JCI Accreditation Standards for Hospitals and Academic Medical Centers (AMC),

8th Edition
Draft Standards for Field Review
Proposed New Standards and Requirements

Note: This document does not include all standards for Hospitals and Academic Medical Centers (AMC), 8th Edition. The
standards in this document are the proposed requirements in the Anesthesia and Surgical Care (ASC) and Medication Management
and Use (MMU) chapters only. To participate in the field review of other chapters of the hospital and AMC standards, please refer
back to the JCIA website.

As a reminder, the field review focuses on newly added or significantly revised requirements. To identify the difference:
• Standards, measurable elements, intents, and guidance that are new or have undergone significant changes that have impacted
the intent of the requirement are in RED font.
• Standards, measurable elements, intents, and guidance that are in BLACK font may have undergone changes, but the intents
remained the same.
Prior to the publication, a complete summary of changes will be included in the manual along with an updated and complete
reference list for each chapter.

Field Review Questionnaire: To participate in the field review of this chapter, please complete the survey below:
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Field Review Period: October 23- November 13, 2023

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Anesthesia and Surgical Care (ASC)
Overview
The use of surgical anesthesia, procedural sedation, and surgical interventions are common and complex processes in a health care
organization. They require complete and comprehensive patient assessment, integrated care planning, continued patient monitoring,
and criteria-determined transfer for continuing care, rehabilitation, and eventual transfer and discharge. As individual patient
response may move along that continuum, anesthesia and procedural sedation use should be organized in an integrated manner.
Thus, this chapter addresses moderate and deep sedation/analgesia to general anesthesia where the patient’s protective reflexes
needed for a patent airway and ventilatory function maintenance are at risk. This chapter does not address the use of minimal
sedation for the purposes of anxiolysis or sedation required in the ICU for ventilator tolerance.

Procedural sedation and anesthesia are defined as the administration of medication to an individual, in any setting, for any purpose, by any
route, to induce a partial or total loss of sensation for the purpose of conducting an operative or other procedure. Definitions of
four levels of sedation and anesthesia include the following:

Minimal sedation (anxiolysis): A drug induced state during which patients respond normally to verbal commands. Although cognitive
function and coordination may be impaired, ventilatory and cardiovascular functions are unaffected.

Moderate sedation/analgesia (“conscious sedation”): A drug-induced depression of consciousness during which patients respond
purposefully to verbal commands, either alone or accompanied by light tactile stimulation. Reflex withdrawal from a painful
stimulus is not considered a purposeful response. No interventions are required to maintain a patent airway, and spontaneous
ventilation is adequate. Cardiovascular function is usually maintained.

Deep sedation/analgesia: A drug-induced depression of consciousness during which patients cannot be easily aroused but respond
purposefully following repeated or painful stimulation. The ability to independently maintain ventilatory function may be impaired.
Patients may require assistance in maintaining a patent airway and spontaneous ventilation may be inadequate. Cardiovascular
function is usually maintained.

Anesthesia (this chapter): Consists of general anesthesia and spinal or major regional anesthesia. It does not include local anesthesia.
General anesthesia is a drug-induced loss of consciousness during which patients are not arousable, even by painful stimulation. The
ability to independently maintain ventilatory function is often impaired. Patients often require assistance in maintaining a patent
airway, and positive pressure ventilation may be required because of depressed spontaneous ventilation or drug-induced depression
of neuromuscular function. Cardiovascular function may be impaired.

Because surgery carries a high level of risk, information about the surgical procedure and care after surgery is carefully planned,
based on the patient’s assessment, and documented. Special consideration is given to surgery that involves implanting a medical
device, including the reporting of devices that malfunction, as well as a process for follow-up with patients in the event of a recall.

Note: The anesthesia and surgery standards are applicable in settings where anesthesia and/or procedural sedation are used and
where surgical and other invasive procedures that require consent are performed. Such settings include hospital operating theatres,
day surgery or day hospital units, endoscopy, interventional radiology, dental and other outpatient clinics, emergency services,
intensive care areas, or elsewhere.

Standards
The following is a list of all standards for this function. They are presented here for your convenience without their intent statements
or measurable elements. For more information about these standards, please see the next section in this chapter, Standards, Intents,
Guidance, and Measurable Elements.

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Organization and Management
ASC.1 The hospital provides sedation and anesthesia services to meet patient needs, and in accordance with laws and regulations.

Sedation Care
ASC.2 The administration of procedural sedation is standardized throughout the hospital.
ASC.2.1 Practitioners responsible for procedural sedation and staff responsible for monitoring patients receiving
procedural sedation are qualified.
ASC.2.2 Procedural sedation is administered and monitored according to professional practice guidelines and
documented in the patient’s health record.
ASC.2.3 The risks, benefits, and alternatives related to procedural sedation are discussed with the patient, their
family, or those who make decisions for the patient.

Anesthesia Care
ASC.3 A qualified individual conducts a preanesthesia assessment and preinduction assessment.
ASC.4 Each patient’s anesthesia plan of care is discussed with the patient and/or those who make decisions for the patient and
documented in the patient’s health record.
ASC.5 Each patient’s physiological status during anesthesia and surgery is monitored according to professional practice
guidelines and documented in the patient’s health record.
ASC.5.1 Each patient’s postanesthesia status is monitored, and the patient is discharged from the recovery area by a
qualified individual or by using established criteria.

Surgical Care
ASC.6 Each patient’s surgical care is planned based on the results of the preoperative assessment and documented in the
patient’s health record.
ASC.6.1 The risks, benefits, and alternatives are discussed with the patient and their family or those who make
decisions for the patient.
ASC.6.2 Information about the surgical procedure is documented in the patient’s health record to facilitate
continuing care.
ASC.6.3 Patient care after surgery is planned and documented.
ASC.6.4 Surgical care that includes the implanting of a medical device is planned with special consideration for how
standard processes must be modified.

Standards, Intents, Guidance, and Measurable Elements

Organization and Management

Standard ASC.1
The hospital provides sedation and anesthesia services to meet patient needs, and in accordance with laws and regulations.

Intent of ASC.1
With the complexities involved in sedation and anesthesia care, the hospital must have a system in place for providing such services
reflective of its patient population, clinical services offered, and health care practitioners’ needs.

Guidance for ASC.1

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Sedation and anesthesia are commonly viewed as a continuum from minimal sedation to full anesthesia. Sedation and anesthesia use
are complex processes that must be integrated into patient care planning encompassing the stages of sedation and anesthesia.
Sedation and anesthesia require a complete and comprehensive patient assessment (pre-sedation/anesthesia), continued patient
monitoring (intra procedure/operative sedation/anesthesia), and objective recovery criteria (post procedure/operative
sedation/anesthesia). These services are provided according to professional practice standards for care, meet all applicable local and
national laws and regulations, and must be available at all times for emergencies. It is the recommendation of the Association of
periOperative Registered Nurses (AORN, 2022) that the hospital provides the same standard of care (i.e., patient monitoring,
equipment) for patients who are receiving procedural sedation/analgesia and anesthesia in non-operating room anesthesia locations
(e.g., interventional cardiology, endoscopy, dental, radiology, office-based surgery) as for patients receiving moderate
sedation/analgesia and anesthesia in the OR.
Sedation and anesthesia services may be provided by the hospital, by agreement with a contracted service (for example, an
individual anesthesiologist or anesthesia group practice), or both. Any use of contract anesthesia services is based on the
recommendation of the qualified individual responsible for managing the sedation and anesthesia services. Sedation and anesthesia
services are under the direction of one or more individuals who are qualified by documented training, expertise, and experience,
which are consistent with applicable laws and regulations. This individual(s) assumes professional and some management
responsibilities for the anesthesia services provided.

Measurable Elements of ASC.1

❑ 1. The hospital provides sedation and anesthesia services that meet the needs of the patients the hospital serves.
❑ 2. The hospital provides sedation and anesthesia services that comply with laws and regulations .
❑ 3. A qualified individual(s) assumes professional responsibility for the anesthesia services provided regardless of the location
at the hospital. Responsibilities include:
a) Developing, implementing, and maintaining policies and procedures
b) Providing administrative oversight
c) Maintaining any necessary quality improvement programs
d) Monitoring and reviewing all sedation and anesthesia services

4. This qualified individual(s) is responsible for managing the sedation and anesthesia services, including ensuring the
following:
a) Sedation and anesthesia services are uniform throughout the hospital.
b) Sedation and anesthesia services are available at all times for emergencies.
c) The responsibilities for monitoring and reviewing all sedation and anesthesia services are defined and carried out.

5. The hospital has a process for the selection of contract anesthesia services that includes the following:
a) An updated contract anesthesia service list that must be used to select contract anesthesia services approved by
hospital leadership and the qualified individual professionally responsible for anesthesia services.
b) The contract anesthesia service must have acceptable records of performance and follow applicable laws and
regulations.
c) The hospital must have a record of all the completed training and education for each contract anesthesia staff as
required by the hospital.
d) There is a current contract in place when contract anesthesia services are used.

Sedation Care

Standard ASC.2
The administration of procedural sedation is standardized throughout the hospital.

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Intent of ASC.2
Procedural sedation is often performed in many areas of the hospital outside of the operating theatre. Because procedural sedation,
like anesthesia, poses significant potential risks to patients, the administration of procedural sedation must be uniform throughout
the hospital.

Guidance for ASC.2

Clinical practice guidelines and standardization of practices have demonstrated improvement in outcomes, in particular, processes
that include protocols and checklists, which have proven to reduce patients harm through standardization and communication. As a
result, standardized processes optimize moderate procedural sedation practices regardless of the site the service is performed, guide
appropriate patient selection, decrease the risk of adverse patient outcomes (for example, apnea, airway obstruction, respiratory
arrest, cardiac arrest, death), promote sedation education, training, and research, and encourage the use of evidence-based data to
promote cross-specialty uniformity for moderate sedation practices.

Procedural sedation is defined as “the technique of administering sedatives or dissociative agents with or without analgesics to induce
an altered state of consciousness that allows the patient to tolerate painful or unpleasant procedures while preserving
cardiorespiratory function.” Regardless of the medication, dose, or route of administration, when a medication is used for the
purposes of altering the patient’s cognitive state in order to facilitate a specific procedure, it is considered procedural sedation.

Hospitals must develop specific guidelines for how and where procedural sedation may be used. The qualifications of staff
participating in the procedure, the medical equipment, the supplies, and the monitoring must be the same wherever procedural
sedation is provided in the hospital. For patients under care for procedural sedation, an individual trained in advanced life support
and emergency medical equipment and supplies appropriate for the age and history of the patient and the type of procedure being
performed are immediately available. Immediately available can be defined as availability within five minutes.

Measurable Elements of ASC.2

❑ 1. The hospital has established a policy and standardized processes for procedural sedation throughout the hospital.
❑ 2. The standardized policy and process(es)for procedural sedation must be understood by all practitioners permitted to
administer procedural sedation and include identifying and addressing at least the following:
a) Areas in the hospital where procedural sedation may occur
b) Special qualifications or skills of staff involved in the procedural sedation process
c) Differences between pediatric, adult, and geriatric populations or other special considerations
d) Medications used in conjunction for certain populations such as nitrous oxide used in conjunction with other
analgesics for pediatric patients during moderate and deep sedation.
e) Immediate availability and use of specialized medical equipment, as appropriate to the patient
f) Informed consent process for both the procedure and the use of sedation
g) An individual with advanced life-support training is immediately available for patients under care for procedural
sedation or anesthesia

❑ 3. Emergency medical equipment and supplies are immediately available and customized to the type of sedation being
performed and the age and medical condition of the patient.
❑ 4. An individual with advanced life-support training appropriate for the age and history of the patient, is immediately
available for patients under care for procedural sedation or anesthesia.

Standard ASC.2.1
Practitioners responsible for procedural sedation and staff responsible for monitoring patients receiving procedural sedation are
qualified.

