Analyte
ABO group 100%
Rh group 100%
Rh phenotype 80%
Unexpected antibody detection 90%
Antibody identification 90%
Compatibility testing 100%
Subgroups of A Educational
Direct antiglobulin test Educational
GRADING
Grades are determined as follows:
Number of acceptable responses for each analyte
X 100 Analyte Score =
Total number of challenges for the analyte
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Immunohematology
Satisfactory – 100% score achieved for ABO/Rh group and compatibility testing, >80% score achieved for unexpected antibody detection and antibody identification, AND > 80% for Rh phenotype, if performed.
Unsatisfactory - <100% score achieved for ABO/Rh group and/or compatibility testing, <80% score achieved for unexpected antibody detection and/or antibody identification, AND/OR <80% score achieved for Rh phenotype, if performed.
The cumulative overall performance grade is determined by the current and two previous overall performance grades. A laboratory that receives an unsatisfactory overall performance on two of three consecutive testing events is considered to be unsuccessful.
NOTIFICATION
If samples have not arrived or are unacceptable for testing, the laboratory is required to notify the section within five business days of the announced shipment date. Proficiency test samples are shipped using United Parcel Service (UPS).
REPLACEMENT SAMPLES
The laboratory may request replacement samples under circumstances in which the routine laboratory practice for patient testing is to collect
additional specimens, e.g., laboratory accident or instrument failure.
Replacement samples will be provided up to the published submission date.
Page 82 of 132 Revised 06/2009
Mycobacteriology
CATEGORY DESCRIPTION
Program Contacts
Vincent E. Escuyer, Ph.D.
Jeremy Rivenburg, B.S.
Telephone: 518-474-2193
GENERAL: This category is for laboratories that process and examine acid-fast smears for mycobacteria and also isolate and identify any and all mycobacteria.
GENERAL – S: This category is for laboratories performing testing as outlined in the General category description that also perform
susceptibility testing. Laboratories in this category must identify Mycobacterium tuberculosis.
RESTRICTED: This category is for laboratories that process and
examine smears for acid-fast bacilli, isolate and identify mycobacteria as belonging to Mycobacterium tuberculosis complex and report as such.
Laboratories holding this category may also isolate and identify
Mycobacterium avium complex organisms and Mycobacterium gordonae and may isolate mycobacteria other than those included in the
Mycobacterium tuberculosis complex and submit these to a reference laboratory for identification.
RESTRICTED – S: This category is for laboratories performing testing as outlined in the Restricted category description that also perform
susceptibility testing. Laboratories in this category must identify Mycobacterium tuberculosis.
SMEARS ONLY: This category is for laboratories that only examine smears for acid-fast bacilli. Laboratories holding this category must submit all specimens for growth detection and identification to a laboratory holding a New York State permit in the appropriate Mycobacteriology category.
PROFICIENCY TESTING OFFERED
(CMS regulated analytes or tests are indicated with an asterisk) Acid Fast smears (Microscopy)*
Mycobacterium identification*
Susceptibility Testing*
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Mycobacteriology
Proficiency test samples may include, but are not limited to, the following list of organisms:
Mycobacterium abscessus Mycobacterium asiaticum Mycobacterium avium complex Mycobacterium bovis
Mycobacterium chelonae Mycobacterium flavescens Mycobacterium fortuitum Mycobacterium gastri Mycobacterium gordonae Mycobacterium intracellulare Mycobacterium kansasii Mycobacterium malmoense Mycobacterium scrofulaceum Mycobacterium shimoidei Mycobacterium szulgai
Mycobacterium terrae complex Mycobacterium tuberculosis
For all tests with no available New York State proficiency test (PT) the laboratory shall have a system for verifying the reliability and accuracy of test results and shall perform this verification process at least twice each year.
TEST KIT AND FREQUENCY OF MAILING
Smears Only - Proficiency test kits consist of five slides for microscopy and are mailed overnight delivery twice per year.
Restricted /General - Proficiency test kits consist of five slides for
microscopy and five samples for identification. These samples are mailed overnight delivery twice per year.
Restricted S /General S - Proficiency test kits consist of five slides for microscopy and five samples for identification and susceptibility testing.
These samples are mailed overnight delivery twice per year.
SOURCE OF SAMPLES
Samples are prepared by Wadsworth Center staff from well-characterized strains or from clinical specimens. A suspension of hog gastric mucin is seeded with live strains of Mycobacterium sp. and/or normal flora.
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Mycobacteriology
SAMPLE VALIDATION
Acceptable responses must be authenticated by 80% or more of the reference laboratories or 90% of the laboratories holding a New York State permit.
