Inspections, Compliance, Enforcement, and Criminal Investigations
Siouxland Community Blood Bank Response Letter
Siouxland Community Blood Bank
Your not-for-profit Independent Community Blood Center
January 16, 2006
Mr. Joseph G. Kramer, Compliance Officer
Food and Drug Administration
Kansas City District
11630 West 80th Street
Lenexa, Kansas 66214-3340
RE: WARNING LETTER
Ref. KAN 2006-09
Dear Mr. Kramer,
This is in response to the Warning Letter issued December 23, 2005. We want to assure you that the safety of the blood supply is the goal of the Siouxland Community Blood Bank. We understand the serious nature of the deviations listed in the Warning Letter and have instituted interim corrective and preventive procedures to ensure that the deviations will not be repeated.
The Siouxland Community Blood Bank will also institute long term corrective and preventive action and will monitor the actions taken to ensure the corrective action is effective. We believe the steps that have been taken; together with the planned corrective actions described in the response to the Warning Letter, will achieve compliance with FDA regulations.
We have retained an external consultant who will perform cGMP and Quality Assurance training. The external consultant, (b)(4) has expertise in these areas. In addition to training, Ms. (b)(4) will audit the blood center to determine compliance with FDA regulations. Ms. (b)(4) will conduct a review of the procedures and when needed flow chart the processes to ensure all of the manufacturing steps have clear instructions for the user of the procedure. Training will be evaluated to determine if changes are needed.
We would like to meet with the Compliance Director to provide an update of the corrective and preventive actions taken in response to the Warning Letter. We understand that by demonstrating compliance we would eliminate the need for the Warning Letter restrictions.
Janette E. Twait, MS, MT(ASCP)
Chief Executive Officer, Authorized Official
The responses to the Warning Letter will follow the order as listed in the letter and the response will be in bold italics for ease of reference.
Failure to maintain donor identification throughout donation process [21 CFR 606. 160(c)], specifically, questionable unit number traceability and data entry into wrong donor record. For example,
• On (b)(7)(C) a phlebotomist started the collection of double red cell unit, affixing unit (b)(7)(C) # to (b)(7)(C)'s donor record. The same phlebotomist started donor (b)(7)(C)'s whole blood collection using collection bag unit # (b)(7)(C), without affixing a unit # to (b)(7)(C)s donor record. The unit label was affixed to (b)(7)(C)'s donor record after the discrepancy was noted. At the end of both procedures, the phlebotomist had both units at the same work station and discovered (b)(7)(C)'s donor record had no unit # (b)(7)(C); in an attempt to correct the error, the phlebotomist removed the wrong unit # (b) (7)(C) and placed it on (b)(7)(C)'s donor record. Ultimately, the two donors'records had the same unit #(b)(7)(C). The whole blood unit # was discarded and the double red cell unit # (b)(7)(C) was distributed.
• On (b)(7)(C) double red cell collections were started at the same time. Donor (b)(7)(C) sat in a chair, a phlebotomist affixed unit (b)(7)(C) to his donor record. Another phlebotomist came to assist and, while (b)(7)(C) was in the restroom, put (b)(7)(C)'s donor card at a different station in order to start the collection process on (b)(7)(C) in (b)(7)(C)'s original chair. All of (b)(7)(C)'s paperwork was then labeled as unit # (b)(7)(C) returned from the restroom, sat in a different chair, and the phlebotomist started (b)(7)(C)'s collection. At the end of both procedures (b)(7)(C) and (b)(7)(C) had the same unit #(b)(7)(C) on their donor records. When the donor records were returned from the mobile, unit # (b)(7)(C) was affixed to (b)(7)(C)'s donor record. Management decided to distribute both units (b)(7)(C) and (b)(7)(C).