Intent of ASC.2.1
Complications related to procedural sedation primarily include cardiac or respiratory depression. Thus, certification in at least basic
life support is essential. In addition, knowledge of the pharmacology of the sedation agents used, as well as reversal agents, decreases
the risks of adverse outcomes.

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Guidance for ASC.2.1
The qualifications of the physician, dentist, or other staff responsible for the patient receiving procedural sedation are important.
Understanding the methods for procedural sedation as they relate to the patient and the type of procedure performed improves the
patient’s tolerance of an uncomfortable or painful procedure and decreases the risks of complications.

The health care practitioner performing the procedure should not be responsible for performing continuous monitoring of the
patient. A separate, qualified individual, such as an anesthesiologist or a trained and competent nurse, should assume responsibility
for providing uninterrupted monitoring of the patient’s physiological parameters and assistance in supportive or resuscitative
measures.

Measurable Elements of ASC.2.1

❑ 1. Health care practitioners responsible for providing procedural sedation show evidence of competence in at least the
following:
a) Techniques and various modes of sedation
b) Pharmacology of sedation drugs and the use of reversal agents
c) Monitoring requirements
d) Response to complications
e) Airway assessment

❑ 2. The individual responsible for patient monitoring during procedural sedation is competent in at least the following:
a) Monitoring requirements
b) Response to complications
c) Use of reversal agents
d) Recovery criteria
e) Airway assessment
❑ 3. Procedural sedation competencies for all staff involved in sedation are documented in the personnel records.

Standard ASC.2.2
Procedural sedation is administered and monitored according to professional practice guidelines and documented in the patient’s
health record.

Intent of ASC.2.2
Many factors influence the patient’s response to sedation and can affect the degree to which a patient is sedated. The presedation
assessment helps identify any factors that may impact the patient’s response to procedural sedation and also helps to identify what
findings from monitoring during and after the procedure may be significant.

Guidance for ASC.2.2

The degrees of sedation occur on a continuum from mild to deep sedation, and a patient may progress from one degree to another.
Many factors influence the patient’s response to sedation and can affect the degree to which a patient is sedated. Factors include the
medications administered, the route and dosages, the age of the patient (pediatric, adult, or geriatric), and the patient’s health history.
For example, history of impairment of major organs, current medications that may interact with sedating medications, drug
allergies, previous adverse response to anesthesia or sedation, and substance abuse may each have an impact on patient response to
procedural sedation. If the patient’s physical status is high risk, consideration is given to the additional clinical needs of the patient
and the appropriateness of procedural sedation.
Patients undergoing procedural sedation require monitoring of their level of consciousness, ventilator and oxygenation status, and
hemodynamic variables at a frequency based on the type and amount of medication administered, the length of the procedure, and
the type and condition of the patient. Important considerations during the sedation procedure include the patient’s ability to
maintain protective reflexes; an independent, continuous patent airway; and the capability to respond to physical stimulation or

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verbal commands. A qualified individual is responsible for performing uninterrupted monitoring of the patient’s physiological
parameters and assistance in supportive or resuscitation measures until the patient has been safely recovered.
When the procedure has been completed, patients may continue to be at risk for complications due to delay in the full absorption of
the sedating drug, respiratory depression, and/or lack of stimulation from the procedure. Patients continue to require monitoring
until they have reached near their baseline level of consciousness and hemodynamic parameters. Complications associated with
moderate sedation and analgesia may be avoided if signs and symptoms of adverse drug effects such as cardiovascular
decompensation or cerebral hypoxia are detected and treated in a timely manner. Patient monitoring includes strategies for the
following:
• Monitoring patient level of consciousness assessed by the response of patients during procedures performed with
moderate sedation/analgesia
• Monitoring patient ventilation and oxygenation, including ventilatory function, by observation of qualitative clinical
signs, capnography, and pulse oximetry
• Hemodynamic monitoring, including blood pressure, heart rate, and electrocardiography
• Contemporaneous recording of monitored parameters
• Availability/presence of an individual responsible for patient monitoring
In addition to monitoring the physiological criteria, the frequency of monitoring and documentation, and general guidance and/or
parameters for recovery goals are important strategies to include. Objective, established criteria help identify patients who are
recovered and/or ready for discharge and are utilized by qualified individual(s) who are not fully qualified anesthesiologists, but
authorized by the individual(s) responsible for managing the anesthesia services.

Measurable Elements of ASC.2.2

❑ 1. A presedation assessment is performed and documented that includes at least the following criteria when evaluating risk
and appropriateness of procedural sedation for the patient:
a) Identify airway problems that may influence the type of sedation used
b) Evaluate at-risk patients for appropriateness of procedural sedation
c) Select and plan the type and level of sedation needed based on the patient assessment, identified risks, and type of
procedure being performed
d) Safely administer sedation based on the plan
e) Interpret findings from patient monitoring during procedural sedation and recovery
❑ 2. A qualified individual monitors the patient during the period of sedation and documents the monitoring in the health
record.
❑ 3. Established criteria are used and documented for the recovery and discharge from procedural sedation when a patient is
discharged by an authorized individual other than a fully qualified anesthesiologist.
❑ 4. The presedation assessment is performed by an individual(s) qualified to do so and documented in the patient health
record.

❑ 5. The following criteria are based on professional practice guidelines and defined in the hospital policy:
a) Scope and content of the presedation assessment
b) Criteria for the recovery and discharge from procedural sedation, including criteria for monitoring

Standard ASC.2.3
The risks, benefits, and alternatives related to procedural sedation are discussed with the patient, their family, or those who make
decisions for the patient.

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Intent of ASC.2.3
Adequate information and education must be provided to the patient, patient, their family, or decision maker on the
risks, benefits, and alternatives related to procedural sedation so an informed decision can be reached when obtaining
consent for the procedure.

Guidance for ASC.2.3

The procedural sedation planning process includes educating the patient, their family, or decision maker on the risks, benefits, and
alternatives related to procedural sedation. This discussion occurs as part of the process to obtain consent for procedural sedation as
required in PCC.4.2 and PCC.4.3. A qualified individual provides this education.

Measurable Elements of ASC.2.3

❑ 1. The patient, family, and/or decision makers are educated on the risks, benefits, and alternatives of procedural sedation.
❑ 2. The patient, family, and/or decision makers are educated about postprocedure sedation recovery and pain management.
❑ 3. A qualified individual provides and documents the education.

Anesthesia Care

Standard ASC.3
A qualified individual conducts a preanesthesia assessment and preinduction assessment.

Intent of ASC.3
Since anesthesia carries such a high level of risk, administration is carefully planned. Therefore, an anesthesiologist or another
qualified individual conducts the preanesthesia assessment.

Guidance for ASC.3

The patient’s preanesthesia assessment is the basis for the anesthesia plan of care, which includes identifying what findings from
monitoring during anesthesia and recovery may be significant, and for the use of postoperative analgesia. The preanesthesia
assessment may be carried out some time prior to admission or prior to the surgical procedure or shortly before the surgical
procedure, as in emergency and obstetrical patients.

The preinduction assessment is separate from the preanesthesia assessment, as it focuses on the physiological stability and readiness
of the patient for anesthesia and occurs immediately prior to the induction of anesthesia. Then, when anesthesia must be provided
emergently, the preanesthesia assessment and preinduction assessment may be performed immediately following one another, or
simultaneously, but are documented independently.

Measurable Elements of ASC.3

❑ 1. A preanesthesia assessment is performed that includes at least the following criteria when evaluating risk and
appropriateness of anesthesia for the patient:
a) Identify airway problems that may influence the type of anesthesia used
a) Evaluate at-risk patients for appropriateness of anesthesia
b) Select the anesthesia and plan anesthesia care
c) Safely administer an anesthetic based on patient assessment, identified risks, and type of procedure
d) Interpret findings from patient monitoring during anesthesia and recovery
e) Provide information for the use of analgesia following surgery
❑ 2. A separate preinduction assessment is performed to reevaluate patients immediately before the induction of anesthesia.
❑ 3. The preanesthesia assessment and the preinduction assessment are performed by an individual(s) qualified to do so and
documented in the patient health record.

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❑ 4. The scope and content of the preanesthesia assessment and the preinduction assessment are based on
professional guidelines and defined in the hospital policy.

Standard ASC.4
Each patient’s anesthesia plan of care is discussed with the patient and/or those who make decisions for the patient and
documented in the patient’s health record.

Intent of ASC.4
The anesthesia planning process includes educating the patient, their family, or decisionmaker on the risks, benefits, and alternatives
related to the planned anesthesia. This discussion occurs as part of the process to obtain consent for anesthesia as required in
PCC.4.2.

Guidance for ASC.4

Anesthesia care is carefully planned. The plan includes information from other patient assessments and identifies the anesthesia to
be used, the method of administration, other medications and fluids, monitoring procedures, and anticipated postanesthesia care. An
anesthesiologist or a qualified individual provides this education.

When postoperative pain management is provided by anesthesia services, the postoperative pain management plan is reviewed and
discussed with the patient by the anesthesiologist or other qualified individual and documented in the patient’s health record. The
anesthesia agent, dose (when applicable), anesthetic technique, and qualified individual administering the anesthesia are documented
in the patient’s anesthesia record.

Measurable Elements of ASC.4

❑ 1. A qualified individual plans and documents the anesthesia care in the patient’s health record.
❑ 2. The patient, family, and/or decisionmakers are educated on the risks, benefits, and alternatives of anesthesia.
❑ 3. When applicable, the patient, family, and/or decisionmakers are educated, prior to the procedure being performed, about
the options available for postoperative pain management; this education is documented.
❑ 4. The anesthesia agent, dose (when applicable), and anesthetic technique are documented in the patient’s anesthesia record.
❑ 5. The anesthesiologist, or other qualified individual allowed to administer anesthesia, and the anesthesia assistants are
identified in the patient’s anesthesia record.
❑ 6. Anesthesia care is administered and monitored according to professional practice guidelines and as defined in the hospital
policy.

Standard ASC.5
Each patient’s physiological status during anesthesia and surgery is monitored according to professional practice guidelines and
documented in the patient’s health record.

Intent of ASC.5
Physiological monitoring provides reliable information about the patient’s status during anesthesia (general, spinal and regional) and
the recovery period. Monitoring information guides medical and nursing care and identifies the need for diagnostic and other
services.

Guidance for ASC.5

Results of monitoring trigger key intraoperative decisions as well as postoperative decisions, such as return to surgery, transfer to
another level of care, or discharge. Monitoring findings are entered into the patient’s health record. Monitoring methods depend on
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the patient’s preanesthesia status, the anesthesia choice, and the complexity of the surgical or other procedure performed during
anesthesia. In all cases, however, the overall monitoring during anesthesia and surgery is consistent with professional practice and
defined in hospital policy. The results of monitoring are documented in the patient’s health record.

Measurable Elements of ASC.5

❑ 1. The frequency and type of monitoring during anesthesia and surgery are based on the patient’s preanesthesia status, the
anesthesia used, and the surgical procedure performed.
❑ 2. Monitoring of the patient’s physiological status is consistent with professional practice guidelines.
❑ 3. The results of monitoring are documented in the patient’s health record.

Standard ASC.5.1
Each patient’s postanesthesia status is monitored, and the patient is discharged from the recovery area by a qualified individual or by
using established criteria.

Intent of ASC.5.1
The ongoing, systematic collection and analysis of data on the patient’s status in recovery support decisions about moving the
patient to other settings and less intensive services.

Guidance for ASC.5.1

Monitoring during the anesthesia period is the basis for monitoring during the postanesthesia recovery period. Monitoring consists
of several elements such as the list of physiological criteria to be monitored, frequency of monitoring and documentation, and
general guidance and/or parameters for recovery goals. Monitoring during the postanesthesia recovery period must be performed
according to professional practice guidelines and as defined in the hospital policy. Recording of monitoring data provides the
documentation to support discontinuing recovery monitoring or the discharge decisions. When the patient is transferred directly
from the operating theatre to a receiving unit, monitoring and documentation are the same as would be required in the recovery
room.