GRADING
Grades are determined as follows:
Microscopy 20 points per slide Identification
20 points per sample Susceptibility Testing
Each organism found within the Mycobacterium tuberculosis complex will receive an equal number of points for each of the five first line drugs.
Final grade is a combination of the grades for microscopy, identification and susceptibility as appropriate for the category.
Failure to attain an overall testing score of at least 80% is unsatisfactory performance.
NOTIFICATION
The laboratory is required to notify the section within three days of shipment that samples have not arrived or are unacceptable for testing.
Proficiency test samples are shipped using Federal Express.
REPLACEMENT SAMPLES
The laboratory may request replacement samples under circumstances where in routine laboratory practice the recourse in patient testing is to collect additional specimens, e.g., laboratory accident or instrument failure. Replacement samples will be provided up to three business days from the shipment date.
Page 85 of 132 Revised 06/2009
Mycology
CATEGORY DESCRIPTION
Program Contacts
Vishnu Chaturverdi, Ph.D.
Ping Ren, Ph.D.
Telephone: 518-474-4177
E-mail:
[email protected] Web:
www.wadsworth.org/ptp/mycology
GENERAL: This category is for laboratories that isolate and identify to genus or, when clinically relevant, to genus and species fungi (yeasts and molds) routinely encountered in a clinical microbiology laboratory.
Laboratories that cannot satisfactorily identify molds but can identify yeast-like fungi may hold a permit in Mycology -Yeast only. This category now includes anti-fungal susceptibility testing.
YEAST ONLY: This category is for laboratories that isolate and identify to genus and species yeast-like fungi routinely encountered in a clinical microbiology laboratory. Yeasts are defined as, but not limited to,
unicellular fungi that may be identified with commercial yeast identification systems. This category now includes anti-fungal susceptibility testing for yeast.
DIRECT DETECTION: This category is for laboratories that perform direct antigen detection methods.
RESTRICTED: This category is for laboratories that perform only KOH preparations or any mycology test not subject to proficiency test
requirements.
Page 86 of 132 Revised 06/2009
Mycology
PROFICIENCY TESTING OFFERED
(CMS regulated analytes or tests are indicated with an asterisk) Culture and Identification*
Susceptibility testing for yeast Cryptococcus neoformans Antigen
Yeast proficiency test samples may include, but are not limited to, the following list of organisms:
Blastoschizomyces capitatus Geotrichum klebahnii Candida albicans Geotrichum penicillatum Candida ciferrii Geotrichum sp.
Candida dubliniensis Hansenula anomala Candida famata Hansenula sp.
Candida glabrata Kodamaea ohmeri
Candida guilliermondii Malassezia furfur complex Candida haemulonii Malassezia pachydermatis Candida inconspicua Malassezia sp.
Candida kefyr Pichia anomala Candida krusei Pichia guilliermondii Candida lambica Pichia ohmeri Candida lipolytica Pichia sp.
Candida lusitaniae Prototheca sp.
Candida norvegenesis Prototheca wickerhamii Candida parapsilosis Prototheca zopfii Candida pelliculosa Rhodotorula glutinis Candida pseudotropicalis Rhodotorula minuta Candida rugosa Rhodotorula mucilaginosa
Candida sp. Rhodotorula rubra
Candida tropicalis Rhodotorula sp.
Candida utilis Saccharomyces cerevisiae Candida viswanathii Saccharomyces sp.
Candida zeylanoides Schizosaccharomyces sp.
Clavispora lusitaniae Sporobolomyces salmonicolor Cryptococcus albidus Torulopsis famata
Cryptococcus gattii Torulopsis glabrata Cryptococcus humicola Trichosporon asahii
Cryptococcus laurentii Trichosporon beigelii Cryptococcus neoformans Trichosporon capitatum
Cryptococcus sp. Trichosporon cutaneum Cryptococcus terreus Trichosporon inkin Cryptococcus uniguttulatus Trichosporon mucoides Geotrichum candidum Trichosporon sp.
Geotrichum capitatum Yarrowia lipolytica
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Mycology
Mold proficiency test samples may include, but are not limited to, the following list of organisms:
Absidia coerulea Cokeromyces recurvatus Absidia corymbifera Cokeromyces sp.
Absidia sp. Conidiobolus coronatus Acremonium sp. Conidiobolus sp.
Alternaria alternata Cunninghamella bertholletiae Alternaria sp. Cunninghamella sp.
Aphanoascus fulvescens Curvularia sp.
Aphanoascus sp. Cylindrocarpon sp.
