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New York State Laboratory Permit
New York State Laboratory Permit
Category Descriptions 2009-2010
Category
Andrology
This category is required for laboratories that perform andrology tests on patients and/or donors for the assessment of fertility or for the assessment of semen intended for use in artificial insemination or assisted reproductive procedures. These tests include, but are not limited to, sperm concentration/count, sperm motility, sperm morphology, semen biochemical tests, cervical mucus penetration tests, anti-sperm or anti-ovary antibody tests, sperm-egg interaction tests, and post-vasectomy testing. Post-vasectomy testing for the presence or absence of viable sperm may also be performed under the category of Hematology. Measurements of hormones, such as FSH or LH activity, are included in the Endocrinology category; molecular tests for Y chromosome genes or other inherited forms of infertility are included in the Genetic Testing category.
Bacteriology
General. This category is for laboratories that examine any type of clinical specimens for aerobic and/or anaerobic bacteria. These laboratories are expected to identify organisms to the genus and species level and may also perform antimicrobial susceptibility testing, molecular assays and direct detection techniques. This category also includes the testing described under any of the categories listed below.
Gram Stains. This category is for
laboratories that prepare and examine gram-stained smears
for the presence of bacterial organisms.
Restricted. This category is for
laboratories that restrict their testing to one or more of
the following:
Gonorrhea And Chlamydia, for laboratories
testing specimens for Neisseria gonorrhoeae and/or
Chlamydia trachomatis.
Throat Cultures, for laboratories that
perform throat cultures for Group A Streptococcus
only.
Urine Screening, for laboratories
performing diagnostic tests for the presence of bacteria in
urine. These laboratories may report growth/no growth of
bacteria or may report a quantitative result.
Urine Culture, for laboratories that
isolate and identify bacteria from urine by culture.
Identification may range from gram stain reactions to full
genus and species identification, as well as antimicrobial
susceptibility testing.
Antigen Detection, for laboratories that
use antigen detection techniques to examine specimens for
Neisseria meningitidis, Streptococcus pneumoniae,
Haemophilus influenzae, Group B Streptococcus and/or
Escherichia coli K1.
Direct Detection - Group A Streptococcus,
for laboratories using direct detection techniques to
examine throat specimens for the presence of Group A
Streptococcal antigens.
Other. This category is for laboratories
that perform only specialized tests, including molecular
assays.
Blood pH and Gases
This category is for laboratories performing measurements
of blood pH, pCO2 and/or pO2. Blood Gas laboratories may
also perform testing for carboxyhemoglobin, oxyhemoglobin,
methemoglobin and carbon monoxide under this category or
they may be performed by a laboratory holding the category
of Clinical Chemistry.
Blood Services
Blood banks that collect and test blood for transfusion must hold the category below that describes the scope of their services. Blood banks may also need to hold additional categories as follows, if testing is performed on-site: Immunohematology (tests related to blood collection and transfusion, and/or other immunohematologic tests), Diagnostic Immunology-Donor Services Serology (serologic tests for infectious agents), HIV (Screening Tests Only, General or Viral Identification, for donor HIV testing), Clinical Chemistry (ALT or total protein testing), Hematology (donor and unit related hematologic tests), Virology-Molecular Techniques Only (nucleic acid testing for viral agents other than HIV) and Bacteriology-Restricted (bacterial detection).
Collection. This category is required for blood banks that collect blood or plasma for transfusion purposes, with or without the collection of autogeneic (autologous) units. If the blood bank performs any testing (blood grouping, hemoglobin, etc.) on blood donors, it must also hold the appropriate categories as described above.
Collection - Autogeneic (Autologous) Only.
This category is required for blood banks that collect only blood for autogeneic (autologous) transfusion and do not cross over these units or their components for allogeneic use. If the blood bank performs any testing (blood grouping, hemoglobin, etc.) on autogeneic blood donors, it must also hold the appropriate categories as described above.
Transfusion. This category is required for blood banks that perform pre-transfusion testing and issue blood or blood components for transfusion. Such sites must also hold Immunohematology. A permit in Blood Services-Transfusion covers transfusions performed at any facility owned and operated by the hospital AND located on the campus of the hospital. Non-hospital based facilities performing transfusions on-site that do not meet these criteria must apply for designation as a
LIMITED TRANSFUSION SERVICE. Requests for information about Limited Transfusion Services should be directed to the Blood and Tissue Resources Program at (518) 485-5341.
