Category Archives: Quality

JCI Standard MCI.20.1, ME 1 (Part 2) – infection prevention and control, in “The organization has a process to aggregate data in response to identified user needs.”

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As I had posted in the post JCI Standard MCI.20.1 – patient based data and aggregate data, in a process available to aggregate data to meet the needs of internal and external users (this link will open in a new tab of your current browser window), in this post I shall continue on infection prevention and control. This post is also a follow-up from the previous post on risk management in JCI Standard MCI.20.1, ME 1 (Part 1) – risk management, in “The organization has a process to aggregate data in response to identified user needs.” (this link will open in a new tab of your current browser window).

Infection prevention and control is one of a hospital’s four (4) performance improvement (PI) activities other than risk management, utility system management, and utilisation review PI activities a hospital is required to meet the Joint Commission International (JCI) Standard MCI.20.1, Measurable Element (ME) 1 which requires that a hospital as “The organization has a process to aggregate data in response to identified user needs.”

Although the details of infection prevention control are beyond the scope of this post and blog, I shall embark to highlight some aspects of infection prevention and control here. It is going to be a long post.

Health care–associated infections (HAIs) or also referred to as health care–acquired Infections, are infections acquired in the hospital or other health care facilities that were not present or incubating at the time of the patient’s admission. Hospital (or ‘nosocomial’) infection is infection acquired either by patients while they are in hospital, or by members of hospital staff.  (eds. Adam & Christina 2009) define the term infection as “generally used to refer to the deposition and multiplication of bacteria and other micro-organisms in tissues or on surfaces of the body with an associated tissue reaction.”

At the time of the patient’s admission due to an illness – which impairs the body’s normal defense mechanisms, often the reason for hospital admission, the patient is in the state of risk for infection in which the patient is at increased risk for being invaded by pathogenic organisms because the patient has not been exposed to in the past what the hospital environment now provides the exposure to a variety of virulent organisms, therefore the patient has not developed any resistance to these organisms.

Health care personnel in hospitals who usually fail (eds. Adam & Christina 2009) to practice proper handwashing procedures or to change gloves between patient contacts, contribute to most HAIs been transmitted  to hospitalised patients who are at risk from the most common HAI endemic infections in hospitals caused by multi-resistant tuberculosis, Clostridium difficile one of the major hospital infections in the elderly, vancomycin-resistant enterococci in some specialised units, and cross-infection with methicillin-resistant Staphylococcus aureus (MRSA) that affect the urinary tract, upper and lower respiratory tracts, gastrointestinal tract, conjunctiva, and skin.

HAIs have received increased attention due to their overwhelming consequences in terms of cost, morbidity, and mortality.  One of the reasons for this increased attention is that these infections which are preventable through the adherence to numerous strict guidelines, legal requirements and other recommendations when caring for patients, is that they frequently occur in people whose health is already compromised by disease, age, or injury.

The data presented in the 1999 Institute of Medicine (IOM) study reported that an estimate of  between 44,000 and 98,000 patients die as the result of preventable medical errors in hospitals each year and also reported that hospital-acquired infections, many of which can be prevented, take another 100,000 lives.

In the United States of America, payers have begun to refuse reimbursement for additional care resulting from treatment for an infection not present on admission with the underlying rationale that HAIs are preventable complications and denying reimbursement provides a strong incentive for quality improvement actions to avert them.

Then there are site-specific infection prevention to reduce (i) postoperative surgical wound infections through the use of appropriate surgical site preparation and also prophylactic antibiotic therapy, (ii) ventilator-associated pneumonia by for example minimizing the duration of intubation, (iii) central venous catheter infections for example with the use of sterile technique and full barrier precautions, (iv) urinary tract infection by avoiding unnecessary or prolonged use of indwelling bladder catheters, and (v) resistant organisms for example methicillin-resistant Staphylococcus aureus (MRSA) by employing (a) active surveillance procedures in which cultures are routinely obtained at scheduled intervals to promote earlier identification of resistant organisms, and (b) careful management of antibiotic use.

To address each type of HAI, many hospitals have adopted a series of practices called a “bundle” at a significant cost,  failure to use all the measures prescribed in the “bundle”, for example in the approach to preventing central line-associated bloodstream infections  (CLBSI) (this bundle includes the entire procedure for insertion, the daily cleaning protocols, and the protocols for use of the central line catheter) may adversely affect patient outcomes but adopting a “bundle” has been shown to decrease the incidence of the target infection, and thus been effective  in improving quality of care which may then offset the significant cost.

