Inspections, Compliance, = Enforcement, and=20 Criminal = Investigations

Email this page

FDA Home >=20
Inspections, = Compliance,=20 Enforcement, and Criminal Investigations >=20
Enforcem= ent=20 Actions >=20
Warning=20 Letters =

Baptist Medical = Center

Department of Health and = Human=20 Services

Public Health Service
Food and = Drug=20 Administration

Dallas District

4040 North Central Expressway

Dallas, Texas 75204-3145

May 14, 2009
2009-DAL-WL-10

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Keith Swinney, President
Baptist Medical=20 Center
111 Dallas Street
San Antonio, Texas 78205

Dear Mr. Swinney:

The Food and Drug Administration (FDA) conducted inspections of = your=20 hospital
blood bank, located at 111 Dallas Street, San Antonio, Texas = 78205,=20 from
October 16, 2008 through December 12, 2008 and March 23, 2009 = through=20 April
3, 2009. During the inspections, FDA investigators documented=20 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=20 products to be adulterated within
the meaning section 501 (a)(2)(B) = (21=20 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=20 not limited to the
following:

December 12, 2008 FDA 483:

1) Failure to maintain and/or follow written standard operating=20 procedures
(SOPs) that include all steps to be followed in the = collection,=20 processing,
compatibility testing, storage, and distribution of blood = and=20 blood components
for transfusion including all steps for = pre-transfusion=20 testing, including
precautions to be taken to identify accurately the = recipient blood samples and
crossmatched donor units [21 CFR = 606.100(b)(8)].=20 For example

a) Your firm failed to establish a = written SOP=20 to ensure that pre-Page
transfusion test results are entered into the = (b)(4) database system correctly and that there is a = review of=20 the data entry.
Specifically, on October 7, 2008, a blood bank = technician=20 entered a
patient's (ID# (b)(4)) blood group as A = Positive=20 in the (b)(4)
database system. This result was = obtained=20 using the manual technique
and was incorrect. The patient's correct = type, O=20 Positive, had
previously been determined using automated typing. As=20 a
consequence of the error, the patient received two ABO=20 incompatible
units of red cells and the FOA was notified of a = possible=20 transfusion
related fatality on October 11, 2008.

b) Your firm failed to establish a = procedure to=20 describe the steps
necessary to validate discrepant pre-transfusion = test=20 results.
Specifically, on April 11, 2008, Patient ID(b)(4)=20 was found to
be positive for a red cell antibody using the = automated=20 (b)(4)
method. When the antibody screen was repeated = using a=20 manual
method, the result was negative. The result from the manual = test=20 was
accepted without investigating the discrepant result obtained on=20 the
automated instrument.

c) Your firm's SOP, Test Result Entry = (b)(4) Computer
System. is incomplete because it = fails to=20 provide detailed instructions
to ensure correct specimen = identification.=20 Specifically, on October 6,
2008, a blood bank technician, performing = a=20 manual ABO retype on a
specimen, identified the specimen by scanning = the=20 barcode affixed to a
Blood Bank Sample Collection Record instead of = the=20 barcode affixed to
the specimen. Consequently, an incorrect blood = group was=20 entered in
the computer database for the patient and as described = above,=20 the
patient received two units of ABO incompatible red cells.

d) Your firm's SOP, Sample Collection = and=20 Retention (b)(4) System, dated May 8, 2008, fails to = provide=20 adequate
directions regarding the correct method for applying the=20 (b)(4) ID Label (barcode label) to the sample = collection=20 tube.
"Proper application of the label is essential to ensure that = the sample=20 is
correctly identified by the (b)(4) automated = testing=20 instrument.

e) Your firm has failed to establish = a written=20 SOP to describe the steps
necessary to identify blood bank specimens = when=20 either the (b)(4) hand held scanner is unable to read = the=20 (b)(4) ID Label or during system downtime. = Specifically, on=20 October 6, 2008, a blood bank technician was unable to use = the
scanner to=20 enter results for patient ID# (b)(4) in the = (b)(4)=20 instrument database. The technician manually entered = a
random number=20 which failed to provide a link to the patient's = specimen.
Consequently, an=20 incorrect blood group was entered in the computer
database for the = patient=20 and as described above, the patient received
two units of ABO = incompatible=20 red cells.

2) Failure to review all records pertinent to the lot or unit = before the=20 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=20 to meet any of it's
specifications must be made and recorded [21 CFR=20 606.100(c)].

a) Your firm failed to follow your = SOP, Patient=20 and Specimen
Management (b)(4) Computer System.=20 Specifically, on
August 11, 2007 and July 19, 2008, your firm failed = to=20 adequately
search the historical data for two patients who had=20 previously
demonstrated clinically significant antibodies. As a = result, both=20 patients
received units that were not phenotypically matched. Your=20 investigation
and follow-up activities did not include revision of = the SOPs=20 in order to
prevent a reoccurrence of the transfusion of unsuitable=20 blood.

b) From January 19 through October = 25, 2008=20 errors were made during
data entry operations. You failed to conduct = an=20 adequate investigation
into these occurrences. Specifically, there = was no=20 determination of a
cause for the errors and the corrective actions=20 implemented were
inadequate.

3) Failure to ensure that equipment used in the compatibility = testing of=20 blood and
blood products performs in the manner for which it was = designed so=20 as to
assure compliance with requirements for blood and blood = products. [21=20 CFR
606.60(a)]. Specifically, during the inspection, the FDA = investigator=20 noted that
the (b)(4) occasionally failed to = function=20 properly. The
scanner IS-used 'to 'electronically identify patient = specimens=20 submitted for
compatibility testing.

