CLINICAL AUDIT IN HOSPITAL - NABH 5th Edition - PSQ 5

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TABLE OF CONTENTS

Introduction
What is Clinical Audit
Clinical Audit team
Define the Frequency of Clinical Audit
Some Examples of Audit Parameters
Stages in Clinical Audit
Clinical Audit Documentation
 
 
INTRODUCTION

 

In this blog article, I have explained the Clinical Audit methodology for auditing NABH process conformance in a hospital (refer PSQ-5)

In NABH, there is requirement for both Clinical Audit (PSQ-5) and Medical Audit (IMS.7)

Both medical audit and Clinical Audit are quality tools by which the patient care processes can be monitored continuously for quality improvement and process improvement

I have shared my experience and observations here

 

 

WHAT IS CLINICAL AUDIT

Clinical Audit helps to improve the patient care outcomes through systematic review of clinical and medical processes and patient care services against defined audit parameters (criteria)

Clinical Audit is a peer group review

A clinical or medical process is selected, and all aspects of that process are audited to check :-

1. The appropriateness of care provided to the patients
2. The appropriateness of other related services provided to the patients

Once the clinical or medical process is selected, a representative sample size of data is selected to audit all aspects of that clinical or medical process, to assess the outcome of patient care

 

Example of Clinical Audit - Patient safety in blood transfusion process

Clinical Audit will include all the aspects of this process

Start point of audit will be - the time when the treating Doctor orders blood transfusion

End point of the audit will be - the time of completion of blood transfusion

 

The intermediary steps of sending requisition to the Blood Bank, verification of the requisition by the Blood Bank, issue of required blood by the Blood Bank, safe transportation to the patient’s bed side, safe transfusion, constant monitoring of the patient during transfusion, adverse transfusion reaction (if any) and actions taken, etc., will be audited

The Clinical Audit team should also audit the various documents and records, like the notes made by the Doctors and Nurses in the patients’ case files, the Transfusion Informed Consent Forms, the blood requisition and issue records

 

 

CLINICAL AUDIT TEAM

There should be a Multidisciplinary Clinical Audit team consisting of medical / clinical and nursing staff, Lab Technicians, Radiology Technicians, Blood Bank Technicians, Pharmacy staff, and any other persons that you deem fit. Also include members of the Quality team, management staff, and other qualified persons

 

For the Clinical Audits you may invite Surgeons and Consultants from different specialities to witness the audit, or to be a part of the audit (this is required to make them understand the Clinical Audit process and the importance of conducting such an audit)

Sometimes if the Surgeons / Consultants feel prejudiced, this invitation to witness an audit and be a part of it will help in dispensing such feelings. They will get a clear idea about the importance of conducting such audits, and the importance of adhering to clinical / medical best practices

 

For similar reasons, you may also invite Nurses and other direct patient care handlers to witness the Clinical Audits

For each audit every time invite different Surgeons / Consultants, Nurses, Technicians, Dieticians, on rotation basis

Include both full time and visiting Surgeons / Consultants, temporary or contract Nurses, Dieticians and Technicians

 

Remember that the audit team members:-

1. Should be committed to their work
2. Should be actively involved in developing action plans (corrective and preventive actions)
3. Should be actively involved in identifying opportunities for improvement
4. Should be fair and impartial (audit without prejudice and without favouritism)
5. Should communicate effectively and efficiently with the auditees
6. Communication among the audit team members should also be effective and efficient, for the audit to be successful

The Clinical Audit team should review the various clinical / medical processes to identify problems. Once a problem is detected in a process which the team feels is important from patient safety point of view, the team may select that process for audit

The team may also select processes which are important from business angle, because the aim of Clinical Audit is to improve patient care services and thereby improve the healthcare business

You may also conduct Clinical Audit of outsourced processes, to ensure that the outsourced service providers are meeting your quality requirements (examples - outsourced Imaging services, Dental services, Pharmacy services)

 

DEFINE THE FREQUENCY OF CLINICAL AUDIT

The Clinical Audit should be conducted at least twice a year as per the Clinical Audit plan (or schedule). You may also decide to have the audit more frequently (once in 3 months), if you want

The audit dates should be made known to all concerned (auditors and auditees) well in advance

Clinical Audit is not a surprise audit. The auditees should be informed about the audit dates in advance, so that they can be prepared for the audit

 

It is preferable to also circulate the audit parameters (criteria) to the auditors and the auditees prior to the audit date, so that they can be aware of the same

Audit parameters are actually the quality parameters which should be an integral part of a clinical / medical process

During Clinical Audit, the auditors audit these quality parameters to find out whether they are being followed properly or not. Any deficiency that is detected in a parameter is pointed out to the auditees, so that necessary action can be taken to correct the deficiency and improve the process further