The time of arrival at and discharge from the recovery area (or the time recovery begins and the time of discontinuation of recovery
monitoring) and monitoring findings for the postanesthesia recovery period are documented in the patient’s health record.

Measurable Elements of ASC.5.1

❑ 1. Patients are monitored during the postanesthesia recovery period according to professional practice guidelines and as
defined in the hospital policy.
❑ 2. Monitoring findings are documented in the patient’s health record.
❑ 3. Patients are discharged from the postanesthesia unit or recovery monitoring is discontinued in accordance with one of the
following alternatives:
a) The patient is discharged, or recovery monitoring is discontinued by a fully qualified anesthesiologist or other
individual authorized by the individual(s) responsible for managing the anesthesia services.
b) The patient is discharged, or recovery monitoring is discontinued by a nurse or similarly qualified individual in
accordance with postanesthesia criteria developed by hospital leadership, and the patient’s health record contains
evidence that criteria are met.
c) The patient is discharged to a unit that is capable of providing postanesthesia or postsedation care of selected patients,
such as a cardiovascular intensive care unit or neurosurgical intensive care unit, among others.
❑ 4. The following anesthesia recovery times are recorded in the patient’s health record:
a) Time recovery starts
b) Time recovery phase is complete

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 Surgical Care

Standard ASC.6
Each patient’s surgical care is planned based on the results of the preoperative assessment and documented in the patient’s health
record.

Intent of ASC.6
The preoperative assessment is a clinical risk assessment to determine if it is safe for the patient to undergo surgery, therefore, an
important deciding factor to move forward with planning the surgical procedure. In addition, the assessment is used to select the
appropriate surgical procedure and determine patient needs related to the surgery.

Guidance for ASC.6

The preoperative assessment evaluates the patient’s condition and needs prior to surgery. The assessment includes
• physical exam and test results,
• medical needs,
• psychological needs,
• social needs, for example, safe housing and support with activities of daily living
• economic needs, for example, ability to pay for post-operative medication or medical equipment
• discharge needs, for example, transfer to rehabilitation center or home nursing needs

Results of the preoperative assessment are documented in the patient’s health record prior to surgery. The assessment provides
information necessary to
• select the appropriate surgical procedure and the optimal time to perform the surgery;
• perform the procedures safely; and
• interpret the findings of patient monitoring during surgery.
Surgical procedure selection depends on factors such as
• patient history
• physical status
• diagnostic data
• risks and benefits of the procedure for the patient.
Procedure selection considers the information from the initial assessments and reassessments, diagnostic tests, and other available
sources. The assessment process is carried out in a shortened time frame when an emergency patient needs surgery.
The planned surgical care is documented in the patient’s health record and includes a preoperative diagnosis. The name of the
surgical procedure alone does not constitute a diagnosis.

Measurable Elements of ASC.6

❑ 1. A preoperative assessment is performed and documented by a qualified provider before surgery.
❑ 2. The preoperative assessment includes to following:
a) Physical exam and test results
b) Medical needs
c) Psychological needs
d) Social needs
e) Economic needs
f) Discharge needs
❑ 3. Surgical care for each patient is planned based on the preoperative assessment information.
❑ 4. A preoperative diagnosis and the planned surgical procedure are documented in the patient’s health record prior to the
procedure.

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Standard ASC.6.1
The risks, benefits, and alternatives are discussed with the patient and their family or those who make decisions for the patient.

Intent of ASC.6.1
Adequate information and education must be provided to the patient, their family, or the decision maker on the risks,
benefits, and alternatives related to surgical care to participate in care decisions and to provide the informed consent
required in PCC.4.2.

Guidance for ASC.6

Patient education and engagement can be promoted through improvement in the patient and family’s health literacy
(the ability to obtain, understand, and act on health information). For example, providing information that a reasonable
patient would want and would need to know that relates to the planned surgical procedure and care to make an
informed decision. In addition, when blood or blood products may be needed, information on the risks and alternatives is
discussed. The patient’s surgeon or other qualified individual, as defined by the hospital, provides this information.

Measurable Elements of ASC.6.1

❑ 1. The patient, family, and decisionmakers are educated on the following elements related to the planned surgical procedure:
a) Name of test, procedure, or treatment covered by the informed consent;
b) Name of responsible practitioner(s) performing the procedures(s);
c) Risks and benefits of the planned procedure
d) The likelihood of success, potential complications, the recovery process, and possible results of nontreatment;
e) Surgical and nonsurgical options and/or alternatives available to treat the patient
f) The need for, risks and benefits of, and alternatives to blood and blood-product use
❑ 2. The patient’s surgeon or other qualified individual as defined by the hospital, provides and documents the education.

Standard ASC.6.2
Information about the surgical procedure is documented in the patient’s health record to facilitate continuing care.

Intent of ASC.6.2
A patient’s postsurgical care depends on the events and findings of the surgical procedure. Most important, all actions and results
essential to the patient’s condition are entered in the patient’s health record.

Guidance for ASC.6.2

Patient information can be presented in various formats such as templates (either paper or electronic), an operative report such as a
written operative progress note, nursing or other treatment or care service notes. To support a continuum of postsurgical
supportive care, the information about the surgery is recorded in the patient’s health record immediately after surgery, prior to the
patient being transferred from the surgical or the postanesthesia recovery area. The time immediately after surgery is defined as
“upon completion of surgery, before the patient is transferred to the next level of care.”

Information may also be contained in other notations in the health record. For example, amount of blood loss and transfused blood
may be recorded in the anesthesia record, or information about implantable devices may be shown using a manufacturer’s preprinted
sticker. Defining the time immediately after surgery for example, “upon completion of surgery, before the patient is transferred to
the next level of care” ensures that pertinent information is available to the next caregiver. If the surgeon accompanies the patient
from the operating theatre to the next unit or area of care, the operative note, template, or progress note can be written in that unit
or area of care.

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Note: Documentation of information on nonsurgical procedures and treatments, such as invasive diagnostic procedures,
interventional treatments, and other diagnostics and treatments, is identified in COP.2.1.

Measurable Elements of ASC.6.2

❑ 1. Surgical reports, templates, or operative progress notes include at least the following elements:
a) Pre-operative diagnosis and planned procedure
b) Postoperative diagnosis
c) Name of operative surgeon and assistants
d) Procedures performed and description of each procedure findings
e) Perioperative complications
f) Tubes and/or drains placed intraoperatively
g) Surgical specimens sent for examination
h) Amount of blood loss and amount of transfused blood
i) Date, time, and signature of responsible physician
❑ 2. The hospital identifies information that may routinely be recorded in other specific areas of the health record.
❑ 3. The surgical report, template, or operative progress note is available immediately after surgery before the patient is
transferred to the next level of care.

Standard ASC.6.3
Patient care after surgery is planned and documented.

Intent of ASC.6.3
Each patient’s postsurgical medical and nursing care needs differ depending on the surgical procedure performed and the health
history of the patient.

Guidance for ASC.6.3

Postsurgical care planning can begin before surgery based on the patient’s assessed needs and condition and the type of surgery
being performed. Some patients may require care from other services, such as physical therapy or rehabilitation; therefore, it is
necessary to plan for that care, including the level of care, care setting, follow-up monitoring or treatment, and the need for
medication or other treatment and services. The postsurgical plan of care also includes the patient’s immediate postoperative needs.

The postsurgical care is planned, documented in the patient’s health record within 24 hours, and verified by the responsible service
to ensure continuity of services during the recovery or rehabilitative period. Postsurgical needs may change as the result of clinical
improvement or new information from a routine reassessment, or they may be evident from a sudden change in the patient’s
condition. The plan of care is revised based on these changes and documented in the health record as notes to the initial plan or as a
revised or new plan of care.

Measurable Elements of ASC.6.3

❑ 1. All postsurgical care, treatment, and services meets the patient’s immediate postsurgical needs.
❑ 2. The continuing postsurgical plan(s) is documented in the patient’s health record within 24 hours by the responsible
surgeon or verified by a co-signature from the responsible surgeon on the documented plan entered by the surgeon’s
delegate.
❑ 3. The continuing postsurgical plan of care includes care, treatment, and services based on the patient’s assessed needs.
❑ 4. When indicated by a change in the patient’s needs, the postsurgical plan of care is updated or revised based on the
reassessment of the patient by the health care practitioners.

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Standard ASC.6.4
Surgical care that includes the implanting of a medical device is planned with special consideration for how standard processes must
be modified.

Intent of ASC.6.4
Surgical procedures involving the implantation of medical devices require that routine surgical care be modified to account for
special factors.

Guidance for ASC.6.4

Surgical procedures that involve the implantation of a medical device are common for many medical specialties. Medical devices
have become critical components of health care, not only in their effects on patient morbidity and mortality but also in their ability
to extent the quality of life of the patient. An implantable medical device is defined as a device that is placed into a surgically or naturally
formed cavity of the body to continuously assist, restore, or replace a function or structure of the body, deliver medications, or
monitor body functions throughout the useful life of the device. These special considerations may be incorporated into guidelines,
protocols, operating policies, or other documents to guide the surgical team and facilitate consistent processes and outcomes.
An implantable medical device can be a prosthesis (such as a hip), a stent, a cardioverter defibrillator, a pacemaker, intraocular
lenses, and an infusion pump, among other examples. The ability to track implantable medical devices is essential for tracking
surgical site infections and identifying patients who may have received nonsterile implants. In addition, the tracking process allows
the hospital to assess the reliability of the sterilization process. Therefore, the hospital has a process for tracking implantable medical
devices.
In the event of a recall of an implantable medical device, the hospital informs and follows up with those patients who received the
device. The hospital develops and implements a process for contacting and following up with the patients, including those who may
be outside the country. The hospital determines the time frame for contacting patients (for example, within 24 hours of the official
recall notification of a lifesaving device). This time frame may be longer for a non-lifesaving device. The patient receives information
on the implantable device such as the unique device identifier, how long-term tracking of the device will be supported, the process
for notification in case of a problem with the device, and education on how sharing device information supports patients' long-term
health care, safety surveillance and future research to advance practices and patient safety with the device.

Measurable Elements of ASC.6.4

❑ 1. The hospital’s surgical services identify the types of implantable medical devices that are included within its scope of
services.
❑ 2. Policies and practices, at least, must include the following:
a) Election of devices based on current science and research
b) Verification that implants are present in the operating theatre
c) Verification of the qualifications and training of any outside technical staff required during the implant procedure (for
example, the manufacturer’s representative who may be required to calibrate the device)
d) Reporting process for implantable device–related adverse events
e) Reporting of implantable device malfunctions to regulatory agencies
f) Unique infection prevention and control considerations
g) Any special discharge instructions for the patient
❑ 3. The patient receives information on the implantable device that at the least includes the following:
a) Identifying information on the device including the unique device identifier
b) How long-term tracking of the device will be supported
c) Process for notification in case of a problem with the device
d) Education on how sharing device information supports patients' long-term health care, safety surveillance and future
research.
4. The hospital has a process for tracking implantable medical devices.
❑ 5. The hospital implements a process for contacting and following up with patients in a defined time frame after receiving
notification of a recall of an implantable medical device.
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Medication Management and Use
(MMU)
Overview
Medications are a critical component of the care provided to patients and are used for diagnostic, symptomatic, preventive, curative,
and palliative treatment and management of diseases and conditions. According to the American Nurses Association, “Almost two-
thirds of the U.S. populations takes at least one medication per day, and more than half of the populations take at least two.
Globally, medication errors and unsafe medication practices are the leading cause of injury and avoidable harm in health care
systems, carrying an estimated annual cost of 42 billion dollars, excluding lost wages and productivity. Medication related harm
represents 50% of healthcare’s reported preventable harm, with prescribing and monitoring errors leading as highest risk factors.
For example, in Europe, the rate of medication errors in hospitals at the prescription stage is 0.3% - 9.1% and from 1.6% - 2.1% at
the dispensing stage. A study in the United Kingdom, it was estimated that 28% of the 237 million medication errors that happening
at some point in the medication process are potentially clinically significant. But errors can occur at all stages of the medication
management process: prescribing (21.3%), transcription (1.4%), dispensing (15.9%), administration (54.4%) and monitoring (7.0%).
Also, a study in Spain concluded that medication errors accounted for 37.4% of the total number of adverse events.
A medication system that supports optimal medication management must include processes that support safe and effective
medication use. Safe, effective medication use involves an interdisciplinary, coordinated effort of health care practitioners applying
the principles of process design, implementation, and improvement to all aspects of the medication management process, which
includes the selecting, procuring, storing, ordering/prescribing, transcribing, distributing, preparing, dispensing, administering,
documenting, and monitoring of medication therapies. Although health care practitioners’ roles in medication management vary
greatly from one country to another, sound medication management processes for patient safety are universal, and must be
supported by scientific evidence and guidance for prescribers such as in the development of a program for antibiotic stewardship
and the use of accepted medication practice guidelines.
Note: Medication is defined as any prescription medications; sample medications; herbal remedies; vitamins; nutraceuticals; over-the-
counter drugs; vaccines; diagnostic and contrast agents used on or administered to persons to diagnose, to treat, or to prevent
disease or other abnormal conditions; radioactive medications; respiratory therapy treatments; parenteral nutrition; blood derivatives;
and intravenous solutions (plain, with electrolytes and/or drugs), as well as solutions administered/used on the patient by the
surgical team during surgical/invasive procedures.

