Medical Records Department in Hospital (MRD) - NABH 5th Edition

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INTRODUCTION

I have been closely associated with the healthcare sector since long now, and have gained considerable first-hand knowledge about NABH and ISO-9001 Quality Management System

In this blog I have given information on process requirements of hospital’s Medical Records Department (MRD) in conformance with NABH 5th edition

I have tried to give references to as many Objective Elements as possible

In all the hospitals, a combination of both soft copies and hard copies are maintained. Some patients’ records are maintained electronically in the HIS (Hospital Information System), and the nature of some records make it necessary to maintain them as physical hard copies in paper format

This blog is divided into the following Sections

• Categorisation of objective elements
• Mandatory requirements
• Scope of MRD services
• Administrative Policies and Protocols of MRD
• Documented procedures
• Some important functions of MRD
• Storage and retrieval of medical records
• Security of medical records
• Access to clinical records
• Completeness of medical records
• Retention and destruction of medical records
• Medical Audit Process (IMS.7) ***
• Continual Quality Improvement (Key Performance Indicators, Quality Objectives)
• Training needs of the department

*** I will give detailed explanation of the Medical Audit process in a separate blog

CATEGORISATION OF OBJECTIVE ELEMENTS

In the 5th edition of NABH, the objective elements have been categorised into Core, Commitment, Achievement, Excellence

While defining and streamlining the MRD processes and functions, you will have to keep in mind the requirements of these 4 categories

Core - patient care processes cannot be functional without these basic activities. These objective elements form an integral part of healthcare services, and are very crucial for successful treatment of patients and patient safety

Commitment - the hospital is committed to offer certain patient care services to the patients, and is committed to ensure that patients get the best medical care / clinical care services and recover fast (by committing you are ensuring that the patients get those services from you)

Achievement - the hospital takes the initiative of doing something over and above regular patient care services (example - making use of the latest technology to improve confidentiality of patient data). In the Artificial Intelligence (AI) Era, this should not be a difficult task

Excellence - is your endeavour to reach the highest level by offering the best quality of patient care services. You may also refer to this endeavour as “medical best practices”

MANDATORY REQUIREMENTS

All NABH requirements are mandatory, but here I have given only those few which, according to me, are really very important

It is mandatory to maintain records of both OPD and IPD patients. It has often been seen that hospitals usually give importance to only IPD records

Though the files of OPD patients are given back to them, the hospitals must develop some system of maintaining OPD treatment records of patients either in physical hard copy format or in electronic soft copy format

What I recommend is that you develop a system of on-the-spot scanning of OPD records before putting them in the file and handing over the file to the patient. The scanned copies should be sent to MRD on a daily basis. Thereafter it should be the responsibility of the MRD to align the scanned copies of patients’ records with the soft copy records of the patients

The Unique Identification Number of each patient should be well defined and established, to ensure proper alignment of hard copy and soft copy records of patients. Each individual hard copy and soft copy record of a patient should contain the Unique Identification Number (IMS.3-a Commitment)

It is the responsibility of the direct patient care providers to ensure the requirements of IMS.3-a are complied with

Both IPD and OPD records of patients should be maintained in the MRD

It is mandatory for MRD to codify all diagnoses as per ICD / SNOMED CT (IMS.4-a Commitment), after the files of the discharged patients are received in the department

It is the responsibility of the doctors / surgeons to document every diagnosis in the medical records, preferably as per ICD / SNOMED CT

It is mandatory to clearly display the sign postings / signages of MRD department in an understandable language. As per NABH, it is necessary to have sign postings in at least two languages - the local language of the area and any other language

As per objective element FMS.2-c (Core), the internal and external sign postings of the hospital should be displayed in a manner understood by the patients / family members and the community

SCOPE OF MRD SERVICES

As per objective element AAC.1-c (Commitment), all the departments should define their scope of services

Therefore, the scope of services provided by MRD should be defined, documented, and implemented well

The scope of services should be reviewed periodically by the department head, and kept updated all the time

The scope of services of MRD should be:-

1. Commensurate with the scope of services of the hospital

2. Communicated well to the MRD staff

3. Understood well by the MRD staff

Other departments should also have a working knowledge of MRD scope of services. This will enable all the hospital staff / doctors to interact properly with MRD in their day-to-day work

