Definition/Introduction
Quality refers to a product or service's ability to meet its purpose or consumer need. Quality management is the overarching system for achieving and managing quality. Subsets of quality management include quality assurance, the process that ensures quality, and quality control, the method of evaluating quality.[1] The quality movement began with quality control, the fundamental unit or structure of the quality management system.[1] It was first noted in manufacturing and engineering in the 1920s and refers to the essential tasks or activities that confirm that a product, service, or unit fulfills its intended goal.[1] Quality control involves setting standards and maintaining operations within these parameters via inspection and data collection.[2]
Quality assurance, which started in the 1950s, emphasizes providing confidence that quality requirements are met.[2] This is important to both internal stakeholders, such as leadership, and to patients, accreditors, and other external parties. Quality assurance employs quality control tools to meet its goals, and the information gained is used to certify that performance remains at the level of identified quality standards. Quality assurance reacts to imperfections in the system to achieve ideal outcomes. To differentiate quality control and quality assurance, here is a clinical example: quality control is the task of collecting data based on surgery erroneously performed on the wrong side of a patient’s body, while quality assurance involves the process of operating rooms having a “time out” before the beginning of surgery to confirm the proper side and site of surgery.
Quality management, the overarching umbrella that encompasses both quality control and quality assurance, refers to the administration of systems design, policies, and processes that minimize, if not eliminate, harm while optimizing patient care and outcomes.[3] It entails a more comprehensive approach to not only maintaining quality but also improving it. It utilizes quality control and quality assurance in addition to other quality management models, such as total quality management (TQM) or continuous quality improvement (CQI).
There is a perception that quality assurance is no longer applicable, as it implies that quality is static and that once specifications are met, there is no need to strive for a better product or service. But this is not the case.[2] Organizations may be in different stages of delivering and achieving quality, or all stages may co-exist at once. Within an organization, each department or unit may also be in different stages. The pursuit of quality involves quality assurance and quality management. Even when one achieves the best service, new regulations and factors can change the dynamics and environment, necessitating a restart of the improvement cycle.
Traditionally, this has been done within a hospital by a committee that has identified a concern regarding some aspect of a specific treatment or procedure. After identifying the quality concern, standards for acceptable vs unacceptable levels of performance are set. Quality control measures involve collecting and analyzing data to assess whether minimum performance standards are met and to determine whether corrective actions are needed to improve overall quality and ensure quality assurance.
Quality assurance has become very important to the continued delivery of quality healthcare. In 1976, the National Association for Healthcare Quality (NAHQ) was founded in the United States to equip healthcare professionals and organizations with the tools to ensure excellent quality of care. NAHQ certifies individuals in the healthcare quality profession (CPHQ) and trains healthcare professionals in essential competencies in quality assurance, including patient safety, patient care coordination, performance and process improvement, risk management, data analytics, population health, and compliance with standards and regulations.
Professionals train for competency in quality assurance at all levels of patient care delivery. Quality measurement efforts have even become intertwined with reimbursement within the United States healthcare system to ensure providers take certain actions. This paradigm represents a shift in payment policy towards ensuring the quality of care rather than the incredibly complex task of assigning value to care. Some examples of quality metrics include surgical wound infection rates, rate of hospital readmission within 30 days, operative mortality rates, maternal-fetal mortality, nosocomial infections, vaccination rates based on population demographic, rate of patients referred to appropriate screening tests as defined by the United States Preventative Services Task Force (USPSTF), number of diabetic patients meeting goal hemoglobin A1c <7%, and proper timing of inpatient medication administration.[4][5][6][7][8][9][10]
Issues of Concern
Despite the potential improvements intended by both traditional and modern quality assurance projects, several limitations and drawbacks remain. "Quality," by nature, is difficult to quantify. Assurance of quality is often more closely related to ensuring the standard of care was met than to ensuring a specific metric. By assuming a binary set of outcomes (ie, yes or no), these metrics become inflexible and fail to account for the complexities of patients' needs and goals of care. For example, in a diabetic patient, the standard recommendation for hemoglobin A1c is <7%. However, in the case of a palliative care patient, there may be minimal potential health gains or even potential harm associated with strict adherence. Yet, quality assurance metrics flag the provider regardless. Additionally, binary metrics can reflect negatively on the healthcare provider regarding patient autonomy and the right to refuse recommended treatment. Finally, tying quality assurance metrics to reimbursement adds administrative burden to an already costly healthcare system. Insurance companies utilize thousands of metrics to calculate payment adjustments, resulting in a burdensome system with difficult calculations and interpretations. In 2014, the American Medical Association publicly called on the Centers for Medicare & Medicaid Services to simplify and streamline the process.[5][10][5][11][12]
Another possible issue with the concept of quality assurance is that, since the 1990s, the pursuit of healthcare quality has been shifting from quality assurance to quality improvement. The Joint Commission's 1992 Accreditation Manual for Hospitals began moving toward the concept of CQI.[13][14] There was also a shift in terminology, from determining and meeting "thresholds" in quality assurance to establishing and measuring "goals" within a CQI process. The goals in the CQI scenario are now aligned with accepted standards of care.[13] TQM is also seen by The Joint Commission as the next logical evolution of quality improvement methods, while CQI addresses the shortcomings of current quality assurance programs.[15]
Clinical Significance
While we note that there has been a shift from quality assurance to CQI or TQM, quality assurance remains relevant in terms of goals. For example, quality assurance remains a driving force for harmonization and standardization for laboratory medicine.[16] For instance, medical testing laboratories must demonstrate inter-laboratory equivalence to meet the international standard ISO 15189:2012.[16] Organizations such as the Centers for Disease Control and Prevention consider harmonizing laboratory results essential to reduce bias, increase precision, and enhance confidence in test results.
Teaching hospitals continue to use and benefit from quality assurance systems by utilizing peer review at surgical audit meetings.[17] Another study that reviewed the relationship between quality assurance metrics and safety culture found that both are interrelated.[18] While the safety culture provided insights into attitudes toward care, the quality assurance metrics provided more detail on direct patient care.
Since its development, quality assurance has been intimately intertwined with clinical practice. Practitioners tend to view interventions intended to improve their practice positively. Basic quality assurance activities, such as continuing medical education requirements and surgical equipment checklists, have become commonplace. New quality assurance metrics are being tested regularly and affect healthcare providers across all specialties, including hospital and nursing managers, medical doctors, nurses, medical technicians, medical records officers, and quality improvement officers.[19][20][21][22]
Nursing, Allied Health, and Interprofessional Team Interventions
Quality assurance and quality improvement efforts, and multidimensional and successful efforts involve an industry-wide contribution from players at all levels of care delivery. The most successful efforts originate from initiatives supported at the very top of an organization. When individuals at all levels of an organization and across all phases of quality improvement receive quality assurance training, each position interacts more effectively with other professionals and makes greater efforts to achieve the best results. Quality assurance training should be a priority for all allied health professionals committed to safe and efficient patient care.[23][24][25]