Transfusion/Storage Only. This category is required for hospital transfusion services that issue blood or blood components for transfusion, but perform no pre-transfusion testing on-site. If ABO and/or Rh grouping are performed, Immunohematology must also be held.
Plasma Processing. This category is required for facilities that fractionate plasma into infusable derivatives and/or perform viral inactivation/reduction of pooled plasma.
Cellular Immunology
Laboratories analyzing the function and/or phenotype of cells in the immune system must hold any or all of the categories below that describe the scope of their services.
Lymphoid Function. This category includes testing lymphocyte function by
in vitro assays (e.g., antigen-induced proliferation, alloantigen-stimulated proliferation, mitogen-stimulated proliferation, cytolytic assays, and cytokine or immunoglobulin production). The determination of cytokines in serum, plasma or CSF is included in the Cytokine category.
Lymphoid and T-Lymphoid Immunophenotyping.
These categories include identification and enumeration of non-malignant lymphocytes that bear different surface markers for the purpose of assessing the immunological status of an individual (e.g., quantifying CD4+ T-lymphocytes).
Lymphoid Immunophenotyping. This category is for laboratories that perform tests for any markers in addition to CD3/CD4 and CD3/CD8.
T-Lymphoid Immunophenotyping. This category is for laboratories that restrict their testing to the CD3/CD4 and CD3/CD8 markers. Laboratories in this category will take a proficiency test restricted to the quantification of the CD4+ and CD8+ T-Lymphoid populations.
Non-Lymphoid Function. This category includes testing monocytic
and myeloid functions by in vitro assays (e.g., neutrophil generation of reactive oxygen species, monocyte phagocytosis, and production of cytokines.) Analysis of serum, plasma or CSF cytokines is included in the Cytokine category, described below.
Non-Lymphoid Immunophenotyping. This category includes methodologies to quantify the number of non-malignant leukocytes other than lymphocytes (e.g., viable Lin-/CD34+ stem cells; CD55 & CD59 for PNH; CD15s, CD11a, b, c & CD18 for LAD; and TLRs for innate immunity).
Malignant Leukocyte Immunophenotyping.
This category includes identification and characterization of leukemias or lymphomas in blood and tissue specimens based on cell phenotype (including cell surface and cytoplasmic antigens) with or without ploidy analysis.
Clinical Chemistry
This category is for laboratories performing one or more of
the analytes available in the New York State proficiency
testing program. A list of these analytes can be found in
the Program
Guide available on our website. All diagnostic clinical
chemistry tests including substrates, enzymes,
electrolytes, and metal analyses are included in this
category, and laboratories issued a Clinical Chemistry
permit may perform a full scope of clinical chemistry
testing except in those areas defined by the Blood pH and
Gases, Trace Elements, Therapeutic Substance
Monitoring/Quantitative Toxicology, Endocrinology and/or
the Genetic Testing-Biochemistry categories.
Clinical Chemistry-Restricted. This
category is for laboratories that only perform tests for
substrates, enzymes, and electrolytes that are not included
in the New York State proficiency testing program for
clinical chemistry, except for tests that are included in
the Blood pH and Gases, Trace Elements, Therapeutic
Substance Monitoring/Quantitative Toxicology, Endocrinology
and/or the Genetic Testing-Biochemistry categories. A list
of the tests included in the New York State proficiency
testing program for clinical chemistry is included in the
Program
Guide available on our website.
Cytogenetics
Cytogenetics is the analysis of the numerical and structural chromosome complement of human cells. Methods used include metaphase chromosome analysis by G-banding, fluorescence in situ hybridization (FISH), and comparative genomic hybridization (CGH). Please note that FISH to detect structural chromosome aberrations and/or to enumerate chromosome number must be performed as an adjunct method to standard metaphase chromosome analysis. Laboratories performing CGH must hold permits in both Cytogenetics and Genetic Testing - Molecular. Alternatively, a cytogenetics laboratory may document joint efforts with a genetic testing laboratory to assure appropriate integrated molecular and confirmatory cytogenetics services for CGH.
