Inspections, Compliance, Enforcement, and Criminal Investigations
Baptist Medical Center
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
4040 North Central Expressway
Dallas, Texas 75204-3145
May 14, 2009
RETURN RECEIPT REQUESTED
Keith Swinney, President
Baptist Medical Center
111 Dallas Street
San Antonio, Texas 78205
Dear Mr. Swinney:
The Food and Drug Administration (FDA) conducted inspections of your hospital
blood bank, located at 111 Dallas Street, San Antonio, Texas 78205, from
October 16, 2008 through December 12, 2008 and March 23, 2009 through April
3, 2009. During the inspections, FDA investigators documented deviations from
applicable current Good Manufacturing Practice (cGMP) regulations for blood
and blood components, Title 21, Code of Federal Regulations (21 CFR) Parts
600-680. These deviations caused your blood products to be adulterated within
the meaning section 501 (a)(2)(B) (21 U.S.C. 351) of.the Federal Food, Drug, and
Cosmetic Act (the Act)
At the close of both inspections, you were issued a Form FDA-483, Inspectional
Observations, which listed a number of deviations including, but not limited to the
December 12, 2008 FDA 483:
1) Failure to maintain and/or follow written standard operating procedures
(SOPs) that include all steps to be followed in the collection, processing,
compatibility testing, storage, and distribution of blood and blood components
for transfusion including all steps for pre-transfusion testing, including
precautions to be taken to identify accurately the recipient blood samples and
crossmatched donor units [21 CFR 606.100(b)(8)]. For example
a) Your firm failed to establish a written SOP to ensure that pre-Page
transfusion test results are entered into the (b)(4) database system correctly and that there is a review of the data entry.
Specifically, on October 7, 2008, a blood bank technician entered a
patient's (ID# (b)(4)) blood group as A Positive in the (b)(4)
database system. This result was obtained using the manual technique
and was incorrect. The patient's correct type, O Positive, had
previously been determined using automated typing. As a
consequence of the error, the patient received two ABO incompatible
units of red cells and the FOA was notified of a possible transfusion
related fatality on October 11, 2008.
b) Your firm failed to establish a procedure to describe the steps
necessary to validate discrepant pre-transfusion test results.
Specifically, on April 11, 2008, Patient ID(b)(4) was found to
be positive for a red cell antibody using the automated (b)(4)
method. When the antibody screen was repeated using a manual
method, the result was negative. The result from the manual test was
accepted without investigating the discrepant result obtained on the
c) Your firm's SOP, Test Result Entry (b)(4) Computer
System. is incomplete because it fails to provide detailed instructions
to ensure correct specimen identification. Specifically, on October 6,
2008, a blood bank technician, performing a manual ABO retype on a
specimen, identified the specimen by scanning the barcode affixed to a
Blood Bank Sample Collection Record instead of the barcode affixed to
the specimen. Consequently, an incorrect blood group was entered in
the computer database for the patient and as described above, the
patient received two units of ABO incompatible red cells.
d) Your firm's SOP, Sample Collection and Retention (b)(4) System, dated May 8, 2008, fails to provide adequate
directions regarding the correct method for applying the (b)(4) ID Label (barcode label) to the sample collection tube.
"Proper application of the label is essential to ensure that the sample is
correctly identified by the (b)(4) automated testing instrument.
e) Your firm has failed to establish a written SOP to describe the steps
necessary to identify blood bank specimens when either the (b)(4) hand held scanner is unable to read the (b)(4) ID Label or during system downtime. Specifically, on October 6, 2008, a blood bank technician was unable to use the
scanner to enter results for patient ID# (b)(4) in the (b)(4) instrument database. The technician manually entered a
random number which failed to provide a link to the patient's specimen.
Consequently, an incorrect blood group was entered in the computer
database for the patient and as described above, the patient received
two units of ABO incompatible red cells.
2) Failure to review all records pertinent to the lot or unit before the release or
distribution of a lot or unit of final product. A thorough investigation of any
unexplained discrepancy or the failure of a lot or unit to meet any of it's
specifications must be made and recorded [21 CFR 606.100(c)].
a) Your firm failed to follow your SOP, Patient and Specimen
Management (b)(4) Computer System. Specifically, on
August 11, 2007 and July 19, 2008, your firm failed to adequately
search the historical data for two patients who had previously
demonstrated clinically significant antibodies. As a result, both patients
received units that were not phenotypically matched. Your investigation
and follow-up activities did not include revision of the SOPs in order to
prevent a reoccurrence of the transfusion of unsuitable blood.
b) From January 19 through October 25, 2008 errors were made during
data entry operations. You failed to conduct an adequate investigation
into these occurrences. Specifically, there was no determination of a
cause for the errors and the corrective actions implemented were
3) Failure to ensure that equipment used in the compatibility testing of blood and
blood products performs in the manner for which it was designed so as to
assure compliance with requirements for blood and blood products. [21 CFR
606.60(a)]. Specifically, during the inspection, the FDA investigator noted that
the (b)(4) occasionally failed to function properly. The
scanner IS-used 'to 'electronically identify patient specimens submitted for
April 3, 2009 FDA 483:
1) Failure to establish adequate laboratory controls to provide for identification
and handling of all test samples so that they are accurately related to the
specific unit of product being tested [21 CFR 606.140(c)]. Specifically, on
February 26, 2009, a blood bank technician placed a barcode label for Patient
ID#(b)(4) on the blood sample for Patient ID# (b)(4). In addition,
the technician placed the barcode label for Patient ID# (b)(4) on the
blood sample from Patient ID# (b)(4) The mislabeled blood samples
were then tested by the (b)(4) automated test instrument. A second
technician, who subsequently performed manual ABO retypes on the two
blood samples, failed to identify the tubes as being mislabeled. Consequently,
Patient ID# (b)(4) was transfused with two units of ABO incompatible
red cells on February 26, 2009. On March 13, 2009 FDA was notified of a
possible transfusion related fatality.
2) Failure to review all records pertinent to the lot or. unit before the release or
distribution of a lot or unit of final product. A thorough investigation of any
unexplained discrepancy or the failure of a lot or unit to meet any of its
specifications must be made and recorded [21 CFR 606.100(c)]. Specifically,
on January 19, 2009, a blood bank technician performed an antibody
identification on a sample from a patient with a previously positive antibody
screen. The technician failed to identify an anti-E antibody in the sample and
the patient received two units of incompatible E positive units. The units were
distributed without a review of pertinent antibody records, which was not
conducted until two days later.
3) Failure to observe, standardize, and maintain equipment and failure of
equipment to perform in the manner for which it was designed so as to assure
compliance with the official requirements for blood and blood components [21
CFR 606.60(a)]. Specifically, the following observations were made during
review of your firm's validation of the interface between the automated blood
testing instrument (b)(4) and the database system, (b)(4)
a) Validation sample testing and data collection was conducted on
December 9, 2008, prior to approval of the validation test plan on.
December 19, 2008;
b) The validation pass/fail criteria was not met;
c) The validation test plan was not followed; and
d) The validation data was incomplete.
4) Failure to maintain and follow written SOPs including all steps to be followed
in the compatibility testing and storage of blood and blood components for
homologous transfusion [21 CFR 606.100(b)].
a.) The following SOPs fail to include all steps to be followed:
i. Patient Re-Types Transfusion Services effective January 11,
2009, permits the same blood bank technician to perform both
the manual and automated test if a second blood bank
technician is not available. Your firm indicated that this
instruction should have been removed 'during revisions following
the December 2008 inspection.
ii. (b)(4) Operation Manual, effective February 14, 2009, permits the blood' bank technician to affix
the barcode accession label on the blood specimen collection
tube without verification of adequate labeling prior to testing.
This contradicts your SOP, Blood Bank Sample Collection,
effective March 18, 2009, which indicates barcode labels are to
be placed on specimen collection tubes by a nurse or
phlebotomist and verified at the time of collection.
b.) Written SOPs were not followed:
iii. On January 19, 2009, a blood bank technician did not use the
"homozygous rule-out" in accordance with the SOP Antibody
Identification Gel testing. dated November 14, 2008.
iv. The Patient Retypes Transfusion Services SOP, dated January 11, 2009, requires performance of ABO retypes by a second
technician, if there is one available. On February 26, 2009, the
same blood bank technician performed both automated and
manual testing when another blood bank technician was
available for the retype.
v. The Communication Log. was not reviewed (b)(4) in
accordance with your SOP, Communication Between Shift Transfusion
Services Operation Manual, effective November 25, 2008.
This letter is not intended to be an all-inclusive list of deficiencies at Baptist
Medical Center. It is your responsibility to ensure that all blood and blood
components processed and issued by your blood bank are in compliance with
the Act and the cGMP regulations. You should investigate and determine the
cause of the violations and take prompt action to correct these violations. Failure
to correct these violations may result in administrative and/or regulatory action
without further notice.
We request that you notify this office in writing, within' fifteen (15) working days of
the receipt of this letter, of the specific steps you have taken to correct the noted
violations, including an explanation of specific steps you are taking to identify and
prevent recurrence of similar violations. If corrective action cannot be completed
within fifteen (15) working days. please state the reason for the delay and the
time frame within which the corrections will be completed.
Please send your reply to: Sherrie L. Krolczyk, Compliance Officer at the above
address. If you have any questions regarding any issue in the letter, please
contact Ms. Krolczyk at (214) 253-5312.
Reynaldo R. Rodriguez, Jr.
Dallas District Director