Complaint Investigation

Before CLIA, quality-conscious laboratories considered the QA process to be the means to achieving accurate and reliable test results, identifying areas of laboratory services in need of improvement, and eliminating sources of error and complaints. Other labs never considered QA at all, or only briefly, before moving on to "more important" matters.

After ten years of CLIA implementation, Knapp·Frazer Consulting sincerely hopes that most labs in the latter column have moved to the former. All businesses want to offer reliable products, improve service, and eliminate complaints. Don't we?

What Complaints?

The exchange often goes something like this:
CLIA Inspector: Do you document complaints?
Lab Director: No, we don't get complaints.
CLIA Inspector: How do you know that you don't get complaints if your staff doesn't document them?
Lab Director: Good question.

In the typical laboratory, or any other business, the person handling incoming calls hears most of the complaints and activates some internal filter to decide which, if any, of them get passed on to a supervisor or manager. While ignorance may be bliss, it does nothing to improve service or customer satisfaction. Customers who are not satisfied soon become someone else's customers.

Part of staff motivation for not relaying complaints is that someone is likely to get into trouble as a result. The first step, then, is to eliminate the blame factor.

Just the Facts

Like the news reporter, staff involved in complaint investigation must discover who, what, where, how, and why. A complaint or incident report form should be available to those staff members likely to receive complaints. The form should prompt staff to obtain as much information as possible from the patient or other individual making the complaint. When did the incident occur? Where? What happened? What was the immediate result or outcome?

HIPAA allows patient information to be used for QA purposes, but limiting ID to patient initials and DOB works in most situations. Should the need arise to add copies of the patient's chart or lab reports to the incident report, you might obscure patient ID on the copies. Reveal complete patient identification to those with a need to know.

The staff member documenting the incident should sign and date the report and forward it to the individual(s) responsible for QA within the lab and/or for the larger organization. If a non-laboratorian receives all complaints, those involving the laboratory should be forwarded to lab staff.

Please note that required information does not include the name of the employee(s) who might be considered responsible for the incident. No blame, remember.

The Systems Approach

Next, verify the complaint by investigating the given facts and determining how and why by looking at records and events surrounding the incident. Interview staff as necessary to get a complete picture of events. Remember, no blame.

Occasionally, the investigation will reveal that the complaint was made as the result of a misperception or exaggeration. Most complaints are justified, however, and an evaluation must be made as to the cause of the incident. Were any policies broken -- or followed -- that may have contributed to the incident? Was a piece of equipment involved in the incident? Had it been properly maintained? Correctly operated?

After identifying the probable cause(s), what steps can be taken to reduce and, hopefully, eliminate future occurrences? Take whatever corrective action is warranted. Rewrite a policy or protocol; retrain staff; repair/replace equipment; use or install a safety device...

Problem solved? The final step in a comprehensive complaint investigation is to monitor the effectiveness of the corrective action. If additional complaints of the same type are received, it's time to start again at square one.

Knapp • Frazer Consulting • 707.539.6621 • info@knapp-frazer.com
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