Apophysomyces elegans Dactylaria constricta var. gallopava Apophysomyces sp. Dactylaria sp.
Arthrographis kalrae Drechslera biseptata Arthrographis sp. Drechslera sp.
Aspergillus candidus Emericella nidulans
Aspergillus clavatus Emmonsia parva
Aspergillus flavus Emmonsia sp.
Aspergillus fumigatus Engyodontium album Aspergillus glaucus Epicoccum sp.
Aspergillus nidulans Epidermophyton floccosum Aspergillus niger Epidermophyton sp.
Aspergillus ochraceus Eurotium sp.
Aspergillus sp. Exophiala dermatitidis Asperigillus sydowii Exophiala jeanselmei Aspergillus terreus Exophiala moniliae Aspergillus thermomutatus Exophiala sp.
Aspergillus ustus Exophiala spinifera Aspergillus versicolor Exserohilum rostratum Athrinium sp. Exserohilum sp.
Aureobasidium pullulans Fonsecaea compacta Aureobasidium sp. Fonsecaea pedrosoi Basidiobolus ranarum Fonsecaea sp.
Basidiobolus sp. Fusarium oxysporum Beauveria bassiana Fusarium solani
Beauveria sp. Fusarium sp.
Bipolaris sp. Geomyces sp.
Blastomyces dermatitidis Gliocladium sp.
Blastoschizomyces sp. Helminthosporium sp.
Botrytis sp. Hendersonula toruloidea Chaetomium globosum Hendersonula sp.
Chaetomium sp. Histoplasma capsulatum Chrysosporium keratinophilum Hormonema sp.
Chrysosporium sp. Humicola sp.
Cladophialophora carrionii Lecythophora sp.
Cladophialophora sp. Leptosphaeria sp.
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Mycology
Cladosporium sp. Madurella sp.
Metarrhizium sp. Scedosporium sp.
Microsporum audouinii Schizophyllum commune Microsporum canis Schizophyllum sp.
Microsporum cookei Scopulariopsis brevicaulis Microsporum gypseum Scopulariopsis brumptii Microsporum nanum Scopulariopsis sp.
Microsporum persicolor Scytalidium dimidiatum Microsporum sp. Scytalidium hyalinum Mortierella sp. Scytalidium lignicola Mucor circinelloides Scytalidium sp.
Mucor racemosus Sepedonium sp.
Mucor sp. Sporothrix schenckii
Myceliophthora sp. Sporothrix sp.
Nattrassia mangiferae Sporotrichum sp.
Neosartorya pseudofischeri Stachybotrys atra Neosartorya sp. Stachybotrys sp.
Nigrospora sp. Stemphylium sp.
Oidiodendron sp. Syncephalastrum racemosum Onychocola canadensis Syncephalastrum sp.
Ophiostoma stenoceras Trichoderma sp.
Paecilomyces lilacinus Trichophyton ajelloi Paecilomyces sp. Trichophyton concentricum
Paecilomyces variotii Trichophyton equinum Penicillium marneffei Trichophyton erinacei Penicillium sp. Trichophyton fischeri Phaeoannellomyces sp. Trichophyton interdigitale Phaeoannellomyces werneckii Trichophyton kanei Phialemonium sp. Trichophyton megninii
Phialophora richardsiae Trichophyton mentagrophytes Phialophora sp. Trichophyton raubitschekii Phialophora verrucosa Trichophyton rubrum Phoma sp. Trichophyton schoenleinii Pithomyces sp. Trichophyton soudanense Pseudallescheria boydii Trichophyton sp.
Pseudallescheria sp. Trichophyton terrestre Rhinocladiella sp. Trichophyton tonsurans Rhizomucor pusillus Trichophyton verrucosum Rhizomucor sp. Trichophyton violaceum Rhizopus oryzae Trichothecium sp.
Rhizopus sp. Ulocladium sp.
Saksenaea vasiformis Ustilago sp.
Scedosporium apiospermum Verticillium sp.
Scedosporium inflatum Wallemia sp.
Scedosporium prolificans Wangiella dermatitidis
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Mycology
For all tests with no available New York State proficiency test (PT) the laboratory shall have a system for verifying the reliability and accuracy of test results and shall perform this verification process at least twice each year.
TEST KIT AND FREQUENCY OF MAILING
General - Proficiency test kits for the category consist of five mold samples and are mailed three times per year. The second event of the year contains samples for yeast only. One known yeast specimen will be included for laboratories offering antifungal susceptibility testing.
Yeast Only - Proficiency test kits for the category consist of five yeast samples and are mailed three times per year. One known yeast
specimen will be included for laboratories offering antifungal susceptibility testing.