 

Ideally, the Clinical Audit is carried out over a period of time, may be 7 days or more (this is required to get a good volume of data, so that the audit findings can be relied upon as a true representation of the actual problem)

Prepare a format of Clinical Audit plan (schedule). Circulate a copy of this plan to the auditors and the auditees, along with the audit parameters

Sample format of Clinical Audit plan

 

CLINICAL AUDIT PLAN			Audit duration 9 days
Audit will be conducted in 2 Phases as per defined parameters  (audit parameters have been attached separately)			Audit dates From: xx/xx/xx To: xx/xx/xx
DATE	Audit Phase	Audit team members	TIME
			FROM	TO
PHASE-1 audit
xx/xx/xx	documents, patients’ case files, registers, forms, etc. will be scrutinised	Give the names of auditors here	9:00 am	12:00 pm
xx/xx/xx			10:00 am	1:00 pm
xx/xx/xx			1:30 pm	3:30 pm
PHASE-2 audit
xx/xx/xx	active cases will be scrutinised (admitted cases on date of audit)	Give the names of auditors here	8:00 am	12:00 pm
xx/xx/xx			2:00 pm	5:00 pm
xx/xx/xx			8:00 pm	11:00 pm

STAGES IN CLINICAL AUDIT

The stages given below will give you a rough idea about how to organise a Clinical Audit

1. Select a topic (process, function, method)
2. Define the audit parameters (criteria)
3. Prepare the audit schedule (plan)
4. Share the audit schedule with the auditors and the auditees (process owners), a few days before the audit date
5. Share the audit parameters with the auditors and the auditees, a few days before the audit date
6. Conduct the audit as per audit schedule (in case of any change in plan, the same should be intimated to the auditors and auditees in advance)
7. Prepare a detailed audit report
8. Share the audit report with the auditors and the auditees
9. Give recommendations for improvement, and recommend corrective actions / preventive actions for all the detected deficiencies
10. Conduct follow-up audit to measure the improvements in the process (for your next Clinical Audit, instead of selecting a new topic, you can conduct this follow-up audit)

The follow-up audit date should also be mentioned in the audit report, so that the auditees can be prepared for the follow-up audit in advance

Collect further data during the follow-up audit. Analyse this data with the data of the previous audit. This will enable the audit team and the auditees to find out whether the desired improvement has taken place or not

Prepare a detailed report of the follow-up audit and share this report with the auditors and the auditees for ready reference and information

The audit team members should conduct periodic re-audits of the same processes, to monitor and review the improvements on a continuous basis. Depending on the re-audit results, take further actions (if required) in consultation with the auditees

The auditors should remember that it may not always be possible for the auditees (process owners) to implement the recommended actions, due to infrastructure problem or monetary constraints. Therefore, the actions recommended by the auditors should be in consonance with the available infrastructure and financial capabilities of the hospital

CLINICAL AUDIT DOCUMENTATION

Retain records (evidences) of:-

1. All the Clinical Audits, follow-up audits, re-audits, etc.
2. The corrective and preventive actions taken
3. The periodic review and monitoring reports

Remember that in the Clinical Audit report, confidentiality of patient and staff identity should be maintained and their names should not be revealed

For patients, instead of the name you may use the patient ID number

For staff, instead of the names you may use some other form of identification (examples - staff ID number, doctor ID number)

In the audit reports, both the negative aspects (deficiencies) and the positive aspects (good points) should be captured

Against each deficiency, give the action plan to rectify the deficiency and further actions that should be taken for improvement

It is preferable if you also mention the action closure date for each identified deficiency (that means, by which date the action should be completed). Remember that as per NABH, actions should be taken within a defined time frame

Once the actions have been taken by the auditee, the differences between the recommended actions and the actual actions taken should be clearly documented

The audit report should be made available to all concerned for reference, so that the auditees are able to take necessary corrective actions / preventive actions for improvements

RESPONSIBILITIES OF THE CLINICAL AUDIT TEAM

The audit team members should discuss the findings of the Clinical Audit with the concerned persons (Surgeons, Consultants, Nurses, Technicians, Management Staff, Quality team), and devise suitable corrective / preventive actions for all the deficiencies

Conduct a thorough root cause analysis (RCA) of the identified deficiencies, so that suitable corrective actions / preventive actions (CA/PA) can be devised and finalised for implementation

After the required actions are taken by the concerned persons, the same should be objectively verified by the Clinical Audit team for their appropriateness, and the same should be documented in the audit report as evidence

No action point should be considered as closed without objective verification by the audit team (objective verification means verifying whether the action has actually been taken or not)

The audit team should carry out periodic review of the corrective and preventive actions taken, to ensure effectiveness of the actions taken. Make the results of all such reviews known to the auditees

