Learn — Quality assurance, audit & patient safety

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Quality assurance — standards, indicators and the PDCA cycle

Quality assurance is the planned and systematic process of setting standards of care, measuring the care actually given against them and acting on the difference, so that a patient receives care that is safe, effective, timely, efficient, equitable and centred on the patient. It is the controlling function applied to clinical care, and it has grown from periodic inspection into continuous quality improvement and total quality management, in which every process is improved all the time by the people who run it.

Donabedian's framework sorts quality into structure (what the service has — staff numbers, equipment, policies), process (what is done — hand hygiene, the drug round, documentation) and outcome (what happens to the patient — infection rates, falls, satisfaction); a standard is a written statement of the expected level of care, a criterion is a measurable element of it, and an indicator is a rate that tracks a criterion, so catheter-associated urinary tract infections per 1,000 catheter-days is an outcome indicator.
The quality cycle is set the standard, measure practice against it by audit or indicator, compare, act on the gap and measure again; Deming's PDCA (Plan–Do–Check–Act, the Shewhart cycle) is the improvement loop, and the re-audit that asks whether compliance improved after training is the Check step.
Total quality management, from Deming, Juran and Crosby, rests on customer focus, the commitment of top management, quality as everyone's responsibility, continuous improvement, decisions on data and prevention rather than inspection; Crosby's zero defects, Juran's trilogy of planning, control and improvement, Six Sigma's DMAIC, Lean's removal of waste and benchmarking against the best performer are its named tools.
Quality assurance is retrospective and finds fault after the event, whereas quality improvement is prospective and improves the process before the next patient; in an Indian hospital the structures are a quality committee, a quality nurse or coordinator, a nursing quality manual and indicators reported monthly — medication errors, falls, pressure injuries, hospital-acquired infections, hand-hygiene compliance and patient satisfaction.
The seven basic tools are the check sheet, the Pareto chart, the histogram, the run or control chart, the flowchart, the scatter plot and the fishbone diagram, and a problem is worked with them in that order — count it, rank it, chart it, map the process, find the cause.
Standards come from the Indian Nursing Council, from NABH, from evidence-based guidelines and from the hospital's own policies, and nursing-sensitive indicators are the outcomes that nursing care most directly changes — pressure injuries, falls, catheter infections, medication errors and patient satisfaction with nursing.

Nursing audit — structure, process and outcome; retrospective and concurrent

A nursing audit is the systematic, documented examination of nursing care against explicit standards, done to find out whether the care given met them and to correct what did not. It may look at the structure of the ward, the process of care or its outcome, and it may be done retrospectively from the records of discharged patients or concurrently while the patient is still being nursed.

A retrospective audit examines the records of discharged patients — case sheets and nursing notes scored against a checklist of criteria — and the Phaneuf audit, which scores seven functions of nursing from the closed record, is its classic form; a concurrent (open-chart) audit examines current records and observes care while the patient is still in the ward, so it can correct the care in time; a prospective audit sets the criteria before the care begins.
The steps are: form the audit committee and choose the topic, set the standards and their criteria, build the tool (a checklist), collect the data from a sample of records or observations, analyse it against the standard, report with recommendations, act on them and re-audit to close the loop.
Audits are classified by focus into structure, process and outcome audits (Donabedian), by method into record audit, observation, patient interview, self-audit and peer review, and by scope into a single ward or the whole nursing service; medical audit and nursing audit run in parallel, and clinical audit covers both.
The audit committee is usually a small group of nurses with a chair, regular meetings, written terms of reference and a reporting line to the hospital quality committee; an audit is educational and corrective rather than punitive, and its findings are shared with the staff whose care was audited.
The usual topics are nursing documentation, medication administration, pressure-injury prevention, pain assessment, discharge teaching and infection-control practice, and the result is expressed as a compliance rate against each criterion, which is what the re-audit is compared with.
Audit is not research: audit measures practice against a standard already accepted and needs no ethics approval or patient consent under the hospital's quality policy, whereas research creates new knowledge, needs ethics committee approval and needs the participants' consent.

Accreditation — NABH and the Quality Council of India

Accreditation is the public recognition by an independent body that a health-care organisation has been assessed and meets published standards of quality and patient safety; it is voluntary, periodic, and based on self-assessment followed by an external survey. In India the National Accreditation Board for Hospitals and Healthcare Providers, NABH, does this for hospitals, and its standards shape the policies a ward nurse works under.

NABH was set up in 2005 as a constituent board of the Quality Council of India (QCI, established in 1997), which also houses NABL, the accreditation board for testing and calibration laboratories; NABH is a member of ISQua, the International Society for Quality in Health Care, and its hospital standards carry ISQua accreditation.
The NABH standards for hospitals, in their sixth edition (January 2025), are grouped into patient-centred chapters — access, assessment and continuity of care, care of patients, management of medication, patient rights and education, infection prevention and control — and organisation-centred chapters — patient safety and quality improvement, responsibilities of management, facility management and safety, human resource management and the information management system.
Each standard is broken into objective elements that surveyors score; the cycle runs from application and self-assessment through a pre-assessment and a final assessment to accreditation for four years with surveillance in between, and NABH also offers entry-level certification, standards for small healthcare organisations and programmes for nursing excellence, blood banks, dental and AYUSH facilities.
The other names an examination pairs with it are Joint Commission International (JCI), the international accreditor from the United States; ISO 9001, which certifies a quality management system rather than clinical care; and for public facilities the National Quality Assurance Standards (NQAS) of the Ministry of Health (2013) and the Kayakalp scheme for cleanliness.
What accreditation asks of the nursing service is concrete: written policies and procedures, credentialing and competency records for every nurse, patient identification with two identifiers, medication reconciliation and high-alert drug practices, the surgical safety checklist, hand-hygiene compliance, an incident reporting system and monthly quality indicators.

