The Principles of Clinical Cytogenetics - Extra Materials - Springer

104 Michael Watson and Steven Gersen
• Summarize the findings of the laboratory
• Crosscheck the findings against the various specimen labels for labeling errors
• Interpret the test results, where appropriate
• Establish a reporting process to outside individuals so that the data, individual issuing the report,
individual receiving the data, and the report date are properly documented
Preliminary Reports
Although potentially risky, preliminary results are sometimes released by a laboratory before the
full chromosome analysis has been completed. Preliminary reports are often issued verbally once
enough data have been collected to formulate a likely indication of the final result or once the data
already available are clinically critical and must be communicated to a physician. Once verified, it is
important to follow an established procedure for reporting preliminary results. Individuals reporting
the data should be qualified to interpret the preliminary findings and to give an indication of the
possible outcome once a complete study has been conducted. It is important for this individual to
document the microscope analysis data, the patient and cytogenetic data reported, date of the report,
and individual receiving preliminary data. It is also vital to impress upon the person receiving the
report what might change once the study is completed.
Final Reports
A final report will summarize and interpret the results of the study. Some states and regulatory
agencies also require a statement describing the limitations of chromosome analysis, and many laboratories
choose to include such a statement whether required or not. A procedure for the creation of
final reports should include a checklist to ensure that all appropriate procedures have been completed
and that all data are clerically correct. Once completed, final reports can be generated electronically
or on paper. If a preliminary report was provided, any variations from that should be stated.
Once the final report has been completed, a record should be kept of the individuals to whom a
report was issued, as well as the date(s) of issue. In most instances, a report is typed or printed
electronically by a computer program and filed in a patient folder. Patient folders are retained in the
laboratory or filed in an outside facility. Whether stored within a laboratory or at an off-site facility,
it is important to have access that allows prompt data retrieval.
QUALITY ASSURANCE
Laboratories can experience a variety of difficulties with samples themselves; some of these are
inevitable and therefore are not preventable (insufficient volume, wrong sample type, no living cells
present, etc.). Others may be the result of collection or transport of the specimen, incorrect labeling,
or other human error at sample collection, during transport, or in the laboratory. There are also a
number of difficulties that can arise in the laboratory after an appropriate specimen has been received
without incident.
Any of these can result either in an incorrect diagnosis or in failure to reach one at all. Therefore,
it is very important for a laboratory to document all problems that arise and, by determining ways to
prevent similar occurrences, improve overall quality.
It is also important to monitor specific types of laboratory test outcome in order to judge one’s
laboratory’s performance. This is most commonly done when a laboratory can expect a particular
distribution of outcomes. In studies of products of conception, review of distribution of results can
inform the laboratory of potential problems with tissues provided and dissected for study (e.g., if the
male : female ratio is not close to 1). In leukemia and cancer testing, there may be subsets of cases for
which there is an expectation of study success rate and abnormality detection rates. For instance,
among patients entered in national cancer cooperative group studies, there is usually a groupwide
expectation based on prior performance of laboratories in the group.