Running banner: Striving for excellence to improve service delivery
Mission
The MDC Clinical laboratories are striving for excellence to improve service delivery to the patients through their perspective clinicians.
Vision
It is the vision of the MDC Clinical laboratories to be a Centre of Excellence not only for Erbil and the greater Kurdistan, but also to the whole of Iraq to meet International standards for quality and to be International accredited by ISO 15189 at the end of 2012.
Core values:

• Teamwork-not I but we
• Clinical results that meet the highest standards of quality with low Turn Around Time (TAT)
• Continues change to improve service delivery – using the FAT principle: FOI-Find an opportunity for improvement, attitude and teamwork
• Continuous development of our staff (Lifelong learning)
• Be at the forefront of the latest technologies and methodologies in the fields of Clinical Pathological Diagnostically Services.
• Provide a safe working environment for our staff
• Diversity
• Handling of confidentiality over our results
• Respect for each other and our valued customers

MDC is working to be first Laboratory in the region to achieve International Accreditation as a Quality Provider of Medical Testing under the International Standard ISO 15189:2007 Medical laboratories - particular requirements for quality and competence.
Accreditation looks at the management of medical laboratories, covering the organizational and quality assurance activities required to ensure that pre examination, examination and post examination activities of laboratories are conducted in such a manner that they meet the needs and requirement of the user.

Laboratory Diagnostics

Laboratory Diagnostics
Laboratory Diagnostics MDC is state of the art; complete with new generation automated analyzers and computerized Laboratory Information Systems (LIS). The LIS will house the patient database, associated test results and reports and will be networked to our automated analyzers, ensuring correct, accurate and traceable results at all times.
The LIS will have the capacity to archive and subsequently retrieve all patient, tests and result data performed within the laboratory ensuring full patient history, traceability and audit capability as part of our Quality Assurance program. Disciplines to be offered initially include: Hematology, Clinical Chemistry, Microbiology, Anatomical Pathology (Histopathology, Cytopathology) and Serology (Infectious disease, Autoimmune, Allergy testing).
MDC will introduce more complex testing and analyses, such as Molecular Diagnostics, HLA Typing for transplantation, karyotyping and cytogenetic in the future as required. All Departments are staffed by a professional team of doctors, scientists and technicians using state of the art methods, materials and automated analyzers. Provision of accurate, reliable and timely results, interpretation and services are the primary goals of the laboratory.

Clinical Chemistry
Clinical chemistry is positioned to be responsive to the needs of the health system, developing and implementing new tests which are not available locally and had to be performed abroad.
Clinical chemistry department perform a wide range of clinical chemistry analysis on serum, plasma, CSF and Urine by developed automated clinical chemistry analyzer like Architect (C8000) and Axsym.
In this department control for all tests are run two times a day with starting every shift.

Below are some of the tests which are performed in this department:
- Cardiac tests (Troponin, CKMB, D-Dimer).
- Pancreatic tests (Lipase, Amylase).
- Lipid -, Lever-and Kidney tests, Electrolytes.
- Reproductive tests (FSH, Estrogen, Progesterone, LH, Beta HCG, Prolactin).
- Endocrinology tests.
- Thyroid hormones.
- Cancer marker ( CA125, Ca15.3, CA19.9, CEA, Free PSA, Total PSA)
- Immunology tests(IgG , IgA , IgM , IgE, ComplementC3, Complement C4)
- Other tests like Ferritin, Cortisol, Accp, Rheumatoid factor, C-reactive protein


Serology
The serology department performs a Wide range of Serological investigations including
- Diagnostic identification of infection of infectious antibodies or antigen in blood, Urine or Stool.
- CMV, Rubella, Toxoplasma, Hepatitis Viruses (A, B, C), HIV…..

