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 the past 14 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 2025 the following programs included in the scope are accredited by the NABL as per ISO/IEC 17043:2010.

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)

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*)

MICROBIOLOGY

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

              (b) Medical Mycology Program (MICRO-02)

Clinical Pathology

               (a) Urine Routine Analysis (Urine-R)

Antinuclear Antibodies (ANA-IFA)

ANA Profile (Line Blot) Program

Histopathology

                (a) Histopathology Program (HISTO-01)

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

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

Routine IHC Module - Pan Cytokeratin (PCK) , CK-7, CK-20, HMWCK - (34betaE12),P63 , 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*)

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

Introducing New QAP Programmes for Year 2025

Extended Immunology Programme – 25-Hydroxy Vitamin D, T3, T4, TSH. FT3, FT4 Anti-TG,Anti-TPO, Cortisol, ACTH, LH, FSH, PRL, Progesterone, Estradiol, hCG, Testosterone, DHEA Sulfate, Ferritin, Iron, TIBC, Vitamin B12, Serum Folate, Immunoglobulin IgG, IgA, IgM, IgE.

Tumor Marker program – CA125, HE4, CEA, PSA, Free-PSA, AFP, hCG, CA-15-3, CA-19-9, B-2-Microglobulin.

Coagulation Program – PT, INR, APTT, TT, Fibrinogen.

Prostate IHC Module – p63, HMWCK – (34ßE12), AMACR.

Molecular Respiratory RNA Flu Panel – Influenza A, Influenza B, H1N1, H3N2, RSV.

Flow Cytometry-(CD4 & CD8) – CD-4, CD-8.

Introducing New QAP Programmes for Year 2025

ISO/IEC 17043 Accredited Programs – Basic Clinical Biochemistry (BIO-01), Extended Clinical Biochemistry (BIO-02), Glycosylated Haemoglobin (HbA1c) (BO-03), Basic Clinical Immunology (IMMUNO-01), Extended Serology (SERO-02), Microbiology (MICRO-01), Urine Routine Analysis (Urine-R), Antinuclear Antibodies (ANA-IFA), Histopathology (HISTO-01), Cytopathology (CYTO), SARS-CoV-2 (MOL PCR-00).

Applied for ISO/IEC Accreditation Programs – Protein Electrophoresis (BIO-04), Basic Serology (SERO-01), Hematology (HEMAT-01), Digital Hematology (DLC) (HEMAT-02), Hemoglobin Electrophoresis (HEMAT-03), Mycology (MICRO-02), ANA Profile (Line Blot) (ANA Profile), Histopathology-Histochemistry (HISTO-02 Special Stain, Breast IHC Module (HISTO IHC-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).

AIM

The RML-QAP comprehensively covers a range of medical laboratory specialties, including Clinical Biochemistry, Clinical Immunology, Serology, Clinical Hematology, Microbiology, Clinical Pathology, Antinuclear antibodies (ANA-IFA), ANA Profile (Line Immuno Assay), 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.