Standards
The following is a list of all standards for this function. They are presented here for your convenience without their intent statements
or measurable elements. For more information about these standards, please see the next section in this chapter, Standards, Intents,
Guidance, and Measurable Elements.

Organization and Management

MMU.1 The hospital manages it medication management processes.
MMU.1.1 The hospital implements a program for the prudent use of antibiotics based on the principle of
antimicrobial stewardship.
MMU.1.2 The hospital has a medication recall system process.
MMU.1.3 The hospital has a process for handling expired medications.

Selection and Procurement

MMU.2 The hospital implements a process for the selection and procurement of medications.

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Storage
MMU.3 Medications are properly and safely stored.
MMU.3.1 Emergency medications are available, uniformly stored, monitored, and secure when stored out of the
pharmacy.

Ordering and Transcribing

MMU.4 The hospital identifies those qualified individuals permitted to prescribe or to order medications.
MMU.4.1 The hospital identifies safe prescribing, ordering, and transcribing practices and defines the elements of a
complete order or prescription.
MMU.4.2 The hospital has a medication reconciliation process.

Preparing and Dispensing

MMU.5 Medications are prepared and dispensed in a safe and clean environment.
MMU.5.1 The hospital’s process for radiopharmaceuticals is in accordance with laws, regulations, and guidelines.
MMU.5.2 Medication prescriptions or orders are reviewed for appropriateness.
MMU.5.3 A system is used to safely dispense medications in the right dose to the right patient at the right time.

Administration
MMU.6 Medication administration is safely performed by qualified individuals.
MMU.6.1 Policies and procedures govern medications brought into the hospital by the patient or family, medication
prescribed for patient self-administration, and medications brought into the hospital as samples.

Monitoring
MMU.7 The hospital monitors and responds to actual or potential adverse drug events and adverse drug reactions.
MMU.7.1 The hospital implements a process for identifying, reporting, managing, and tracking all medication errors
and near miss events (or close calls).

Standards, Intents, Guidance, and Measurable Elements

Organization and Management

Standard MMU.1
The hospital manages it medication management processes.

Intent of MMU.1
Medications are an important resource in patient care and must be organized effectively and efficiently.

Guidance for MMU.1

A safe medication management system addresses an organization’s medication processes and is not only the responsibility of the
pharmaceutical service but also of managers and health care practitioners, nurses, and other clinicians. How this responsibility is
shared depends on the hospital’s structure and staffing. In cases where a pharmacy is not present, medications may be managed on
each clinical unit according to hospital policy. In other cases when a large central pharmacy is present, the pharmacy may organize
and control medications throughout the hospital. Effective medication management includes all parts of the hospital—inpatient,
outpatient, specialized units, and other clinical areas where medications are used or stored.

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However medication is organized within the hospital, a qualified individual directly supervises the activities of the pharmacy or
pharmaceutical service. The individual is trained and, if required, appropriately licensed and/or certified. Applicable laws and
regulations are incorporated into the organizational structure and the operations of the medication management system used in the
hospital. This individual, or another qualified individual, is responsible for overseeing the interdisciplinary team established to
develop medication management practices (policies, processes, etc.) in the hospital.
To ensure efficient and effective medication management and use, the hospital conducts a systems review at least once a year. The
annual review identifies how well the system is working and allows hospitals to understand the need and priority of continued
system improvements in quality and safety of medication use.

Measurable Elements of MMU.1

❑ 1. A qualified individual oversees the medication management interdisciplinary team established to develop the policies and
processes for medication management in the hospital.
❑ 2. The medication management interdisciplinary team develops policies and a plan for a uniform medication management
system that complies with applicable laws and regulations and includes the following processes, as applicable:
a) Planning
b) Selection and procurement
c) Storage
d) Ordering
e) Preparing, dispensing, and distribution
f) Administration
g) Monitoring the effects of medication
h) Medication error and adverse event reporting
i) Evaluation
j) Formal processes for management of medication shortages and substitutions
❑ 3. At minimum, the medication management interdisciplinary team is comprised of an infection prevention and control
professional, a physician, a nurse, and hospital leadership.
❑ 4. All settings, services, and individuals who manage medication processes are included in the organizational structure.
❑ 5. A licensed pharmacist or other qualified individual directly supervises the activities of the pharmacy or pharmaceutical
service and ensures compliance with applicable laws and regulations.
❑ 6. The hospital documents at least one review annually of the medication management system.
❑ 7. Appropriate and updated sources of drug information are readily available to those involved in medication use.

Standard MMU.1.1
The hospital implements a program for the prudent use of antibiotics based on the principle of antimicrobial stewardship.

Intent of MMU.1.1
hospitals must implement measures to ensure optimal use of antibiotics in order to reduce the development and spread of resistant
bacteria and deliver better patient outcomes.

Guidance for MMU.1.1

The overuse and misuse of antibiotics has resulted in the growth of multi-drug resistant microorganisms that are increasingly
resistant to available antibiotics. Antibiotic resistance has been classified as an urgent public health and socioeconomic problem on a
global scale. What is more, antimicrobial resistance has been estimated to have been responsible for the deaths of at least of 1.27
million people worldwide and associated with nearly 5 million deaths in 2019, and in 2022 was listed as one of the top 10 global
health threats.
In addition to the growth of multi-drug resistant microorganisms, there are often side effects and/or complications to antibiotic
treatment, including acquiring Clostridioides difficile (C. diff ), kidney or liver damage, hearing loss, hemolytic anemia, and other such

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complications. The proper use of antibiotics is important in the prevention of unnecessary complications due to improper antibiotic
use.
Health care practitioners are contributing to the development of antimicrobial resistance in several ways. For example, using
antibiotics when they are not indicated at all, continuing antibiotics when they are no longer necessary, using a broad-spectrum
antibiotic when it is not required or continuing it unnecessarily after the sensitivity results are received, using the wrong antibiotic or
prescribing the wrong dose, or continuing the prophylactic antibiotic after it is no longer recommended.
To reduce the development and spread of resistant microorganisms and deliver better patient outcomes, hospitals must implement
measures to ensure appropriate use of antibiotics. Implementation of an antibiotic stewardship program will help hospitals reach the
goal of providing patients requiring antibiotic treatment with the right antibiotics, when indicated, at the right time, at the right dose,
and for the right duration.
The program includes guidelines for the optimal use of antibiotic therapy for treatment of selected and/or high-risk infections such
as sepsis, pneumonia. endocarditis, meningitis, UTI, and MDRO infections. Guidelines would also include the proper use of
prophylactic antibiotic therapy.
An antibiotic stewardship program may include the following elements: monitoring indications for all or selected antimicrobials
prescribed, tracking patterns of antibiotic prescribing practice, and monitoring antimicrobial resistance trends with an antibiogram,
informing staff on antibiotic use and resistance on a regular basis, and educating staff about optimal antibiotic use. Many
antimicrobial stewardship programs also monitor Clostridioides difficile trends as a surrogate marker. It is imperative for the
program to have the support of hospital leadership, which includes leadership’s commitment to providing support that includes
staffing, financial resources, evidence-based resources, and technology to ensure an effective stewardship program. In addition to
infection prevention and control professionals, the antibiotic stewardship program involves physicians, nurses, pharmacists, trainees,
and others.

Tracking the effectiveness of the program is an important element of the program’s success. Examples of data that can help
measure effectiveness include:
• All antimicrobial use (general and restricted)
• Evidence of a decrease in the inappropriate use of antibiotics and a decrease in multidrug-resistant organisms
• Documentation that prescribers are following accepted clinical practice guidelines.
• Appropriate optimal use of prophylactic antibiotics
• Monitor Clostridioides difficile trends as a surrogate marker
• Develop a list of restricted antimicrobials and monitor prescription pattern and amount used.

Successful tracking of the effectiveness of the program requires a mechanism for oversight. Oversight may include an individual,
a small work group, a coordinating interdisciplinary team, a task force, or some other mechanism. Examples of strategies to
optimize antibiotic prescribing:
• Preauthorization for general and specific antibiotics that includes an internal review and approval process prior to use.
• Prospective review and feedback regarding antibiotic prescribing practices, including the treatment of positive blood
cultures, by a member of the antibiotic stewardship program.
• Tracking, trending and analysis of multi-drug resistant organism occurrences
• Tracking, trending, and analysis of prescription patterns and amount used of the restricted antimicrobials on the
hospital’s list.

Measurable Elements of MMU.1.1

❑ 1. The hospital implements a program for antibiotic stewardship that is based on scientific evidence, accepted clinical practice
guidelines, and local laws and regulations and at minimum, includes the following:
a) Documentation indicating that the scope of the antibiotic stewardship program includes the entire hospital and all
services associated with the hospital.
b) Implementation of at least two evidence-based clinical practice guidelines to improve antibiotic use for the most
common indications.
c) Evaluation of adherence to at least one of the evidence-based clinical practice guidelines the hospital implements
(including antibiotic selection and duration of therapy, where applicable).

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❑ 2. The hospital has an interdisciplinary team that oversees the antibiotic stewardship program. The interdisciplinary team is
defined and includes at minimum, an infection prevention and control professional, a physician, a nurse, a pharmacist, and
hospital leadership.
❑ 3. The antibiotic stewardship program demonstrates coordination among all components of the hospital responsible for
antibiotic use and resistance, including, but not limited to, the infection prevention and control program, the quality
assessment and performance improvement program, the medical staff, nursing services, and pharmacy services.
❑ 4. The program includes guidelines for the optimal use of antibiotic therapy for treatment of selected and/or high-risk
infections, including the proper use of prophylactic antibiotic therapy.
❑ 5. There is a mechanism to oversee the program for antibiotic stewardship and the program’s effectiveness is monitored
according to the hospital’s policy.
❑ 6. The antibiotic stewardship program collects, analyzes, and reports data to hospital leaders, infection prevention and
control, quality improvement department, pharmacy leaders, all staff, and other stakeholders per the hospital’s policy.
❑ 7. The antibiotic stewardship program uses program data to improve performance of antibiotic stewardship activities.
❑ 8. Patients and families of the antimicrobial stewardship program receive education on the program.

Standard MMU.1.2
The hospital has a medication recall system process.

Intent of MMU.1.2
Hospitals must ensure that they have a process for receiving notifications of medication recalls and for identifying, retrieving,
returning, or safely and properly destroying, medications recalled by the manufacturer or supplier when found to be either defective
or potentially harmful.

