SMILE JOHNS HOPKINS UNIVERSITY BALTIMORE MD USA AUTHOR ERIN

Author: Erin Gover

Document Number:

Pro71-13

Effective (or Post) Date:

7 August 2008

Review History

Date of last review:

17 May 2017

Reviewed by:

Heidi Hanes

SMILE Comments: This document is provided as an example only. It must be revised to accurately reflect your lab’s specific processes and/or specific protocol requirements. Users are directed to countercheck facts when considering their use in other applications. If you have any questions contact SMILE.

Element
Present

CONTENT-SPECIFIC REQUIRED ELEMENTS

SPECIMEN COLLECTION

a)

b)

c)

d)

e)

f)

g)

h)

i)

j)

k)

l)

A description of the laboratory’s specimen collection process, which includes, but is not limited to, the following as applicable:

1. Personal Protection Equipment (PPE) worn by staff;

2. Identify who can draw the specimen;

3. Consent and other paper work in order;

4. Proper identification of the patient;

5. Preparation of the subject;

6. Type of collection container and amount of specimen to be collected;

7. Special conditions (i.e., time of day, etc.);

8. Types and amounts of preservatives or anticoagulants;

9. Step by step procedure for collecting specimens;

10. Special handling (mixing, refrigeration, separation, etc.) between collection and time received by the laboratory;

11. Proper specimen labeling; and

12. Types of containers to be used for transport of specimen.

Venous blood collection: Special steps as applicable to vein selection, needle selection, procedures when IV’s are present, etc.

Heel Stick or Capillary collection: Specific step-wise collection procedures, patient requirements (i.e., infants or when venous collection is unsuccessful, etc.), appropriate collection tubes (i.e., pediatric tubes and volumes)

Arterial blood collection procedures are highly discouraged. However, if they are included, instructions must be included to limit the conditions under which they are collected. Detailed precautions, limitations on collection personnel, special training requirements, and emergency steps must also be included.

A description of the specimen collection process for unusual or non-blood specimens (e.g., urine specimens collected under aseptic or “clean-catch” conditions to ensure quality and avoid contamination of specimen).

A description of policy or procedure when no specimen or an inadequate sample is collected and must be rejected.

A description of the laboratory’s training requirements for personnel collecting specimens.

Comments:

PRECAUTIONS

a)

b)

c)

d)

Description of what to do for adverse reactions

1. Fainting.

2. Excessive bleeding.

3. Hematoma.

4. Nausea

Comments:

LIMITATIONS OR SOURCES OF ERROR

Limitations to the procedure.

Potential problems (sources of error) and appropriate action if those problems are encountered.

Comments:

References:

• OSHA 29 CFR Part 1910.1030: Bloodborne Pathogens

• CLSI. Procedures for Handling and Processing of Blood Specimens; Approved Guideline – Third Edition. CLSI document H18-A3 (ISBN 1-56238-555-0). CLSI, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898, USA, 2004.

• Clinical Laboratory Improvement Amendment (CLIA) Self- Assessment Questionnaire

• College of American Pathologists (CAP), Laboratory General Checklist for Laboratory Accreditation Program

• ICH E6 Good Clinical Practice: Consolidated Guidance (GCP)