microbiology analyst training procedure

Caduceon Environmental Laboratories Page: 1 of 12 Microbiology Analyst Training Revision Date: 23 Nov, 2015 CP-008 Revision #: 1.0 Management Review: RL Quality Review: SKB

Microbiology Analyst Training Procedure

1.0 Scope 1.1 This operating procedure details the training of new and current employees to perform routine

methods and procedures as described in the Caduceon Microbiology Methods Manual.

2.0 Purpose 2.1 This training procedure is to be used to train analysts to perform a method within the microbiology

lab. Successful completion of the training plan will result in a rating of Proficient being assigned to the analyst for the performance of the method.

2.2 Accompanying data to verify analyst proficiency shall be supplied to the Supervisor for review. The

Supervisor will verify the data to determine the level of competency of the analyst in performing the new method. Once the final data is approved by the Supervisor, the data and rating recommendation will be passed to the Quality Assurance Officer and Laboratory Branch Manager for final approval.

2.3 The Quality Assurance Officer and the Laboratory Branch Manager together will assess the

accuracy and precision of the data in order to determine and assign the analyst a proficiency rating. If the data is accepted, then the Laboratory Branch Manager will approve the analyst rating of

Proficient and all accompanying data and other necessary papers will be placed in the analyst’s permanent employee file to be kept in the Laboratory Branch Manager’s office.

2.4 Data produced during the training process, will be compared to data generated by the instructor and

existing QC data acceptance criteria. This includes target values as well as upper and lower acceptance limits for the particular QC being generated. If training data are within the accepted limits, the data should be deemed acceptable. If the data is outside these limits, it may be rejected outright. However, experience of the instructor and Supervisor may be used to determine that the data is considered acceptable. Acceptance of this type of data should be accompanied by a written explanation from the Supervisor on the appropriate training form.

3.0 Procedure 3.1 New personnel or current personnel unfamiliar with microbiology methods, procedures or

instruments will be trained by an analyst proficient with that operation. 3.2 Each analyst-in-training (trainee) will have Analyst Training Forms (Appendix A-E) completed by the

instructor. These forms will be submitted to the Supervisor by the instructor at the appropriate stages of training. The trainee will not be permitted to proceed to the next step until the data in that step is accepted by the Supervisor.

3.2.1 The trainee will read the method, procedures and other supporting documentation (ie:

instrument manuals) after an initial meeting with the instructor. Once the method and documentation review is complete, the trainee will meet with the instructor to address questions and to ensure a proper understanding of the methods’ scopes, principles, and theories, along with QC and safety requirements. The instructor will also familiarize the trainee with the work area and equipment. The instructor will record the date of completion and documentation reviewed for each step at Items #1-5 of Appendix A.

3.3 The instructor will review the method procedures outlined in section 3.4 in the presence of the

trainee. At this time the instructor will explain the steps of each procedure while the trainee follows the steps in the written method/procedure.

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3.3.1 Upon completion of the instructor’s method review, the trainee will repeat the procedure

while explaining the steps in their proper sequence to the instructor, therefore reinforcing an understanding of the procedure.

3.3.2 Depending on the duties of the trainee they may be taught and deemed proficient for the entire method or for certain sections only. Once the trainee has demonstrated an understanding of a procedure of a method, the trainee is ready to begin the hands on portion of the training. This is recorded on Appendix A, Item #6.

3.4 Method Procedures

3.4.1 Media Preparation: Part 1 (Agar & plates) 3.4.1.1 The instructor will demonstrate the media preparation, plate pouring and media QC

procedure in the presence of the trainee by following section 7.1 to 7.2.11 of one of the Microbiology media preparation methods (EC-01, TC-001, DC-001, FC-001, FS-001 or HPC-001). Record media prep demonstration info on Appendix B, Part 1

3.4.1.2 At this time the trainee will explain the procedure as per step 3.3.1, then follow the

method procedure and prepare a small batch (approx 500 mL) of the same media, pour the media into plates, store, and perform media QC under the supervision of the instructor. Record media prep demonstration info on Appendix B, Part 2

3.4.1.3 Once the instructor feels that the trainee has satisfactorily demonstrated the proper

media preparation techniques they may move to step 3.4.2. (if applicable to the method.) If the media passes QC and meets acceptance criteria it may then be used for inter-tech comparison and trainee duplicate analysis/filtration training (step 3.4.4) or for regular application. If the data is rejected, the training procedure will begin again at step 3.4.1.1.

