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Accreditation scope for

MED/TEST 328

Helse Møre og Romsdal HF

Avdeling for medisinsk mikrobiologi

Mikrobiologi Hjelset
Oppdølvegen 2
6450 Hjelset

Telephone: 711 22110
E-mail: mikromolde@helse-mr.no
Internet: http://www.helse-mr.no/
The laboratory meets the requirements in

NS-EN ISO 15189:2022


*Partially suspended (Voluntary or involuntary)


Accreditation includes:
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The administrative / geographical unit:
Mikrobiologi Hjelset
Avdeling for medisinsk mikrobiologi
6450 Hjelset


Permanent facility
M1610 Medical microbiology, bacteriology
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Abscess content
Parameter
Pathogenic bacteria, fungi
Reference standard
Internal method
Internal method identity
5488, 37095, 30257, 35793, 33745, 35555
Comment
Culturing
Object
Blood
Parameter
Pathogenic bacteria, fungi
Reference standard
Internal method
Internal method identity
26677, 32146, 28665, 26632
Comment
Culturing, BactAlert VirtuO
Object
Blood, sterile fluids, tissues and lower respiratory tract
Parameter
Pathogenic bacteria, fungi
Reference standard
Internal method
Internal method identity
29707
Comment
Gram stain, microscopy
Object
Feces
Parameter
Clostridium difficile, toxin-producing
Reference standard
Internal method
Internal method identity
14595
Comment
Real-time PCR, GeneXpert
Object
Feces
Parameter
Clostridium difficile, toxin-producing
Reference standard
Internal method
Internal method identity
5403
Comment
Immunochromogen
Object
Feces
Parameter
E.coli enterohemorrhagic (EHEC)/E. coli enterotoxigenic (ETEC) gene stx1, stx2, eaeA DNA
Reference standard
Internal method
Internal method identity
37244, 34515, 32639, 38092, 30320, 65664, 65708
Comment
Real-time PCR MP96, MP24, CFX Opus, LCPRO
Object
Feces
Parameter
Salmonella, Shigella, Yersinia, Campylobacter, Vibrio, EHEC
Reference standard
Internal method
Internal method identity
5406, 34515, 34516, 26066, 34748
Comment
Culturing
Object
Fresh sputum sample and NALC-treated sputum sample
Parameter
Mycobacterium tuberculosis complex PCR
Reference standard
Internal method
Internal method identity
32670
Comment
Real-time PCR, GeneXpert
Object
Feces
Parameter
Campylobacter group C. difficile (Toxin A/B) ETEC (LT/ST) STEC (stx1/stx2) Shigella spp./EIEC Salmonella spp. Vibrio cholerae Yersinia enterocolitica
Reference standard
Internal method
Internal method identity
67300 67303
Comment
xMAP technology
Object
Genital secretions
Parameter
Pathogenic bacteria, fungi
Reference standard
Internal method
Internal method identity
5474, 35817, 35793
Comment
Culturing
Object
Genital secretions
Parameter
Neisseria gonorrhoeae
Reference standard
Internal method
Internal method identity
5474, 19221, 35817, 355555
Comment
Culturing
Object
Genital secretions Urine
Parameter
Mycoplasma genitalium
Reference standard
Internal method
Internal method identity
40037, 39820
Comment
Real-time PCR, Alinity
Object
Genital secretions, urine
Parameter
Neisseria gonorrhoeae
Reference standard
Internal method
Internal method identity
40037, 39820
Comment
Real-time PCR, Alinity
Object
Genital secretions, urine
Parameter
Chlamydia trachomatis
Reference standard
Internal method
Internal method identity
40037, 39820
Comment
Real -time PCR, Alinity
Object
Induced sputum Expectoration Bronchoalveolar lavage fluid Urine Pus Gastric aspirates Synovial fluids Pleural fluids Tissue
Parameter
Mycobacteria
Reference standard
Internal method
Internal method identity
7102, 7110, 7101, 7107, 7109, 7099, 57960, 7269
Comment
Dyrkning, BD BACTEC
Object
NALC and untreated expectorate Induced sputum Bronchoalveolar lavage fluid BAL
Parameter
Mycobacterium tuberculosis complex PCR
Reference standard
Internal method
Internal method identity
