While the Parker Hughes Cancer Center promoted its state-of-the-art medical treatment, behind the scenes its clinic and laboratory didn't measure up to standards for patient safety.
One clinic doctor was so concerned about apparently inaccurate test results from the lab that he stopped using it in December 2001.
The Red Cross, which formerly sold blood products to the Roseville clinic, concluded in a February 2002 audit that lab and other clinic staff members did not follow crucial safety regulations to ensure that patients receiving transfusions were given the correct blood.
The Red Cross concluded that Parker Hughes' procedures and practices did not follow industry standards for transfusion medicine. The audit said the clinic should "obtain the expertise" to bring it in line.
Two months before that audit, Dr. Ron Falcon, then at Parker Hughes, said he found that the center's lab was turning out results that indicated his HIV patients were getting worse, when their conditions had not significantly changed.
Falcon, who no longer works at the clinic, said that he initially had used an outside lab but switched in December 2001 to the clinic's lab. He said Parker Hughes' medical director, Dr. Fatih Uckun, wanted him to use the in-house lab so it could bill for the tests.
Falcon said the results were so far off that he suspected serious problems with the lab equipment. He said he asked Uckun to have the equipment checked and to test some samples at an outside lab for comparison.
"Most of the samples I was getting back from his [Uckun's] lab had numbers that were not believable," said Falcon, now working for an HIV pharmaceutical company in Chicago. Falcon said Uckun refused his request.
Falcon, who'd been hired by Uckun in August 2001, said he went back to using an outside lab. It was easy to justify, he said. "I have to make decisions on changing medications that affects the life of these patients," he said.
In March 2002, Uckun unexpectedly closed the HIV clinic, apparently without notice to patients or the clinic staff, including Falcon. One patient received a letter dated three days after the clinic was closed, which read, "We understand that you will continue to have health needs in the immediate future and recommend you establish your care at another clinic which can provide for them."
Uckun declined to answer questions for this article but said in an interview in September that Parker Hughes arranged for the clinic's patients to receive care with the remaining Parker Hughes doctors or at other clinics.
Clinic transfusions end
After the Red Cross stopped blood sales to Parker Hughes, the clinic no longer offered on-site transfusions, a key part of cancer care.
Dr. Jim Breitenbucher, vice president of medical affairs at Fairview-University Medical Center in Minneapolis, said Uckun told him during a hospital meeting last summer that "his blood supplier had discontinued supplying blood related to concerns over the ability of Parker Hughes to handle blood in their lab."
As a result, Parker Hughes patients were sent to Fairview-University Medical Center for transfusions, he said.
The Red Cross audit does not say whether patients were harmed because of the safety issues it uncovered. However, the lab's transfusion records contained several references to transfusion reactions, the audit said.
The Red Cross' auditor wrote that Uckun asked her to stop her review while she was examining procedures and patient charts. "The audit was discontinued before the auditor could verify that these events [transfusion reactions] were properly investigated, documented and maintained in the patient medical chart," the auditor wrote.
The Red Cross conducted an audit because it was considering a long-term contract to supply blood to the clinic, Red Cross officials said. At the time, tensions had developed between the two organizations. Red Cross officials said their staff members had been treated disrespectfully by the clinic's medical staff. The Red Cross said it stopped supplying blood products and lab services to the clinic in November 2001. "We said we would not do business with them until the regulatory practice issue was resolved," Red Cross spokesman Jon Siess said. "The questions raised in the audit were never resolved."