#06-5558 Accrd Manual V7 - COLA

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CYTOLOGY>747. EThe individual’s capabilities as a screener?Capabilities are evaluated by reviewing an individual’s education, experience and prior workload limits.748. EReevaluated every 6 months?Do the workload limits include:749. EExamination of a maximum of 100 slides by an individual in any 24 hr. period including all laboratory sites?750. EA single patient specimen is counted as a “slide”?751. EThe 100 slides must be examined in no less than 8 hours?752. EIf working less than 8 hours, the number of slides is reduced by the following formula:number of hours examining slides x 100 divided by 8?1. Non-gynecologic slides prepared using automated or semi-automated or other liquidbased slide preparationtechniques and covering less than 50% of a slide surface are counted as ? slide. Maximum workloadlimits for non-gynecologic specimens is 100 slides for traditional smear technique; 200 slides for automated,semi-automated, or liquid-based techniques. Combinations of the above should be pro-rated.2. Automated or semi-automated screening devices that require less than 100% of the slide be reviewed mayhave a higher workload limit than 100 slides. It is cautioned, however, that such devices must be operatedaccording to the manufacturer’s directions. Any deviation from these directions could be considered amodification of the FDA approved procedure and require validation.3. Histopathology slides and previously examined cytology slides are not counted in the work-load limits oftechnical supervisors doing primary screening.753. EDoes the cytology laboratory maintain records of the total number of slides examined and hours worked in each24 hours at all laboratory sites, by each individual who performs primary screening?754. EAre there records of the work-load limits for each individual who performs primary screening?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .FOR MORE INFORMATION CONTACT COLA PHONE 800.981.9883 | FAX 410.381.8611 | ON-LINE www.cola.org87
CYTOLOGYEnsuring Quality of Examination ProceduresThe laboratory shall establish and follow written policies and procedures for a quality assessment plan todetect errors and to ensure the accuracy of cytological examinations.755. EDoes the laboratory has and follows written policies and procedures to detect errors and ensure accuracy ofcytology examinations?Policies and procedures should ensure that all cytology specimens are positively identified, that cytologyspecimens and slides maintain identification, that all required reviews are performed and that request formsare reviewed for consistency of identification and patient history during microscopic examination.Prior to the release of cytology reports, are there policies and procedures to:756. EReview ten percent of the slides reported by each cytology general supervisor or cytotechnologist as negativefor reactive or reparative changes, or reported as negative for epithelial cell abnormalities and other malignantneoplasms?Epithelial cell abnormalities and other malignant neoplasms are defined at 783-792. One-person cytologylaboratories, consisting of a technical supervisor or a laboratory which employs pathologists qualified astechnical supervisors, are not required to perform the ten percent review, but must have a program to detecterrors, which at a minimum, must include cytologic/histologic correlations and retrospective reviews of negativecases.757. ERandomly select cases for review from negatives and from groups of high risk patients based on availablepatient information?758. EHave the review performed by:• A technical supervisor, or• A cytology general supervisor, or• A cytotechnologist?CLIA certified laboratories must document which individuals are qualified to conduct the ten percent reviewand use personnel qualified to meet CLIA requirements:(1) a technical supervisor qualified under §493.1449 (b) or (k) Refer to the COLA Personnel RequirementsTable (Technical Supervisor).(2) a cytology general supervisor qualified under §493.1469 Refer to the COLA Personnel RequirementsTable (General Supervisor ).(3) a cytotechnologist qualified under §493.1483 with experience specified at §493.1469(b)(2).] Refer to theCOLA Personnel Requirements Table (Cytotechnologist)759. EAre there policies and procedures to complete all reviews at 756-758 prior to the release of the cytology reportson those cases?Do the cytology quality control procedures include:760. EA comparison of clinical information, when available in the laboratory, with cytology reports?88. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .FOR MORE INFORMATION CONTACT COLA PHONE 800.981.9883 | FAX 410.381.8611 | ON-LINE www.cola.org
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#06-5558 Accrd Manual V7 - COLA

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