Diagnostic Quality Assurance in Cytopathology
Marluce Bibbo and Catherine M Keebler
In tro d u c tio n
C y t o lo g ic T e r m in o lo g y
Q u a lity A s s u ra n c e M e a su re s
L a b o r a to i
R e c o rd s , L o g s , a n d F ile s
In te rn a l Q u a lity A s s u ra n c e M e ch a n ism s
L a b o r a to r y D ir e c to r s
C y t o t e c h n o lo g is t s
+. •
p h y s ic a l L a b o r a to r y F a c ilitie s
S a fe ty p r e c a u t io n s
C o m p u te r-A s s is te d Q u a lity A s s u ra n c e M e ch a n ism s
E q u ip m e n t
Ex te rn a l Q u a lity A s s u ra n c e M e ch a n ism s
S p e c im e n C o lle c t io n
p re p a r a tio n , F ix a tio n , a n d S t a in in g p r o c e d u r e s
S lid e E v a lu a tio n W o r k lo a d
C o n c lu d in g R e m a rk s
Cytopathologists are concerned about and committed to qual-
ity assurance and quality control in their laboratories. These
practices include, among others, the use of intralaboratory and
extradepartmental consultations, case reviews, correlation of
cytologic and histopathologic specimens, hierarchic review of
cytopathology, and review of completed diagnostic reports. Most
of the quality assurance techniques are well described.1-18,20,21
In the past, formal organization and mandatory documenta-
tion of these quality assurance efforts may have been limited or
deficient. Formal rules may be difficult to apply, because labo-
ratories and screening programs vary depending on the volume
and type of cytodiagnostic material received and on the size and
experience of its staff members. Even though the detailed design
of a quality assurance program emanates from the cytopathol-
ogy laboratory director, basic quality control and quality assur-
ance principles of structure, organization, documentation, and
systematic review must be in place.
The enactment of the Clinical Laboratory Improvement
Amendment of 1988 by the US Department of Health and
Human Services,22 the convening of two national conferences on
cytologic quality assurance by the Centers for Disease Control,
Atlanta, Georgia,23-25 the publication of the
Quality Assurance
by the College of American Pathologists (1988),26 the
American Medical Association Committee Report on the sub-
ject,27 the publication of the
Compendium on Quality Assurance,
Proficiency Testing and Workload Limitations in Clinical Cytology
by the Tutorials of Cytology,28 and the proposal by the National
Cancer Institute Workshop on the Bethesda System of reporting
cytologic findings,29 as well as editorials, letters to the editors,30
and general public interest led to the assurance of high diagnos-
tic standards and fostered intense activities in the quality assur-
ance and quality control sectors.3,24,28,31-52
Quality Assurance Measures
Cytopathology is a practice of medicine and represents a medi-
cal consultation, in both gynecologic and nongynecologic
anatomic sites. The basic principles of quality assurance apply
to all types of cytologic specimens.
The following represents several
quality assur-
ance stipulations to which most cytopathologists will probably
Laboratory Directors
The laboratory should be directed by a legally qualified phy-
sician with a specialist qualification in pathology, including
special training and expertise in cytopathology. In a case in
which the current laboratory director or co-director (associate
cytopathologist) does not have board qualification in pathol-
ogy but has had special training in cytopathology, this situation
may be approved under a "grandfather clause." The director or
designated medical professional is responsible for proper per-
formance and reporting of all tests done in the cytopathology
laboratory. The director or designated cytopathologist should be
physically present in the laboratory to direct the staff, be avail-
able for consultations, review all reactive and abnormal gyneco-
logic cytology samples, review fine needle aspiration samples,
and review all nongynecologic samples. In addition, a supervi-
sor or senior cytotechnologist should be assigned to review 10%
of the negative cases, including high-risk cases as designated by
cytologic findings, clinical findings, and patient histories. This
procedure should help to detect any discrepancies in interpreta-
tion that may occur prior to issuing the final cytologic report.
In addition the director should develop a quality assurance
plan, a manual of laboratory policies/procedures, and ensure
the written policies and procedures reflect actual laboratory
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