ANSI-ASQ National Accreditation Board
APPLICATION FOR ISO 15189 ACCREDITATION
Please complete this application electronically.
Organization Name:
(As to be officially listed on certificate and scope of accreditation. Separate application required for each accreditation location.)
Accreditation Location:
(As to be officially listed on certificate and scope of accreditation.)
Mailing Address:
(If different from Accreditation Location.)
Website Address:
Authorized Representative Name:
Contact to be listed on Scope of Accreditation (if different from above):
Telephone:
Facsimile:
Email:
Note: Please supply an email address that is checked daily. We use email to communicate when reports have been uploaded,
invoicing, and changes to requirements.
Accounting Contact:
Telephone:
Email:
Note: Even if this contact is the same as above, please complete to ensure we have the appropriate individual for invoicing.
Legal Status:
Government Body
Corporation – Not for Profit
Staff Size: Managerial:
Corporation, Proprietorship, LLC
Other
Technical:
Does the organization perform in-house calibrations?
Yes
No
If the organization performs in-house calibrations, list the devices or attach a list:
Does the organization perform on-site tests?
Yes
No
Does the organization maintain multiple laboratory sites?
Yes
No
Note: If yes, please contact us directly for guidance and requirements for multi-site organizations.
Does the laboratory have specimen collection sites?
Yes
No
Does the organization maintain point of care testing (POCT) sites (i.e., tests done near where the patient is
located)?
Yes
No
If yes, list the POCT sites:
Has the organization ever been accredited to ISO/IEC 17025 or ISO 15189?
Yes
No
Note: If previously or currently accredited to ISO/IEC 17025 or ISO 15189, please attach copies of certificate, scope and
previous reports issued by organization’s accreditation body. The process cannot begin until these reports are received.
If yes, has the organization’s accreditation been suspended in the past 12 months?
Is the laboratory registered with the FDA?
Yes
Yes
No
No
If yes, provide registration number:
ACLASS-FQS Form 61
ISO 15189 Application
Page 1 of 21
January 31, 2014
Attach Draft Scope of Accreditation: Guidance for preparation of the draft Scope for ISO 15189 Accreditation is
provided on the following pages. Your draft scope of accreditation must be completed and submitted for the ANSIASQ National Accreditation Board (“the Company”) to better serve you. Please be advised that failure to submit a
draft scope of accreditation prior to the assessment may result in your assessment being delayed.
Authorization
My organization has submitted payment for the non-refundable application fee. We understand that the Company
will invoice us for other accreditation activities when they are performed, and that all invoices are due net 30 days.
We understand that the Company will use its best efforts to schedule accreditation services on dates agreeable to us
and that when we agree to specific dates the Company will confirm the dates in writing. We understand that if we
cancel confirmed dates within 30 days prior to the first confirmed date, the Company will charge us 50% of the daily
fee for each cancelled date. We further understand that there may be additional charges for review of corrective
action and/or a follow-up visit for any nonconformance.
We certify that we have read and agree to comply with the applicable requirements and the Company’s
Accreditation System and Document 16, including use of the Company symbol. We certify that we have read and
agree to the Responsibilities and Obligations of the Customer in Appendix A of this application. We agree to
cooperate fully and supply to the Company all information and documentation needed before, during, and after the
accreditation process. We further agree to allow the release of PT/ILC reports directly to the Company from
providers of such services, as applicable. We attest that our organization is a legally identifiable entity and maintains
the appropriate resources to serve our customers.
I am authorized by my organization to apply to the Company for accreditation. I am further authorized to agree that
my organization will pay the Company for any charges billed, net 30 days, for services leading to accreditation
rendered at the request of my organization.
Authorized Representative Signature
ACLASS-FQS Form 61
Date:
ISO 15189 Application
Page 2 of 21
January 31, 2014
Preparation of Draft Scope of Accreditation
The following information must accompany the Application for Accreditation to assist in preparation of the Scope
of Accreditation. Using the format on the following page, provide the following information:
1.
Reference to the general field of medical testing covered under the scope.
2.
Identification of the group of products, materials, or items tested, including any relevant matrices.
3.
Identification of the specific tests or types of tests performed.
4.
Identification of the specification, standard (method), or technique used. These may be laboratory-specific but,
whenever possible, they should be based on internationally accepted test procedures.
5.
Other information as applicable such as detection limit, range, type of equipment used, etc. The key equipment
or technology designation is always included here. Limits and ranges are typically not included unless the
applicant lab desires to market particularly sensitive capabilities.
6.
The Company requires scopes of accreditation to meet NIST SP 811 Guide for the Use of the International
System of Units (SI), where available. NIST 811 Guide was prepared by the National Institute of Standards and
Technology for those who need assistance in the use of the SI in their work, including the reporting of results of
measurements. NIST SP 811 can be accessed at www.aclasscorp.com/documents/industry-guidancedocuments.aspx.
The table following will be used to develop the draft Scope of Accreditation for your laboratory. A list of suggested
test areas follows the table. Please check all that apply to your laboratory.
ACLASS-FQS Form 61
ISO 15189 Application
Page 3 of 21
January 31, 2014
Draft Scope of Accreditation – Medical Testing
Using the listing provided in Appendix B, complete the table below by typing and submitting electronically in
Microsoft Word to allow for future modifications (table may be expanded as needed).
Specialty
ACLASS-FQS Form 61
Sub-specialty
Test/Analyte
ISO 15189 Application
Page 4 of 21
Method
Matrix
January 31, 2014
Appendix A
Responsibilities and Obligations of the Customer
By signing the application, the customer hereby requests the ANSI-ASQ National Accreditation Board (“the
Company”) to perform ISO 15189 accreditation activities pursuant to the application submitted to the Company by
the customer (“Accreditation Activities”). The Company shall perform the Accreditation Activities in accordance
with the Company’s current Accreditation System. The Company shall make available to the customer at the
customer’s request the documents comprising the Company’s ISO 11895 Accreditation System.
The Company shall determine in its sole discretion whether the customer meets the Company’s requirements for
accreditation to the applicable requirements as set forth in the Company’s ISO 15189 Accreditation System
(“Accreditation Criteria”). In the event the Company determines that the customer meets the Accreditation Criteria,
the Company shall deliver to the customer the Company’s Certificate and Scope of Accreditation, which shall
include a copy of the Company accreditation symbol. The Certificate and Scope of Accreditation shall be deemed
evidence of the customer’s status as accredited pursuant to the Company’s Accreditation Criteria.
The Company shall have the right to carry out surveillance and reassessment pursuant to the Company’s ISO 15189
Accreditation System to verify the customer’s continuous compliance to the Accreditation Criteria.
The customer shall conform to the following:
a.
Maintain impartiality and integrity for all services provided under their scope of accreditation.
b.
Commit to meeting the requirements of the Company’s Accreditation Criteria including adapting to changes in
the requirements for accreditation.
c.
Take such actions as necessary to allow the Company to perform the Accreditation Activities, including
providing for the examination of documentation and the assessment of all areas, records, and personnel for the
purposes of assessment, surveillance, reassessment, resolution of complaints, and access to relevant documents
that provide insight into the level of independence and impartiality from any related body.
d.
Record and address complaints, report complaints to the Company, and otherwise continuously comply with all
relevant provisions of the Accreditation Criteria and claim accreditation only in respect of requirements and
scope for which the customer has been granted accreditation (the Company’s certificate and scope of
accreditation do not cover subcontracted calibrations).
e.
Notify the Company within 30 days of changes to customer’s laboratory management system or changes
significantly affecting customer (such as a change of ownership, change of location, change in key personnel
including top management, main policies, resources, or change in equipment or if analysis of a complaint or
other information indicates that customer no longer complies with the Accreditation Criteria) (“Change”).
f.
Allow the Company to conduct surveillance and/or reassessment of the customer in the event of a Change.
g.
Not expose assessors or others representing Company to unsafe working conditions or environments, and
provide all assessors and others appropriate protective equipment.
h.
