QAI CLA102
/ Quality and Accreditation Institute
Centre for Laboratory Accreditation
Application Form forMedical Laboratories
Issue No.: 01 / Issue Date : November 2017

REVISION SHEET

Sl. No. / Page No. / Item No. / Date of Amendment / Amendment / Reasons
1
2
3
4
5

CONTENTS

Sl. No.

/
Title
/ Page No.
1 / Information & Instructions for completing an Application Form / 4
2 / Fee Structure, assessment charges and guidelines for travel, boarding and lodging / 5
3 / Application Form / 7

Information & Instructions for Completing an Application Form

  1. Quality & Accreditation Institute (QAI)’s Center for Laboratory Accreditation (CLA) offers accreditation services to medical laboratories both in India and overseas.
  1. A laboratory implementing the requirements of ISO 15189:2012 is eligible to apply under Medical Laboratory accreditation program.
  1. Application shall be made in the prescribed form QAI CLA 102 only. Applicant laboratory is requested to submit the following:
  • Three copies of completed application forms
  • Two copies of self-assessment tool kit along with referenced documents (soft copy)
  • Two copies of Quality Manual
  • Prescribed application fees
  • Signed copy of QAI CLA 002‘Terms and Conditions for Obtaining and Maintaining Accreditation’
  1. Application form and self-assessment tool kit can be downloaded as a word file. Incomplete application and insufficient number of copies submitted may lead to delay in processing of your application.
  2. The applicant laboratory shall provide copy of appropriate document(s) in support of the information being provided in this application form.
  3. Laboratory is advised to familiarize itself with QAI CLA101‘Information Brochure for Medical Laboratories’ and QAI CLA002 ‘Terms and Conditions for Obtaining and Maintaining Accreditation’ before filling up this form.
  4. The applicant laboratory shall intimate QAI CLA about any change in the information provided in this application such as scope applied for accreditation, personnel and location etc. within 15 days from the date of changes.
  5. Completed application may please be sent to:

Quality and Accreditation Institute Pvt. Ltd.

416, Krishna Apra Plaza, Sector 18

Noida-201301, U.P., India

Tel.: +91-120 4113234

Fee Structure, assessment charges and guidelines for travel, boarding and lodging

Type of Laboratory / No. of patients/ day/ locations / Application fee
(non-refundable, to be paid along with the application) / Accreditation Fee (per year from the date of accreditation)
Very Small Laboratories / Below 30 patients/day/location / Rs. 20,000/- / Rs. 30,000/-
Small Laboratories / 31-100 patients/day
/location / Rs. 25,000/- / Rs. 35,000/-
Medium / 101 – 400 patients/ day/ location / Rs. 40,000/- / Rs. 55,000/-
Large Laboratories / 401 – 1000 patients/ day/ location / Rs. 100,000/- / Rs. 125,000/-
Very Large Laboratories / Laboratories operating from multiple locations (more than one location in the same city) / Above 1000 patients/ day/location
or Laboratories operating from multiple locations (more than one location in the same city) / Rs. 2,00,000/- / Rs. 2,20,000/-
Charges For Collection Centers:
Number of Collection Centers / up to 10 / Rs. 3,000/- / Rs. 3,000/-
>10 – 50 / Rs. 6,500/- / Rs. 6,500/-
> 50 – 100 / Rs. 13, 000/- / Rs. 13, 000/-
More than 100 / Rs. 25,500/- / Rs. 25,500/-

In addition to the above mentioned fee, GST @18.0 % or as applicable from time to time to be paid.

Assessment Charges: In addition to the above fee, laboratory shall bear the cost of following:

  1. Travel of the assessment team
  2. Boarding & Lodging

Guidelines for Travel, Boarding and Lodging:

  1. Travel to be made by Air in economy class (Apex fare) or by train in 2nd AC Class or by AC Bus.
  2. The laboratory will provide the tickets for travel as per above guidelines. If the journey is made by own car, the re-imbursement will be as per company’s rules or restricted to 2nd AC Class fare by train.
  3. The laboratory shall also make arrangements for boarding & lodging for the assessment team. A single occupancy AC accommodation may be provided for each Assessor/ Observer in a reasonably good hotel/ guesthouse and arrangement for local transportation from temporary residence to the laboratory site and airport/ railway station/ bus stand.

Fee Payment:

All payments through Demand Draft/ Check/ Bank Transfer shall be made in favour

of'Quality and Accreditation Institute Pvt. Ltd.' payable at Noida/New Delhi.

Bank Transfer details are:

Beneficiary name: Quality and Accreditation Institute Pvt. Ltd.

Beneficiary Address: 416, Krishna Apra Plaza, Sector 18, Noida-201301, India

Bank Account number: 003105031612

Bank Details: ICICI Bank Limited, K-1, Senior Mall, Sector 18, Noida-201301, India

Bank Swift Code: ICICINBBNRI

Bank IFSC Code: ICIC0000031

Application Form for Medical Laboratory Accreditation

We apply for QAI CLA accreditation of our medical laboratory as per details given below:

First Accreditation /

Renewal of Accreditation

1. Laboratory Details

1.1 / Name of the Laboratory ______

Complete Address(s)______

Telephone No. ______E-mail ______

1.2 / Does the laboratory operate from different locationshaving same legal identity within the city? / Yes / No
If yes, whether application for accreditation covers all locations / Yes / No
1.3 / Do you conduct Testing in the following Category
(if yes, please clearly indicate in the scope of accreditation, sl. no. 2.2, the test conducted)
a. /
Site Facility (when undertaking testing at site of the customer)
/
Yes/No
b. /
Permanent Facility
/ Yes/No
c. / Mobile Laboratory / Yes/No

1.4Name of the Parent Organisation ______

(if laboratory is a part of a bigger organisation)

Telephone No. ______E-mail ______

1.5Legal identity of the laboratory and date of establishment______

(Please give registration number and name of authority who granted the registration. Copy of the certificate shall be enclosed)

1.6Type of laboratory by service

Open to othersYes/No

Partly open to othersYes/No

An in-house activityYes/No

1.7Category for which accreditation is being sought

(please put a cross in the box)

Very Small Laboratory / Large Laboratory
Small Laboratory / Very Large Laboratory
Medium Laboratory / Multiple Location Laboratory

1.8Number of collection centers

Upto 10 / 11- 50 / 51- 100 / More than 100

1.9Details of primary sample collection facilities including franchise or any other source of collection sample other than the permanent facility

(Provide list of all facilities with complete contact details. List of facilities shall segregate in terms of ownership, management and franchisee.)

1.10Other accreditations______

2.Details of Accreditation Sought

2.1 Disciplines for which accreditation is sought (please put a cross in the appropriate box)

Clinical Biochemistry
Clinical Pathology

Haematology and Immunohaematology

Microbiology and Serology
Histopathology
Cytopathology
Genetics

Note 1. Laboratories performing site testing shall clearly identify the specific tests/

examination performed at site.

Note 2. Laboratories are encouraged to provide estimates of Measurement of

Uncertainty (MU) / % CV. MU should be calculated at a confidence probability of 95%.

2.2 Scope of Accreditation

Discipline: Clinical Biochemistry

Sl.No. / Type of Samples examined/
Tested / Specific tests/ examination performed / Standard (method), Principle /Methodology or Technique used / Range of testing/ Limit of detection / %CV / MU( )

Discipline: Clinical Pathology

Sl. No. / Type of Samples examined/
Tested / Specific tests/ examination performed / Standard (method), Principle /Methodology or Technique used / Range of testing/ Limit of detection / %CV / MU( )

Discipline: Haematology and Immunohaematology

Sl. No. / Type of Samples examined/
tested / Specific tests/ examination performed / Standard (method), Principle /Methodology or Technique used / Range of testing/ Limit of detection / %CV / MU( )

