PROMOTING STANDARDS IN THE PRIVATE HEALTH SECTOR … · 100353 IFC's Mission IFC, a member of the World Bank Group, creates opportunity for people to escape poverty and improve their

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QUALITY, SAFETY, ETHICS

PROMOTING STANDARDS

IN THE PRIVATE HEALTH SECTOR

Guide to Assessing Health Care Organizations

Contact Information

Health and Education Department

2121 Pennsylvania Avenue, NW

Washington, DC 20433 USA

ifc.org

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100353

IFC's MissionIFC, a member of the World Bank Group, creates opportunity for people to escape poverty and improve their lives. We foster sustainable economic growth in developing countries by supporting private sector development, mobilizing private capital, and providing advisory and risk mitigation services to businesses and governments. For more information, visit www.ifc.org.

http://www.ifc.org

IFC Guide to Assessing Health Care Organizations 1

Contents

Introduction 3

Background 4

Purpose of the guide 4

Health care standards used 4

Why are quality standards important? 5

Quality challenges for health care organizations in emerging markets 5

Layout of this Guide 6

Essentials 6

Facility tour 9

What areas to visit 10

Scope 10

Layout 10

Interviews 25

Clinical Governance and Leadership 26

Ethics and Patient Rights 30

Quality Measurement and Improvement 38

Patient Safety 46

Facility Safety and Emergency Management 49

Appendices 57

Appendix I: IFC Code of Conduct for Health Care Organizations 58

Appendix II: Glossary 60

2 IFC Guide to Assessing Health Care Organizations


introduction


introduction

BACkgroundIn recent years, IFC has become increasingly active in the private health sector in developing countries. We are now the largest multi-lateral investor in the private health sector, worldwide. Since 2000 we have provided over US$1.5 billion of financial support (mainly through debt and equity financing) to over 80 projects in more than 30 countries. This support has enabled some $4 billion of investment in the private health sector.

Health care organizations supported by IFC provide employment for around 35,000 people and treat 5.5 million patients annually. About one third of our clients are based in IDA countries (mainly poorer developing countries). And about one fifth of our clients have achieved some form of internationally recognized accreditation.

A key part of IFC’s due diligence of health care organizations includes an examination of systems of quality and patient safety and attention to ethical issues.

This guide was developed with support from the Joint Commission International (JCI).

PurPose oF the guIdeThis guide is intendend to assist IFC staff to undertake an on-site assessment of the quality of care and safety of the hospital environment.

The guide complements the commercial due diligence (which covers, for example, business, financial, legal and insurance issues). Some essential aspects of Facility Safety (e.g. fire precautions etc) are covered; however, the guide does not replace IFC’s separate Environmental, Life and Fire Safety Assessment.

heAlth CAre stAndArds usedThe evaluation in this guide is based on 31 Health Care Standards covering five key areas.

Clinical governance and leadership• Governance documents• Management responsibility for operations• Oversight of contracts• Departmental scope of services, policies, and procedures• Space and equipment planning• Staff recruitment, retention and development

ethics and Patient rights• Verification of professional staff credentials• Processes to support patient and family rights • Informed consent • Framework for ethical management• Organ and tissue donation and transplantation• Reproductive health policies and procedures/IVF• Termination of pregnancy services• Clinical research

Quality Measurement and Improvement• Clinical practice guidelines and pathways• Leaders’ involvement and support• Infection prevention and control• Medications use• Sentinel events

Patient safety• Patient identification• Effective communication• High alert medications• Correct site, procedure, and patient for surgery • Health care associated infections• Risk of falls


Facility safety and emergency Management • Environmental safety and security• Hazardous materials plan• Emergency management planning• Fire/smoke plans• Medical equipment maintenance• Utilities management

Familiarization with these standards will be helpful in understanding the intent of the questions. More information on these standards can be found in IFC’s Self Assessment Guide for Health Care Organizations.

The standards were adapted from the Joint Commission International Accreditation Standards for Hospitals, 3rd Edition1.

Why Are QuAlIty stAndArds IMPortAnt?Why should private health care providers be interested in promoting standards of quality, safety and ethics?

The consequences of poor standards can be disastrous. Stories of unethical business practices are increasingly common in the news media and have resulted in the demise of individuals and whole health care organizations. No hospital executive wants to find their hospital or one of their staff in the news because of a patient being caused serious injury or death.

Ethical and responsible conduct is not only important for public relations, but it is also a necessary element in risk management. The reputation of a health care organization is critical in influencing patients seeking services. And, for those organizations aspiring to attract medical tourism, a good reputation is imperative. Hospitals with good reputations also benefit from lower recruitment and orientation costs, as staff retention is high and the most qualified professionals tend to seek jobs with them.

Solid, supportive leaders who work closely with the staff to improve standards also find that patient and staff satisfaction increase. These outcomes create a sense of achievement and pride in the organization.

Quality improvement is linked to performance improvement because improving quality tends to reduce costs. For example, when clinicians are uncertain about the best course of action to take, they tend to do more – e.g. more tests, more procedures and more observation. Therefore, health care organizations that undertake more analysis and promote evidence-based medicine are more likely to reduce waste. In fact, some health professionals state that “the opposite of quality is waste” - and waste reduction requires removing process flaws and non-value adding processes.

From a commercial perspective, all of these outcomes can translate into financial dividends.

QuAlIty ChAllenges For heAlth CAre orgAnIzAtIons In eMergIng MArkets

regulatory enforcement

Many developing countries have inadequate regulations for the private health sector, or do not properly enforce the regulations in place. Such environments often allow substandard and unethical practices to flourish. This can breed mistrust and confusion among the general public, who have little information to rely on when choosing between providers. And it tends to tarnish the reputation of health care providers in general.

resources

Most health care workers in developing countries want to provide high quality care, but many do not have access to the most current research on providing the best care and treatments. Furthermore, they are frequently limited by constraints on resources (e.g. equipment, supplies, training and staff) required to carry out the international recommendations for evidence-based practice.

In many organizations, staff members have not been trained in Quality Improvement approaches used to investigate and solve problems. Nonetheless, Quality Improvement methodology is increasingly being used effectively in many developing countries to help health care teams to identify problems and to find and implement solutions.

Infrastructure and equipment

According to the WHO, at least 50% of medical equipment in developing countries is unusable or only partly usable. Often the equipment is not used due to lack of skills or commodities. As a result, diagnostic procedures or treatments cannot be performed. This leads to substandard or hazardous diagnosis or treatment that can pose a threat to the safety of patients and may result in serious injury or death.

Even new facilities/hospitals may not be designed with safety in mind, as many countries do not have well-developed building construction codes. As a result, many do not have proper fire protection or utility back-up systems.

Sometimes health care organizations in developing countries receive donated equipment, but with no programs for on-going maintenance. In many cases, when the equipment malfunctions, it ends up unused. Also, staff may be unaware of the danger that under-maintained equipment poses and continue to use it despite potential injury.

Many organizations do not have sufficient general/facilities maintenance staff. This can lead to problems such as non-functioning toilets, leaking roofs, and hand rails hanging loosely from walls. These examples point to the need for diligence on the part of hospital management to put measures in place to assess safety in the environment and to take corrective actions.

1 Joint Commission International (2007) Joint Commission International Accreditation standards for hospitals, 3rd edition, oakbrook terrace, Illinois, usA.


systems and processes

Most patients admitted to a hospital tend to assume that they are in safe hands. Unfortunately, this is frequently not the case. News stories increasingly report patients undergoing the wrong surgery, being prescribed incorrect medications, or developing dangerous infections. And it is often difficult to explain to the public why these occur. For example, hand-washing is known to be the most common cause of hospital-acquired infections – and most people cannot comprehend why this is a problem. The issue is more complex than it seems (requiring organization-wide attention to procedures, training and attitudes) – and can be particularly challenging in developing countries, where access to soap, clean water and functioning sinks may be limited.

lAyout oF thIs guIdeThe assessment includes two parts:

Part 1: Facility tourFor the facility tour, the guide sets out:• Suggested areas to visit,• Questions to ask,• A description of why each question is relevant,• Observations to make, and• Columns for assessing compliance and noting observations and

comments.

Part 2: Interviews with senior management and clinical staffTo support this part of the assessment the guide is organized in three columns: • The first column lists each standard along with several “measureable

elements”. It is likely that the assessor will not be able to cover all of the measureable elements during the visit. Therefore a judgment will usually be made on where to focus, based on the specific circumstances of the project.

• The second column lists questions that can be used to measure compliance with the standard.

• The last column is for noting observations and comments.

essentIAlsEssentially, the appraiser should seek evidence that:1. The management of the organization understands the concepts and

importance of quality, safety and ethical standards;2. The management is committed to reaching international standards; 3. The management has implemented systems and structures to

continuously improve standards; and4. Key personnel are held accountable for standards within the

organization.

Contact details

If you have any questions relating to this guide, please contact:

Emmett MoriartyPrincipal Health Sector [email protected]

Ioan Cleaton-JonesSenior Health Sector [email protected]




Facility tour


Facility tour

WhAt AreAs to vIsItThis facility tour guide can be used by IFC staff members who visit the hospital/health care facility as part of their overall assessment. You should visit the following areas:

• Patient care unit (ward),• Emergency department (ER)• Pharmacy• Intensive care unit (ICU)• Surgical/operating room• Maternity ward• Sterilization area

If time allows, other units/departments might be visited.

sCoPeThe guide covers assessment of:

• The physical environment• Infection control and prevention practices• Medication management• Quality measurement and improvement

lAyoutFor each question below, there is a column to explain the importance/relevance of the question, followed by a column providing information about what to look for to make an assessment. Mark “Y” if the question is totally satisfied; or mark “N” if there is no evidence that the question is satisfied. Writing comments will be helpful, especially when describing observations, giving feedback and recommending possible improvements.

The results of the facility tour should be combined with the findings from the management team interviews and documentation review (described in the Interviews section).


observations and questions

rationale look for Met? observations/

Comments

Why is this question

important?

how is this question assessed?

y n Why did you give

this score?

general/physical environment

1) What public notices, information etc are available in the main foyer/ reception area?

Information posted in public demonstrates the organization’s accountability to the community that it serves.

