Informed Consents – 5 required documentation in the medical record providing information to patient and family

“Every human being of adult years and sound mind has a right to determine what shall be done with his own body….”, is an often quoted (in bioethics and legal literature) statement by Justice Cardozo from the well-known case Schloendorff v. Society of New York Hospital, 105 N.E. 92, 1914.

Informed consent as Wikipedia informs us “is a phrase often used in law to indicate that the consent a person gives meets certain minimum standards”. It is interesting to note that this term was first used by Paul G. Gebhard, an attorney well educated from Yale and Harvard Law School and the senior partner in the government, health care and association group of the Chicago law firm of Jenner & Block, in a 1957 medical malpractice case in which a patient contended that a physician at a Stanford University hospital had not fully disclosed the risk in a recommended treatment.

As an informed consent grants the right to a patient to be involved in their care decision, the inform consent informs a patient of those factors related to the planned care required for an informed decision.

Informed consent can be obtained when at several points in the care process. Informed consent can thus be obtained when a patient is admitted for inpatient care before certain procedures or treatments for which the risk is high.

It is important to know the following:

  • the consent process is clearly defined in the hospital’s policies and procedures incorporating relevant laws and regulations
  • the role patients and families in the informed consent process – (i) they are informed as to what tests, procedures, and treatments require consent and how they can give consent (for example, given verbally, by signing a consent form, or through some other means), (ii) they understand who may, in addition to the patient, give consent
  • trained designated staff members inform patients, obtain and document patient consent. Here I like to quote the Malaysian Medical Council  (MMC) which “upholds that the responsibility for obtaining consent lies with the  practitioner performing the procedure. He is the best person who can ensure that the necessary information is communicated and discussed”,  as stated in its “A Guidebook for House Officers”, paragraph 4.12, pages 37-38, dated 23 April 2008. A statement from a booklet by the MMC,  “Good Medical Practice”,  paragraph 3.7, page 13 also defines and states the role of doctors in providing an informed consent.

Now that you as a HIM/MR practitioner finished reading from the above a brief overview of the basic human right of a patient to informed consent, you need to know the kind of documentation that goes into a medical record.related to informed consent which is obtained before surgery, anesthesia, use of blood and blood products, and other high-risk treatments and procedures.

A medical record will contain an informed consent for :

  1. surgical or invasive procedures
  2. anesthesia other than local including moderate (“conscious”) and deep sedation
  3. blood and blood products used
  4. high-risk procedures and treatments

When informed consent is taken, the following will also be recorded in a medical record:

  1. identity of the individual providing information to patient and family
  2. patient’s signature or a record of verbal consent

Thus,  the 5 required documentation in the medical record providing information to patient and family includes numbers 1 to 4 as given above and number 5, ” identity of the individual providing information to patient and family and the patient’s signature or a record of verbal consent”

Whether or not your hospital is been accredited by the Joint Commission International(JCI), you need to play your role to ensure that an informed consent is documented in the medical record when a patient had surgery, anesthesia, used of blood and blood products, and undergone other high-risk treatments and procedures.

If you hospital is been accredited by JCI, then you must be informed that JCI Standard *PFR.6.4 applies to an informed consent documentation in a medical record. JCI Standard PFR.6.4 states that “Informed consent is obtained before surgery, anesthesia, use of blood and blood products, and other high-risk treatments and procedures”.

Still on the subject of JCI accreditation, it’s good to be aware not only of JCI Standard PFR.6.4, but also I think as an informed HIM/MR pratitioner to also know the following too:

  1. that a hospital has a clearly defined informed consent process described in policies and procedures
  2. who are trained to implement these policies and procedures
  3. what is clearly explained regarding any proposed treatment(s) or procedures to the patient and, when appropriate, the family

In addition, be informed that:

  1. designated staff members who are trained, not only to carry out the process of giving out the informed consent but also obtain and document patient consent in accordance to the  JCI Standard PFR.6 which states that “Patient informed consent is obtained through a process defined by the organization and carried out by trained staff in a language the patient can understand”.
  2. these trained designated staff members provide information as stated the elements (a) to (h) as in the JCI Standard PFR.6.1 which states that “Patients and families receive adequate information about the illness, proposed treatment(s), and health care practitioners so that they can make care decisions”

So much more to be informed on informed consent, and I think I covered pretty much already on JCI Standards PFR.6, PFR.6.1 and PFR.6.4

*PFR stands for Patient Family Rights

10 facts about a discharge summary

When a patient is discharged from a hospital, a discharge summary or clinical résumé to document the care provided to the patient during his or her inpatient hospitalisation is prepared by any qualified individual such as the patient’s physician, a house medical officer, or a clerk.

