Wednesday, May 13, 2020

NABL Launched Entry level Accreditation for Small Medical Labs " Medical Entry Level Testing (MELT) Labs Program"


NABL Entry Level

NABL  Launched voluntary entry level scheme for Medical Labs . The program namely "NABL Medical Entry Level Testing (MELT) Labs Program”. 

This program mainly for the medical labs performing basic tests to gain in quality practices and access to quality of health care, particularly in villages & small towns. Will help them to move towards ISO 15189 Accreditation after three years.


NABL will be reviewed the application and recognition will be taken based on performance in proficiency testing (PT)/EQA.

Recognition certificate is valid for 3 years.

NABL - Recognition Fee (For Three Years) : Rs.15,000 

NABL will conduct on-site assessment (surveillance) during recognition period (within 3 years). Surveillance charge to be paid on actual basis during at the time of onsite assessment).

Minimum Eligibility Criteria to submit Application : 

  • Satisfactorily participated in Proficiency Testing (PT) program conducted by accredited PT provider as per ISO/IEC 17043 before submission of application.

  • Test parameters covered in last six months in PT programs shall be considered.

  • Scope once recognized cannot be changed during recognition period. 

  • Laboratory shall be legally identifiable (Legal Registration). Photocopy of any one of applicable document to be uploaded in the portal.

        • Company Act (Copy of Registration under 2013 Act.)
        • Proprietorship Firm (Bank Passbook, Account statement)
        • Government/Autonomous Organization (Copy of Goverment Notification / Self Declaration etc.)
        • Partnership Firm (Copy of Registration under 1932 Act.)
        • Societies Registration Act (Copy of Registration under 1860 Act).
        • Indian Trust Act (Copy of Registration under 1882 Act.)
        • Limited Liability Partnership (Limited Liability Partnership Act, 2008)

Requirement to submit the Application

Application has to be submitted from Laboratory premises – for geo tagging of laboratory premises and equipment.


Documents to be kept ready (scan copy) before submitting Application

Copy of Legal Identity of Laboratory

PT/EQA  Participation report for the applied scope ( Reports of past 6 months from the date of application)

Equipment Calibration Report / AMC of the equipment record & Equipment Image (Through Mobile App) required to test the parameters under the applied scope.


The Interested Labs can access the below NABL link for submitting the Application.



Scope of Tests (Basic/Routine Tests) Applicable for this NABL Program : 

HIV-1 Antibodies

Clinical Biochemistry : 
RFT, CPK ,LDH,Sodium,Chloride,D. Bilirubin,Lipid Profile,Cholesterol,Triglyceride,LFT,HDL,Amylase,Potassium,Magnesium, HbA1c, GGT, LDL, Lipase, Glucose, Calcium, Inorganic Phosphorus.

Haematology : 
Haemogram, Lymphocyte,Monocyte,Basophils,Eosinophils,Neutrophils.

Clinical Pathology (Urine Routine Examination) : 
Protein, Glucose, pH, Leukocytes, Specific Gravity, Ketones, Bilirubin, Nitrite, Blood (Haemoglobin), Urobilinogen

Infectious Serology/ Immunology (Rapid tests) :
RA Factor , CRP , Typhoid (IgG / IgM) , WIDAL for Typhoid , Anti HCV/ HCV Ab , HBsAg , ASO , HIV Antigen + HIV Ab , Syphilis Serology.


NABL - MELT Program - Application Check list (to be filled/upload photo evidence in NABL Mobile App)

https://play.google.com/store/apps/details?id=com.a7techies.nablqasbcuser&hl=en_US&gl=US

Checklist Section (to be filled in App)

Infrastructure

Signage: A signage within or outside the facility should be made available containing the following

information:

1.

Laboratory Display Board (Outside or on laboratory entrance)

2.

Name of the person-in-charge with qualification

3.

Fee structure: To be displayed separately including type of investigation and charges for all

routine tests.

Hygiene and Safety (wherever applicable)

1.

General cleanliness

·         Dust free

·         Good house keeping

2.

Universal standard safety precautions

Space requirement

1.

Registration, waiting space room, public utilities, safe drinking water etc.

2.

Sample collection room/area

3.

Washing area

4.

Preservation of the specimen and slides

5.

Temperature control for specialized equipment etc.

6.

Counselling room for HIV (If HIV test is done)

7.

Basins

Legal or Statutory requirements as applicable

1.

Valid Registration Certificate for under the provisions of Biomedical Waste Management

2.

Valid Pollution Control Board registration certificate

Record maintenance and reporting

1.

Reports of all patient’s date wise as per regulatory requirement or till next audit, whichever is

later.

2.

Medico legal records, if applicable (as per relevant law).