Arrange witnessing of services performed at the request of the Company, including allowing third parties
selected by the Company to witness Company assessments.
i.
Not use its accreditation in a manner that may bring the Company into disrepute.
j.
Pay the Company for the Accreditation Activities as set in Company procedures.
The Company logo is a registered trademark solely owned by the ANSI-ASQ National Accreditation Board. As long
as the customer maintains its status as accredited by the Company pursuant to the Company’s Accreditation Criteria,
the customer shall have the non-exclusive and non-transferable right to use the Certificate and Scope of
Accreditation and the accreditation symbol (except as provided for in the paragraph directly below) in the
customer’s advertising, and marketing materials and campaigns, certificates, and reports. In no event shall the
customer use the Certificate and Scope of Accreditation and the accreditation symbol (or a confusingly similar
certificate and scope of accreditation or symbol) in a misleading or unauthorized manner, including but not limited
to representing that the Certificate and Scope of Accreditation and the accreditaion symbol exemplifies a product,
ACLASS-FQS Form 61
ISO 15189 Application
Page 5 of 21
January 31, 2014
service, or performance conformity certification; using the Certificate and Scope of Accreditation or the
accreditation symbol in connection with requirements or activities not approved by the Company; or otherwise
acting to bring the Company or the accreditation symbol in disrepute.
If the Company expresses any concern with respect to the use of the Certificate and Scope of Accreditation or the
accreditation symbol as being inconsistent with or impermissible under this Application or the Company’s ISO
15189 Accreditation System, (“Improper Use”), the Company may ask the customer to cease and desist the
Improper Use, and it shall be deemed to be a condition to the customer’s continued accreditation that such Improper
Use be immediately discontinued. In addition, in the event of such Improper Use or in the event the Company
determines that the customer is not complying with any obligation of the customer under this Agreement or the
Accreditation System, the Company shall have the right upon written notice to the customer to (a) suspend its
Accreditation Activities until the customer complies with its obligation, (b) determine that the customer is no longer
entitled to identify itself as accredited by the Company and to require the customer (temporarily or permanently) to
cease using in any manner the Certificate and Scope of Accreditation (and to return such Certificate and Scope of
Accreditation), the accreditation symbol and/or accreditation mark, (c) refuse to issue a Certificate and Scope of
Accreditation to the customer, (d) require corrective action, (e) publish the customer’s transgression, or (f) take other
legal action. In the event the Company takes any of the foregoing actions, the Company shall not be required to
reimburse any amount to the customer.
The Company and its assessor shall perform the Accreditation Activities in a workmanlike manner consistent with
the Company’s current Accreditation System. The warranty set forth in this section is the sole and exclusive
warranty of the Company under this application and the services contemplated to be provided herein and no other
express or implied warranties exist, including but not limited to any warranty of merchantability and any warranty of
fitness for a particular purpose. The customer acknowledges that the Company does not warrant and has no liability
or responsibility for (and such liability and responsibility belongs solely to customer) the laboratory and safety of
any product or service produced, manufactured, delivered, sold or otherwise distributed by customer.
The Company and the customer are independent parties and nothing set forth in this Application creates a joint
venture, partnership or other concerted activity.
If, in the Company’s sole discretion, an assignment and/or activity by the customer effects a Change to the
customer’s management system under this Application and/or changes made by the Company to the Accreditation
Criteria, the customer shall cooperate and take the actions necessary to allow the assignment to occur based on a
reassessment and/or surveillance visit or such other activity as the Company reasonably deems necessary.
These Responsibilities and Obligations of the Customer shall be governed by, and construed and enforced in
accordance with, the laws of the State of Wisconsin. Any dispute under this Application shall be resolved pursuant
to the appeals procedure adopted by the Company from time to time. In the event the customer makes any claim that
a dispute is not subject to the appeals process or has not been adjudicated pursuant to the rules provided therein, the
customer shall not have the right to bring any action with respect thereto before a court of law or equity, but shall
only have the right to seek a determination from one arbitrator pursuant to the rules of the American Arbitration
Association as to whether such dispute was subject to the appeals process or was adjudicated pursuant to the rules
provided therein. Such arbitration shall be conducted in the State of Wisconsin, and each party shall bear its own
expense for such arbitration.
ACLASS-FQS Form 61
ISO 15189 Application
Page 6 of 21
January 31, 2014
Appendix B
Scope Specialty Listing
Identify the proposed scope Specialty Areas including Methods and Test/Analyte:
Pathology – Histopathology
Category
Anatomic Pathology
Autopsy
Electron Microscopy
Interoperative
Consultation
Molecular Anatomic
Pathology
Test/Analyte
Routine processing, Surgical Pathology
FNA accessioned and processed in Surgical
Pathology
Autopsy Forensic
Autopsy, Routine
Partial performance of autopsy off-site
Tissue processing, Autopsy Pathology
Specimen processing, Electron Microscopy
Intraoperative consultation (frozen sections)
Mohs procedures (dermatopathology)
FISH on histologic sections
ISH
Bone marrow surgical pathology
Image analysis
Oral pathology (oral specimen exam)
Skin scrapings for parasites, Surgical Pathology
Method
HER2, immunohistochemistry staining
Immunofluorescence stain, tissue biopsy
Immunohistochemistry staining
Special stains – histochemistry
Gross Description/Post mortem exam
Dissection
Microscopic evaluation, Autopsy Pathology
Pathologist interpretation, Electron Microscopy
CMV,ISH
EBV, ISH
HPV, ISH
HSV, ISH
ISH assay other (please list)
KAPPA light chain mRNA, ISH
