Challenges in implementation of FMS as per NABH stds

Dr. Sidhartha Satpathy Professor, Deptt of Hospital Admn AIIMS, New Delhi

Presentation Format
Introduction to FMS Why is safety required? S d d i Standards in FMS S Challenges faced in hospitals Country specific issues! The way forward Conclusion

Introduction to FMS chapter

Forms o s major ajo co component po e t o of t the e structure st uctu e criteria defined by Prof. Donabedian. g Gets a lot of attention as it is tangible! Consumes substantial amount of the capital expenditure in any hospital/project. A large number of statutory issues have to be coordinated with various agencies. Covers disaster management issues involving the hospital and local agencies.

Intent
Provision of a safe and secure environment for patients, families, staff & visitors. Conducts regular Facility Inspection rounds, and takes appropriate action to ensure safety. Provides for safe water, electricity and manifold system. Program P f clinical for li i l and d support t service i equipment i t and d management. Plans for emergencies g within the facilities and the community. Manages hazardous materials in a safe manner
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Why is safety required?

Massive fire at AMRI hosp, 90+ persons lost their lives incl 4 staff

Why is safety required?

Newborn dies, parents file complaint against hospital
TNN Oct 27, , 2012, , 04.23AM IST
Neonatal Intensive Care Unit| Institute of Medical Sciences KOLLAM: The parents of a two-day-old baby, who died at the Shanker's Institute of Medical Sciences (SIMS) here on October 19, has alleged negligence on the part of the hospital authorities for the death. Based on a complaint by Shyamkumar, the father of the newborn, Kollam East police have registered a case against the hospital authorities authorities. Shyamkumar has alleged that the hospital authorities cheated him and his relatives by hushing up the real reason behind the death of the child. "There was a large burn on the back of the child and we were not informed about it," he said. It was on October 17 that Shyamkumar's wife, Bismi, was admitted to the hospital for her second delivery. She gave birth to a baby girl the next day. The child looked healthy and weighed around 2.5 2 5 kg at the time of birth. birth On the night of October 19 19, the baby was taken to the Neonatal Intensive Care Unit (NICU) by one of the nurses saying that the child had developed some complications. Shyamkumar said the child looked healthy then. By next day morning, he was informed that the baby's condition was serious and it was put on ventilator. But, it was on Sunday last that Shyamkumar got to see the large burn mark on the back of the baby in the photographs taken during the time of preparing the inquest. One of his relatives, a doctor, suggested that the burn might have been caused by the incubator or warmer in the NICU.

Why is safety required?

Incubator deaths at Rajendra Hospital Patiala in 2010, faulty indigenous equipments blamed

Why is safety required?

Disaster affected hospital, where 50+ patients died

FMS.1 FMS. The organization has a system in place to provide a safe and secure environment
Safety committee coordinates development, development implementation, ..... P i Patient safety f d i devices are installed i ll d across the h organization and inspected periodically. Facility inspection rounds-Once or twice/year, documented, corr & prev action taken
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FMS.2:The orgns environment and FMS. facilities operate to ensure safety of patients, patients their families, families staff and visitors
Facilities are appropriate to the scope of services of the organization. Up-to-date drawings are maintained which detail the site layout, floor plans and fire escape routes. routes Adequate space, signposting, potable water & y, testing, g, and maintenance p plan electricity,
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FMS.3 The organization has a FMS. programme for engineering support services
a) The organization plans for equipment b) Equipment E i t is i selected, l t d rented, t d updated d t d or upgraded by a collaborative process. c) Equipment are inventoried and proper logs are maintained as required. d) Qualified & trained personnel operate, operate documented maintenance plan for elec, HVAC water tanks, DG sets, BMW equipment etc
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National Building Code

First Edition 1970 First Revision 1983 Second Revision 2005 Ten Chapters 1040 pages Published by BIS

NBC 2005 : An Overview

Single g document in which info from various Indian Standards is compiled It lays down minimum provisions designed to protect the h safety f of f the h public bl esp. with h regard to
Structural sufficiency Provisions related to EQ safety Fire hazards & safety y Health Aspects of buildings

NBC 2005 : An Overview.

