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CLIA after year 1: no help to patients, and a hindrance to labs.

MLO's national survey of labs operating under a complex law reveals a profession coping, but with mixed emotions about the merits.

THE LAW WAS PASSED in 1988 and 6 years have gone by," says Bernard E. Statland, M.D., Ph.D., vice president of National Health Laboratories in Nashville, Tenn. "Because it's been such a long gestation period, everyone has gotten a bit nervous waiting to see what the baby will look like."

Well, laboratorians have now lived with the implemented Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) for a year plus and the verdicts from MLO's national survey are in. In brief:

* Roughly two out of three laboratorians feel CLIA has failed to improve the quality of patient care and has adversely affected the clinical laboratory profession.

* For the most part, labs are neither hiring nor firing personnel as a result of CLIA, and there is little pressure from hospital administrations to hire less qualified workers.

* Equal numbers of laboratories dropped and added tests. For every laboratorian who knew of a physicians' office lab (POL) or clinic that is sending out more tests as a result of CLIA, there is another laboratorian who noticed no such thing. One third of laboratorians, however, know of a POL or clinic that has ceased testing entirely as a result of CLIA.

* Most labs have been able to enroll in an approved proficiency testing (PT) program for every regulated analyte, and have not failed a PT event two or more times.

* While most labs have not yet been inspected under CLIA, half of those that have played host to Federal surveyors describe the experience as being about the same as previous non-CLIA inspections.

* Three out of five CLIA-inspected labs were cited for deficiencies, but 7 out of 10 who were so cited described their penalties as being relatively mild. Despite a lot of worrying about being forced out of business, too few labs had serious, "condition-level" deficiencies to make for meaningful statistics.

And while the CLIA regulations clearly are causing problems in certain areas of laboratory management, the overall impression is one of a profession coping with relative ease, if not eagerness or elation.

* Staffing adjustments. The vast majority of respondents (95%) said that their labs did not have to make staff reductions as a result of CLIA. The remaining 5% reported staff reductions devolving from the regulations. There is no way to know if this reduction was, indeed, a direct result of CLIA or was caused by simultaneous economic pressure and consequent downsizing.

Nearly 9 out of 10 laboratorians (88%) said that their labs had not had to hire additional personnel as a result of CLIA. Of the 12% of labs that hired extra staff, a median of one employee was added, and, in 60% of cases, that laboratorian was a medical technologist.

"Laboratory help-wanted ads aren't reflecting CLIA titles," notes Richard B. Passey, Ph.D., professor of pathology at the University of Oklahoma Health Sciences Center, who for several years has been presenting CLIA workshops for the National Committee for Clinical Laboratory Standards and the American Association for Clinical Chemistry. He says this absence is further indication that the laboratory hiring situation isn't reflecting CLIA changes. "The ads aren't asking for technical or general supervisors. Either hospital personnel departments don't know about the need for such staff or the lab people who are writing the ads aren't concerned with getting CLIA-qualified employees."

Many laboratories are filling CLIA-mandated slots entirely from within. Nearly all respondents (94%) said that their labs were able to designate qualified existing personnel to fill such roles as director, technical consultant, clinical consultant, technical supervisor, and general supervisor. Only 6% of labs were unable to fill those roles with persons already on the payroll.

Eighty-eight percent of respondents denied receiving pressure from their administrations to change their staffing mix by lowering personnel standards; 8% reported such pressure, and 4% were unsure.

* Sanctions and licensure. Under CLIA, the director or owner of a lab can be banned for serious and continuing violation of the rules. This near-ultimate penalty has rarely been applied (at least so far). The vast majority of respondents (96%) were unaware of any bannings; 4% knew of a director or owner who was so sanctioned.

When asked how CLIA's personnel standards have changed the way they think about the licensure of laboratory professionals, two out of five (43%) said they were more in favor of state licensure. Eight percent were less in favor of licensure; nearly half (49%) reported their opinions unchanged.

