American National Red Cross/Biomedical Services — FDA 483 Findings

Two months after closing SP 419, SP 501 was opened as a potential system problem on 9/13/00 when the Acting CEO requested an investigation of labeling problems indicating mislabeling of units is the most serious kind of tror because it can result in significant harm to the patient.

A BSL 02-084 was issued on April 25, 2002, which reminded regions to resolve donor identification holds within 48 hours.

The effectiveness check for SP 625 indicates an investigation will be initiated if the average response time om fractionators for “found” units is greater than 150 days and the number of “not found” units is not greater than 800 its.

On 6/12/02, a region reported in Biological Product Deviation Report #2002-011-001692 the erroneous release of three components labeled incorrectly as CMV negative.

BHQ issued BSL 01-151 entitled “Final Record Review ofthe Releasing Donor Identification Hold Query” on 7/26/01 which made BSL 01-064 obsolete.

In July 2001 BSL 01-147 was issued indicating “based on data that has been submitted” the manual erification of the CMY labeling would continue until further notice.

During the conversion to NBCS in 1997, the regions were informed that they would be provided instructions on handling frozen Red Blood Cells that could not be loaded into the NBCS system after implementation.

A special audit was conducted in August 2001 when the region’s management notified regional QA ofa ‘possible falsification of records.” The report states “The fact that only the cumulative loss records were altered would have an affect on donor safety and not product quality.” Al...

During this inspection, another System Problem #646 was opened following the second occurrence Deviation #2002-002-001618) of the distribution of a component whose CMV status had been incorrectly labeled.

There is no formal training for regional personnel performing the donor file check investigations.

BHQ has allowed a workaround to be in place since 7/13/94 for a software problem in the NDDR system.

BHQ failed to ensure that training for BSDs 62.210M and 62.200M was effectively and properly provided ta

BHQ has failed to implement a software change to the NBCS to assist the regional users with manufactunng timing requirements, so that unsuilable products are not manufactured and ultimately released due to timing requirements during manufacturing.

Other regions were found to be having difficulty following the procedures.

BHQ has not reviewed retroactively donor files in NBCS to determine whether donors were properly evaluated and selected from the pick pan during donor registration.

On 1/31/02, Sir aewas run on a few regions as a “spot check.” It was determined at this time that the arolina Region had {1 donations without the correct assertion and that five components from two subsequent donations had been released and were recalled.

Our review of deviations from 1/1/02 to 6/17/02 during this inspection revealed failure to follow procedures or properly quarantining unsuitable products identified through the MRB in at least 17 deviations and at least 35 deviations when products were not properly quarantined when post donation information was received or BDRs were incomplete.

BHQ’s investigation into the problem and the various corrective actions implemented between 6/15/00 hrough 4/16/02 did not address why the regional users were not following the procedures and whether the established employee training was adequate to prevent this problem from recu...

Blood products from approximately 48 donors were collected and distributed even though the donors had reported to the health historian various information that should have made them ineligible to donor, such as living in Europe for two years and having a history of hepatitis.

BHQ initially informed the regions on 6/29/00 in BSL 00-115 entitled “Limitations Between NBCS and the National Deferral Register (NDDR), Follow-up to BSL 00-090 and Enhancements to Procedures,” that the NBCS allows punctuation in the donor’s record but the NDDR database will reject the records that contain certain punctuation in the donor name field.

We requested a query ofinventory reconciliation problems for the period 7/1/00 through 6/30/02.

It was not until 1/15/02 whena region submitted a potential system problem that BHQ assigned system problem (SP) #625 and prepared a corrective action plan.

QA has also failed to perform the effectiveness check designed for SP 616 within the established timeframe documented in SP 616.

The region responded to the audit findings indicating that when the MQ” assertion was added there was mo requirement to perform a lookback and place the unit in quarantine.

During FDA's review of the Hotline records documenting investigation of employee problem reports, they were found to be incomplete, inadequate or lack complete corrective action.

On 12/19/01, a QA audit determined that one region had 508 records on registration hold because information on the blood donation record was discovered either to be missing or discrepant with the information currently inNBCS for the donors.

The corrective action plan for SP 625 included a root cause and it was determined that the plasma recall group cannot process recalls in a timely manner because there is no electronic system in place to accurately locate units ithin a shipment, The corrective action plan indicates one of the corrective actions would be to implement a new software system by the third quarter in 2002 to track recalls on Recovered Plasma units and to manage the Recovered Plasma inventory at the plasma warehouse.

