1.0        TITLE:
    Cytology Laboratory Equipment Maintenance
     
    2.0        PRINCIPLE:  
    Maintenance is performed on all equipment on a regular basis. Maintenance sheets are available to document orders, and to ensure
    that equipment is kept in proper working order at all times, and working at full capacity. Work orders entered into the computer
    when equipment is not working properly, and service by biomedical engineering in a timely manner is documented.
           Salihya Company is the one responsible for the preventive maintenance. The CP numbers of
           Mr. Essam and Hamdi Al-Sayed Zahrawi are 0506972960 and 0560828129 respectively.
     
    3.0        POLICY:
    3.1  All equipment in Cytology Laboratory must be in good running condition all the time.
    3.2  Instrument maintenance, service and repair records are promptly available to, and usable by, the technical staff operating the
    equipment.
    3.3  Reagents, Procedures and equipments must be monitored on regular intervals and on receipt of new reagents and equipment.
    Procedures should be revised whenever needed and documented.
     
    4.0        PROCEDURE FOR EQUIPMENT MAINTENANCE
    Reagents, Instrumentation  
    Centrifuge.
    Vortex.
    PrepStain slide processor (SurePath) for LBC –Liquid Based Preparation  
    Chemical Safety Cabinet
    Proof Fire Safety Cabinet     
    Microscopes                   
           Fume Hood                 
    Automated stainer                         
    Refrigerator                                        
    Printers
 open in browser PRO version  Are you a developer? Try out the HTML to PDF API                                                  pdfcrowd.com
    Computers
    Biological Safety Cabinet
     
    Step-by-step Description: 
    There is maintenance sheets located in the file cabinet in the Cytology preparatory laboratory for each piece of
    equipment. These sheets are specific for each individual piece.
    1.         Microscopes, vortex, and centrifuge are maintained daily, or as used.
    2.         All instruments including PrepStain processor have specific and detailed maintenance sheets, including monthly, weekly and daily
    requirements if applicable.
                            These are maintained daily as used by the technicians and interns.
            3.         All maintenance sheets are followed, according to the manufacturer's requirements, and according to safety regulations.
    4.         Electrical and safety checks are made by biomedical engineering service, and equipment is given a sticker to note the date of
    inspection.
    5.         Countertops and sinks are disinfected with Hosbicide spray, 5% Clorox solution that is made daily.
    6.         Refrigerator temperature and cleaning is regularly done according to the schedule.
     
    5.0        PROCEDURE DAILY MEASURING OF THE REFRIGERATOR TEMPERATURES:
    Refrigerators needed to keep chemicals, specimens etc. should be set at a certain temperature, preferably between 2-8 C. By
    checking the temperature on a regular basis, you maintain the required temperature and notice a breakdown of the equipment almost
    immediately.
        The temperature of the refrigerator is measured daily with a permanently placed thermometer.  The temperatures are daily
        documented in a chart (Lab. Med.-Form 15A) and reviewed monthly by the Supervisor; assessed and filed.
    ·         Any big temperature increase/decrease is being reported immediately to a senior/section head.
    ·         The supervisor initiate corrective action and if necessary contact Biomed.
     
    6.0        PREPSTAIN (LBC) PROCESSOR VALIDATION AND MAINTENANCE INSTRUCTIONS
    The PrepStain System (formerly the AutoCyte PREP System) is a liquid-based thin layer cell preparation process. The PrepStain
    System produces the SurePath slides that are intended as replacements for conventional gynecologic Pap smears. SurePath slides are
 open in browser PRO version  Are you a developer? Try out the HTML to PDF API                                                  pdfcrowd.com
    intended for use in the screening and detection of cervical cancer, pre-cancerous lesions, atypical cells and other cytologic categories
    as defined by The Bethesda System for Reporting Cervical/Vaginal Cytologic Diagnoses.
     
    6.1   Before implementing use of new gynecologic liquid- based method and instrument automated preparations, the laboratory must
    validate and document the functioning of the instrument in its own specific laboratory environment. The laboratory must document the
    specific validation procedure used.
    6.2  Operating instructions for maintenance must be followed to produce an optimal result.
     
    6.3  Procedure for Validation:
    6.3.1        Internal validation: At least 20 random samples should be evaluated for cellular quality, staining … by at least two
    pathologists.
    SEE LBC validation file.
    6.3.2        External Validation (Manufacturer’s Validation)-Split Sample
    -TriPath Imaging conducted a prospective, masked, split sample, matched- pair clinical investigation at multiple sites to compare the
    diagnostic results of SurePath slides produced by the PrepStain System with conventionally prepared Pap smears.
    -Following the recommendations of the FDA “Points to Consider” document for Cervical Cytology Devices, each conventional Pap
    smear was prepared first, and then the residual specimen remaining on the broom-type sampling device was deposited into a
    SurePath Fluid Collection Vial.
    -Each preserved cell suspension was processed according to the PrepStain protocol.
    The resulting SurePath slide and the matching conventional Pap smear slide were screened manually and diagnosed independently
    using diagnostic categories consistent the Bethesda System. At each site, a pathologist evaluated all abnormal cases. The study used
    an independent reference pathologist at a designated referral sites who reviewed all abnormal and discrepant cases, repair cases and
    5% of the abnormal cases form all sites in a masked fashion to provide diagnostic “truth” for each case.
    -To compare the sensitivities of the SurePath and conventionally prepared Pap smear slides when read manually, the level of the
    abnormality for the case was determined by the reference pathologist and compared to the diagnoses made by the study sites.
    In the statistical test, discrepant results for the two preparation methods were compared. Refer to TriPath Imaging Inc.,PrepStain
    Product Insert; page 2-6 for the results of the study.                                                                                               
     
    6.4  Procedure for Maintenance:
    Materials Required
 open in browser PRO version  Are you a developer? Try out the HTML to PDF API                                                  pdfcrowd.com
    Materials Required
    Shallow (approximately 100 ml.) container beaker or equivalent
    Deionized (DI) water, DI water clean-up container
    Alcohol, alcohol clean up container
    Lint free cloth or tissue paper
    A gallon container with cap
    Cleaning solution
    -          Add 180 ml. of bleach (chlorox) to a 1 gallon container
    -          Fill container to 1 gallon (3,600 ml.) with distilled water
    -          Cap and invert gently to mix.
    Step by step
          1.  Daily preventive maintenance (the day of used)
       -    Perform System clean up
    2. Weekly preventive maintenance
                  -     Flush stain and vacuum lines
    3.  Monthly preventive maintenance
                   -     Replace vacuum pump felt silencer. This should be done by the supplier.
      -     Clean all water bottles.
     
    NOTE: Steps for the preventive maintenance…. Please refer to PrepStain Operator’s Manual (Chapter 6).
    For Trouble shooting…Please refer to PrepStain Operator’s Manual (Chapter 7)
    7.0        Responsibility:
    Applies to all Cytology laboratory staff, Biomed Department and Salihya Company.
     
    8.0        Attachment/Form:
    Laboratory Equipment Maintenance Forms
     
    9.0        Distribution:
    -  LMD Administration
    -  Biomed Department
 open in browser PRO version  Are you a developer? Try out the HTML to PDF API                                                  pdfcrowd.com