Microbiology

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Microbiology



MICROBIOLOGY


Bacterial culture programs ship one week prior to Non Chemistry shipping dates


BOLD type indicates analytes reported to CMS                ∆ - denotes Point of Care Testing/Waived Programs



Proficiency Testing Requirements


Unlike other specialties under CLIA, Microbiology does not have specific analytes. Instead, laboratories are responsible for selecting Proficiency Testing that covers all aspects of testing offered by their laboratory. The general requirement that Proficiency Testing be comprised of 3 events per year with 5 samples per event applies (with the exception of Acid Fast Smears). The all aspects of testing offered requirement means that the laboratory must cover all subspecialties, all basic techniques employed and all organisms tested by the laboratory.  


In order to facilitate selection of methods to cover all aspects of testing performed in your laboratory, the Microbiology Section of the catalog is organized by Sub Specialty, then by laboratory technique. That is you will find under Bacteriology programs covering Culture and Identification, Antimicrobial Sensitivity, Gram Stain, Direct Antigen and so on. In order to insure that you meet the 3 by 5 sample requirement, we typically start the listing with a base program or series of base program options comprising 5 samples and offering one or more testing techniques. You should select one of those base programs that most closely reflect the level of service offered by your laboratory. Once you have established base programs, you should select additional supplemental programs to cover all aspects of testing offered by your laboratory.


Unless you are performing waived testing only, typically a supplemental program alone will not be sufficient to meet the CLIA 3 X 5 requirement. If you perform only a limited test menu, please be careful in selecting programs that your selection meets this requirement for each basic laboratory technique and subspecialty. A variety of 5 vial programs are offered to make meeting this requirement easier.


As always, it is ultimately the responsibility of the laboratory to insure that they are ordering an adequate selection of Proficiency Testing to meet CLIA requirements.  Be aware that Deemed Accrediting Agencies will have their own additional requirements or specific interpretations of how to meet the proficiency standard. When in doubt you should discuss this with your laboratory’s Deemed Accrediting Agency.






BACTERIOLOGY – Culture and Identification



BACTERIOLOGY [2009503]

$300

5 challenges per testing event

Pure and mixed cultures will be included for identification. Sources will vary.

One of the five specimens per testing event will be for Antimicrobial Susceptibility.  Additionally, one culture per event will be a mixed culture and require that all organism found be reported.


                                               

2-Blood Cultures

3-Throat Cultures

1-Genital Cultures

3-Urine Cultures

2-Wound or Ear Culture (Aerobic & Anaerobic)

1-CSF Cultures

3-Stool cultures


       

       

BACTERIOLOGY, COMPLETE [1011393]

$360      

5 challenges per testing event

Pure and mixed cultures will be included for identification. Sources will vary. Additional procedures include actual method specific specimens to assure compliance with regulatory requirements.

One of the five specimens per testing event will be for regulated Antimicrobial Susceptibility.  Additionally, one culture per event will be a mixed culture and require that all organism found be reported.


3-Strep A Antigen  

15-Gram Stains

1-Antimicrobial sensitivity, supplemental non-CMS

1-CSF Cultures

3-Stool cultures

6-Blood Cultures - Supplemental

2-Blood Cultures

3-Throat Cultures        

6-Urine for Colony Count

1-Genital Cultures

3-Urine Cultures


2-Wound or Ear Culture (Aerobic and Anaerobic)

15-Organism Morphology


       


CAMPYLOBACTER, 2-VIAL supplemental [2002183]

$94

2 challenges per testing event

Pure and mixed cultures will be included for identification, or antigen screen.  


Must be enrolled in a 5-vial Bacteriology Culture and Identification program, or if reporting as extent 2 must be enrolled in a 5-vial Bacteriology Direct Antigen program.



GENITAL CULTURE 5-VIAL [2009523]

$240

5 challenges per testing event

Pure cultures for identification of genital pathogens, Strep Group B and/or Neisseria gonorrhea.   CMS reported



THROAT CULTURE [2009573]

$290

5 challenges per testing event

Pure and mixed cultures will be included for identification, antigen screen and/or Gram stain.  CMS reported.



THROAT/URINE CULTURE [2009583]

$290

5 challenges per testing event

Pure and mixed cultures will be included for identification. Per Event, samples are as follows:


3-Urine Culture identifications

1-Antimicrobial susceptibility

2-Throat Culture identifications

1-Colony Count

       


URINE CULTURE AND COLONY COUNT [2009593]

$265

5 challenges per testing event

Pure and mixed cultures will be included for identification. Per Event, samples are as follows:


5-Culture identifications

1-Antimicrobial susceptibility

1-Colony Count


       


URINE COLONY COUNT [2091063]

$192

2 challenges per testing event

Pure and mixed cultures in a lyophilized pellet for bacterial colony count and ID.

Supplemental testing only; culture samples for supplemental testing only, and must be ordered in addition to another 5-vial CLIA acceptable bacteriology culture and ID program.



BACTERIOLOGY – Antimicrobial Sensitivity


Antimicrobial Applicability        


As indicated in CMS guidelines, participants enrolled in a Microbiology program that perform antimicrobial testing will be flagged for inappropriate selection of antimicrobial agents per CLSI Guidelines (formerly NCCLS) M02-12, M07-A10 and M100 S25. Inappropriate selection of antimicrobials as indicated by the CLSI guidelines will be scored as misses.


BACTERIOLOGY [2009503]

$300   

5 challenges per testing event

See Culture and ID section above for program description.


BACTERIOLOGY, COMPLETE [1011393]

$360

5 challenges per testing event

See Culture and ID section above for program description.