Prenatal. Laboratories may perform prenatal and preimplantation cytogenetic diagnosis. Laboratories applying for this category must satisfy reference sample (dual evaluation) requirements for amniotic fluid, chorionic villus and fetal blood specimens, and must submit method validation documentation for approval to offer preimplantation testing.
Restricted. Laboratories may perform cytogenetic tests exclusive of prenatal diagnosis and cancer cytogenetics.
Cancer. Laboratories may perform diagnostic evaluations of blood dyscrasias and acquired cytogenetic changes of neoplasias. Approved laboratories may offer FDA-cleared UroVysion™ (Abbott Molecular, Inc.) assay under their Cytogenetics - Cancer permit; laboratories holding the permit category of Oncology - Molecular and Cellular Tumor Markers may continue to offer this assay.
Cytokines
This category includes the quantification of cytokines in serum, plasma, or CSF,
including but not limited to, interleukins, chemokines, or interferons, by methods
such as ELISA, FIA, or RIA. Cytokines include both immune-active molecules as well
as molecules that influence the activity of other organ systems. The measurement
of cytokines in leukocytes, or the measurement of cytokines in supernatant
from in vitro lymphocyte or leukocyte cultures would be included in the appropriate Cellular Immunology category (Lymphoid Function or Non-Lymphoid Function).
Cytopathology
This category is for laboratories examining cells and tissue fragments that have
exfoliated freely from tissue surfaces or that have been collected by brushing,
scraping, washing, lavage or needle aspiration. The laboratory must hold each
appropriate subcategory for the testing being performed as described below:
Gynecological Testing Not Including HPV. This category is for laboratories that perform gynecological cytopathology testing on patient specimens for diagnostic or prognostic purposes. All laboratories offering gynecologic cytopathology services are required to enroll in a proficiency testing program approved by the Centers for Medicare and Medicaid Services (CMS). The New York State Department of Health is currently not approved by CMS.
Non-Gynecological Testing. This category is for laboratories that perform non-gynecological cytopathology testing on patient specimens for diagnostic or prognostic purposes.
Diagnostic Immunology
The Diagnostic Immunology categories are for laboratories
performing the following types of tests:
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Serologic tests for autoantibodies, excluding tests for antibodies against blood cells performed under the categories of Hematology, Immunohematology, and Histocompatibility; and excluding tests for antibodies against spermatozoa performed under the category of Andrology.
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Serologic tests for specific markers of infectious diseases or exposure to such diseases (e.g., antibody/antigen), excluding tests for HIV, which are performed under the HIV category.
-
Tests for nonspecific indicators of infectious diseases or exposure to such diseases (e.g., immunoglobulin or complement levels).
Diagnostic Services Serology. This
category is for laboratories that perform any diagnostic
immunologic test on patient specimens for diagnostic or
prognostic purposes.
Donor Services Serology. This category is for donor banks,
and laboratories under contract to donor banks, that perform tests on donors
of human organs, tissues and/or blood for transfer, transfusion or transplantation.
Mandated tests include syphilis-reagin or treponemal antibody, hepatitis B surface
antigen (HBsAg), hepatitis B core antibody (anti-HBc), hepatitis C antibody
(anti-HCV), and human T lymphotropic virus I/II antibody. However, donor
banks that perform any additional serologic tests, e.g., cytomegalovirus
(CMV) antibody, must also hold this category. Donor Services laboratories
must also hold the category Diagnostic Services Serology if they perform tests
on patient specimens for diagnostic or prognostic purposes.
Endocrinology
This category is for laboratories evaluating endocrine function and vitamin status in the body
by measuring hormones, vitamins and related analytes in body fluids.
Fetal Defect Markers
This category is for laboratories performing gestational age-dependent (any trimester or combinations thereof)
assays to screen for chromosomal abnormalities or other defects of the fetus (e.g., neural tube defects).
The analytes are measured in maternal serum, amniotic fluid, and other bodily fluids. Results from these
tests are generally quantitative. Methodologies used include radioimmunoassay (RIA), enzyme immunoassay (
EIA) or chemiluminoassay. Results must be compared to the individual laboratory normative data of weekly
values. Laboratories that measure gestational age-dependent AFP in amniotic fluid for neural tube defects
by quantitative methods and as a statistical comparison to an internal normative curve must also determine
contamination with fetal blood. Methods used include counter immunoelectrophoresis, radioimmunodiffusion,
isoelectric focusing (centrifuged fluids), and Kleinhauer-Betke elution technique (uncentrifuged fluids) for the determination of fetomaternal bleed occurring during amniocentisis.