* Education. Three-fifths of laboratorians (62%) responding to the survey said that their labs had rewritten and expanded their new-employee orientation processes to comply with the new Federal regulations. (Of that figure, 19% rewrote or expanded their orientations dramatically; 43% did so minimally.) Thirty-eight percent reported their orientation programs unchanged.

Whatever CLIA is doing, it is not sending laboratorians back to school. Ninety-four percent of respondents do not plan to obtain degrees that would allow them to perform the same testing or other work (supervising, for example) that they do now. Six percent intend to seek more education.

With or without extra schooling, CLIA is providing a sizable number of laboratorians with new career options. Nearly one-third of respondents (30%) report they or a colleague in their laboratory have begun acting as a consultant to POLs as a result of CLIA. But 70% were not consulting and knew no one taking that path.

* Test menu changes. Responses were split regarding whether laboratorians knew of POLs or clinics that have begun sending out more tests as a result of CLIA. Independent laboratorians were more likely than hospital lab workers to note increased send-outs by POLs and clinics (62% versus 49%, respectively).

The smaller the hospital, the more likely respondents were to be aware of increased POL and clinic send-outs. Fifty-six percent of laboratorians at small hospitals claimed to know of such a trend; only 48% of midsize and 40% of large hospital laboratorians agreed.

One third of respondents (35%) were aware of POLs or clinics that had stopped testing entirely as a result of CLIA; 65% were not. Independent lab respondents again were more likely than hospital laboratorians to note the trend (49% versus 33%, respectively). Forty-one percent of small-hospital lab workers knew of POts or clinics that discontinued testing; 33% of midsize- and 24% of large-hospital laboratorians agreed.

Figure 1 shows how respondents' labs performed with regard to adding or dropping tests or instruments or changing methodologies in the first year of CLIA. While approximately equal numbers of total respondents dropped tests as added them (41% and 42%, respectively), nearly as many (38%) changed methodologies.

The consequences of such actions were sometimes dramatic. Nearly two-thirds of respondents began sending out tests that they previously did in-house. Of those laboratorians who reported having dropped tests because of CLIA, 86% were sending the work out.

Nearly three out of four respondents (73%) said that their labs had verified or established performance specifications for tests added since Sept. 1, 1992. Fifteen percent had not done so; 12% were unsure.

* Proficiency testing. Nearly 9 out of 10 respondents (88%) reported that their labs had been able to enroll in an approved proficiency testing (PT) program for every regulated analyte; 9% were not able to do so; 3% were unsure. Respondents sent in a long list of analytes for which they were having trouble finding approved PT programs. Only three of the tests listed, however--Pap smear, respiratory syncytial virus, and C4--are regulated analytes under CLIA.

When asked if their lab had failed a PT event for a specific analyte two or more times, most respondents (89%) said no. Nine percent reported several failures; 2% were unsure. The procedures for which respondents had multiple PT failures include HDL, BUN, glucose, C|O.sub.2^, digoxin, and hematocrit. Penalties will be imposed for PT failures incurred after Jan. 1, 1995.

* Complexity and accreditation. Nine out of 10 labs surveyed by MLO (90%) were classified under CLIA as high complexity. Nine percent were moderate complexity, and less than 1% were waived labs. Almost all hospital labs (97%) were classified as high complexity; 84% of independent labs were so designated.

Eighty-five percent of respondents' labs were signed up with an accrediting agency; 15% were not. Hospital labs were more likely to be signed up than independent and group practice labs (95% versus 67%, respectively). Urban and suburban labs were more likely to have an accrediting agency than rural facilities (86% and 91% versus 78%, respectively). The breakdown among national certifying agencies is CAP, 70%; JCAHO, 54%; and COLA, 10% (multiple responses were accepted).

As of press time, only one state (Washington) has achieved state-exempt status and only one national accrediting organization, COLA, has attained the "deemed" status necessary to stand in as an alternate to HCFA for inspections. Labs that selected CAP or JCAHO as their accrediting agency are "on hold" as far as CLIA surveys are concerned. Deemed status is expected to be forthcoming soon for both CAP and JCAHO.