Guidance for MMU.1.2

Defects to a medication product may be related to incorrect packaging, potential contamination, or poor manufacturing, resulting in
impurities or errors in strength/potency. Sometimes, the makers of the drug will identify a problem with their drug and voluntarily
recall it. Other times, a government agency will request that the medicine be recalled after receiving reports of problems from the
public. Communications of medication recalls may come directly from the manufacturer or from regulatory authorities. The recall
process includes any medications compounded within the hospital in which products that have been recalled have been used.
There is a policy or procedure that addresses any use of, or the destruction of medications known to be expired or outdated. An
expired medication is one that is past the expiration date listed on the original packaging from the manufacturer. An outdated
medication is one that is opened and is typically safe and effective to use for a short period of time after opening (shelf life). These
outdated medications should be marked with a date of expiration based on when they were opened so that staff know the end date
of use.

Measurable Elements of MMU.1.2

❑ 1. The hospital implements a process for receiving and acting on notifications of recalled medications, including medications
compounded within the hospital in which products that have been recalled have been used.
❑ 2. The process includes identifying, retrieving, and returning, or safely and properly destroying, medications recalled by the
manufacturer, supplier, or regulatory agency.
❑ 3. The hospital isolates recalled medications from the rest of the medication stock to prevent accidental use or distribution
and clearly labeled as "Recalled."
❑ 4. The hospital notified patients who have received recalled medication and provide them with appropriate guidance.

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❑ 5. The hospital has a process to inform healthcare providers about the recall and advise them on alternative treatments if
necessary.
❑ 6. The process includes documentation of all actions taken related to the recall of a medication, including details such as the
recall notice, affected lot numbers, actions taken, communications sent, and any responses received.

Standard MMU.1.3
The hospital has a process for handling expired medications.

Intent of MMU.1.3
Hospitals must ensure that they have a process for identifying, retrieving, returning, or safely and properly destroying, expired
medications.

Guidance for MMU.1.3

There is a policy or procedure that addresses any use of, or the destruction of medications known to be expired or outdated. An
expired medication is one that is past the expiration date listed on the original packaging from the manufacturer. A "beyond use
date"(BUD) is the date and/or time after which the product should not be used. A “beyond use date” medication is defined as a
medication that is opened, or used not in original form or conditions manufacturer provides and is typically safe and effective to use
for a short period of time after opening (shelf life). This would apply to a refrigerated medication- which has a useable time outside
of the refrigerator or an insulin vial which is opened and used for 28 days, or a sterile admixture that is compounded using other
components. These "beyond use date" medications should be marked with a date of expiration based on when they were opened so
that staff know the end date of use.

Measurable Elements of MMU.1.3

❑ 1. The hospital establishes and implements a process for the following:
a) Identifying, retrieving, and returning opened and unopened, expired medications and outdated medications.
b) Use of unopened, expired medications and outdated medications.
c) Destruction of medications known to be expired or outdated.
❑ 2. The hospital isolates expired medications from the rest of the medication stock to prevent accidental use or distribution
and clearly labeled as "expired."
❑ 3. The process includes documentation of all actions taken related to the expired medication.

Selection and Procurement

Standard MMU.2
The hospital implements a process for the selection and procurement of medications.

Intent of MMU.2
The hospital has a method for overseeing the hospital’s medication list, including how listed medications are used; ensuring
medications for prescribing or ordering are stocked; and procuring medications not stocked or normally available to the hospital or
for times when the pharmacy is closed. These methods and processes exist to support the hospital’s mission, patient needs, and
types of services provided.

Guidance for MMU.2

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Every hospital must decide which medications to make available for prescribing and ordering by the health care practitioners. The
hospital develops a list (often referred to as a formulary) of all the medications it stocks or that are readily available from contracted
services. In some cases, laws and regulations may determine the medications on the list or the source of those medications.
Medication selection is a collaborative process that includes patient need and safety as well as economics. Medications are
occasionally out of stock due to delayed delivery, national shortages, or other reasons not anticipated through normal inventory
control.
The hospital has a method, such as designating an interdisciplinary team, to maintain and to monitor the medication list and to
monitor the use of medications in the hospital; for example, monitoring the use of antibiotics. Those involved in the oversight of
the list include health care practitioners involved in the ordering, dispensing, administering, and monitoring processes for
medications. The interdisciplinary team reports its findings, recommendations, and program status to hospital leadership. Criteria for
selecting medications, which, at a minimum, include the following:
• Indications for use
• Effectiveness
• Drug interactions
• Potential for errors and abuse
• Adverse drug events
• Sentinel event advisories
• Population(s) served (for example, pediatrics, geriatrics)
• Other risks
• Costs
There is a process or mechanism to monitor patient response to newly added medications. For example, when the decision is made
to add a new type of medication or a new class of drugs to the list, there is a process to collect, aggregate, and monitor data related
to appropriateness of indication, how the drug is prescribed (dosage or route, for example), and any unanticipated adverse events or
conditions associated with the new drug during the introductory period. The list is reviewed at least annually based on emerging
safety and efficacy information and information on usage and adverse events.
On occasion, medications not stocked or readily available to the hospital are needed and there is a process to approve and procure
such medications. For example, patients who are on home infusions who become inpatients may not have enough medication to
continue the infusion while in the hospital. Such specialty medications may include lifesaving infusions for pulmonary hypertension
and those used in insulin pumps. There is a process to approve and procure such medications. Also, there are occasions when
medications are needed during the night or when the pharmacy is closed. Each hospital needs to plan for these occurrences and
educate staff on procedures to follow in the event they occur.

Measurable Elements of MMU.2

❑ 1. The interdisciplinary team collaborates with hospital leaders to develop criteria for determining how decisions are made for
which medications are available for dispensing or administering.
❑ 2. The list of medications by both brand name and generic name, stocked in the hospital or readily available from contracted
services is reviewed annually.
❑ 3. The process used to develop and monitor the list (unless determined by regulation or an authority outside the hospital) is
developed by the interdisciplinary team in collaboration with hospital leaders.
❑ 4. There is a process for procuring medications during the following:
a) At night or when the pharmacy is closed
b) When a medication is not on formulary, stocked or readily available in the hospital

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 Storage

Standard MMU.3
Medications are properly and safely stored.

Intent of MMU.3
The oversight of medication storage includes all locations where medications are stored to ensure consistency with
product stability and protection from loss or theft.

Guidance for MMU.3

Medications may be stored within a storage area, in a pharmacy or pharmaceutical service, on the patient care units, in unit
pharmacies, or the nursing station in the clinical unit. There are some types of medications that require special handling; for
example, radioactive medications and hazardous medications pose a safety risk, and investigational medications may require special
storage and/or consent.

Measurable Elements of MMU.3

❑ 1. Medications are stored under conditions suitable for product stability, including medications stored on individual patient
care units and ambulances, as applicable.
❑ 2. The hospital stores all medications, including biologicals and controlled (scheduled) medications, in a secured area to
prevent diversion, and locked, as applicable, in accordance with law and regulation. These medications accurately
accounted for according to applicable laws and regulations.
❑ 3. There is a process for managing medications or products requiring special handling, such as hazardous medications,
radioactive medications, and investigational medications.
❑ 4. Medications and chemicals used to prepare medications are accurately labeled with contents, expiration dates, and
applicable warnings.
❑ 5. All medication storage areas, including medication storage areas on patient care units and ambulances (as applicable), are
periodically inspected to ensure that medications are stored properly.
❑ 6. Medications are protected from loss or theft throughout the hospital.

Standard MMU.3.1
Emergency medications are available, uniformly stored, monitored, and secure when stored out of the pharmacy.

Intent of MMU.3.1
Quick access to appropriate emergency medications is critical when patient emergencies occur. Each hospital plans the uniform
location of emergency medications which facilitates quick access to the correct medications in emergencies.

Guidance for MMU.3.1

Emergency resuscitation is a highly stressful, time-sensitive situation. As a result, the risk of medication errors occurring during
emergency resuscitation may be higher. The Institute for Safe Medication Practices (ISMP) identifies that commonly reported
contributing factors to this higher risk of errors include:
• look-alike product packaging or drug names;
• disorganized and non-standardized emergency carts;
• excessive stock in emergency carts;
• distractions caused by the hectic environment;
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 • poorly communicated verbal orders;
• inexperienced staff;
• alternative drugs in emergency carts;
• confusing or missing information about drugs; and
• multiple concentrations of a drug in emergency cart drawers.
Therefore, when patient emergencies occur, quick access to appropriate emergency medications is critical.

Each hospital plans the location of emergency medications and the medications to be supplied based on the populations served. For
example, agents to reverse anesthesia are found in the operating theatres. Emergency cabinets, carts, bags, or boxes can be used for
this purpose. Emergency medications are stored uniformly to facilitate quick access to the correct medications. For example, in
each emergency cart in the hospital, the emergency medications are in the same drawer, and the medications are laid out in the same
manner within the drawer of each cart. This is particularly important for staff who may need to access an emergency medication
from a cart they do not typically use. Storage of medications in pediatric emergency carts is different from adult emergency carts;
however, the medications are stored uniformly within each type of cart. While common emergency medications used in pediatric
resuscitation are not different than those used in adult resuscitation, the dosage is often different and weight-based, or it requires a
different concentration whereas adult dosages are generally (but not always) given by dose. For example, a common dose of
Epinephrine used for adult cardiac arrest is 1 mg and for the pediatric population it is weight-based and recommended at 0.01
mg/kg by the AHA PALS protocol. The hospital must ensure that emergency carts also have the necessary tools and drug
concentrations to facilitate dosing of pediatric medications in an emergency.

The hospital establishes a procedure or process to prevent abuse, theft, or loss of the medications to ensure access to emergency
medications when needed, as well as ensuring that medications are replaced when used, damaged, or out of date. For example,
incorporating emergency cart checks into the daily work of the unit staff can help to ensure the integrity of the cart and its contents.
The hospital must understand the balance between ready access and security for locations where emergency medications are stored
such as instances, but also keep in mind that access to emergency medications must not require a specific individual(s) on the unit to
unlock the emergency cart. In instances such as these, if the individual(s) is unavailable, the medications are no longer readily
accessible, even though they may be secure.
Consistency and uniformity in the approach to emergency resuscitation may significantly reduce the risks and improve patient
outcomes. One strategy a hospital can take is a risk-based approach to increase safety and improve patient outcomes by looking at
internal data from previous emergency situations to review the availability of emergency medications or reviewing public literature
on the subject. Examples of strategies identified in the literature include the following:
• Use a strategy to differentiate between adult and pediatric medications; for example, using separate adult and pediatric carts
or, when using a universal cart, storing the medications and equipment in separate adult and pediatric drawers.
• Keep a designated medication box for neonates in areas that care for neonates.
• Standardize cart and drawer layout throughout the hospital.

Measurable Elements of MMU.3.1

❑ 1. Emergency medications are immediately available in the patient care areas or are readily accessible within the hospital to
meet emergency needs.
❑ 2. The hospital establishes and implements a consistent and uniform process for how emergency medications are stored;
maintained; replaced when used, damaged, or out of date; and protected from loss or theft.
❑ 3. Access to emergency medications shall not require a specific individual or keys to unlock the emergency cart
❑ 4. The hospital uses a risk-based approach, to identify and implement strategies to improve the efficiency and accuracy of
medication administration during emergency resuscitation. This approach at minimum includes the following:
a) Review of internal data from previous emergency situations to assess the availability of emergency medications.
b) Review of literature on the subject

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 Ordering and Transcribing

Standard MMU.4
The hospital identifies those qualified individuals permitted to prescribe or to order medications.

Intent of MMU.4
Each hospital is responsible for identifying those individuals with the requisite knowledge and experience and who are also
permitted by licensure, certification, laws, or regulations to prescribe or to order medications.

