Guidance [Health Devices Aug 1998;28(8):277-92]
Problem Reporting and Its
A nurse observes that an infusion pump is associated
with an underdelivery of medication to a patient and sends the device for
repair. The biomedical engineering department examines the device, finds it to
be working properly, and returns it to service. The same scenario has been
repeated several times before.
End of incident? Probably not. The reason for the
occurrence is still a mystery. Was the user not familiar with how to program the
pump? Was the pump inherently difficult to program? Was the pump's software
faulty? Or might the problem have been caused by misinstallation of, or damage
to, the disposable infusion set—a separate device altogether? With none of these
questions answered, the problem could recur in a week or a month or a year—and
the next time it happens, perhaps a patient will suffer a reaction or even
What should be an automatic
follow-up to this—or any other—incident is prompt reporting of the problem to
the appropriate staff in the hospital and also, perhaps, to the supplier, ECRI,
and the appropriate government agency.
What Is Problem Reporting?
Put simply, problem reporting is the communication of a
device deficiency or user-related issue to those who are likely to provide or
contribute to a constructive response. An effective problem reporting system
accurately determines which problems should be reported and provides a mechanism
to make, act on, and track reports, and to track any corrective actions. Several
different types of problem reporting systems have evolved during the past few
decades. They can be grouped broadly into three areas:
- In-house incident reporting systems
- Private, nongovenmental systems, such as ECRI's
Problem Reporting System and User Experience Network (UEN)
- Systems maintained by government agencies, such as
the U.S. Food and Drug Administration's (FDA) Medical Device Reporting (MDR)
system and the U.K.'s Medical Devices Agency (MDA), which is charged with
meeting the vigilance requirements of the European Union's (EU) Medical
Devices Directive (MDD)
The common goal of these systems is to help reduce the
likelihood, seriousness, and recurrence of medical device problems.
The Benefits of Problem Reporting
Within the hospital, an effective reporting system not
only helps prevent problems from recurring but also helps meet the requirements
of the government, insurers, or certifying bodies (such as the Joint Commission
on Accreditation of Healthcare Organizations [JCAHO] in the United States). It
also helps lower the institution's liability profile. But reporting
device-related problems also has much broader ramifications and can ultimately
benefit the entire healthcare community.
For example, disseminating information about device problems outside the hospital prompts the publication of information about those problems. This serves to notify others that the problem exists, possibly helping them avoid the problem altogether, and can prompt an informed person or organization to develop a solution. Medical journals often print letters and case reports describing a problem that arose while using a device and providing recommendations on how the problem can be avoided. A few governments (notably the United States, the United Kingdom, Australia, and Canada) provide user feedback through published articles. In the United States, for example, FDA issues Notices, Public Health Advisories, Safety Alerts, and product recalls (see the discussion under U.S. Problem Reporting Systems, below, for more information). And ECRI consistently, speedily, and comprehensively publishes information about problems—most notably in the Hazard Reports and UEN articles seen in Health Devices and in the weekly abstracts in Health Devices Alerts (HDA).
Moreover, this wealth of published information is also
easily retrievable through databases such as FDA's Manufacturer and User
Facility Device Experience (MAUDE) and MDR systems, ECRI's HDA database, Index
Medicus, Grateful Med, and MEDLINE. Purchasing managers, for instance, can glean
from these databases the relative number and types of problems associated with a
particular device, making it easier to select a reliable model. Similarly,
accident investigators, lawyers, and risk managers need to know about problem
trends to help identify the causes of accidents and ways to prevent them.
Consider the incident described at the beginning of this
article. If the problem were appropriately reported, then risk management,
nursing, and pharmacy staff might review procedures for using the pump and
identify a lack of training that led to the incident. The supplier might realize
that the instructions for using the pump are too complex or confusing. ECRI
might alert others to the potential for such an incident and provide specific
recommendations to prevent it, while strongly encouraging the supplier to
address the problem. The government might require corrective measures to prevent
similar problems in the future. This government action could be logged into a
number of problem reporting databases throughout the world and help identify
trends in incidents involving the device in question.
Problem Reporting within the Hospital
Who Should Report
Problem reporting is not the exclusive province of any
department or specialty. Anyone who is involved with or who discovers a problem
should report it internally—not just physicians and nurses, but also engineers
and any other staff members who use or maintain medical devices.