* Inspections. Figure 2 shows the incidence and the consequence of CLIA inspections. Nearly one out of every four labs (23%) has been inspected for CLIA (not CAP or JCAHO) since Sept. 1, 1992. The great majority of labs (77%), however, have not been inspected.

Of those facilities that have been visited by surveyors, independent labs were three times more likely than hospital labs to have been inspected (47% versus 15%, respectively). According to the University of Oklahoma's Passey, the chance of being inspected is largely a matter of which accrediting agency a lab chooses.

"Independent labs have, as a role, been inspected by HCFA since CLIA '67 went into effect," he says. "They are accustomed to inspections by HCFA, which now surveys for CLIA '88. Hospital labs, on the other hand, probably checked the accreditation box for CAP or JCAHO--their professional organizations--and are waiting for them to attain deemed status."

Checking the box to which Passey refers amounts to requesting that someone other than HCFA inspect your lab. Three out of four respondents (75%) checked the accreditation box; 25% did not. And, indeed, MLO's survey shows that hospital labs were more likely than independent facilities to have checked the "other than HCFA" accreditation box (84% versus 59%, respectively). Consequently, many hospital laboratories are awaiting inspection.

* How tough? More than half the labs inspected (54%) reported that the experience was about the same as previous, non-CLIA inspections. Thirty-nine percent found CLIA inspections more rigorous than previous surveys; 7% found CLIA inspections easier.

When facing an inspection, "Don't worry so much," advises the lab manager of a small, not-for-profit hospital lab in rural Minnesota. "Be honest with the inspector and do your best. In my experience, they are willing to help--not punish--if you have a cooperative attitude."

Quite a different view is held by the education coordinator at a large, urban university hospital in Ohio. "Be prepared for |surveyors^ who are very rigid, go by the book, and are unwilling to accept the logic of alternatives to existing ways of performance," she warns. These inspectors "may lack the scientific or theoretical background to really understand what is being done." In Part 2 of this series, respondents who have survived CLIA inspections offer more advice, both general and specific, that will help you pass muster when CLIA comes to call.

Fifty-eight percent of CLIA-inspected laboratories were cited for a deficiency; 42% escaped citation. Among those laboratories cited, most (71%) said that their deficiency was below condition level without immediate jeopardy.

Passey feels that such a low percentage of serious problems represents either "wishful thinking" or lack of understanding on the part of cited labs as to the difference between condition- and standard-level deficiencies. "If you don't have a QC system, that's a condition-level deficiency," Passey explains. "If you have a QC system but it doesn't do two controls a day, that's a standard-level deficiency." Passey believes that there are more condition-level deficiencies than are shown in the survey. As things stand, MLO noted too few condition-level problems to make for meaningful statistics.

* Near-patient testing. Forty-one percent of respondents said that their laboratories perform near-patient testing; 59% said that they do not.

Of those that do, 59% report that CLIA has not impacted this work. Thirty-eight percent of respondents say that CLIA has affected near-patient testing; 3% were unsure.

Of those who report that CLIA has impacted their point-of-care testing, the majority (61%) reported an increase in such testing.

An overwhelming percentage of respondents (91%) report that someone from their lab was assigned to provide either technical consultation or supervision for near-patient testing in their facilities; 8% said that no laboratorian was assigned those responsibilities; 2% were unsure.

Three out of five near-patient testing sites (61%) do not have their own CLIA licenses; 28% do, and 12% of respondents were unsure. More than half (53%) of the labs surveyed have only one CLIA license. Seventeen percent have two licenses; 9% have three; 5% have four; and 12% have five or more. The mean is 1.6.

MLO asked laboratorians whose facilities had only one CLIA license what the lab director should do to monitor non-waived testing performed outside the central lab by non-laboratory personnel. Two out of three respondents (67%) felt that he or she should monitor bedside QC using trained lab personnel. Slightly more than half the respondents (53%) argued that the director should monitor the testing itself, using trained lab personnel. These and other options are shown in Figure 3.