LAMBDA light chain mRNA, ISH
FISH Any Assay
HER2, brightfield in situ hybridization (CISH)
HER2, IHC path interpretation (off-site staining)
HER2, IHC staining and path interpretation on-site
Solid tumor, breast CA HER2, paraffin-embed
Gross evaluation, non-pathologist
Gross evaluation, pathologist
Microscopic evaluation, Surgical Pathology
Pathologist interpretation, FNA
Tzanck smears, Surgical Pathology
Pathology – Cytopathology
Processing
Screening
Gynecologic Cytopathology
Non-Gynecologic Cytopathology
Cytology immunohistochemistry staining
FNA accessioned and processed in Cytology
Liquid based preparation
Specimen staining
Automated PAP screening/re-screening
Screening by cytotech, gynecologic cytology
Screening by cytotech, non-gynecologic cytology
Screening by pathologist, gynecologic cytology
Screening by pathologist, non-gynecologic cytology
Pathologist interpretation, gynecologic cytology
Pathologist interpretation, FNA
Pathologist interpretation, non- gynecologic cytology
Tzanck smear interpretation
Pathology – Pathology
Arrays
Capillary electrophoresis
ACLASS-FQS Form 61
Molecular Pathology - Methods
Molecular analysis of leukemias and lymphomas
Molecular genetic disease testing
ISO 15189 Application
Page 7 of 21
January 31, 2014
Fluorescence in situ hybridization (FISH)
Gel electrophoresis
ISH for congenital abnormality
ISH for neoplastic disorder
ISH, other
In situ hybridization (ISH)
Ligase chain reaction (LCR)
Molecular infectious disease testing
Molecular oncology
Molecular pathology techniques
Nucleic acid amplification
PCR testing
Western blot
Pathology – Pathology
Method
Molecular methods
Nucleic acid amplification
Nucleic acid probe
FISH
ISH
DNA polymorphisms
DNA microarray, PCR
Molecular Pathology
Test/Analyte
BRCA 1/2
Multiple endocrine neoplasia 2
Myotonic dystrophy
Canavan Disease
Niemann-Pick Disease
Prader-Willi/Anelman Syndrome
Cystic fibrosis
Prothrombin
DMD/Becker
RhD
Factor V Leiden
Spinal muscular atrophy
Fanconi Anemia
Spinocerebellar ataxia
Tay-Sachs Disease
Factor V Leiden
Fragile X
Friedreich’s ataxia
Bact. ID other, (please list)
Mycobacteria ID, other (please list)
Mycobacterium tuberculosis
Bordetella parapertussis
Bordetella pertussis
Fungal
CMV
N. gonorrhoeae
Parasite ID (please list)
Enterovirus
EBV
Chlamydia
Enterovirus
Strep B
Fungal ID (please list)
Viral ID, other (please list)
West Nile virus
Bact. ID other
Mycobacterium spp
Mycobacterium tuberculosis
Mycobacterium tuberculosis
Candida spp
N. gonorrhoeae
Chlamydia trachomatis
Strep A
Trichomonas
Strep B
Fungal ID
Bacterial ID
N-myc amplification (Neuroblastoma)
Chromosome 3,7,17 aneuploidy (Bladder
Solid tumor, breast CA HER2, paraffin-embedded
Cancer)
FISH for congenital abnormality
Topoisomerase II amplification
FISH for neoplastic disorder, other (please list) Fungal ID
Congenital abnormality
t(11;14)(q13;q32) (Mantle Cell Lymphoma)
Neoplastic disorder, other (please list)
t(11;18)(q21;21) (Extranodal MZBL)
t(8:14)(q24;q32) (Burkitt’s Lymphoma
t(11;22)(q24;q12) (Ewing’s Sarcoma /PNET)
t(8:22)(q24;q11) (Burkitt’s Lymphoma)
t(14;18)(q32;q21) (Follicular Lymphoma)
t(x;18)(p11;q11) (Synovial Sarcoma)
t(2,8)(p11;q24) (Burkitt’s Lymphoma)
CMV
EBV
Forensic identity
Parentage testing
Gene expression level, tumor
Sarcoma translocation
Identification of sequences, tumor
Chemistry – General Chemistry
Bilirubin, total, whole blood
CO2, whole blood
Calcium, ionized, whole blood
Carboxyhemoglobin
Chloride, whole blood
Creatinine, whole blood
Glucose, whole blood
ACLASS-FQS Form 61
Blood Gases - Test/Analyte
O2 saturation
Oncotic pressure
Osmolality, whole blood
Oxyhemoglobin
PCO2
PO2
Potassium, whole blood
ISO 15189 Application
Page 8 of 21
January 31, 2014
Hematocrit (direct measure / calculate),
Lactate, whole blood
Magnesium, ionized, whole blood
Methemoglobin
Sodium, whole blood
Urea, whole blood
pH, body fluid
pH, venous/arterial
Chemistry – General Chemistry
ALT, serum / plasma / whole blood
AST, whole blood,
Acetoacetic acid
Acetone
Acid phosphatase
Albumin, CSF
Albumin, body fluid
Albumin, serum/plasma/whole blood
Albumin, urine
Alkaline phosphatase, serum/plasma/whole
blood
Ammonia
Amylase, body fluid
Amylase, pancreatic, serum/plasma
Amylase, serum/plasma/whole blood
Amylase, urine
Beta-hydroxybutyrate
Bilirubin, body fluid
Bilirubin, direct, diazo (neonatal),
serum/plasma
Bilirubin, direct, serum/plasma
Bilirubin, direct, spectrophotometric
(neonatal)
Bilirubin, direct, whole blood
Bilirubin, total, neonatal, serum/plasma/
whole blood
Bilirubin, total, neonatal, Transdermal
Bilirubin, total, serum/plasma
C-reactive protein, qualitative
C-reactive protein, quantitative
CK-MB, serum/plasma
CK-MB, whole blood
CO2, serum
CO2, whole blood
Calcium, body fluid
Calcium, ionized, serum/plasma/whole
blood
Calcium, serum/plasma
Calcium, total, whole blood
Calcium, urine
Carbon monoxide
Chloride, body fluid
Chloride, serum/plasma
Chloride, urine
Chloride, whole blood
Cholesterol, body fluid
Cholesterol, serum / plasma / whole blood
Creatine kinase (CK)
Creatinine, body fluid
Creatinine, semi-quant, urine
Creatinine, serum/plasma
ACLASS-FQS Form 61
General Chemistry - Test/Analyte
Fecal fat
Fetal fibronectin
Fructosamine, serum/plasma/whole blood
Myoglobin, whole blood
Occult blood, gastric
Urea, urine
Urea, whole blood
Uric acid, body fluid
Uric acid, serum
Glucose, quantitative, urine
Protein, total, serum
Protein, total, urine
Protein, total, whole blood
Reducing substances, fecal
Sodium, CSF
Sodium, body fluid
Sodium, serum/plasma/whole blood
Sodium, urine
Sugar water test
TIBC
Glucose, serum/plasma
Glucose, whole blood
HDL cholesterol, serum/plasma/whole
blood
Hemoglobin, plasma
Iron
Ketone, serum
LD, body fluid
LD, serum
Triglycerides, body fluid
Triglycerides, serum/plasma/whole blood
Troponin I
LD1, serum/plasma
LDL cholesterol, serum / plasma / whole
blood
Lactate, CSF
Lactate, body fluid
GGT, serum/plasma/whole blood
Glucose, body fluid
Lactate, plasma
Lactate, whole blood
Lipase, body fluid
Lipase, serum
Lipase, urine
Lithium
Magnesium, ionized, serum / plasma
Magnesium, serum / plasma
Magnesium, urine
Magnesium, whole blood
Uric acid, urine
Viscosity, serum/plasma
hCG, qualitative, serum
hCG, quantitative, serum
hCG, urine, non-waived
hCG, urine, waived
pH, body fluid
pH, gastric
pH, stool
Ketone, whole blood
Microalbumin, qualitative
Microalbumin, qualitative
Mucin clot, body fluid
Myoglobin, serum / plasma
Myoglobin, urine
Oncotic pressure
Osmolality, serum/plasma
Osmolality, urine
Osmolality, whole blood
PAMG-1 protein detection, fluid
Phosphorus, body fluid
Phosphorus, serum/plasma/whole blood
Phosphorus, urine
