Cultural Procedures General Requirements Flashcards

1
Q

What is the acceptable temperature range for the work area?

A

16-27°C

This range ensures a comfortable working environment for laboratory procedures.

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2
Q

What is the minimum lighting requirement at the working surface?

A

> 50 foot-candles (preferably 100)

Adequate lighting is essential for accurate analysis and procedures.

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3
Q

What is the maximum microbic density of air allowed in the laboratory for plating procedures?

A

≤ 15 colonies/SPC or RAC plate, ≤ 10 colonies/PAC plate, ≤ 5 colonies/PPAC plate in 15 min exposure

Corrective actions must be taken if these limits are exceeded.

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4
Q

What are the safety requirements regarding food and drinks in the laboratory?

A

Eating and drinking not permitted; food and drinks not stored

This is to maintain a sterile and safe working environment.

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5
Q

What type of protective clothing is required for analysts?

A

Buttoned/snapped lab coats/uniforms and protective eye-wear

Lab coats/uniforms must remain on-site to prevent contamination.

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6
Q

What must be available for safe working conditions in the laboratory?

A

Safety equipment

This includes items like eyewash stations, fire extinguishers, and first aid kits.

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7
Q

What documents must be accessible to analysts in the laboratory?

A

Current Safety Data Sheets (SDS)

SDS provide essential information on hazardous substances used in the lab.

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8
Q

What is the purpose of having a functioning fume hood in the laboratory?

A

To ensure safe handling of hazardous materials

The sash must be at an acceptable level for optimal safety.

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9
Q

What are the requirements for flammable solvent areas in the laboratory?

A

Continuously well ventilated and temperature controlled

This helps to prevent the risk of fire or explosion.

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10
Q

What is the proper disposal method for contaminated samples?

A

Disposed of properly

This includes following specific protocols for hazardous waste.

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11
Q

True or False: Analysts can store food and drinks in the laboratory.

A

False

Storing food and drinks in the lab poses contamination risks.

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12
Q

Fill in the blank: The work area should be reasonably free from _______.

A

dust and drafts

A clean environment is crucial for laboratory accuracy.

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13
Q

What is the importance of having a safe working environment in the laboratory?

A

To prevent accidents and ensure safe handling of materials

Refer to OSHA guidelines for specific safety protocols.

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14
Q

What should be done with contaminated glassware or plasticware?

A

Disposed of or decontaminated properly

This is important to prevent cross-contamination and ensure safety.

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15
Q

List three general requirements for the work area in cultural procedures.

A
  • Level table or bench
  • Clean and well-ventilated
  • Freedom from congestion and traffic

These requirements help maintain an efficient and safe workspace.

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16
Q

What types of storage space are required in a laboratory?

A

Cabinets, drawers, and shelves adequate

Adequate storage is essential for maintaining an organized laboratory environment.

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17
Q

What conditions should the areas of a laboratory meet?

A

Areas neat, clean and orderly

Cleanliness and order are crucial for safety and efficiency in laboratory operations.

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18
Q

What maintenance standards should floors, walls, and ceilings meet in a laboratory?

A

Floors clean, walls and ceilings in good repair

Good maintenance prevents hazards and promotes a professional environment.

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19
Q

What should be done to ensure a laboratory is free of pests?

A

Laboratory free of insects and rodents

A pest-free environment is vital for preventing contamination and ensuring accurate results.

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20
Q

How long must laboratory-related records be maintained for state central labs?

A

Three (3) years

This duration ensures compliance with regulatory requirements.

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21
Q

What is the minimum record retention period for other laboratories?

A

Two (2) years

States may require longer retention periods.

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22
Q

What types of records must be available for laboratory evaluations?

A

Quality control and sample records

These records are essential for assessing laboratory performance and compliance.

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23
Q

What should be included in records when corrective actions are taken?

A

Records contain written corrective actions when taken

Documenting corrective actions is crucial for quality assurance.

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24
Q

What writing materials are allowed for laboratory records?

A

Records written in ink or other indelible substance

Pencil or erasable ink not allowed to prevent alterations.

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25
Q

What is the correct procedure for making corrections to quality control records?

A
  1. Make a single line through the incorrect information
  2. Write in the correct information next to the incorrect information
  3. Person making the correction initials the information
  4. If not obvious, include reason for correction

Proper correction procedures help maintain the integrity of records.

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26
Q

What documentation is required for electronic/computer records?

A
  1. Software must be well documented
  2. Protocols and policies are documented clearly
  3. Records must be indexed and cross referenced

This ensures that electronic records are reliable and easily accessible.

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27
Q

What must be included in a policy statement regarding software use?

A

Policy statement on the use of the software

Clear policies help ensure consistent and secure use of laboratory software.

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28
Q

How should records allow for tracking of samples?

