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U.S. Department of Health and Human Services

Food

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M-I-05-3: APPENDIX N BULK MILK TANKER SCREENING TEST FORM

 

June 2, 2005
 

Milk Safety References
National Conference on Interstate Milk Shipments (NCIMS)

[Unless otherwise stated all tolerances are ±5%]
 

  1. __________ Work Area
    1. __________ Ample working space and utilities
    2. __________ Clean well ventilated, test kit used in temperature range specified by manufacturer, reasonably free from dust and drafts
    3. __________ Adequate lighting, [NCIMS CERTIFIED LABORATORIES and CERTIFIED INDUSTRY SUPERVISORS, > 50 foot- candles at working surface (pref 100)]
  2. __________ Storage Space
    1. __________ Cabinets, drawers, and shelves adequate
    2. __________ Areas neat, clean and orderly
       
  3. __________ Thermometers for Use with Test Kits and Laboratory Equipment
    1. __________ Thermometer traceable to NIST Certified thermometer
      1. __________ Traceable thermometer checked at ice point annually
    2. __________ Range of thermometers appropriate for designated use
    3. __________ Graduation interval not greater than 1.0C [NCIMS CERTIFIED LABORATORIES and CERTIFIED INDUSTRY SUPERVISORS, 0.5C]
    4. __________ Accuracy of test thermometers checked against traceable thermometer annually (including electronic thermometers)
      1. __________ Accurate to ±1C
      2. __________ Results recorded and thermometers tagged with date, identification, temperature checked and correction (±0.0 if none)
      3. Thermometers calibrated on-site
      4. __________ Thermometers calibrated at another location
        1. __________ Location calibrated: ___________________
        2. __________ Calibrations current and acceptable
        3. __________ Copy of calibration record on-site
    5. __________ Records maintained
    6. __________ Dial thermometers not permitted
  4. __________ Refrigeration
    1. __________ Size adequate for workload
    2. __________ Maintains samples at 0-4.4C
    3. __________ Reagents stored as per manufacturer instructions
    4. __________ Not used to store food or drink for consumption
    5. __________ NCIMS CERTIFIED LABORATORIES and CERTIFIED INDUSTRY SUPERVISORS, dedicated for milk work only, NO PATHOGENS STORED
  5. __________ Freezer
    1. __________ Size adequate for workload
    2. __________ Maintains -15C or below
    3. __________ Not used to store food or drink for consumption
    4. __________ Record temperature daily from thermometer with bulb submerged in anti-freeze liquid, [NCIMS CERTIFIED LABORATORIES and CERTIFIED INDUSTRY SUPERVISORS, AM and PM]n
    5. __________ Record temperature daily from 2 thermometers with bulbs submerged in liquid, placed on upper and lower shelves of use [NCIMS CERTIFIED LABORATORIES and CERTIFIED INDUSTRY SUPERVISORS, AM and PM]
    6. __________ NCIMS CERTIFIED LABORATORIES and CERTIFIED INDUSTRY SUPERVISORS, dedicated for milk work only, NO PATHOGENS STORED
  6. __________ Balance, electronic (if necessary)
    1. __________ Weight capability appropriate for intended use
    2. __________ Accurate to 0.01g for preparations of positive controls
    3. __________ Appropriate sensitivity for calibration of pipetting devices within a tolerance of ±5% (0.001g sensitivity appropriate in most instances)
