Quality Assurance


Quality refers to the ability of a product or service to meet its purpose or consumer need.  Quality management (QM) serves as the overarching system used to achieve and manage quality. Subsets of quality management include quality assurance (QA), the process that ensures quality, as well as quality control (QC), the manner of evaluating quality.[1]

The quality movement began with QC, the fundamental unit, or structure within the system of QM.[1] It was first noted with manufacturing and engineering in the 1920s and referred to the essential tasks or activities that confirm a product, service, or unit fulfills its intended goal.[1] QC involves setting standards and maintaining operations within these parameters via inspection and data collection.[2]

QA, which started in the 1950s, emphasizes providing confidence that quality requirements will be met.[2] This is important both to internal stakeholders such as leadership as well as to patients, accreditors, and other concerned external parties.  QA employs QC tools to meets its goals, and the information gained is used to certify that performance remains at the level of identified quality standards. QA reacts to imperfections in the system to achieve ideal outcomes. To differentiate QC and QA, here is a clinical example: QC  is the task of collecting data based on surgery erroneously performed on the wrong side of a patient’s body, while QA involves the process of operating rooms having a “time out” before the beginning of surgery to confirm the proper side and site of surgery.

QM, the overarching umbrella that encompasses both QC and QA, 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There is a perception that QA is no longer applicable as it implies that quality is static and that once specifications are met, there is no need to strive for a better product or service, but such is not the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 also may be in different stages. The pursuit of quality is a network involving QC, QA, and QM. Even when one achieves the best service, there will always be new regulations and factors that could change the dynamics and environment, leading to a need to start the cycle of improvement all over again.

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 level of performance are set. QC measures will collect data to determine whether the minimum acceptable standard is reached or whether any action is necessary to improve overall performance (QA).

QA 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 instructs healthcare professionals in essential competencies in quality assurance; this includes 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 improvement intended from both traditional and modern QA projects, several limitations and drawbacks exist. "Quality" by nature, is difficult to quantify. Assurance of quality often can be more related to assuring the standard of care was met than by assuring a specific metric. By assuming a binary set of outcomes (i.e., yes or no), these metrics become inflexible and do not take into account complexities related to patients' needs and goals of care. For example, in the case of 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, QA metrics will flag the provider regardless. Additionally, binary metrics have the potential to reflect the respect of patient autonomy and the right to refuse recommended treatment negatively on the healthcare provider. Finally, tying QA 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 (CMS) to simplify and streamline the process.[5][11][12][10]

Another possible issue with the concept of QA 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 QA to establishing and measuring "goals" as part of a continuous quality improvement (CQI) process. The goals in the CQI scenario are now equal to the accepted standards of care.[13] TQM is also seen by The Joint Commission as the next logical evolution of QI methods, while CQI poses solutions to the shortcomings of current QA programs.[15]

Clinical Significance

While we point out that there has been a shift from QA to QCI or TQM, QA remains relevant based on goals. For example, QA 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 the harmonization of laboratory results as essential to reduce bias, increase precision, and increase confidence in the test results.

Teaching hospitals continue to use and benefit from QA systems by utilizing peer review at surgical audit meetings.[17] Another study that reviewed the relationship between QA metrics and safety culture found that both are interrelated.[18] While the safety culture informed of attitudes toward care, the QA metrics provided more details of direct patient care.  

Since its development, QA has been intimately intertwined with clinical practice. Practitioners tend to positively view interventions intended to improve their practice. Basic quality assurance activities such as continuing medical education (CME) requirements and checklists for surgical equipment have become commonplace. New QA metrics are being tested all the time and affect healthcare providers on 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

QA 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 involved in all levels of an organization and all phases of quality improvement receive training in QA, each position more effectively interacts and communicates with other professionals and efforts to achieve the best results. QA training should be a priority for all allied health professionals committed to safe and efficient patient care.[23][24][25]



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