Just over half the respondents (53%) said their lab was not responsible for training non-laboratory personnel in lab techniques; 43% felt the opposite; 4% were unsure.

* The hardest part of CLIA. We asked respondents to check off those aspects of laboratory life that are or are likely to give them the most trouble under CLIA. We broke the list down into four categories: general lab, personnel, instruments and methodology, and record keeping. Multiple responses were allowed to the questions, the results of which are shown in Figure 4.

General lab. Three out of four respondents (72%) had the most trouble with reading the Federal Register and understanding what they were supposed to do. Over half (53%) had a problem with general paperwork. Writing policies and procedures was a source of grief to 43%.

Personnel. More than three-fourths of laboratorians responding to the survey (77%) had difficulty conducting and documenting annual competency reviews for testing personnel. Thirty-two percent had trouble finding personnel (in general and due to the staffing shortage). Twenty-seven percent had a hard time identifying and documenting the duties of specified laboratory titles. Hospital laboratorians had more trouble than independent lab workers in conducting and documenting annual competency reviews (79% versus 70%, respectively).

Instruments and methodology. Forty-five percent of respondents said that informing CLIA of changes in methodology was causing them trouble. Evaluating and documenting patient test results in relation to the findings of other assays and to patient diagnoses was a problem for 40% of laboratorians. Thirty-eight percent of respondents had difficulty meeting CLIA standards for QC and QA.

Record keeping. Sixty percent of those responding to the survey had trouble with personnel records. Maintaining QA records caused problems for 56%; keeping test records was hard for 31%.

The vast majority of laboratorians (88%) said that their records were readily accessible and could be easily produced within 4 hours. Five percent reported that they were unable to match that time; 7% were unsure.

* Quality of patient care. There is no doubt that CLIA '88 has, in its first year of implementation, had a profound affect on laboratory life. Laboratorians who thought that nothing could top the tide of regular paperwork now are swamped by more, for example. Though formally unmeasured by this survey, anxiety levels, as revealed through survey comments, also appear to have skyrocketed. But how are patients affected, if at all?

Figure 5 shows how laboratorians feel about CLIA. Nearly two out of three respondents (64%) believe that CLIA has not affected the quality of patient care. Fifteen percent believe that CLIA has raised the quality of care; 17% think that the Federal rules have lowered the quality of care; 4% had no opinion.

There was a variety of opinions about CLIA according to job title within the lab. CLIA was seen as making no difference in patient care by 81% of laboratory directors, 66% of lab managers, and 59% of laboratory supervisors.

When asked what effect CLIA has had on the lab profession, seven out of ten respondents (69%) described a negative impact; 13% said that CLIA has been good for the profession; 15% felt it made no difference; and 3% had no opinion. Midwestern and Western laboratorians were more likely to find that CLIA has been bad for the profession than those employed in the East and South (73% and 74% versus 63% and 65%, respectively).

* The Clintons and CLIA. Dr. Bernard E. Statland wonders if laboratorians are overly concerned with the punitive aspects of CLIA. "We are uncertain as to whether the CLIA bite has any teeth at all and, if it does, are they incisors or molars?" he asks. "There is this tremendous fear of CLIA, and we're all worried. But we now see POL advocates, working through the AMA, negotiating with the Government to ease the regulations".

"If that comes about, we will see hospitals doing the same thing," Statland predicts. "I believe that when the dust finally settles, CLIA will not be as punitive as we have all been led to believe. You can't have a situation where, because one analyte is off, a small town's only hospital fails CLIA and is closed down."

In Part 2 of this article, laboratorians who have undergone a CLIA inspection offer advice to their colleagues. Respondents also engage in a free-flowing discussion of the impact of the CLIA regulations after year 1.

Survey methodology

On Jan. 10, 1994, MLO mailed a 7-page questionnaire with a postpaid return envelope to MLO's 1,587-member Professional Advisory Panel, consisting of MLO readers who have agreed to participate in our surveys. The questionnaire was prepared by the editors of MLO in collaboration with the Medical Economics research department, which later compiled data based on the results.

