www.todylaboratories.com

External QualityAssessment Schemes

www.todylaboratories.com

EQA programs are invaluable tools used by laboratories to periodically assess their performance by means of interlaboratory comparisons.

Results are objectively compared between laboratories using: • the same working method or different methods;• the same equipment or different equipment;• the same producer of reagents or different producers.

Comparison of all results provides insight into performance that is not available to the individual participants. Moreover, the information offers a basis for quality improvement initiatives.

EQA evaluation reports also offer a comparison of different methods and equipment for the same test; thus, providing an assessment of reliability. Besides the use of daily quality controls, the external quality programs enhance confidence in reporting patient test results.

ISO 17043 ISO 9001

www.todylaboratories.com

todylaboratories© is an authorized EQA Schemes administrator ISO 17043 accredited for clinical laboratories.

• EQA Schemes are fully accredited to help meet the current regulatory needs of clinical laboratories.

• more than 50 schemes in which you can enroll to up to 12 monthly participations each;

• the evaluation reports with Z score calculation and graphical representation of result’s Bias to facilitate monitoring the evolution over time of this essential perfor-mance indicator;

• ranges for the following areas: Biochemistry, ESR, Gynaecological Pathology Hematology, HIV Antibodies, Hepatitis A+B+C, Hormones and tumor markers, Infection Disease Serology, Mycology, Microbiology, Parasitology, Preanalytical phase, Transfusion - Immunohematology, Urine Chemistry.

The results can be uploaded by each participant onto our dedicated website, under strict confidential and secure conditions using a unique username and password. The evaluation reports for each survey can be downloaded in the same secure manner by each participant.

Dedicated website

Each participating laboratory can choose any number of months, even 12 months per year, for enrolling to our schemes, according to own quality assurance strategy. This flexibility in terms of periodicity and frequency of participation proves adequate to satisfy the needs of each laboratory and also allows the creation of data archives for a historical analysis of the laboratory performance.

Frequency of participation

Create account and register at www.todylaboratories.com or contact us to place an order. After registering the 1st order, each laboratory is given a unique participation code.

www.todylaboratories.com

P A R T I C I P A T I O N F L O W

1

Order desired EQA schemes using www.todylaboratories.com dedicated area; choose the product category and select the participation months.2

home order now permits

General Biochemistry, TQBC00201 2 3 4 5 6 7 8 9 10 11 12

A)

ORDER TYPE

PURCHASE ORDER

FREE SAMPLES ORDER

EQAS budget estimate & sign upB)

SAVE EQAS SIGN UPD)

Please choose the product category and selectthe participation months for the desired programs.

C)

After your laboratory order is confirmed, the documents attesting the registration to the respective programs are sent to you by e-mail.

www.todylaboratories.com

P A R T I C I P A T I O N F L O W

3

The ordered samples are shipped to you. All specimens ordered for the same month of participation are sent in one package.

4

Test specimens as a patient sample under routine laboratory conditions and strictly following the attached instructions for use.

5

Submit results before the deadline set for each program through our website, www.todylaboratories.com.

www.todylaboratories.com

P A R T I C I P A T I O N F L O W

6

Review your evaluation reports - qualitative or quantitative - and assess your perfor-mance. 7

account contact

sheet buyer

account modification

unsubscribe from email offers

password change

invoices/reports

reports external control

account status

complaints

download reports

upload results

TQHP0027-Sep-2017

Survey Sample code Expected result Own results

9/2017 HP0317 Negative Negative5/2017 HC0217 Positive Positive3/2017 HC0117 Negative Negative9/2016 HC0316 Positive Positive

- - - -- - - -- - - -- - - -- - - -- - - -- - - -- - - -

Results Own result Expected result n (results number)Own group Negative Negative 17All groups Negative 181

HCV AntibodiesReagent General Biological Corporation

Method (comparison group) ELISA

Results distribution Result history

Own result 22,71 µUI/ml

Survey Sample code x (mean) Own results Bias (Diff%) Target limits

9/2017 IM0317 25,52 22,71 -11,015/2017 IM0217 0,40 0,34 -15,003/2017 IM0117 4,76 3,16 -33,61

- - - - -- - - - -- - - - -- - - - -- - - - -- - - - -- - - - -- - - - -- - - - -

