Policy QPCMI06001.13
Department of Microbiology
Quality Manual
Section: Microbiology Lab Specimen
Management Manual
Prepared by: QA Committee
Issued by: Laboratory Manager
Approved by: Laboratory Director
Page 1 of
11
Subject Title: Specimen Rejection Criteria
Original Date: March 1, 2003
Revision Date: March 26, 2016
Annual Review Date: March 26, 2016
Purpose:
To provide Microbiology specimen rejection criteria and the procedure to follow when
rejecting specimens for process.
Procedure:
When it is determined that a specimen is not suitable for processing, following the
specimen rejection criteria listed below,
1. document the receipt of the specimen in LIS (as specimen “received”)
2. enter the appropriate LIS QA code (listed below) into the QA field in LIS order/entry
screen
3. result the report in LIS with the appropriate resulting message (listed below)
4. notify the ward/sender by telephone immediately
5. document the telephone message in the LIS with the name of the person accepting the
call
Specimen Rejection Criteria
Leaking Specimens
Leaking specimens pose a problem in microbiological specimens:
1) they may be an infectious hazard to those handling the specimen
2) they may provide misleading result if they are contaminated and the contaminants are
interpreted as pathogens





Leaking specimens are not routinely processed in Microbiology
The ward is notified immediately by telephone; reason for rejection and the name of
the person accepting the telephone notification is documented in the computer.
LIS QA Code: LEAK
LIS Report Comment: Specimen leaked in transit. Informed ……… on … floor
Culture not done.
DO NOT remove the specimen from the biohazard bag when accessioning.
Irreplaceable specimen may be processed but a comment is added to the report
indicating possible contamination.
TORONTO MEDICAL LABORATORIES/MOUNT SINAI HOSPITAL, DEPARTMENT OF MICROBIOLOGY
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Policy QPCMI06001.13
Page 2 of 11
Department of Microbiology
Quality Manual
Section: Microbiology Lab Specimen
Management Manual
Subject Title: Specimen Rejection
Criteria
In a biological safety cabinet, open the biohazard bag and place the specimen onto
paper towels and spray the specimen with VIRALEX. Leave for 5 minutes. Plant the
specimen and then place the specimen into a new clean biohazard bag. Change
gloves.
Unlabelled / Mislabeled Specimens
Unlabelled and mislabeled specimens are not routinely processed in the Microbiology
Laboratory. The ward is notified immediately by telephone; reason for rejection and the
name of person accepting the telephone notification is documented electronically.
If the specimen is “irreplaceable”, e.g. CSF, OR specimen, the microbiologist or chargetechnologist must speak to the doctor and/or nurse who collected the specimen or was
present during the procedure. It is essential to obtain an accurate matching description of
the specimen and container. The above person has to accept responsibility for the
specimen. Record the information on the report – full name, position, time, and date. If
problem cannot be resolved, keep the specimen in the problem basket for a week, send a
final report the reason for rejection and attempts made to notify the ward and file an
incident report internally.
Wrong Transport Media
Specimens collected in the wrong transport media will be rejected. Bacteria, viruses and
other microorganisms require specific transport media to be viable for certain tests. If an
incorrect media is used, the test will be cancelled, specifying which transport media is to
be used.
TORONTO MEDICAL LABORATORIES/MOUNT SINAI HOSPITAL, DEPARTMENT OF MICROBIOLOGY
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Policy QPCMI06001.13
Page 3 of 11
Department of Microbiology
Quality Manual
Section: Microbiology Lab Specimen
Management Manual
CRITERIA
Unlabelled specimen
with requisition or HIS
order (for specimen that
can be replaced)
Unlabelled specimen
with requisition or HIS
order (for specimen that
cannot be replaced)
Unlabelled specimen
without requisition or
HIS order
Mislabeled specimen (for
specimen that can be
replaced)
Mislabeled specimen (for
specimen that cannot be
replaced)
Subject Title: Specimen Rejection
Criteria
REPORT COMMENT
"No specimen with this patient's name was received.
Please repeat if necessary. Informed…… on ……ward."
LIS QA Code
UNLB
"No specimen with this patient's name was received. Test
was performed on the unlabelled specimen. Informed……
on ……ward."
UNLB
If there is an incomplete name or initial on the specimen,
enter into the LIS and result as “Specimen not labeled”
and keep the specimen in the problem for 48hrs.
"The specimen received with this order/requisition is
labeled with another patient's name and has therefore not
been processed. Informed …… on ……ward."