Potassium, body fluid
Uric acid, urine
Viscosity, serum/plasma
hCG, qualitative, serum
hCG, quantitative, serum
hCG, urine, non-waived
hCG, urine, waived
pH, body fluid
pH, gastric
pH, stool
ISO 15189 Application
Page 9 of 21
Troponin T
UIBC
Urea, body fluid
Urea, serum
G-6-PD screen
Glucose, cerebrospinal fluid (CSF)
Ketone, whole blood
January 31, 2014
Creatinine, urine, quantitative
Creatinine, whole blood
Cryofibinogen
Cryoglobulin
Potassium, serum/plasma/whole blood
Potassium, urine
Protein, body fluid
Protein, total, CSF
Chemistry – Special Chemistry
Methods
Liquid scintillation counter
MS ID by selected ion monitoring
MS ID by total current
Nephelometry
Prenatal screening for neural tube defects
Radioimmunoassay (RIA)
Sweat collection
Sweat testing for cystic fibrosis, confirmation
Sweat testing for cystic fibrosis, screening
Therapeutic drug monitoring
Thin layer chromatography (TLC)
Atomic absorption spectrophotometer
Colorimeter and/or spectrophotometer
Electrophoresis or isolectric focusing
Enzyme immunoassay (EMIT)
Enzyme-linked immunosorbent assay (ELISA)
Flame photometer
Fluorescent immunoassay
Gas chromatography (GC)
Gas chromatography/mass spectrometry
High performance liquid chromatography
Immunoassay
Indicator patch system
Inductively coupled plasma - Mass Spectometry
11-deoxycortisol
17-Hydroxycorticosteroids
17-Ketogenic steroids
17-Ketosteroids
17-hydroxyprogesterone
3-Methoxytryamines
5-Hydroxyindoleacetic acid, urine
Acetaminophen
Alcohol, rapid test, saliva, medical
Alcohol/volatiles, serum, medical
Alcohol/volatiles, whole blood, medical
Allergen profiles/panels
Amikacin
Amitriptyline
Anti-DNA
Anti-JO-1
Anti-RNP antibody
Anti-SCL-70
Anti-SS-A antibody
Anti-SS-B antibody
Anti-Sm antibody
Antihistone antibodies
Antinuclear antibody, qualitative
Antinuclear antibody, quantitative
Special Chemistry - Test/Analyte
APT, fetal hemoglobin
Arsenic
ASO, qualitative
ASO, quantitative
ASO, semi-quantitative
Complement C5
Complement CH50
Complement, total
Copper
Coproporphyrins
Cortisol, serum/plasma
CMV antibody, IgG
CMV antibody, IgM
CMV antibody, total
Cyclosporine, whole blood
Cystatin C
D-xylose
DHEA sulfate
Deoxypyridinoline (DPD)
Desipramine
Digitoxin
Digoxin
Digoxin, free
Diphtheria antibodies
Antinuclear antibody, titer / pattern
ACTH
Disopyramide
Dopamine
IgD, electrophoresis
IgD, quantitative
IgG, electrophoresis
IgG, quantitative, CSF
Mucopolysaccharide diagnosis
Mucopolysaccharides compound analysis
Mumps antibody
Mycophenolic acid
Mycoplasma pneumoniae antibody
Myelin basic protein, CSF
Myoglobin, serum/plasma
Mucopolysaccharides compound analysis
Myelin basic protein, CSF
Myoglobin, serum/plasma
Myoglobin, urine
N-telopeptides (NTX)
N-acetylprocainamide (NAPA)
Nitrogen, total, urine
Norepinephrine
Normetanephrine
Nortriptyline
Oligoclonal bands, CSF
Oxalate, urine
Paraprotein identification
(M-Protein)
Kappa/lambda ratio
LD1
Abnornal Hgb detection
(Specify Method)
Acylcarnitine
Adrenal antibody
Albumin electrophoresis, CSF
Doxepin
LD isoenzymes (LD1,LD2,LD3,LD4,LD5)
EBNA, antibody
EBV antibody
EBV-VCA, antibody
Aldolase, serum
Aldosterone, serum/plasma
Aldosterone, urine
Alkaline phosphatase, bone specific
Elastase
Epinephrine
Erythropoietin, serum
Estradiol
Lead, blood
Lead, urine
Lecithin:Sphingomyelin (L:S) ratio,
amniotic
Leflunomide
Lidocaine
Lipoprotein electrophoresis
Lipoprotein (a)
ACLASS-FQS Form 61
ISO 15189 Application
Page 10 of 21
January 31, 2014
Alpha-1 acid glycoprotein
Alpha-1 microglobulin
Alpha-1-antitrypsin
Alpha-fetoprotein, amniotic fluid, prenatal
Alpha-fetoprotein, maternal serum,
prenatal
Alpha-fetoprotein, tumor marker
Aluminum
Amino acid, newborn screening
Amino acid, qualitative
Amino acid, quantitative
Amiodarone
Androstenedione
Angiotensin converting enzyme (ACE)
Anti-CCP
Anti-DNase B
Anti-LKM
Anti-Saccharomyces cerevisiae antibody
Anti-cardiolipin IgA
Anti-cardiolipin IgG
Anti-cardiolipin IgM
Anti-cardiolipin polyclonal
Anti-glomerular basement membrane
(GBM)
Anti-myeloperoxidase (MPO) antibody
Anti-neutrophil cytoplasmic antibody
(ANCA)
Anti-parietal cell antibody
Anti-phosphatidyl serine
Anti-proteinase 3 (PR3) antibody
Anti-smooth muscle antibody
Anti-thyroglobulin antibody
Antiendomysial antibody
Antifungal drug levels, quantitative
Antigliadin antibody IgA
Antigliadin antibody IgG
Antimitochondrial antibody
Antiplatelet antibody, immunoassay
Antithyroid peroxidase (antimicrosomal
ab)
Antitissue transglutaminase antibody
Apolipoprotein A1
Apolipoprotein B
Beta-2-glycoprotein
Beta-2-microglobulin, serum
Beta-2-microglobulin, urine
Bence Jones protein
Bilirubin delta OD450, amniotic fluid
Bladder tumer associated antigen,
BNP
Borrelia burgdorferi antibody
C1 esterase inhibitor
C-peptide
C-reactive protein, high sensitivity
(hsCRP)
C-reactive protein, qualitative
C-reactive protein, quantitative
ACLASS-FQS Form 61
Estriol, total
Estriol, unconjugated
Estrogen receptors
Estrone-3-glucuronide
Ethosuximide
Lithium, serum / plasma / whole blood
Luteinizing hormone (LH)
Lysozyme
Manganese
Mercury
FSH, urine, waived
Ferritin
Fetal fibronectin
Fetal lung maturity by FPIA, amniotic
fluid
Flecainide
Folate, serum
Follicle stimulating hormone (FSH)
Fructosamine, serum / plasma
G-6-PD quantitative
Galactose
Gamma globulin electrophoresis (CSF)
Gastrin
Gentamicin
Glomerular filtration rate
Growth hormone
HAV antibody, total
HAV antibody, total, RIA
Metanephrine
Metanephrines, total
Methotrexate
Microbial identification, gas
chromatography
Parathyroid hormone (PTH)
Parathyroid hormone (PTH), intact
Parvovirus B19 antibody
Phenobarbital
Phenylalanine (PKU)
Phenytoin
Phenytoin, free
Phosphatidylglycerol, amniotic
Platelet crossmatch, immunoassay
Prealbumin
Primidone
Porphobilinogen
Porphyrins, quantitative
HBc antibody, IgM, EIA
HBc antibody, IgM, RIA
Procainamide
Progesterone
HBc antibody, total, EIA
HBc antibody, total, RIA
HBe antibody
HBe antibody, RIA
HBeAg
HBs antibody, RIA
HBsAg
H. pylori antibody, serum / plasma, EIA
method
H. pylori antibody, serum / plasma, nonEIA method
H. pylori antibody, whole blood
HAV antibody, IgM
Cortisol, urine
Progesterone receptors
Prolactin
Prostate specific antigen (PSA)
Prostate specific antigen (PSA), complex
Prostate specific antigen (PSA), free
Prostatic acid phosphatase (PAP)
Protein electrophoresis, CSF
Protein electrophoresis, serum
HAV antibody, IgM, RIA
HCV antibody
HER2, immunoassay
HHV-6 antibodies
HIV antigen
HIV-1 antibody, immunoassay
HIV-1 p24 Antigen
HIV-1/2 antibody, immunoassay
HIV-2 antibody, immunoassay
HIV-1 antibody rapid test
HIV-1/2 antibody rapid test
HLA B27 typing, ELISA (disease assoc.)
