Regulatory Requirements for Health Care Systems

Patient Focused Functions &
National Patient Safety Goals

Section 1 : Patient- Focused Functions

Ethics, Rights, and Responsibilities
• Provision of Care, Treatment and Services
• Medication Management
• Surveillance, Prevention, and Control of Infection

Ethics, Rights, and Responsibilities
Overview

The goal of the ethics, rights, and responsibilities function is to improve care, treatment, services, and outcomes by recognizing and respecting the rights of each patient and by conducting business in an ethical manner. Care, treatment, and services are provided in a way that respects and fosters dignity, autonomy, positive self regard, civil rights, and involvement of patients.

Care, treatment, and services consider the patient’s abilities and resources; the relevant demands of his or her environment; and the requirements and expectations of the providers and those they serve. The family is involved in care, treatment, and service decisions with the patient’s approval.

A hospital’s adherence to ethical care and business practices significantly affects the patient’s experience of and response to care, treatment, and services. The standards in this chapter address the following processes and activities related to ethical care and business practices:
o Managing the hospital’s relationships with patients and the public in an ethical manner
o Considering the values and preferences of patients, including the decision to discontinue care, treatment, and services
o Helping patients understand and exercise their rights
o Informing patients of their responsibilities in care, treatment, and services
o Recognizing the hospital’s responsibilities under law

Patients deserve care, treatment, and services that safeguard their personal dignity and respect their cultural, psychosocial, and spiritual values. These values often influence the patient’s perceptions and needs.

By understanding and respecting these values, providers can meet care, treatment, and service needs and preferences.

Ethics, Rights, and Responsibilities Standards

Organization Ethics

• RI.1.10 The hospital follows ethical behavior in its care, treatment, and services and business practices.
• RI.1.20 The hospital addresses conflicts of interest.
• RI.1.30 The integrity of decisions is based on identified care, treatment, and service needs of the patients.
• RI.1.40 When care, treatment, and services are subject to internal or external review that results in the denial of care, treatment, services, or payment, the hospital makes decisions regarding the provision of ongoing care, treatment, services, or discharge based on the assessed needs of the patients.
Ethics, Rights, and Responsibilities
Individual Rights
• RI.2.10 The hospital respects the rights of patients.
• RI.2.20 Patients receive information about their rights.
• RI.2.30 Patients are involved in decisions about care, treatment, and services provided.
• RI.2.40 Informed consent is obtained.
• RI.2.50 Consent is obtained for recording or filming made for purposes other than the identification, diagnosis, or treatment of the patients.
• RI.2.60 Patients receive adequate information about the person(s) responsible for the delivery of their care, treatment, and services.
Ethics, Rights, and Responsibilities
• RI.2.70 Patients have the right to refuse care, treatment, and services in accordance with law and regulation.
• RI.2.80 The hospital addresses the wishes of the patient relating to end-of-life decisions.
• RI.2.90 Patients and, when appropriate, their families are informed about the outcomes of care, treatment, and services that have been provided, including unanticipated outcomes.
• RI.2.100 The hospital respects the patient’s right to and need for effective communication.
• RI.2.110 Not applicable
Ethics, Rights, and Responsibilities
• RI.2.120 The hospital addresses the resolution of complaints from patients and their families.
• RI.2.130 The hospital respects the needs of patients for confidentiality, privacy, and security.
• RI.2.140 Patients have a right to an environment that preserves dignity and contributes to a positive self image.
• RI.2.150 Patients have the right to be free from mental, physical, sexual, and verbal abuse,neglect, and exploitation.
• RI.2.160 Patients have the right to pain management.
Ethics, Rights, and Responsibilities
• RI.2.170 Patients have a right to access protective and advocacy services.
• RI.2.180 The hospital protects research subjects and respects their rights during research, investigation, and clinical trials involving human subjects.
• RI.2.190 In hospitals that provide opportunities for work, a defined policy addresses situations in which patients work.
Individual Responsibilities
• RI.3.10 Patients are given information about their responsibilities while receiving care, treatment, and services.