"The specimen received with this order/requisition is
labeled with another patient's name. Test was performed
on the mislabeled specimen. Informed …… on …..ward"
UNLB
MSLB
MSLB
“The specimen received with this order/requisition is
labeled as …...... Informed …….on……….ward"
Other Specimen Rejection Criteria by Tests
SPECIMEN
TEST
REJECTION CRITERIA REPORT COMMENT
TYPE
(LIS Result Code)
STOOL
C&S
 Not submitted in enteric
 Specimen not received
pathogen transport media.
in enteric transport
medium.
 Patient admitted for 72
 "This specimen was not
hours or more.
cultured for community
acquired enteric
pathogens because the
patient has been
hospitalized for 3 or
more days. Discuss with
the Medical
Microbiologist if
necessary."
 Multiple specimens
 "This specimen has not
collected from the same
been processed as a
in-patient the same day
specimen submitted
TORONTO MEDICAL LABORATORIES/MOUNT SINAI HOSPITAL, DEPARTMENT OF MICROBIOLOGY
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LIS QA
Code
WTPM
>72H
RPTS
Policy QPCMI06001.13
Page 4 of 11
Department of Microbiology
Quality Manual
Section: Microbiology Lab Specimen
Management Manual
SPECIMEN
TYPE
TEST
STOOL
O&P
STOOL
C. difficile
toxin
Subject Title: Specimen Rejection
Criteria
REJECTION CRITERIA REPORT COMMENT LIS QA
(LIS Result Code)
Code
(only one specimen per
from the same day has
patient per test per day is
already been processed."
to be processed).
RPTS
 Stools from outpatients
 "Multiple specimens
often arrive in batches and received. Only the most
are usually a series taken
recently collected
from separate days.
specimen has been
Process the most recent
processed."
sample and reject the
UNST
others.
 All formed stools except  “Formed stool received.
when S. typhi requested.
Test cancelled.”
 Stool sample in Cary-Blair  “This specimen was not UNST
transport medium with
processed as the
yellow indicator indicating transport medium failed
failure of the buffering
to stabilize the specimen
system to maintain a
and maintain a neutral
neutral pH.
pH.”
 Not submitted in SAF
 "Specimen not received WTPM
container
in SAF (fixative for
parasite)."
 Patients who have been
 "This specimen was not >72H
admitted more than 72
processed for
hours
community acquired
enteric pathogens
because the patient has
been hospitalized for 3
or more days. Discuss
with the Medical
Microbiologist if
necessary."
Submitted in enteric
"Specimen received in
WTPM
pathogen transport medium enteric pathogen
or SAF container.
transport medium.
Unsuitable for C. difficile
testing. Please repeat."
OR
"Specimen received in
WTPM
SAF (fixative for
TORONTO MEDICAL LABORATORIES/MOUNT SINAI HOSPITAL, DEPARTMENT OF MICROBIOLOGY
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Policy QPCMI06001.13
Page 5 of 11
Department of Microbiology
Quality Manual
Section: Microbiology Lab Specimen
Management Manual
SPECIMEN
TYPE
TEST
C. difficile
toxin
(cont’d)
C. difficile
Subject Title: Specimen Rejection
Criteria
REJECTION CRITERIA REPORT COMMENT
(LIS Result Code)
parasite). Unsuitable for
C. difficile toxin testing.
If you have any
questions, please call the
Microbiology Lab."
Formed Stool
“Formed stool received.
Test cancelled.”
Rectal Swab
“Rectal swab received;
unsuitable for testing.
Please resubmit a stool
sample.”
Negative within 7 days
“This patient has tested
negative for C.difficile
toxin B gene within the
past week. A single
negative test is sufficient
to rule out C.difficile. If
you believe your patient
has developed diarrhea
due to C.difficile since
the previous negative
result and would like
repeat testing,
please contact the
Microbiologist-on-call.”
Positive within 15 days
“This patient has tested
positive for C.difficile
toxin B gene within the
past 15 days. Do not
repeat C.difficile toxin
testing unless the patient
has received a full course
treatment (14 days) and
has developed recurrent
symptoms of
C.difficile. Repeat
TORONTO MEDICAL LABORATORIES/MOUNT SINAI HOSPITAL, DEPARTMENT OF MICROBIOLOGY
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LIS QA
Code
Policy QPCMI06001.13
Page 6 of 11
Department of Microbiology
Quality Manual
Section: Microbiology Lab Specimen
Management Manual
SPECIMEN
TYPE
TEST
toxin
(cont’d)
Foley catheter
tips and ETT
C&S
Subject Title: Specimen Rejection
Criteria
REJECTION CRITERIA REPORT COMMENT LIS QA
(LIS Result Code)
Code
C.difficile toxin testing is
not indicated in patients
who have clinically
responded to treatment.”
