Accreditation …. Recognition over the world
Accreditation of your healthcare organization is essential to improve the quality, safety, and efficiency of health care services.
NTC provides advices and solutions to improve the provided services to your patient through a professional gap analysis and conducting on site visits to increase Staff competency and Productivity
For medical labs: Medical laboratory services are essential in the diagnosis and assessment of the health of patients. Their services encompass arrangements for requisition, patient preparation, patient identification, collection of samples, transportation, storage, processing and examination of clinical samples, together with subsequent result validation, interpretation, reporting and advice. Medical laboratory services should therefore meet the needs of all patients, clinical personnel responsible for patient care and any other interested parties.
The laboratory's aim is not only to provide accurate results, but to do so on the right patient within a meaningful timeframe as regards clinical management, using appropriate laboratory procedures and with a respect for ethics, confidentiality and the safety of the patient.
Medical Laboratories needs to leverage the competencies of their staff, establish and implement a Quality management system that ensure fulfillment of certain Quality standard in order to be accredited and recognized as best in Quality Lab.
1What is the laboratory accreditation?
Laboratory accreditation is a means of determining the technical competence of laboratories to perform specific types of testing. It also provides formal recognition to competent laboratories, thus providing a ready means for patient to identify and select a laboratory with reliable testing services that meet their needs.
2We are a hospital lab; Can the lab be accredited apart from other hospital departments?
Yes, The lab can be accredited apart from other hospital departments to demonstrate its competency to carry out the medical analysis.
3What is ISO 15189?
ISO 15189 (Medical laboratories - Particular requirements for quality and competence) This standard issued by International Organization for Standardization ISO and it contains quality and technical requirements that the laboratories must meet. This standard specifically addresses factors relevant to a laboratory’s ability to produce precise, accurate test results, including: • technical competence of staff; • validity and appropriateness of test methods, including pre- and post-analytical elements such as sample collection and reporting; • sample quality, including patient identification, handling and transport to maintain sample integrity; • a review of the history relating to previous patient results and any known clinical agnoses; • procedures relating to the use of “referral laboratories” such as specialized testing centres for specific diseases; • traceability of measurements and calibrations to relevant standards; • suitability, calibration and maintenance of test equipment; • testing environment; • quality assurance of test data; • acceptable turnaround time; application of appropriate ethical values
4How can the lab be accredited according to ISO 15189?
To be accredited lab according to ISO 15189: • Define the accreditation scope. • Prepare and implement QMS (Management & Technical) according to ISO 15189 • Participate in proficiency testing (PT) program. • Fulfillment the accreditation body requirements. • Submit accreditation application.
5Why we need a quality and accreditation consultant to apply ISO 15189?
ISO 15189 contains a general requirements, The Lab will need the support of a professional consultation Firm in order to apply the Iso15189 requirements either Technical or Management.
6What is the Accreditation Process after implementation of the ISO15189 requirements?
- Submit application form with all supported documents to One of the Authoritative and internationally recognized accreditation bodies. - Receive assessment Team from the accreditation body to assess and witness the Lab staff competence and ensure compliance to the ISO15189 standard regulations. - Receive an Official Accreditation certificate attested from the Accreditation body and the international Laboratory accreditation cooperation (ILAC) this after resolving of any noncompliance issues raised during the assessment visit. - Annual surveillance visit will be conducted every 12 months to ensure that the Lab continue to Comply with the ISO15189.
7Can the lab ask the accreditation body directly to provide training or a consultation services to help the lab to be comply with ISO 15189 and accreditation requirements?
Accreditation bodies work as a third party organization and are not allowed to give any consultancies (no specific technical information or solutions) and the lab can request this service from competent and professional consultation firm
8How NTC consultation will support the Lab during the accreditation Process?
- Conduct a Gap Analysis to define the Gaps and how to close it. - Develop a Quality Management system to cover the ISO15189 requirements. - Support in Implementation of the Quality Management system. - Continuous Technical Training including Quality Assurance, Uncertainty of Measurements, Safety. - Conduct Internal Audit Workshop. - Conduct Internal Audits and simulation audits to close any non conformities. - Support the Lab before and during the assessment of the accreditation body. - Support in closing the NCs raised during the assessment visit and ensure a correct root cause analysis and implementation of corrective, preventive action.
9Why shall we select NTC?
- NTC is formed of a group of highly professional and well selected consultants, they have a vast experience in the Lab practice and we are collaborating with Canadian international firms working in the same field to share experience and ensure working under internationally recognized and approved procedure and guidelines.