3.4.2 Media Preparation: Part 2 (Ec MUG Broth & tubes)

3.4.2.1 If applicable to the method, steps 3.4.1.1 and 3.4.1.3 may also be followed for the preparation of EC MUG Broth for confirmation testing. Following the instructor’s demonstration, the trainee will prepare a small batch (approx 250mL) as per section 7.8.1 of one of the Microbiology Membrane Filtration methods such as: EC-001, TC-001, DC-001, and FC-001. Record media preparation information as well as data acceptance/rejection by the instructor on Appendix B, Part 2.

3.4.2.2 It is only necessary that steps 3.4.1 and 3.4.2 are performed once satisfactorily per media type/method by the trainee to demonstrate proper media preparation technique.

3.4.3 Membrane Filtration and Incubation: Part 1 (Mock sample analysis)

3.4.3.1 The instructor will set up approximately 10(mock) samples filled with tap water and label them with various tests and dilutions (from 1X to 1000X). The instructor will then demonstrate the entire filtration/incubation procedure using some mock samples by following section 7.4 and 7.5 of one of the Microbiology Membrane Filtration methods (EC-001, TC-001, DC-001, FC-001, FS-001 or HPC-001).

3.4.3.2 At this time, prior to commencing, the trainee will explain the entire procedure as per step 3.3.1, and will also perform the entire method procedure by filtering and plating the mock samples with the appropriate dilutions under the supervision of the instructor.

(Old/used plates clear of contamination or expired plates may be used for this

portion of the exercise).

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3.4.3.3 The instructor will observe the trainee perform the entire procedure, while making

corrections and suggestions throughout the exercise, where necessary. The instructor will ensure the trainee is following procedure and using proper filtration, pipetting and plating techniques for all dilutions. If the instructor is not content, the procedure will be repeated. The mock filtration portion of the training may be repeated several times until the instructor feels the technique has been properly performed by the trainee.

3.4.3.4 Completion of each step shall be dated and initialed by both the instructor and the

trainee on training Appendix C, Part 1.

3.4.3.5 Once the instructor feels that the trainee has satisfactorily demonstrated the proper membrane filtration and sample analysis procedure, the training may move to step 3.4.4.

3.4.4 Membrane Filtration and Incubation: Part 2 (Inter-tech comparison and trainee duplicate analysis)

3.4.4.1 The instructor will prepare a bacterial suspension as per steps 3.5.12 to 3.5.14 of SOP-

041 for inter-tech sample analysis by membrane filtration. 3.4.4.2 The instructor will then perform the entire filtration/incubation procedure using the

prepared bacterial suspension sample by following section 7.4 and 7.5 of one of the Microbiology Membrane Filtration methods DC-001. Using Differential Coliform agar

plates, the instructor will analyse 3 different volumes of the suspension (0.1mL, 0.5mL

and 1.0mL) to obtain varying bacterial colony levels. The instructor’s plates are then incubated for 24 hours at 35

oC and the colonies counted for comparison with

trainee colony recovery.

3.4.4.3 The trainee will perform the entire procedure following section 3.4.4.2, unassisted (with

supervision) for a series of samples. The trainee will analyse the above volumes from the same suspension in triplicate for repeatability. All results generated by the trainee and instructor must be recorded on Training Appendix C, Part 2 and submitted to the section supervisor for review.


analysis of the bacterial suspensions with agreeable results and that all QC meets acceptance criteria the training may move to step 3.4.5.

3.4.4.5 The criteria for section 3.4.4.3 shall be that the trainee’s colony recoveries for

repeatability should be no greater than 20% difference of each other. Should a recoveries be less than 10cfu the acceptance criteria will be at the discretion of the Supervisor

3.4.4.6 The criteria for section 3.4.4.4 will be that the trainee’s colony recoveries should be

equal to or no greater than 20% difference to that of the instructor. Should a recovery of the suspension less than 10cfu the acceptance criteria will be at the discretion of the Supervisor.

3.4.5 Inter-Tech Colony Counting Proficiency (Appendix D, Part 1)

3.4.5.1 The instructor will review the colony counting procedures in the presence of the trainee using routine sample plates. At this time the instructor will explain the various media types and the colony identification; while the trainee follows the appropriate method sections (7.6) and SOP-042 (Colony Counting Proficiency).

3.4.5.2 Upon completion of 3.4.5.1 the instructor will provide an assortment of media plate types containing various levels of contamination for the trainee to count. Plates from section 3.4.4 may also be used for inter-tech counting.

