State Fails to Act on Lab Mix-Ups at Alvarado : Regulation: Lab technicians mistakenly gave mismatched blood to two patients at the hospital in the past two years, contributing to one man’s death.

Mix-ups in the medical lab at Alvarado Hospital in San Diego resulted in two seriously flawed blood transfusions since 1989, including one in which an elderly man died hours after receiving a large dose of incompatible red blood cells, according to a confidential state file obtained by The Times.

A state Department of Health Services investigation alleges that the 84-year-old Alvarado patient suffered an “adverse and fatal reaction” to the mistaken transfusion during open-heart surgery in November, 1989, the file shows.

The file also documents a second major transfusion “error” at Alvarado on May 15 of this year, when another patient was given mismatched blood and suffered a milder, nonfatal reaction.

In both cases, health department officials traced the mix-ups to sloppy work in the Alvarado medical lab and recommended taking unusually strong action: suspending or revoking the licenses of the two laboratory technicians responsible.

But the state so far has failed to act on those recommendations, allowing the technicians to keep their licenses and continue to work in the hospital lab, records and interviews show.

Nearly two years after the first transfusion mistake at Alvarado, state health officials acknowledge that they should have been quicker in deciding what, if any, action to take against the technicians.

“Let’s face it, we didn’t do a good job,” said Michael G. Volz, chief of laboratory services for the state health department and the official in charge of the investigations.

“No excuses, no explanations from this end,” he said. “It’s obviously an issue of great importance to me and the department as a whole. We certainly acknowledge that this issue has not been brought to closure in an appropriate amount of time.”

Volz and Alvarado administrators stressed, however, that the incidents described in the confidential file are “isolated” and not part of a pattern at the College Area hospital that threatens public health. Federal and state inspections have repeatedly demonstrated that the Alvarado lab uses the proper procedures to analyze blood and other specimens, they say.

Gary Sloan, Alvarado’s administrator and chief operating officer, said the hospital even began double-checking all lab blood tests in the wake of the second bad transfusion five months ago.

“We’ve reviewed our procedures top to bottom with blood bank specialists, and we think we’ve done everything--and then some--to ensure these incidents don’t occur again,” Sloan said.

He and other Alvarado officials also vehemently denied allegations contained in the confidential state file that the hospital’s incorrect transfusion in 1989 killed a patient. They agreed, however, that the patient’s reaction to the large dose of mismatched blood was a complication that could have contributed to his death some 10 hours after surgery.

“I don’t think you can rule it out,” Sloan said. “Obviously, the transfusion reaction is a contributing factor.”

The question of whether, as state investigators believe, Alvarado’s 1989 transfusion mistake killed the elderly patient may never be definitively answered, some officials say. No autopsy was performed on the man before his body was cremated and the ashes scattered at sea.

“This is going to be one of those inconclusive (cases) because the autopsy is the only thing that could tell you that,” said Mary Ann Touralt, consumer safety officer with the U.S. Food and Drug Administration in Washington. “This is going to be a ‘you never know . . .’ ”

A Times investigation shows that the surgeon who filled out the death certificate--listing a “blood transfusion reaction” as a “significant factor contributing to death”--failed to call the San Diego County medical examiner’s office, which routinely examines cases involving accidental deaths. In addition, the hospital itself failed to immediately contact federal authorities about the mistake, as required by federal health regulations.

Meanwhile, the executor of the patient’s estate said he would have demanded an autopsy had hospital officials or doctors told him about the botched transfusion in 1989. He said he knew nothing about the mix-up or the state investigation until contacted recently by The Times.

The death certificate “doesn’t say there was something medically that was done wrong, and there was a reaction to that,” said Claude A. Bailey, the executor and an El Cajon tax consultant. “If I had known then, I would have requested an autopsy just to clear the air. . . “ This “covering up sounds like a Watergate in the hospital. . . . I’m appalled.”

Transfusion-related deaths are unusual, statistics indicate. In 1990, blood banks nationwide reported only 53 such incidents to the FDA, which is charged with conducting a follow-up investigation to scrutinize lab procedures. Hospital authorities say the FDA made such an investigation at Alvarado and found no procedural problems, but the agency Friday declined to release its report.

Cases such as Alvarado’s, in which the same lab is responsible for two seriously flawed transfusions, are even more rare, state officials say.

“For the same thing to happen, or something similar to happen, in the same facility in two years might be categorized as highly unusual,” said William S. Argonza, who works for Volz and is in charge of the Department of Health Services’ Laboratory Field Services unit in Berkeley.

In all, there are 2,200 medical labs and 19,000 technicians licensed by the state to perform a wide range of crucial medical tests. Besides cross-matching blood for transfusions, they can analyze patient specimens to confirm such conditions as pregnancy, diabetes, syphilis, measles, rheumatoid arthritis, high cholesterol, kidney problems and AIDS.

Argonza’s unit is charged with routinely inspecting the labs and its employees. Its public files show that investigators have reported only minor problems over the years at Alvarado, where a staff of 51 technicians and supervisors each month performs 90,000 diagnostic tests, 1,800 of which are blood cross-matches.

