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GUIDANCE TO THE REQUIREMENTS FOR CLINICAL LABORATORIES SEEKING ACCREDITATION WHO USE REMOTE ANALYTICAL AND REPORTING SERVICES FOR ROUTINE WORK

This guidance is intended to promote good laboratory practice by bringing together the relevant CPA standards in a readily accessible form. It is not a substitute for the standards themselves, but should act as an aide memoire to departments that require to make use of a remote pathology service.
  1. A POLICY 

    A department applying for accreditation that wishes to use a remote reporting service for routine* pathology examinations shall first establish a clear policy for this. This shall include details of the referring and receiving laboratories, the nature and amount of work to be sent and the duration of the use of the service.

    * Routine pathology is work included in the repertoire of a department, normally carried out on-site, that has for any reason to be sent elsewhere for analysis or interpretation. It does not refer to work sent for a specialist opinion. 
  2. PROCEDURES

    In order to carry out this policy the referring laboratory will require a set of procedures These shall include a procedure(s) for:
    · establishing the needs and requirements of the users (A2)
    · selection of the work to be sent away, with a clear indication of sample types (e.g. whole blood samples, serum, urine, wet tissue, or prepared     slides) (E6 , H 4.1)
    · maintaining a record of all specimens referred (E6) 
    · ensuring the safe and secure transport of the material (E3, E4)
    · tracking of the material at all times and monitoring its return where indicated(E6, H 4.1)
    · monitoring the return of reports from the receiving department (E6)
    · auditing the reports returned, in conjunction with those of the referring department (H4)
    · dealing with differing opinions given by the referring and receiving departments in cases where the receiving department provides an interpretative as well as an analytical service (G4, G5)
    · data entry in the referring laboratory’s system, especially avoiding transcription errors and duplicate reporting (D2)
    · confirming and implementing reference range changes if necessary (F2, G2)
    · defining turnaround times for urgent requests (E 6)
    · establishing criteria for urgent reporting, including “out of hours” and telephoned reports ( G 3) 
    · reviewing the receiving department’s Accreditation status and EQA performance (E6, H5)
    · assessing the satisfaction of the users (H2).
  3. RECORDS

    In order for assessors to establish compliance with these recommendations there shall be records kept in the referring and receiving departments.
    These records shall include:
    · copies of the policy and procedure(s) described above ( A 9)
    · lists of the referred material with dates of sending samples, receiving reports and the return of material (A 10)
    · results of audits (A 11)
    · discussions with users (A 2)
    · evidence of the current accreditation status and EQA participation of the receiving department ( A 1)
    NOTE
    Additional procedures, that are not part of CPA standards, may be needed to comply with national guidelines in individual pathology disciplines.