Patient safety and risk management — sentinel events and root cause analysis

Patient safety is freedom from accidental or preventable harm during health care, and risk management is the organised effort to identify, analyse and reduce the events that cause such harm and the liability that follows them. Its instruments are the incident reporting system, the classification of events by seriousness, root cause analysis of the worst of them and the changes to the system that come out of it, on the principle that most errors are made by good people working in bad systems.

An adverse event is harm caused by care rather than by the disease, a near miss is an error that reached no patient, and a sentinel event is an unexpected occurrence involving death or serious physical or psychological injury, or the risk of it — wrong-site, wrong-patient or wrong-procedure surgery, a retained instrument or swab, an ABO-incompatible transfusion, infant abduction, suicide during care, a maternal death — which must be reported at once and followed by a root cause analysis; never events are the serious, largely preventable events that should never happen.
The incident report is written by the person who found the incident, as soon as possible, in facts without blame, and goes to the quality or risk office; it is not filed in the patient's record and the nursing notes never mention that one was made — the record carries the clinical facts of what was found and done; its purpose is to find system problems and prevent recurrence, and a just culture consoles human error, coaches at-risk behaviour and disciplines only reckless behaviour.
Root cause analysis is a retrospective, systematic inquiry after a serious event that asks what happened, why it happened and what will prevent it, using the fishbone diagram and the five whys to reach causes in the system rather than in one person; failure mode and effects analysis is the prospective version done before a new process starts, and Reason's Swiss-cheese model explains how harm reaches the patient only when the holes in successive defences line up.
The patient-safety goals every accreditor shares are: identify the patient with two identifiers — name and hospital number, never the bed number; improve communication with read-back and SBAR; make medication safe with a high-alert drug list, look-alike sound-alike separation and an independent double check; use the surgical safety checklist (sign in, time out, sign out); prevent infection with hand hygiene; and prevent falls and pressure injuries with risk scoring such as the Morse fall scale.
The risk management process is to identify risks (from incident reports, audits, complaints and claims), analyse them by frequency and severity, treat them by eliminating, reducing, transferring (insurance) or accepting them, and monitor them in a risk register that covers clinical, non-clinical (fire, security) and financial risk.
After an event the order is fixed: the patient first (assess, treat, inform the doctor), then the record of what was found and done, then the incident report — and the patient or family is told what happened, which is disclosure, not an admission of liability.

Nursing records and documentation — rules, correcting an error, legal weight

Nursing records are the written or electronic account of the care a patient received, the observations made and the patient's response, and reports are the oral or written summaries that pass that information between nurses, shifts and departments. The record is a legal document — in a court the rule is that care not recorded was not given — and its quality is judged by whether it is accurate, complete, timely, legible, objective and signed.

The rules of charting: record at the time or as soon after as possible, in chronological order with the date and the 24-hour time, in permanent ink, legibly, using only the hospital's approved abbreviations, objectively — what was observed and measured, with the patient's own words in quotation marks — never opinion, every entry signed with name and designation, no blank lines left for a later entry and nothing erased.
An error is corrected by drawing a single line through the wrong entry so that it can still be read, writing 'error' or 'wrong entry', initialling and dating it and then writing the correct entry; correction fluid, overwriting, scribbling out or removing a page are alterations of a legal record; a late entry is labelled as late with the actual time it was written.
After an incident such as a fall the record carries the facts — the time, what was found, the assessment done and the care given — and never the words 'incident report filed'; the incident report is a separate document for the quality system and is not part of the patient's record.
Records are patient records (the admission sheet, nursing assessment, care plan, TPR and intake–output charts, the medication administration record, nurses' notes and the discharge summary), ward records (census, admission and discharge register, duty roster, inventory and equipment registers, the incident register) and legal or statutory records (consent forms, birth and death registers, the medico-legal case register and police intimation); the charting methods are narrative, SOAP and SOAPIE, PIE, focus (DAR) charting, charting by exception and the problem-oriented record.
Reports carry the record between people: the change-of-shift handover, at the bedside or the desk, in a structured form such as SBAR; transfer and discharge reports; the incident report; the ward sister's daily and monthly reports on census, staff and incidents; and telephone reports and orders, which are read back and countersigned by the prescriber within the time the hospital's policy sets.
Records belong to the hospital and the information in them to the patient: access is limited to care, audit and a lawful demand, inpatient records are retained for the period the hospital's policy and the state's clinical-establishment rules set (three years is the common minimum) and medico-legal records until the case is closed, and electronic records follow the same rules with an audit trail, a personal password never shared and a log-out after every entry.

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