Specimen transport and management
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Specimen Transport and Management. Version 5.0, August 2012. Objectives. Discuss the importance of adequate collection, handling, and transport of specimens Discuss specimen flow and chain of custody List the criteria for specimen rejection

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Specimen transport and management

Specimen Transportand Management

Version 5.0, August 2012


Objectives

Objectives

  • Discuss the importance of adequate collection, handling, and transport of specimens

  • Discuss specimen flow and chain of custody

  • List the criteria for specimen rejection

  • Explain the importance of prompt clinic notification regarding specimen quality and panic values

  • Discuss the importance of maintenance of optimal conditions during specimen storage and shipment


Pre assessment question 1

Pre-Assessment Question #1

The following ‘order of draw’ should be followed when performing a venipuncture:

  • Blood culture, Prothrombin Index/Partial Thromboplastin Time (PI/PTT), chemistry (plain tube), Complete Blood Count (CBC) Ethylenediaminetetraacetic Acid (EDTA), glucose (Oxalate/Fluoride)

  • PI/PTT, blood culture, glucose (Oxalate/Fluoride), CBC (EDTA), chemistry (plain tube)

  • Blood culture, chemistry (plain tube), glucose (Oxalate/Fluoride), CBC (EDTA), PI/PTT

  • Chemistry (plain tube), blood culture, PI/PTT, CBC (EDTA), glucose (Oxalate/Fluoride)


Pre assessment question 2

Pre-Assessment Question #2

Is it important to record the identity of the phlebotomist who collected participant information on the requisition form?

  • Yes

  • No


Pre assessment question 3

Pre-Assessment Question #3

Which of the following are reasons to reject a specimen?

  • The wrong tube was used to collect the specimen

  • The specimen is not labeled or is labeled incorrectly

  • The request form includes adequate information

  • A and B only

  • B and C only

  • None of the above


Pre assessment question 4

Pre-Assessment Question #4

Notification records should include which of the following:

  • Identification (ID) of person making the contact

  • Date and time of contact

  • A description of the problems when accomplishing the task

  • B and C only

  • All of the above


Pre assessment question 5

Pre-Assessment Question #5

Before shipping samples, which of the following tasks must be ensured:

  • Number of specimens in box corresponds to the number listed on the shipping manifest

  • ID numbers on the specimen tubes match those on the shipping manifest

  • Shipping date matches the study protocol

  • A and B only

  • B and C only

  • All of the above


What would you do

What Would You Do?

Fred opens a specimen transport container and prepares to receive a packet of Sodium Heparin tubes for Peripheral Blood Mononuclear Cells (PBMC) processing. He notes from the requisition form that the specimens were collected four days earlier.

  • What action should he take?

  • How can this be prevented from recurring in the future?


Specimen quality

Specimen Quality

What is Specimen Integrity?


Specimen quality cont d

Specimen Quality (cont'd)

The reliability and accuracy of all laboratory test results depends on the quality of the specimen submitted


Specimen quality cont d1

Specimen Quality (cont'd)

  • Labeled

Collected

The specimens should be properly:

  • Transported

  • to thelaboratory

  • Handled


Specimen collection and transport

Specimen Collection and Transport

Inadequate collection and improper transport of specimens result in:

  • Inaccurate and invalid results

  • Results delay

  • Participant discomfort

  • Increased costs

  • Misdiagnosis, incorrect treatment

  • Reduced quality of care


Specimen management

Specimen Management

Collection

Labeling

Transport

Receipt

Specimen:

Referral

Processing

Storage

Disposal

Shipping


Specimen collection sop

Specimen Collection SOP

Specimen labeling

Contents:

Venipuncture guidelines

Order

of draw

Standard labeling practices must be implemented and enforced with all users of the laboratory services.

All specimen tubes must be properly identified with the Patient Identifications (PID).


