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Praise versus protest - views from both sides of the fence.

Over the past few years, an increasing number of lab professionals have begun to feel better about the Clinical Laboratory Improvement Amendments of 1988. In Part 1 of this series,[1] MLO reported what appeared to be an improvement in laboratorians' current opinions of CLIA compared with results from our 1994 survey.[2] Current national survey statistics reveal 43% of respondents believe CLIA has had a positive effect on their labs, and 46% believe CLIA has had a positive effect on the profession as a whole.

While a marked number of respondents contend that CLIA has hurt their labs and the profession as a whole (20% and 38%, respectively), these numbers do compare favorably to the roughly two-thirds of respondents who 4 years ago said that CLIA hurt patient care. It is interesting to note that younger laboratorians with fewer than 20 years' experience are more likely than their counterparts who have been in the field for more than 20 years to look upon CLIA positively (52% versus 44%, respectively).

CLIA's impact on the industry

While about one-quarter (26%) of lab professionals surveyed said their labs have experienced no significant changes as a result of CLIA, others indicated that the regulations have had a huge impact on their facilities. A weighty increase in administrative work (23%) and additional policies and procedures (14%) topped the list of changes.

In some departments, more competent personnel have been required to monitor compliance, leaving less-educated personnel to process tests (5%). CLIA has changed the workload, too. In 3% of labs surveyed, certain types of tests have been discontinued and sent out to other facilities. Increases in test volume due to additional competency testing (4%) as well as to the closing of physicians' office laboratories (POLs) (2%) - unable to stay open due to CLIA's rigorous requirements - were noted. Furthermore, 2% of respondents reported increased stress levels associated with meeting CLIA's requirements.

On an upbeat note, 7% of respondents said that CLIA has led to better documentation, quality assurance (QA), and quality control (QC). In addition, respondents were asked to rate which areas of their labs, if any, have improved since CLIA was enacted and to rate the degree to which they felt CLIA played a part in these improvements [ILLUSTRATION FOR FIGURE 1 OMITTED]. Surprisingly, respondents said they feel CLIA has had the greatest effect on the improvement of personnel competency; however, there is a vocal minority of respondents who are very disappointed with CLIA's lowered personnel standards.

On the other end of the spectrum, our respondents felt CLIA has had the least positive effect on their outreach programs.

A necessary evil

Numerous survey respondents told MLO they believe CLIA has improved the quality of clinical laboratory medicine and made testing personnel aware of the importance of accuracy in test results they report. based on survey comments, it appears more laboratorians today than in the past also believe CLIA has increased awareness of safety issues at all levels of employment, improved overall specimen management, and promoted standardization of practices. In addition, several respondents noted a better working relationship between the laboratory and nursing personnel due to laboratorians' ultimate responsibility for ensuring that other departments comply with POCT regulations.

According to a medical director in Massachusetts, while the regulations have been irritating, they've been a necessary evil as well. "CLIA has closed down marginal labs, and improved others." However, Pontius admits that in this regard, CLIA has not been "the godsend the lab profession had hoped for." Nevertheless, she says the regulations have "greatly improved testing in physician offices and brought recognition throughout the healthcare industry to the fact that test results are important and that quality is vital to those results."

Tired of "jumping through hoops"

Lab personnel who believe that CLIA has hurt their facilities and their industry offered MLO an array of colorful terms to describe their distaste of Uncle Sam's law: "total overkill" ... "a bureaucratic red-tape nightmare" ... "a nuisance" ... "a taxpayer's rip-off" ... "a joke" ... to name a few. Indeed, the annoyance of those against these regulations rang out loud and clear in survey comments. A medical director from Ohio said she is unable to express adequately "the disgust and anger I feel for this kind of Marxist interference of the government in the medical profession!"

Where do such fighting words come from? According to many survey participants, their industry was doing fine before the government intervened. A section supervisor from Illinois notes that a tremendous amount of time and resources have been wasted "jumping through hoops" for the government "which, in our experience, does not correlate with any real improvement in patient care."

"Regulations on top of regulations combined with excessive documentation does not ensure quality," according to a laboratory director from Ohio. She says the CLIA regulations represent "a typical approach by overzealous congressmen to improve an industry they know nothing about."

CLIA's exhaustive documentation requirements were noted repeatedly as redundant, excessive, time-consuming tasks that take laboratorians away from "real work" and lead to an appreciable increase in employee stress. Many laboratorians say that they spend more time documenting everything from QC, instrument maintenance, and surveys - and less time providing patient care. "Employees have little time to interact with patients anymore," laments a chief technologist from Virginia. "We're all too busy chasing the paper trail."

Several labs reported that due to budgetary constraints, their departments have been unable to hire additional FTEs to keep up with the paper work and other CLIA-associated duties. Consequently, "The burden of CLIA compliance has fallen on the supervisors, most of whom are already overworked," says a laboratory manager in California.

Checking the checkbooks

According to survey results, not all labs have had to dig too deep into their pockets to accommodate the CLIA regulations beyond the costs associated with certification and inspection. About one-fifth (21%) of panelists said that there has been no need to shell out additional money. Many respondents feel CLIA has been a minimal financial burden because its standards are much less demanding than those of the College of American Pathologists and the Joint Commission on Accreditation of Healthcare Organizations.

Increased costs associated with CLIA have been limited, for facilities that were already meeting, if not exceeding, most of the CLIA regulations due to their individual state's requirements. Others explained that because their supervisors have been able to absorb additional administrative duties associated with CLIA, costs have remained in tow.

"The cost burden associated with CLIA is unfortunate," observes Pontius, "but that's the price labs must pay to obtain an insurance policy." A laboratory pays money each year and implements what is required, she relates. "Then, if its laboratorians wind up in court having to attest to the quality of their work, they have the ammunition they need to prove they adhere to the quality standards set forth by the federal government."

Documentation required by CLIA has hit the lab's checkbook hard, however. According to a laboratory technical consultant from Ohio, the additional time needed to document QA for the CLIA inspectors is "wreaking havoc on our lab wages because this task does not constitute a dollar-producing workload. Reimbursement is down, while 'form' documentation is way up."

"CLIA has produced more work, more paper files, and a substantial increase in costs for controls and other materials," says a section supervisor from Ohio. 'The only thing that matters to stockholders are billables - which now have taken a back seat [to CLIA]."

Cries for a level playing field

A common lament observed was the perception that POLs are held unjustifiably to less rigorous standards. Respondents expressed extreme opposition to the AMA's current movement to dilute the concept of site neutrality. "The most disturbing part of CLIA is the government's reluctance to impose across-the-board standards on all hospitals and POL doctors," contends a laboratory manager from Michigan. (The AMA continues its campaign to persuade Congress that POLs should be exempt from federal requirements under CLIA due to the extreme hardship these complex regulations impose on physicians and their patients.)

Lab professionals opposed to relaxing the regulations for POLs assert that hospital labs are being unfairly targeted and that POLs, more than any other facility, need government regulation. A lab director from California says she is extremely disheartened that special interest groups keep watering down CLIA's original intent, exonerating the labs that need the most regulation.

"Unfortunately, hospital and reference labs, both of which were already following standard lab procedure, have to contend with more regulatory pressures and costs than ever before," notes a lab manager from Indiana, "while POLs are free to follow their own guidelines." She continues, "Physicians with office labs will cut corners and still charge the same for their tests. Hospitals, on the other hand, are left with the constant challenge of maintaining high quality without the ability to raise prices."

A lab business support manager in Illinois points out the waivers given to POLs have had a severe negative impact on the morale of lab professionals. "It's insulting that hospital labs are required to undergo inspection, while POLs, for the most part, are being waived, even if a receptionist is operating the analyzers."

These derogatory comments beg the question of whether some lab professionals understand what the CLIA personnel requirements are. It seems that many laboratorians are under the impression that POLs are performing the same types of tests, in terms of complexity, that higher volume hospital labs perform and that physician offices are allowed to skate past regulations. Waivers are only available for tests that (1) "are cleared by FDA for home use; (2) employ methods that are so simple and accurate as to render the likelihood of erroneous results negligible; or (3) pose no reasonable risk of harm to the patient if the test is performed incorrectly."[3]

According to Sharon Miller, PhC, MT(ASCP), CLS(NCA), professor and associate dean, Clinical Laboratory Sciences, College of Health and Human Sciences, Northern Illinois University, DeKalb, IL, and MLO Editorial Advisory Board member, every laboratory test requires a certain level of understanding - even those that fall under the waived category. "It is imperative that laboratorians understand not only how to perform a particular test but also why the test is being run in the first place."

Pontius points out some POLs are running moderately complex tests that require the watchful eye of the government. Case in point: Pontius recently visited a solo practitioner in a small North Carolina community whose practice is more complex than some smaller hospital labs. "This physician stands to have his COLA [Commission on Office Laboratory Accreditation] accreditation denied because he refuses to implement the necessary components of quality control and quality assurance." The reason: "His personnel don't have a clue as to how to run the instrument," nor does the physician himself.

