1. Quality is the result of the commitment to achieving excellence

2. It is not a product of a single activity

a. A variety of behaviors and actions are involved that

1) Occur on a continuum

2) Occur at all levels of an organization

3. It seeks to improve outcomes by improving processes and structures

4. It cannot be “assured” but rather measured, managed, and improved on

5. Quality is a result that can be described subjectively and evaluated by

a. Comparison of actual outcomes against desired outcomes

b. Comparison of performance over time (stability)

6. Quality is challenging when providing high-volume, high-risk therapies

7. Quality or performance systems are designed to allow the organization to provide high-volume, high-risk therapies and services via competent expertise, knowledge, and appropriate assessment and monitoring

1. Quality control

a. “On-line” inspection during manufacture or process implementation

b. Compares the product or service with a theoretical standard or model

c. Detects “defects” before use or dispensing to the consumer

2. Quality assurance (traditional)

a. Retrospective review of care through chart audit or other document review

b. Compares results data with an arbitrary and static “threshold”

c. Results in a pass versus fail determination

3. Quality assessment (QA)

a. Combines retrospective and concurrent review of care through observation and reviews

b. Monitors outcomes and customer perceptions/satisfaction

c. Analyzes trends for variances

d. Compares results data with a moving “threshold” based on trends and variability

4. Quality improvement (QI)

a. Builds upon the data or measurements obtained in QA

b. Uses that data to develop improvement priorities, plans

c. Evaluates the effectiveness of the improvement strategy via repeated data collection and measurement

5. Continuous quality improvement

a. Builds on the principles of QA/QI

b. Integrates full organization; not limited to “clinical” departments within the organization but includes administrative, financial, medical, and environmental control departments

c. Promotes and emphasizes multidisciplinary coordination and integration

d. Evaluates the full patient care experience with the facility or organization

6. Performance improvement (PI)

a. Differentiates between “quality” (subjective) and “performance” (specific and objective)

b. Recognizes that certain measurable elements of performance impact significantly the total patient experience

7. Total quality management (TQM)

a. Patient-focused strategic vision

b. Involves all levels of the organization from leadership down

c. Based on the concepts of Juran, Crosby, and Deming

d. Six Sigma and lean manufacturing are examples of TQM

1. Performance standards

a. Overview

1) Statements of expected quality and performance as defined by the organization

2) Can be separated by “domains of care”: structures, processes, and outcomes

3) Can be separated by “domains of organizational structure”: governance, practice, and care

b. Provide the framework for providing and monitoring the delivery of care and are:

1) Value-driven, measurable, and achievable

2) Combine individual, societal, institutional, and professional values

3) Predetermined and regularly reviewed

4) Written

5) Approved by an authoritative body or entity

6) Accepted by those individuals most affected

c. Provide a framework within which to define “variances,” “defects,” or unacceptable levels of performance

1) Malpractice

2) Product failure

3) Noncompliance

4) Protocol failure

5) Risk occurrences

d. Provide a framework for resolving ethical conflicts between the healthcare professional’s duty to the patient and responsibilities as an employee within the healthcare organization

2. Classifications of standards by domains of care

a. Structure standards

1) Describe conditions and mechanisms that support provision of care

2) Include the mission, philosophies, and goals of the organization

3) Environmental design, equipment, condition of environment of care

4) Policies, procedures, protocols, and pathways that establish requirements

b. Process standards

1) Describe activities and procedures provided during the provision of care

2) Evaluate actual procedures provided versus written procedures

3) Based on direct measurements or observations of the procedures as they occur

c. Outcome standards

1) Describe the desired product or expected result of the provision of care

2) Include clinical therapeutic outcomes, adverse events, and patient perceptions and satisfaction

3) Can be expressed as measurement of negative events (i.e. phlebitis rates) or positive events (i.e. resolution of infection; improvement of pain level)

4) Based on direct measurements or observations of the results of the care upon completion

3. Classifications of standards by organizational structure

a. Standards of governance

1) Emphasize the role of the organizational leadership

2) Evaluate the commitment of leadership to provide resources needed for patient care