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3.4.5.3 The trainee will be provided with a copy of the previous day’s bench sheets filled out with all information with the exception of bacterial colony counts. The trainee will record their bacterial counts on their copy of the bench sheets provided.

3.4.5.4 Repeat step 3.4.5.3 for each type of media.

3.4.5.5 The media types and count dates are recorded on Appendix D, Part 1

3.4.5.6 Copies of both the instructor and trainee bench sheets with bacterial colony counts are

attached with Appendix D. Should the trainee’s results be within 2 standard deviations of the proficient analyst count the trainee will be considered proficient.

3.4.5.7 Once the instructor feels that the trainee has satisfactorily demonstrated the colony

counting procedures the training may move to step 3.4.6.

3.4.6 Inter-Tech Confirmation Testing (Appendix D, Part 2)

3.4.6.1 Confirmation testing to be performed on each membrane filtration method as per the applicable method specifications and recorded on MF-05.

3.4.6.2 The instructor will first demonstrate the procedure in the presence of the trainee.

3.4.6.3 The trainee will then perform the procedure with supervision.

3.4.6.4 Complete Appendix D, Part 2 including Method ID, media type and analysis date. Record results on appropriate forms. Attach the completed MF-05 form to Appendix D.

3.4.6.5 Results between instructor and trainee must be in 100% agreement otherwise the trainee will be required to repeat the entire procedure.


inter-tech confirmation testing and that all QC meets acceptance criteria the training may move to step 3.4.7.

3.4.7 Trainee Real Sample Analysis (To be performed by the Trainee with minimal supervision) (Appendix E, Part 1)

3.4.7.1 The trainee will perform the entire membrane filtration procedure unassisted with

minimal supervision for a series of non-drinking water client samples. The minimum number of samples that the trainee must analyze is 10 along with all required QC samples for that run, including a positive control, duplicates, method blanks and within run blanks.

3.4.7.2 The trainee is required to complete all appropriate paperwork following all required method steps and procedures with minimal supervision.

3.4.7.3 Appendix E, Part 1 must be completed and include copies of all pertinent paperwork. 3.4.7.4 Once the instructor feels that the trainee has satisfactorily demonstrated the proper

membrane filtration and sample analysis procedure and that all QC meets acceptance criteria the training is complete.

3.4.8 All Trainee’s data will be reviewed by the supervisor who will then submit and provide their

recommendation to the manger and QA officer.

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3.4.9 The QA Officer and Lab Branch Manager will review all data from the training plan, along with the recommendation from the section supervisor and any other information supplied. If

accepted the trainee will be declared Proficient in all of the membrane filtration analytical methods for microbiology. This will be documented by completion of Appendix E, Part 2. Should any step in the training be rejected the instructor will be advised of further action to be taken.

3.4.10 If predetermined by management due to staffing requirements or if only a portion of the duties listed above will be performed by the trainee the trainee may be deemed proficient for any one or all of the sections listed in this procedure. At any point all completed forms may be submitted for review as described in 3.4.8 and the trainee may be deemed proficient for specific tasks. An example of this process which is commonly performed is

training of staff for section 3.4.5 Inter-Tech Colony Counting Proficiency which would allow the proficient staff to perform bacterial enumeration of routine samples.

3.5 Continued analyst proficiency will be contingent upon the ability of the analyst to produce QC data

that meets all the required criteria.

4 Responsibility

4.1 It is the responsibility of a proficient analyst to follow all necessary documentation when

proceeding to train a new or existing employee. 4.2 It is responsibility of the Instructor, Supervisor, QA Officer and Lab Manager to review and

approve the training documentation before the analyst will be deemed proficient to proceed with analysis.

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Appendix A: Training Form #1

Instructor (Name & Position): Name of Trainee:

Method(s) Trained on: Enumeration of Micro-organisms in Water by Membrane Filtration

Initial Training Requirements

1. Reviewed the following method documentation:

Date & Initial

Name and ID of Document(s) reviewed Trainee/Instructor

SOP #’s:

Method procedure(s) Trained on: (Instructor Initials)

Media Preparation______ Membrane Filtration & Dilutions_____ Incubation Requirements_____ Colony Counting Proficiency_____ Recording & Reporting Data____ Confirmation Testing_____

2. Instructor has demonstrated the above procedure(s) for trainee 3. Trainee understands principles & QC requirements of the method(s) 4. Familiar with Safety requirements 5. Familiar with the work area and equipment 6. Trainee is ready to proceed to the step 3.4 of the Training Procedure

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Appendix B: Training Form #2 Instructor (Name & Position): Name of Trainee:

