Rejected Specimen Policy

LTD: Rejected Specimen Policy  Version 7

Purpose:

To provide guidelines for specimen labeling and specimen rejection to the

laboratory and all Akron Children’s Enterprise.

Clinical Significance:

Wrong-patient errors can lead to significant medical error and patient harm.

Patient identification errors can occur in all stages of diagnosis and treatment,

especially at the time of specimen collection. Mislabeled specimens create the

greatest risk for misdiagnosis and for this reason will routinely NOT be

processed. Irretrievable specimens are the only exception to this rejection policy.

Due to the inherit risk to the patient,

ABSOLUTELY NO mislabeled blood bank samples will be accepted by our

laboratory. Mislabeled Blood Bank samples cannot be used regardless if

considered irretrievable. Specimens with only one complete patient

identifier may NOT be accepted regardless if the collector is willing to

come to the laboratory and provide and label the specimen with a second

identifier

Policy:

 Positive patient identification must occur throughout the collection, testing and

reporting process for all specimens submitted to the laboratory.

 The use of two (2) positive patient identifiers must be used throughout the

entire collection and testing process. Acceptable patient identifiers are:

- Name

- Date of birth

- Medical record number

 All specimens must be labeled in the presence of the patient, immediately

after collection and within site of the patient. Confirmation of the patient

identifiers should occur at this time.

 The physical label should be placed on the portion of the container that

contains the specimen. DO NOT label a removable portion of the container.

 Specimens may be rejected that do not meet patient preparation, collection,

labeling, processing, storage or transport criteria. Specific criteria are

available in the Laboratory Test Directory.

 All rejected specimens will be communicated to the physician/nursing unit.

Documentation will be entered into the LIS.

 

Proper Labeling Requirements:

 

 ALL specimens, regardless of type, should be labeled immediately after

collection before leaving the patient’s room/bedside.

 ALL labels MUST include:

- Two (2) patient identifiers

- Collection date

- Collector identification

 If lab generated collection labels are not used then the specimen MUST be

accompanied by an audit trail or requisition that contains the same two (2)

patient identifiers used to label the specimen.

 ALL BLOOD BANK SPECIMENS are required to be labeled correctly and

MUST be accompanied by a double-signed blood bank requisition.

- Full instructions are available for Blood Bank specimen acceptability in

“Blood Bank Guidelines and Procedures.” There is a separate policy for

Akron and Mahoning Valley Campuses. Links are provided under

“Additional Procedures” in this policy.

Definitions:

 Collector – trained caregiver who is present with the patient during collection

of the specimen. Each collector should use their employee number or other

identifier that is traceable to them when collecting specimens.

 Mislabeled specimen – any specimen with incorrect patient information. The

incorrect information could be one (1) or both patient identifiers duplicate

labeling (labeling with two (2) or more patient’s information) or missing label.

- ANY specimen for Blood Bank WILL NOT be accepted if mislabeled.

- Discrepant information between the request form and specimen can be

considered mislabeled when the labeled specimen cannot be verified.

 Suboptimal specimen – specimens that do not meet the ideal requirements of

collection. Some suboptimal specimens can be used for testing, for example

a sample with one patient identifier that the collector is willing to complete the

labeling. Other suboptimal specimens cannot be used for testing, such as a

clotted sample. Some interpretation may be needed on suboptimal

specimens. Contact the supervisor with any questions. The following list is

meant as examples and is not all inclusive as each test has its own

requirements:

- Improperly collected and/or preserved samples (i.e. clotted, hemolyzed,

contaminated)

- Volume not sufficient for testing

- Specimen container contaminated by specimen (leaking specimen)

- Patient not properly prepared for testing (i.e. not fasting)

- Specimen labeling issues

 Specimens with only one patient complete patient identifier may be

accepted ONLY if the specimen collector is willing to come to the

laboratory and provide and label the specimen with a second identifier

 Specimens received without collection times if necessary (i.e. glucose

tolerance)

 Specimens without collector’s identification

 Patient Identifier – a unique piece of information that can identify a patient.

Acceptable patient identifiers are name, date of birth, medical record number,

blood bank identification bands (if used). A room or bed number is not an

acceptable patient identifier.

 Specimen – any sample used for medical testing. Specimens are also

commonly referred to as samples.

 Label – a preprinted or handwritten material attached to a specimen

identifying who the sample was taken from. At Akron Children's we

have generated labels that will supply the patient and test information

required. If generated labels are not available all samples may be labeled

with legible handwriting. Two identifiers are still required.

 Laboratory Test Directory (LTD) – a listing of offered tests available on the

myKidsnet homepage under Departments and Laboratory

 Rejected Specimen – Specimen that is not acceptable for testing in the

laboratory. Rejected specimens may be due to labeling error, quality of

sample of quantity of sample.

 Irretrievable Specimen – specimens that are not reproducible due to clinical

state and are critical to the diagnosis or treatment of the patient or specimens

that are difficult or traumatic to obtain. These specimens are the only

exceptions to this policy.

 LIS – Laboratory Information System

Handling Mislabeled and Unusable Specimens:

1. Upon receipt of a mislabeled or unusable specimen in the laboratory, notify

the physician or nursing unit of the issue with the specimen.

a. If the test cannot be reported, the tests must be canceled in the LIS.

b. The following information MUST be recorded in the LIS:

 Collector ID

 Who you reported the specimen to

 Time you reported unusable specimen

 Reason for recollection (mislabeled, clotted, etc.)

c. The test will need to be reordered and recollected at the decision of the

registered provider.

d. If notified that the specimen is irretrievable, see below “Handling of

Irretrievable Specimens”

2. Mislabeled specimens WILL NOT be accepted unless irretrievable. Enter the

mislabeled specimen in Midas and complete a “Mislabeled Specimen

Exception Request Form” (instructions for both can be found as an

attachment to this procedure).

