RML Quality Assurance Program

“Continuous Efforts and Execution leads to quality excellence”

RML QAP Program is one of the oldest, largest, most cost-effective, and Accredited Clinical Laboratory QAP Programs in India, running since past 15 years. Its goal is to provide a top quality assurance program that would help in raising the quality standards of the participating labs in the most cost-effective manner. The term RML-Quality Assurance Program (RML-QAP) is seen as a powerful tool to help laboratories to demonstrate their competence in sample testing. QAP enables laboratories to monitor their accuracy and quality of results over time, identify trends and help them to take necessary corrective action.

The team of RML QAP is provided India’s first NABL ISO/IEC 17043:2010 accredited SARS CoV-2 QAP. Last year we also successfully completed a pilot program- QAP for ANA-IFA in the year 2021 and 2022 and now awaiting its accreditation.

SCOPE

The new cycle of the Quality Assurance Program [QAP] shall begin in January 2026 the following programs included in the scope are accredited by the NABL as per ISO/IEC 17043:2023.

CLINICAL BIOCHEMISTRY

              (a) Basic Clinical Biochemistry (BIO 01)

              (b) Extended Clinical Biochemistry (BIO 02)

              (c) Glycosylated Hemoglobin-HbA1c Program (BIO-03)

              (d) Protein Electrophoresis (BIO-04)

              (e) Extended Thyroid Program (BIO-05)

(f) Maternal Screen (BIO-06)

CLINICAL IMMUNOLOGY

(a) Basic Clinical Immunology (IMMUNO-01)

(b) Extended Immunology Program (IMMUNO-02)

(c) Tumor Marker Program (IMMUNO-03)

SEROLOGY

              (a) Basic Serology (Sero-01)

              (b) Extended Serology (Sero-02)

(c) Viral Marker Panel Test (Seo-03*)

(d) Fungal Serology (Sero-04*)

(e) Coeliac Serology (Sero-05*)

CLINICAL HEMATOLOGY

              (a) Hematology Program (HEMAT-01)

              (b) Digital Hematology Cell Morphology Program (HEMAT-02)

(c) Hemoglobin Electrophoresis -HB-VARIENTS (HEMAT-03)

(d) Coagulation Program (HEMAT-04)

(e) ABO-Rh Program (HEMAT-05*)

(f) Direct-Coombs Test (HEMAT-06*)

MICROBIOLOGY

              (a) Microbiology (MICRO-01) Unstained fixed smears & Culture vials

              (b) Medical Mycology Program (MICRO-02)

CLINICAL PATHOLOGY

(a) Urine Routine Analysis (Urine-01)

(b) Urine Routine Analysis (Automated) (Urine-02*)

INDIRECT IFA

Antinuclear Antibody (ANA-IFA-01)

IFA-Anti Mitochondrial Antibody (IFA 02*)

IFA-Anti Smooth Muscle Antibody (IFA 03*)

IFA-Anti Gastric Parietalcell Antibody (IFA 04*)

IFA-Anti Endomysium Antibody (IFA 05*)

ANA Profile (Line Blot) Program

Histopathology

                (a) Histopathology Program (HISTO-01)

                (b) Histopathology-Histochemistry (Special Stains) HISTO-02

(c) Digital Histopathology (HISTO-03*)

Histo-IHC- Breast IHC Module (HISTO IHC-00)

Routine IHC Module - Pan Cytokeratin (PCK), CK-7, CK-20, CK-5/6, Vimentin,, Desmin, GATA 3, S-100, CD-45(LCA), CD-3, CD-20, CD-68, CD-34, BCL 2, BCL 6, Napsin –A, Chromogenin A, Synaptophysin, PAX 5, CEA, Ki67.

Histo-IHC-23 - Prostate IHC Module

Cytopathology Program – Cytopathology (CYTO)

Molecular PCR Programs

                (a) SARS-CoV-2 (MOL PCR-00)

                (b) HBV DNA Quantitative (MOL PCR-01)

                (c) HCV RNA Quantitative (MOL PCR-02)

                (d) Dengue-RNA (MOL PCR-03)

                (e) Chikungunya-RNA (MOL PCR-04)

                (f) HPV-DNA (MOL PCR-05)

                (g) MTB-DNA (MOL PCR-06)

                (h) NTM-DNA (MOL PCR-07)

                (i) HLA-B27 DNA (MOL PCR-08)

                (j) Malaria (MOL PCR-09)

(k) Respiratory RNA Flu Panel (MOL PCR-10)