Discipline: Microbiology & Serology

Sl. No. / Type of Samples examined/tested / Specific tests/ examination performed / Standard (method), Principle /Methodology or Technique used

Discipline: Histopathology

Sl. No. / Type of Samples examined/tested / Specific tests/ examination performed / Standard (method), Principle /Methodology or Technique used

Discipline:Cytopathology

Sl. No. / Type of Samples examined/tested / Specific tests/ examination performed / Standard (method), Principle /Methodology or Technique used

Discipline: Genetics

Sl. No. / Type of Samples examined/tested / Specific tests/ examination performed / Standard (method), Principle /Methodology or Technique used

3. Organisation

3.1 Senior Management (Name, Designation, Telephone, E-mail)

3.1.1 Chief Executive/ Director/ Head of the laboratory ______

3.1.2 Laboratory Director______

3.1.3 Quality Manager______

3.1.4 Contact person for QAI-CLA ______

3.2Organisation Chart

3.2.1.Indicate in an organisation chart the operating departments of the Medical laboratory for which accreditation is being sought (please append)

3.2.2Indicate how the testing laboratory is related to its own parent organisation (where applicable)

3.3Human Resources

3.3.1 Details of staff

Sl.No. / Name / Designation+ / Academic and Professional Qualifications* / Experience related to present work (in years)

+ Quality Manager shall have completed a training course on ‘Internal Audit & Quality

Management System as per ISO 15189’

* Please clearly indicate the field of specialisation

4. Equipment and Reference Materials:

List of major test equipment available for use:

Sl.No. / Name of equipment / Model/ type/ year of make / Receipt date & date placed in service / Range and accuracy / Date of last calibration / Calibration
due on * / Calibrated by**

List of reference materials available for use:

Sl. No. / Name of reference material/ strain/ culture / Source / Date of expiry/ validity / Traceability

* The laboratory to decide the calibration interval based on ISO 10012 or ILAC-G24

** Please mention name of calibration agency. In case the equipment is calibrated in-

house, same needs to be clearly indicated under this column.

  1. Proficiency Testing

Participation in PT / any other Inter Laboratory Comparison/EQAS(for details and requirements please refer to ISO/ IEC 17043)

Sl. No. / Product/ Material / Details of Test(s)/ examination / Date of Testing/ examination / Organizing body / Performance in terms of z score or any other criteria / Corrective action taken (if required)
  1. Application Fees

7.1Application fees (Rs).______

7.2DD/At par cheque number/ bank transfer reference number______

______

  1. Declaration by the laboratory
We declare that

8.1We are familiar with the terms and conditions of maintaining accreditation (QAI CLA 001), which is signed and enclosed with the application. We also undertake to abide by them.

8.2We agree to comply fully with the requirements of ISO15189 for the accreditation of medical laboratory.

8.3We agree to comply with accreditation procedures and pay all costs for any assessment carried out irrespective of the result.

8.4We agree to co-operate with the assessment team appointed by QAI CLA for examination of all relevant documents by them and their visits to those parts of the laboratory that are part of the scope of accreditation.

8.5We undertake to satisfy all national, regional and local regulatory requirements for operating the laboratory.

8.6No adverse action has been initiated / taken against the laboratory in the past. (If yes, please provide the details with present status ………………………………………………………..)

8.7 All information provided in this application is true to the best of our knowledge and ability.

Signature of CEO/Laboratory Head/ Laboratory Director ______

Name & Designation ______

Date & Place ______

Quality and Accreditation Institute

Centre for Laboratory Accreditation

416, Krishna Apra Plaza, Sector 18

Noida-201301, U.P., India

Tel.: +91-1204113234

Website:

Twitter@QAI2017

Quality and Accreditation Institute
Centre for Laboratory Accreditation
Doc. No.: QAI CLA 102 / Application Form for Medical Laboratories
Issue No.: 01 / Issue Date: November 2017 / Page No.: 1/13