Transmission of infection as an occcupational hazard in all hospital settings is a major concern when caring for infected patients made worse by the presence of resistant organisms which causes extra concern and makes treatment difficult.

Universal precautions are usually mandated for use with patients who pose the hidden danger when they have not been diagnosed as having an infection and for whom specific infection control measures have therefore not been prescribed. Universal precautions is a critical protective strategy with measures that include hand decontamination upon entering and leaving every patient encounter, isolation and the use of disposable gowns and gloves in addition to hand decontamination for patients with certain particularly dangerous types of infections. Provision of sharps containers wherever needles were used and the provision of a supply of gloves and protective eyewear for employee use are some other measures as part of universal precautions.

Blood-borne pathogens are not the only pathogens of concern in the healthcare environment. Body Substance Precautions are also used in all hospital settings to protect patients and staff members from infections that might be transmitted by any body substance, for example to protect staff members from the tuberculosis (TB) organism.

Confidentiality should be maintained at all times by Health Information Management (HIM) / Medical Records (MR) practitioners who may be needed to provide medical records of staff members exposed to HBV, HCV and HIV infection for review at the time of exposure of the source of their occupational exposure to the bloodborne pathogens including results of blood tests, admitting diagnosis and past medical history.

HIM / MR practitioners may be needed to work closely with an infection control officer at most hospitals which usually designate this officer who has the expertise to guide the staff in planning appropriate infection control procedures to protect staff members from blood-borne pathogens to prevent the spread of HIV, hepatitis B, and other such blood-borne pathogens.

HIM / MR practitioners may be involved in the development of policies and procedures is a key role for any infection control team. The central document is a collection of procedures (sometimes called an infection control policy or infection control manual).

As I have said in my previous posts, most hospitals today are involved in processes of quality improvement.

In the context of HAI, (eds. Adam & Christina 2009,  p. 5) defines ‘surveillance which is a vital component of infection control as ‘the ongoing systematic collection and analysis of data about a disease (or organism) that can lead to action being taken to control or prevent the disease.’

As part of these processes, ongoing data are collected and analysed for problems or opportunities for improvement including using infection control and quality improvement data to improve care. An example of the use of infection control data reviewed from interviews in regard to care practices for patients with catheters in an intensive care unit (ICU) about the series of urinary tract infections for example by the same strain of Serratia as the infective agent that had been identified in all patients in that unit, showed that a deviation from the standard protocol for the unit with the use of one measuring container used by an infected patient cultured positive for the Serratia, and using it from patient to patient easily had transmitted the organism to another patient’s catheter, and the infectious agent could have been spread from patient to patient in this manner.

Quality of care aggregate data takes many forms, revealing such things as infection rates and unplanned returns to the operating room. Infection rates for example MRSA wound infections per 1000 bed days or per 1000 admissions are commonly computed rates like other rates for example average length of stay, based on discharge statistics data that are accumulated when patients are discharged. At the local level, (eds. Adam & Christina 2009) infection rates from surgical wound infections fed back to practising surgeons can demonstrate results in lowering infection rates.

Other forms quality of care aggregate data on HAIs is the reporting of infections.

A daily report generated by a laboratory-based system is able to give information based around ‘alert’ organisms that have the potential to cause outbreaks, for example the percentage of Staphylococcus aureus that are methicillin resistant and/or the percentage of wound swabs showing S. aureus.

Reporting is generated as recommended by (eds. Adam & Christina 2009) through (i) weekly reports by the Infection Control Nurse (ICN) and sent to the wards, departments and clinicians containing  information on alert organisms and infectious patients including simple graphs that provide rapid feedback on current issues while they are still fresh, (ii) monthly reports sent to all members of the Infection Control Team (ICT) within two or three days of the new calendar month, (iii) quarterly reports that includes recommendations to management and education data on who attends the sessions, and (iv) a comprehensive annual report intended for the board members.

Local data must include ‘details’ of wards and consultants – to establish the ‘ownership’ of the data as well as the competitive element,  needs to be analysed promptly and sent to the ward/clinician as daily and weekly reports.

All of the above are my observations, experiences and readings on infection prevention and control activities and processes in a hospital setting to aggregate data in response to identified user needs. They are by no means complete, in future posts I shall document on latest trends and developments in infection prevention and control activities.