A root cause analysis was performed to determine if a change in the procedure is required to ensure the correct donor number is placed on the bag of blood, donor card, and the samples taken at the time of collection. The procedure and training in the revised procedure began on January 4, 2006 with a scheduled completion date of (b)(4)
The revised processes will include the following:
1. The supervisory team leaders of the collection process and/or other trained collection staff began performing verification of all donors and the unit numbers of the automation and second phlebotomy donor record files on January 10 2006. This step occurs prior to the actual collection of blood. A second verification of unit numbers performed by the phlebotomist continues to occur at the end of the phlebotomy process. A third verification step will be performed as an audit of the completed donor file, products, and pilot tubes by another staff person.
This process will continue for 90 days and will then be evaluated to determine if it is beneficial and an effective preventive and corrective action.
2. Automation areas will only be used for automated donors and assigned primary automation operators. This will provide consistency of the work flow. We will control donor flow so that donors do not come into the area and sit in the chair while the operator sets up the instrument. This will allow total focus on the procedural steps and unit number affixation.
3. The process will no longer allow prelabeling of kits for double cell donation. The procedure will require that the unit numbers assigned to the donor will be placed on the samples collected, the donor record file and the collection bag. This provides consistency in procedures.
4. On January 13, 2006 additional automation mobile chairs are used and designated for use in automated collections. This will help prevent the need for donors to change chairs since these chairs have arm adjustments to accommodate use of the left or right arm
5. We have suspended the Automation Double Red Cell training program for additional staff as of January 9, 2006. We will perform a review and evaluation of the training program to ensure all appropriate steps and critical tasks are identified before resuming the training program and to ensure that the steps essential to identifying the donor and associated products are explicitly stated and their critical nature emphasized. The trainers will be retrained so that all critical steps in the procedure are clearly communicated to trainees.
6. The donor record file was changed to add a colored area where the assigned unit number is to be affixed. This began on January 4, 2006. This will be a visual aid in preventing unit number omission.
7. Color coding will also be used for the ancillary equipment used for automated collections. This visual tool will aid in preventing mix up of donor specific items.
We recognize the need to correctly identify the unit of blood with the donor record as well the donor record file so the donor and the test results of the donor may be traced. The procedure will include the need to discard all units involved when an error is detected.
On four occasions Data Entry Staff entered donor information into the wrong donor record:
•On (b)(7)C) donor (b)(7)(C) ((b)(4) ID# (b)(7)(C)) donated whole blood unit #(b)(7)(C) this donor's information was entered into donor (b)(7)(C)'s (SafeTrace ID# (b)(7)(C) ) donor computer record.
• On (b)(7)(C) donor (b)(7)(C) ((b)(4) ID# (b)(7)(C)) donated (TWO DBL RBC'S) unit # (b)(7)(C); this donor's information was entered into donor (b)(7)(C)'s (SafeTrace ID# (b)(7)(C)) donor computer record.
• On (b)(7)(C) donor (b)(7)(C) ((b)(4) ID#(b)(7)(C)) donated whole blood unit # (b)(7)(C) this donor's information was entered into donor (b(7)(C)'s (SafeTrace ID # (b)(7)(C)) donor computer record.
• On (b)(7)(C) donor (b)(7)(C) (b)(4) ID# (b)(7)(C) donated whole blood unit #(b)(7)(C), this donor's information was entered into donor (b)(7)(C)'s (SafeTrace ID# (b)(7)(C)) donor computer record.
These errors were identified at the time of laboratory test result entry when the computer performed critical control point review and determined that the ABO of the current donation did not match the donor's historical ABO.
A root cause analysis was performed to determine if a change in the procedure for donor search is required to ensure the correct donor selection is performed by the data entry staff. The procedure and training in the revised procedure began on January 4, 2006 and will be completed by (b)(4) Competency evaluations will be performed to determine the effectiveness of the training.
The revised processes will include:
1. Additional donor search criteria will allow the use of a longer donor name fragment and date of birth or an exact match using the donor's unique (b)(4) ID number. This revised procedure will be monitored to determine if it corrects and prevents data entry inconsistency.
2. A revised process with a job aid for the initial handling of donor cards into the data entry work areas.
3. The data entry training programs will be revised to ensure all appropriate steps and critical tasks are identified to determine if the steps essential to identifying the donor and associated products are clearly communicated to trainees.
