(a)
The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following:
(1)
Results reported from calculated data.
(2)
Results and patient-specific data electronically reported to network or interfaced systems.
(3)
Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations.
(b)
Test report information maintained as part of the patient's chart or medical record must be readily available to the laboratory and to CMS or a CMS agent upon request.
(c)
The test report must indicate the following:
(1)
For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number.
(2)
The name and address of the laboratory location where the test was performed.
(3)
The test report date.
(5)
Specimen source, when appropriate.
(6)
The test result and, if applicable, the units of measurement or interpretation, or both.
(7)
Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability.
(d)
Pertinent “reference intervals” or “normal” values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results.
(e)
The laboratory must, upon request, make available to clients a list of test methods employed by the laboratory and, as applicable, the performance specifications established or verified as specified in
§ 493.1253. In addition, information that may affect the interpretation of test results, for example test interferences, must be provided upon request. Pertinent updates on testing information must be provided to clients whenever changes occur that affect the test results or interpretation of test results.
(f)
Except as provided in
§ 493.1291(l), test results must be released only to authorized persons and, if applicable, the persons responsible for using the test results and the laboratory that initially requested the test.
(g)
The laboratory must immediately alert the individual or entity requesting the test and, if applicable, the individual responsible for using the test results when any test result indicates an imminently life-threatening condition, or panic or alert values.
(h)
When the laboratory cannot report patient test results within its established time frames, the laboratory must determine, based on the urgency of the patient test(s) requested, the need to notify the appropriate individual(s) of the delayed testing.
(i)
If a laboratory refers patient specimens for testing—
(1)
The referring laboratory must not revise results or information directly related to the interpretation of results provided by the testing laboratory;
(2)
The referring laboratory may permit each testing laboratory to send the test result directly to the authorized person who initially requested the test. The referring laboratory must retain or be able to produce an exact duplicate of each testing laboratory's report; and
(3)
The authorized person who orders a test must be notified by the referring laboratory of the name and address of each laboratory location where the test was performed.
(j)
All test reports or records of the information on the test reports must be maintained by the laboratory in a manner that permits ready identification and timely accessibility.
(k)
When errors in the reported patient test results are detected, the laboratory must do the following:
(1)
Promptly notify the authorized person ordering the test and, if applicable, the individual using the test results of reporting errors.
(2)
Issue corrected reports promptly to the authorized person ordering the test and, if applicable, the individual using the test results.
(3)
Maintain duplicates of the original report, as well as the corrected report.
(l)
Upon request by a patient (or the patient's personal representative), the laboratory may provide patients, their personal representatives, and those persons specified under
45 CFR 164.524(c)(3)(ii), as applicable, with access to completed test reports that, using the laboratory's authentication process, can be identified as belonging to that patient.
Notes, amendments, and revision history
Amendments
[68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22, 2003, as amended at 79 FR 7316, Feb. 6, 2014]
Source
Source: 68 FR 3703, Jan. 24, 2003, unless otherwise noted.
Authority
Authority: 42 U.S.C. 263a, 1302, 1395x(e), 1395x(s)(3) and (s)(17).
Source
Source: 55 FR 9576, Mar. 14, 1990, unless otherwise noted.
Amendments
[68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22, 2003, as amended at 79 FR 7316, Feb. 6, 2014]