In the foyer, look for publicly displayed:

• license to legally provide health services,

• details of ownership,

• organization’s mission/objectives/ values,

• senior manager(s) in charge, and

• list of services provided.

Also:

• accreditations and certifications,

• names of partner institutions,

• complaint procedures, hotlines etc,

• suggestion box,

• public health information (e.g. relating to local health issues, vaccinations, safe motherhood etc), and

• a current list of prices.

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2) Is the facility accessible for disabled/ incapacitated people?

Many health service users are disabled or temporarily incapacitated as a result of their condition or treatment.

Check for ease of access, e.g:

• wheelchair ramps,

• hand-rails,

• elevators,

• non-slip floor surfaces,

• disabled toilet facilities,

• clear signs,

• help-desk,

• porters, and

• general layout light and space.

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Comments


important?



this score?

3) Is the facility in good condition?

Observe for signs of neglect, e.g:

• cracks/holes or peeling paint on walls, ceilings, floors,

• water leakage,

• mould,

• graffiti, and

• litter.

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4) Do the patient waiting areas/rooms have adequate ventilation and sufficient lighting, space and seating?

Patient comfort is an important aspect of good quality services.

Visit the waiting areas/rooms to assess that:

• seating is available for all clients,

• lighting is sufficient for reading, and

• they are not overcrowded.

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5) Do the consultation/examination rooms have adequate ventilation, and sufficient lighting and space?

There is sufficient lighting to examine clients and to read and write. A window is desirable for light and ventilation, and a fan if air conditioning is not available. Space is sufficient to include a desk, two chairs and an examination table.

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6) Are safety hazards managed?

Visible hazards indicate a lax attitude towards safety.

Check for exposed wires, cords on floors, wet/slippery floors, secure construction of shelves and brackets, broken windows, unsecured oxygen tanks, etc.

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7) What types of injuries data are collected on the unit? And what is done with the data?

Sharps injuries for staff are a concern in areas where invasive procedures may be performed such as surgical rooms, phlebotomy/specimen taking areas and radiology.

Staff should indicate that data is collected for sharps and other injuries.

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Comments


important?



this score?

8) Is a current inspection sticker present on medical equipment? If no inspection sticker is used, how does the organization ensure that equipment is adequately maintained?

Check a few pieces of medical equipment, such as intravenous (IV) pumps or ventilators for a date-marked inspection sticker. Check the date for the next inspection.

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9) Are hazardous chemicals stored properly?

All hazardous chemicals need to be labeled, dated and stored in a safe location, e.g. in a secure cabinet or room.

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10) If a container of a hazardous material broke or spilled, what would the staff do?

Staff should know how to reduce/prevent harm from exposure to hazardous materials.

Staff should be able to refer to hazardous materials instruction sheets to describe how they would manage the situation.

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11) Are fire safety measures in place?

Patient and staff safety should be a priority concern. Every effort must be made to prevent fires. If a fire occurs, staff must know how to use fire equipment and evacuate clients safely. Fire exits should not be locked.

Fire extinguishers (and preferably sprinkler systems) are located in all patient care areas, are in working condition, and are checked regularly. Ensure that emergency exits are available from all areas, e.g. consulting rooms, wards and waiting areas. These should be clearly signposted and unlocked. Determine whether the fire alarm system works (e.g. as required by local regulations).

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12) Are employees wearing ID badges?

Make observations to note if all staff are wearing an ID badge.

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Comments


important?



this score?

13) Are patient records secured?

Patient records are confidential and must be stored in a secured location, i.e. no unauthorized personnel have access to them at any time.

Patient records are kept behind the nurse’s station or in another secure location.

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14) Is there evidence of people smoking within the facility?

Smoking in patient care areas is a health hazard to patients, staff and visitors.

Take note of presence of cigarette butts in stairwells, offices, toilet facilities, etc.

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15) Does the facility have an adequate supply of drinking water?

There is a water storage tank that would supply the facility in case of water supply disruption. The water is rendered safe by filters or chemicals The quality of the water is tested periodically.

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16) Does the facility have provisions for emergency electrical power?

There is a UPS2 system for critical equipment (e.g. Operating Room, anesthesia, respirators) and/or an emergency generator that can supply power to critical care areas

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17) Is there adequate protection for staff and clients for exposure to x-rays?

Excessive radiation exposure is harmful.

Visit the x-ray department and observe whether staff members are wearing dosimeters and that lead aprons are available.

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Comments


important?



this score?

Infection prevention and control

18) Is the facility clean overall, particularly in immediate patient care areas?

Organisms can live for long periods of time on surfaces and be transmitted to patients by hands of personnel. Cleaning should be with an accepted disinfectant/detergent agent. Soap and water may be necessary at times (e.g. to clean off visible soil) before disinfectant/detergent is used.

There is no litter. Floors, walls, doors, and furniture are free of visible dirt and facilities are in good order in all areas. There is no clutter, work services are in good repair and cupboards are clean and tidy. Immediate patient care areas are cleaned regularly.

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19) Are there sinks, running water, soap, and non-reusable towels (or driers) available for staff to wash their hands in all patient care areas?

When sinks and running water are not close to patient care areas, staff members are less likely to wash their hands as required. Drying hands on reusable towels is a means of transmitting germs, therefore, disposable or non-reusable towels should be used.

Visit patient care areas to determine whether running water is available for hand-washing. (This may be tap water or a container with a spigot). Paper towels, single-use towels, or hand dryers should be available to dry hands (no shared cloth towels). Observe whether staff wash their hands.

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20) Is alcohol-based hand rub available for routine hand hygiene?

When sinks and running water are scarce and not located near the point of care, alcohol-based rubs are to be used and are equivalent in effectiveness to hand washing if used appropriately.

Visit patient care sites to determine whether alcohol-based hand rubs are available and that staff use them appropriately, e.g. apply, rub and allow to dry completely. Not to be used after toileting.

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Comments


important?



this score?

21) Are clean non-reusable towels and soap available for washing hands after use of the toilets for staff and clients?

Body secretions acquired during toileting may contain large numbers of potential pathogens which if transferred to patients can cause infections.

Visit staff and client toilets and check to see if there are materials for washing and drying hands properly.

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22) Are toilets available for staff and clients in a sanitary condition?

As above Toilets are clean with no unpleasant odors. Toilets flush properly.

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23) Are plastic goggles, aprons (or gowns) and non-sterile and sterile gloves available?

Personal protective gear needs to be available to protect staff from undue exposure to blood and other body fluids.

Check that goggles, gowns and gloves are available for all staff performing or assisting with procedures, e.g. CPR3 room, minor surgery.

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24) Are non-penetrable (puncture-proof) containers for disposing of sharps available and no more than two-thirds full?

Sharps containers should be designed to protect staff from injury. They should be sealed for disposal and should never be emptied.

Visit clinical areas where injections and sharps are used. Check that sharps containers are readily available and are non-penetrable (e.g. hard plastic, glass or very thick cardboard) and have openings to insert needles/sharps that cannot be retrieved. Check that boxes are no more than two-thirds full.

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25) Are sharps containers discarded after use?

Sharps containers should not be emptied and reused because of the risk of a sharps injury.

Ask staff how they discard of sharps containers. They should indicate that they seal the opening and place it in a secure location for waste pickup.

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Comments


important?



this score?

26) Are medical waste containers available, labelled and with lids?

Regular and medical wastes must be disposed of differently and therefore must be separate; color-coding is preferable (red is generally used for medical waste).

Check that containers used for medical waste have lids and are labeled “medical waste”. Red bags are used only for medical waste and not stored on the floor. Preferably containers can be opened with a foot pedal.

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27) Are containers for medical (infectious) wastes labelled to indicate “bio hazard”?

Containers of potentially infectious/dangerous medical waste should have a biohazard symbol.

Check containers for clear bio-hazard warning labels. ..........................................

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28) What types of Infection Control (IC) data are collected on the unit? And what is done with the data?

Generally data collected are related to invasive devices such as intravenous catheters, urinary catheters, or ventilators, and for surgical procedures.

Staff should indicate that data are collected for wound, urinary tract, blood stream, or respiratory tract infections as determined by the assessment of risk in the organization. Data should be sent to authorities as required and data should be analyzed and used to make improvements

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29) When staff members suspect a patient has acquired an infection in the hospital, what do they do?

There should be a clear process and procedure in place to guide staff in the actions to take if a patient has an infection.

Staff might respond that they contact the physician and/or the IC professional. Or they might indicate that they initiate isolation.

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30) Is the flooring in patient rooms and procedure areas made of hard materials that can be mopped (no carpets)?

Carpets harbor bacteria and should not be used in patient rooms or procedure areas.

Check floors in patient rooms and areas where procedures are performed.

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31) Are the numbers of people in Intensive Care Unit (ICU) rooms limited?

Crowded rooms increase chances of cross contamination.

Visit ICU and observe whether the rooms appear crowded with people.

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Comments


important?



this score?

32) Are the doors to surgery closed when a procedure is being performed? Is traffic flow limited?

Maintaining a sterile environment is imperative during surgery.

Visit the surgery area and observe whether the doors to surgery are closed and strict rules for entry and passing certain points are upheld.

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33) Is there a surgical scrub area in the Operating Room that is clean, has adequate soap, disposable towels and a means of shutting off the water without use of hands?

A sterile “scrub” is critical to reducing the potential for infecting surgical sites. Turning off the water faucet with the hands re-contaminates them.

Observe the surgical scrub area for cleanliness and availability of soap and towels. Look at the type of faucet to see if the water can be shut off without use of the hands.

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34) Are surgical staff members properly gowned, masked and gloved?

Proper gowning, masking and gloving are necessary to maintain sterility during surgery and for reducing the potential for infecting the surgical site.

Observe whether staff members are wearing their gowns/masks outside of the Operating Room, e.g. in lounges or other administrative areas or outside of the surgical suite. (They should not). Staff should wear gowns and masks at all times when inside the surgical suites; and sterile gloves prior to performing surgery.

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35) Is there a central sterilization area (i.e. a unit for sterilizing and disinfecting medical and surgical equipment and instruments) with a functioning autoclave?

Sterilization should take place in an area designated for the purpose. There needs to be a separation between dirty and clean/sterile supplies. The flow pattern for supplies and equipment should be from dirty to clean.

