Central Blood Banks and Reference Laboratories Accreditation Program

The critical importance of quality control and safety measures in medical laboratories and blood banks is unquestionable.
Central Blood Banks and Reference Laboratories Accreditation Program
  • Medical laboratories represent an essential part of diagnostics and treatment; doctors rely heavily on lab results for diagnosis, prescribing treatment and weighing its effectiveness. Without a steadfast commitment to accuracy, incorrect results may negatively affect diagnoses and treatments, which could cause grave damage to the health of patients or even cause death. The reputation of the doctor, the lab, and especially the healthcare institution is at stake with every test. In addition to significant health concerns, carelessness may result in legal consequences.

    Accordingly, CBAHI committees have developed quality and safety standards for medical laboratories and blood banks to ensure that the diagnosis, treatment, and long-term treatment planning is secure and reliable.

    The National Standards for Medical Laboratories and Blood Banks require periodic reviews of procedures that vary with the scope of each lab. They examine equipment, safety controls, infection control, and explain how to secure qualified staff as well as many other aspects of the operations.

    The medical laboratory and blood bank accreditation program was developed with the regional reference laboratories of the Ministry of Health in mind. These large laboratories conduct advanced laboratory tests that are not conducted in all laboratories.

    Eligibility for Accreditation:

    Reference Laboratory is defined as the laboratory that performs quality, cost effective, high volume and / or esoteric testing on biological samples referred from hospitals, clinics and other laboratories. All licensed standalone and hospital based laboratories providing lab services and/ or blood products to other hospitals, clinics and other laboratories are eligible for inclusion in CBAHI's accreditation program. However, eligibility for conduction of a survey visit is contingent upon fulfilling all of the following requirements: 
  • The entity meets all licensing requirements to operate (and therefore, has a valid license), as indicated by the statutes and regulations of the local healthcare authorities.
  • The entity meets any additional licensing requirement/s as indicated by other relevant authorities (most notably valid certificate from the Civil Defense, and any radiation related licensing requirements).
  • The entity meets the legal definition of a Central Blood Bank/ Reference Laboratory as per the local and international guidelines in this regard.
  • The entity has been in operation for at least 12 months before the on-site survey.

  • Accreditation Pathway

    CBAHI is committed to its mission of promoting healthcare quality and patient safety by supporting healthcare facilities to continually comply with accreditation standards. There are several activities a healthcare facility will go through to obtain CBAHI accreditation:

    Registration with CBAHI
    Registration with CBAHI for the purpose of accreditation is required for all eligible healthcare facilities, and is the first step towards attaining accreditation whether for hospitals or for all other accreditation programs offered by CBAHI.

    Medical Laboratories and Blood Banks are required to register by completing the Healthcare Facility Registration Form available on CBAHI’s homepage. Registration is a quick, yet an important step that provides the Healthcare Accreditation Department at CBAHI with the basic information about the registering facility. Upon successful registration, the medical labs and blood banks seeking CBAHI accreditation shall receive the following resources:
  • National Standards for Medical Laboratories
  • Medical Laboratories Accreditation Guide

  • Healthcare Accreditation Guide provides all required information to help the laboratory prepare for the survey visits. It contains an abstract of each survey activity that includes logistical needs, session objectives and suggested participants.

    CLBB Orientation Programs
    CBAHI provides ongoing orientation programs at different locations throughout the year. Medical laboratories are highly encouraged to attend at one of the orientation programs offered by CBAHI, free of charge. Although any medical laboratory can attend, the priority goes for the ones selected for the current year accreditation program. During these orientation sessions, standards, accreditation policies, and survey process are all explained in detail. This is a good opportunity for the medical laboratory representatives to enquire about the intent of a standard and how it will be implemented. Dates and venues of the orientation programs will be communicated to the medical laboratories in a timely manner.

    Self-Assessment Tool (SAT)

    All medical laboratories enrolled in accreditation are required to conduct a comprehensive self-assessment using the SAT provided by CBAHI. This tool is intended to support the medical laboratories in assessing how close it is to a satisfactory compliance with the standards and requirements. It also gives an idea of how much preparation and time the medical laboratory needs before it can request a survey visit. Usually, SAT is for the internal use of the healthcare facility but it might be required by CBAHI to help deciding on the preparedness of the facility prior to conducting a survey.

    Self-assessment is utilized by several other accreditation organizations to help them –if properly and objectively conducted- to have a better insight on the baseline situation of each medical laboratory and provides for a common communication tool between the medical laboratory seeking accreditation and the accrediting body. When both parties reach a compromise about the level of preparedness for a survey visit based on the self-assessment findings, a survey can be scheduled at a tentative date suitable for both.

    Mock Survey

    Upon reaching a satisfactory level of compliance with all applicable standards, a mutual agreement is made concerning the exact date of a Mock Survey, which is recommended but not mandatory. Some medical laboratories may go for an upfront Real Survey.

    For enquiries related to mock and real surveys, please contact: clbb@cbahi.gov.sa

    Requesting CBAHI for a survey

    Regardless of the type of survey (mock/ real survey) three activities are to be completed by the medical laboratory before conducting a survey visit:
  • Service Agreement
  • All provisions of this agreement must be reviewed before sending survey application.
  • Survey application form
  • The medical laboratory has to submit successfully a completed Survey Application Form.
  • Evidence of payment of surveying fees
  • There are two payment methods for submitting survey fees to CBAHI:
    1. The medical lab could deposit the required fees in CBAHI’s bank account and send a copy of receipt to CBAHI (scanned copy or actual receipt).
    2. The medical lab could send CBAHI a certified cheque.

    Real survey
  • The maximum number of mock surveys a medical lab or blood bank can go for is subject to several variables (e.g. the available resources at CBAHI, the level of commitment demonstrated by the healthcare facility towards achieving compliance with the standards, findings of the self-assessment and so on).
  • Mock survey is a valuable opportunity for education and learning from the experienced peer surveyors who are exposed to wide variation of best practices during their work in their healthcare organizations.
  • Upon request and availability of resources, CBAHI can provide Consultative Visit for more in-depth explanation of one or more of the functions/areas covered by the standards.

  • Future Accreditation Programs

    New national standards are currently being developed for ambulatory and home healthcare centers.
    Ambulatory Healthcare Centers are the outpatient clinics or polyclinics (e.g. Dispensaries, Dental Centers, Diagnostic Centers, etc.). They all have one common feature. They do not provide admission services and therefore patients are treated and sent home in less than 24 hours.

    Eligibility for Accreditation:
    All ambulatory care centers in the Kingdom of Saudi Arabia will be eligible for CBAHI accreditation in accordance with the following criteria:
  • The center provides healthcare services addressed by the CBAHI’s National Ambulatory Care Centers Standards.
  • The center meets all licensing requirements to operate (and therefore, has a valid license when applicable), as indicated by the statutes and regulations of the Ministry of Health.
  • The center has been in operation for at least 12 months before the on-site survey.

  • Ambulatory Healthcare Centers Registration Form:

    Registration with CBAHI for the purpose of accreditation is required for all eligible healthcare facilities, and is the first step towards attaining accreditation whether for Ambulatory Healthcare Centers or for all other accreditation programs offered by CBAHI.

    For further inquiries regarding Ambulatory Healthcare Accreditation Program, please contact: