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Short answer: specimen integrity is the condition of a specimen when it reaches the testing laboratory, meaning it is correctly identified, collected, stored, transported and still fit to give a valid result. In the United States, 42 CFR 493.1242 requires a laboratory to write down and follow policies for labeling, storage, transport conditions and acceptability or rejection, and 42 CFR 493.1283 requires records of receipt and of any specimen that fails its criteria. The regulation sets no numeric limits; each laboratory sets its own.
This page is general reference for laboratory and clinic staff. It is not medical advice and contains no collection procedures.
Definition and scope
“Specimen integrity” is a working term, not a defined regulatory phrase. In practice it groups four questions a receiving laboratory asks about every specimen: is it labeled so it can be matched to the right person, is there enough of it, was it kept and moved under the right conditions, and is it in a usable state (for blood, free of interfering hemolysis). The sections below tie each question to the clause that makes a laboratory write down its answer.
Several related topics already have their own CASRAI pages, so this page does not repeat them: how labeling errors happen and are prevented at the point of collection, what the requisition must carry, the two-patient-identifier requirement and specimen container requirements. For the term itself, see biospecimen.
What CLIA requires labs to write down (42 CFR 493.1242)
Under 42 CFR 493.1242(a), the laboratory “must establish and follow written policies and procedures for each of the following, if applicable”: patient preparation, specimen collection, specimen labeling, specimen storage and preservation, conditions for specimen transportation, specimen processing, specimen acceptability and rejection, and specimen referral. The labeling item specifies “patient name or unique patient identifier and, when appropriate, specimen source.”
The clause names the topics but gives no volumes, temperatures or time limits. Those values belong in the performing laboratory’s own procedures and test catalog, which is why two laboratories can legitimately reject different specimens for the same test.
What gets recorded (42 CFR 493.1242(b) and 493.1283)
A written policy is only half of the chain. Section 493.1242(b) requires the laboratory to “document the date and time it receives a specimen.” Section 493.1283(a) requires test records to include the positive identification of the specimen, the date and time of receipt into the laboratory, and “the condition and disposition of specimens that do not meet the laboratory’s criteria for specimen acceptability.” The requisition side is covered by 42 CFR 493.1241, which says the test request must solicit, among other things, the requester, the patient name or unique identifier, the tests ordered, and specimen source and collection date and time when applicable.
Cross-walk: acceptance question to clause
| Question the lab must answer | Clause that requires a written policy or record | What the clause leaves to the lab |
|---|---|---|
| How must the specimen be labeled? | 493.1242(a)(3) | The exact label format beyond name or unique identifier and, when appropriate, source |
| How is it stored and preserved before testing? | 493.1242(a)(4) | Methods and any limits |
| Under what conditions may it be transported? | 493.1242(a)(5) | Conditions and limits |
| When is it acceptable or rejected? | 493.1242(a)(7) | All acceptance criteria, including quantity and condition |
| When did it arrive? | 493.1242(b); 493.1283(a)(2) | How the date and time are captured |
| Is it positively identified in the test record? | 493.1283(a)(1) | The identification method |
| What happened to a specimen that failed? | 493.1283(a)(3) | The form of the record and the disposition |
| What did the requisition capture? | 493.1241 | Form design |
Volume and temperature are not listed as separate headings in the regulation. How a laboratory fits them in (collection, storage and preservation, transport conditions and acceptability) is an interpretation of where they naturally sit; the rule itself does not name them.
Hemolysis: in vitro versus in vivo
Hemolysis, the breakdown of red blood cells in a blood specimen, is a common reason for rejection and is more nuanced than “bad collection.” A 2019 review in the Oman Medical Journal (wan Azman and colleagues) explains that in vitro hemolysis results from pre-analytical causes tied to sample collection, such as needle size, tube mixing and transport, whereas in vivo hemolysis happens in the patient and “does not rely on the skills and practice of healthcare providers.” One practical clue the authors describe is serial samples: if an earlier sample was clean and the current one is hemolyzed, in vitro hemolysis is suspected. They also note there is no consensus on how to distinguish the two.
The same paper states that the impact of in vitro hemolysis on measured potassium is well documented, and that visual assessment is highly inaccurate and almost impossible to standardize. In the survey it reports, 56% of laboratories still used visual assessment, against 43% using an automated hemolysis index. The authors recommend that laboratories have standard operating procedures on how to detect, analyze and report hemolysis. That recommendation fits directly under the written acceptability policy that 493.1242(a)(7) requires.
Where it matters for labs, clinics and supply decisions
- Labels and containers: the labeling policy only works if the collection setting has labels and containers matching it. See specimen containers and biohazard specimen bags for what those items are.
- Quality system: the preanalytic policies sit inside a laboratory’s wider quality system, described in quality management systems for laboratories.
- Referral and multi-site work: 493.1242(a)(8) makes specimen referral a policy topic of its own, so a laboratory sending specimens elsewhere needs that written down too.
Common misunderstandings
- “CLIA sets rejection limits.” It does not. Sections 493.1242 and 493.1283 require policies and records; the criteria are the laboratory’s.
- “A hemolyzed specimen was badly collected.” Not necessarily; in vivo hemolysis exists and is hard to tell apart from in vitro hemolysis.
- “You can see hemolysis, so a visual check is enough.” The review above calls visual assessment highly inaccurate and hard to standardize.
- “Rejection ends the paperwork.” Section 493.1283(a)(3) requires the condition and disposition of non-conforming specimens to be recorded.
FAQ
What is a mislabeled specimen?
A specimen whose label does not let the laboratory positively match it to the right person and request. Section 493.1242(a)(3) requires the laboratory’s labeling policy to cover patient name or unique patient identifier and, when appropriate, specimen source. Whether a given mislabeled specimen is rejected or corrected is set by the laboratory’s own policy; see specimen labeling error prevention.
What are the specimen labeling requirements?
At the federal CLIA level, the labeling policy must include the patient name or unique patient identifier and, when appropriate, the specimen source. Anything further, such as a second identifier, a collection time or a particular label layout, comes from the laboratory’s procedures, accreditor or requisition. See the two-patient-identifier requirement.
Does CLIA set a hemolysis limit?
No. The text of 42 CFR 493.1242 and 493.1283 contains no numeric hemolysis, volume or temperature limit; those belong to the performing laboratory.
Sources
- 42 CFR 493.1242, Standard: Specimen submission, handling, and referral. www.law.cornell.edu/cfr/text/42/493.1242 (checked 2026-11-01).
- 42 CFR 493.1241, Standard: Test request. law.cornell.edu/cfr/text/42/493.1241 (checked 2026-11-01).
- 42 CFR 493.1283, Standard: Test records. law.cornell.edu/cfr/text/42/493.1283 (checked 2026-11-01).
- wan Azman W N, Omar J, Koon T S, Tuan Ismail T S. Hemolyzed Specimens: Major Challenge for Identifying and Rejecting Specimens in Clinical Laboratories. Oman Med J 2019;34(2):94-98. PMC6425048 (checked 2026-11-01).