HSV antibody
HTLV antibody, IFA
RBC volume
Red cell mass
Renin
Rheumatoid factor, qualitative
Rheumatoid factor, quantitative
Rheumatoid factor, semi-quantitative/titer
RSV antibody
Rubella antibody, qualitative
Rubella antibody, quantitative
Rubella antibody, semi-quantitative
Rubeola antibody
Salicylate
Schillings test
Selenium
HBs antibody, EIA
IgE, electrophoresis
Serotonin
Sex hormone-binding globulin (SHBG)
ISO 15189 Application
Page 11 of 21
Protein electrophoresis, urine
Pyridinoline (PYD)
Quinidine
RBC folate
January 31, 2014
CA 15-3
CA 19-9
CA 27-29
CA 72-4
CA-125
CEA
CK-MB, serum / plasma
CK isozymes (CK1,CK2,CK3)
C-Telopeptide (CTX)
Cadmium, blood
Caffeine
Calcitonin
Carbamazepine
Carbamazepine, free
Carbohydrate deficient transferrin
Carnitine
Carotene
Catecholamines, free
Catecholamines, total
Ceruloplasmin
Chlamydia antibody
Cholinesterase (RBC, plasma, or
serum)
Chromium
Complement C3
Complement C4
Cadmium, urine
APT, fetal hemoglobin
Arsenic
ASO, qualitative
ASO, quantitative
ASO, semi-quantitative
Complement C5
Complement C4
Cadmium, urine
Vitamin B12
VWF Multimeric Analysis
Vanillylmandelic acid, urine
Vitamin A
Vitamin B1
Vitamin D
IGF-1 / Somatomedin C
IgE, quantitative
IgG subclasses
IgG, quantitative
IgM, electrophoresis
IgM, quantitative
Imipramine
Immunofixation electrophoresis, CSF
Immunofixation electrophoresis, serum
Immunofixation electrophoresis, urine
Infectious mononucleosis
Influenza antibody
Inhibin A
Insulin
Insulin antibody (EIA)
Insulin antibody (RIA)
Interleukin receptors, other
Interlukin-2 receptor
Intrinsic factor antibody
HTLV-1 antibody, immunoassay
HTLV-I/II antibody
Haptoglobin
Sirolimus (Rapamycin)
Sperm antibodies
Stone analysis
Sweat chloride
Sweat conductivity
Sweat osmolality
Sweat sodium
Syphilis antibodies, EIA method
T3 uptake
T3, free
T3, total
T4, free
T4, total
Tacrolimus
Testosterone, bioavailable
Testosterone, free
Testosterone, total
Tetanus antibodies
Theophylline
Thyroglobulin, serum
Thyroid binding globulin
Topiramate
Hemoglobin A1C
Hemoglobin A2 quantitation
(hemoglobinopathy)
Hemoglobin F quantitation
(hemoglobinopathy)
Hemoglobin solubility (sickling test)
Hep. Delta antibody
Heparin antibody
Heparin induced platelet antibody
Homocysteine
Homovanillic acid
IgA, electrophoresis
IgA, quantitative
Vitamin D, 1,25 dihydroxy
Vitamin D, 25-hydroxy
Vitamin E
West Nile virus antibody
Zinc
Zinc protoporphyins
Toxoplasma antibody
Tobramycin
Transferrin
Tricyclics, total, quantitative, serum
Troponin I
Troponin T
Trypsin
TSH rapid screen, whole blood,
TSH, serum
Urinary organic acid, qualitative
Urinary organic acid, quantitative
Uroporphyrin
Valproic acid
Valproic acid, free
Vancomycin
Varicella-zoster antibody
Chemistry – Toxicology
Atomic absorption spectrophotometer
Colorimeter and/or spectrophotometer
Enzyme immunoassay
Enzyme-linked immunosorbent assay
Fluoroimmunoassays
Gas Chromatography
High performance liquid chromatography
Legal Testing
MS ID by ion ratios and retention times
MS ID by total spectra
Medical Testing
Pure controlled subst. requiring a license
Screening kits only (no instruments)
ACLASS-FQS Form 61
Methods
Urine drug screening, pre-employment
Urine drug screening, workplace
Whole blood tox. testing (non-alcohol)
Serum drug quantitation, by LC/MS/MS
Serum drug quantitation, by immunoassay
Serum drug quantitation, by immunoassay
Serum drug screen, by immunoassay
Serum toxicology, by GC
Serum toxicology, by GC/MS
Serum toxicology, by HPLC/LC
Serum toxicology, by TLC
Trace metals
ISO 15189 Application
Page 12 of 21
January 31, 2014
Test/Analyte
Serum drug quantitation, by GC
Serum drug quantitation, by GC/MS
Serum drug quantitation, by HPLC
Urine drug quantitation, by GC
Urine drug quantitation, by GC/MS
Urine drug quantitation, by HPLC
Urine drug quantitation, by immunoassay
Urine drug screen, immunoassay, extended
Urine toxicology, by GC
Urine toxicology, by GC/MS
Urine toxicology, by HPLC/LC
Urine toxicology, by TLC
Alcohol, rapid test, saliva, legal
Alcohol, rapid test, saliva, medical
Alcohol / volatiles, serum, legal
Alcohol / volatiles, whole blood, legal
Alcohol / volatiles, serum, medical
Alcohol / volatiles, whole blood, medical
Ethylene glycol, serum
Lead, urine
Lead, blood,
Nicotine/Cotinine rapid test,
Specimen integrity testing, creatinine
Specimen integrity testing, pH
Specimen integrity testing, spec gravity
Chemistry – Urinalysis
Methods
Urinalysis automated imaging systems (sediment)
Test/Analyte
pH, other
pH, stool
PAMG-1 protein detection, fluid
Protein, qualitative, urine
Reducing substance, fecal
Reducing substance, glucose, urine
Reducing substances other than glucose
pH, other
pH, stool
PAMG-1 protein detection, fluid
Protein, qualitative, urine
Reducing substance, fecal
Reducing substance, glucose, urine
Reducing substances other than glucose
Specific gravity, body fluid
Specific gravity, urine
Sperm, presence or absence (post vasectomy)
Trichomonas, presence or absence
Urinalysis dipstick, automated
Urinalysis dipstick, manual,
Urinary tract infection rapid screen
Urine sediment microscopy (including crystal ID)
Urobilinogen
WBC, manual, urine
Wet mount for Trichomonas
Wet mount for yeast
APT, fetal hemoglobin
Acetone
Creatinine, semi-quant, urine
Crystal identification, body fluid
Eosinophils in urine
Fat bodies, urine
Fecal fat test
APT, fetal hemoglobin
Acetone
Creatinine, semi-quant, urine
Crystal identification, body fluid
Eosinophils in urine
Fat bodies, urine
Fecal fat test
≈
Fern test, vaginal fluid
hCG, qualitative, serum
hCG, urine
KOH prep
Ketone, serum
Microalbumin, qualitative
Myoglobin, urine
Occult blood, fecal
Occult blood, gastric
Osmolality, urine
pH, gastric
Cytogenetics – Cytogentics
Conventional Cytogenetic analysis
Amniotic fluid cell chromosome analysis
Blood and bone marrow chromosome analysis
Blood lymphocyte chromosome analysis
Breakage study
Chorionic villus chromosome analysis
Chromosome 3,7,17 aneuploidy, FISH (Bladder Cancer)
FISH for congenital abnormality
FISH for neoplastic disorder
ACLASS-FQS Form 61
Methods
Fluorescence in situ hybridization (FISH)
Test/Analyte
Solid tumor chromosome analysis
Solid tumor, breast CA HER2,
paraffin-embedded, FISH
Tissue cultures for referral
Topoisomerase II amplification, FISH
t(11;14)(q13;q32), FISH (Mantle Cell Lymphoma)
t(11;18)(q21;21), FISH (Extranodal MZBL)
t(11;22)(q24;q12), FISH (Ewing’s Sarcoma/PNET)
t(14;18)(q32;q21), FISH (Follicular Lymphoma)
ISO 15189 Application
Page 13 of 21
January 31, 2014
t(2,8)(p11;q24), FISH (Burkitt’s Lymphoma)
t(8:14)(q24;q32), FISH (Burkitt’s Lymphoma)
t(8:22)(q24;q11), FISH (Burkitt’s Lymphoma)
Fetal/neonatal blood chromosome analysis
Karyotyping
Loss of 9p21 [Urovysion], FISH
(Bladder Cancer)
N-myc amplification, FISH (Neuroblastoma)
Non-neoplastic fibroblast chromosome analysis
t(x;18)(p11;q11), FISH (Synovial Sarcoma)
PHA-Stimulated blood chromosome analysis
Hematology – Flow Cytometry
CD 34+ enumeration
DNA analysis
Fetal red blood cell assay
HLA B27 typing, flow cytometry
(disease assoc.)