Hematology
The Hematology department is one of the important parts of MDC, capable of running all the basic Hematological invs. In addition to other investigations that are not available in other labs including factor Coagulation assay quantative Hb subtype estimation, thanks to our unique coagulometer machine in STAGO and Sebia machine for Hb Electrophoresis in addition to a state of art (ELL-DYNN)supplier machine for CBC which also capable of reading twenty two hematological parameters in addition to certain Cell markers (CD4,3,CD61,41)so it can be requarded as miniflow cytometer we are intended to extend department in future to include flow cytometer and cytogenetic study.

Microbiology
Microbiology unit is well equipped to provide fundamental diagnostic testing in bacteriology, Microbiology, Mycology and Paraseitology.
The Unit has Phonix 100 System for bacterial Identification and antimicrobial susceptibility testing which provides most accurate and reliable results (MIC, according to NCCLS guidelines).
The Microbial anti gen detection section provides, Rapid detection of a variety of pathogens especially, in areas of meningitis, Enteric, Viral and Parasitic diseases.
BACTEC 9240 automatic system with dual function for Blood culture, Fungus culture and Mycobacterium culture is available and BACTEC, MGIT 960system for Mycobacterium culture Identification and susceptibility testing for mycobacterium Tuberculosis complex that gives a rapid result compared to the conventional procedure.

Pathology
To provide an accurate diagnosis so that the clinicians can provide better treatment to our patients.
Histopathology and Cytopathology
Surgical pathology
Biopsy of any tissue: Excision biopsy Incisional biopsy
The surgical pathology include: gastrointestinal -, bronchial -, renal -, urinary bladder -, liver -, gallbladder-, and pancreas-biopsy.
Bone and joint - , thyroid gland -, breast -, uterus and ovarian -, testicular -, lymph node -, and skin biopsy etc...
Cytopathology
Include:
1- Cervical smear
2- Exfoliative cytology e.g. sputum, pleural fluid, ascetic fluid, pericardial fluid, urine etc...
3- Fine needle aspiration cytology e.g. Breast, Thyroid etc…

Phlebotomy Services
MDC is equipped to provide sample collection services on site, ample off street parking is available. MDC has fully equipped phlebotomy rooms with expertly trained staff to collect samples appropriate for the tests required.
MDC uses BD Vacutainer evacuated tubes with or without additives to ensure optimal samples are delivered to the laboratory, minimizing pre-analytical sample problems.
On-site phlebotomy services are available for company/corporate testing by prior appointment. Please contact the laboratory to arrange.

Sample Quality
MDC has strict sample quality and identification requirements. Samples failing to meet these requirements will not be analyzed. As such samples wherever possible are to be collected at MDC, the exception to this is surgical materials for Histopathology or Cytopathology.
MDC will provide suitable containers and instructions for collection of Urine, Semen, Faecal and Sputum samples dependant on testing requirements.

Special specimen instructions for specific tests

Instructions for random Urine Collection for the female patient.
Explain carefully to patients the mechanics of midstream collection and the importance of collecting an uncontaminated specimen.
A clean – catch specimen is necessary to confirm the presence or absence of infecting organisms in the urine. The specimen must be free of any contaminating matter that might be present on the genital organs-therefore patients should be urged to follow the following steps:
1. If you are menstruating, first insert a fresh tampon or use cotton to stop the flow.
2. Separate the skin folds around the urinary opening
3. Wash the urinary opening and its surroundings from front to back with sterile antiseptic pad
4. Begin urinating into the toilet, making sure you keep the skin fold apart with the fingers of one hand.
5. Wait until stream is well established before moving the container into the path of the stream to catch the rest of the urine. Do not touch the container to the genital area
Instructions for random Urine Collection for the male patient
1. Wash the end of the penis well with soap and water. Let it dry
2. Begin urinating into the toilet. Wait until the urine stream is well established before moving the container into the path of the stream to catch the rest of the urine. Do not touch the container to the genital area.
3. Cleansing agents, such as soap or detergent, must be rinsed away from the urethral area before the specimen is collected.
4. Urine for culture must be transferred to a urine transport tube that contains preservative immediately after collection if specimen is not analyzed immediately