Direct Detection - Proficiency test kits for the category consists of five samples and are mailed two times per year.
SOURCE OF SAMPLES
The proficiency test samples are prepared by Wadsworth Center staff from clinical and reference fungal strains available in the collection collection. Crytococcus antigen samples are prepared and standardized according to the method described by Evans and Theriault (1953).
SAMPLE VALIDATION
Acceptable responses must be authenticated by 80% or more of the referee or participating laboratories.
Page 90 of 132 Revised 06/2009
Mycology
GRADING
Grades are determined as follows:
Identification of Molds and Yeast
Number of acceptable responses
X 100 Event Score =
Number of fungi present + Number of Incorrect Responses
Antifungal Susceptibility
A maximum score of 100 is equally divided among the drugs selected by the individual laboratory. Acceptable results for antifungal susceptibility testings are MICs with +/- 2 dilutions range and interpretation where applicable as per NCCL/CLSI guidelines.
Direct Antigen Detection
Presence of Absence of Cryptococcus neoformans antigen
Failure to attain an overall testing score of at least 80% is unsatisfactory performance.
NOTIFICATION
The laboratory is required to notify the section within five days of
shipment that samples have not arrived or are unacceptable for testing.
Proficiency test samples are shipped using Federal Express.
REPLACEMENT SAMPLES
The laboratory may request replacement samples under circumstances where in routine laboratory practice the recourse in patient testing is to collect additional specimens, e.g., laboratory accident or instrument failure. Replacement samples for the category Yeast-Only will be provided up to five business days from the shipment date. Replacement samples for the category General will be provided up to ten business days from the shipment date.
Page 91 of 132 Revised 06/2009
Oncology
CATEGORY DESCRIPTION
Program Contacts
Erasmus Schneider, Ph.D.
Telephone: 518-474-2088 E-mail:
[email protected] Soluble Tumor Markers:
M. Pat Fox, M.S. Molecular and Cellular Tumor Markers:
This category includes tests used in tumor screening, diagnosis,
prognosis and management, including the standard serum-based tumor markers, as well as tests for tumor cell specific alterations. Due to the different methodologies used, there are two categories:
SOLUBLE TUMOR MARKERS (formerly Sera and Soluble Tumor Markers): This category is for laboratories performing tests for soluble tumor markers found in body fluids such as serum, urine, etc. Results from these tests are generally quantitative. Methodologies used include radioimmunoassay (RIA), enzyme immunoassay (EIA), or
chemiluminoassay, as well as mass spectrometry and bead-based assays such as Luminex.
MOLECULAR AND CELLULAR TUMOR MARKERS: This category is for laboratories performing tests on cellular material to detect tumor-specific acquired genetic or phenotypic alterations. It includes, but is not limited to, tests that detect gene rearrangements, chromosomal
translocations, and/or mutations as well as detection of altered
gene/protein expression. Also included in this category are the detection of gene amplifications in interphase cells only (e.g. Her2/neu,
UroVysion™, TOP2A, etc.) and ex-vivo determination of
chemotherapeutic drug sensitivity. Methodologies used are generally, though not exclusively, molecular biology-based, such as those involving an amplification step, hydridization and electrophoresis, and any
combination of these. Results can be qualitative or quantitative.
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Oncology
PROFICIENCY TESTING OFFERED
(CMS regulated analytes or tests are indicated with an asterisk) Soluble Tumor Markers
alpha-fetoprotein tumor markers (AFPTM)*
CA125 CA15-3 CA19-9 CA27.29
Carcinoembryonic antigen (CEA) Prostate Specific Antigen (PSA) Complexed PSA (cPSA) Free PSA (fPSA)
% Free PSA
Molecular and Cellular Tumor Markers
Gene rearrangements and chromosome translocations, and gene mutations associated with leukemia/lymphoma
TEST KIT AND FREQUENCY OF MAILING
Soluble Tumor Markers - Proficiency test kits consist of five samples and are mailed three times per year.
Molecular and Cellular Tumor Markers - Proficiency test kits consist of three samples and are mailed three times per year.
SOURCE OF SAMPLES
Soluble Tumor Markers -The proficiency test samples are prepared by Wadsworth Center staff. The base matrix consists of a bovine serum albumin solution in phosphate buffered saline supplemented with the test analytes.
Molecular and Cellular Tumor Markers - The proficiency test samples are prepared by Wadsworth Center staff. The base matrix consists of normal donated whole blood supplemented with leukemia or lymphoma cells.
Page 93 of 132 Revised 06/2009