Back-to-back inspections show site-to-site variability.

Pyramid Biological, Colton, Van Nuys and San Diego, CA, Los Angeles District.

Four inspections of Pyramid Biological's California plasma centers during 1996 showed variation in compliance at three facilities, with observations differing in both type and number, recently released inspection records show.

Investigator Timothy LaFave's April 1996 audit of the Colton, CA, site, described as a licensed automated source plasma center, revealed two deficiencies, according to the EIR.

The report said room temperature climbed to 85 degrees in the plasma collection area while donor processing continued, despite an SOP that called for notifying the center manager and prohibited using the machines under these conditions.

On two more days, donors were still being processed until the investigator called management's attention to the escalating temperature, according to the EIR. Finally, the center shut down voluntarily until the air conditioning was repaired, keeping the temperature in the 70s, the report said.

LaFave also faulted temperature storage records, finding no initialed temperature recorder charts, the EIR said. To fix this, the center reassigned another recorder from a freezer that was used only for storing ice, moving it to the one used for storing plasma.

Less than three weeks later, in a May-June inspection, FDA audited Pyramid's San Diego site. While Investigators Vincent Iacono and Maxine Fritz found no repeats of previous validation and testing deficiencies, they did find five new problems in donor screening and communication with donors.

For instance, the center physician did not discuss the risks of automated plasmapheresis, the EIR said. He also gave no AIDS information, asking instead if the donors had read the information provided. The report described Pyramid's procedures as "somewhat vague in this regard."

During initial exams of two new donors, the physician also failed to ask questions relating to high risk for HIV, the records stated.

In another case, the center did not follow up when a Western blot positive whole blood donor failed to respond to a notification letter; neither did the center perform a lookback.

An HBsAG-positive donor slipped through screening without written approval to donate twice weekly, the EIR added, and another donor was accepted without any documented need two weeks and three days after a 277 ml whole blood loss. In addition, the investigators found the donor reject card file out of alphabetical order.

The report said management did not argue with the items and promised to make corrections.

2nd San Diego audit finds new faults

Iacono returned alone in August 1996 after the center moved to a new address. Once more, the investigator did not cite reruns of old observations, but did find new ones -- just two this time. His concerns centered on donor records and equipment maintenance.

One donor had two separate active donor files, one for plasma and one for blood. Iacono warned that this made it difficult to monitor dona-tion intervals. The center determined that this case of duplicate files was a lone exception, according to the EIR.

A second observation cited failure to perform checks after equipment underwent repair.

In September 1996, Pyramid's Van Nuys site was inspected by Investigator Ronald Koller. Koller reported in the EIR that he checked donor screening, an initial donor exam, phlebotomy procedures, donor record files, SOPs and test results as well as records for quality assurance, quality control, training and shipping, but the records showed no violations.

Pyramid Biological, Colton, CA, 4/30-5/2/96 ; San Diego, 5/22, 23, 24 & 6/5/96 and 8/6, 8, 21/96; Van Nuys, CA, 9/23-26/96, Doc. 107998M, $9.50 plus handling.

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