    4. __________ Checked monthly with Class S or S1, or equivalent ASTM 1, 2, or 3 weights (Appendix N drug testing only laboratories may check every 6 months)
    5. __________ Checked annually by a qualified service representative
    6. __________ Records maintained
  7. __________ Pipettors, calibrated, fixed volume or electronic only [Required for NCIMS Certified Laboratories and Certified Industry Supervisors]
    1. __________ Calibrate with ten (10) consecutive measurements, by weight or by volume (> 1.0 ml using a class A graduated cylinder), using separate tip for each measurement, every 6 months
    2. __________ Average of all 10 measurements must be ±5% of specified delivery volume, records maintained
    3. __________ Or, calibrate with 10 consecutive readings once every 6 months using the Artel PCS Pipette Calibration System, average of all 10 readings Must be ±5% of specified delivery volume, records/ printouts maintained
      1. __________ Instrument, printer connected by manufacturer supplied cable or instrument connected to computer via serial cable
      2. __________ Instrument and printer (if applicable) connected to 120v/60Hz power
      3. __________ Reagent kits and Instrument Calibrator kits stored at room temperature
        1. __________ Lot # __________ Exp. Date __________
      4. __________ Reagent Blanks and Sample Solutions are the same lot
      5. __________ Certificates of Calibration for Reagent Kit and Instrument Calibrator kit maintained in records
      6. __________ Instrument Validation Guide available
      7. __________ PCS Pipette Calibration System Procedure, follow manufacturer's Procedure Guide and instrument prompts
        1. __________ Uncover and insert Blank into the instrument
        2. __________ Determine which volumes are to be calibrated
        3. __________ Select the correct Sample Solution and aliquot sufficient amount into working vessel provided
        4. __________ Using the Pipettor to be verified, aspirate the Sample Solution from the working vessel and deliver it into the Blank seated in the instrument
        5. __________ When appropriate number of measurements are collected, press 'End of Run' button
        6. __________ Record results and file Pipette Calibration Certificate (printout)
      8. __________ PCS Pipette Calibration System Procedure, follow manufacturer's Procedure Guide and instrument prompts
        1. __________ Following manufacturer's Procedure Guide and instrument prompts, perform an instrument calibration every 30 days or just prior to use .
        2. __________ Record results and file Calibration Certificate (printout)
      9. __________ PCS Calibration System Validation, upon receipt, validate the instrument by following the manufacturer's protocol
    4. __________ Pipettors etched with identification (imprinted serial numbers acceptable) and tagged with date calibrated
    5. __________ Appropriate tips for pipettor(s) used
    6. __________ Pipetting devices calibrated on-site
    7. __________ Pipetting devices calibrated at another location
      1. __________ Location calibrated: ___________________
      2. __________ Calibrations current and acceptable
      3. __________ Copy of calibration record on-site
    8. __________ Records maintained
  8. __________Deionized Water or Equivalent, or as specified by manufacturer 

