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Human Tissue Standards (2.2.3)

Human Tissue Standards (2.2.3) - Policies, Clinical, UW Health Clinical, General Care and Procedures, Blood Products

2.2.3


UW HEALTH CLINICAL POLICY 1
Policy Title: Human Tissue Standards
Policy Number: 2.2.3
Category: UW Health
Type: Ambulatory and Inpatient
Effective Date: December 1, 2015

I. PURPOSE

To provide central oversight and establish similar processes for handling human tissue, for clinical use, as
required.

II. POLICY ELEMENTS
A. The Joint Commission (TJC) and the U.S. Food and Drug Administration (FDA) have promulgated standards
and regulations that apply to human tissue. TJC standards (TS.03.01.01, TS.03.02.01, TS.03.03.01) apply
to all human tissue (including those purchased from a vendor) and all clinical areas or departments that
store and/or issue human tissue for use. The FDA regulations ("Current Good Tissue Practice" and "Donor
Eligibility") apply to "manufactured" human tissue and, thus, the clinical departments that manuf acture the
human tissue. For purposes of this policy, "manufacture" means recover, process, storage, labeling, use,
and/or distribution of human tissue for concurrent or subsequent use. The Current Good tissue Practice
(CGTP) and other regulations are contained in 21 CFR Part 1271, along w ith provisions relating to
establishment registration. These regulations w ill apply to Human Cells, Tissues, and Cellular and Tissue-
Based Products (HCT/Ps) recovered on or after the rule's effective date, May 25, 2005. HCT/Ps recovered
before the effective date of the new rules are subject to 21 CFR 1270, and subparts A and B of Part 1271,
as appropriate. In addition, 21 CFR Part 1271 subparts A, B, C, F, 21CFR 1271.150(c), and 21 CFR
1271.155 of subpart D apply to reproductive HCT/Ps.
B. The “Tissue and Blood Products Committee” (TBPC) mission includes w ithout limitation:
i. Ensuring that UW Health policies regarding the use, management, storage and distribution of
tissues and blood products meets applicable standards and regulations; and providing general
oversight to UWHC departments involved w ith tissues and/or blood products.
C. UW Health has determined that human tissue is stored and/or issued from the follow ing clinical areas:
i. Transfusion Services (Blood Bank) – University Hospital (600 Highland Avenue)
ii. Hematopoietic Stem Cell Laboratory (HSCL) – University Hospital
iii. Operating Room (Cardiac Surgery) – University Hospital
iv. Clinical Labs – The American Center
D. Each department identif ied in section II. C. is responsible for review ing current policies and making
necessary revisions and/or additions to meet the TJC and/or FDA requirements that affect their department.
Compliance w ith these standards and regulations must be evident in/on departmental documents such as
policies, procedures, forms, records, etc. As per regulations, vendor instructions should be follow ed unless
other validated and approved processes are in place.
III. PROCEDURE
A. Common Procedures. While each area may be responsible for adopting slightly different policies based on
the human tissue that is present and used in their area, the follow ing three procedures apply to all
departments that manufacture, store, and/or issue human tissue:
i. Ordering Human Tissue
a. Internal – human tissue dispensed for use in conjunction w ith patient care must be
ordered by a physician and documented in the patient’s medical record
b. External – each department must establish and maintain an inventory and purchasing
process that is subject to approval. Human tissue may only be purchased from vendors
that have been licensed by state agencies and/or have registered as a tissue
establishment w ith the FDA.
ii. Vendor Recalls
a. Vendor Communication. All communications from vendors regarding recalls of human
tissue shall be forw arded to Transfusions Services from any hospital department.
b. Tissue Disposition. Transfusion Services w ill w ork w ith the appropriate department and
that department w ill search for, and quarantine or destroy, all tissue from the same lot
and/or same donor as instructed by the vendor.



UW HEALTH CLINICAL POLICY 2
Policy Title: Human Tissue Standards
Policy Number: 2.2.3

c. Clinical Follow -up. If it is determined that a patient received tissue subsequently recalled
by the vendor, Transfusion Services w ill consult w ith the patient’s attending and/or primary
physician to communicate the issue and determine the appropriate course of treatment.
iii. Adverse Events
a. Internal Reporting of Adverse Events. All adverse events involving human tissue must be
reported using the Patient Safety Net and forw arded to Transfusion Services or HSCL as
appropriate, and Risk Management. An adverse event is any untow ard, undesirable, and
usually unanticipated event resulting in clinical complication (e.g., requires additional
treatment, is life threatening, results in temporary or permanent disability) or death to a
patient. Adverse events include, but are not limited to the follow ing:
1. Contamination of product resulting in infection to the patient;
2. Structural damage to organ or surrounding tissues
b. Investigation
1. Transfusion services w ill investigate all adverse events related to human tissue
(excluding HSCL products) and w ill report relevant f indings to Risk Management,
and, as applicable, to the Tissue and Blood Products Committee. Any human
tissue suspected of contamination must be quarantined during the investigation.
If the tissue is determined to have caused an infection it w ill be destroyed or
returned to vendor. The Medical Director of Transfusion Services in conjunction
w ith the patient's physician may make exceptions. Patients w ill be informed of all
risks if it is determined that they have, or because of a medical emergency, w ill
receive human tissue that has infectious agents know n to be transmissible by
tissue.
2. The HSCL, in conjunction w ith the Medical Director of the HSCL, w ill investigate
all serious and unexpected adverse events related to infusion of hematopoietic
related stem cell products, per HSCL standard operating procedure 1.15
“Investigation of Immediate Adverse Events to Cellular Infusions”. An Adverse
Reaction Investigation Form is completed and review ed by the HSCT Manager
and the Medical Director of the HSCL lab w ho w ill report relevant f indings to Risk
Management and Tissue and Blood Products Committee. After review of the
laboratory data, the HSLC Medical Director or the attending physician decide
follow up action and the f inal disposition of the product.
c. External Reporting
1. FDA. Transfusion services and HSCL w ill report any adverse event resulting from
contaminated human tissue to the FDA using the appropriate FDA form.
2. Source facilities. Transfusion services in conjunction w ith Risk Management w ill
report all adverse events to the facility w here the product w as purchased.

IV. COORDINATION

Author(s): Manager, Transfusion Services
Senior Management Sponsor: SVP and General Counsel
Approval committees: Tissue and Blood Products Committee; UW Health Clinical Policy Committee
UW Health Clinical Policy Committee Approval: October 19, 2015

UW Health is a cohesive, united and integrated academic medical enterprise comprised of several entities.
This policy applies to facilities and programs operated by the University of Wisconsin Hospitals and Clinics
and the University of Wisconsin Medical Foundation, Inc., and to clinical facilities and programs
administered by the University of Wisconsin School of Medicine and Public Health. Each entity is
responsible for enforcement of this policy in relation to the facilities and programs that it operates.

V. APPROVAL

Jeff Grossman, MD
UW Health CEO

Teresa Neely
SVP and CAAO



UW HEALTH CLINICAL POLICY 3
Policy Title: Human Tissue Standards
Policy Number: 2.2.3


J. Scott McMurray, MD
UW Health Clinical Policy Committee

VI. REFERENCES

2014 Joint Commission Resources – Chapter – Transplant Safety
21 CFR Part 1271 and 21 CFR Part 1270
HSCL standard operating procedure 1.15, Investigation of Immediate Adverse Events to Cellular Infusions

VII. REVIEW DETAILS
Version: Revision
Next Revision Due: December 1, 2018
Formerly know n as: Hospital Administrative policy #7.03