#06-5558 Accrd Manual V7 - COLA

More documents

Recommendations

Info

CYTOLOGY>721. EAre there procedures to process slides which can not be successfully screened by instruments?Instruments used to screen slides may produce flags to alert personnel that a problem has been detectedwith the slide itself, such as wrong type or size coverslip or a broken slide. Flags may also be triggered byabnormal results. Such circumstances require further action and review by laboratory staff.Slides which can not be successfully screened by instruments must be processed in accordance with instrumentmanufacturer’s instructions, as applicable, and laboratory defined procedures. If this procedureinvolves reprocessing on the instrument, the presumed reason for the initial failure should be documentedand confirmed by a rapid manual review of the slide. In cases where the slide is examined and reported manually,a record of the presumed reason for the instrument screening failure should also be documented.CLIA workload limits relative to automated or semi-automated screening devices can be found at 744-754.722. EAre corrective actions taken and documented when tolerance limits for the instrument are exceeded and whenslides cannot be successfully screened?It is important that the laboratory review and understand the limitations of an instrument used in the screeningprocess. Tolerance limits are defined by the manufacturer as the operating or performance limitations forthe technology, as approved by the FDA.723. EDoes the cytology laboratory meet the general laboratory equipment and analytic systems requirements forCOLA accreditation?The laboratory must have written procedures, verify performance specifications; and perform maintenanceand function checks, calibration and calibration verification procedures, and control processes as appropriatefor its automated and semi-automated instruments.Specimen Collection and ManagementThe laboratory shall have and must follow policies and procedures for the collection and handling of specimens.724. EAre the preferred methods of slide preparation described?The cytology laboratory should provide its customers with specific information on the preferred methods forthe submission of gynecologic cytology material such as submission in liquid media or on glass slides andshould address methods of fixation for material on glass slides. Methods for submission of non-gynecologicfluid samples, such as possible malignant effusions, should also be addressed.725. EIs the laboratory’s accepted method of slide labeling described?Cytology slides must be labeled with the patient’s name and with an additional form of identification suchas patient number or date of birth.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .FOR MORE INFORMATION CONTACT COLA PHONE 800.981.9883 | FAX 410.381.8611 | ON-LINE www.cola.org83
CYTOLOGY726. EAre the proper methods for collection, handling and transportation of slides or samples described?The laboratory is responsible for developing written policy to define acceptable methods for handling andtransportation of cytology specimens.Are there policies and criteria for:727. EUnacceptable specimens?728. ERejection of specimens?729. ENotification of requesting physician when samples are unacceptable or are rejected?The laboratory examination request form shall contain sufficient information to identify the patient and therequestor, and shall provide pertinent clinical data.In addition to the general requirements for requisition forms, does the laboratory’s request form for PAPsmears contain:730. ELast menstrual period?731. EAge or date of birth?732. ESex of the patient?733. EPrior abnormal cytology or biopsies?734. EPertinent clinical information?This may include relevant medications the patient may be taking.735. EPregnancy or menopause?736. EDoes the cytology laboratory meet the general specimen requisition, collection and management requirementsfor COLA accreditation?The laboratory shall be in compliance with all criteria within this subsection as well as COLA general criteriafor Specimen Collection (PRE 10 – PRE 19) and Requisitions (PRE 1 - PRE 9).84. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .FOR MORE INFORMATION CONTACT COLA PHONE 800.981.9883 | FAX 410.381.8611 | ON-LINE www.cola.org
Page 1 and 2:
COLA LABORATORYACCREDITATION CRITER
Page 3 and 4:
CRITERIA FOR QUALITY LABORATORY PER
Page 5 and 6:
Page 7 and 8:
Page 9 and 10:
Page 11 and 12:
Page 13 and 14:
Page 15 and 16:
Page 17 and 18:
Page 19 and 20:
Page 21 and 22:
Page 23 and 24:
Page 25 and 26:
Page 27 and 28:
Page 29 and 30:
Page 31 and 32:
Page 33 and 34: CRITERIA FOR QUALITY LABORATORY PER
Page 65 and 66: IMMUNOHEMATOLOGY & TRANSFUSION SERV
Page 81 and 82: CYTOLOGY706. EThe cytotechnologists
Page 83: CYTOLOGYLaboratory Safety and Envir
Page 87 and 88: CYTOLOGY740. EAre non-gynecologic s
Page 89 and 90: CYTOLOGYEnsuring Quality of Examina
Page 91 and 92: CYTOLOGYAre there documented evalua
Page 93 and 94: CYTOLOGY795. EAre unsatisfactory sp
Page 95 and 96: CYTOLOGY94. . . . . . . . . . . . .
Page 97 and 98: HISTOPATHOLOGY816. EResponsibilitie
Page 99 and 100: HISTOPATHOLOGY830. EHIV and AIDS831
Page 101 and 102: HISTOPATHOLOGYThe laboratory shall
Page 103 and 104: HISTOPATHOLOGY859. EAre the stained
Page 105 and 106: HISTOPATHOLOGY873. EAre unsatisfact
show all

#06-5558 Accrd Manual V7 - COLA

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?