Microbiology

THROAT/URINE CULTURE [2009583]

$290

5 challenges per testing event

See Culture and ID section above for program description.


URINE CULTURE AND COLONY COUNT [2009593]

$265

5 challenges per testing event

See Culture and ID section above for program description.



BACTERIOLOGY – Gram Stain and Morphology



GRAM STAIN [2009543)

$170 

5 challenges per testing event

Purified bacterial smears for Gram stain.  One slide with 5 wells.  CMS reported.  Includes two educational DigitalScopeTM slide images available online only.


View DigitalScope® Image (Neisseria gonorrhea, urethral smear)


View DigitalScope® Image (Streptococcus pneumonia, CSF)



BACTERIOLOGY, COMPLETE [1011393]

$360

5 challenges per testing event

See Culture and ID section above for program description.


BACTERIOLOGY – Direct Antigen



C. DIFFICILE TOXIN ANTIGEN DETECTION [2009723]

$309  

5 challenges per testing event

Lyophilized vials for detection of C. difficile toxin.  CMS reported.



CHLAMYDIA/GC/STREP GROUP B ANTIGEN SCREEN [2009513]

$415

5 challenges per testing event

Swab specimens for Chlamydia trachomatis, Neisseria gonorrhea and Streptococcus sp., Group B antigen screens; these specimens cannot be cultured.  CMS reported.



SHIGA TOXIN [2001743]

$224

2 challenges per testing event

Specimens for Shiga Toxin 1 and 2.

For supplemental testing only, must be ordered in addition to another 5-vial CLIA acceptable other Bacteriology antigen programs.



∆ STREP GROUP A ANTIGEN, WAIVED [1011323]

$100

2 challenges per testing event

Pre-inoculated swabs for antigen screening using waived methods only.



STREP GROUP A ANTIGEN, 5-VIAL [2009563]

$185

5 challenges per testing event

Pre-inoculated swabs for antigen screening only.

Any method requiring live bacteria, such as cultures, stains or DNA probe methods should enroll in the Throat Culture or other appropriate Bacteriology Culture and ID module.  CMS reported.



UREASE, RAPID CAMPY LIKE ORGANISM (CLO) [1002163]

$149

2 challenges per testing event

Simulated gastric samples for use with CLOtest, PyloriTek or similar methods.


BACTERIOLOGY – CLIA Specified Serology

See SEROLOGY Section


MICROBIOLOGY – Molecular



VAGINOSIS SCREEN [2009803]

$360

5 challenges per testing event

Lyophilized cultures compatible with all molecular probe and antigen detection methods for the following vaginal pathogens:


Candida albicans

Trichomonas vaginalis

Gardnerella vaginalis


CHLAMYDIA/GC/STREP GROUP B ANTIGEN SCREEN [2009513]

$415

5 challenges per testing event

See BACTERIOLOGY – Direct Antigen section above for program description.



MRSA [2001723]

$150

2 challenges per testing event

Culture swab samples for the detection Methicillin Resistant S. aureaus using ChromAgar and molecular probe methods.  


MYCOBACTERIOLOGY



ACID-FAST SMEARS [2009495]

$190

5 challenges per testing event *


Prepared, fixed slides for acid-fast staining        *1st & 3rd events only


MYCOLOGY – Microscope Identification



KOH PREPARATION [2001623]

$175  

2 challenges per testing event


Glass slides to represent a KOH examination.


MYCOLOGY – Molecular



VAGINOSIS SCREEN [2009803]

$360

5 challenges per testing event


See Bacteriology - Molecular section above for program description.


PARASITOLOGY – Identification (Microscopy)



PARASITOLOGY [2009553]

$270

5 challenges per testing event

Specimens include fecal specimens (formalinized and PVA), peripheral blood smears and DigitalScopeTM slide images.  CMS reported.


View Digital Scope Image (Entameba coli)


View Digital Scope Image (Entameba histolyica/dispar)


PARASITOLOGY – Direct Antigen/Molecular



CRYPTOSPORIDIUM/GIARDIA IMMUNOASSAY [2009673]

$229

5 challenges per testing event


Formalinized fecal specimens for analysis of Cryptosporidium and Giardia.  CMS reported.


VIROLOGY – Direct Antigen


HEPATITIS MARKERS [2009623]

$244

5 challenges per testing event


See Serology section above for program description.



HIV MARKERS [2009483]

$229

5 challenges per testing event


See Serology section above for program description



∆ HIV MARKERS, RAPID, WAIVED [1011283]

 $166

2 challenges per testing event


See Serology section above for program description


ROTAVIRUS, 2-VIAL ADD ON [A2002173]

$140

2 challenges per testing event


Liquid specimens for the detection of Rotavirus.

Supplemental testing only; must be ordered in addition to another CMS acceptable 5-vial Viral Antigen program.



ROTAVIRUS, 5-VIAL [2002163]

$285

5 challenges per testing event


Liquid specimens for the detection of Rotavirus.  CMS reported.



∆ VIRAL ANTIGEN SCREEN, WAIVED METHODS [2002153]

$170  

2 challenges per testing event*


Liquid specimens for detection of the following analytes using waived methods only:  

                                     *1st & 3rd events only

Adenovirus

Influenza Type A & Influenza Type B

Respiratory syncytial virus (RSV) antigen

       


VIRAL ANTIGEN SCREEN, 5 VIAL

$325 

5 challenges per testing event


Lyophilized vials for detection of the following analytes:


Adenovirus

Influenza Type A & Influenza Type B

Respiratory syncytial virus (RSV) antigen

       


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