MICROBIOLOGY

ACID-FAST SMEARS

Five slides per testing event, 2 testing events per year

These specimens will only be included in the first and third shipments. The specimens are prepared, unstained slides.

Perform your normal staining procedures and code either the absence or presence of acid-fast bacilli, using only the code 12 (for acid-fast bacilli absent) or code 13 (for acid-fast bacilli present). The Acid-fast Smears program is limited to Mycobacteriology Type 1 (Extent 1) laboratories only (those which only report acid-fast smear results). Therefore, extent coding is not relevant for this program.

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BACTERIOLOGY

GENITAL CULTURE

THROAT CULTURE

THROAT/URINE CULTURE

URINE CULTURE

Five specimens per testing event, Diluents packaged separately

Inspect the fiberboard container carefully for all inclusions. Five specimens are provided for each culture program. After inventorying the contents of the container, store them in a refrigerator until ready for use.

Special Safety Precautions-These specimens contain pathogens or potential pathogens and should be considered infectious and handled as though they are capable of transmitting disease. They should be handled and disposed of only by personnel trained to work with pathogenic bacteria. All laboratory precautions and safety measures appropriate to handling live cultures should be practiced when working with these specimens.  In addition to the Precautions section on page 4, one should be especially careful to avoid aerosol creation, inhalation, ingestion or injection of bacteria. These specimens should be autoclaved and disposed of as biohazardous waste.

Instructions for Culture Specimens-One swab, lyophilized sample swab or pellet and rehydration fluid is provided for each specimen

1. Remove the tube from the outside packaging. No warming is required, samples may be used cold.
2. Remove the cap that holds the swab and rehydrate using the fluid provided, then inoculate media.   If rehydration fluid is missing or leaked during transport for the swab, use 0.5 mL sterile broth, or sterile saline to rehydrate swab.  
3. For colony count pellet where applicable, open sample vial and empty the pellet into the dilution fluid bottle.  Reseal the fluid container and mix vigorously until the pellet is completely dissolved and the suspension is homogenous in appearance.  This simulates a urine sample.
4. For single plate inoculation: For heavy growth, rotate the swab while streaking the entire plate in all quadrants. For isolated colonies, rotate the swab over the first quadrant only. Utilize a sterile loop to streak the remaining quadrants as per your normal laboratory procedure.
5. For multiple plates or Uricult users: Submerge the swab portion only into the provided rehydration broth for 15 to 30 seconds. Remove the moist swab and use it to streak plates as per your laboratory’s procedure. The broth may be capped and stored as you would any other stock broth. Uricult users should use the inoculated broth to wet the test paddle.

Determining Type (Extent) of Laboratory Service-All participants, regardless of the extent of their laboratory practice, evaluate the same specimens. In order to be graded appropriately, you must report the extent of laboratory practice (Extent 0, 1, 2, 3, 4 or 5) for each specimen according to the CLIA regulations below.

§ 493.911

Bacteriology.

1. Types of services offered by laboratories. In bacteriology, for proficiency testing purposes, there are five types of laboratories:

1. Those that interpret Gram stains or perform primary inoculation, or both; and refer cultures to another laboratory appropriately certified for the subspecialty of bacteriology for identification;
2. Those that use direct antigen techniques to detect an organism and may also interpret Gram stains or perform primary inoculation, or perform any combination of these;
3. Those that, in addition to interpreting Gram stains, performing primary inoculations, and using direct antigen tests, also isolate and identify aerobic bacteria from throat, urine, cervical, or urethral discharge specimens to the genus level and may also perform antimicrobial susceptibility tests on selected isolated microorganisms;
4. Those that perform the services in paragraph (a)(3) of this section and also isolate and identify aerobic bacteria from any source to the species level and may also perform antimicrobial susceptibility tests; and
5. Those that perform the services in paragraph (a)(4) of this section and also isolate and identify anaerobic bacteria from any source.

Determine your extent as follows:

Extent 0. Those that do not process or would refer this specimen source to another laboratory appropriately certified for the subspecialty of bacteriology for identification.