In my next post on JCI Standard MCI.20.1, ME 1 I shall dwell on utilisation review PI activities a hospital is required to meet the JCI) Standard MCI.20.1, ME 1.

References:
Adam, PF & Christina, B (eds.) 2009, Ayliffe’s Control of Healthcare-Associated Infection A practical: handbook, 5th edn, Hodder Arnold, London, UK

Caroline, BR & Mary, TK 2012, Textbook of basic nursing, 10th edn, Wolters Kluwer Health, Lippincott Williams & Wilkins, Philadelphia, USA

Janice, RE, Celia, LH 2012, Nursing in todays world : trends, issues & management, 10th edn, Wolters Kluwer Health | Lippincott Williams & Wilkins, Philadelphia, PA, USA

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

JCI Standard MCI.20.1, ME 1 (Part 1) – risk management, in “The organization has a process to aggregate data in response to identified user needs.”

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A hospital collects and analyses aggregate data to support patient care and its organisation management.

Aggregate data provides a profile of the hospital over time and allows the comparison of the hospital’s performance with other hospitals. Thus, aggregate data are an important part of the hospital’s performance improvement (PI) activities.

PI facilitates desired outcomes by monitoring and evaluating the quality and appropriateness of patient care, measuring both process and outcome and conducting trend analyses, pursuing opportunities to improve patient care, ensuring high-quality care, and developing standards for monitoring quality of care.

Most hospitals are involved in processes of quality improvement. As part of these processes, on-going data are collected regarding outcomes and analysed for problems or opportunities for improvement. When outcomes are known, then addressing areas for possible improvement in outcomes becomes possible. In response to identified user needs, hospitals can understand its current performance by monitoring and evaluating aggregate data through risk management, utility system management, infection prevention and control, and utilisation review and identify opportunities for improvement.

Allow me to take you about the PI activities of risk management, utility system management, infection prevention and control, and utilisation review.  We will look at how a hospital through the PI activities of risk management, utility system management, infection prevention and control, and utilisation review meets the Joint Commission International (JCI) Standard MCI.20.1, Measurable Element (ME) 1 which requires that a hospital as “The organization has a process to aggregate data in response to identified user needs.”

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Risk is defined as the chance of loss. Risk management can be defined as identifying circumstances that put patients or a hospital at risk for adverse outcomes and putting into operation methods that avoid, prevent, and to mitigate (reduce or eliminate) the risks. Hospital adopted risk management when there were many problems in malpractice that caused risk to be a potential problem for hospitals, thus sentinel event monitoring was added to the hospital accreditation process in the mid-1990s.

Risk management is about the focus on an individual case, investigation of the post-event, implementing strategies to address the event, regulatory compliance with legal standard of care, unexpected outcomes which drive the process despite performing all of the regulatory requirements in a timely and competent manner, and been reactive that is relying (Barbara 2011) “on lessons learned from past mistakes, which they apply to the case at hand in order to “defend” the actions of those involved.”

Risk management is about the various strategies to fix problems. Examples of risk management techniques are practice modification (an example of risk management is avoiding the use of a code cart that has not been restocked properly or as for an individual patient, it may be confirming that all the protocols are followed when giving intravenous medications to the patient), insurance transfer, or risk avoidance such as when we eliminate the risk by closing of an obstetrics unit or mental health services or reducing the privileges of a specific provider who may not have the requisite skill to safely perform a specific procedure.

I remember the relatively low numbers of sentinel events reported annually from hospitals that had to report such events, – as it was then and I am sure it is still today,  commonly recognised that there are limitations of a reporting system. However, I am certain that aggregate data collected over the years have proved invaluable toward understanding specific types of hospital based errors. In Malaysia, sentinel events in private hospitals is part of a mandatory incident reporting system in accordance to the ACT 586, Private Healthcare Facilities And Services Act 1998, Private Healthcare Facilities And Services (Private Medical Clinics Or Private Dental Clinics) Regulations 2006, Regulation 13. Ministry of Health Malaysia hospitals are required to follow THE MALAYSIAN INCIDENT REPORTING AND LEARNING SYSTEM, in incident reporting for adverse events with the general objective “To facilitate a learning organisation through the reporting of and learning from adverse incidents, “near misses” and hazards so that a just and safe culture will be nurtured amongst health care providers, in our efforts to enhance the safety of the Malaysian health care system.”, which requires mandatory reporting of specific event types to further foster the sharing of lessons learned. Despite this shared learning, I am sure we still have medical errors occurring in our hospitals and clinics every day.

