Assault
An act or threat causing another to be in fear of immediate battery.
Battery
Intentional harmful or offensive touching or use of force on a person without consent or legal justification.
Breach of Confidentiality
Failure to keep privileged medical information private.
Civil Actions
Legal actions in which the alleged injured party sues for monetary damages.
Center for Medicare and Medicaid Services
What is CMS?
Competencies
Educational standards for phlebotomy programs.
Defendant
In a lawsuit, a person against whom the complaint is filed.
Delta Check
Comparison of current results of a lab test with previous results for the same test on the same patient.
Deposition
A process in which one party questions another under oath while a court reporter records every word.
Discovery
Formal process in litigation that involves taking depositions and interrogating parties involved.
Due Care
The level of care that a person of ordinary intelligence and good sense would exercise under the given circumstances.
Fraud
Deceitful practice or false portrayal of facts by either words or conduct.
Good Laboratory Practices.
1. Keep Manufacture's instructions
2. follow instructions for collection & handling
3. properly identify patient
4. label specimen with unique identifier
5. inform patient of test prep
6. read product insert to achieve optimal r
What are GLP's? Examples?
Informed Consent
Implies voluntary and competent permission for a medical procedure, test, or medication.
Invasion of Privacy
Violation of one's right to be left alone.
Malpractice
A type of negligence committed by a professional.
Negligence
Failure to exercise due care.
Plaintiff
Injured party in the litigation process.
QA - Quality Assurance
Program that guarantees quality patient care by tracking outcomes
QC - Quality Control
System of checks and controls to ensure consistency
QI - Quality Improvement
Develops guidelines for all processes used and all personnel involved. Continuous self-review to identify aspects of the system that require improvement to ensure that the public receives the highest quality prehospital care.
QSE - Quality System Essentials
12 fundamental components used to develop a quality management process. Written and monitored.
Quality Indicators
Guides used as monitors of all areas of patient care - MEASURABLE, well defined, objective, specific and clearly related.
Respondeat Superior
Latin phrase meaning "Let the master respond". In other words, employers must answer for damages their employees cause within the scope of their practice.
Standard of Care
The normal level of skill and care that a healthcare practitioner would be expected to practice to provide due care for patients.
Statute of Limitations
A law setting a length of time after an alleged injury in which the injured person is permitted to file a lawsuit.
Threshold Values
The level of acceptable practice beyond which quality patient care cannot be assured - (like 3% error rate (lab must stay under or face actions)
Tort
A wrongful act, other than breach of contract, committed against ones person, property, reputation, or other legally protected right.
Vicarious Liability
Liability imposed by law on one person for acts committed by another. Temporary/Contract Hire.
Joint Commission on Accreditation of Healthcare Organizations. Oldest and largest health care standards-setting body in the nation.
What is JCAHO?
College of American Pathologists
Specific to lab/phleb only
What is CAP?
American Society for Clinical Pathology - CAP is outgrowth of this organization
What is ASCP?
Clinical Laboratory Improvement Amendments of 1988
- Administered by CMS
- sets regulations that establish quality standards for all laboratories of any size
What is CLIA '88?
Clinical and Laboratory Standards Institute-sets the standards for ALL laboratories and procedures. Formerly NCCLS.
What is CLSI?
Certificate of Waiver (COW Lab)-simple, low risk of error, urinalysis
2) Moderate-provider performed microscopy
3) High Complexity-blood bank, genetics
What are the 3 Categories (types) of Labs?
National Accrediting Agency for Clinical Laboratory Sciences.
Provides accreditation or approval for lab education programs.
What is NAACLS?
Sentinel Event
Early Warning - signals the need for immediate investigation and response
before analysis - patient prep, collection procedures, specimen handling (most fall under phlebotomist responsibility, except patient prep; can't guarantee what the patient does)
What is the pre-analytical phase of lab testing?
during the test - falls under laboratory technician
What is the analytical phase of lab testing?
most often is a clerical error in recording or reporting of results
What is post-analytical phase of lab testing?
Specimen Collection Manual
Details how to prep patient and collect a high-quality sample.
Specimen Collection Procedures
-IDENTIFICATION of Patient (MOST IMPORTANT!)
-Equipment: Puncture Devices, Evacuated Tubes,
-Labeling
-Technique
- Collection Priorities
- Delta Checks
Medical Record / Chart
Chronologic Documentation of Patient Care: must be legible, use standard abbreviations and can be used as a legal document
Communication between physicians and others involved in care
Procedure Manual
Explains ALL policies & procedures that apply to ALL lab tests
Contains: Purpose, policy, method, equipment/supplies, step by step, limitations or variables, corrective actions, validation, normal values, review/revision dates, approvals
Safety Manual
Explains guidelines for safety, chemical, electrical, fire and radiation procedures.
Infection Control Manual
Guidelines for precautions to take when dealing with patient or specimens to avoid contamination or exposure
(e.g., handwashing)
Risk
Chance of loss or injury.
Risk Management
Internal process focused on identifying and minimizing risk.
Generic Steps: identification, treatment, education, future plan.
Res ipsa Loquitur
the thing speaks for itself"
Breach of duty so obvious it does not need further explanation.
1. day act committed
2. when injury was discovered
3. day of last medical treatment in a series
4. when an injured minor reaches the "age of majority
Statute of Limitations: 4 Dates when it can start
Expressed Consent
Consent required for high risk procedures, surgeries and experimental drugs.. usually in writing.
Implied Consent
Patient's actions imply consent - extending arm out for draw
HIV Consent
informed consent with info about test purpose, use, meaning and limitations (rules set by each state)
Consent for Minors
Under the Age of Majority as specified by that state. Violation constitutes a liability of assault and battery.
Refusal of Consent
patient has the right to refuse anything. must be noted in chart and if possible have a waiver signed by patient
1) When alleged incident occurs
2) Consult an attorney (attempt settlement)
3) Trial phase (damages awarded)
4) Appeal (usually by losing party)
Four Phases of Litigation
Equipment Check Forms
Forms used to record equipment checks on tube additives, vacuum strength, and expiration dates (for verification of new lot numbers). Refrigerator temperatures, which must be recorded daily, are often the responsibility of the phlebotomist. Control checks
What are some Internal Reports?
Examples include:
-Near Miss/Occurence Report (errors made)
-Incident Reports (e.g., wrong test collected/ run, patient falls. ID problem, state consequences, and describe corrective action.)
-Performance Improvement Plans may be needed to correct frequen