Quality Assurance and Legal Issues in the Lab

Flashcards covering Quality Assurance, Legal Issues, and Documentation in clinical laboratory settings, including TQM, CQI, CLIA, various legal concepts, and patient consent.

Who was the leader associated with Total Quality Management (TQM) and the use of statistics to analyze production processes?

Dr. Edwards Deming

What organization brought Deming’s idea of Total Quality Management to healthcare, emphasizing Continuous Quality Improvement (CQI)?

Joint Commission on Accreditation of Healthcare Organizations (JCAHO)

What is the role of the Joint Commission on Accreditation of Healthcare Organizations (JCAHO)?

It is a nongovernmental agency that regulates hospitals and other health-related facilities and services.

Which organization ensures quality in pathology and laboratory services through proficiency testing and continuous lab inspections, also meeting Medicare/Medicaid standards?

College of American Pathologists (CAP)

What federal regulations, passed by Congress in 1988, establish quality standards for all laboratories?

Clinical Laboratory Improvement Amendments (CLIA) of 1988

What are two of the five key areas addressed by CLIA quality standards for laboratories?

Quality control and quality assurance (other answers include proficiency testing, laboratory records, personnel qualifications)

What are the three categories of testing recognized by CLIA?

Waived, Moderate (includes provider-performed microscopy), and High complexity

Which category of CLIA testing is defined as simple with a low risk of error?

Waived

What global nonprofit organization develops and promotes best practices, voluntary guidelines, and standards for all areas of clinical and laboratory testing?

Clinical and Laboratory Standards Institute (CLSI)

What agency accredits laboratory programs in community colleges, private colleges, and universities through external peer review and on-site evaluation?

National Accrediting Agency for Clinical Laboratory Sciences (NAACLS)

What is required of all departments in healthcare regarding Continuous Quality Improvement (CQI) or Quality Assurance?

Ongoing evaluations of their activities, plan of actions, and corrective actions

What are the two components of 'Doing the Right Thing' in the dimensions of performance?

The efficacy of the procedure or treatment in relation to the patient’s condition, and the appropriateness of a specific test, procedure, or service to meet the patient’s needs.

What is the definition of Quality Assurance (QA) in phlebotomy?

A program that guarantees quality patient care by tracking outcomes through scheduled reviews of elements of patient care.

What are three elements of patient care tracked by a Quality Assurance (QA) program in phlebotomy?

Patient preparation, specimen collection, and patient identification.

What characteristics must QA Indicators possess?

Measurable, well-defined, objective, specific, and clearly related to an important aspect of care

What are the 12 fundamental components identified by CLSI used to develop a quality management process, applicable to simple or complex operations?

Quality System Essentials (QSEs)

What are the three processes of the 'path of workflow' for Quality System Essentials (QSEs)?

Pre-analytical, Analytical, and Post-analytical

What are three important pre-analytical factors that phlebotomists must consider?

Patient identification, patient preparation, and specimen collection procedures.

What is the main focus of quality in patient care?

Quality Patient Care

What is a 'threshold' in the context of quality assurance?

A predetermined level of practice, such as a maximum acceptable post-op infection rate or hematoma rate after a venipuncture.

What should exceeding a quality indicator threshold trigger?

An investigation, which may lead to a corrective action plan.

What are examples of data used for quality improvement efforts?

Patient satisfaction reports, observing patients or employees, laboratory results, log books, incident reports, and patient records.

Both process and outcome must be reviewed to improve what aspect of patient care?

Quality of patient care

What are two areas of phlebotomy subject to Quality Assurance (QA)?

Patient preparation and specimen collection procedures.

What is the purpose of documenting a patient's record?

To aid the practice of medicine, aid communications between healthcare providers, serve as a legal document, and help the hospital evaluate performance outcomes.

What details are typically found in a Nursing Services Manual/Specimen Collection Manual?

Type and minimum amount of specimen needed, special handling required, reference values for tests, days testing is available, and normal laboratory values.

How often must the Laboratory Procedure Manual be updated?

At least annually

What should an internal (incident) report identify, state, and describe?

The problem, the consequence, and the action taken.

Quality Control (QC) is a component of which larger program?

The QA (Quality Assurance) program

How frequently must QC be performed on a glucometer before performing a patient's specimen?

Every 24 hours

What built-in controls are common in kits like Quick Strep kits, pregnancy tests, and occult blood tests?

Positive and negative controls

What are two critical aspects of evacuated tubes that must be checked for quality control?

Adequate vacuum and adequate additive

What quality control procedure compares current laboratory test results with previous results for the same test on the same patient?

Delta Checks

What is mandatory to maintain proficiency and consistency in the laboratory field, especially for re-certification with organizations like ASCP?

Continuing Education

What is the crucial phrase regarding documentation in healthcare?

If you didn't write it down, you didn't do it.

What are the two main areas of law?

Criminal Law and Civil Law

What area of law addresses the need to investigate crimes, prosecute defendants, and hold offenders accountable?

Criminal Law

What distinguishes a misdemeanor from a felony?

A misdemeanor is usually a crime carrying less than one year of jail time, whereas a felony is a more serious crime punishable by imprisonment longer than a year.

What area of law addresses situations where people have been harmed, and an economic award might remedy the situation, protecting individual rights?

Civil Law

What legal concept defines a civil wrong that results in an injury or harm constituting the basis for a claim by the injured party?

Tort

What are the three general categories of Tort?

Intentional torts, negligent torts, and strict liability torts.

What is the difference between assault and battery?

Battery occurs when the victim has been actually touched, while assault occurs when the victim has been threatened but not touched.

With what crimes can a phlebotomist be charged if they attempt to collect a blood specimen without the patient’s consent?

Assault and battery

What is an example of fraud in a healthcare setting?

Billing for services that were not rendered.

What act involves invasion of privacy and may give rise to damages for embarrassment, mental suffering, and trespass, such as entering a patient’s room without knocking?

Intrusion upon seclusion

What type of civil wrong involves doing something or failing to do something that a reasonable person would or would not do in the same situation, resulting in harm?

Negligence

What are the three requirements for a legal claim of negligence?

A legal duty owed by one person to another, a breach of that duty, and harm done as a direct result of the action.

What term describes negligent conduct that causes damage in the medical field?

Medical Malpractice

What legal principle states that employers are liable for the actions of their employees, even if the employee is at fault?

Respondeat superior

What legal concept imposes responsibility for an injury on someone who did not directly cause it, often applying to employers for employee actions?

Vicarious liability

What term refers to the period from when an injury occurs or is discovered to the final date a lawsuit can be filed?

Statute of limitations

What are two ways healthcare professionals can avoid lawsuits?

Acquire informed consent before specimen collection and respect patient's right to confidentiality.

What is required for voluntary and competent permission for a medical procedure, test, or medication, involving providing the patient with information about methods, risks, and consequences?

Informed Consent

What type of consent is required for treatments involving surgery, experimental drugs, or high-risk procedures, and may be given verbally or in writing?

Expressed Consent

What type of consent is given when a patient who is unable to give direct consent receives treatment under the legal assumption they would want it, such as in emergency situations?

Implied Consent

What is the age of majority determined by, and what is required for minors to receive medical consent?

State law; parental or legal guardian consent is needed.

What is the first step in the litigation process?

Injured party consults attorney

What is a process focused on identifying and minimizing situations that pose risk to patients and employees?

Risk Management

What form of sex discrimination, violating Title VII of the Civil Rights Act of 1964, involves unwelcome conduct of a sexual nature that can create a hostile work environment?

Sexual Harassment