April 3, 2009 FDA 483:

1) Failure to establish adequate = laboratory=20 controls to provide for identification
and handling of all test = samples so=20 that they are accurately related to the
specific unit of product = being tested=20 [21 CFR 606.140(c)]. Specifically, on
February 26, 2009, a blood bank = technician placed a barcode label for Patient
ID#(b)(4) = on=20 the blood sample for Patient ID# (b)(4). In = addition,
the=20 technician placed the barcode label for Patient ID# = (b)(4) on=20 the
blood sample from Patient ID# (b)(4) The = mislabeled=20 blood samples
were then tested by the (b)(4) = automated test=20 instrument. A second
technician, who subsequently performed manual = ABO=20 retypes on the two
blood samples, failed to identify the tubes as = being=20 mislabeled. Consequently,
Patient ID# (b)(4) was = transfused=20 with two units of ABO incompatible
red cells on February 26, 2009. On = March=20 13, 2009 FDA was notified of a
possible transfusion related = fatality.

2) Failure to review all records = pertinent to=20 the lot or. unit before the release or
distribution of a lot or unit = of final=20 product. A thorough investigation of any
unexplained discrepancy or = the=20 failure of a lot or unit to meet any of its
specifications must be = made and=20 recorded [21 CFR 606.100(c)]. Specifically,
on January 19, 2009, a = blood bank=20 technician performed an antibody
identification on a sample from a = patient=20 with a previously positive antibody
screen. The technician failed to = identify=20 an anti-E antibody in the sample and
the patient received two units = of=20 incompatible E positive units. The units were
distributed without a = review of=20 pertinent antibody records, which was not
conducted until two days = later.

3) Failure to observe, standardize, = and=20 maintain equipment and failure of
equipment to perform in the manner = for=20 which it was designed so as to assure
compliance with the official=20 requirements for blood and blood components [21
CFR 606.60(a)]. = Specifically,=20 the following observations were made during
review of your firm's = validation=20 of the interface between the automated blood
testing instrument=20 (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=20 validation test plan on.
December 19, 2008;
b) The validation = pass/fail=20 criteria was not met;
c) The validation test plan was not followed; = and
d)=20 The validation data was incomplete.

4) Failure to maintain and follow written SOPs including all = steps to be=20 followed
in the compatibility testing and storage of blood and blood=20 components for
homologous transfusion [21 CFR 606.100(b)].

a.) The following SOPs fail to = include all=20 steps to be followed:

i. = Patient Re-Types=20 Transfusion Services effective January 11,
2009, permits the same = blood bank=20 technician to perform both
the manual and automated test if a second = blood=20 bank
technician is not available. Your firm indicated that=20 this
instruction should have been removed 'during revisions = following
the=20 December 2008 inspection.

ii. (b)(4) Operation = Manual,=20 effective February 14, 2009, permits the blood' bank technician to = affix
the=20 barcode accession label on the blood specimen collection
tube without = verification of adequate labeling prior to testing.
This contradicts = your=20 SOP, Blood Bank Sample Collection,
effective March 18, 2009, which = indicates=20 barcode labels are to
be placed on specimen collection tubes by a = nurse=20 or
phlebotomist and verified at the time of collection.

b.) Written SOPs were not = followed:

iii. On January 19, 2009, a blood = bank=20 technician did not use the
"homozygous rule-out" in accordance with = the SOP=20 Antibody
Identification Gel testing. dated November 14, 2008.
iv. = The=20 Patient Retypes Transfusion Services SOP, dated January 11, 2009, = requires=20 performance of ABO retypes by a second
technician, if there is one = available.=20 On February 26, 2009, the
same blood bank technician performed both = automated=20 and
manual testing when another blood bank technician = was
available for=20 the retype.
v. The Communication Log. was not reviewed=20 (b)(4) in
accordance with your SOP, Communication = Between=20 Shift Transfusion
Services Operation Manual, effective November 25, = 2008.

This letter is not intended to be an=20 all-inclusive list of deficiencies at Baptist
Medical Center. It is = your=20 responsibility to ensure that all blood and blood
components = processed and=20 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=20 and take prompt action to correct these violations. Failure
to = correct these=20 violations may result in administrative and/or regulatory = action
without=20 further notice.

We request that you notify this = office in=20 writing, within' fifteen (15) working days of
the receipt of this = letter, of=20 the specific steps you have taken to correct the noted
violations, = including=20 an explanation of specific steps you are taking to identify = and
prevent=20 recurrence of similar violations. If corrective action cannot be=20 completed
within fifteen (15) working days. please state the reason = for the=20 delay and the
time frame within which the corrections will be = completed.

Please send your reply to: Sherrie L. = Krolczyk,=20 Compliance Officer at the above
address. If you have any questions = regarding=20 any issue in the letter, please
contact Ms. Krolczyk at (214)=20 253-5312.
Sincerely,
/S/
Reynaldo R. Rodriguez, Jr.
Dallas = District=20 Director
RRR:slk

= ; =20

Page=20 Last Updated: 06/09/2009
Note: If you need help = accessing=20 information in different file formats, see Instructions=20 for Downloading Viewers and Players.

Combination=20 Products=20
Advisory=20 Committees=20
Science = &=20 Research=20
Regulatory = Information=20
Safety=20
Emergency=20 Preparedness=20
Internation= al=20 Programs
News &=20 Events=20
Training and = Continuing=20 Education=20
Inspections/Compliance =
= State=20 & Local Officials=20
Consumers=20
Industry=20
Health=20 Professionals

Inspections, Compliance, = Enforcement, and=20 Criminal = Investigations

Section Contents Menu

Baptist Medical = Center