3. Unusable samples include but are not limited to:

a. Clotted samples for whole blood or coagulation testing

b. Hemolysis of samples that can erroneously affect test results

c. Contamination of any sample

d. Specimen quantity not sufficient (QNS) for testing

e. Specimen container contaminated by specimen (leaking container)

f. Wrong anticoagulant/tube type

Handling of Irretrievable Specimens:

1. The laboratory defines an irretrievable specimen as one of the following two

(2) types:

- Specimens in which the clinical state cannot be reproduced and the

results are critical to the diagnosis and treatment of the patient.

 Example: blood culture obtained prior to an antibiotic start

- Specimens that are traumatic or difficult to obtain. Examples include but

are not limited to:

 CSF collection

 Bone marrow

 Surgical Specimen

 Catheter tips

2. Mislabeled specimens will ONLY be processed if they meet the above criteria.

3. For samples collected on campus, the collector MUST come to the laboratory

to label the specimens and complete the “Mislabeled Specimen Exception

Form.” As part of the form completion, documentation on the reverse side of

the form explaining how the collector is certain of specimen identification must

be recorded.

4. For samples collected at outside locations (ex. ACHP’s, Urgent Cares, etc.), a

laboratory employee must have a phone conversation with the collector. If

convinced, the entire specimen package must be sent back to the site for

labeling by the collector.

5. If laboratory personnel are not satisfied by the evidence provided by the

specimen collector and the clinician insists on relabeling, the laboratory will

reach out to a pathologists/medical director to intercede in the situation.

6. ALL reports of testing should include the following statement: “Specimen was

originally rejected due to mislabeling”

7. Mislabeled specimens accepted as irretrievable MUST have a “Mislabeled

Specimen Exception Request Form” filled out and submitted to the laboratory

supervisor, a Midas event on file or both.

Handling Suboptimal Specimens:

1. Suboptimal specimens require some judgment on the part of the performing

laboratorian to determine usefulness of analysis. It is preferable to obtain a

new acceptable specimen. Any question on acceptability should be taken to

the laboratory supervisor.

2. A comment should accompany any results noting any suboptimal specimen

characteristics.

3. Suboptimal specimens could include but are not limited to:

a. A sample with a single positive identifier or lacking collection time or

initials

 If the collector is still available on site and willing to properly complete

identification of the sample they may come to the laboratory and

complete the appropriate labeling and the laboratory will accept the

sample.

b. Slightly hemolyzed samples that will not severely affect testing results.

c. QNS specimen that have multiple tests ordered. Contact the care

provider to obtain instructions for which tests to perform first. All

remaining tests unable to perform should be canceled and recollected.

d. Specimens in which the patient was not properly prepared (i.e. fasting).

The laboratory should notify the practitioner to obtain instruction on

whether or not to proceed with testing. If it is determined to not test,

cancel the test making appropriate notations.

Handling Mislabeled Specimens Found After Resulting:

1. Current results may not match previous results. It is important to determine if

the current or previous results are discrepant.

2. Contact the care provider and explain the discrepant results.

3. Discrepant results should be made “Not Available” as soon as possible in the

LIS.

4. A credit should be submitted for testing that is discrepant.

Procedure Notes:

Steps to Complete Laboratory Mislabel Specimen Form 

1 Obtain form

2 Notify the collection area of mislabeled specimen

3. Receive the sample in the LIS – Complete and SAVE the specimen collector, Collection date and time and receipt date and time

4. Document on the form and in the LIS who was notified in Step 2 include date and time

5. Follow-up (on form):

 Check if the test was canceled (floor must reorder) – When cancelling

an order use the canned message “Mislabel form on file” and record

initials and date of person notified. Any free text comments should be

made on form.

 Check if Processing Exception requested (were results reported and

needed to be made “not available”) if so once results were retracted,

print and attach. Complete a no charge form.

6. Submit completed form to Laboratory Supervisor or Manager

7. A Midas event will need to be completed for each mislabeled specimen.
  Document the Midas number on the form if it is completed.

Midas Tips

Step Instructions

1. To place a Midas event – go to MyKidsNet at the bottom of the page
  under “Quick Links” select “Safety Event Reporting”

2 Select “Test/Procedure/Treatment” from Patient Safety Event

3. You must have patient information to attach your Midas Event to. Select
  the date of the event. Using Patient Name or Medical Record Number to select patient

4.  Select correct account and OK, then Yes

5. Complete each line with a red asterisk (*). Any line with three (3) dots
  (…) has a drop down if you click on the box with the 3 dots. Use these drop downs whenever possible

6. Please be as specific as possible while including as much concise
  information as available. Ex: “lab collected specimen labeled with two
  different patient identifiers (patient A and patient B)” versus “bad
  specimen.” Use professional language; include test names and who notified.

References:

College of American Pathologists, Laboratory General Checklist, Specimen

Collection, Handling and Reporting (pages 19-34). 08/22/2019.

CLSI. Accuracy in Patient and Sample Identification; Approved Guideline. CLSI

document GP33-A. Wayne, PA: Clinical and Laboratory Standards Institute;

2010.