CMS SOM App. A, Tag A-0405

(1) Drugs and biologicals must be prepared and administered in accordance with Federal

and State laws, the orders of the practitioner or practitioners responsible for the patient’s

care, and accepted standards of practice.

(i) Drugs and biologicals may be prepared and administered on the orders of other

practitioners not specified under §482.12(c) only if such practitioners are acting in

accordance with State law, including scope of practice laws, hospital policies, and

medical staff bylaws, rules, and regulations….

(2) All drugs and biologicals must be administered by, or under supervision of, nursing or

other personnel in accordance with Federal and State laws and regulations, including

applicable licensing requirements, and in accordance with the approved medical staff

policies and procedures.

Interpretive Guidelines §§482.23(c)(1), (c)(1)(i) and (c)(2)

According to the Institute of Medicine of the National Academies, medication errors are among

the most common medical errors, harming at least 1.5 million people each year.

2F

3 It has been

estimated that drug-related adverse outcomes were noted in nearly 1.9 million inpatient hospital

stays (4.7 percent of all stays), and 838,000 treat-and-release ED visits (0.8 percent of all visits).3F

4

Although technological advances in electronic order entry, medication administration, and

electronic medical records hold a great deal of promise for decreasing medication errors, there

are a multitude of human and environmental factors that will impact their success. The

increasing complexity of medical care and patient acuity present significant challenges that

require an approach to medication administration that takes advantage of available technology

while recognizing that it must be integrated into the medication administration work processes in

a manner that meets the needs of patients and promotes their safety.

The regulations at §482.23(c) and §482.23(c)(1) promote safety in the preparation and

administration of drugs and biologicals to hospital patients by requiring preparation and

administration in accordance with:

• Federal and State law;

• Accepted standards of practice;

• Orders of the practitioner(s) responsible for the patient’s care, as permitted under State law,

hospital policy and medical staff bylaws, rules and regulations; and

• Medical staff-approved policies and procedures.

Federal and State Law

Federal law regulates the approval and classification of drugs and biologicals. Individual States

establish laws and regulations which specify the scope of practice for various types of licensed

healthcare professionals, including which medications they may prescribe and administer,

including controlled substances.

Accepted Standards of Practice

Hospital policies and procedures for the preparation and administration of all drugs and

biologicals must not only comply with all applicable Federal and State laws, but also must be

consistent with accepted standards of practice based on guidelines or recommendations issued by

nationally recognized organizations with expertise in medication preparation and administration.

Examples of such organizations include, but are not limited to:

3Institute of Medicine. Preventing Medication Errors. Washington DC: The National Academies Press, 2007.

4Lucado, Jennifer, et al, Medication-Related Adverse Outcomes in U.S. Hospitals and Emergency Departments.

Statistical Brief #109, April, 2011. Healthcare Cost and Utilization Project, Agency For Healthcare Research and

Quality, Rockville, MD.

• American Society of Health-System Pharmacists (http://www.ashp.org/default.aspx)

• Infusion Nurses Society (http://www.ins1.org)

• Institute for Safe Medication Practices (www.ismp.org)

• National Coordinating Council for Medication Error Reporting and Prevention

(www.nccmerp.org)

• U.S Pharmacopeia (www.usp.org)

Orders of an authorized practitioner

Drugs must be administered in response to an order from a practitioner, or on the basis of a

standing order which is appropriately authenticated subsequently by a practitioner. (See

§482.23(c)(1) (ii) concerning standing orders.) Generally, the ordering practitioner is the

practitioner(s) responsible for the care of the patient. However, other practitioners not specified

under §482.12(c) may write orders for the preparation and administration of drugs and

biologicals, if they are acting in accordance with State law, including scope of practice laws,

hospital policies and procedures, and medical staff bylaws, rules and regulations. This includes

practitioners ordering outpatient services who do not have privileges in the hospital but who are

permitted under their State scope of practice and authorized by hospital and medical staff policy

to order outpatient services.

