Originally published in CAP TODAY
Each laboratory inspector has his or her own inspection style, but most use some combination of three methods. In an audioconference titled "Best Inspector Practices," Renee Ellerbroek, MD, the CAP's North Central regional commissioner, explained each method and how to get the best results.
First, the "teach me" method. The inspector of a particular section selects an instrument or analyte and asks the laboratory staff to demonstrate how things work—as if they were teaching a new technician or technologist. "The laboratory would be asked to teach the inspector about the procedure for the test, instrument setup and maintenance, calibration, QC, proficiency testing, reagents, carryover studies," and more, says Dr. Ellerbroek, of Iowa Pathology Associates/Regional Laboratory Consultants, Des Moines.
This need not be an entirely analytic phase method. The same style can be used, for example, in phlebotomy or the lab information system section.
Method No. 2, the drill-down technique, is a comprehensive look at a select group of analytes. "If the lab is from top to bottom looking good on a sampling of a few carefully selected tests, chances are there is an overall commitment to quality," Dr. Ellerbroek says. A variety of individuals should be questioned, she says. "That's the only way to find out if there's a disconnect between laboratory management and what happens at the bench."
Which analytes to select? They can be high volume (if performed improperly, a lot of patients are affected), low volume (they're done so infrequently that some testing personnel may not know the procedures well), high impact (HIV, CSF studies, blood cultures, for example), from the variant proficiency testing report (those challenges that have not scored 100 percent in the last testing periods), a previous deficiency, or new analytes or tests done on a new instrument.
Say that a lab had difficulty with proficiency testing and one or more of those analytes are selected for review. "Look at the QC data before and during the time of the failure," Dr. Ellerbroek advises. "Look for shifts that occur even within acceptance ranges—for example, a shift that occurs due to a change in reagent lot. This may reveal that recalibration was needed and wasn't performed, or that it was done but not done properly." As an example, the calibrators may have deteriorated or concentrated. Also, the manufacturer may not require re-calibration with reagent lot changes, but the lab's historical QC data may indicate that it may be necessary to do it anyway.
Next, look at the instrument maintenance, Dr. Ellerbroek continues. "Maybe the lab isn't following through with the proper maintenance recommendations. Or maybe there is a reason they need to exceed those recommendations."
Then review setup procedures, carryover studies, reagent validation, analytical measurement range determination, and competency. "If you uncover problems, then ask for more information," Dr. Ellerbroek says.
Technique No. 3 is to follow the specimen from origin to reporting and beyond, and it's used commonly by laboratory general and blood bank inspectors. The idea is to read policies and training procedures, observe workflow and how people do their jobs, and ask questions.
Begin where the specimen originates, Dr. Ellerbroek says. "Review requisitions. Are they clear and easy to read? Do they contain all of the required information?" Visit the pneumatic tube station, phlebotomy area, and courier drop. Ask questions like, "What happens when a tube of blood comes to you unlabeled or mislabeled?" or "How do you account for all of the specimens at a certain pick-up site?" Who do they call when a patient has a reaction in phlebotomy and how do they respond to needlesticks or blood spills? Ask about training, specimen rejection criteria, maintaining specimen integrity, patient ID, and the lost-specimen protocol.
In accessioning, ask if there is support from the manager, pathologist, or both if there's a problem, and what they do when a test is ordered that they're not familiar with.
Move next to the analytical area —the bench—where you should ask open-ended questions that will elicit responses to perhaps several checklist questions at a time. Ask employees about their PT policies (Is PT conducted in a manner identical to patient testing?), training and competency protocols (Do they feel they've been trained properly?), the instrument they work with (setup, maintenance, reagents, calibration, if there are problems with it and how they're handled), and carryover studies, analytical measurement ranges, and reagent validation studies (What are the procedures and are they followed?). Observe safety practices and quiz employees, as in "Could you describe your policy for controlling bloodborne pathogen exposure—or tell us where to find it?"
Look for a strong quality control plan and find out if it's being followed. "This is best accomplished," Dr. Ellerbroek says, "by talking to as many individuals as possible who perform QC in that department." QC results have to be acceptable before patient results are released, and the director or his or her designee has to conduct a monthly review. Verify that target QC ranges are validated for quantitative tests and that they're calculated in-house. "This is a frequent deficiency in point-of-care testing and blood gas testing," Dr. Ellerbroek says. "Initially, it's acceptable to verify that QC is in the manufacturer's range, but good laboratory practice includes later calculation of the lab's own range from a statistically valid number of determinations."
Establish that there are documented tolerance limits and look at the actions that are taken when controls fall outside those limits.
A good inspector, Dr. Ellerbroek says, will request QC data on "noisy"
tests—those that are less precise and may experience more frequent
QC failures as a result, for example, bilirubin, CO2,
Make sure outliers have comments from the technologist doing the testing. Examine the procedure for determining acceptance ranges and the lab's policies and troubleshooting records for bringing these tests back into QC range. And look at the actual instrument printout to see if the lab is doing multiple QC determinations and then choosing only the best-looking data and discarding the rest.
When multiple employees are quizzed about an issue and different answers are given, reconcile the discrepancies with the supervisor, Dr. Ellerbroek advises.
She offers a tip that experienced blood bank inspectors use, but says "it really can be used for any discipline." Ask to look at a policy or procedure that has been changed recently. Study what precipitated the change, such as what problem or regulatory consideration was identified to spur a change in policy. What steps were taken in the process of making a change, and how was the section educated about the change? How will competency be maintained?
You've now reached the postanalytical phase where you will want to review the laboratory's reports. Are reference ranges and units clearly indicated, and do they make sense to you? How does the lab highlight abnormal results?
"Review some corrected reports also to see that they are clearly identified as such" and that they contain the original and corrected values, Dr. Ellerbroek says. Look at calculated lab values—are they verified and how often?
Look also at the critical values protocol—how are the values determined and is the medical director involved? How are they reported, what is the policy on who can take the report, and what are the policies on documentation?
Here, you'll also want to check out the information system—downtime procedures, alternative access routes, posted or shared passwords, for example.
Finally, confirm that the lab's practices for results filing and retrieval and retention match its own policies and the CAP's requirements.
As an inspector, you will want to determine if the laboratory is using its quality management plan to improve quality or "if it's just going through the motions to fulfill a requirement," says Dr. Ellerbroek, who suggests asking how the monitors are selected.
"Does the lab select challenging processes to look at? How often do they change? Do they cover all three phases of testing and multiple areas of the lab?" Ask how the lab responds to problems that QM projects expose, how employees learn of policy changes that result from the findings, and how involved the lab director is. "Is there evidence of evaluation of the plan's effectiveness? A simple signature is not enough," Dr. Ellerbroek says.
One or two or all three inspection methods can be used, depending on the inspector's "experience, personality, and preparedness," she says. Each one requires that a lot of time be spent in the area of the lab where the testing is done. "And, remember," Dr. Ellerbroek advises, "always stay focused on patient care and employee safety."
Sherrie Rice is editor of CAP TODAY.