The following is a list of Fee-for-Service (FFS) outpatient laboratory Facility Approval Categories by fee item.
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1 MINISTRY OF HEALTH FEE FOR SERVICE OUTPATIENT LABORATORY FACILITY APPROVAL CATEGORIES October 1, 2015 Revised March 15, 2019 Introduction The following is a list of Fee-for-Service (FFS) outpatient laboratory Facility Approval Categories by fee item. For billing and payment purposes, prospective facility operators will identify in their Application for a New Approved Laboratory Facility what Facility Approval Category or level of Fee-for-Service outpatient laboratory service a facility is resourced to provide. The Laboratory Services Act requires that the laboratory facility that is the subject of a proposed approval must be accredited to a standard satisfactory to the minister. The Diagnostic Accreditation Program (DAP) has been established as the accreditation standard by the minister. As part of the facility Approval process, the minister assigns one or more Category levels to each approved laboratory facility, reflecting the laboratory services (benefits) the facility is authorized to provide. These Categories are intended to correspond with the DAP accreditation disciplines. For example, a Category 1 facility would only be approved to provide, and subsequently submit claims to the minister for, laboratory services corresponding to the fee items (tests and procedures) listed under Category 1. Operators may only submit claims for fee items listed under the Category approved for that facility. If the capability or capacity of an approved laboratory facility is changed, a new Facility Category may be assigned by the minister. Facility Approval Categories and associated laboratory medicine fee items include: Category 1 - General laboratory tests and procedures Category 2A - Hematology Category 2B - Microbiology Category 2C - Clinical Chemistry Category 2M Category 3 minus all Microbiology fee items Category 3 Full Approval minus the Specialty Categories Categories 2A through Category 3 also include approval to conduct Category 1 tests. Category 3 includes Categories 1 and 2 plus the remainder of tests and procedures in the Laboratory Services Schedule of Fees, unless specifically excluded, as certain fee items could be restricted to specialty sites. The following Specialty Categories and associated fee items are specifically excluded from Category 3: Category 2G Cytogenetics Category 2V Virology Category 2S Specialized 1
2 FACILITY APPROVAL CATEGORIES AND ASSOCIATED FEE ITEMS FACILITY CATEGORY 1 GENERAL LABORATORY TESTS AND PROCEDURES Venepuncture Examination Eosinophils /Secretions/Excretions Haemoglobin cyanmethaemoglobin method, and/or haematocrit Haemoglobin other methods Secretion smear for eosinophils Sedimentation rate Candida Culture Fungus, direct examination, KOH preparation Stained Smear Trichomonas and/or Candida, direct examination Examination for pinworm ova Glucose semiquantitative (dipstick analysed visually or by reflectance meter) Occult Blood faeces Fecal Immunochemical Test (FIT) For Sample Collection Only Pregnancy Test, immunologic urine Urinalysis Complete diagnostic, semi-quant and micro Urinalysis Chemical or any part of (screening) Urinalysis Microscopic examination of centrifuged deposit ECG tracing, without interpretation (technical fee) Sperm, Seminal examination for presence or absence FACILITY CATEGORY 2A HEMATOLOGY includes Category 1 tests Clot retraction Direct antiglobulin (Coombs ) test, polyspecific performed other than as part of a cross-match procedure Eosinophil count Fibrin/fibrinogen degradation products Hematology Profile (to include automated Hbg, WBC, Hct, RBC indices and differential white cell count when indicated) Infectious mononucleosis - slide agglutination Latex test (rheumatoid factor) Partial thromboplastin time (PTT) substitution test Platelet estimation on film Preparation of plasma, per unit Prothrombin Time RBC antibody detection, per tube RBC morphology including platelet estimation Reticulyocyte count and/or Heinz bodies Rh(D) typing Sickle cell identification Thrombin time 1 While fee item ECG tracing is primarily a Medical Services Commission fee item, approved specimen collection stations may continue to offer ECG services (technical fee) and laboratory operators may continue to submit claims for this service. 2
3 FACILITY CATEGORY 2B MICROBIOLOGY includes Category 1 tests Antibiotic susceptibility test Biochemical identification of micro-organism per organism Routine culture Cervical Culture Vaginal Culture Uretheral Culture Combined Vagnio-Anorectal or Vaginal Culture Genital Culture Other Site Stool culture (to include Campylobacter identification) Biochemical identification of micro-organism in stool Molecular identification, stool isolate Streptococci rapid test Throat or nose culture Throat or nose culture each additional culture Urine colony count culture FACILITY CATEGORY 2C CLINICAL CHEMISTRY includes Category 1 tests Primary base fee Split base fee (collecting facility) Split base fee (referral facility) Albumin serum/plasma Albumin transudate/exudate Alanine aminotransferase (ALT) Alkaline phosphatase Amylase cyst Amylase serum/plasma Amylase transudate/exudate Amylase urine Aspartate aminotransferase (AST) Bicarbonate serum/plasma Bicarbonate urine Bile pigments and salts, qualitative urine Bilirubin, total serum/plasma Bilirubin, total transudate/exudate Bilirubin, direct Blood, qualitative gastric Calcium total, serum/plasma Calcium urine random Cells, count CSF and other body fluids Cell differential CSF and other body fluids Chloride serum/plasma Chloride urine random Chloride whole blood Cholesterol, total Creatine kinase (phosphokinase) Creatinine random urine Creatinine time urine collection Glucose gestational assessment Glucose Tolerance Test Gestational Protocol 3