The minor irregularities were quickly corrected, and the lab was recently reissued a license, the public files show. No mention is made of the two seriously flawed transfusions.

But the confidential file obtained by The Times paints a different picture.

“Several oversights on the part of this facility raise questions as to the technical capability of the laboratory personnel,” Argonza wrote in a June, 1990, memo summarizing his unit’s investigation into the first transfusion mistake at Alvarado. “There were also several errors made in record maintenance and reliability of information by the laboratory administration.”

The file contains considerably more detail about the bad 1989 transfusion and shows that the only way investigators found out about it was when a health department inspector overheard a conversation during a visit to another San Diego medical lab in February, 1990, more than two months after the death of the patient.

The resulting investigation, the file shows, uncovered a series of blunders, starting with the technician who picked up the wrong specimen of blood in the lab and ending with the attending physician, who signed a hospital discharge report that said the patient had an “uneventful stay” and was sent home--the day after he died.

The patient was George E. Francois, an 84-year-old retired plumber from San Diego who cut short a fishing trip in the Sierra Nevada because of chest pains. An angiogram revealed that Francois’ arteries were 95% blocked, and he agreed to undergo a quadruple coronary bypass on Nov. 7, 1989, after suffering a heart attack a day earlier at home, his doctors said.

There was no question that the procedure was risky, said Christopher Elia, the San Diego surgeon who operated on Francois. Advanced age and a deteriorating heart increased Francois’ chances of dying from the procedure from a normal 1% to 25%, he said.

Bailey, Francois’ friend and executor, said Francois was in good spirits and still had a strong grip before the operation.

“I was there the night before, and we were watching Joe Montana on ‘Monday Night Football,’ ” Bailey said. “He seemed to be quite up and everything.”

At 6:30 the next morning, the Alvarado lab mistakenly released four units of Type A red blood cells for a transfusion into Francois, the confidential file shows.

Surgeons gave him two units--or a little more than a pint--before they discovered it was incompatible for Francois, a Type O. He received several more units of the correct blood, and left surgery shortly after noon. He died after 10 p.m.

The amount of mismatched blood given to Francois was three to five times what experts say was needed to produce a strong, even deadly, reaction. Type O antibodies would immediately begin killing off the Type A cells, resulting in fever, chills, a sudden drop in blood pressure, shock and kidney failure, experts say.

The effect could be particularly dangerous for a patient who already has a weak heart, said Thomas A. Lane, director of the UC San Diego Medical Center Blood Bank.

“It’s the worst-case scenario,” he said.

The confidential file shows that investigators traced the mistake to technician Nannette DeLeon, who graduated in 1963 from the University of Santo Tomas in the Philippines. She is an experienced technician who had worked for 15 years at hospitals in New Jersey, Connecticut and Ottawa before joining Alvarado, records show.

In his 1990 memo, addressed to Volz and the health department’s legal chief, Argonza wrote that, the day before surgery, DeLeon “erroneously used the blood specimen of one patient for another patient (Francois) being cross-matched for transfusion purposes.”

“Consequently, Mr. Francois was transfused with two units of incompatible blood, which resulted in an adverse and fatal reaction. The surgery section of the hospital became aware of the problem the same day, when specimens were drawn from the transfused patient for additional cross-matching,” he wrote.

Elia, the doctor who performed the surgery, acknowledged that the mix-up was the first time a laboratory sent the wrong type of blood for a patient in any of his 10,000 operations. “It’s a major problem, but thank God it doesn’t happen too often,” he said.

However, Elia and hospital officials strongly disputed the state’s allegation that the mix-up led directly to Francois’ death.

Elia said he immediately began treating Francois once the error was discovered. Two hospital committee reviews of the case subsequently concluded that Francois showed clinical signs of only a “minor” reaction, the confidential files show.

“Patient was felt to be a high-risk cardiac surgical candidate,” one of the committees concluded in a memo released by Alvarado officials to the state. “This was considered a surgical death not related/caused by the transfusion error.”

But Francois’ death certificate indicates otherwise: Although it gives the immediate cause of death as a heart attack brought on by long-term coronary disease, it also lists “blood transfusion reaction” as a “significant condition contributing to death.”

“No doubt about it--it didn’t help the situation, knowing that he received a unit of bad blood,” said Elia, who filled out and signed the certificate.

The confidential file shows that Argonza urged department attorneys to suspend or revoke DeLeon’s technologist license, but that recommendation has so far gone unheeded. In fact, records show the state did not suspend any lab technician’s license during fiscal 1990-91.

In a short interview, DeLeon told The Times: “I can remember I did a mistake, but I have to look back in the report that was given to the (hospital) administration.” She declined a request for a second interview.

Hospital records included in the state’s confidential file show that, on their own, Alvarado administrators suspended DeLeon for a day without pay, sent her to counseling and noted the incident in her personnel file.

Although state investigators singled out DeLeon for the 1989 mistake, their confidential reports and exhibits also show additional problems and criticisms of other people involved in the Francois case. They include:

* A hematology supervisor, who performed cross-matching tests on samples of the Type A blood transfused into Francois and came up with two different results for compatibility. Argonza concluded that the supervisor “is not knowledgeable or confident about transfusion techniques used in (the) section.”

