Chapter 1 · Selecting and evaluating referral laboratories

The laboratory must have a documented process for selecting referral laboratories. Selection criteria must include: accreditation status (ISO 15189 or equivalent), analytical performance data, turnaround time performance, and cost. Preference must be given to accredited referral laboratories. The laboratory must evaluate referral laboratory performance at defined intervals and retain evaluation records. When a referral laboratory is changed, the reason must be documented.

Chapter 1 · Practical example

Selecting a referral laboratory — documented criteria only

Referral laboratory selection must use documented quality criteria — accreditation status, analytical performance, EQA participation, TAT, and service agreement. Personal recommendation is not a criterion.

▲ The situation

A laboratory director needs a referral partner for molecular genetics testing. A clinician recommends a commercial laboratory he has used before. No formal evaluation has been performed.

Reference: ISO 15189:2022 Clause 7.7

✓
Good practice

The quality manager evaluates three candidate laboratories against documented criteria: ISO 15189 or UKAS accreditation scope including molecular genetics, last two EQA performance reports, written TAT commitment, and pricing. One laboratory meets all criteria. A service agreement is signed. The evaluation is documented with the selection rationale on file.

✗
Poor practice

The director begins referring immediately based on the clinician’s recommendation. Eighteen months later, an accreditation assessor asks for evidence of referral laboratory evaluation. The commercial laboratory, it transpires, holds ISO 15189 accreditation for haematology and immunology — not molecular genetics. All molecular genetics referrals were processed outside the referral laboratory’s accredited scope. This is a major nonconformity.

● What this means for your practice

Personal recommendation is not due diligence. Every referral laboratory must be evaluated against documented criteria before use. The evaluation record is the laboratory’s evidence that it selected a competent partner — and it must cover the specific scope of testing being referred.