Every healthcare institution should carefully instruct
its personnel about the importance of immediately reporting any device-related
adverse incident or product defect, as well as facilitating any subsequent
investigation. ECRI has published a poster, "Accidents Happen—An Immediate
Action Plan" that instructs healthcare workers on the steps to take following an
incident. These instructions include securing the equipment involved and
preserving the scene so that an investigation can be conducted. All staff
members should be made aware of these instructions.
What Should Be Reported?
Reportable Problems and Outcomes
A problem can be defined as an event that is unexpected
within the normal use of a medical device and that causes or could potentially
cause harm or difficulty. Healthcare workers need to be aware of what sorts of
device-related events and outcomes should be reported.
Health-Threatening Problems. Obviously, any incident
or device problem that directly harms a patient or caregiver must be reported.
Examples are administering the wrong dosage of a potent medication and the
occurrence of an airway fire during a tonsillectomy. Some problems hold a less
obvious potential for harm but still require reporting. These include mislabeled
packaging and a device failure detected during setup; either could cause injury
During ECRI's 27 years of investigating medical device
problems and accidents, we have identified the causes and adverse outcomes of
most types of device problems. From these, we have identified nine basic types
of problems that should be reported. We have also identified the serious
outcomes that can result from these incidents. These problems and outcomes are
Difficulties and Nuisances. Difficulties are
problems involving ease-of-use issues, increased maintenance, repeated repair
requests, higher costs, or other nuisances. They include incomplete distribution
of service bulletins and poor seals leading to device corrosion. Difficulties
generally do not pose a significant risk of harm but should be reported
internally and often externally to improve the quality, timeliness, and
cost-effectiveness of care.
Sometimes the difference between a serious problem and a
minor difficulty is not readily apparent. Consider the infusion pump problem
described at the beginning of this article. While the problem did not cause a
patient injury, it certainly had the potential to do so. And in any event, the
time and effort wasted in checking the pump created a difficulty. Should it be
reported internally? Yes. Externally? Probably—so that others can be made aware
of it and perhaps even diagnose the cause. Discussing such an event with a
knowledgeable third party (e.g., risk manager, ECRI) can help determine its
What to Include in a Report
A problem report should allow readers to identify the
device, the problem, and the actual or potential outcome or difficulty.
Identifying Information. To begin with, the
patient's name and physician and the device user's name should be recorded.
(Note, however, that if the report will be sent to an outside agency, patient
and staff confidentiality and liability issues may arise. Facilities need to
have policies in place addressing these issues—as well as the other
confidentiality issues described below.)
The device or its packaging will typically be labeled
with the device's name, supplier, serial number, model number, catalog number,
lot number, or other specific identifiers; all these should be reported. The
report should also include the age of the device and the date it was last
inspected and/or serviced, the expiration date of a disposable device, how long
the device was in use, the facility's history of use of the product line, and
the date of the incident. These items are not only important for initial record
keeping but also help define the type of problem (e.g., manufacturing defect,
user error, adverse clinical effect) and provide perspective on the incidence of
the problem. Any accessories used with the device should also be listed and
described. Finally, the reporter should also provide his or her complete
address, telephone number, fax number, and e-mail address so he or she can be
contacted for further detail if needed. (Note, however, that e-mail
transmissions may not be secure, and the advisability of sending sensitive
information by this method should be carefully considered.)
Description of the Incident. A clear and complete
description of the incident is critical to the report's usefulness. Such a
description explains what happened, how it happened, why it happened, when it
happened, where it happened, what the outcome was, and any other information
that could be pertinent. Without all this information, the report becomes next
to useless in helping to prevent future problems.
What constitutes a comprehensive description depends on
the complexity of the problem. Most reports can be defined in one or two short
paragraphs. In a few cases, a simple descriptive sentence is all that is needed:
"The cannula was found to be broken in its package." In contrast, some problems
require a full-page description supplemented with photographs or
Unfortunately, problem reports are too often sketchy and
vague, which can create difficulties in identifying trends or otherwise applying
the information the reports provide. The medical device databases are replete
with reports stating only that the device "broke." Some reports, on the other
hand, provide exhaustive detail about the patient's prior condition, the
procedure, or follow-up treatment, but fail to explain the basic problem that
caused the incident. Although irrelevant details should be avoided, the more
essential details the report contains, the more useful it will be.
