Quality Assurance and
Legal Issues in Healthcare
• 1988-introduction of quality improvement
– QI reduces waste
– Leads to improved productivity
– Leads to reducing costs
• Joint Commission on Accreditation Healthcare Organizations (JAHCO)
– Voluntary, nongovernmental agency
– Establishes standards for the operation of hospitals and other healt6h-related facilities
and services
Quality Assurance and
Legal Issues in Healthcare
• Clinical Laboratory Improvement Amendments of 1988 (CLIA)
– Federal regulations administered by the Center for Medicare and Medicaid Services
(CMS)
– Established quality standards that apply to all facilities, including clinics and physicians
offices that do laboratory testing
– Three categories of testing based on difficulty and degree of risk of harm to patient if
test is performed incorrectly
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Waived complexity
Moderate complexity
High complexity
• National Committee for Clinical Laboratory Standards
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International , nonprofit, educational organization
Representatives from the profession, industry, and government
Develop voluntary guidelines and standards for all areas of the laboratory
Phlebotomy program approval and certifications exam questions based on guidelins and
standards
Quality Assurance and
Legal Issues in Healthcare
• National Accrediting Agency for Clinical Laboratory Sciences (NAACLS)
– Non profit
– Provides either accreditation or approval for clinical lab education programs
– Approval process includes:
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On site peer evaluation
Whether the program meets certain educational standards (competencies)
Designed to improve student outcomes
Maintain quality educational experience
• Quality Assurance in Phlebotomy
– Pre-analytical factors can result in errors in testing
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Patient preparation
Specimen collection procedures
Specimen handling procedures
Quality Assurance and
Legal Issues in Healthcare
• Quality Control in Phlebotomy
– A component of QA program
– Phlebotomist responsibility to check that all operations procedures are performed
correctly
Areas of Phlebotomy Subject to QC
• Patient Preparation Procedures
– Starts before specimen collected
– Check user manual to prepare a patient
• Specimen Collection Procedures
– Patient ID most important
– Assure quality and sterility of every needle and lancet. Quickly inspect
before use.
– Check expiration dates on each tube before use
– Labeling must be exact
– Proper phlebotomy technique using national standards
– Know collection priorities such as timed specimens
– Perform delta checks
Documentation
• Medical records
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A chronological documentation of a patient’s care
Must be accurate and up-to-date
Used by physician to develop patient care plan
Can be used to communicate between other HCP involved with
patient’s care
– May serve as a legal document
– Assists with total quality management
Documentation
• The User Manual
– A QA document found in nursing units
– A chart form of type and minimum amount of specimen required
– Includes: special handling, reference values, and normal turnaround time (TAT)
• Procedure Manual
– Must be available to all lab employees for standardization purposes
– States lab policy and procedures that apply to each test
– Information in Procedure Manual
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Purpose of procedure
Specimen type and collection method
Equipment & supplies required
Detailed step-by-step procedure
Limitations and variable of the method
Corrective actions
Method validation
Normal values and references
Documentation
• QA Forms
– Required by JCAHO to show documentation on all QC checks
– Record equipment checks such as refrigerator, incubator temps, centrifuge
– Incident reports when problems occur
Legal Issues
• Divisions of the Law
– Criminal Law
• Designed to protect all members of society from injurious acts of others
• Either felonies or misdemeanors
– Civil Law
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Action between two private parties
Torts most common in healthcare
Assault
Battery
Fraud
Invasion of privacy
Breach of confidentiality
Negligence
Malpractice
Malpractice
• Associated with any professional misconduct
• Must use standard of care
– Have a duty to protect patients from harm
– All healthcare professionals perform duties in any other reasonable person
with same experience and training
• Respondeat superior
– Employers are liable for actions of employees even if the employee is at fault
• Vicarious liability
– Injury occurs as result of a negligent act committed by an independent
contractor, the hiring healthcare facility that hired the person is liable
• Malpractice Insurance
– Necessary if employer may give insurance company right to recover damages
from an employee who is found to be negligent
Avoiding Lawsuits
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Acquire informed consent
Respect patient’s right to confidentiality
Strictly adhere to procedures and practices
Use proper safety containers and devices
Listen and respond appropriately to patient’s request
Accurately & legibly record all info concerning patient
Document incidents
Participate in continuing education
Perform at standard of care
Never perform procedures that you are not trained to do
Patient Consent
• Informed consent
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Voluntary permission for a procedure, test, or medication
Must tell patients all risks and consequences involved before consent given
Information must be in terms patient understands
Interpreters may be needed
Blood collection on minors or mentally incompetent requires parent/guardian
consent
• Expressed consent
– May be given verbally or in writing