Visit the sterilization area. Check for overall cleanliness. Observe the flow pattern of supplies and equipment (dirty items come into the department, are sterilized and placed in a clean area). Ask the staff how well the autoclave functions. (Check maintenance log).

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Comments


important?



this score?

36) Is the process of sterilization carried out properly?

The hospital should follow manufacturers’ recommendations for use of equipment, monitoring for function, and maintenance. Boiling instruments is not recommended and flash (rapid) sterilization should be limited to emergency needs.

Ask the sterilization staff about the process that they use to sterilize equipment; there should be a posted procedure or manual with the steps outlined. Ask whether boiling or flash sterilization is used.

Verify that disposable instruments are not re-used.

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37) Are there rooms to isolate patients with communicable diseases?

Some patients with infections must be segregated from others, particularly if the infection is transmitted by air or if there are infectious secretions that cannot be contained.

Determine if there are any isolation rooms and if any have negative pressure to prevent airborne disease.

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Medications management

38) Does the facility have adequate supplies of medicines to meet patient care needs?

Ask staff whether they experience stock-outs. ..........................................

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39) Are all the medicines stocked and dispensed within their expiry dates?

Medicines that have expired may no longer be effective.

Check a few medicines to ensure that they are stocked within their expiry dates.

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40) Are medicines stored properly and securely?

Medicines must be stored under proper conditions to assure effectiveness. And securely to reduce risk of tampering or theft.

Check a refrigerator in which medications are stored to see if a temperature log is maintained (and no food stored). Check if medications are kept in a locked or supervised location.

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Comments


important?



this score?

41) Is a medicine inventory system in use?

Effective inventory systems help to ensure that medicines are available.

A process for routine stocking of medicines according to an established level of use is in place so that stock is available, but not in excessive amounts that would result in expiry before use. This could be done using stock cards that list a minimum and maximum stock.

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42) Are emergency resuscitation equipment/ supplies and medicines easily accessible?

Emergency equipment/supplies must be immediately accessible in the Emergency Department and other critical care areas where acute medical emergencies may occur.

Emergency equipment and supplies are available. Check whether the emergency supplies/equipment are easily accessible, e.g. in a “crash-cart”.

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43) Is there a system for checking and maintaining the emergency resuscitation supplies/equipment and medicines?

Because emergency equipment/supplies are not used often, a testing and maintenance program is required to ensure their availability and functioning when needed.

There is a mechanism to check the functioning of the emergency equipment on a routine basis. The medicines and supplies are stored according to a checklist and are within their expiry dates. The emergency supplies are secured between uses.

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44) Are medication rooms/cabinets, particularly narcotic cabinets, locked?

Check that medications cabinets are secured. ..........................................

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45) Multi-dose vials that have been opened are dated and discarded within their specified time frame?

Once the seal has been broken, the vial has the potential for being contaminated.

Multi-dose vials are often opened and left on the counter or medication cart. Check to see if an opened vial has the date and time that it was opened.

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Comments


important?



this score?

Quality measurement and improvement

46) Are clinical practice guidelines used?

Clinical guidelines standardize care based on current research. They may be in the form of protocols or flow charts.

Ask clinicians what type of clinical guidelines or protocols they are using.

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47) What types of improvements have been made in quality?

The success of quality improvement efforts is realized at the unit level.

Staff members are able to give examples of quality improvement activities and results.

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48) When an incident or adverse event occurs, how do the staff handle it? (What process is followed?)

Tracking types of incidents helps the organization identify risks and find ways to reduce the potential of recurrence.

Staff can describe the steps that they take, first to take care of the patient and then to report the incident.

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49) How are patients identified prior to performing tests, procedures or treatments?

Wrong-patient errors occur in virtually all aspects of diagnosis and treatment.

Ask staff members how they identify patients. Well-designed policies and/or procedures require the use of two patient identifiers, not including the use of the patient’s room number or location. (Identifiers for neonates may be different from those defined for adult patients).

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50) What steps do staff members take when they receive a verbal or phone order?

The most error-prone communications are patient care orders given verbally, including those given over the telephone.

Ask staff members on units what they do when receiving a telephone order or test result.

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Comments


important?



this score?

51) Are concentrated electrolytes managed according to policy?

Accidental administration of concentrated electrolytes can be fatal.

Concentrated electrolytes are not kept on the units, except where policy permits. Check in these areas, e.g. Emergency Department, ICU, that they are properly stored and labeled.

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52) Is a checklist and time out process used prior to surgery?

Wrong-site, wrong-procedure, wrong-patient surgery is a disturbingly common occurrence

Talk with surgery staff members regarding their pre-operative processes. Are they aware of the WHO Surgical Safety Checklist (or similar)?

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53) Have patients been assessed for their risk of falls?

Falls account for a significant proportion of injuries in hospitalized patients

Ask staff how they identify patients that are at risk of falls.

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54) Does the operating room have a “scavenging system“?

All areas in which inhalation anesthesia (i.e. using gases) is carried out should be equipped with a scavenging system in order to reduce the exposure of personnel to waste anesthetic gases vented from the breathing system.

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55) Are the isolation room facilities and/or operating rooms equipped with negative pressure?

Negative pressure prevents cross-contamination. The ventilation system is designed so that air flows from the corridors, etc into the negative pressure room, ensuring that contaminated air cannot escape to other parts of the facility

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ClInICAl governAnCe And leAdershIP

standards and Measureable elements

Questions observations/Comments

Cgl.1 governance documentation

Governance responsibilities and accountabilities are described in bylaws, policies and procedures, or similar documents that guide how they are to be carried out.

1) The organization’s governance structure is described in written documents.

2) Strategic and management plans and operating policies and procedures are developed and approved by the governing body.

3) An annual budget is developed and approved to allocate the resources required to meet the organization’s mission.

4) A license to operate the organization, as required, is obtained and posted.

Please provide an organizational chart?

Describe the structure of the organization. (governing body, leadership positions, etc)

What types of clinical committees exist? (Examples may include: infection control, quality, pharmacy, safety, and morbidity/mortality)

How would you describe the level of effectiveness of these committees?

How is the organization’s strategic plan developed?

What are the key organizational objectives and strategies planned for this year?

How is the budget developed?

To what extent is the budget adequate to deliver the planned strategies?

Does the organization have all the necessary licenses?

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Cgl.2 senior management responsibility

A senior manager or director is responsible for operating the organization/facility and complying with applicable laws and regulations.

1) A senior manager or director manages the organization’s day-today operations, including human, financial and other resources.

2) The senior manager or director ensures compliance with approved policies.

3) The senior manager or director ensures compliance with applicable laws and regulations.

4) The senior manager or director responds to any reports from inspecting and regulatory agencies.

5) The organization’s leaders plan services with recognized leaders in the community and other health care organizations.

Who is responsible for managing the organization/facility?

Does the organization have a set of administrative policies (e.g. an administrative manual or standard operating procedures)?

How do you ensure that the organization is meeting laws and regulations?

What types of facility inspections do you undergo? (e.g. MoH, Civil Defense, fire agency, government or other regulatory agencies)

When was the last inspection? What were the findings?

How did you address these issues?

How do you involve the community and other organizations in planning services?

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Cgl.3 oversight of contracts

The leaders provide oversight of contracts for clinical and non-clinical services.

1) Contracts and other arrangements are monitored, as appropriate to the nature of the contract, as part of the organization’s quality management and improvement program.

2) Services provided under contracts and other arrangements meet patients’ needs.

What types of services are contracted out? (e.g. housekeeping, food, laundry, laboratory)

How do you oversee the quality of these services?

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Cgl. 4 scope of services provided

The directors of each clinical department identify, in writing, the scope of services provided and the criteria for the department’s professional staff.

1) The scope of services and policies and procedures describe the current and planned services provided by each department.

2) There is coordination of services within and between departments (e.g. through regular staff meetings, intra-departmental meetings, reporting mechanisms, and development of admission/discharge criteria).

3) The director develops and applies criteria related to the required education, skills, knowledge and experience of the department’s professional staff.

4) The director of each clinical department ensures that there is a formal process for authorizing all medical professionals who admit and treat patients that is commensurate with their training and qualifications (i.e. clinical privileges).

Does each department have a written description of the services that they provide? [Look for these in the departments during the facility tour]

Does each department have a set of policies and procedures to guide the work being done? [Look for these in the departments during the facility tour].

How are services coordinated and integrated within the hospital? (e.g. management meetings, staff meetings, reporting processes, etc)

Are there written job descriptions for each staff member? [Request examples].

Describe the process for awarding clinical privileges.

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Cgl.5 resource planning

Senior managers recommend space, equipment, staffing, and other resources needed by the department or service.

1) Departmental directors/managers recommend space, equipment, and numbers and qualifications of staff needed to provide services.

2) Directors/managers have a process to respond to resource shortages.

How are departmental directors/managers involved in the budgeting process?

If a manager needs to replace or add a new piece of equipment, what is the process for requesting, and approving, the item?

What problems have you had in meeting staffing needs?

What strategies have you used to meet staffing needs? (e.g. use of overtime, reallocation of staff to different units)

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Cgl.6 staff recruitment, retention and development

The organization’s leaders ensure that there are uniform programs for the recruitment, retention, development, and continuing education of all staff.

1) There is a program for staff recruitment and retention.

2) Managers have established an orientation program specifically for their department staff (i.e in addition to the organization’s general orientation program).

3) There is a program for staff personal development and continuing education.

4) The organization provides a staff health and safety program.

How do department managers determine staffing needs?

What means are used to obtain staff to meet these needs?

How are new staff members oriented to their roles and responsibilities (e.g. general orientation to review personnel policies, safety, infection control, quality, etc)? Does the orientation cover departmental policies/procedures as well as specific duties (based on the individual’s job description)?

How do you assure that each staff member is competent to do their job? (initially and on-going).

Does the organization provide a Staff Handbook (or similar) which describes HR procedures, rules, code of staff conduct etc?

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ethICs And PAtIent rIghts



ePr.1 verification of credentials

The organization has an effective process for gathering, verifying, and evaluating the credentials (license, education, training, and experience) of staff permitted to provide patient care.

1) Licensure, education and training are, as a minimum, verified based on laws/regulations.

2) The organization gathers evidence of education/training, current licensure and competence.

