Ana səhifə

Laboratory manager


Yüklə 0.52 Mb.
səhifə1/10
tarix27.06.2016
ölçüsü0.52 Mb.
  1   2   3   4   5   6   7   8   9   10

Microbiology Department

Policy & Procedure Manual



MI\QC\v18

Page of

Section: Quality Control Manual

Issued by: LABORATORY MANAGER

Original Date: April 11, 2001

Approved by: Laboratory Director

Revision Date: March 24, 2015

Annual Review Date: October 2, 2014




QUALITY CONTROL MANUAL

TABLE OF CONTENTS


MAINTENANCE OF ISOLATES FOR QUALITY CONTROL 3

QUALITY CONTROL OF CULTURE MEDIA 4

SHEEP/HORSE BLOOD STERILITY TESTING 10

KIRBY BAUER QUALITY CONTROL 11

E-TEST QUALITY CONTROL 17

ROSCO Diagnostica Tablets QC 19

TREK Sensititre Weekly QC 20

HIGH LEVEL AMINOGLYCOSIDE RESISTANCE SCREEN PLATE (QUAD) QC 21

REAGENT AND TEST KITS QUALITY CONTROL 22

EQUIPMENT QC & MAINTENANCE 24

SEROLOGY QC 26

QUALITY CONTROL REVIEW 27

APPENDIX II - Bacteriology QC Bench Workflow 29

APPENDIX III - Ordering New QC ORGANISMS in Soft 35

APPENDIX IV - Order Entry for New QC TESTS 37

APPENDIX V - Printing QC Labels Procedure 38

APPENDIX VI - Bench Quality Control Documentation in LIS 39

APPENDIX VII - SOFT for micqc 46

APPENDIX VIII - Media for QC Bench On-Receipt 48

APPENDIX IX - Reagents for QC Bench On-Receipt 50

APPENDIX X - Registering Antibiotics 52

APPENDIX XI - Weekly Susceptibility QC 54

APPENDIX XII - Rarely Used Antibiotic Discs 57

APPENDIX XIII - QC Antibiotic Inventory 58

Record of Edited Revisions 59


VITEK QUALITY CONTROL See Vitek Manual


MAINTENANCE OF ISOLATES FOR QUALITY CONTROL




STOCK CULTURES
Reference strains for quality control are originally obtained from ATCC, Microbiologicals or other commercial sources as lyophilised cultures. Follow manufacturer's instructions and subculture these lyophilised cultures. Upon receipt, each new strain will be will be entered in Soft like a patients specimen (see order entry instructions Appendix III - Ordering New QC Organisms in Soft) and then frozen in triplicate in the appropriate QC storage box. See Laboratory Information Systems for Freezing QC Strains in SoftStore.
Store the sub-cultured isolates in trisodium citrate glycerol at -70oC. These frozen cultures are used as STOCK CULTURES and should be replaced annually.
Viruses are kept in DMSO in liquid nitrogen.

WORKING CULTURES
Working cultures are stored on TSB agar slants at 4o to 8oC or on Chocolate agar or Blood Agar for fastidious organism. See the working List of Quality Control Organisms for storage requirements and freezer location. These cultures are replaced monthly by sub-culturing twice to the appropriate solid media from the frozen Stock Cultures. The fresh subcultures are then placed in the appropriate racks and the previous months cultures are discarded.

Virus working cultures are propagated in the appropriate tube culture cell lines.




BEFORE TESTING
Before testing, cultures are sub-cultured from the working cultures onto solid media before use.

Not applicable for viruses



QUALITY CONTROL OF CULTURE MEDIA



PROCEDURE FOR QC ON COMMERCIALLY PREPARED MEDIA:

All prepared media received will be examined visually for colour change, precipitate, lysis of blood, contamination etc. Any atypical observation should be brought to the attention of the QA technologist. An incident report form will then be filled out and faxed to the supplier.


