In the previous article, the incorporation of “design and development of products and services” into the healthcare sector has been discussed (Clause 8.3 of ISO-9001:2015)
This article outlines the importance of incorporating “risk based thinking” of ISO-9001 into healthcare services (this is the core concept of ISO-9001:2015. Refer 0.3.3 and A.4)
ISO-9001 focuses on Performance Indicators - this can be considered similar to the Quality Indicators of NABH
The quality management principles of ISO-9001 are very much applicable to the quality management practices of the healthcare sector
Given below is a short diagrammatic representation of the perfect alignment of “risk based thinking” of ISO-9001 with the “risk based approach” of healthcare services
In ISO-9001 “risk based thinking” is the core concept of all quality related activities, viz., identifying the risks that may hamper performance and at the same time identifying the opportunities that may enhance performance
Risk assessment and risk management automatically become an integral part of all patient care and support service activities; a lot of Preventive Actions (controls) are required to be implemented at every level to prevent any potential mishap and ensure patient safety in error-free service delivery
In ISO-9001:2015 there is no separate provision for Preventive Action, because preventive action is an integral part of “risk based thinking”, which provides for a strong Quality Management System (refer A.4). There is provision only for Corrective Action as a tool for further improvement, in other words, continual quality improvement (refer Clauses 9.2.2, 9.3.2, 10.1, 10.2)
Important aspects of “Risk Based Thinking”:-
One - Patient safety risk
Two - Business risk
Three - Reputation risk
The first two risks are tangible and the third risk in intangible, and all three are interlinked - any problem in one will have a negative impact on the other two
Retain records of all crucial findings, recommended actions, actions taken, gap between desired results and actual results. This will be helpful in finding opportunities for improvement
In all your risk analysis exercises, take into account the statutory and regulatory requirements
Patient Safety risk
Patient safety is the core of all healthcare services all over the world. Therefore, take into consideration the risks associated with services during the delivery process and also post delivery
Identify the possible risk factors in your patient safety goals. Remember to identify the possible risk factors also in your infection control activities
Some examples - zero medication error, zero wrong patient wrong surgery, zero patient fall, zero ventilator associated pneumonia, zero urinary tract infection, zero surgery related infection at site of suture
Business risk
When you are considering the needs and expectations of the interested parties, do a thorough analysis of the potential and present risks involved. These interested parties are directly and indirectly involved in your hospital’s processes, and are directly and indirectly affected by those processes. This risk analysis provides scope for recognizing opportunities for further improvement (continual quality improvement), which is required for sustaining the business
Risk analysis of outsourced services should also be included in your business risk assessment, viz., Housekeeping, Security, Catering, Pharmacy, Blood Bank, Ambulance, Laundry, Biomedical Engineering
Reputation risk
Harm to the reputation of a business organisation is a very well-known aspect
The healthcare organisation should also do a reputation risk assessment, because the healthcare sector often comes into the news for all the wrong reasons; more so because the sector deals directly with human lives
Because reputation risk is intangible, therefore a thorough analysis of the potential risks should be carried out
One - Determine what could be the potential risks or accusations
Two - Rate them as per the probability and severity (chances of occurrence and the impact)
Three - Determine the control measures (Preventive Action)
Four - Device contingency plan to tackle a situation in case it actually does occur
Five - Set a periodic review process for the controls and contingency plans. Based on the review results, make changes if required
Six - If reputation risk actually does take place, then it should be dealt with quickly and most effectively
Guideline given here should enable a healthcare center to carry out the risk analysis of its services in an effective manner, to enhance patient safety and customer satisfaction
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