It also covers aspects p related to
administration of regulations development control rules general building requirements stipulations regarding construction materials rules for design of electrical installations, lights, A/c, lifts requirements i of f ventilation il i and d accousties i requirement of plumbing services viz. water supply, drainage and sanitation measures for safety of public/workers rules erection of signs and outdoor display structures

NBC- 2005 : CONTENTS NBC

Part 0 : Part 1: Part 2: Part 3: Part 4: Part 5: P t 6: Part 6

Integrated approach Definition Administration Development p Control Rules and General Building requirement Fire and Life Safety Building materials St t l design Structural d i
Loads, forces and effects Soils and foundation Timber and Bamboo Masonry Concrete (Plain, reinforced, pre-stressed) Steel Prefabrication, systems building and mixed/components construction

NBC- 2005 : CONTENTS NBC

Part 7: Constructional practices and safety Part 8 : Building services
Lighting and ventilations A/c, Heating and mech. Ventilation Accousties sound installation and wire control Accousties, Installation of lifts and escalation

Part 9 : Plumbing g services Part 10: Landscaping, signs and outdoor display structures

FMS.4 The organization has a FMS. programme f for b bio-medical d l equipment management
a) The organization plans for bio-med equipment b) Equipment E i t are selected, l t d rented, t d updated d t d or upgraded by a collaborative process. c) Equipment are inventoried and proper logs are maintained as required. d) Equipments are operated by qualified & trained staff, periodically inspected & calibrated, proper maintenance plan.
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Medical Device(WHO & GHTF)

device'- means any instrument, apparatus, implement, l machine, h appliance, l implant, l in vitro reagent or calibrator, software, material or other similar or related article:

`Medical

a) intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of: -diagnosis, prevention, monitoring, treatment or alleviation of disease, -diagnosis, monitoring, treatment, alleviation of or compensation for an injury, -investigation, replacement, modification, or support of the anatomy or of a physiological process, -supporting or sustaining life, -control of conception, -disinfection of medical devices, -providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body;
b)

M di l D Medical Device i (D (Definition fi iti )

which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means.

Medical Equipment(WHO)
Medical devices requiring calibration, calibration maintenance, repair, user training and decommissioning- activities usually managed decommissioning by clinical engineering. Medical equipment is used for the specific purposes of diagnosis and treatment of disease or rehabilitation following disease or injury. injury

Medical devicesdevices adverse events

Each year about 400 people are killed or seriously
injured in adverse events involving medical devices as p per study y in NHS, , UK In a study published in 2004 by Brockton J Hefflin et al in USA, during a one year period, reports of 10,395 medical deviceassociated adverse events were accumulated using the National Electronic Injury Surveillance System(NEISS)

Medical devices-adverse devices adverse events..

Study by L Beydon et al of the French government database (maintained by the Agence Francaise de Securite Sanitaire des Produits de Sante), devices for ventilation and infusion, and monitors of all kinds accounted for most of the reports, representing 37%, 30% and d 12% respectively, ti l of f all ll reports. t

Medical Equipment issues!!

Technology Review(2012) 664 medical equipments at Beth Israel Med Center were found using outdated operating systems with risk of malware infections

FMS.5 The organization has a FMS. programme for medical gases, vacuum and d compressed d air
a) Documented procedures govern procurement, handling, storage, distribution, g and replenishment p of medical g gases. usage b) These are handled, stored, distributed and used in a safe manner c) Safety issues, alternate sources, operational & breakdown plan should be available.
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FMS.6 The organization has plans FMS. for fire and non-fire emergencies within i hi the h facilities f ili i
a) The organization has plans and provisions for early detection, abatement and containment of fire and non-fire emergencies. g b) Documented safe exit plans must be available, and staff trained reg their role c) Mock drills shd be held at least twice in a year, and service maintenance plan for fire eqpt. eqpt
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Evacuation of patients

Table top exercises and mock drills will not succeed during actual disasters!!

FMS.7 The organization FMS. g plans for p handling community emergencies, epidemics id i and d other th disasters di t
a) The organization identifies potential emergencies. b) The Th organization i i has h a documented d d disaster di management plan, tested at least twice/year c) Prov of medical supplies, eqpt; along with staff training reg their role.
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FMS.8 The organization has a plan FMS. for management of hazardous materials
a) Hazardous materials are identified within the organization. i ti b) The organization implements processes for sorting, labelling, handling, storage, transporting and disposal of hazardous material. c) ) Plan Pl f managing for i spills ill with i h staff ff education d i and training in handling such cases.
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Safety Culture
The way things are done around here when no one is here.when looking!

Stuart Matthews