(l) BCR ABL Quantitative (MOL PCR-11*)

Flow cytometry Programs- Flow Cytometry-(CD4 & CD8) (FLOW-01)

Introducing New QAP Programmes for Year 2026

SEROLOGY

1. Viral Marker Panel Test (Seo-03*)
2. Fungal Serology (Sero-04*)
3. Coeliac Serology (Sero-05*)

HISTOPATHOLOGY

a. Digital Histopathology (HISTO-03*)

CLINICAL PATHOLOGY

a. Urine Routine Analysis (Automated) (Urine-02*)

MOLECULAR PCR PROGRAM

a. BCR ABL Quantitative (MOL PCR-11*)

INDIRECT IFA

a IFA-Anti Mitochondrial Antibody (IFA 02*)

b IFA-Anti Smooth Muscle Antibody (IFA 03*)

c IFA-Anti Gastric Parietalcell Antibody (IFA 04*)

d IFA-Anti Endomysium Antibody (IFA 05*)

CLINICAL HEMATOLOGY

a. ABO-Rh Program (HEMAT-05*)

b. Direct-Coombs Test (HEMAT-06*

Introducing New QAP Programmes for Year 2026

ISO/IEC 17043 Accredited Programs – Basic Clinical Biochemistry (BIO-01), Extended Clinical Biochemistry (BIO-02), Glycosylated Hemoglobin (HbA1c) (BIO-03), Basic Clinical Immunology (IMMUNO-01), Extended Immunology Program (IMMUNO-02), Basic Serology (SERO-01), Extended Serology (SERO-02), Hematology (HEMAT-01), Digital Hematology (DLC) (HEMAT-02), Hemoglobin Electrophoresis (HEMAT-03), Microbiology (MICRO-01), Mycology (MICRO-02), Urine Routine Analysis (Urine-R), Antinuclear Antibodies (ANA-IFA) (IFA 01), ANA Profile (Line Blot) (ANA Profile), Histopathology (HISTO-01), Histopathology-Histochemistry (HISTO-02 Special Stain), Breast IHC Module (HISTO IHC-00), Cytopathology (CYTO), SARS-CoV-2 (MOL PCR-00), HBV DNA Quantitative (MOL PCR-01), HCV RNA Quantitative (MOL PCR-02), Dengue-RNA (MOL PCR-03), Chikungunya-RNA (MOL PCR-04), HPV-DNA (MOL PCR-05), MTB-DNA (MOL PCR-06), NTM-DNA (MOL PCR-07), HLA-B27 DNA (MOL PCR-08), PCR Malaria (MOL PCR-09).

Applied for ISO/IEC Accreditation Programs – Protein Electrophoresis (BIO-04), Extended Thyroid Programme (BIO-05), Maternal Screen (Anti-natal Test) (BIO-06), Tumor Marker Program (IMMUNO-03), Coagulation Program (HEMAT-04), Routine IHC Module (HISTO-01-21), Prostate IHC Module (Histo IHC-23), Respiratory RNA Flu Panel (MOL PCR-10), Flow Cytometry-(CD4 & CD8) (FLOW-01).

AIM

The RML-QAP comprehensively covers a range of medical laboratory specialities, including Clinical Biochemistry, Clinical Immunology, Serology, Clinical Hematology, Microbiology, Clinical Pathology, Antinuclear antibodies (ANA-IFA), ANA Profile (Line Blot), Histopathology, Histo-IHC, Cytopathology Program, Molecular PCR Program, Flowcytometry Program etc.

Quality policy

RML-QAP is committed to providing accurate reliable, timely, and unbiased Professional practice with the complete satisfaction of all participants by maintaining its confidentiality. We are committed to follow good professional practice and comply with the requirements of quality management systems. All staff familiarize themselves with the quality documentation and implement the policies and procedures at all times.

RML- QAP is designed to monitor laboratories’ continuing performance, identification of problems in the lab, and initiation of action for improvement. The program is evaluated the laboratory performance against the pre-established criteria by means of inter-laboratory comparison.

• To improve the quality of analytical measurement of the laboratory.

• To establish the effectiveness and precision of the testing method.

• To check the individual testing performance.

• To develop confidence in the test result of the laboratory.

Quality Objectives

• Maximum benefit of our service for our participants with the highest possible quality.

• Achieve participant satisfaction through regular interaction and feedback.

• Strictly confidential treatment of all information obtained within the scope of activity.

• Rise of our competence by intensive development of the quality of our services.