Indeterminate within 7
days
This patient has tested
indeterminate for
C.difficile toxin B gene
within the past week.
Indeterminate results
indicate either detection
of low levels of
C.difficile toxin B gene
or a false positive result.
If your patient has signs/
symptoms consistent
with C.difficile infection,
an indeterminate result
most likely reflects a low
level positive result and
the test does not need to
be repeated. If you would
like repeat testing for
another reason, please
contact the
Microbiologist-on-call.
Interfering substance
Not Processed. Due to
the presence of
interfering substance(s)
in the specimen, the
presence or absence of C.
difficile target DNA
could not be determined.
If testing is still required,
please submit a new
specimen.
Unsuitable specimen
"Specimen unsuitable for
culture…. because
TORONTO MEDICAL LABORATORIES/MOUNT SINAI HOSPITAL, DEPARTMENT OF MICROBIOLOGY
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UNST
Policy QPCMI06001.13
Page 7 of 11
Department of Microbiology
Quality Manual
Section: Microbiology Lab Specimen
Management Manual
SPECIMEN
TYPE
tips (adult)
SPUTUM
TEST
C&S
Subject Title: Specimen Rejection
Criteria
REJECTION CRITERIA REPORT COMMENT
(LIS Result Code)
of….add qualifier."
> 25 squamous epithelial
"Greater than 25
cells/lower power field
squamous epithelial cells
except from PMH patients. per low power field."
TORONTO MEDICAL LABORATORIES/MOUNT SINAI HOSPITAL, DEPARTMENT OF MICROBIOLOGY
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LIS QA
Code
Policy QPCMI06001.13
Page 8 of 11
Department of Microbiology
Quality Manual
Section: Microbiology Lab Specimen
Management Manual
SPECIMEN
TYPE
Urine
TEST
C&S
Subject Title: Specimen Rejection
Criteria
REJECTION CRITERIA REPORT COMMENT
(LIS Result Code)
 Condom catheter
 "Specimen unsuitable
for culture…. because
of….add qualifier."
}UNST
 Foley catheter tips and
 “Specimen unsuitable
bags
for culture because the
specimen appears to be
a Foley catheter tip or
bag.” }CATH
 Leaking specimens
 “Specimen unsuitable
for culture because the
specimen is leaking.”
}LEAK
 Inappropriate/swab/non-  “Specimen unsuitable
sterile container
for culture because the
specimen was received
in a non sterile
container. }NOST
 >24 hr delay before
 “Specimen was
specimen received (in
received in the lab >24
Sterile Specimen
hours after it has been
Container)
collected; unsuitable for
culture.” }>24H
 >48 hr delay before
 “Specimen was
specimen received (in
received in the lab >48
Urine C&S Preservative
hours after it has been
tube.
collected; unsuitable for
culture.” }>48hr
 Duplicate specimens
 “This is a duplicate
(more than one processed
order. This test has been
urine within 24 hrs)
cancelled.” }DUPL
 Insufficient quantity
“Insufficient quantity of
received in the Urine
urine received. Please fill
C&S Preservative tube.
grey top tube with urine
to the indicated line.
Suggest repeat specimen
 Specimen received in the if clinically indicated.”
wrong tube.
}INSG
 “Specimen received in
TORONTO MEDICAL LABORATORIES/MOUNT SINAI HOSPITAL, DEPARTMENT OF MICROBIOLOGY
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LIS QA
Code
 UNST
 UNST
 LEAK
 UNST
 DLAY
 DLAY
 RPTS
 UNST
 UNST
Policy QPCMI06001.13
Page 9 of 11
Department of Microbiology
Quality Manual
Section: Microbiology Lab Specimen
Management Manual
SPECIMEN
TYPE
TEST
Dry Swabs
C&S
Blood cultures,
tissues, sterile
body fluids
C&S
All specimens
other than
urine, blood
cultures, tissues
and sterile body
fluids.
All specimen
types except :
 Tissue
 Sterile body
fluid
 Brain and liver
abscess
 Aspirated pus
 Bone and soft
tissue biopsies
with diagnosis
of gas
gangrene,
narcotizing
C&S
Anaerobic
culture
Subject Title: Specimen Rejection
Criteria
REJECTION CRITERIA REPORT COMMENT
(LIS Result Code)
wrong tube for C&S
testing. Please submit
urine in grey top tube
that specifies "Urine
C&S Preservative" and
fill to the indicated
line.” }WRNG
If received in the lab >1
"Specimen not received
hour after collection.
in transport medium and
was in transit for > 1
hour.” Spec}DRY
If received in the lab >48
Process specimen. Enter
hours after collection.