Complicating the picture, however, is the fact that too
much detail can raise liability concerns. While most internal problem reporting
systems provide a degree of confidentiality, the occurrences described in a
report may be so specific that the actual incident will be identifiable by
parties outside the institution (e.g., a lawyer or expert witness reviewing a
problem reporting database). The information in the report can be potentially
damaging in any subsequent legal action, especially if the information is
preliminary or inaccurate. Therefore, reports should be reviewed by risk
management or legal counsel (if deemed necessary) before being sent out of the
Who Receives the Report and the Actions They Take
Problems are typically reported first to the facility's
risk manager or other problem reporting coordinator. This person ensures that
there is a system in place to evaluate the problem, act on it to prevent its
recurrence within the facility, and report it as required or requested by
outside agencies. Some facilities have a dedicated risk manager. Others use the
operating room supervisor, biomedical engineering director, chief engineer,
purchasing manager, or head nurse as the problem reporting coordinator. Still
others give such staff members the authority to report problems directly to
Depending on the specifics of the problem (e.g.,
severity, potential for litigation), the risk manager or problem reporting
coordinator must ensure that certain actions are taken and that the efforts of
various groups are coordinated, as listed here.
- Review and follow up on the internal report form.
- Contact the problem's reporter for more detail on
- Have the biomedical engineering staff impound the
device, including disposables, until its performance can be reviewed. If
appropriate, consider quarantining other similar devices pending preliminary
- If the model name is unfamiliar, ask the purchasing
manager or the clinical engineering department to identify the supplier of
the problem device(s).
- Contact the supplier's quality assurance manager or
regulatory affairs officer to report the problem and, if appropriate,
coordinate repair or replacement of the problem device.
- Review ECRI's HDA database for similar problems.
- If appropriate, have an independent third party
investigate the problem.
- Based on the preceding steps, evaluate the problem
and identify the cause.
- Document any investigation
- Make recommendations for corrective actions to
prevent future occurrences.
- Develop preventive policies or procedures.
- Have the chief physician or head nurse review these
new policies or procedures.
- Have the nurse educator or clinical educator set up
user education programs.
Ensure that corrective action is taken.
- Have the risk manager or safety
committee order the implementation of preventive procedures.
- Follow up to ensure that
preventive recommendations are implemented, and verify that they are
- Complete any required
regulatory reports (e.g., FDA MedWatch Mandatory Form
Determine what to report and how to report it; be
judicious in making this determination (e.g., consult legal counsel).
- If a report was not
submitted to a regulatory agency, internally document the
- Provide a report summarizing the problem and its
- the safety committee, quality assurance office, and
others who may be concerned about the problem;
- regulatory agencies as required (e.g., annual
reports to FDA); and
- Retain appropriate documents and materials.
The Importance of Timely Reporting
Regardless of the type of event, the speed of its
reporting can have significant consequences. For example, stocks of disposable
devices are used up quickly, and any problem involving a specific device lot
needs to be promptly addressed to help prevent other occurrences. Problems that
are very likely to recur or cause serious injury or death also require fast
Some governments have time specifications for reporting.
For example, in the United States, FDA requires healthcare facilities, under
penalty of fines, to report some types of device incidents within 10 working
days of their becoming aware that a specific device caused the incident.
Similarly, the EU and Canada require manufacturers to report incidents within 10
days. Timely methods for alerting other governments to serious, widespread
problems are being developed by the Global Harmonization Task Force, which is
working to make various countries' problem reporting systems as compatible as
Problem Reporting to Outside Organizations
Procedures Involved in Outside Reporting
Once it has gone through the necessary in-house
processing, a problem may need to be reported to a governmental or regulatory
agency or other organization—such as FDA in the United States or MDA in the
United Kingdom—and in some cases to the manufacturer of the device(s) involved
in the problem. The problem reporting coordinator must be familiar with the
prevailing national requirements and thus be able to identify how and under what
circumstances outside reporting is appropriate. Problems should also be reported
to ECRI, which, while not a governmental agency, encourages facilities to use
its Problem Reporting System.
When a report is received by most suppliers or agencies,
it is subject to the same general process. The report is first reviewed to
determine its severity and likelihood of recurrence. These factors will
determine how the report is acted on. For example, a report identifying a known
complication may not require action, while an incident determined to be caused
by a defective device may initiate a recall or the publication of a notice about
the problem. The agency will often notify the reporter about the outcome of his
or her report.