Order of draw

Order of Draw

The order in which vacuum tubes are drawn during venipuncture can affect the specimen quality

Additives from one tube may contaminate the next tube


Order of draw cont d

Order of Draw (cont’d)

  • Sterile tubes for culture

1

  • Sodium Citrate

2

Clinical and Laboratory Standards Institute (CLSI) recommends the following order of draw

  • Serum tubes with or without clot activator/gel

3

4

  • Heparin

5

  • EDTA

6

  • Oxalate/Fluoride tubes


Specimen labeling

Specimen Labeling

Laboratory should enforce

proper specimen labeling practices


Specimen handling

Specimen Handling

Documented guidelines for use by the clinic staff:

  • Sample preparation

  • Sample transport

  • Specimen rejection criteria


Collection forms

Requisition

Forms

Collection Forms

Specimen Tracking Forms


Requisition form

Requisition Form

1st Section: Laboratory, Study ID

  • Testing Laboratory

  • Study ID


Requisition form cont d

Requisition Form (cont’d)

2nd Section: Demographics

  • PID Number

  • Initials (Optional)

  • Gender

  • Date of Birth


Requisition form cont d1

Requisition Form (cont’d)

3rd Section: Visit Details

  • Specimen Collection Date

  • Specimen Collection Time

  • Visit

  • Phlebotomist


Requisition form cont d2

Requisition Form (cont’d)

4th Section: Collection

  • Tube quantity and type

  • Visit specific investigations listed

  • Collection instructions


Requisition form cont d3

Requisition Form (cont’d)

5th Section: Specimen Receipt

  • Specimen receipt confirmation

  • Receipt comments


Specimen transport

Specimen Transport

Documented procedures required to address:

Biohazard labeling requirements of transport containers

Specimen transport from offsite facilities

Specimen transport within the facility


Standard precautions

Standard Precautions

All specimens should be treated as potentially hazardous!


Specimen receipt

Specimen Receipt

Assessment of quality and volume

Verification of specimen details

Identity of the receiving personnel

Specimen receipt date

and time


Specimen rejection criteria

Specimen Rejection Criteria

Unlabeled specimen

Mislabeled/incompletely labeled specimen

Inadequate information on request form

Specimen collected in a wrong tube

Insufficient or clotted specimen

Specimens received past assay stability


Specimen rejection requires

Specimen Rejection Requires

  • Prompt notification of rejected specimens to the clinic

  • Documentation of notification

  • Cumulative review of notification records to be discussed at study team meetings


Clarification notification form

Clarification/Notification Form


Data clarification notification form

Data Clarification/Notification Form

31


Skill check

Skill Check

You are about to perform an Human Immunodeficiency Virus (HIV) enzyme-linked immunosorbentassay (EIA) run on 24 specimens. Upon recording the PIDs on the plate template, you notice two specimens that have the same PID. How would you proceed?

  • Consult with the supervisor; discard the two specimens; notify study clinic

  • Abandon the whole run and seek clarification before proceeding

  • Consult with the supervisor; proceed with testing; if both negative or positive, report results

  • All of the above

  • None of the above


Specimen referral

Specimen Referral

Shipping manifests

Analyte stability

Specimen audit trail


Skill check1

Skill Check

A Section Supervisor notes that the potassium value generated by the analyzer is 9.2 mmol/l (reference range 3.1 – 5.0). Select the most appropriate steps that should be taken.

  • Release the results

  • Verify that quality control (QC) and calibration are acceptable before releasing the results

  • Verify QC and calibration; notify the clinic and document notification before releasing the results

  • Check the specimen for hemolysis; verify QC and calibration; notify the clinic; and document notification before releasing the results


Specimen chain of custody

Specimen Chain of Custody

Audit trail information includes

Collection

Transport

Specimen Type

Testing Required

Receipt

Condition

Testing Personnel

Study, Site


Critical values

Critical Values

Definition

Results that require prompt and rapid clinical attention to avert significant study participant/patient morbidity or mortality

Values should be defined by the Laboratory Director, in consultation with clinicians served

Policy/procedure for immediate contact of key study personnel


Critical values cont d

Date and time of notification

ID of personnel making the contact

Person notified and

message relayed

Problems encountered with accomplishing the task

Critical Values (cont'd)

Notification records should include:


Critical values cont d1

Critical Values (cont'd)

An emergency telephone contact list for the key study personnel

The laboratory should implement a policy that personnel receiving verbal or phone orders must read back the entire order to verify accuracy of transcription


Skill check2

Skill Check

The only sample for the day from the study clinic (30-minute drive away) is received at the Central Laboratory for CBC testing on a Friday afternoon. A PID number mismatch is noted between the request form and the specimen label although it appears that one digit seems to have been omitted on the specimen label. The clinic closes early on Fridays. Per the Laboratory Standard Operating Procedure (SOP), specimens with PID mismatches should be rejected.