Pontius agrees wholeheartedly with those who believe POLs should be CLIA-regulated and admits it's scary to think that one day POLs may become exempt.

"The threat of POLs being eliminated from CLIA has been greatly reduced," maintains Judith A. Yost, MA, MT(ASCP), director, Division of Outcomes and Improvement, Center for Medicaid and State Operations, Health Care Financing Administration, Baltimore, MD. "This is due, primarily, to the ongoing successful efforts of CLIA supporters using data that reflect the poor quality performance in POLs." She adds that more information about these findings can be found in articles published in the February 11, 1998, issue of the Journal of the American Medical Association.

Other reports point out that there may be significant merit to the argument by physician groups that CLIA requirements should be reduced or eliminated for POLs by virtue of the immediacy of the patient encounter - quick, accessible results being more important for immediate patient care than highly accurate results. However, this argument raises the question of "how much quality assurance is enough to prevent a clinically significant random error?"[4] The support of organized medicine for the Archer-Hutchison Bill (FIR 2250; S 1068) that seeks exemption of POLS from all CLIA requirements (except those doing cytology testing) is based in part on studies that claim decreased availability of testing in POLs is directly attributable to CLIA.[5]

Managed care may also obviate the head-butting between POLs and the government because health maintenance organizations may impose their own requirements or require POLs to seek accreditation from the private sector (e.g., JCAHO, CAP, etc.). There is also some speculation that, due to managed care, repeal of CLIA probably would not return POLs to the same pre-CLIA non-regulated environment.[5]

Shoddy personnel requirements

Many survey respondents complained about what they perceive to be paltry education and training requirements for testing personnel. An administrative coordinator from Colorado deplores the minimum requirements that allow "a person with a high school education to operate in a moderate complexity setting. Such an individual would not know the terminology or the importance of quality assurance in everyday operations. With all the hospital medical technologist programs closing, I don't know where these individuals will get the required training."

Such complaints were frequent and loud in our survey. A lab director from Ohio is appalled that with supervision, it's possible for a high school graduate to conduct testing. In that state, "One need only pass the ninth-grade proficiency test to graduate. Would you want someone with a ninth-grade education working with your specimens?"

Pontius believes high school graduates can be trained to run complex tests ... if they are trained properly and if they have an aptitude for it. "It all boils down to what constitutes good training, which is open to broad interpretation." In some instances, she explains, training is nothing more than a sales rep coming in and spending an hour or two with an employee on an instrument. "Others may be 'trained' by receiving a written test procedure from a physician, who instructs them to read and initial it ... end of story."

While Pontius believes beefing up training requirements for lab professionals might make things better, she admits the situation is a "catch 22." "Stricter requirements," she explains, "would give the AMA more inducement to say 'Do away with it for POLS!'"

A lab manager from Pennsylvania attests CLIA's personnel standards have downgraded the MT field and have had a serious negative impact on students entering MT programs.

Miller expressed grave concerns over the likely outcome of lowering personnel standards. "Those of us who have been involved in educating lab personnel for many years are deeply troubled by what appears to be the steady erosion of the perception of the laboratorian as a healthcare professional."

She continues, "Many dedicated individuals have fought for recognition of laboratorians' important role in providing patients with quality care based on laboratory data. Certainly technology in the profession continues to evolve," she says, "but contrary to the assertions of some sales reps, sophisticated equipment is not 'idiot proof.' Lab personnel must possess a certain level of skill to perform tests, but they also must be able to put results in perspective and to assess their validity on the spot. A framework of knowledge is needed to spot inconsistencies and to take appropriate action."

Miller reminds readers that test results are often critical in clinical decision making. "It makes no sense to assert that a well-intentioned but minimally qualified person is an appropriate provider of such information."

"CLIA may have only minimum personnel standards," says Yost, "but nothing precludes a laboratory from maintaining higher staff qualification requirements." She points out there are a multitude of safeguards incorporated into the regulations. The laboratory director, for instance, has overall responsibility for quality. In addition, she says, a laboratory must meet strict QC, QA, proficiency testing (PT), and patient test management requirements.

"Long before CLIA became effective," says Yost, "technology demonstrated that a highly trained laboratory professional is no longer mandatory in an automated environment. The field of clinical laboratory science must adapt to be in step with the current and future healthcare arena." Numerous employment opportunities are available for today's med techs, she adds, including that of technical supervisor, lab manager/administrator, teacher, researcher, and consultant. "It is up to the individual to identify and pursue these opportunities."