4 91705 Glucose quantitative CSF Glucose joint fluid Glucose serum/plasma Glucose transudate/exudate Glucose urine Glucose tolerance test, 2 to 5 hours Glucose tolerance test 6 hr. or more Glutamyl transpeptidase (GTP) High density lipoproteins cholesterol (HDL cholesterol) Lactate - whole blood Lactate dehydrogenase CSF Lactate dehydrogenase serum/plasma Lactate dehydrogenase transudate/exudates Lipase Fecal Immunochemical Test (FIT) Analysis Only ph, pco2, and po Potassium serum/plasma Potassium urine random Potassium whole blood Pregnancy Test Serum Proteins total, quantitative CSF etc Proteins timed urine collection Proteins total, joint fluid Proteins total, serum or plasma Proteins total, transudate/exudate Purine, Pyrimidine and Creatinine Disorder Screen Salicylates, qualitative, serum Salicylates, qualitative, urine Sodium random urine Sodium serum/plasma Sodium whole blood Triglycerides serum/plasma Triglycerides transudate/exudate Troponin Urea amniotic fluid Urea CSF Urea serum/plasma Urea urine random Urea whole blood Uric acid random urine Uric acid serum/plasma Uric acid synovial fluid Urinalysis, macroscopic, to include any/all of dipstick, specific gravity, visual Urinalysis, microscopic Microalbumin, semiquantitative Protein creatinine ratio, urine Urobilinogen, qualitative urine Amphetamines Benzodiazepines Tetrahydrocannabinoids (THC) Cocaine/Cocaine metabolite Ethanol Methadone metabolite 4
5 92511 Opiates Methadone Oxycodone, screening assay Fentanyl, urine screening immunoassay Urine, drug use screen - per analyte FACILITY CATEGORY 2M Category 3 minus all Microbiology fee items contained in the Laboratory Services Schedule of Fees includes Category 1 tests FACILITY CATEGORY 3 FULL APPROVAL: includes Categories 1 and 2 plus the remainder of tests and procedures in the Laboratory Services Schedule of Fees, unless specifically excluded, as certain fee items could be restricted to specialty sites. The following Categories and associated fee items are specifically excluded from Category 3: FACILITY CATEGORY 2G CYTOGENETICS Cytogenetic analysis of short term blood culture (lymphocytes) Cytogenetic analysis of bone marrow/malignant effusion Cytogenetic analysis of chorionic villus sampling Cytogenetic analysis of cultured amniotic fluid Cytogenetic analysis of cultured tissue (skin, amnion etc) Cytogenetic analysis of prenatal foetal blood sample Cytogenetic analysis of solid tumours Telomere Length testing for Telomere Biology Disorders (TBDs) 2-panel assay, by flow cytometry fluorescent in-situ hybridization (Flow-FISH) Telomere Length testing for Telomere Biology Disorders (TBDs) 2-panel assay, by flow cytometry fluorescent in-situ hybridization (Flow-FISH) Cytogenetic analysis using fluorescent in-situ hybridization Cytogenetic analysis/fluorescence in situ, single Cytogenetic analysis/fluorescence, uncultured Special staining (Giemsa II, DAPI/SCE, NOR) Special banding (Q-, R-, C-) Amniotic cell culture grown for biochemical analysis only Chromosomal breakage studies Investigation of chromosomal mosaicism High resolution chromosome analysis FACILITY CATEGORY 2V VIROLOGY Serological tests - 1 to 3 antigens Serological tests - 4 or more antigens Smear or section for electron microscopy Virus isolation Hepatitis B virus (HBV) identification by nucleic acid amplification, direct-quantification BK Polyoma virus identification by nucleic acid amplification, direct-quantification Cytomegalovirus viral (CMV) identification by nucleic acid amplification, direct-quantification HBV drug resistance mutation analysis 5
6 FACILITY CATEGORY 2S SPECIALIZED Factor V Leiden/PGM 1 st Gene Factor V Leiden/PGM 2 nd Gene Acid Fast organisms culture Acid Lipase, white blood cells Acylcarnitine profiling Alpha-iduronidase, white blood cells Alpha-mannosidase, white blood cells Apoprotein E genotyping Aryl sulfatase A white blood cells Aryl sulfatase B white blood cells Aryl sulfatase C fibroblasts Aryl sulfatase C white blood cells B-galactosidase white blood cells B-glucosidase white blood cells Beta-mannosidase, white blood cells Culturing skin fibroblasts for biochemical or DNA analysis Fecal Elastase Galactocerebrosidase white blood cells Glutathione peroxidase Hexosaminidase serum Hexosaminidase, white blood cells I g A Anti-gliadin antibodies I g F- I (Somatomedin C) Mitochondrial preparation muscle N-acetyl-Galactosamine-6-sulfate sulfatase, white blood cells Organic Acids Respiratory chain enzymes - muscle Sphingomyelinase white blood cells Thiopurine Metabolites Transferrin Isoelectric focusing (qualitative) Very long chain fatty acids Vitamin A Vitamin B Vitamin B Vitamin E White blood cell preparation for lysosomal enzyme testing Cytogenetic analysis/fluorescence, subtelomeric 6
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