The Problem Reporting Systems of Different
Even though problem reporting is important throughout healthcare, supplier, and regulatory circles, only a few governments (e.g., the United States, EU member states, Australia, Japan) require that problems involving death or serious injury
be reported to the supplier and/or a governmental agency. The requirements of
these countries generally apply to users, facilities, and/or device suppliers,
and fines can be imposed on those who do not report. Below, we detail the
reporting protocols of some of the better-known problem reporting
U.S. Problem Reporting Systems
FDA's MDR and MedWatch Systems. FDA set up its
problem reporting system, the MDR system, in 1984, based in part on ECRI's
Problem Reporting System. In its initial stages, the MDR system required device
manufacturers and importers to report device-related deaths, serious injury, and
certain malfunctions identified through user reporting. Subsequently, as a
result of the Safe Medical Devices Act (SMDA) of 1990, the MDR system expanded
to include the requirement that healthcare facilities report to the manufacturer
events in which a device caused or contributed to death or serious injury. As
noted earlier, healthcare facilities must report these incidents no later than
10 working days after becoming aware of them. SMDA also requires facilities to
provide FDA with an annual summary of reported incidents (using FDA Form 3419).
In addition, SMDA requires facilities to develop, implement, and maintain
written procedures for medical device problem reporting.
Problem reports were initially collected in FDA's Device
Experience Network (DEN) database. Under SMDA, a new database was created, the
MAUDE system. In late 1997, the MAUDE database was made publicly available. It
will eventually incorporate the DEN and will be linked to other FDA databases
such as the device registration and premarket review databases. This linkage
should enable better identification and tracking of problems and trends.
FDA provides two MedWatch forms for problem reporting:
Form 3500A, which is used for mandatory reporting "by user-facilities,
distributors, and manufacturers," and Form 3500, which is used "for voluntary
reporting by health professionals of adverse events and product problems." (The
identity of facilities filing many of the MedWatch reports would have become
public knowledge had not ECRI and FDA urged legislators to change the law—the
Modernization Act of 1997—to provide anonymity for database reporters. This
change was enacted just before the MAUDE database was made public.) ECRI has set
up a Computerized Problem Reporting System through which healthcare facilities
and users can electronically file MedWatch forms with FDA or manufacturers. ECRI
forwards the forms and automatically files the required annual reports.
Once FDA receives a report from the healthcare facility
or the manufacturer, it enters the report in its database. Health hazards and
trends are identified, an assessment is conducted, and additional information
may be requested from the user or the manufacturer. Manufacturers are required
to investigate, evaluate, and identify the underlying cause of each problem
reported to them. Often the manufacturer initiates solutions to the problem, and
FDA typically relies on the manufacturer's conclusions to close the problem's
file or start any needed regulatory action (e.g., recall, retrofit).
Depending on an incident's nature and severity, FDA occasionally publishes Notices, Public Health Advisories, or Safety Alerts to make healthcare providers, facilities, and organizations aware of the problem. Notices are letters sent to healthcare professionals and organizations involved in a particular problem. Public Health Advisories are widely distributed statements about a problem, its risks, and general recommendations for its prevention. Safety Alerts are also widely distributed but specifically address high-risk problems involving death or serious injury. Problems reported to FDA are also communicated through the FDA Medical Bulletin, the U.S. Centers for Disease Control and Prevention's Morbidity and Mortality Weekly Report, the American Journal of Nursing, the Journal of the American Medical Association, and ECRI's Health Devices Alerts. And some problems also result
in medical device recalls, either voluntarily by the manufacturer or imposed by
JCAHO's Sentinel Event Program. In early 1996, JCAHO
released its Sentinel Event Policy, which encouraged healthcare organizations to
voluntarily report certain events to the organization. This policy defines a
sentinel event as "an unexpected occurrence involving death or serious physical
or psychological injury, or the risk thereof." It also describes the steps by
which a hospital should uncover the root causes of problems to improve its
quality of care, which goes a step beyond FDA reporting requirements. JCAHO's
attempts to enforce this policy have created some controversy, and the future of
the policy is not clear.
The European Union's Medical Devices Directive
The EU recently enacted the MDD, which requires EU
member states to establish vigilance systems for monitoring medical device
problems. These systems will eventually be harmonized, and the information from
them will be shared throughout the EU. Incidents, as the EU calls medical device
problems, are defined as device-related events that cause, or have the potential
to cause, death, injury, deterioration of health, or unreliable test results.
They are reported to the local Competent Authority—usually a national regulatory
body—which has the governmental authority to act on the problems as it sees fit.
Reports are required from manufacturers and are voluntary from users.
The U.K.'s Competent Authority, for example, is MDA. One of MDA's agencies is the Adverse Incident Centre (AIC), established in 1987 as the National Reporting and Investigation Centre. AIC actively solicits and collects user reports on incidents (called adverse incidents in the United Kingdom) and on minor faults and discrepancies that
may indicate poor quality assurance with a device. AIC received 5,383 reports in
1997 and anticipates that this number will increase by about 500 reports each
year. AIC typically deals with routine reports by working with the supplier to
understand the problem and how to correct it. More serious reports are actively
investigated by both AIC and experts within MDA. This type of investigation may
result in Hazard Notices, Safety Notices, or Safety Action Bulletins that
communicate the problem and its corrective measures to U.K. healthcare
facilities, manufacturers, and—possibly in the future—appropriate
In addition to member states of the EU, other countries
are cooperating with the MDD, even though they are not bound by its provisions.
These countries include signatories of the European Free Trade Agreement,
Australia, and Canada.
ECRI's Problem Reporting System
ECRI founded the concept of medical device problem
reporting in 1971 and continues it today by encouraging voluntary problem
reports from its network of member institutions and other contacts around the
world. Hospitals in this network—or anyone else wishing to report a device
problem—can complete our Problem Reporting Form. (As an alternative, we also
accept copies of FDA MedWatch forms.) Upon receipt, the report is quickly
reviewed for seriousness and likelihood of recurrence. Dangerous problems
receive immediate action. Other, less critical problems are cross-checked in our
problem reporting, HDA, and FDA databases for similar reports. (One tool for
classifying these reports is ECRI's Universal Medical Device Nomenclature
System , or UMDNS.
In our weekly triage meeting, experienced engineers and
scientists sort the recently received reports into four categories:
- Problems that call for further investigation. These
reports are assigned to an engineer or scientist knowledgeable about the
involved device or technology. This person further reviews our databases for
other information on the problem and contacts the reporter and supplier in an
effort to resolve the problem and prevent its recurrence. (We do not divulge
any information about the reporter or the facility to anyone except the
supplier, and then only if it is appropriate and the reporter agrees.) The
involved device may be examined, similar devices may be tested, and the
device's design may be reviewed. However, many problems are concluded through
telephone discussions, and the report files are closed but retained in our
- Isolated incidents. These are events that appear
unlikely to recur (e.g., the device was operated under unusual circumstances,
the problem involved a random component failure). Information on these
incidents is maintained in ECRI's problem reporting database so that trends
can be identified if similar reports are received.
- Known complications. These are problems that have a
known history of occurrence. They will often have been described in the
literature. Users should read the literature to become aware of the potential
problems associated with the use of any given device.
- New problems—that is,
those of a type never before reported. These are evaluated and then
re-sorted into either of the first two
Some investigated reports result in conclusions that need to be communicated to the healthcare community. A problem that presents an immediate and serious danger of a widespread nature is quickly acted on and results in an ECRI Hazard Bulletin, which is sent to all Health Devices System members, all hospitals in North America, and most ministries of health around the world. Problems that are likely to cause harm are described in a Hazard Report published in Health Devices. Problems that are unlikely to cause harm but that will cause some difficulty or nuisance are defined in a UEN article, also published in Health Devices. Some problem report investigations prompt the supplier to distribute a voluntary statement about the problem and its corrective action; these statements are abstracted in HDA (as are all
Hazard Reports and most UEN articles).
To date in our 27 years of doing this work, ECRI has
published more than 25 Hazard Bulletins, about 800 Hazard Reports, and more than
300 UEN articles. These have resulted in hundreds of improvements to medical
devices and the avoidance of countless deaths and injuries.
Mining the Databases for Information
The Utility of Database Information
Problem reporting databases around the world contain
valuable information that healthcare institutions can use to identify trends in
medical device incidents and solve specific device-related problems. For
example, as described earlier, ECRI's Problem Reporting System relies on
database searches to help define the seriousness of problems, as well as the
likelihood of their recurrence.
