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Specimen Rejection (1502.5.07)

Specimen Rejection (1502.5.07) - Policies, Clinical, UWHC Clinical, Department Specific, Clinical Laboratories

1502.5.07

UWHC Clinical Laboratories Original Date: August 15, 2007
Current Version Date: December 2015
Document Title: Specimen Rejection
Document ID: 1502.5.07 Page 1 of 4

Effective Date: January 5, 2016
Medical Director Date Medical Director Date Admin. Director Date
Teresa Darcy, MD 1/7/2014 Suzanne Selvaggi, MD 1/9/14 Marilee Welliver 1/3/14
Teresa Darcy, MD 1/8/2015 Kurt Reed, MD 1/15/14 Marilee Welliver 1/12/15
Teresa Darcy, MD 12/23/2015 Suzanne Selvaggi, MD 1/7/15 Michele A. Marggi 12/21/15
Teresa Darcy, MD 1/11/2016 Kurt Reed, MD 1/7/15 Michele A. Marggi 1/8/16
David T. Yang, MD 1/7/2017 Suzanne Selvaggi, MD 1/5/16 Michele A. Marggi 1/5/17
Suzanne Selvaggi, MD 1/7/17






I. Purpose

The purpose of the policy is to outline settings in which the Clinical Laboratories may reject
specimens submitted for laboratory testing.

II. Policy

The Clinical Laboratories reserve the right to reject specimens submitted for testing.
Specimens may be rejected throughout the pre-analytical and analytical phases of testing.

III. Pre-analytical Rejection Criteria
A. Specimen collection or transport requirements are not met. (Requirements found in
Laboratory Test Directory on Uconnect).
1. Incorrect container for testing (Note: for referral testing for pediatric patients, Clinical
Laboratories will make a reasonable attempt to identify a testing site which can use the
specimen collected).
2. Incorrect preservative or additive or transport container
3. Incorrect specimen type for the testing requested. (Note: for referral testing for
pediatric patients, Clinical Laboratories will make a reasonable attempt to identify a
testing site which can use the specimen collected).
4. Specimens received which have been transported or stored at the wrong temperature.
5. Collection to receipt interval exceeds specimen stability.
B. Patient/specimen identification is absent, incomplete, or in question. The criteria for
rejection are outlined in Clinical Laboratory Policy 5.06.
C. Consent required by law for testing was not obtained.
D. Person ordering the test is not allowed by state law to order tests. For additional
information, refer to UWHC Patient Care Orders Policy 8.16.
E. No scientific evidence supporting utilization of test or testing, requests which fall outside
standards of practice. All rejections for this category are to be reviewed by the Laboratory
Medical Director or designee.
F. Testing requested has exceeded predefined criteria to recommendations on frequency of
testing. Such tests will be canceled by the laboratory as duplicates as defined by the
clinical staff in conjunction with the laboratory.
G. When a diagnostic equivalent test has been defined by clinicians and Clinical Laboratories
faculty, the ordered test will be canceled and the equivalent test substituted.
H. Quantity not sufficient for ordered testing. If multiple tests were ordered and specimen
quantity is sufficient for some but not all of the requested testing, the ordering source will
be contacted to prioritize tests requested.
I. Specimens which present a hazard to staff of the Clinical Laboratories. Examples include
broken slides, syringes with needles attached, and leaking specimen containers.

UWHC Clinical Laboratories Original Date: August 15, 2007
Current Version Date: December 2015
Document Title: Specimen Rejection
Document ID: 1502.5.07 Page 2 of 4



J. Specimens where the laboratory cannot reasonably meet the safety requirements to safely
collect or test the specimen.
K. Expired specimen containers will not be used for specimen collection or accepted for
patient testing.

IV. Analytical Rejection Criteria

A. Analytical requirements for testing and rejection criteria are defined in each analytical test
procedure.
B. Request for testing that has not been validated by the laboratory. In such cases the
laboratory will attempt to find a referral testing source for the test.
C. Inadequate specimen such as dry brush/swabs.
D. Sample unsuitable for analysis – too viscous, line contamination, interfering substances
present or instrument flags which indicate testing interference.
E. Abnormal Flags – Any instrument flag which indicates specimen quality interferes with test
results.
F. Hemolysis
1. Laboratory testing can be affected by hemolysis in two ways:
1. release of erythrocyte constituents into the serum or plasma
2. direct interference (colorimetric) by hemoglobin on various assays
2. There are certain tests where hemolysis can have a significant effect on the results. A
search for another acceptable specimen that was drawn at the same time will always be
done before performing testing on a hemolyzed specimen or canceling a test.
3. The Clinical Laboratories will not report results on the following tests:

4. If the laboratory is canceling the test, the ordering location or provider will be called and
told the test will not be reported due to hemolysis. The ordering location will be asked to
reorder the test if clinically indicated.
Any Hemolysis - Specimens with any degree of hemolysis
APTT Fibrin monomer
Folate Heparin level
Haptoglobin Tissue Transglutaminase (TTG), IgA
All Special Coag tests except: Heparin Ab and Von Willebrand Factor Ag or Activity
Moderate or Gross Hemolysis - The following tests will not be performed if moderate or
gross hemolysis is observed. Cancel as “Hemolyzed – specimen unsatisfactory.” Call
ordering source and notify them that the test will be canceled.
Ammonia
Beta-Hydroxybutyrate (BOH)
Gross Hemolysis - he following tests will not be performed if gross hemolysis is
observed. Cancel as “Hemolyzed – specimen unsatisfactory.” Call ordering source and
notify them that the test will be canceled.
Potassium Von Willebrand Factor Ag or Activity
Lactate dehydrogenase Methotrexate
Protime Fibrinogen

