Medical Audit in Hospital - Review of Medical Records - NABH 5th Edition IMS.7

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The medical audit process (review of medical records) should be done in a transparent manner, sharing the findings openly and equally with all the concerned persons

INTRODUCTION

In this blog, I have explained the medical audit methodology for auditing patient care processes in conformance with NABH IMS.7

Carrying out review of medical records is a mandatory requirement of IMS.7. This review is actually audit of the medical records, in other words, auditing the medical files of both admitted and discharged patients

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

It is a requirement of NABH that the hospital should carry out regular reviews of medical records (case files) of patients. This review of medical records is done through Medical audit, to find out whether the clinical care provided to the patients:-

1. Have been in consonance with the needs of the patients
2. Is as per best clinical practices
3. Is as per NABH process requirements

In Clinical audit all aspects of a clinical process are audited. Clinical audit includes not only the clinical care provided to the patients, but also other related patient care services which form a part of the complete clinical process

Example - Patient safety in blood transfusion process (all the different steps involved in this process is audited during clinical audit)

NOTE :- At the end of this blog, I have given a short comparison between Medical Audit and Clinical Audit

In continuation of this blog, I have written another article on Checklists for review of medical records - click here to read it

THE ESSENCE OF MEDICAL AUDIT

Review of medical records (IMS.7) is required:-

1. To ensure that patients are provided clinical care as per their clinical and medical needs, and as per clinical best practices
2. To ensure that NABH process requirements and quality requirements are always met

Medical audits should be carried out at frequent intervals, preferably every 6 (six) months, and records of all such audits should be retained as evidences

Your hospital should also retain records of corrective and preventive actions taken based on the medical audit reports, and the outcomes and effectiveness of those actions taken

MEDICAL AUDIT TEAM

The persons selected for the medical audit should be made aware of the nature and purpose of medical audit, and should have very good knowledge of all the processes

Form a multidisciplinary Medical Audit Team. The team should consist of:-

1. Medical and nursing staff (include paramedics, if you want)
2. Technicians (Blood Bank technicians, Laboratory technicians, O.T. technicians, etc.)
3. Members from Quality Control team
4. Medical Records Department staff ***
5. Management staff
6. Any other qualified persons you may want to include

*** Medical Records Department staff should be involved because files of not only admitted patients, but also discharged patients should be audited

MAKE THIS YOUR HOSPITAL’S GOOD PRACTICE

For the medical audit you should invite persons who are not members of the medical audit team. That means, you should 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 medical audit process and the importance of conducting such an audit)

Through their involvement with the medical audit process, these invited surgeons / consultants will become more aware of:-

1. The importance of proper and correct documentation in the case files of patients
2. The importance of legibility in the case notes and in prescribing medications
3. The importance of conforming with antibiotic policy
4. The importance of conforming with medical abbreviations protocol

According to me, these 4 are the most important factors that should be taken care of

Sometimes if the surgeons / consultants feel prejudiced, this invitation to witness the medical audit and to be a part of it will help in dispensing off such feelings. They will get a clear idea about the importance of conducting such audits

For each medical audit, invite different surgeons / consultants (include both full time and visiting surgeons / consultants)

MEDICAL AUDIT PARAMETERS

Define the parameters that you would like to include in your medical audit

Based on my experience, I have given some examples of documentation parameters, clinical / medical parameters, and surgical parameters that you may include (you should remember to select parameters which are a requirement of NABH processes)

It is NABH requirement that the audit process should include medical records of both admitted and discharged patients, in appropriate proportions (IMS.7-e)

It is preferable to divide the parameters into different Phases for convenience of audit, and to ensure that all the parameters of each Phase are audited properly

Ideally, the medical audit process is carried out over a period of time, may be 7 (seven) days or more

I have divided the entire medical audit process into 3 (three) Phases:-

1. Phase 1 - documentation parameters should be checked in the medical records of patients (for both admitted and discharged patients)
2. Phase 2 - clinical / medical parameters should be checked in the medical records of patients (for both admitted and discharged patients)
3. Phase 3 - surgical parameters should be checked in the medical records of patients (for discharged patients only)

Phase 1 audit can be carried out by non-medical staff

Audit of Phases 2 and 3 should be carried out by doctors, surgeons, and any other person who you feel is qualified for it

In all the 3 phases, I have given examples of:-

1. Audit parameters
2. Sample selection methods (medical records selection methods)

These examples are only for guidance, and to help you to understand the medical audit methodology

It is upto you as to what parameters you will select for the medical audit, and how you will conduct the audit

