Good Samaritan Hospital's laboratory regularly failed to follow up on labeling problems that put patients at risk of errors such as receiving the wrong blood type, while Union Memorial Hospital's blood bank director didn't properly ensure the safety of transfusion recipients, state inspectors recently found.
Both laboratories are at risk of getting kicked out of the Medicare program and losing their state licenses if these and other problems that inspectors found aren't corrected.
But both also have submitted plans of correction to the state, and Carol Benner, director of the Maryland Office of Health Care Quality, said, "We're confident at this point that they're getting the problems fixed."
Inspectors weren't able to identify instances in which patients definitely were harmed.
But, Benner said, "we're not sure" because in some cases the labs failed to keep adequate records.
Labs at both Baltimore hospitals continue to function without restrictions as the state monitors their progress.
The hospitals expressed confidence in their labs and said the problems largely have been fixed. Good Samaritan, with 330 beds, and Union Memorial, with 283 beds, are part of the MedStar Health system.
State inspectors found the violations when they went in this fall to check the work of the College of American Pathologists, a private inspection agency that had accredited both laboratories.
The findings, which come on the heels of the college's failure to identify serious problems in Maryland General Hospital's lab, raise questions anew about whether an inspection system that relies heavily on private agencies is working, government officials said.
"This is just more evidence that we may have to look at a whole new system of evaluating these labs," U.S. Rep. Elijah E. Cummings, a Baltimore Democrat who intends to sponsor federal laboratory oversight legislation, said yesterday.
But Cummings said the college recently has made changes that he finds encouraging, including immediately sharing its reports with Maryland officials and promising to revoke accreditation if a laboratory harasses a whistleblower.
State Sen. Paula C. Hollinger, a Baltimore County Democrat and chairwoman of a committee that is also preparing legislation, said the findings that the college had missed violations were "terrible."
But she said the state has no choice but to continue working with private accrediting agencies because its health department is too short-staffed to take on inspections of all labs.
The federal Centers for Medicare and Medicaid Services determined Nov. 15 that the violations were serious enough to put the labs at risk for losing Medicare funding.
In many cases the inspectors took the labs to task for failing to follow up on problems the labs had discovered.
State and college officials said the problems appeared more serious at Good Samaritan, where inspectors found the laboratory didn't properly complete competency checks of employees and didn't adequately follow up on specimen-labeling and other problems.
The laboratory didn't have consistent policies for addressing unlabeled and mislabeled specimens before they reached the lab, leading to a failure to discover that "labeling issues were global and could cause delay in patients' treatment/diagnosis and could lead to erroneous test results," the report said.
The problems included a patient specimen that arrived in the laboratory marked "STAT," bearing two labels with two patient names on them.
In another instance, a specimen from the emergency room showed the patient could have had a heart attack, but the specimen was mislabeled. There was no notation indicating whether the patient with heart problems was ever identified.
"The labeling of samples for blood typing was in fact a serious issue and one that needed to be corrected immediately," Benner said. "Obviously, patients would be at risk for getting the incorrect blood."
At Union Memorial, the lab was cited for failing to review the records of transfusion reactions in a timely manner, failing to have a system in place to document and remedy problems reported to the lab and failing to document that its pathologists and cytotechnologists got appropriate continuing education.
Inspectors also found that electronic systems for reporting problems and assessing lab quality were flawed. They cited the lab for failing to have a written procedure for monitoring the contamination rate in blood cultures, as well as failure to properly document certain quality control tests.
Union Memorial President Harrison Rider said the hospital is ready for the state to come back and review the lab.
"We're very confident in this lab," he said. "Nobody was misdiagnosed. Nobody had to be retested."
Good Samaritan Hospital also said its lab hadn't produced any inaccurate test results. No patients need to be retested and no patient was adversely affected by anything related to the tests, the hospital said.
Hospital President Lawrence Beck said all of the state's recommendations already have been implemented. "We are confident that we will meet the [health] department's standards fully," he said.
The college found far fewer violations at both hospitals, even though at Union Memorial, the state and college inspected the lab on the same day, Sept. 16. The state later returned. The state's inspection of Good Samaritan began Sept. 20, after a June inspection by the college.
Earlier this year, when Maryland General's lab problems became publicly known, the college was criticized for failing to find major problems during its review. The lab had been sending out potentially inaccurate HIV and hepatitis results to hundreds of people.
Maryland General's laboratory has since corrected its major problems and is back in compliance with Medicare.
But many of the violations that state inspectors found at Union Memorial and Good Samaritan took place outside the laboratories in other parts of the hospital, said Dr. Ronald B. Lepoff, chairman of CAP's commission on accreditation.
The college hasn't previously been responsible for looking for problems that happen with patient specimens outside the lab, he said.
"The state expected the lab to ensure the emergency department didn't make any more labeling errors," Lepoff said. "We don't object to these interpretations. They're just new."