Electronic Somatic Cell Count Foss Template.pdf

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DATE standard Solution 100K 200K 300K 200K 300K 500K 300K 500K 600K 500K 600K 800K ELECTRONIC SOMATIC CELL Exp DATE record Maintain sample COUNT item run MS Water
ELECTRONIC SOMATIC CELL COUNT
Foss 250/300/360/400
[Unless otherwise stated all tolerances are ±5%]
FORM FDA 2400h-1  (3/01)
Page 1 of 2
LABORATORY
LOCATION
DATE
LAB #
X = DEVIATION
U = UNDETERMINED
O = NOT USED
NA = NOT APPLICABLE
DEPARTMENT OF HEALTH AND HUMAN SERVICES
PUBLIC HEALTH SERVICE
FOOD AND DRUG ADMINISTRATION
MILK LABORATORY EVALUATION FORM
EF
1. Laboratory Requirements (see CP, item 33 & 34) .....................
a. Unpreserved samples may be run up to 72 hours after initial
collection
b. Samples may be run up to 7 days after initial collection if
preserved with 0.02% 2-bromo-2-nitropropane-1, 3-diol
(Bronopol™) or 0.05% potassium dichromate (K2Cr2O7) ...........
c. Comparative test with DMSCC .................................................
1. Performed by each analyst performing ESCC test ...............
2. Test 4 samples (100K - 200K; 300K - 500K; 600K - 800K
and 900K - 1.2M) in triplicate for both DMSCC (three
separate smears each) and ESCC (three separate sub-
samples each, do not read same sample three times) .........
3. Results must be shown to be acceptable prior to official
testing by analyst performing comparison, i.e. analyst is
not certified until found acceptable (co-requisite for
certification) .......................................................................
4. Copy of comparison and results in QC record (or easily
accessible file in laboratory) ...............................................
d. Analysts certified for DMSCC ..................................................
APPARATUS
2. See Cultural Procedures, items 1 - 5 .........................................
3. Automated Electronic Somatic Cell Counters ............................
a. Fossomatic 250 _______ .......................................................
b. Fossomatic 300 _______ .......................................................
c. Fossomatic 360 _______ .......................................................
d. Fossomatic 400 _______ .......................................................
4. Water Bath ..................................................................................
a. Circulating and thermostatically controlled to 37 - 42C ..........
REAGENTS
5. Stock Dye/Buffer Solution ...........................................................
a. Dissolve 2.5g (or number of tablets specified by manufac-
turer) ethidium bromide (C21H20BrN3) in 1 liter MS water
(caution TOXIC, use gloves when handling and do not breath
dust), heat to 40 - 60C and mix to dissolve .............................
b. Add 400g tripotassium citrate monohydrate (C6H5O7K3·H2O),
14.5g citric acid monohydrate (C6H8O7·H2O), and 4 liters MS
water, heat to 40 - 60C and mix to dissolve .............................
c. Add dye and buffer solutions together and mix .......................
d. Add 50 mL neutral detergent, Triton X-100 to mixture and stir
until dissolved .........................................................................
e. Store refrigerated (0 - 4.4C) in airtight, light-proof container
for no longer than 90 days ......................................................
f. Date prep. ____________ Exp. Date ____________ ..............
6. Stock Detergent Solution ............................................................
a. Dissolve 10 mL neutral detergent, Triton X-100 in 1 liter of
MS water and heat 40 - 60C to complete solution ..................
b. Store refrigerated (0 - 4.4C) in airtight, container for no
longer than 30 days .................................................................
c. Date prep. ____________ Exp. Date ____________ ..............
7. Ammonium Hydroxide (NH2OH) Solution, reagent Grade, 25% ....
8. All stock dye/buffer and detergent solutions labeled with
date prepared and expiration date ...........................................
WORKING SOLUTIONS
9. Dye/Buffer Solution .....................................................................
a. Dilute 1 L dye/buffer stock solution (item 5) with 9 L MS
water ........................................................................................
b. Protect from light and use within 21 days ...............................
c. Date prep. ____________ Exp. Date ____________ ..............
10. Rinsing Solution (use within 7 days) ..........................................
a. Add 10 mL of stock neutral detergent stock solution (item 6)
and 25 mL of ammonium hydroxide solution (item 7) and
suspend to 10 L with MS water ...............................................
b. Date prep. ____________ Exp. Date ____________ ..............
11. Optionally, use manufacturer’s reagent kits and instructions
specific for each instrument .......................................................
12. All working dye/buffer and rinsing solutions labeled with date
prepared and expiration date .....................................................