41013
Comment
Real-time PCR, BD MAX
Object
Lower respiratory tract
Parameter
Pathogenic bacteria, fungi
Reference standard
Internal method
Internal method identity
30155, 7267, 35555
Comment
Culturing
Object
Lower respiratory tract
Parameter
Mycobacterium tuberculosis Staining and microscopy of ZN preparation
Reference standard
Internal method
Internal method identity
25809, 7268
Comment
ZN staining, Aerospray, Microscope, Assessment
Object
Sample from positive MGIT tubes
Parameter
Mycobacterium tuberculosis complex Antigen test
Reference standard
Internal method
Internal method identity
15918
Comment
Immunkromogen
Object
Pure culture, bacteria
Parameter
Sensitivity testing
Reference standard
Internal method
Internal method identity
5238, 28865
Comment
Disc diffusion
Object
Pure culture, bacteria, fungi
Parameter
Sensitivity testing
Reference standard
Internal method
Internal method identity
4510
Comment
Double dilution series using MIC, Vitek 2, Vitek 2 XL
Object
Pure culture, bacteria, fungi
Parameter
Sensitivity testing
Reference standard
Internal method
Internal method identity
5305, 35793
Comment
MIC value with gradient strip
Object
Pure culture, bacteria, fungi
Parameter
Identification
Reference standard
Internal method
Internal method identity
22599
Comment
Mass spectrometry, Maldi Tof, Vitek MS
Object
Secretion
Parameter
Methicillin resistent Staphylococcus aureus
Reference standard
Internal method
Internal method identity
5475, 39246, 35301, 35555
Comment
Cultivation
Object
Secretion
Parameter
Enterococci, vancomycin resistant (VRE)
Reference standard
Internal method
Internal method identity
21436, 21437
Comment
Cultivation
Object
Secretion
Parameter
Streptococcus agalactiae
Reference standard
Internal method
Internal method identity
39246
Comment
Cultivation
Object
Secretion, expectoration
Parameter
Pseudomonas aeruginosa
Reference standard
Internal method
Internal method identity
39246
Comment
Cultivation
Object
Secretion, feces
Parameter
ESBL-producing bacteria
Reference standard
Internal method
Internal method identity
21437, 25904
Comment
Cultivation
Object
Spinalfluid
Parameter
Pathogenic bacteria, fungi
Reference standard
Internal method
Internal method identity
5489. 33745, 35555
Comment
Culturing
Object
Sterile fluids (except blood and spinalfluid)
Parameter
Pathogenic bacteria, fungi
Reference standard
Internal method
Internal method identity
26677, 33745
Comment
Culturing, BactAlert VirtuO
Object
Sterile fluids (except blood and spinalfluid)
Parameter
Pathogenic bacteria, fungi
Reference standard
Internal method
Internal method identity
5488, 37095, 30257, 35793, 33745, 35555
Comment
Culturing
Object
Wound secretion
Parameter
Pathogenic bacteria, fungi
Reference standard
Internal method
Internal method identity
5488, 37095, 30257, 35793, 35555
Comment
Culturing
Object
Urine
Parameter
Pathogenic bacteria, fungi
Reference standard
Internal method
Internal method identity
4397, 9896, 40581, 35555
Comment
Culturing
Object
Urine
Parameter
Legionella pneumophila antigen
Reference standard
Internal method
Internal method identity
8571
Comment
Immunkromogen Digival reader
Object
Urine
Parameter
Pathogenic bacteria and fungi
Reference standard
Internal method
Internal method identity
66055 66056
Comment
Cultivation with WASP-lab Exception: Use of the AI ​​function for determination
Object
Urine, spinalfluid
Parameter
Streptococcus pneumoniae antigen
Reference standard
Internal method
Internal method identity
8571
Comment
Immunkromogene, Digival reader
Object
Tissue
Parameter
Pathogenic bacteria, fungi
Reference standard
Internal method
Internal method identity
26677, 39876
Comment
Culturing, BactAlert VirtuO
Object
Tissue
Parameter
Pathogenic bacteria, fungi
Reference standard
Internal method
Internal method identity
35306, 32747, 33745, 35555