Provision of Care, Treatment, and Services Overview

Care, treatment, and services are provided through the successful coordination and completion of a series of processes that include appropriate initial assessment of needs; development of a plan for care, treatment, and services; the provision of care, treatment, and services; ongoing assessment of whether the care, treatment, and services provided are meeting the patient’s needs, and either the successful discharge of the patient or referral or transfer of the patient for continuing care, treatment, and services.
Provision of Care, Treatment, and Services
The provision of care, treatment, and services to patients is composed of four core processes or elements:

1. Assessing patient needs
2. Planning care, treatment, and services
3. Providing the care, treatment, and services the patient needs
4. Coordinating care, treatment, and services
Provision of Care, Treatment, and Services
These core elements may also include the following activities:
o Providing access to the appropriate levels of care and/or disciplines for patients
o Providing interventions based on the plan for care, treatment, and services
o Teaching patients what they need to know about their care, treatment, and services
o Coordinating care, treatment, and services, if needed, when the patient is referred, transferred, or discharged

The elements that make up the provision of care, treatment, and services are related to each other through an integrated and cyclical process that may occur over minutes, hours, days, weeks, months, or years, depending on the setting and the needs of the patient. This cyclical process may occur among multiple organizations or within a single organization. The standards in this chapter address the processes in this cycle, including those provided for patient populations with unique needs or patients who are receiving interventions or services that are problem prone.
The core processes or elements of the provision of care, treatment, and services should not be seen as separate steps, rather as interrelated activities in an integrated and ongoing care process.

The activities related to the provision of care, treatment, and services should be capable of moving easily between elements as required to meet patients’ needs and maintain the continuity of care, treatment, and services

Provision of Care, Treatment, and Services Standards

• PC.1.10 The hospital accepts for care, treatment, and services only those patients whose identified care, treatment, and service needs it can meet.
Assessment
• PC.2.10 Not applicable
• PC.2.20 The hospital defines in writing the data and information gathered during assessment and reassessment.
• PC.2.30 Through PC.2.110 Not applicable
• PC.2.120 The hospital defines in writing the time frame(s) for conducting the initial assessment(s).
Provision of Care, Treatment, and Services
• PC.2.130 Initial assessments are performed as defined by the hospital.
• PC.2.140 Not applicable
• PC.2.150 Patients are reassessed as needed.

Additional Standard for Victims of Abuse
• PC.3.10 Patients who may be victims of abuse or neglect are assessed. (See standard RI.2.150.)
• PC.3.20 Through PC.3.50 Not applicable
Provision of Care, Treatment, and Services
Additional Standards for Patients Being Treated for Addictions
• PC.3.60 Through PC.3.110 Not applicable
• PC.3.120 The needs of patients receiving psychosocial services to treat alcoholism or other substance use disorders are assessed.

Additional Standard for Patients Being Treated for Emotional or Behavioral Disorders
• PC.3.130 The needs of patients receiving treatment for emotional or behavioral disorders are assessed.
• PC.3.140 Through PC.3.220 Not applicable
Provision of Care, Treatment, and Services
Diagnostic Services
• PC.3.230 Diagnostic testing to determine the patient’s health care needs is performed.
Planning Care, Treatment, and Services
• PC.4.10 Development of a plan for care, treatment, and services is individualized and appropriate to the patient’s needs, strengths, limitations, and goals.
Providing Care, Treatment, and Services
• PC.5.10 The hospital provides care, treatment, and services for each patient according to the plan for care, treatment, and services.
Provision of Care, Treatment, and Services
• PC.5.20 Not applicable
• PC.5.30 Not applicable
• PC.5.40 Not applicable
• PC.5.50 Care, treatment, and services are provided in an interdisciplinary, collaborative manner.
• PC.5.60 The hospital coordinates the care, treatment, and services provided to a patient as part of the plan for care, treatment, and services and consistent with the hospital’s scope of care, treatment, and services.
Provision of Care, Treatment, and Services
Education
• PC.6.10 The patient receives education and training specific to the patient’s needs and as appropriate to the care, treatment, and services provided.
• PC.6.20 Not applicable
• PC.6.30 The patient receives education and training specific to the patient’s abilities as appropriate to the care, treatment, and services provided by the hospital.
• PC.6.40 Not applicable
• PC.6.50 The hospital provides academic education to children and youth as needed.
Nutritional Care
• PC.7.10 The hospital has a process for preparing and/or distributing food and nutrition products as appropriate to the care, treatment, and services provided.
Pain
• PC.8.10 Pain is assessed in all patients.
• PC.8.20 Not applicable
• PC.8.30 Not applicable
• PC.8.40 Not applicable
Provision of Care, Treatment, and Services
Access to the Outdoors
• PC.8.50 Unless contraindicated, the hospital accommodates patients’ needs to be outdoors when patients experience long lengths of stay.
Additional Standard For Hospitals with Behavioral Health Units
• PC.8.60 In accordance with patients’ needs, good standards of personal hygiene and grooming are taught and maintained, particularly bathing, brushing teeth, caring for hair and nails, and using the toilet, with due regard for privacy.
Provision of Care, Treatment, and Services
End-of-Life Care
• PC.8.70 Comfort and dignity are optimized during end-of-life care.
Specific Procedures
• PC.9.10 Not applicable
• PC.9.20 Not applicable
Availability of Resuscitation Services
• PC.9.30 Resuscitation services are available throughout the hospital.
Provision of Care, Treatment, and Services
Restraint and Seclusion
• PC.10.10 Through PC.10.120 Not applicable
• PC.11.10 The hospital’s leaders determine the hospital’s approach to the use of restraint for nonpsychiatric patients and limit its use to those situations where there is appropriate clinical justification.
• PC.11.20 Performance improvement processes seek to identify opportunities to reduce the risks associated with restraint use through preventive strategies, innovative alternatives, and process improvements.
Provision of Care, Treatment, and Services
• PC.11.30 Hospital policies and procedures guide appropriate and safe use of restraint.
• PC.11.40 Any use of restraint (to which these standards apply) is initiated pursuant to either an individual order (standard PC.11.50) or an approved protocol (standard PC.11.60), the use of which is authorized by an individual order.
• PC.11.50 Individual orders for initiating and renewing restraint are consistent with hospital policies and procedures and with the patient’s needs and clinical condition.
• PC.11.60 Protocols for restraint use contain criteria to ensure only clinically justified use.
• PC.11.70 Patients in restraint are monitored.
• PC.11.80 Not applicable
• PC.11.90 Not applicable
• PC.11.100 Each episode of restraint use is documented in the patient’s medical record, consistent with hospital policies and procedures.
Provision of Care, Treatment, and Services
Behavioral Health Care Restraint and Seclusion
• PC.12.10 The leaders establish and communicate the hospital’s philosophy on restraint and seclusion to all staff with direct care responsibility.
• PC.12.20 Staffing levels and assignments are set to minimize circumstances that give rise to restraint or seclusion use and to maximize safety when restraint and seclusion are used.