HLA single antigen typing other than B27, flow
Kappa / lambda ratio, flow cytometry
Leukemia Immunophenotyping
Lymphocyte phenotyping
Test/Analyte
Lymphoma Immunophenotyping
PNH analysis (CD55/CD59)
Platelet antibody, direct, flow cytometry
Platelet crossmatch, flow cytometry
Reticulocyte count, flow cytometry
T4/CD4
T8/CD8
Hematology – Body Fluid Analysis
Body fluid analysis
Semen analysis, automated methods
Body fluid cell count, automated
Body fluid cell count, manual
Body fluid differential
Crystal identification, body fluid
Eosinophil, urine
Mucin clot, body fluid
Sperm count screen, rapid test, waived
Methods
Semen analysis, manual methods
Test/Analyte
Sperm count, automated
Sperm count, manual
Sperm morphology (differential)
Sperm motility
Sperm stain for WBC
Sperm viability
Sperm, presence or absence (post vasectomy)
Hematology – Coagulation
Coagulation, electromechanical
Coagulation, photo-optical
ACT
APC resistance
Alpha-2-antiplasmin
Antithrombin III
Bleeding time, any method
Capillary fragility test
Circulating anticoagulants or inhibitors
Clot retraction
D-dimer, qualitative, plasma
D-dimer, qualitative, whole blood
D-dimer, quantitative
Dilute Russel’s viper venom time
Euglobulin lysis
FDP, plasma
FDP, serum
Factor VIII assay
Factor assays other than VIII
Fibrin monomers
Fibrinogen
ACLASS-FQS Form 61
Methods
Coagulation, tilt-tube
Test/Analyte
Heparin Xa
Heparin assay (heparin/protomine titration)
INR, plasma
INR, whole blood
Lupus anticoagulant
Mixing studies
Plasminogen
Platelet aggregation or function studies
Protein C
Protein S
PT, plasma
PT, whole blood,
PTT, plasma
PTT, whole blood
Platelet aggregation asprin assay,
Reptilase
Ristocetin cofactor
Thrombelastograph (TEG)
Thrombin time
ISO 15189 Application
Page 14 of 21
January 31, 2014
Hematology – Coagulation
Automated CBC QC, moving averages
Automated CBC QC, preserved whole blood
Automated CBC QC, retained patient specimens
Automated CBC commercial calibration
Automated CBC calibration, whole blood
Bone marrow – cytochemistry
Bone marrow – morphology
Abn. Hb detection
all methods except solubility)
APT, fetal hemoglobin
Blood film
(WBC differential, RBC morphology)
Cryofibrinogen
Cryoglobulin
Donath Landsteiner
ESR, automated
ESR, manual
Eosinophil count
Eosinophils, nasal smear
Fecal leukocytes (stain)
G-6-PD screen
Ham test (acidified serum)
Hematocrit,
Hemoglobin solubility (sickling test)
Heinz body preparation
Hemoglobin A2 quantitation (hemoglobinopathy)
Hemoglobin F quantitation (hemoglobinopathy)
Hemosiderin, urine
Methods
Bone marrow collection (assist)
Hemocytometry counts, whole blood
(WBC and/or Plts)
Reticulocytes - automated
Reticulocytes – manual
Special stains, Hematology
WBC differential - automated
WBC differential - manual
Test/Analyte
Hemoglobin, non-waived
Hemoglobin, plasma
Hemoglobin, waived
Kleihauer-Betke stain (fetal cell quantitation)
Lamellar body count
LE cell preparation
Leukocyte alkaline phosphatase score
Osmotic fragility
nRBC count, automated
Parasite ID, blood, other than malaria
Parasite ID, malaria
Platelet count (PLT)
Platelet count, platelet-rich plasma
RBC count
RBC indices (e.g. MCV, RDW)
Reticulocyte count
Sugar water test
Viscosity, serum/plasma
WBC count, automated
Histocompatibility
Transplant Program Support - Test/Analyte
BM/stem cell transplantation, related donor
Solid organ transplant, non-renal, live donor
BM/stem cell transplantation, unrelated donor
Solid organ transplant, renal, cadaveric donor
Platelet transfusion support
Solid organ transplant, renal, live donor
Solid organ transplant, non-renal, cadaveric donor
Transplant, other (e.g., Islet cell)
BM/stem cell transplantation, related donor
Solid organ transplant, non-renal, live donor
BM/stem cell transplantation, unrelated donor
Solid organ transplant, renal, cadaveric donor
Platelet transfusion support
Solid organ transplant, renal, live donor
Solid organ transplant, non-renal, cadaveric donor
Transplant, other (e.g., Islet cell)
HLA Cellular Function Analysis - Test/Analyte
Mixed lymphocyte cultures (MLC)
HLA Flow Cytometry - Test/Analyte
HLA B-Cell crossmatching
HLA Class II antibody ID
HLA B27 typing (disease assoc.)
HLA Class II antibody screening
HLA Class I antibody ID
HLA T-Cell crossmatching
HLA Class I antibody screening
HLA Molecular – Test/Analyte
HLA B27 typing, PCR (disease assoc.)
HLA Class II typing, generic (SSP/SSO)
HLA Class I typing, generic (SSP/SSO)
HLA Class II typing, high resolution (SSP/SSO)
HLA Class I typing, high resolution (SSP/SSO)
HLA Class II typing, high resolution sequencing
HLA Class I typing, high resolution sequencing
HLA Class II typing, micro-bead assay (SSO)
HLA Class I typing, micro-bead assay (SSO)
Monitoring engraftment (chimerism)
HLA Serology – Test/Analyte
ABO antibody titer for transplant
HLA Class I typing
ABO grouping for transplantation
HLA Class II antibody ID
ACLASS-FQS Form 61
ISO 15189 Application
Page 15 of 21
January 31, 2014
Group A subtyping for transplantation
HLA B-Cell crossmatching
HLA B27 typing (disease assoc.)
HLA Class I antibody ID
HLA Class I antibody screening
HLA Class II antibody screening
HLA Class II typing
HLA T-Cell crossmatching
Mixed lymphocyte cultures (MLC)
HLA Solid Phase Assays - Test/Analyte
HLA Class I antibody ID, immunoassay
HLA Class II antibody ID, immunoassay
HLA Class I antibody ID, micro-bead assay
HLA Class II antibody ID, micro-bead assay
HLA Class I antibody screening, immunoassay
HLA Class II antibody screening, immunoassay
HLA Class I antibody screening,
HLA Class II antibody screening,
micro-bead assay
micro-bead assay
Diagnostic Immunology - General
Automated blood banking test system
Gel techniques
Hemagglutination
Immunoassay
Immunodiffusion
Immunofluorescence
ABO blood grouping
APT, fetal hemoglobin
ATP, immune cell function assay
ASO, qualitative
ASO, quantitative
ASO, semi-quantitative
Adrenal antibody
Adenovirus antigen, DFA
Adenovirus antigen, non-IF method
Allergen profiles/panels
Alpha-1 acid glycoprotein
Alpha-1 microglobulin
Alpha-1-antitrypsin
Antibody screen
Anti-CCP
Anti-cardiolipin IgA
Anti-cardiolipin IgG
Anti-cardiolipin IgM
Anti-cardiolipin polyclonal
Anti-DNA
Anti-DNase B
Anti-ENA
Antiendomysial antibody
Antigliadin antibody IgA
Antigliadin antibody IgG
Anti-glomerular basement membrane (GBM)
Antihistone antibodies
Anti-JO-1
Anti-LKM
Antimitochondrial M2 antibody (AMA-M2)
Antimitochondrial antibody
Anti-myeloperoxidase (MPO) antibody
Anti-neutrophil cytoplasmic antibody (ANCA)
Antinuclear antibody, qualitative
Antinuclear antibody, quantitative
Antinuclear antibody, titer/pattern
Anti-parietal cell antibody
Anti-phosphatidyl serine
ACLASS-FQS Form 61
Methods
Latex agglutination
Nephelometry
Solid phase techniques
Syphilis serology
Turbidimetric method
Test/Analyte
Giardia antigen, preserved specimen
Glucan assayHHV-6 antibodies
H. pylori antibody, serum/plasma, EIA method
H. pylori antibody, serum/plasma, non-EIA method
H. pylori antibody, whole blood