These periodic reviews can actually be the next round of Clinical Audits

SOME EXAMPLES OF AUDIT PARAMETERS

In your Clinical Audit parameters, you should remember to

1. Select parameters which are a requirement of NABH processes
2. Include clinical and nursing best practices, and other national / international benchmarks
3. Ensure that all the legal requirements are complied with

Example 1

Clinical Audit of “Pharmacy medication dispensing process”

Start time - the time of receiving the requisition in the Pharmacy

End time - the time of dispensing the medications

To conduct the Clinical Audit, a sample size that is representative of monthly admission volume should be taken, for greater assurance in audit results

You could include the following parameters:-

1. Time taken to arrange the medications as per the requisition
2. Time taken to retrieve the correct medications (that means the auditors will also have to audit the medicine storage system and also whether NABH requirements are being followed or not)
3. Dispensing errors (dispensing wrong medication, dispensing correct medication but with wrong strength, confusion with Sound Alike Look Alike medication, etc.)
4. Actions taken to prevent dispensing errors
5. Actions taken in case dispensing error actually takes place
6. Near misses (this means detecting and correcting the errors before dispensing the medications)
7. Any other parameters that you would like to add

NOTE : near miss is a good factor. If you are able to detect and correct an error before the error actually takes places, it means your preventive actions (controls) are strong

The Clinical Auditors may look at improving the preventive actions to further strengthen the dispensing process

Apart from observing the medication dispensing process of active patients, also scrutinise the Pharmacy records of past patients. This will give you a comprehensive analysis of Pharmacy department’s services

In the records of past patients, you could look for the following parameters:-

1. Number of dispensing errors
2. Number of near misses
3. Actions taken to rectify errors
4. Actions taken to prevent errors, and effectiveness of the actions taken
5. Any other parameters that you would like to add

Example 2

Clinical Audit of “X-Ray process”

Start time - the time when patient is brought into the Imaging department

End time - the time of issuing the X-Ray report

To conduct the Clinical Audit, a sample size that is representative of monthly admission volume or monthly X-Ray volume should be taken, for greater assurance in audit results

You could include the following parameters:-

1. How the patient is received into the Imaging department
2. Waiting time before the patient is taken into the X-Ray room
3. Time taken to issue provisional report
4. Time taken to issue the final report
5. Whether wrong report was issued (that means, the report of another patient was issued)
6. Co-relating X-Ray report with doctor’s requisition (whether X-Ray was conducted as per doctor’s recommendation, or wrong X-Ray was done)
7. Actions taken to rectify errors, and effectiveness of the actions taken
8. Patient interview (also interview the active patients and/or their relatives to understand the problems faced by them)
9. Near misses (this means detecting and correcting the errors before taking X-Ray, and before issuing the report)
10. Any other parameters that you would like to add

Apart from observing the X-Ray process of active patients, also scrutinise the records of past patients. This will give you a comprehensive analysis of the Imaging department’s patient care services

In the records of past patients, you could look for the following parameters:-

1. Time taken to issue provisional report
2. Time taken to issue the final report
3. Whether wrong report was issued (that means, the report of another patient was issued)
4. Co-relating X-Ray report with doctor’s requisition (whether X-Ray was conducted as per doctor’s recommendation, or wrong X-Ray was done)
5. Actions taken to rectify errors, and effectiveness of the actions taken
6. Near misses (this means detecting and correcting the errors before taking X-Ray, and before issuing the report)
7. Any other parameters that you would like to add

NOTE : I have given these examples of parameters only to clarify how the audit parameters should be defined, you may or may not agree with these parameters

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INTRODUCTION

This blog article is in continuation of my previous blog about medical records review (medical audit in hospitals). To read the previous blog article click here

In this blog article, I will give you information on the various types of Checklists that are required for reviewing the medical records of patients (also known as Medical Audit Checklist), as per the requirements of IMS.7 NABH 5th Edition

SOME IMPORTANT MEDICAL AUDIT CHECKLISTS 

I have given the formats of some of the more prominent Checklists, without which the Medical Audit cannot be conducted. In addition to these, you may prepare Checklists (CL) of your own, as per your audit requirements

Since the review of medical records (Medical Audit) is carried out as per pre-defined parameters and clinical best practices (IMS.7-d), therefore, the Checklists should be prepared carefully, to ensure that every audit requirement is covered

I have given the formats of the following prominent Checklists

1. Documentation in patients’ records - audit this in both discharged files and admitted files
2. Clinico-Pathological and Clinico-Radiological co-relations - audit this in discharged files, and also admitted files, if possible
3. Conformance with Antibiotic Policy - audit this in discharged files, and also admitted files, if possible
4. Length of stay of surgery patients - audit this in discharged files