Guidance for MMU.4

Selecting a medication to treat a patient requires specific knowledge and experience. A hospital may place limits on prescribing or
ordering by an individual, such as for controlled substances, chemotherapy agents, or radioactive and investigational medications.
Individuals permitted to prescribe and to order medications are known to the pharmaceutical service or others who dispense
medications. In emergency situations, the hospital identifies any additional individuals permitted to prescribe or to order
medications.

Measurable Elements of MMU.4

❑ 1. Only those permitted by the hospital and by relevant licensure, laws, and regulations prescribe or order medications.
❑ 2. The hospital establishes and implements a process to place limits, when appropriate, on the prescribing or ordering
practices of individuals.
❑ 3. Individuals permitted to prescribe and to order medications are known to the pharmaceutical service or others who
dispense medications.

Standard MMU.4.1
The hospital identifies safe prescribing, ordering, and transcribing practices and defines the elements of a complete order or
prescription.

Intent of MMU.4.1
A common cause of adverse events in the hospital setting is medication errors. Strategies to reduce the variation in writing orders
such as defining required elements of a complete order or prescription helps reduce the risk of medication errors and improve
patient safety.

Guidance for MMU.4.1

One recent study reported that “Medication errors are most common at the ordering or prescribing stage. Typical errors include the
healthcare practitioner writing the wrong medication, wrong route or dose, or the wrong frequency. These ordering errors account
for almost 50% of medication errors.” In paper records, illegible medication prescriptions or orders are one cause of medication
errors that jeopardize patient safety and may delay treatment. Strategies to reduce illegibility of written orders are important in
reducing the risk of medication errors. Safe prescribing, ordering, and transcribing are guided by hospital policies and procedures.
Medical, nursing, pharmacy, and administrative staff collaborate to develop and to monitor the policies and procedures. Relevant
staff are trained in correct prescribing, ordering, and transcribing practices.
All orders and prescriptions contain the name of the drug, the dose and/or strength, and the frequency and route of administration.
For example, it might be part of the medical history. Also, examples of some additional information that the prescription order
should contain when appropriate:
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 • PRN (pro re nata, or “as needed”) orders: indications for use, detailed directions for overlapping orders for example,
more than one medication for pain.
• Weight-based or otherwise adjusted orders: for example, children, frail elderly, those with compromised renal function,
and oncology patients
• Adjusted for therapeutic range: for example, dosages may need to be updated based on laboratory values for specific
medications, such as heparin infusions or phenytoin.
There are processes in place to manage medication orders. Thus, this standard sets hospitalwide expectations for medication orders.
The processes are reflected in complete orders entered in the health record, the pharmacy or dispensing unit receiving the
information needed for dispensing, and the administration of the medication based on a complete order.

A diagnosis, condition, or indication for use must be present for each medication ordered. This information can be anywhere in the
health record and need not be on the order itself.

When managing titrated medication, the following information must be present in the titration orders: the medication name,
medication route, initial rate of infusion (dose/unit of time), incremental units to which the rate or dose can be increased or
decreased, how often the rate or dose can be changed, the maximum rate or dose of infusion, and the objective clinical measure to
be used to guide changes. Examples of objective clinical measures to be used to guide titration changes include blood pressure
measurement, weight-based heparin protocols, Richmond Agitation–Sedation Scale (RASS)
www.atsjournals.org/doi/full/10.1164/rccm.2107138, and the Critical-Care Pain Observation Tool (CPOT)The Effect of Training
the Nonverbal Pain Scale (NVPS) on the Ability of Nurses to Monitor the Pain of Patients in the Intensive Care Unit - PMC
(nih.gov).

Measurable Elements of MMU.4.1

❑ 1. The hospital establishes, implements, and trains staff on a process for the safe prescribing, ordering, and transcribing of
medications in the hospital.
❑ 2. A diagnosis, condition, or indication for use exists for each medication ordered.
❑ 3. All orders and prescriptions contain the following elements:
a) Name of the drug
b) Dose
c) Frequency
d) Route of administration

❑ 4. Additional elements of complete medication orders or prescriptions include at minimum, the following as appropriate to
the order:
a) Data necessary to accurately identify the patient
b) When generic or brand names are acceptable or required
c) Specific guidelines for the use of PRN orders
d) Weight-based orders
e) Rates of administration for intravenous infusions
f) Special orders such as titrating, tapering, or t range orders
g) Titration orders include the medication name, medication route, initial rate of infusion (dose/unit of time),
incremental units to which the rate or dose can be increased or decreased, how often the rate or dose can be changed,
the maximum rate or dose of infusion, and the objective clinical measure to be used to guide changes.
❑ 5. The hospital implements a policy that includes the following types of medication orders:
a) As needed (PRN) orders: Orders acted on based on the occurrence of a specific indication or symptom
b) Standing orders: A prewritten medication order and specific instructions from the physician or other
licensed practitioner to administer a medication to a person in clearly defined circumstances
c) Automatic stop orders: Orders that include a date or time to discontinue a medication
d) Titrating orders: Orders in which the dose is either progressively increased or decreased in response to the
patient’s status
e) Taper orders: Orders in which the dose is decreased by a particular amount with each dosing interval

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 f) Range orders: Orders in which the dose or dosing interval varies over a prescribed range, depending on the
situation or patient’s status
g) Signed and held orders: New prewritten (held) medication orders and specific instructions from a physician
or other licensed practitioner to administer medication(s) to a patient in clearly defined circumstances that
become active upon the release of the orders on a specific date(s) and time(s)
h) Orders for compounded drugs or drug mixtures not commercially available
i) Orders for medication-related devices (for example, nebulizers, catheters)
j) Orders for investigational medications
k) Orders for herbal products
l) Orders for medications at discharge or transfer
❑ 6. The hospital implements a process to manage the following medication orders:
a) Incomplete, illegible, or unclear; including measures to prevent continued occurrence
b) Special types of orders, such as emergency, standing, or automatic stop, and any elements unique to such orders
c) Verbal, telephone, and text medication orders and the process to verify such orders
d) Precautions for ordering medications with look-alike or sound-alike names
❑ 7. Medications prescribed or ordered are documented in the patient’s health record or inserted into the patient’s health
record at discharge or transfer.

Standard MMU.4.2
The hospital has a medication reconciliation process.

Intent of MMU.4.2
Medication ordering and transcribing is an important process of safe medication management for the patient and for reducing the
risks for adverse events. Patients entering a hospital are often taking multiple medications at home. Obtaining an accurate list of
those medications and documenting them in the patient’s health record helps reduce the risk of an adverse event.

Guidance for MMU.4.2

Medication discrepancies can affect patient outcomes. It can be difficult to obtain a complete list from every patient in an encounter,
and accuracy is dependent on the patient’s ability and willingness to provide this information. A credible effort to collect this
information is recognized as meeting the intent of the requirement. Examples of a credible effort may include contacting the
patient’s pharmacy and/or family members or consulting with the patient’s primary physician.
Medication reconciliation is defined as the process of identifying the medications currently being taken by an individual. These
medications are compared to newly ordered medications, and discrepancies are identified and reconciled. The types of information
that clinicians use to reconcile medications include but are not limited to, medication name, dose, frequency, route, and purpose.
Hospitals should identify the information that needs to be collected to reconcile current and newly ordered medications and to safely
prescribe medications in the future. Height and weight information are not collected for every patient. However, the hospital must
have a process to ensure that all required information for safe prescribing is collected and documented in the patient’s health record
(MMU.4, ME 1). This can be accomplished by collecting height, weight, age, and other information from every patient, by
identifying categories of patients (for example, pediatric renal impairment, oncology, burn injuries, cardiology) or types of
medications (for example, chemotherapy or other medications calculated by Body Surface Area) for which specific information
must be collected, such as height and weight.
Good medication management practices include a review of a proposed new medication against the list of medications the patient is
currently taking to improve the quality and safety of adding a new medication to the patient’s treatment plan and reduce the risk of
an adverse medication event. A listing of all current medications is recorded in the patient’s health record and is available to the
pharmacy, nurses, and physicians. The hospital establishes a process to compare the patient’s list of medications taken prior to
admission against the initial orders.

Measurable Elements of MMU.4.2

❑ 1. The hospital identifies the information needed to reconcile current and newly ordered medications.

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❑ 2. The patient’s health records contain a list of current medications taken prior to admission or registration as an outpatient,
and this information is made available to the patient’s health care practitioners and the pharmacy as needed.
❑ 3. Medication reconciliation includes comparing the initial medication orders with the list of medications taken prior to
admission, according to the hospital’s established process.
❑ 4. A medication review is conducted when there are changes to the patient’s level of care, unit, or healthcare practitioner
service.
❑ 5. Medication reconciliation is included in the patient’s discharge planning process for medication management.

Preparing and Dispensing

Standard MMU.5
Medications are prepared and dispensed in a safe and clean environment.

Intent of MMU.5
Some medications and solutions require preparation under very specific guidelines to prevent contamination and risk of
infection to the patient.

Guidance for MMU.5

The pharmacy or pharmaceutical service and others with proper training and experience prepare and dispense medications in a clean
and safe environment that complies with laws, regulations, and professional practice standards. The hospital identifies the standards
of practice for a safe and clean preparation and dispensing environment.
For example, standards of practice can include how medication preparation areas are to be cleaned and when a mask should be
worn, or a laminar airflow hood should be used in the preparation of a medication. Staff compounding and preparing these
medications are trained in the principles of medication preparation and aseptic technique. Similarly, positive or negative pressure
rooms and laminar airflow hoods are available and used when indicated by professional practices; for example, in the preparation of
sterile compounding, total parenteral nutrition (TPN) admixtures, chemotherapy, and epidurals. Due to the need for positive and
negative pressure capabilities and laminar airflow hoods to prepare these medications, it is recommended that they be exclusively
prepared in the pharmacy unless the patient care unit is specialized with the needed safety equipment and staffed with trained
individuals (for example, a specialized oncology unit). A common situation in medication preparation that carries a risk of
transmitting contagious diseases is the use of single-use and multidose vials on more than one patient. The misuse of these vials has
caused harm to individual patients through occurrences and outbreaks of bloodborne pathogens and associated infections in both
inpatients and outpatients—including hepatitis B and C virus, meningitis, and epidural abscesses.

Sterile compounding is defined as the combining, admixing, mixing, diluting, pooling, reconstituting, repackaging, or
altering of a drug or bulk drug substance to create a sterile medication. Ensuring a safe compounding environment takes
organization and diligence. Facility requirements are intended to establish a safe environment for compounded sterile
preparations (CSPs). The International Organization for Standardization (ISO) air cleanliness classification of the
compounding environment is a critical measure that can be affected by facility design; therefore facility architecture is
taken into account when establishing a sterile compounding area. Environmental Monitoring and related documentation
must be completed on a routine basis to ensure adequate environmental, and personnel controls are in place to prevent
contamination of CSPs.

Hazardous Medication Compounding is the compounding of hazardous drugs that pose a risk of exposure to patients,
and healthcare workers. For example: drugs that are carcinogenic, teratogenic or have developmental toxicity,
reproductive toxicity, organ toxicity at low doses, genotoxicity, or structure and toxicity profiles of new drugs that mimic
existing hazardous drugs. Hospitals must follow all applicable requirements based on laws and regulations, professional
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standards of practice, and hospital policy, including education, training, and responsibilities of staff handling hazardous
drugs; facility and engineering controls; procedures for deactivating, decontaminating and cleaning; spill control; and
documentation of the above. These standards apply to all healthcare personnel who receive, prepare, administer,
transport or otherwise come in contact with hazardous drugs and all the environments in which they are handled.

Literature identifies standards and safe practices for the use of single-dose and multidose vials; for example, ensuring that all
needles and syringes are single patient use only and never reentering a vial with a used needle or used syringe. Medications that do
not require pharmacy-specific safety measures such as sterile compounding rooms or laminar flow hoods and that are stored in and
dispensed from areas outside the pharmacy (for example, patient care units) comply with the same cleanliness measures required in
the pharmacy. In addition, medication dispensing areas located on patient care units should be free from clutter and distraction.