In accordance with standard practice, all practitioner orders for the administration of drugs and

biologicals must include at least the following:

• Name of the patient;

• Age and weight of the patient, to facilitate dose calculation when applicable. Policies and

procedures must address weight-based dosing for pediatric patients as well as in other

circumstances identified in the hospital’s policies. (Note that dose calculations are based

on metric weight (kg, or g for newborns). If a hospital permits practitioners to record

weight in either pounds or using metric weight, the opportunity for error increases, since

some orders would require conversion while others would not. Accordingly, hospitals

must specify a uniform approach to be used by prescribing practitioners. For example, a

hospital could require all prescribers to use pounds or ounces and have the electronic

ordering system or the pharmacy convert to metric);

• Date and time of the order;

• Drug name;

• Dose, frequency, and route;

• Dose calculation requirements, when applicable;

• Exact strength or concentration, when applicable;

• Quantity and/or duration, when applicable;

• Specific instructions for use, when applicable; and;

• Name of the prescriber.

Medical Staff Approved Policies and Procedures

The hospital’s medical staff must approve policies and procedures for medication administration,

consistent with the requirements of Federal and State law and accepted standards of practice. It is

recommended that the medical staff consult with nurses, pharmacists, Quality Assessment and

Performance Improvement program staff, and others in developing these policies and

procedures. The adopted policies and procedures must address key issues related to medication

administration, which include but are not limited to:

Personnel authorized to administer medication

§482.23(c)(2) requires that all drugs and biologicals are administered by, or under the

supervision of, nursing or other personnel, in accordance with Federal or State law and approved

medical staff policies and procedures. State law requirements include licensure requirements.

Policies and procedures must identify categories of licensed personnel and the types of

medications they are permitted to administer, in accordance with state laws. The policies and

procedures must also address education and training for all personnel administering drugs and

biologicals.

Medication administration education and training is typically included in hospital orientation or

other continuing education for nursing staff and other authorized healthcare personnel. Training

or continuing education topics regarding medication administration may include but are not

limited to the following:

• Safe handling and preparation of authorized medications;

• Knowledge of the indications, side effects, drug interactions, compatibility, and

dose limits of administered medications;

• Equipment, devices, special procedures, and/or techniques required for medication

administration;

Policies and procedures must address the required components of the training and if the training

provided during hospital orientation imparts sufficient education or whether ongoing in-services

or continuing education will be required to demonstrate competence.

Basic safe practices for medication administration

The hospital’s policies and procedures must reflect accepted standards of practice that require the

following be confirmed prior to each administration of medication (often referred to as the “five

rights” of medication administration practice):

• Right patient: the patient’s identity— acceptable patient identifiers include, but are not

limited to: the patient’s full name; an identification number assigned by the hospital; or

date of birth. Identifiers must be confirmed by patient wrist band, patient identification

card, patient statement (when possible) or other means outlined in the hospital’s policy.

The patient’s identification must be confirmed to be in agreement with the medication

administration record and medication labeling prior to medication administration to ensure

that the medication is being given to the correct patient.

• Right medication: the correct medication, to ensure that the medication being given to the

patient matches that prescribed for the patient and that the patient does not have a

documented allergy to it;

• Right dose: the correct dose, to ensure that the dosage of the medication matches the

prescribed dose, and that the prescription itself does not reflect an unsafe dosage level (i.e.,

a dose that is too high or too low);

• Right route: the correct route, to ensure that the method of administration – orally,

intramuscular, intravenous, etc., is the appropriate one for that particular medication and

patient; and

• Right time: the appropriate time, to ensure adherence to the prescribed frequency and time

of administration.

NOTE: the “5 rights” focus specifically on the process of administering medications. The

medication process is generally recognized as consisting of five stages: ordering/prescribing;

transcribing and verifying; dispensing and delivering; administering; and monitoring/reporting.

Errors may occur in other components of the process, even when there is strict adherence to the

“5 rights” of medication administration, for example when there has been a prescribing or a

dispensing error. Hospitals are also expected to comply with requirements under the

Pharmaceutical Services CoP at §482.25 and the patient safety requirements under the Quality

Assessment and Performance Improvement CoP at §482.21, using a comprehensive systems

approach to all components of the medication process.

