The organisation plans for equipment in accordance with its services and strategic plan.  (This shall also take into consideration future requirements. The equipment shall be appropriate to its scope of services. A good reference for minimum equipment is the IPHS guideline).

Equipment are selected, rented, updated or upgraded by a collaborative process. (Collaborative process implies that during equipment selection there is involvement of end-user, management, finance, engineering and biomedical departments. The organisation could define differential financial clearance in accordance with the policy. For example, purchase of BP apparatus can be done by the departmental head).

Equipment are inventoried and proper logs are maintained as required. (A unique identifier is provided for each equipment. This includes equipment on a rental basis and equipment kept for demonstration purpose. The relevant quality conformance certificates/marks along with manufacturer factory test certificate needs to be retained as part of documentation for all equipment).

Qualified and trained personnel operate and maintain the medical equipment. (The operator of the medical equipment is trained to use medical equipment in safe and effective manner. Eg: Nurse trained to use Blood gas analyser, ECG machine and syringe pump etc Maintenance of bio-medical equipment shall be done by a bio-medical engineer/technician or instrumentation engineer/technician with relevant training and experience.).

Equipment are periodically inspected and calibrated for their proper functioning. (The organisation has weekly/monthly/annual schedules of inspection and calibration of equipment, which involve measurement, in an appropriate manner. The organisation either calibrates the equipment in-house or outsources, maintaining traceability to national or international or manufacturer‘s guidelines/standards. The organisation shall ensure that calibration and conformance testing of the equipment has been done prior to commissioning).

There is a documented operational and maintenance (preventive and breakdown) plan for equipment. * (The operator is trained in handling the equipment. The operational plan must assist the operator in operating the equipment on a daily basis. The original equipment manual is a good source for this. In case this is not available the organisation shall develop the operational plan for the concerned equipment. The operational plan of medical equipment includes evaluation of safe usage of equipment like validation with respect to instruction manual, user training on equipment, operational check of equipment and verification of set parameter .The maintenance plan includes periodic checks, execution of timely preventive maintenance, and response to any breakdown issues including at night & weekends. There shall be a planned preventive maintenance tracker).

There is a documented procedure for equipment replacement and disposal. * (The organisation shall plan for this keeping in mind the strategic plans, upgrade/update path and the equipment log. Organisation shall condemn(dispose) equipment in a systematic manner).

The procedure addresses medical equipment recalls. * (Recalls are on based on letters/hazard notice issued from manufacturer and or from regulatory authorities. This may not be a routine occurrence but whenever hospital authorities receive or become aware of such recalls, it should be immediately acted upon and the said medical equipment should not be put into further clinical use till the issue is resolved).

Response times are monitored from reporting to inspection and implementation of corrective actions.  (A complaint attendance register is to be maintained (physical or electronic) to indicate the date and time of receipt of complaint, allotment of job and completion of job. Completion of the job should always be ratified by the user department).

The management is conversant with the applicable laws and regulations and undertakes the responsibility to adhere to the same. (The management of the hospital is conversant with the different statutory requirements as per the scope of services and ensures to adhere to the same. The hospital conducts its functioning as a duly permitted legal entity in accordance with the relevant registering authority(s). The Head of the hospital gives an undertaking in a standardised format that he/she is conversant with the applicable laws and regulations and has adhered to the same).

The organisation has a formal documented agreement for all outsourced services.  (The agreement shall specify the service parameters. Even if a sister concern is providing services, there shall be an agreement with that unit).

The organisation monitors the quality of the outsourced services.  (The frequency of monitoring shall be determined by the organisation but shall not be less than once year. This shall be done keeping in mind the criticality of that service towards providing patient care. It is preferable that the monitoring be done as per the service standards laid down by the organisation).

Monitoring includes utilisation of space, manpower and equipment. (Critical equipment down time).

The organisation has appropriate engineering controls to prevent infections. * (This shall include the design of patient care areas (optimum spacing between beds is one-two metres), operating rooms, air quality and water supply. Issues such as air-conditioning plant and equipment maintenance, cleaning of AC ducts/filters, AHUs, cleaning / replacement of filters, see page leading to fungal colonization, replacement/repair of plumbing, sewer lines (in shafts) should be included. Water-supply sources and system of supply, testing for water quality must be included. Any renovation work in hospital patient-care areas should be planned with infection control team with regard to architectural segregation, traffic flow, use of materials, etc. Refer to NABH guidelines on OT air-conditioning).

Appropriate facilities and equipment/appliances/instrumentation are available in the operating theatre.  (The organisation shall ensure that the operating theatre has facilities for pre-op holding, separate changing rooms for males and females, hand-washing area, operating rooms, waiting area for relatives, storage area, collection area for waste and linen and recovery room. In addition to the equipment required for anaesthesia and surgery, there shall be equipment for resuscitation, radiation protection (where applicable) etc.

Scope of Department.

Staff Interview.