NOTE:-

“defined” does not mean that the scope of services has to be displayed. But it is preferable if MRD’s scope of services is displayed in the department at a prominent place clearly visible to everyone

You will have to mandatorily display the scope of services only if the Objective Element mentions the word “display” or “displayed”

ADMINISTRATIVE POLICIES AND PROTOCOLS OF MRD

You should define and document the administrative policies and procedures of your department, and should also implement them well. The policies and procedures should be communicated to all the MRD staff in an appropriate manner

The administrative policies and procedures should be reviewed periodically and kept updated all the time

MRD administrative policies and procedures should consist of at least the following:-

1. Duty hours and staff strength (if the department works in shifts, then shift-wise staff strength should also be defined, along with the timings)
2. Holidays
3. Leave rules
4. Organisational chart of the department, showing the reporting structure and the designations (HRM.1-f Commitment)
5. Behaviour code and dress code (HRM.2-c Core)
6. Moral and ethical values
7. Disciplinary rules (HRM.8)
8. Competency matrix for all the posts / designations in MRD (HRM.1-d Commitment)
9. Job responsibilities and authorities matrix of all the posts / designations in MRD (HRM.1-d Commitment)
10. Compliance with applicable Statutory and Regulatory requirements
11. Protocol to be followed for emergency requirements during non-working hours (example - doctor urgently needs past records of a patient when MRD is closed) (IMS.4-h Commitment)
12. Quality improvement initiatives of the department’s processes and functions (as per requirements of NABH, and as per hospital’s policies) (PSQ.4)

The job specifications and job descriptions should be defined for each category of staff (HRM.1-d Commitment)

HRM.1-d is the joint responsibility of the HR department and the head of MRD (department head)

The contents and characteristics of each job should be defined (job description). Also, the qualifications, skills, experience, and competence required for performing the job should be defined (job specification)

The competency matrix should be developed keeping in mind the job description

The job responsibilities and authorities of each post / designation should be aligned with the competency matrix, to ensure that the right task is assigned to the right person

Staff competency and qualifications are often assessed by the NABH assessors during the assessment schedules

Competency matrix is the guideline which will prevent wrong deputation of work

The competency matrix should be reviewed periodically and kept updated all the time. Depending on changes in MRD processes, the competency matrix may also have to be changed

All the staff must be able to clearly understand their responsibilities and authorities, and must be competent and skilled enough to discharge their duties efficiently

DOCUMENTED PROCEDURES

NABH gives a lot of importance to well defined processes and functions, which should be properly implemented, maintained and monitored continuously

It is also mandatory to maintain all the departmental processes and functions as documented procedures (procedures can be Manual, Standard Operating Procedure, Work Instruction, Check List, etc.)

All the concerned MRD staff should have access to the documented procedures for their information and ready reference

Documented procedures may be made available online in electronic soft copy format or physically in hard copy format

Documenting the procedures is required to standardize all the working processes of the department. All the MRD staff should follow only one particular method of doing a work. This is the specific reason why there should be a documented procedure for the department’s processes and functions (If each person will follow a different method for doing the same work, it will lead to confusion, and confusion will lead to deterioration in the quality of the work)

Once a process (working method) is officially approved, the process should be documented to standardise it. Thereafter, all the MRD staff should be made aware of that standardised method of doing the work

Whenever changes are made in a process, the same should be captured in the documented procedure also

If a new process is introduced, it should be included in the documented procedure

Also, if a process is discontinued, the same should be removed from the documented procedure

The documented procedure should be reviewed periodically and kept updated all the time

As per objective element IMS.6-a (Core), the hospital should have an effective method for document control

Each hospital has its own method of controlling officially approved documents. An important part of document control is to ensure that no one has unauthorised access to the documents - this is applicable to both electronic soft copies and physical hard copies

The documents should be protected from unauthorised changes, additions, deletions, damage / destruction, loss, theft, etc.

