Chapter 2 Test Study Guide: Quality
Assurance and Legal Issues in Health
Care
Quality Assurance in Health Care
Quality: is the degree of excellence of something
Quality Assurance (QA): in health care includes all the activities and
programs put in place to guarantee the excellence of patient care
The Joint Commission (TJC)
One of the key players in bringing quality assessment review
techniques to healthcare
The oldest and largest setting body in healthcare in the United States
Evaluating Risk (SAFER)
SAFER provides an on-site post-survey tool called the SAFER Matrix
that illustrates the likelihood of harm to a patient, visitor, or staff that
is due to an area of noncompliance
The likelihood of harm associated with the deficiency is rated low (rare,
but could happen, moderate (could occasionally happen), or high
(could happen at any time)
Patient Safety and Sentinel Events
One of the ways the TJC demonstrates its commitment to safety for
HCO patients and employees is through its sentinel (early warning)
event policy
Sentinel event (SE): any unfavorable event that is unexpected and
results in death or serious physical or psychological injury
According to the policy, if an SE occurs, the HCO is required to:
- Perform a thorough and credible analysis of the root cause
- Develop an action plan
- Implement improvements in practice to reduce risk
- Monitor improvements to determine if they are effective
National Patient Safety Goals (NPSGs)
The 2023 NPSGs for the clinical laboratory are:
- Identify patients correctly
, - Improve staff communication
- Prevent infection
Clinical Laboratory Improvement Amendments of 1988
Waived tests: are simple and have a low risk of erroneous results
Laboratories subject to CLIA ’88 regulations that perform only waived
tests must apply for a certificate or waiver (CoW or CW)
After discovering significant gaps in the quality of waived testing
practices, CMS began on-site visits to approximately 2% of CoW
laboratories across the United States every year
One of the educational tools that CLIAC has developed for CoW
laboratories is called Good Laboratory Practices (GLPs)
- GLPs consist of a list of 10 recommendations that emphasize QA in
collecting and performing blood work using waived testing kit
Clinical and Laboratory Standards Institute
The Clinical and Laboratory Standards Institute (CLSI): is a global,
nonprofit standards developing organization with representatives from
the profession industry and government
The organization uses a widespread agreement process to develop
voluntary guidelines and standards for all areas of the laboratory
QA Processes
A QA program strives to guarantees quality service through scheduled
reviews that look at the appropriateness, applicability, and timelines of
patient care
It is important to adopt appropriate process improvement (PI)
techniques to identify problems or inadequacies and make changes
that prevent errors
Quality Indicators
One of the most important aspects of setting up a QA identification and
evaluation process is establishing quality indicators to monitor certain
areas of patient care
Quality indicators: are measurements or values that provide
information on the effectiveness or quality of processes
- They must be measurable, well defined, objective, and specific and
provide information on which action can be taken for improvement
Thresholds and Data
Threshold values must be established for all quality indicators
Assurance and Legal Issues in Health
Care
Quality Assurance in Health Care
Quality: is the degree of excellence of something
Quality Assurance (QA): in health care includes all the activities and
programs put in place to guarantee the excellence of patient care
The Joint Commission (TJC)
One of the key players in bringing quality assessment review
techniques to healthcare
The oldest and largest setting body in healthcare in the United States
Evaluating Risk (SAFER)
SAFER provides an on-site post-survey tool called the SAFER Matrix
that illustrates the likelihood of harm to a patient, visitor, or staff that
is due to an area of noncompliance
The likelihood of harm associated with the deficiency is rated low (rare,
but could happen, moderate (could occasionally happen), or high
(could happen at any time)
Patient Safety and Sentinel Events
One of the ways the TJC demonstrates its commitment to safety for
HCO patients and employees is through its sentinel (early warning)
event policy
Sentinel event (SE): any unfavorable event that is unexpected and
results in death or serious physical or psychological injury
According to the policy, if an SE occurs, the HCO is required to:
- Perform a thorough and credible analysis of the root cause
- Develop an action plan
- Implement improvements in practice to reduce risk
- Monitor improvements to determine if they are effective
National Patient Safety Goals (NPSGs)
The 2023 NPSGs for the clinical laboratory are:
- Identify patients correctly
, - Improve staff communication
- Prevent infection
Clinical Laboratory Improvement Amendments of 1988
Waived tests: are simple and have a low risk of erroneous results
Laboratories subject to CLIA ’88 regulations that perform only waived
tests must apply for a certificate or waiver (CoW or CW)
After discovering significant gaps in the quality of waived testing
practices, CMS began on-site visits to approximately 2% of CoW
laboratories across the United States every year
One of the educational tools that CLIAC has developed for CoW
laboratories is called Good Laboratory Practices (GLPs)
- GLPs consist of a list of 10 recommendations that emphasize QA in
collecting and performing blood work using waived testing kit
Clinical and Laboratory Standards Institute
The Clinical and Laboratory Standards Institute (CLSI): is a global,
nonprofit standards developing organization with representatives from
the profession industry and government
The organization uses a widespread agreement process to develop
voluntary guidelines and standards for all areas of the laboratory
QA Processes
A QA program strives to guarantees quality service through scheduled
reviews that look at the appropriateness, applicability, and timelines of
patient care
It is important to adopt appropriate process improvement (PI)
techniques to identify problems or inadequacies and make changes
that prevent errors
Quality Indicators
One of the most important aspects of setting up a QA identification and
evaluation process is establishing quality indicators to monitor certain
areas of patient care
Quality indicators: are measurements or values that provide
information on the effectiveness or quality of processes
- They must be measurable, well defined, objective, and specific and
provide information on which action can be taken for improvement
Thresholds and Data
Threshold values must be established for all quality indicators