STANDARD 4: Quality Management System

4.1 General 

1. The healthcare organization shall develop, implement, and maintain an effective, ongoing, healthcare organization-wide, risk-based quality management system, performance improvement program, and integrated patient safety plan. 

2. The healthcare organization’s Top management shall ensure that this system reflects the complexity and resource requirements of the scope of all services offered, including those which are outsourced. 

3. The healthcare organization shall implement points of control at appropriate stages to verify that process and/or patient requirements are met appropriately. These points of control shall be met prior to release or process completion. Examples include but are not limited to a: 

a) process for reporting critical and/or unexpected diagnostic results; 

b) process for management and follow up of patients who intend to leave the healthcare organization against medical advice; 

c) process for "hand-off" communication between staff (doctor to doctor, doctor to nurse, nurse to nurse) at the time of change of shifts or transfer between units within the healthcare organization; 

d) process for patients permitted to leave the organization during the planned course of treatment; 

e) process for central sterile and decontamination validations; 

f) process for surgery "time-out" and pre-operative surgical site identification; 

g) process for discharge of a patient from one healthcare environment to another; 

h) processes for preventing medication errors; 

i) process for other critical patient related or internal healthcare organization requirements as determined to be necessary throughout all services. These required points of process control shall be created to assure that the service requirements 

are complete, and the intended results have been achieved – unless set aside by the patient or other relevant authority. 

4. The identification of the person or other relevant authority approving the conditions noted in 3. above shall be required. 

5. Documented information shall be retained. 

4.2 Quality Management System Requirements 

1. The healthcare organization is required to have the following as part of the quality management system: 

a) understanding the context and purpose of the healthcare organization including external and internal issues relevant to its purpose; 

b) defined interested parties that are relevant to the healthcare organization management system; 

c) a defined scope of service based on resources available, and an ongoing risk analysis program consistent with achieving intended results; 

d) a process approach with inputs required and outputs expected; 

e) sequences and interactions with that processes; 

f) effective control of these processes; 

g) scheduled internal surveys and management review; 

h) a policy for surveillance of high risk, problem prone processes or functions; 

i) a policy to monitor and measure the severity, prevalence, and incidence of problems related to the internal or external processes of the healthcare organization; 

j) a policy for the management of underperformance of performance; 

k) a process to improve quality of care, patient safety, and effect healthcare organization outcomes. 

2. A multi-disciplinary Committee shall be established to guide the Quality management system. The membership of this Committee shall consist of a Managing Director, Medical Director, Nursing Director, medical staff leaders and pharmacy representative. Additionally, representatives from information technology, risk management, physical environment and other ancillary departments as identified shall be included. 

3. This Committee shall monitor, measure, oversee, evaluate, and modify the healthcare organization QMS as needed no less than yearly. NOTE 1 If the healthcare organization is currently certified to ISO 9001 and/or EN 15224, the Certification Body (CB) that currently certifies the healthcare organization shall be a recognized by IAF. This should be verified prior to the organization’s accreditation survey. In that case requirements 4.2, 4.5, 4.6 and 4.7 under STANDARD 4 will not be surveyed. 

 4.3 Quality Policy, Mission, Vision, and Values 

1. The healthcare organization shall establish, implement, and maintain a quality policy, mission, vision, and values that: 

a) is appropriate to the purpose and context of the organization and supports its strategic direction; 

b) provides a framework for setting quality objectives; 

c) includes a commitment to satisfy applicable requirements; 

d) includes a commitment to continual improvement of the quality management system. 

2. The quality policy, mission, vision, and values shall: 

a) be available and be maintained as documented information; 

b) be communicated, understood and applied within the healthcare organization; 

c) be available to relevant interested parties, as appropriate. 

4.4 Control of Documented Information 

1. The healthcare organization shall develop and implement a policy for the control of documented information. 

2. This documented information required by the healthcare organization quality management system and by this AACI standard and other relevant, legal, and regulatory standards shall be controlled to ensure: 

a) it is available and suitable for use, where and when it is needed; 

b) it is adequately protected (e.g., from loss of confidentiality, improper use, or loss of integrity). 

3. For the control of documented information, the healthcare organization shall address the following activities, as applicable: 

a) review for suitability and adequacy; 

b) authorization and approval of documented information by Top management; 

c) appropriate identification and description (a title, date, author, or reference number); 

d) distribution, access, retrieval and use; 

e) storage and preservation, including preservation of legibility; 

f) control of changes (e.g. version control); 

g) retention and disposition. 

4. Documented information of external origin determined by the healthcare organization to be necessary for the planning and operation of the quality management system shall be identified as appropriate and be controlled. 

5. Documented information retained as evidence of conformity shall be protected from unintended alterations. 

NOTE 1 Documented information includes information which by its character shall be either retained and/ 

or maintained. This includes documents of internal and external origin determined to be necessary for the maintenance of the healthcare organization as stated above. This information and the appropriate storage methodology may take multiple forms, i.e. hard copy, digital storage, video, audio, etc. 

  4.5 Quality Objectives and Plan 

1. The healthcare organization shall establish quality objectives/goals at relevant functions, levels and processes needed for the management system. 

2. The healthcare organization shall establish and define an ongoing organization process that enables and supports improvement by way of established objectives. These objectives shall be relevant to conformity of service offered, measurable, and selected to improve health outcomes and to identify and reduce medical errors. Additionally, they shall be consistent with the healthcare organization quality policy, mission, vision and consistent with statutory and regulatory rules and regulations. 

