• Chemical, electrical, fire, & radiation safety – Internal (incident) reports
• Identify problem, state consequence, describe correction
• Exposure control
• Should state facts, not feelings
• Disaster plans
• Handling hazardous materials
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Risk Management Legal Issues
• Definition • Tort: Definition – Invasion of privacy
– Identifying & minimizing risks to patients & employees – A wrongful act against – Breach of confidentiality
person, property, – Malpractice
– Two ways of managing risk: reputation
• Controlling risk to avoid incidents – Negligence
– Committed without just
• Paying for occurrences after they happen cause, intentional or not – Res ipsa loquitur
• Tort: Types – Respondeat superior
• Steps
– Assault – Standard of care
1. Identification of risk
– Battery – Statute of limitations
2. Treatment of risk
– Fraud – Vicarious liability
3. Education of employees & patients
4. Evaluation of what should be done in future
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Legal Issues (cont’d) Legal Issues (cont’d)
• Malpractice Insurance • Avoiding Lawsuits
– Compensates insured in event of malpractice liability 1. Acquire informed consent before collecting specimens
– Individual workers are not typically targets of lawsuits 2. Respect a patient’s right to confidentiality
– Workers may be named as codefendants, though
3. Strictly adhere to accepted procedures & practices
– Depending on risk, worker may need professional liability policy
4. Use proper safety containers & devices
5. Listen & respond appropriately to patient’s request
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Legal Issues (cont’d) Legal Issues (cont’d)
• Avoiding Lawsuits • Informed Consent
6. Accurately & legibly record all patient info – Implies voluntary & competent permission
7. Document incidents or occurrences – Requires adequate information given to patient
– Nontechnical terms
8. Participate in continuing education to maintain proficiency
– Obtained before procedure
9. Perform at prevailing standard of care
10.Never perform procedures you are not trained to do
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Legal Issues (cont’d) Legal Issues (cont’d)
• Expressed Consent • Implied Consent
– Should be specific & cover all procedures to be performed – Patient’s actions imply consent
– Verbal: should be followed by entry in patient’s chart – May be necessary in emergencies
– Written – Laws vary from state to state
• Gives best possible protection • HIV Consent
• Must be signed by provider & patient – Most states have legislation for consent for HIV tests
• Must be witnessed by 3rd party – Client must be advised on:
• Test & its purpose
• How test will be used
• Meaning of test & its limitations
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Legal Issues (cont’d) Legal Issues (cont’d)
• Consent for Minors • Litigation Process
– Minor cannot give consent for medical treatment – Phase 1: Patient incident occurs or injury is recognized
– Parental or guardian consent is required – Phase 2
– Personnel who violate this rule are liable for assault & battery • Injured party consults attorney
• Refusal of Consent • Attorney requests medical records, takes case
– Patient has constitutional right to refuse medical procedure • Negotiations for settlement
– Refusal may be based on religious or personal beliefs • If no settlement, complaint is filed
– Refusal usually must be verified in writing • Discovery: taking depositions & interrogating witnesses
– Phase 3: Trial
– Phase 4: Appeal
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Legal Issues (cont) Test Info Chapter 2: Quality Assurance & Legal Issues
• Tort: Wrongful act other than breach of contract committed against • What department coordinates with lab for TDM?
someones person, property, reputation or other legally protected right. • Know: HIPAA, OSHA, CLIA ‘88, CLSI, CAP, NAACLS, Joint Commission, NPSGs
• Assault: Act or threat causing another to be in fear of immediate battery • Legal Issues: assault, battery, invasion of privacy, breach of confidentiality, tort, fraud
(harmful touching) etc.
• Battery: Intentional harmful or offensive touching of, or use of force on, • Difference between implied and informed consent
another person without consent or legal justification. • Good Samaritan Law
• Invasion of Privacy: The violation of one’s right to be left alone • Quality assurance, quality indicators, delta check, importance of documentation,
outcomes, threshold values, risk management
• Breach of confidentiality: Failure to keep privileged medical information
private • Manuals: safety, collection, procedure
• There will also be situation questions
• Negligence: The failure to exercise due care, the level of care that a person
of ordinary intelligence and good sense would exercise under given • Know your study questions
circumstances. What a reasonable person would or would not do.
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