Extent 1. Those that interpret Gram stains or perform primary inoculation, or both; and refer cultures to another laboratory appropriately certified for the subspecialty of bacteriology for identification.

Extent 2. Those that use direct antigen techniques to detect an organism and may also interpret Gram stains or perform primary inoculation, or perform any combination of these.

Extent 3. Those that, in additions to interpreting Gram stains, performing primary inoculations, and using direct antigen tests, also isolate and identify aerobic bacteria from throat, urine, cervical, or urethral discharge specimens to the genus level and may also perform antimicrobial susceptibility tests on selected isolated microorganisms.

Extent 4. Those that perform the services of Extent 3 laboratory and also isolate and identify aerobic bacteria from any source to the species level and may also perform antimicrobial susceptibility tests.

Extent 5. Those that perform the services of Extent 4 laboratory and also isolate and identify anaerobic bacteria from any source.

• Subject each specimen to your protocol for each source as described at each specimen number on your reporting form.
• Based on what you would report in the context of your specific laboratory practice, determine your extent for each specimen independently of each other, according to the definitions on the reporting form and clarified in the following table:

We are required to categorize participants by extents and labs who fail to report their extent will be categorized as Extent 5.  This must be reported with each event.  For proficiency testing, you are required to report to the same extent as you would a patient.  You may select a different Extent for each specimen.  Your surveyor will evaluate your reports accordingly.

Coding for Presumptive Culture Identification-Participants reporting presumptive identifications by culture must not use result codes 750 to 911. If performing isolations only with selective media, these participants might need to report code 948 (No pathogen isolated), but should not report either code 949 (No aerobic growth) or 951 (No aerobic or anaerobic growth). CMS requires that we challenge many common pathogens found in a specific sample type. When reporting a negative result, select an answer which reflects the organisms you would normally detect (i.e. select code 927 if you only screen for Strep A and do not test for N. gonorrhoeae with throat cultures.)

Coding Extent 3, 4 and 5 Results-For Specimens 1, 2, 3 and 4, participants using Extent 3, 4 or 5 can report only the organism(s) which they consider to be the significant pathogen(s) that is/are clearly responsible for the illness described, excluding immunocompromised patients. Opportunistic pathogens occurring in immunocompromised patients, when included, will always appear in Specimen 5. All organisms, non-pathogens as well as pathogens, must be identified in Specimen 5. Code your answers using the Result Code list on the Microbiology Instructions.

Antimicrobial susceptibility tests (ASTs) are to be performed on the most significant pathogen in Specimen 1 only, using the AST codes listed on the Microbiology Instructions. Caution: If you routinely report ASTs, but do not report ASTs for a particular specimen type or organism, you must report Result Code 100 or 196 as appropriate to your normal laboratory handling of such organism/specimens.  Failure to do so will result in a Did Not Report being sent to CMS.  Otherwise, leave method and result blank if you do not perform susceptibility testing in your lab.

Due to CMS requirements, participants will be flagged for inappropriate selection of AST’s, as listed in the latest version of CLSI guidelines for Microbiology:  M02-A12, M07-A10, and M100-S27.  

BACTERIOLOGY COMPLETE

BACTERIOLOGY culture program listed above PLUS the following additional supplements.

GRAM STAIN, BACTERIOLOGY COMPLETE

Gram Stain:  Perform your normal staining procedure on the pathogen(s) isolated from the swabs in Bacteriology.  If not enrolled in regular Gram Stain, this will be reported to CMS.

Code the Gram stain and organism morphology from the list provided on the form.

STREP A SCREEN, Supplemental, BACTERIOLOGY COMPLETE

Strep A Screen is a supplemental program for Bacterial Antigens.  For CLIA purposes you must be enrolled in and report a Bacterial Antigen from one of the following programs; Strep A Antigen Screen, Chlamydia/GC/Strep B, or C. difficile Antigen.  Per CLIA requirements for Bacteriology there will be occasional samples that are either completely negative or contain no pathogen.  You should report "010 Negative" for such samples.

Strep A Screen:  Report results only for Bacteriology Sample 2.