Skill check3

Skill Check

What should the laboratory personnel do?

  • Assume that this was a transcription error and process the sample

  • Reject the sample as per SOP instruction

  • Process the sample and withhold release of results until the issue is resolved

  • Place the specimen in the refrigerator for resolution of the query the following week


Specimen retention

Specimen Retention

Protocol-specific procedures

  • Which specimens?

  • How do we store?

  • How long do we store?

Policy for disposal of biohazardous waste


Specimen storage

Specimen Storage

Research samples are an invaluable resource

42


Specimen storage cont d

Specimen Storage (cont'd)

Research Laboratories should invest in dedicated

sample storage facilities

Round the clock monitoring of storage conditions to ensure that the integrity of samples is maintained

Fully documented disaster recovery

procedures should be implemented


Specimen storage cont d1

Specimen Storage (cont'd)

Repositories

Sample repositories should be created by suitably storing the samples

Relevant records for repositories should be traceable and accessible

Specimen aliquots must be properly labeled before storage


Specimen shipping

Specimen Shipping

Proper organization, packaging, shipping, and handling of specimens ensure specimen integrity, while maintaining timely and safe transfer of specimens

All federal and in country Transportation of Dangerous Goods Regulations must be met for the transportation of specimens


Specimen shipping cont d

Specimen Shipping (cont'd)

Before dispatch of samples, ensure that

the shipping manifest:

  • Matches the number of specimens in the box

  • Matches the ID numbers on specimen tubes

  • Contains the necessary data for each PID

  • Includes the shipping date and other laboratory information (e.g., name and address)


Specimen shipping cont d1

Specimen Shipping (cont'd)

Certification

Personnel who ship specimens must have International Air Transport Association (IATA) dangerous goods training

Training must be renewed every two years

Certification must be on file and available for inspection


What would you do1

What Would You Do?

Fred opens a specimen transport container and prepares to receive a packet of Sodium Heparin tubes for PBMC processing. He notes from the requisition form that the specimens were collected four days earlier.

  • What action should he take?

  • How can this be prevented from recurring in the future?


Post assessment question 1

Post-Assessment Question #1

The following ‘order of draw’ should be followed when performing a venipuncture:

  • Blood culture, PI/PTT, chemistry (plain tube), CBC (EDTA), glucose (Oxalate/Fluoride)

  • PI/PTT, blood culture, glucose (Oxalate/Fluoride), CBC (EDTA), chemistry (plain tube)

  • Blood culture, chemistry (plain tube), glucose (Oxalate/Fluoride), CBC (EDTA), PI/PTT

  • Chemistry (plain tube), blood culture, PI/PTT, CBC (EDTA), glucose (Oxalate/Fluoride)


Post assessment question 2

Post-Assessment Question #2

Is it important to record the identity of the phlebotomist who collected participant information on the requisition form?

  • Yes

  • No


Post assessment question 3

Post-Assessment Question #3

Which of the following are reasons to reject a specimen?

  • The wrong tube was used to collect the specimen

  • The specimen is not labeled or is labeled incorrectly

  • The request form includes adequate information

  • A and B only

  • B and C only

  • None of the above


Post assessment question 4

Post-Assessment Question #4

Notification records should include which of the following:

  • ID of person making the contact

  • Date and time of contact

  • A description of the problems when accomplishing the task

  • B and C only

  • All of the above


Post assessment question 5

Post-Assessment Question #5

Before shipping samples, which of the following tasks must be ensured:

  • Number of specimens in box corresponds to the number listed on the shipping manifest

  • ID numbers on the specimen tubes match those on the shipping manifest

  • Shipping date matches the study protocol

  • A and B only

  • B and C only

  • All of the above


References

References

  • Guideline H18-A3: Procedures for the Handling and Processing of Blood Specimens

  • www.legacyhealth.org

  • www.csmc.edu

  • www.uhl.uiowa.edu

  • www.vh.org


Wrap up

Wrap Up


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