Category Archives: JCI Standards PFR

JCI Standard MCI.4 – accuracy and timeliness of information in the hospital through effective communication

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My intention in bringing this post to a Health Information Management (HIM) / Medical Records (MR) practitioners reader specifically and to all other readers in general, is to understand the dynamics of communication and your role in managing patient-specific information in a hospital setting when the leaders of the hospital agree to an essential condition  whereby effective communication must prevail among and between professional groups; structural units, such as departments; between professional and non-professional groups; between health professionals and management; between health professionals and families; and with outside organisations.

In making this agreement for effective communication throughout the hospital setting, I agree the stipulations that this issue is primarily a leadership function of the hospital’s leaders. This agreement is stipulated in the Joint Commission International (JCI) Standard MCI.4 which states that “Communication is effective throughout the organization”, especially so if you are practising in a hospital accredited or seeking JCI accreditation status or undergoing re-survey for JCI accreditation status.

The reader as a leader of a structural unit setting and relevant service needs to be aware of the following conditions in this agreement for effective communication:

  1. for patient care to appear seamless, processes must be in place for communicating relevant information in an accurate and timely manner throughout one’s structural unit, such as the HIM / MR department and between other structural units in the hospital; this is to ensure that the processes are designed and implemented to support continuity and coordination of care as patients move through the hospital from admission to discharge or transfer, several departments and services and many different health care practitioners may be involved in providing care; for example from emergency services to inpatient admission
  2. the hospital defines the patient-specific information, example patient’s weight and other physiological information available from the medical record, required for an effective review process and is facilitated by a record (profile) i.e via medication administration records (MAR) or medication list, also to be found within a medical record for all medication administered to a patient except emergency medications and those administered as part of a procedure; the medical record folder is updated after a review of a patient receiving medications, example the folder is tagged with an alert sticker for allergies or sensitivity; this review also facilitates the medication reconciliation process across the continuum of care and the process continues upon discharge and transfer of the patient, and the complete list of patient medications is shared with the next provider of patient care
  3. effective communication occurs in the hospital among the hospital’s programs ranging from the emergency services, inpatient admission, diagnostic services and treatment services, surgical and non-surgical treatment services and outpatient care programs for seamless care
  4. since patients frequently require follow-up care to meet on-going health needs or to achieve their health goals, there is a plan by the hospital’s leaders with the leaders of other health care organisations in its community for effective communication to occur between the leaders of these other health care organisations in its community during referrals; the plan establishes contact with known resources i.e. the patient’s home community and identified specific individuals and agencies that are most associated with the hospital’s services and patient population in order that they help support continuing health promotion and disease prevention education
  5. there are policies and procedures developed to support and to promote patient and family participation in care processes to ensure that continuity and coordination are evident to the patient; effective communication thus occurs with patients and families in these circumstances:
    1. patients and families are involved in care decisions by effective communication thus occurs with patients and families when (i) they understand how and when they will be told of planned care and treatment(s), (ii) understand their right to participate in care decisions to the extent they wish and learn about how to participate in care decisions
    2. inpatients and outpatients who leave against medical advice when patients, or those making decisions on their behalf, may decide not to proceed with the planned care or treatment or to continue care or treatment after it has been initiated guided by a process for the management and follow-up of such cases
    3. effective communication thus occurs with patients and families when those who provide education encourage patients and their families to ask questions and to speak up as active participants
    4. effective communication occurs with patients and families when indicated, planning for referral and/or discharge begins early in the care process ie. soon after admission as inpatients and, when appropriate, includes the family
    5. effective communication occurs with patients and families when patients are reassessed to plan for continued treatment or discharge
    6. effective communication occurs with patients and families such that symptoms and complications are prevented to the extent reasonably possible during the care of the dying patient
  6. and finally. the reader as a leader must not only set the parameters of effective communication but also serve as role models with effective communication of the hospital’s mission and appropriate policies, plans, and goals to all staff.

I acknowledge the role of effective communication and its pervasiveness in creating, gathering and sharing health information in meeting challenges and improving health care outcomes. In this post, I think I have achieved to address some pertinent issues relevant to effective communication when implementing the requirements of the JCI Standard MCI.4 specifically and also delving into the issues of effective communication in general.

