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Title: Section 58-1.13 - General requirements for performance of anatomic pathology and cytopathology procedures

Effective Date


58-1.13 General requirements for performance of anatomic pathology and cytopathology procedures.

(a) Facilities.

(1) Laboratory space: (i) work areas must be clean, well-lighted and well-ventilated;

(ii) utilities (water, gas, suction, electricity) must be available, as needed;

(iii) microscopic work area(s), including space and furniture, must be conducive to high-quality performance;

(iv) cytopreparation area(s) must be separate from screening and clerical/secretarial area(s) so that personnel are protected from hazardous fumes and screening areas are free from distractions;

(v) there must be sufficient space for quality control, administrative, and clerical functions; and

(vi) storage of records and specimens must be in compliance with section 58-1.11 (c) and (d) of this Subpart.

(2) Safety precautions:

(i) health and safety precautions comparable to those required in hospital laboratories must be maintained; and

(ii) universal precautions must be enforced when liquid specimens are handled.

(3) Equipment and reference resources:

(i) there must be an adequate number of high-quality, well-maintained binocular microscopes;

(ii) preventive maintenance of microscopes and other equipment must be performed, as recommended by the manufacturer, and documented in a log book; and

(iii) a core reference library should be conveniently available on the laboratory premises.

(4) Support personnel. There should be adequate clerical and laboratory assistant personnel, whose number and type are dependent on the volume of work.

(5) Salaries. The method of compensation should not adversely affect the quality of performance. Cytotechnologists should be free from quota or other pressures that limit appropriate slide review time.

(b) Laboratory operation. (1) Specimens must be identified properly and must be accompanied by a complete test requisition containing minimal clinical information.

(2) A laboratory procedure manual describing the handling and storage of specimens from origination to final report, including collection, preservation, transportation, rescreening protocol and standards for specimens or slides, must be available in the work area.

(3) Solutions and stains:

(i) solutions and stains must be labelled to indicate concentration, expiration date, and storage requirements;

(ii) stains must be monitored daily and written records thereon maintained;

(iii) cross-contamination of specimens must be avoided. Non-gynecologic specimens must be stained separately from gynecologic specimens. Solutions must be filtered or replaced daily; particular care must be taken to filter solutions after processing body fluid specimens; and

(iv) solutions and stains must be kept covered when not in use and stored at appropriate temperatures.

(4) Microscopy:

(i) all microscopy must be performed on the laboratory premises; and

(ii) cytotechnologist functions should include evaluation of the adequacy of specimens, marking of areas appropriate for further review, and rendering of a provisional interpretation.

(c) Special requirements for histopathology, oral pathology and dermatopathology.

(1) All special stains shall be controlled for intended reactivity by the use of positive tissue sections, processed at the same time as the unknown tissue sections. Acid-fast staining procedures must include both a positive and a negative control slide.

(2) All unprocessed remnants of tissue specimens shall be retained in a fixative solution until the portions submitted for microscopy have been examined and diagnosed by a pathologist.

(3) Stained slides and paraffin blocks shall be retained for a minimum of 20 years from the date of examination.

(4) It is recommended that copies of reports be kept in numeric and alphabetic cross files. A numerical accession record satisfies the numeric file recommendation.

(5) Records must indicate the total number of blocks taken and the name of the pathologist who diagnosed the case.

(6) A duplicate copy of all reports, or the capability to reproduce the same, must be retained by the laboratory for 20 years.

(7) All slides referred for consultation must have the patient's name and other identifiers written on the label.


VOLUME A-1 (Title 10)