Phase -1 of the Medical Audit

Medical audit team members who may audit the parameters of Phase 1 are referred to as “Team A”:-

1. Nursing department staff
2. Quality Control team member
3. Medical Records Department staff
4. Technicians (Blood Bank Technicians, Lab Technicians, etc.)
5. Management staff

These persons should have adequate knowledge of process requirements

The following documentation parameters may be selected for Phase 1 audit:-

1. Checking for documentation errors (examples - proper and legible entry of date, time, name, signature by the surgeons / consultants in all the case notes, and other records)
2. Legibility of documentation (particularly the medication chart should be clear, legible and preferably in capital letters)
3. Medical abbreviations (no unauthorised or error-prone abbreviations should be used. Your hospital should have an officially approved list of medical abbreviations, and the surgeons / consultants should follow that abbreviations list strictly)
4. Completeness of medical records files (the medical records files of patients should contain all the records from the day of admission to the day of discharge, including copy of the Discharge Summary. No record should be missing (Examples - O.T. notes missing in a surgical case file, Discharge Summary not found in the case file, etc.)
5. Completely filled forms and documents (Examples - Informed consent forms filled completely, Initial assessment sheets filled completely, Anaesthesia chart filled completely, etc.)

Phase -2 of the medical audit

Medical audit team members who may audit the parameters of Phase 2 are referred to as “Team B”:-

1. Surgeons / consultants (this is called peer group review)
2. In your phase 2 audit, invite surgeons / consultants from different specialities to witness the audit, or to be a part of the audit

The following Clinical / Medical parameters may be selected for Phase 2 audit:-

1. Checking conformance with antibiotic policy in the medical records (rational use of antibiotics). Your hospital should have an antibiotic policy. This policy should be made known to all the surgeons / consultants and other medical staff (HIC.3-e, HIC.3-f, HIC.3-g)
2. Scrutinising the various diagnostic reports for their appropriateness with the disease, and the subsequent line of treatment given (examples - clinico-pathological co-relation, Sonography reports, etc.). As per ISM.4-c, the results of all investigations should be a part of the medical record
3. Post event analysis of CPR / BLS performed on patients
4. Adverse anaesthesia event (action taken and outcome)
5. Adverse drug events monitoring report
6. Adverse reactions to contrast dyes and/or other drugs used in diagnostic procedures, actions taken and the outcome
7. Culture and sensitivity report for all surgical wounds (any instance of surgical site infection, actions taken and outcome)
8. Reports on monitoring and review of infection control process
9. Conformance with ICD coding (IMS.4-a)

ICD CODING

Based on my experience, I would recommend that you check for ICD coding conformance in all discharged medical records for a selected period of time (Example - 3 months, 6 months). Repeat this review process every 3 months or 6 months and maintain proper records of the findings

Discuss the findings with the concerned persons, and initiate corrective and preventive actions. Thereafter, the actions taken should be monitored and reviewed to ensure continued sustainability

As per Objective Element IMS.4-a, for all in-patients, the treating doctor / surgeon must document the diagnosis preferably as per ICD/SNOMED CT. In the Medical Records Department, all such diagnosis should be codified as per ICD/SNOMED CT

REVIEW OF ANTIBIOTIC POLICY (HIC.3-e, HIC.3-f, HIC.3-g)

During the medical audit process, you may review the antibiotic policy for its continued suitability and update it accordingly, based on the medical audit findings

Invite doctors, surgeons, Pharmacy team / Pharmacovigilance team, and the management team for a discussion on the antibiotic policy, so that it can be upgraded in conformance with the hospital’s medical, clinical and surgical requirements

Retain documented evidences of all such discussions and the outcomes

Inform all the concerned persons about the new and revised antibiotic policy. Make this new and revised antibiotic policy available to all concerned and remove the previous version from circulation

Phase-3 of the Medical Audit

Medical audit team members who may audit the parameters of Phase 3 are referred to as “Team B”:-

1. Surgeons / consultants (this is called peer group review)
2. In your phase 3 audit, invite surgeons / consultants from different specialities to witness the audit or to be a part of the audit

For this phase, you should lay down some medical best practices guidelines of your own, or follow some national / international best practices guidelines. Audit the selected parameters as per those guidelines

The following surgical parameters may be selected for Phase 3 audit:-

1. What should be minimum length of stay of Laparoscopic Appendectomy patients (you may decide that such patients should be discharged on the 3rd day after surgery, where the day of surgery is considered as “day zero”)
2. What should be minimum length of stay of Laparoscopic Myomectomy patients (you may decide that such patients should be discharged on the 2nd day after surgery, where the day of surgery is considered as “day zero”)
3. What should be minimum length of stay of Tonsillectomy patients (you may decide that such patients should be discharged on the 8th day after surgery, where the day of surgery is considered as “day zero”)