References:

  1. Dale, EB & Daena, JG (eds.) 2009, Communicating to manage health and illness, Routledge, London, UK
  2. Joint Commission International, 2010, Joint Commission International Accreditation Standards For Hospitals, 4th edn, JCI, USA
  3. Michelle, AG & Mary, JB 2011, Essentials of Health Information Management: Principles and Practices, 2nd edn, Delmar, Cengage Learning, NY, USA
  4. Sheila, P & Sandra, H (eds.) 2007, Health communication Theory and practice, Open University Press, McGraw-Hill Education, England, UK

Informed consent in clinical research, clinical investigation, and clinical trials

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Secondary purposes of the patient medical record do not relate directly to patient care and includes providing data for use in clinical research, epidemiology studies, education, public policy making, facilities planning, and health care statistics.

Some examples of  patient medical record that do not relate directly to patient care but providing data for use in clinical research include the following:

  1. Alzheimer Registry to collect data to evaluate prevalence of Alzheimer’s disease and related disorders by providing non-identifying information and data for policy planning purposes and to support research
  2. Birth Defects Registry which maintains national surveillance for collecting information on birth defect incidence, to monitor annual trends in birth defect occurrence and mortality, to conduct research studies to identify genetic and environmental risk factors for birth defects, and  promote educational activities for the prevention of birth defects
  3. Cardiac Registry that captures cardiac surgery information as a research tool for assessing cardiac patient outcomes and pinpointing how patient care can improve
  4. Cancer Registry for the management of cancer data collection, recording data elements for each entry that become part of a national registry which is used for education, prevention, quality improvement, and research activities
  5. Trauma Registry of all trauma admissions, deaths in the emergency department due to trauma, recording data elements for each entry that become part of a national registry which is used for education, prevention, quality improvement, and research activities

In this post I shall focus on informed consent that must be obtained when a patient decides to participate in clinical research, clinical investigations, or clinical trials, and skip the discussion on privacy issues and requirements when health care providers routinely allow medical professionals engaged in clinical or epidemiological research to access patient records, abstract individually identifiable information (e.g., date of birth, birthplace, and so on), and exchange that information with other researchers.

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Informed consent is an ongoing process during which information is presented to an individual patient and families to enable them to voluntarily decide whether or not to participate in or continue participation in clinical research, clinical investigations, or clinical trials. The information provided at the time the decision to participate was made serves as the basis for the informed consent. Informed consent for research involves presenting the research information orally and  obtaining written consent on an approved consent form prior to entering a subject into a study and documenting the consent process in the subjects’ medical record or research file.

Health Information Management (HIM) / Medical Records (MR) practitioners need to be aware that medical records of patients in an ongoing process when such patients participate in clinical research, clinical investigations, or clinical trials will contain the following:

  1. the informed consent form must be dated
  2. the identity of the individual providing the information to the patient and family and obtaining the consent must noted in the patient’s medical record
  3. consent is documented in the patient’s medical record by signature or record of verbal consent

If you are wondering why the patient’s family is involed in obtaining the consent, then the reader should be aware that a family member or person involved in the care of the patient as the participant  are usually encouraged to participate in the consenting process because (i) of the potential subject’s physical and mental state at the time of obtaining the consent, and (ii) to allow time for the patient to consider whether to participate and to discuss the research with his/her family over a period of time (which may include days or weeks). This is especially when particularly complex issues about the research are discussed, an investigator might consider testing the subject’s understanding of the information by asking questions about the presentation and when a family member or person involved in the care of the participant should be encouraged to participate in the consenting process.

At this jucture, I like to advice HIM / MR practitioners who wish to know more about the process of obtaining  informed consent from potential research subjects to explore the ‘Informed Consent  and Authorization Toolkit for Minimal Risk Research’ developed by the Agency for Healthcare Research and Quality (AHRQ). Although this toolkit is applicable in the United States and subject to the Health Insurance Portability and Accountability Act (HIPAA) requirements, it is a good read for understanding  the process to facilitate the process of obtaining informed consent and authorisation from potential research subjects if any such HIM / MR practitioner(s) is/are working at a hospital where clinical research, clinical investigations, or clinical trials is a common activity.

HIM / MR practitioners must also be aware that the Joint Commission International (JCI) Standard PFR.8 which states that “Informed consent is obtained before a patient participates in clinical research, clinical investigation, and clinical trials” and its four (4) Measurable Elements (ME) which must be met fully at hospitals that are JCI accredited or seeking JCI accreditation status or undergoing re-survey for JCI accreditation status.

