2. Aim:

Safety audit is aimed at assessing the adequacy of patient safety management system in the organization through:

i. Hazard identification and risk analysis

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ii. Review and analysis of the adverse events with a view to identify the causes

iii. Identifying the deficiencies in the system

iv. Suggesting the corrective measures

v. Evaluating the effectiveness of corrective measures after a predetermined period. The process of re-audit and evaluation continues until the deficiencies have been eliminated. Safety Audit can be Internal (conducted by own team of auditors trained in safety audit) or it can be External, where a team of experts from outside the organization comes and audits the safety system in the organization.

3. Safety Audit can be Retrospective or Concurrent:

Retrospective audit is based on retrospective review of the records of adverse events, their causes identified and the corrective actions taken.

Concurrent audit is the real time adult of the efficacy of safety system by observing the processes and activities in the course of occurrence.

Unannounced surveys by surveyors of JCI, is an example of such audits. The audit is carried out by using a patient safety check list of criteria related to the safety related standards.

In a study conducted in Children’s Hospital, Boston, USA (2003) a check list containing 36 criteria and focusing on errors associated with delays in care, equipment failure, diagnostic studies or information transfer, was used. The audit was conducted real time during and after the morning work rounds.

In a period of 5 weeks a total of 338 errors of a broad range were detected such as unlabeled medication on the bed side, ID band missing or at wrong place, faulty alarm was setting on the pulse oxymeters or delays in communication information transfer leading to delayed care.

The advantage of concurrent audit is that many of the errors are detected in time and often prevented before the damage is done to the patient. It also leads to speedy changes in policies, protocols and practices and feedback to the staff concerned.

4. Criteria for the Audit:

The criteria selected for the audit should be simple, objective and relevant to the safety hazards and standards applicable and prescribed in the Safety manual of the organization or the accreditation standards applicable to the organization.

It is also important that whatever safety hazard is being studied, it should be studies in all aspects so that all the error prone elements are attended to.

For instance, for elimination of the risk of medication errors some of the criteria selected for the check list could be:

1. Correctly written doctor’s orders

2. Verification of high risk drug orders

3. Correct drug identification by the nurse

4. Correct patient identification by use of at least two identifiers other than the room number

5. Record of patient’s drug allergies

6. Record of medications prior to hospitalization.

5. Aspects Important to the Audit:

To be complete and meaningful, a safety audit should include a review and evaluation of:

1. The patient safety management system including the identification of safety hazards in the organization and the safety measures adopted.

2. Actual implementation of the system by the care givers.

3. Record of the adverse events, their causes, corrective measures taken, their effectiveness and the system of reporting of adverse events.

4. Observations during the last audit and the actions taken on them.

5. Comparison of the overall current Hazard Potential of the hospital with that assessed by the previous audit.

The scope and objectives of safety audit should be clearly defined and the process planned in detail before commencement of the audit.

The audit is carried out using standard methods and techniques and the observations/interpretations/conclusions should be recorded to provide a documented feedback. To be meaningful, the audit must be objective and completely free from any bias or conflict of interests.

6. Patient Safety Check List for Safety Audit:

Following are some of the safety related check points for carrying out Safety Audit in the hospital. The list can be suitably expanded/modified depending upon the requirement.

The list should be finalized in the beginning of the year and once finalized; it should be adhered to without any changes.

1. Does the hospital have a documented safety management program?

2. Does the hospital have a safety management committee that is functional and active?

i. Did the committee carry out half yearly Hazard Identification and Risk Analysis (HIRA) in every area of the hospital? Are the records available?

ii. What hazards were identified during the survey?

iii. What corrective actions were taken to eliminate the hazards detected?

iv. What was the impact? Were the actions taken effective in eliminating the risk?

v. Did the safety committee have regular monthly meetings as per the fixed schedule?

vi. What safety issues were discussed in the meetings?

vii. Does the Safety Committee receive and scrutinize the reports on safety training carried out such as fire safety drills?

viii. What were the major accomplishments of the Safety Committee over the course of the past year?

3. Did the hazard identification survey include equipment safety also? If so:

i. What equipments were identified as safety hazards and what were the remedial measures taken?

ii. What was the impact of actions? Did the equipment become fully operational and reliable? If not what actions were taken?

iii. Was the equipment maintenance program found effective? If not, what were the problems and what remedial measures were taken?

iv. Is there a planned schedule of recalibration of equipment? Is it being followed?

v. Were the equipment users given any training in correct usage and maintenance of equipment?

4. What sentinel/adverse/near miss events happened/were reported in the hospital during the past year?

i. Were all these events fully investigated?

ii. Is the record of all the adverse events available including the investigations carried out and the causes identified and the corrective measures implemented?

5. What was the recorded incidence of the following during the year compared to the incidence last year?

a. Cases of medical negligence during the year:

i. Deaths due to negligence

ii. Wrong patient/wrong site/wrong surgery

iii. Medication errors

iv. Sampling errors

v. Incidence of pressure ulcers

vi. Post operative deaths

vii. Complaints received from the patients

viii. Incidence of variation between the preoperative diagnosis and the tissue report.

b. Instances of physical safety violations during the year:

i. Instances of physical assault, molestation/rape of patients

ii. Instances of theft/swapping of babies

iii. Instances of theft of patient’s property

iv. Instances of suicide by patients

v. Instances of burns (electric cautery, hot water bottle, physiotherapy equipment

vi. Instances of slip/trip/fall

vii. Instances of power failure leading to complications/deaths

viii. Instances of complications/deaths due to equipment failure

ix. Instances of fire, major or minor and the losses suffered

x. Instances of lift failure/accidents

xi. Instances of building collapse/fall of plaster from ceiling/walls.

6. Does the hospital have an effective infection control program?

i. Availability of infection control manual

ii. Availability of infection control committee

iii. Availability of a full time Infection control nurse

iv. What is the incidence of HAI?

v. Incidence of surgical site infection (SSI)

vi. Incidence of catheter related infection

vii. Incidence of needle stick injury cases

viii. Is there any improvement over the incidence recorded last year?

7. Did the hospital have the following committees functional and effective?

i. Quality Management committee

ii. Equipment Management and Equipment Audit committees

iii. Drugs and Therapeutics committee

iv. Medical and Nursing audit committees

v. Hospital Ethics committee

vi. Blood Transfusion committee.

8. Was the half yearly facility inspection carried out by the Medical Superintendent?

i. What was the safety related observations?

ii. What corrective actions were taken and when?

9. Were there any safety related problems projected by the Heads of Department?

i. Were adequate solutions found and actions taken?

ii. Have those problems been solved?

10. What were the criteria set for annual evaluation of success of the Safety Management Program?

11. What were the budgetary allocations for improvement in safety? Were the funds adequate?

12. What was the report of the internal audit carried out?

13. What is the overall hazard potential of the hospital compared to the previous year?

14. What are the goals and objectives set for the Safety Management Program for the current year?