For Information – Not Required/Not to be Cited

Recent literature* identifies up to nine “rights” of medication administration including:

 Right patient

 Right drug

 Right route

 Right time

 Right dose

 Right documentation

 Right action (appropriate reason)

 Right form

 Right response

However, other sources refer to 8 or 10 “rights, and some of these topics, such as right action, appear to involve

prescribing and/or dispensing. Accordingly, there does not (yet) appear to be consensus about expanding beyond

the 5 “rights.”

*Reference: Elliott, M. and Lis, Y. (2010). The Nine Rights of Medication Administration: An Overview. British Journal of

Nursing, Vol. 19, 5, 300-305.

Hospitals are encouraged to promote a culture in which it is not only acceptable, but also

strongly encouraged, for staff to bring to the attention of the prescribing practitioner questions or

concerns they have regarding medication orders. Any questions about orders for drugs or

biologicals are expected to be resolved promptly, whether they arise prior to the preparation,

dispensing, or administration of the medication.

Hospitals must also ensure staff adherence to accepted standards of practice required to prevent

healthcare-associated infections related to medication preparation and/or administration,

including compounded sterile preparations (CSPs). Adherence to these standards is assessed

under the infection control CoP at 42 CFR 482.42.

A drug or biological is outdated after its expiration date, which is set by the manufacturer based

on stability testing under specified conditions as part of the U.S. Food and Drug Administration’s

(FDA) approval process. It should be noted that a drug or biological may become unusable prior

to its expiration date if it has been subjected to conditions that are inconsistent with the

manufacturer’s approved labeling.

A drug or biological is also outdated after its “beyond-use date” (BUD), which may be reached

before the expiration date, but never later. The BUD is the date and time after which the

medication must not be used, stored or transported. The BUD takes into account the specific

conditions and potential for deterioration and microbial growth that may occur during or after the

original container is opened, while preparing the medication for dispensing and administration,

and/or during the compounding process if it is a compounded medication.

The BUD is to be based on information provided by the manufacturer, whenever such

information is available. The hospital must maintain and implement policies and procedures that

provide clear and consistent direction to pharmacy staff regarding how to determine a BUD

when complete BUD information is not available from the manufacturer.

Timing of Medication Administration

Appropriate timing of medication administration must take into account the complex nature and

variability among medications; the indications for which they are prescribed; the clinical

situations in which they are administered; and the needs of the patients receiving them. The

chemical properties, mechanism of action, or therapeutic goals of some medications require

administration at the exact time prescribed, or within a narrow window of its prescribed

scheduled time, to avoid compromising patient safety or achievement of the intended therapeutic

effect. However, the therapeutic effect of many other medications is uncompromised by a much

broader window of time for administration. Consequently, the application of a uniform required

window of time before or after the scheduled time for the administration of all medications,

without regard to their differences, could undermine the ability of nursing staff to prioritize

nursing care activities appropriately. This could also result in staff work-arounds that jeopardize

patient safety due to the imposition of unrealistic or unnecessary time constraints for medication

administration. Instead, hospital policies and procedures must specifically address the timing of

medication administration, based on the nature of the medication and its clinical application, to

ensure safe and timely administration. The policies and procedures must address at least the

following:

• Medications not eligible for scheduled dosing times;

• Medications eligible for scheduled dosing times;

• Administration of eligible medications outside of their scheduled dosing times and

windows; and

• Evaluation of medication administration timing policies, including adherence to them.

Medications or categories of medication not eligible for scheduled dosing times

The policies and procedures must identify medications or categories of medication which are not

eligible for scheduled dosing times, either in general or in specific clinical applications. These

are medications that require exact or precise timing of administration, based on diagnosis type,

treatment requirements, or therapeutic goals. The policies and procedures must reflect

consideration of factors including, but not limited to, the pharmacokinetics of the prescribed

medication; specific clinical applications; and patient risk factors. Examples of medications that

hospitals may choose to identify as not eligible for scheduled dosing times may include, but are

not limited to:

• Stat doses (immediate);

• First time or loading doses (initial large dose of a drug given to bring blood, tissue or fluid

levels to an effective concentration quickly);

• One-time doses; doses specifically timed for procedures;

• Time-sequenced doses; doses timed for serum drug levels;

• Investigational drugs; or

• Drugs prescribed on an as needed basis (prn doses).