UWHC Clinical Laboratories Original Date: August 15, 2007
Current Version Date: December 2015
Document Title: Specimen Rejection
Document ID: 1502.5.07 Page 3 of 4



5. Slight Hemolysis - Samples with an index of 30-149 (slight hemolysis) will be run
(unless specified in section IV.F.3) and reported without consultation with the ordering
location or provider.
6. Moderate & Gross Hemolysis
1. ED, Cancer Center and NICU: Samples with an index of ≥150 (moderate
hemolysis) or ≥250 (gross hemolysis) will be run immediately (unless
specified in section IV.F.3) and reported without consultation with the ED,
Cancer Center or NICU. Testing will be cancelled as indicated in the above
chart and/or appropriate comments will be added to the result.
2. Other Units/Clinics: Samples with an index of ≥150 (moderate
hemolysis) or ≥ 250 (gross hemolysis) will require consultation with the
ordering location or provider to determine if they would like the sample
recollected or run with the appropriate comments appended to the results
(unless specified in section IV.F.3).
7. There are two exceptions to the above policy:
1. The patient’s hemolysis is occurring in vivo and is not the result of
phlebotomy. This is relatively rare, occurring in severe burn cases, or a
hemolytic process such as a transfusion reaction. The nursing unit or
provider must inform the Laboratory if this is the case;
2. Intra Operative Autotransfusion QC (IOP) specimens are always grossly
hemolyzed and results can be reported.

V. Other

A. Under special circumstances, the laboratory may decline to forward a specimen to a
referral laboratory when the party responsible for payment of testing has not been defined.
Each individual case will be reviewed.
1. For patients covered by Federal Insurance Programs, the process outlining financial
responsibility for payment is defined by the institution and must be followed for
laboratory testing.
2. For services that are non-covered by patient insurance, patient has not signed
acceptance of financial responsibility.
3. Services covered by patient insurance requiring prior authorization; no prior
authorization obtained and patient has not signed acceptance of financial
responsibility.
B. The Laboratory cannot charge for a duplicate test within the same day that is repeated to
confirm initial results or due to problems with specimens.

VI. Notification of ordering location and collector for rejected samples

A. With the exception of III.F and III.G, Clinical Laboratories staff will notify the ordering
source location of each cancellation and the reason for the cancellation. All specimens
received by the laboratory will be accessioned for tracking purposes.

B. Notification of the ordering source and collector is important so that the test can be
reordered and recollected while providing feedback to the collector on issues relating to
specimen quality.

C. For rejected tests collected by non-laboratory staff, the ordering source will be notified.
Laboratory staff making the call will identify the patient using two patient identifiers, tests
rejected, reason for rejection and collector if indicated. The laboratory will state what

UWHC Clinical Laboratories Original Date: August 15, 2007
Current Version Date: December 2015
Document Title: Specimen Rejection
Document ID: 1502.5.07 Page 4 of 4



should be done to prevent future rejection. (i.e., draw peripheral in opposite arm as IV,
state correct tube type, state special collection or delivery conditions as applicable).
1. Each specimen ID event will be reported in the UHC Patient Safety Net System
(PSN). Collector, if known, will be listed in the PSN.

D. For rejected tests collected by Clinical Laboratory staff, the ordering source will be notified.
Laboratory staff will identify the patient using two patient identifiers, tests rejected, and
reason for rejection and that the collector is being notified of the problem.
1. Each specimen ID event will be reported in the PSN. Collector, if known, will be listed
in the PSN. Laboratory managers will follow-up with collector for each specimen ID
event.
2. Rejections due to other collection issues are documented and reported through the
PSN or internal Laboratory QA Variance Reporting system. Managers will follow-up
with collector for each reported event.

E. For rejected tests collected and submitted by clients, the client laboratory staff will be
notified according to procedure. This may be done by phone, fax or email. Notification will
include two patient identifiers and the reason for the rejection.

VII. Monitors

A. Hemolysis may be monitored for selected hospital departments monthly (i.e., Cancer
Center and ED). Hemolysis at laboratory collection sites is monitored at least yearly.
When hemolysis exceeds service team determined targets, the manager for the area will
be notified. The laboratory will provide hemolysis information by collector upon request.
B. Blood Culture Contamination Rate
1. Blood culture contamination rates are calculated monthly by the Microbiology
Laboratory and reviewed periodically by the Microbiology Service Team. The blood
culture contamination rate is also calculated and sent to the ED monthly.
Contamination rates for other individual areas can also be calculated upon request.
2. If the monthly rate exceeds the service team determined targets, managers are
notified.
C. Rejected Test Rate
1. Each laboratory department monitors the rate of rejected tests on a monthly basis.
Rejected tests are categorized by rejection criteria in order to identify trends and/or
areas for improvement.

VIII. References
A. Clinical Laboratory Policy 5.06 Acceptance Policy for Specimen ID
B. UWHC Administrative Policy 8.16 Patient Care Orders

IX. Related Documents
A. Clinical Laboratories Policy 5.02 Canceling Laboratory Test Orders

X. Appendices and Forms – Not applicable

XI. Coordination and Review

Medical Directors
Administrative Director
Laboratory Operations Group