Measurable Elements of MMU.5

❑ 1. Medication preparation and dispensing adhere to laws, regulations, and professional standards of practice.
❑ 2. Medications are prepared and dispensed in clean, uncluttered, safe, and functionally separate areas with appropriate
medical equipment and supplies.
❑ 3. Staff preparing/compounding sterile products/medications are trained and competent in the principles of medication
preparation and aseptic techniques and are provided resources to support the medication preparation process.
❑ 4. During preparation, staff visually inspect the medication for particulates, discoloration, or other loss of integrity.
❑ 5. Guidelines for use of single-use and multidose vials are identified and implemented in the medication processes.
❑ 6. Medications stored, prepared, and dispensed from areas outside the pharmacy (for example, patient care units) comply
with the same cleanliness measures required in the pharmacy.

Standard MMU.5.1
The hospital’s process for radiopharmaceuticals is in accordance with laws, regulations, and guidelines.

Intent of MMU.5.1
A process to prepare and dispense radiopharmaceuticals in accordance with laws and regulations and guidelines helps
monitor the safety and efficacy of the radioactive drugs intended for patient care and treatment in the hospital.

Guidance for MMU.5.1

The United States Pharmacopeia and the National Formulary (USP-NF) defines a radiopharmaceutical as a “finished
dosage form that contains a radioactive substance in association with one or more other ingredients and that is intended
to diagnose, stage a disease, monitor treatment, or provide therapy. A radiopharmaceutical includes any non-radioactive
reagent kit or radionuclide generator that is intended to be used in the preparation of any such substance. The terms
“radiopharmaceutical” and “radioactive drug” are commonly used interchangeably.” When handling, preparation and
dispensing radiopharmaceuticals, compliance with local radiation laws and regulations for staff and environmental
safety is critical.

Measurable Elements of MMU.5.1

❑ 1. The hospital has a process to prepare and dispense radiopharmaceuticals in accordance with laws and regulations.
❑ 2. The hospital has a process to prepare and dispense radiopharmaceuticals in accordance with clinical practice guidelines.
❑ 3. Radiopharmaceuticals are prepared by, or under the supervision of, an appropriately trained and qualified individual (for
example, registered pharmacist or Doctor of Medicine or Osteopathy.)
❑ 4. Sterile radiopharmaceutical facilities must be designed and controlled to minimizing airborne contamination, provide a
well-lighted and comfortable working environment.

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❑ 5. When radiopharmaceuticals are delivered to the department from an external source, the radiopharmaceutical must arrive
in appropriate shielding equipment, as applicable, and the delivery person must be escorted to the department by hospital
security.
❑ 6. Radiopharmaceuticals are transported and stored in accordance with laws and regulations and guidelines to maintain their
stability and radioactivity until they are administered.
❑ 7. Radiopharmaceuticals are packaged in appropriate containers, and labeled to provide the following essential information:
a) Name of the radiopharmaceutical
b) Dosage
c) Expiration date
d) Radiation warning symbol(s)

Standard MMU.5.2
Medication prescriptions or orders are reviewed for appropriateness.

Intent of MMU.5.2
Good medication management includes two reviews of each prescription or order:
• The appropriateness of the medication for the patient and his or her clinical needs performed at the time the medication is
prescribed or ordered
• The verification at the time of administration that the medication is exactly as ordered or prescribed

Guidance for MMU.5.2

Each newly prescribed or ordered medication is reviewed for appropriateness, including when the dosage or other appropriateness
factors noted below changes; for example, when new drugs are prescribed, and therapeutic duplication may be an issue or when a
potential medication interaction may occur. The hospital defines what patient-specific information is required for the
appropriateness review of the order or prescription. For example, if a newly prescribed medication can affect the kidneys or liver,
the appropriateness review includes specific clinical information about the patient’s renal and liver function, as well as when these
organ functions change.
The process to conduct an appropriateness review for an order or prescription prior to dispensing includes evaluation of
appropriateness of the drug, dose, frequency, and route of administration, therapeutic duplication, allergies, or sensitivities, and
interactions between the medication and other medications or food, variation from hospital criteria for use, patient’s weight and
other physiological information, current or potential impact as indicated by laboratory values, and other contraindications.
The hospital determines the manner in which the appropriateness review is conducted. For example, the appropriateness review
may be conducted by individuals competent to do so by virtue of education and training, such as licensed pharmacists, or as
specified by privileging specific to performing appropriateness reviews for licensed independent practitioners with training and
competency in performing an appropriateness review process; or for nurses or other professionals with training and demonstrated
competency in the review process.
The hospital may choose to use clinical decision support programs associated with medication management to enhance the process
or to conduct the appropriateness review process in conjunction with a designated licensed professional or trained individual,
nonetheless, clinical decision support alone does not suffice for a full appropriateness review, and is therefore not accepted as an
alternative in terms of meeting the requirement for conducting an appropriateness review. For example, many electronic
medication ordering systems are designed to review the order for the complete elements of an appropriateness review, including
patient-specific clinical information, and provide an alert to the ordering individual of a contraindication to prescribing the
medication. When the ordering individual overrides the alert, the hospital develops a process for a full review of the order by a
health care practitioner who is trained and demonstrates competence in a full appropriateness review.
Appropriateness reviews must be conducted even when circumstances are not ideal. For example, if the central pharmacy or a unit
pharmacy is not open, or the drug will be dispensed from stock on the ward or clinic, the appropriateness review may be conducted
in conjunction with the verification review when the ordering individual will administer the medication and monitor the patient.

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When the ordering individual is not available to administer the medication and monitor the patient, critical elements of the
appropriateness review may be performed by other trained and competent individuals for administration of the first dose of the
medication. However, the entire appropriateness review must be performed by a licensed pharmacist, or other licensed professional,
such as a nurse or physician, competent in the knowledge required for a full appropriateness review within 24 hours.
The critical elements of the appropriateness review may be conducted by other licensed trained individuals during times when the
pharmacy is not available. These individuals require documented training in conducting the critical elements of the appropriateness
review and will be supported by reference materials, computer programs, and other resources. Thus, when a physician calls in a new
medication order during the night for a patient, the trained individual will write down and read back the order and then conduct an
appropriateness review for the identified critical elements. A second review will be required by a licensed pharmacist or other
licensed professional, such as a nurse or physician competent in the knowledge required for a full appropriateness review, within 24
hours.
There may be circumstances in which the full appropriateness review is not practical, such as in an emergency or when the ordering
physician is present for ordering, administering, and monitoring of the patient (for example, in the operating theatre or the
emergency department), or with oral, rectal, or injectable contrast in interventional radiology or diagnostic imaging where the
medication is part of the procedure.
To facilitate the appropriateness review, those performing the review require access to the patient’s medication record as well as to
the clinical information that is pertinent to the review process; for example, information related to the patient’s renal or liver
function when a medication can affect or be affected by those organs. This information is essential to the appropriateness review.
When computer programs are used to cross-check drug-drug interactions and drug allergies, the programs are current and updated
according to recommendations of the program manufacturers. In addition, when print reference materials are used, the most current
versions of the materials are utilized.

Measurable Elements of MMU.5.2

❑ 1. The hospital defines the patient-specific information required for an effective review process, and the source or availability
of this information is available at all times when the pharmacy is open or closed.
❑ 2. Each prescription or order is reviewed for appropriateness in a manner, identified by the hospital, prior to dispensing and
administration, except in an emergency or when the ordering physician is present for ordering, administering, and
monitoring of the patient, in accordance with laws and regulations.
❑ 3. The process to conduct an appropriateness review (the first review) for an order or prescription prior to dispensing
includes evaluation of the following:
a) Appropriateness of the drug, dose, frequency, and route of administration
b) Therapeutic duplication
c) Real or potential allergies or sensitivities
d) Real or potential interactions between the medication and other medications or food
e) Variation from hospital criteria for use
f) Patient’s weight and other physiological information
g) Current or potential impact as indicated by laboratory values
h) Other contraindications
❑ 4. Individuals permitted to conduct appropriateness reviews are:
a) Judged competent to do so, by qualified individual(s)
b) Permitted to do so by privileges or job descriptions
c) Provided resources to support the review process.
❑ 5. When the designated licensed professional is not available to perform the full appropriateness review, a trained individual
conducts and documents a review of the following critical elements for the first dose, prior to the full appropriateness
review that must be conducted within 24 hours:
a) Allergies
b) Lethal drug-drug interactions
c) Weight-based dosing
d) Potential organ toxicity

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❑ 6. Clinical decision support programs used in conjunction with a designated licensed professional or trained individual for the
full appropriateness review, as well as other computer programs and print reference materials used to cross-check the
critical elements of an appropriateness review, are current and updated.
❑ 7. After the medication order has been reviewed, all concerns, issues, or questions are clarified with the individual prescriber
before dispensing.

Standard MMU.5.3
A system is used to safely dispense medications in the right dose to the right patient at the right time.

Intent of MMU.5.2
Medication use has become increasingly complex, and medication errors are a major cause of preventable patient harm.
A uniform system for dispensing and distributing medications can help reduce the risk of medication errors.

Guidance for MMU.5.3

The hospital dispenses medications in the most ready-to-administer form possible to minimize opportunities for error during
distribution and administration. The issue of the most ready-to-administer form becomes crucial during emergent situations in which
immediate administration of the medication is lifesaving (for example, during resuscitation). The central pharmacy and other
medication-distribution points throughout the hospital use the same system. The system supports accurate dispensing of
medications in a timely manner.

Dispensing practices and recordkeeping include must include anti-diversion strategies. When medications are prepared by someone
different from the person administering the medication, the risk of a medication error is increased. Thus, when a medication is
removed from its original packaging or prepared and dispensed in a different form/container—and not immediately administered—
the medication must be labeled with the name of the medication, the dosage/concentration of the medication, the date of
preparation, the date of expiration, and two patient identifiers. When medications are prepared for use during a surgical procedure in
the operating theatre and unused portions are discarded immediately following the surgical procedure, the patient’s name and
expiration date may not be necessary.

Measurable Elements of MMU.5.3

❑ 1. The hospital dispenses medications and maintains records in accordance with law and regulation, licensure, and
professional standards of practice.
2. Medications are dispensed in the most ready-to-administer form available.
❑ 3. The system supports accurate and timely dispensing and documentation of dispensing practices that meet patient needs.
❑ 4. The hospital has a policy for medication labeling practices that at minimum includes the following:
a) Information on medication labels
b) Medications not immediately administered
c) Preparing individualized medications for multiple patients
d) When a patient medication(s) is prepared by someone other than the person administering the medication.
❑ 5. All medications prepared in the hospital are correctly labeled with the following:
a) Medication name, strength, and amount (if not apparent from the container)
b) Expiration date when not used within 24 hours
c) Expiration date and time when expiration occurs in less than 24 hours
d) The date prepared and the diluent for all compounded intravenous admixtures and parenteral nutrition formulas

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 Administration

Standard MMU.6
Medication administration is safely performed by qualified individuals.

Intent of MMU.6
Each hospital is responsible for identifying those individuals with the requisite knowledge and experience and who are also
permitted by licensure, certification, laws, or regulations to administer medications.

Guidance for MMU.6

Administering a medication to treat a patient requires specific knowledge and experience. A hospital may place limits on medication
administration by an individual, such as for controlled substances or radioactive and investigational medications. In emergency
situations, the hospital identifies any additional individuals permitted to administer medications.
The health record of each patient who receives medication contains a list of the medications prescribed or ordered for the patient
and the dosage and times the medication was administered. Included are medications administered “as needed.” If this information
is recorded on a separate medication form, the form is inserted in the patient’s health record at discharge or transfer.
The hospital defines the verification process to be used in administering medications. When the medication is prepared and
dispensed on the patient care unit, the process of appropriateness review described in MMU.5.1 must also be carried out by a
qualified individual.
In support of the patient’s engagement in all aspects of his or her medical care and treatment, patients are informed about the
medication they are being given and provided with an opportunity to ask questions about the medications. Medications are
administered to the patient on a timely basis and noted in the patient’s health record.

