Guide to Apply for Accreditation of Medical Laboratory in Kenya

Apply for Accreditation of Medical Laboratory in Kenya The general criteria for accreditation of medical laboratories are contained within the ISO 15189:2012 Medical Laboratories- Particular Requirements for quality and competence.

Medical laboratory accreditation is a means of determining the technical competence of a medical laboratory to perform specific types of testing, measurement, and calibration of equipment. Medical laboratory accreditation also provides a formal recognition to competent laboratories, thus providing a ready means for customers to identify and select reliable testing and measurement services able to meet the customers’ needs.

Medical laboratory services are essential to patient care and therefore have to be available to meet the needs of all patients and the clinical personnel responsible for the care of these patients. These services include arrangements for requisition, patient preparation, patient identification, the collection of samples, transportation, storage, processing, and examination of clinical samples together with subsequent validation, interpretation, reporting, and advice, in addition to the considerations of safety and ethics in medical laboratory work. Accreditation of Medical Laboratory in Kenya

Contacts – Accreditation of Medical Laboratory in Kenya

• Embankment Plaza, 2nd floor, Longonot Road, Upper Hill Nairobi, Kenya
• info@kenyaaccreditation.org
• +254 725 227 640
  +254 787 395679
• https://www.kenas.go.ke/
• Mon to Fri – 8:00am to 5:00pm
  (Weekends Closed)

Currently, KENAS is offering accreditation to the following medical laboratories:

• General medical/clinical laboratory accreditation
• Research medical laboratory accreditation
• Forensic medical laboratory accreditation
• Blood transfusion laboratories
• X-ray laboratory accreditation

Click to open the listed documentsKENAS Guide to implementing ISO 15189

Gap Analysis of ISO15189 – Accreditation of Medical Laboratory in Kenya

 1 file(s)  1.15 MBDOWNLOADKENAS Guide to medical Laboratory accreditation

KENAS-Guide-to-medical-Laboratory-accreditation

 1 file(s)  289.17 KBDOWNLOADKENAS ISO 15189 checklist

KENAS-ISO-15189-checklist

 1 file(s)  774.23 KB

Procedure – Accreditation of Medical Laboratory in Kenya

• Medical laboratory accreditation is a means of determining the technical competence of a medical laboratory to perform specific types of testing, measurement and calibration of equipment. Medical laboratory accreditation also provides a formal recognition to competent laboratories, thus providing a ready means for customers to identify and select reliable testing and measurement services able to meet the customer’s needs.
• Medical laboratory services are essential to patient care and therefore have to be available to meet the needs of all patients and the clinical personnel responsible for the care of these patients. These services include arrangements for requisition, patient preparation, patient identification, the collection of samples, transportation, storage, processing, and examination of clinical samples together with subsequent validation, interpretation, reporting, and advice, in addition to the considerations of safety and ethics in medical laboratory work.

Apply In-Person

1. The applicant has to submit his/her accreditation enquiry to a Kenya Accreditation Service (KENAS) Staff. This can be either through telephone, email or visiting KENAS offices. Contact information of KENAS can be obtained in our “office and contact “ information section of this page or through the following link
2. This is followed by a formal response by KENAS Officer on the terms and conditions applicable to provision of accreditation services.
3. The applicant should submit the duly filled and signed formal application. The application from can be obtained from KENAS Offices or downloaded from their website through the following link. You submit the application form with all the required documents.
4. This is followed by review of the application including support documents provided by the applicant.( desk assessment /document review)
5. After review, there is a formal response to the applicant regarding the outcome of the review of the application and documentation.
6. This is followed by an on-site assessment visit. Corrective Action Requests will be made to the applicant for review.
7. Follow up assessment of the client is done to determine effective implementation of the corrective action requires (CAR’s) raised.
8. An independent accreditation commitee will then make a formal accreditation decision as outcome and/or report of the assessment.
9. After this a formal communication will be made to the applicant on the decision made.
10. Upon a successful assessment. The applicant will be issued with an accreditation certificate.
11. Periodical surveillance assessments are done of the accredited conformity assessment body.

Required Documents

1. Application form
2. Cross reference matrix of internal documents against the normative standard
3. Quality Manual
4. Operating Procedures/ Methods
5. Evidence of PT / ILC
6. Application Fee paid

Office Locations & Contacts

Kenya Accreditation Service (KENAS)
Embankment Plaza, 2nd floor, Longonot Road, Upper Hill
P. O. Box 47400 – 00100 Nairobi
Telephone: +254 725 227 640
Fax: +254 787 395679
Email: info@kenyaaccreditation.org
Website:KENAS

Eligibility

• This accreditation service is available CURRENTLY to the following medical laboratories:

1. General medical/clinical laboratory accreditation
2. Research medical laboratory accreditation
3. Forensic medical laboratory accreditation
4. Blood transfusion laboratories
5. X-ray laboratory accreditation

Fees

• Gazetted Fees

FIRST SCHEDULE Assessment fees

• Application – KShs. 40,000
• Document Review – KShs.95, 000
• Assessment (initial) – KShs. 250,000

Second Schedule Other Charges

• Pre-assessment – KShs.50,000
• Additional Assessor per day – KShs.60,000
• Application for Extension (all inclusive, except for VAT) – KShs. 250,000
• Review of re-submitted Documents – KShs. 45,000

Third Schedule Annual fees

• Annual Accreditation Fee – KShs.192,500

NOTE:

• Any fee charged shall be subject to value added tax.
• The assessment fee has taken into account one assessor unit for two days.
• The assessor unit consists of one lead assessor, a technical expert/assessor and Kenya Accreditation Service support required to facilitate the assessment. For complex assessment or wider scopes, the additional assessor/expert shall be charged based on the rate indicated on other charges.
• These fees do not cover the cost of travel and accommodation outside Nairobi. The fees shall be borne by the client in the event that there are no established assessors within the region or location.
• The Kenya Accreditation Service shall retain as penalty ten percent in value of accreditation assessments that are cancelled less than five days to the assessment date.