The corrective action plan indicates that BSL 02-009 was issued on 1/29/2002 on management ofproducts and donors when blood donation record information is missing or discrepant.

The corrective action plan required -for system problem #618 was to issue a field communication for management of post donation information (PDI).

The corrective action for SP #545 included a cross-functional meeting on 12/14/00, 2000 to determine onversion plans for a switch from dock-on in line filters.

When hotline reports (that could affect quality, safety, purity of blood products) are received indicating supervisors have been informed by the employee of the problem and failed to investigate and take corrective action, the investigation reports do not indicate that an appropriate investigation of the supervisors failure to correct the problem has * [been conducted.

QA failed to perform a thorough assessment of this problém in a timely manner.

BHQ does not provide adequate oversight ofinventory management deviations occurring in the regions.

In March 2001, BSL 01-043 only required the manual verification for a period of four months in order to determine the effectiveness of the software change related to CMV labeling delivered in NBCS version This BSL as issued despite the fact the regions had already identified the computer change as ineffective.

The original effectiveness check designed for SP 616 and approved by QA in 3/02 is inadequate because QA expects only a “90% reduction in the number of components identified as exceeding timing guidelines.” This is an nacceptable practice for BHQ to expect nothing less than a 100% reduction.

BPDR #2002-041-000380 (11/1/01) indicates during an audit in another region 29 records in November 2001 had questions that were not answered and the omissions were not discovered during the regional review process.

There are no training records associated with investigating hotline reports for individuals reportedly responsible for directing the investigations and closing the investigations of the hotline reports.

The plasma disposition notification form for the Greater Chesapeake and Potomac Region, dated 9/5/02, indicates there are at least 52 out of 162 units ofplasma that could not be found for recall/market withdrawal.

Quality Assurance is not responsible for reviewing and ensuring hotline records are appropriately investigated and corrective action taken.

BHQ implemented BSL 00-126 entitled “Follow Up Actions Required for Releasing Donor Identification Holds” on 6/15/2000 as part of the corrective action.

On 6/7/2002, the Vice President, QA Blood and Piasma Operations, recommended this pilot be conducted in ‘© additional regions to determine if the recommendations from the trial will have similar effects in other regions.

On 3/13/01, BHQ implemented BSL 01-044 entitled “Update #2: Follow-Up Actions Required for Releasing Donor identification Holds” to provide additional information on releasing donor identification holds and instructions for performing the monthly reviews.

A pilot program was approved in two regions on 7/30/2001 to study the effect of performing BDR review prior to blood collection.

BHQ does not review the regional deviations associated with the donor file check to assess the reasons ineligible donors were not placed into the NDDR at the time the donor was found to be in either an : or @B category.

BHQhad to install a software fix to address the problem that was occurring when the NDDR hits were not appearing on thesRiigiaieapremnnat queries.

A review of Biological Product Deviations (those deviations which are filed with the FDA because nsuitable blood products were released) for the period 12/30/01 through 6/1/02 identified approximately 35 occurrences fin which blood products were released.

A review of SIPGun on 9/28/00 was not completed and documented until 2/7/02.

During the ime of the extended implementation date (9/01!-12/01) for BSL 01-123 in SP #545, there were at least three additional occurrences of labeling errors that happened during the leuko-reduction process (BPDR # 2001- 042-002154, 2001-020-004254, and 2001-017-003996).

BHQ did not provide proper guidance to the regions on how to initiate a search as instructed in the monthly IBSLs to the regions, until FDA addressed this during the inspection of the Greater Chesapeake and Potomac Region.

There are no wnitten procedures that address BHQ’s review of corrective action plans submitted by the regions when a region exceeds the established UCL.

BHQ failed to follow LOP 10.515, Donor File Check Procedures, Effective Date 1/6/00, whichrequires monthly distribution of the Donor File Check list to all regions.

BHQ does not have an adequate inventory management procedure in place to ensure that the disposition of blood products can be readily determined.

During the current inspection, our review of approximately 49 deviation reports revealed that in approximately 22 cases the CMV labeling error was discovered at distribution.

BSLs 01-043 and 01-147 required regions to report CMV labeling deviations noted during the manual review effectiveness check) to BHQ.