In performing a rapid Group A antigen screen on these specimens, follow the same procedure used on patient specimens, unless you use the Quidel QuickVue In‐Line product or the BioStar OIA method.  Quidel QuickVue In‐Line participants must follow special instructions for proficiency testing found in the kit's package insert.  BioStar OIA participants must pre‐wet each swab with 3‐4 drops of Reagent 4 (Wash Solution) or sterile saline prior to testing.  If the specimen's fluid content is inadequate for other procedures, add sterile saline (generally 1‐2 drops) to the swab and express the fluid.  Code your answers as either 010 for negative or 011 for positive.  Code the method used by entering the appropriate code from the list below.

BLOOD CULTURE, Supplemental, BACTERIOLOGY COMPLETE

Two lyophilized pellet specimens per testing event, diluents packaged separately

Inspect the fiberboard container carefully for all inclusions. Two specimens are provided. After inventorying the contents of the container, store them in a refrigerator.

1. Open the lyophilized sample vial.  Empty the dilution fluid buffer into the sample vial with pellet.
2. Recap the sample vial and mix the contents of the container vigorously.  Mix until pellet is completely dissolved and the suspension is homogenous in appearance.
3. Proceed to test as you would a patient sample in your laboratory.

ANTIMICROBIAL SUSCEPTIBILITY, Supplemental non-CMS, BACTERIOLOGY COMPLETE

This is a supplemental program for susceptibility testing on Specimen 1 with antimicrobials other than those listed in the latest version of CLSI guidelines for Microbiology:  M02-A12, M07-A10, and M100-S27.  For CLIA grading purposes you must report these non-CLSI codes in the Bacteriology Complete report form and not in the Bacteriology report form.

URINE COLONY COUNT, BACTERIOLOGY COMPLETE

Special Safety Precautions-These specimens contain pathogens or potential pathogens and should be considered infectious and handled as though they are capable of transmitting disease. They should be handled and disposed of only by personnel trained to work with pathogenic bacteria. All laboratory precautions and safety measures appropriate to handling live cultures should be practiced when working with these specimens.

C. DIFFICILE TOXIN/ANTIGEN DETECTION

Five lyophilized specimens per testing event, 1.0 mL

Special Safety Precautions-These specimens contain pathogens or potential pathogens and should be considered infectious and handled as though capable of transmitting disease. Specimens should be handled and disposed of by personnel trained to work with pathogenic organisms. All laboratory precautions and safety measures appropriate to handling live cultures should be practiced when working with these specimens, see Program Guide - General Instructions for more precautions. Be especially careful to avoid aerosol creation, inhalation, ingestion or injection of organisms. These specimens should be autoclaved and disposed of as biohazardous waste. If the kit contains broken specimens, autoclave the kit with minimal exposure of the contents to the atmosphere and immediately request replacement samples.

Specimen Analysis-Re-suspend each specimen by adding 1.0 mL of sterile distilled water. Use a sterile syringe and needle to add the water into the vial. Gently swirl the vial to dissolve the contents. Allow 1-3 minutes for the contents to completely dissolve. Process the specimens according to your kit manufacturer’s instructions.

Report a code 10 for negative and 11 for positive. Code the instrument by entering the appropriate code from the list on the reporting form.

CAMPYLOBACTER, 2 vial supplemental

Two swabs per testing event.

Intended as supplemental program and you may report any Campylobacter test method here.  Perform test per your patient testing protocol.

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.

CHLAMYDIA/GC/STREP GROUP B ANTIGEN SCREEN

Five swab specimens per testing event for the following analytes:

Each specimen may contain one or more bacteria, but no attempt should be made to culture or stain these specimens.

Special Safety Precautions-These specimens contain pathogens or potential pathogens and should be considered infectious and handled as though they are capable of transmitting disease. They should be handled and disposed of only by personnel trained to work with pathogenic bacteria. All laboratory precautions and safety measures appropriate to handling live cultures should be practiced when working with these specimens see Program Guide - General Instructions for more precautions. Be especially careful to avoid aerosol creation, inhalation, ingestion or injection of bacteria. These specimens should be autoclaved and disposed of as biohazardous waste.