3. The healthcare organization shall have an on-going documented quality plan. The quality plan shall include actions required to achieve objectives, improve processes, assigned management responsibilities, and established timelines related to the objectives. 

4. The healthcare organization shall monitor, measure, analyze, report, and make required corrections and corrective actions relative to these objectives (including adverse patient events and other aspects of performance that assess processes of care) as needed. 

5. This activity shall be communicated to the healthcare organization and relevant stakeholders, and the necessary updates and modifications shall be undertaken in the interest of process control and customer satisfaction. 

  4.6 Measurement, Monitoring, and Analysis 

1. The healthcare organization shall evaluate all organized services and processes, both direct and supportive, including services provided by any contracted services to improve performance and customer satisfaction. This evaluation shall include rate-based monitoring and measuring of specific quality indicators as determined by Top management to include all services clinical, supportive, non-clinical, and outsourced entities. 

2. The monitoring shall include the analysis of data related to these processes. This data shall be collected from a scheduled calendar of internal surveys, and/or other methodology (see NOTE 2 below) within each department or service at intervals as needed – not to exceed one year. Subsequently, the healthcare organization shall take appropriate corrective actions. 

3. Individual(s) not assigned to the surveyed department or service in question shall conduct the internal surveys. These persons shall be competent to perform these duties. 

4. Measurement, monitoring and analysis of processes throughout the organization require established measures that have the ability to detect variation that identifies problem processes, positive and negative outcomes, and the effectiveness of actions taken to improve performance and/or reduce risks. Top management of the healthcare organization shall define the frequency and detail of the risk analysis as set forth in STANDARD 10. The following functions or processes shall be included but are not limited to: 

a) threats to patient and staff safety (i.e. falls, patient identification, injuries); 

b) medication therapy/medication use; to include medication reconciliation, look alike-sound alike medications, use of dangerous abbreviations, and use of chemotherapeutic drugs; 

c) risk of improper narcotic use and efforts to prevent addiction and to facilitate abuse 

rehabilitation; 

d) surgery and other operative and invasive procedures; to include wrong site/wrong patient/wrong procedure; 

e) ionizing radiation and, nuclear medicine therapy; 

f) anesthesia/moderate sedation; 

g) blood and blood components; 

h) restraint use/seclusion; 

i) effectiveness of pain management system; 

j) opioid therapy oversight; 

k) infection control system, including healthcare organization acquired infections (HAI); 

l) utilization management system; 

m) patient flow issues, to include reporting of patients held in the emergency department or the PACU for extended periods of time (as defined by the healthcare organization); 

n) customer/patient satisfaction, both clinical and support areas; 

o) patient complaints/grievance; 

p) staff satisfaction; 

q) discrepant pathology reports; 

r) unanticipated deaths, adverse and/or sentinel events; 

s) near misses and/or other adverse events including sentinel events; 

t) critical and/or pertinent processes, both clinical and supportive; 

u) high risk low frequency processes; 

v) medical record delinquency; 

w) physical environment management systems; 

x) high-risk equipment including those associated with unexpected injuries; 

y) radiology patient and staff safety requirements including exposure monitoring; 

z) high-risk procedures related to research and clinical trials; 

aa) discharge and transfer hazards. 

5. Results of these internal surveys and other data surveillance shall be analyzed and reported to Top management for their review and any necessary corrections/corrective actions as noted in STANDARD 2. 

NOTE 1 The healthcare organization shall collect and analyze data in the respective areas listed above to demonstrate that these processes are controlled as required. Methodology for analysis and investigation may include internal or external audit outcomes, statistical analysis, FMEA, root cause analysis or other reliable investigative methodology. 

NOTE 2 All departments and services provided are to be included as a part of the Quality management oversight for the healthcare organization. These will include, all internal and externally provided processes. 

NOTE 3 A sentinel event shall be defined as an unexpected occurrence or variation that leads to death or serious physical or psychological harm. Near misses or adverse events are errors in medical care that are clearly identifiable, preventable, and serious in their consequences for patients. 

  4.7 Management Review 

1. Top management shall periodically review the adequacy, suitability, and continuing effectiveness of the healthcare organization’s policy, mission, vision, procedures, and performance results in keeping with the requirements of this standard and other requirements to which the healthcare organization subscribes. 

2. Corrections and corrective actions for the purpose of process improvement and customer satisfaction shall be implemented where appropriate. 

3. The input for the management review shall include as a minimum: 

a) status of actions from previous reviews; 

b) status of on-going and completed corrective actions; 

c) changes to both external and internal issues that may impact on the quality management system; 

d) analyzed results from the measurement of quality objectives and key indicators; 

e) outcomes related to grievance procedures; 

f) patient satisfaction; 

g) results of utilization review; 

h) performance and evaluation of external contractors; 

i) internal survey results. 

4. The outputs of the management review shall be documented, and this shall include decisions and actions related to: 

a) opportunities for improvement; 

b) any need for changes to the quality management system; 

c) resource needs; 

d) corrections or corrective actions relating to nonconforming processes or procedures; 

e) patient satisfaction. 

5. The results of management review output shall be reported to the Governing Body, or its designated quality Committee as needed, but at least annually. 

6. Documents relating to the management review in this section shall be retained and maintained as documented information. 

NOTE 1 Management review is a formal evaluation by Top management to assure the effectiveness, adequacy, and compliance of the quality management system and the associated mission and vision. The results of this data collection and analysis of other process improvement activities shall be subject to input. Methodology used by this review may take the form of Root cause analysis, performance improvement report, non-conformity report, specific performance projects and/or analysis or failure, Failure models and effect analysis (FMEA).