PS: I am not a Doctor, I have given these 3 above examples only to explain the medical audit process

While auditing the surgical cases, the auditors should scrutinise the reason for the extended length of stay and find out whether the delayed discharge was for some permissible reason

Examples

1. Was it because of some post-operative complication in the patient’s medical condition?
2. Was some change made in the patient’s care plan or in medication?
3. Did the patient develop some other disease while undergoing treatment?
4. Was the patient kept back unnecessarily, in spite of being fit for discharge?

The findings should be documented and discussed with the treating consultants / surgeons to find out the exact reason for the delay in discharge, and whether it is possible to avoid those reasons in future

Records of all the discussions with the consultants / surgeons should also be retained (preferably as an Annexure to the medical audit report)

If you will keep all the documented records in one place, it will be easier to locate them and refer to them in future

All the reports and records pertaining to the medical audit should be shared with all the concerned persons for their ready reference

NOTE:

For the Phase-3 audit, you may select critical parameters that you would like to be audited

For both Phase-2 and Phase-3 audits, case files of surgeon / consultant who is a member of the medical audit team should be audited by some other surgeon / consultant from the team (but not in a secretive manner. Let the surgeon / consultant know that his or her files are being audited. Discuss the observations with him or her as you progress in your audit)

There should not be any self-audit of case files (medical records)

There should be complete transparency in the medical audit process

I have given these 3-phase examples of parameters to make you understand the audit process. For all the 3 Phases of medical audit, you may select your own parameters

SAMPLE SELECTION METHODS FOR THE DIFFERENT PHASES OF MEDICAL AUDIT

NABH demands that the representative sample size selected for the audit (review) should be selected using statistical principles. So, you will have to devise your own statistical method or use some national / international statistical principle (IMS.7-b, IMS.7-e)

Admitted patients

The sample size of files selected should be representative of the total admission on the day of audit. If the number of admissions is less, then audit all the files (IMS.7-e)

Discharged patients

The sample size of files selected should be representative of the total discharge for the month or months in consideration (examples - 1 month, 3 months, etc.) (IMS.7-e)

The sample sizes should be selected separately for admitted patients and discharged patients

NOTE :

For admitted patients, you should consider files of patients still admitted at the time of medical audit (also known as active patients)

For discharged patients, you should consider files for 3 or 4 months. These files will have to be retrieved from the Medical Records department (remember, you should not ignore files of death patients - IMS.7-b)

How sample size for Phase 1 and Phase 2 audits should be selected (files of both surgery and non-surgery patients)

Decide upon a percentage formula for selecting representative sample sizes for discharged patients and admitted patients (remember that the samples for discharged patients and admitted patients should be selected separately)

You may devise your own formula or use national / international formula for sample selection

You could either use an excel sheet for the calculation or use your hospital’s software system for the same

How sample size for Phase 3 audit should be selected (files of surgery patients only)

Use your sample selection method to select surgery case files for a defined period of time (examples - 3 months, 4 months). The selected case files should be retrieved from the Medical Records department

Select only those surgery files in which the length of stay is more than the defined criteria. The length of stay calculation should start from the date of surgery, where the date of surgery is taken as “day zero”

While selecting sample files, exclude those files in which two different surgeries have been performed on the patient

NOTE:

1. The sample medical records selected for Phase 1 audit may also be used for the Phase 2 audit
2. In Phase 3, you may also audit the parameters of Phase 2
3. But in Phase 2, you should not audit the parameters of Phase 3, because the sample selection methods will be different for both the Phases

DEFINE THE FREQUENCY OF MEDICAL AUDIT

The medical audit should be conducted at least twice a year as per the medical audit plan (or programme)

The audit dates should be made known to all concerned well in advance

The audit parameters for the 3 Phases should also be made available to all the concerned persons

Sample format of medical audit plan (programme)

MEDICAL AUDIT PLAN			Audit duration 9 days
Audit will be conducted in 3 Phases as per defined parameters  (for details of the parameters refer Annexure - A)			Audit dates   From: xx/xx/xx To: xx/xx/xx
DATE	CATEGORY	AUDIT TEAM MEMBERS	TIME
			FROM	TO
PHASE-1 audit (documentation parameters)
xx/xx/xx	Case files of discharged patients	Team A	9:00 am	1:00 pm
xx/xx/xx	Case files of admitted patients	Team A	1:30 pm	3:30 pm
PHASE-2 audit (clinical / medical parameters)
xx/xx/xx	Case files of discharged patients	Team B	10:00 am	12:30 pm
xx/xx/xx	Case files of admitted patients	Team B	2:00 pm	4:30 pm
PHASE-3 audit (surgical parameters)
xx/xx/xx	Case files of discharged patients	Team B	4:00 pm	6:00 pm
Annexure- A (Audit parameters for the 3 Phases) - attached separately

