CYTOLOGY>Examination proceduresThe laboratory shall have and must follow a written procedure manual for cytology.737. EDoes the cytology laboratory have a written procedure manual that complies with the procedure manualrequirements for <strong>COLA</strong> accreditation?The laboratory shall be in compliance with all criteria within this subsection as well as <strong>COLA</strong> general criteriafor Procedure <strong>Manual</strong> (APM 1 - 19). The procedure manual must be accessible to individuals performing thepreparation of specimen or examination of specimen.The laboratory shall have staining procedures appropriate for cytology specimens.738. EAre all gynecologic cytology slides stained with Papanicolaou or modified Papanicolaou method?The Papanicolaou stain is a polychrome method that enhances differences in cellular morphology. A nuclearstain, hematoxylin, and two cytoplasmic counterstains, OG-6 and EA are used. The Papanicolaou stain provideswell-defined nuclear detail, stains cytoplasm of various cell types different colors and renders the cytoplasmtransparent. A variety of formulations for the stain exist. The actual staining technique may varyamong labs depending on the type of stains used and the lab’s modification of the staining method.Modifications of the staining procedure must include the four main steps of the standard Papanicolaoustaining method: fixation, nuclear staining, cytoplasmic staining and clearing. The procedure manual mustcontain staining times, rinsing times, and number of dips currently in use.Laboratories may use staining procedures, other than the Papanicolaou method, for staining non-gynecologicspecimens.Written staining procedures for gynecologic specimens must reflect:• Stains used (i.e., Harris, Gill or other type of hematoxylin, OG-6, modified OG-6, EA36, EA50, EA65, modifiedEA) or the identity of a combination counterstain;• Solutions used (water, alcohol, clearing reagent, acid and bluing agent);• Concentration of each solution used (i.e., percentage of alcohol, acid, ammonium hydroxide or lithium carbonatesolution);• Length of time or number of dips slides are placed in each stain or solution;• The staining dishes must be labeled to reflect content (not just lids); and• Procedure for placing coverslips on slides.739. EDo the staining procedures include steps to prevent cross-contamination between gynecologic and non-gynecologicspecimens during staining?The laboratory must develop policies and procedures for the prevention of crosscontamination betweengynecologic and non-gynecologic specimens. The majority of gynecologic specimens are fixed prior to transportationto the laboratory. Commonly used methods include separate staining dishes for various specimens(i.e., gynecologic specimens, CSF, sputa, other body fluids), or separate staining times (i.e., gynecologicspecimens in the morning and non-gynecologic specimens in the afternoon), with the staining disheswashed in between, or a separatory funnel setup.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .FOR MORE INFORMATION CONTACT <strong>COLA</strong> PHONE 800.981.9883 | FAX 410.381.8611 | ON-LINE www.cola.org85
CYTOLOGY740. EAre non-gynecologic specimens, with a high potential for cross-contamination, stained separately from othernon-gynecologic specimens and are the staining solutions filtered or changed after the staining?A monochrome stain such as toluidine blue may be used to determine the cellularity of non-gynecologicspecimens. Once the specimen has been concentrated, a drop of specimen can be stained and the cellularityevaluated microscopically. Highly cellular specimens have a high potential for cross-contamination. Oneoption would be for the laboratory to stain these specimens after routine staining has been completed.741. EAre the stained slides reviewed daily for the expected staining characteristics?The cytology laboratory must ensure that gynecologic and non-gynecologic stains have been tested toensure predictable staining characteristics on a daily basis.742. EDoes the cytology laboratory document all control procedures on a daily basis?The cytology laboratory must document all control procedures including slide staining reactions, expirationdates of stocks, reagents, working stains and solutions made in the laboratory. Measurements, reactions,and/or observations that demonstrate that controls were tested prior to use must be recorded.The laboratory shall have written workload policies for individuals (including cytotechnologists and pathologists)who perform primary screening.743. EHas laboratory management established cytology workload limits in compliance with local, regional andnational regulations?> NOTE: The following criteria for workload limits are CLIA requirements.744. EAre the workload limits for each individual who performs primary screening established by the TechnicalSupervisor?Are the workload limits based on each screener’s documented performance using:745. E10% of the screener’s cases reported as negative?746. EA comparison with the technical supervisor’s confirmation of patient smears for abnormalities found at 783-792?86. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .FOR MORE INFORMATION CONTACT <strong>COLA</strong> PHONE 800.981.9883 | FAX 410.381.8611 | ON-LINE www.cola.org