H. pylori antigen, EIA
H. pylori detection, urease
hCG, qualitative, serum
hCG, urine
HIV-1 antibody rapid test
HIV-1/2 antibody rapid test
HSV antibody
HSV antigen, DFA
HSV antigen, non-IF method
Heparin antibody
C. difficile cytotoxin assay
CMV antibody, IgG
CMV antibody, IgM
CMV antibody, total
CMV antigen, DFA
Ceruloplasmin
Circulating immune complex (C1q)
Chlamydia antibody
Chlamydia antigen, DFA
Heparin-induced platelet antibody
Human Granulocytic Ehrlichiosis antibody
Haptoglobin
IgG subclasses
IgA
IgD
IgE
IgG
IgM
Infectious mononucleosis
Infectious mononucleosis, POCT
Influenza antibody
Influenza antigen, DFA
Influenza antigen, non-IF method
ISO 15189 Application
Page 16 of 21
January 31, 2014
Antiplatelet antibody
Anti-proteinase 3 (PR3) antibody
Anti-phosphatidyl serine
Antiplatelet antibody
Anti-proteinase 3 (PR3) antibody
Anti-RNP antibody
Anti-SCL-70
Anti-SS-A antibody
Anti-SS-B antibody
Anti-Sm antibody
Anti-Saccharomyces cerevisiae Ab
Anti-smooth muscle antibody
Antitissue transglutaminase antibody
Antithyroid peroxidase (antimicrosomal antibody)
Anti-thyroglobulin antibody
Aspergillus Galactomannan assay
Bacterial meningitis antigens
Beta-2-glycoprotein
Bladder tumer associated antigen
Bordetella antigen
Bordetella pertussis, DFA
Borrelia burgdorferi antibody
Brucella antibodies
Brucella antigen
C1 esterase inhibitor
C-reactive protein, qualitative
C-reactive protein, quantitative
C. difficile antigen
Chlamydia antigen, EIA
Cold agglutinin
Complement C3
Complement C4
Complement C5
Complement CH50
Complement, total
Cryofibinogen
Cryoglobulin
Cryptococcal antigen
Cryptosporidium antigen, non-preserved specimen
Cryptosporidium antigen, preserved specimen
Darkfield examination, syphilis
Direct antiglobulin test (DAT)
Donath Landsteiner
EBNA, antibody
EBV antibody
EBV-VCA, antibody
FTA-ABS
Febrile agglutinins
Fetal fibronectin
Fungal serology (antibodies)
Giardia antigen, non-preserved specimen
Insulin antibody
Kappa / lambda ratio
LE latex
Lactoferrin
Legionella antibody
Legionella antigen, broncho-alveolar lavage
Legionella antigen, urine
MHA-TP/TP-PA/PK-TP
Microalbumin, qualitative
Microalbumin, quantitative
Mycoplasma pneumoniae antibody
Mumps antibody
Occult blood, fecal
Occult blood, gastric
pH, gastric
Parainfluenza type 2 antigen, DFA
Parvovirus B19 antibody
Phosphatidylglycerol, amniotic
Platelet crossmatch, solid phase
Prealbumin
Quantiferon-TB, whole blood
RPR
RSV antibody
RSV antigen, DFA
RSV antigen, non-IF method
Rh type (includes weak D)
Rheumatoid factor, qualitative
Rheumatoid factor, quantitative
Rheumatoid factor, semi-quant/titer
Rotavirus antigen, non-IF method
Rubella antibody, qualitative
Rubella antibody, quantitative
Rubella antibody, semi-quantitative
Rubeola antibody
Sperm antibodies
Strep A rapid antigen
Strep B rapid antigen
Strep pneumoniae urinary antigen
Streptococcal antibody
Syphilis antibodies, EIA method
Syphilis antibodies, solid phase method
Toxoplasma antibody
Transferrin
USR
VDRL
Varicella-zoster antibody
Varicella-zoster antigen, DFA
Viral antigen detection other, DFA
Viral antigen detection other, non-IF method
Weil-Felix agglutinins
West Nile virus antibody
Microbiology - Bacteriology
Anaerobic cultures
Bacterial culture, complete ID
Bacterial culture, partial ID
Bacterial culture, screen for growth only
Bacteriology, drug susceptibility testing
ACLASS-FQS Form 61
Methods
Genital cultures
Plating cultures only (set-up)
Respiratory cultures
Stool cultures
Urine cultures
ISO 15189 Application
Page 17 of 21
January 31, 2014
Blood cultures
Cerebrospinal fluid cultures
Antimicrobial susceptibility, anaerobes
Antimicrobial susceptibility, other
Antimicrobial susceptibility, urine
Bacterial identification gonococcus
Bacterial identification, other
Bacterial identification, throat
Bacterial identification, urine
Mycoplasma culture
Pneumococcal serotypes, antibodies
Salmonella / Shigella typing
Shiga-like toxin, stool
Urine colony count
Bacterial antigen detection, other
Bacterial meningitis antigens
Bacterial vaginosis rapid test
Bordetella antigen
Bordetella pertussis, DFA
Brucella antigen
C. difficile antigen
C. difficile cytotoxin assay
Chlamydia antigen, DFA
Chlamydia antigen, EIA
Darkfield examination, syphilis
Eosinophils, nasal smear
Wound cultures
Test/Analyte
Fecal fat testing
Fecal leukocytes
Gram stain, gonococcus
Gram stain, other
H. pylori antigen, EIA
H. pylori detection, urease
Lactoferrin
Legionella antigen, bronchoalveolar lavage
Legionella antigen, urine
Occult blood, fecal,
Occult blood, gastric
Reducing substances, fecal (Bact)
Sperm, presence or absence (post vasectomy)
Strep A rapid antigen
Strep B rapid antigen
Strep pneumoniae urinary antigen
Trichomonas antigen
Trichomonas culture
Urinary tract infection rapid screen
Wet mount for Trichomonas
Wet mount for yeast
pH, gastric
pH, stool
Microbiology - Bacteriology
Molecular Microbiology
Methods
DNA probe non-amplified methods (FDA-approved)
Nucleic acid amplification methods (FDA-approved)
Test/Analyte
Bact. ID other, nucleic acid probe
Legionella pneumophilia, nucleic acid amplification
CMV, nucleic acid amplification
MRSA, nucleic acid amplification
Candida spp., nucleic acid probe
Mycobacterium spp., nucleic acid probe
Chlamydia trachomatis, nucleic acid amplification
Mycobacterium tuberculosis, nucleic acid amplification
Chlamydia trachomatis, nucleic acid probe
Mycobacterium tuberculosis, nucleic acid probe
Fungal id, nucleic acid probe (FDA-approved)
N. gonorrhoeae, nucleic acid amplification
Gardnerella vaginalis, nucleic acid probe
N. gonorrhoeae, nucleic acid probe
HCV qualitative, nucleic acid amplification
Strep A, nucleic acid probe
HCV viral load
Strep B, nucleic acid amplification
HIV-RNA, quantitative, nucleic acid amplification
Strep B, nucleic acid probe
HPV, hybrid capture
Trichomonas, nucleic acid probe
Microbiology – Mycobacteriology
Fluorescent microscopy
Mycobacterial culture, complete ID
Mycobacterial culture, partial ID
Acid fast bacillus smear
Antimycobacterial susceptibility
Methods
Mycobacterial culture, screen for growth only
Mycobacteriology, drug susceptibility testing
Test/Analyte
Mycobacterial identification
Mycobacterial screening
Microbiology – Mycology
Mycology culture, complete ID
Mycology culture, partial ID
ACLASS-FQS Form 61
Methods
Mycology culture, screen for growth only
Mycology, drug susceptibility testing
Test/Analyte
ISO 15189 Application
Page 18 of 21
January 31, 2014
Antifungal susceptibility
Aspergillus Galactomannan assay
Candida albicans ID from culture
Candida albicans by germ tube/quick test
Candida, direct ID from vaginal specimen
Cryptococcal antigen
Dermatophyte identification
Fungus identification
Glucan assay
India ink
KOH prep
Microbiology – Parasitology
Fluorescent microscopy
Parasitology, Complete ID
Cryptosporidium antigen, non-preserved specimen
Cryptosporidium antigen, preserved specimen
E. histolytica antigen detection
Fecal suspension
Giardia antigen, non-preserved specimen