Amniotic fluid screening results for neural tube defects need to be confirmed by electrophoretic
identification of acetylcholinesterase. Please note that Prenatal screening for chromosomal abnormalities using plasma-derived DNA or RNA amplification techniques (e.g., SEQureDx) is performed under the category of Cytogenetics - Prenatal.
Forensic Identity
This category is for laboratories that perform procedures for the determination of identity, or for the
determination of parentage, for forensic purposes. At this time, the standards for this category are those
on 1) the New York State DOH Forensic Identity Standards and 2)the recommendations of the federal DNA Advisory
Board (DAB) and issued by the Director of the Federal Bureau of Investigation as the "Quality Assurance
Standards for Forensic DNA Testing Laboratories" issued in October 1998 and the "Quality Assurance Standards
for Convicted Offender DNA Databasing Laboratories" issued in April 1999. Additional information relating
to these standards can be found in the document "Quality Assurance Audit For Forensic DNA and Convicted
Offender DNA Databasing Laboratories". The standards and the DBA audit document can be accessed via the FBI's web site at
www.fbi.gov.
Genetic Testing
The Genetic Testing categories are for laboratories performing procedures for the purpose of providing
information for the diagnosis of a genetic disease or its carrier state or risk assessment for drug metabolism,
disease susceptibility and/or hemostasis. Predisposition testing for inherited cancers; preimplantation
diagnosis (including molecular analysis of blastocysts from embryos to detect single gene disorders,
haplotype analysis for complex mutations, or HLA haplotyping for a sibling match prior to implantation)
and pharmacogenetics applications are all included in the Genetic Testing category.
This category includes the use of genetic markers to test for zygosity for pregnancy management and
maternal cell contamination in the context of genetic diagnosis and tests using genetic markers to
monitor disease progression. Laboratories performing comparative genomic hybridization (CGH) must
hold permits in both Cytogenetics and Genetic Testing - Molecular. Alternatively, a laboratory performing Genetic testing may document joint efforts with a cytogenetics laboratory to assure appropriate integrated molecular and confirmatory cytogenetics services for CGH. Some applications of these
methodologies are not included in the Genetic Testing categories. Laboratories may also need to hold the additional categories including Forensic Identity, Histocompatibility, Immunohematology, Parentage/Identity, and Oncology - Molecular and Cellular Tumor Markers (for somatic changes in tumor tissue) due to the purpose of testing.
Genetic Testing - Molecular. Diagnostic genetic testing utilizing DNA and/or RNA-based methodologies.
Genetic Testing - Biochemistry. Genetic testing utilizing biochemical
procedures in laboratories where a specific genetic diagnosis or carrier status is
being determined.
Hematology
Cellular Hematology. Laboratories performing one or more of the following cellular hematology tests: white cell count, red cell count, hemoglobin, hematocrit, automated differentials, and platelet count, with or without other tests such as red cell indices, reticulocyte count, and erythrocyte sedimentation rate must hold this category. Laboratories performing manual differentials, or manual confirmation of abnormal automated differentials, must hold the Cytohematology Diagnostic category described below.
Coagulation. Laboratories performing routine coagulation testing including prothrombin time, activated partial thromboplastin time and quantitative fibrinogen, with or without other tests such as thrombin time, factor assays and bleeding time, must hold this category.
Cytohematology Diagnostic. Laboratories performing manual differentials, smear examinations, or automated differentials with manual confirmation performed on-site must also hold this category. If blood-borne parasites are observed during the routine smear examination, they may be reported, however the examination of blood smears specifically for parasites, or the identification of parasites beyond the genus level, requires a permit in the Parasitology-Blood Borne Parasites category.
Histocompatibility
General. This category is for laboratories performing all phases
of histocompatibility testing for organ/tissue transplantation. Testing should
include HLA antigen typing, antibody screening, and when necessary, crossmatching.
Please note that HLA testing for pharmacogenetics must be performed under the
category of Genetic Testing - Molecular. Laboratories performing testing to monitor the status of a patient following an organ or tissue transplant must hold the category of Transplant Monitoring.