-20% x+20%

Results x (mean) SD CV% n (results number) x±20% (target limits) Z scoreOwn group 25,52 8,22 32,19 10 20,42 - 30,62 -0,34All groups 31,28 5,62 17,95 89 25,02 - 37,53 -1,53

TQIM0024-Sep-2017

TSH (µUI/ml) Reagent Tody LaboratoriesMethod (comparison group) ELISA/EIA

Results distribution Result history

QU

AN

TITA

TIV

E R

EP

OR

TQ

UA

LITA

TIV

E R

EP

OR

T

At the end of one EQAS cycle, a participation certificate is issued. This includes all the EQA programs to which the laboratory has participated.

www.todylaboratories.com

P A R T I C I P A T I O N F L O W

8

Continue to evaluate the performance of your lab by participating in the next cycle.9

www.todylaboratories.com

Clinical Chemistry • human based serum, lyophilized• 10 months/year

Analytes: ALT, Uric acid, ALP, Amylase, AST, Total bilirubin, Direct bilirubin, Indirect bilirubin, Ionized calcium, Total calcium, Cholesterol, Cholesterol HDL, Cholesterol LDL, Cholinesterase, Creatinine, Iron, Gamma GT, Glucose, Hapto-globin, Chloride, Sodium, Potassium, Phosphorus, LDH, Magnesium, Protein, Triglycerides, Urea, Albumin, Pancreatic amylase, Lithium, TIBC, Transferrin, Total CK, CK-MB, Lipase, Copper, CO2, IgA, IgE, IgG, IgM

code

Protein electrophoresis• human based serum, lyophilized• 10 months/year

Analytes: Total proteins, albumin, alfa 1 globulin, alfa 2 globu-lin, beta 1 globulin, beta 2 globulin, total beta globulins, gammaglobulins

Specific proteins• human based serum, liquid stable• 10 months/year

Analytes: ASO, CRP, RF, C3, C4, IgA, IgG, IgM

BIOCHEMISTRY (quantitative)

Coagulation• human based serum, liquid stable• 10 months/year

Analytes: Prothrombin quick time, Prothrombin index%, Prothrombin INR, APTT, APTT ratio, Fibrinogen, Antithrombin III

COAGULATION (quantitative)

Hepatitis A, B and C (serology)• human based serum, liquid stable• 12 months/year

Analytes: HAV IgM + HAV total Ab, HCVAb, HBsAg, HBsAc, HBc IgM+HBc total Ab, HBeAg, HBeAc

HIV 1+2, antibodies (serology)• human based serum, liquid stable• 12 months/year

Analytes: HIV 1+2 Ab

HEPATITIS & HIV (qualitative)

Hormones and Tumor markers(quantitative+qualitative)

• human based serum, lyophilized• 10 months/year

Analytes: quantitative results from serum - T3, T4, Free T3, Free T4, TSH, LH, FSH, Estradiol, Progesterone, Testosterone, Prolactin, hCG, CEA, AFP, PSA, Free PSA, IgE, C-peptide, Insulin, Ferritin, 17-OH progesterone, Cortisol, Free-Estriol, PTH, TPO Ab, ACTH, Vit B12, 25OH Vit D, Folic Acid; qualita-tive results from serum - TSH, CEA, AFP, Prolactin, PSA, IgE.

Hormones, urine tests(qualitative)

• human based urine, liquid stable• 4 months/year

Analytes: FSH, LH

HORMONES & TUMOR MARKERS (quantitative+qualitative)

TQBC0020

TQEF0031

TQSR0030

TQCO0023

TQHP0027

TQHV0028

TQIM0024

TQIM0024-U

www.todylaboratories.com

Evaluation of blood cell morphology (qualitative)

• 1 digital image blood smear • 10 months/year

Analytes: Leucocyte differential count (manual method), evaluation of blood cell morphology (microscopy)

Glicated haemoglobin (quantitative)

• human based blood, lyophilized• 4 months/year

Analytes: HbA1c

Reticulocyte count(quantitative)

• human based blood, liquid stable• 4 months/year

Analytes: Reticulocyte (manual and automated)

HEMATOLOGY (quantitative+qualitative)

Syphilis serology• human based serum, liquid stable• 12 months/year

Analytes: RPR, VDRL, TPHA, Syphilis antibodies

Borrelia burgdorferi Ab.• human based serum, liquid stable• 2 months/year

Analytes: B. burgdorferi Ab. IgG+IgM

Helicobacter pylori Ab.• human based serum, liquid stable• 12 months/year

Analytes: anti-H. pylori Ab.