Donna M. Falcone, MSM, MT(ASCP), an independent laboratory project consultant in Naperville, IL, says the apparent decrease: in required formal education and experience concerns many lab people. "Will there be new roles for us in the coming years, or any roles at all, for that matter? I choose to believe that change, in whatever form, can be a positive thing." Laboratory science, she says, is not the same profession it was "when some of us entered into it 10, 20, even 30 years ago. With the growth in technology, evolution of the profession was bound to occur. We need to look for the unique and exciting opportunities this evolution brings with it."

Favorable forecast

Despite how anyone feels about CLIA, studies have shown this federal law has improved the quality of laboratory testing in the U.S. According to HCFA, the total number of deficiencies in all labs has dropped by 43% from the first to second survey, with a 3% drop in the average number of deficiencies per lab.[6] Further, HCFA believes its approach to surveys and PT promotes cooperation with providers while ensuring minimum quality standards for lab tests. "CLIA has demonstrated that by utilizing an educational approach, combining performance incentives with a QA focus, laboratory performance does improve over time," notes Yost.

"CLIA may be forcing the reorganization of the standard hospital laboratory," says Falcone, "but with that realignment may come the creation of unique positions suited for people with our skill set. This does not mean we should stand by passively while the proposed rules are debated in the legislature. We have a responsibility to the profession to keep abreast of the issues and offer our input, where appropriate." She urges readers to access CLIANet, an AACC/Dade-sponsored Internet Web site at http://www.clianet.org that posts regular updates on the discussions held by the Clinical Laboratory Improvement Advisory Committee.

According to Yost, the final CLIA regulations are under development. She says they will be "user friendly and incorporate the current QA focus to correspond to our surveys. Additionally, in the future, we plan to identify quality indicators for labs to measure true performance."

Pearls of wisdom regarding CLIA inspections

* Be absolutely certain you can account for each QC event in each batch on each day and that you can answer for each failure. Make sure procedures match package inserts.

- Laboratory manager, Massachusetts

* Join professional laboratory societies (and read their literature) so you can keep up with CLIA's requirements and, as a result, avoid over- or under-reacting on inspection day.

- Laboratory director, Washington

* Do everything by the book. While JCAHO and CAP inspections are much harder, CLIA has sharp teeth when you fail to comply.

- Laboratory manager, Tennessee

* Consult with industry peers to learn about current trends to obtaining inspection success.

- Director of quality assurance, Indiana

* Find out what departments other than your own are running lab tests (e.g., OR, ER, Ob-Gyn, Nursery, etc.), and make sure they are meeting the regulatory requirements, too.

- Section supervisor, Oregon

* Be courteous and open minded with inspectors, but be ready to challenge any deficiencies with which you disagree.

- Medical director, Wisconsin

* Ask yourself: "Would I object to having my own personal lab tests run in my facility?" If the answer is no, your inspection should run smoothly.

- Section supervisor, Montana

References

1. An update on CLIA compliance, Part 1: The serf-assessment survey. MLO. 1998;30(1): 36-40.

2. Jahn M. CLIA, Part 1: CLIA after year 1: No help to patients, and a hindrance to labs. MLO. 1994;26 (5):20-26.

3. Code of Federal Regulations, Title 4 - Public Health and Human Services, Part 493. Laboratory Requirements. Revised October 1, 1996. From http://www.cdc.gov/phppo/dls/42cfr493.htm. October 27, 1997.

4. Bachner P. Is it time to turn the page on CLIA '88? JAMA. 1998;279(6)473-475.

5. Schwarz B, Fries S, Fitzgibbon AM, Lipman H. Pediatricians' diagnostic approach to pharyngitis and impact of CLIA 1988 on office diagnostic tests. JAMA. 1994;271:234-238.

6. Health Care Financing Administration. Quality of care - Clinical Laboratory Improvement Amendments. Revised November 19, 1996. From http://www.hcfa.gov/medicare/hsqb/clia1.htm. Accessed October 27, 1997.

Suggested reading

Jahn M. CLIA, Part 2: Dealing with inspections and paperwork under CLIA. MLO. 1994;26(5):30-36.
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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 2
Author:Berger, Darlene; Buttitta, Pasquale; Trotto, Nancy E.
Publication:Medical Laboratory Observer
Date:Jun 1, 1998
Words:3411
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