3) There is a separate record maintained of the credentials of every professional staff member that contains copies of any required license, certification, or registration and other documents required by the organization.

4) There is a standardized procedure to review each record at least every three years to assure current licensure, registration, etc.

How do you verify the credentials of professional clinical staff (e.g. physicians, nurses, pharmacists)?

[Review staff files of at least one physician, nurse and pharmacist].

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ePr.2 support for patients’ and family rights

The organization is responsible for providing processes that support patients’ and families’ rights during care.

1) Policies and procedures guide and support patient and family rights in the organization.

2) Vulnerable groups, e.g. children, disabled individuals, the elderly, mentally ill, and others identified by the organization, are protected against abuse.

3) The organization respects patient health information as confidential.

4) The organization informs patients and families about their rights to refuse or discontinue treatment and the available care and treatment alternatives.

5) Patients are aware of their right to voice a complaint and the process for doing so.

Has a statement of Patients’ Rights been developed and written?

If so, what are these rights?

How are the patients informed of their rights?

How do you protect patients, particularly women, children, people with mental illness, and the elderly from abuse?

When a patient or family decide to refuse or discontinue treatment, how is this handled?

When a patient or family has a complaint, how is this handled?

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ePr.3 Informed consent

Patients’ informed consent is obtained through a process defined by the organization and carried out by trained staff.

1) The organization has a clearly defined informed consent process described in policies and procedures.

2) Designated staff members are trained to implement the policies and procedures.

3) Patients give informed consent consistent with the policies and procedures.

a. Patients are informed of their condition.

b. Patients are informed about the proposed procedures and treatment(s) and who is authorized to perform them.

c. Patients are informed about potential benefits and drawbacks of the proposed treatment(s) and possible problems related to recovery.

d. Patients are informed about possible alternatives to the proposed treatment(s) and possible results of non-treatment.

e. Patients are informed about the likelihood of successful treatment(s).

f. Patients know the identity of the physician or other practitioner responsible for their care.

4) The organization has a process for when others can grant informed consent.

What is the process for obtaining informed consent?

[Review two patient records that have undergone a procedure/surgery to check whether consent was obtained].

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ePr.4 ethical management

The organization establishes a framework for ethical management that ensures that patient care is provided within business, financial, ethical, and legal norms and that protects patients and their rights.

1) The organization leaders establish ethical and legal norms that protect patients and their rights.

2) The organization discloses its ownership.

3) The organization honestly portrays its services to patients and provides clear admission, transfer, and discharge policies.

4) The organization honestly and accurately bills for services.

5) The organization discloses and resolves conflicts when financial incentives and payment arrangements may compromise patient care (e.g. payment of referral fees, bribes or kickbacks).

6) Staff are supported when confronted by ethical dilemmas in patient care and professional ethical issues.

7) The organizational structure(s) and processes support safe reporting of ethical and legal concerns (including “whistle-blowing”)?

Does the organization have a Code of Conduct4 or document describing its expectations regarding ethical conduct?

If, for example, you receive a report that a physician working for the organization is accepting bribes (e.g. kick-backs, under-the table payments, “red envelopes”), how would you handle the situation?

Provide an example of an ethical issue that has arisen and how it was dealt with? (e.g. end of life decisions)

How do you disclose the ownership of this organization?

What mechanism do you use to verify the accuracy of billing?

Do you provide receipts for all payments received?

What mechanism is in place to ensure that concerns regarding ethical and legal issues can be reported without retribution?

What is your policy on “whistle-blowing”?

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4 see Appendix I for IFC Code of Conduct for health Care organizations.


5 Who guiding Principles on human organ transplantation (1989). Available at: www.who.int/ethics/topics/transplantation_guiding_principles/en/index.html6 World Medical Association statement on human organ donation and transplantation. (2006) Available at: www.wma.net/e/policy/wma.htm



ePr.5 organ and tissue donation and transplantation

The organization informs patients and families about how to choose to donate organs and other tissues.

1) The organization supports patient and family choices to donate organs and other tissues.

2) Policies and procedures guide the procurement, donation and transplantation processes.

3) Staff are trained in the relevant policies and procedures.

4) Valid informed consent is obtained from live donors.

5) The organization cooperates with relevant organizations and agencies in the community to respect and implement choices to donate.

Does the organization participate in organ donation? (harvest and/or transplant)

[If yes, request to see the policies/procedures].

How are staff trained/prepared to implement these policies/procedures?

Are staff trained in recognized international guidelines on organ donation and transplantation and in the contemporary concerns and issues5, 6.

What national or international organizations/agencies are connected with your program?

In some countries, paid-for kidney donation from living persons has become a lucrative market. How does the organization make sure that it does not support or condone this practice? [Including indirectly as part of a transplant “supply chain”]

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http://www.who.int/ethics/topics/transplantation_guiding_principles/en/index.html

http://www.wma.net/e/policy/wma.htm




ePr.6 Assisted reproductive services/IvF

Where applicable, the organization sets policies and oversees assisted reproductive health practices such as IVF.

1) Infertility treatment is integrated into a wider reproductive and child health package of services.

2) The organization has written policies regarding assisted reproductive health technologies that ensure that the rights of women as users of these technologies are legal and within ethical boundaries (e.g. considering local social and cultural considerations).

3) Health care providers at each level are trained to perform screening, examination, diagnosis, referral and treatment services as appropriate.

4) Procedures and equipment for the techniques are standardized.

5) Prior to treatment, health personnel provide patients with full information of the risks and implications of the procedures undertaken.7

6) Where applicable, donors are provided with full information of the risks and implications of the procedure. (These might include issues relating to confidentiality).

7) A registry is kept of the results of direct treatment (e.g. pregnancy rates), pregnancy outcome, child development and side effects of treatment for the women.

8) Registries are linked, where possible, with national health registries.

Does the organization provide assisted reproductive health technologies, e.g. IVF?

If so, how does this program fit within the organization, e.g. relating to other services or departments?

How does the organization handle key ethical issues, e.g. relating to parental age limits, same-sex couples, gender selection, multiple embryo transfer, donor anonymity? Request to see the relevant policies/procedures.

Some clients seek these services for gender selection, what is the organization’s position on this issue?

What type of information is provided to patients regarding the risks, etc.? Request to see consent form and/or review a medical record.

What type of information is provided to donors (where applicable), regarding the risks, etc.? Request to see consent form and/or review a medical record.

What is the organization’s policy towards donors – e.g. regarding recruitment, target groups, compensation, anonymity (or otherwise), number of potential offspring, aftercare, etc?

What type of data do you keep regarding these procedures? [Request to see the registry].

What have been the outcomes of your program? [Request to see aggregated data/report].

Are your data linked with a national data registry?

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7 Who. Current Practices and Controversies in Assisted reproduction. report of a meeting on “Medical, ethical and social Aspects of Assisted reproduction” Who headquarters, geneva, switzerland, 17-21 september 2001. Available at: www.who.int/reproductive-health/infertility/36.pdf

http://www.who.int/reproductive-health/infertility/36.pdf




ePr.7 termination of pregnancy services

Where applicable, the organization sets policies and oversees termination of pregnancy services8 .

1) Termination of pregnancy is integrated into a wider package of gynecological or reproductive services.

2) The organization has written policies regarding termination of pregnancy that ensure that the rights of women as users of these services are within legal and accepted ethical boundaries (e.g. considering local social and cultural values).

3) Health care providers at each level are trained to perform screening, examination, diagnosis, referral and treatment services as appropriate.

4) Procedures and equipment for the techniques are standardized.

5) Prior to treatment, health personnel provide patients with full information of the risks and implications of the procedure.

Does the organization provide termination of pregnancy services.

If so, how does this program fit within the organization, e.g. relating to other services or departments?

How does the organization handle key ethical issues, e.g. relating to consent, juvenile mothers, confidentiality, gender selection? [Request to see the relevant policies/procedures.]

Some clients seek these services for gender selection, what is the organization’s position on this issue?

What type of information is provided to clients regarding the risks, etc? Request to see a consent form and/or review a medical record.

What type of data do you keep regarding these procedures?

Are your data linked with a national data registry?

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ePr.8 Clinical trials

The organization informs patients and their families about how to gain access to clinical research, investigations, or clinical trials involving human subjects.

1) Appropriate patients are identified and informed about how to gain access to those research, investigations, clinical trials and/or experimental procedures, technologies and pharmaceuticals relevant to their treatment needs.

2) Policies and procedures guide the information and decision process.

Are any experimental drugs or treatments tested in the organization?

If so, what is the process for approving research protocols and obtaining patient consent? [Request to see records of patients involved in studies].

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8 Who. Preventing unsafe Abortion: www.who.int/reproductivehealth/topics/unsafe_abortion/en/index.html

http://www.who.int/reproductivehealth/topics/unsafe_abortion/en/index.html




3) Written informed consent is obtained and includes the following information:

a. expected benefits,

b. potential discomforts and risks,

c. alternatives that might help,

d. procedures that patients must follow,

e. process for reviewing research protocols,

f. the process for withdrawing from participation, and

g. the process for weighing the benefits and risks to the subjects.

4) Patients are assured that their refusal to participate or withdraw from participation will not compromise their access to the organization’s services.

5) The organization has a committee or other mechanism to oversee all research within the organization. Oversight activities include:

a. a formal prior approval process – e.g. that considers ethical issues and potential benefits of the trial prior to its commencement,

b. a review process,

c. a process to weigh relative risks and benefits to subjects,

d. processes to provide confidentiality and security of research information,

e. ensuring that the informed consent process and other ethical aspects are appropriate,

f. compliance with all regulatory aspects of clinical research, and

g. monitoring serious adverse events and intervening in the interest of patient safety if required.

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QuAlIty MeAsureMent And IMProveMent



QMI.1 Clinical practice guidelines

Clinical practice guidelines and clinical pathways are used to guide clinical care.

1) Clinicians use clinical practice guidelines to guide patient care processes.

2) The organization uses the following process in implementing clinical practice guidelines and clinical pathways:

a. select from among those applicable to the services and patients of the organization (mandatory national guidelines are included in this process, if available);

b. evaluate for their applicability and science;

c. adapt when needed to the technology, drugs, and other resources of the organization or to accepted national professional norms;

d. formally approve or adopt by the organization;

e. implement and monitor for consistent use and effectiveness;

f. support with staff trained to apply the guidelines or pathways; and

g. update periodically.