MEDICAL AUDIT DOCUMENTATION

Audit all the parameters of each phase and document the findings - you should document both the negative aspects (deficiencies) and the positive aspects (good points)

The medical audit report should be made available to all concerned for reference, and for necessary corrective actions and preventive actions

Discuss the findings of the medical audit with the concerned persons (surgeons, consultants, etc.) and devise suitable corrective and preventive actions for all the deficiencies. Remember that as per NABH, these actions should be taken within a defined time frame, and the actions taken should be documented

After the required corrective and preventive actions are completed by the concerned persons, these should be objectively verified by the medical audit team as evidence of completion

Retain all the medical audits reports and also retain records of the corrective and preventive actions taken

Confidentiality of patient and staff identity should be maintained, and their names should not be mentioned in the medical audit report

For patients, instead of the name you may use the patient ID number. For staff, instead of the names, you may use the staff ID number or the doctor ID number

The medical audit team should carry out periodic review of the corrective and preventive actions taken, to ensure effectiveness of the actions taken and their continued sustainability

Make the results of all such reviews known to the concerned persons (surgeons / consultants, etc.) so that, if required, they can take actions to improve the processes further

Sample format of Medical Audit Report

MEDICAL AUDIT REPORT		Report dated : xx/xx/xx
Audit was conducted in 3 Phases	Audit was conducted from date xx/xx/xx to date xx/xx/xx	Report Prepared by : XYZ
xxxxxxxx were invited to witness Phase 2 and Phase 3 of the audit, and to also take part in the audit
PHASE 1
Sample size audited	Give the details of sample size
Audit findings	Give the details
Actions required	Give the details
Actions to be taken by	Mention the name(s) of the person(s)
Actions to be completed by	Mention the date
Actual date of completion	Mention the details, along with the date
Objective verification of completed action by the Medical Audit team	Mention the details of the findings, along with the date
Review date	Mention the date, along with the review findings
PHASE 2
Same as Phase 1
PHASE 3
Same as Phase 1

OTHER PARAMETERS THAT YOU MAY INCLUDE IN YOUR MEDICAL AUDIT PLAN

You may interview the patients (or their relatives) to know whether they are informed about food and drug interaction, about safe and effective use of medication, about the care plan and the expected outcome of the treatment, about post-discharge care, etc. (Maintain confidentiality of the patients while documenting the findings)

Hospital Pharmacy Store and Retail Pharmacy - storage and issue of medications (whether safety requirements and NABH requirements are being followed or not)

To conclude, here is a COMPARISON BETWEEN MEDICAL AUDIT AND CLINICAL AUDIT

Both medical audit and clinical audit are ways in which the patient care processes can be monitored continuously, for quality improvement and process improvement

Differences between Medical Audit and Clinical Audit

Medical Audit	Clinical Audit
It is not always a peer group audit	It is a peer group audit
The medical records files of patients are audited:- For their timeliness, legibility and completeness To review the appropriateness of the clinical care provided to the patients	A clinical process is selected, and all aspects of that clinical process are audited to check :- The appropriateness of clinical care provided to the patients The appropriateness of other related services provided to the patients
The performances of the treating consultants / surgeons are audited in the medical records files	All the aspects of the clinical process are audited (not only the performances of the consultants / surgeons)
A representative sample size of medical records (patients’ files) is selected on random sampling basis	Once the clinical process is selected, a representative sample size of data is selected for audit

Similarities between Medical Audit and Clinical Audit

1. Both the audits are conducted in a planned manner
2. The audits are conducted against certain pre-defined parameters, and clinical best practices
3. The audits are conducted to identify the deficiencies, errors, and drawbacks relating to patient safety and patient care, and to identify the opportunities for improvement
4. Conformance to NABH requirements is also audited in both the audits
5. The objectives of the audits are continual quality improvement and process improvement
6. Based on the outcome of the audits, appropriate corrective and preventive actions are taken to rectify the errors and to improve the processes. The actions taken are monitored on a continuous basis, to ensure that the improvements are sustained

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

😁😃

On a lighter note - I hope you had the patience to read through this long blog till the end