The policies and procedures must ensure timely administration of such medications. In addition

they must specify if the policy for the administration of these medications will be applied

hospital-wide or only for specific diagnosis types, hospital units or clinical situations.

Medications eligible for scheduled dosing times

Medications eligible for scheduled dosing times are those prescribed on a repeated cycle of

frequency, such as once a day, BID (twice a day), TID (three times a day), hourly intervals

(every 1, 2, 3 or more hours), etc. The goal of this scheduling is to achieve and maintain

therapeutic blood levels of the prescribed medication over a period of time. Medication

administration policies and procedures typically establish standardized dosing times for the

administration of all ‘scheduled’ medications. For example, medications prescribed for BID

(twice a day) administration might, under a given hospital’s policies and procedures, be

scheduled to be administered at 8am and 8pm. Another hospital might choose to schedule BID

medications at 7:30 am and 7:30 pm. Use of these standardized times facilitates the medication

administration process, e.g., by providing to the hospital’s pharmacy that morning doses of all

BID drugs must be dispensed and delivered to patient units in time for the scheduled

administration. For the nursing staff, the scheduled administration time might prompt

prioritization of additional activities that may be required, in the case of particular drugs, such as

vital sign assessment or the collection and review of blood work, to ensure safe and timely

medication administration.

Policies and procedures for medications eligible for scheduled dosing times must also address:

first dose medications, including parameters within which nursing staff are allowed to use their

own judgment regarding the timing of the first and subsequent doses, which may fall between

scheduled dosing times; retiming of missed or omitted doses; medications that will not follow

scheduled dosing times; and patient units that are not subject to following the scheduled dosing

times.

Time-critical scheduled medications

Time-critical scheduled medications are those for which an early or late administration of greater

than thirty minutes might cause harm or have significant, negative impact on the intended

therapeutic or pharmacological effect. Accordingly, scheduled medications identified under the

hospital’s policies and procedures as time-critical must be administered within thirty minutes

before or after their scheduled dosing time, for a total window of 1 hour.

It is possible for a given medication to be time- critical for some patients, due to diagnosis,

clinical situation, various risk factors, or therapeutic intent, but not time-critical for other

patients. Therefore, hospital policies and procedures must address the process for determining

whether specific scheduled medications are always time-critical, or only under certain

circumstances, and how staff involved in medication administration will know when a scheduled

medication is time-critical. Examples of time-critical scheduled medications/medication types

may include, but are not limited to:

• Antibiotics;

• Anticoagulants;

• Insulin;

• Anticonvulsants;

• Immunosuppressive agents;

• Pain medication (non-IV);

• Medications prescribed for administration within a specified period of time of the

medication order;

• Medications that must be administered apart from other medications for optimal

therapeutic effect; or

• Medications prescribed more frequently than every 4 hours.

Non-time-critical scheduled medications

Non-time critical scheduled medications are those for which a longer or shorter interval of time

since the prior dose does not significantly change the medication’s therapeutic effect or

otherwise cause harm. For such medications greater flexibility in the timing of their

administration is permissible. Specifically:

Medications prescribed for daily, weekly or monthly administration may be within 2 hours

before or after the scheduled dosing time, for a total window that does not exceed 4 hours.

• Medications prescribed more frequently than daily but no more frequently than every 4

hours may be administered within 1 hour before or after the scheduled dosing time, for a

total window that does not exceed 2 hours.

Missed or late administration of medications

The hospital’s policies and procedures must address the actions to be taken when medications

eligible for scheduled dosing times are not administered within their permitted window of time.

This includes doses which may have been missed due to the patient being temporarily away from

the nursing unit, for example, for tests or procedures; patient refusal; patient inability to take the

medication; problems related to medication availability; or other reasons that result in missed or

late dose administration. Likewise, policies and procedures must also outline guidelines for the

administration and timing of new medications which are initiated between standardized dosing

times.

