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Date: Tuesday, June 11, 1996 FOR IMMEDIATE RELEASE Contact: HCFA Press Office(202)690-6145
The Health Care Financing Administration announced today that it has ordered Warner B. Massey, M.D., Pathology Services in Tyler, Texas, to cease all Pap smear and other cytology testing because, among other serious deficiencies, it incorrectly read laboratory tests done to detect cancerous or precancerous cells on 32 cases.
The suspension, which is effective today, forces the laboratory to stop all cytology testing and cancels Medicare payments to the laboratory.
HCFA completed a survey of the laboratory's cytology services on May 23 and determined that the laboratory posed an immediate and serious threat to patient health and safety. The survey identified four categories of deficiencies in which the laboratory failed to provide services that met national standards.
HCFA Administrator Bruce Vladeck said, "We are deeply troubled by these findings, because physicians depend on accurate and reliable testing to provide appropriate care to their patients."
Diagnostic cytology, including Pap smear testing, is the study of human cell structure to detect cancerous or precancerous changes. Warner B. Massey Pathology Services, located at 119 E. Houston St., in Tyler, performed approximately 28,000 cytology tests annually. The laboratory employs two full-time technical supervisors and one part-time cytotechnologist.
In addition to the suspension of the laboratory's certificate of operation and cancellation of its Medicare payments, on June 10, the laboratory was subject to a fine of $10,000.
HCFA said the amount of the fine takes into consideration the immediate jeopardy posed to the lab's patients and the laboratory's history of non-compliance with federal regulations.
Today, HCFA sent letters to physicians of individuals whose cytology specimens were listed as having known diagnostic discrepancies. The letters recommend that the patient be called in for an immediate follow-up visit. HCFA also will send a more general letter to all physicians who sent cytology specimens to the laboratory, specifying the problems uncovered at the laboratory and the actions taken.
"Our number one concern is that patients get high-quality health care," Vladeck said. "We will take appropriate action to see that patients whose specimens had been sent to Warner B. Massey Pathology Services receive appropriate follow-up to assure accurate diagnosis."
HCFA's survey team reviewed the cytology services offered by
Massey Pathology Services and the specimens sent to the laboratory for interpretation. The team identified four categories in which the laboratory failed to provide services that met national standards.
In addition, the survey team identified diagnostic discrepancies on 32 cytology slides obtained from both gynecological and non-gynecological specimens. These slides represent, HCFA said, a random sample of slides, as well as a targeted review of slides previously reviewed by the laboratory as part of its quality control program.
The cumulative effect of these deficiencies and diagnostic discrepancies resulted in the finding that Massey Pathology Services failed to provide quality cytology services to its patients.
HCFA cytology contractors originally surveyed Massey Pathology Services in February 1994. At that time, HCFA found that the laboratory posed an immediate and serious threat to public health and safety. Through extensive consultation with the Texas Department of Health and HCFA's Dallas Regional Office, as well as subsequent follow-up surveys, the laboratory was able to come back into compliance and resume normal testing.
HCFA's enforcement actions were taken under provisions of the Clinical Laboratory Improvement Amendments of 1988 (CLIA), which protects individuals served by laboratories against substandard testing of specimens. CLIA also safeguards the public against health and safety hazards that result from improper laboratory activities. In addition, laboratories are required to achieve and maintain compliance with CLIA requirements to ensure accurate and reliable test results.