Performance quality control testing for routine media supplied by OXOID / BIOMEDIA is not required except the following:


Bile Esculin agar

Brilliance agar (VRE)

Campylobacter agar

CARROT broth

Chocolate agar

Denim Blue agar

Haemophilus Isolation agar

Haemophilus Test Medium

High-Level Aminoglycoside/Vancomycin resistant screen plate (QUAD)

Inhibitory mould agar

Kanamycin/Vancomycin agar

MacConkey-Cefpodoxime agar

MacConkey-Colistin agar

Martin-Lewis agar

MGP broth

Motility media

MR-VP broth

Mueller Hinton agar

OCBL agar

ONPG-PAM

Ornithine broth

Oxacillin screen control plate

Oxacillin screen plate

Skirrow's Campylobacter agar

Sorbitol-MacConkey agar

TCBS agar

Thermonuclase agar

TSI slant

Urea slant

Vancomycin screen plate

On receipt of these media, a sufficient amount of each lot (see Appendix VIII - MEDIA FOR QC BENCH ON RECEIPT) for amount will be set aside for performance testing.




  1. Create testing labels for any of the above media. See hyperlink referring to Ordering QC Labels. Go to the receiving worklist “QC Media on receipt”. Assemble the media to be tested and use the “Template for QC Media On Receipt”, to wand the appropriate organisms for each media. Labels will print in the order that you wand them. (Note: If you have more than 1 lot number for a particular media type, you will have to exit the receiving list after ordering the labels for the first lot and re-enter the work list for each subsequent lot.)




  1. Register each item into the “micqc” module of the LIS. See Appendix VII - SOFT FOR MICQC.




  1. Note: For Oxacillin, NACL, VISA, BHI with casein, VANCO, and High level Gent/Strep. plates, print a bar-code registration label for each plate received by doing the following:

  • Upon receipt of these media, go to micqc registration.

  • Choose Media.

  • A (add)

  • Choose correct media under media id.

  • Type in the lot number.

  • If the lot has been received previously, add a letter “A” on the end of the number. If this lot has also been received previously, try “B” etc.

  • Put in the expiry date.

  • Enter. Enter. F9.

  • Choose a label printer.

  • For number of copies, choose the number of plates for the lot number you are receiving.

  • Put the labels in a poly-bag and place the plates and their respective labels in wire wrack in the walk-in refrigerator (MIRM2). Be sure to put newest lots to the back of the shelf and move older lots forward.




  1. Using the testing labels generated, label a saline tube for suspensions of each organism required, and affix one label to the media being tested and another label for 1 representative purity plate for each organism.




  1. For all isolates except N. gonorrhoeae, H. influenzae and C. jejuni:

Prepare a saline suspension of all required isolates to a turbidity to match 0.5 McFarland Standard. Inoculate media using a calibrated 1µL (0.001 mL) loop. Incubate as required and inspect cultures at 24 and 48 hours.

  1. For N. gonorrhoeae, H. influenzae and C. jejuni:

Prepare a saline suspension of all required isolates to a turbidity to match 0.5 McFarland Standard. Make a 1:10 dilution; remove 300ul from a standard blank Vitek saline tube (3.0mL) and pipette 300uL of the 0.5 McFarland suspension into the saline.


  1. Inoculate media using a calibrated 1µL (0.001 mL) loop. For Oxacillin Screen, QUAD and Vancomycin Screen plates inoculate with a swab.




  1. Incubate as required and inspect cultures at 24 and 48 hours.




  1. Record as “OK” in the LIS or if not acceptable, enter this into the “Result Comment” field in the LIS, fill out an incident form, inform the supplier, and remove the media from the refrigerator shelf.


ORGANISMS FOR MEDIA QC

MEDIA

ORGANISMS

EXPECTED RESULTS

Oxacillin screen plate

S. aureus LPTP 8610

Growth

S. aureus ATCC 43300

Growth

S. aureus ATCC 29213

No growth

S. aureus ATCC 43387

No growth

Campylobacter agar

Campylobacter jejuni ATCC 29428*

Growth

E. coli ATCC 25922

No growth

CARROT broth

S. agalactiae ATCC 12386

S. pyogenes ATCC 19615

E. coli ATCC 25922

Orange + growth

No colour + Growth

No colour + No growth


Chocolate agar

N. gonorrhoeae ATCC 43069*

Growth

H. influenzae ATCC 10211*

Growth

Brilliance agar (VRE)

