It may sound overly dramatic, but purchasing hospital supplies literally can be a matter of life or death.
Nowhere was this more apparent than at St. Agnes Medical Center in Philadelphia, where two patients may have died this summer because of a miscalculation in coagulation studies related to administration of the blood-thinning drug Coumadin. Because the lab tests were not accurately measuring the blood-clotting ability of patients' blood, an untold number of patients were given too much of the lifesaving-but tricky-to-administer drug. Another death has since been attributed to the error, according to the Philadelphia medical examiner's office in September. In total, the error affected 932 patients who had such lab tests performed at 172-bed St. Agnes from June 2 to July 25-although, fortunately, not all with the same tragic results (Aug. 6, p. 4).
But it was a misguided ordering error that sparked the complicated series of events that led to the tragedy, according to the Pennsylvania Department of Health.
Here is how it happened:
The hospital decided to change the chemical reagent used in a test to determine how quickly blood is coagulating, choosing a more sensitive chemical. The reagent, manufactured by Instrumentation Laboratory, Lexington, Mass., was so new it had not yet been assigned its own catalog number, according to state health officials.
Meanwhile, hospital officials are unclear as to whether they lacked a catalog number supplied by the manufacturer or Fisher Scientific International, a Hampton, N.H.-based distributor of laboratory supplies. Regardless, the laboratory worker in charge of ordering the new reagent wrote the old number on the order form along with an asterisk, indicating that it was the incorrect catalog number, says Richard McGarvey, a spokesman for the state health department. The order then traveled through several hands in the hospital before it was electronically transmitted to the vendor.
"Somewhere in that process, the asterisk was dropped," McGarvey says. "So what they ended up ordering was the old reagent, but they treated it as if it were the new one."
As a result, on the presumption that the more sensitive test was being used, doctors increased the doses of Coumadin that they prescribed, putting patients at risk of bleeding to death.
That was just the first of a series of errors that contributed to what both state health and hospital officials characterize as a systemic problem. For example, although it may not have been readily apparent from the label or bottle, reagents come with package inserts with explicit instructions. If lab workers had read the insert, they would have realized it was not the reagent ordered. The lab also neglected to run parallel studies in which results are compared with blood samples that have been run through both the old and new products, McGarvey says. There was never any order verification either, he says.
"If they had followed hospital procedures, the error would have never occurred," McGarvey says.
Hospital officials fully realize that purchasing practices need to be tightened, says Teresa Heavens, a hospital spokeswoman. Changes to the laboratory quality-assurance program were made in mid-August, including several changes in purchasing procedures. Among them is a new external requisition purchasing policy detailing a step-by-step approach to ordering new lab reagents from vendors. In addition, two new policies address the reagent verification process.
"From a purchasing standpoint, we realize some of our practices need tightening," Heavens says. "The bottom line is there was a system failure and the ultimate safeguards that needed to be in place were not."
A missing asterisk
That said, the initial mistake was chillingly innocent. In explaining the need for an asterisk on the purchasing order, Heavens says, "the technician ordered the new reagent the way she was instructed by the sales representative for the company. She was instructed to use the former reagent number with an asterisk."
It was unclear who gave the technician these instructions. Heavens says the reagent was purchased through a longstanding contract with Fisher Scientific, but the distributor categorically denies any involvement.
"According to the reports and information our company has available to us from many sources including the state health department, this is strictly an internal issue to St. Agnes Medical Center and therefore does not involve Fisher," said Gia Oei, a Fisher spokeswoman, responding to questions via e-mail.
Regardless, Heavens says, St. Agnes is pointing the finger in one direction: internally.
"Our analysis revealed there were problems at all ends, and this was a system failure. Many mistakes were made in the process, including interpretation of how to order the new reagent," Heavens says.
"The thing we've learned in a very challenging way is that there should be a standard in terms of ordering, and you shouldn't have to pencil in or write asterisks. There should be an order number and entry number."
As an epilogue, St. Agnes announced in mid-September that its laboratory was fully operational and blood coagulation studies had resumed with the state health department's blessing-about six weeks after the hospital first disclosed the errors. Besides reviewing the correction plan, state health investigators reviewed every other test performed in the St. Agnes lab and found no other problems, hospital officials said at the time.
"With these new policies, procedures and practices in place in the lab, we have reaffirmed our commitment to patient safety and security," Sister Marge Sullivan, St. Agnes' president and chief executive officer, said in a written statement.