Only the current and relevant versions of all the procedures, manuals, forms / formats, checklists, work instructions, registers, policies, and protocols should be made available for use. Old versions should be removed from circulation and archived / stored as per retention period based on the hospital’s policies (IMS.6-b Core)

Only authorised persons should have full access to the editable copies (Master Copies)

These authorised persons should have:-

1. The right to create the documents
2. The right to officially approve, authorise and release the documents
3. The right to review the documents for their relevance and acceptability
4. The right to make changes / update the documents

All other staff should be given access only to the Controlled Copies, which have only viewing rights and reading rights

But in some cases, to facilitate proper work the staff will have to be given printing rights to certain documents which are stored online (examples - checklists, consent forms, charts, feedback forms, etc.)

All changes / additions / deletions should be made only in the editable copy (Master Copy). Thereafter a copy of the document should be made available to everyone in a controlled manner (Controlled Copy) for their use and reference (IMS.6-a)

The words “CONTROLLED COPY” should be mentioned on the copy which is released for everyone’s reference and use

IMPORTANT - Even if someone makes changes / additions / deletions in the Controlled Copy of the document, it is not officially accepted as valid. Only those changes / additions / deletions that are made in the editable Master Copy are officially accepted as valid

All the documented procedures should be reviewed periodically and kept updated all the time. Only the latest updated versions should be made available for use, the old versions should be removed from circulation. This kind of document control is required to avoid confusion among the staff, and to ensure that only the latest versions are always followed (IMS.6-a)

The old versions of documents which are removed from active use, should be archived / retained as per retention period based on the hospital’s policies (IMS.6-b)

All the in-use current documents should be identifiable - that means the documents should be identifiable as belonging to MRD, and the content of the document should also be identifiable

You could use a numbering system for creating unique identification numbers (UID) for each document

UID number is also known as Control Number

Example - 1

XXX / MRD / WI-001-FileReceipt / Ver-1.0

Where XXX is the name of the hospital, WI-001 is the serial number of the Work Instruction

“FileReceipt” identifies the content of the document - it is a Work Instruction for receiving medical records files from other departments

Ver-1.0 means this is the first version

Example - 2

XXX / MRD / WI-002-Backup / Ver-1.1

Where XXX is the name of the hospital, WI-002 is the serial number of the Work Instruction

“Backup” identifies the content of the document - it is a Work Instruction for creating backup of medical records

Ver-1.1 means this is the second version (the first version 1.0 has been replaced with this modified second version)

SOME IMPORTANT FUNCTIONS OF MRD

1. Storage and retrieval of medical records (maintaining proper inventory of patients’ files and other records - both hard copies and electronic soft copies)
2. Ensuring security of medical records (preventing theft / mishandling of patients’ files and records - both hard copies and soft copies) (IMS.5-c Core, IMS.6-c Commitment)
3. Retention and destruction of medical records in compliance with Statutory and Regulatory requirements. Some medical records may have to be retained permanently (IMS.6-b Core, IMS.6-d Commitment)
4. Allowing access to medical records by doctors, nurses, patients, and their family members, legal authorities (Police, Lawyers, Municipality, etc.)
5. Completeness of medical records (no document should be missing from the files) - this is a very important NABH requirement (IMS.3, IMS.4)
6. Medical audit (IMS.7) - MRD staff should be a part of the medical audit process, and should carry out their audit duties in a responsible manner
7. Continual quality improvement of departmental processes through quality indicators and quality objectives (IMS.2-e Commitment, PSQ.2)
8. Training needs of the department (HRM.3, HRM.4, HRM.5, HRM.6)

Apart from these functions, you may add other functions which are specific to your department’s needs and the hospital’s requirements

STORAGE AND RETRIEVAL OF MEDICAL RECORDS

This is the most important function of MRD - ensuring proper storage of medical records and other documents pertaining to patient care - both hard copies and electronic soft copies

The store room / storage area should be well lit, and the racks / lockers / cabinets should be kept clean and should be kept locked, to prevent unauthorised entry

The medical records should be clearly labelled and neatly arranged in a systematic manner, for easy identification and quick retrieval

All the racks, lockers, cabinets should be given some form of identification numbers (numerical or alphabets, or a combination of numerical and alphabets)

You can devise a system of storing the medical records month-wise as per their Unique Identification Number (UID), for easy identification and quick retrieval. This UID can be the patient’s IP number or OP number

An inventory of all the medical records should be maintained in the software system, indicating their UID and storage location. The UID given in the inventory should tally with the UID of the store room

