The committee should have clearly spelt out objectives, system of functioning and authority matching the responsibility. It has the following broad responsibilities:

i. Quarterly facility inspection rounds of the hospital to identify any hazards requiring corrective actions

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ii. Investigation of all adverse events

iii. Recommend corrective actions

iv. Review of effectiveness of the corrective actions implemented.

3. Every department/service should be asked to identify all known/possible hazards in their area of activity and put up recommendations after thorough intradepartmental discussions among the entire staff.

4. After scrutiny of the reports and on site study of the problems, the PSMP committee should prepare a report about the hazards identified, priorities allocated, the actions warranted, an estimate of the funds required and the time frame for implementation of the program.

5. A practical and proactive approach like HFMEA may be utilized where possible for risk identification and prevention.

6. There must be a system of regular periodic (at least half yearly) inspections of the facility by the administrator along with the chief of maintenance services. The observations must be documented along with the corrective actions taken.

7. The program must include:

i. Regular planned maintenance of the facility along with the allocation of funds

ii. Planned preventive maintenance of all the equipment to make it fully operational and reliable at all times

iii. An ongoing Fire safety program, with special emphasis on training of staff in fire fighting drills, periodic mock drills with a record of observations/actions recommended/taken, a system of planned preventive maintenance of firefighting equipment and annual inspection by the local Fire service

iv. An unobtrusive and yet effective security system with detailed protocols for safety/ security of patients, particularly the vulnerable groups

v. A reliable hazard free power supply. This will include high quality safe cabling/ wiring, periodic inspection/repair of all connections/switches/sockets in every department and eliminating all loose wire connections to prevent any electric fires/ electrocution. Overloading of sockets due to their paucity is quite hazardous and should be avoided providing adequate number of good quality sockets as required.

8. Approach to safety must be based on safe practices.

i. Display of warning signs to forewarn the people about the possible hazards such as waxing, washing/cleaning of the floors

ii. Denial of access to the roof tops and the power plant/high voltage equipment areas, radiation hazard areas in radio diagnosis/ radio therapy/nuclear medicine

iii. Enforcing the use of personal protective equipments while performing the hazard prone jobs

iv. Protective vaccination of staff at high risk of infections

v. An efficient system of surveillance and reporting of events so that no events are missed by the staff assigned responsibility of collection and processing the data.

9. Simultaneously, the departments may be asked to prepare their standard working protocols based on best practices, starting with the activities involving commonly occurring/serious hazards.

10. The protocols, duly scrutinized by the committee, and approved by the MS may be issued as official documents for implementation wherever applicable.

It may be noted that these protocols are expected to be the outcome of collective thinking by all concerned and therefore, should be prepared after active discussions and involvement of all concerned staff.

Further, the recommendations should be such as are practically possible and not just theoretical.

11. The standardized protocols may specially address the live problems such as mentioned below:

i. Medication errors, sampling errors, wrong reporting, occurrence of bed sores, thermal burns, wound infections

ii. Wrong patient/wrong site/wrong procedure (surgical/non surgical).

iii. Hospital acquired infections, with particular emphasis on protection of vulnerable patients/patients with compromised immunity (HIV/AIDS cases, burns cases/1 patients on cytotoxic drugs/steroids).

iv. Physical safety and security of patients, especially new born babies /female patients.

12. Hospital must have a documented procedure for credentialing and privileging of manpower.

13. A documented program of clinical/nursing audit with special protocols for review, investigation of all cases with complications/nosocomial infections/unexpected events and all unexpected/unnatural deaths.

14. A formal, effectively functioning Ethics Committee with

i. A policy and procedure for approval / monitoring and control of all experimental research activities as per the ICMR Guidelines

ii. Responsibility for monitoring and ensuring compliance with the Code of Professional Conduct prescribed for doctors and other staff.

15. A documented system of reporting/monitoring and analysis of all Sentinel/adverse events, (even near miss events) and maintaining a record of the causative factors and preventive/corrective actions taken. All events must be subjected to root cause analysis to detect the exact cause or failure mode.

16. Indemnity insurance policy of a suitable amount for protection of the hospital again all legal liabilities arising out of any harm to patients, public or staff.

17. Insurance of all buildings and costly equipments.

18. Professional Indemnity policy taken by all the doctors on the panel of the hospital.

19. A system of periodic safety audit and annual review of effectiveness of the PSMP on the basis of predetermined criteria such as:

i. Overall and event specific incidence of sentinel/adverse/near miss events

ii. Incidence of recurrence of adverse events in spite of implementation of corrective actions

iii. Incidence of new/unforeseen adverse events

iv. Known hazards against which preventive/corrective actions could not be taken because of lack of funds or other reasons

v. Number of safety violations leading to litigation

vi. Quantum of losses (human lives, monetary) due to adverse events compared to previous years

vii. No. of hazards identified and the overall hazard potential (HP) calculated as compared to the previous year. There should be a progressive fall of the overall HP every year, so that there is no hazard with individual HP.