Procedure Trained on: Media Preparation

Equipment Trained on: Analytical Balance□ Stirrer/Hot Plate□ Autoclave□ pH Meter□

Incubators□

Part 1 Demonstrated by Instructor: (Demonstrated by instructor)

Type of Media Demonstration Date(s) Media Batch

QC Preparation Trainee’s

Initials Instructor’s

Initials

Part 2 Performed by Trainee (with supervision)

*See attached media preparation documentation and QC. Data accepted: Yes No Authorized by: If no, why:

Type of Media Prepared

Media Preparation

Date

Media Batch Number

Trainee’s Media Batch QC Meets

Acceptance Criteria YES/NO

Media QC Acceptance

Date

Instructor’s/Trainee Initials

/

/

/

/

/

/

/

/

/

/

/

/

/

/

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Appendix C: Training Form #3 Instructor (Name & Position): Name of Trainee:

Procedure Trained on: Membrane Filtration Exercise

Equipment Trained on: Membrane Filtration System□ Incubators□ Semi-Auto Pipette□

Filter Dispenser□ Vacuum System□

Part 1 Membrane Filtration and Incubation Procedure: Mock Sample Analysis Exercise (Demonstrated by instructor and performed by trainee with supervision, using mock samples with various dilutions set up by the instructor to observe proper pipetting and dilution aliquot delivery).

Procedures Performed by Instructor and Trainee Instructor’s

Initials

Trainee’s

Initials

Training

Date

Area and Equip. Preparation and set up

Sample set up and QC requirements

Microbiology daily analyses bench sheet and QC logs

Aseptic techniques

Dilutions and pipetting technique

Mock sample filtration

Plating/Membrane filter positioning

Incubation requirements

Recording and Reporting Data

Trainee has satisfactorily demonstrated proper procedure/techniques and may proceed to the Inter-Tech

Comparison and Trainee Replicate Analysis step. Yes □ No □ Instructor Initials: If no, why:

Part 2 Membrane Filtration and Incubation Procedure (performed by trainee with supervision)

Inter-tech Comparison and Trainee Replicate Analysis: (Bacterial suspension prepared by instructor) Media Type: Analysis Date:

Suspension Volume

Analysed

Instructor’s Results

(Colony Recovery)

Trainee’s Colony Recovery Results Trainee’s Method QC Acceptable (Yes/No)

Instructor’s Initials #1 #2 #3 #4

0.1mL + Control

0.5mL OAB

1.0mL Blanks

*See attached documentation. Data accepted: Yes No Authorized by: If no, why:

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Appendix D: Training Form #4 Instructor (Name & Position): Name of Trainee:

Procedure(s) Trained on: Colony Counting Proficiency and Confirmation Testing

Part 1 Colony Counting Proficiency (Trainee / Instructor Inter-tech comparison counting)

Method ID Media Type Count Date Acceptable (Yes/No)

Instructor Initials

EC TC-001 DC Agar

*See attached documentation (copy of bench sheet with counts). Data accepted: Yes No Authorized by: If no, why:

Part 2 Confirmation Testing (Trainee / Instructor Inter-tech comparison)

Method ID Media Type Analysis Date Acceptable (Yes/No)

Instructor Initials

*See attached documentation. (MF-05) Data accepted: Yes No Authorized by: If no, why:

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Appendix E: Training Form #5 Instructor (Name & Position): Name of Trainee: Method Trained on (Name & ID):

Part 1 Real Sample Analysis (To be performed by the Trainee with minimal supervision)

Sample ID Media Type Analysis Date Instructor’s

Initials

*Trainee’s Method QC meets acceptance criteria (+Controls & Blanks) Yes No

*See attached documentation.

Trainee has demonstrated proper procedure/techniques Yes □ No □ Instructor Initials:

Data accepted: Yes No Authorized by: If no, why:

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Part 2 Assignment of Proficiency Training Plan Completed for the following Method(s) ID ID ID ID ID ID ID ID After completion of the training plan for the above Method(s), and based on the data presented, a rating of

Proficient has been assigned to Analyst (Name/Signature: on Date: Supervisor (Name/Signature): Authorization by: Quality Assurance Officer (Name/ Signature): Lab Branch Manager (Name/ Signature): un

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Log of Revisions

Date Rev Description Author

23 Nov, 2015

1.0 New Procedure RHL

Document Review This document was last reviewed and authorized by: Laboratory Branch Manager Date This document was last reviewed and authorized by: This document was last reviewed and authorized by: This document was last reviewed and authorized by:

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microbiology analyst training procedure

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