Examples

RA-01/IP-361 to IP-400-Jan-20XX

RA-02/IP-401 to IP-460-Jan-20XX

RA - stands for rack

01 and 02 - stand for the rack numbers

IP-xxx - stands for the file UID (IP number of the patient)

Jan-20XX - stands for the month and year

You may create the medical records inventory in an excel sheet, and protect the sheet with a login ID and password. Only authorised person(s) from MRD should have access to the login ID and password (IMS.5-a Core)

Similarly, the electronic soft copies of medical records should be stored in a manner so that they can be located / identified easily through identification numbers, and can be accessed only by authorised persons through unique login IDs and passwords. Creating this system is the responsibility of the I.T. department - all hospitals have their own software creation and maintenance protocol

SECURITY OF MEDICAL RECORDS (IMS.5-a Core, IMS.5-b Core, IMS.5-c Core, IMS.5-d Achievement)

All the medical records, patients’ data and information should be stored in a secure manner to prevent theft, loss, misuse, damage, and destruction / deletion

The hard copies of records should be protected from damage by fire, water, pests

The electronic soft copies should be protected from deletion / damage due to server crash, software malfunction. The various software systems containing patient data / information should give access only to the end users of those systems, to prevent loss, destruction / deletion, and misuse (examples – tampering with medical entries, copying the data to some other location, deletion, making unauthorised changes, virus attack) (IMS.5-a, IMS.5-c)

The confidentiality, integrity, and security of medical records / data / information should be maintained. Only authorised persons should have access to medical records / data / information of patients. The computers / laptops should be well protected with login IDs and passwords, and only authorised persons should have access to those login IDs and passwords (IMS.5-a)

MRD must implement a proper system of backup procedure for all hard copies of medical records, data, and information pertaining to patient care. Creating backups of electronic soft copies should be the responsibility of the I.T. department (IMS.5-c, IMS.5-d)

All backups should be created in a timely manner and preserved properly

During working hours, the MRD should never be unmanned, and during non-working hours the MRD should be kept locked

No unauthorised entry should be allowed in the storage area - make sure that the office section and the storage section are separate

To safeguard the hard copies of medical records from theft / misuse, etc., you could have a system whereby only Doctors, CEO, Medical Director, Dean, Nursing Director, any other person whom you consider eligible, will be allowed to take the records outside the department

Others like nurses, RMOs, paramedics, dieticians, senior administration staff, auditors, etc. who need to work on patient data, will be allowed to have access to the medical records but will not be allowed to take the records out of the MRD. Such persons should be provided a place in the MRD itself, where they can sit and do their work (IMS.5-a)

MRD should maintain a tracking system for hard copies of medical files which are issued and are allowed to be taken outside the department. It is the MRD’s responsibility to ensure that the files are returned back to the department on time, and that no documents / records are missing from the files. MRD can use tracker cards or bin cards to maintain records of all issues and returns (IMS.5-a)

As per objective element IMS.5-d (Achievement), the hospital must use appropriate technology to improve confidentiality, integrity, and security of medical records / data / information

The Hospital Information System (HIS) and the various software systems and software modules should be kept updated with the latest available technology. This is the responsibility of the I.T. department, but MRD should ensure the technology is serving their purpose. Wherever required, MRD should give recommendations for changes / improvements to the I.T. department

As per NABH, IMS.5-d is an achievement, so all your technology advancements and improvements will be looked upon as an achievement by the NABH assessor team

ACCESS TO CLINICAL RECORDS

I have already mentioned some of these points in the previous sections, but to emphasize the importance of the requirements, I am mentioning them once again here

There is provision in NABH for giving access to clinical records, but only to authorised persons

Doctors, nurses, top management, patients and their family members, legal authorities (police, lawyers, etc.), municipal authorities, and any other valid entities, have the right to access privileged health records of patients

MRD’s responsibility - MRD should define the circumstances under which the medical records will be made available, and also the duration for which they will be made available

Define a list of the internal and external persons / agencies who will be considered eligible to access medical records of patients

Internal - doctors, nurses, Dean, CEO, Medical Director, Nursing Director, Dieticians, senior management staff, auditors

External - legal practitioners who handle Medico-Legal Cases, Police, any other authorities

MRD should:-

• Have a documented procedure for making medical records available to internal and external persons / agencies
• Define who will be authorised to give approval for issue of the medical records (this person should be someone from the top management level)

While sharing patient’s clinical records with others, it has to be ensured that confidentiality, integrity and security of data is maintained (no tampering with sentences or words contained in the records, no unauthorised addition / deletion, no overwriting, no missing document, etc.)

