ISO-7101:2023 for Healthcare - Healthcare Quality Management System

ISO has released the 1st edition of Healthcare Organization Management (HOM), requirements for management systems for quality in healthcare organisations

It is based on Annex SL structure of 10 Clauses, where auditable Clauses are from 4 to 10

Here I have given a brief overview of these auditable Clauses and those requirements which I feel are important. Later on in my other videos, I shall give a detailed analysis of the auditable clauses

On going through the Clauses, it is obvious that many aspects have been taken from NABH, to align with its requirements

Clause 4 - Context of the Organization

What is important?

Here your hospital is required to determine whether climate change is a relevant issue or not, and whether your stakeholders have any requirements related to climate change

Under clause 4, one more important requirement is your scope should include both clinical and non-clinical activities, and you are also required to consider those clinics, sites or outreach centres where services are being provided by you

Clause 5 - Leadership

What is important?

Out of many I have identified the following as the important ones:-

1. Defining a code of conduct
2. Creating a culture of quality by implementing, empowering and rewarding quality monitoring across the organisation
3. Promoting safety for service users
4. Promoting safety and wellbeing of the workforce
5. Ensuring transparency of communication and knowledge management
6. Ensuring impartiality, confidentiality and privacy are maintained and monitored

A very important requirement is that the healthcare Quality Policy should also be communicated, understood, and applied to services that are provided at a distance, like mobile and satellite clinics, health outposts, outreach centres, and professionals providing telehealth

Under Clause 5, the top management is required to demonstrate leadership and commitment towards service user focus (that means towards the patients)

This means:-

1. Meeting the requirements of the patients and ensuring that the patients are clearly aware of their rights
2. There is an established method for patient feedback and grievances, and resolving their issues effectively
3. Making changes to the hospital’s processes based on lessons learned from patients’ experiences
4. The top management is also required to create an environment of co-production to encourage the patients to participate in their own care

One more important requirement here is that healthcare services should be made available and affordable to the economically challenged, underprivileged and vulnerable sections of the society

Clause 6 - Planning

What is important?

Here risk identification, and risk management plan have been addressed in details, more in line with the requirements of NABH, including near misses, adverse events, and sentinel events

Your healthcare quality objectives should include assessment of patients’ experiences. You are also required to consider the socio-economic status, culture, and diversity of the patients

As per Clause 6, your hospital is required to consider the United Nations Sustainable Development Goals (SDGs) to establish the healthcare quality objectives

Clause 7 - Support

What is important?

Here “competence” has been given a lot of importance.

Your hospital is required to:-

1. Maintain a documented procedure for recruitment defining the requirements for competence, education, qualification, training, technical knowledge, skills, and experience
2. Maintain a documented procedure for credentialing and privileging of healthcare professionals and support workforce, as appropriate (support workforce here would indicate Nurses and Paramedics, and maybe also Dieticians)

In Clause 7, service user communication, clinical communication, and external communication have been added

Under service user communication, the hospital is required to:-

1. Provide information on services, rights and responsibilities
2. Handle enquiries, agreements or requests, and actions taken, if any
3. Obtain patients’ feedback regarding services, and also their complaints
4. Ensure that the feedback mechanisms are accessible, understandable, and are appropriate to the patient’s education level and access to resources

Under clinical communication, the hospital is required to:-

1. Safeguard the security and privacy of patients’ personal information
2. Ensure that verbal orders and communication of clinical results are controlled and verified for accuracy
3. There should be a proper system of maintaining the clinical records to demonstrate proper tracking of communication between different professionals and service sites
4. Communication containing personal health information should follow proper national or international standards of privacy
5. Maintain documented information about clinical communication training of employees

Under external communications, the hospital is required to define the communication channels with external parties

An important requirement of maintaining and retaining documented information is management and control of:-

1. The hospital’s Information Management System (IMS)
2. Electronic information
3. Audit of records

Your hospital’s IMS should be validated for its proper functionality. Whenever changes are made to the IMS, those should be tested and validated before implementation

IMS should be protected from unauthorised access, tampering and loss, there should be provisions for backup, and there should be contingency plans to prevent service disruption

If your hospital has outsourced IMS services to an external service provider, then you should ensure that the provider conforms to the requirements of this ISO Standard

Your hospital should have a process to decide how and when you will share data required by external databases and for reporting purpose

Clause 7 has further stated that there should be an established process for using and safeguarding electronic health information, maintaining proper backups of the digital files

Your hospital is required to maintain complete clinical records of every patient, and you should ensure that both the healthcare providers and patients have access to the clinical records in a timely manner

Your hospital is required to define and identify both what is considered as clinical records and non-clinical records, and you are required to conduct audits of both clinical and non-clinical records periodically

Clause 8 - Operation

What is important?

Clause 8 is too long containing 12 sub-clauses, and each clause has various sub-points. Here I have given a brief about the important requirements

Clause 8 is basically about:-

1. Controlling externally provided processes, products, and services, including services provided by governmental agencies
2. Hospital infrastructure and building maintenance
3. Monitoring the turnaround time for breakdowns and repairs of equipment
4. Safety and facility inspections
5. Having a maintenance plan of the entire hospital premises
6. Having adequate backups of water, electricity, and medical gases
7. Preventing water contamination
8. Conducting preventive maintenance of buildings, firefighting systems, air-conditioning systems, electrical systems, water supply systems and medical gas systems at predefined intervals
9. Conducting mock drills of emergency plans
10. Having properly displayed exit plans and assembly areas, and proper emergency evacuation plans
11. Proper maintenance of the air conditioning system, as per defined requirements, with provision for positive pressure and negative pressure rooms with proper air exchange facilities
12. Making provisions for unforeseen natural and manmade calamities
13. Having adequate fire detection, abatement and containment plan
14. Making provisions for personal protective gear to the workers who handle equipment and devices
15. Having adequate infection control implementations
16. Having emergency response plans for both man-made and natural calamities
17. Inspection and calibration of measuring equipment, with traceability certificates
18. Equipment and devices used for service deliveries should be identified and controlled (you can assign specific identification numbers to the equipment and devices)

Clause 9 - Performance evaluation

What is important?

To evaluate the performance of your hospital, you are required to establish a healthcare quality monitoring system in accordance with your hospital’s healthcare quality policy and quality requirements

The top management has to ensure that the quality monitoring system is effective and efficient, and produces time-sensitive and usable results

The organisation has to define which clinical and non-clinical indicators will be used to measure the effectiveness of its operations

The defined indicators should be in alignment with recognized national and international health indicators

Healthcare quality indicators should be identified on the basis of:-

1. Outcomes from clinical and non-clinical services
2. Patient safety issues
3. Adverse events
4. Clinical and non-clinical risk identification, minimisation and mitigation strategies and results
5. Delivering appropriate and continued care to patients, including during transfer to other healthcare facilities
6. Waiting time
7. Experiences of patients
8. Waste reduction efforts
9. Morbidity, mortality and quality of life and wellbeing

Your hospital is required to define the methods to be used by the quality monitoring system, which should mandatorily include:

1. Internal and external audits
2. Use of clinical and non-clinical indicators
3. Use of data from internal Health Information Systems (HIS)
4. Benchmarking

Your hospital is required to conduct internal audits at planned intervals

To ensure that the quality management requirements of your hospital:-

1. Conform to your own requirements and to the requirements of this ISO Standards
2. Is effectively implemented and maintained

This ISO Standard has specified that audit should be conducted at least once every 12 months. It is also ISO requirement that the audits should be conducted by trained and qualified individuals

The top management is required to conduct review of the hospital’s quality management system at planned intervals. It is preferable if you condut this review after conclusion of the internal audit

Clause 10 - Improvement

What is important?

Improvement activities should involve identification, management and reporting of non-conformities arising out of:-

1. Process deviations
2. Effectiveness of planning
3. Patient / family member feedbacks
4. Workforce performance
5. Workforce complaints and grievances
6. Undesired clinical outcomes
7. Risk management
8. Patient safety incidents and near misses
9. Internal audits

The organisation should empower all the relevant persons, including patients, their relatives and other visitors, to report real and potential non-conformities

I have covered the important aspects of all the auditable clauses to the best of my abilities. In my later blogs I will try to give detailed explanations of each Clause separately

Thank you for reading till the end 😊😊😊