HIM / MR practitioners must also check on the process of obtaining signed informed consent when patients voluntarily decide whether or not to participate in or continue participation in a research study which must comply with the requirements of any existing hospital guidelines or hospital policy.  HIM / MR practitioners can be proactive to suggest or initiate proper documentation in medical records for patients who participate in in a research study at the hospital they work at.

Lastly, HIM / MR practitioners do take note that the JCI Standard PFR.8  is checked for compliance in the Medical Record Review Tool form used in the Medical Record Review process if your hospital is already JCI accredited or seeking JCI accreditation status or undergoing re-survey for JCI accreditation status.

References:
The Agency for Healthcare Research and Quality (AHRQ), Informed Consent and Authorization Toolkit for Minimal Risk Research,  viewed 20 October 2012,< http://www.ahrq.gov/funding/grants/policies/informedconsent/index.html >

Joint Commission International 2010, Joint Commission International Accreditation Standards For Hospitals, 4th edn, JCI, USA

Michelle, AG & Mary, JB 2011, Essentials of Health Information Management: Principles and Practices, 2nd edn, Delmar, Cengage Learning, NY, USA

When others can grant consent

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Previous posts about patient informed consent on this blog provided insight into required documentation in a medical record, and they were built upon requirements on:

  1. how a process defined by the hospital and carried out by trained staff in a language the patient can understand, facilitates acquiring patient informed consent
  2. how patients and families can make care decisions after they receive adequate information about the illness, proposed treatment(s), and about health care practitioners who have primary responsibility for the patient’s care or who is authorised to perform procedures or treatment(s)
  3. informed consent which is obtained before surgery, anaesthesia, use of blood and blood products, and other high-risk treatments and procedures

Image credit : http://www.eidohealthcare.com/

In this post I shall discuss about a hospital process within the context of existing law, culture, and custom when others can grant informed consent as the last required documentation in the medical record for patient informed consent.

Informed consent is based (Michelle & Mary, 2011) upon the principle of autonomy which refers to an individual’s right to choose and the ability to act on that choice. The individuality of a patient as an individual with a right to decide for them is respected when autonomy is maintained.

A frequently occurring ethical dilemma confronting autonomy is when informed consent for care sometimes requires that people other than (or in addition to) the patient be involved in decisions about the patient’s care. This is especially true when the patient does not have the mental or physical capacity to make care decisions, when culture or custom requires that others make care decisions, or when the patient is a child. It should not be surprising that the process of seeking informed consent when informed consent for care sometimes requires that people other than (or in addition to) the patient be involved in decisions about the patient’s care presents doctors and other health professionals with difficult ethical issues.

When the patient is a child, parental or guardian consent should be obtained before treatment is initiated on a minor. If a patient is a minor and the parents or legal guardian deny a lifesaving treatment, a court may be obtained by the hospital authorities to overrule the decision.

When a patient is either comatose or near death, there is usually knowledgeable concurrence by the prescribing doctor who writes a do not resuscitate (DNR) order and the patient’s family or guardian about actions to prolong the patient’s life. The principles of informed consent must be respected by the prescribing doctor. A hospital will have policies in place that provide a mechanism (process) that respects local law, culture, and custom for reaching a DNR decision as well as for resolving conflicts in decision-making.

At a later time, if a patient with dementia is unable to give informed consent for procedures and thus unable to make decisions competently, responsibility for decision-making often falls on the family. The family can make decisions on behalf of the patient, using the patient’s expressed preferences from an advance directive stating the his or hers preferences for caregiver procedures, treatments, and life-sustaining measures, completed while he or she was still mentally competent to understand and make health decisions.

Parents and guardians will be required to provide informed consent to disclose to those who need to know a minor’s human immunodeficiency virus (HIV) status to provide medical care and services care. Such confidential HIV related information will indicate that the minor had an HIV-related test; or has HIV infection, HIV-related illness, or Acquired Immunodeficiency Syndrome (AIDS) or any information that could indicate that the minor has been potentially exposed to HIV.

The Joint Commission International (JCI) requires that a hospital “establishes a process, within the context of existing law and culture, for when others can grant consent” and “individuals, other than the patient, granting consent are noted in the patient’s record” through its Standard PFR.6.2 (JCI, 2011).

In all circumstances irrespective if the hospital is JCI accredited or not, Health Information Management (HIM) / Medical Records (MR) practitioners must look out for relevant informed consent form documentation that must be available in the medical record for a (i) minor, (ii) mentally incompetent patients, (iii) DNR patients, (iv) patients with dementia, and (v) minors diagnosed or suspected as HIV infected.