This discharge summary placed in the patient’s record provides information for continuity of care and facilitates a medical staff committee review and it can also be used to respond to requests from authorised individuals or agencies (e.g., a copy of the discharge summary will suffice instead of the entire patient record).

10 contents of a discharge summary documents the patient’s hospitalisation which includes:

  1. the reason(s) for admission
  2. significant physical and other findings(e.g. brief clinical statement of chief complaint and history of present illness)
  3. significant diagnoses and co-morbidities(example, Principal diagnosis: Cellulitis and gangrene, left foot and lower leg. Comorbidities: Diabetes mellitus, insulin dependent, controlled. Staphylococcus aureus coagulase positive septicemia. Urinary retention)
  4. diagnostic and therapeutic procedures(example, Principal procedure: Amputation, left leg, above knee. Secondary procedures: Suprapubic cystostomy with permanent suprapubic drainage)
  5. significant medication and treatments(medical and surgical) and patient’s response to treatment, including any complications and consultations
  6. patient’s condition/status at discharge
  7. discharge medications and all medications to be taken at home
  8. follow-up instructions(patient education when applicable), to patient and/or family (relative to physical activity, medication, diet, and follow-up care)  including instructions for self-care, and that the patient/responsible party demonstrated an understanding of the self-care regimen
  9. unless contrary to policy, laws, or culture, patients are given a copy
  10. a copy is provided to the practitioner responsible for patient’s continuing or follow-up care

I am sure your hospital policy and procedures defines when a discharge summary must be completed, and that it must be placed in the record.

Such a policy and procedures are affirmed by the Joint Commission International(JCI) standard ACC.3.2 which states that “the clinical records of inpatients contain a copy of the discharge summary” and requires that a discharge summary must be prepared at discharge by a qualified individual, it contains follow-up instructions, that a copy  is placed in the patient record, the patient is given a copy of the discharge summary unless not allowed by hospital policy, laws, or culture, and a copy of the discharge summary is provided to the practitioner responsible for the patient’s continuing or follow-up care.

JCI Standard ACC.3.2 is expanded by JCI Standard ACC.3.2.1 which further qualifies the contents of a complete discharge summary.

The above 10 facts listed above covers all that is required by the 6 MEs of ACC.3.2 and the 6 MEs of ACC.3.2.1, when the discharge summary placed in a medical record is reviewed during a Medical Records Review.

Note : In Malaysia, the patient’s physician or a senior medical officer but NEVER a clerk, is responsible to prepare the discharge summary.

5 transfer process entries that must be entered in a medical record

A patient might require a hospital transfer for a number of reasons. The patient or the family might want a second opinion, the current hospital cannot address the needs of the patient, or the new hospital offers more advanced care among other reasons.

When a patient is transferred to another hospital or health care organisation, the transfer process is documented in the patient’s medical record.

A HIM/MR professional needs to be aware of five transfer process entries which must be included in a medical record when a patient is transferred to another hospital or health care organisation.

These 5 transfer process entries as documented in the medical record will state and/or contain :

  1. the name of the hospital or health care organisation and name of the individual agreeing to receive the patient
  2. any documentation or other notes as required by the policy of the transferring hospital for example, a signature of the receiving nurse or physician, name of the individual who monitored the patient during transport
  3. the reason(s) for transfer
  4. any special conditions related to transfer such as when space at the receiving hospital or health care organisation is available, or the patient’s status
  5. any change in patient condition or status during transfer for example, the patient dies or requires resuscitation

If your hospital is in the process of becoming a Joint Commission International(JCI) accredited hospital, you need to know that the JCI Standard ACC.4.4 requires that a transfer process from one hospital(health care organisation) includes the above mentioned 5 transfer process entries in the patient’s medical record.