Validity

• Accreditation is valid for a period of one year.

Documents to Use

• Application Form for Accreditation
• ISO 15189 CHECKLISTS MEDICAL LABORATORY ACCREDITATION SCHEME

Required Information

• Contact details
  • Organization
  • Address (Physical)
  • Address (Postal)
  • Telephone
  • Email
  • Website
  • Contact person
  • Position within the organization
  • Type and Nature of business
  • If organization operate on several sites
• Organization details
  • The Legal Status of your organization
  • Total Number of Staff
  • List the conformity Assessment Services offered
  • If your conformity Assessment activities are part of a larger organization
  • Other organization activities
• Scope of accreditation
• Declaration
• Signature

Need for the Document

• The general criteria for accreditation of medical laboratories are contained within the ISO 15189:2012 Medical Laboratories- Particular Requirements for quality and competence.
• A laboratory interested in the KENAS MLA should first seek to become familiar with the requirements of ISO 15189: Medical Laboratory-Particular Requirements for Quality and Competence, KENAS ISO 15189 checklist, criteria for Conformity (ies) to which the laboratory is seeking accreditation and regulations.
• These documents can be downloaded from the KENAS website www.kenyaaccreditation.org except for the ISO 15189 standard which can be purchased from the National Standards body (Kenya Bureau of Standards) and the regulations which would be specific to the laboratory based on its establishment.

Information which might help

• Accreditation is a formal third party confirmation that Conformity Assessment Bodies (CABs) are competent to carry out specific conformity assessment activities. Conformity Assessment Bodies are those bodies that assess the compliance and or conformance of products, services and suppliers to guided specifications and requirements e.g. Testing and Calibration Laboratories, Proficiency testing Laboratories, Inspection and verification bodies, Medical Laboratories, Certification bodies etc.
• Accreditation is distinct from certification because certification focuses on an organization overall compliance with systems and products standards rather than the technical competence which is what accreditation focuses on. Therefore accreditation becomes a formal recognition to the CABs that they are competent to carry out conformity assessment tasks.
• Responsibility and Obligation of the Medical Laboratory The principal function of accreditation is for laboratories to deliver quality, efficient laboratory services and reliable test results. Accreditation assessment ensures that laboratories meet explicit quality management criteria and recognizes the laboratory’s technical competence
• Laboratories are required to provide objective evidence, management commitment, and communication within and outside the laboratory, client satisfaction, and continual improvement through effective IQC/EQA/PT reporting practices.
• Laboratories can only claim accreditation with respect to the scope for which they have been granted accreditation by KENAS.
• Significant changes in their statutes or operations in respect to legal, commercial, ownership and organizational or other such matters that may affect the ability of the laboratory to fulfill its accreditation requirements are required to be communicated within thirty days to KENAS.
• Responsibility and Obligations of KENAS MLAS

1. Information about the current accreditation status of medical laboratories granted accreditation will be made publicly available on the KENAS website as well as the Kenya gazette;
2. Notice on changes to accreditation requirement shall be given on time and expressed views of interested parties taken into account with regard to the precise form and effective date of changes before effecting the changes;
3. Information about all international arrangement shall be available to interested parties;
4. Information shall be available on suitable ways of obtaining traceability of measurements and participating in proficiency testing and or interlaboratory comparison;
5. Changes in accreditation fees shall be communicated to the laboratories.

External Links

• Accreditation Process
• Step by step Process
• Service Delivery Charter
• KENAS Guide to implementing ISO 15189 – KENAS Guide ISO 15189
• Guide to medical Laboratory accreditation

Others

The Health and Safety pillar of the Kenya Accreditation Service was formed to offer accreditation to conformity assessment bodies (laboratories) that offer services that pertain to;

1. Human health
2. Animal Health

The pillar offers accreditation to the following schemes:

Medical Laboratory Accreditation in accordance with ISO 15189 :2012

• The medical laboratory accreditation to ISO 15189 is available to laboratories performing tests in various fields of human pathology including anatomical pathology (histology and cytology), chemical pathology, microbiology, hematology, immunohematology, cytogenetics, molecular biology and immunology, blood transfusion services and assisted reproductive technologies.

Veterinary Laboratory accreditation in accordance with ISO 17025 + OIE- Quality standard and guidelines for Veterinary Laboratories : Infectious Diseases

• Veterinary Laboratory accreditation covers facilities that test animals and animal products for the diagnosis, monitoring, and treatment of disease. The scheme accommodates government and private facilities, veterinary practices and university veterinary schools.

Proficiency Testing Providers in accordance with ISO/IEC 17043

• KENAS accreditation of proficiency testing scheme providers’ enables organizers that are interested in planning, providing and evaluating proficiency testing schemes to achieve and demonstrate a level of competence. The program provides testing, calibration, and medical laboratories providers with a fully functional and operational system of accredited providers of proficiency testing schemes conforming to international criteria.

Medical Reference Measurement Laboratories in accordance with ISO 15195

• The accreditation of Medical Reference Measurement laboratories by KENAS enables the labs to demonstrate a level of competence and global recognition.

Pharmaceutical Laboratories in accordance with ISO/IEC 17025

• KENAS accreditation of pharmaceutical laboratories enables pharmaceutical laboratories that are interested in accreditation by demonstrating a level of competence and global recognition.