Appendix

 

Cervical Cytology Practice Guideline

Approved by the ASC Executive Board November 10, 2000

 

 

XIV.   APPENDIX

XIV.A.  Creating a Guideline Document

Since the late 1980′s “guidelines” have attained growing importance.  Guidelines draw from relevant literature, educational and workshop curricula and important elements of daily clinical practice. They are unique and fill important gaps in the literature.

Processes by which Guidelines are created have received systematic study and description.1

Five general attributes to guide the development and evaluation of practice parameters/guidelines have been recommended.   These are:

  1. Practice parameters/Guidelines should be developed by or in conjunction with physician organizations,
  2. Practice parameters/Guidelines should explicitly describe the methodology and process used in their development,
  3. Practice parameters/Guidelines should assist practitioner and patient decisions about appropriate health care for specific clinical circumstances,
  4. Practice parameters/Guidelines should be based on current professional knowledge and reviewed and revised at regular intervals, and
  5. Practice parameters/Guidelines should be widely disseminated.

XIV.B.  25 Standards for a Practice Guideline

The format and content of this Guideline are based in large measure on the principles and procedures suggested by Shaneyfelt et al.138  Modifications to the 25 standards appear in italics.

Development and Format
1. Purpose of guideline is specified.
2. Rationale and importance of the guideline are explained.
3. The participants in the guideline development process and their areas of expertise are specified.
4. Targeted health problem or technology is clearly defined.
5. Targeted patient population is specified.
6. Intended audience or users of the guideline are specified.
7. The principal preventive, interpretive, or therapeutic options available to clinicians, patients and cytologists are specified.
8. The health outcomes are specified.
9. The method by which the guideline underwent external review is specified.
10. An expiration date or date of scheduled review is specified.
 
Evidence Identification and Summary
11. Method of identifying scientific evidence is specified.
12. Time period from which evidence is reviewed is specified.
13. The evidence used is identified by citation and referenced.
14. Method of data extraction is specified.
15. Method for grading or classifying the scientific evidence is specified.
16. Formal methods of combining evidence or expert opinion are used and described.
17. Benefits and harms of specific health practices are specified.
18. Benefits and harms are quantified.
19. The effect on health care costs from specific health and laboratory practices are specified.
20. Costs are quantified.
 
Formulation of Recommendations
21. The role of value judgments used by the guideline developers in making recommendations is discussed.
22. The role of patient and cytologist preferences is discussed.
23. Recommendations are specific and apply to the stated goals of the guideline.
24. Recommendations are graded according to the strength of the evidence.
25. Flexibility in the recommendations is specified.

XIV.C.  PROCEDURES USED IN THE CREATION OF THE ASC CERVICAL CYTOLOGY PRACTICE GUIDELINE

In 1997 the ASC President charged two committees, the Cytopathology Practice Committee and the Quality Assurance Committee to create a Practice Guideline for cervical cytology.  The charge was to address technical, interpretive, information management, quality control and quality assurance, documentation, and medico-legal aspects of cervical cytology.  These Committees were composed of experienced and expert cytologists who also enlisted the expertise and knowledge of others to produce a complete and helpful resource.  The composition of the group reflected a broad cross section of cytology practices, including cytopathologists or cytotechnologists from small, medium and large hospital laboratories, and representatives from large-scale commercial laboratories.

The first work product was an outline.  Next, expanded drafts were created based on the outline.  Relevant references were identified and ranked by committee members according to their scientific merit.  Content was refined and drafts were circulated for editing.  Committee discussions originally centered around the document’s content then on purpose and form. Committee members relied at least in part on eight categories of guideline attributes:

  1. Validity,
  2. Reliability/Reproducibility,
  3. Clinical Applicability,
  4. Clinical Flexibility,
  5. Clarity,
  6. Multidisciplinary Process,
  7. Scheduled Review, and
  8. Documentation.1

Contributors to the development of this Guideline:

American Society of Cytopathology Executive Board
Seena Aisner, M.D.p
R. Marshall Austin, M.D.cp
John Bishop, M.D.
Bruce Buschmann, C.T. (ASCP)cq
Cherise Cortese, MDc
Richard M. DeMay, M.D.c
Leslie Dodd, M.D.q
Gary Gill, C.T. (ASCP), CFIAC
Shirley Greening, J.D., C.T. (ASCP)cp
Heinz Grohs, M.D.
Paul A. Krieger, M.D (Former Chair, Cytopathology Practice Committee)p
Dina R. Mody, M.D. (Chair, Former Quality Assurance Committee)q
Ann T. Moriarty, M.D.cq
Marianne U. Prey, M.D. (Chair, Cytopathology Practice Committee)c
Andrew Renshaw, M.D.
Martha Sack, M.D.q 
Norma Sharamitaro, C.T. (ASCP)c 
Mary Sidawy, M.D.p 
Theresa Somrak, JD, C.T. (ASCP)p 
Suzanne Van Lancker, C.T. (ASCP)q 
Alice Wright, C.T.p 
Suzanne Zachariah, M.S., C.T. (ASCP)q 

Current Cytopathology Practice Committee
Previous Cytopathology Practice Committee
Previous Quality Assurance Committee

XIV.E.  NATIONAL REGULATORY REQUIREMENTS AND PROFESSIONAL ORGANIZATION CRITERIA

XIV.E.1.  Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88)

CLIA ’88 considers cytology as high complexity testing.  All mandates that apply to high complexity labs apply to the cytology laboratory.  These are listed in the Federal Register.139  For additional information refer to www.hcfa.gov/medicaid/clia/cliahome.htm.

 

XIV.E.2.  Laboratory Inspection and Accreditation

Laboratories are inspected by the state or by agencies that have received deemed status by the Health Care Financing Administration (HCFA) of the federal government.  The two national agencies with deemed status are the Laboratory Accreditation Program (LAP) of the College of American Pathologists (CAP) and the Joint Commission on Accreditation of Hospitals Organization (JCAHO).  Organizations with deemed status have inspection requirements that are equivalent to or more stringent than Federal regulations. For additional information refer to www.cap.org/HTML/ftpdirectory/checklistftp.html and www.jcaho.org/trkhco_frm.html

XIV.E.3.  National Committee for Clinical Laboratory Standards (NCCLS)

NCCLS is a non-profit, educational organization that provides a communication forum for the development, promotion and use of national and international standards.  NCCLS documents describe laboratory procedures, bench and reference methods and evaluation protocols applicable within all the major laboratory disciplines.  It has published “Papanicolaou Technique: Approved Guideline-Second Edition,” that describes safety issues and procedures for cervicovaginal specimen collection, preparation, fixation, staining and storage of slides.  For additional information refer to www.nccls.org.


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Bibliography/References

Institute of Medicine (IOM), Committee on Clinical Practice Guideline. Guideline for Clinical Practice – From Development to Use. Field MJ, Lohr KN, (eds.). Washington, D.C: National Academy Press; 1992, p 8.

138  Shaneyfelt  TM, Mayo-Smith MF, Rothwangl J. Are guidelines following guidelines? The methodological quality of clinical practice guidelines in the peer reviewed medical literature. JAMA 1999; 281:1900-1905.

139  Clinical Laboratory Improvement Amendments of 1988; Final Rule. Federal Register. Feb. 28, 1992; 57: 7001-7243.