However, do take note that the JCI Medical Records Review Tool does not list documentation required by policy requirements of the transferring hospital, as one of its measurable elements.

JCI Standard MCI.19.4 – Patient Clinical Record, Medical Records Review, Medical Records Review Protocol, Analysis & Report

In my previous post on the MMRT form, you noticed I payed attention to the nitty-gritty of forms processing. I took care to make the MMR for my organisation a success by testing out the form myself and gain first hand experiences, so must you!

Let’s us move on.

Now that I am done telling you about the MMR and the MMRT form, and all the relevant other steps in the review process, imagine that a process session had just ended.

Once a review process session is just over, it is only courteous as team leader for you to thank every review team member before they disperse.

You need to collect back all the medical records used during the review and verify with the medical records request form received from the HIM/MR department. You will get someone to assist you on this task. The records are then carted away immediately to the HIM/MR department by their staff.

Collect all MMRT forms and start data entry into a computer pretty soon. Check the forms for accuracy and completeness for doing data entry.

I used MS Excel to enter data from the TOTAL Y/N column from the MMRT form, i.e total scores of Y and  N  respectively for each standard reviewed, into a spreadsheet according to the reviewer’s name. A formula entered in this spreadsheet computed the NA(Not Available) score.

Then I used MS Word and MS Excel together to prepare a report using the total scores for each standard in the MMRT form for all the reviewers. This score for Y, N and NA is for the sample size chosen, that is 100.

The report is a combination of a radar diagram plotted from the absolute values for Y, N and NA for each standard in the MMRT form, a table to show these values from the findings, and the standard stated before each table and graph.

I made no inferences to the findings, the report was merely a report of the findings from the review process, as I felt making inferences was for the quality leaders to make during an appropiate forum/meeting and for them to make appropiate comments and recommend remedial measure(s) for the shortcomings.

Below you can view how a radar graph looks like for the standard AOP.1.8.2 and two of its MEs from one of the MMRs done.

I am not presenting an actual report due to ethical considerations.

So this ends the posts on JCI Standard 19.4!

<Goodluck with JCI Standard 19.4 >

JCI Standard MCI.19.4 – Patient Clinical Record, Medical Records Review, Medical Records Review Protocol, Medical Records Review Tool

To continue on MMR, I shall discuss a little about the MMR tool form (the form will open in a new tab of your current window), for a start.

I have modified the form with some features that are not available on the form presented in the Hospital Survey Process Guide. I made the modifications based on my experiences leading the team in the MMR process. I think the following changes in the form are to facilitate a successful MMR process:

  • a header section with the hospital’s name printed, and also a box to enter the review date, on all 3 pages of the form
  • the right-most column, the column TOTAL Y/N,  is divided into two columns, one for Y and the other for N
  • standard ACC.3.2 is on one page, on page 3
  • a remarks box, only on page 3
  • a box for the reviewers name and another box for the reviewer’s signature, only on page 3
  • a footer section for all the 3 pages – the page number insert, since the original form does not have a page number

In the form found in the guide, the TOTAL column(the right-most column) was only one column. So after I  counted the number of Ys and Ns for each row, my entry in this column showed as  the number of Ys and Ns separated by a forward slash. For example if I entered “3/5” in this column to denote a count of 3 Ys and 5 Ns. I found it messy and mistake prone when  I  picked-up this entry(this “3/5” way of recording) during data entry into a computer. Thus I modified the form by adding 2 columns under the TOTAL column, i.e. one for Y and another for N, and in doing so I found it easier and mistake free during data entry into the computer..This is an experience you get when you do the data entry yourself in the early stages of testing out the MMR form.

I think the remarks box is important for the reviewer to enter remarks, which was otherwise written haphazardly, when the form found in the guide was used as-is

The form also did not have a place to write the reviewer’s name and his / her signature, I thought these two modifications were important for tracing the form’s author.

The footer section with page numbers is helpful in sorting the forms during data entry into a computer.

These are some of the things I made to the MMRT form. I shall add some tips and guidance at a later date.

There is nothing permanent except change
Diogenes Laërtius in Lives of the Philosophers Book IX, section 8