1. TAIEX Workshop on the Accreditation of Medical and Clinical Laboratories (55902) “Outsourcing in medical laboratories activities: Examination by referral laboratories (second opinion consultations and subcontracting) External services and supplies Advisory services” Aliki Stathopoulou Kyiv, 5-6 February 2015

2. Medical laboratories with limited testing menus may seek the cooperation of other laboratories in performing all the requested examinations on samples received. ISO 15189 specifies the relevant requirements for referral laboratories. According to the definition in ISO 15189, a referral laboratory is an external laboratory to which a sample is submitted for a supplementary or confirmatory examination procedure and report. Reasons for requesting supplementary or confirmatory examination could be:  Diagnosis (analytical performance based on bias and imprecision)  Therapy follow-up (analytical performance based on imprecision)  TDM (therapeutic drug monitoring): efficacy of administrated dose (analytical performance based on bias and imprecision) Examination by referral laboratories

3. The purpose and definition of referral laboratories are different from those of subcontractors, but there may be other times when medical laboratories use subcontractors. Unless it is specified by regulation, accreditation bodies may extend the relevant requirements for a referral laboratory to the subcontractor when medical laboratories subcontract their examinations due to limitation of competence, resource, time, etc. In general, subcontractor means the external organization which performs subcontract work, whether because of unforeseen reasons (e.g. workload, need for further expertise or temporary incapacity) or on a continuing basis (e.g. through permanent subcontracting, agency or franchising arrangements). Examination by referral laboratories

4. Obligations of the referring laboratory, regarding the selection of referral laboratories:  Procedure for selection and evaluation of subcontractors and consultants (for second opinion)  Monitoring quality of referral labs  Evaluation of competence of subcontractors  Register of subcontractors  Reporting results from subcontractors, responsibilities for the report  Follow-up of results, TAT  Information on requestors Examination by referral laboratories

5. The lab shall have an effective procedure for selection and evaluation of subcontractors and/or consultants (second opinion for cytological, histopathological, hematological and other tests). The laboratory must be reviewed by the referring laboratory even if it is accredited. Monitoring the quality of referral labs could include: - pre and post examination procedures - no conflicts of interest - used methods are fit-for-purpose - responsibilities for the interpretation of the results Examination by referral laboratories

6. Evaluation of competence of all subcontractors and/or referral labs that it uses: - is this laboratory licensed? - is this laboratory accredited for the referred tests? - Participation in an EQA program? - Scientific reputation of the laboratory, is the expertise still available? etc. The lab shall maintain a register/file of - laboratories, and consultants from whom second opinions are sought (a detailed list in kept in the lab or lab ’ s homepage). - all samples that have been referred - a duplicate of the report (in the patient record). An electronic report kept by the lab can satisfy this requirement. The report must also indicate which examinations (or interpretation, opinion) were performed by a referral laboratory or consultant. The referring lab is responsible for reporting results from subcontractors, including to the report all essential elements of the results (the same elements as if the lab has done it itself). Examination by referral laboratories

7. The interpretation of the results could be that referral laboratories used, not necessarily at the exact format and wording, however, without alterations that could affect clinical interpretation (interpretative remarks may be added). Respective responsibilities for the interpretation and reporting of examination results must be clearly defined. Follow-up of results. Information on requestors (name and address of referral lab, accreditation status etc). Examination by referral laboratories

8. Other information needed from referral laboratories *Conditions for sampling, patient preparation *Type, volume of sample(s) *Needed information *Transport conditions *Price, contact person, TAT Pick-up of samples How will be reported? * In primary sample collection manual of the subcontractor Examination by referral laboratories

9. External services and supplies Procedure for selection, and use of purchased external services, equipment and consumable supplies that affect the quality of its service Procedure for acceptance/rejection and storage (even if the laboratory is not the receiving facility, it shall ensure that the receiving location has adequate storage and handling to maintain purchased items in a manner that prevents damage or deterioration) Procedure for release Traceability acceptance and use Evaluation of suppliers (lab shall maintain records of these evaluations) and list of approved suppliers

10. Evaluation only for critical suppliers and providers of services that affect the quality of examinations External suppliers: kits, LIS provider measurement equipment, sampling tubes, … Internal providers of services: Hospital logistics, IT, Maintenance PT providers Referral laboratories (accreditation according to ISO 15189) Calibration laboratories (accreditation according to ISO 17025) External services and supplies

11. Evaluation of new equipment and consumable: Verification of compliance with standard specifications or method requirements Examination of quality control samples (with known results) Documentation of supplier ’ s QMS certification - including US FDA (Food and Drug Administration) Quality System Regulations (QSRs) and ISO (ISO 9000:2008), or ISO 13485, or must comply with the European IVD Directive (CE Mark) External services and supplies

12. The laboratory shall establish and maintain for a period of time, an inventory control system for supplies, including: recording of lot numbers of reagents, control materials and calibrators the date of receipt in the laboratory the expiry date, and the date the material is placed in service All of these quality records shall be available for the management review. External services and supplies

13. There must be a demonstrate contact between the laboratory and his clients (prescribers). Description of the regular contacts between the lab and other clinical departments into the hospital. (management of antibiotics, transfusion committee, oncology, diabetes care,..) Private labs must demonstrate that they maintain a regular contact with their prescribers. Customer satisfaction may be checked by a survey or contacts. However this item of the standard may not be used as an obligation to give advantages or to stimulate overconsumption. (ethical considerations). Advisory services

14. The laboratory shall establish arrangements for communicating with users on the following: advice on choice of examinations (mostly on outpatients if no doctor ’ s consultation exist) and use of the services, including required type of sample, clinical indications and limitations of examination methods and the frequency of requesting the examination; professional judgments on the results of examinations There shall be systematic communication between laboratory staff and clinical staff to promote effective utilization of laboratory services and to consult on scientific and logistic matters. Where applicable, the laboratory staff shall interact with clinicians participation in clinical rounds) to advise on the effectiveness of laboratory services in general as well as in individual cases. Advisory services

15. Thank you!