D.31- SPECIMEN PROCEDURES SOP- JUNE 2022.pdf
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- Solicitation number
- 36C24224R0049
About this file
This document is a Standard Operating Procedure (SOP) from the Syracuse VA Medical Center that establishes procedures for decontaminating and returning surgical specimens and devices to patients or physicians upon request. The SOP outlines the specific steps required, including washing the specimen, cleaning with bleach, labeling the container, and providing written warnings. It also specifies the approval process, documentation requirements, and disposal procedures.
The related federal contract opportunity is a Request for Proposal (RFP) for Community Based Outpatient Clinic (CBOC) services to provide primary care to veteran patients in the Auburn, NY area. The contract will cover a base year with nine one-year option periods. The NAICS code is 621498 - All Other Outpatient Care Centers, with a $25.5 million size standard. The solicitation number is 36C24224R0049, and proposals are due by the date indicated in the solicitation. This is an unrestricted procurement, and the Department of Veterans Affairs, Veterans Health Administration, Veterans Integrated Service Network 2 is the contracting agency.
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Text version
SPECIMEN PROCEDURES
SOP 113-004
Syracuse VA Medical Center Syracuse, NY 13210
Signatory Authority:
Chief of Pathology and Laboratory
Responsible Owner:
Pathology and Laboratory
Service Line(s):
Pathology and Laboratory
Effective Date:
June 2022
Recertification Date:
June 2027
1. PURPOSE AND JUSTIFICATION
a. The purpose of this standard operating procedure (SOP) is to establish procedures on decontaminating specimens and devices when a request is made to be released to a patient or physician. This SOP must be followed by all Syracuse VAMC personnel.
b. This SOP sets forth procedures and processes to ensure compliance with MCP 11-107, Release of Surgical Pathology Specimens and Devices to Patients and Physicians, dated May 2022.
2. PROCEDURES
a. The Request for Specimen Return.
(1) Specimen(s) will only be released to the patient with a signed release form, a legal representative with a court order or funeral home.
(2) Histology must be notified of a request for the return of a surgical specimen/device.
(a) The Specimen Release Form must be completed and signed by the requesting person and submitted to Histology.
(b) The person releasing the specimen/device must sign the form when the specimen/device is released.
(3) The Pathologist of Record or the Pathologist covering for the Pathologist of Record must approve of the request for the release of the specimen/device.
(a) The Chief Pathologist will make the final decision if there is uncertainty about releasing a specimen/device.
(4) Specimens/devices may not be released to a patient or physician until at least two weeks after the completion of the surgical report.
Attachment D.31 RFP 36C24224R0049
June 2022 SOP 113-004
(5) For outside vendor requests for specimens/devices, VA District Counsel must be consulted prior to the release of the tissue or device.
b. Decontamination.
(1) Specimens/devices must be safely decontaminated before release to the patient or physician.
(a) If the specimen is non-tissue and submitted in formalin (stones, teeth, etc.):
1. Wash specimen with running water to remove traces of 10% neutral buffered formalin (NBF).
2. Clean with fresh bleach solution and let it soak in bleach for a minimum of 15 minutes.
3. Rinse well with water.
4. Allow to air dry.
5. Place in a dry, clean, and sterile container and label it with the patient’s reprinted label.
6. Also include a formalin label on it since the specimen was exposed to formalin.
7. Parafilm the container and put the container into a Mitsubishi pouch bag and heat seal it tight.
8. Stick a “Return to Patient” sticker on it.
(b) If the specimen is non-tissue and not submitted in formalin (i.e., hardware, implants, foreign bodies, etc.):
NOTE: Histology will not return any malfunctioning hardware or devices.
1. Wash specimen with running water to remove any traces of tissues or blood.
2. Clean with fresh bleach solution and let it soak in bleach for a minimum of 15 minutes.
3. Rinse well with water.
4. Allow to air dry.
5. Place in a dry, clean, and sterile container and label it with the patient’s reprinted label.
6. Parafilm the container and put the container into a Mitsubishi Pouch Bag and heat seal it tight.
7. Stick a “Return to Patient” sticker on it.
NOTE: Soft tissue (human tissue) will not be returned to the patient or physician.