• PC.12.30 Staff is trained and competent to minimize the use of restraint and seclusion and, when use is indicated, to use restraint or seclusion safely.
Provision of Care, Treatment, and Services
• PC.12.40 The initial assessment of each patient at admission or intake assists in obtaining information about the patient that could help minimize the use of restraint or seclusion.
• PC.12.50 Nonphysical techniques are the preferred intervention in behavior management.
• PC.12.60 Restraint or seclusion is limited to emergencies in which there is an imminent risk of a patient physically harming himself or herself, staff, or others, and nonphysical interventions would not be effective.
Provision of Care, Treatment, and Services
• PC.12.70 A licensed independent practitioner orders the use of restraint or seclusion.
• PC.12.80 The patient’s family is notified promptly of the initiation of restraint or seclusion.
• PC.12.90 A licensed independent practitioner sees and evaluates the patient in person.
• PC.12.100 Written or verbal orders for initial and continuing use of restraint and seclusion are time limited.
• PC.12.110 Patients in restraint or seclusion are regularly reevaluated.
• PC.12.120 Clinical leaders are told of instances in which patients experience extended or multiple episodes of restraint or seclusion.
• PC.12.130 Patients in restraint or seclusion are assessed and assisted.
• PC.12.140 Patients in restraint or seclusion are monitored.
• PC.12.150 Restraint and seclusion are discontinued when the patient meets the behavior criteria for their discontinuation.
• PC.12.160 The patient and staff participate in a debriefing about the restraint or seclusion episode.
• PC.12.170 Medical records document that the use of restraint or seclusion is consistent with hospital policy.
• PC.12.180 The hospital collects data on the use of restraint and seclusion.
• PC.12.190 Hospital policies and procedures address prevention of restraint and seclusion and, when employed, guide their use.
Provision of Care, Treatment, and Services
Standards for Additional Special Procedures
Operative or Other High-Risk Procedures and/or the Administration of Moderate or Deep Sedation or Anesthesia
• PC.13.10 Not applicable
• PC.13.20 Operative or other procedures and/or the administration of moderate or deep sedation or anesthesia are planned.
• PC.13.30 Patients are monitored during the procedure and/or administration of moderate or deep sedation or anesthesia.
Provision of Care, Treatment, and Services
• PC.13.40 Patients are monitored immediately after the procedure and/or administration of moderate or deep sedation or anesthesia.
Additional Special Procedures
• PC.13.50 Electroconvulsive therapy is used with adequate justification, documentation, and regard for patient safety.
• PC.13.60 Psychosurgery or other surgical treatments for emotional, mental, or behavioral disorders are performed with adequate justification, documentation, and regard for patient safety.
Provision of Care, Treatment, and Services
• PC.13.70 Use of behavior management procedures conforms to the patient’s treatment plan and hospital policy.
• PC.14.10 Through PC.14.30 Not applicable
Discharge or Transfer
• PC.15.10 A process addresses the needs for continuing care, treatment, and services after discharge or transfer.
• PC.15.20 The transfer or discharge of a patient to another level of care, treatment, and services, different professionals, or different settings is based on the patient’s assessed needs and the hospital’s capabilities.
Provision of Care, Treatment, and Services
• PC.15.30 When patients are transferred or discharged, appropriate information related to the care, treatment, and services provided is exchanged with other service providers.
Waived Testing
• PC.16.10 The hospital establishes policies and procedures that define the context in which waived test results are used in patient care, treatment, and services.
• PC.16.20 The hospital identifies the staff responsible for performing and supervising waived testing.
Provision of Care, Treatment, and Services
• PC.16.30 Staff performing tests have adequate, specific training and orientation to perform the tests and demonstrates satisfactory levels of competence.
• PC.16.40 Approved policies and procedures governing specific testing-related processes are current and readily available.
• PC.16.50 Quality control checks, as defined by the hospital, are conducted on each procedure.
• PC.16.60 Appropriate quality control and test records are maintained.

