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The self-assessment survey.

Perhaps the most important legal event in the last twenty years for the clinical laboratory profession was the passage of the Clinical Laboratory Improvement Amendments (CLIA) of 198& The requirements for recordkeeping, documentation of personnel competency, and other minimum standards set forth in these amendments would change the everyday routines of laboratorians all over the U.S.

In 1994, MLO published a poll of laboratorians' opinions of CLIA '88 that was conducted one year after its implementation in 1992. At that time, roughly two out of three laboratorians felt CLIA had failed to improve the quality of patient care and that it had adversely affected the clinical laboratory profession. Since then, a lot has happened. More and more tests have been granted waived status; HCFA has indicated it will accept JCAHO, COLA, and CAP accreditation in lieu of a CLIA inspection. HCFA and COLA have developed self-surveys for use by labs in good standing with CLIA regulations. Managed care has driven the consolidation of POLs into larger group practice labs as well as the consolidation of reference and hospital labs. Because of these and other changes in the clinical laboratory landscape, we thought it was time to see if these opinions had changed as well as to assess the overall effect of CLIA as seen by the average laboratorian.

In our survey, we asked how laboratorians are coping with CLIA inspections and what effect they think CLIA has had on the laboratory profession. Respondents were asked who last inspected their labs; how their inspections were conducted (i.e., on-site inspection or a self-assessment questionnaire); how much notice they received before each inspection, and whether they felt that notice was sufficient; and the types of deficiencies found during their most recent inspections.

In addition, we asked respondents to tell us how demanding, in terms of effort, each phase of an inspection is (i.e., preparation, review of results, formation of corrective action plans, etc.); whether their labs experienced any improvements since CLIA was enacted and if so, the extent to which they attribute any changes to CLIA; what additional costs their labs have incurred to comply with CLIA requirements; and their opinions of the overall effect CLIA has had on both their labs and the clinical laboratory profession as a whole.

A demographic profile of the laboratorians who participated in this study can be found on page 40 (see box, "Methodology").

Overall, an improved perception of CLIA

We like to think the overall impression laboratorians have of CLIA's effect on laboratory testing has become more favorable over the past four years. It is the personal opinion of 43% of the respondents that CLIA has had a positive effect on their laboratories, and 46% believe CLIA has had a positive effect on the clinical laboratory profession as a whole. Approximately one-fifth (20.3%) of survey respondents said they thought CLIA has had a negative effect on the lab, which we think compares favorably to the two-thirds of respondents who said in 1994 that they thought CLIA hurt the quality of patient care. Time and again, laboratorians told us they thought CLIA had improved marginal labs and improved the quality of testing done in POLs. More about the overall impression laboratorians have of CLIA and where it's going will be presented in Part 2 of this report.

Who's inspecting whom?

Of the 82% of respondents who reported that their laboratories are inspected by one or more non-governmental agencies, most said they are inspected by CAP, followed by JCAHO, and COLA [ILLUSTRATION FOR FIGURE 2 OMITTED]. Seventy-eight percent of the respondents' labs have been inspected at least once within the past two years. CAP, COLA, and JCAHO have received deemed status under CLIA '88, so labs that undergo an accreditation survey don't have to undergo a separate federal inspection because HCFA recognizes the standards of these organizations to be at least equivalent to those of CLIA '88. Because most of our respondents are inspected by an accrediting body rather than HCFA, most of our data reflect the inspection experience of laboratorians who have undergone an accreditation survey.


As for notification that an inspection was to take place, 62% of respondents said they received at least one month's notice by their accrediting agency; however, 11% reported their labs were notified less than a week before the inspection. The majority of respondents (96%) feel their labs received sufficient notice prior to the last inspection. Among those who felt too little notice was given, the only real complaint was that more notice would ensure that key personnel would be available and present at the inspection.

Some labs that must undergo inspection by a state agency (either in place of or in addition to an inspection by CLIA or an accrediting body) receive no notice prior to an inspection. New York, for example, makes unannounced inspections (not including POLs) for laboratory licensure. Many respondents do not appreciate this. "The inspector showed up at the crack of dawn," a lab manager from New York City complains. "I had to cab down to the lab to meet him. It just makes a stressful situation more stressful."