Instructions for 24 hour Urine Collection
1. Upon rising in the morning, urinate into the toilet, emptying your bladder completely. Do not collect this sample. Note the exact time and print on the container label.
2. Collect all urine voided for 24hours after this time in the container provided by the Laboratory. All urine passed during 24-hour time period (day or night) must be saved. Urine passed during bowel movements must also be collected.
3. Refrigerate the collected urine between all voiding or keep in a cool place.
4. At exactly the same time the following morning, void completely again (first time after wakening), and add this sample to the collection container. This completes your 24 hour collection.
5. Take the 24 hour urine specimen to the Laboratory as soon as possible, maintaining the cool temperature in transit by placing the specimen in a portable cooler or insulated bag.

Instructions for passing semen:
1. Patient should be abstinence from sexual intercourse or masturbation for 3 days prior to the collection of semen.
2. The total volume of semen should be passed into the provided container.
3. It is preferable that the patient pass the specimen at the laboratory. If not, it is important then to deliver the specimen as soon as possible to the laboratory, not later than 1 hour after collection.
4. Please mark the container with your full name and the time when the specimen was collected.
5. Make sure that the lid of the container is properly locked so that the specimen do not leak during transport.

Specimen test instructions:
Creatinine clearance test
The Creatinine Clearance Test compares levels of Creatinine in urine with the Creatinine level in blood, usually based on assessment of a 24 hour urine sample and a blood sample drawn at the end of 24 hour period. Clearance is measured in milliliters/minute (ml/min)
A 24 hour urine sample generally required. Occasionally 6 or 12 hour urine collections can be done alternatively. The Laboratory will instruct you if necessary to discontinue drags that may interfere with the test.

1.1 On day 1, urinate into the toilet upon rising in the morning
1.2 Collect all subsequent urine (special container) for the next 24 hours.
1.3 On day 2,urinate into the container in the morning upon arising
1.4 Cap the container. Keep in the refrigerator or a cool place during the period.
1.5 Label the container with your name, date, time of completion, your weight and length and return the container to the Laboratory.

Oral Glucose Tolerance Test (OGTT)

Indication: Diagnosis of Diabetes Mellitus
Methods and Criteria for Diagnosing Diabetes Mellitus

Symptoms of diabetes plus:
Random venous plasma glucose concentration ? 203,13 mg/dl (?11.1 mmol/L) or
Fasting venous plasma glucose concentration ?126.1mg/dl ( ?7.0 mmol/L) or
Plasma glucose concentration ?203.13 mg/dl (?11.1 mmol/L) 2 hours after 75g anhydrous glucose (or equivalent) in an oral glucose tolerance test (OGTT).

In the absence of symptoms, diagnosis requires confirmation by at least one
additional glucose result on another day.
If neither random nor fasting venous plasma glucose results are diagnostic of diabetes
mellitus, but either are 6.1mmol/L, an OGTT should be performed and the 2 hour OGTT
value should be used.


Contraindications:
None.

Pre-Procedure:
Unrestricted carbohydrate diet for 3 days prior to the test.
Fast from 22:00 hours the previous night. (fast > 10 hours)
Water allowed.
Morning medication is omitted and taken when test completed.

Procedure:
Arrange morning appointment.
Check that patient has been fasting since 10:00pm night before the test.

Explain procedure.

Fasting blood sample collected by venepuncture. (collect in a 2.7ml yellow tube) .
Give patient 410mls of Lucozade from a standard Lucozade bottle. (70kcal/100mmls.) Equivalent of 75g anhydrouws glucose.
Patients should consume the glucose load within 5 minutes.
Time of patient finishing the glucose load is recorded on the fasting blood sample tube & on the clinical chemistry form as time 0 (eg. 0 = 8.40)
Second blood sample is taken at +120 minutes. Blood sample tube & clinical chemistry form should be clearly labelled with this time. (e.g. +120 = 10.40)
Patient should be seated & remain within the department throughout test. No smoking is allowed. Patient should be offered light breakfast when test has been completed and reminded to take medication if applicable.
Blood samples sent to lab on completion of test.
If any glucose is lost by vomiting, test should be discontinued.