Specimen Analysis-Follow the instructions for rehydration as indicated below:

1. Insert swab into the 1 mL PBS provided.
2. Vortex 10 seconds.  Allow to soak a minimum of 30 minutes.
3. Use swab or fluid according to manufacturer’s requirements for swab or urine (fluid) samples.

Follow your manufacturer’s recommendations for this final step. If the manufacturer’s directions for incubation time in the transport media are not clear, please allow a minimum of 30 minutes.

Code your answers as either code 10 for negative or code 11 for positive. Code the method(s) used by entering the code(s) from the appropriate list(s) of methods provided on the reporting form. Specimens compatible with the DNA probe test kit.

CRYPTOSPORIDIUM/GIARDIA IMMUNOASSAY

Two formalinized fecal specimens per testing event.

Perform you normal procedure and code results as 010 for negative and 011 for positive.  Code the method used by entering the appropriate code listed on the reporting form.

These samples are not compatible with methods requiring fresh specimens.

GRAM STAIN

Five unstained samples per testing event, plus two Educational Digital Image Slides

Perform your normal staining procedure, including fixing of smears, and code your answers as either 401 (gram-negative) or 402 (gram-positive).  Code the organism morphology from the list provided on the forms.

Educational slides - Digital slide images are only available online at our website http://www.aab‐pts.org as a link to your online reporting form.  The digital slide images require access to a computer with access to the AAB-PTS website via the internet. Additionally, it requires Internet Explorer version 11.0 or later (limited support for IE 9 and 10), FireFox 4.0 or later, Safari 3 or the latest Google Chrome version.

MRSA

Two specimens per testing event, Diluents packaged separately

Inspect the fiberboard container carefully for all inclusions. Two specimens are provided for each culture program. After inventorying the contents of the container, store them in a refrigerator.

1. Remove the tube from the outside packaging. No warming is required, samples may be used cold.
2. Remove the cap that holds the swab and rehydrate using the fluid provided, then inoculate media.   If rehydration fluid is missing or leaked during transport, use 0.5 mL sterile broth, or sterile saline to rehydrate swab.
3. Test rehydrated swabs in the same manner as patient swabs.

Special Safety Precautions-These specimens contain pathogens or potential pathogens and should be considered infectious and handled as though they are capable of transmitting disease. They should be handled and disposed of only by personnel trained to work with pathogenic bacteria. All laboratory precautions and safety measures appropriate to handling live cultures should be practiced when working with these specimens.

PARASITOLOGY

Five specimens per testing event

This program will be reported to CMS. Sample 1 is a paired formalin preserved feces (1A) and a PVA slide (1B) for direct examination and concentration procedures. Do not report both (1A) (1B) samples. Specimens 2 and 3 are formalin preserved feces for direct examination and concentration procedures. Occasionally, blood smears will be substituted for fecal specimens.

For liquid samples, if you choose to shake/mix the vial, be sure to allow material to settle and concentrate at least 5 minutes before sampling. Pipette sample from the concentrated material at the bottom of the vial.

For participants using stool fixatives that contain a mercuric chloride substitute (zinc sulfate, etc.), remember that the proficiency testing specimens you receive for permanent staining have been preserved in PVA using the mercuric chloride fixative base. If you use the Trichrome or iron hematoxylin staining method for your mercuric chloride substitute fixatives, you may have eliminated the 70% alcohol/iodine step and the following 70% alcohol rinse step from your method. However, when you stain the proficiency testing fecal smears, you will need to incorporate the iodine step plus the next 70% alcohol rinse back into your staining protocol prior to placing your slides into the Trichrome stain or iron hematoxylin stain. These two steps are designed to remove the mercury from the smear and then to remove the iodine; therefore, when your slide is placed into the Trichrome or iron hematoxylin stain, both the mercury and iodine are no longer present in the fecal smear. If you fail to incorporate these two steps into your staining protocol, the quality of your proficiency testing stained smears will be poor.