BHQ only allows the regions to investigate a case that exceeds the ARC’s pre-established limit of ten units for litigation reasons or when contacted by a local health department.

ARC uses a system known as the “Hotline” as another means in which an employee can report concers or problems related to the manufacturing of blood products, donor and patient safety as well as human resource matters.

Blood products from approximately 58 donors were found to be collected and distributed even though the donors had reported to the health historian information about traveling to a malarial endemic area.

Reportedly, SIP s@iMfMFwas run again on 9/28/00 as an effectiveness check.

BSL 01-064 required all regions to review the results ofa query (SIP @§@#9 to determine whether they were releasing donor identification holds in the proper sequence.

BHQ then developed a query (SIAR to determine whether any donor records had a change in their last Mame, SSN, or DOB, did not have anfiilass assertion, and was a hit with someone on the NDDR using their current record or before image record.

BSD 43.101M, Donor Deferral Register, is inadequate because it does not include the complete Donor File eck process required to be performed by the regions.

There are no written procedures for receiving, investigating and correcting problems reported by employees ough the “ARC hotline.”

BHQ does not monitor the corrective action plan implemented by the regions when unsuitable products can mot be located, yet BHQ monitors the corrective action plans when the regions exceed the ARC’s established upper control limit (UCL), formerly known as the acceptable quality l...

On 7/26/02, another region reported in Biological Product Deviation Report #2002-002-001618 the erroneous release of one component labeled incorrectly as CMV negative when the components tested CMV positive.

The problem with utilizing punctuation in the donor name field continued.

BHQ allows the regions to take up to one year to research whether the donors on the BHQ consolidated donor file check list donated in their regions.

On 2/27/2001, it was discovered that BHQ’s Biomedical Information Staff failed to manually enter three donor records into the March 2001.

The ARC does not perform a thorough investigation ofsuspected post transfusion hepatitis (SPTHEP) cases as required in Section II.B.14.a of the May 12, 1993 Consent Decree.

After closure of the system problem #511 and without BHQ taking any system-wide corrective action allegations of significant record keeping irregularities continued to be received.

SPTHEP Case investigated by the Greater Chesapeake and Potomac Region, was a follow p to a post transfusion hepatitis fatality that occurred at a hospital on November [9, 2001.

On July 25, 2001, a region submitted a potential system problem on the CMV labeling process as a result of an FDA

QRBRA case #199404 was submitted by the Indiana-Ohio Region on 4/21/00 because two donors were submitted by region to the NDDR several times but were still not appearing in the NDDR.

BHQ has exempted donors placed in certain Category/Subcategory ‘#@ from having to be included ina monthly donor file check.

A retrospective review by the Southern California Region revealed that of the 4012 HBsAg confirmed positive donors who were identified during the review dates of 1979 through 1987, 243 ofthose were missing from the INDDR.

In July 2001, the North Central Region discovered that Red Blood Cell components were not being manufactured within eight hours of collection when held at room temperature.

Lar Case #73 173, dated 11/10/98, a region requested information on a database change so that their distribution records would accurately reflect the disposition when BHQ had diverted a shipment the region had made to another consignee.

BHQ failed to implement an effectiveness check to ensure regions were properly following the workaround.

Following the software “fix” and correction to any incorrect records, SIP di@@iMewas mun in all regions on 11/16/99 15603 and 155498).

BHQ has failed to implement adequate labeling procedures to prevent mix ups such as discrepant blood pes, reported and determined to be caused by test tube mix up at collection; two different blood donor records with the same whole blood number; the whole blood number on primary bags not matching the whole blood number on the satellite bags and the mix during the sterile docking procedure of filters used for the leukoreduction ofblood components, During he previous inspection ofBHQ in April 2000, system problem # 419 was reviewed.

BHQ has failed to maintain an adequate inventory and distribution system by which the distribution of ransfusable blood products can be readily determined to facilitate recall, if necessary.

ARC began a manual verification ofCMV labeled components following the February-April 2000 FDA inspection undl a computer enhancement was delivered to all regions in December 2000.

The change control forms used to track the BSL 02-084 development indicate that an effectiveness check ould be performed and a report would be mun to ensure all discrepancies/holds greater than 48 hours had been identified.

BHQ performeda retrospective review ofrecords on 4/15/02 and noted that the Puerto Rico Region had reported to BHQ on 11/16/00 the failure to correct duplicate records as required.