On-site versus self-assessment

On February 13, 1996, HCFA's performance-based survey, called the Alternative Quality Assessment Survey (AQAS), became available to labs in good standing with CLIA. The AQAS is a self-survey issued by HCFA to assess a facility's compliance in lieu of an on-site inspection. Labs in good standing are those labs cited with zero or very few minor deficiencies on their previous inspection and satisfactory proficiency testing results. The questionnaire covers every facet of CLIA, but not to the same extent as an on-site survey.

State agencies may issue and review the AQAS, and laboratories are required to return the completed AQAS within 15 days of receiving the survey. HCFA conducts verification inspection of 5% of labs that use the AQAS to evaluate the survey's effectiveness and to validate accuracy of responses. In 1996, 10-15% of labs were eligible to use the AQAS. HCFA thought the AQAS would serve as an incentive for labs to improve their CLIA status.

Later, COLA offered its own off. site self-survey called the Performance-Based Survey (PBS), which is equivalent to HCFA's AQAS. As with the AQAS, a facility seeking participation in the PBS program must meet certain criteria. These include having zero or limited deficiencies on the last on-site inspection, successful participation for the previous year in PT, and having no changes in the lab director or ownership. Also, a lab may not go more than every other two-year cycle without having an onsite inspection. The PBS consists of the same 299 questions already available in Section Four of COLA's Accreditation Manual. Participants will have to answer applicable questions and, for some, send supporting documentation to verify answers. Some states don't allow use of the self-survey or only allow it for certain laboratories. Check with your local state government to find out if this applies to your lab. No differences in regulatory fees exist between on-site inspection cycles and cycles where participants use the self-assessment survey. This is one reason why labs that are eligible for the self-assessment survey have the option to retain the on-site survey. Why would a lab want the on-site survey? Two masons: 1) instant feedback on areas needing improvements and 2) constructive input on operations. Alternatively, the self-assessment survey enables a laboratory to avoid a potentially disruptive on-site survey and acknowledges labs that have been good performers.

So, how did the self-survey stack up against the on-site inspection? Not only were 88% of respondents' most recent inspections performed on-site by a representative of their accrediting agency, but most respondents preferred this type of inspection over the self-assessment questionnaire (77% vs. 23%). We found no significant preference on the part of any specific type of lab, such as a hospital lab, reference lab, or POL, for one type of survey over the other [ILLUSTRATION FOR FIGURE 1 OMITTED].

On-site: Instant feedback, professional interaction

Among those who prefer an on-site inspection, 48% explained they like the informative feedback they receive from the inspector during an on-site visit. Respondents said that an on-site inspection provides them with an opportunity to discuss relevant professional issues and allows them a chance to ask questions (40%). The personal exchange of information and the opportunity to discuss issues of compliance were mentioned frequently as important aspects of an on-site survey. A chief technologist from Tennessee says, "Sometimes I can show that we are performing a test adequately but in an unorthodox way. Also, the inspector offers helpful suggestions for meeting requirements." In general, our respondents valued the input of their inspectors. Getting an immediate response from inspectors rather than waiting for a paper trail from HCFA or an accrediting body was mentioned frequently as a distinct advantage.

Another 23% said they think this type of inspection is more thorough and objective than a self-assessment questionnaire. The on-site inspection "keeps everyone on their toes," according to a lab director from California. A medical technologists from Pennsylvania said, "on-site inspections allow no room for stretching the truth. Everything is black and white for the inspector.'

Five percent felt the on-site survey was more convenient and less time-consuming. "It's easier to show inspectors what we do to satisfy requirements than fill out paperwork," a lab manager from New York said.

Other comments we received indicated that the on-site inspection brings home the importance of compliance to laboratory personnel. One respondent said it was difficult to convince people of the importance of regulatory compliance with only a self-assessment questionnaire, and many other respondents said they thought lab staffers tend take the on-site inspections more seriously.

Self-assessment: Convenient consistent, and flexible scheduling

Of the 23% of respondents who prefer the self-assessment questionnaire to on-site inspections, their reasons varied as follows:

* 32% find it more convenient than an on-site inspection. A lab manager from North Carolina said "I can do the self-survey at my convenience and correct problems immediately." Another advantage is having control of the schedule for performing the self-assessment. This eliminates any problems with sufficient or nonexistent notification.

