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Healthcare Quality Assurance and Legal Issues

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What is the goal of quality assurance in healthcare?

To improve performance and guarantee quality patient care by identifying and minimizing situations that pose risk to patients and employees.

What is the purpose of protocols in healthcare?

To identify and minimize situations that pose risk to patients and employees.

What is The Joint Commission (TJC)?

An independent, non-profit organization that establishes standards for the operation of hospitals and other health-related facilities and services.

What is the purpose of the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88)?

To establish quality standards that apply to all facilities, including clinics and physicians’ office laboratories, that test human specimens.

Who administers the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88)?

The Centers for Medicare and Medicaid Services (CMS).

What do the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) standards address?

Quality assurance, quality control, proficiency testing, laboratory records, and personnel qualifications.

What is the aim of the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) standards?

To ensure the accuracy, consistency, and reliability of patient test results regardless of the location, type or size of the laboratory.

What is the purpose of continuous quality improvement (CQI) programs?

To continuously improve performance and guarantee quality patient care.

What is the purpose of the Clinical Laboratory Improvement Advisory Committee (CLIAC)?

to provide technical and scientific advice and guidance to the CMS

What are the three categories of testing recognized under CLIA '88 regulations?

waived, moderate, and high complexity

What is the name of the educational tool developed by CLIAC for CoW laboratories?

Good Laboratory Practices (GLPs)

What is the main goal of a Quality Assurance (QA) program?

to prevent problems in the future by evaluating present and past performance

What is the relationship between Quality Control (QC) and Quality Assurance (QA)?

QC is a component of a QA program

What stage of laboratory testing is the focus of quality assessment in phlebotomy?

preanalytical stage

What is the name of the organization that develops voluntary guidelines and standards for laboratory testing?

Clinical and Laboratory Standards Institute (CLSI)

What is the purpose of phlebotomy QC checks?

to make certain procedures are performed correctly

What is a tort?

A wrongful act committed against someone's person, property, reputation or other legally protected right, for which the individual is entitled to damages awarded by the court.

What is an assault?

An act or threat causing another to be in fear of immediate battery.

What is battery?

An intentional harmful or offensive touching of or use of force on another person without consent or legal justification.

What is fraud?

A deceitful practice for false portrayal of facts either by words or by conduct, often done to obtain money or property.

What is an invasion of privacy?

The violation of one's right to be left alone, which can involve a physical intrusion or the unauthorized publishing or release of private information.

What is breach of confidentiality?

The failure to keep privileged medical information private.

What is negligence?

Doing or not doing something that a reasonable person would not do or do.

What is res ipsa loquitur?

A Latin phrase meaning 'the thing speaks for itself', which applies to the rule of evidence in a case of negligence.

What is the primary purpose of maintaining accurate and up-to-date medical records?

To provide an aid to the practice of medicine, communication, and as a legal document, and to evaluate performance outcomes.

What information is typically included in a patient's medical or clinical record?

History of examinations, medical testing, laboratory reports, prescriptions written, and supplies used.

What is the definition of risk in the context of healthcare?

The chance of loss or injury.

What is the primary focus of risk management in healthcare?

Identifying and minimizing situations that pose risk to patients and employees.

What is sexual harassment considered a form of?

Sex discrimination.

What federal law makes it illegal to discriminate in employment on the basis of sex, race, color, national origin, and religion?

Title VII of the Civil Rights Act of 1964.

Why is it important to maintain accurate and legible medical records?

To provide an objective account of the patient's past and present medical history.

What is the purpose of utilization review in healthcare?

To monitor and evaluate the appropriateness and cost-effectiveness of care.

What is crucial for obtaining a quality specimen?

The patient must be prepared properly.

What are acceptable 'person-specific' identifiers according to the JCAHO?

The individual's name, assigned ID number, telephone number, date of birth, social security number, address, and photography.

Why is it essential to ensure the quality and sterility of every needle?

To ensure patient safety.

What is the purpose of a delta check?

To compare current results of a laboratory test with previous results for the same test on the same patient.

Why is documentation critical in healthcare?

To prevent medical errors due to wrong information.

What is the purpose of a patient's record?

To provide a chronological documentation of the medical care given.

What is the importance of labeling in specimen collection?

Labeling must be exact.

Why is it important to prioritize specimen collection?

To recognize which specimen request is the most critical and involves special collection criteria.

Study Notes

Quality Assurance in Healthcare

  • Quality assurance is a program designed to prevent problems in the future by evaluating present and past performance to guarantee quality service.
  • The Joint Commission (TJC) is an independent, non-profit organization that establishes standards for healthcare facilities and services.

Regulatory Agencies

  • Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) are federal regulations that establish quality standards for laboratory testing.
  • CLIA '88 aims to ensure the accuracy, consistency, and reliability of patient test results.
  • The Clinical Laboratory Improvement Advisory Committee (CLIAC) provides technical and scientific advice to the Centers for Medicare and Medicaid Services (CMS) for administering CLIA '88 regulations.

Clinical and Laboratory Standards Institute

  • The Clinical and Laboratory Standards Institute (CLSI) is a global, non-profit organization that develops voluntary guidelines and standards for laboratory testing.
  • CLSI uses a widespread agreement process to develop standards for all areas of the laboratory.

Quality Assurance and Quality Control

  • Quality assurance (QA) is a program designed to prevent problems in the future by evaluating present and past performance.
  • Quality control (QC) is a component of a QA program that involves using all available QC checks on every operational procedure or process.

Areas of Phlebotomy Subject to Quality Assessment

  • Patient preparation procedures are crucial for obtaining a quality specimen.
  • Identification of patients using "person-specific" identifiers, such as name, ID number, date of birth, and social security number, is essential.
  • Equipment, such as puncture devices and evacuated tubes, must meet CLSI standards.
  • Labeling, technique, and collection priorities are critical components of phlebotomy.
  • Delta checks help ensure quality in testing by comparing current results with previous results.

Documentation

  • Documentation is critical in all areas of healthcare.
  • The patient's record is a chronological documentation of medical care.
  • Medical records must be kept on hospital patients, but not required for physicians in private practice.
  • Accurate and up-to-date medical records are essential for providing medical care, communication, and legal documentation.

Risk Management

  • Risk management is an internal process focused on identifying and minimizing situations that pose risk to patients and employees.
  • Risk management aims to avoid incidents and paying for occurrences after they have happened.
  • Sexual harassment is a form of sex discrimination and falls under Title VII of the Civil Rights Act of 1964.
  • Tort actions include assault, battery, fraud, invasion of privacy, breach of confidentiality, malpractice, and negligence.
  • Res ipsa loquitur is a Latin phrase that means "the thing speaks for itself," which applies to the rule of evidence in a case of negligence.
  • Respondeat superior is a Latin phrase that means "let the master respond," which holds an employer liable for the actions of an employee.

This quiz covers quality assurance and legal issues in healthcare, focusing on improving patient care and minimizing risks.

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