Specimens 4 and 5 are digital images; therefore, do not report frequencies on specimens 4 and 5.

This program uses DigitalScopeTM, using internet access. Please review computer system requirements for using the DigitalScopeTM. Digital slide images are only available online at our website http://www.aab‐pts.org as a link to your online reporting form.  The digital slide images require access to a computer with access to the AAB-PTS website via the internet. Additionally, it requires Internet Explorer version 11.0 or later (limited support for IE 9 and 10), FireFox 4.0 or later, Safari 3 or the latest Google Chrome version.

T. saginata

       Entameba hartmanii

Enter the extent of your laboratory for parasitology using the following criteria:

Extent 0. Those that do not process or would refer this specimen to another laboratory appropriately certified for the subspecialty of parasitology for identification.

Extent 1. Those that are able to determine the presence or absence of parasites by direct observation (wet mount) and refer specimens to another laboratory appropriately certified in the subspecialty of parasitology for identification.

Extent 2. Those that identify parasites using concentration preparations and/or permanent stains.

Report the extent of your parasitology practice for each specimen based on the definitions above.

Participants that report Extent 0 on all five samples, will receive a “DC” (discontinued testing) on their graded report for that testing event.

Code your answers with the Parasitology Organism Codes listed on the reporting form.  Code 524 [parasite(s) found, not identified] is appropriate only for Extent 1 specimens.  Laboratories receiving specimens which are not routinely processed (such as blood smears) should report Extent 0 (laboratories which do not process or would refer specimen).

We are required to categorize participants who fail to report their extent(s) as Extent 2 and to grade accordingly.

Specimen Instructions

Specimen 1 is a paired formalin preserved feces (1A) and a PVA slide in a foil pouch (1B) from the same patient for direct examination and concentration procedures.

For the PVA specimen sent, remember that the proficiency testing specimens you receive for permanent staining have been preserved in PVA using the mercuric chloride free fixative base. If you use the Trichrome or iron hematoxylin staining method for your mercuric chloride substitute fixatives, you may eliminate the iodine step and the following 70% alcohol rinse step from your method.

Specimens 2 and 3 are formalin preserved feces for direct examination and concentration procedures.  Occasionally, blood smears will be substituted for a fecal specimen.

Specimens 4 and 5 are Digital Images – Stool, 1000X maximum magnification.  Use micrometer embedded in viewer to measure organisms.  The links to the slides and case histories can be found by navigating to your online Parasitology reporting form.  You may navigate throughout the slide to look for additional examples of organisms.  However, report only the identity of the selected organisms inside the selection box.

With very rare exceptions, the organisms in any proficiency testing (PT) specimens that you are asked to identify will be few to many in number.  The presence of a very rare organism probably reflects something that was not seen in the screening process.  Therefore, we ask that you report any rare secondary organism in the comments section and not in the organism result field.

Under no circumstances should you ever send any proficiency testing sample to another laboratory for testing. Per CMS requirement, this emphatically includes samples that you would normally send out for confirmation or follow up identification. This is to be followed REGARDLESS of your laboratory policy on such follow up testing. CMS will immediately revoke the license of any laboratory found to be referring proficiency testing samples, even if they are following their laboratory procedures for confirmation. Equally, CMS requires that you not perform testing on any sample that you suspect may be a proficiency testing sample received from another laboratory. You also must report laboratories you suspect of such activity. Severe penalties will apply to laboratories that perform proficiency testing for other laboratories or sites as well.

ROTAVIRUS, 2-VIAL ADD-ON, 1.0 mL

Two liquid vials per event – Supplemental testing only. Must be ordered in addition to another CMS acceptable viral antigen screen program

ROTAVIRUS, 5-VIAL, 1.0 mL

Five liquid vials per event

Special Safety Precautions - These specimens contain inactivated pathogens or potential pathogens and should be handled and disposed of as though they are capable of transmitting disease. They should be handled and disposed of only by personnel trained to work with pathogenic organisms at BSL-2.

Specimen Analysis –Process the specimens according to the manufacturer’s instructions, of your kit.