HLA Typing Only. This category is for laboratories offering only HLA antigen typing. This category would apply to those laboratories performing histocompatibility testing for initial pre-transplant typing, bone marrow donor screenings or for disease associations.
Histopathology
The Histopathology categories are for laboratories performing gross and microscopic examination of tissues, including immunohistochemistry tests. Laboratories performing Human papillomavirus (HPV) on tissue only may do so under this category and are not required to participate in New York State proficiency testing for HPV at this time.
General. Testing includes all tissue.
Oral Pathology. Testing is limited to the
oral cavity.
Dermatolopathology. Testing is limited to
skin.
Human Immunodeficiency Virus
The Human Immunodeficiency Virus (HIV) categories are for laboratories performing serological or molecular tests for HIV for diagnostic or prognostic purposes; for expedited maternal/newborn testing; for screening potential candidates for donations of gametes, blood, or other body fluids; for testing insurance applicants; and/or for laboratories performing HIV testing as part of a clinical trial. Laboratories applying for the Screening Only, General or Viral Identification categories must have a director or assistant director with a certificate of qualification in Diagnostic Immunology and/or Virology, as appropriate to the testing performed.
Screening Tests Only. This category is for
laboratories performing initial antibody testing for HIV,
or p24 antigen tests, but NOT performing
any confirmatory tests such as Western blot or IFA.
General. This category is for laboratories
performing any testing included in the Screening Tests Only-
category and performing confirmatory tests such as Western
blot or IFA, or for laboratories performing only
confirmatory testing.
Viral Identification. This category is for
laboratories performing molecular methods for qualitative
detection, quantitation, genotyping, phenotyping, or
cultivation of the virus.
Immunohematology
Laboratories that perform red blood cell, granulocyte or platelet related testing for blood collection, transfusion or pregnancy associated purposes must hold this category. Methodologies include serologic, molecular and flow cytometric techniques for tests such as:
- Red blood cell antigen and antibody testing
- Direct antiglobulin testing
- Compatibility testing
- Granulocyte antigen and antibody testing
- Platelet antigen and antibody testing
- Assessment of fetomaternal hemorrhage
Mycobacteriology
General This category is for laboratories that process and examine acid-fast smears
for mycobacteria perform culture. These laboratories may also 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 complex.
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.
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.
Yeasts 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.
Oncology
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.
Human Papillomavirus (HPV) Testing. This category is for laboratories that perform HPV testing on patient specimens for diagnostic or prognostic purposes regardless of methodology.
Parasitology
General. This category is for laboratories that examine patient specimens (feces, blood, urine, tissue biopsies and touch-preps) for parasites. In order to qualify for a permit in Parasitology-General, laboratories will be required to demonstrate proficiency in diagnostic techniques for intestinal and blood parasites.
Blood-Borne Parasites Only. This category
is for laboratories that only examine blood smears for
blood-borne parasites.
Restricted. This category is for
laboratories with a restricted test menu, for example,
laboratories that perform only specialized tests (including
molecular assays) not subject to proficiency testing.
Parentage/Identity Testing
The Parentage/Identity testing categories are for laboratories that perform procedures for determination of parentage, including human leukocyte antigen testing and DNA testing. Laboratories performing parentage and/or identity tests for forensic purposes must hold a permit in the Forensic Identity category. Laboratories performing parentage or identity testing for non-forensic purposes must hold this category.
Therapeutic Substance Monitoring/Quantitative Toxicology
This category is for laboratories providing quantitative analysis of drugs (therapeutic or abused) in serum and/or blood. Drugs represented include, but are not limited to, digoxin, procainamide, quinidine, phenobarbital, phenytoin, gentamicin, theophylline, acetaminophen, salicylate, lithium and ethanol, including breath alcohol for non-forensic purposes.
Toxicology
Laboratories that provide toxicology testing must hold a
permit in one or more of the following categories:
Blood Lead. This category is for laboratories that perform blood lead measurements. Electrolytes such as sodium, potassium, magnesium and calcium are included under the Clinical Chemistry category. Trace elements such as arsenic, cadmium, mercury, copper, zinc, selenium and aluminum are included under the Trace Elements category.