Interpretation:

Diagnosis Fasting 120 min

Normal:
Fasting: < 100mg/dl (<6.1 mmol/l )
2hrs: < 140 mg/dl (<7.8 mmols/l)

Diabetes mellitus: Fasting ?126.21 mg/dl ( ? 7.0 mmols/l) or 2hrs ? 200.13 mg/dl (? 11.1 mmols/l)

Impaired glucose tolerance (1GT ): Fasting < 126.21 mg/dl (< 7.0 mmols/l) and 2 hrs ? 140.63mg/dl (? 7.8 mmols/l) and < 200.13 mg/dl (< 11.1 mmols/l)

Impaired fasting glycaemia (1FG): Fasting ?109.9 mg/dl (? 6.1 mmols/l) and < 126.21 mg/l (<7.0 mmols/l) and 2 hrs < 140.63 mg/dl (< 7.8 mmols/l)

Different values apply for other types of blood sample
Reference: WGH Clinical Biochemistry Handbook RIE Clinical Biochemistry Handbook
ACB News Issue 444, April 2000, Page 11 – “Revised Diagnostic Criteria for Diabetes” –
Dr Andrew Day.

Reviewed by Dr J A McKnight, June 2000. Updated May2008 K Gough
GCT (For evaluating gestational diabetes-GDM)
The glucose challenge test (GCT) is performed in weeks 24 to 28 of gestation for patients at moderate risk and in early pregnancy for patients at high risk, regardless of the time of the last meal. The test involves the oral intake of 50 g of glucose within 2 minutes and measurement of plasma glucose level after 1 hour. Patients with a glucose level of more than 140 mg/dL on the GCT (14% to 18% of all pregnant women) must then undergo the OGTT for confirmation of GDM. This subgroup accounts for about 80% of all women with GDM. Some medical centers use a cutoff of 130 mg/dL on the GCT, which identifies more than 90% of all affected patients, but it increases the subgroup that requires an OGTT to 20% to 25% of all pregnant women. The OGTT identifies patients with diabetes by glucose loading. Before testing, patients ingest a 3-day diet of more than 150 g carbohydrate with regular physical activity followed by a fast of at least 8 hours (but not more than 14 hours). The test is performed in the morning of the fourth day. For diagnosis, the values of two of the four criteria listed in this figure must surpass the predetermined cutoff value, as indicated. According to the most recent recommendations [022], clinicians can use a 75- or 100-g glucose load and cutoff values equal to both tests. It is important to emphasize that capillary fingerstick glucose values are not accepted for diagnosis. The diagnosis of GDM must be based solely on plasma glucose

Conversions

*You can convert mmol/L to mg/dL using these factors for calculation.

TEST NAME	CONVERTING FACTOR (mg/dL)
1. GLUCOSE	**18.03
2. CHOLESTEROL	38.67
3. TRIGLYCERIDE	88.54
4. HDL	38.67
5. LDL	38.67
6. UREA	2.801
7. CREATININE	11.3
8. URIC ACID	16.81
9. PHOSPHOROUS	3.097
10. TOTAL BILIRUBIN	0.05847
11. CALCIUM	4.008
12. MAGNESIUM	2.430

**For example: Glucose: 1 mmol/L is equal to 18.03 mg/dL.

Clinical Chemistry Calculations:
For calculations go to http//www.MDCALC.com or request the laboratory to calculate these for you.
For example:
Creatinine clearance
Plasma Creatinine (PCr) : mg/dL
Urine Creatinine (UCr) : mg/dL
Total Urine Volume:
Total Collection Time:
* Height :
* Weight :
Creatinine Clearance1 : mL/min
Corrected Creatinine Clearance1 : mL/min/1.73 m2