As per objective element IMS.5-e (Commitment), in case access to medical records needs to be given to external agencies as required by law, authorization should be taken from the patient before doing so. This is more applicable to medico-legal cases, where patient’s health information will have to be disclosed to the lawyer, police, or any other authority

Since the records are stored in the MRD, therefore it is a very crucial role of the MRD staff.

As per objective elements PRE.2-j (Commitment) and IMS.5-f (Commitment), patients and their family members have the right to access their clinical records

The MRD / hospital authorities should comply with the Code of Medical Ethics laid down by the Medical Council of India (MCI), and ensure that every patient has access to his / her medical record

Other statutory requirements should also be complied with

As per objective element IMS.1-g (Commitment), it is mandatory to share certain types of treatment related information with the Corporation / Municipal body, as per prevailing laws and regulations

Examples - information regarding notifiable diseases, births / still births, deaths, dengue, malaria, H1N1, Covid cases, MTP (Medical Termination of Pregnancy)

Sending these reports to the Corporation in authorise formats is the responsibility of the MRD

As per objective element IMS.4-h (Commitment), care providers should have proper access to current and past medical records of patients 24 hours a day, both in HIS and in the MRD (Care providers are the doctors, nurses, dieticians, etc.)

In case patients’ past records are required during non-working hours when the MRD is closed, there should be an authorised person available to unlock the MRD and retrieve the medical records of patients

The care providers should be given their own specific user ID and passwords to access the electronic medical records of patients in the Hospital Information System (HIS) 24 hours a day (IMS.5-a Core)

This system of making the medical records available to direct patient handlers 24 hours a day should be a very well laid out process, which should be maintained as a documented procedure. In that procedure you should also define who will be authorised to give approval for issue of the medical records during non-working hours, and who will be authorised to unlock the department or the record room to issue the record

It is preferable if a Register is maintained for entering the details of all such issues

COMPLETENESS OF MEDICAL RECORDS

As per Standard IMS.3, all patients getting treated in the hospital must have complete and accurate medical records

This means, the medical records (files) should have all the treatment related papers / documents filed in proper chronological order (IMS.3-c Core), from the time of admission to the time of discharge, containing the complete history of the treatment and care provided during the entire duration of the patient’s stay in the hospital. No paper / document should be missing from the file

The same methodology also applies for electronic soft copies of medical records

It is the MRD’s responsibility to check all the hard copies of patients’ files received in the department for completeness, and inform the sender department in case any document is found missing

VERY IMPORTANT:- As per objective element IMS.3-b (Commitment), the contents of the medical record should be identified and documented

This means, there should be a method for identifying the papers / documents by their names

The best way of doing this is by creating a common standardised Checklist of the contents of medical records. This Checklist should be available in each patient’s file

The Checklist will guide the MRD staff while checking for completeness of medical files

In the standardised Checklist mention the Serial Number in which the records should be arranged in the file

A small example of the Checklist is given here for guidance:-

Sr. No.	Contents of Medical Records	Present in File
		Yes	No
1	Discharge Summary
2	Registration Form
3	Admission Form
4	TPA papers (if any)
5	Doctor’s Initial Assessment Sheet
6	Nurse’s Initial Assessment Sheet
7	Nutritional Initial Assessment Sheet

NOTE - I have put Discharge Summary at the beginning, because the Discharge Summary gives a complete picture of the patient’s treatment from the time of admission to the time of discharge (past history and current history of patient, reason for admission, diagnosis and treatment given)

Make this Checklist available to all concerned departments, so that the records can be arranged in this pattern in the patients’ files before they are sent to MRD

If a particular column in the Checklist is not applicable, then that column should be marked as NA (Not Applicable)

For instance, for all non-surgery patients, the relevant columns in the Checklist can be indicated as NA (examples - anaesthesia chart, pre-op checklist, operation note, post-op recovery notes, etc.)