Comment
Culturing
Object
Ear secretion
Parameter
Pathogenic bacteria, fungi
Reference standard
Internal method
Internal method identity
37095, 35793, 35555
Comment
Culturing
Object
Upper respiratory tract
Parameter
Pathogenic bacteria, fungi
Reference standard
Internal method
Internal method identity
33641, 37095, 33641, 35555
Comment
Culturing
Object
Upper respiratory tract Lower respiratory tract
Parameter
Legionella spp.-DNA Legionella pneumophila-DNA
Reference standard
Internal method
Internal method identity
30320, 36233, 32409, 33135
Comment
Real-time PCR
Object
Upper rspiratory tract, Lower respiratory tract
Parameter
Atypical respiratory bacteria panel: Bordetella pertussis DNA, Bordetella parapertussis DNA, Mycoplasma pneumoniae DNA, Chlamydophila pneumoniae DNA
Reference standard
Internal method
Internal method identity
30320, 37244, 62525, 33135, 65664
Comment
Real-time PCR MP96, MP24, PSU, LC PRO
Object
Eye secretion
Parameter
Pathogenic bacteria, fungi
Reference standard
Internal method
Internal method identity
5476, 30901, 37095, 35555
Comment
Culturing
M1640 Medical microbiology, virology
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Feces
Parameter
Adenovirus F40/41 Astrovirus Norovirus GI/GII Rotavirus A Sapovirus GI/GII/GIV/GV
Reference standard
Internal method
Internal method identity
67300 67303
Comment
xMAP technology
Object
Plasma
Parameter
Cytomegalovirus
Reference standard
Internal method
Internal method identity
40037, 40467
Comment
Real -time PCR, Alinity
Object
Serum, plasma
Parameter
Hepatitis B virus
Reference standard
Internal method
Internal method identity
40037, 40467
Comment
Real -time PCR, Alinity
Object
Serum, plasma
Parameter
Hepatitis C virus
Reference standard
Internal method
Internal method identity
40037, 40467
Comment
Real -time PCR, Alinity
Object
Wound secretions, Spinal fluid, Eye chamber fluid
Parameter
Enterovirus-RNA
Reference standard
Internal method
Internal method identity
30320, 67149, 65664, 65708, 55988, 33135
Comment
Real-time PCR MP96, InGenius, LC PRO, CFX Opus
Object
Wound secretions, Spinal fluid, Eye chamber fluid
Parameter
Varicella zoster-virus-DNA
Reference standard
Internal method
Internal method identity
30320, 67149, 65664, 65708, 55988, 33135
Comment
Real-time PCR MP96, InGenius, LC PRO, CFX Opus
Object
Wound secretions, Spinal fluid, Eye secretions,
Parameter
Herpes simplex-virus type 1-DNA, Herpes simplex-virus type 2-DNA
Reference standard
Internal method
Internal method identity
30320, 67149, 65664, 65708, 55988, 33135
Comment
Real-time PCR MP96, InGenius, LC PRO, CFX Opus
Object
Upper rspiratory tract, Lower respiratory tract
Parameter
Respiratory Virus Panel: Adenovirus DNA, Rhinovirus RNA,, Human metapneumovirus RNA Respiratory syncytial virus RNA
Reference standard
Internal method
Internal method identity
30320, 37244, 57782, 34900, 33135, 65664, 65708
Comment
Real-time PCR MP96, MP24, LCPRO, CFX OPUS
Object
Upper rspiratory tract, Lower respiratory tract
Parameter
SARS CoV-2 (N-gen), Influenza A/B
Reference standard
Internal method
Internal method identity
30320, 37244, 42952, 33135, 65708, 65664
Comment
Real-time PCR MP96, MP24, CFX OPUS, LC PRO
Object
Eye secretion
Parameter
Adenovirus-DNA
Reference standard
Internal method
Internal method identity
30320, 37244, 52319, 22156, 57782, 33135, 65664
Comment
Real-time PCR MP96, MP24, LC PRO
M1650 Medical microbiology, parasitology
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Blood smear
Parameter
Malaria
Reference standard
Internal method
Internal method identity
30962
Comment
Light microscope
Object
Feces
Parameter
Parasites
Reference standard
Internal method
Internal method identity
23292
Comment
Light microscope
Object
Feces
Parameter
Cryptosporidium group Entamoeba histolytica Giardia lamblia
