College of American Pathologists
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Capitol Scan

August 2004
Carl Graziano

State rescreening bill for Pap tests still too stringent

Opposition by the College and New Jersey pathologists to state legislation that would have required physician certification of all Pap tests prompted lawmakers to amend the bill to require, instead, review by qualified personnel—not necessarily physicians—of a randomly selected 20 percent sample.

But even with that change, the CAP and New Jersey Society of Pathologists continue to oppose the legislation, which would impose a rescreening requirement twice as stringent as that under the federal Clinical Laboratory Improvement Amendments of 1988.

The rescreening amendment came June 7 during consideration of the bill by the New Jersey Senate Health, Human Services and Senior Citizens Committee. The legislation, Senate Bill No. 1541/Assembly Bill 2732, would supplement the New Jersey Clinical Laboratory Improvement Act.

In testimony presented June 7 before the Health, Human Services and Senior Citizens Committee, the CAP and New Jersey Society of Pathologists opposed language in the bill that would have required a physician to certify, through signature, the results of each gynecological specimen examination performed by cytotechnologists. The requirement, the groups said, "contemplates a level of physician review that, if applied nationally, would effectively shut down the Pap test as a widely accessible screening test." The requirement also would have increased Pap testing costs and lengthened turnaround times for results, the CAP and NJSP argued.

Committee members amended the bill in response to that testimony, presented by Elliot A. Krauss, MD, CAP state issue advisor for New Jersey. It now requires that clinical laboratories ensure and document that "random samples of at least 20 percent of gynecological smears which have been interpreted to be in one of the benign categories by personnel not possessing director or supervisor qualifications are rescreened for proper staining and correct interpretation by the laboratory director, supervisor qualified in cytology or cytotechnologist."

In their testimony, the CAP and NJSP pointed out that CLIA requires periodic review of 10 percent of negative gynecologic slides by an experienced supervisor or cytologist. To further ease concerns about quality, the groups noted that thin-layer preparation and other technological advances have improved the accuracy of Pap tests, lessening the need for more regulation. But, the CAP and NJSP said, studies show an irreducible false-negative rate of about five percent for Pap testing.

The two organizations said, "We urge the committee to recognize the tremendous success and the inherent limitations of the Pap test and to reject the provisions in the legislation that would mandate physician review of all gynecological test results."

Unchanged by the rescreening amendment is a provision in the bill that would require, as a condition of continued employment, continuing education for each cytotechnologist employed by a clinical laboratory. The CAP and NJSP said, "The provision does not specify the type of continuing education that is required, how many CME credits are required, the time interval over which they are required, and other specifics of the continuing education requirement; however, as a general rule, we are in favor of continuing education and we do not oppose this provision."

Federal support for SNOMED in advisory panel’s report

The federal government should provide financial incentives to encourage full integration of the CAP’s SNOMED CT into the electronic health record, a presidential advisory panel has recommended in a final report.

Also in its report, "Revolutionizing Health Care Through Information Technology," the President’s Information Technology Advisory Committee recommends that the government make "freely available" standard, automated mapping of SNOMED CT to the International Classification of Diseases, Tenth Revision, Clinical Modification, or ICD-10-CM.

The advisory committee, established in 1991, advises the president, Congress, and federal agencies on issues related to information technology research and development. The committee recently received a final draft of the report from a subcommittee and gave it final approval June 17 at a meeting in Arlington, Va.

In a report preamble, the committee wrote, "Although the potential of IT to improve the delivery of care while reducing costs is enormous, concerted national leadership is essential to achieving this objective." It said barriers to nationwide use of health information technology "can only be addressed by the Federal government" and that infrastructure costs are a barrier to provider adoption of electronic health record, or EHR, systems.

The committee said in its report, "[T]he current payment system does not provide incentives to make the investment, since many benefits of an effective health information system go primarily to patients and to those who pay for their care, rather than to the hospitals and doctors who invest in the hardware, software, and training."

Reflecting this concern was the advisory committee’s chief recommendation for SNOMED: "Federal incentives are needed to enable the incorporation of SNOMED-CT into EHR systems so that those systems can exchange normalized expressions of clinical concepts, implement standard computer-aided decision-support protocols to reduce medical errors and provide more detailed information for quality-improvement programs."

The panel also recommended:

  • Making SNOMED "part of a core set of standardized clinical vocabulary" and supporting it "as a continually improving standard that is kept up to date."
  • Establishing government-sponsored financial incentives for electronic health record systems to generate SNOMED-CT-coded clinical information (in federal pay-for-performance programs, for example).
  • Revising federal health program reimbursements to base them on the reporting of diagnoses and procedures coded in SNOMED CT for clinical purposes.
  • Ensuring that the migration of ICD-9-CM to ICD-10-CM not "retard the adoption and implementation" of SNOMED in electronic health record systems.

"Each of these incentives must be researched, developed, and supported in the long term to assure successful implementation," the committee said in the report. The National Library of Medicine, the National Center for Health Statistics, and the Centers for Medicare and Medicaid Services should oversee federal efforts related to SNOMED and coordinate with other federal health care interests, the group recommends.

President Bush has set a 10-year goal of establishing electronic health records for most Americans. In a recent speech, Bush pointed to last year’s agreement between the CAP and the National Library of Medicine to license SNOMED CT for public use as a sign of progress toward his goal. In a May 6 meeting attended by College leaders, Health and Human Services secretary Tommy Thompson announced that the English edition of SNOMED CT core content is now available, at no cost, through the National Library of Medicine’s Unified Medical Language System Metathesaurus.

A push for the patient safety bill

The College and more than 100 other national and state medical organizations have urged senators to bring patient safety legislation to a full Senate vote.

The College and other groups made their appeal on behalf of the Patient Safety and Quality Improvement Act (S. 720), which won approval in the Senate Health, Education, Labor and Pensions Committee last year. In March 2003, the House passed a companion bill, H.R. 663.

In one of two letters sent June 18, the CAP and other groups asked Senate majority leader Bill Frist (R-Tenn.) and minority leader Tom Daschle (D-SD) to bring S. 720 to the Senate floor for a vote. A second letter asked other senators to encourage their leaders to schedule a full Senate vote on the measure.

The legislation, which the College has backed in the House and Senate, would create public and private patient safety organizations to collect voluntary, confidential provider reports of medical errors and respond with information on how to prevent errors. The bills would establish strong confidentiality and legal protections for providers who submit reports, including prohibitions on the discovery or subpoena of PSO data in civil, criminal, or administrative proceedings. Both bills also would prohibit the disclosure of confidential data under Freedom of Information Act requests and its use in adverse employment actions.

"Currently, there is a disincentive for physicians and other health care professionals to engage in a reporting system because of the fear of litigation," the groups wrote, noting the value of the bill’s confidentiality provisions. "The program is modeled after a similar system set up in the aviation industry. Aviation safety has improved dramatically because pilots and ground crews can report mistakes without fear of retribution."

The legislation has been stalled in the Senate, where Democrats have complained that its confidentiality provisions go too far and could serve to shield willfully negligent providers from prosecution for harm caused to patients. Democrats also question the law’s preemption of state error reporting laws. Supporters, however, point out that the law would only preempt less restrictive state laws.

If the Senate passes S. 720, a House-Senate conference committee would reconcile it with the House legislation and then send a final bill back to both chambers for full votes.

Carl Graziano is CAP manager of government communications.