Friday, February 24, 2023

Quality Objectives of ISO-9001 incorporated into Healthcare Services


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In the previous article, the importance of incorporating “risk based thinking” into the healthcare sector has been discussed
This article further outlines the importance of risk based thinking by emphasizing the importance of Quality Objectives (Clause 6.2 of ISO-9001:2015)

Risk based thinking is the platform for setting Quality Objectives, this is the doorway to opportunities for improvement and continual quality improvement
Quality Objectives are to ISO-9001, as are the Key Performance Indicators to NABH (refer Annexure)
Monitoring Key Performance Indicators (KPI) in NABH is mandatory and all the NABH accredited healthcare centres have to mandatorily conform to this requirement. The methodology to be used for capturing and monitoring the KPI data have been outlined in the Annexure itself. But ISO-9001 has not defined any parameters for Quality Objectives, your hospital is free to define and set its own Quality Objectives as per the requirements of your patient care processes

Importance of setting Quality Objectives in patient safety goals
In addition to the mandatory KPIs, your hospital should also set Quality Objectives to further strengthen the quality improvement initiatives
It is essential to set Quality Objectives for all the critical patient care activities, this will enable your hospital to monitor the critical activities more accurately (examples - time taken to register patients, time taken to issue STAT report, time taken to issue medicine from Pharmacy Store during non-working hours)
While defining the Quality Objectives, you will realize that many of these critical activities are already a part of your patient safety goals and risk management plan, or are included in the mandatory KPIs

REMEMBER that Statutory and Regulatory requirements cannot be set as Quality Objectives because these are requirements which have to be complied with mandatorily (examples - Timely renewal of PNDT License, Timely submission of infectious diseases data to the Municipal Corporation)

Objectives are quality tools for monitoring, measuring, reviewing, and maintaining the success and sustainability of patient safety goals
The most important aspect of Quality Objectives is that once achieved, the goals should be sustained and maintained successfully

ISO-9001 demands that a documented information for Quality Objectives should be maintained (Clause 6.2.1). Incorporate this requirement into your healthcare processes
Here, maintaining a documented information means preparing and maintaining a documented process or methodology
Your documented information can be a Work Instruction, outlining the steps to be followed in identifying and setting an objective; further actions that should be taken to ensure achievement of the objective
The Work Instruction should be made available to everyone for reference

This is how you can prepare the Work Instruction for identifying and setting Quality Objectives
General Guidelines
All the departments shall have Quality Objectives for all critical activities and opportunities for improvement
There shall not be any limitations to the number of Quality Objectives a department can set (it can be just one or it can even be 10 or more)
For every Quality Objective the department shall chart out roles and responsibilities of the staff

Now coming to the actual step-wise guidelines
Step 1 - the department shall identify the critical activities / opportunities for improvement and set the objectives (examples - bed sore; phlebitis; needle stick injury; breakdown time and up time of critical medical equipment)
Step 2 - once the objectives have been set, the department shall analyse the risks associated with the objectives (this risk assessment shall be done also from the business risk point of view). A separate risk management programme shall be initiated for all the identified potential risks
Step 3 - the department shall lay down the course of action to achieve the objectives
Step 4 - all the objectives should shall be bound by a time frame (examples - 1 week, 1 month, 3 months, 1 year)
Step 5 - all the objectives shall be quantifiable (measurable in terms of numbers, percentages, units)
Step 6 - the Quality Objectives shall be practically achievable, measurable, and monitorable. Once achieved, they shall be sustainable
Step 7 - the department shall implement a review process for each Quality Objective, to determine the progress made. The review may be done at intervals of 1 week, 3 weeks, 2 months, quarterly, half-yearly, etc., depending on the criticality and importance of each Quality Objective. The more critical ones shall be reviewed more frequently
Step 8 - even after achieving a Quality Objective, it shall be monitored and reviewed periodically, to ensure that the achievement is being sustained. If the nature of the Quality Objective is such that after achieving the target it does not require to be monitored further, then the same shall be mentioned in the Quality Objective format

The following standardized format shall be used by all the departments for capturing, monitoring, reviewing, and measuring each Quality Objective. In this format, the right column is required to be filled in with details

Factor identified for setting as an objective

 

Process / Function to which the factor belongs

 

Location / Department

 

Current statistics

 

Objective to be achieved

 

Date of setting the objective

 

Time frame for achieving the objective

 

Frequency of review

 

Quantifiable in terms of (tick whichever is applicable)

Numbers  /  Percentages  /  Units

Person(s) entrusted with the objective

 

Responsibilities and authorities of the person(s) described briefly

 

Proposed course of action to achieve the objective

 

Reviewed on date

 

Whether target has been achieved (tick whichever is applicable)

Yes     /     No

What are the statistics on review

 

Reasons for not achieving the objective

 

Revised objective

 

Revised course of action to achieve the objective

 

Next review date

 

Whether target has been achieved (tick whichever is applicable)

Yes     /     No

What are the statistics on review

 

Reasons for not achieving the objective

 

(Note :- in this way, the format will continue till the target is achieved)

 

If the objective has been achieved, filling up this column is mandatory

Does the objective require continuous monitoring even after achievement (tick whichever is applicable)

Yes     /     No

If yes, then please use the subsequent format



If the nature of the objective is such that it needs to be reviewed and monitored even after the target has been achieved, then the department shall use the following format

Name the achieved objective

 

Achieved target

 

Achieved on date

 

Monitoring will continue (tick whichever is applicable)

Daily / Weekly / Monthly / Quarterly

 

Review frequency (tick whichever is applicable)

Quarterly / Half-yearly / Yearly

 

Whether the achieved target is being sustained (tick whichever is applicable)

Yes  /  No

Further details required to be documented, if any

 



I have made the above Work Instruction a bit lengthy because I wanted to capture all the details of setting a Quality Objective. Once you understand the requirements, you should be able to prepare your own Work Instruction as your own judgement

All the Quality Objectives that you set should be:-
Practically achievable - do not set a target which cannot be achieved
Measurable - should be quantifiable, that is why objective should always be set in numeric / percentages (examples - 25 minutes, 60 days, 0 deviation, 15%)
Monitorable - measuring and monitoring are actually done together. While measuring the achievement you are also monitoring the progress or regress
Bound by a time frame - you should be able to achieve an objective within the defined time frame (examples - 1 month, 3 months, 1 year)
Once achieved, should be sustainable - the nature of an objective may be such that you will be required to continue monitoring and reviewing it even after it has been achieved, to ensure its continued sustainability

Periodic of review of all Quality Objectives is mandatory to ensure that they are moving along the desired target path
It is mandatory to retain evidences (records) of all activities related to Quality Objectives and, of course, the Key Performance Indicators

This guideline should enable your hospital to define and set Quality Objectives, to enhance patient safety and customer satisfaction

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