Reference standard
Internal method
Internal method identity
67300 67303
Comment
xMAP technology
M1660 Medical microbiology, infection immunolgy
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Serum, plasma
Parameter
Borrelia, IgG antibody Plus VLsE
Reference standard
Internal method
Internal method identity
65942
Comment
ELISA, Immunomat
Object
Serum, plasma
Parameter
Borrelia, IgM antibody
Reference standard
Internal method
Internal method identity
65942
Comment
ELISA, Immunomat
Object
Serum, plasma
Parameter
Cytomegalovirus, IgG antibody
Reference standard
Internal method
Internal method identity
65942
Comment
ELISA, Immunomat
Object
Serum, plasma
Parameter
Cytomegalovirus, IgM antibody
Reference standard
Internal method
Internal method identity
42629
Comment
ELFA, bioMerieux VIDAS
Object
Serum, plasma
Parameter
Cytomegalovirus, p52, IgM-antibody
Reference standard
Internal method
Internal method identity
65942
Comment
ELISA, Immunomat
Object
Serum, plasma
Parameter
Epstein-Barr-virus, IgM-antibody
Reference standard
Internal method
Internal method identity
30676
Comment
Imunkromogen
Object
Serum, plasma
Parameter
Epstein-Barr-virus-CA, IgG-antibody
Reference standard
Internal method
Internal method identity
65942
Comment
ELISA, Immunomat
Object
Serum, plasma
Parameter
Epstein-Barr-virus-CA, IgM-antibody
Reference standard
Internal method
Internal method identity
65942
Comment
ELISA, Immunomat
Object
Serum, plasma
Parameter
Hepatitis B-core, Total antibody
Reference standard
Internal method
Internal method identity
42629
Comment
ELFA, bioMerieux VIDAS
Object
Serum, plasma
Parameter
Parvovirus B-19, IgG antibody
Reference standard
Internal method
Internal method identity
65942
Comment
ELISA, Immunomat
Object
Serum, plasma
Parameter
Parvovirus B-19, IgM antibody
Reference standard
Internal method
Internal method identity
65942
Comment
ELISA, Immunomat
Object
Serum, plasma
Parameter
Varicella zoster, IgG-antibody
Reference standard
Internal method
Internal method identity
65942
Comment
ELISA, Immunomat
Object
Serum, plasma
Parameter
Denguevirus NS1-antigen, Denguevirus IgG-antibody, Denguevirus IgM-antibody
Reference standard
Internal method
Internal method identity
23284
Comment
Immunkromogen
Object
Serum/plasma
Parameter
Hepatitis A, total antibody
Reference standard
Internal method
Internal method identity
66082
Comment
eCLIA, Roche eModul
Object
Serum/plasma
Parameter
Hepatitis A, IgM antibody
Reference standard
Internal method
Internal method identity
66082
Comment
eCLIA, Roche eModul
Object
Serum/plasma
Parameter
Hepatitis B, core antibody
Reference standard
Internal method
Internal method identity
66082
Comment
eCLIA, Roche eModul
Object
Serum/plasma
Parameter
Hepatitis B, e-antigen
Reference standard
Internal method
Internal method identity
66082
Comment
eCLIA, Roche eModul
Object
Serum/plasma
Parameter
Hepatitis B, e-antibody
Reference standard
Internal method
Internal method identity
66082
Comment
eCLIA, Roche eModul
Object
Serum/plasma
Parameter
Hepatitis B, s-antigen
Reference standard
Internal method
Internal method identity
4387, 66082
Comment
eCLIA, Roche eModul
Object
Serum/plasma
Parameter
Hepatitis B, s-antibody
Reference standard
Internal method
Internal method identity
66082
Comment
eCLIA, Roche eModul
Object
Serum/plasma
Parameter
Hepatitis C, antibody
Reference standard
Internal method
Internal method identity
4387, 66082
Comment
eCLIA, Roche eModul
Object
Serum/plasma
Parameter
Human immunodeficiency virus (HIV), combo, antigen/antibody
Reference standard
Internal method
Internal method identity
4387 , 66082
Comment
eCLIA, Roche eModul
Object
Serum/plasma
Parameter
Rubella, IgG antistoff
Reference standard
Internal method
Internal method identity
66082
Comment
eCLIA, Roche eModul
Object
Serum/plasma
Parameter
Syphilis
Reference standard
