D.21 Labeling of Specimens 02.pdf

DEPARTMENT OF VETERANS AFFAIRS (VA)

SALT LAKE CITY HEALTH CARE SYSTEM

Salt Lake City, Utah

MEMORANDUM 113.02 May 21, 2018

LABELING OF LABORATORY SPECIMENS AND

REJECTION OF UNACCEPTABLE SPECIMENS

1. PURPOSE:

To establish policy to insure the integrity and appropriateness of patient samples submitted for laboratory testing; communicate the requirements for proper identification and transport; and establish the criteria used to reject improperly submitted laboratory specimens.

2. POLICY:

Specimens received by Pathology and Laboratory Medicine Service (P&LMS) must have been

LEGIBLY labeled in the presence of the patient by the provider collecting the sample with at least the patient’s full name and full social security number (SSN). Specimens must be accompanied by a viable Computerized Patient Record System (CPRS) order number and/or a completed Pathology Consult. Time and date of collection are important parameters used to verify proper specimen collection transport times, assess specimen viability, document times for epidemiologic testing, and for the correct interpretation of test results. The documentation of anatomic site must be completed when orders are placed for specimens other than routine blood collections. All specimen labels must be initialed by the individual collecting the sample to provide accountability if needed.

Specimens that are unlabeled, mislabeled (wrong patient, name/SSN mismatch), partially labeled

(missing information) or accompanied by an incomplete Pathology Consult will not be accepted for laboratory testing, unless the specimen is determined to be irretrievable. The process for accepting a mislabeled irretrievable specimen is described in Paragraph. Specimens that are rejected will be discarded and re-collection will be required. The collecting ward, clinic, facility, ordering provider or person who collected the specimen will be notified in the event a specimen is rejected.

3. RESPONSIBILITY:

a. The Chief of Pathology & Laboratory Medicine Services provides clinical oversight of the Pathology and Laboratory Medicine Service and provides guidance to the

Laboratory Manager regarding appropriate specimen criteria for laboratory testing.

b. The Laboratory Manger is responsible for determining appropriate specimen criteria for laboratory testing and ensuring CAP and CLIA regulations are being adhered to.

D.21 LABELING OF SPECIMENS

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c. The Laboratory Quality Assurance Coordinator is responsible for the tracking, collection and publication of quality assurance data in the monthly Quality Assurance

Report to include numbers of mislabeled and rejected specimens.

d. Department Lead Technologists are responsible for submitting changes in testing or specimen requirements and criteria to the Laboratory Manager.

e. Medical Technologists/Technicians: Responsible for the knowledge of appropriate specimen criteria for laboratory testing and for the procedures contained in this guideline.

f. Employees collecting specimens for laboratory testing: Responsible for the proper and appropriate collection of specimens for laboratory testing, and timely submission of samples to the Laboratory.

4. PROCEDURES:

a. LABELING: For proper identification and handling, the following information must be included on ALL specimens and any accompanying requisition (if required): This labeling must be performed in the presence of the patient.

• Full Name and Social Security Number

• CPRS assigned Order Number

• Date and Time of collection

• Initials of person collecting the specimen

b. TRANSFUSION SERVICES:

1) A Type and Screen Collection Form (VA Form 10-126) is required for a Type and

Screen Order and must be filled out completely and signed. The Blood Bank Arm

Band Number must be included on both the specimen and collection form. For patients who are being Typed and Screened for the first time in this facility, a second sample is required, and that second sample must be collected, properly labeled, and initialed by a different staff member than the first sample. The second staff member also needs to include their information and sign the Type and Screen

Collection Form (VA Form 10-126).

2) Exceptions to Rejection:

Phlebotomist’s Name not printed on BB Type & Screen Form

(VAF 10-126)

Allow correction

No initials on sample. Allow correction

No BB Armband # on VAF 10-126 but sample labeled correctly. Allow correction

No signature of phlebotomist on VAF 10-126 but tube has initials. Allow correction

c. PRE-ANALYTICAL REJECTION CRITERIA:

1) Unlabeled specimens: Will NOT be accepted, notification will be made IF the collection location is known or can readily be determined.

2) Mislabeled specimens: Will NOT be accepted, notification will be made.

3) Partially labeled specimens:

a) Full Name missing: Reject & Notify ordering location.

b) Full Social Security Number missing: Reject & Notify ordering location.

c) Date and/or time missing: Contact ordering location to acquire information.

d) Order Number missing or incorrect: Contact ordering location to acquire information.

e) Pathology Consult missing/incomplete: Contact ordering location to provide required documentation.

4) Specimen Integrity Issues: Reject & notify the ordering location when the following conditions are encountered. Specific sample collection, storage and transport requirements for each orderable test are available in CPRS and VistA system.

a) Specimens are attached to or accompanied by sharps (needle or scalpel).

b) Specimens exceed transport time or temperature limits.

c) Specimen received is not appropriate for testing ordered.

d) Specimen quantity is insufficient for testing ordered.

e) Specimen label is applied to a removable container lid.

f) Specimens are received in unapproved, leaking or grossly soiled containers.

d. ANALYTICAL REJECTION CRITERIA: Specimens are examined by the technologist performing the assay to determine the extent of interference and determine acceptance or rejection depending on the test(s) to be performed.

