Standards Of Specimen Handling In Operation Theatre : Does It Affect Adjuvant Treatment Decision?

From an oncosurgeon’s perspective

Introduction: The purpose of the standards is to provide an outline that healthcare workers (HCWs) in the perioperative setting can use to develop and implement policies and procedures for the handling and care of surgical specimens. The standards are presented with the understanding that it is the responsibility of the healthcare facility to develop, approve, and establish policies and procedures for the handling and care of surgical specimens according to established healthcare facility protocols.

Rationale: The handling of specimens before they reach the pathology department is referred to as the preanalytic phase. Involving many HCWs and many steps including communication of information among the surgical team members, labeling, packaging and transport of the specimen that may contribute to increasing the risk of error.

Mislabeling errors: In one six-month study conducted at a university healthcare facility, the following was identified:

• Of 10,354 surgery department specimens, 38 had errors.
• Of the 21,351 total number of specimens studied that originated from various hospital departments, 54 of 91 mislabeled specimens originated from the surgery department. Out of those 54, the surgical procedures in which specimens were most commonly mislabeled are:
• Breast
• Skin
• Colon
• Prostate

Loss of specimen: When addressing loss of specimen, there are two categories:

• Procedure that can be repeated in order to obtain another specimen;
• Specimen that cannot be replaced, such as an excised organ or tumor.
• Delay in submerging specimen in formalin: after removal of specimen from the patients body the specimen should be properly marked and labelled for the site identification and immediately should be put in formalin (10%) because delay may lead to unavoidable shrinkage of margins. This shrunk margins may falsely be perceived as positive for tumor or close margins especially in anatomically compromised areas such as:
  • CRM (circumferentially resected margins) in pelvis
  • Surgeries of parametrium
  • Head and neck tumors and
  • Esophageal resections.

The second and third category represents the greatest concern since an

• incomplete diagnosis,
• misdiagnosis, or
• delayed treatment, and could result in wrong treatment, causing the patient to undergo additional treatment as a safety measure even though it may not be needed, or cause treatment of wrong area of the body.

* Additionally, for both categories, the healthcare facility is facing possible litigation.

As previously mentioned, delivering a specimen to the pathology department involves following steps including:

1. 1. 1. Correctly identify the patient.
      2. Correctly identify and confirm the specimen by the surgical team.
      3. Placing the specimen in an appropriate container and preservative.
      4. Correctly label the specimen.
      5. Complete the pathology requisition slip.
      6. Transport the specimen to the pathology department.

Standard of Practice I: The proper handling and care of specimens begins during the preoperative phase of patient care and preparations including all communications should involve the surgical team.

Standard of Practice II: Specimens to be transported to the pathology department should be placed in the proper container to preserve and protect the specimen.

Standard of Practice III: HCWs should practice appropriate precautions in the handling of specimens and the containers to protect the specimen as well as to prevent self-contamination.

Standard of Practice IV: Specimen containers should be properly labeled.

The following information should be written on the label in the operating room by the circulator:

1. Type of specimen
2. Site of specimen including left or right side
3. Two unique identifiers, eg patient name and hospital number13
4. Date and time specimen received from CST
5. Type of preservative, if used
6. Surgeon’s name
7. Suture tag if present and placement, eg 12 o’clock position or lower left Quadrant

Standard of Practice V: Preservative solutions should be handled, distributed and disposed of by HCWs in accordance with established healthcare facility policies and procedures.

Standard of Practice VI: Specimens designated for frozen section should be properly handled, transported and disposed of according to healthcare facility policies and procedures.

Standard of Practice VII: Aerobic and anaerobic culture specimens should be properly obtained, handled, transported and disposed of according to healthcare facility policies and procedures.

Standard of Practice VIII: Anaerobic culture specimens obtained with a syringe should be properly handled, transported and disposed of according to healthcare facility policies and procedures.

Standard of Practice IX: Radioactive specimens should be properly handled, transported and disposed of according to healthcare facility policies and procedures.

Standard of Practice X: The handling and reporting processes of defective medical device specimens should be established by the healthcare facility in accordance with federal regulations.

Standard of Practice XI: Foreign objects such as bullets are medical-legal evidence and should be properly managed in order to preserve the evidence as well as follow healthcare facility policies and procedures for documenting the chain of custody.

Standard of Practice XII: Healthcare facilities should establish policies addressing specimens that are identified as not having to be submitted to the pathology department, specimens that only require gross examination and specimens that should undergo routine microscopic examination.

Standard of Practice XIII: A systems approach should be utilized when developing the healthcare facility’s procedures and policies for identification, handling, communication, documentation, transportation and disposition of specimens.

• A systems approach places emphasis on viewing the process as a whole in the handling and transport of specimens. A systems approach focuses on the safeguards that can be established to reduce the risk of errors. Additionally, if an error occurs in the handling of a specimen, the system/policies and procedures can be reviewed and revised as necessary to avoid a future system error.

a) Establishing consistent methods of verbal and written communication as well as chain of custody is essential to decreasing the risk of errors. The development of a flowchart that can be periodically reviewed is a useful aid.

b) Immediately placing the specimen into the container and labeling the container reduces the risk of losing the specimen during clean-up of the

c) The use of pre-printed forms, including checklists, laboratory requisition slips and daily specimen logs indicating information to be entered reduces the need for HCWs to rely on memory and ensure that all required information for processing specimens is obtained.

A checklist that is completed by the circulator prior to the specimen being transported out of the OR aids in reducing error.

The checklist can serve as a double check for accuracy; it can be prompted by the circulator asking “has the specimen been verified” and each member of the surgical team verifying.

d) A requisition form should accompany all specimens delivered to the pathology or laboratory department. The healthcare facility should have a pre-printed requisition form. Pertinent information may be stamped on the form using the patient’s addressograph card. The following information should be completed on the form:

1. Patient’s name
2. Patient’s healthcare facility identification number
3. Patient’s unit and/or room number
4. Clinical diagnosis
5. Surgeon’s name
6. Source of specimen to include anatomical location where the specimen was removed, side, etc.
7. Type of tissue
8. Date and time of collection in the OR
9. Study requested, eg culture, Gram stain, frozen section, etc.
10. Other pertinent clinical information.
11. Name of circulator who completed documentation and preparation of the specimen for transport to the pathology or laboratory department

e) Chain of custody tracking should be established within the system for handling specimens. The chain of custody process should be simplified and the number of hand-offs kept at a minimum; each hand-off is represented as a potential source of error.

A surgery department specimen log book should be used to record each specimen to include name of specimen, two patient identifiers, date, time of log-in, and name of each HCW involved in the transport of the specimen.

f) The pathology, laboratory and surgery departments should agree upon an established schedule for the pick-up/transport of permanent specimens.

g) To create ownership of the process of handling specimens, a healthcare facility department, such as the pathology department, should be designated as overseeing the system, including development and revision of policies.

• Periodic training of HCWs involved in the handling of specimens should be completed. The training should involve review of policies and procedures, as well as receiving feedback from HCWs for improvement of the system.

Dr. Seema Singh
Consultant – Surgical Oncology
RGCIRC, Niti Bagh, South Delhi