These policies and procedures must identify parameters within which nursing staff are allowed to

use their own judgment regarding the rescheduling of missed or late doses and when notification

of the physician or other practitioner responsible for the care of the patient is required prior doing

so. In either case, the reporting of medication errors that are the result of missed or late dose

administration must be reported to the attending physician in accordance with requirements at

§482.25(b)(6). See interpretive guidance at §482.25(b)(6) for more details on internal reporting

requirements

Evaluation of medication administration timing policies

Hospitals must periodically evaluate their medication administration timing policies, including

staff adherence to the policies, to determine whether they assure safe and effective medication

administration. Consistent with the QAPI requirements at 42 CFR 482.21(c)(2), medication

errors related to the timing of medication administration must be tracked and analyzed to

determine their causes. Based on the results of the evaluations of the policies and the medication

administration errors, the medical staff must consider whether there is a need to revise the

policies and procedures governing medication administration timing.

Assessment/Monitoring of Patients Receiving Medications

Observing the effects medications have on the patient is part of the multi-faceted medication

administration process. Patients must be carefully monitored to determine whether the

medication results in the therapeutically intended benefit, and to allow for early identification of

adverse effects and timely initiation of appropriate corrective action. Depending on the

medication and route/delivery mode, monitoring may need to include assessment of:

• Clinical and laboratory data to evaluate the efficacy of medication therapy, to anticipate

or evaluate toxicity and adverse effects. For some medications, including opioids, this

may include clinical data such as respiratory status, blood pressure, and oxygenation and

carbon dioxide levels;

• Physical signs and clinical symptoms relevant to the patient’s medication therapy,

including but not limited to, somnolence, confusion, agitation, unsteady gait, pruritus, etc.

Certain types of medications are considered inherently high risk for adverse drug events.

Although mistakes may or may not be more common with these drugs, the consequences of

errors are often harmful, sometimes fatal, to patients. (See also the discussion of high-risk

medications (typically referred to as “high-alert” medications) in the guidance for §482.25(a)(1))

For Information – Not Required/Not to be Cited

The Institute for Safe Medication Practices (ISMP) makes available a list of high alert

medications, which it defines as those medications that bear a heightened risk of causing

significant patient harm when they are used in error. The current list may be found at:

http://www.ismp.org/Tools/highAlertMedicationLists.asp

In addition, certain factors place some patients at greater risk for adverse effects of medication.

Factors including, but not limited to, age, altered liver and kidney function, a history of sleep

apnea, patient weight (obesity may increase apnea or smaller patients may be more sensitive to

dose levels of medications), asthma, history of smoking, drug-drug interactions, and first-time

medication use may contribute to increased risk.

Consideration of patient risk factors as well as the risks inherent in a medication must be taken

into account when determining the type and frequency of monitoring. Further, to enhance

continuity of care/safe medication administration, it is essential to communicate all relevant

information regarding patients’ medication risk factors and monitoring requirements during

hand-offs of the patient to other clinical staff, such as when patients are transferred internally

from one unit to another, during shift report at change of shift, etc. This would apply to hand-offs involving not only to nursing staff, but also to any other types of staff who administer

medications, e.g., respiratory therapists.

Adverse patient reactions, such as anaphylaxis or opioid-induced respiratory depression, require

timely and appropriate intervention, per established hospital protocols, and must also be reported

immediately to the practitioner responsible for the care of the patient. (See the guidance for

§482.23(c)(5) and §482.25(b)(6), concerning reporting of adverse medication-related events.)

An example of vigilant post-medication administration monitoring in the case of a high-alert

medication where patient factors may increase risk would be regularly checking vital signs,

oxygen level via pulse oximetry, and sedation levels of a post-surgical patient who is receiving

pain medication via a patient controlled analgesia (PCA) pump. Narcotic medications, such as

opioids, are often used to control pain but also have a sedating effect. Patients can become

overly sedated and suffer respiratory depression or arrest, which can be fatal. Timely assessment

and appropriate monitoring is essential in all hospital settings in which opioids are administered,

to permit intervention to counteract respiratory depression should it occur. (See also the

discussion of the requirements for intravenous medications at §482.23(c)(4)).

