I hope this example will help to explain how a simple random sample is realised. This chart is to help you to understand what I wrote under the Sampling Technique paragraph in the post JCI Standard MCI.19.4 – Patient Clinical Record, Medical Records Review, Medical Records Review Protocol

You can click on the above image to view a larger image in a new tab, in the same window.

I have endeavored to make this protocol as general as possible and with no direct references to any organisation. This protocol is a framework you can modify and make it better to suit your organisation and needs.

In this post which is rather long, I shall avoid showing the relevant appendices on random tables, sampling technique example and the Medical Records Review Tool form, but they will appear separately in subsequent posts.

TITLE
Medical Records Review Protocol

SUMMARY
As part of a hospital’s performance improvement activities, hospitals regularly access(review) medical records  based on a sample representing the practitioners providing care and the types of care provided for completeness, accuracy, and timeliness of the information they contain as required by the Joint Commission International(JCI) standards.

DESCRIPTION
Rationale
A medical record (patient clinical record as per Joint Commission International documentation) is a systematic documentation which serves as the business record for a patient encounter for every patient assessed or treated in a health care organisation as an inpatient, outpatient, or urgent care patient.
A medical record contains sufficient information of all health care services provided to a patient, and is a repository of information that includes demographic data(patient’s personal and social data) to identify the patient, as well as documentation to support diagnoses, justify the treatment,  record treatment results, and an account of follow-up and final outcome to promote continuity of care among health care practitioners.
Statutes, accreditation standards, and professional associations frequently impose standards relating to the legibility, accuracy, and completeness of medical records. The Joint Commission International (JCI) standards of accreditation for hospitals require that data be collected in a timely, economic, and efficient manner using the degree of accuracy and completeness necessary for the data’s required use.
A hospital’s bylaws or policies normally require medical staff members to complete patient records within the specified time, and include punitive measures for those who fail to comply.
Usually, the Health Information Management(HIM) /Medical Records(MR) department head has the responsibility for making sure that records are completed within a specific time. Therefore, the HIM/MR department should establish procedures for notifying attending physicians when records are incomplete.

Objective(s)
A Medical Records Review(MMR) ensures the quality of a medical record is complete and accurate with the following objectives:

1. to ensure only authorised individuals identified by organisational policy make entries in the medical record
2. to create awareness of the importance of creating an accurate medical record and the legal and medical implications of failing to do so
3. to enable healthcare professionals to plan and evaluate a patient’s treatment and to ensure the continuity of care among multiple providers
4. to enable a healthcare provider to establish that a patient received adequate care.

METHODOLOGY
Design
The MMR is based on a sample representing the practitioners providing care and the types of care provided.

Subjects or participants
A sample of subjects is selected by selecting a total number of medical records randomly selected from a total number of medical records of the patients who visited during the current or past year to represent the population of practitioners providing care and the types of care provided.
Medical records of the expired patients are not included in the review.

Sample size
A convenience sample size of one hundred(100) medical records is drawn from a population size of 2 percent(%) of the total admissions or inpatients in one month, in a given year.

DATA MANAGEMENT AND ANALYSIS
Data Collection
Sampling Technique

• The discharge register listing (computerised) or the admissions register (manual) is used to collect the sample.
• A time period e.g for example the last calendar month is chosen.
• Simple random sampling using a five (5) digit random number table available in most statistics textbooks is used to select the sample.
• A data collection form with columns headers “No.”, “Subject No.”, “Random No.” and “MRN” is used to collect the 100 samples.
• “No.” is the number in the series, “Subject No.” is the subject number given to a selected sample, “Random No.” is the random number selected from the random table and “MRN” is the Medical Records Number.
• Each medical record selected using the random table is coded(given) a “Subject No.” beginning with “00” and ends with “99”, denoting the sample size of 100 medical records.
• From the 5 digit random table, choose the last two-digits from the left of the 5 digit number.
• Close your eyes and put your pen on one of the numbers in the random number table, for example XXX45. This will be your starting point and the first subject number.
• Record “45” in column labeled “Random No.” beside column labeled “Subject No.” along the first row labeled number “1” in column labeled “No.”, in the data collection form.
• Starting with the first selected number, choose a direction (up, down, left or right).
• Record the next 2 digit random numbers that appear in the table in their respective columns and rows, in the data collection form while moving in the chosen direction until you have selected 100 numbers which lie between 00 and 99.
• Any numbers which have already been selected are ignored.
• Using the data collection form and the listing or the register, choose the first entry with the last 2 digits of the MRN in the listing or register for the chosen period which corresponds to the first random number for subject number “00”. Enter the MRN in the “MRN” column in the data collection form.
• Likewise, check every consecutive entry in the listing or the register and enter each MRN in the “MRN” column in the data collection form for all entries with the last 2 digits of the MRN corresponding to the random numbers recorded in the data collection form.
• Count the number of entries in the listing or the register checked to collect the sample size(n=100) divided by the total number of discharges or admissions for the chosen month, to derive the percentage of the population sample size.

Medical Records Review Tool
A form is constructed with a listing of the JCI medical records documentation standards.  A criteria “Yes”, “No” and “Not applicable (NA)” is used as the options in the Medical Records Review Tool form to access each standard listed.

Process
The data collection form is used by the HIM/MR Department to retrieve the selected medical records for the medical records review.
The review process is conducted on an arranged date and held periodically as stated in the Terms of Reference(ToR) of the Medical Records Review Committee.
The HIM/MR Department despatches the selected medical records for the medical records review to a predetermined area in the hospital premises for the review process.
The review process is conducted by the medical staff, nursing staff, and other relevant clinical professionals who are authorised to make entries in the patient record.
The MRRT form is used to review and score the selected medical records using the set criteria.
The MRRT forms are completed with reviewer details and signed, and collected by a Person-In-Charge.