Medication Management Overview

Medication management is often an important component in the palliative, symptomatic, and curative treatment of many diseases and conditions. A safe medication management system addresses a hospital’s medication processes, including the following (as applicable):
● Selection and procurement
● Storage
● Ordering and transcribing
● Preparing and dispensing
● Administration
● Monitoring
Effective and safe medication management involves multiple services and disciplines working closely together. These standards address activities involving various individuals within a hospital’s medication management system, including, as appropriate to the setting, licensed independent practitioners, health care professionals, and staff involved in medication management processes.

A well-planned and implemented medication management system supports patient safety and improves the quality of care by doing the following:

● Reducing practice variation, errors, and misuse
● Monitoring medication management processes in regard to efficiency, quality, and safety
● Standardizing equipment and processes across the hospital to improve the medication management system


Medication Management
o Using evidence-based good practices to develop medication management processes
o Managing critical processes associated with medication management (depicted in the illustration on page MM-2) to promote safe medication management throughout the hospital
o Handling all medications in the same manner, including sample medications

An effective medication management system includes mechanisms for reporting potential and actual errors and a process to improve medication management processes and patient safety based on this information. The most effective feedback and improvement systems usually operate in hospitals with a non-punitive culture.

The “Medication Management” chapter (standards MM.1.10 through MM.8.10) addresses critical medication management processes, including those undertaken by the hospital and those provided through contracted pharmacy services. When pharmacy services are provided through a contract, the contract should address responsibility for these standards and performance expectations. A hospital receiving pharmacy services should monitor the performance of contracted services.

Medication Management Standards

Patient-Specific Information
• MM.1.10 Patient-specific information is readily accessible to those involved in the medication management system.
Selection and Procurement
• MM.2.10 Medications available for dispensing or administration are selected, listed, and procured based on criteria
Medication Management
Storage
• MM.2.20 Medications are properly and safely stored throughout the hospital.
• MM.2.30 Emergency medications and/or supplies, if any, are consistently available, controlled, and secure in the hospital’s patient care areas.
• MM.2.40 A process is established to safely manage medications brought into the hospital by patients or their families.
Medication Management
Ordering and Transcribing
• MM.3.10 Only medications needed to treat the patient’s condition are ordered.
• MM.3.20 Medication orders are written clearly and transcribed accurately.
Preparing and Dispensing
• MM.4.10 All prescriptions or medication orders are reviewed for appropriateness.
• MM.4.20 Medications are prepared safely.
• MM.4.30 Medications are appropriately labeled.
• MM.4.40 Medications are dispensed safely.
Medication Management
• MM.4.50 The hospital has a system for safely providing medications to meet patient needs when the pharmacy is closed.
• MM.4.60 Not applicable
• MM.4.70 Medications dispensed by the hospital are retrieved when recalled or discontinued by the manufacturer or the Food and Drug Administration for safety reasons.
• MM.4.80 Medications returned to the pharmacy are appropriately managed.
Medication Management
Administering
• MM.5.10 Medications are safely and accurately administered.
• MM.5.20 Self-administered medications are safely and accurately administered.
Monitoring
• MM.6.10 The effects of medication(s) on patients are monitored.
• MM.6.20 The hospital responds appropriately to actual or potential adverse drug events and medication errors.
Medication Management
High-Risk Medications
• MM.7.10 The hospital develops processes for managing high-risk or high-alert medications.
• MM.7.20 Not applicable
• MM.7.30 Not applicable
• MM.7.40 Investigational medications are safely controlled and administered.
Evaluation
• MM.8.10 The hospital evaluates its medication management system.

Surveillance, Prevention, and Control of Infection Overview

Prevention of health care–associated infections (HAIs) represents one of the major safety initiatives a hospital can undertake, making the effective evaluation and possible redesign of existing infection prevention and control programs (hereafter referred to as the “IC program”) a priority. The Centers for Disease Control and Prevention (CDC, 2000)* estimates that each year, approximately 2 million patients admitted to acute care hospitals in the United States acquire infections that were not related to the condition for which they were hospitalized.

These infections result in approximately 90,000 deaths and add between $4.5 to $5.7 billion per year to patient care costs (CDC, 1992). While the precise causes of HAIs are difficult to identify, it has been estimated that approximately one third of HAIs could be prevented using current recommendations.
Effective infection prevention and control requires an integrated, responsive process involving collaboration by many programs, services, and settings throughout the hospital to develop, implement, and evaluate the IC program.

