Laboratories, on the non-technical side
Facility, safety, document and staff-file evidence for medical laboratories and blood banks preparing for CBAHI's laboratory programme.
CBAHI runs a national programme for medical laboratories and blood banks. We prepare the non-technical evidence a survey reads: facility safety, hazardous materials, cold storage records, document control, staff files and equipment registers. Your laboratory specialists own method validation, quality control and result reporting, and we work beside them.
The benches changed, the inventory did not
A laboratory holds reagents, fixatives and flammables in quantity, and what it holds changes whenever a method or a supplier changes. The hazardous materials inventory is usually written once and left. The data sheets end up in a binder in the manager's office rather than at the bench where the chemical is used. Reagent fridges and freezers are logged, but nobody has written down what happens to the stock when the power fails. Reagent inserts and manufacturer instructions sit outside document control, so an old version stays at the bench.
- The inventory lists reagents the laboratory stopped buying and misses the ones it started
- Safety data sheets are kept away from the point of use
- Temperature records exist, with no written plan for a power failure
- External documents, such as reagent inserts, sit outside document control
- Licence and orientation dates in the staff files have no expiry register behind them
The work a laboratory buys
The same CBAHI method we run for a hospital, pointed at the parts of a laboratory the survey reads around the science.
CBAHI readiness
The non-technical evidence, prepared against your survey date, with a gap report and an evidence index.
Read moreCBAHIFacility management and safety
Hazardous materials, fire safety and utilities, with the inspection and test records in your file.
Read moreCBAHIPolicies and records
Procedures, forms and external documents under one control, and an expiry register across the staff files.
Read moreCBAHIMock survey
The survey rehearsed at the bench and in the files, with time to close what it finds.
Read moreWith ITF FMFacility management for healthcare
Reagent fridges, freezers and building services maintained, with the records in your survey format.
Read moreWhat the survey reads outside the science
| Requirement | What it means on site |
|---|---|
| CBAHI laboratory programme | Medical laboratories and blood banks have their own national programme, run by CBAHI's section for specialised programmes. |
| Measurable elements | Each standard carries numbered measurable elements, assessed by document review, observation and staff interview. The bench is observed and the people at it are interviewed. |
| Hazardous materials | An inventory that matches what is on the shelves, and the data sheet at the point of use. |
| Cold storage | A temperature record for each reagent fridge and freezer, and a written plan for a power failure. |
| Document control | Procedures, forms and external documents such as reagent inserts, each at its current version where it is used. |
| ISO 15189 | The international standard for medical laboratory quality and competence. Its technical requirements need laboratory specialists; document control and staff records are shared ground with the CBAHI work. |
Laboratory managers ask these first
Do you help with method validation or ISO 15189?
Method validation, quality control, proficiency testing and the technical side of ISO 15189 need laboratory specialists, from your team or an adviser you appoint. Our part is the facility, safety, document and staff-file evidence the same survey reads. A later ISO 15189 project then finds document control and staff records already running.
How is the hazardous materials inventory built?
By walking the benches and the stores, not by copying the purchase list. Each chemical is listed where it is kept, with its hazards and its data sheet, and the data sheet goes to the point of use. The inventory then has an owner and a review date.
Can ITF FM maintain our reagent fridges and freezers?
Yes, where you want it to. The maintenance records and the temperature review then land in your file in the format the survey reads, beside the power failure plan.
Do the records need history before the survey?
Yes. A surveyor looks for compliance sustained over the months before the visit. Temperature logs, drills and document reviews need months behind them, so the records start before the documents are perfect.
What does a typical engagement look like?
A private medical laboratory in Dammam is preparing for CBAHI's laboratory programme. The gap assessment finds a hazardous materials inventory that no longer matches the benches, data sheets in the manager's office, reagent fridges logged with no power failure plan, reagent inserts outside document control and staff licence dates with no expiry register. The inventory is rebuilt by walking the benches, the data sheets move to the point of use, a power failure plan is written for the cold storage and the inserts join the document register as external documents. The laboratory ends up holding the gap report, the hazardous materials inventory, the cold storage log and plan, a document register, a staff file expiry register and an evidence index.
Part of one system
Every division keeps records to the same standard, so the second one you need works the way the first one did.
Walk the benches with us
Send your survey date and the programme you are surveyed under. The gap assessment starts at the bench and ends in your document register.