What a human tissue donor has to be screened for

A rule about the person, not the product

Most manufacturing rules are about a process. This set is about where the starting material came from, and it applies to products made from human cells or tissue.

Whether a given preparation falls inside that category is decided by a separate four-part test, covered elsewhere on this site. What follows is what applies once it does.

The requirement has a name: a donor-eligibility determination. It rests on two things done to a donor, screening and testing, and it has to be made by a specific person.

It also has teeth before it is made. There is a prohibition on use that runs until the determination is complete.

One determination, and a prohibition until it exists

The general rule is written without qualifications, and then a short list of exceptions is added later.

The requirement is that "A donor-eligibility determination, based on donor screening and testing for relevant communicable disease agents and diseases, is required for all donors of cells or tissue used in HCT/Ps."

The prohibition is the next paragraph. An HCT/P "must not be implanted, transplanted, infused, or transferred until the donor has been determined to be eligible."

The determination is also somebody's job by name. A responsible person "must determine and document the eligibility of a cell or tissue donor."

Two halves, and both have to come back clean

Eligibility is not a single judgment. It is the result of a records review and a laboratory test, and both have to pass.

On the screening side, the donor has to be shown to be "free from risk factors for, and clinical evidence of, infection due to relevant communicable disease agents and diseases."

The donor also has to be free from communicable disease risks associated with xenotransplantation, which is the use of animal material in a person.

On the testing side, the results have to be negative or nonreactive, with one narrow exception written into the testing section itself.

What the medical records are read for

Screening is defined as a review of documents rather than a conversation.

The establishment "must screen a donor of cells or tissue by reviewing the donor's relevant medical records" for risk factors and clinical evidence of specific agents.

The named agents are listed rather than left general. "Human immunodeficiency virus," "Hepatitis B virus," "Hepatitis C virus," "Human transmissible spongiform encephalopathy, including Creutzfeldt-Jakob disease," and "Treponema pallidum."

Certain material adds to the list. A donor of viable, leukocyte-rich cells or tissue is also screened for cell-associated agents including Human T-lymphotropic virus.

A shortcut exists, and it is bounded

Repeat donation is handled expressly, which is more useful than it sounds because it shows what the rule is willing to trade away.

Where a complete screening was done on a living donor "within the previous 6 months," an abbreviated procedure may be used on repeat donations.

The abbreviated version is not a skip. It has to determine and document any changes in the donor's medical history since the previous donation that would make the donor ineligible.

The regulation says that includes relevant social behavior, so the shortcut still reaches the questions that produce most exclusions.

The test has to be a particular kind of test

Testing is where the requirement gets specific about instruments and laboratories, and this is the paragraph most worth knowing.

The establishment "must test using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions."

The laboratory is named too. Required testing "must be performed by a laboratory that either is certified to perform such testing on human specimens under the Clinical Laboratory Improvement Amendments of 1988," or has met equivalent requirements.

Timing is fixed as well. The specimen is collected "at the time of recovery of cells or tissue from the donor; or up to 7 days before or after recovery," with named exceptions for certain donations.

Where the material sits while the answer is pending

The gap between recovery and a determination is handled by quarantine, and the quarantine has physical requirements.

An establishment "must keep an HCT/P in quarantine" until the determination is complete. The quarantined product "must be easily distinguishable from HCT/Ps that are available for release and distribution."

Shipping before the determination is allowed, and it comes with paperwork. The records have to identify the donor, state that the determination is not complete, and travel with the product.

One of those records is a flat instruction: "Stating that the product must not be implanted, transplanted, infused, or transferred until completion of the donor-eligibility determination."

The urgent-need exception, and the labels it forces

There is a route for using a product before the answer is in, and it is written as a labeled exception rather than a quiet one.

Where there is a documented urgent medical need, the subpart does not prohibit use. The product must then be prominently labeled "NOT EVALUATED FOR INFECTIOUS SUBSTANCES" and "WARNING: Advise patient of communicable disease risks."

Whatever screening and testing results exist have to accompany it, along with a list of everything not yet done.

The obligation does not end there. The establishment "must complete the donor-eligibility determination during or after the use of the HCT/P, and you must inform the physician of the results of the determination."

An ineligible donor, and what may still happen

A failed determination does not automatically mean destruction, and the permitted uses are specific.

Storage comes first. Product from ineligible donors is stored or identified "in a physically separate area clearly identified for such use," or under other procedures adequate to prevent improper release.