3) At least one guideline or pathway per year is adapted, adopted or updated.

Are clinicians using internationally recognized clinical guidelines? Sources of guidelines include:

• WHO, e.g. for Integrated Management of Childhood Illnesses (IMCI)9 and Safe Motherhood10?, and

• National Institute for Health and Clinical Excellence (NICE)

If so, what types of guidelines/protocols are being followed?

What is the process for implementing these guidelines?

How do you determine that clinicians are implementing the guidelines properly?

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9 Who. Management of Childhood Illnesses. resources available at: www.who.int/child_adolescent_health/topics/prevention_care/child/imci/en/index.html10 Who. safe Motherhood resources available at: www.who.int/making_pregnancy_safer

http://www.who.int/child_adolescent_health/topics/prevention_care/child/imci/en/index.html

http://www.who.int/making_pregnancy_safer




QMI.2 leadership involvement and support

The organization’s leaders collaborate to carry out a Quality Improvement and Patient Safety Program.

4) The Quality and Patient Safety program employs a systematic approach.

5) A multidisciplinary committee meets on a regular basis to provide guidance to the quality improvement process.

6) The leaders set priorities for improvement and patient safety activities and provide technology and support, consistent with the organization’s resources.

a. Those responsible for governance regularly receive and act on reports of the Quality Improvement and Patient Safety Program.

b. There is a training program for staff that is consistent with their role in the Quality Improvement and Patient Safety Program.

c. The organization’s leaders identify key measures (indicators) to monitor clinical and managerial structures, processes, outcomes and patient safety. Clinical monitoring includes:

d. clinical outcomes (e.g. survival rates, readmission rates, complications rates);

e. aspects of laboratory services,

f. aspects of radiology and diagnostic imaging services,

7) medication errors and near misses,

a. infection control, surveillance, and reporting, and

b. clinical research (when applicable).

Does the organization have a Quality Improvement and Patient Safety Program (or similar)?

Does the organization have a Quality Improvement and Patient Safety Committee (or similar)?

Who participates on this team/committee (e.g. medical director, heads of departments, nursing director)?

How often does it meet?

What are its terms of reference? [Request to see the TORs]

[Request recent minutes to review issues raised and follow-up actions].

What quality methods do you use? (e.g. root-cause analysis, plan-do-study-act approach, fishbone diagram, cause/effect analysis, flow charting)

Does the organisation currently have, or plan to have, any form of local or international accreditation – e.g. ISO, JCI, MRQP etc?

• planned timetable,

• dates achieved,

• resources/assistance required, and

• budget.

What indicators are you measuring? [Request to see list/document]. And how are these being used to improve quality?

What methods are used to determine patient satisfaction?

What have you learned from your patients?

What actions have you taken to improve patient satisfaction?

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QMI.2 leadership involvement and support

The organization’s leaders collaborate to carry out a Quality Improvement and Patient Safety Program.

1) The Quality and Patient Safety program employs a systematic approach.

2) A multidisciplinary committee meets on a regular basis to provide guidance to the quality improvement process.

3) The leaders set priorities for improvement and patient safety activities and provide technology and support, consistent with the organization’s resources.

4) Those responsible for governance regularly receive and act on reports of the Quality Improvement and Patient Safety Program.

5) There is a training program for staff that is consistent with their role in the Quality Improvement and Patient Safety Program.

6) The organization’s leaders identify key measures (indicators) to monitor clinical and managerial structures, processes, outcomes and patient safety. Clinical monitoring includes:

a. clinical outcomes (e.g. survival rates, readmission rates, complications rates);

b. aspects of laboratory services,

c. aspects of radiology and diagnostic imaging services,

d. medication errors and near misses,

e. infection control, surveillance, and reporting, and

f. clinical research (when applicable).

Does the organization have a Quality Improvement and Patient Safety Program (or similar)?

Does the organization have a Quality Improvement and Patient Safety Committee (or similar)?

Who participates on this team/committee (e.g. medical director, heads of departments, nursing director)?

How often does it meet?

What are its terms of reference? [Request to see the TORs]

[Request recent minutes to review issues raised and follow-up actions].

What quality methods do you use? (e.g. root-cause analysis, plan-do-study-act approach, fishbone diagram, cause/effect analysis, flow charting)

Does the organisation currently have, or plan to have, any form of local or international accreditation – e.g. ISO, JCI, MRQP etc?

• planned timetable,

• dates achieved,

• resources/assistance required, and

• budget.

What indicators are you measuring? [Request to see list/document]. And how are these being used to improve quality?

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c. Managerial monitoring includes:

d. procurement of routinely required supplies and medications essential to meet patient needs,

e. reporting of activities as required by law and regulation,

c. risk management,

d. utilization management,

e. patient and family expectations and satisfaction,

f. staff expectations and satisfaction,

g. prevention and control of events that jeopardize the safety of patients, families, and staff, and

h. financial management.

9) Data are aggregated, analyzed, and transformed into useful information – and acted upon.

10) The organization documents the improvements achieved and sustained.

How did those actions affect the results of patient satisfaction?

What other types of improvements have you made?

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QMI.3 Infection Prevention and Control

There is a designated coordination mechanism for all infection control activities that involves physicians, nurses, and others as appropriate to the size and complexity of the organization.

1) There is a designated mechanism for coordination of the infection control program that is based on current scientific knowledge, practice guidelines and laws/regulations.

2) The organization’s leaders allocate adequate resources for the infection control program.

3) The infection control program includes systematic and proactive surveillance activities to determine usual (endemic) rates of infection and outbreaks of infectious diseases.

Does the organization have an Infection Control (IC) committee?

What is the role of the Infection Control Committee? – and key activities?

Who comprises the membership?

What are the roles and responsibilities of the members?

On what other committees does the Infection Control Committee have representation?

How are staff members provided with education about IC and their roles?

How is attendance? Is there administrative attendance on a regular basis? How often does the group meet?

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7) Managerial monitoring includes:

a. procurement of routinely required supplies and medications essential to meet patient needs,

b. reporting of activities as required by law and regulation,

c. risk management,

d. utilization management,

e. patient and family expectations and satisfaction,

f. staff expectations and satisfaction,

g. prevention and control of events that jeopardize the safety of patients, families, and staff, and

h. financial management.

8) Data are aggregated, analyzed, and transformed into useful information – and acted upon.

9) The organization documents the improvements achieved and sustained.

What methods are used to determine patient satisfaction?

What have you learned from your patients?

What actions have you taken to improve patient satisfaction?

How did those actions affect the results of patient satisfaction?

What other types of improvements have you made?

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QMI.3 Infection Prevention and Control

There is a designated coordination mechanism for all infection control activities that involves physicians, nurses, and others as appropriate to the size and complexity of the organization.

1) There is a designated mechanism for coordination of the infection control program that is based on current scientific knowledge, practice guidelines and laws/regulations.

2) The organization’s leaders allocate adequate resources for the infection control program.

3) The infection control program includes systematic and proactive surveillance activities to determine usual (endemic) rates of infection and outbreaks of infectious diseases.

Does the organization have an Infection Control (IC) committee?

What is the role of the Infection Control Committee? – and key activities?

Who comprises the membership?

What are the roles and responsibilities of the members?

On what other committees does the Infection Control Committee have representation?

How are staff members provided with education about IC and their roles?

How is attendance? Is there administrative attendance on a regular basis? How often does the group meet?

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4) The organization has established and implemented processes to prevent or reduce the incidence of health care–associated infections.

a. Respiratory tract infections are included as appropriate to the organization,

b. Urinary tract infections are included as appropriate to the organization,

c. Intravascular invasive devices are included as appropriate to the organization,

d. Surgical wounds are included as appropriate to the organization,

e. Epidemiologically significant diseases and organisms are included as appropriate to the organization and its community, and

f. Emerging or reemerging infections are included as appropriate to the organization and its community.

5) Equipment cleaning and sterilization methods in a central sterilization service are appropriate for the type of equipment.

6) Laundry and linen management are appropriate to minimize risk to staff and patients.

7) Disposal of infectious waste and body fluids are managed to minimize transmission risk.

8) Sharps and needles are collected in dedicated, puncture-proof containers which are not re-used.

9) Kitchen sanitation and food preparation and handling are appropriate to minimize infection risk.

10) The risks and impact of renovation/construction projects on air quality and infection control activities are assessed and managed.

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11) Patients with known or suspected contagious diseases are isolated in accordance with the organization’s policy and recommended guidelines.

12) Universal procedures, including for gloves, masks, eye protections and hand disinfection, are appropriately implemented.

13) All staff members are oriented to the policies, procedures, and practices of the infection prevention and control program.

14) Patients and their families are educated about reducing the risk of transmitting infectious diseases, immunizations, personal hygiene, hand washing, cough etiquette, as appropriate.

15) There is a comprehensive program and plan to reduce the risk of health care–associated infections in health care workers.

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QMI.4 use of medications

Use of medications in the organization complies with applicable laws and regulations and is efficiently organized to meet patient needs.

1) Policies guide all phases of medication management and medication use in the organization, including:

a. when generic or brand names are acceptable or required,

b. the data necessary to accurately identify the patient,

c. the required elements of the order or prescription,

d. whether or when indications for use are required on a PRN (pro re nata, or “as needed”) or other medication order,

e. special precautions or procedures for ordering drugs with look-alike or sound-alike names,

Request to see the policies and procedures regarding medication use.

Is there a Pharmacy and Therapeutics committee?

If so, what are the terms of reference?

How are decisions made regarding the medications that are stocked at the facility?

When a physician requests a new medication that is not stocked in the hospital, how is this handled?

Describe the system for reporting medication errors and near misses.

What safeguards are in place to ensure that counterfeit and sub-standard drugs do not enter the organization.

[Note: Most of these standards may be evaluated during the facility tour].

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f. actions to be taken when medication orders are incomplete, illegible, or unclear,

g. the permitted additional types of orders such as emergency, standing, automatic stop, etc., and any elements required in such orders,

h. the use of verbal and telephone medication orders, and the process to verify such orders,

i. the types of orders that are weight based, such as for children,

j. the types of orders that require additional information, such as vital signs or lab results,

k. destruction of medications known to be expired or outdated, and

l. special precautions and double verification while handling high risk medications (the list of which should include insulin, chemotherapy drugs, radioactive drugs, concentrated electrolytes, anti coagulants, and sedatives).