It is the concerned department’s responsibility to ensure that all the papers are arranged in the medical record file as per the Checklist, before sending them to the MRD. The completely filled Checklist should also be put in the file (the Checklist should be the first document in the file, followed by the Discharge Summary and the rest of the documents / records)

The MRD staff should cross check the contents of the patient’s file with the Checklist, to ensure that all the records are present in the file

If any document is found missing, MRD should inform the concerned department / person immediately. It is the responsibility of the department / person to locate the missing record and send it to the MRD, so that the record can be put in the patient’s file

MRD staff should follow-up to ensure that the missing paper / document is located and sent to the MRD at the earliest

As per objective element IMS.3-c Core, if a particular record / document cannot be located, then a note to that effect should be put in the medical file of the patient. It is preferable, if this note is put by an authorised person of that department from where the record / document is missing

If your hospital maintains medical records in electronic soft copy format, then the Checklist should also be made available in electronic soft copy format, with proper linkage to respective medical records of patients

RETENTION AND DESTRUCTION OF MEDICAL RECORDS (IMS.6-b Core, IMS.6-d Commitment)

Ensure all legal requirements are complied with while developing the retention / destruction protocol of patient's clinical records, data, and information as per requirements

Define the time frame for which a record should be retained in the storage section before they are archived / destroyed. Some medical records may have to be retained permanently (example - medico-legal case files)

If you decide to archive the medical records at an outsourced location, then there should be a proper documented and signed MOU / Agreement with the outsourced vendor. This MOU / Agreement should be renewed and kept updated all the time

There are service providers who provide fire proof, pest proof, water proof, tamper proof storage facilities for medical records

Recently discharged medical records should not be archived to an outsourced location. You should define the time period for which the medical records will be kept in the MRD, before they are sent to an outsourced location for safe keeping

In case any old case file of a patient is required by a medical practitioner or the legal department / police, then there should be a protocol for retrieving such files from the outsourced vendor

You should create proper backup (scanned copies) of all hard copies of medical records before destroying / archiving them, or before sending them to the outsourced vendor for safe keeping

The MRD staff should be properly trained in creating backups of hard copies. A scanning machine can be used for this purpose. The backup copies should be stored securely with limited access to authorised person(s) only

Proper backup system should also be available for electronic soft copies of medical records / data / information. It is preferable if backup of electronic soft copies is taken by the I.T. department

The MRD should define the retention periods for all categories of medical records - out-patient, in-patient and medico legal cases (MLC. Retention periods for the different categories should be defined in conformance with MCI rules and other legal requirements of the State authority

If other types of records / documents (registers, forms, sheets, etc.) are also used for capturing patient-related information, then MCI and State rules will be applicable for defining the retention periods of such data, records / documents also

As per objective element IMS.6-c (Commitment), the retention process should provide appropriate confidentiality and security of all the medical records, data and information. This is applicable for all types of hard copies and electronic soft copies of patients’ records / data / information

As already mentioned earlier, all the computer terminals should be protected with login ID and password, giving limited access only to the end users. A protocol for restricted entry into the MRD storage area should be defined and implemented well

It is preferable if MRD displays the protocol in some prominent area in the department, where it will be clearly visible to everybody entering the department

As per objective element IMS.6-d (Commitment), there should be a documented procedure for the destruction of medical records, data and information

You are required to define and document a destruction protocol, and implement the protocol well. While defining the protocol, ensure that you comply with all the Statutory and Regulatory requirements, wherever applicable

Once the retention period is over, the medical records / data / information can be destroyed, with due approval from the concerned authorities (both internal authority and external authority)

Internal authority can be the top management. External authority may be some Government body, as applicable in your area

MEDICAL AUDIT PROCESS (Standard IMS.7 - review of medical records)

Audit of medical records is a very crucial process in ensuring quality management of patient care processes

When and how to conduct the medical audit is management decision, and it should be conducted as per NABH requirements (IMS.7-a Core)

As per objective element IMS.7-d (Commitment), it is necessary to carry out periodic review of medical records based on identified parameters

The minimum requirement of review parameters is timeliness, legibility, and completeness of the medical records. Other parameters that could also be included are completeness of consent forms, availability of operation notes / procedure notes, prescription written in legible and capital letters, etc.