Giardia antigen, preserved specimen
Giemsa stain
Modified acid fast stain for intestinal parasites
Methods
Parasitology, Partial ID
Parasitology, Screen only
Test/Analyte
Ova and parasite exam
Parasite ID, arthropod
Parasite ID, blood, other than malaria
Parasite ID, fecal
Parasite ID, malaria
Parasite ID, other
Pinworm prep
Pneumocystis, DFA
Microbiology – Virology
Tzanck smears
Viral culture, complete ID
Adenovirus antigen, DFA
Adenovirus antigen, non-IF method
CMV antigen, DFA
CMV antigen, IFA
Chlamydia culture
HSV antigen, DFA
HSV antigen, non-IF method
Herpes culture
Methods
Viral culture, partial ID
Test/Analyte
Influenza antigen, DFA
Influenza antigen, non-IF method,
Parainfluenza type 2 antigen, DFA
RSV antigen, DFA
RSV antigen, non-IF method
Rotavirus antigen, non-IF method
Varicella-zoster antigen, DFA
Viral antigen detection other, DFA
Point of Care
ACT
ALT, whole blood
AST, whole blood
Adenovirus antigen, IF method
Albumin, whole blood
Alcohol, rapid test, saliva, medical
Alkaline phosphatase, whole blood
Amines, vaginal
Amylase, whole blood
BNP, whole blood
Bacterial vaginosis rapid test
Bilirubin, direct, whole blood
Bilirubin, total, Transdermal
Bilirubin, total, whole blood
Bladder tumer associated antigen
Bleeding time
Borrelia burgdorferi antibody
CK-MB, whole blood
CO2, whole blood
Calcium, ionized, whole blood
Calcium, total, whole blood
Chloride, whole blood
ACLASS-FQS Form 61
Test/Analyte
Occult blood, fecal
Occult blood, fecal, physician performed
Occult blood, gastric
Fern test, physician performed
Fern test, saliva
Fern test, vaginal fluid
Fructosamine, whole blood
Fructosamine, whole blood
Fungus slide preparation
GGT, whole blood
GGT, whole blood, waived
Glucose, whole blood
H. pylori antibody, whole blood
Occult blood, gastric, physician performed
Ovulation test (LH)
Oximetry
PAMG-1 protein detection, fluid
PCO2, whole blood
PO2, whole blood
PT, whole blood
PTT, whole blood
Phosphorous, whole blood
ISO 15189 Application
Page 19 of 21
January 31, 2014
Cholesterol, whole blood
Creatinine, semi-quant, urine
Creatinine, whole blood
Crystal exam, fluid
D-dimer, quantitative
ESR, automated
ESR, manual
Eosinophils, nasal smear
Eosinophils, nasal smear, physician performed
Estrone-3-glucuronide
FSH, urine
Fecal leukocytes, physician performed
H. pylori antigen, EIA
H. pylori detection, physician performed
H. pylori detection, urease
HDL cholesterol, whole blood
HIV-1 antibody rapid test, waived
HIV-1/2 antibody rapid test
Hematocrit (direct measure/calculate)
Hemoglobin A1C
Hemoglobin, calculated
Hemoglobin, plasma
Hemoglobin, total (direct measure)
Hemoglobin
Heparin assay (heparin/protamine titration)
INR, whole blood
Infectious mononucleosis
Influenza antigen, non-IF method
Influenza antigen, non-IF method
KOH prep
KOH prep, physician performed
Ketone, whole blood
LDL cholesterol, whole blood
Lactate, whole blood
Lead, blood
Lithium, whole blood
Magnesium, ionized, whole blood
Microalbumin, qualitative
Microalbumin, quantitative
Myoglobin, whole blood
N-telopeptides (NTX)
Nicotine/Cotinine rapid test
O2 saturation
Pinworm prep
Pinworm prep, physician performed
Platelet aggregation aspirin assay
Platelet function
Post-coital mucus exam, physician performed
Potassium, whole blood
Pro BNP
Protein, total, whole blood
RSV antigen, IF method
Reducing substances, fecal
Skin scrapings for scabies/lice
Sodium, whole blood
Specific gravity
Sperm count screen, rapid test
Sperm presence/absence
Sperm presence/absence, physician performed
Strep A rapid antigen
Synovial fluid for crystals, physician performed
TSH rapid screen, whole blood
Thrombelastograph (TEG)
Trichomonas antigen
Trichomonas antigen
Triglycerides, whole blood
Urine sediment microscopy, physician performed
Urine sediment, microscopic
Vaginal wet mount, physician performed
Vaginal wet prep
hCG, urine
pH, amniotic fluid, physician performed
pH, gastric
pH, other
pH, scalp
pH, vaginal
pH, whole blood
Troponin I
Troponin T
Urea, whole blood
Urinalysis dipstick, automated
Urinalysis dipstick, manual
Urinary tract infection rapid screen
Urine dipstick, physician performed
Urine drug screen, single use kit
Immunohematology – ABO/RH; Antibody Detection; Antibody Identification; Compatibility Testing
Transfusion Service (NOT registered with the FDA)
Adsorptions
Apheresis
Autologous collections
Automated test systems
Blood issuance for transfusion
Blood storage
Bone marrow/progenitor cell collection
Bone marrow/progenitor cell processing
CD 34+ performed in stem cell lab
Computer crossmatch
Elutions
ACLASS-FQS Form 61
Methods
ABO blood grouping
Antibody screen
Antibody screen (prenatals only)
Antibody identification
Antibody titration
Cold agglutinin
Compatibility testing
Cryofibinogen
Cryoglobulin
Direct antiglobulin test (DAT)
Test/Analyte
Donath Landsteiner
ISO 15189 Application
Page 20 of 21
January 31, 2014
Gel techniques
Intra-operative/peri-operative blood collection
Perinatal testing
Rho (D) Immune Globulin (RhIG) work-up
Selection of blood/compon. for transfusion
Solid phase techniques
Storage and issue of tissues
Therapeutic phlebotomy
Transfusion reaction evaluation
Fetal-maternal bleed screen (rosette)
Hemoglobin and/or hematocrit donor screen
Kleihauer-Betke stain (fetal cell quantitation)
Platelet antibodies for crossmatching
Platelet crossmatch
RBC antigen typing
RBC antigen typing for parentage testing only
Rh type (includes weak D)
Immunohematology – ABO/RH; Antibody Detection; Antibody Identification; Compatibility Testing
Blood Establishment (FDA Registered)
Adsorptions
Apheresis
Autologous collections
Automated test systems
Blood component irradiation
Blood component modification, other
Blood component preparation (e.g., FFP)
Blood component washing
Blood issuance for transfusion
Blood storage
Bone marrow/progenitor cell collection
Bone marrow/progenitor cell processing
CD 34+ performed in stem cell lab
Donor collection, emergency
Donor collection, routine
Elutions
Gel techniques
Intra-operative/peri-operative blood collection
Mobile donor stations
Perinatal testing
Remote donor stations
Rho (D) Immune Globulin (RhIG) work-up
Selection of blood / components for transfusion
Sickle cell screening on donor units
Solid phase techniques
ACLASS-FQS Form 61
Methods
Computer crossmatch
Confirmation of donor unit blood type
Donor blood testing, on-site
ABO blood grouping
Antibody screen
Antibody screen (prenatals only)
Antibody identification
Antibody titration
Cold agglutinin
Compatibility testing
Cryofibinogen
Cryoglobulin
Direct antiglobulin test (DAT)
Test/Analyte
Storage and issue of tissues
Therapeutic phlebotomy
Transfusion reaction evaluation
Donath Landsteiner
Fetal-maternal bleed screen (rosette)
Hemoglobin and/or hematocrit donor screen
Kleihauer-Betke stain (fetal cell quantitation)
Platelet antibodies for crossmatching
Platelet crossmatch
RBC antigen typing
RBC antigen typing for parentage testing only
Rh type (includes weak D)
ISO 15189 Application
Page 21 of 21
January 31, 2014