Volunteer gets answers on Red Cross blood safety

By LEONARD GLENN CRIST
SALEM — After reading an article online about a $4.6 million fine leveled against the American Red Cross for distributing “unsuitable blood products,” Mahlon Griffith became concerned about the organization he has volunteered with for over 20 years.

So Griffith, a 75-year-old retired postmaster from Damascus who coordinates Red Cross blood drives for three area Ruritan Clubs, decided to look for answers.

He initially contacted the Red Cross trying to find the answers to two specific questions: Is there a problem with the blood supply? And if there is no problem, why did the Red Cross accept the $4.6 million dollar fine in February from the Food and Drug Administration?

Griffith said Red Cross officials brushed him off.

In a follow up phone call, Griffith reminded the Red Cross that he had a blood drive coming up on May 20. Griffith said he was considering canceling the blood drive if he couldn’t get satisfactory answers.

That grabbed the attention of David H. Plate, CEO of the Red Cross Northern Ohio Region. On Thursday, Plate and Dan May, the Red Cross’ regional quality director, met with Griffith in Salem to discuss his concerns.

Plate said he took Griffith’s concerns seriously because he was aware of no blood drive sponsor that had ever before threatened to cancel a drive due to organizational controversy. May said it was fairly unprecedented for Plate and himself to meet with a sponsor. Normally the Red Cross public relations department handles such questions, May said.

“David and I decided we owed you,” May said.

For more than 20 years, Griffith has coordinated blood drives every two months for the Damascus, Goshen Center and Beloit Ruritan clubs. Instead of relying on the regional office to notify potential donors, as most blood drives do, Griffith and four volunteers personally call a list of about 250 people to remind them of the drives.

Roughly 40 to 50 people donate blood at each drive sponsored by Griffith, which amounts to about 700 units of blood being donated each year, Plate said.

One person’s donation, Plate explained, generally becomes three units of blood: one unit of red cells, used for general transfusions; one unit of platelets, used for more serious situations; and one unit of plasma which is used for transfusions and also for the manufacture of medical products.

The Red Cross Northern Ohio Region, which covers 19 counties in northeast Ohio and western Pennsylvania, collects about 220,000 units of blood each year, Plate said. In total, the Red Cross handles 42 percent of the nation’s blood supply.

Griffith’s blood drives may be small but are not insignificant, Plate said.

“For a small Methodist church in that community to draw 44 donors is remarkable,” Plate said. Griffith’s personal touch is what brings so many donors in on a consistent basis, he said.

Griffith said he didn’t want to scare donors away with his concerns, but he wanted to know what is going on within the Red Cross. The $4.6 million dollar fine wasn’t sitting well with him.

“$4.6 million could go a long way,” Griffith said.

The fine was just the latest in a string of FDA penalties against the Red Cross. Previous fines since 2003 totaled more than $15 million for violations of blood safety regulations and the terms of a consent decree.

The consent decree, first established in 1993 and updated in 2003, forces the Red Cross to comply with FDA laws and regulation aimed at ensuring the safety of the national blood supply. The 2003 update added financial penalties for every violation.

The February fine was leveled against the Red Cross after an FDA review of 113 different blood recalls between 2003 and 2006 found the organization had failed to follow various standard operating procedures, including asking donors about foreign travel or health status and improperly testing blood.

The FDA stated there was no serious threat to public health due to the safety breaches.

The article Griffith read regarding the fine, written by the Cybercast News Service, investigated what happened to the recalled blood. A request by CNS was made to the Red Cross to divulge where the blood went and if it was transfused into patients. The Red Cross declined to give the information.

The article quoted a Red Cross spokesperson who stated the senior leadership of the Red Cross had determined that because of limited resources it would take too much to compile such information.

May said some of the recalled blood was in the northeast Ohio area and he said he was sure some had been transfused into patients, though he couldn’t provide details as to how many, where or when. No patients suffered adverse health consequences as a result of a transfusion of recalled blood, May said.

There are three classes of blood recalls, May said. All of the recalls reviewed by the FDA were considered a class three risk, which is a minor risk. A class two risk is temporarily harmful and a class one risk could be fatal.

For a class three risk, the Red Cross must notify the hospital where the recalled blood was delivered, May said. Because it is considered a minor risk, the hospital has discretion as to whether to notify patients in the event recalled blood was transfused, May said. The Red Cross does not necessarily hear back from the hospital if the recalled blood was transfused, he said.

The Red Cross also does not “want to panic the public,” May said.

Class three recalls are often clerical errors or minor errors where protocol wasn’t followed 100 percent correctly, May said. The Red Cross must follow 99 different standard operating procedures when handling donated blood. If just one procedure is not correctly followed, the blood must be discarded. There are times when the blood isn’t hazardous, but because the Red Cross didn’t cross its Ts or dot its Is, there is a recall, May said.

In a class one or class two recall, there would be much more accountability for where the blood went, May said. For instance, if HIV positive blood was transfused into a patient, the FDA would be notified and an investigation would be opened immediately, May said.

“The blood is as safe as it can be,” May reassured Griffith.

The Red Cross agrees with all of the FDA regulations, May said. Instead of legally fighting the $4.6 million FDA fine, the national board of governors instead decided to pay it and work toward improving the organization, May said.

At the end of the meeting, Griffith said he felt satisfied Plate and May addressed his concerns.

The blood drive on May 20 will happen as planned. The drive is scheduled to run from 1-7 p.m. at the Damascus United Methodist Church, 260 Valley Road, Damascus.

“I think the meeting was very fruitful,” Griffith said.

Leonard Glenn Crist can be reached at lcrist@salemnews.net