The design and scope of the IC program are based on the risk that the hospital faces related to the acquisition and transmission of infectious disease.
The goal of an effective IC program is to reduce the risk of acquisition and transmission of HAIs.
Hospitals must do the following to achieve this goal:
1. The hospital incorporates its infection control program as a major component of its safety and performance improvement programs
2. The hospital performs an ongoing assessment to identify its risks for the acquisition and transmission of infectious agents
3. The hospital uses an epidemiological approach that consists of surveillance, data collection, and trend identification
4. The hospital effectively implements infection prevention and control processes
5. The hospital educates and collaborates with hospital-wide leaders to effectively participate in the design and implementation of the IC program
6. The hospital integrates its efforts with health care and community leaders to the extent practicable, recognizing that infection prevention and control is a communitywide effort
7. To remain a viable community resource, the hospital must plan for responding to infections that potentially overwhelm its resources

A program with aims of such broad scope and depth requires the direct involvement of hospital leaders. Only with the ongoing attention and direction of hospital leadership can the appropriate scope of the IC program be determined and adequately resourced

Surveillance, Prevention, and Control of Infection Standards

The IC Program and Its Components
• IC.1.10 The risk of development of a health care–associated infection is minimized through a hospitalwide infection control program.
• IC.2.10 The infection control program identifies risks for the acquisition and transmission of infectious agents on an ongoing basis.
• IC.3.10 Based on risks, the hospital establishes priorities and sets goals for preventing the development of health care–associated infections within the hospital.
Surveillance, Prevention, and
Control of Infection
• IC.4.10 Once the hospital has prioritized its goals, strategies must be implemented to achieve those goals.
• IC.5.10 The infection control program evaluates the effectiveness of the infection control interventions and, as necessary, redesigns the infection control interventions.
• IC.6.10 As part of emergency management activities, the hospital prepares to respond to an influx, or the risk of an influx, of infectious patients.
Surveillance, Prevention, and
Control of Infection
Structure and Resources for the IC Program
• IC.7.10 The infection control program is managed effectively.
• IC.8.10 Representatives from relevant components /functions within the hospital collaborate to implement the infection control program.
• IC.9.10 Hospital leaders allocate adequate resources for the infection control program.

National Patient Safety Goals JCAHO Requirements Overview


 As with Joint Commission standards, accredited organizations are evaluated for continuous compliance with the specific requirements associated with the National Patient Safety Goals.

 Compliance with these requirements is assessed by the Joint Commission through on-site surveys and Evidences of Standards Compliance (ESCs).

 In mid-cycle, the organization also assesses its own compliance in the Periodic Performance Review (PPR).

 Organizations are judged to be either compliant or not compliant with each goal.

 If an organization does not fully comply with all the requirements associated with a goal, the organization will be assigned a requirement for improvement for the goal in the same way that noncompliance with an element of performance (EP) for a standard generates a requirement for improvement for that standard.

 All requirements for improvement generate follow-up requirements, and can impact the accreditation decision, as determined by established accreditation decision rules of “The New Joint Commission Accreditation Process” chapter for the current decision rules).

 Failure to resolve a requirement for improvement for a goal can ultimately lead to loss of accreditation.

Purpose of the NPSG


 The purpose of the Joint Commission’s National Patient Safety Goals is to promote specific improvements in patient safety.

 The goals highlight problematic areas in health care and describe evidence and expert-based solutions to these problems. Recognizing that sound system design is intrinsic to the delivery of safe, high-quality health care, the goals focus on system-wide solutions, wherever possible.

 Although the requirements associated with the National Patient Safety Goals are generally more prescriptive than Joint Commission standards requirements, organizations may request Joint Commission approval of specific alternative approaches to meeting National Patient Safety Goal requirements.

 The Joint Commission also provides guidance on how to achieve effective compliance with each goal’s requirements.

 Three of the requirements associated with the 2004 National Patient Safety Goals that related to preventing wrong site, wrong procedure, and wrong person surgery have been incorporated into the Universal Protocol for ambulatory care, critical access hospitals, hospitals, and office-based surgery, effective July 1, 2004.

 The 2004 goals and requirements are now replaced by the Universal Protocol for these programs, and their compliance with these three requirements are now scored at the Universal Protocol, which is also provided in this chapter on pages NPSG-4–NPSG-5.

Origin of the NPSG


 The National Patient Safety Goals are derived primarily from informal recommendations made in the Joint Commission’s safety newsletter, Sentinel Event Alert.