    SAMPLES
  9. __________ Sample Requirements
    1. __________ Prevent contamination with disinfectants from hands or other sources
    2. __________ Ascertain temperature of bulk milk tanker
    3. __________ If sample will not be tested without delay then a temperature control (TC) sample must be taken, transported and maintained with the tanker sample until it is tested
    4. __________ Secure a representative sample for drug residue testing and transport to testing location promptly, preferably on ice to maintain temperature
    5. __________ Tanker samples tested promptly upon arriving at the testing location, measure TC when provided
      1. __________ Temperature of bulk milk tanker may be used for temperature as received and tested if sample testing begins without delay
      2. __________ If test kit indicates a positive result, confirmation completed (when necessary) within 72 hours of initial collection
    6. __________ Record time, date and temperature of samples as received and tested
    7. __________ Determine sample temperature by inserting pre-cooled thermometer (pre-cooling of electronic/digital thermometer probes is not necessary) into temperature control (TC), if no TC, aliquot samples for testing and measure temperature using one of the producer samples
    8. __________ Do not accept producer samples (about ¾ full) that are over filled
    9. __________ If raw milk exceeds 4.4C on receipt do not test (samples may be received at 7C if time of receipt is £ 3 hours from collection and arrival temperature is equal to or less than temperature of collection)
    PERFORMANCE TESTING
  10. __________ Performance Testing
    1. __________ Run a positive and negative control before use on each new lot of kits, must give appropriate results, records maintained
    2. __________ Run a negative and positive control DAILY (on days testing), at each test site, must give appropriate results, if not, re-run controls (may be necessary to prepare new controls), if problem persists discontinue testing, contact State regulatory and seek technical assistance, records maintained
    3. __________ If available from manufacturer, check instrument calibration with check devices DAILY (on days testing), must give appropriate results, if not, discontinue testing and seek technical assistance, records maintained
    4. __________ If more than one analyst performs analysis, have different analyst run performance check on rotational basis
    FOLLOW-UP ON TEST KIT POSITIVE RESULTS [Must comply with M-a-86, current revision]
  11. __________ Verification of Initial Positive Tanker Samples
    1. __________ The SAME sample is re-tested by the SAME analyst using the SAME test kit in DUPLICATE along with a positive and negative control
    2. __________ Positive and negative controls give the appropriate result(s)
    3. __________ If one or both duplicates is positive the tanker sample is PRESUMPTIVE POSITIVE and the sample is referred to the designated certified laboratory or Certified Industry Supervisor (CIS) as specified by the facility's protocol as per Agreement with the State Regulatory Agency
    4. __________ Presumptive positive samples must be forwarded to a certified laboratory, not tested by screening facility; producer samples must be tested by a certified laboratory
    5. __________ If both duplicates are negative milk may be received and processed, record and report as NOT FOUND
    6. __________ If positive and/or negative controls do not give appropriate results, re-run controls and samples. If problem persists seek technical assistance
    7. __________ Complete Positive report form and maintain records of all analyses
      1. __________ For Presumptive Positive samples maintain a copy of the positive report form and forward the original to the certified laboratory or CIS
  12. __________Confirmation of Presumptive Positive Tanker Samples ________ [Only in a certified laboratory or by a CIS (refer to M-a-85 current revision for listing of test kits to assure equivalence)]
    1. __________ The SAME sample [or if it can be demonstrated that the original sample is suspect, a re-sample may be used at the State's discretion] is tested in DUPLICATE along with a positive and negative control
    2. __________ Positive and negative controls give the appropriate result(s)
    3. __________ If one or both duplicates is positive the tanker sample is CONFIRMED POSITIVE, milk may not be processed, contact State Regulatory
    4. __________ Producer trace back performed on all producer samples from the load, see item 13
    5. __________ If both duplicates are negative milk may be received and processed, record and report as NOT FOUND, producer trace back is not performed
    6. __________ If positive and/or negative control do not give appropriate results, re-run controls and samples, if problem persists seek technical assistance
    7. __________ Complete Positive report form and maintain records of all analyses
      1. __________ For Confirmed Positive samples maintain a copy of the positive report form and forward the original to the State Regulatory Agency
  13. __________Trace back of Producers on a Confirmed Positive Tanker ________ [Only performed in a certified laboratory or by a CIS (refer to M-a-85 current revision for listing of test kits to assure equivalence), this process is also to be followed when doing PMO Section 6 analyses for drugs]
    1. __________ Perform an initial single test on each producer sample along with a single positive and negative control for the series
    2. __________ Positive and negative controls give the appropriate result(s)
    3. __________ If any producer sample is positive the sample is SUSPECT and that/those sample(s) must be re-tested
    4. __________ The SAME sample is re-tested by the SAME analyst using the SAME test in DUPLICATE along with a positive and negative control
    5. __________ Positive and negative controls give the appropriate result(s)
    6. __________ If one or both duplicates is positive the producer sample(s) is (are) POSITIVE
    7. __________ If both duplicates are negative record and report the appropriate producer sample(s) NOT FOUND
    8. __________ If positive and/or negative control do not give appropriate results, re-run controls and samples, if problem persists seek technical assistance
    9. __________ Complete Positive report form and maintain records of all analysis
      1. __________ For Confirmed Producer Positive samples maintain a copy of the positive report form and forward the original to the State Regulatory Agency
    REPORTING AND RECORDS
  14. __________ Reporting and Records
    1. __________ Report as Positive (+) for beta-lactam, specific drug or inhibitor (when a non-specific microbial inhibitor test used without beta-lactamase) when demonstrated
    2. __________ Report as Not Found (NF) when demonstrated
    3. __________ Record test performed, interpretation of unknowns (samples) and controls
    4. __________ Records, including all printouts, maintained for 2 years
    MISCELLANEOUS
  15. __________ Miscellaneous
    1. __________ Material safety data sheets (MSDS) on file
    2. __________ Current, applicable survey forms available in laboratory
    3. __________Positive Report Forms available with instructions
    4. __________ Personnel adequately trained
    5. __________ Required split/check sample participation