Internal method
Internal method identity
4387, 66082
Comment
eCLIA, Roche eModul
Object
Serum/plasma
Parameter
Toxoplasma gondii, IgM antibody
Reference standard
Internal method
Internal method identity
66082
Comment
eCLIA, Roche eModul
Object
Serum/plasma
Parameter
Toxoplasma gondii, IgG antibody
Reference standard
Internal method
Internal method identity
66082
Comment
eCLIA, Roche eModul
Object
Spinal fluid
Parameter
CXCL 13-Neuroborreliosis biomarker
Reference standard
Internal method
Internal method identity
27055, 39458
Comment
ELISA, Immunomat
M31 Flexible accreditation
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Respiratory tests Sterile liquids Biopsies and tissue Body secretions Body fluids Bacteria Urine
Parameter
Bacteria Yeast Virus Parasites Antibodies Antigens
Reference standard
Internal method
Internal method identity
Measurement principle/analysis platforms which is accredited under medical microbiology (M16) Procedure for FA: 63689 ID log: 00886
Comment
An updated list of methods included in the flexible scope of accreditation, is available with the organization.
The administrative / geographical unit:
Mikrobiologi Ålesund
Ålesund sykehus
6026 Ålesund


Permanent facility
M1610 Medical microbiology, bacteriology
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Abscess content
Parameter
Pathogenic bacteria, fungi
Reference standard
Internal method
Internal method identity
5488, 37095, 30257, 35793, 33745, 35555
Comment
Culturing
Object
Blood
Parameter
Pathogenic bacteria, fungi
Reference standard
Internal method
Internal method identity
26677, 32146, 28665, 26632
Comment
Culturing, BactAlert VirtuO
Object
Blood, sterile fluids, tissues and lower respiratory tract
Parameter
Pathogenic bacteria, fungi
Reference standard
Internal method
Internal method identity
29707
Comment
Gram stain, microscopy
Object
Feces
Parameter
Clostridium difficile, toxin-producing
Reference standard
Internal method
Internal method identity
5403
Comment
Immunkromogene
Object
Feces
Parameter
Clostridium difficile, toxin-producing
Reference standard
Internal method
Internal method identity
14595
Comment
Real-time PCR, GeneXpert
Object
Genital secretions
Parameter
Neisseria gonorrhoeae
Reference standard
Internal method
Internal method identity
5474, 19221, 35817, 355555
Comment
Culturing
Object
Genital secretions
Parameter
Pathogenic bacteria, fungi
Reference standard
Internal method
Internal method identity
5474, 35817, 35793
Comment
Culturing
Object
Lower respiratory tract
Parameter
Pathogenic bacteria, fungi
Reference standard
Internal method
Internal method identity
30155, 7267, 35555
Comment
Culturing
Object
Pure culture, bacteria
Parameter
Sensitivity testing
Reference standard
Internal method
Internal method identity
5238, 28865
Comment
Disc diffusion
Object
Pure culture, bacteria, fungi
Parameter
Identification
Reference standard
Internal method
Internal method identity
22599
Comment
Mass spectrometry, Maldi Tof, Vitek MS
Object
Pure culture, bacteria, fungi
Parameter
Sensitivity testing
Reference standard
Internal method
Internal method identity
5305, 35793
Comment
MIC value with gradient strip
Object
Pure culture, bacteria, fungi
Parameter
Sensitivity testing
Reference standard
Internal method
Internal method identity
4510
Comment
Double dilution series using MIC, Vitek 2, Vitek 2 XL
Object
Secretion
Parameter
Methicillin resistent Staphylociccus aureus
Reference standard
Internal method
Internal method identity
5475, 39246, 35301, 35555
Comment
Cultivation
Object
Secretion
Parameter
Streptococcus agalactiae
Reference standard
Internal method
Internal method identity
39246
Comment
Cultivation
Object
Secretion
Parameter
Enterococci, vancomycin resistant (VRE)
Reference standard
Internal method
Internal method identity
21436, 21437, 35555