Challenges in Identifying Data Trends
Certain difficulties inherent in problem reporting can present challenges to
effective trending of database information.
Lack of a Unified Database
In an ideal world, every problem report from across the
globe would be held in a single consolidated database. Unfortunately, such a
database does not yet exist. The largest centralized repository of problem
reporting data is ECRI, whose databases contain almost 850,000 citations. We are
working to merge our databases with those of countries such as Australia,
Canada, and the United Kingdom. And, as noted, the Global Harmonization Task
Force is working along similar lines. Perhaps someday these efforts will result
in a single unified repository for problem reports accessible from anywhere in
Overreporting is the filing of more than one problem
report describing the same problem or incident. This can happen if a problem is
separately reported to ECRI, the supplier, and FDA, ending up as three separate
database citations. Or a device's market share can skew the statistics: a
particular model may have no greater rate of problems than any other but still
be the subject of a greater number of reports because it is more widely
Overreporting suggests a greater incidence of a problem
than actually exists. Although this might occasionally prove beneficial—by
allowing a serious problem to be identified and remedied all the more quickly—it
is more likely to overload problem reporting systems with extraneous data. Most
systems can do little to cross-check for overreporting. Therefore, it is
important that data be interpreted by persons—such as investigators—who are
knowledgeable about the devices and about the specific types of incidents and
how they occur.
On the other hand, a particular problem may not be
reported by everyone who experiences it, leading to the conclusion that the
problem is not as great as it really is. For example, suture needles are known
to fail from several understood causes, yet these failures are infrequently
reported because "everyone knows" that needles break occasionally. As a result,
the actual reasons for some of the failures may never be identified and
therefore may never be corrected.
In late 1997, FDA stated that it receives about 100,000
medical device reports a year, but the agency considers this number just the tip
of the medical device problem iceberg. Based on information from our contacts
throughout the world healthcare community, ECRI agrees that medical device
problems are grossly underreported. Accurate reporting of every problem—which
requires adequate staffing of the problem reporting function and, in some cases,
enforcement within or from outside the hospital—would help eliminate
underreporting and improve the quality of healthcare.
Failing to Attribute the Problem to the Correct
Often, several devices are involved in an incident.
Careless investigating or reporting could result in all these devices being
reported as "causing" the incident, when in fact only a single device, or
perhaps the interaction between two devices, was the source of the problem. Such
carelessness results in both overreporting and misreporting—overreporting
because the same incident is cited several times, and misreporting because the
actual cause of the incident is not identified.
This difficulty can be minimized by meticulous
investigation of the incident (by an independent third party if warranted),
clear understanding of the roles of every device involved in the incident, and
accurate reporting that cites only the root-cause device or devices.
Identifying Subtle Trends
Trends in problem reporting data are sometimes obvious
but more often are not. Obvious trends can be seen, for example, in multiple
reports of broken (and unsterile) packaging in specific lots of a product or
early failure of a brand of defibrillator batteries. On the other hand, reports
of "underdose" and "overdose" involving a particular infusion pump could have
any number of causes: they could be separate problems, or they could be caused
by poor infusion data entry, complex software, battery failure, use of the wrong
infusion set, or several other difficulties. Without clear, detailed reports or
significant, knowledgeable investigation, specific trends cannot be easily
identified from these sorts of problems.
The Future of Problem Reporting
With experience comes wisdom. In the United States,
problem reporting has evolved over three decades into a tool that has been
wisely used by the healthcare community to reduce deaths, injuries, and costs.
And this evolution will continue. New computer systems and programs are enabling
faster reporting and better data analysis. Other countries are developing their
own problem reporting systems, often adapting to their own needs the methods
established by ECRI and FDA. Efforts—such as those of the Global Harmonization
Task Force—to link various agencies' problem reporting systems may soon allow a
problem reported in Australia to alert device users in Russia to the problem and
inform them of how to avoid it. Eventually, problem trends will be quickly
identified and prevented from growing.
But this will not happen without the continued reporting
efforts of the nurses, physicians, and engineers who work with the devices and
see the problems firsthand. All these individuals must be encouraged to clearly
report problems and see to it that those problems are corrected.