Report Comment:
“Specimen was received
in the lab >48 hours after
it has been collected;
results should be
interpreted accordingly.”
}>48H
If received in the lab >48
"Specimen was received
hours after collection.
in the lab >48 hours
after it has been
collected; unsuitable for
culture."}>48hr
Not submitted in special
anaerobic transport media.
“No anaerobic swab
received; anaerobic
culture not done."
TORONTO MEDICAL LABORATORIES/MOUNT SINAI HOSPITAL, DEPARTMENT OF MICROBIOLOGY
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LIS QA
Code
WTPM
DLAY
DLAY
WTPM
Policy QPCMI06001.13
Department of Microbiology
Quality Manual
Section: Microbiology Lab Specimen
Management Manual
SPECIMEN
TYPE
fasciitis or
narcotizing
cellulitis
BLOOD
All specimen
types (unless
otherwise
authorized)
Page 10 of
11
Subject Title: Specimen Rejection
Criteria
TEST
REJECTION CRITERIA REPORT COMMENT
(LIS Result Code)
CMV
antigenemia
Assay
- Not submitted in EDTA
(purple top)
- Clotted blood (inadequate
mixing of anticoagulant
after collection or red top
tube)
Virology:
PCR assay
“CMV Antigenemia
WTBE
cannot be processed on
red top tubes. Please
collect blood in an EDTA
(lavender top) tube.”
- Extremely low leukocyte
counts or insufficient
volume (generally <2 mL)
- More than 3 samples from
the same person in the
same week, unless
authorized
“Insufficient white blood
cells to perform test.”
-Specimens collected in
SAF, Enteric, charcoal,
Amies/eswab or other nonviral transport media.
“Specimen received in
unsuitable transport
media therefore not
processed for Virology.”
WNST
“This specimen was
RPTS
taken too soon after the
previous one, therefore
not processed for
virology. Please refer to
previous specimens.”
TORONTO MEDICAL LABORATORIES/MOUNT SINAI HOSPITAL, DEPARTMENT OF MICROBIOLOGY
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LIS QA
Code
WTPM
Policy QPCMI06001.13
Department of Microbiology
Quality Manual
Section: Microbiology Lab Specimen
Management Manual
Page 11 of
11
Subject Title: Specimen Rejection
Criteria
Record of Edited Revisions
Manual Section Name: Specimen Rejection Criteria
Page Number / Item
Page 1 procedure added
Page 3 Unlabelled/mislabeled specimen categories added
Page 4 Blood and sterile sites new
Stool C&S modified (transfer from Enterics Manual)
Virology acceptable times changed
Annual Review
Expand C. difficile toxin criteria
Annual Review
Annual Review
Annual Review
Annual Review
Annual Review
Annual Review
Added insufficient specimen in urine preservative tube
Added Urine tubes other than urine preservative tube
Annual Review
Annual Review
Added: C.diff indeterminate within 7 days & Interfering substance
Removed: WNV IgM and IgG serology (no longer done)
Annual Review
Annual Review
Date of Revision
Signature of
Approval
November 19, 2004
November 19, 2004
November 19, 2004
March 27, 2004
January 27, 2005
July 23, 2006
May 15, 2007
August 13, 2007
May 31, 2008
May 31, 2009
May 31,2010
May 31, 2011
May 31, 2012
November 9, 2012
November 9, 2012
May 31, 2013
May 09, 2014
March 26, 2015
Dr. T. Mazzulli
Dr. T. Mazzulli
Dr. T. Mazzulli
Dr. T. Mazzulli
Dr. T. Mazzulli
Dr. T. Mazzulli
Dr. T. Mazzulli
Dr. T. Mazzulli
Dr. T. Mazzulli
Dr. T. Mazzulli
Dr. T. Mazzulli
Dr. T. Mazzulli
Dr. T. Mazzulli
Dr. T. Mazzulli
Dr. T. Mazzulli
Dr. T. Mazzulli
Dr. T. Mazzulli
Dr. T. Mazzulli
March 26, 2016
Dr. T. Mazzulli
TORONTO MEDICAL LABORATORIES/MOUNT SINAI HOSPITAL, DEPARTMENT OF MICROBIOLOGY
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