E. faecalis ATCC 51299

Blue colonies

E. gallinarum ATCC 49573

No growth

E. faecalis ATCC 29212

No growth

E. coli ATCC 25922

No growth

C. albicans ATCC 10231

No growth

E. faecium

Purple colonies

Haemophilus isolation agar

S. aureus ATCC 29213

No growth

H. influenzae ATCC 10211*

Growth

Denim Blue agar

S. epidermidis ATCC 12228

No growth

S. aureus ATCC 43300

Blue colonies

S. aureus ATCC 29213

No growth

S. aureus LPTP 8610

Blue colonies

E coli ATCC 25922

No growth

E. faecalis ATCC 29212

No growth


MEDIA

ORGANISMS

EXPECTED RESULTS

Martin-Lewis agar

N. gonorrhoeae ATCC 43069*

P. mirabilis ATCC 12453

S. epidermidis ATCC 12228

Growth

No growth

No growth


Mueller Hinton agar

with Gentamicin 10g disc


Mueller Hinton agar

with TMP/SMX disc



P. aeruginosa ATCC 27853

E. faecalis ATCC 29212

16-21 mm zone

20 mm zone


QUAD screen

(Streptomycin + Gentamicin)

(Vancomycin)





E. faecalis ATCC 49532

Gent-Growth

Strep-No growth

Vanc-No growth


E. faecalis ATCC 49533

Gent-No growth

Strep-Growth

Vanc-No growth


E. gallinarum ATCC 49573

Gent-No growth

Strep-No Growth

Vanc-Growth


Sorbitol-MacConkey agar

E. coli ATCC 25922

Pink colonies

E. coli O157:H7 LPTP 8608-3

Colourless colonies

OCBL

Burkholderia cepacia ATCC 25608

P. aerugionosa ATCC 27853

Growth –Yellow

Growth -Not yellow



TCBS

Vibrio aglinolyticus ATCC 17749

E. coli ATCC 25922

Growth-Yellow

No growth



MCPOD

(MacConkey agar with 2 g/ml cefpodoxime)



K. pneumoniae ATCC 13883

K. pneumoniae CAP 98D-A

No growth

Growth


Inhibitory Mould agar

T. mentagrophytes ATCC 9533

Growth

Kanamycin / Vancomycin agar

B. fragilis ATCC 25285

E. coli ATCC 25922

Growth

No growth



* Use the 1:10 dilution of the 0.5 McFarland suspensions for inoculation.


MEDIA

ORGANISMS

EXPECTED RESULTS

VISA screen plate

S. aureus LPTP 8610

Growth

S. aureus ATCC 43300

Growth

S. aureus ATCC 29213

No growth

S. aureus ATCC 43387

No growth

E. gallinarum ATCC 49573

Growth



PROCEDURE FOR QC ON MEDIA PREPARED IN-HOUSE:
Visual inspection includes observing the media for colour change, precipitate, lysis of blood, etc. Any atypical observation should be brought to the attention of the QA technologist. If the medium is visually satisfactory, write "OK" in the space provided.
pH testing will be performed on the final medium after it has solidified and cooled to room temperature. Record the value obtained in micqc Results Entry List “Procedure Actions” Comment (F7).
For blood that has been added to freshly prepared agar, one drop is put onto BA and incubated at 35oC for 48 hours and then at RT for a further 48 hours.
Sterility testing will be performed on all media prepared in our laboratory. One plate or tube from each batch will be incubated at 35oC for 48 hours, one at room temperature for 48 hours.

Performance testing will be done using the Standard Loop method. One plate from each batch will be tested when first prepared and again on each successive 7 days until the supply in the refrigerator is depleted or the expiry date is reached.


If expected results are not attained, the QA technologist or Charge technologist must be informed. QA technologist or Charge technologist will implement appropriate corrective action. The lab will be notified through LIS e-mail if needed.

  1   2   3   4   5   6   7   8   9   10


Verilənlər bazası müəlliflik hüququ ilə müdafiə olunur ©atelim.com 2016
rəhbərliyinə müraciət