3) Emphasize the commitment of leadership to performance and QI

b. Standards of practice

1) Emphasize the role of the organization’s practitioners and care providers

2) Emphasize the importance of accountability and competency

3) Emphasize the use of professional research and national standards to establish acceptable practice within the organization

c. Standards of patient care

1) Evaluate the sum total of the patient’s experience

2) Emphasize the outcome of the patient’s experience

3) Frequently are standards that require integration of all organizational levels and departments toward a common goal

1. Education

a. Staff

1) Established minimum educational requirements for job categories

2) Confirmation of educational backgrounds

3) Ongoing job-based education and training in job tasks and information for patient care

4) Requirements for ongoing professional continuing education activity outside of employment

5) Involves active participation in programs and sharing of information with other healthcare professionals

b. Patients and caregivers

1) Established minimum teaching standards for procedures, treatment, therapies, and/or disease states

2) Integration of educational standards and materials into the patient teaching process

3) Validation of patient learning through interview or other competency validation

4) Evaluation of patient teaching through patient/caregiver satisfaction measurement

c. Leadership and staff regarding performance improvement

1) Established educational plan for leadership and staff on principles of QA/QI and TQM

2) Incorporates collection, translation, and use of data toward improvement

d. Healthcare community

1) Organization may participate in research and development to:

a) Support the use of an internal policy or protocol not supported in the medical literature

b) Improve patient care

c) Add to the existing scientific body of knowledge

1) Participate in nursing research to advance the science of infusion nursing

e. Orientation

1) Familiarizes the nurse to

a) Organization and department structure

b) Policies, procedures, and practice guidelines

c) Accountability and autonomy

d) Communication and collaboration

2) Reviews critical safety information

3) Includes didactic and clinical (“hands on”) education

4) Requires competency validation (see Section IV)

5) Should be documented on checklist or other organization-approved document

2. Policies, procedures, and other documents that guide care and services

a. Direct healthcare delivery within a specific organization

b. Identify acceptable courses of action for personnel

c. Should be:

1) Reviewed annually

2) Revised as necessary

3) Representative of organizational and national standards and current evidence-based practices

d. Policy

1) Based on state law, federal regulations, standards of practice, and state of the art in the practice area

2) Defined as a course or statement of action

3) Must be specific, concise, and clinically sound

4) Must be achievable within the resources of the organization

5) Must be written and formally approved by the organization it is designed to serve

6) Must be circulated and revised as necessary

7) Must have associated documentation verifying annual review

8) Revised as necessary

9) Represents organizational standards

10) Reflects national standards and current evidence-based practice

e. Procedure

1) Based on state law, federal regulations, standards of practice, and the state of the art in the practice area

2) Involves psychomotor skills performed by healthcare practitioners

3) Reflects contemporary standards of practice

4) Includes a series of precise steps that outline the recommended manner in which skills should be performed

f. Practice guidelines/protocols/clinical pathways

1) Typically multidisciplinary

2) Direct clinical care decisions based on the current state of knowledge

3) List important aspects of providing a specific treatment or using (or operating) equipment/device

4) Incorporate Risk Evaluation and Mitigation Strategies (REMSs) as required by the Food and Drug Administration (FDA)

g. Job descriptions

1) Describe the duties and responsibilities within a particular role

2) Further define tasks and activities necessary to fulfill a role successfully

3) Clinically sound and performance based

4) Provide for self-inventory (self-assessment)

5) Address achievable behaviors and actions

6) Stated in measurable terms using measurable statements

7) Assist in the identification and resolution of performance problems

8) Reviewed annually, revised as necessary with input from the employee

3. A formal structured model and process for performance and QI

a. Characteristics of an organization PI program

1) It is described in written documents

2) It is authorized and approved by the organization leadership

3) It is ongoing, flexible, and continually active

4) It incorporates the organization mission and goals

5) It incorporates the expectations and needs of the patient

6) It assists the organization in balancing the benefit and costs of provision of patient care

7) It has similar elements as the nursing process in that it includes:

8) Models typically are cyclic

9) It identifies the areas of needed improvement through review of

b. Measures

1) Characteristics