4. We have suspended the entry of donation information at the mobile sites. Data entry of donation information will be only performed at the main fixed site.
5. A daily audit process was implemented to compare each donor card with the summary registration list based on the donor donation data entered.
We offer the following suggestion for your consideration in data entry audits. At your option, you may wish to use duplicate donor search criteria during performance of your data entry audit checklist
The data entry staff performs a duplicate donor criteria check at the end of the donation entry process. It is a requirement (critical control point) of the (b)(4) computer system to perform a duplicate donor search prior to labeling of any product. This procedure was provided to the Investigator at the time of the inspection. The duplicate donor check must be performed after the entry of the donation information.
On (b)(7)(C) whole blood donor (b) (7)(C) (unit # (b)(7)(C)) experienced a severe reaction Failure to follow written SOP's in the processing of blood and blood components [21 CFR 606.l00(b)]. Specifically,
Donors remain eligible (not deferred), in spite of having experienced a severe reaction.
• documented as Convulsions and Tetany. To date, the donor's status is "no deferral".
• On (b) (7)(C) whole blood donor (b)(7)(C) (unit #(b)(7)(C)) experienced a severe reaction (Convulsions) and a moderate reaction (Unconsciousness). To date, the donor's status is "no deferral".
The SOP # (b)(4) Medical Conditions states "(b)(4)". The firm's SOP (b)(4) does not distinguish between convulsions resulting from medical conditions and convulsions experienced as the result of a donor reaction.
We requested a survey from blood centers belonging to America's Blood Centers and have input from AABB members to determine the general practice of the industry regarding donors who have convulsions following blood donations and found that the majority of the blood centers do not have a policy that requires deferring a blood donor for an extended period of time following a convulsion.
The procedure will be revised to include an evaluation to determine if the convulsion was a reaction to blood collection or if the convulsion results from a pre-existing medical condition. If there is agency policy regarding a time line for deferral of donors who experience a convulsion after blood collection please tell us where this policy has been published.
When donors experienced a second phlebotomy, employees failed to affix a second unit number to the donors record at the time of donation. Someone other than the phlebotomist who performed the collection procedure later affixed a unit number.
• On (b)(7)(C) donor (b)(7)(C)'s first phlebotomy was labeled unit #(b)(7)(C). When the first phlebotomy failed, the employee did not update the record by voiding the first unit# and affixing a second unit #. A second phlebotomy unit # (b)(7)(C) was affixed 5/22/2005 upon discovery.
• On (b)(7)(C) donor (b)(7)(C)'s first phlebotomy was labeled unit # (b)(7)(C). When the first phlebotomy failed, the employee did not update the record by voiding the first unit # and affixing a second unit #. A second phlebotomy unit #(b)(7)(C) was affixed 12/30/2004 by the QA director.
The SOP (b)(4) states, for non pre-labeled collection sets: (b)(4); and states for pre-labeled collection sets, "(b)(4)".
A root cause analysis was performed to understand why the procedure was not followed and to determine if the procedure has easy to understand instructions for staff to follow. The procedure will be revised to clarify the steps required when a second phlebotomy is performed. Training in the revised procedure will be performed. Competency evaluations will be done to ensure that the training was effective. The procedure will be monitored by Quality Assurance to evaluate if the procedure is followed.
Failure to submit a Biological Product Deviation Report (BPDR) within 45 days [21 CFR 606.171]. Specifically,
• BPDR 2005-007 discovered 1/18/2005 was reported 8/16/2005.
• BPDR 2005-006 discovered 12/14/2004 was reported 8/16/2005.
The procedure for submitting BPDRs to CBER within 45 days was revised to include an electronic system to ensure that reports will be sent in the stated time line. Training in the procedure was performed. Quality Assurance will monitor each report to ensure timely submission to the agency.
Member of America's Blood Centers
1019 Jones St. • P.O. Box 1566 • Sioux City, IA 51102
Telephone (712) 252-4208· (800) 798-4208 • FAX (712) 252-1013
Member of American Association
of Blood Banks