 The Sentinel Event database, which contains de-identified aggregate information on sentinel events reported to the Joint Commission, is the primary, but not the sole, source of information from which the Alerts, as well as the National Patient Safety Goals, are derived.

 A broadly representative Sentinel Event Advisory Group works with Joint Commission staff on a continuing basis to determine priorities for, and develop, goals and associated requirements.

 As part of this development process, candidate goals and requirements are sent to the field for review and comment.

 Selected existing and new goals and requirements are annually recommended by the Advisory Group to the Joint Commission’s Board of Commissioners for final review and approval.

 The Advisory Group also assists the Joint Commission in evaluating potential alternatives to goal requirements that have been suggested by individual organizations.

Goal 1: Improve the accuracy of patient identification.


Requirement 1A
 Use at least two patient identifiers (neither to be the patient’s room number) whenever administering medications or blood products; taking blood samples and other specimens for clinical testing, or providing any other treatments or procedures.
 Note: The preceding requirement is not scored here. It is scored at standard PC.5.10, EP 4.

Goal 2: improve the effectiveness of communication among caregivers

Requirement 2A
 For verbal or telephone orders or for telephonic reporting of critical test results, verify the complete order or test result by having the person receiving the order or test result “read-back” the complete order or test result.

 Note: The preceding requirement is not scored here. It is scored at standard IM.6.50, EP 4.

Requirement 2B
 Standardize a list of abbreviations, acronyms and symbols that are not to be used throughout the organization.

 Note: The preceding requirement is not scored here. It is scored at standard IM.3.10, EP 2.

Requirement 2C
 Measure, assess and, if appropriate, take action to improve the timeliness of reporting, and the timeliness of receipt by the responsible licensed caregiver, of critical test results and values.

Goal 3: Improve the safety of using medications.

Requirement 3A
 Remove concentrated electrolytes (including, but not limited to, potassium chloride, potassium phosphate, sodium chloride >0.9%) from patient care units.

 Note: The preceding requirement is not scored here. It is scored at standard MM.2.20, EP 9.
Goal 3: Improve the safety of using medications.

Requirement 3B
 Standardize and limit the number of drug concentrations available in the organization.
 Note: The preceding requirement is not scored here. It is scored at standard MM.2.20, EP 8.

Requirement 3C
 Identify and, at a minimum, annually review a list of look-alike/sound-alike drugs used in the organization, and take action to prevent errors involving the interchange of these drugs.

Goal 5: Improve the safety of using infusion pumps.

Requirement 5A
 Ensure free-flow protection on all general-use and PCA (patient controlled analgesia) intravenous infusion pumps used in the organization

Goal 7: Reduce the risk of health care–associated infections

Requirement 7A
 Comply with current Centers for Disease Control and Prevention (CDC) hand hygiene guidelines.
 Note: The preceding requirement is not scored here. It is scored at standard IC.4.10, EP 2.

Requirement 7B
 Manage as sentinel events all identified cases of unanticipated death or major permanent loss of function associated with a health care–associated infection.


Goal 8: Accurately and completely reconcile medications across the continuum of care.

Requirement 8A
 During 2005, for full implementation by January 2006, develop a process for obtaining and documenting a complete list of the patient’s current medications upon the patient’s admission to the organization and with the involvement of the patient. This process includes a comparison of the medications the organization provides to those on the list.

Requirement 8B
 A complete list of the patient’s medications is communicated to the next provider of service when it refers or transfers a patient to another setting, service, practitioner or level of care within or outside the organization.

Goal 9: Reduce the risk of patient harm resulting from falls.

Requirement 9A
 Assess and periodically reassess each patient’s risk for falling, including the potential risk associated with the patient’s medication regimen, and take action to address any identified risks.
Universal Protocol

 This universal protocol is intended to prevent Wrong site, wrong procedure, and wrong person surgery.

 It is based on the consensus of experts from the relevant clinical specialties and professional disciplines and is endorsed by nearly 50 professional medical associations and organizations.