Erythrocyte Protoporphyrin. This category
is for laboratories that perform erythrocyte protoporphyrin
determination using an extraction method with a
conventional fluorometer or a hematofluorometer.
Forensic Toxicology. The Forensic Toxicology categories are for laboratories that provide the analysis of urine and alternative specimens, including hair, oral fluid, sweat and breath, for abused substances where the legal defensibility of laboratory services must be established and maintained. Such services include pre-employment screening; for cause (i.e., incident/accident-related) and return to work testing, random employment testing; any testing situation where employment, benefits or services may be terminated or denied as the result of positive finding; and postmortem toxicology testing conducted by private sector laboratories. Laboratories qualifying for these categories must have protocols for specimen chain-of-custody and laboratory security.
Forensic Toxicology - Initial Testing
Only. This category is appropriate for laboratories that offer forensic drug-testing limited to initial (screening) testing only. Laboratories holding this category must refer presumptive positive specimens to a laboratory holding a Forensic Toxicology-Comprehensive permit for confirmatory testing.
Forensic Toxicology - Comprehensive This category is appropriate for laboratories that offer on-site confirmation analysis of presumptive positive drug screens using confirmatory methods acceptable to the Department.
Clinical Toxicology. The Clinical Toxicology categories are for laboratories that offer qualitative toxicology testing, including ethanol, the results of which are intended to assist medical professionals in patient management.
Clinical Toxicology - Initial Testing
Only. This category is appropriate for laboratories that offer a clinical toxicology testing but do not provide on-site confirmation of presumptive positive initial tests.
Comprehensive. This category is appropriate for laboratories that provide clinical toxicology testing, including on-site confirmation of presumptive positive initial tests.
Trace Elements
This category is for laboratories that perform testing for trace elements (e.g., arsenic, cadmium, mercury, copper, zinc, selenium, aluminum) in clinical specimens, including whole blood, serum or urine. Laboratories that perform blood lead testing must apply for the Toxicology - Blood Lead category. Electrolytes such as sodium, potassium, calcium and magnesium are included under the Clinical Chemistry category.
Transplant Monitoring (formerly Engraftment Monitoring)
This category is for laboratories performing testing to monitor the status of a patient following an organ or tissue transplant. This includes engraftment monitoring, molecular assays that monitor for rejection and the Cyclex ImmunKnow assay for monitoring immune status following transplant.
Urinalysis
This category is for laboratories that perform a qualitative or semi-quantitative analysis of urinary glucose, protein, ketones, pH, hemoglobin, bilirubin, specific gravity, and a microscopic evaluation of urine for cellular and formed elements such as casts, crystals, white blood cells, and red blood cells. Laboratories holding this category may also report the presence of bacteria, yeast, and Trichomonas; however, the culture or identification of these elements may only be performed under the appropriate microbiology category. Quantitative urine testing is performed under appropriate categories of Clinical Chemistry or Toxicology.
Urine Pregnancy Testing
This category is for laboratories performing urine pregnancy tests. Serum
pregnancy tests (serum beta-hCG determinations) for the purpose of assessing
pregnancy are covered by the category of Endocrinology.
Virology
General. This category is for laboratories that perform virus isolation and identification or molecular techniques for any of the viral agents normally encountered in a clinical virology laboratory.
Herpes Group Viruses Only. This category is for laboratories that limit their services to the examination of specimens for either herpes simplex 1 and 2, or all of the following herpes group viruses: herpes simplex type 1, herpes simplex type 2, cytomegalovirus and varicella zoster virus.
Direct Antigen Detection. This category is for laboratories that restrict their services to the examination of specimens for one or more of the following viruses by a FDA approved kit (e.g., enzyme linked immunosorbent assay, latex agglutination, etc.): rotovirus, respiratory syncytial virus and influenza. Commercially available reagents must be used. Please note that PT materials are not designed for and should not be used for direct fluorescence antigen detection of these agents.
Wet Mounts
This category is for laboratories that perform a direct, unstained examination of urogenital specimens (vaginal and urethral secretions) for the presence or absence of Trichomonas vaginalis, yeast, or bacteria, or to identify clue cells. It also includes tests for vaginal pH. Laboratories performing Gram stains on urogenital specimens must hold the category of Bacteriology-Gram Stains.