Three uses are then not prohibited by the subpart. One is where "The HCT/P is for allogeneic use in a first-degree or second-degree blood relative." The others are a directed reproductive donor and a documented urgent medical need.

Each of those carries a biohazard legend and a warning about communicable disease risks. Anything else goes to nonclinical purposes, labeled "For Nonclinical Use Only."

Who is outside the requirement

The exceptions are narrow, and the largest one is about material returning to the person it came from.

No determination, screening or testing is required for "Cells and tissues for autologous use," or for reproductive cells or tissue donated by a sexually intimate partner of the recipient.

Those exceptions come with their own labels rather than silence. Material stored for autologous use is labeled "FOR AUTOLOGOUS USE ONLY."

The procedures behind all of this are themselves regulated. Any departure from a procedure relevant to preventing communicable disease transmission has to be recorded and justified "at the time of its occurrence."

What a reader can take from this

The practical value here is a vocabulary, not a checklist. None of these records is published, and no rule in the subpart entitles a patient to see one.

The first useful distinction is autologous versus allogeneic. Material from another person carries the whole donor-eligibility apparatus; material returned to the same person does not.

The second is that a warning legend on this kind of product is a defined thing rather than a marketing choice. The phrases quoted above are prescribed by regulation, word for word.

And the third is what none of this covers. Donor eligibility is about communicable disease transmission. It says nothing about whether a product works, and this article makes no claim that any product sold as a peptide is or is not covered by these rules.

Sources

Each document below is named as it names itself, with the date printed on that document rather than the day it was read.

1. Title 21 Code of Federal Regulations section 1271.45, What requirements does this subpart contain — the requirement of a donor-eligibility determination based on screening and testing for all donors of cells or tissue used in HCT/Ps at (b), and the prohibition on implantation, transplantation, infusion or transfer until the donor has been determined to be eligible at (c) — Electronic Code of Federal Regulations, Office of the Federal Register, November 2004
2. Title 21 Code of Federal Regulations section 1271.75, How do I screen a donor — the review of the donor's relevant medical records at (a), with the named communicable disease agents; the additional screening for donors of viable, leukocyte-rich cells or tissue at (b); the genitourinary agents for reproductive donors at (c); the mandatory ineligibility findings at (d); and the abbreviated procedure for a living donor screened within the previous six months at (e) — Electronic Code of Federal Regulations, Office of the Federal Register, March 2006
3. Title 21 Code of Federal Regulations section 1271.80, What are the general requirements for donor testing — the timing of specimen collection at (b), and at (c) the requirement to use appropriate FDA-licensed, approved or cleared donor screening tests in accordance with the manufacturer's instructions, performed by a laboratory certified under the Clinical Laboratory Improvement Amendments of 1988 or meeting equivalent requirements — Electronic Code of Federal Regulations, Office of the Federal Register, May 2005
4. Title 21 Code of Federal Regulations section 1271.60, What quarantine and other requirements apply before the donor-eligibility determination is complete — the quarantine obligation at (a), the requirement that quarantined product be easily distinguishable from releasable product at (b), the records that must accompany a shipment made before the determination at (c), and the urgent medical need provision with its two prescribed label legends and follow-up duties at (d) — Electronic Code of Federal Regulations, Office of the Federal Register, January 2001
5. Title 21 Code of Federal Regulations section 1271.65, How do I store an HCT/P from a donor determined to be ineligible, and what uses of the HCT/P are not prohibited — the physically separate storage at (a), the three uses not prohibited by the subpart together with their biohazard legend and warning statements at (b), and the nonclinical use labeling at (c) — Electronic Code of Federal Regulations, Office of the Federal Register, January 2001
6. Title 21 Code of Federal Regulations section 1271.50, How do I determine whether a donor is eligible — the determination based on screening and testing, the requirement that a responsible person determine and document it, and the two conditions an eligible donor must satisfy — Electronic Code of Federal Regulations, Office of the Federal Register, January 2001
7. Title 21 Code of Federal Regulations section 1271.90, Are there other exceptions and what labeling requirements apply — the exceptions for cells and tissues for autologous use and for reproductive material from a sexually intimate partner at (a), and the required labeling for excepted products at (c) — Electronic Code of Federal Regulations, Office of the Federal Register, June 2016
8. Title 21 Code of Federal Regulations section 1271.47, What procedures must I establish and maintain — the definition of establish and maintain, the review and approval of procedures by a responsible person before implementation, their availability where the operations are performed, and the requirement to record and justify any departure at the time of its occurrence — Electronic Code of Federal Regulations, Office of the Federal Register, January 2001