Lab Test Procedure : Rejected Specimen Policy

Mislabeled Specimen Exception Request Form

PURPOSE: The purpose of this policy is to describe the process of how and when a specimen will be rejected.

SCOPE / RESPONSIBILITY: It is the requirement of Akron Children's Hospital Enterprise as specified when sending specimen to the laboratories operated by Akron Children's Hospital to follow the guidelines as dictated in this policy.

Applies to: Akron Children's Hospital Enterprise

POLICY:
Universal criteria for specimen rejection are listed below. There may be specific criteria on an individual test which can be found in the Laboratory Test Directory (https://www.akronchildrens.org/cms/site/c87600c34e086d21/index.html). Particular attention should be given to the specific rejection reasons for Blood Bank (BB) specimens.

A mislabeled specimen (see Guidelines for definition) is the rejection reason creating the greatest risk of potential misdiagnosis. For this reason mislabeled specimens will routinely NOT be processed. Only two exceptions to this rejection policy will be considered and then only when the appropriate procedure is followed.
a. Specimens in which the clinical state cannot be recreated and the results are critical to the diagnosis/treatment of the patient - e.g. specimens that were collected for culture prior to antibiotic treatment.
b. Specimens which are difficult/traumatic to obtain - e.g. CSF, bone marrow, surgical specimen, stimulation tests, other irretrievable specimens such as catheter tips.
Specimens resulting from the following two circumstances will not be considered for processing regardless of the situation:
Mislabeled Blood Bank Specimens (including those with missing information) will not be considered for processing regardless of the situation.
Mislabeled STAT Outpatient Specimens received after hours.

Suboptimal specimens as defined in the Guidelines section
will be:
a. processed at the discretion of the Department of Pathology with physician input considered when provided.
b. retained in the laboratory until the physician or patient care unit ordering the test is notified.
c. cancelled by the Laboratory unless they were already reported, in which case the results will be made unavailable and the test no-charged.
d. re-ordered according to the Laboratory Specimen Recollect Policy.

GUIDELINES:
Reasons for rejection are broken into two general categories as follows:
Mislabeled Specimens
1. Definition
a. Any specimen with an incorrect patient label, which is described as a label in which either or both of the two patient identifiers is incorrect or a specimen with no label affixed to it.
b. Specimens for Blood Bank testing with any type of mismatched, incorrect or missing information must be redrawn.

Suboptimal Specimens
1. Definition
a. Specimen improperly collected and/or preserved (Clotted, hemolyzed, contaminated, etc.)
b. Specimen sample volume not sufficient for requirement of test protocol.
c. Specimen container contaminated by specimen (i.e., infectious hazard).
d Patient not properly prepared for test sample requirements.
e Specimen submitted without a properly completed request form. (This will include mismatches in which the specimen has the correct label, but incorrect paperwork.)
f. Specimen labeling problems
1. Specimens received without two patient identifiers. Specimens received with only the patient name will be accepted as one of the identifiers only if the individual drawing the specimen is available to provide the second patient identifier (excluding Blood Bank specimens).
2. Specimens received without collection time when required and/or collector's employee number.

Procedure for Handling Mislabeled or Suboptimal Specimens:
1. In all cases, the physician/nursing unit will be notified when a specimen is rejected. In any case where the test cannot be reported, it will be cancelled. The test will need to be reordered and recollected at the decision of the physician or patient care unit according to the Laboratory Specimen Recollect Policy. When a mislabeled specimen is one defined as "difficult/traumatic to obtain", the physician must be notified and request the specimen be processed for one of the reasons listed in the next step.

2. Mislabeled specimens will only be processed if they meet one of the two criteria described in the policy section according to the following procedures. In both cases the laboratory will, if needed, be responsible for making any corrections to the report of the specimen to include a note stating that the "specimen was originally rejected due to mislabeling".
a. Inpatient/Outpatient (On Campus) Setting
1. The manager/designee (clinical coordinator) of the individual mislabeling the specimen must be contacted.
2. He/she must validate the circumstances and assure that the specimen indeed belongs to the designated patient.
3. He/she must complete the appropriate mislabeled specimen form including signature.
4. After receiving the completed form, the laboratory will return the specimen to the area who collected the specimen. The manager / designee must relabel the specimen or supervise the relabeling of the specimen.
5. The laboratory will then process and report the requested tests.
6. The pathologist will later review and sign the request form.
b. Outpatient Setting (Off Campus) - Mislabeled, off hours, STAT specimens will not be considered for processing. (Routines will be addressed the next business day.)
1. During off-hours, the physician/manager responsible for the patient must be contacted in the case of a STAT so the specimen can be recollected. From 8 a.m. to 5 p.m., requests to relabel a specimen should follow steps 2 through 5.
2. He/she must validate the circumstances and assure that the specimen indeed belongs to the designated patient.
3. Mislabeled specimen form must be completed and the physician must sign this form. The form should be faxed to the lab. (Fax: Inpatient - 330-543-3156, Outpatient 330-543-3732.)
4. The laboratory staff will refer the request to the pathologist who makes the final decision whether to proceed with processing the specimen. If approved, he will sign the form and return to the laboratory staff. If not approved, the pathologist will contact the requesting physician/manager and let them know of his decision.
5. Both signatures must be in place since it is the laboratory staff who will be relabeling the specimen in accord with the form signed by the physician and the pathologist.

3. Suboptimal specimens (e.g. wrong anticoagulant/tube, Blood Bank specimen received on ice, contaminated with IV fluid, coagulation specimens whose tubes are over or underfilled, dry swab, etc.)
a. Specimens improperly collected and/or preserved will be evaluated by the technical staff and/or medical director as to the clinical usefulness of analysis. It is preferable to obtain a totally new appropriate specimen. If analysis of the unsatisfactory specimen is to continue, a comment indicating potential interpretation problems should be included in the report.
b. QNS specimens will be cancelled by the laboratory. If there are multiple tests ordered but only enough specimen for a portion of the tests, the patient care unit or physician will be contacted when possible for instructions as to which tests to perform.
c. Specimens in which the outside of the container is minimally contaminated will be transferred to a clean container and processed. A recollected specimen may be requested when major contamination has occurred. These specimens will be cancelled by the laboratory.
d. Specimens submitted in which the patient was not properly prepared will result in notification of the physician. A decision will be made as to whether to continue with the analysis. Tests in which the analysis will not be conducted will be cancelled according to the Laboratory Test Cancellation Policy.
e. Specimens submitted without completed request forms will result in the physician and/or patient care unit being contacted for the required information. Once properly completed and received by the laboratory, the specimen will be analyzed.





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