* 29% felt it was more thorough and provides for more continuity. "Following a self-assessment questionnaire is more consistent than allowing individual bias [of inspectors] to encroach upon judgment," comments a lab manager from Illinois. Several respondents thought on-site surveys were sometimes subjective. "Inspectors are not always qualified or skilled to do the inspection," says a section supervisor in Arizona. "Many inspectors only focus on areas in which their lab received citations." A section supervisor in Florida told MLO, "Individual inspectors can be arbitrary and nit-picky."

* 25% said they feel less pressured with the self-survey. A lab director in Alabama said that it was "not as nerve racking, and with increased downsizing, we don't have sufficient employees to assist the surveyor."

* 17% found on-site evaluations to be disruptive "I had to add staff so techs could spend time with inspectors," said a lab manager in Oregon. A lab manager in Kentucky said the paper survey is "equally meaningful and would not destroy one or two days of productivity."

Despite the inconsistencies among inspectors that many respondents mentioned, 68% of them felt their last inspection was no more or less rigorous than previous inspections.


Fifty-eight percent of respondents reported their labs were cited for deficiencies during their most recent inspection [ILLUSTRATION FOR FIGURE 3 OMITTED]. This figure is identical to the percent of labs reporting citations for deficiencies in 1994; however, national data from HCFA indicate that the total number of deficiencies in all laboratories has dropped by 43% from a lab's first to second survey with a 3% drop in the average number of deficiencies per lab. HCFA attributes this to its educational approach to surveys and PT, in which it tries to promote cooperation with providers while ensuring minimum quality standards for lab tests. We found improper documentation topped the list at 41% of citations reported in our survey, with a similar deficiency, inadequate procedure manuals, coming in second at 26.9% of surveyed labs.

None of the respondents' labs were subject to monetary sanctions for the deficiencies cited during their last inspection, and 90% said all deficiencies cited have subsequently been corrected.

In Part 2 of this report, find out how demanding laboratorians thought each phase of the inspections was and what improvements they've seen since CLIA was enacted. We'll also take a look at the costs of compliance and the overall effect CLIA has had on the laboratory profession, as well as some sharp differences of opinion with regard to CLIA's personnel requirements, and whether quality of lab testing has improved under CLIA.


One of MLO's most valuable resources is the group of laboratorians that constitute its Professional Advisory Panel. These professionals are an essential link to the clinical laboratory environment. They've agreed to participate in studies such as this to share their knowledge and experience with MLO and its readers. The sample used for this study consisted of the 1,669 laboratorians belonging to the Panel.(*)

Each laboratorian received a four-page questionnaire with a cover letter and a self-addressed, postage-paid return envelope. No incentive was provided for returning the completed questionnaire. On August 11, 1997, the questionnaires were mailed. On the cutoff date, September 15, 1997, 600 questionnaires were returned, resulting in a 36% response rate. The sample consisted primarily of female respondents (61%), with the typical laboratorian holding the title of lab manager (30%). Eighteen percent of the respondents were section supervisors, 16% were non-physician lab directors, 8% were medical technologists, 6% were medical directors/pathologists, and another 6% were chief technologists. The remaining 16% consisted of medical laboratory technicians (MLTs), microbiologists, clinical chemists, cytotechnologists, histotechnologists, and an unspecified group classed as "other." Most of these laboratorians work in non-profit hospital laboratories (54%), with the average hospital holding approximately 298 beds (mean).

The administration/management department is where most respondents work (52%), followed by the chemistry section (11%), hematology (10%), microbiology (6%), blood banking (4%), LIS (1%), histology (1%), and immunology (1%). In terms of education, most laboratorians have a BS/BA degree (54%), but 23% have also pursued masters' degrees (MS/MA, MBA). the average respondent has maintained his or her current job title for approximately 9 years (mean), has been employed at the same laboratory for 12 years (mean), and has been in the laboratory profession for 22 years (mean).

a Disclaimer: Please note that because the sample was derived from a pool of MLO readers and not all laboratorians, the information disclosed cannot be extrapolated to the entire clinical laboratory disclosed cannot be extrapolated to the entire clinical laboratory profession. The study is designed to share the professional experience of a group of typical laboratorians.

Pasquale Buttitta is a research analyst for Medical Economics Co., publisher of MLO in Montvale, NJ
COPYRIGHT 1998 Nelson Publishing
No portion of this article can be reproduced without the express written permission from the copyright holder.
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Title Annotation:MLO's National CLIA '88 Survey, part 1
Author:Berger, Darlene; Buttitta, Pasquale
Publication:Medical Laboratory Observer
Date:Jan 1, 1998
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