Analysis
The MRRT forms are used to prepare a report.
The results of the review process are incorporated into the organisation’s quality oversight mechanism

ETHICAL CONSIDERATIONS
Members of the review process will honor patients’ rights to privacy with respect to information in the medical records. All reports will be free of patient identifiers.

Disclaimer:
I am no expert in statistical methods, however I have prepared this protocol based on my experiences and working knowledge on the  Medical Records Review process similar to the one I had prepared as MCI Champion for the organisation I had worked for.

Once a leader is appointed to champion MCI Standards, one of the first steps leading this challenge is to gather a team to define a terms of reference (ToR) document.for a Medical Records Review Committee (MRRC) which will oversee the mechanism to conduct the Medical Records Review.

In this post, I shall propose a ToR for a MRRC.

But before that a little about what this ToR document is all about. It defines all aspects of how a MRRC will conduct a regular assessment of “patient clinical record content and the completeness of patient clinical records” as part of a hospital’s performance improvement activities, as required by JCI Standard MCI.19.4

The ToR also defines the objective and the scope of the evaluation, outlines the responsibilities of the MRRC and provides a clear description of the resources available to conduct the study, in this case the hospital’s multidisciplinary professionals and authorised groups enable this through a process of regular review and evaluation of patient care records,

The ToR document includes the definition and function – when is one needed, and what are its objectives, what should be included in the review(content),  what needs to be in place(preparation) for a member of the MRRC to facilitate the completion of a high quality evaluation, what steps (process) should be taken to develop an effective ToR, and the roles and responsibilities of designated members.

Now, below is one sample of a ToR for a MRRC I like to propose.

MEDICAL RECORDS REVIEW COMMITTEE (MRRC)

TERMS OF REFERENCE(ToR)

INTRODUCTION

Medical records form the basis for patient care planning, support diagnoses and treatment. They also provide the basis to evaluation of the patient’s condition, treatment as well as continuity of care. It is therefore pertinent that every doctor, nurse, allied health practitioner and those authorised to make entries in the patient records ensure that the content and timeframes of clinical documentation conform to the highest professional standards, to meet patient, legal and accrediting bodies’ requirements.

OBJECTIVE

The MRRC is established as part of the hospital’s quality improvement activities to ensure standards of patient care documentation are maintained in conformance to legal and regulatory bodies, including professional and accrediting agency standards. The hospital’s multidisciplinary professionals and authorised groups enable this through a process of regular review and evaluation of patient care records.

KEY FUNCTIONS

The Committee shall on a regular basis, review and evaluate medical records to ensure:

1. that they are maintained in a complete, legible and timely manner and with pertinent and useful clinical information and overall adequacy to provide the highest standard of patient care.
2. that the records are adequately completed at all times so as to facilitate continuity of care and communication among all those providing patient care services as well as allowing quality improvement activities to be performed.
3. ¹that the review and evaluation includes records of patients currently receiving care (active patients) as well as records of discharged patients, and covers inpatient areas, outpatient clinics and emergency room and is based on a sample representing the practitioners providing care and the types of care provided
4. that record contents required by laws or regulations are included in the review process
5. that the patient record review is carried out by conducted by the medical staff, nursing staff, and other relevant clinical professionals who are authorized to make entries in the medical record or to manage medical records

MEMBERSHIP

ROLES AND RESPONSIBITIES

Chairman

1. He / she shall lead the team and be responsible for setting directions, goals and objectives.
2. He / she shall provide and update to the ²JCI Management Committee and relevant regulatory / accrediting bodies concerning patient care standards documentation and quality of clinical records keeping in the hospital.
3. He / she shall lead the team during the JCI MCI – Medical Records Interview

Co-Chair

1. He / she shall assist the team in achieving set directions, goals and objectives.
2. He / she shall chair the meeting in the absence of the Chairman.

Members

1. He / she shall be familiar with the key ³Licensing & Accreditation requirements including Joint Commission International Accreditation Standards and document control procedures pertaining to medical records.
2. He /she shall review identifies problems relating to patient care standards documentation and document control.
3. He /she shall initiate, recommend or provide solutions to non-conforming standards and deficient clinical records, through designated channels; verify the implementation of preventive measures and monitor its effectiveness.

MEETING

1. The Committee shall meet at least once a month.
2. Ad-hoc meeting may be convened to discuss urgent matters.
3. The members shall serve for a minimum of a 2-year period and may be re-appointed to another term.
4. The quorum shall be seventy-five present (75%) of membership.

¹ The TOR must specifiy what type of medical records will be reviewed and evaluated, example the MRRC may review and evaluate inpatient medical records only

²Main committee overseeing quality improvements

³Example, International Standards Organisation(ISO)

Once the ToR document is ready, it is time for discussion and approval by the MRRC and then forwarded to the MCI Committee for its endorsement.

Next, I shall be presenting a ToR for the MCI Committee and followed by the methodolgy to conduct a review and last, some discussion on presenting the results to senior leaders in quality.

References:

• Joint Commission International, 2010, Joint Commission International Accreditation Standards For Hospitals, 4th Edition, USA, JCI
• Dawn,R., Nidhi, K., and Arianne, W., 2011, Writing Terms Of Reference For An Evalaution: A  How-To Guide, Independent Evaluation Group(IEG), The World Bank, Washington, USA