Checklist No.1

Checklist (CL) for documentation in patients’ records

In this Checklist include those documentation parameters which are mandatory as per NABH 5th edition

I have given just a few examples

This CL is common for both discharged files and admitted files

For individual case files, mark as NA (Not Applicable) whichever parameter is not applicable (examples - operative notes in cases of non-surgery patients, discharge summary in files of patients who are still admitted)

IP No. of patient xxxxxx	Discharged file OR Admitted file (tick whichever is applicable)		Date of scrutiny xxxx
Parameters	Evidenced in case file		Remarks, if any
	Yes	No
Medication orders are legible, dated, timed, signed, named (MOM.5-c)
Medication prescription written in all capitals (KPI parameter PSQ.3-d)
Entries in medical records are signed, named, dated, timed (IMS.3-e, IMS.3-f)
Medical records with incomplete and/or improper consent (KPI parameter PSQ.4-c)
Operation note is present in case file (COP.14-e)
Discharge summary is completely filled (AAC.14)
Copy of Discharge Summary present in case file (IMS.4-f)
Missing records in patient’s file (IMS.3-c)

Checklist No.2

Checklist for Clinico-Pathological / Clinico-Radiological co-relation

The Doctors / Surgeons and the heads of Pathology / Radiology departments should decide on the parameters that should be audited, as per requirements of NABH 5th edition, and any other requirement that you feel is important

PATHOLOGY DEPARTMENT

AAC.7-f states that the Laboratory Quality Assurance program should address clinico-pathological meetings

I have given example of a sample format below, as per my knowledge. Actually, the Doctors / Surgeons are the best persons to prepare this Checklist

IP No. of patient xxxxx	Discharged file OR Admitted file (tick whichever is applicable)	Date of scrutiny : xxxxx
Parameters	Tests recommended as per patient’s medical condition / treatment needs	Lab results found to be co-relating clinically		Treatment provided as per test results
		Yes	No	Yes	No
To be decided by qualified medical personnel		Give details here	Give details here	Give details here	Give details here

RADIOLOGY DEPARTMENT

AAC.10-f states that the Imaging Quality Assurance program should address clinico-radiological meetings

I have given example of a sample format below, as per my knowledge. Actually, the Doctors / Surgeons are the best persons to prepare this Checklist

IP No. of patient xxxxx	Discharged file OR Admitted file (tick whichever is applicable)	Date of scrutiny : xxxxx
Parameters	Investigations recommended as per patient’s medical condition / treatment needs	Investigation results found to be co-relating clinically		Treatment provided as per investigation results
		Yes	No	Yes	No
To be decided by qualified medical personnel		Give details here	Give details here	Give details here	Give details here

 

Checklist No.3

Checklist for Compliance with Anti-biotic Policy (HIC.3-e, HIC.3-f, HIC.3-g)

The Doctors / Surgeons and the Infection Control team should prepare this Checklist based on the parameters to be audited, as per the requirements of NABH 5th edition, and as per Anti-biotic policy requirements

Highly skilled medical personnel can only prepare this Checklist, so I have not given any sample format here

Checklist No.4

Checklist for Length of Stay of Surgery Patients (AAC.13-e, AAC.13-f)

Parameters related to this should be decided by the Surgeons / Doctors

For this, select a few surgery categories (examples - Total Knee Replacement, Caesarean Section delivery, Hernia, etc.). Decide upon the length of stay for each category of surgery patients

From discharged patients’ files for a period of 3 or 4 months, select a representative sample size of surgery files on random selection basis using statistical principles (if the number of surgeries has been few, then select all the files)

Given below is a sample format

Name of Surgery : xxxxx			IP No. of Patient  xxxxx		Defined length of stay : xxxxx days
Date of admission	Date of surgery	Date of discharge	Length of stay	Delayed by how many days	Reason for delayed discharge, if any	Reason for delayed discharge has been mentioned in the case file
					Here mention all the reasons, examples - patient developed post-surgery complications, discharge was delayed without any apparent reason, etc.	Here mention whether the reason for delayed discharge has been documented in the case file or not

 

The parameters given in the 4 above points are very important, which should be audited mandatorily

In addition to these, you may also include other parameters related to patient safety initiatives

Examples -

• Anaesthesia complications and actions taken (adverse anaesthesia events - COP.13-j)
• Scrutiny of Emergency Response Reports / Cardio-pulmonary resuscitation report (COP.5-d, COP.5-e, COP.5-f)
• Patients who received appropriate prophylactic antibiotics within the specified time frame (this is a KPI parameter PSQ.3-b)

NOTE :- my knowledge is based on my years of experience in the Administration department of a reputed super-speciality hospital in Mumbai. I am not a Doctor or a Nurse, but I write on topics which were a part of my job profile

I sincerely hope that you find this article helpful and informative

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