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States may not wait for HCFA's lead on POL regs.

States may not wait for HCFA's lead on POL regs

The summer months came and went in Washington without word from the Health Care Financing Administration (HCFA) on regulations to implement the Clinical Laboratory Improvement Amendments (CLIA) of 1988.

Though HCFA's interpretation of the law has been eagerly awaited, the agency was, at this writing, apparently still deciding how to exercise the latitude it was granted by Congress. Among the stickiest issues was how stringent to make clinical lab personnel requirements, and the treatment of physician office labs (POLs).

One section of CLIA '88 gives the Administration certain authority to grant waivers from the certification requirements scheduled to take effect Jan. 1, 1990.

Under the law, waivers may be granted to labs performing only "simple" tests as determined by the Health and Human Services Department (HHS). Such tests are generally described as having "an insignificant risk of erroneous result." But it's still not clear which tests HHS will place in that category, or how many POLs might escape certification requirements.

Other aspects of POL regulation, such as inspection and personnel standards, will not take effect until July 1, 1991, thus giving the Administration more time to set its approach. Another section of the Federal statute, however, says it is not intended to supersede any state laws equal to or more stringent than CLIA '88. Interestingly, that language permits additional tinkering with the "patchwork" regulatory scheme CLIA supporters sought to correct.

The provision may loom large in the coming year and could even make HCFA's tack toward POL regulation a moot point in many areas. State officials read the same headlines about the need for lab quality control as their colleagues in Washington. And some have developed or are developing their own approaches to QA.

A study by the HHS Inspector General's office last year found that 16 states at that time regulated POLs, and another four had some form of legislation pending. The IG estimated that approximately 10 per cent of 98,000 total POLs identified fall under some pattern of state requirements.

Federal officials need look no further than their own front yard for an indication of ongoing efforts to regulate POLs. The District of Columbia government this year enacted its own clinical laboratory act, which awaited publication of implementing regulations at press time.

Supporters on the city council say they consider the package to be model legislation they hope the state governments can look to for guidance in considering their own reforms.

The legislation was sponsored by council member John Wilson, whose office reports that a number of other state approaches were reviewed as part of the drafting process. The District's law perhaps most closely resembles Pennsylvania's in that it creates a "tiered" system pegging regulatory requirements to three categories of POL.

When the statute is implemented, probably early next year, it will be unlawful to operate any POL in Washington without a license from the mayor's office.

The mayor is to issue a Level I, II, or III POL license authorizing one or more categories or subcategories of testing. The categories include bacteriology, mycology, parasitology, virology, serology, blood chemistry, endocrinology, toxicology, urinalysis, immuno-hematology, and hematology.

A Level I POL may perform "simple" tests, defined as noninstrumental in nature with results determined by a visual signal.

Level II POLs may also perform "basic" tests, or those that require a series of steps, reagents, additions, or instrumentation and are interpreted visually. Level III labs may perform simple, basic, and "complex" tests that require sophisticated techniques, interpretation of multiple signals, or proven technical skill. These latter two categories are subject to inspection requirements for procedures, methods, materials, staff, and equipment. No POLs will be allowed to do Pap smears or other "exempt" tests as determined by the mayor.

POLs applying to do business will first be considered for a 90-day probationary license subject to monitoring under a proficiency testing (PT) program. If a satisfactory result is registered, the city will issue a two-year provisional license, renewable if other conditions are met.

Ongoing PT must take place on a quarterly basis and be successfully completed for each category of licensed testing. The external programs must be approved by the mayor on advice of a nine-member advisory board composed of provider, government, medical equipment, and consumer representatives.

Regarding personnel requirements, each POL must appoint a supervisory physician to be responsible for proper performance of all testing. Group practices must also appoint an assistant supervisory physician. Those supervisors and any other personnel performing or supervising tests must each year successfully complete five hours of continuing medical education specific to management, staffing, clinical procedures, or testing techniques of lab services.

The District of Columbia Medical Society has worked closely with the city government on the law and appears satisfied with the final product. A spokesman for the society said the main concern now is lining up doctors to serve on the advisory board overseeing regulatory implementation.

The new District law is perhaps most remarkable for its approach to POL regulation, although it actually covers testing requirements for other facilities as well. Such provisions state, for example, that hospital and independent clinical labs are also subject to quarterly PT reviews and inspections.

Regarding personnel, the law says those facilities must have a clinical lab technologist who holds a baccalaureate degree in medical technology or in a chemical, physical, or biological science and has at least one year of lab experience or acceptable training. Personnel requirements below the level of technologist will be determined by the lab director as sufficient for assigned duties.

Similar to Federal reforms, the District's law calls for limits on the number of slides a cytotechnologist may examine in one day, and requires that no less than 10 per cent of all negative Pap smears be rescreened.

Penalties for noncompliance with the rules range from revocation of license to fines and/or imprisonment if a facility is knowingly and willfully operated in an unlawful manner.

As states consider adjustments to their regulation of laboratories, they are also weighing changes in certificate of need (CON) programs intended to control the allocation of state resources and reimbursement.

A recent survey by the American Hospital Association found that of the 39 states that currently have CON programs, 24 are deliberating changes.

Many of those are said to be considering an expansion of CON requirements to new categories of providers such as physician offices. Nebraska and West Virginia, for example, are seeking to include physician offices in the process if they meet certain thresholds for the purchase of medical equipment. Such thresholds could be challenged by the extent of lab testing being done in the office.

Whether through CON reviews or additional reforms in laboratory regulation, it appears states may be moving ahead with their own vision of the proper role for government supervision in the delivery of health services.
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Title Annotation:Health Care Financing Administration; physician office laboratories
Publication:Medical Laboratory Observer
Date:Oct 1, 1989
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