2) The pharmacy (or pharmaceutical service) and use of medications comply with applicable laws and regulations.

3) An appropriately licensed, certified, and trained individual supervises all pharmaceutical service activities.

4) The organization maintains a list of medications available for prescribing and ordering which is appropriate to its mission, patient needs, and services provided.

5) There is a process established for when medications are not available that includes a notification to prescribers and suggested substitutions.

6) Medications are protected from loss or theft throughout the organization.

7) Medications are stored under conditions suitable for product stability.

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8) Controlled substances are accurately accounted for according to applicable laws and regulations.

9) Emergency medications are available in the units where they will be needed or readily accessible within the organization to meet emergency needs.

10) Only those personnel permitted by the organization and by relevant licensure, laws and regulations are allowed to prescribe or order medications.

11) Medications prescribed or ordered are recorded for each patient and dose.

12) Medications are prepared and dispensed in clean and safe areas with appropriate equipment and supplies, and adhering to law, regulation, and professional standards of practice.

13) Staff members preparing sterile products are trained in aseptic techniques.

14) There is a uniform medication dispensing and distribution system in the organization.

15) Medications are appropriately labeled after preparation.

16) Medication effects on patients are monitored, including adverse effects.

17) Adverse effects are reported in the time frame required by the organization’s policy.

18) Medication errors and near misses are reported in a timely manner using an established process.

19) The organization uses reported information on medication errors and near misses to improve medication use processes.

20) An antibiotic policy is developed and implemented by clinical teams in collaboration with microbiology staff.

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QMI.5 sentinel events

The organization has a defined process for identifying and managing sentinel events.

1) The hospital leaders have established a definition of a sentinel event that at least includes:

a. unanticipated death unrelated to the natural course of the patient’s illness or underlying condition,

b. major permanent loss of function unrelated to the natural course of the patient’s illness or underlying condition, and

c. wrong-site, wrong-procedure, wrong-patient surgery.

2) The organization’s leaders adopt a process by which it identifies high-risk areas in terms of patient and staff safety.

3) The organization’s leaders undertake a formal assessment of patient and staff safety risks at least once per year.

When a serious (sentinel) event occurs, such as an unexpected death or surgery performed on the wrong patient, what actions are taken?

[Request the relevant policy/procedure].

What types of trends have you seen regarding such events?

What actions have been taken? Results?

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PAtIent sAFety



Ps.1 Patient identification

The organization develops an approach to improve the accuracy of patient identification.

1) A collaborative process is used to develop policies and/or procedures that address the accuracy of patient identification.

2) The policies and/or procedures require the use of two patient identifiers, not including the use of the patient’s room number or location.

3) Patients are identified before administering medications, blood, or blood products.

4) Patients are identified before taking blood and other specimens for clinical testing.

5) Patients are identified before providing treatments and procedures.

Has the organization implemented Patient Safety goals?

If so, which goals?

How have these been implemented?

What are the results?

How are patients identified before surgery/testing/prescribing etc?

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Ps.2 safe communication

The organization develops an approach to improve the effectiveness of communication among caregivers.

1) A collaborative process is used to develop policies and/or procedures that improve the accuracy of verbal and telephone communications.

2) For verbal and telephone ordering of tests, and for test results, the following steps are taken:

a. The complete verbal or telephone order or test result is written down by the receiver,

b. The complete verbal or telephone order or test result is read back by the receiver of the order or test result, and

c. The order or test result is confirmed by the individual who gave the order or test result.

What policies and procedures are in place regarding accepting verbal or telephone orders?

How were these policies and procedures developed?

How do you monitor to determine whether the procedures are followed?

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Ps.3 high-alert medications

The organization develops an approach to improve the safety of high-alert medications.

1) A collaborative process is used to develop policies and/or procedures that address the location, labeling, and storage of concentrated electrolytes.

2) Concentrated electrolytes are not present in patient care units unless clinically necessary, and actions are taken to prevent inadvertent administration in those areas where permitted by policy.

What policies and procedures are in place regarding storage of concentrated electrolytes on the units?

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Ps.4 Correct site, procedure, patient for surgery

The organization develops an approach to ensuring correct-site, correct-procedure, and correct-patient surgery.

1) A collaborative process is used to develop policies and/or procedures to ensure the correct site, correct procedure, and correct patient, including procedures done in settings other than the operating room.

2) The organization uses a clearly understood mark for surgical site identification and involves the patient in the marking process.

3) The organization uses a process to verify that all documents and equipment needed are on hand, correct, and functional.

4) The organization uses a checklist and time-out procedure just before starting a surgical procedure.

What do you know about:

• the WHO Global Patient Safety Challenge11 (launched June 2008)?

• the WHO Surgical Safety Checklist12?

• the WHO Safe Surgery Implementation Manual13?

• the WHO Draft Guidelines for Adverse Event Reporting and Learning Systems (2005)14?

To what extent are these guidelines implemented in the organization?

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11 Who, available at: www.who.int/patientsafety/en/12 Who, available at: www.who.int/patientsafety/safesurgery/ss_checklist/en/13 Who, available at: www.who.int/patientsafety/safesurgery/ss_checklist/en/14 Who, available at: www.who.int/patientsafety/events/05/reporting_guidelines.pdf

http://www.who.int/patientsafety/en/

http://www.who.int/patientsafety/safesurgery/ss_checklist/en/

http://www.who.int/patientsafety/safesurgery/ss_checklist/en/

http://www.who.int/patientsafety/events/05/Reporting_Guidelines.pdf




Ps.5 health associated infections

The organization develops an approach to reduce the risk of health care–associated infections.

1) The organization has adopted or adapted currently published and generally accepted hand hygiene guidelines.

2) The organization implements an effective hand hygiene program.

Has the organization adopted hand hygiene guidelines?

How are hand-washing practices monitored? And, if so, what is the rate of compliance?

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Ps.6 risk of falls

The organization develops an approach to reduce the risk of patient harm resulting from falls.

1) A collaborative process is used to develop policies and/or procedures that address reducing the risk of patient harm resulting from falls within the facility.

2) The organization implements a process for the initial assessment of patients for fall risk and reassessment of patients when indicated by a change in condition, medications, etc.

3) Measures are implemented to reduce fall risk for those assessed to be at risk.

What efforts does the organization take to prevent patient falls?

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FACIlIty sAFety And eMergenCy MAnAgeMentNote: This section covers some of the essential areas of Facility Safety (e.g. fire precautions etc). It does not replace IFC’s s separate, and more detailed, Environmental, Life and Fire Safety Assessment.



Fse.1 environmental safety and security

The organization plans and implements a program to provide a safe and secure physical environment.

1) The program ensures that all staff, visitors and vendors are identified and all security risk areas are monitored and kept secure.

2) The organization has a documented, current, accurate inspection of its physical facilities.

3) The organization has a plan to reduce evident risks based on the inspection.

4) The organization plans and budgets for upgrading or replacing systems, buildings, or equipment needed for the continued operation of a safe and effective facility and to meet legal and regulatory requirements.

When was the facility last formally inspected for safety issues?

Who conducted this inspection?

What were the findings of this inspection?

What actions were taken to respond to the recommendations?

What plans (if any) does the organization have for upgrading equipment or infrastructure? If so, what budget has been made/approved?

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Fse.2 hazardous materials

The organization has a process (e.g. described in a Hazardous Materials Plan) for managing hazardous materials.

1) The organization identifies hazardous materials and waste and has a current list of all such materials stored within it.

2) The plan describes procedures for:

a. maintaining an inventory of hazardous materials and waste,

b. handling, storage, and use of hazardous materials,

c. reporting and investigating spills, exposures, and other incidents,

d. proper disposal of hazardous waste,

e. ensuring that proper protective equipment and procedures are used during use, spill, or exposure,

f. maintaining documentation, including any permits, licenses, or other regulatory requirements, and

g. proper labeling of hazardous materials and waste.

3) Hazardous materials and waste are managed according to a Hazardous Materials/Waste Plan.

What training/processes are in place to assist staff in dealing with hazardous materials?

Does the organization have a Hazardous Materials Plan (or similar)?

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Fse.3 emergency management

The organization develops and maintains an Emergency Management Plan and a program to respond to likely community emergencies, epidemics, and natural or other disasters.

1) The organization has identified the major internal and external disasters and major epidemic events which pose significant risks of occurring.

What are the most likely types of disasters that could affect the organization?

What have you done to prepare for these possibilities?

When was the last Emergency Preparedness test undertaken? (And what were the key findings/improvements?)

[Request to see the organization’s Disaster Plan].

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2) The organization plans its response to likely disasters. The plan(s) provide(s) for

a. determining the type, likelihood and consequences of hazards, threats, and events,

b. determining the organization’s role in such events,

c. communicating strategies for such events,

d. managing of resources during events, including alternative sources,

e. managing clinical activities during an event, including alternative care sites, and

f. the identification and assignment of staff roles and responsibilities during an event.

3) The plan is tested annually. All staff members participate in at least one emergency-preparedness test per year.

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Fse.4 Fire and smoke plans

The organization plans and implements a program to ensure that all occupants are safe from fire, smoke, or other emergencies in the facility.

1) The organization has a program to ensure that all occupants are safe from fire, smoke, or other non-fire emergencies. A Fire Safety Plan identifies:

a. the frequency of inspecting, testing, and maintaining fire protection and safety systems, consistent with requirements,

b. procedures for safely evacuating the facility in the event of a fire or smoke,

c. the process for testing (exercising all or a portion of the plan), at least twice per year,

d. the necessary education of staff to effectively protect and evacuate patients when an emergency occurs, and

e. the participation of staff members in at least one fire safety test per year.

2) The program includes the assessment of fire risks when construction is present in, or adjacent to, the facility.

3) Fire detection and abatement systems are inspected, tested, and maintained at a frequency determined by the organization.

4) A Fire and Smoke Safety evacuation plan is tested at least twice a year.

5) Staff are trained to participate in the Fire and Smoke Safety Plan.

6) Staff participate in at least one fire and smoke safety test per year.

[Request to see the Fire (and Smoke) Safety Plan].