A

Records will allow tracking of sample from submission to final report

Tracking ensures accountability and traceability in laboratory processes.

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29
Q

What must be retained when corrections are necessary?

A

Old information, identity of the person making the change, date of the change, reason for the change

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30
Q

What is the retention period for regulatory records?

A

Two years (three years for State Central Labs)

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31
Q

What happens if records are not available at the time of audit?

A

The facility will be cited for not having records and will be subject to penalties

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32
Q

What type of temperature measuring device is required?

A

NIST traceable temperature measuring device or equivalent with certificate

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33
Q

How often must the temperature measuring device be checked?

A

Annually at ice point

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34
Q

What should be included in the reference temperature measuring device identity?

A

Serial #, Date of Certificate, Ice Point Date

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35
Q

What is the maximum graduation interval for temperature measuring devices in the range 0-100°C?

A

Not more than 0.5°C

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36
Q

What is the maximum graduation interval for temperature measuring devices outside the range 0-100°C?

A

Not more than 1.0°C

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37
Q

What types of thermometers are mentioned for measuring temperature?

A

Mercury-in-glass (MIG), alcohol/spirit (AIG), electronic/digital thermometers

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38
Q

What type of protection is recommended for mercury thermometers?

A

Plastic lamination

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39
Q

What must be checked for all test temperature measuring devices?

A

Accuracy checked before initial use and annually

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40
Q

Against what should the accuracy of test temperature measuring devices be checked?

A

NIST traceable thermometer

41
Q

What is the accuracy requirement for temperature measuring devices when checked?

A

Accurate to ±1°C when checked at temperature(s) of use

42
Q

What should be done with the results of accuracy checks?

A

Record/document results; tag individual devices

43
Q

What information should be included on the tag for individual devices?

A

Identification/location, date of check, temperature(s) checked, correction factors (as applicable)

44
Q

To what precision should temperature measuring devices be read?

A

To the nearest graduation/recording interval

Labs may optionally interpolate between graduations.

45
Q

What must the software in a Temperature Monitoring System do?

A

Record temperature reading from each sensor/probe at the same or greater frequency as stipulated for MIG or AIG thermometers

Optionally, it may register an alert/alarm when temperatures are out of the acceptable range.

46
Q

What should be documented when temperatures are out of the acceptable range for more than two hours?

A

The event must be documented and corrective action taken as necessary; maintain records

47
Q

What is an optional feature for temperature monitoring systems in case of power failure?

A

A minimum two-day backup power source (battery/electrical)

This applies to the temperature monitoring system and/or all required sensors/probes.

48
Q

How often must temperature monitoring system records be available for auditing?

A

Records must be available/accessible as described in item 2.f above

49
Q

What is required for automatic temperature recording instruments?

A

They must be compared weekly against an accurate thermometer; record results

50
Q

Are dial thermometers allowed for use in the laboratory?

A

No, dial thermometers are not used in the laboratory

51
Q

What is the acceptable temperature range for refrigeration of samples?

A

0.0-4.5°C

If the temperature is out of range, record samples as not analyzed (NA).

52
Q

What is prohibited from being stored in the refrigeration unit?

A

Food or drink for consumption

53
Q

What temperature recording is required from temperature measuring devices?

A

Record/download temperature (corrected) daily, in AM and PM, from two temperature measuring devices with bulbs or sensor/probe immersed in liquid (in sealed containers)

54
Q

Where should temperature measuring devices be located in the refrigeration unit?

A

On upper and lower shelves of use

55
Q

What is the requirement for the size of refrigeration units?

A

Size adequate for workload

56
Q

What is the requirement for the size of freezers?

A

Size adequate for workload

57
Q

What is the maximum temperature for storage of frozen milk products?

A

15°C or below

This temperature is crucial for maintaining the integrity of frozen milk products.

58
Q

What should not be stored in the freezer used for frozen milk products?

A

Food or drink for consumption

The freezer is designated solely for specific storage related to laboratory use.

59
Q

How often should temperature records be downloaded?

A

Daily, in AM and PM

Temperature must be monitored from a device with a bulb or sensor immersed in liquid.

60
Q

What types of pipets are mentioned?

A

Glass, Plastic

Different materials may be used for various applications in the laboratory.

61
Q

What are the requirements for pipettors?

A
  • Appropriate capacity
  • Must conform to APHA specifications
  • Graduations distinctly marked with contrasting color

These specifications ensure accuracy and compliance with standards.

62
Q

What should be done with pipettors that have broken tips or scratches?

A

Discard them

Defective pipettors can lead to inaccurate measurements.

63
Q

How often should pipettor accuracy be checked?

A

Once every 6 months

This ensures consistent performance and reliability in measurements.

64
Q

What is the acceptable accuracy range for the average of ten weighings?

