The Principles of Clinical Cytogenetics - Extra Materials - Springer

Quality Control and Quality Assurance 111
1984, which created certification examinations in this field. Australia has its own confidentiality
policy that is summarized in an NPAAC document entitled Guidelines for Data Communication. For
more information, see www.health.gov.au/npaac/pdf/cytogen.pdf.
Related Topics
We have covered most issues involved in the generation of clinical results in the cytogenetics
laboratory, which was the goal of this chapter. However, no such work would be complete without
making mention of the ancillary QA/QC that must also be dealt with on an ongoing basis:
• Safety. In decades past, laboratory design and protocols put the specimen first and the technologist
second. Mouth pipetting was common, even with potentially toxic reagents (Giemsa stain, for
example, is frequently dissolved in methanol). Gloves were not used, and “medical waste” was
any garbage can that had come in contact with a specimen. Cytogenetics labs often reeked of
acetic acid (used in fixing samples; see Chapter 4). Laminar flow hoods (“sterile hoods”) were
constructed with no separation between the specimen and the technologist and utilized a back-tofront
horizontal flow of filtered air. The sample was protected from microbial contamination as air
blew over it directly into the technologist’s face! The reader is reminded that hepatitis existed long
before AIDS.
Today’s hoods feature split vertical airflow and protective glass windows. Pipetting devices are
typically required, and, in the United States, MSDS (material safety data sheets) for every reagent
used in the lab must be available to all employees. Acceptable concentrations of all volatile
reagents are maintained via ventilation systems and are monitored, and universal precautions govern
every process that involves contact with patient samples. Most laboratory inspections include
a safety component. All laboratories should have general and specific laboratory, chemical, biological,
and, if needed, radiation safety programs.
• FISH. Many of the multitudinous and ever-expanding uses of this versatile technology are employed
in the clinical cytogenetics laboratory (and many, we should remember, are used in other
settings). Guidelines typically involve probe validation, use of controls, and training.
• Reference laboratories. Not every cytogenetics lab performs every type of test on every type of
sample. Some specimens require additional noncytogenetic testing. Some laboratories experience
backlogs or other similar difficulties, which require that some samples be sent to another lab to
enable them to “catch up.” For these reasons, proper record keeping and other regulations exist to
ensure proper handling and timely reporting of results for such specimens.
• Ethics policies. Although most laboratories that perform prenatal testing consider themselves to
be “pro choice” concerning a patient’s right to make informed decisions, many feel compelled to
contribute only clinically relevant data to such a process. Prenatal analysis for “gender selection”
does not fall into this category, and such studies are, therefore, often refused by laboratories with
this type of policy. Because of the obvious difficulties faced by all involved with such issues, a
written policy, created by an internal ethics committee, can be extraordinarily helpful.
• Health Insurance Portability and Accountability Act of 1996 (HIPAA). The HIPAA privacy rules
created new requirements for health care providers to protect the privacy and security of individually
identifiable health information. This is defined as information that is created or received by a
health care provider that relates to the past, present, or future physical or mental health of condition
of an individual, the provision of care to an individual, or past, present, or future payment for
the provision of health care to an individual, or information that identifies an individual. They are
fully in effect as of April 14, 2003. The requirement to comply is triggered when the medical
geneticist of the institution at which he or she practices electronically transmits health information
for billing or other purposes. Once required to comply, the requirements apply to all information,