Does the facility comply with local fire safety laws?

Has an inspection for fire safety been conducted – by whom? What were the results? Have necessary improvements been made?

What types of fire risks have been identified?

What has the organization done to reduce the potential risk of fire?

What type of training is provided for staff to respond to a fire?

What is the organization’s policy regarding smoking in the facility?

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7) The organization develops and implements a policy and plan to limit smoking that:

a. applies to all patients, families, staff and visitors, and

b. eliminates smoking in the organization’s facilities or minimally limits smoking to designated non–patient care areas that are ventilated to the outside.

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Fse.5 Medical equipment Maintenance

The organization has a program for inspecting, testing, and maintaining medical equipment and documenting the results.

1) There is a program to test new, to provide ongoing maintenance, and to keep an inventory of all medical equipment.

2) Qualified individuals provide inspection, testing and maintenance services.

3) Data are collected and documented for the medical equipment management program.

What is your program for maintaining medical equipment?

Who is responsible for maintaining equipment?

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Fse.6 Medical utilities management

Potable water, electrical power and medical gases are available 24 hours a day, seven days a week, through regular or alternate sources, to meet essential patient care needs.

1) Potable water, electrical power, and medical gases are available 24 hours a day, seven days a week.

2) The organization has identified the areas and services at greatest risk when power fails or water is contaminated or interrupted.

3) The organization plans alternate sources of power and water in emergencies.

4) Key systems such as utilities, medical gas, and ventilation are identified, inspected, tested and maintained by the organization.

5) Water quality is monitored regularly.

6) Data are collected and analyzed for the medical utility management program for purposes of planning and improvement.

7) For each component of the organization’s facility management and safety program, staff members are trained so that they can effectively carry out their responsibilities.

How does the organization ensure an uninterrupted supply of potable water, electrical power, and medical gas – especially in patient care areas.

What types of problems do you have with water supply?

If the water is contaminated or there is a lack of water, what actions are taken?

How often is water quality monitored?

How often do you have electrical outages?

What actions are taken?

What are alternate sources for water and power?

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Additional IFC information resources - environmental, fire and life safety

More detailed resources are available online at:

IFC Environmental, Health and Safety Guidelines for Health Care Organizations www.ifc.org/ifcext/sustainability.nsf/AttachmentsByTitle/gui_EHSGuidelines2007_HealthCareFacilities/$FILE/Final+-+Health+Care+Facilities.pdf

IFC Performance Standards on Social and Environmental Sustainability www.ifc.org/ifcext/sustainability.nsf/AttachmentsByTitle/pol_PerformanceStandards2006_full/$FILE/IFC+Performance+Standards.pdf

IFC Environmental, Health and Safety General Guidelines (section on Life and Fire Safety in section 3.3, p79-81) www.ifc.org/ifcext/sustainability.nsf/AttachmentsByTitle/gui_EHSGuidelines2007_GeneralEHS/$FILE/Final+-+General+EHS+Guidelines.pdf

http://www.ifc.org/ifcext/sustainability.nsf/AttachmentsByTitle/gui_EHSGuidelines2007_HealthCareFacilities/$FILE/Final+-+Health+Care+Facilities.pdf

http://www.ifc.org/ifcext/sustainability.nsf/AttachmentsByTitle/gui_EHSGuidelines2007_HealthCareFacilities/$FILE/Final+-+Health+Care+Facilities.pdf

http://www.ifc.org/ifcext/sustainability.nsf/AttachmentsByTitle/pol_PerformanceStandards2006_full/$FILE/IFC+Performance+Standards.pdf

http://www.ifc.org/ifcext/sustainability.nsf/AttachmentsByTitle/gui_EHSGuidelines2007_GeneralEHS/$FILE/Final+-+General+EHS+Guidelines.pdf



appendices


PurPose To establish a culture of openness, trust and integrity in business practices. This document will serve to guide behavior to ensure ethical conduct based on the values of the International Finance Corporation (IFC).

PolICyOrganizations receiving funds from the IFC are expected to maintain high standards of professional and business integrity, to comply with all applicable laws, rules and regulations, deter wrongdoing and to avoid situations and behaviors that could reasonably be foreseen to reflect negatively on the integrity or reputation of IFC.

Prior to financing agreements, officers of the organization are to receive this document and are required to execute a Code of Conduct Statement. This statement will indicate that the document has been read and understood, that the organization will conduct business to the expectations outlined, that prohibited conduct will be avoided, and any relevant conflicts will be disclosed.

The intent of these guidelines is not to attempt to foresee or define each situation that does or might involve a breach in ethics. The intent is rather to focus on situations that are viewed as likely to pose actual or potential concerns or to reflect negatively on the integrity or reputation of IFC. The intent is also to focus on IFC’s expectation that, in questionable or unforeseen situations, timely disclosure will facilitate satisfactory resolution before any such situation becomes problematic.

During and, as applicable, subsequent to the agreement with IFC, the following issues shall be disclosed and avoided or managed as appropriate:

1. Compliance with laws and regulationsThe organization will ensure all activity by or on behalf of the organization is in compliance with applicable laws and regulations.

2. Adherence to ethical standardsOrganizations will accurately and honestly represent their services and will not engage in any activity intended to defraud any individual or organization of money, property or honest services.

3. Client FocusThe organization has the responsibility to ensure that there are no compromises in delivering the highest standard of services and that every aspect of their operations promotes and reflects these standards. No one is to take unfair advantage of anyone through manipulation, concealment, abuse of privileged information or misrepresentation of material facts.

4. non-discriminationDiscrimination or harassment on the basis of race, color, religion, gender, nationality, age or disability is not tolerated.

5. ConfidentialityThe organization shall maintain the confidentiality of clients and that of their service users and other confidential information in accordance with applicable legal and ethical standards.

6. recordsAll organizational records, documents and reports must be accurate, complete, and un-tampered.

7. Avoidance of Conflict of InterestExecutives, managers, employees, and Board members owe a duty of loyalty to the organization. Persons holding such positions may not use their positions to profit personally or to assist others in profiting in any way at the expense of the organization.

8. Business relationshipsBusiness transactions with vendors, contractors and other third parties shall be transacted appropriately, without offers, solicitation or acceptance of gifts and favors or other improper inducements in exchange for influence or assistance in a transaction. Business activities must be conducted on the basis of fair competitive practices. All purchases of services and supplies must be from qualified and reliable sources and be based upon objective factors, consistent with the organization’s policies and procedures.

9. occupational safetyThe organization abides by all laws and regulations regarding occupational safety. This requires an active participation in maintaining a safe working environment and includes observance of established safety procedures and making recommendations for changes where they are needed.

10. Clinical researchThe organization has a committee or other mechanism to oversee all research within the organization. Any person enrolled in clinical research is fully informed of the risks and benefits and their right to refuse to participate or drop out of the activity without risk of reprisal.

APPendIx I: IFC Code oF ConduCt For heAlth CAre orgAnIzAtIons


11. organ donation and transplantThe organization complies with the WHO Guiding Principles on Human Organ Transplantation.

Organ retrieval from living persons is not undertaken where there are reasonable grounds to suspect that the donation is coerced or that a financial consideration is expected by the donor.

The organization permits the allocation of organs on the basis of morally relevant criteria only.

Transplantation is prohibited when the chance of success is insufficient to justify the risks.

The buying and selling of organs are not performed or condoned by the organization.

The harvesting of organs without prior consent from dead patients (or their legal representative) are not performed or condoned by the organization.

12. gender selectionSex selection, by selectively terminating a pregnancy for non-medical reasons, is not performed or condoned. This encompasses a number of related practices, including pregnancy ultrasound scanning, where there are reasonable grounds to suspect a risk of termination of pregnancy dependent upon the determined sex of the embryo of fetus.

13. Assisted reproductive technologiesInterventions of human procreative processes [e.g. invitro fertilization (IVF), gamete intrafallopian transfer (GIFT), artificial insemination by donor (AID)] are carried out with due consideration to donor confidentiality, parental age limits, same sex couples, ownership of donated sperm/eggs, multiple embryo transfer and genetic testing. All such procedures are carried out within the laws and regulations of the country.

Exploitation of clients seeking reproductive assistance (e.g. non-required testing procedures or procedures unlikely to yield results), or of egg donors is prohibited.

Harvesting of stem cells must only be done with the express permission of the donor under the laws and regulations of the country.

14. Female genital MutilationFemale circumcision is not performed or condoned by the organization.


accreditation1. The process in which an independent external “accrediting”

organization (usually non-governmental) assesses a health care organization to determine if it meets a formal set of standards designed to improve the quality of care.

2. The positive formal decision by an accrediting organization that a health care organization meets an applicable set of standards.

adverse event An unanticipated, undesirable, or potentially dangerous occurrence in a health care organization. Also see sentinel event.

client A recipient of health care regardless of the state of health. Clients may, for example, include people receiving screening or preventative services. Patients’ families may also be considered as clients. Clients are sometimes classified as being “internal” and “external”; “internal” clients/customers are people who work inside the organization (e.g. physicians, staff, management) and “external” are those that use the services of the organization (e.g. patients, families, insurers, vendors).

clinical governance The means by which organizations ensure the provision of quality clinical care by making individuals accountable for setting maintaining and monitoring performance standards.15

clinical pathway An agreed-upon treatment regime that includes all elements of care. (There are several terms used for clinical pathway - such as “care pathway” or “care map”).

clinical practice guidelines Statements that help practitioners and patients choose appropriate health care for specific clinical conditions (for example, recommendations on the case management of diarrhea in children under the age of five years). The practitioner is guided through all steps of consultation (questions to ask, physical signs to look for, lab exams to prescribe, assessment of the situation, and treatment to prescribe).

clinician A health professional, such as a physician, psychiatrist, psychologist, or nurse, involved in clinical practice (as distinguished from one specializing in research).

competence A determination of an individual’s skills, knowledge, and capability to meet defined expectations, as frequently described in a job description.

confidentiality1. The restricted access to data and information to individuals who

have a need, a reason, and permission for such access.