Measurable Elements of MMU.6

❑ 1. Only authorized clinical staff administer medications. The hospital defines those who are authorized to administer
medication, with or without supervision, in accordance with law and regulation. The hospital may place limits, when
appropriate, on the medication administration of individuals.
2. The hospital implements a process for medication administration to verify the medication is correctly administered in
accordance with the medication prescription or order.
3. Prior to administration, the individual administering the medication must complete the following:
a) Identity of the patient
b) Verifies that the medication selected matches the medication order or prescription and product label including time,
frequency, dose, and route
c) Visually inspects the medication for particulates, discoloration, or other loss of integrity
d) Verifies that the medication has not expired
e) Verifies that no contraindications exist
f) Verifies that the medication is being administered at the proper time, in the prescribed dose, and by the correct route
g) Discusses any unresolved concerns about the medication with the patient’s physician or healthcare practitioner, (if
different from the physician or healthcare practitioner), and/or staff involved with the patient’s care, treatment, and
services
❑ 4. Medications are administered as prescribed on a timely basis and noted each dose is recorded in the patient’s health record.
❑ 5. Prior to administering a new medication, the patient or family is informed about any potential clinically significant adverse
drug reactions or other concerns regarding administration of a new medication and have an opportunity to ask questions.
This education is documented in the patient’s health record.
❑ 6. Before administering a radioactive pharmaceutical for diagnostic purposes, staff verify that the dose to be administered is
within 20% of the prescribed dose, or, if the dose is prescribed as a range, staff verify that the dose to be administered is
within the prescribed range.
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Standard MMU.6.1
Policies and procedures govern medications brought into the hospital by the patient or family, medication prescribed for patient self-
administration, and medications brought into the hospital as samples.

Intent of MMU.6.1
The hospital needs to define its responsibilities for the safe use of these medications to protect the safety of the patient
and the quality of care provided.

Guidance for MMU.6.1

Medications that are not dispensed from the hospital pharmacy, such as medications brought in by the patient or family or
medication samples require special processes for labeling, storage, and control of use. The hospital controls the availability and has a
process for determining the identity, safety, and any other relative contraindications to use patient-supplied or sample medications.
The hospital must be aware of current regional trends related to the prevalence of counterfeit medications and active recalls for
medications and the associated active pharmaceutical ingredients.
The hospital must perform a risk assessment for medications brought in by the patient that addresses where the patient obtained the
medication, when the medication was obtained, and how the medication was stored at home. Medications brought into the hospital
by the patient or his or her family or prescribed within the hospital for self-administration are known to the patient’s physician and
noted in the patient’s health record.
The hospital implements a process for patient self-administration of medications, administration of medications by a family, and the
management, use, and documentation of medication or medication samples brought in by the patient/family. The processes include
determining competence before allowing them to administer medications, as well as address training, supervision, and
documentation.

Measurable Elements of MMU.6.1

❑ 1. The hospital defines when medications brought into the hospital by patients or their families or brought into the hospital
as samples can be administered.
❑ 2. The hospital implements a process that includes the following written documentation for medications brought in by the
patient/family or for medication samples:
a) Receipt (denoting how the hospital received the medication from the patient or other source)
b) Identification
c) Labeling
d) Storage
e) Control and distribution
❑ 3. The hospital performs a risk assessment for medications brought in by the patient/family that addresses where and when
the medication was obtained and how the medication was stored at home.
❑ 4. The hospital performs a risk assessment for sample medications brought in by the patient or provided by other sources
that addresses where and when the medication was obtained and how the medication was stored prior to arrival.
❑ 5. Before use or administration of a medication brought into the hospital by a patient, their family, or a licensed practitioner,
the hospital identifies the medication and visually evaluates the medication’s integrity.
❑ 6. The hospital implements a process to govern patient self-administration of medications and the management, use, and
documentation of medication or medication samples brought in by the patient/family.
❑ 7. If self-administration of medications is allowed, the hospital follows the processes that guide the safe and accurate self-
administration of medications or the administration of medications by a family. The processes address training,
supervision, and documentation.
❑ 8. The hospital educates patients and families involved in self-administration and documents in the patient’s health record
about the following:
a) Medication name, type, and reason for use

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 b) How to administer medication, including process, time, frequency, route, and dose
c) Anticipated actions and potential side effects of the medication administered
d) Monitoring the effects of the medication
e) Proper storage of medication
❑ 9. The hospital determines that the patient or the family member who administers the medication is competent at medication
administration before allowing them to administer medications.

Monitoring

Standard MMU.7
The hospital monitors and responds to actual or potential adverse drug events and adverse drug reactions.

Intent of MMU.7
The purposes of monitoring are to evaluate the medication’s effect on the patient’s symptoms or illness, as well as blood count, renal
function, liver function, and other medication-related physical and biological effects with medications, to evaluate the patient for
adverse effects, and to response to the noted effects accordingly.

Guidance for MMU.7

Definitions of adverse drug events and adverse drug reactions are referenced in the JCI policy for sentinel events and as follows:
Adverse drug event: an injury resulting from a medical intervention related to a medication, including harm from an adverse drug
reaction or a medication error.
Adverse drug reaction: a response to a medicinal product that is noxious and unintended and that occurs at doses normally used in
humans for the prophylaxis, diagnosis, or treatment of disease or for the restoration, correction, or modification of physiological or
psychological function.

Patients, their physicians, nurses, and other health care practitioners work together to monitor patients on medications. Based on
monitoring, the dosage or type of medication can be adjusted when needed. It is appropriate to closely monitor the patient’s
response to the first dose(s) of a medication new to the patient. Such monitoring is intended to identify the anticipated therapeutic
response as well as allergic responses, unanticipated drug-drug interactions, or a change in the patient’s equilibrium raising the risk of
falls, among others.
Monitoring medication effects includes observing, timely responding to, and documenting any adverse effects. The hospital has a
policy that identifies all adverse effects that are to be recorded and those that must be reported. The hospital establishes a
mechanism for reporting adverse events when required and the time frame for reporting.

Measurable Elements of MMU.7

❑ 1. The hospital follows a process to monitor, respond to, and document actual or potential adverse drug events, and adverse
drug reactions.
❑ 2. The hospital follows a written process addressing prescriber notification in the event of an adverse drug event, and adverse
drug reactions.
❑ 3. The hospital complies with internal and external reporting requirements for actual or potential adverse drug events and
adverse drug reactions.
❑ 4. The hospital utilizes a standardized process for reporting adverse drug effects as part of the hospital quality program.
❑ 5. Adverse drug effects are reported as identified by the process in the time frame required.
6. The hospital conducts a root cause analysis of data when adverse drug event patterns, or undesirable trends occur.
7. The hospital uses the analysis of adverse drug related events to improve medication use processes.

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Standard MMU.7.1
The hospital implements a process for identifying, reporting, managing, and tracking all medication errors and near miss events (or
close calls).

Intent of MMU.7.1
The information from data analysis is used to learn where proactive process changes can reduce or eliminate the related events, near
misses, and complications.

Guidance for MMU.7

Every day at least one death in the U.S. happens as a result of a medication error, and approximately 1.3 million people annually are
injured due to medication errors. We know that unless there has been an injury or death, many errors go unreported. Underreporting
has, in part, been attributed to a failure of a standardized definition of an error. While qualifying the exact origin of medication
errors and quantifying the prevalence accordingly may be challenging due to variations in definition, classification systems, healthcare
system organization, and the implementation and utilization of incident reporting systems, examples of general medication errors
such as 12-38% in the United Kingdom, 42% in Sweden, 20% in Saudi Arabia, and 58% in Mexico, support the claim that
medication errors are a global issue.

JCI defines a medication error as “a preventable event that may cause or lead to inappropriate medication use or patient or resident
harm while the medication is in the control of the health care professional, patient, resident, or consumer. Such events may be
related to professional practice; health care products; procedures and systems, including prescribing; order communication; product
labeling, packaging, and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use.” A
mediation near miss event is defined as “a medication error or event that did not reach the patient. Also called a close call.

Processes are developed and implemented for the purposes of identifying, tracking, trending, analyzing, and reporting errors and
adverse events, near misses, and complications. In addition, to proactively learn where systems may be vulnerable to adverse events,
the program collects data and information on “near-miss” events and complications—a process variation that did not affect the
outcome—and evaluates them to prevent the actual occurrence of adverse events. Routine measurement data, as well as data from
intensive assessments, contribute to this understanding of where improvement should be planned and what priority should be given
to the improvement.

The hospital is responsible for planning and implementing changes for improvement based on the analysis of errors or adverse
events, near misses, and complications. The process includes defining a medication error and near miss, using a standardized format
for reporting, and educating staff on the process and importance of reporting. The hospital establishes a definition of a near miss
and what types of events are to be reported, as well as potential complications related to the care, treatment, and services provided.

Definitions and processes are developed through a collaborative process that includes all those involved in the different steps in
medication management. The Agency for Healthcare Research ad Quality defines a medication error as “… an error (of commission
or omission) at any step along the pathway that begins when a clinician prescribes a medication and ends when the patient actually
receives the medication.” The National Coordinating Council for Medication Error Reporting and Prevention similarly defines a
medication error as: “… any preventable event that may cause or lead to inappropriate medication use or patient harm while the
medication is in the control of the healthcare professional, patient, or consumer. The World Health Organization (2016) identified
key factors associated with medication errors, many that can be attributed to the following categories: the healthcare practitioner,
patient, care team, work environment, task, computer system and the primary-secondary care interface.

Healthcare Organizations who foster a culture of safety focus on safe medication management practices, which include promoting
the reporting of errors without fear of retribution. The documentation and reporting of errors are the first step in learning from
them and avoiding repeat occurrences. To benefit the organization and improve safety. The information must be documented,
reported and the data must be analyzed to identify opportunities for improvement. Without implementing a process that includes
utilization of the data for improving safety practices, fractured movement is resulted. For example, a survey in Europe showed the
following results:

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 • 8% of hospitals do not record medication errors in a database, and only 13% of hospitals make medication errors data
available to the public. However, 33% of hospitals do not have medication errors’ databases for sharing continual
improvements.
• 14% of hospitals do not routinely track medication errors, and 71% of hospitals track medication errors centrally and are
mainly used as a root cause analysis to resolve incidents and investigated at regular quality meetings. Nevertheless, 23% of
hospitals do not use that system regularly.

The reporting process is part of the hospital’s quality and patient safety program. The reports are directed to one or more individuals
who are accountable for taking action. The program focuses on preventing medication errors through understanding the types of
errors that occur in the hospital and in other organizations and why near misses occur. Improvements in medication processes and
staff training are used to prevent errors in the future. The pharmacy participates in such staff training. In addition, strategies to
improve communication among the professionals involved in prescribing, validating, preparing, administrating, and dispensing
medication are key to reduce medication errors.

Measurable Elements of MMU.7.1

❑ 1. The hospital adopts definitions of medication error and near misses from established and updated guidelines.
❑ 2. The hospital established a policy and implements processes for the following:
a) Identifying medication errors and near misses
b) Timely reporting of medication errors and near misses
c) Managing medication errors and near misses including investigating, developing an action plan(s) and
following up on the actions over time as applicable.
d) Tracking medication errors and near misses
❑ 3. Those accountable for acting and following up on the reports are identified.
❑ 4. The hospital conducts a root cause analysis of the data when medication error and near miss patterns, or undesirable
trends occur.
5. The hospital uses the analysis of medication errors and near misses related events to improve medication use processes.

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World Health Organization. Global antimicrobial resistance surveillance system (GLASS)rReport: Early implementation 2017–2018. 2018. Accessed Jan 4, 2020.
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*Not a complete literature review

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