3.

Duration of preservation of record (as applicable from time to time)

Standards on basic processes

1.

Infection Control practices - as per Bio Medical Waste Management Rules, 2016

2.

Patient Information

3.

Kit inserts used as SOPs)

4.

Complaints redressal mechanism





NABL MELT Program - Certificate Model :


NABL Entry level MELT Certificate
NABL MELT Program (Entry level) Certificate Model



For further details, refer to the below NABL Link





Following are the NABL Accredited (ISO 17043) PT/EQA Providers for Medical Testing. 

CMC EQAS-Department of Clinical Biochemistry,

Christian Medical College,

ASHA Building, 6th Floor,

Vellore, Tamil Nadu

Ph: 0416 22282170, 8220648805

Fax: 0416 2232035

Email:pchristudoss@yahoo.com,

clinqc@cmcvellore.ac.in

Contact Person: Dr. Pamela Christudoss


ISHTM-AIIMS, External Quality Assurance Programme, 

Dept. of Hematology

R. No. 209, 2nd Floor, New Private Ward

Department of Hematology, AIIMS

Ansari Nagar, New Delhi-110029

Ph: 011-26594670 / 26546266

Mobile : 09899546664 / 09871713554

Email: accuracy2000@gmail.com

Contact Person: Dr. Renu Saxena/ Dr. Ravi Ranjan


RML-Quality Assurance Program (RML-QAP),

Division of RML research Foundation Society

B-171, Nirala Nagar, Lucknow U.P

Ph: 0522 2788444/ 08299794870 / 9519712299

Fax: 0522 2788555

Email: rmlresearchfoundation@gmail.com

Contact Person: Dr. Divya Singh / Dr Sohaib Farooqui


National AIDS Research Institute, Proficiency

Testing (PT) Unit,

Plot No. 73, ‘G’Block, M.I.D.C.,

Bhosari, Pune, Maharashtra-411026

Ph: 020-27331200

Fax: 020-27331071

Email: nari@nariindia.org

Contact Person: Mrs. Varsha Kale


IAMM EQAS New Delhi, Department of clinical

Microbilogy & Immunology, Sir Ganga Ram

Hospital, New Delhi

Rajinder Nagar,

New Delhi – 110060

Phone No. – 011- 42251153 / 44

E.mail – iammeqas.dlh@sgrh.com

Dr. Chand Wattal


CMC Micro EQAS, Department of Clinical

Microbiology, Christian Medical College,

8th Floor, ASHA Building

Christian Medical College

Vellore – 632004

Phone No – 0416 – 2282588

E.mail – eqas@cmcvellore.ac.in,

micro@cmcvellore.ac.in

Contact Person: Dr. John Antony Jude Prakash


CMC Viro Eqas, Department of Clinical Virology,

CMC, Vellore

9th Floor, ASHA Building

Christian Medical College, Vellore – 632004

Phone No – 0416 – 2283455 / 2282312

Fax No. – 0416 – 2232103

E.mail – virology@cmcvellore.ac.in,

kannangair@cmcvellore.ac.in

Contact Person: Dr. Rajesh Kannangai


Metropolis Healthcare Ltd./EQAS,

Unit No. 409-416, 4th Floor,

Commercial Building-A, Kohinoor City,

Kohinoor Mall, Kirol Road, Kurla (W)

Mumbai-400070

Ph: 022-30840777

Email: mhleqas@metropolisindia.com,

Vishalwadhwa.n@metropolisindia.com

Contact Person: Dr. Vishal Wadhwa


International PT/EQA Providers in India :
(ISO 17043 Certified from International Certification Bodies such as UKAS (UK) & A2LA(USA))

Biorad (USA) - EQAS
India, Bio-Rad Laboratories (India) Pvt. Ltd., Bio-Rad House, 86-87, Udyog Vihar Phase IV, Gurgaon, Haryana 122 015 • Phone 1-800-180-1224 • Telefax 91-124-2398115



Randox (UK) - RIQAS
India - Randox Laboratories India Pvt. Ltd.,

Plot no. 191 to 195 & 246 to 250
Bommasandra Jigni Link Road , Industrial Area,
Bangalore , 560105, 
Tel: +91 80 6751 5000  , Fax: +91 80 2802 5012




Reference Source
  • https://nabl-india.org/,  News & Announcement
  • NABL 700 - Directory of Accredited Proficiency Testing Provider (Issue 1, Issue Date - 1/5/2020)


POSTED BY: 

Mr.V.SELVAM, M.Sc (Biochemistry)
Consultant - ISO 9001 & NABL (ISO 15189 & ISO 17025)
Chennai, Tamilnadu, India
✆ +91-9940014466

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