By the cutoff date, Feb. 4, 1994, respondents had returned 750 usable questionnaires, yielding a 47% response rate. Note: Because the sample represents a selected panel of laboratorians, results may not necessarily represent the views and experiences of all laboratorians.

* Of those laboratorians returning usable questionnaires, 31% listed their titles as lab manager or administrative technologist, 20% as lab supervisor, 12% as lab director, 9% as section head, and 7% as chief or assistant chief technologist. The remainder include MT/MLT (6%), education coordinator (2%), pathologist (2%), and other titles (8%).

* Fifty-three percent are employed by nonprofit hospitals; 12% by independent labs; 7% by Government or Armed Forces hospitals; 7% by group practice labs; 6% by proprietary hospitals; 6% by POLs; and 9% by other labs.

* Forty-three percent of respondents are employed in urban settings; 31% work in suburban settings; and 26% work in rural areas.

* Degrees held by recipients are B.S./B.A. (73%); M.S./M.A. (19%); M.B.A (6%); M.D. (5%); Ph.D. (4%); M.H.A. (1%); and M.P.H. (1%). Twelve percent had other degrees. Multiple responses were accepted.

* Half the respondents have been in the laboratory profession for more than 20 years and 24% have practiced for between 16 and 20 years. Eighteen percent boast of between 11 and 15 years of experience; 7% have between 6 and 10 years of work behind them; less than 2% have worked in labs for 5 years or less. The mean is 22 years of lab experience.

* Respondents live in all segments of the United States: the Midwest (33%), South (30%), West (19%), and East (18%).
Hospital size

Hospitals and medical centers in this article have been categorized in the
following groups:

Small 1-199 beds
Midsize 200-399 beds
Large 400 or more beds

The Clintons and CLIA

In an attempt to muster physician support for its health care plan, the Clinton Administration has hinted that it may favor modification of CLIA to make it less burdensome for physicians' office laboratories (POLs). One possibility is adding a less restrictive category of "highly reliable" tests that could be performed in POLs.

* Three out of four respondents to MLO's survey (76%) believe that the result of such modifications would be lower quality of patient care. Three percent felt that such changes would raise the quality of care; 15% felt that the proposed alterations would have no effect; 5% of respondents had no opinion.

* Laboratorians' opinions of politically motivated CLIA changes varied according to lab type, number of hospital beds, and geographic region of the country. More hospital than independent laboratorians felt that the proposed changes would lower the quality of care (82% versus 72%, respectively). More staff members of midsize hospital labs disapproved of the possible changes than did those working in small and large facilities (87% versus 81% and 80%, respectively). And more Eastern laboratorians disapproved than did clinical laboratory professionals working in the West, South, and Midwest (82% versus 78%, 77%, and 70%, respectively).

* MLO asked laboratorians their opinions about the Clinton health care plan in general. Half (51%) disapproved of the plan; 26% approved; and 23% had no opinion. Of those who disapproved of the plan, 65% of independent and 48% of hospital laboratorians did so. Fifty-one percent of hospital laboratorians working in midsize facilities disapproved of the Clinton plan; 48% of small- and 45% of large-hospital laboratorians also disapproved.

* The 51%-26% disapproval/approval ratio seen in MLO's survey of clinical laboratory professionals may be contrasted with a 41%-34% rate revealed in a poll of the general public taken at about the same time.|1^


1. Fineman H, Clift E, Cohn B. Health care's war of words. Newsweek. Feb. 14, 1994; 26-28.
Figure 1
Changing test menus, instruments, or methodologies because of CLIA

As a direct result of CLIA, my lab:

 Hospital Independent
 All labs labs labs

Dropped tests 41% 31% 49%(*)
Added tests 42 50 28(*)
Changed methodologies 38 38 34(*)
Added instruments 32 32 34(*)
Dropped instruments 10(*) 9(*) 8(*)

Because of these actions, my lab:

 All labs

Began sending out tests we previously did in-house 64%
Switched from moderate to high complexity testing 26(*)
Switched from high to moderate complexity testing 18(*)
Switched from moderate complexity to waived testing 1(*)

Multiple responses were accepted.
* There was a low response to this part of the question.
Figure 2
Inspections: How often, how tough, how damaging?