TORCH + Chlamydia Ab.• human based serum, liquid stable• 4 months/year

Analytes: Toxoplasma gondii IgG+IgM, Rubella IgG+IgM, CMV IgG+IgM, Herpes 1/2 IgG+IgM, Chlamydia trachomatis IgA+IgG+IgM

Epstein Barr Virus Ab.• human based serum, liquid stable• 2 months/year

Analytes: EBV Ab. IgG+IgM

INFECTIOUS DISEASE SEROLOGY (qualitative)

Basic blood count(quantitative)

• human based blood, liquid stable• 10 months/year

Analytes: Hb, HCT, RBC, WBC, PLT, MCV, MCH, MCHC, MPV, RDW-SD, RDW-CV, LYM, MON, PCT, PDW-SD, PDW-CV

code

TQFL0036

TQHG0026

TQRT0047

TQHM0021

TQSS0034

TQHE0035

TQTC0055

TQBB0057

TQEB0056

Anti-Rh (Anti-D),ab. screening and titration

• human based serum, liquid stable• 4 months/year

Analytes: anti-D antibodies

ABO and Rh grouping• human based blood and serum, liquid stable• 12 months/year

Analytes: OAB and Rh grouping

TRANSFUSION/IMMUNOHEMATOLOGY (qualitative)TQRH0051

TQAB0033

PARASITOLOGY (qualitative)

Giardia intestinalis, Ag. detection in faeces

• stool samples, liquid stable• 4 months/year

Analytes: G intestinalis antigen

Parasites in faeces, virtual microscopy

• virtual images at high resolution• 12 months/year

Analytes: screening and identification of intestinal parasites TQPI0068

TQGS0052

www.todylaboratories.com

General bacteriologyFaecal cultureThroat streptococcal cultureConjunctival swabNasal swabEar swabPusUrethral swabCervical swabUrine culture

• Lyophilised microorg.• 4 months/year

Fungal culture-pusFungal culture-throatFungal culture-stoolFungal culture-conjunctival swabFungal culture-nasal swabFungal culture-ear swabFungal culture-urethral swabFungal culture-vaginal swabFungal culture-urine

• Lyophilised microorganism• 4 months/year

MICROBIOLOGY (qualitative) codecode

TQFN0048-416TQFN0048-EXTQFN0048-CPTQFN0048-415TQFN0048-414TQFN0048-413TQFN0048-411TQFN0048-412TQFN0048-UC

TQBG0037-ETQCP0038-ETQEX0040-ETQSB0415-ETQSB0414-ETQSB0413-ETQSB0416-ETQSB0411-ETQSB0412-ETQUC0039

Gynaecological cytology,Babes-Papanicolaou

• stained smear (virtual images at high resolution)• 6 months/year

Analytes: Pap abnormalities of cervical cells

PATHOLOGY (qualitative)TQBP0050

Erythrocyte sedimentation rate• human based blood, liquid stable• 12 months/year

Analytes: ESR

ESR (quantitative)TQVS0032

Urine chemistry (quantitative)

• human based urine, liquid stable• 4 months/year

Analytes: Protein, Glucose, Microalbumin, Creatinine, Uric Acid, Calcium, Chloride, Cortisol, Magnesium, Osmolality, Phosphorus, Potassium, Sodium, Urea, Amilase

Urine chemistry (strip+sediment)• urine strip test (semi-quantitative)

• human based urine, liquid stable• 12 months/year

• urine sediment examination • virtual images at high resolution• 12 months/year

Analytes: Blood, Glucose, hCG, Ketones, Leukocytes, Nitrite, pH, Protein, Relative density, Albumin, Bilirubin, Urobilinogen

Analytes: identification of cells and other particles - leukocytes, erythrocytes, casts, crystals and other particles

URINE CHEMISTRY (quantitative+qualitative)

www.todylaboratories.com

Helicobacter pylori antigen,detection in faeces

• stool samples, liquid stable• 12 months/year

Analytes: H. pylori Antigen in faeces

Faecal occult blood – FOB• stool samples, liquid stable• 12 months/year

Analytes: Haemoglobin in faeces

OTHERS (qualitative)

code

TQUQ0043

TQUR0022

TQHS0045

TQFB0044

www.todylaboratories.com