2. An individual’s right to personal and informational privacy, including for his or her health care records.

continuum of care Matching the individual’s ongoing needs with the appropriate level and type of care, treatment, and service within an organization or across multiple organizations.

continuity of care The degree to which the care of individuals is coordinated among practitioners, among organizations, and over time.

contracted services Services provided through a written agreement with another organization, agency, or individual. The agreement specifies the services or personnel to be provided on behalf of the applicant organization and the fees to provide these services or personnel.

credentialing The process of obtaining, verifying, and assessing the qualifications of a health care practitioner to provide patient care services in or for a health care organization. The process of periodically checking staff qualifications is called recredentialing.

credentials Evidence of competence, current and relevant licensure, education, training, and experience. Other criteria may be added by a health care organization. Also see competence; credentialing.

data Facts, clinical observations, or measurements collected during an assessment activity. Data before they are analyzed are called “raw data.”

disaster See emergency

discharge The point at which an individual’s active involvement with an organization or program is terminated and the organization or program no longer maintains active responsibility for the care of the individual.

15 Pietroni, Advancing Clinical governance (1998). Available at: www.clinicalgovernance.scot.nhs.uk/documents/Clinical_governance_definitions.pdf

APPendIx II: glossAry

http://www.clinicalgovernance.scot.nhs.uk/documents/Clinical_Governance_Definitions.pdf


emergency1. An unanticipated or sudden occasion, as in emergency surgery

needed to prevent death or serious disability.

2. A natural or man-made event that significantly disrupts the environment of care (for example, damage to the organization’s building(s) and grounds due to severe winds, storms, or earthquakes); that significantly disrupts care and treatment (for example, loss of utilities such as power, water, or telephones due to floods, civil disturbances, accidents, or emergencies in the organization or its community); or that results in sudden, significantly changed or increased demands for the organization’s services (for example, bioterrorist attack, building collapse, or plane crash in the organization’s community). Some severe emergencies are called “disasters”.

ethical Conforming to accepted standards of moral, social or professional behavior.

governance The individual(s), group, or agency that has ultimate authority and responsibility for establishing policy, maintaining quality of care, and providing for organization management and planning. Other names for this group include “board,” “board of trustees,” “board of governors,” “board of commissioners,” and “governing body.”

harvesting, of organs Removal of an organ for means of transplantation.

hazardous materials and waste Materials whose handling, use, and storage are guided or defined by local, regional, or national regulation, hazardous vapors, and hazardous energy sources. Although JCI considers infectious waste as falling into this category of materials, not all laws and regulations define infectious or medical waste as hazardous waste.

health care–associated infection(s) (hAI) Also known as nosocomial infections. Any infection(s) acquired by an individual while receiving care or services in a health care organization. Common HAIs are urinary infections, surgical wound infections, pneumonia, and blood stream infections.

health care professional Any person who has completed a course of study and is skilled in a field of health. This includes a physician, dentist, nurse, or allied health professional. Health care professionals are often licensed by a government agency or certified by a professional organization.

IdA The International Development Association is the part of the World Bank that helps the world’s poorest countries. Established in 1960, IDA aims to reduce poverty by providing interest-free credits and grants for programs that boost economic growth, reduce inequalities and improve people’s living conditions.

indicator A measure used to determine, over time, an organization’s performance of functions, processes, and outcomes.

infectious waste See hazardous materials and waste

informed consent Agreement or permission accompanied by full information on the nature, risks, and alternatives of a medical procedure or treatment before the physician or other health care professional begins the procedure or treatment. After receiving this information, the patient then either consents to or refuses such a procedure or treatment.

in-service education Organized education, usually provided in the workplace, designed to enhance the skills of staff members or teach them new skills relevant to their jobs and disciplines.

inpatient Generally, persons who are admitted to and housed in a health care organization at least overnight.

intent statement A brief explanation of a standard’s rationale, meaning, and significance, noted in this manual under the heading Intent. Intent statements may contain detailed expectations of the standard that are evaluated in the on-site survey process.

invasive procedure A procedure involving puncture or incision of the skin, or insertion of an instrument or foreign material into the body.

job description Explanation of an employment position including duties, responsibilities, and conditions required to perform the job.


leader An individual who sets expectations, develops plans, and implements procedures to assess and improve the quality of the organization’s governance, management, clinical, and support functions and processes. The leaders described in these standards include at least the leaders of the governing body; the chief executive officer and other senior managers; departmental leaders; the elected and the appointed leaders of the medical staff and the clinical departments and other medical staff members in organizational administrative positions; and the nurse executive and other senior nursing leaders.

licensure A legal right that is granted by a government agency in compliance with a statute governing an occupation (such as physicians, nurses, psychiatry, or clinical social work, or the operation of a health care facility).

measure1. To collect quantifiable data about a function, system, or process

(one “measures”).

2. A quantitative tool. Also see “indicator.”

medical equipment Fixed and portable equipment used for the diagnosis, treatment, monitoring, and direct care of individuals.

medical record See patient record/medical record.

medical waste See hazardous materials and waste.

medication Any prescription medications; sample medications; herbal remedies; vitamins; over-the- counter drugs; vaccines; diagnostic and contrast agents used on or administered to persons to diagnose, treat, or prevent disease or other abnormal conditions; radioactive medications; respiratory therapy treatments; parenteral nutrition; blood derivatives; and intravenous solutions (plain, with electrolytes and/or drugs).

medication, high-risk or high-alert Those drugs that carry a risk for errors that can lead to significant adverse outcomes.

medication error Any preventable event that may cause inappropriate medication use or jeopardize patient safety. Also see sentinel event.

mission statement A written expression that sets forth the purpose, or “mission,” of an organization or one of its components. The generation of a mission statement usually precedes the formation of goals and objectives.

monitoring The review of information on a regular basis. The purpose of monitoring is to identify the changes in a situation. For example, the health information specialist of the district health management team reports every month the cases of meningitis occurring in villages at risk.

multidisciplinary Including representatives of a range of professions, disciplines, or service areas.

near miss Any process variation that did not affect an outcome but for which a recurrence carries a significant chance of a serious adverse outcome. Such a “near miss” falls within the scope of the definition of an adverse event. Also see adverse event.

nosocomial infection(s) See health care–associated infection(s)

organizational chart A graphic representation of titles and reporting relationships in an organization, sometimes referred to as an “organogram” or “organization table.”

patient record/medical record/clinical record A written account of a variety of patient health information, such as assessment findings, treatment details, progress notes, and discharge summary. This record is created by physicians and other health care professionals.

plan A detailed method, formulated beforehand, that identifies needs, lists strategies to meet those needs, and sets goals and objectives. The format of the plan may include narratives, policies and procedures, protocols, practice guidelines, clinical paths, care maps, or a combination of these.

policy A plan or course of action adopted by the organization intended to influence or determine decisions.

primary source verification Verification of an individual health care practitioner’s reported qualifications by the original source or an approved agent of that source. Methods for conducting primary source verification of credentials include direct correspondence, documented telephone verification, or secure electronic verification from the original qualification source or reports from credentials verification organizations that meet requirements.


privileging The process whereby a specific scope and content of patient care services (that is, clinical privileges) are authorized for a health care practitioner by a health care organization, based on evaluation of the individual’s credentials and performance.

procedure Step-by-step instructions on how to perform a technical skill.

process A series of actions (or activities) that transform the inputs (resources) into outputs (services). For example, a rural health education program will require that staff develop an education strategy, develop educational materials, and deliver the education sessions.

program Services designed to meet the needs of a particular patient population.

protocol Scientific treatment plan or study outline—including types of trial participants, schedule, procedures, medications and dosages, etc.—for using an experimental procedure or a new treatment with the intent of measuring human applications.

qualified individual An individual or staff member who can participate in one or all of the organization’s care activities or services. Qualification is determined by the following: education, training, experience, competence, applicable licensure, law or regulation, registration, or certification.

quality of care The degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge. Dimensions of performance include the following: patient perspective issues; safety of the care environment; and accessibility, appropriateness, continuity, effectiveness, efficacy, efficiency, and timeliness of care.

recruiting Seeking; normally new employees or other members of an organization.

risk management program Clinical and administrative activities that organizations undertake to identify, evaluate, and reduce the risk of injury to patients, staff, and visitors and the risk of loss to the organization itself.

root cause analysis A process for identifying the basic or causal factor(s) that underlie variation in performance, including the occurrence or possible occurrence of a sentinel event. Also see sentinel event.

safety The degree that the organization’s buildings, grounds, and equipment do not pose a hazard or risk to patients, staff, or visitors.

scope of practice The range of activities performed by a practitioner in a health care organization. The scope is determined by training, tradition, law or regulation, or the organization.

scope of services The range of activities performed by governance, managerial, clinical, and support personnel.

security Protection from loss, destruction, tampering, or unauthorized access or use.

sentinel event An unanticipated occurrence involving death or major permanent loss of function.

side effect Pharmacological effect of a drug, normally adverse, other than the one(s) for which the drug is prescribed.

staff As appropriate to their roles and responsibilities, all people who provide care, treatment, and services in the hospital (e.g. medical staff and nursing staff ), including those receiving pay (e.g. permanent, temporary, and part-time personnel, as well as contract employees), volunteers, and health profession students.

clinical staff Are those who provide direct patient care (physicians, nurses, etc.).

nonclinical staff Are those who provide indirect patient care (admissions, food service, etc.).

standard A statement that defines the performance expectations, structures, or processes that must be in place for an organization to provide safe and high-quality care, treatment, and service.

transfer The formal shifting of responsibility for the care of a patient from (1) one care unit to another, (2) one clinical service to another, (3) one qualified practitioner to another, or (4) one organization to another organization.


utility system Organization-wide system and equipment that support the following: electrical distribution; emergency power; water; vertical and horizontal transport; heating, ventilating, and air conditioning; plumbing, boiler, and steam; piped gases; vacuum systems; or communication systems, including data-exchange systems. May also include systems for life support; surveillance, prevention, and control of infection; and environment support.

variation The differences in results obtained in measuring the same event more than once. The sources of variations can be grouped into two major classes: common causes and special causes. Too much variation often leads to waste and loss, such as the occurrence of undesirable patient health outcomes and increased cost of health services.

IFC'S MissionIFC, a member of the World Bank Group, creates opportunity for people to escape poverty and improve their lives. We foster sustainable economic growth in developing countries by supporting private sector development, mobilizing private capital, and providing advisory and risk mitigation services to businesses and governments. For more information, visit www.ifc.org.

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