Has your lab had a CLIA inspection since Sept. 1, 1992?

 No 77%
 Yes 23

If yes, was the inspection:

 About the same as previous inspections? 54%
 More rigorous than previous inspections? 39
 Less rigorous than previous inspections? 7(*)

Was your lab cited for a deficiency?

 Yes 58%
 No 42

If yes, was the deficiency:

 Below condition level without immediate jeopardy? 71%
 Condition level without immediate jeopardy? 12(*)
 Condition level with immediate jeopardy? 2(*)
 Other 15(*)

* There was a low response to this part of the question.

Figure 3
How to monitor non-waived bedside testing performed by non-lab personnel

Monitor QC using trained lab personnel 67%
Monitor testing using trained lab personnel 53
Conduct competency evaluations of non-lab staff 50
Monitor testing using designated, trained, non-lab personnel 21
Monitor testing personally 9(*)
Do not monitor; let testing unit take responsibility 8(*)
Other 9(*)

Multiple responses were accepted.
* There was a low response to this part of the question.
Figure 4
The worst of CLIA: Laboratories reveal the hardest parts of the law

 Percent of
Aspects of respondents who
lab life found it a problem

General lab
* Reading the Federal Register and
 understanding what we are supposed
 to do 72%
* General paperwork 53
* Writing policies and procedures 43
* Preparing for an inspection 41
* Filling out HCFA Forms 114 25
 (Lab Personnel Report) and 116
 (General Information)
* Preparing for a PT event 10

* Conducting and documenting the 77%
 annual competency review of
 all testing personnel
* Finding personnel in general 32
 due to staffing shortage
* Identifying and documenting the 27
 duties of specified titles (see breakdown at
 bottom right)
* Informing CLIA of a change 24
 in key personnel
* Hiring personnel appropriate 16
 to our complexity level

Instruments and methodology
* Informing CLIA of a change 46%
 in methodology
* Evaluating/documenting patient test 40
 results in relation to the findings of
 other assays and patient diagnoses

Instruments and methodology
* Meeting CLIA standards for QC/QA 38%
* Evaluating the validity of modified 34
 instruments or tests
* Assuring that patient test manage- 32
 ment meets CLIA standards
* Assuring there is a PT program for 30
 every regulated analyte
* Selecting/changing instruments 26
* Meeting CLIA standards for 26
 procedure manuals
* Selecting/changing menus 21
* Matching personnel with 16
 tests and instruments

Record keeping

* Keeping personnel records 60%
* Keeping QA records 56
* Keeping test records 31
* Keeping QC records 27
* Keeping PT records 17

Which laboratory job titles are a problem
to identify and document?
* Technical supervisor 79%
* General supervisor 69
* Laboratory director 66
* Testing personnel 65
* Clinical consultant 61
* Technical consultant 53

Multiple responses were accepted.
Figure 5
How laboratorians feel about CLIA

How had CLIA affected
patient care?

Made no difference 64%
Lowered the quality of care 17
Raised the quality of care 15
No opinion 4

How has CLIA affected
the laboratory profession?

Had a negative effect 69%
Made no difference 15
Had a positive effect 13
No opinion 3
COPYRIGHT 1994 Nelson Publishing
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1994 Gale, Cengage Learning. All rights reserved.

Article Details
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Title Annotation:CLIA, Part 1; includes related articles; Clinical Laboratory Improvement Amendments of 1988
Author:Jahn, Mike
Publication:Medical Laboratory Observer
Article Type:Cover Story
Date:May 1, 1994
Previous Article:Lab coalition pushes its reform agenda.
Next Article:Dealing with inspections and paperwork under CLIA.

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