START UP
13. Cell Counter ................................................................................
a. Check that the amount of dye/buffer solution (item 9) and
rinsing (cleaning) solution (item 10) in instrument supply
containers is of sufficient volume for the number of samples
to be run ..................................................................................
b. Solutions not used beyond expiration date(s) .........................
c. Turn on power and cycle at least six times ..............................
d. Perform a zero check before starting any measurements,
within acceptable limits, single counts up to 5 and mean up
to 3 ..........................................................................................
e. IF ANY ABOVE PARAMETERS ARE WRONG, CORRECT
BEFORE PROCEEDING ............................................................
f. Records maintained on all parameters each time instrument is
used .........................................................................................
14. Milk Standards ............................................................................
a. Commercially prepared: ___________________
Lot# ___________  Date Rcd. ____________ .......................
1. Four standards in ranges 100K - 200K, 300K - 500K,
600K -  800K and 900K - 1.2M ..........................................
2. Do DMSCC in triplicate on each standard in set and
average counts, records maintained ....................................
3. DMSCC check performed in rotation by all certified
analysts ...............................................................................
4. Standards used within one week ........................................
LABORATORY
LAB #
LOCATION
DATE
FORM FDA 2400h-1  (3/01)
Page 2 of 2
ELECTRONIC SOMATIC CELL COUNT
Foss 250/300/360/400
[Unless otherwise stated all tolerances are ±5%]
e. Repeatability — a standard in the 300K to 800K range must
have a coefficient of variation (CV) of 5% or less on 10
replicates (Refer to Operating Manual), records maintained ......
f. THESE PARAMETERS MUST BE ACHIEVED BEFORE
PROCEEDING ..........................................................................
16. Testing Samples ..........................................................................
a. Heat samples to 37 - 42C (using a temperature control) and
read within 30 minutes of reaching temperature; samples
must not be reused and must be discarded after use ...............
b. Mix by inverting at least 2x, place in rack and put onto
automatic track, run within 10 minutes of reaching the testing
temperature .............................................................................
17. With continuous operation: .........................................................
a. Run a standard or optionally a control/sample (item 14d) in
the 500K to 800K range hourly, must be within 5% of the
original established instrument average value (optionally,
within 10% of original DMSCC average) .................................
b. Run control 6x .........................................................................
c. Run zero control (as in item 13d) ...........................................
d. Maintain records ......................................................................
18. Routine maintenance ..................................................................
a. Perform as described in operating manual ..............................
b. Maintain records ......................................................................
REPORTS
19. Computing and Reporting Counts ..............................................
a. Count obtained x 1000 is the cell count/mL milk ....................
b. In reporting electronic somatic cell counts (ESCC/mL), record
only first two left hand digits, raising second digit to next
higher number when third digit is 6 or more ..........................
c. Report the two left hand digits (rounded) ...............................
1. If the third digit is 5 the second digit is rounded by the
following rule .....................................................................
a. When the second digit is odd round up, raise the second
digit by 1 (odd up, 235 = 240) .......................................
b. When the second digit is even round down, delete the and
report the second digit as is (even down, 225 to 220) .......
d. If count on instrument is < 100 report as < 100,000
ESCC/mL ........................................................................
b. Certified provider: _______________________
Lot# ___________  Exp. Date ____________
Date Rcd. ____________ ........................................................
1. Four standards in ranges 100K - 200K, 300K - 500K, 600K
- 800K and 900K - 1.2M .....................................................
2. Maintain copies of all provided DMSCC values ..................
3. Measure and maintain records of temperature (0 - 7.2C) of
standards as received ..........................................................
4. Maintain copies of all correspondence regarding problems ....
c. Laboratory prepared (weekly) ..................................................
1. Prepare from raw milk > 18 hours old preserved with
0.05% potassium dichromate (K2Cr2O7) .............................
2. Or, preserved with 0.02% 2-bromo-2-nitropropane-1, 3-diol
(Bronopol™) .........................................................................
3. Standards cannot be preserved with formalin .....................
4. Prepare 4 standards in ranges 100K - 200K, 300K - 500K,
600K - 800K and 900K - 1.2M, used within one week .......
Date prep. ____________ Exp. Date ____________ .........
5. Do DMSCC in triplicate on each standard and average
counts, records maintained .................................................
6. DMSCC check performed in rotation by all certified
analysts ...............................................................................
d. Hourly Control Sample (instrument drift check) ......................
1. Use one of the standards (items 14a or b) in the 500 - 800k
range, run in triplicate and determine average ....................
2. Optionally, prepare sufficient control/sample 500 - 800k
range, run in triplicate and determine average ....................
PROCEDURE
15. Testing Standards (each time instrument used) ........................
a. Heat standards to 37 - 42C (using a temperature control) and
read within 30 minutes of reaching temperature, used once
and then discarded, i.e. do not re-use .....................................
b. Mix by inverting at least 2x, place in rack and put onto
automatic track, run within 10 minutes ...................................
c. Run the standards six times and average the counts for each
level, records maintained .........................................................
d. Each standard’s average must be within 10% of the DMSCC
(item 14) for that level, except within 15% for 100K - 200K
standard, records maintained ..................................................