Through hospital administrators, the supervisor has declined comment, but lab manager James R. Scull said the supervisor is a capable employee.

* A second Alvarado lab technician, working on the day of surgery, who mistakenly matched yet another unit of Type A blood as being compatible with Francois. The mistake was caught, and the technician said he committed the error because he was “in such a rush that he used previous data for his recordings”--in essence repeating DeLeon’s mistake--before his cross-match was actually complete. “Under ordinary practice, previous data is never copied for a new cross-match situation,” Argonza said.

The technician declined comment.

* Hospital administrators, who failed to notify the FDA about the transfusion-related death, although federal regulations require written notice within seven days. The confidential file shows that Scull, the lab manager, wrote to the FDA only after the state instructed him to do so in early February, 1990.

Hospital officials said they didn’t report the incident because they didn’t know about the FDA requirement at the time.

* Francois’ attending physician, who never mentioned his death in her hospital discharge summary. In fact, the summary has Francois leaving the hospital one day after his death to seek a second opinion about the bypass operation. “Since the patient had an uneventful stay, without any bleeding, he was then discharged on 11-8-89,” it says.

Manorama Reddy, the doctor who prepared the summary, blamed the wrong date on “human error.” She said the details contained in the summary were actually about Francois’ hospital stay a few days earlier to undergo an angiogram test at Alvarado.

“Looks like I dictated a couple of discharge summaries and mixed up the dates, that’s all,” she said.

Meanwhile, further interviews and record checking by The Times revealed that doctors failed to report the transfusion-related death to the county medical examiner, who said he would have conducted an autopsy had he known.

“Those are the things that we are quite sensitive to,” said Brian Blackbourne, the medical examiner. “That’s the kind of case that should have been reported to us, if they knew that.”

Elia said he called Blackbourne’s office, reported the circumstances of the death and was told no autopsy was necessary. But the certificate he filled out indicates that he did not contact the coroner. And Blackbourne said a review of his office telephone logs shows no call from Elia around the time of Francois’ death.

Although the existing hospital charts can document the extent of Francois’ reaction to the bad transfusion, Blackbourne said, an autopsy would have fully explained why the man died. “We could determine the extent of the heart disease and hemoglobin in the kidneys,” he said.

Elia also said he told the patient’s family about the transfusion problem. But Bailey, Francois’ executor, said he never heard of the mix-up or the state investigation until he was informed by The Times. He said doctors simply explained that his friend’s heart was 75% gone and gave out after the operation.

Doctors “never mentioned anything about a blood mix-up or a blood problem,” said Bailey, who was given power of attorney to administer the estate of Francois, who left behind an infirm wife and mentally ill son. “The only thing they asked was how his body was going to be removed and how soon.”

He also disputed a notation in the Alvarado file that noted that the patient’s family refused an autopsy--the same thing FDA officials said hospital officials reported to them.

Bailey said he told the doctors that an autopsy was up to them: “I said, ‘You do whatever the state requires . . . .’ They said, ‘Do you want an autopsy?’ I said, ‘For me, I don’t want one, but do what you usually do.’ ”

The state’s confidential file has considerably less information about the second transfusion mix-up at Alvarado on May 15, which state health officials said was promptly reported by the hospital.

A brief memo in the file says an unnamed patient suffered a “hemolytic reaction” when he received a unit of blood that tested positive for the Kell antigen, which affects about 10% of Caucasians.

The unit was labeled Kell negative, however, and the memo said the hospital’s own review showed the “error was most likely due to a mix-up of unit segments,” or blood samples, in the lab by technician Florante Limiac.

“Recommendation: That this matter be forwarded to (state health department attorneys) for possible revocation” of Limiac’s license, the state memo concludes.

Hospital officials said Limiac was also suspended for a day without pay and continues to work at Alvarado on a per-diem basis. Limiac could not be reached for comment, and state files did not have his background.

Despite the state’s severe recommendations for both DeLeon and Limiac, Alvarado administrators say they took appropriate action against the employees.

“There are no set standards for any kind of corrective action to be taken (against) the employee--not from the state, not from the professional organizations,” said Scull, the lab manager. “It is certainly regrettable that these kind of events occurred, but you can’t take human error out of the laboratory.

“Both were more devastated by their part in these instances than anything else we could do for them. They recognized that. My corrective action was appropriate. I don’t want to lose them,” said Scull, who added there is a shortage of qualified lab technicians.

In the state Department of Health Services office in Berkeley, Volz apologized for the length of time it has taken the state to make up its mind about what to do with the employees. Although his subordinates have recommended revoking both technicians’ licenses, he said that could be overturned and another action taken.

“The case has not been brought to closure, and the time frame, from the department’s perspective, is unacceptably long,” Volz said. “We’re taking immediate steps to rectify this particular case, as well as any other case that is open.”

Volz said it will take at least five weeks before the health department can gather and evaluate enough additional material to forward disciplinary recommendations to the state attorney general’s office for action.