Health Information Management (HIM) / Medical Records (MR) practitioners need to know that their HIM / MR Department that supplies the raw material (i.e., the medical-record documentation), serves as one of the strongest allies of the risk management activities and risk and quality managers turn to this department regularly for support and services. It is common for routine requests for case review analysis with expedited requests made during times of accreditation surveys and on-site inspections.

The role of this department in identifying adverse events and quality-of-care concerns hospital-acquired conditions (HAC) – examples of HACs are foreign object retained after surgery, air embolism, blood incompatibility, catheter-associated urinary tract infection.

HIM / MR practitioners working in a HIM / MR department may be required to identify these HACs and initiate a report to the risk and quality departments for peer review and quality analysis.  HIM / MR practitioners must also be aware that another early indicator for a potential claim against a hospital is a request for medical records, especially by a lawyer. Medical-records staff should notify their risk management / QA department and the hospital top management upon receipt of such requests.

Readers, I know for a fact I have not been able to cover all aspects of risk management in this post but it is enough to give you a brief overview of what risk management is about and how it affects the HIM / MR practitioner. In a future post, I will expand on discoverability of medical records in medical-malpractice cases that is the written discovery as the first phase of the discovery process in a medical-negligence case, when there is a request to produce documents and tangible items, such as medical records, films, and pathology slides.

As I posted in the post JCI Standard MCI.20.1 – patient based data and aggregate data, in a process available to aggregate data to meet the needs of internal and external users (this link will open in a new tab of your current browser window), given the wide issues of concern for the two requirements about JCI Standard MCI.20.1, I shall continue on the other PI activity of infection prevention and control in another post.

References:
Barbara JY 2011, Principles of risk management and patient safety, Jones & Bartlett Learning, Sudbury, MA, USA

Caroline, BR & Mary, TK 2012, Textbook of basic nursing, 10th edn, Wolters Kluwer Health, Lippincott Williams & Wilkins, Philadelphia, USA

Janice, RE, Celia, LH 2012, Nursing in todays world : trends, issues & management, 10th edn, Wolters Kluwer Health | Lippincott Williams & Wilkins, Philadelphia, PA, USA

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

Patient Safety Unit, Medical Care Quality Section, Medical Development Division 2012, INCIDENT REPORTING & LEARNING SYSTEM: “From Information to Action”, Ministry of Health Malaysia, viewed 28 November 2012, <http://hkbatas.moh.gov.my/v2/uploads/UPDATED_INCIDENT_REPORTING_2012_KKM.pdf>

Private Healthcare Facilities And Services Act 1998, Private Healthcare Facilities And Services (Private Medical Clinics Or Private Dental Clinics) Regulations 2006, viewed 28 November 2012, <http://www.mma.org.my/Portals/0/pdf/prv_health_fac.pdf>

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

Wager, KA, Frances, WL & John PG 2005, Managing health care information systems : a practical approach for health care executives,1st edn, Jossey-Bass A Wiley Imprint, San Francisco, CA, USA

The risks, benefits, and alternatives of surgery

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I had posted in the post Risks, benefits, and alternatives of anaesthesia (this link will open in a new tab of your current browser window) on the anaesthesia planning process which includes educating the patient, his or her family, or decision maker on the risks, benefits, and alternatives related to the planned anesthesia and postoperative analgesia. This discussion occurs as part of the process to obtain consent for anesthesia (including moderate and deep sedation). In anaesthesia care, an anesthesiologist or a qualified individual provides this education.when the risks, benefits, and alternatives are discussed with the patient, his or her family, or those who make decisions for the patient.

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Likewise prior to surgery, patients and their families or decision makers receive adequate information to participate in care decisions and to provide the informed consent.

The information provided includes:

  1. the risks of the planned procedure;
  2. the benefits of the planned procedure;
  3. the potential complications; and
  4. the surgical and nonsurgical options (alternatives) available to treat the patient.

In addition, when blood or blood products may be needed, information on the risks and alternatives is discussed.

The patient’s surgeon or other qualified individual provides this information.