STREP GROUP A ANTIGEN SCREEN, WAIVED

Two specimens per testing event

STREP GROUP A ANTIGEN SCREEN

Five specimens per testing event

Specimens are inoculated with killed bacteria and therefore no attempt should be made to culture or stain these specimens. Participants reporting results of bacterial culture or staining techniques must subscribe to the Bacteriology,

GC Culture, Gram Stain, Throat Culture, Throat/Urine Culture or Urine Culture programs. DNA Probe methods or any other method requiring live bacteria should be tested with the Throat Culture program.

In performing a rapid Group A antigen screen on these specimens, follow the same procedure used on patient specimens.

If you use the Quidel QuickVue In-Line product or the BioStar OIA method then you must follow special instructions for proficiency testing found in the kit’s package insert. BioStar OIA participants must pre-wet each swab with 3-4 drops of Reagent 4 (wash

solution) or sterile saline prior to testing. If the specimen’s fluid content is inadequate for other procedures, add sterile saline (generally 1-2 drops) to the swab and express the fluid.

Code your answers as either code 10 for negative or code 11 for positive. Code the method used by entering the appropriate code from the list on the form.

SHIGA TOXIN

Two specimens per testing event, 1 mL

This is a two sample programs consisting of Shiga Toxin positive and negative organisms.  This is a liquid stable sample, no rehydration is required.

Introduce the required volume of specimen directly into the immunoassay per manufacturer specifications similar to what would be done for a control without further processing.

Code your answers as either 10 for negative or 11 for positive.  Be careful to select the correct line for reporting your method; Shiga Toxin 1, Shiga Toxin 2, or Shiga Toxin 1 or 2.

URINE COLONY COUNT

Two lyophilized pellets (containing pure and mixed cultures) and two dilution fluids for bacterial colony counts

This program is for supplemental testing only. You must enroll in one of our 5 vial Microbiology Culture programs for CMS reporting.

Instructions

Each Colony Count specimen consists of a lyophilized pellet in a vial contained in a foil pouch and a 99 mL dilution fluid.  Before testing, warm all appropriate media, the vial specimen and the dilution fluid to room temperature.

1. Open the lyophilized sample vial. Empty the pellet from the vial into the dilution fluid bottle.
2. Reseal the dilution fluid container and mix the contents of the container vigorously.  Mix until the pellet is completely dissolved and the suspension is homogenous in appearance.
3. The entire contents of the dilution bottle (which now contains the dissolved lyophilized pellet) simulates a urine sample.

Proceed to test as you would a patient sample in your laboratory (The bottle will accommodate dip paddles)

Under no circumstances should these samples be referred to another laboratory for further work regardless of your laboratory’s procedures.  CMS mandates that any laboratory referring proficiency testing specimens will lose their license regardless of intent!

Perform identification as per your standard laboratory procedure.  If you do not perform IDs, simply leave this line blank.  Select an identification which reflects the level to which you would typically report results.  That is do not report Staphylococcus epidermidis when you would typically only identify the organism as a general Staph species or even as normal flora.

Special Safety Precautions-These specimens contain pathogens or potential pathogens and should be considered infectious and handled as though they are capable of transmitting disease. They should be handled and disposed of only by personnel trained to work with pathogenic bacteria. All laboratory precautions and safety measures appropriate to handling live cultures should be practiced when working with these specimens.

In addition to the Precautions section on page 4, one should be especially careful to avoid aerosol creation, inhalation, ingestion or injection of bacteria. These specimens should be autoclaved and disposed of as biohazardous waste.

UREASE, RAPID (Campylobacter Like Organism – CLO)

Two specimens per testing event

This is a two sample program consisting of filter paper disks saturated with urease positive and negative organisms to simulate a tissue sample.  It should be compatible with all Rapid Urease based detection methods.

For gel methods, use sterile forceps to press the disk into the gel just as you would for a normal tissue sample.

Code your answers as either 10 for negative or 11 for positive.  