1. Anion gaps

1. Anion gap (AG)
1.1 AG= Na+ - Cl- - HCO3__
AG corrected for abnormal Albumin: C AG
C AG - for every decrease of the Albumin level by 10g/I the AG will change by 2,5 AG range: 8-12


1.2 Delta anion gap (delta-delta)

Delta AG= (AG-12)/(24-HCO3-)

Delta AG range: 1-1,6
A value of less than 1 indicates that the HCO3- has decreased out of proportion to the elevation of the anion gap and suggests the presence of non-anion metabolic acidosis. A delta anion gap that exceeds the value of 1,6 indicate the anion gap has increased out of proportion to the rise in HCO3- and suggests the presence of a concomitant metabolic alkalosis.

1.3 Urine Anion Gap (UAG)
UAG=Na+ + k+ - CI-
UAG range: -20 to 0


2. Corrected ionized calcium (cCa++)

When the Albumin is smaller than 40: Ca++ +(40-Alb) x 0,025

When the Albumin is larger than 40; Ca++ - (Albumin-40) x 0,025

3. Creatinine clearances
3.1Corrected

Urine creatinine in micromoles/l/Serum creatinine in micromoles /1 x urine volume in ml/time in minutes x1,73/surface area of the patient

(surface area calculated from body surface nomogram)


3.2 Uncorrected
Urine creatinine in micromoles/l/serum creatinine in micromoles /I x Urine volume in mls/time in minutes

4. MDRD (Modification of Diet in Renal Disease)
GFR (ml/min/1.73=1,86 x serum creatinine x age x 0,742 if female x 1,21 if African American


5. Cockrofts Gault (Prediction of creatinine clearance from serum creatinine)
Females=(140-pt age) x weight x 1,04/serum creatinine
Males=(140-pt age) x weight x 1,23/serum creatinine
These formulae does not hold true for patients who are obese, pregnant or who have oedema.

6. Phosphate/ Creatinine Clearance ratio (Cp/Cer)
Serum creatinine x urine phosphate/serum phosphate x urine creatinine. Range: smaller than 0,15
Abnormal-often raised with hyperparathyroidism

7. % Tubular reabsorbed phosphate-% TRP
TRP% (1-clearance of phosphate/creatinine clearance x 100
Normal: 84%-95%
Abnormal: reduced values found in hyperparathyroidism

8. Calsium/creatinine: Ca/Cr
Random urine calcium in mmoles/l/random urine creatinine in mmoles/I
The random pre-menopausal mean is 0,26 with a range of 0,22-0,30 A ratio of larger than 0,30 suggests increased bone loss

9. Microalbumin/creatinine ratio
Urine microalbumin in mg/I/urine creatinine in mmols/l

10. Albumin/globulin
Albumin/globulin

11. % iron saturation
Iron/transferrin x 4,4

12. TIBC (Total iron binding capacity)
Transferrin in g/l x 22,75 or transferrin in mg/I x 0,02275

13. Protein/creatinine index (PCC)
Random protein urine in g/l/random urine creatinine in mmols/I x 0,113

14. CKMB ratio
100 x CKMB/CK

15. LDL
Cholesterol -HDL-Triglyceride/2,18

Calculations that the laboratory can do for clinicians
• Creatinine and corrected creatinine clearance
• Creatinine clearance using Cockcroft-Gault
• Creatinine clearance using MDRD
• Anion Gap
• Delta Gap
• Calsium corrected for Hypoalbuminemia
• Microalbumin/Creatinine ratio
• Reticulocyte index
• Absolute neutrophil count (ANC)
• Coversion factors to convert mmols/l to mg/dl


Helpful websites
• American Society for clinical pathology (ASCP)
• College for American pathology (CAP)
• Clinical Medical Management Association (CLMA)
• Healthcare Financial Medical Association (HFMA)
• The Joint Commision Laboratory Services
• Westgard Web-Westgard QC
• Clinical Laboratory Improvement Amendments of 1998 (CLIA 88)
• National Committee for Clinical Standards (NCCLS)