Health Information Management (HIM) / Medical Records (MR) practitioners need to be aware that medical records of patients must show evidence of the education process  in an ongoing process prior to surgery. Medical records must contain documentation on this process as required by the Joint Commission International (JCI) Standard ASC.7.1 which clearly states that “The risks, benefits, and alternatives are discussed with the patient and his or her family or those who make decisions for the patient.”, and its three (3) 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 be aware that the Joint Commission International (JCI) Standard PFR.6.4 which clearly states that “Informed consent is obtained before surgery, anesthesia, use of blood and blood products, and other high-risk treatments and procedures.” I had posted about informed consent in the post Informed Consents – 5 required documentation in the medical record providing information to patient and family (this link will open in a new tab of your current browser window).

Lastly, HIM / MR practitioners do take note that the JCI Standard ASC.7.1  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:
Joint Commission International 2010, Joint Commission International Accreditation Standards For Hospitals, 4th edn, JCI, USA

Standards Concerning Medical Record Documentation – Part 1

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To round-up and complete the subject on the necessary and relevant documentation in a medical record as can be found in the 4th Edition of Joint Commission International (JCI) Accreditation Standards For Hospitals, in this post of two posts, I shall take bring you the final count down of all such necessary and relevant documentation in a medical record.

Health Information Management (HIM) / Medical Records (MR) practitioners please take note (from my knowledge about JCI quality standards) that there are 28 standards with 37 requirements for what information must be recorded in the medical record by the hospital’s various health care providers. Here I mean that there are 37 types of entries that must  be recorded (which includes entries related to the 28 standards) in a medical record.

In the post Medical information that require documentation in medical records (this link will redirect you to a new tab of your current browser window), I had presented all the necessary requirements about of medical information that require documentation in a medical record which explicitly stated what is to be documented in a medical record and also standards which implicitly indicated  medical information that require documentation in a medical record. I had a count of seven (7) standards which explicitly state what is to be documented in a medical record with a total of ten (10) requirements which includes explicit and implicit instances that require documentation in a medical record.

For surgical information that require documentation in a medical record, I had made a count of twelve (12) standards* – or also as one can say “requirements”, which explicitly state what is to be documented in a medical record. There are no standards that indicate implicitly any necessity for surgical information to be documented in a medical record. This bit of information I carried in the post Surgical information that require documentation in medical records (this link will redirect you to a new tab of your current browser window).

Thus from the above, I have a total count of twenty-two (22) standards that make up medical and surgical documentaion in a medical record.

Now, from subsequent posts I had written about other standards that make up for what information that must be recorded in the medical record by the hospital’s various health care providers, I have a count of nine (9) such posts. Here are the relevant links to the posts :

PFE.2 : Medical records should contain the patient’s educational needs assessment documentation

PFE.2.1 : The assessment findings from patient’s and family’s ability to learn and willingness to learn are documented in the patient’s record

ACC.4.4 : 5 transfer process entries that must be entered in a medical record

PFR.6.2 When others can grant consent

PFR.6.3 : General consent is not informed consent

PFR.8 : Informed consent in clinical research, clinical investigation, and clinical trials

ASC.5.1 : Risks, benefits, and alternatives of anaesthesia

MCI.19.3 : JCI Standard MCI.19.2 & MCI19.3 – Patient Clinical Record – (i) the author can be identified for each patient clinical record entry, (ii) the date of each patient clinical record entry can be identified, and (iii) when required by the hospital, the time of an entry can be identified.

MCI.19.1.1 : JCI MCI19.1 & MCI19.1.1 – Patient Clinical Record – the clinical records of emergency patients include (i) arrival time, (ii) conclusions at the termination of treatment, (iii) the patient’s condition at discharge, and (iv) any follow-up care instructions.

In the coming weeks, I shall be posing on six (6) more standards that require for what remaining information that must be recorded in the medical record by the hospital’s various health care providers.

Once again, I must reiterate that I believe a HIM / MR practitioner working in a hospital must be aware and knowledgeable that the quality of his or her medical records, in his or her custody and care is determined by their contents. The medical records must contain all of the medical information as I spoken of above, recorded in them. This condition is regardless of the type of hospital they work at, irrespective if his or her hospital had acquired JCI accreditation status or one that is seeking JCI accreditation status or it is one that is not seeking JCI accreditation status at all.

*I have updated the post "Surgical information that require documentation in medical records" due to a technical error

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

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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