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Reflections of a CLIA surveyor.

The final regulations of the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) were published in the Federal Register Feb. 28, 1992. When inspections began in September 1992, physicians' office laboratories (POLs) became part of the regulated medical industry since CLIA covers all labs, regardless of site.

I have been a CLIA surveyor for two and a half years. The bulk of my surveys have been POLs ranging in size from one-doctor, one-nurse, two-test facilities to large group practices with both laboratory and x-ray capabilities. The more I survey, the more I am convinced that it is just as necessary to survey a POL, if not more so, than a hospital lab. POLs, often lacking the resources needed to hire staff with academic laboratory training, rely on nurses and the information gleaned from product representatives, package inserts, and newsletters to maintain their labs.

The CLIA regulations require labs to meet specific criteria in five areas: proficiency testing, quality control, patient test management, personnel, and quality assurance. Of these areas, I've found proficiency testing and quality control criteria to be violated most frequently, with quality assurance close behind. Below are a few observations on these three areas:

Proficiency testing

Since 1994, all labs have been required to enroll in proficiency testing (PT) programs and perform challenge tests. Successful grades - defined as having 80% of the results correct for each analyte - were required a year later, yet proficiency requirements were frequently misunderstood. Many of the POLs I've surveyed had not enrolled in PT programs by inspection time. Reasons varied from "We didn't understand what we had to do" to "We thought we'd wait until the survey so you could tell us what to do." Others enrolled when they received the letter announcing the imminent inspection.

Once enrolled, some facilities were able to cope with the paperwork; others did not realize there was a deadline for performing appropriate tests and left the packages in the refrigerator waiting for a quiet day or for their best person to return from vacation.

Quality control

According to CLIA's quality control (QC) regulations, each test must have two levels of controls performed each day of testing, yet I found countless labs not performing any controls at all, or performing only one, and forgetting to record results. Again, reasons for noncompliance varied. Admittedly, many test procedures are simple to perform, but it is difficult for a person without lab training to grasp the concepts of why quality assurance is necessary and what happens when it doesn't work.

Quality assurance

Quality assurance is another confusing area. QA is a familiar program in a hospital or for-profit laboratory, but almost totally unknown in a POL. I try to instill in testing personnel the background knowledge needed to recognize aberrant results and cope with problems. I tell physicians a properly followed QA program provides the checks and balances needed for their labs to be deficiency free by inspection time. I explain, describe, and give examples. CLIA also mandates that a technical consultant oversee the laboratory. In the POL setting, this usually is a physician, whose time, unfortunately, is devoted primarily to seeing patients.

Case studies

Laboratorians who have lived through CLIA '67 don't have a good sense of how a POL operates or of what to expect from an in inspection. Below are two scenarios based on personal experience that illustrate how diverse individual POLs are, and as a result, how no two POL inspections are the same.

A small POL. My appointment to conduct an initial inspection of this small POL consists of meeting primarily with the nurse who performs most of the laboratory work. I meet the doctor at the end of the survey. The office performs throat cultures, complete blood counts, and small chemistry profiles.

First I review the agenda, then go over the various forms CLIA demands. This information has been sent to the POL ahead of time and includes a list of tests performed, a list of all persons connected with the laboratory, and an ownership form. I look at PT records, check QC logs, review patient test management, ask about QC, and get a tour of the facility. As I review the list of people involved in laboratory activities, I explain the doctor usually is the director, clinical consultant, technical consultant - and sometimes even a testing person.

After looking at the doctor's credentials hanging on a wall, I ask to see the credentials of other testing personnel.

"Now," I continue, "I'd like to see your PT records." They proudly tell me that they have received passing scores (80% or better) for all challenges and produce a notebook containing information and two challenge reports, one with one incorrect chemistry making the score 80%. When I ask what corrective action was taken in response to the PT failure, I was told no action was taken. They should review the returned reports, I explain, and investigate and correct any problems found to contribute to an unsuccessful PT challenge. This is a necessary part of their record keeping system, I explain.

Next, we move on to QC records. The chemistry QC results were acceptable. Each day they have performed and recorded the controls. I congratulate them on their attention to detail. Then I turn to hematology records. First I find a six-week gap with no record of any controls. I ask if the office was closed or the machine was down for repairs. "No, we had problems with our supplier and couldn't buy the controls we wanted," I'm told.

When I ask if they still did patient testing, they tell me yes and that the machine never deviated from usual results. I try to make it clear that the issue isn't negotiable; controls must be run.

Further along in the log sheets, I find controls are recorded only sporadically next to patient results. The person who usually does that test, I'm told, had the day off and the machine was left running overnight so the fill-in employee would not have to worry about start-ups and controls. Again I explain that CLIA regulations require controls to be tested during each eight-hour operating period to verify the reliability of the test system.

The lab staff performs QC on bacitracin disks the first day of each month. One lab worker feels the incubator to make sure it isn't too hot. I hand out an example of a six-month temperature chart and tell them to use a thermometer to accurately determine the incubator temperature. I also explain that CLIA regulations require the laboratory to check bacitracin disks more frequently than once a month; they should be checked each week they are used for patient testing

At this point in the inspection, someone asks if I am going to shut them down. Another person asks if there will be fines. I reassure them on both counts. At this point, I give relevant examples of how to apply QA to their facility, for example, reviewing QC and PT information for significant variation. Before I leave, I tell them they will be given time to correct the deficiencies and that I can be called with questions.

An HMO-owned laboratory. My next stop is at a medium-sized family practice owned by a large health maintenance organization. I have visited other practices owned by the same HMO and know there will be no surprises. This particular practice conducts rapid streps, strep throat cultures, and urine colony counts.

Suzie and Sam, the two technical consultants from the main office, introduce me to the practice manager. The relevant laboratory books are piled on the lunchroom table. Ownership and personnel papers are in order; personnel files, including high school diplomas, are in a notebook; proficiency reports, complete with reviews and corrective action, are in another notebook. They show me all the QC records, temperature charts, media checks, and bacitracin disk checks.

As I look over the temperature charts, I notice gaps. I remark that temperatures have been missed frequently. The practice manager explains the office is closed on weekends, but I explain, "There are more gaps than weekends can account for." Reaching for my calendar to check the days without recorded temperatures, a pattern emerges. For the past two months, temperatures have not been taken on Tuesdays and Thursdays. Suzie sighs. "I knew you'd pick up on that," she says. The practice manager adds, "The new part-time nurse works those days." Sam laughs ruefully and says, "This is the quarter that the QA review will look at temperatures." But I use this observation to focus on the performance capability of the new employee as well. Personnel training and assessment records are reviewed and found to be complete.

As the inspection continues, I find no further deficiencies. Procedure and policy books are complete. Work logs have appropriate information. There are no expired reagents or supplies. The QA program is thorough and includes documented problem-solving activities. During the exit interview, I commend the practice manager for maintaining good records and tell her the facility is in compliance with CLIA regulations.

As you can see, there is tremendous variation in the number of tests done in a POL and in the attention to detail and grasp of the various regulations. Most facilities are willing to learn and do their best to comply, but I have encountered open hostility as well. This is partly due to the feeling that an inspection implies a questioning of the abilities and integrity of the laboratory staff.

CLIA is still a new program, and as such, keeps changing. Still, it is a necessary program that I hope will continue.

Sylvia Miskoe is a laboratory surveyor and consultant for the State of New Hampshire in Concord.
COPYRIGHT 1996 Nelson Publishing
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Title Annotation:Clinical Laboratory Improvement Amendments of 1988
Author:Miskoe, Sylvia
Publication:Medical Laboratory Observer
Date:Jul 1, 1996
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