U.S. Rep. Elijah E. Cummings says major changes may be needed in the regulation of laboratories in light of the serious problems at Maryland General Hospital.
Cummings has arranged a congressional hearing tomorrow on the issues arising out of the lab breakdowns that threatened patient safety at the Baltimore hospital, which is in his district. Maryland General sent patients more than 450 questionable HIV and hepatitis test results, and managers failed to act until a former staff member contacted the state health department.
Although the hospital has retested many patients and found the original results were mostly accurate, Cummings says that doesn't resolve the problem.
"They were very lucky," Cummings said. "But we cannot base public policy on luck. That's not good enough when it comes to life-and-death issues."
Investigations of Maryland General - which have resulted in the resignation of the hospital president and the two top lab officials - have also shown major weaknesses in hospital inspections done by government and private organizations.
Cummings said he hopes testimony at the hearing tomorrow will address whether the lab and inspection problems go beyond Maryland General, and whether more rigorous and coordinated inspections are necessary across the country.
"Our main concern," said Cummings, "is to find out what happened here. It may be necessary to tighten the federal standards."
Noting that the hospital lab had been given the top rating by the College of American Pathologists after a review in April last year, Cummings said he wants to find out how the inspectors could have reached that conclusion in the midst of serious problems.
The hearing before a subcommittee of the House Government Reform Committee will include a half-dozen witnesses, among them a representative of CAP and officials of the Centers for Medicare and Medicaid Services and the U.S. Food and Drug Administration.
Maryland General is an affiliate of the University of Maryland Medical System, which is expected to send a representative to testify. Two former Maryland General lab workers and a representative of Adaltis US, the company that sold the blood analyzer that produced the questionable test results, also are expected to attend.
Cummings arranged for the hearing after the disclosure that during a 14-month period ending in August last year, the hospital gave out more than 450 HIV and hepatitis test results despite instrument readings showing that the test results might be inaccurate. State and federal inspectors later turned up pages and pages of violations of testing standards.
CAP, which had previously accredited the laboratory "with distinction," later suspended its approval for two key laboratory divisions.
State Health Secretary Nelson J. Sabatini has been highly critical of the hospital inspection system, saying it limits the ability of state inspectors to review hospitals unless there has been a specific complaint.
At one point, Sabatini threatened to revoke the approved status for about 120 hospital laboratories across the state unless CAP provided state officials with what the organization said was a confidential report on Maryland General. CAP complied.
Cummings said another issue he hopes to have resolved is whether the various state and federal regulatory agencies, along with private accrediting groups such as CAP, should be required to share information on licensed facilities.
"There's certainly a question as to the communication between these entities," said Cummings. "We've got to make sure there's coordination. Here we had one party not knowing what the other was doing."
The congressman said CAP officials have assured him that their inspection standards were even tougher than those required by the federal government.
"If that's the case," Cummings said, "then maybe we need to tighten the federal standards."
He added that he was still puzzled by the fact that CAP gave Maryland General such a high rating when later inspections showed there was so much wrong.
"How could they come up with the results they came up with?" he asked.
Yet another issue, he said, is whether the FDA is adequately regulating testing equipment like the Adaltis Labotech, which produced the questionable results. Cummings said he will also be trying to determine what other facilities across the country are using that equipment and what, if anything, the FDA is doing about it.
"Our main goal is patient safety. When people go into one of these facilities, they need to be confident the results are accurate," Cummings said.