Guideline text:
(Rev. 95, Issued: 12-12-13, Effective: 06-07-13, Implementation: 06-07-13)

§482.25(b)(6) - Drug administration errors, adverse drug reactions, and incompatibilities 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 upto-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?

(Rev. 37, Issued:  10-17-08; Effective/Implementation Date:  10-17-08)

§482.25(b)(7) - Abuses and losses of controlled substances must be reported, in accordance with applicable Federal and State laws, to the individual responsible for the pharmaceutical service, and to the chief executive officer, as appropriate.

## Survey Procedures §482.25(b)(7)

- Interview the pharmacists, or pharmacy employees to determine their understanding of the controlled drug policies.
- Conduct a spot check of drug use and other inventory records to ensure that drugs are properly accounted for.
- Review reports of pharmaceutical services to determine if there are reported problems with controlled drugs and what actions have been taken to correct the situation.
- Interview the Pharmacy Director, pharmacist and pharmacy employees to determine their understanding of the controlled drug policies. Is there a policy and procedure for handling controlled drug discrepancies?
- Review reports of pharmaceutical services to determine if there are reported problems with controlled drugs and what actions have been taken to correct the situation.
- Determine if controlled drug losses were reported to appropriate authorities in accordance with State and Federal laws.

Structured rule (JSON):
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