Since medical audit involves the scrutiny and review of medical records of both admitted and discharged patients, therefore the MRD staff should be actively involved in the medical audit process

There should be a defined process for handing over the selected medical records (files of patients) to the medical audit team, and taking them back in a timely manner

At the time of taking back the files, the MRD staff should ensure that no documents / records are missing from any file

Proper evidences of handing over and taking back should be retained by the MRD

Scrutinising some medical audit parameters require expert judgement of doctors / surgeons. Whereas, some parameters can be checked by the MRD staff

A few examples of parameters which can be checked by the MRD staff:-

1. No document should be incomplete, no column should be left blank, handwriting should be legible, medication order should be in capital letters
2. All the documents should be named, signed, dated and timed by the persons making the entries
3. No document should be missing from the patient’s file. All the treatment details of the patient from the day of admission to the day of discharge should be available in the patient’s file (examples - registration form, admission form, initial assessment sheet, consent form, doctors’ notes, nurses’ notes, anaesthesia chart, operation notes, doctor’s prescription and medication administration chart, investigation reports, patient’s progress notes, discharge summary, etc.)

The checked parameters should be entered in a Checklist by the MRD staff and handed over to the Medical Audit team for their scrutiny and necessary action

CONTINUAL QUALITY IMPROVEMENT

As per NABH, ensuring quality improvement and process improvement are the most important responsibilities of the respective department heads (HODs)

As per Intent of Chapter 6 (PSQ), department leaders should play an active role in patient safety and quality improvement

Quality Objectives and Key Performance Indicators (KPIs) are important tools for monitoring and measuring the success of quality improvement activities

Each and every MRD staff should be equally involved in all quality improvement activities. They should have good knowledge of their department’s quality objectives / KPIs, and should understand the importance of achieving the targets

It is necessary to retain proper records of all the quality objectives / KPI activities and outcomes

Setting quality objectives for process improvement and quality improvement is the requirement of ISO-9001:2015 (Clause 6.2)

Monitoring the quality indicators (KPIs) for process improvement and quality improvement is mandatory requirement of NABH (PSQ.3 and PSQ.4)

ISO-9001 has not defined any quality objectives. The hospital is free to decide its own quality objectives.

NABH has defined the Key Performance Indicators which have to be mandatorily monitored and measured

MRD staff could be directly involved in capturing some of the quality indicator (KPI) data, and reporting the same to the concerned department / person for immediate correction, corrective action and preventive action

The following quality indicator data could be captured by MRD

PSQ.4-c : Percentage of medical records having incomplete and / or improper consent

MRD staff could check this KPI in the medical records files of discharged patients received in the department, and document the findings in the KPI data sheet

Percentage of medical records having incomplete and / or improper consent

For this quality indicator, the unit of measurement is “percentage” and the frequency of data collection / monitoring is “monthly”

Formula is:

Number of medical records having incomplete and / or improper consent divided by number of discharges and deaths, multiplied by 100

(the discharge files of death patients should also be included in this indicator)

Number of medical records having incomplete and / or improper consent X 100

Number of discharges and deaths

As per NABH, incomplete consent means if any essential element or requirement of consent is missing (examples - date is missing, a column has been left blank, name of patient is missing)

Improper consent means if a consent obtained is invalid or void (examples - consent has been obtained from the wrong person, consent has been obtained by the wrong person)

Consent has been obtained from the wrong person - means consent can be given only by the patient / patient’s guardian / patient’s family member(s). Consent cannot be given by some other person

Consent has been obtained by the wrong person - means consent has been taken from the patient by someone who is not authorised to take it (example - consent for surgery should be taken by the operating surgeon or by a doctor member of the operating team. Consent for surgery cannot be taken by anybody else)

In addition to the above, the MRD staff could also collect KPI data for other parameters, like missing records in the files of patients, files not having discharge summary, and any other parameter that your department thinks fit

Each medical record file coming to MRD should be checked for these identified parameters

If any parameter is found to be missing, it should be captured in the KPI data sheet immediately and informed to the concerned department / person without delay, for necessary correction, corrective action and preventive action

Please note, the KPI report should be made known to the top management on a monthly basis

