CMS SOM App. A, Tag A-0508

must be immediately reported to the attending physician and, if appropriate, to the

hospital’s quality assessment and performance improvement program .

Interpretive Guidelines §482.25(b)(6)

Hospitals are required to ensure that the attending physician is made immediately aware of drug

administration errors, adverse drug reactions, and incompatibilities. When the attending

physician is unavailable, the covering physician must be notified. When the covering physician

must be notified, the patient’s attending physician must be notified as soon as he/she is available.

In addition, when appropriate, such events must also be reported to the hospital-wide Quality

Assessment and Performance Improvement (QAPI) program.

The hospital must adopt policies and procedures that identify the types of events that must be

reported immediately to the attending physician, as well as those to be reported to the QAPI

program.

• Drug administration error:

The National Coordinating Council Medication Error Reporting and Prevention

definition of a medication error is “Any preventable event that may cause or lead to

inappropriate medication use or patient harm while the medication is in the control of the

health care professional, patient, 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.”

In the context of this regulation, however, “drug administration error” is limited to those

errors in administration that actually reach the patient, i.e., a medication actually is

administered to a patient when it should not be, or the wrong dose is administered, or the

wrong root of administration is used, etc., or a medication that should have been

administered to the patient has not been administered in a timely manner, as discussed in

the medication administration standard at 42 CFR 482.23(c).

• Adverse drug reaction:

The American Society of Health-System Pharmacists (ASHP) defines an adverse drug

reaction (ADR) as “Any unexpected, unintended, undesired, or excessive response to a

drug that:

1. Requires discontinuing the drug (therapeutic or diagnostic)

2. Requires changing the drug therapy

3. Requires modifying the dose (except for minor dosage adjustments)

4. Necessitates admission to a hospital

5. Prolongs stay in a health care facility

6. Necessitates supportive treatment

7. Significantly complicates diagnosis

8. Negatively affects prognosis, or

9. Results in temporary or permanent harm, disability, or death.

Consistent with the definition, an allergic reaction (an immunologic hypersensitivity

occurring as the result of unusual sensitivity to a drug) and an idiosyncratic reaction (an

abnormal susceptibility to a drug that is peculiar to the individual) are also considered

ADRs.”

• Drug incompatibilities

A drug incompatibility occurs when drugs interfere with one another chemically or

physiologically. Drugs known to be incompatible must not be mixed, administered

together, or administered within a timeframe where they will interfere with each other.

When IV medications are administered with known incompatibilities, an error has

occurred and it needs to be reported to the attending physician immediately. Any

unexpected reaction that occurs between IV medications not previously identified as

incompatible also needs to be reported.

Hospitals can minimize the risk of administering incompatible medications by making

available pertinent resources, such as drug incompatibility charts and online

incompatibility references. The incompatibility information needs to be readily available

to staff administering medications. The information needs to be kept up-to-date as the

information is frequently updated by drug manufacturers.

The immediate reporting requirement applies to drug administration errors, adverse drug

reactions or incompatibilities that have harmed or have the potential to harm the patient. If the

outcome of the drug administration error is unknown, the physician must also be notified without

delay.

Drug administration errors that result in no or insignificant harm to the patient must also be

documented in the medical record but do not require immediate reporting to the attending

physician. For example, if an analgesic dose is missed during the night shift, it can be reported

first thing in the morning. Hospital staff is expected to use their clinical judgment, based on

patient presentation and assessment in accordance with hospital policy and procedures, to

determine whether immediate reporting is required.

On the other hand, for purposes of reporting to the hospital’s QAPI program, hospitals must, in

accordance with the requirements of the QAPI CoP at 42 CFR 482.21(c)(2), track and report not

only the errors that cause or risk harm to the patient, but also those which do not. Such “near

misses” and suspected ADRs may reveal important information about systems vulnerabilities

that the hospital should address in order to avoid events that result in harm.

Hospitals must establish policies and procedures for reporting of medication errors, ADRs, and

incompatibilities, and ensure that staff is aware of the reporting process. For those events that

require immediate reporting, the hospital’s policies must establish timeframes for reporting that

are based on the clinical effect of the error on the patient.

To improve staff willingness to report medication error incidents, hospitals are encouraged to

adopt a non-punitive approach that focuses on system issues rather than individual health care

professionals. A non-punitive approach is likely to encourage reporting by those who otherwise

may fear retribution or hospital disciplinary action.

In addition to employing broad definitions of medication errors and ADRs for QAPI tracking

purposes and encouraging the reporting of medication errors, ADRs and drug incompatibilities,

the hospital must take additional steps to identify these events as part of its QAPI program where

medical errors and adverse patient events are measured, analyzed and tracked. Reliance solely

on incident reporting fails to identify the majority of errors and adverse reactions. Proactive

identification includes observation of medication passes, concurrent and retrospective review of

a patient’s clinical records, ADR surveillance team, implementation of medication usage

evaluations for high-alert drugs, and identification of indicator drugs that, when ordered,

automatically generate a drug regimen review for a potential adverse drug event.

The hospital must have a method by which to measure the effectiveness of its systems for

identifying and reporting to the QAPI program medication errors and ADRs. Such methods

could include use of established benchmarks for the size and scope of services provided by the

hospital, or studies on reporting rates published in peer-reviewed journals. Hospitals are

encouraged, and may be required by State law, to participate in statewide and national reporting

of drug administration errors, adverse drug reactions, and incompatibilities. National

organizations include, but are not limited to, the Food and Drug Administration’s (FDA)

MedWatch Reporting Program and the Institute for Safe Medication Practices (ISMP)

Medication Errors Reporting Program.

Survey Procedures §482.25(b)(6)

• Does the hospital have policies and procedures that define medications errors, ADRs, and

drug incompatibilities? Do they address the circumstances under which they must be

reported immediately to the attending physician, as well as to the hospital’s QAPI

program? Do they address how reporting is to occur?

• Are all medication errors and suspected ADRs promptly recorded in the patient’s medical

record, including those not subject to immediate reporting?

• If upon review of a sample of records, a suspected ADR or medication error is identified,

determine if it was reported immediately to the attending or covering physician, in

accordance with the hospital’s written policies and procedures. If it is reported to a

covering physician, determine if it was also reported to the attending physician when

he/she became available.

• Ask hospital staff what they do when they become aware of a medication error, ADR or

drug incompatibility. Are staff aware of and do they follow the hospital’s policy and

procedures?

• Ask hospital staff how they manage drug incompatibilities. What tools do they use in the

clinical setting to minimize the risk of incompatibilities? How is the information related

to drug incompatibilities made available to the clinical staff administering IV medications

(posters, online tools, etc.)? How often is the information updated to ensure accuracy?

• Interview hospital staff to ascertain awareness of the hospital’s policy on reporting and

documentation of medication errors and adverse drug reactions.

• How does information regarding medication errors, adverse drug reactions, and

incompatibilities get reported to the hospital QAPI program? Ask staff to speak to the

process.

• For QAPI reporting purposes, is the hospital’s definition of an ADR and medication error

based on national standards?