VAGINOSIS SCREEN

Five samples for molecular analysis of the following:

Swabs contain simulated clinical material and proper precautions should be taken for handling of etiologic agents.  Perform testing for the presence of Trichomonas, Gardnerella, or Candida using molecular probe test systems.

Affirm Method:        

1. Open each foil pouch at the tear slit and remove the swab from the foil pouch.

2. Place the swab into the Sample Collection Tube provided by the manufacturer.

3. Add 12 drops of Lysis Solution to the tube.

4. Rotate the swab to dislodge as much material as possible, snap or cut the shaft so that the swab fits into the tube.  Note: These swabs have not been pre-scored

Place the cap back onto the Sample Collection Tube containing the swab and proceed following the manufacturer’s instructions for extraction and automated processing.

Other Molecular Methods: Please contact your manufacturer for any special instructions for testing PT material.

Code the reagent and instrument used by entering the appropriate codes from the lists provided on the reporting form.

VIRAL ANTIGEN SCREEN, WAIVED

Two liquid samples for WAIVED METHODS ONLY, 2 events per year for the following antigens:

This program is for waived methods only. Non-Waived methods must enroll in the Viral Antigen Screen Program.

Special Safety Precautions - These specimens contain inactivated pathogens or potential pathogens and should be handled and disposed of as though they are capable of transmitting disease. They should be handled and disposed of only by personnel trained to work with pathogenic organisms at BSL-2.

Specimen Analysis – Liquid samples are ready for testing. Process the specimens according to the manufacturer’s instructions for liquid nasal wash samples.

Users of Sekisui OSOM A&B should use the following special instructions:  Add 135 μL of sample and 135 μL (maximum of 300 μL) of extraction buffer to one of the testing tube provided in the OSOM test kit. Add strip and allow to sit for 10 minutes, then read.

For Influenza methods that do not discriminate between Type A and Type B, please report results as Influenza Type A only as either Positive results as 514 or Negative results as 010.

These samples are for non‐IF antigen detection methods only.

VIRAL ANTIGEN SCREEN

Five lyophilized specimens per testing event for analysis of the following analytes:

These samples are for non-IF antigen detection methods only

Special Safety Precautions-These specimens contain pathogens or potential pathogens and should be considered infectious and handled as though they are capable of transmitting disease. They should be handled and disposed of only by personnel trained to work with pathogenic bacteria. All laboratory precautions and safety measures appropriate to handling infectious materials should be practiced when working with these specimens. In addition to the Precautions section on page 4, one should be especially careful to avoid aerosol creation, inhalation, ingestion or injection of bacteria. These specimens should be autoclaved and disposed of as biohazardous waste.

Specimen Analysis-Re-suspend each specimen by adding 1.0 mL of sterile distilled water. Use a sterile syringe and needle to add the water into the vial. Gently swirl the vial to dissolve the contents. Allow 1-3 minutes for the contents to completely dissolve. Process the specimens according to the manufacturer’s instructions for liquid nasal wash samples.

Users of Sekisui OSOM A&B should use the following special instructions.  Add 135 μL of sample and 135 μL (maximum of 300 μL) of extraction buffer to one of the testing tube provided in the OSOM test kit. Add strip and allow to sit for 10 minutes, then read.

For Influenza methods that do not discriminate between Type A and Type B, please report results as Influenza Type A only as either Positive results as 514 or Negative results as 10.

Code your answers using the result codes on the reporting form. Code your method(s) used by entering the appropriate code(s) from the lists on the reporting form.

CLIA requires a total of 5 viral antigen challenges. Be sure to test all 5 samples. Partial results or blanks will be scored as misses. Your accrediting agency may require you to perform proficiency testing for all antigen tests done in your laboratory.

KOH PREPARATION

Two specimen challenges per event.

Storage and Stability:

Store specimens at 2-8 °C until testing can be performed.

Detailed Testing Instructions:

1. Etiologic agents that may be present in these specimens have been treated to render them noninfectious; however, because no method can offer complete assurance that all organisms are nonviable, handle specimens as if capable of transmitting disease.
2. Test each specimen for the presence or absence of fungal elements as you would test a routine patient specimen by KOH prep on a glass slide.