MRD should also prepare a data sheet for bed occupancy rate and ALOS (average length of stay), and share the data with the top management on a monthly basis. Some hospitals also send this data to the Corporation on a monthly basis

While calculating the bed occupancy rate and ALOS, do not include beds which are not in use or have not been commissioned for patient use

Though quality objectives are not the requirement of NABH, but it is a good practice to set objectives to improve your department’s processes / functions

It is preferable to set quality objectives for all the critical and important activities of the department (examples - maintaining scanned backup copies of all medical records, preventing loss / theft of medical records, checking all medical records arriving in the department in a timely manner, maintaining properly updated inventory of all medical records)

The quality objectives should be:-

• Bound by a time frame
• Practically achievable
• Monitorable
• Measurable
• Once achieved, should be sustainable

Bound by a time frame - means a time should be set for achieving the objectives (3 months, 6 months, etc.)

Practically achievable - means the target should be easy to achieve. Do not set a target which cannot be achieved or is difficult to achieve

Monitorable - the tasks / activities associated with the objective should be easily monitorable

Measurable - means the objective should be quantifiable, can be easily counted and calculated (percentage, number of days, etc.)

Sustainable - once the objective is achieved, you should be able to maintain and sustain it on a continuous basis (this is possible only if the objective is practically achievable)

TRAINING NEEDS OF THE DEPARTMENT

Training is the responsibility of the HR department. But certain aspects should be handled at the department level (HRM.3-a Core)

As per objective element HRM.3-i (Commitment), during induction training, the staff members should be oriented on the department / unit / service / programme’s policies and procedures. As per NABH, this induction training should be given at the department level

The head of the department should plan the training calendar of the department, and ensure that the trainings are conducted as per the calendar

Training calendar is the planner, which can be prepared for the whole year in advance. Modifications are allowed, as per department’s training requirements

Training calendar should consist of the training topics, dates of training, name of the trainer(s), frequency of refresher / repeat trainings (as applicable)

Staff members should be appropriately trained based on their specific job descriptions (Standard HRM.5). The topics selected for training should ensure professional development of the MRD staff (Standard HRM.4)

Some examples of training topics for MRD

• ICD coding
• Indexing files received in MRD
• Checking the medical records files received in MRD for correctness and completeness
• Process of issuing files to doctors, and receiving the files back from the doctors
• Proper preservation of medical records

Training should also be conducted

1. When job responsibilities change, or when a new machine / equipment or new technology is introduced (HRM.4-c Commitment)
2. When a new MRD process or function is implemented
3. When changes are made in an existing MRD process / function

You may prepare Work Instructions, Check Lists, informative leaflets, etc. on various training topics and make these available to the MRD staff for their ready reference and guidance

Records of training, repeat training, and evaluation should be retained, along with training evidence (HRM.3-a)

Training evidence means preparing a training attendance sheet containing the training topic, date on which training was given, name and signature of the trainer(s), names and signatures of the trainees

Evaluation of training effectiveness is a mandatory requirement (objective element HRM.4-e Excellence)

Evaluation should be done:-

1. Immediately after the training is completed

2. Also, after a certain time gap

Immediately after the training is completed, you can carry out evaluation through verbal interview, through written test, or any other method that you consider appropriate

Evaluation after a time gap is required to ensure that training was effective and has resulted in improvement of competency at the workplace. You can carry out evaluation through verbal interview, through observation during work, or any other method that you consider appropriate

During evaluation, you should focus on knowledge, skill and attitude of the trainees. Based on the evaluation report, you may have to conduct repeat training on the same topic

NOTE:- Non-conformances raised during internal audit / NABH assessment is a very good tool for evaluating the effectiveness of the trainings given

For all department level trainings, MRD should retain proper records of all the trainings, re-trainings / repeat trainings, and evaluations - this means, training calendar, training attendance record, training evaluation record  (HRM.3-a Core)

As per objective element HRM.4-b (Commitment), the HR department is required to maintain records of all the trainings provided, and so MRD should give a copy of training records to the HR department

To end this blog, I apologise that, yes, it is rather a long one, but I have tried to give as much information as possible here

I will also be releasing separate blogs on other important process requirements as per NABH, viz., Medical Audit, Clinical Audit, Key Performance Indicators, and a host of other topics

Keep visiting my blog site

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