As part of the monitoring process, staff are expected to include the patient’s reports of his/her

experience of the medication’s effects. Further, when monitoring requires awakening the patient

in order to assess effects of the medications, the patient and/or the patient’s representative must

be educated about this aspect of the monitoring process. In addition, hospitals are encouraged to

educate the patient and his/her representative and/or family members about notifying nursing

staff promptly when there is difficulty breathing or other changes that might be a reaction to

medication.

Hospital policies and procedures are expected to address how the manner and frequency of

monitoring, considering patient and drug risk factors, are determined, as well as the information

to be communicated at shift changes, including the hospital’s requirements for the method(s) of

communication.

Documentation

Note that documentation of medication administration is addressed in the Medical Records CoP,

at §482.24(c), which specifies the required content of the medical record. Within this regulation

§482.24(c)(vi) requires that the record contain: “All practitioners’ orders, nursing notes, reports

of treatment, medication records, radiology, and laboratory reports, and vital signs and other

information necessary to monitor the patient’s condition.” Documentation is expected to occur

after actual administration of the medication to the patient; advance documentation is not only

inappropriate, but may result in medication errors. Proper documentation of medication

administration actions taken and their outcomes is essential for planning and delivering future

care of the patient. See the guidance for the various parts of §482.24(c) concerning

documentation in the medical record. Deficiencies in documentation would be cited under the

applicable Medical Records regulation.

Survey Procedures §§482.23(c)(1), (c)(1)(i), and (c)(2)

Verify that there is an effective method for the administration of drugs. Use the following

indicators for assessing drug administration:

• Verify that there are policies and procedures approved by the medical staff and governing

body concerning ordering of drugs and biologicals by practitioners.

• Verify that there are policies and procedures approved by the medical staff covering who

is authorized to administer medications, and that the policies are followed.

• Verify nursing staff authorized to administer drugs and biological are practicing

within their State-permitted scope of practice.

• Are personnel other than nursing personnel administering drugs or biologicals? If

yes, determine if those personnel are administering drugs or biologicals in

accordance with Federal and State laws and regulations, including scope of practice

laws, hospital policy, and medical staff by-laws, rules and regulations. Use the

above procedures to determine compliance.

• Verify that there are policies and procedures approved by medical staff addressing the timing

of medication administration.

• Verify that the hospital has, consistent with its policies, identified medications: which are:

• not eligible for scheduled dosing times;

• Eligible for scheduled dosing times and are time-critical; and

• Eligible for scheduled dosing times and are not time-critical.

• Verify the hospital has established total windows of time that do not exceed the following:

• 1 hour for time-critical scheduled medications;

• 2 hours for medications prescribed more frequently than daily, but no more

frequently than every 4 hours; and

• 4 hours for medications prescribed for daily or longer administration intervals.

• Verify that the hospital’s policy describes requirements for the administration of identified

time-critical medications. Is it clear whether time-critical medications or medication types

are identified as such for the entire hospital or are unit-, patient diagnosis-, or clinical

situation- specific?

• Review a sample of medical records to determine whether medication administration

conformed to an authorized practitioner’s order, i.e., that there is an order from an authorized

practitioner, or an applicable standing order, and that the correct medication was

administered to the right patient at the right dose via the correct route, and that timing of

administration complied with the hospital’s policies and procedures. Check that the

practitioner’s order was still in force at the time the drug was administered.

• Observe the preparation of drugs and their administration to patients [medication pass] in

order to verify that procedures are being followed

• Is the patient’s identity confirmed prior to medication administration?

• Are procedures to assure the correct medication, dose, and route followed?

• Are drugs administered in accordance with the hospital’s established policies and

procedures for safe and timely medication administration?

• Does the nurse remain with the patient until oral medication is taken?

• Are patients assessed by nursing and/or other staff, per hospital policy, for their risk

to their prescribed medications?

• Are patients who are at higher risk and/or receiving high-alert medications monitored

for adverse effects?

• Are staff knowledgeable about intervention protocols when patients experience

adverse medication-related events?

• Interview personnel who administer medication to verify their understanding of the policies

regarding timeliness of medication administration.

• Are they able to identify time-critical and non-time-critical scheduled medications?

Medications not eligible for scheduled dosing times?

• Are they able to describe requirements for the timing of administration of time critical

and non-time critical medications in accordance with the hospital’s policies?