HIM/MR practitioners must be aware that informed consent will not be present in the medical record for patients in certain extreme emergencies such as when an unconscious patient is admitted to an emergency room and procedures may be performed without specific written or verbal consent, as no one may be available to give consent. HIM/MR p can update their awareness by checking out specific protocols in documentation maintained for example from their hospital Quality Department  that must be followed for example, (i) that allow for two doctors to sign an emergency consent, and (ii) a court order to administer treatment is obtained for cases of extreme emergencies.

A hospital policy usually contains clauses to the above exceptions for informed consent when others can grant consent within the context of existing law and culture. I like to advise HIM/MR practitioners to also check out relevant hospital policy to reference and formulate a section on informed consent HIM/MR best practices including circumstances when other can give consent on behalf of patients, in the Medical Records Policy.

References :
Joint Commission International 2010, Joint Commission International Accreditation Standards For Hospitals, 4th edn, JCI, USA

Michelle, AG & Mary, JB 2011, Essentials of Health Information Management: Principles and Practices, 2nd edn, Delmar, Cengage Learning, NY, USA

Sue, CD & Patricia, KL 2011, Fundamentals of Nursing: Standards & Practice, 4th edn, Delmar, Cengage Learning, NY, USA

General consent is not informed consent

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If you are a patient presenting for a routine health care service, for example  general medical, paediatric, family planning, obstetric, Immunization, STD, TB, and/or HIV clinic services, then you will asked to fill up a  general consent  form to be completed prior to any of these services being rendered.  This is not informed surgical or invasive procedure consent form.

Image credit : Tung Shin Hospital, Kuala Lumpur, Malaysia <http://www.tungshin.com.my/useful-info/admission-discharge/>

The general consent is usually obtained when the patient is admitted as an inpatient to the hospital or when the patient is registered for the first time as an outpatient.  However in the U.S., the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule “permits, but does not require, a covered entity voluntarily to obtain patient consent for uses and disclosures of protected health information for treatment, payment, and health care operations. Covered entities that do so have complete discretion to design a process that best suits their needs.”

Patients are given information on the scope and limits of the general consent, such as which tests and treatments are included under the general consent. Patients are also given information about those tests and treatments for which a separate informed consent will be obtained.

The hospital defines how a general consent is documented in the patient’s medical record, for example the general consent to treatment may be located by a Health Information Management (HIM) / Medical Records (MR) practitioner.to be found on the reverse of the face sheet (or admission/discharge record).

General consent forms are also used at teaching hospitals and patients are advised that doctors, nurses and other healthcare professionals in training will be involved in the patient’s care and treatment.

A general consent usually contains information as follows:

  1. a general consent form authorises the attending doctor, other doctors and healthcare professionals who may be involved in a patient’s care, to provide a diagnosis, care and treatment considered necessary or advisable by the doctor(s)
  2. the general consent form does not guarantee the patient about the result of his or her examination or treatment at the hospital
  3. the general consent notes if it is likely that students and other trainees will participate in care processes
  4. provisions in the general consent form inform patients that their decision to seek care from a hospital is not based upon any understanding, representation or advertisement that the doctors treating them are employees, agents or apparent  agents of the hospital, and that they also understand that they have the opportunity to request that their own doctor participate during in their care at the hospital
  5. the general consent form may also authorise a hospital to examine, use, store and dispose of any tissue, fluids or specimens removed from a patient’s body during his or her outpatient visit or hospital stay

Agreeing to a general consent for treatment by a patient before admission as an inpatient or been registered for the first time as an outpatient, may apply at any (Malaysian) hospital setting. However, hospitals that are Joint Commission International (JCI) accredited or seeking JCI accreditation status or re-applying for JCI accreditation status  need to comply with the JCI Standard PFR6.3 which implies that “General consent , is clear in its scope and limits.” The medical record must contain a copy of the general consent in any hospital setting.

References :
Joint Commission International 2010, Joint Commission International Accreditation Standards For Hospitals, 4th edn, JCI, USA

Michelle, AG & Mary, JB 2011, Essentials of Health Information Management: Principles and Practices, 2nd edn, Delmar, Cengage Learning, NY, USA

U.S. Department of Health & Human Services, What is the difference between “consent” and “authorization” under the HIPAA Privacy Rule?, viewed 4 September 2012 < http://www.hhs.gov/hipaafaq/use/264.html>

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

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“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