Press Release [see full text and additional documents at http://webserver.health.state.pa.us/health/cwp/view.asp?A=190&Q=229407 ]

FOR IMMEDIATE RELEASE

[Pennsylvania] HEALTH DEPARTMENT ANNOUNCES PRELIMINARY RESULTS OF ST. AGNES INVESTIGATION

HARRISBURG (Aug. 15) -- Secretary of Health Robert S. Zimmerman Jr. today announced preliminary results of the Department of Health’s investigation into a laboratory error discovered in late July at St. Agnes Hospital in Philadelphia.

“As the agency charged with protecting the health and safety of Pennsylvanians, we take seriously our responsibility to study this situation, identify the problems, and take action so the problems can be corrected and the public can be assured that measures are taken to prevent such mistakes in the future,” Secretary Zimmerman said.

“This first part of our investigation, which we’re reporting on today, has mainly focused on the underlying causes of the laboratory error. We wanted to discover what happened and the chain of events that allowed an error of this nature to occur.

“It was clear from the start that an incorrect formula number was used -- causing an error in the calculation of the Prothrombin Test (often referred to as a Protime Test or PT, which checks the rate at which blood is clotting). That error resulted in patients receiving a higher dosage of an anticoagulant drug. It was unclear what in the existing quality-assurance systems allowed the error to happen and not be detected for seven weeks.”

The Department of Health investigation noted errors in the ordering procedures for a new test reagent (the chemicals used in the test); the selection and implementation of that new reagent; and the evaluation of laboratory final reports that were not promptly identified and corrected by the laboratory’s quality-assurance program.

The department found that:

· Although the hospital had conducted a review and decided to switch to a more sensitive PT test, it did not properly address timeframes for the implementation of the more sensitive test and properly order the new, more sensitive reagent. When ordering the new reagent, the hospital used an incorrect catalog number. Although the ordering form noted the need for the new reagent, this notation was not carried through the ordering process, and, once the order arrived, the laboratory did not ensure that the supplies they thought they ordered were indeed what they received;

· Upon receipt of the supplies, the laboratory did not perform adequate verification and testing to ensure appropriate testing results. Things such as direct analysis with reference materials, parallel testing of old vs. new reagents and checking against routine controls were not conducted adequately; and

· Once the presumed new reagent was being used, the department found that the laboratory did not address calculations of Prothrombin time test in that its quality-control practices monitored instrument readings only in seconds and not in the term used to report patient values, International Normalized Ratios (INR). As a result, the laboratory quality-assurance review did not identify miscalculations of INR due to the use of an International Sensitivity Index of 1.01 rather than 2.028 when performing Prothrombin time tests.

The department also noted some questions about the packaging of the new supplies that were ordered, and has turned those concerns over to the federal Food and Drug Administration (FDA), which is responsible for the labeling of products.

Secretary Zimmerman noted that the staff at St. Agnes is cooperating with the department’s ongoing investigation, and that the lab has had a consistent record over the years of meeting regulatory requirements. Soon after the incident was discovered, St. Agnes voluntarily stopped doing the PT lab analysis at its facility and has been sending that work to another hospital lab.

As a result of the laboratory investigation, St. Agnes has been issued a condition-level deficiency, which means the Department of Health cannot attest to the capability of the laboratory to produce reliable patient values on PT tests. When a condition deficiency is cited, the laboratory is considered to be out of compliance with the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA) and state regulations, which means it could lose its authorization to perform clinical diagnostic testing and to bill for services provided to Medicare and Medicaid recipients.

The laboratory has 10 days from receipt of the deficiency letter to submit a plan of correction to the department, which acts as an agent for the federal government on these follow-up issues. If the plan of correction is not acceptable, the department will notify the Centers for Medicare and Medicaid Services regional office, along with a recommendation that the laboratory’s CLIA certification be limited, suspended or revoked.

In addition, the plan of corrective action will determine if St. Agnes can again begin performing PT tests. The department will conduct unannounced compliance checks of all laboratory procedures throughout the next year to assure that they are in compliance with scientific standards and state regulations.

The department lab investigative team has looked at every other test performed in the St. Agnes lab that uses a formula calculation and has found no other problems.

The second component of the department’s preliminary investigation was a review of St. Agnes’ skilled nursing facility within the hospital –- a facility with 19 long-term-care beds. St. Agnes originally reported it believed that two nursing facility residents died as a result of the lab error. The department did not find evidence that the care given and decisions made in the nursing facility attributed to those deaths. The department’s last two annual surveys of the nursing facility found it was deficiency free, and there have been no complaints filed against this facility in the last 30 months, the time period for which the department records those results on its website.

The department will continue a broad, in-depth clinical review of the incident, looking for other missed opportunities for prevention and intervention and determining the full effect and extent of the error. It is looking to answer questions such as the current health status and clinical management of persons who were tested and where else in the seven-week period the error might have come to someone’s attention.

The clinical review is expected to take several more weeks.

Once the entire clinical review is completed, the department will determine deficiencies and administer appropriate penalties against St. Agnes for all deficiencies found.

During this investigation and review, the department has worked with the Philadelphia Department of Public Health and its Medical Examiner’s Office; the federal Centers for Medicare and Medicaid Services (formerly known as HCFA); the Centers for Disease Control and Prevention (CDC); and the FDA.

The Medical Examiner is expected to release his findings later today. The Medical Examiner is responsible for determining and investigating the cause of deaths, while the Department of Health is charged with investigating the larger public health issues and concerns.

The results being announced by the department today were given to the hospital yesterday. The department also is sending an overview of the laboratory component of its investigation to hospitals across the state in a provider bulletin to educate them about the problems St. Agnes encountered, so they can learn from those mistakes.

“This was a very serious error, and we offer our condolences to the families mourning the loss of loved ones,” Secretary Zimmerman said. “I’ve personally met with Sister Marge Sullivan, St. Agnes’ CEO, and know how the hospital community is grieving over this event. At this point, the most important thing the Department of Health can do is to assure that the errors have been discovered and are being corrected, and that not only this hospital, but all facilities in Pennsylvania are safe for our citizens.”

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2001 COMMONWEALTH OF PENNSYLVANIA Department of Health Commonwealth News Bureau Room 308, Main Capitol Harrisburg, PA 17120

CONTACT: Richard McGarveyAmy Kelchner(717) 787-1783

-- Andre Weltman (aweltman@stat.epa.us), August 16, 2001