Medical Lab Services

 

ACDIMA BioCenter Medical Laboratory, as part of ACDIMA BioCenter, functions in accordance with Good Clinical Practices (GCP) principles - Good Laboratory Practice (GLP), local regulations, in-house procedures, and ISO 15189:2012 standard.

Laboratory quality is defined as the accuracy, reliability, and timeliness of reported test results. The laboratory results must be as accurate as possible, all aspects of the laboratory operations must be reliable and reporting must be timely in order to be useful in a clinical or public health setting.

ACDIMA BioCenter Medical Laboratory follows the internal documentation management system implemented and maintained in ACDIMA BioCenter and continually improved its effectiveness following the requirement of international standards.

The laboratory is provided with sufficient space and reliable infrastructure to perform the work to ensure the quality, safety & efficacy of the services provided and to meet Jordan Ministry of Health, JFDA, GCP, GLP requirements and ISO 15189:2012 standard.

The laboratory design provides an efficient and safe environment for the laboratory staff, other health care personnel, patients/volunteers, and the community.

Personnel is trained on the basics of safety and biohazardous material handling.

The laboratory facility consists of:

  • The reception area where requisition forms are received and reports disbursed.

  • Specimen collection area.

  • Analytical work area.

  • Documentation area.

  • Waste disposal facility including biological wastes.

  • Toilets.

In addition to the ancillary facility including: 

  • Separate area for staff for hand washing and eating.

  • Controlled temperature freezer and refrigerator with electronic monitoring and alarm system (Rotronic System).

  • Controlled environmental conditions.

  • Stores for medical and analytical supplies and reagents under the required storage conditions.

  • Disposal facilities for dangerous material.

  • Purified water supply for analytical purposes.

  • Uninterrupted power supplies and electrical generator.

  • Fire extinguisher, smoke detector alarm system, and blanket for fire control

 

Sample processing in Medical Laboratory passes through three phases:

Pre-examination

Sample management:

  • Specimen collection and transport.

  • Blood Collection and Specimen Handling.

  • Sample labeling with a unique identification.

  • Test requisition: The laboratory must make available an electronic test request form that specifies all the information (unique identifier, gender, date of birth, examination requested, date of sample collection) that will be needed for proper handling and reporting.

Examination:

  • Method Validation: 

The laboratory has QC measures to monitor the examination phase of testing (qualitative, quantitative, and semi-quantitative).

  • Quality Control (QC):

Internal QC’s are used to ensure the results are valid, these controls are run on both qualitative (result is positive or negative) and quantitative (a result is a number or value) tests. The examinations results are documented by the medical technologist on the MLU files to create a permanent traceable record. If QC results did not pass, subjects examination results cannot be reported. When problems occur the laboratory investigates, corrects, and repeats sample testing.

 

Reference ranges: it depends on the examination procedure used, it is reviewed and approved by ACIMA BioCenter Medical Laboratory Director and Medical Director.

  • List of examinations performed in Medical Laboratory:​

  • In-house medical laboratory providing full medical screening tests, including chemistry, hematology, urinalysis, coagulation, serology, alcohol screening, a drug of abuse testing, cotinine, and pregnancy testing if it is required.

 

List of routine tests performed by ACDIMA BioCenter Medical Laboratory:

 

1. Chemistry:

1.1. Alanine Amino Transferase (ALT/ GPT).

1.2. Alkaline Phosphatase (ALP).

1.3. Aspartate Amino Transferase (AST/ GOT).

1.4. Amylase.

1.5. Gamma-glutamyl Transferase (GGT).

1.6. Bilirubin, Total, and direct.

1.7. Creatinine.

1.8. Blood Sugar.

1.9. Chloride.

1.10. Calcium.

1.11. Magnesium.

1.12. Iron.

1.13. Glycosylated Hemoglobin (HbA1c).

1.14. Sodium.

1.15. Total protein.

1.16. Urea.

1.17. Uric Acid.

1.18. Potassium.

1.19. Cholesterol-Total.

1.20. High-Density Lipoprotein (HDL).

1.21. Low-Density Lipoprotein (LDL).

1.22. Triglycerides.

1.23. Creatine Phosphokinase (CPK).

1.24. Trpoinin I.

1.25. Phosphorus.

1.26. Ferritin.

1.27. Transferrin.

 

 2. Hematology:

2.1. Hemoglobin.

2.2. Hematocrit (PCV).

2.3. Mean Corpuscular Volume (MCV).

2.4. Mean Corpuscular Hemoglobin (MCH).

2.5. Mean Corpuscular  Hemoglobin  Concentration (MCHC).

2.6. Neutrophils.

2.7. Lymphocytes.

2.8. Monocytes.

2.9. Eosinophils.

2.10. Basophils.

2.11. Platelets.

2.12. Red Blood Cells (RBCs).

2.13. White Blood Cells (WBCs).

2.14. Prothrombin Time (PT).

2.15. Partial Thromboplastin Time (PTT).

3. Urine analysis:

 

3.1. Leukocytes.

3.2. Nitrite.

3.3. Protein.

3.4. Glucose.

3.5. Ketones.

3.6. Urobilinogen.

3.7. Bilirubin.

3.8. Hemoglobin.

3.9. Specific Gravity.

3.10. pH.

3.11. RBCs.

3.12. WBCs.

3.13. Microscopic examination.

4. Serology:

 

4.1. Human Immunodeficiency Virus (HIV).

4.2. Hepatitis B surface antigen (HBsAg).

4.3. Hepatitis C virus antibody (HCV-Ab).

4.4. Venereal Disease Research Laboratory (VDRL).

 

 

Post-examination:

 

  • Examination results are reviewed by the head of the Medical Laboratory and approved by the medical laboratory director.

  • All patient/volunteer’s source documents are kept in the ACDIMA BioCenter archive facility for at least 10 years.

All ACDIMA BioCenter Medical Laboratory results are recorded into a private database and on paper base subject’s form.

1. Chemistry:

  • Roche Cobas C311 chemistry analyzer

  • Roche Cobas C111 chemistry analyzer

  • AVL 9180 electrolyte analyzer

Chemistry analyzer

3. Coagulation section:

  • STA compact max® 2

Coagulation section

5. Urine analysis:

  • Zeiss Primo Star Binocular Microscope

Urine analysis

2. Hematology:

  • Sysmax XP-300™ automated hematology analyzer

  • Beckman Coulter AC.T diff™ hematology analyzer

Hematology

4. Serology:

  • Linear ® ELISA reader and washer

Serology

Accreditation:

  • JAS ISO with the code or number “ISO 15189:2012”

  • BioRad

JAS ISO with the code or number “ISO 15189:2012” - BioRad
 Medical Lab Services | ACDIMA Center | Bioequivalence and Pharmaceutical Studies | CRO