1) Hemolysis: Grossly Hemolyzed specimens will be rejected. Any degree of hemolysis in the specimen will affect the listed analytes and assay values will not be reported.

• ALC (alcohol) - decreased result

• AMON (ammonia) - increased result

• AST - increased result

• AMY- increased result

• CK (creatinine kinase) – increased result

• CTNI - decreased result

• Direct Bilirubin - decreased result

• FT4 - increased result

• GGT - increased result

• IRON - increased result

• K (potassium) - increased result

• LA (lactic acid) - increased result

• LDI (lactate dehydrogenase) - increased result

• LIP (lipase) - increased result

• MG (magnesium) - increased result

• MMB - decreased result

• PHOS - increased result

• SPEP/UPEP (serum or urine electrophoresis) - causes artifacts

• TOTAL PROTEIN - increased result

2) Lipemia: Lipemia is not necessarily cause for rejection but it can interfere with many test results.

3) Icterus: Icterus is not necessarily cause for rejection although moderate to gross icterus can interfere with many test results. Increased Bilirubin may affect the following Assays:

• Acetaminophen - decreased result

• Cholesterol - decreased result

• Salicylate - decreased result

4) Clotted Samples: Anti-coagulated samples for Hematology and Coagulation testing will be rejected if visibly clotted.

e. POST-ANALYTICAL REJECTION CRITERIA

1) I.V. contamination: Samples contaminated or diluted with intravenous fluid or medication will yield spurious results which are normally only apparent after the analysis is completed. Contamination will be investigated per QPOL-GEN-061 Delta

Check Protocol. Recollection of all samples drawn with the same collection time will be requested in all suspected instances after consultation with the provider.

2) Assay Limits: Certain analytes (esp. anions & cat ions) which breach assay limits may indicate sample unsuitability. Refer to the department specific assay procedure for guidance. Recollection will be performed after consultation with the provider.

3) Quantity Not Sufficient (QNS): Questionable specimens will be assayed to assist in evaluating sample integrity and determine acceptability. Partial results will be reported when necessary.

4) Platelet Clumps: When PLT and/or MPV are “flagged”, perform a slide scan to validate the suitability of the sample. Cancel the PLT and/or MPV per department policy.

5) Fibrin: Reject the sample, cancel the order and perform notification.

f. NOTIFICATION: A Staff Nurse, Charge Nurse or Provider at the ordering location will be informed of the reason a specimen requires reordering and recollection. Unless otherwise specified by policy the ordering location personnel will be contacted.

g. DOCUMENTATION: Specific & appropriate comments will be entered into CPRS when testing is cancelled, to include: Name and Title of individual notified, Time of notification and Technologist/Technician/Phlebotomist initials.

h. IRRETRIEVABLE SAMPLES: Some samples (i.e. CSF & Body Fluids, BAL, and Bone

& Tissue) cannot be easily recollected or replaced. In the event, any of the above criteria applies to an irretrievable sample contact the PROVIDER IMMEDIATELY for correction. If the provider does not respond promptly, contact the ordering location

Charge Nurse or Staff Nurse. Correction must occur prior to further processing of samples or initiation of testing. This may impact the suitability for testing if corrective action is delayed. Samples will be preserved in the most suitable manner.

i. SUPERVISORY ASSISTANCE: If a provider for any reason is not able to resolve an issue with the laboratory staff present, contact the laboratory manager or night manager for further assistance. In the event the situation is still not resolved, contact the On-Call

Pathologist. If there is still no resolution, contact the Chief, Pathology and Laboratory

Medicine Service.

5. REFERENCES:

• VHA Handbook 1106.01, October 2008

• College of American Pathologists Inspection Checklist, 2016

• VHA Directive 2009-035, July 22, 2009; “Pre-Phlebotomy Patient Identification, Specimen Identification and Labeling of Blood Bank Specimens”

• Clinical and Laboratory Standards Institute AUTO-12P, Specimen Labels:

Content and Location, Fonts, and Label Orientation; Proposed Standard

• Joint Commission National Patient Safety Goals 2012

6. RECISSION: Memorandum 113.02, “Labeling of Laboratory Specimens and Rejection of Unacceptable Specimens”, July 30, 2014.

7. RECERTIFICATION DATE: On or before the last day of May 2021

8. FOLLOW-UP RESPONSIBILITY:

a. Chief, Pathology & Laboratory Medicine Services (113) is responsible for administration and content of the program.

b. Service Chiefs of services which submit specimens to P&LMS have follow-up responsibility to ensure compliance and that all concerned employees are informed of the procedures.

//s//

Shella Stovall, MNA, RN

Director