(2) The specimen/device must be placed into a clean container or bag that is labeled with the following:
(a) Patient’s full name.
(b) Patient’s full social security number.
(c) The type of specimen or device must also be on the container.
(3) A written caution will be included with the specimen/device to notify the patient or physician of the possible risk of receiving potentially hazardous material.
(4) A formalin warning label will be placed on the container if the original specimen was received in Histology in formalin.
c. Specimen Release.
(1) A signed release of information form by the patient or legally authorized representative is required.
(2) The specific specimen must be identified.
(3) Signed receipt on the date of release of the specimen form along with the receipt of any hazardous warnings/safety instructions.
(4) The release of the specimen/device must be documented in the “Surgical Material Released Log” in Histology.
(5) If a patient requests a specimen/device for litigation, VA District Counsel must be consulted prior to release.
(a) The specimen must be held for at least 90 days for analysis by an expert.
d. Returning the Specimen/Disposal.
(1) If the patient wishes to return the specimen(s) to the laboratory for disposal, such as hardware or stones, the item(s) must be cleaned and dry and may be discarded in the biohazard waste.
(2) Specimens released to funeral homes will only be disposed at the funeral home or via incineration or burial.
(3) The Histology lab will only dispose of specimens that were released from the Department.
3. ASSIGNMENT OF RESPONSIBILITIES
None.
4. DEFINITIONS
None.
5. REFERENCES
a. VHA Handbook 1106, Pathology and Laboratory Medicine Service Procedures, January 29, 2016. Direct LINK. NOTE: This is an internal VA website that is not available to the public.
b. MCP 11-107, Release of Surgical Pathology Specimens and Devices to Patients and Physicians, dated June 2022. NOTE: This is an internal VA website that is not available to the public.
6. REVIEW
At minimum at recertification, when there are changes to the governing document (for example, national policy or a health care accreditation body mandate), and any regulatory requirement for more frequent review.
7. RECERTIFICATION
This SOP is scheduled for recertification on or before the last working day of June 2027.
In the event of contradiction with national policy, the national policy supersedes and controls.
8. SIGNATORY AUTHORITY
SEENA KUMAR, M.D.
Chief of Pathology and Laboratory Medicine Date Approved: June 8, 2022
NOTE: The signature remains valid until rescinded by an appropriate administrative action.
DISTRIBUTION: SOPs are available at: Syracuse Medical Center Document Control SharePoint (DCS). https://dvagov.sharepoint.com/sites/VHASYR/svdc. NOTE: This is an internal VA website that is not available to the public.
Attachment D.31 RFP 36C24224R0049 https://vaww.va.gov/vhapublications/index.cfm https://vaww.va.gov/vhapublications/index.cfm https://dvagov.sharepoint.com/sites/VHADiagnosticservices/PLMS/edcen/Document%20Library/Forms/AllItems.aspx?id=%2Fsites%2FVHADiagnosticservices%2FPLMS%2Fedcen%2FDocument%20Library%2FDirective%20Guidance%2F1106%5F01%5FHK%5F2016%2D01%2D29%2Epdf&parent=%2Fsites%2FVHADiagnosticservices%2FPLMS%2Fedcen%2FDocument%20Library%2FDirective%20Guidance https://dvagov.sharepoint.com/sites/VHASYR/svdc/SitePages/Syracuse-VAMC-Document-Control-SharePoint.aspx https://dvagov.sharepoint.com/sites/VHASYR/svdc/SitePages/Syracuse-VAMC-Document-Control-SharePoint.aspx https://dvagov.sharepoint.com/sites/VHASYR/svdc/ https://dvagov.sharepoint.com/sites/VHASYR/svdc/ https://dvagov.sharepoint.com/sites/VHASYR/svdc/
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