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New York State Laboratory Permit
Category Descriptions 2006-2007

CLEP

Category

[Category Descriptions: PDF file]

Andrology

This category is 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 antigen 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 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.

Antigen Detection - Group A Streptococcus, for laboratories using antigen 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 fully 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,) Clinical Chemistry (ALT or total protein testing), Hematology (donor and unit related testing) Virology-Molecular Techniques Only (nucleic acid testing for viral agents other than HIV) and Bacteriology-Restricted (bacterial detection).

Collection. This category is 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 other testing (blood grouping, hemoglobin, etc.) on blood donors, it must also hold the appropriate category as described above.

Collection - Autogeneic (Autologous) Only. This category is 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 other testing (blood grouping, hemoglobin, etc.) on autogeneic blood donors, it must also hold the appropriate category as described above.

Transfusion. This category is for blood banks that perform pre-transfusion tests and issue blood or blood components for transfusion. Such sites must also hold Immunohematology. A hospital's permit in Blood Services-Transfusion covers transfusions performed at any facility which is 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 serivces 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 for facilities that fractionate plasma into infusable derivatives and/or perform viral inactivation 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.

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.

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., 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 Immunophenotyping. This category includes methodologies to quantify the number of non-malignant leukocytes other than lymphocytes (e.g., Lin-, CD34+ stem cells, CD55 & CD59 for PNH, or CD15s, CD11a, b, c & CD18 for LAD.

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. The categories described below are based upon the diagnostic services that are currently performed by the laboratory or that they intend to offer.
Prenatal Cytogenetics. 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 Cytogenetics. Laboratories may perform cytogenetic tests exclusive of prenatal diagnosis and cancer cytogenetics.

Cancer Cytogenetics. Laboratories may perform diagnostic evaluations of blood dyscrasias and acquired cytogenetic changes of neoplasias.

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 of in vitro lymphocyte or leukocyte cultures would be included in the Cellular Immunology Lymphoid Function or Non-Lymphoid Function category.

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.

Diagnostic Immunology

The Diagnostic Immunology categories are for laboratories performing the following types of tests:

  • 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.
  • 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 by measuring hormones and related analytes in body fluids. Analytes in this category include: all peptide and steroid hormones, thyroxine (T4) triiodothyronine (T3), T-3 uptake, TSH, LH, FSH, serum hCG (qualitative or quantitative), catecholamines, folic acid, and all vitamins.

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). Amniotic fluid screening results for neural tube defects need to be confirmed by electrophoretic identification of acetylcholinesterase.

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 based on the recommendations of the federal DNA Advisory Board 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 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 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. In addition, 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. Some applications of these methodologies are excluded from approval in the genetic testing category, such as paternity testing, forensic testing, somatic changes in tumor tissue (molecular oncology) and tissue typing services.

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.

HLA Typing Only. This category is for laboratories offering only HLA antigen typing. This category would apply to those laboratories performing histocompatibility testing for bone marrow donor screening or for disease associations. Laboratories that perform HLA antigen typing for parentage testing only and not as a diagnostic test need only hold a permit in the category of the Paternity/Identity Testing HLA Only.

Histopathology

The Histopathology categories are for laboratories performing gross and microscopic examination of tissues, including immunohistochemistry tests.

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 immunohematologic tests, such as ABO group, Rh group, subgroups of A, direct antiglobulin test, Rh phenotype, unexpected antibody detection and identification, and compatibility testing for blood collection, transfusion or other purposes such as prenatal testing, must hold this category.

Mycobacteriology

General OR General-S. These categories are for laboratories that conduct all clinical tests for detection, isolation and identification of all mycobacteria (General), and for those that perform in vitro susceptibility studies (General-S).

Restricted OR Restricted-S. These categories are for laboratories that examine smears for acid-fast bacilli, attempt to isolate acid-fast bacilli, identify Mycobacterium tuberculosis, Mycobacterium bovis, and Mycobacterium bovis BCG, and Mycobacterium africanum as members of the Mycobacterium tuberculosis complex. They may also identify Mycobacterium avium complex and Mycobacterium gordonae. Laboratories holding the Restricted-S category may conduct in vitro susceptibility testing for Mycobacterium tuberculosis complex. Laboratories performing susceptibility testing 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.

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, those fungi that may be identified with commercial yeast identification systems. This category now includes anti-fungal susceptibility testing.

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, as outlined in the Program Guide available on our website.

Oncology

This category includes tests used in tumor screening, diagnosis, prognosis and management, including serum and soluble tumor markers, as well as tests for tumor cell specific alterations. Due to the different methodologies used, there are two categories:

Sera and Soluble Tumor Markers. This category is for laboratories performing tests for serum and other soluble tumor markers found in body fluids. Results from these tests are generally quantitative. Methodologies used include radioimmunoassay (RIA), enzyme immunoassay (EIA), chemiluminoassay, or mass spectrometry (e.g. SELDI-TOF). Also included in this category are markers for bladder cancer found in urine, whether measured quantitatively (e.g., NMP22) or qualitatively (e.g., Bard BTA).

Molecular and Cellular Tumor Markers (formerly 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 chromosomal rearrangements by Southern blot or (RT)-PCR, detection of mutations in oncogenes or tumor suppressor genes (e.g., p53) by any technique (e.g., sequencing, SSCP, and chip analysis) and detection of altered gene/protein expression by DNA chip analysis, Western blot or any other appropriate semi-quantitative technique. Also included in this category is ex vivo determination of chemotherapeutic drug sensitivity.

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 perfoming parentage or identity testing for non-forensic purposes must hold a permit in one or more of the following categories:

HLA Testing Only. This category is for laboratories offering parentage or identity testing by human leukocyte antigen (HLA) testing.

DNA Testing Only. This category is for laboratories offering parentage or identity testing by Restriction Fragment Length Polymorphism (RFLP)or Short Tandem Repeat (STR).

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. (NOTE: Laboratories that qualify for this category also qualify to perform testing allowed under the Clinical Toxicology-Initial Testing Only category).

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. (NOTE: Laboratories that qualify for this category also qualify to perform testing under the Forensic Toxicology-Initial Testing category and any of the clinical toxicology categories).

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.

Clinical Toxicology - 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 molecular tests to monitor the status of a transplanted organ or tissue. This includes monitoring of engraftment following transplantation of hematopoietic progenitor cells (e.g. bone marrow) by short tandem repeat (STR) analysis and monitoring for rejection using gene expression analysis.

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, including tests for human papilloma virus formerly included under the Direct (Antigen) Detection category.

Herpes Group Viruses Only. This category is for laboratories that limit their services to the examination of specimens for either herpes simplex type 1 and 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 an FDA approved kit (e.g., enzyme linked immunosorbent assay, latex agglutination, etc.): rotavirus, respiratory syncytial virus, and influenza. Commercially available reagents must be used. The director and/or assistant director must hold a certificate of qualification in either virology or bacteriology.

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.