Comment
Cultivation
Object
Secretion, expectoration
Parameter
Pseudomonas aeruginosa
Reference standard
Internal method
Internal method identity
39246
Comment
Cultivation
Object
Secretion, feces
Parameter
ESBL-producing bacteria
Reference standard
Internal method
Internal method identity
21437, 25904, 35555
Comment
Cultivation
Object
Spinalfluid
Parameter
Pathogenic bacteria, fungi
Reference standard
Internal method
Internal method identity
5489. 33745, 35555
Comment
Culturing
Object
Sterile fluids (except blood and spinalfluid)
Parameter
Pathogenic bacteria, fungi
Reference standard
Internal method
Internal method identity
5488, 37095, 30257, 35793, 33745, 35555
Comment
Culturing
Object
Sterile fluids (except blood and spinalfluid)
Parameter
Pathogenic bacteria, fungi
Reference standard
Internal method
Internal method identity
26677, 33745
Comment
Culturing, BactAlert VirtuO
Object
Wound secretion
Parameter
Pathogenic bacteria, fungi
Reference standard
Internal method
Internal method identity
5488, 37095, 30257, 35793, 35555
Comment
Culturing
Object
Urine
Parameter
Legionella pneumophila antigen
Reference standard
Internal method
Internal method identity
8571
Comment
Immunkromogen Digival reader
Object
Urine
Parameter
Pathogenic bacteria, fungi
Reference standard
Internal method
Internal method identity
4397, 9896, 40581, 35555
Comment
Culturing
Object
Urine, spinalfluid
Parameter
Streptococcus pneumoniae antigen
Reference standard
Internal method
Internal method identity
8571
Comment
Immunkromogene, Digival reader
Object
Tissue
Parameter
Pathogenic bacteria, fungi
Reference standard
Internal method
Internal method identity
26677, 39876
Comment
Culturing, BactAlert VirtuO
Object
Tissue
Parameter
Pathogenic bacteria, fungi
Reference standard
Internal method
Internal method identity
35306, 32747, 33745, 35555
Comment
Culturing
Object
Ear secretion
Parameter
Pathogenic bacteria, fungi
Reference standard
Internal method
Internal method identity
37095, 35793, 35555
Comment
Culturing
Object
Upper respiratory tract
Parameter
Pathogenic bacteria, fungi
Reference standard
Internal method
Internal method identity
33641, 37095, 33641, 35555
Comment
Culturing
Object
Eye secretion
Parameter
Pathogenic bacteria, fungi
Reference standard
Internal method
Internal method identity
5476, 30901, 37095, 35555
Comment
Culturing
M1640 Medical microbiology, virology
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Respiratory samples
Parameter
SARS CoV-2 Influenza A/B (N-gen)
Reference standard
Internal method
Internal method identity
41364
Comment
Real-time PCR, BD MAX
M1650 Medical microbiology, parasitology
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Blood smear
Parameter
Malaria
Reference standard
Internal method
Internal method identity
30962
Comment
Light microscope
M1660 Medical microbiology, infection immunolgy
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Serum, plasma
Parameter
Denguevirus NS1-antigen, Denguevirus IgG-antibody, Denguevirus IgM-antibody,
Reference standard
Internal method
Internal method identity
23284
Comment
Immunkromogen
Object
Serum, plasma
Parameter
Epstein-Barr-virus, IgM-antibody
Reference standard
Internal method
Internal method identity
30676
Comment
Imunkromogen
M31 Flexible accreditation
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Respiratory tests Sterile liquids Biopsies and tissue Body secretions Body fluids Bacterial strains Urine
Parameter
Bacteria Yeast Virus Parasites Antibodies Antigens
Reference standard
Internal method
Internal method identity
Measurement principle/analysis platforms which is accredited under medical microbiology (M16) Procedure for FA: 63689 ID log: 00886
Comment
An updated list of methods included in the flexible scope of accreditation, is available with the organization.