What has to be on the lab report you were sent

The report is the regulated object, not just the number

A certified laboratory does not simply produce a value. The rules treat the report itself as something with required contents.

Seven items must appear. Positive patient identification, either a name and identification number or a unique identifier and identification number. The test performed. The test report date. The result, with units or an interpretation where applicable.

Then the specimen source, where that matters. And two that are easy to overlook.

One is "The name and address of the laboratory location where the test was performed." That is the location, not the brand on the letterhead.

The other is "Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability." A report on a sample that arrived in poor condition is supposed to say so.

Reference ranges are the laboratory's, and they are available on request

The range printed beside your result is not a universal constant. The regulation ties it to the specific laboratory.

Pertinent reference intervals or normal values, as determined by the laboratory performing the test, "must be available to the authorized person who ordered the tests", and to whoever is responsible for using the results.

There is a wider entitlement behind that, and it is rarely used. On request, the laboratory must make available to clients a list of the test methods it uses and, where applicable, the performance specifications it established or verified for them.

The same paragraph goes further. "information that may affect the interpretation of test results, for example test interferences, must be provided upon request."

And when something changes, clients are supposed to hear about it. Pertinent updates must be provided whenever changes occur that affect results or their interpretation.

A request has to exist before a specimen is tested

The paperwork starts before the sample does. "The laboratory must have a written or electronic request for patient testing from an authorized person."

Oral requests are allowed, but only on a clock. The laboratory has to solicit a written or electronic authorization "within 30 days of the oral request", and keep either the authorization or documentation of trying to get it.

The requisition has to solicit specific information, and the list is longer than most people expect. The requesting person's name and address, the patient's name or unique identifier, sex, and age or date of birth.

Also the tests to be performed, the specimen source where appropriate, and the date and, if appropriate, time of collection.

One item on the list is about reachability rather than the patient. Where applicable, the requisition asks for a contact person so that imminently life threatening results, or panic or alert values, can actually be reported to someone.

When the laboratory sends your sample somewhere else

Testing is frequently referred onward, and the rules on that are specific.

The first is a prohibition on editing. A referring laboratory "must not revise results or information directly related to the interpretation of results provided by the testing laboratory".

The second is a disclosure. The authorized person who ordered the test must be notified by the referring laboratory of the name and address of each laboratory location where the test was performed.

The referring laboratory may let the testing laboratory report directly to the ordering person, but must retain or be able to produce an exact duplicate of that laboratory's report.

For a reader who bought a panel through a website, this is the mechanism that makes the actual bench identifiable. The location is required on the report, and the ordering clinician is entitled to be told each place the work was done.

Urgent results, late results, and wrong results

Three situations have their own rules, and they read as a hierarchy of urgency.

A result indicating an imminently life-threatening condition, or a panic or alert value, requires the laboratory to "immediately alert the individual or entity requesting the test", and whoever is responsible for using the results.

A delay is handled with judgment rather than a fixed rule. Where the laboratory cannot report within its own established time frames, it must decide, based on the urgency of the tests requested, whether to notify the appropriate people.

An error carries three duties. Promptly notify the person who ordered the test. "Issue corrected reports promptly" to that person. And "Maintain duplicates of the original report, as well as the corrected report."

That last duty is the one worth knowing. A corrected result does not erase the original. Both are kept, which means the history of a corrected number is retrievable rather than gone.

Two machines, one test, and the check nobody sees

Laboratories often run the same test on more than one instrument, or at more than one site. That creates a risk that two identical samples produce two different numbers.

The rule addresses it directly. Take a laboratory performing the same test on different methodologies or instruments, or at multiple testing sites. It must have a system that "twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites."

A second system looks at individual results rather than instruments. The laboratory must be able to identify and assess results that appear inconsistent with the patient's age, sex, diagnosis or clinical data, the distribution of results, or the relationship with other parameters.

Both have to be documented.

Underneath sits the performance work. Before reporting patient results on an unmodified cleared test system, a laboratory has to demonstrate it can obtain accuracy, precision and reportable range comparable to the manufacturer's. It must also verify that the manufacturer's reference intervals suit its own patient population.

Where a laboratory modifies a cleared system or builds its own, the list is longer and it has to establish the specifications itself, including analytical sensitivity and specificity with interfering substances.

How long any of this survives

Retention is set item by item, and the periods differ enough to matter.

Test requisitions and authorizations are kept for at least two years. So are proficiency testing records, quality system assessment records, and quality control and patient test records.

A copy of each test procedure is kept for at least two years after that procedure is discontinued, and each procedure has to carry its dates of initial use and discontinuance.

Reports have their own rule. The laboratory must retain, or be able to retrieve, a copy of the original report, including final, preliminary and corrected versions, "at least 2 years after the date of reporting."

Pathology reports are the exception, at "at least 10 years after the date of reporting." Histopathology slides are also ten years, cytology slides five, and pathology blocks two.

Closure does not end this. If the laboratory ceases operation, it must make provisions to ensure records, slides, blocks and tissue are retained and available for those periods.

Getting a copy, and what this article does not establish

Release is restricted by default. Results go only to authorized persons, those responsible for using them, and the laboratory that initially requested the test.

One paragraph opens a direct route. On request by a patient or a personal representative, the laboratory may provide access to completed test reports that its own authentication process can identify as belonging to that patient.

That sits alongside the health-privacy access right covered elsewhere on this site, and the two are separate doors to the same document.

Three limits belong here. Only subparts J and K of part 493 were read. None of it was checked against any seller's actual report, because this describes what a certified laboratory must do, not what any company sends.

And the rules govern a laboratory, not the business that arranged the draw. A seller that bundles a panel with a product is a client of the laboratory, and the duties above run to the person who ordered the test.

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 42 Code of Federal Regulations section 493.1291, Standard: Test report, read in full for the seven required items, the reference interval and methods disclosures, the referral rules, the alert duty and the corrected report duties — Electronic Code of Federal Regulations, Office of the Federal Register, February 2014
2. Title 42 Code of Federal Regulations section 493.1241, Standard: Test request, read in full for the authorization requirement, the thirty-day oral request rule and the requisition contents — Electronic Code of Federal Regulations, Office of the Federal Register, January 2003
3. Title 42 Code of Federal Regulations section 493.1281, Standard: Comparison of test results, read in full — Electronic Code of Federal Regulations, Office of the Federal Register, January 2003
4. Title 42 Code of Federal Regulations section 493.1253, Standard: Establishment and verification of performance specifications, read for the verification and establishment lists — Electronic Code of Federal Regulations, Office of the Federal Register, August 2003
5. Title 42 Code of Federal Regulations section 493.1105, Standard: Retention requirements, read in full for the record, report, slide and block periods and the closure provision — Electronic Code of Federal Regulations, Office of the Federal Register, August 2003
6. Title 42 Code of Federal Regulations section 493.1200, Introduction, read for the quality system covering the preanalytic, analytic and postanalytic phases — Electronic Code of Federal Regulations, Office of the Federal Register, August 2003