IV Nongynecological Cytology Analysis

Nongynecological Cytology Practice Guidlines

prepared by the American Society of Cytopathology, Cytopathology Practice Committee.

Adopted by the ASC Executive Board, March 2, 2004

 

IV Nongynecological Cytology Analysis

 

IV.A. Individual Qualifications

According to the Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88) a qualified pathologist must examine all non-gynecological cytology specimens.48 In laboratories with cytotechnologists there must be a qualified pathologist serving as laboratory director or technical supervisor, and a general supervisor as defined by CLIA 88.49  Adequate support personnel should be available to minimize clerical duties.

IV.B. Environment and Equipment

Elements of the working environment and equipment used to analyze nongynecological cytology specimens are identical to those used for cervical cytology analysis. These were reported under the guidelines for cervical cytology practice50 and are reiterated below. Examination of all cytology slides should be performed in a comfortable area of the laboratory with minimal distraction. Adequate space, facilities and equipment must be available to the pathologist and cytotechnologist to perform their duties. Ergonomics play a vital role in the pathologist’s and cytotechnologist’s workstation to minimize the risk of repetitive motion injury and musculoskeletal strain. Regular monitoring and maintenance of all equipment and instruments is essential. Proper equipment and resources include: sufficient desk or bench space, a cushioned chair with seat and height adjustment as well as adjustable back support, and a microscope in good working order. Arm rests that fit the desktop, tilting microscope heads, rubber focus knob adapters and devices that adjust microscope height are available options that increase the comfort of the pathologist and cytotechnologist. Other factors include diffuse, moderate room illumination, a non-reflective desk surface, and a comfortable, quiet, draft-free room separate from the processing area 6,51 where protective equipment is required. Clerical and record-keeping areas of the laboratory should be conveniently located.52

IV.C. Analysis Time

The amount of time a cytotechnologist spends screening a slide is variable. Factors which influence all types of cytologic specimen screening time include method of sample preparation (liquid based vs. conventional), overall sample cellularity, blood, inflammation or other obscuring factors, clinical history, complexity of findings and the cytotechnologist’s experience and state of mind. For cytotechnologists workload limits must be set for each individual based upon an evaluation of the individual’s capability and must not exceed the limits set by CLIA ’88.53 Individual workload limits apply to slides screened per hour and in any given 24-hour period. Screening rates must be monitored to ensure compliance with the workload limits established for each individual.

In settings where cytology cases are screened and interpreted solely by a pathologist, the same factors listed above are applicable. Nongynecological specimens should be reported in a timely fashion.6

IV.D. Screening Process

As reported for the cervical cytology practice guidelines54 certain procedures should be followed. The process of screening should always begin with a check of slide identification (name and/or identifying number) against the accompanying accession slip, test request or pertinent laboratory document. The examiner must consider available patient history provided by the ordering clinician.

The screening process usually begins with a low power scan of the specimen to assess background and overall adequacy. The actual screening process is usually performed with a 10X objective. Higher magnification is used for more detailed observation of potentially abnormal areas. The slide should be screened in a systematic and thorough process. The cytotechnologist is responsible for locating and identifying reportable findings. To facilitate review the location of any abnormal cells or reportable findings should be marked in a consistent pattern by all cytotechnologists within the laboratory. When marking slides, care should be taken to avoid covering other significant cellular material.

IV.E. Recording Results and Hierarchical Review

After examining and marking the slide, the cytotechnologist records his or her findings. All findings must be recorded accurately, legibly and precisely for future reviewers and data entry personnel. Cytotechnologists should be able to discuss the basis of their interpretations as well as demonstrate them at the microscope. All nongynecological slides must be referred to a qualified pathologist for final interpretation.

IV.F. Variability in Practice

Depending on the practice setting, nongynecological cytology cases may be initially screened by a cytotechnologist with final interpretation rendered by a pathologist, or screened by a cytotechnologist, reviewed by a supervisory level cytotechnologist and the final interpretation rendered by a pathologist. Although all cytotechnologists are trained to evaluate specimens from all body sites, how specimens are assigned for evaluation may vary among laboratories. In laboratories without cytotechnologists the pathologist both screens and makes the final cytologic interpretation. Laboratories may also vary in methods used for cytologic preparation including filters, cytocentrifugation specimens, liquid based preparations and/or conventional smears. These various types of preparations may result in one-half or less of the total available slide area covered with cells. According to CLIA ’88 such slides may be counted as half a slide, which may become relevant for a cytotechnologist’s workload calculation.55 Which preparations count as whole or half slides may vary from laboratory to laboratory. However, within an individual laboratory whole or half slide determination should be consistent.

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Bibliography/References

6     College of American Pathologists. Commission on Laboratory Accreditation Inspection Checklist 2002 edition, Northfield, Illinois.

48     Clinical Laboratory Improvement Amendments of 1988; Final Rule.  Federal Register. Jan. 24, 2003; Vol. 68: 493.1274(e)(3).

49     Clinical Laboratory Improvement Amendments of 1988; Final Rule.  Federal Register. Feb. 28, 1992; 57; 493.1449.

50     Cervical Cytology Practice Guidelines: American Society of Cytopathology. Acta Cytologica 2001; 45:201-226.

51     Occupational Safety and Health Administration.  Occupational exposure to blood borne pathogens.  Federal Register Final Rules-Title 29. 1991; 56(235), amended 1996; 60 (30).

52     Patten FW.  “Organization of the Laboratory”  In:  Weid GL, Keebler CM, Koss LG, Reagan JW (Eds.)  Compendium on Diagnostic Cytology (6th ed.)  Chicago:  Tutorials of Cytology; 1990.

53     Clinical Laboratory Improvement Amendments of 1988; Final Rule.  Federal Register. Jan. 24, 2003; Vol. 68: 493.1274(d).

54     Cervical Cytology Practice Guidelines: American Society of Cytopathology. Acta Cytologica 2001; 45:201-226.

55     Clinical Laboratory Improvement Amendments of 1988; Final Rule.  Federal Register. Jan. 24, 2003; Vol. 68: 493.1274(d)(2)(iii)