In developing this protocol, consensus was reached on the following principles:

 Wrong site, wrong procedure, wrong person surgery can and must be prevented.

 A robust approach—using multiple, complementary strategies—is necessary to achieve the goal of eliminating wrong site, wrong procedure, wrong person surgery.

 Active involvement and effective communication among all members of the surgical team is important for success.

 To the extent possible, the patient (or legally designated representative) should be involved in the process.

 Consistent implementation of a standardized approach using a universal, consensus-based protocol will be most effective.

 The protocol should be flexible enough to allow for implementation with appropriate adaptation when required to meet specific patient needs.

 A requirement for site marking should focus on cases involving right/left distinction, multiple structures (fingers, toes), or levels (spine).

 The universal protocol should be applicable or adaptable to all operative and other invasive procedures that expose patients to harm, including procedures done in settings other than the operating room.

In concert with these principles, the following steps, taken together, comprise the Universal Protocol for Eliminating Wrong Site, Wrong Procedure, Wrong Person Surgery™ (Universal Protocol)

Pre-operative verification process


 Purpose: To ensure that all of the relevant documents and studies are available prior to the start of the procedure and that they have been reviewed and are consistent with each other and with the patient’s expectations and with the team’s understanding of the intended patient, procedure, site and, as applicable, any implants. Missing information or discrepancies must be addressed before starting the procedure.

 Process: An ongoing process of information gathering and verification, beginning with the determination to do the procedure, continuing through all settings and interventions involved in the preoperative preparation of the patient, up to and including the “time out” just before the start of the procedure.

Marking the operative site


 Purpose: To identify unambiguously the intended site of incision or insertion.

 Process: For procedures involving right/left distinction, multiple structures (such as fingers and toes), or multiple levels (as in spinal procedures), the intended site must be marked such that the mark will be visible after the patient has been prepped and draped.

“Time out” immediately before starting the procedure


 Purpose: To conduct a final verification of the correct patient, procedure, site and, as applicable, implants.

 Process: Active communication among all members of the surgical/procedure team, consistently initiated by a designated member of the team, conducted in a “fail-safe” mode, i.e., the procedure is not started until any questions or concerns are resolved.

The organization fulfills the expectations set forth in the Universal Protocol and associated implementation guidelines.


Requirement 1A
 Conduct a preoperative verification process as described in the Universal Protocol.

Requirement 1B
 Mark the operative site as described in the Universal Protocol.

Requirement 1C
 Conduct a “time out” immediately before starting the procedure as described in the Universal Protocol.
 Note: The preceding element of performance is not scored here. It is scored at standard PC.13.20, EP 9.

Recently Asked Questions


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Question:  Do the standards covering patients focused functions take into consideration feedback from patients regarding safety and quality of care received from health care organizations during the accreditation survey?  Answer:  Yes, surveyors usually talk to patients and their families during the survey. Part of the tracer methodology is to talk to patients. They will verify several aspects in the Pt rights, education and provision of care through their interview with the patients and their families.

Question:  Does JCAHO endorse the Institute of Healthcare Improvement's program Saving 100,000 Lives? If so, how can the data collected be utilized by JCAHO?   Answer:  I am not sure what the correct answer is. Perhaps other readers can send in their answer to this question. This question was answered by Farrokh Alemi, Ph.D.

Question:  Does a patient have the right to choose their anesthesia service provider, i.e., attending, resident, or nurse at an Ambulatory Surgery Center? A situation arose where the patient was told you take what we give you. Neither you nor the surgeon has any say re: who administeres the anesthesia.   Answer:  What do you think if you were the patient? Do you have such a right or do you think it is disruptive. You may be interested in discussion of refusal of care provided at http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=9729816

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Suggestion:  Thanks for compiling and condensing the standards covering all patient-focused functions. It serves as an easy reference of looking up standards. However, since national patient safety goals are continuously updated, a link in the lecture to JCAHO latest NPSG may be helpful.

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