A

±5% of specified delivery volume

This applies to both weight and volume checks if ≥ 1.0 mL.

65
Q

What is the Artel PCS® used for?

A

Pipette Calibration System

It provides a method to check pipettor accuracy through readings.

66
Q

How frequently should the PCS Pipette System be calibrated?

A

Every 30 days or just prior to use

Regular calibration ensures accuracy in measurements.

67
Q

What must be done with the results of pipettor calibrations?

A

Record results and file Calibration Certificate

Maintaining records of calibration is essential for quality control.

68
Q

What is the procedure for testing several pieces from each batch for residual acid or alkali?

A

Test with aqueous 0.04% bromothymol blue. If not dark green to light blue, re-rinse and test again. Maintain records.

69
Q

What must be recorded upon receiving samples in the laboratory?

A

Time, date, temperature of samples, and initials or license/permit number of the person who received them.

70
Q

How should sample temperature be determined?

A

Insert a pre-cooled thermometer into TC, which must be at least half the size of the largest test container.

71
Q

Who should perform the temperature determination of samples?

A

Trained personnel. Maintain records of training.

72
Q

What information is required for finished product samples?

A

Date, time, temperature of collection, and sample collector’s name and license/permit number.

73
Q

Is the sample collection information required to reside in laboratory records?

A

No, but it must be available at the same facility.

74
Q

What producer information is required for NCIMS certified laboratories to accept a sample?

A

Producer identification and date of collection at the farm.

75
Q

What are the options for recording the time of sample collection?

A

On the sample or on the records supplied.

76
Q

Fill in the blank: The final rinse should be done with _______ or DI water.

A

[MS]

77
Q

True or False: The temperature determination process requires a pre-cooled electronic thermometer.

A

False

78
Q

What is a Pilot sample (TC)?

A

A sample for testing that is collected under specific conditions

TC stands for Temperature Control.

79
Q

What is required for non laboratory records?

A

Records that are not required to reside in the laboratory include:
* Hauler/Sampler name and license/permit number
* Temperature at time of collection at the farm

80
Q

What is the purpose of a Temperature Control (TC) sample?

A

To ensure proper temperature conditions are maintained for samples received at the laboratory

TC samples can include bulk milk tanker samples, finished product samples, or a single TC per cooler.

81
Q

List the options for Temperature Control (TC) samples.

A

Options include:
* Producer Bulk Milk Pick Up Tanker (TC)
* Finished/Packaged Product Sample (TC)
* A single TC per cooler/shipping container
* Any sample in a cooler/shipping container if TC is not available

82
Q

What are the sample requirements for NCIMS laboratories to accept samples for Section 6 testing?

A

Requirements include:
* Producer samples must be about ¾ full
* Samples must be 0.0 to 4.5°C at receipt
* Samples must not be leaking
* Tops of samples must be protected from direct contact with ice
* Unprotected samples must not be submerged in water/ice

83
Q

True or False: Samples can be frozen to be accepted for testing.

A

False

Liquid samples must not be frozen to be accepted.

84
Q

What should be done if milk sample temperature control exceeds 4.5°C on receipt?

A

Do not test microbiologically

Samples may be tested if temperature does not exceed 7.0°C and time of receipt is ≤ 3 hours from collection.

85
Q

Fill in the blank: Samples must not be ______.

A

leaking

86
Q

What is the acceptable temperature range for liquid samples upon receipt?

A

0.0 to 4.5°C

87
Q

What happens if the tops of samples are not protected?

A

They must not be submerged in water and/or ice or slush.

88
Q

What is the temperature range for storing samples until tested?

A

0.0-4.5°C

If samples are frozen, contain ice crystals, or exceed 4.5°C, they should not be tested and recorded as Lab Accident (LA).

89
Q

How long can samples held at 13°C±1°C be tested for official ESCC?

A

183 hours

90
Q

What is the maximum time allowed for testing samples after collection?

A

60 hours

91
Q

If no time of collection is available, what time should be used for testing?

A

12:01 AM of the day of collection

92
Q

What must be done first if chemical tests are to be performed on samples?

A

Remove portions for microbiological analyses

93
Q

What information must be recorded when samples are tested?

A

Date, time, and temperature of samples

94
Q

What must be shown on the test information for sample analysis?

A

Date, time, temperature at start of analysis, and analyst’s name or initials

95
Q

What should bench sheets or records contain?

A

All results (raw and calculated) in proper format for tests performed

96
Q

What controls must be recorded for each group of samples?

A

Results of all applicable controls

97
Q

List the controls included in the plate count procedure.

A
  • Microbic air density
  • Dilution buffer
98
Q

True or False: Samples can be tested if they have ice crystals present.

A

False

99
Q

What is the reference for sample requirements mentioned?

A

Appendix N GR item 9